Prosthetic cardiac valve devices, systems, and methods

A system for treating a diseased native valve in a patient includes a valve prosthesis and a delivery device. The prosthesis includes an anchor and a frame. The delivery device includes an outer sheath, an inner shaft, an anchor guide, and a tether. The anchor is shaped to encircle chordae or leaflets of a native valve. The frame is configured to sit within the anchor. The inner shaft is positioned within the outer sheath and translatable and rotatable relative to the outer sheath. The anchor guide is attached to a distal end of the inner shaft and has a curved distal section. The tether is configured to detachably couple to the anchor and to longitudinally translate the anchor within the inner shaft and anchor guide. The anchor is configured to be actuated from a delivery configuration to the deployed configuration when the anchor is translated out of the anchor guide.

BACKGROUND

Blood flow between heart chambers is regulated by native valves—the mitral valve, the aortic valve, the pulmonary valve, and the tricuspid valve. Each of these valves are passive one-way valves which open and close in response to differential pressures. Patients with valvular disease have abnormal anatomy and/or function of at least one valve. For example, a valve may suffer from insufficiency, also referred to as regurgitation, when the valve does not fully close and allows blood to flow retrograde. Valve stenosis can cause a valve to fail to open properly. Other diseases may also lead to dysfunction of the valves. While medications may be used to treat the disease, in many cases the defective valve may need to be repaired or replaced at some point during the patient's lifetime. Existing valves and surgical repair and/or replacement procedures may have increased risks, limited lifespans, and/or are highly invasive. Some less-invasive transcatheter options are available, however these generally are limited to aortic valve procedures, are limited in their patient-to-patient flexibility, and often take longer than desired to implant. It would therefore be desirable to provide a less invasive procedure for repair and replacement of heart valves, including the mitral valve, quicker surgical methods, and/or prosthetic valves that can accommodate a variety of individual patients.

Additionally, existing valve repair/replacement procedures are often complicated and time-consuming. Currently available procedures often require the placement of more than one component—for example, a prosthetic valve and a mechanism to anchor it to the native anatomy. Such procedures generally utilize multiple delivery catheters to carry the various components and delivery of each component separately to the valve, which can be time-consuming (particularly if components are delivered sequential), complicated, and/or dangerous. For example, some devices provide rotational anchoring elements to capture the native anatomy such as the chordae tendineae in order to reduce delivery time. However, such anchoring elements, often by design, capture and pull the chordae along during their rotation, which can torque or otherwise stress and damage the chordae during deployment of the anchor elements, resulting in the need for additional medical interventions for the patient. Moreover, such anchoring elements may require extrusion from a low-profile (e.g., elongated) delivery configuration to an expanded configuration at or near the native valve. In at least some instances, extrusion of the anchoring elements can be complicated and may not reliably deploy into the correct expanded configuration relative to the delivery device. Incorrect deployment may result in additional time to retract and re-deploy the anchoring element, more complicated anchoring procedures, and/or damage to the native tissue. It would therefore be desirable to provide quicker, less-complicated, less dangerous, and more reliably deployable valve assemblies for valvular replacement and repair.

SUMMARY

The present disclosure generally relates to treating a diseased native valve in a patient and more particularly relates to prosthetic heart valves.

The present disclosure relates to prosthetic cardiac devices, and in some embodiments, prosthetic heart valves such as catheter-based mitral valves.

The present disclosure generally relates to treating a diseased native valve in a patient and more particularly relates to deployment of prosthetic heart valves and extrusion of anchoring elements from delivery devices.

The present disclosure generally relates to treating a diseased native valve in a patient and more particularly relates to delivery devices, systems, and methods for delivering and deploying a valve prosthesis. The valve prosthesis can include a spiral anchor and a frame structure adjacent the diseased native valve, and the spiral anchor can be deployed around one or more structures of the heart. The anchor can be configured to anchor the frame structure to the native valve when the frame structure is expanded therein.

In general, in one embodiment, a system for treating a diseased native valve in a patient includes an anchor and a tether. The anchor includes a delivery configuration and deployed configuration. The anchor in the deployed configuration is shaped to encircle chordae or leaflets of a diseased native valve in a patient. The tether is detachably coupled to the anchor and configured to longitudinally translate the anchor within a lumen of a delivery device. The anchor is configured to be actuated from the delivery configuration to the deployed configuration when the anchor is translated out of the lumen of the delivery device.

This and other embodiments can include one or more of the following features. The anchor can be configured to be actuated from the delivery configuration to the deployed configuration adjacent a native valve in a patient. The system can further include the delivery device. The delivery device can include an anchor guide having the lumen. The anchor can be configured to be disposed within the lumen of the anchor guide in the delivery configuration. The anchor can be configured to be actuated out of lumen of the anchor guide into the deployed configuration by the tether. The anchor guide can have a curvature that matches a curvature of the anchor in the deployed configuration. The anchor can include an elongated shape in the delivery configuration. The anchor can include a curved shape in the deployed configuration. The curved shape can include a spiral shape. A distal end of the tether can include a preset curved shape. The system can further include a retention wire configured to couple a distal end of the tether to a proximal end of the anchor. The anchor can be configured to wrap at least partially around a frame structure in the deployed configuration. The anchor can include a super-elastic material. The anchor can include nitinol. The system can further include a frame structure having an unexpanded configuration and an expanded configuration. The expanded configuration can be a generally tubular shape. The frame structure can include an expanded outer periphery in the expanded configuration and a compressed outer periphery when subject to an external radial force in the unexpanded configuration. The compressed outer periphery can be smaller in diameter than the expanded outer periphery. The system of can further include the delivery device which can include an inner shaft. The anchor can be configured to be disposed in a lumen of the inner shaft and maintained in the delivery configuration by radial constriction from the inner shaft. Advancement of the anchor out of the lumen of the inner shaft by translation of the tether can actuate the anchor into the deployed configuration. The tether can be configured to extend from the anchor to a proximal end of the delivery device. The delivery device can further include an outer sheath. The inner shaft can be disposed within the lumen of the outer sheath. The outer sheath can be steerable. The tether can be configured to advance towards an opening of the lumen of the inner shaft to advance the anchor out of the lumen of the inner shaft and actuate the anchor into the deployed configuration. The anchor can be configured to wrap at least partially around the inner shaft in the deployed configuration. A central axis of the anchor can be co-axial with a longitudinal axis of the inner shaft when the anchor is in the deployed configuration. A distal end of the inner shaft can include an anchor guide. The anchor guide can be configured to correctly orient the anchor relative the longitudinal axis of the inner shaft in order to facilitate concentric wrapping of the anchor around the inner shaft as the anchor is deployed from the delivery configuration to the deployed configuration. A distal end of the tether can have a shape corresponding to a shape of the anchor guide. A distal end of the anchor guide can include a preset curved portion. The tether can include a wire disposed in a housing. The housing can be flexible. A free end of the anchor can extend radially outward from the curved shape. The system can further include a frame structure configured for expanding within the native valve of the patient. The system can further include a frame structure. The anchor can be configured to be fully advanced from an atrial side of the native valve into a ventricle of the heart and anchor the frame structure to the native valve when the frame structure is in an expanded configuration adjacent the native valve. An unexpanded configuration of the frame structure can be sized and dimensioned for percutaneous insertion and the expanded configuration is sized and dimensioned for implantation in the native valve of the patient. The frame structure can include a first and second opposite ends. The first end can be configured to extend above a native valve, and the second end can be configured to extend below the native valve when the frame structure is anchored to the native valve. The frame structure can be configured to sit below the native valve when the frame structure is anchored to the native valve. The system of can further include a frame structure, and a valve segment within the frame structure can include a biocompatible one-way valve. At least a portion of the valve segment can be positioned within at least a portion of the frame structure. The valve segment can include at least one leaflet having an inner layer and an outer layer. The frame structure can be attached to the outer layer at one or more ends of the frame structure. The valve segment can include a plurality of leaflets.

In general, in one embodiment, a method for treating a diseased native valve in a patient includes: (1) Advancing a distal end of a delivery device from a first side of a native valve to a second side of the native valve. The delivery device includes an inner shaft which includes an anchor guide, and an anchor is disposed within a lumen of the inner shaft. The anchor includes a delivery configuration and a deployed configuration; (2) Holding the anchor with within the lumen of the inner shaft with a longitudinally-translatable tether. The anchor is detachably coupled to the tether; (3) Actuating the anchor from the delivery configuration to the deployed configuration adjacent the native valve by translating the tether distally within the lumen of the inner shaft to translate the anchor out of an opening in the delivery device; and (4) Rotating a free end of the deployed anchor around one or more structures on the second side of the native valve.

This and other embodiments can include one or more of the following features. Rotating the free end of the deployed anchor can include rotating the anchor with the anchor guide. The method can further include retracting the anchor guide while holding the anchor with the tether. A distal end of the tether can be coupled to a proximal end of the anchor with a retention wire, and the method can further include releasing the anchor from the tether by de-coupling the retention wire from the anchor. The method can further include steering the distal end of the delivery device such that the distal end of the delivery device points towards the first side of the native valve. The anchor can be configured to wrap at least partially around the delivery device in the deployed configuration. The anchor can be configured to wrap at least partially around a frame structure in the deployed configuration. A central axis of the anchor can be co-axial with a longitudinal axis of the inner shaft when the anchor is in the deployed configuration. A distal end of the inner shaft can include the anchor guide. The anchor guide can be configured to correctly orient the anchor relative the longitudinal axis of the inner shaft in order to facilitate concentric wrapping of the anchor around the inner shaft as the anchor is actuated from the delivery configuration to the deployed configuration. Actuating the anchor can include actuating the anchor from the delivery configuration to the deployed configuration on the first side of the native valve and can further include advancing the anchor in the deployed configuration through the native valve to the second side of the native valve. Advancing the anchor can further include pushing the anchor through the native valve. Advancing the anchor can further include rotating the anchor through the native valve. Actuating the anchor can include positioning the anchor such that it is located only on the second side of the native valve. The distal end of the delivery device can be detachably coupled to a frame structure, and the method can further include expanding the frame structure within the native valve from an unexpanded configuration to an expanded configuration. Expanding the frame structure can occur while holding the anchor with the tether. The frame structure can include a first and second opposite ends, and expanding the frame structure can include expanding the frame structure such that the first end extends above the first side of the native valve and the second end extends below second side of the native valve. Expanding the frame structure can include expanding at least a portion the frame structure within at least a portion of the deployed anchor to anchor the frame structure to the native valve. The method can further include releasing the frame structure from the distal end of the delivery device. Expanding the frame structure and releasing the frame structure can occur simultaneously. The method can further include retracting the delivery device from the patient. The method can further include de-coupling the anchor from the tether. The method can further include retracting the tether from the patient. The one or more structures can include one or more valve leaflets of the native valve. The one or more structures can include one or more chordae of the left ventricle. The native valve ca be in a heart of a patient. The method can further include transseptally inserting the distal end of the delivery device into a left atrium of the heart. The native valve can include a mitral valve. The first side of the native valve can include a left atrium. The second side of the native valve can include a left ventricle.

In general, in one embodiment, a delivery system for delivering a prosthesis to a diseased valve includes an outer sheath, an inner shaft, and an anchor guide. The outer sheath has a central axis. The inner shaft is within the outer sheath and is translatable and rotatable relative to the outer sheath. The anchor guide is attached to a distal end of the inner shaft. The anchor guide includes a proximal section that is on-axis with the central axis and a distal section that curves about the central axis in a tapered spiral.

This and other embodiments can include one or more of the following features. The delivery system can further include a tether configured to extend through the inner shaft and anchor guide to attach to an anchor of the prosthesis. The tether can be further configured to deploy the anchor from the anchor guide. The outer sheath can be steerable. The anchor guide can be configured to correctly orient an anchor of the prosthesis relative to a longitudinal axis of the inner shaft in order to facilitate concentric wrapping of the anchor around the inner shaft as the anchor is deployed from the anchor guide. The distal section can transition continuously from a high pitch, low radius curve at a proximal end to a low pitch, high radius curve at a distal end. A distal-most plane of the distal section can be orthogonal to the central axis. A curvature of the distal section can be configured to match a curvature of an anchor of the prosthesis. The inner shaft and the anchor guide can be of unitary construction.

In general, in one embodiment, a delivery system for delivering a prosthesis to a diseased valve includes an outer sheath, an inner shaft, and an anchor guide. The outer sheath has a central axis. The inner shaft is positioned within the outer sheath and is translatable and rotatable relative to the outer sheath. The anchor guide is attached to a distal end of the inner shaft. The anchor guide includes a proximal section that is on-axis with the central axis and a distal section that curves about the central axis. The inner shaft and anchor guide are configured to rotate relative to the outer sheath.

This and other embodiments can include one or more of the following features. The delivery system can further include a tether configured to extend through the inner shaft and anchor guide to attach to an anchor of the prosthesis. The tether can be further configured to deploy the anchor from the anchor guide. The outer sheath can be steerable. The anchor guide can be configured to correctly orient an anchor of the prosthesis relative to a longitudinal axis of the inner shaft in order to facilitate concentric wrapping of the anchor around the inner shaft as the anchor is deployed from the anchor guide. The distal section can transition continuously from a high pitch low radius curve at a proximal end to a low pitch, high radius curve at a distal end. A distal-most plane of the distal section can be orthogonal to the central axis. A curvature of the distal section can be configured to match a curvature of an anchor of the prosthesis. The inner shaft and the anchor guide can be of unitary construction.

In general, in one embodiment, a delivery system for delivering a prosthesis to a diseased valve includes an outer sheath, an inner shaft, and an anchor guide. The outer sheath has a central axis. The inner shaft is positioned within the outer sheath and is translatable and rotatable relative to the outer sheath. The anchor guide is attached to a distal end of the inner shaft. The anchor guide includes a proximal section that is on-axis with the central axis and a distal section that curves about the central axis. A distal end of the anchor guide points in a direction that is orthogonal to the axis of the inner shaft.

This and other embodiments can include one or more of the following features. The delivery system can further include a tether configured to extend through the inner shaft and anchor guide to attach to an anchor of the prosthesis. The tether can be further configured to deploy the anchor from the anchor guide. The outer sheath can be steerable. The anchor guide can be configured to correctly orient an anchor of the prosthesis relative to a longitudinal axis of the inner shaft in order to facilitate concentric wrapping of the anchor around the inner shaft as the anchor is deployed from the anchor guide. The distal section can transition continuously from a high pitch, low radius curve at a proximal end to a low pitch, high radius curve at a distal end. A distal-most plane of the distal section can be orthogonal to the central axis. A curvature of the distal section can be configured to match a curvature of an anchor of the prosthesis. The inner shaft and the anchor guide can be of unitary construction.

In general, in one embodiment, a method for treating a diseased native valve in a patient includes: (1) Advancing a distal end of a delivery device into a first chamber of a heart. The delivery devices includes an outer sheath and an inner shaft including an anchor guide; (2) Extending the anchor guide out of the outer sheath into the first chamber; (3) Rotating the inner shaft within the outer sheath until the anchor guide is in a desired orientation in the first chamber; (4) Extending an anchor out of a distal end of the anchor guide such that the anchor deploys within the first chamber; (5) moving the delivery device and the deployed anchor into a second chamber of the heart through a native valve annulus; and (6) Rotating the inner shaft within the outer sheath so as to rotate the anchor guide within the second chamber and so as to rotate the deployed anchor about one or more native valve structures.

This and other embodiments can include one or more of the following features. The method can further include retracting the anchor guide while holding the anchor with a tether of the delivery system. A distal end of the tether can be coupled to a proximal end of the anchor with a retention wire, and the method can further include releasing the anchor from the tether by de-coupling the retention wire from the anchor. The method can further include steering the outer sheath such that the distal end of the delivery device points towards the first chamber. The method can further include steering the outer sheath while moving the delivery device and the deployed anchor into the second chamber of the heart. The anchor can be configured to wrap at least partially around the delivery device when the anchor is deployed. A central axis of the anchor can be co-axial with a longitudinal axis of the inner shaft when the anchor is in the deployed configuration. The anchor guide can be configured to correctly orient the anchor relative the longitudinal axis of the inner shaft in order to facilitate concentric wrapping of the anchor around the inner shaft as the anchor is actuated from the delivery configuration to the deployed configuration. The method can further include expanding a frame structure within the native valve from an unexpanded configuration to an expanded configuration. Expanding the frame structure can occur while holding the anchor with the tether. The frame structure can include a first and second opposite ends. Expanding the frame structure can include expanding the frame structure such that the first end extends into the first chamber and the second end extends into the second chamber. Expanding the frame structure can include expanding at least a portion the frame structure within at least a portion of the deployed anchor to anchor the frame structure to the native valve. The one or more structures can include one or more valve leaflets of the native valve. The one or more structures can include one or more chordae of the left ventricle. The method can further include transseptally inserting the distal end of the delivery device into the first chamber. The method can further include counter-rotating the anchor guide to reposition the anchor prior to rotating the anchor guide within the outer sheath so as to rotate the deployed anchor about one or more native valve structures.

In general, in one embodiment, a system for treating a diseased native valve in a patient includes a valve prosthesis and a delivery device. The valve prosthesis includes an anchor and a frame. The delivery device includes an outer sheath, an inner shaft, an anchor guide, and a tether. The anchor has a delivery configuration and deployed configuration. The anchor in the deployed configuration is shaped to encircle chordae or leaflets of a diseased native valve in a patient. The frame is configured to sit within the anchor. The inner shaft is positioned within the outer sheath and is translatable and rotatable relative to the outer sheath. The anchor guide is attached to a distal end of the inner shaft and has a curved distal section. The tether is configured to detachably couple to the anchor and to longitudinally translate the anchor within the inner shaft and anchor guide. The anchor is configured to be actuated from the delivery configuration to the deployed configuration when the anchor is translated out of the anchor guide.

In a another aspect, a system for treating a diseased native valve in a patient is provided. The system comprises an anchor comprising a delivery configuration and deployed configuration and a tether detachably coupled to the anchor and configured to longitudinally translate the anchor within a lumen of a delivery device. The anchor in the deployed configuration is shaped to encircle chordae or leaflets of a diseased native valve in a patient. The anchor is configured to be actuated from the delivery configuration to the deployed configuration when the anchor is translated out of the lumen of the delivery device.

In some embodiments, the anchor may be configured to be actuated from the delivery configuration to the deployed configuration adjacent a native valve in a patient.

In some embodiments, the delivery device may comprise an anchor guide having the lumen, the anchor may be configured to be disposed within the lumen of the anchor guide in the delivery configuration, and the anchor may be configured to be actuated out of lumen of the anchor guide into the deployed configuration by the tether. The tether may be configured to extend out of the anchor guide when the anchor is in the deployed configuration.

In some embodiments, the system may further comprise a core wire disposed within a lumen of the anchor and longitudinally translatable therein. The core wire may comprise a proximal curved portion when unconstrained and a distal tip. The core wire may comprise one or more deflection features disposed adjacent the distal tip and configured to be advanced out of the lumen of the anchor.

In some embodiments, the anchor may comprise an elongated shape in the delivery configuration.

In some embodiments, the anchor may comprise a curved shape in the deployed configuration. In some embodiments, the curved shape may comprise a helical shape. In some embodiments, the curved shape may comprise a spiral shape.

In some embodiments, a distal end of the tether may comprise a curved shape that is discontinuous with the curved shape of the anchor.

In some embodiments, the system may further comprise an engagement wire configured to couple a distal end of the tether to a proximal end of the anchor.

In some embodiments, the anchor may be configured to wrap at least partially around a frame structure in the deployed configuration.

In some embodiments, the anchor may comprise a super-elastic material. For example, the anchor may comprise nitinol.

In some embodiments, the system may further comprise a frame structure having an unexpanded configuration and an expanded configuration. The frame structure may comprise an expandable stent. In some embodiments, the expanded configuration may be a generally tubular expanded shape. In some embodiments, the frame structure may comprise an expanded outer periphery in the expanded configuration and a compressed outer periphery when subject to an external radial force in the unexpanded configuration, the compressed outer periphery may be smaller in diameter than the expanded outer periphery. In some embodiments, the frame structure may be balloon-expandable. In some embodiments, the frame structure may be self-expanding.

In some embodiments, the system may further comprise a delivery device. The delivery device may comprise an inner sheath and the anchor may be disposed in a lumen of the inner sheath and maintained in the delivery configuration by radial constriction from the inner sheath. Advancement of the anchor out of the lumen of the inner sheath by translation of the tether may actuate the anchor into the deployed configuration.

In some embodiments, the tether may extend from the anchor to a proximal end of the delivery device.

In some embodiments, the delivery device may further comprise an outer shaft and the inner shaft may be disposed within the lumen of the outer sheath. The outer sheath may be steerable.

In some embodiments, advancement of the tether towards an opening of the lumen of the inner shaft may advance the anchor out of the lumen of the inner shaft and actuate the anchor into the deployed configuration.

In some embodiments, the anchor may be configured to wrap at least partially around the inner shaft in the deployed configuration. Alternatively, or in combination, a central axis of the anchor is co-axial with a longitudinal axis of the inner shaft when the anchor is in the deployed configuration.

In some embodiments, the tether may be configured to extend out of the lumen of the inner shaft when the anchor is in the deployed configuration.

In some embodiments, a distal end of the inner shaft may comprise an anchor guide. In some embodiments, the tether may be configured to extend out of a lumen of the anchor guide when the anchor is in the deployed configuration. In some embodiments, the anchor guide may be configured to correctly orient the anchor relative the longitudinal axis of the inner shaft in order to facilitate concentric wrapping of the anchor around the inner shaft as the anchor is deployed from the delivery configuration to the deployed configuration. In some embodiments, a distal end of the tether may have a shape corresponding to a shape of the anchor guide. Alternatively, or in combination, a distal end of the anchor guide may comprise one or more deflection features. The one or more deflection features may be configured to interact with an opening of an outer shaft of the delivery device and cause deflection of the distal portion of the anchor guide when the inner shaft is advanced out of a lumen of the outer shaft, thereby facilitating positioning of the anchor relative to the outer shaft during actuation from the delivery configuration to the deployed configuration.

In some embodiments, the system may further comprise a frame structure. Expansion of the frame structure to an expanded configuration may detach the frame structure from the delivery device.

In some embodiments, a free end of the anchor may comprise an atraumatic tip.

In some embodiments, a free end of the anchor may comprise a ball tip.

In some embodiments, a free end of the anchor may comprise a loop.

In some embodiments, a free end of the anchor may be configured for piercing tissue.

In some embodiments, the anchor may comprise a spiral wire.

In some embodiments, the tether may comprise a wire disposed in a housing. The housing may be flexible.

In some embodiments, a free end of the anchor may extend radially outward from the curved shape.

In some embodiments, the system may further comprise a frame structure configured for expanding within the native valve of the patient.

In some embodiments, the system may further comprise a frame structure. The anchor may be configured to be fully advanced from an atrial side of the native valve into a ventricle of the heart and anchor the frame structure to the native valve when the frame structure is in an expanded configuration adjacent the native valve. In some embodiments, an unexpanded configuration of the frame structure may be sized and dimensioned for percutaneous insertion and the expanded configuration is sized and dimensioned for implantation in the native valve of the patient. In some embodiments, the frame structure may comprise a first and second opposite ends, the first end extending above a native valve and the second end extending below the native valve when the frame structure is anchored to the native valve. In some embodiments, the frame structure may sit below the native valve when the frame structure is anchored to the native valve.

In some embodiments, the system may further comprise a frame structure and a valve segment within the frame structure comprising a biocompatible one-way valve. In some embodiments, at least a portion of the valve segment may be positioned within at least a portion of the frame structure. In some embodiments, the valve segment may comprise at least one leaflet having an inner layer and an outer layer, and the frame structure may be attached to the outer layer at one or more ends of the frame structure. In some embodiments, the valve segment may comprise a plurality of leaflets.

In another aspect, a method for treating a diseased native valve in a patient is provided. The method comprises a) advancing a distal end of a delivery device from a first side of a native valve to a second side of the native valve, wherein the delivery device comprises an inner shaft comprising an anchor guide, wherein an anchor comprising a delivery configuration and a deployed configuration is disposed within a lumen of the inner shaft; b) holding the anchor with within the lumen of the inner shaft with a longitudinally-translatable tether, wherein the anchor is detachably coupled to the tether; c) actuating the anchor from the delivery configuration to the deployed configuration adjacent the native valve by translating the tether distally within the lumen of the inner shaft to translate the anchor out of an opening in the delivery device; and d) rotating a free end of the deployed anchor around one or more structures on the second side of the native valve.

In some embodiments, rotating the free end of the deployed anchor may comprise rotating the anchor with the anchor guide. Optionally, a proximal end of the anchor may coupled to the anchor guide and rotating the anchor may comprise rotating the anchor guide.

In some embodiments, the method may further comprise retracting the anchor guide while holding the anchor with the tether.

In some embodiments, a distal end of the tether may have a curve shape that is discontinuous with a curved shape of the anchor.

In some embodiments, a distal end of the tether may be coupled to a proximal end of the anchor with an engagement wire. The method may further comprise releasing the anchor from the tether by de-coupling the engagement wire from the anchor.

In some embodiments, the method may further comprise steering the distal end of the delivery device such that the distal end of the delivery device points towards the first side of the native valve.

In some embodiments, the anchor may be configured to wrap at least partially around the delivery device in the deployed configuration.

In some embodiments, the anchor may be configured to wrap at least partially around a frame structure in the deployed configuration.

In some embodiments, a central axis of the anchor may be co-axial with a longitudinal axis of the inner shaft when the anchor is in the deployed configuration.

In some embodiments, a distal end of the inner shaft may comprise the anchor guide.

In some embodiments, the anchor guide may be configured to correctly orient the anchor relative the longitudinal axis of the inner shaft in order to facilitate concentric wrapping of the anchor around the inner shaft as the anchor is actuated from the delivery configuration to the deployed configuration.

In some embodiments, a distal end of the tether may have a shape corresponding to a shape of the anchor guide.

In some embodiments, a distal portion of the anchor guide may comprise one or more deflection features. The one or more deflection features may be configured to interact with an opening of an outer shaft of the delivery device and cause deflection of the distal portion of the anchor guide when the inner shaft is advanced out of a lumen of the outer shaft, thereby facilitating positioning of the anchor relative to the outer shaft during actuation from the delivery configuration to the deployed configuration.

In some embodiments, the tether may comprise a wire disposed in a flexible housing.

In some embodiments, actuating the anchor may comprise actuating the anchor from the delivery configuration to the deployed configuration on the first side of the native valve and advancing the anchor in the deployed configuration through the native valve to the second side of the native valve. In some embodiments, advancing the anchor comprises pushing the anchor through the native valve. Advancing the anchor may further comprise rotating the anchor through the native valve.

In some embodiments, actuating the anchor may comprise positioning the anchor such that it is located only on the second side of the native valve.

In some embodiments, the distal end of the delivery device may be detachably coupled to a frame structure. The method may further comprise expanding the frame structure within the native valve from an unexpanded configuration to an expanded configuration. Expanding the frame structure occurs while holding the anchor with the tether. In some embodiments, the frame structure may comprise a first and second opposite ends and wherein the frame structure may comprise expanding the frame structure such that the first end extends above the first side of the native valve and the second end extends below second side of the native valve. Alternatively. or in combination, expanding the frame structure may comprise expanding at least a portion the frame structure within at least a portion of the deployed anchor to anchor the frame structure to the native valve. In some embodiments, the method may further comprise releasing the frame structure from the distal end of the delivery device. In some embodiments, expanding the frame structure and releasing the frame structure may occur simultaneously. In some embodiments, the frame structure may be balloon-expandable and expanding the frame structure may comprise inflating a balloon disposed within the frame structure, wherein inflation of the balloon causes expansion of the frame structure. In some embodiments, the frame structure may be self-expanding and expanding the frame structure may comprise releasing the frame structure from radial constriction by the delivery device. In some embodiments, the frame structure may comprise a valve segment therewithin comprising a biocompatible one-way valve.

In some embodiments, the method may further comprise retracting the delivery device from the patient.

In some embodiments, the method may further comprise de-coupling the anchor from the tether. In some embodiments, the method may further comprise retracting the tether from the patient.

In some embodiments, the one or more structures may comprise one or more valve leaflets of the native valve. Alternatively, or in combination, the one or more structures may comprise one or more chordae of the left ventricle.

In some embodiments, a free end of the anchor may comprise an atraumatic tip. In some embodiments, a free end of the anchor may comprise a ball tip. In some embodiments, a free end of the anchor may comprise a loop.

In some embodiments, a free end of the anchor may be configured for piercing tissue.

In some embodiments, a free end of the anchor may extend radially outward from the curved shape. In some embodiments, the curved shape may be a spiral shape.

In some embodiments, the native valve may be in a heart of a patient. The method may further comprise transseptally inserting the distal end of the delivery device into a left atrium of the heart. In some embodiments, the native valve may comprise a mitral valve, the first side of the native valve may comprise a left atrium, and the second side of the native valve may comprise a left ventricle.

Another aspect of the present disclosure provides a system for treating a diseased native valve in a patient. The system comprises a frame structure having an unexpanded configuration and an expanded configuration and an anchor comprising a coiled wire having a free end and a coiled shape. The anchor comprises a delivery configuration and a deployed configuration. The anchor is configured to be actuated from the delivery configuration to the deployed configuration adjacent a native valve in a patient, The anchor comprises one or more deflection features disposed along the coiled wire. The one or more deflection features comprise one or more kinks along the coiled wire such that at least a first portion of the coiled wire is discontinuous with the coiled shape of the coiled wire.

In some embodiments, the one or more deflection features may be configured to cause deflection of the free end when the anchor is actuated from the delivery configuration to the deployed configuration.

In some embodiments, a proximal end of the anchor may be coupled to a distal end of the frame structure.

In some embodiments, the anchor may comprise an elongated shape in the delivery configuration.

In some embodiments, the anchor may comprise a helical shape in the deployed configuration.

In some embodiments, the anchor may comprise a spiral shape in the deployed configuration.

In some embodiments, the one or more deflection features may comprise one or more pre-formed waves, bends, and/or humps in the coiled wire. For example, the one or more deflection features may comprise a plurality of waves. Alternatively. or in combination, the coiled wire may comprise a plurality of loops and the one or more deflection features may comprise a plurality of waves, each loop comprising a single wave. In some embodiments, the first portion may comprise the free end and the one or more deflection features may comprise a bend near a distal end of the coiled wire such that the free end of the coiled wire is positioned adjacent one or more loops of the coiled wire in the deployed configuration. Alternatively, or in combination, the first portion may comprise the free end and the one or more deflection features may comprise a bend near a free end of the coiled wire such that the free end of the coiled wire angles towards a proximal end of the coiled wire in the deployed configuration.

In some embodiments, the coiled wire may be configured to wrap at least partially around the frame structure in the deployed configuration.

In some embodiments, the anchor may comprise a super-elastic material. For example, the anchor may comprise nitinol.

In some embodiments, the frame structure may comprise an expandable stent.

In some embodiments, the expanded configuration may be a generally tubular expanded shape.

In some embodiments, the frame structure may comprise an expanded outer periphery in the expanded configuration and a compressed outer periphery when subject to an external radial force in the unexpanded configuration. The compressed outer periphery may be smaller in diameter than the expanded outer periphery.

In some embodiments, the frame structure may be balloon-expandable.

In some embodiments, the frame structure may be self-expanding.

In some embodiments, the device may further comprise a delivery device. The delivery device may comprise an outer sheath. The anchor may be disposed in a lumen of the outer sheath and maintained in the delivery configuration by radial constriction from the outer sheath. Advancement of the anchor out of the lumen of the outer sheath may actuate the anchor into the deployed configuration. The one or more deflection features disposed along the coiled wire may deflect the free end of the coiled wire as they move past an opening of the lumen of the outer sheath during actuation of the anchor from the delivery configuration to the deployed configuration. In some embodiments, the outer sheath may be steerable.

In some embodiments, the delivery device may further comprise an inner shaft. The inner shaft may be disposed within the lumen of the outer sheath. A proximal portion of the frame structure or a proximal end of the anchor may be coupled to a distal portion of the inner shaft. Advancement of the inner shaft towards an opening of the lumen of the outer sheath may advance the anchor out of the lumen of the outer shaft and may actuate the anchor into the deployed configuration. Alternatively, or in combination, the frame structure may be maintained in the unexpanded configuration by radial constriction from the outer sheath and advancement of the inner shaft out of the lumen of the outer sheath may actuate the frame structure into the expanded configuration. In some embodiments, the coiled wire may be configured to wrap at least partially around the inner shaft in the deployed configuration. Alternatively, or in combination, a central axis of the coiled wire may be co-axial with a longitudinal axis of the inner shaft when the coiled wire is in the deployed configuration. In some embodiments, the frame structure may be detachably coupled to the delivery device in the unexpanded configuration during delivery to the native valve. Expansion of the frame structure to the expanded configuration may detach the frame structure from the delivery device.

In some embodiments, the free end may comprise an atraumatic tip. For example, the free end may comprise a ball tip.

In some embodiments, the free end may be configured for piercing tissue.

In some embodiments, the coiled wire may comprise a spiral wire.

In some embodiments, the coiled wire may comprise a helical wire. Optionally, the anchor may comprise a first portion comprising the helical wire and another portion. Alternatively, or in combination, the anchor may comprise a plurality of helical wires. For example, the anchor may comprise at least two helical wires having different diameters. Alternatively, or in combination, the anchor may comprise at least two helical wires having different winding pitches. In some embodiments, the helical wire may have a generally tubular shape. The free end of the helical wire may extend radially outward from the tubular shape. In some embodiments, the helical wire may have a generally frustoconical shape. The free end of the helical wire may extend radially outward from the frustoconical shape. In some embodiments, the helical wire may have a generally cylindrical shape. The free end of the helical wire may extend radially outward from the cylindrical shape.

In some embodiments, the frame structure may be configured for expanding within the native valve of the patient.

In some embodiments, the anchor may be configured to be fully advanced from an atrial side of the native valve into a ventricle of the heart and anchor the frame structure to the native valve when the frame structure is in the expanded configuration adjacent the native valve. The unexpanded configuration may be sized and dimensioned for percutaneous insertion and the expanded configuration may be sized and dimensioned for implantation in the native valve of the patient. The frame structure may comprise a first and second opposite ends, the first end extending above a native valve and the second end extending below the native valve when the frame structure is anchored to the native valve. Alternatively, the frame structure may sit entirely below the native valve when the frame structure is anchored to the native valve.

In some embodiments, the device may further comprise a valve segment within the frame structure comprising a biocompatible one-way valve. At least a portion of the valve segment may be positioned within at least a portion of the frame structure. In some embodiments, the valve segment may comprise at least one leaflet having an inner layer and an outer layer, and the frame structure may be attached to the outer layer at one or more ends of the frame structure. The valve segment may comprise a plurality of leaflets.

Another aspect of the present disclosure provides a system for treating a diseased native valve in a patient. The system comprises a frame structure having an unexpanded configuration and an expanded configuration, an anchor comprising a coiled wire having a free end, and an outer sheath comprising a lumen and an opening. The anchor comprises a delivery configuration when disposed within the lumen of the outer sheath and a deployed configuration when advanced out of the lumen of the outer sheath. The anchor comprises one or more deflection features disposed along the coiled wire and configured to interact with the outer sheath and cause deflection of the free end when the anchor is advanced out of the lumen of the outer sheath through the opening to actuate the anchor from the delivery configuration to the deployed configuration. The anchor is configured to be actuated from the delivery configuration to the deployed configuration adjacent a native valve in a patient.

In some embodiments, the one or more deflection features may be configured to cause deflection of the free end when the anchor is actuated from the delivery configuration to the deployed configuration.

In some embodiments, a proximal end of the anchor may be coupled to a distal end of the frame structure.

In some embodiments, the anchor may comprise an elongated shape in the delivery configuration.

In some embodiments, the anchor may comprise a helical shape in the deployed configuration.

In some embodiments, the anchor may comprise a spiral shape in the deployed configuration.

In some embodiments, the one or more deflection features may comprise one or more pre-formed waves, bends, and/or humps in the coiled wire. For example, the one or more deflection features may comprise a plurality of waves. Alternatively, or in combination, the coiled wire may comprise a plurality of loops and the one or more deflection features may comprise a plurality of waves, each loop comprising a single wave. In some embodiments, the first portion may comprise the free end and the one or more deflection features may comprise a bend near a distal end of the coiled wire such that the free end of the coiled wire is positioned adjacent one or more loops of the coiled wire in the deployed configuration. Alternatively, or in combination, the first portion may comprise the free end and the one or more deflection features may comprise a bend near a free end of the coiled wire such that the free end of the coiled wire angles towards a proximal end of the coiled wire in the deployed configuration.

In some embodiments, the coiled wire may be configured to wrap at least partially around the frame structure in the deployed configuration.

In some embodiments, the anchor may comprise a super-elastic material. For example, the anchor may comprise nitinol.

In some embodiments, the frame structure may comprise an expandable stent.

In some embodiments, the expanded configuration may be a generally tubular expanded shape.

In some embodiments, the frame structure may comprise an expanded outer periphery in the expanded configuration and a compressed outer periphery when subject to an external radial force in the unexpanded configuration. The compressed outer periphery may be smaller in diameter than the expanded outer periphery.

In some embodiments, the frame structure may be balloon-expandable.

In some embodiments, the frame structure may be self-expanding.

In some embodiments, the anchor may be disposed in a lumen of the outer sheath and maintained in the delivery configuration by radial constriction from the outer sheath. Advancement of the anchor out of the lumen of the outer sheath may actuate the anchor into the deployed configuration. The one or more deflection features disposed along the coiled wire may deflect the free end of the coiled wire as they move past an opening of the lumen of the outer sheath during actuation of the anchor from the delivery configuration to the deployed configuration. In some embodiments, the outer sheath may be steerable.

In some embodiments, the system may further comprise an inner shaft. The inner shaft may be disposed within the lumen of the outer sheath. A proximal portion of the frame structure or a proximal end of the anchor may be coupled to a distal portion of the inner shaft. Advancement of the inner shaft towards an opening of the lumen of the outer sheath may advance the anchor out of the lumen of the outer shaft and may actuate the anchor into the deployed configuration. Alternatively, or in combination, the frame structure may be maintained in the unexpanded configuration by radial constriction from the outer sheath and advancement of the inner shaft out of the lumen of the outer sheath may actuate the frame structure into the expanded configuration. In some embodiments, the coiled wire may be configured to wrap at least partially around the inner shaft in the deployed configuration. Alternatively, or in combination, a central axis of the coiled wire may be co-axial with a longitudinal axis of the inner shaft when the coiled wire is in the deployed configuration. In some embodiments, the frame structure may be detachably coupled to the delivery device in the unexpanded configuration during delivery to the native valve. Expansion of the frame structure to the expanded configuration may detach the frame structure from the delivery device.

In some embodiments, the free end may comprise an atraumatic tip. For example, the free end may comprise a ball tip.

In some embodiments, the free end may be configured for piercing tissue.

In some embodiments, the coiled wire may comprise a spiral wire.

In some embodiments, the coiled wire may comprise a helical wire. Optionally, the anchor may comprise a first portion comprising the helical wire and another portion. Alternatively, or in combination, the anchor may comprise a plurality of helical wires. For example, the anchor may comprise at least two helical wires having different diameters. Alternatively, or in combination, the anchor may comprise at least two helical wires having different winding pitches. In some embodiments, the helical wire may have a generally tubular shape. The free end of the helical wire may extend radially outward from the tubular shape. In some embodiments, the helical wire may have a generally frustoconical shape. The free end of the helical wire may extend radially outward from the frustoconical shape. In some embodiments, the helical wire may have a generally cylindrical shape. The free end of the helical wire may extend radially outward from the cylindrical shape.

In some embodiments, the frame structure may be configured for expanding within the native valve of the patient.

In some embodiments, the anchor may be configured to be fully advanced from an atrial side of the native valve into a ventricle of the heart and anchor the frame structure to the native valve when the frame structure is in the expanded configuration adjacent the native valve. The unexpanded configuration may be sized and dimensioned for percutaneous insertion and the expanded configuration may be sized and dimensioned for implantation in the native valve of the patient. The frame structure may comprise a first and second opposite ends, the first end extending above a native valve and the second end extending below the native valve when the frame structure is anchored to the native valve. Alternatively, the frame structure may sit entirely below the native valve when the frame structure is anchored to the native valve.

In some embodiments, the device may further comprise a valve segment within the frame structure comprising a biocompatible one-way valve. At least a portion of the valve segment may be positioned within at least a portion of the frame structure. In some embodiments, the valve segment may comprise at least one leaflet having an inner layer and an outer layer, and the frame structure may be attached to the outer layer at one or more ends of the frame structure. The valve segment may comprise a plurality of leaflets.

Another aspect of the present disclosure provides a method for treating a diseased native valve in a patient. The method comprises advancing a distal end of a delivery device from a first side of a native valve to a second side of the native valve, wherein the delivery device comprises an outer sheath comprising an outer sheath comprising a lumen and an opening, wherein the distal end of the delivery device is detachably coupled to an anchor and a frame structure, the anchor comprising a delivery configuration, a deployed configuration, and one or more deflection features disposed along the anchor and configured to deflect a free end of the anchor when the anchor is actuated from the delivery configuration to the deployed configuration; actuating the anchor from the delivery configuration to the deployed configuration adjacent the native valve by (i) advancing the free end of the anchor out of the lumen of the outer sheath through the opening, (ii) deflecting the free end of the anchor by moving the one or more deflection features disposed along the anchor past the opening of the lumen of the outer sheath, and (iii) advancing a remainder of the anchor out of the lumen of the outer shaft through the opening; expanding the frame structure within the native valve from an unexpanded configuration to an expanded configuration; releasing the frame structure from the distal end of the delivery device; and retracting the delivery device from the native valve.

In some embodiments, the method may further comprise steering the distal end of the delivery device such that the distal end of the delivery device points towards the first side of the native valve.

In some embodiments, the anchor may be configured to wrap at least partially around the delivery device in the deployed configuration.

In some embodiments, the anchor may be configured to wrap at least partially around the frame structure in the deployed configuration.

In some embodiments, a central axis of the coiled wire may be co-axial with a longitudinal axis of the inner shaft when the coiled wire is in the deployed configuration.

In some embodiments, actuating the anchor may comprise releasing the frame structure from radial constriction by the delivery device.

In some embodiments, actuating the anchor may comprise actuating the anchor from the delivery configuration to the deployed configuration on the second side of the native valve.

In some embodiments, actuating the anchor may comprise actuating the anchor from the delivery configuration to the deployed configuration on the first side of the native valve and advancing the anchor in the deployed configuration through the native valve to the second side of the native valve. Advancing the anchor may comprise pushing the anchor through the native valve. Alternatively, or in combination, advancing the anchor may comprise rotating the anchor through the native valve.

In some embodiments, actuating the anchor may comprise positioning the anchor such that it is located only on the second side of the native valve.

In some embodiments, the frame structure may comprise a first and second opposite ends and expanding the frame structure may comprise expanding the frame structure such that the first end extends above the first side of the native valve and the second end extends below second side of the native valve.

In some embodiments, expanding the frame structure may comprise expanding at least a portion the frame structure within at least a portion of the deployed anchor to anchor the frame structure to the native valve.

In some embodiments, expanding the frame structure and releasing the frame structure may occur simultaneously.

In some embodiments, the frame structure may be balloon-expandable and expanding the frame structure may comprise inflating a balloon disposed within the frame structure. Inflation of the balloon may cause expansion of the frame structure.

In some embodiments, the frame structure may be self-expanding and expanding the frame structure may comprise releasing the frame structure from radial constriction by the delivery device.

In some embodiments, the anchor may comprise a coiled wire having a free end and the one or more deflection features may comprise one or more pre-formed waves, bends, or humps in the coiled wire. The one or more features may comprise a plurality of waves. For example, the coiled wire may comprise a plurality of loops and the one or more deflection features may comprise a plurality of waves, each loop comprising a single wave. Alternatively, or in combination, the one or more deflection features may comprise a bend near a distal end of the coiled wire such that the free end of the coiled wire is positioned adjacent one or more loops of the coiled wire in the deployed configuration. Alternatively, or in combination, the one or more deflection features may comprise a bend near a free end of the coiled wire such that the free end of the coiled wire angles towards a proximal end of the coiled wire in the deployed configuration.

In some embodiments, the method may further comprise rotating the free end of the deployed anchor around one or more structures on the second side of the native valve. The one or more structures may comprise one or more valve leaflets of the native valve. Alternatively, or in combination, the one or more structures may comprise one or more chordae of the left ventricle.

In some e

In some embodiments, the free end may comprise an atraumatic tip. For example, the free end may comprise a ball tip.

In some embodiments, the free end may be configured for piercing tissue.

In some embodiments, the coiled wire may comprise a spiral wire.

In some embodiments, the coiled wire may comprise a helical wire. Optionally, the anchor may comprise a first portion comprising the helical wire and another portion. Alternatively, or in combination, the anchor may comprise a plurality of helical wires. For example, the anchor may comprise at least two helical wires having different diameters. Alternatively, or in combination, the anchor may comprise at least two helical wires having different winding pitches. In some embodiments, the helical wire may have a generally tubular shape. The free end of the helical wire may extend radially outward from the tubular shape. In some embodiments, the helical wire may have a generally frustoconical shape. The free end of the helical wire may extend radially outward from the frustoconical shape. In some embodiments, the helical wire may have a generally cylindrical shape. The free end of the helical wire may extend radially outward from the cylindrical shape.

In some embodiments, the frame structure may comprise a valve segment therewithin comprising a biocompatible one-way valve.

In some embodiments, the native valve may be in a heart of a patient.

In some embodiments, the method may further comprise transseptally inserting the distal end of the delivery device into a left atrium of the heart.

In some embodiments, the native valve may comprise a mitral valve, wherein the first side of the native valve comprises a left atrium, and wherein the second side of the native valve comprises a left ventricle.

In another aspect, a system for treating a diseased native valve in a patient is provided. The system includes: a delivery device comprising: an outer sheath assembly comprising an outer sheath and a distal end, wherein the outer sheath assembly comprises a lumen, an inner shaft within the lumen of the outer sheath assembly, wherein the inner shaft comprises a lumen, and an anchor delivery sheath comprising a lumen configured to maintain an anchor in a delivery configuration; and a valve prosthesis comprising a frame structure and the anchor configured to have the delivery configuration and a deployed configuration, wherein the anchor comprises a spiral band having a free end, and wherein the frame structure is maintained in the delivery configuration by radial constriction from one or more of the outer sheath or the distal end of the outer sheath assembly

In some embodiments, the distal end of the outer sheath assembly can be a soft valve capsule. The soft valve capsule can comprise a cylindrical section and a tapered section. The cylindrical section and the tapered section can comprise a unitary body. The cylindrical section and the tapered section can be permanently attached to one another. The cylindrical section can comprise a flexible material disposed between a proximal ring and a distal ring, wherein the distal ring is attached to the tapered section. The flexible material can comprise a helically wound wire. The flexible material can comprise a series of rings linked by a wire. The cylindrical section and the tapered section can be configured to be separated from one another. The cylindrical section can comprise a flexible material disposed between a first ring and a second ring, wherein the first ring is attached to a proximal end of the flexible material and the second ring is attached to a distal end of the flexible material. The flexible material can further comprise a lumen disposed between a first layer of the flexible material and a second layer of the flexible material.

In some embodiments, the cylindrical section can further comprise a coil wire disposed within the lumen and coupled to the second ring, wherein the coil wire, when translated proximally, is configured to slide the distal ring relative to the proximal ring and collapse the flexible material to separate the cylindrical section from the tapered section. The lumen can comprise an inflatable lumen coupled to the distal ring or the distal end of the flexible material and configured to be deflated in order to collapse the flexible material and separate the cylindrical section from the tapered section. The cylindrical section can be releasably attached to the tapered section.

In some aspects, disclosed herein, the frame structure can be maintained in the delivery configuration by radial constriction from the distal end of the outer sheath assembly, wherein the radial constriction is removed by a separation of the outer sheath from the distal end of the outer sheath assembly. The inner shaft can be coupled to at least a portion of the distal end of the outer sheath assembly such that advancement of the inner shaft distally relative to the outer sheath causes the distal end to separate from the outer sheath. The delivery device can further comprise a guidewire disposed within a lumen of the inner shaft. The anchor can be configured to be released from the delivery configuration into an intermediate configuration and further into a deployed configuration. The anchor can be configured to be released into the intermediate configuration on an atrial side of a valve and subsequently pushed to a ventricle side of the valve. The anchor can be configured to be released into the deployed configuration from the delivery configuration on a ventricle side of a valve. The outer sheath can be configured to be steered to an edge of the valve and advanced along the guidewire into the ventricle side of the valve to position the anchor delivery sheath for delivery of the anchor.

In some embodiments, advancement of the inner shaft out of the lumen of the outer sheath can be configured to expand the frame structure into the expanded configuration. The anchor can comprise a spiral shape in the deployed configuration. The anchor can comprise an elongated shape in the delivery configuration. The anchor can comprise one or more locking mechanisms configured to maintain the anchor in the deployed configuration. The one or more locking mechanisms can comprise a frictional band, a polymer coating, or one or more key and one or more key hole features. The anchor can comprise a first loop, a second loop, and one or more locking mechanisms, and wherein the one or more locking mechanisms are configured to couple the first loop to the second loop when the anchor is in the fully deployed configuration.

In some embodiments, the spiral band can comprise one or more loops. The one or more loops can comprise at least 360 degrees of rotation. The spiral band can comprise a plurality of loops. The spiral band can comprise one or more spaces between the plurality of loops. The plurality of loops can spiral radially outward from a central point.

In some embodiments, the anchor can comprise a super-elastic material. The anchor can comprise nitinol. The frame structure can comprise an expandable stent. The expanded configuration can be a generally tubular expanded shape. The frame structure can comprise an expanded outer periphery in the expanded configuration and a compressed outer periphery when subject to an external radial force in the unexpanded configuration, wherein the compressed outer periphery is smaller in diameter than the expanded outer periphery. The frame structure can be balloon-expandable. The frame structure can be self-expanding.

In some embodiments, the free end of the anchor can comprise an atraumatic tip. The free end can comprise a ball tip. The free end can be configured for piercing tissue. The free end can be bent distally. The free end can be bent proximally. The spiral band can comprise a spiral wire. The spiral band can comprise a plurality of spiral wires. The spiral band can comprise a planar spiral band. The spiral band can comprise at least one channel or lumen disposed therein. The spiral band can comprise a hollow spiral band. The at least one channel or lumen can comprise a stiffening member disposed therein. The spiral band can have a circular, tubular, hollow, square, elongated, or triangular cross-section. The spiral band can comprise a tapered spiral band. The tapered spiral band can be configured to taper in height axially.

In some embodiments, the tapered spiral band can be configured to taper from a first end of the tapered spiral band to the free end. The first end can be a proximal end and the free end is a distal end. Subsequent turns of at least a portion of the tapered spiral band nest into each other to reduce a radial footprint of the tapered spiral band. The tapered spiral band can comprise a support structure and a semi-permeable material or impermeable material disposed therein. The semi-permeable material or impermeable material can comprise a webbing material, a fabric, a polymeric material, or an elastomeric material. The free end can be disposed radially outwards from the support structure. The tapered spiral band can further comprise a lumen and a wire disposed within the lumen. The frame structure can be configured for expanding within the native valve of the patient. The unexpanded configuration can be sized and dimensioned for percutaneous insertion and the expanded configuration is sized and dimensioned for implantation in the native valve of the patient.

In some embodiments, the frame structure can comprise a first and second opposite ends, the first end extending above a native valve and the second end extending below the native valve when the frame structure is anchored to the native valve. The frame structure can sit below the native valve when the frame structure is anchored to the native valve.

In some embodiments, the system can further comprise a valve segment within the frame structure comprising a biocompatible one-way valve. At least a portion of the valve segment can be positioned within at least a portion of the frame structure. The valve segment can comprise at least one leaflet having an inner layer and an outer layer, and wherein the frame structure is attached to the outer layer at one or more ends of the frame structure. The valve segment can comprise a plurality of leaflets.

In another aspect, a method for treating a diseased native valve in a patient is provided. The method includes: advancing a distal end of a guidewire from a first side of a native valve to a second side of the native valve; advancing an outer sheath assembly over the guidewire to a native valve; separating a distal end of the outer sheath assembly from an outer sheath of the outer sheath assembly; advancing an anchor delivery sheath from within the outer sheath to deploy an anchor from the anchor delivery sheath; expanding a frame structure of a valve prosthesis within the native valve from an unexpanded configuration to an expanded configuration; securing the anchor to the native valve; and retracting the guidewire from the native valve. Deploying the anchor from the anchor delivery sheath can be followed by advancing the anchor from a first side of the native valve to a second side of the native valve. The first side of the native valve can be the left atrium and the second side of the native valve is the left ventricle.

In some embodiments, the method can further comprise, in (c), separating the distal end of the outer sheath assembly from the outer sheath to release the valve prosthesis from constraint, wherein the valve prosthesis is maintained within one or more of the outer sheath or the distal end of the outer sheath assembly by radial constriction. Separating of the distal end of the outer sheath assembly from the outer sheath can be caused by pushing an inner shaft through a lumen of the outer sheath. The anchor can be deployed from the anchor delivery sheath from a delivery configuration to an intermediate configuration and further into a deployed configuration. The anchor can be released into the intermediate configuration on the first side of the native valve and subsequently pushed to the second side of the native valve. Separating a distal end of the outer sheath assembly from the outer sheath in (c) can be caused by pushing an inner shaft through the lumen of the outer sheath. The outer sheath can be steerable. Advancing the outer sheath assembly over the guidewire to the native valve in (b) can be followed by steering the outer sheath assembly to an edge of the native valve and advancing the distal end of the outer sheath assembly from the first side of the native valve to the second side of the native valve. The outer sheath assembly can be steered to the edge of the native valve to position the anchor delivery sheath for delivery of the anchor.

In some embodiments, the method can further comprise axially separating the distal end of the outer sheath assembly from the outer sheath after the distal end of the outer sheath assembly is located in the second side of the native valve. The anchor can be deployed from the anchor delivery sheath directly into a deployed configuration such that the anchor is wrapped around the chordae tendineae of the native valve. The anchor can be a spiral band. The spiral band can comprise a free end and anchoring can comprise rotating the free end of the anchor around one or more structures of the native valve. The one or more structures can comprise one or more native chordae tendineae of native valve.

In some embodiments, a central point of the spiral band can be co-axial with a longitudinal axis of the delivery device when the spiral band is in the deployed configuration. The valve prosthesis can comprise a valve segment therewithin comprising a biocompatible one-way valve. The native valve can be in a heart of a patient. The method can further comprise transseptally inserting the distal end of the guidewire into a left atrium of the heart. The native valve can comprise a mitral valve, wherein the first side of the native valve comprises a left atrium, and wherein the second side of the native valve comprises a left ventricle. The first side of the native valve can comprise an atrium of the heart, and the second side of the native valve can comprise a ventricle of the heart.

In another aspect, a device for treating a diseased native valve in a patient is provided. The device comprises an anchor comprising an outer jacket, a first lumen disposed within the outer jacket, and a second lumen disposed within the outer jacket. The first lumen is configured to have at least one support structure fixedly disposed therewithin. The second lumen comprises an open lumen configured to allow one or more elongate members to be disposed and longitudinally translatable therein. The anchor comprises a delivery configuration and a deployed configuration. The anchor in the deployed configuration is shaped to encircle chordae or leaflets of a diseased native valve in a patient.

In some embodiments, the anchor may be configured to be actuated from the delivery configuration to the deployed configuration adjacent the native valve.

In some embodiments, the outer jacket may comprise a flexible material. The flexible material may comprise an extruded plastic or a soft textile. The flexible material may comprise polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), or pericardium.

In some embodiments, the first lumen and the second lumen may comprise a single lumen configured to remain at least partially open when the at least one support structure fixedly is disposed therewithin.

In some embodiments, the anchor may comprise an elongated shape in the delivery configuration.

In some embodiments, the anchor may comprise a curved shape in the deployed configuration. The curved shape may comprise a helical shape. The curved shape may comprise a spiral shape.

In some embodiments, the device may further comprise the at least one support structure fixedly disposed within the first lumen. The at least one support structure may comprise a wire or a hypotube.

In some embodiments, the device may further comprise the one or more elongate members disposed within the second lumen. The one or more elongate members may comprise a first wire configured to be advanced through the second lumen and out an opening in the free end into a self-assembly configuration. A distal tip of the first wire may be configured to extend radially outward, proximally, or distally of a curved shape of the anchor in the self-assembly configuration, thereby facilitating positioning of the anchor relative to a delivery device during actuation from the delivery configuration to the deployed configuration. The first wire comprises may comprise or more deflection features disposed adjacent the distal tip. The one or more deflection features may be configured to interact with the free end of the anchor and cause deflection of the distal tip when the first wire is advanced out of the second lumen of the anchor into the self-assembly configuration such that it extends radially outward, proximally, or distally of the curved shape of the anchor. In some embodiments, the one or more deflection features may comprise one or more pre-formed waves, bends, kinks, or humps adjacent the distal tip of the first wire. In some embodiments, the one or more deflection features may comprise one or more kinks along the distal tip of the first wire such that at least a portion of the distal tip is discontinuous with a curved shape of a proximal curved portion of the first wire.

In another aspect, a system for treating a diseased native valve in a patient is provided. The system comprises an anchor comprising an outer jacket and at least two lumens disposed within the outer jacket, the anchor comprising a delivery configuration and a deployed configuration, at least one support structure fixedly disposed within a first lumen of the at least two lumens, a first wire disposed within a second lumen of the at least two lumens, and a second wire disposed within the second lumen, wherein the first and second wires are configured to be longitudinally translatable independent of one another within the second lumen. The anchor in the deployed configuration is shaped to encircle chordae or leaflets of a diseased native valve in a patient.

In some embodiments, the outer jacket may comprise a flexible material. The flexible material may comprise an extruded plastic or a soft textile. The flexible material may comprise polyethylene terephthalate (PET).

In some embodiments, the first wire or the second wire may comprise a super-elastic material. The first wire or the second wire may comprise nitinol.

In some embodiments, the first wire and the second wire may be disposed within a housing. The housing may be flexible and translation of the first wire and the second wire relative to one another may change the curvature of the housing.

In some embodiments, the first wire and the second wire may be coupled to one another at a distal tip.

In some embodiments, the system may further comprise a third wire.

In some embodiments, the first and second wires may comprise pull wires.

In some embodiments, a distal tip of the first wire or the second wire may be configured to be advanced through the second lumen and out an opening in the free end when the first wire or the second wire is in a self-assembly configuration. The first wire or the second wire may be configured to be further advanced through the second lumen into an encircling configuration. The distal tip of the first wire or the second wire may be configured to extend radially outward, proximally, or distally of a curved shape of the anchor in the self-assembly configuration, thereby facilitating positioning of the anchor relative to a delivery device during actuation from the delivery configuration to the deployed configuration. In some embodiments, the distal tip may comprise an atraumatic tip, for example a ball tip. In some embodiments, the distal tip may be configured for piercing tissue.

In some embodiments, the at least one support structure may comprise a wire or a hypotube.

In some embodiments, the at least one support structure may comprise a super-elastic material such as nitinol.

In some embodiments, the anchor may be configured to wrap at least partially around a frame structure in the deployed configuration.

In some embodiments, the system may further comprise a frame structure having an unexpanded configuration and an expanded configuration. The anchor may be configured to wrap at least partially around the frame structure in the deployed configuration. A proximal end of the anchor may be coupled to a distal end of the frame structure. The frame structure may comprise an expandable stent. The frame structure expanded configuration may be a generally tubular shape. In some embodiments, the frame structure may be self-expanding. In some embodiments, the frame structure may be balloon-expandable. The anchor may be configured to be fully advanced from an atrial side of the native valve into a ventricle of the heart and to anchor the frame structure to the native valve when the frame structure is in the expanded configuration adjacent the native valve. A valve segment may be positioned within at least a portion of the frame structure. The valve segment may comprise a biocompatible one-way valve. The valve segment may comprise at least one leaflet having an inner layer and an outer layer, and the frame structure may be attached to the outer layer at one or more ends of the frame structure. In some embodiments, the valve segment may comprise a plurality of leaflets.

In some embodiments, the system may further comprise a delivery device. The delivery device may comprise an outer sheath and the anchor may be disposed in a lumen of the outer sheath and maintained in the delivery configuration by radial constriction from the outer sheath. Advancement of the anchor out of the lumen of the outer sheath may actuate the anchor into the deployed configuration. A pusher portion of the first wire or second wire may extend from a proximal portion of the anchor to a proximal end of the delivery device. The outer sheath may be steerable. In some embodiments, the system may further comprise a frame structure detachably coupled to the delivery device in an unexpanded configuration during delivery to the native valve. In some embodiments, the system may further comprise a frame structure and expansion of the frame structure to an expanded configuration may detach the frame structure from the delivery device. In some embodiments, the delivery device may further comprise an inner shaft. The inner shaft may be disposed within the lumen of the outer sheath. Advancement of the inner shaft towards an opening of the lumen of the outer sheath may advance the anchor out of the lumen of the outer shaft and actuate the anchor into the deployed configuration. In some embodiments, the system may further comprise a frame structure. The frame structure may be maintained in an unexpanded configuration by radial constriction from the outer sheath and advancement of the inner shaft out of the lumen of the outer sheath may actuate the frame structure into an expanded configuration. The anchor may be configured to wrap at least partially around the inner shaft in the deployed configuration. A central axis of the anchor may be co-axial with a longitudinal axis of the inner shaft when the anchor is in the deployed configuration.

In another aspect, a method for treating a diseased native valve in a patient is provided. The method comprises advancing a distal portion of a delivery device from a first side of a native valve to a second side of the native valve, wherein the distal portion of delivery device is detachably coupled to an anchor, the anchor comprising a delivery configuration, a deployed configuration, an outer jacket, a first lumen disposed within the outer jacket, a free end, and at least one support structure fixedly disposed within the first lumen; actuating the anchor from the delivery configuration to the deployed configuration adjacent the native valve by advancing the free end of the anchor out of the delivery device; and retracting the delivery device from the native valve.

In some embodiments, the anchor may further comprise a second lumen disposed within the outer jacket, the second lumen comprising an open lumen configured to allow one or more elongate members to be disposed and longitudinally translatable therein. The first lumen and the second lumen may comprise a single lumen configured to remain at least partially open when the at least one support structure fixedly is disposed therewithin. In some embodiments, the one or more elongate members may comprise a first wire, and the method may further comprise advancing the first wire through the second lumen and out an opening in the free end. The first wire may comprise one or more deflection features disposed adjacent a distal tip thereof, the one or more defection features may be configured to interact with the free end of the cause deflection of the distal tip when the first wire is advanced out of the second lumen of the anchor into a self-assembly configuration, and the method may further comprise deflecting the distal tip of the first wire by moving the one or more deflection features disposed along the distal tip past the opening of the second lumen into the self-assembly configuration such that it extends radially outward, proximally, or distally of the curved shape of the anchor. In some embodiments, the one or more elongate members may comprise a first wire and a second wire, and the method may further comprise advancing the first wire and the second wire through the second lumen and out an opening in the free end. The first wire and the second wire may be configured to be longitudinally translatable independent of one another. In some embodiments, the first wire and the second wire may be disposed in a housing. The housing may flexible, and the method may further comprise translating the first and second wires relative to one another, thereby changing a curvature of the housing. Alternatively. or in combination, the first wire and the second wire may be coupled to one another at a distal tip, and the method may further comprise translating the first and second wires relative to one another, thereby changing the position of the distal tip. In some embodiments, a third wire may be coupled to the first and second wires at the distal tip. In some embodiments, the method may further comprise deflecting a distal tip of the first wire or second wire into a self-assembly configuration or an encircling configuration. The distal tip of the first wire or second wire to may extend radially outward, proximally, or distally of a curved shape of the anchor in the self-assembly configuration, thereby facilitating positioning of the anchor relative to a delivery device during actuation from the delivery configuration to the deployed configuration. The distal tip may comprise an atraumatic tip, for example a ball tip. The distal tip may be configured for piercing tissue. In some embodiments, the method may further comprise rotating a distal tip of the first wire or second wire in an encircling configuration around one or more structures on the second side of the native valve.

In some embodiments, the method may further comprise rotating the free end of the deployed anchor around one or more structures on the second side of the native valve. The one or more structures may comprise one or more valve leaflets of the native valve. The one or more structures may comprise one or more chordae of the left ventricle.

In some embodiments, the at least one support structure may comprise a wire or a hypotube.

In some embodiments, the method may comprise steering the distal end of the delivery device such that the distal end of the delivery device points towards the first side of the native valve.

In some embodiments, the anchor may be configured to wrap at least partially around the delivery device in the deployed configuration.

In some embodiments, the anchor may be configured to wrap at least partially around a frame structure in the deployed configuration.

In some embodiments, a central axis of the anchor may be co-axial with a longitudinal axis of the distal portion of the delivery device when the anchor is in the deployed configuration. The method may further comprise expanding the frame structure within the native valve from an unexpanded configuration to an expanded configuration. The frame structure may comprise a first and second opposite ends and expanding the frame structure may comprise expanding the frame structure such that the first end extends above the first side of the native valve and the second end extends below second side of the native valve. Expanding the frame structure may comprise expanding at least a portion the frame structure within at least a portion of the deployed anchor to anchor the frame structure to the native valve. The method may further comprise releasing the frame structure from the distal end of the delivery device. Expanding the frame structure and releasing the frame structure may occur simultaneously.

In some embodiments, actuating the anchor may comprise releasing a frame structure detachably coupled to the distal end of the delivery device from radial constriction by the delivery device.

In some embodiments, actuating the anchor may comprise actuating the anchor from the delivery configuration to the deployed configuration on the second side of the native valve.

In some embodiments, actuating the anchor may comprise actuating the anchor from the delivery configuration to the deployed configuration on the first side of the native valve and may further comprise advancing the anchor in the deployed configuration through the native valve to the second side of the native valve. Advancing the anchor may comprise pushing the anchor through the native valve. Advancing the anchor may further comprise rotating the anchor through the native valve.

In some embodiments, the native valve may be in a heart of a patient. The method may further comprise transseptally inserting the distal end of the delivery device into a left atrium of the heart. The native valve may comprise a mitral valve, the first side of the native valve may comprise a left atrium, and the second side of the native valve may comprise a left ventricle.

In another aspect, a system for treating a diseased native valve in a patient is provided. The system comprises an inner shaft and a guidewire comprising a distal end configured to be fully advanced from an atrial side of the native valve into a ventricle of a heart. The inner shaft comprises a lumen. The inner shaft may comprise a guidewire lumen. The inner shaft lumen may comprise an anchor deployment component. The guidewire may be advanceable through the guidewire lumen. A valve prosthesis is coupled to the inner shaft. The valve prosthesis comprises an unexpanded delivery configuration and an expanded configuration. The anchor is coupled to the inner shaft and comprises a spiral band having a free end. The valve prosthesis is configured to be actuated from the unexpanded configuration to the expanded configuration adjacent a native valve in a patient. The anchor is configured to be deployed from an anchor deployment component. The anchor may be configured to be deployed from a lateral opening of the inner shaft. The lateral opening may be a side port of the inner shaft. Alternatively, the anchor deployment component may comprise an anchor drive shaft, deployment drive, and an outer shaft configured to retract along the inner shaft to form the lateral opening. The anchor is configured to secure the valve prosthesis to the native valve when the valve prosthesis is deployed into the expanded configuration adjacent the native valve.

In some embodiments, the anchor may be configured to be fully advanced from an atrial side of the native valve into a ventricle of the heart.

In some embodiments, the anchor comprises a delivery configuration and a deployed configuration. The anchor may comprise a spiral shape in the deployed configuration.

In some embodiments, the anchor is configured to be actuated from the delivery configuration to the deployed configuration adjacent the native valve. The anchor may be configured to be deployed adjacent the native valve.

In some embodiments, the delivery device comprises the inner shaft. The anchor is disposed in the inner shaft and maintained in the delivery configuration by radial constriction from the inner shaft, and wherein advancement of the anchor out of the side port of the inner shaft actuates the anchor into the deployed configuration.

In some embodiments, the valve prosthesis is maintained in the unexpanded configuration by radial constriction from the inner shaft. After the anchor is deployed, advancement of a proximal pusher within the inner shaft deploys the valve prosthesis into the expanded configuration.

In some embodiments, the valve prosthesis is detachably coupled to the proximal pusher in the unexpanded configuration during delivery to the native valve. The expansion of the valve prosthesis to the expanded configuration may detach the valve prosthesis from the proximal pusher.

In some embodiments, the inner shaft is steerable. A central point of the spiral band may be co-axial with a longitudinal axis of the inner shaft when the anchor is in the deployed configuration. In some embodiments, the spiral band comprises a one or more loops. The one or more loops may comprise at least 360 degrees of rotation. The spiral band may comprise a plurality of loops. There may be one or more spaces between the plurality of loops.

In some embodiments, the anchor comprises a super-elastic material. In some embodiments, the anchor comprises nitinol.

In some embodiments, the valve prosthesis comprises an expandable frame structure. The expanded configuration may be a generally tubular expanded shape. The valve prosthesis may comprise an expanded outer periphery in the expanded configuration and a compressed outer periphery when subject to an external radial force in the unexpanded configuration, wherein the compressed outer periphery is smaller in diameter than the expanded outer periphery.

In some embodiments, the valve prosthesis may be balloon-expandable or, alternatively, may be self-expanding.

In some embodiments, the free end of the anchor comprises an atraumatic tip, such as a ball tip. In other embodiments, the free end of the anchor is configured for piercing tissue. Alternatively, or in combination, the free end of the anchor may be bent distally. In some embodiments, the free end of the anchor may be bent proximally.

In some embodiments, the spiral band comprises a spiral wire or a plurality of spiral wires. In some embodiments, the spiral band comprises a planar spiral band. The spiral band may comprise at least one channel or lumen disposed therein. The at least one channel or lumen may comprise a stiffening member disposed therein. In some embodiments, the spiral band comprises a hollow spiral band. In some embodiments, the spiral band has a circular, tubular, hollow, square, elongated, or triangular cross-section. Alternatively, the spiral band may comprise a tapered spiral band. The tapered spiral band may be configured to taper in height axially. The tapered spiral band may be configured to taper from a first end of the tapered spiral band to the free end. In some embodiments, the first end is a proximal end and the free end is a distal end. The free end of the anchor may be disposed radially outwards from the support structure.

In some embodiments, subsequent turns of at least a portion of the tapered spiral band may nest into each other to reduce a radial footprint of the tapered spiral band. The tapered spiral band may comprise a support structure and a semi-permeable material or impermeable material disposed therein. The semi-permeable material or impermeable material may comprise a webbing material, a fabric, a polymeric material, or an elastomeric material. The tapered spiral band can further include a lumen and a wire disposed within the lumen.

In some embodiments, the valve prosthesis is configured for expanding within the native valve of the patient. The unexpanded configuration may be sized and dimensioned for percutaneous insertion and the expanded configuration is sized and dimensioned for implantation in the native valve of the patient. The valve prosthesis may comprise first and second opposite ends, the first end being configured to extend above a native valve and the second end being configured to extend below the native valve when the valve prosthesis is anchored to the native valve. The valve prosthesis may be configured to sit below the native valve when the frame structure is anchored to the native valve.

In some embodiments, a valve segment within the valve prosthesis comprises a biocompatible one-way valve. In some embodiments, at least a portion of the valve segment is positioned within at least a portion of the valve prosthesis. The valve segment may comprise at least one leaflet having an inner layer and an outer layer, and wherein the frame structure is attached to the outer layer at one or more ends of the valve prosthesis. The valve segment may comprise a plurality of leaflets.

In another aspect, a method for treating a diseased native valve in a patient is provided. The method comprises (i) advancing a distal end of a guidewire from a first side of a native valve to a second side of the native valve. (ii) advancing a distal end of an inner shaft over the guidewire to the first side of a native valve, (iii) deploying an anchor from an anchor deployment component of the inner shaft, (iv) securing the anchor to adjacent to the native valve, (v) expanding a valve prosthesis within the native valve from an unexpanded configuration to an expanded configuration, (vi) releasing the valve prosthesis from the inner shaft, (vii) retracting the inner shaft from the native valve, and (viii) retracting the guidewire from the native valve.

In some embodiments, securing the anchor comprises deploying the anchor from a delivery configuration to a deployed configuration. In some embodiments, deploying the anchor comprises actuating the anchor from the delivery configuration to the deployed configuration. Deploying the anchor may comprise actuating the anchor from the delivery configuration to the deployed configuration on the second side of the native valve.

In some embodiments, deploying the anchor comprises deploying the anchor from a side port of the inner shaft. Alternatively, deploying the anchor may comprise actuating an outer shaft, an anchor drive shaft, and a deployment drive.

In some embodiments, anchoring the anchor comprises actuating the anchor from the delivery configuration to the deployed configuration on the first side of the native valve and advancing the anchor in the deployed configuration through the native valve to the second side of the native valve. Advancing the anchor may comprise pushing the anchor through the native valve. Advancing the anchor may further comprise rotating the anchor through the native valve. Securing the anchor may comprise positioning the anchor such that it is located only on the second side of the native valve.

In some embodiments, the valve prosthesis comprises a first and second opposite ends, and wherein expanding the valve prosthesis comprises expanding the valve prosthesis such that the first end extends above the first side of the native valve and the second end extends below second side of the native valve. Expanding the valve prosthesis may comprise expanding at least a portion the valve prosthesis within at least a portion of the deployed anchor to anchor the valve prosthesis to the native valve. Expanding the valve prosthesis and releasing the valve prosthesis may occur simultaneously. The valve prosthesis may be balloon-expandable and expanding the valve prosthesis may comprise inflating a balloon disposed within the inner shaft, wherein inflation of the balloon causes expansion of the valve prosthesis. Alternatively, the valve prosthesis may be self-expanding and expanding the valve prosthesis may comprise releasing the valve prosthesis from radial constriction by the inner shaft using a proximal pusher. In some embodiments, the valve prosthesis may comprise a valve segment therewithin comprising a biocompatible one-way valve.

In some embodiments the anchor may be a spiral band. A central point of the spiral band may be co-axial with a longitudinal axis of the delivery device when the anchor is in the deployed configuration. The spiral band may comprise a free end and anchoring may comprise rotating the free end of the anchor around one or more structures on the second side of the native valve. The one or more structures may comprise one or more native chordae tendineae of the left ventricle. The free end of the spiral band may comprise an atraumatic tip, for example a ball tip. Alternatively, the free end of the spiral band is configured for piercing tissue. In some embodiments, the free end of the spiral band is bent distally. Alternatively, the free end of the spiral band may be bent proximally.

In some embodiments, the spiral band may comprise a spiral wire or a plurality of spiral wires. The spiral band may comprise a planar spiral band. The spiral band may comprise a hollow spiral band. In some embodiments, the spiral band may comprise at least one channel or lumen disposed therein. The at least one channel or lumen may comprise a stiffening member disposed therein. The spiral band may comprise a circular, tubular, hollow, square, elongated, or triangular cross-section. In some embodiments, the spiral band comprises a tapered spiral band.

In some embodiments, advancing the delivery device further comprises transseptally inserting the distal end of the guidewire into a left atrium of the heart.

In some embodiments, the native valve is in a heart of a patient. In some embodiments, the native valve comprises a mitral valve, wherein the first side of the native valve comprises a left atrium, and wherein the second side of the native valve comprises a left ventricle. In some embodiments the first side of the native valve comprises an atrium of the heart, and the second side of the native valve comprises a ventricle of the heart. The first side of the native valve may comprise a ventricle of the heart, and the second side of the native valve may comprise an atrium of the heart. Another aspect of the present disclosure comprises a device for treating a diseased native valve in a patient, the device comprising a guidewire, an inner shaft having a lumen through which the guidewire is advanceable, an anchor, and a valve prosthesis. The anchor may be deployed from the inner shaft through a port located on the side of the inner shaft. Alternatively, the anchor may be deployed by a retraction of an outer shaft followed by a series of rotations of an anchor drive shaft followed by an advancement of the outer shaft, followed by an exposure of a deployment drive. The valve prosthesis may be deployed after the anchor is deployed.

In some embodiments, the valve prosthesis is deployed by a proximal pusher located within the inner shaft. The valve prosthesis may comprise first and second opposite ends, wherein when expanded the first end extends above the first side of the native valve and the second end extends below second side of the native valve. Placement of the valve prosthesis may be facilitated by an opening and closing of the valve during a cardiac cycle.

In some embodiments, the valve prosthesis is detachably coupled to the proximal pusher. In some embodiments, when the valve prosthesis is in the expanded position it is released from the proximal pusher.

In some embodiments, the anchor is a spiral band. The spiral band may comprise a free end. The spiral band may be anchored to one or more native chordae tendinae of the left ventricle. The free end may comprise an atraumatic tip, for example a ball tip. The free end may comprise a key configured to fit into a lock located on the band of the anchor. The spiral band may comprise at least one channel or lumen disposed therein.

In another aspect, a system for treating a diseased native valve in a patient is provided. The system comprises an anchor and a core wire disposed within a lumen of the anchor. The anchor comprises a delivery configuration and deployed configuration. The anchor in the deployed configuration is shaped to encircle chordae or leaflets of a diseased native valve in a patient. The core wire is longitudinally translatable in the lumen of the anchor. The core wire comprises a proximal curved portion when unconstrained and a distal tip. The core wire comprises one or more deflection features disposed adjacent the distal tip and configured to be advanced out of the lumen of the anchor.

In some embodiments, the anchor may be configured to be actuated from the delivery configuration to the deployed configuration adjacent a native valve in a patient.

In some embodiments, a proximal end of the anchor may be coupled to a distal end of a frame structure.

In some embodiments, the anchor may comprise an elongated shape in the delivery configuration.

In some embodiments, the anchor may comprise a curved shape in the deployed configuration. For example, the curved shape may comprise a helical shape. Alternatively, or in combination, the curved shape may comprise a spiral shape. Alternatively, or in combination, the curved shape may comprise a coiled shape. In some embodiments, the proximal curved portion may have a shape which corresponds to the curved shape of the anchor.

In some embodiments, the one or more deflection features may comprise one or more pre-formed waves, bends, kinks, or humps in the distal tip portion of the core wire. The one or more deflection features may, for example, comprise one or more kinks along the distal tip of the core wire such that at least a portion of the distal tip is discontinuous with a curved shape of the proximal curved portion. Alternatively. or in combination, the one or more deflection features may comprise a plurality of waves.

In some embodiments, the core wire may comprise a self-assembly state and an encircling state. The one or more deflection features may comprise a bend near the distal tip of the core wire such that the distal tip of the core wire is positioned adjacent one or more loops of the proximal curved portion in the self-assembly state. Alternatively, or in combination, the one or more deflection features may comprise a bend near the distal tip of the core wire such that the distal tip of the core wire angles towards the proximal curved portion in the self-assembly state. In some embodiments, the one or more deflection features may comprise a bend near the distal tip of the core wire such that the distal tip of the core wire in the encircling state is continuous with a curved shape of the anchor in the deployed configuration. In some embodiments, the one or more deflection features may comprise a bend near the distal tip of the core wire such that the distal tip of the core wire angles away from the proximal curved portion in the encircling state.

In some embodiments, the one or more deflection features may be configured to interact with a free end of the anchor and cause deflection of the distal tip when the core wire is advanced out of the lumen of the anchor, thereby facilitating positioning of the anchor relative to a delivery device during actuation from the delivery configuration to the deployed configuration.

In some embodiments, the anchor may be configured to wrap at least partially around a frame structure in the deployed configuration.

In some embodiments, the core wire may comprise a super-elastic material. For example, the core wire may comprise nitinol.

In some embodiments, the system may further comprise a frame structure having an unexpanded configuration and an expanded configuration. The frame structure may comprise an expandable stent. The expanded configuration may have a generally tubular expanded shape. In some embodiments, the frame structure may comprise an expanded outer periphery in the expanded configuration and a compressed outer periphery when subject to an external radial force in the unexpanded configuration. The compressed outer periphery may be smaller in diameter than the expanded outer periphery. In some embodiments, the frame structure may be balloon-expandable. In some embodiments, the frame structure may be self-expanding.

In some embodiments, the system may further comprise a delivery device. The delivery device may comprise an outer sheath. The anchor may be disposed in a lumen of the outer sheath and maintained in the delivery configuration by radial constriction from the outer sheath. Advancement of the anchor out of the lumen of the outer sheath may actuate the anchor into the deployed configuration. In some embodiments, a pusher portion of the core wire may extend from the proximal curved portion to a proximal end of the delivery device. Optionally, the delivery device may further comprise an inner shaft disposed within the lumen of the outer sheath. A proximal portion of a frame structure or a proximal end of the anchor may be coupled to a distal portion of the inner shaft. In some embodiments, advancement of the inner shaft towards an opening of the lumen of the outer sheath may advance the anchor out of the lumen of the outer shaft and actuate the anchor into the deployed configuration. In some embodiments, the system may further comprise a frame structure and the frame structure may be maintained in an unexpanded configuration by radial constriction from the outer sheath. Advancement of the inner shaft out of the lumen of the outer sheath may actuate the frame structure into an expanded configuration. In some embodiments, the outer sheath may be steerable. In some embodiments, the anchor may be configured to wrap at least partially around the inner shaft in the deployed configuration. In some embodiments, a central axis of the anchor may be co-axial with a longitudinal axis of the inner shaft when the anchor is in the deployed configuration. In some embodiments, the system may further comprise a frame structure detachably coupled to the delivery device in an unexpanded configuration during delivery to the native valve. In some embodiments, the system may further comprise a frame structure, wherein expansion of the frame structure to an expanded configuration may detach the frame structure from the delivery device.

In some embodiments, the distal tip may comprise an atraumatic tip. For example, the distal tip may comprise a ball tip.

In some embodiments, the distal tip may be configured for piercing tissue.

In some embodiments, the proximal curved portion may comprise a spiral wire.

In some embodiments, the proximal curved portion may comprise a helical wire.

In some embodiments, the core wire may comprise a first wire and a second wire. The first wire and the second wire may be configured to be longitudinally translatable independent of one another. The first wire and the second wire may be disposed in a housing. The housing may be flexible. Translation of the first and second wires relative to one another may change the curvature of the housing.

In some embodiments, a free end of the anchor may extend radially outward from the curved shape.

In some embodiments, the system may further comprise a frame structure configured for expanding within the native valve of the patient.

In some embodiments, the system may further comprise a frame structure. The anchor may be configured to be fully advanced from an atrial side of the native valve into a ventricle of the heart and anchor the frame structure to the native valve when the frame structure is in an expanded configuration adjacent the native valve. An unexpanded configuration of the frame structure may be sized and dimensioned for percutaneous insertion and the expanded configuration may be sized and dimensioned for implantation in the native valve of the patient. In some embodiments, the frame structure may comprise a first and second opposite ends, the first end extending above a native valve and the second end extending below the native valve when the frame structure is anchored to the native valve. Alternatively, the frame structure may sit below the native valve when the frame structure is anchored to the native valve.

In some embodiments, the system may further comprise a frame structure and a valve segment within the frame structure comprising a biocompatible one-way valve. At least a portion of the valve segment may be positioned within at least a portion of the frame structure. The valve segment may comprise at least one leaflet having an inner layer and an outer layer, and the frame structure may be attached to the outer layer at one or more ends of the frame structure. Alternatively, or in combination, the valve segment may comprise a plurality of leaflets.

In another aspect, a method for treating a diseased native valve in a patient is provided. The method comprises advancing a distal end of a delivery device from a first side of a native valve to a second side of the native valve, wherein the distal end of the delivery device is detachably coupled to an anchor, the anchor comprising a delivery configuration, a deployed configuration, a lumen, an opening, a free end, and a core wire disposed within the lumen, the core wire comprising a proximal curved portion and a distal tip portion, the distal tip portion comprising a distal tip and one or more deflection features disposed therealong and configured to interact with the free end and cause deflection of the distal tip when the core wire is advanced out of the lumen of the anchor through the opening; actuating the anchor from the delivery configuration to the deployed configuration adjacent the native valve by (i) advancing the free end of the anchor out of delivery device, (ii) deflecting the distal tip of the core wire by moving the one or more deflection features disposed along the distal tip portion past the opening of the lumen of the anchor into a self-assembly state, and (iii) advancing a remainder of the anchor out of the lumen of the outer shaft through the opening; and retracting the delivery device from the native valve.

In some embodiments, the method may further comprise steering the distal end of the delivery device such that the distal end of the delivery device points towards the first side of the native valve.

In some embodiments, the anchor may be configured to wrap at least partially around the delivery device in the deployed configuration.

In some embodiments, the anchor may be configured to wrap at least partially around a frame structure in the deployed configuration.

In some embodiments, a central axis of the anchor may be co-axial with a longitudinal axis of the inner shaft when the anchor is in the deployed configuration.

In some embodiments, actuating the anchor may comprise releasing a frame structure detachably coupled to the distal end of the delivery device from radial constriction by the delivery device.

In some embodiments, actuating the anchor may comprise actuating the anchor from the delivery configuration to the deployed configuration on the second side of the native valve.

In some embodiments, actuating the anchor may comprise actuating the anchor from the delivery configuration to the deployed configuration on the first side of the native valve and may further comprise advancing the anchor in the deployed configuration through the native valve to the second side of the native valve. Advancing the anchor may comprise pushing the anchor through the native valve. Alternatively, or in combination, advancing the anchor may comprise rotating the anchor through the native valve.

In some embodiments, actuating the anchor may comprise positioning the anchor such that it is located only on the second side of the native valve.

In some embodiments, the distal end of the delivery device may be detachably coupled to a frame structure. The method may further comprise expanding the frame structure within the native valve from an unexpanded configuration to an expanded configuration. In some embodiments, the frame structure may comprise a first and second opposite ends and expanding the frame structure may comprise expanding the frame structure such that the first end extends above the first side of the native valve and the second end extends below second side of the native valve. In some embodiments, expanding the frame structure may comprise expanding at least a portion the frame structure within at least a portion of the deployed anchor to anchor the frame structure to the native valve. In some embodiments, the method may further comprise releasing the frame structure from the distal end of the delivery device. Expanding the frame structure and releasing the frame structure may occur simultaneously. In some embodiments, the frame structure may be balloon-expandable and expanding the frame structure may comprise inflating a balloon disposed within the frame structure, wherein inflation of the balloon causes expansion of the frame structure. In some embodiments, the frame structure may be self-expanding and expanding the frame structure may comprise releasing the frame structure from radial constriction by the delivery device. In some embodiments, the frame structure may comprise a valve segment therewithin comprising a biocompatible one-way valve.

In some embodiments, the one or more deflection features may comprise one or more pre-formed waves, bends, kinks, or humps in the distal tip portion of the core wire. The one or more deflection features may, for example, comprise one or more kinks along the distal tip of the core wire such that at least a portion of the distal tip is discontinuous with a curved shape of the proximal curved portion. Alternatively. or in combination, the one or more deflection features may comprise a plurality of waves.

In some embodiments, the core wire may comprise a self-assembly state and an encircling state.

In some embodiments, the one or more deflection features may comprise a bend near the distal tip of the core wire such that the distal tip of the core wire is positioned adjacent one or more loops of the proximal curved portion in the self-assembly state.

In some embodiments, the one or more deflection features may comprise a bend near the distal tip of the core wire such that the distal tip of the core wire angles towards the proximal curved portion in the self-assembly state.

In some embodiments, the one or more deflection features may comprise a bend near the distal tip of the core wire such that the distal tip of the core wire in the encircling state is continuous with a curved shape of the anchor in the deployed configuration.

In some embodiments, the one or more deflection features may comprise a bend near the distal tip of the core wire such that the distal tip of the core wire angles away from the proximal curved portion in the encircling state.

In some embodiments, the method may further comprise rotating the distal tip of the core wire around one or more structures on the second side of the native valve.

In some embodiments, the method may further comprise rotating the free end of the deployed anchor around one or more structures on the second side of the native valve. The one or more structures may comprise one or more valve leaflets of the native valve. Alternatively. or in combination, the one or more structures may comprise one or more chordae of the left ventricle.

In some embodiments, the distal tip may comprise an atraumatic tip. For example, the distal tip may comprise a ball tip.

In some embodiments, the distal tip may be configured for piercing tissue.

In some embodiments, the proximal curved portion may comprise a spiral wire.

In some embodiments, the proximal curved portion may comprise a helical wire.

In some embodiments, the core wire may comprise a first wire and a second wire. The first wire and the second wire may be configured to be longitudinally translatable independent of one another. The first wire and the second wire may be disposed in a housing. The housing may be flexible. The method may further comprise translating the first and second wires relative to one another, thereby changing a curvature of the housing.

In some embodiments, a free end of the anchor may extend radially outward from the curved shape.

In some embodiments, the native valve may be in a heart of a patient. In some embodiments, the method may further comprise transseptally inserting the distal end of the delivery device into a left atrium of the heart. In some embodiments, the native valve may comprise a mitral valve, the first side of the native valve may comprise a left atrium, and the second side of the native valve may comprise a left ventricle.

These and other embodiments are described in further detail in the following description related to the appended drawing figures.

INCORPORATION BY REFERENCE

DETAILED DESCRIPTION

The present disclosure is described in relation to deployment of systems, devices, or methods for treatment of a diseased native valve of the heart, for example a mitral valve, aortic valve, or tricuspid. However, one of skill in the art will appreciate that this is not intended to be limiting and the devices and methods disclosed herein may be used in other anatomical areas and in other surgical procedures.

For convenience in explanation and accurate definition in the appended claims, the terms “up” or “upper”, “down” or “lower”. “inside” and “outside” are used to describe features of the present disclosure with reference to the positions of such features as displayed in the figures.

In many respects the modifications of the various figures resemble those of preceding modifications and the same reference numerals followed by subscripts “a”, “b”, “c”, and “d” designate corresponding parts. It will be understood by one of ordinary skill in the art that modifications of corresponding parts of the various figures are interchangeable with one another between embodiments to arrive at multiple combinations with multiple modified parts.

FIG. 1shows a side view of a valve prosthesis system100comprising a frame structure12and an anchor15loaded on a distal end of a delivery device30with the anchor15in an elongated, low-profile delivery configuration.FIG. 2shows a side view of a valve prosthesis system100ofFIG. 1comprising a valve prosthesis10loaded on a distal end of a delivery device30. The valve prosthesis10may have an unexpanded configuration (for example, a compressed configuration as described herein) and an expanded configuration. The valve prosthesis10in the expanded configuration may have a generally tubular expanded shape. In some embodiments, the unexpanded configuration may be sized and dimensioned for percutaneous insertion, and the expanded configuration may be sized and dimensioned for implantation in the native valve of the patient. The valve prosthesis10may be configured to be fully advanced from a first side of a native valve in a patient (e.g., an atrial side) to a second side of the native valve (e.g., into a ventricle of the heart) and anchor to the native valve when the valve prosthesis10is in the expanded configuration adjacent the native valve. It will be understood that the valve prosthesis10may be any valve prosthesis described herein or understood based on the teachings herein to one of ordinary skill in the art.

In various embodiments, the unexpanded configuration may be 18Fr or smaller. In various embodiments, the unexpanded configuration may be 20Fr or smaller. In various embodiments, the unexpanded configuration may be 22Fr or smaller. In various embodiments, the unexpanded configuration may be 24Fr or smaller. In various embodiments, the unexpanded configuration may be 26Fr or smaller. In various embodiments, the unexpanded configuration may be 27Fr or smaller. In various embodiments, the unexpanded configuration may be 28Fr or smaller. In various embodiments, the unexpanded configuration may be 29Fr or smaller. In various embodiments, the unexpanded configuration may be 30Fr or smaller. In various embodiments, the unexpanded configuration may be sized and dimensioned for transseptal access. In various embodiments, the unexpanded configuration may be sized and dimensioned for femoral access.

Referring toFIGS. 58A-58B, the valve prosthesis10can include an anchor15, a frame structure12, and a valve segment14. As used herein. “prosthetic valve” may refer to all manner of prosthetic and artificial replacement valves and leaflets, including tissue (biological valves), tissue-engineered valves, polymer valves (e.g., biodegradable polymer valves), and even certain mechanical valves.

FIGS. 58A-58Bshow an exemplary use of the valve prosthesis10.FIG. 58Ais a section view of a diseased valve comprising a left atrium25and a left ventricle26with the valve prosthesis10implanted into a native valve. The anchor15is wrapped around the native chordae tendineae40of the native valve.FIG. 58Bis a top view of the valve prosthesis10showing the valve segment14and the frame structure12within the native valve.

The valve segment14can be similar to existing transcatheter valves. The valve segment14can be similar to existing surgical tissue valves, and mechanical valves. At least a portion of the valve segment14may be positioned within at least a portion of the valve prosthesis10, for example with the frame structure12of the valve prosthesis10. The valve segment14may include leaflets formed of multi-layered materials for preferential function. The valve segment14may comprise at least one leaflet having an inner layer and an outer layer. The valve segment14may be attached directly to the valve prosthesis10. Alternatively, the valve segment14may be attached to an intermediate valve structure that is in turn connected to the valve prosthesis10. The valve segment14may be connected to the valve prosthesis10before or after the valve prosthesis10has been deployed adjacent a native valve. The valve prosthesis10may be attached to a leaflet of the valve segment14, for example an outer layer of a leaflet, at one or more ends of the valve prosthesis10. The valve prosthesis10may be attached to a leaflet of the valve segment14, for example an outer layer of a leaflet, at one or more intermediate portions of the valve prosthesis10. The valve segment may comprise a plurality of leaflets. The valve segment14may comprise a biocompatible one-way valve. Flow in one direction may cause the leaflet(s) to deflect open and flow in the opposite direction may cause the leaflet(s) to close.

The frame structure12may be configured like a stent. The frame structure12may, for example, comprise a scaffold in a diamond pattern formed from a shape memory material (e.g., NiTi). One of ordinary skill in the art will appreciate that many other structures, materials, and configurations may be employed for the frame structure12. For example, the frame structure12may be formed of a polymer of sufficient elasticity. The frame structure12may be formed of a combination of metal and polymer, such as metal (e.g., shape memory material) covered in polymer. The frame structure12may include a variety of patterns besides diamond shapes. In some embodiments, frame structure12is a closed frame such that blood flow is forced through valve segment therein. One or more skirts and/or seals may help force blood through valve segment.

The anchor can be configured to fix the prosthesis10in place within the body (e.g., within a cardiac valve).

One of ordinary skill in the art will recognize based on the description herein that any of the valve prostheses described herein may comprise any of the frame structure shapes, frame structure designs, frame structure materials, anchor shapes, anchor windings, anchor materials, free end tips, leaflet(s) configurations, or any other of the variable features described herein in any combination thereof as desired.

The valve prosthesis may additionally or alternatively include any of the features of any of the valve prostheses described in PCT/US2019/047542, PCT/US2019/055049, PCT/US2019/057082, and PCT/US2019/068088, the entireties of which are incorporated by reference herein.

Referring toFIGS. 1-2, in some embodiments, the anchor15may comprise a wire20having a free end22. The other end of the anchor15may be coupled to the top (proximal end) or bottom (distal end) of the frame structure12as described herein. Alternatively, or in combination, the other end of the anchor15may not be attached to the frame structure12as described herein. The anchor15may be configured to wrap at least partially around the frame structure12in the deployed configuration. The anchor15may be configured to be fully advanced from a first side of a native valve in a patient (e.g., an atrial side) to a second side of the native valve (e.g., into a ventricle of the heart) and anchor the frame structure12to the native valve when the frame structure12is in the expanded configuration adjacent the native valve.

The anchor15may comprise a delivery (e.g., elongated) configuration (shown inFIG. 1) and a deployed configuration (shown inFIG. 2). The frame structure12may be configured to remain in its unexpanded configuration while the anchor15is in the deployed configuration. In various embodiments, the anchor15may be self-expanding and may move to the deployed configuration as it is removed from the delivery sheath. In various embodiments, the anchor15may be configured to self-assemble when it is deployed in the heart cavity (e.g., left ventricle or atrium). The anchor15may be configured to be actuated from the delivery configuration to the deployed configuration adjacent the native valve using any method or mechanism understood by one of ordinary skill in the art from the description herein. For example, retraction of the guidewire54into a lumen of the inner shaft52of the delivery device30may actuate the anchor15into the deployed configuration. Alternatively, or in combination, the anchor15may be maintained in the delivery configuration by radial constriction from an outer sheath50(see, e.g.,FIG. 3D) of the delivery device30. In such an embodiment, advancement of an inner shaft52of the delivery device30out of the lumen of the outer sheath50may actuate the anchor15into the deployed configuration, as described further herein.

Although referred to as an anchor, one will appreciate that anchor15does not require performing an anchor function in the traditional sense. As will be described in more detail below, the anchor15can guide valve prosthesis10into a desired position within a native valve. The anchor15may also mitigate against undesired entanglement and disturbances to the chordae tendineae and valve leaflets of the cardiac valve, such as the mitral valve.

In some embodiments, the anchor15may be configured to wrap at least partially around a distal portion of the delivery device30, for example around the inner shaft52, in the deployed configuration.

In some embodiments, the anchor15may be actuated from the delivery configuration to the deployed configuration on a first side of the native valve prior to being advanced to a second side of the native valve. For example, the anchor15may be deployed in a left atrium of a heart prior to being advanced to a left ventricle of the heart as described herein.

Alternatively, the anchor15may be actuated from the delivery configuration to the deployed configuration on a second side of the native valve after being advanced to the second side from a first side of the native valve. For example, anchor15may be advanced from a left atrium of a heart prior to being deployed in a left ventricle of the heart.

The anchor15may be detachably coupled to a proximal or distal portion of the frame structure12. Alternatively, or in combination, the anchor15may be detachably coupled to the delivery device30in the delivery configuration during delivery to the native valve. For example, the proximal end57of the anchor15may be detachably coupled to the inner shaft52of the delivery device30and/or a tether78(see, e.g.,FIGS. 89A-89C), for example, by radial constriction from the outer sheath50. Retraction of the outer sheath50away from the proximal end57of the anchor15(or, similarly, extrusion of the distal end of the anchor15out of an opening in the outer sheath50) may detach the anchor15from the delivery device30. Alternatively, or in combination, the proximal end57of the anchor15may be detachably coupled to the inner shaft52of the delivery device30by an attachment element58(seeFIG. 1). Alternatively, or in combination, the proximal end57of the anchor15may be detachably coupled to the inner shaft52of the delivery device30by a weak adhesive.

The anchor15may be configured to rotate when the inner shaft52or other element of the delivery device30is rotated. Rotation of the anchor15may aid in advancement of the anchor15to the second side of the native valve. Alternatively. or in combination, rotation of the anchor15may aid in capture of one or more structures on the second side of the native valve by the free end22as described herein. By capturing one or more structures on the second side of the native valve, the anchor15may maintain its position relative to the native valve and provide an anchor point for the frame structure12when in the expanded configuration.

The wire20of anchor15may comprise a curved wire in the deployed configuration, for example a coiled wire or band, a helical wire or band, or a spiral wire or band as described herein. The wire20may be shaped to encircle chordae and/or leaflets of a diseased native valve. In various embodiments, the wire20may have a curved shape in the deployed configuration and an elongated—rather than curved—shape in the delivery configuration. For example, the wire20may be elongated into a straight shape within the delivery device30. In various embodiments, a portion of the wire20may have a curved encircling shape. In various embodiments, a substantial portion of the wire or band20may have a curved encircling shape. In various embodiments, the wire20may be formed as a flat curve (in the deployed configuration) whereby the loops generally are positioned within the same plane (the plane being perpendicular to a longitudinal axis). In various embodiments, the wire may be formed as a three-dimensional curve (in the deployed configuration) whereby the loops generally are positioned out of plane with one another.

The wire20may comprise a helical wire in the deployed configuration. As used herein, a helix or helical shape may comprise a curve for which the tangent at any point along the curve makes a constant angle with a fixed line (e.g., a central axis). The curve may turn around an axis at a constant or continuously varying distance while moving parallel to the axis. In some embodiments, the wire20may comprise one or more helical portions as described herein.

In various embodiments, free end22extends radially outward from frame structure12, and in particular the remainder of wire20. As will be described below, the free end22is configured to encircle a larger radius than the main coils of the wire20. When the main coils of wire20have a generally curved shape (e.g., spiral, helical, tubular, frustoconoical, etc.), the free end22may extend radially outward from the curved shape. For example, when the main coils of wire20have a generally spiral shape, the free end22may extend radially outward from the spiral shape. When the main coils of wire20have a generally tubular shape, the free end22may extend radially outward from the tubular shape. When the main coils of wire20have a generally helical shape, the free end22may extend radially outward from the helical shape. When the main coils of wire20have a generally frustoconical shape, the free end22may extend radially outward from the frustoconical shape. When the main coils of wire20have a generally cylindrical shape, the free end22may extend radially outward from the cylindrical shape. The free end22may be configured to encircle a larger radius than the main coils of the helical wire20. The larger diameter facilitates capturing of the valve leaflets and/or chordae tendineae within the sweep of the free end22when rotated as described herein.

In various embodiments, the wire or band20may have a generally helical shape in the deployed configuration. In various embodiments, the wire or band20may be elongated-rather than helix-shaped—in the delivery configuration. For example, the wire or band20may be elongated into a straight shape within the delivery device. In various embodiments, a portion of the wire or band20may have a helical shape. In various embodiments, a substantial portion of the wire or band20may have a helical shape. In various embodiments, the helical wire or band20may be formed as a three-dimensional helix (in the deployed configuration) whereby the loops generally are positioned around the same axis (for example, a longitudinal axis of the delivery device30).

Optionally, the anchor15may comprise a first portion comprising the helical wire20and another portion. Alternatively, or in combination, the anchor15may comprise a plurality of helical wires20. For example, the anchor15may comprise at least two helical wires20having the same or different diameters. Alternatively. or in combination, the anchor15may comprise at least two helical wires20having the same or different winding pitches.

The wire20may comprise a spiral wire or band in the deployed configuration. As used herein, a spiral or spiral shape may comprise a curve which emanates from a point (e.g., a central point) having a continuously increasing or decreasing distance from the point. The spiral or spiral shape may be two-dimensional (e.g., planar) or three-dimensional. In some embodiments, the wire or band20may comprise one or more spiral portions as described herein.

In various embodiments, the anchor and/or core wire may have a spiral-shaped deployed configuration. In various embodiments, spiral refers to a shape with windings about a central axis. The spiral may be continuous. The windings may gradually widen (or tighten) along the length. The spiral may be formed in a flat plane perpendicular to the central axis. In various embodiments, the anchor and/or core wire may have a deployed configuration that is not formed in a flat plane, or in other words the deployed shape is formed in a three-dimensional and/or non-degenerate space. In various embodiments, the anchor and/or core wire may have a conical-shaped deployed configuration including, but not limited to, tubular, conical, frustoconical, and/or helical shapes.

In various embodiments, the anchor15may comprise a flat spiral shape. Loops of the flat spiral shaped anchor may be generally positioned within the same plane (the plane being perpendicular to a longitudinal axis of a delivery device) as described herein.

The free end22of the spiral band or wire20may extend radially outward from the frame12, and in particular from the remainder of the spiral band or wire20. The other end of the spiral band or wire20may be coupled to the top or bottom of the frame structure12as described herein. Alternatively, or in combination, the other end of the spiral band or wire20may not be attached to the frame structure12as described herein. The free end22of the spiral band or wire20may facilitate capturing of the valve leaflets and/or chordal tendineae within the sweep of the free end during rotation as described herein. During rotation of the spiral band or wire20, the leaflets and/or chordae tendineae may be captured by the free end22and trapped between the valve frame structure12and an interior surface of the spiral band or wire20.

In various embodiments, the wire or band20may have a generally spiral shape in the deployed configuration. In various embodiments, the wire or band20may be elongated—rather than spiral-shaped—in the delivery configuration. For example, the wire or band20may be elongated into a straight shape within the delivery device. In various embodiments, a portion of the wire or band20may have a spiral shape. In various embodiments, a substantial portion of the wire or band20may have a spiral shape. In various embodiments, the spiral wire or band20may be formed as a flat spiral (in the deployed configuration) whereby the loops generally are positioned within the same plane (the plane being perpendicular to a longitudinal axis).

Optionally, the anchor15may comprise a first portion comprising the spiral wire20and another portion. Alternatively, or in combination, the anchor15may comprise a plurality of spiral wires20. For example, the anchor15may comprise at least two spiral wires20having the same or different diameters. Alternatively, or in combination, the anchor15may comprise at least two spiral wires20having the same or different winding pitches.

The wire20may comprise one or more loops. For example, the wire20may comprise a plurality of loops, which may increase the radial strength of the anchor by increasing friction and addition structural support. The one or more loops of the wire20may be substantially cylindrical around a central axis of the wire20, for example along an axis which is coaxial with a longitudinal axis of a delivery device30. The one or more loops of the wire20may be substantially helical around a central axis or helical axis of the wire20, for example along an axis which is coaxial with a longitudinal axis of a delivery device. The one or more loops of the wire20may spiral radially outward from a central point or central axis of the wire20, for example along an axis which is coaxial with a longitudinal axis of a delivery device30such that the wire20lies approximately along a plane perpendicular to the longitudinal axis of the delivery device30.

The one or more loops (also referred to herein as coils or turns) of the wire or band20may comprise a curved shape that bends around back towards its origin (for example, an arc, ellipsoid, circle, or the like). In some embodiments, a loop may comprise a curved shape that bends back towards its origin but does not cross itself, making a rotation within a range of about 180 degrees to about 360 degrees. For example, a loop may comprise a curve or an arc having a central angle within a range of about 180 degrees to about 360 degrees. In at least some embodiments, the one or more loops may comprise an arc. In some embodiments, a loop may comprise a shape that bends back towards and crosses itself, making at least a 360 degree rotation. In at least some embodiments, the one or more loops may comprise a 360 degree rotation (for example, a circle). In some embodiments, the one or more loops may comprise a 360 degree to 720 degree rotation (for example, a loop crossing itself once and rotating further towards a second crossing and formation of a second360loop).

Interaction of the frame structure12with the one or more loops of the anchor15may create opposing forces therebetween that provide mechanical leverage for anchoring the frame structure12to the one or more anatomical structures. In some embodiments, the one or more loops may comprise at least 360 degrees of rotation when deployed such that the loops wrap around one another and provide additional mechanical leverage against the frame structure12in order to facilitate anchoring of the frame structure12as described herein. Additional loops or partial loops may provide additional mechanical strength and/or leverage.

In some embodiments, the one or more loops of the wire or band20may comprise one or more spaces therebetween. The spaces may facilitate movement of the captured tissue (e.g. chordae and/or leaflets) from the free end22to the center of the spiral structure during rotation of the anchor15as described herein.

The wire20may be configured to wrap at least partially around the frame structure12in the deployed configuration.

In some embodiments, the wire20may be configured to wrap at least partially around a distal portion of the delivery device30, for example around the inner shaft, in the deployed configuration.

The free end22of the wire20may be sized and dimensioned for insertion through the native valve, for example through tissue at or near a commissure of the native valve or through the valve opening itself. In some embodiments, the free end22of the wire20may comprise an atraumatic tip to avoid reduce risk of injury to the native valve tissue and leaflets. For example, the free end may comprise a blunt end, a ball tip, a curved tip (e.g., J-tip or pigtail), or other atraumatic shapes. Alternatively, the free end22of the wire20may be configured for piercing tissue.

In various embodiments, the free end22is separate from and extends outward from the main coils of the anchor15. In various embodiments, the main body coils of the anchor15circumscribe an area (in the case of a spiral coil) or a volume (in the case of a helical coil) having a diameter, and the free end22extends to a radius greater than the diameter of the anchor15. In various embodiments, the free end22extends to a radius substantially greater than the diameter of the anchor15. In various embodiments, the free end22is configured to circumscribe a larger diameter than the anchor15. In various embodiments, the free end22is configured to circumscribe all of the chordae tendineae of the native valve to be treated.

In various embodiments, the free end22may be shaped and configured to reduce the risk of counter-rotation. For example, the tip22may have a curled end to cause the free end22to snag chordae if it is rotated in a direction opposite the anchoring rotation.

The free end22of the wire or band20may optionally rotated around one or more structures on the second side of the native valve such that the one or more structures (e.g., chordae, leaflets, or annulus) are pulled radially inwards towards the longitudinal axis of the anchor15and/or towards the longitudinal axis of the delivery device30. The wire or band20and/or free end22may be configured such that minimal torque is applied to the one or more structures. Alternatively, or in combination, the wire or band20and/or free end22may be configured such that the one or more structures are not rotated, or are minimally rotated, during rotation of the wire or band20. For example, the wire or band20may comprise one or more spaces between loops of the curved wire or band which facilitate radially-inward movement of the captured tissue (e.g. chordae and/or leaflets) from the free end22to the center of the curved structure with little or no torque and/or rotation of the structures during rotation of the wire or band20as described herein. Alternatively or in combination, the wire or band20may be configured such that, when fully deployed none of the structures reside between the loops of the curved encircling shape. Instead, the one or more structures may sit radially inward of the loops in order to facilitate capture of the one or more structures between the wire or band20and the expanded frame structure12. The one or more structures may retain or nearly retain their normal anatomical position when the wire or band20is fully deployed.

Wire20may be formed of a material having sufficient rigidity to hold a predetermined shape. The wire may, for example, be formed of a shape memory material (e.g., NiTi). It may be desirable for at least an end portion (e.g., free end22) to be relatively rigid such that it can exert a force to move chordal tendineae, while still retaining flexibility to be collapsed within a delivery device. In various embodiments, the end portion only needs sufficient rigidity to hold its shape and will deform under a load. For example, the end portion may be configured with a similar rigidity to a guidewire, or slightly stiffer.

In various embodiments, wire20has varying stiffness along its length. The wire20may have two or more segments of differing stiffness and/or the stiffness may transition over its length. In various embodiments, wire20is attached to frame12at multiple points such that free end22is relatively flexible and the wire20is more rigid along portions where it is attached to the frame structure12.

The anchor15may be configured to taper in height axially. For example, the anchor15may be configured to taper in height from a first end of the anchor15, which may be coupled to a delivery device and/or frame structure as described herein, to a free end22of the anchor15. In some embodiments, the anchor15may taper in height from a proximal end to a distal end. Alternatively, the anchor15may taper in height from a distal end to a proximal end. The anchor15may be tapered such that subsequent turns of the tapered anchor15nest into each other so as to reduce a radial footprint of the tapered anchor15. The anchor15may, for example, comprise a solid wire-like spiral band with a taper as described herein. In some embodiments, the anchor15may comprise a plurality of spiral support wires.

FIGS. 66 and 67show top views of two embodiments of an anchor15.FIG. 66is a top view of an anchor15comprising a cylindrical (i.e., a round wire or tubular) spiral band17and a free end22.FIG. 67is a top view of an anchor15comprising a flat (i.e., a flat ribbon) spiral band17and a free end22. As used herein, a spiral or spiral shape may comprise a curve which emanates from a point (e.g., a central point) having a continuously increasing or decreasing distance from the point. The spiral or spiral shape may be two-dimensional (e.g., planar) or three-dimensional.

The spiral band17may be configured to anchor the frame structure12to the native valve when the frame structure12is in the expanded configuration adjacent the native valve. The frame structure12may be configured to be actuated from the unexpanded configuration to the expanded configuration adjacent a native valve in a patient. The spiral band17may be configured to be fully advanced from a first side of a native valve in a patient (e.g. an atrial side) to a second side of the native valve (e.g. into a ventricle of the heart) and anchor the frame structure12to the native valve when the frame structure12is in the expanded configuration adjacent the native valve as described herein.

During deployment and/or rotation of the spiral band17, the leaflets and/or chordae tendineae may be captured by the free end22and trapped between the valve frame structure12and an interior surface of the spiral band17. The free end22and the spiral band17may optionally rotated around one or more structures on the second side of the native valve such that the one or more valve structures (e.g., chordae, leaflets, or annulus) are pulled radially inwards towards the longitudinal axis of the anchor15and/or towards the longitudinal axis of the delivery device30. The spiral band17and/or free end22may be configured such that minimal torque is applied to the one or more valve structures. Alternatively. or in combination, the spiral band17and/or free end22may be configured such that the one or more valve structures are not rotated, or are minimally rotated, during rotation of the spiral band17. For example, the spiral band17may comprise one or more spaces18between loops of the spiral band17, which facilitate movement of the captured tissue (e.g. chordae and/or leaflets) from the free end22to the center of the spiral band17with little or no torque and/or rotation of the structures during rotation of the spiral band17. Alternatively, or in combination, the spiral band17may be configured such that, when fully deployed (for example, as shown inFIG. 67), none of the valve structures reside between the loops of the spiral band17. Instead, the one or more valve structures may sit radially inward of the loops of the spiral band17in order to facilitate capture of the one or more valve structures between the spiral band17and the expanded frame structure12. The one or more valve structures may retain or nearly retain their normal anatomical position when the spiral band17is fully deployed.

The spiral band17may comprise a delivery (e.g. an elongated) configuration and a deployed configuration. The spiral band17may be configured to be actuated from the delivery configuration to the deployed configuration adjacent a native valve in a patient. In various embodiments, the spiral band17may have a generally spiral shape in the deployed configuration. In various embodiments, the spiral band17may be elongated—rather than spiral-shaped—in the delivery configuration. For example, the spiral band17may be elongated into a straight shape within the delivery device. In various embodiments, a portion of the band17may have a spiral shape. In various embodiments, a substantial portion of the spiral band17may have a spiral shape. In various embodiments, the spiral band17may be formed as a flat spiral (in the deployed configuration) whereby the loops generally are positioned within the same plane (the plane being perpendicular to a longitudinal axis).

Spiral band17may be formed of a material having sufficient rigidity to hold a predetermined shape. The wire may, for example, be formed of a shape memory material (e.g. NiTi). It may be desirable for at least an end portion (e.g. free end22) to be relatively rigid such that it can exert a force to move chordal tendineae, while still retaining flexibility to be collapsed within a delivery device. In various embodiments, the end portion only needs sufficient rigidity to hold its shape and will deform under a load. For example, the end portion may be configured with a similar rigidity to a guidewire, or slightly stiffer.

The one or more loops (also referred to herein as coils or turns) of the spiral band17may comprise a shape that bends around back towards its origin (for example, an arc, ellipsoid, circle, or the like). In some embodiments, a loop may comprise a shape that bends back towards its origin but does not cross itself, making a rotation within a range of about 180 degrees to about 360 degrees. For example, a loop may comprise an arc having a central angle within a range of about 180 degrees to about 360 degrees. In at least some embodiments, the one or more loops may comprise an arc. In some embodiments, a loop may comprise a shape that bends back towards and crosses itself, making at least a 360 degree rotation. In at least some embodiments, the one or more loops may comprise a 360 degree rotation (for example, a circle). In some embodiments, the one or more loops may comprise a 360 degree to 720 degree rotation (for example, a loop crossing itself once and rotating further towards a second crossing and formation of a second360loop).

The spiral band17may comprise a spiral wire. The spiral band17may comprise a plurality of spiral wires as described.

In some embodiments, the spiral band17may be configured to wrap at least partially around a distal portion of the delivery device30, for example around the inner shaft, in the deployed configuration.

The spiral band17may comprise one or more loops. For example, the spiral band17may comprise a plurality of loops, which may increase the radial strength of the anchor by increasing friction and additional structural support. The one or more loops of the spiral band17may be spiral radially outward from a central point or central axis of the spiral, for example along an axis which is coaxial with a longitudinal axis of a delivery device30such that the spiral band17lies approximately along a plane perpendicular to the longitudinal axis of the delivery device30.

FIG. 74shows a perspective view of another exemplary anchor15. The exemplary anchor15can include a plurality of lumens71disposed within an outer jacket80.FIG. 75shows a cross-sectional view of the anchor15ofFIG. 74. The anchor15may be substantially similar to any of the anchors described herein except that, instead of a single solid band or wire20, the anchor15may comprise a composite structure. For example, the anchor15may comprise an outer jacket80and one or more support structures81disposed within one or more lumens71of the outer jacket80. The one or more support structures81may be fixedly disposed within the one or more lumens71. In the exemplary embodiment shown, the anchor15may comprise two lumens71with support structures81disposed therein and a third open lumen71. The third open lumen71may allow other device components to slide through the anchor15during delivery.

The outer jacket80may be configured to provide circumferential constraint to the one or more support structures81and/or other structures (e.g., longitudinally translatable core wires74as shown and described with respect toFIGS. 78-80). The outer jacket80may comprise a soft, flexible material. For example, the outer jacket80may comprise an extruded plastic, a soft textile, or a biological material. For example, the outer jacket80may include polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), pericardium, and other materials as would be understood by one of skill based on the description herein. The outer jacket80may have a generally tubular shape. The outer jacket80may have a cross-section of any shape desired, for example a circular, tubular, hollow, square, elongated, ovoid, triangular, or any other shaped cross-section. The cross-sectional shape of the outer jacket80may, for example, be selected to facilitate deployment from the delivery device. Alternatively, or in combination, the shape of the outer jacket80may be selected to reduce pulling, torqueing, or otherwise damaging the one or more native structures as it is rotated therearound. Alternatively. or in combination, the shape of the outer jacket80may be selected to provide sufficient radial strength when a frame structure is expanded therein to anchor the frame structure to the one or more structures therebetween.

In some embodiments, the anchor15may comprise a single lumen71within the outer jacket80. The single lumen71may comprise one or more support structures81disposed therein. Alternatively, or in combination, the first lumen71may comprise one or more translatable and/or removable core wires74(e.g., as shown inFIGS. 78-80) disposed therein. In one embodiment, the single lumen71may be configured to remain at least partially open when at least one support structure81is fixedly disposed therewithin in order to allow one or more translatable core wires74to be disposed within the open portion of the single lumen alongside the at least one support structure81.

In some embodiments, the anchor15may comprise at least two lumens71. For example, the anchor15may comprise a first lumen71and a second lumen71. In some embodiments, the anchor15may further comprise a third lumen71, for example as shown inFIGS. 74-78. In some embodiments, at least one of the plurality of lumens71may comprise one or more support structures81fixedly disposed therewithin. In some embodiments, all of the lumens71may comprise one or more support structures81fixedly disposed therewith. In some embodiments, at least one of the lumens71may be an open lumen71. In some embodiments, at least a portion of at least one of the lumens71may remain partially open after one or more support structures are disposed therewithin. In some embodiments, all of the lumens71may be open (or partially open) lumens71.

It will be understood by one of ordinary skill in the art based on the teachings herein that the anchor15may comprise any number of lumens71desired. For example, the anchor15may comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more lumens71disposed within the outer jacket80.

In some embodiments, the one or more support structures81may comprise one or more stiffening members, wires, hypotubes, guidewires, or the like, or any combination thereof. The one or more support structures81may comprise a super-elastic material such as nitinol. The one or more support structures81may be shaped to correspond to the shape of the outer jacket80of the anchor15.

In some embodiments, the one or more support structures81may comprise one or more stiffening members. The stiffening members may be configured to provide stiffness to the anchor15. In some instances, providing one or more support structures81to the anchor15may make the anchor15radially stiffer than an anchor15that does not include a support structure81(e.g., that is only made up of a single band or wire20). This may advantageously result in fewer anchor turns or loops being required to maintain sufficient engagement of the anchor15with the frame structure12. It will be understood by one of ordinary skill in the art based on the teachings herein that the stiffness of the anchor15may be adjusted based on the material of the support structure(s) and/or number of support structure(s) disposed within the outer jacket80.

The one or more support structures81may be fixedly disposed within a lumen71(or lumens) of the anchor15. It will be understood by one of ordinary skill in the art based on the teachings herein that the any number of support structures81may be disposed within the anchor15as desired. For example, there may be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more support structures81disposed within one or more lumens71of the anchor15as desired.

The one or more support structures81may be formed of a material having sufficient rigidity to hold a predetermined shape. The one or more support structures81may, for example, be formed of a shape memory material (e.g., NiTi). It may be desirable for at least a distal end portion of the support structure81to be relatively rigid such that it can exert a force to move chordal tendineae, while still retaining flexibility to be collapsed within a delivery device30. In various embodiments, the distal end portion of the support structure81has sufficient rigidity to hold its shape, but can be configured to deform under a load. For example, the end portion of the support structure81may be configured with a similar rigidity to a guidewire, or slightly stiffer.

The outer jacket80and/or support structures81of the anchor15may comprise a curved shape in the deployed configuration, for example a coiled shape, a helical shape, or a spiral shape as described herein. The outer jacket80and/or support structures81may be shaped to encircle chordae and/or leaflets of a diseased native valve. In various embodiments, the outer jacket80and/or support structures81may have a curved shape in the deployed configuration. In various embodiments, the outer jacket80and/or support structures81may be elongated-rather than curved—in the delivery configuration. For example, the outer jacket80and/or support structures81may be elongated into a straight shape within the delivery device30. In various embodiments, a portion of the outer jacket80and/or support structures81may have a curved encircling shape. In various embodiments, a substantial portion of the outer jacket80and/or support structures81may have a curved encircling shape. In various embodiments, the outer jacket80and/or support structures81may be formed as a flat curve (in the deployed configuration) whereby the loops generally are positioned within the same plane (the plane being perpendicular to a longitudinal axis). In various embodiments, the outer jacket80and/or support structures81may be formed as a three-dimensional curve (in the deployed configuration) whereby the loops generally are positioned out of plane with one another.

The outer jacket80and/or support structures81may comprise a helical shape in the deployed configuration. In some embodiments, the outer jacket80and/or support structures81may comprise one or more helical portions as described herein.

The free end22of the anchor15may extend radially outward from the frame structure12, and in particular from the remainder of the outer jacket80. In some embodiments, the helical outer jacket80may have a generally tubular shape. The free end may extend radially outward from the tubular shape. In some embodiments, the helical outer jacket80may have a generally frustoconical shape. The free end22may extend radially outward from the frustoconical shape. In some embodiments, the helical outer jacket80may have a generally cylindrical shape. The free end22may extend radially outward from the cylindrical shape. The free end22may be configured to encircle a larger radius than the main coils (also referred to herein as loops or turns) of the helical outer jacket80. The larger diameter may facilitate capturing of one or more structures, for example the valve leaflets of the chordal tendineae within the sweep of the free end22when rotated as described herein.

In various embodiments, the outer jacket80and/or support structures81may have a generally helical shape in the deployed configuration. In various embodiments, the outer jacket80and/or support structures81may be elongated-rather than helix-shaped—in the delivery configuration. For example, the outer jacket80and/or support structures81may be elongated into a straight shape within the delivery device. In various embodiments, a portion of the outer jacket80and/or support structures81may have a helical shape. In various embodiments, a substantial portion of the outer jacket80and/or support structures81may have a helical shape. In various embodiments, the helical outer jacket80and/or support structures81may be formed as a three-dimensional helix (in the deployed configuration) whereby the loops generally are positioned around the same axis (for example, a longitudinal axis of the delivery device30).

The outer jacket80and/or support structures81may comprise a spiral shape in the deployed configuration. In some embodiments, the outer jacket80and/or support structures81may comprise one or more spiral portions as described herein.

In various embodiments, the outer jacket80and/or support structures81may have a spiral-shaped deployed configuration. In various embodiments, spiral refers to a shape with windings about a central axis. The spiral may be continuous. The windings may gradually widen (or tighten) along the length. The spiral may be formed in a flat plane perpendicular to the central axis. In various embodiments, the outer jacket80and/or support structures81may have a deployed configuration that is not formed in a flat plane, or in other words the deployed shape is formed in a three-dimensional and/or non-degenerate space. In various embodiments, the outer jacket80and/or support structures81may have a conical-shaped deployed configuration including, but not limited to, tubular, conical, frustoconical, and/or helical shapes.

The free end22of the outer jacket80may extend radially outward from the frame structure12, and in particular from the remainder of the spiral outer jacket80. The other end of the spiral outer jacket80may be coupled to the top or bottom of the frame structure12as described herein. Alternatively, or in combination, the other end of the spiral outer jacket80may not be attached to the frame structure12as described herein. The free end22of the spiral outer jacket80may facilitate capturing of the valve leaflets and/or chordal tendineae within the sweep of the free end during rotation as described herein. During rotation of the spiral outer jacket80, the leaflets and/or chordac tendineae may be captured by the free end22and trapped between the valve frame structure12and an interior surface of the spiral outer jacket80.

In various embodiments, the outer jacket80and/or support structures81may have a generally spiral shape in the deployed configuration. In various embodiments, the outer jacket80and/or support structures81may be elongated-rather than spiral-shaped—in the delivery configuration. For example, the outer jacket80and/or support structures81may be elongated into a straight shape within the delivery device. In various embodiments, a portion of the outer jacket80and/or support structures81may have a spiral shape. In various embodiments, a substantial portion of the outer jacket80and/or support structures81may have a spiral shape. In various embodiments, the spiral outer jacket80and/or support structures81may be formed as a flat spiral (in the deployed configuration) whereby the loops generally are positioned within the same plane (the plane being perpendicular to a longitudinal axis).

The free end22and/or the outer jacket80may be sized and dimensioned for insertion through the native valve, for example through tissue at or near a commissure of the native valve or through the valve opening itself. In some embodiments, the free end22may comprise an atraumatic tip to avoid reduce risk of injury to the native valve tissue and leaflets. For example, the free end may comprise a blunt end, a ball tip, a curved tip (e.g., J-tip or pigtail), or other atraumatic shapes. Alternatively, the free end22may be configured for piercing tissue.

The outer jacket80and/or free end22may optionally rotated around one or more structures on the second side of the native valve such that the one or more structures (e.g., chordae, leaflets, or annulus) are pulled radially inwards towards the longitudinal axis of the anchor15and/or towards the longitudinal axis of the delivery device30. The outer jacket80and/or free end22may be configured such that minimal torque is applied to the one or more structures. Alternatively. or in combination, the outer jacket80and/or free end22may be configured such that the one or more structures are not rotated, or are minimally rotated, during rotation of the outer jacket80. For example, the outer jacket80may comprise one or more spaces between loops to facilitate radially-inward movement of the captured tissue (e.g. chordae and/or leaflets) from the free end22to the center of the curved structure with little or no torque and/or rotation of the structures during rotation of the outer jacket80as described herein. Alternatively or in combination, the outer jacket80may be configured such that, when fully deployed none of the structures reside between the loops of the curved encircling shape. Instead, the one or more structures may sit radially inward of the loops in order to facilitate capture of the one or more structures between the outer jacket80and the expanded frame structure12. The one or more structures may retain or nearly retain their normal anatomical position when the outer jacket80is fully deployed.

FIG. 76shows a side view of a valve prosthesis10comprising the anchor15ofFIG. 74disposed around a frame structure12in the expanded configuration.FIG. 77shows a top perspective view of the anchor15disposed around frame structure12. The anchor15is shown in a deployed configuration. The anchor15may comprise a delivery (e.g., elongated) configuration (e.g., as shown inFIG. 1) and a deployed configuration (e.g., as shown inFIG. 2). In various embodiments, the anchor15may be self-expanding and may move to the deployed configuration as it is removed from the delivery sheath as described herein. The anchor15may be configured to wrap at least partially around the frame structure12in the deployed configuration. The frame structure12may have an unexpanded configuration (for example, a compressed configuration as described herein) and an expanded configuration as described herein. The frame structure12may be substantially similar to any of the frame structures described herein or understood by one of ordinary skill in the art from the description herein. The anchor15may comprise an outer jacket80and one or more lumens71as described herein. The one or more lumens71may comprise one or more support structures81and/or open lumens71in the deployed configuration. The anchor15may be configured to anchor the frame structure12to the native valve when the frame structure12is in the expanded configuration adjacent the native valve. The frame structure12may be configured to be actuated from the unexpanded configuration to the expanded configuration adjacent a native valve in a patient. The anchor15may be configured to be fully advanced from a first side of a native valve in a patient (e.g. an atrial side) to a second side of the native valve (e.g. into a ventricle of the heart) and anchor the frame structure12to the native valve when the frame structure12is in the expanded configuration adjacent the native valve as described herein. The anchor15may be configured to expand slightly upon expansion of the frame structure12therein in order to account for the increased circumferential distance.

The outer jacket80and/or support structures81may comprise one or more loops. For example, the outer jacket80and/or support structures81may comprise a plurality of loops, which may increase the radial strength of the anchor by increasing friction and addition structural support. The one or more loops of the outer jacket80and/or support structures81may be substantially cylindrical around a central axis of the outer jacket80and/or support structures81, for example along an axis which is coaxial with a longitudinal axis of a delivery device30. The one or more loops of the outer jacket80and/or support structures81may be substantially helical around a central axis or helical axis of the outer jacket80and/or support structures81, for example along an axis which is coaxial with a longitudinal axis of a delivery device. The one or more loops of the outer jacket80and/or support structures81may spiral radially outward from a central point or central axis of the outer jacket80and/or support structures81, for example along an axis which is coaxial with a longitudinal axis of a delivery device30such that the outer jacket80and/or support structures81lies approximately along a plane perpendicular to the longitudinal axis of the delivery device30.

The one or more loops (also referred to herein as coils or turns) of the outer jacket80and/or support structures81may comprise a curved shape that bends around back towards its origin (for example, an arc, ellipsoid, circle, or the like). In some embodiments, a loop may comprise a curved shape that bends back towards its origin but does not cross itself, making a rotation within a range of about 180 degrees to about 360 degrees. For example, a loop may comprise a curve or an arc having a central angle within a range of about 180 degrees to about 360 degrees. In at least some embodiments, the one or more loops may comprise an arc. In some embodiments, a loop may comprise a shape that bends back towards and crosses itself, making at least a 360 degree rotation. In at least some embodiments, the one or more loops may comprise a 360 degree rotation (for example, a circle). In some embodiments, the one or more loops may comprise a 360 degree to 720 degree rotation (for example, a loop crossing itself once and rotating further towards a second crossing and formation of a second360loop).

Interaction of the frame structure12with the one or more loops of the outer jacket80and/or support structures81may create opposing forces therebetween that provide mechanical leverage for anchoring the frame structure12to the one or more anatomical structures. In some embodiments, the one or more loops may comprise at least 360 degrees of rotation when deployed such that the loops wrap around one another and provide additional mechanical leverage against the frame structure12in order to facilitate anchoring of the frame structure12as described herein. Additional loops or partial loops may provide additional mechanical strength and/or leverage.

In some embodiments, the one or more loops of the outer jacket80may comprise one or more spaces therebetween. The spaces may facilitate movement of the captured tissue (e.g. chordae and/or leaflets) from the free end22to the center of the spiral structure during rotation of the anchor15as described herein.

The outer jacket80and/or support structures81may be configured to wrap at least partially around the frame structure12in the deployed configuration.

In some embodiments, the outer jacket80and/or support structures81may be configured to wrap at least partially around a distal portion of a delivery device (e.g., delivery device30ofFIGS. 8-10), for example around the inner shaft, in the deployed configuration.

FIG. 78shows an exemplary anchor15loaded onto a delivery device30. The anchor15may be substantially similar to the anchor ofFIG. 74(with outer jacket80and support structures81therein) except that that it can additionally include one or more core wires74translatably disposed within the open lumen of the anchor15(i.e., in addition to or in place of the fixed support structures81). The anchor15may include a plurality of lumens71disposed therein (through which support structures81extend). One or more of the lumens71may comprise an open lumen configured to allow one or more core wires74(or other elongate member) to be slidably disposed therein. The one or more core wires74may, for example, comprise a first wire74a, a second wire74b, and a third wire74cas shown. The outer jacket80may comprise one or more apertures or openings in the free end22to expose the lumen71to the surgical site. The core wires74can be configured to exit the anchor15through the one or more apertures or openings before, during, or after deployment of the anchor15.

The one or more core wires74may comprise a shape memory material or super-elastic material such as nitinol. In some embodiments, the one or more core wires74may be made of a heat treatable material. The one or more core wires74may be formed of a material having sufficient rigidity to hold a predetermined shape. It may be desirable for at least the distal section77of the one or more core wires74to be relatively rigid such that it can exert a force to move chordal tendineae, while still retaining flexibility to be collapsed within the delivery device30. In various embodiments, the distal portion77has sufficient rigidity to hold its shape, but is configured to deform under a load. For example, the distal section77may be configured with a similar rigidity to a guidewire or slightly stiffer.

The one or more core wires74may comprise one or more sections of wire having the same or different pre-formed shapes to facilitate deployment within the lumen(s)71of the anchor15. For example, the distal section77can have a preformed shape (e.g., include one or more deflection features as described herein). The one or more core wires74may also comprise a proximal curved (or looped) section76proximal to the distal section77. The curved shape of the proximal curved section76may be substantially similar to the curved shape of the anchor15in order to provide robust rotational constraint to the one or more core wires74so that the distal tip75of the one or more core wires does not rotate relative to the anchor15as the distal tip is translated. Alternatively, the proximal curved section76may be configured with a different shape or curvature that the anchor15in order to induce rotation in the distal tip75during translation as desired.

The one or more core wires74may comprise one or more pull-wires.

The one or more core wires74may be translatably disposed within an open lumen71(or lumens) of the anchor15. It will be understood by one of ordinary skill in the art based on the teachings herein that the any number of core wires74may be disposed within the anchor as desired. For example, there may be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more core wires74disposed within one or more lumens71of the anchor15as desired.

The one or more core wires74may be translatable. The one or more core wires74may translate distally and proximally within the lumen71of the anchor15. The one or more core wires74may be longitudinally translatable independent of one another. In some embodiments, the one or more core wires74may comprise a plurality of wires which may be translated relative to one another in order to change the shape of a distal section77and deflect the distal tip75of the wires74to facilitate wrapping of the wires74and/or anchor15around the delivery device30and/or one or more native structures of the valve as described herein. For example, the one or more core wires74may comprise a first wire74aand a second wire74b. The first and second wires74a,74bmay be longitudinally translatable independent of one another within the lumen71of the anchor15. In some embodiments, the one or more core wires74may further comprise a third wire74c. The third wire74may be longitudinally translatable independent of the first and/or second wires74a.74b.

The anchor15with outer jacket80, support structures81, and/or core wires74may be detachably coupled to the delivery device30(seeFIG. 78) and/or a frame structure12(seeFIGS. 76-66) as described herein. The anchor15may be actuated from an elongated configuration to a deployed configuration adjacent a native valve of patient. Referring toFIG. 78, in some embodiments, the anchor15may be deployed from the inner shaft52of the delivery device30by pushing the anchor15out of the inner shaft52(if disposed within the inner shaft52in the elongated configuration), releasing the anchor15from radial constraint by retracting the outer sheath50(if disposed within the outer sheath50in the elongated configuration), or the like as described herein. When deployed from the delivery device30, the anchor15may wrap at least partially around a distal portion of the delivery device30(e.g., around the inner shaft52if disposed within the inner shaft52or around the outer sheath50if disposed within the outer sheath50). A central axis of the anchor15may be co-axial with a longitudinal axis of the delivery device30when the anchor15is in the deployed configuration. In some embodiments, deployment of the anchor15from the delivery device30such that the anchor15wraps concentrically or coaxially around a longitudinal axis32of the delivery device30may be directed, at least in part, by the positioning of the free end22relative to the delivery device30. Correctly positioning the free end22relative to the delivery device30may result in efficient and/or deployment.

In some embodiments, deployment of the anchor15may be facilitated by longitudinal translation of the one or more core wires74within the lumen(s)71in order to advance or retract the distal tip75of the one or more core wires74away from or towards the free end22of the anchor15in order to change the shape of the distal portion of the anchor15.

The one or more core wires74may be translated within the lumen(s)71of the anchor15before, during, or after deployment of the anchor15from the undeployed configuration to the deployed configuration. For example, the one or more core wires74may be translated within the anchor15before deployment of the anchor15into a self-assembly state in order to facilitate wrapping of the anchor15around the delivery device30(e.g., by extending past the free end22of the anchor15). Alternatively, or in combination, the one or more core wires74may be translated within the lumen(s)71of the anchor15during deployment of the anchor15in order to actively or reactively “wiggle” or deflect the angle of the free end and/or distal tip as it deploys as described herein. Alternatively. or in combination, the one or more core wires74may be translated with the anchor15into an encircling state in order to facilitate grasping of and rotation of the anchor15around the one or more native valve structures as described herein.

The one or more core wires74may facilitate deployment of the anchor15from the delivery configuration to the deployed configuration. For example, the one or more core wires74may be configured to be advanced through the one or more lumens71of the outer jacket80and out an opening in the free end22of the anchor15into a self-assembly configuration. A distal tip75of one or more of the core wires74(e.g., a distal tip of a first wire and/or a second wire) may be configured to extend radially outward, proximally, or distally of a curved shape of the anchor15in the self-assembly configuration. The self-assembly configuration may facilitating positioning of the anchor relative to a delivery device during actuation from the delivery configuration to the deployed configuration.

The distal tip75of the one or more core wires74may be advanced into a self-assembly configuration prior to or during deployment of the anchor15from the delivery device30in order to facilitate wrapping of the one or more core wires74and anchor15around the delivery device30into the correctly deployed configuration. In the self-assembly state, the distal tip75may be deflected prior to or during deployment of the anchor15such that the distal tip75overlaps with one or more turns of the anchor15in order to ensure that the free end22wraps back around the delivery device30.

In the self-assembly state, the distal tip75of the one or more core wires74may be deflected or angled proximally (e.g., towards a proximal portion of the anchor15and a distal end of the delivery device30), distally (e.g., away from a proximal portion of the anchor15and towards a proximal portion of the delivery device30), and/or radially (e.g., radially outwards or inwards from the main body of the anchor15and away from or towards the delivery device30). In some embodiments, for example, the distal tip75may be positioned adjacent one or more loops of the anchor15when the anchor15is in the deployed configuration. Alternatively, or in combination, the distal tip75may be positioned such that it angles towards a proximal end of the anchor15when the anchor15is in the deployed configuration. Alternatively, or in combination, the distal tip75may be positioned such that it angles towards a distal end of the delivery device30when the anchor15is in the deployed configuration.

In at least some instances, it may be sufficient to initially advance the distal tip75into the self-assembly configuration during wrapping as described herein in order to form the first loop of the anchor15around the delivery device30. Once the first loop as wrapped around the delivery device30, the remaining loops may be more inclined or biased to wrap correctly around the delivery device30without additional deflection or manipulation. The one or more core wires74may remain in the self-assembly configuration for the entirety of the deployment of the anchor15from the delivery device30. Alternatively, once the free end22has made a first loop around the delivery device30facilitated by the distal tip75, the distal tip75may be translated proximally and retracted at least partially back into the anchor15for the remainder of the deployment of the anchor15.

Alternatively, or in combination, the one or more core wires74may facilitate capture of and rotation of the anchor15around the one or more structures as described herein. For example, during and/or following core wires74may be configured to be advanced (or further advanced from the self-assembly configuration) into an encircling configuration. A distal tip75of the one or more core wires74(e.g., a first wire and/or a second wire) may be configured to angle away from the anchor15in the encircling configuration.

In the encircling configuration, the distal tip75of the one or more core wires15may be configured to deflect or angle proximally (e.g., towards a proximal portion of the anchor15and a distal end of the delivery device30), distally (e.g., away from a proximal portion of the anchor15and towards a proximal portion of the delivery device30), and/or radially (e.g., radially outwards or inwards from the main body of the anchor15and away from or towards the delivery device30, respectively).

In at least some instances, deflection (e.g., angling proximally, distally, and/or radially outward) of the distal tip75away from the loops of the anchor15may aid in capture of the one or more structures by forming a “grabber” arm. For example, during rotation of the anchor15, the grabber arm distal tip75may be rotated to capture the one or more structures of the native valve.

The distal tip75of the one or more core wires74may optionally rotated around one or more structures on the second side of the native valve such that the one or more native valve structures (e.g., chordae, leaflets, and/or annulus) are pulled radially inwards towards the longitudinal axis of the anchor15and/or towards the longitudinal axis of the delivery device30. The distal tip75, anchor15, and/or free end22may be configured such that minimal torque is applied to the one or more native structures. Alternatively, or in combination, the distal tip75, anchor15, and/or free end22may be configured such that the one or more native valve structures are not rotated, or are minimally rotated, during rotation of the anchor15.

Following deployment of the anchor15and/or rotation of the free end22(optionally facilitated by distal tip75as described herein) around the one or more structures of the native valve and/or expansion of the frame structure12within the anchor15adjacent the native valve, the one or more core wires74may be removed from the system, leaving the composite anchor15wrapped around the frame structure12at the native valve. By removing the one or more core wires74from the system following correct deployment of the valve prosthesis10, potential complications related to having a discontinuously shaped distal end and/or translatable element left within the native valve may be reduced. Alternatively, the one or more core wires74may be fixed and left in the system following correct deployment if desired.

In various embodiments, the one or more core wires74may have a spiral-shaped deployed configuration. In various embodiments, spiral refers to a shape with windings about a central axis. The spiral may be continuous. The windings may gradually widen (or tighten) along the length. The spiral may be formed in a flat plane perpendicular to the central axis. In various embodiments, the one or more core wires74may have a deployed configuration that is not formed in a flat plane, or in other words the deployed shape is formed in a three-dimensional and/or non-degenerate space. In various embodiments, the one or more core wires74may have a conical-shaped deployed configuration including, but not limited to, tubular, conical, frustoconical, and/or helical shapes.

The distal tip75of the one or more core wires74may extend radially outward from the frame structure12, and in particular from the remainder of the spiral one or more core wires74and/or anchor15. The distal tip75of the one or more core wires74may facilitate capturing of the valve leaflets and/or chordal tendineae within the sweep of the free end during rotation as described herein. During rotation of the anchor15and one or more core wires74extending distally therefrom, the leaflets and/or chordae tendineae may be captured by distal tip75and trapped between the valve frame structure12and an interior surface of the anchor15and/or one or more core wires74.

In various embodiments, the one or more core wires74may have a generally spiral shape in the deployed configuration. In various embodiments, the one or more core wires74may be elongated-rather than spiral-shaped—in the delivery configuration. For example, one or more core wires74may be elongated into a straight shape within the delivery device. In various embodiments, a portion of the one or more core wires74may have a spiral shape. In various embodiments, a substantial portion of the one or more core wires74may have a spiral shape. In various embodiments, the spiral one or more core wires74may be formed as a flat spiral (in the deployed configuration) whereby the loops generally are positioned within the same plane (the plane being perpendicular to a longitudinal axis).

The distal tip75of the one or more core wires74may be sized and dimensioned for insertion through the native valve, for example through tissue at or near a commissure of the native valve or through the valve opening itself. In some embodiments, the distal tip75of the one or more core wires74may comprise an atraumatic tip to avoid reduce risk of injury to the native valve tissue and leaflets. For example, the distal tip75may comprise a blunt end, a ball tip, a curved tip (e.g., J-tip or pigtail), or other atraumatic shapes. Alternatively, the distal tip75of the one or more core wires74may be configured for piercing tissue.

In various embodiments, the distal tip75may be shaped and configured to reduce the risk of counter-rotation. For example, the distal tip75may have a curled end to cause the distal tip75to snag chordae if it is rotated in a direction opposite the anchoring rotation.

The distal tip75of the one or more core wires74may optionally rotated around one or more structures on the second side of the native valve such that the one or more structures (e.g., chordae, leaflets, or annulus) are pulled radially inwards towards the longitudinal axis of the anchor15and/or towards the longitudinal axis of the delivery device30. The distal tip75of the one or more core wires74may be configured such that minimal torque is applied to the one or more structures. Alternatively, or in combination, the distal tip75of the one or more core wires74may be configured such that the one or more structures are not rotated, or are minimally rotated, during rotation of the anchor15.

In some embodiments (e.g., instead of or in addition to having multiple core wires74), one or more of the core wires74and/or distal end of the anchor15may comprise one or more deflecting features such that, when advanced distally past the free end22of the anchor15, a distal tip of the one or more core wires74may be caused to “wiggle” or deflect away from the curvature of the anchor body15and change the deployment angle of the distal tip out of the anchor body15in order to facilitate wrapping of the anchor15around the delivery device30as described herein (e.g., radially outward, proximally, or distally of the curved shape of the anchor). The deflecting features may, for example, comprise one or more pre-formed waves, bends, kinks, or humps adjacent the distal tip75of the one or more core wires74. For example, the one or more deflection features may comprise one or more kinks along the distal tip75of one or more of the core wires74such that at least a portion of the distal tip75is discontinuous with a curved shape of a proximal curved portion of the one or more core wires74. The movable core wires74may be translated within the anchor15before, during, or after deployment of the anchor15from the undeployed configuration to the deployed configuration. For example, the one or more core wires74may be translated within the lumen(s)71of the anchor15before deployment of the anchor into a self-assembly state in order to facilitate wrapping of the anchor15around the delivery device (e.g., by extending past the free end22of the anchor15and acting similarly to the free end22comprising the deflecting features described herein). Alternatively, or in combination, one or more core wires74may be translated within the lumen(s)71of the anchor15during deployment of the anchor15in order to actively or reactively “wiggle” or deflect the angle of the distal tip as it deploys. Alternatively, or in combination, the one or more core wires74may be translated with the lumen(s)71of the anchor15into an encircling state in order to facilitate grasping of and rotation of the anchor15around the one or more native structures as described herein. By utilizing movable core wires74comprising one or more deflecting features, the anchor15may comprise a relatively simpler shape compared to an anchor having one or more deflecting features itself, which may facilitate design and fabrication of the anchor. For example, the anchor15may have a shape with a substantially continuous curvilinear shape and/or the reduction of complex bends. Alternatively, or in combination, the behavior of the free end22of the anchor15and/or the free end75of the core element74may be optimized to facilitate various deployment and/or implantation steps of the anchor. The lumen71of the anchor15may be sized and dimensioned to match or be slightly larger than the diameter of the one or more core wires74in order to enable translation therein. In some embodiments, the one or more core wires74may be made of a shape memory material such as nitinol in order to allow shaping of the one or more core wires74. In some embodiments, the one or more core wires74may be made of a heat treatable material in order to allow shaping thereof. The anchor15may be relatively stiffer than the core wire74. The anchor15may be sufficiently stiffer than the one or more core wires74such that the core wire74anchor15experiences little or no deflection itself when the one or more core wires74are disposed therein. The anchor15may be relatively stiffer than the one or more core wires74in order to prevent or reduce deflection of the anchor body when the movable core element is disposed in a lumen thereof. In some embodiments, the one or more core wires74may comprise a relatively more complex shape compared to the anchor in order to guide and the free end22of the relatively stiffer anchor15.

FIG. 79shows proximal deflection of a distal tip75of one or more core wires74disposed within an open lumen of an exemplary anchor15.FIG. 80shows distal deflection of a distal tip75of one or more core wires74disposed within an open lumen of an exemplary anchor15. The anchor15may comprise multiple translatable core wires74disposed therein. The anchor15may be substantially similar to any of the anchors described herein, for example a helix-shaped anchor having a three lumens or channels71in the deployed configuration as shown. The anchor15may be detachably coupled to a delivery device30as described herein. The anchor15may be directly coupled to a frame structure12, for example at a proximal or distal end thereof, as described herein. Alternatively, or in combination, the anchor15may be detachably coupled to the delivery device30prior to deployment at the native valve. Alternatively. or in combination, the anchor15may be operably coupled to the frame structure12and/or delivery device30by a proximal pusher section73of the one or more core wires74as described herein. The delivery device30may be substantially similar to any of the delivery devices described herein. For example, a proximal end of the anchor15may be detachably coupled to the inner shaft52during delivery to the native valve. Alternatively, or in combination, a proximal end of the anchor15may be coupled to a distal end of the frame structure or a proximal end of the frame structure. Alternatively, or in combination, a proximal end of the anchor15may be coupled to a proximal pusher section73of the one or more core wires74, thereby operably coupling the anchor15to the delivery device30. Alternatively, or in combination, the delivery device30may comprise an actuation arm82which may be detachably coupled to a proximal end of the anchor15and configured to push the anchor15out of the delivery device30from the delivery configuration to the deployed configuration. For example, longitudinal translation and/or rotational motion of the actuation arm82may be translated to the anchor15to facilitate deployment as described herein. The anchor15is shown in a deployed configuration. The anchor15may comprise a delivery (e.g., elongated) configuration (e.g., as shown inFIG. 1) and a deployed configuration (e.g., as shown inFIG. 2). In various embodiments, the anchor may be self-expanding and may move to the deployed configuration as it is removed from the delivery sheath as described herein. The anchor15may be configured to wrap at least partially around the frame structure12in the deployed configuration. The anchor15may be configured to wrap at least partially around a distal end of the delivery device30in the deployed configuration.

The one or more core wires74may comprise a plurality of wires which may be translated relative to one another in order to change the shape of a distal tip portion77and deflect the distal tip75of the wires74to facilitate wrapping of the wires74and/or anchor15around the delivery device30and/or one or more native structures as described herein. For example, the one or more core wires74may comprise a first wire74aand a second wire74b. The first and second wires74a,74bmay be longitudinally translatable independent of one another within the lumen71of the anchor15. In some embodiments, the one or more core wires74may further comprise a third wire74c. The third wire74may be longitudinally translatable independent of the first and/or second wires74a.74b. Translation of the first, second, and/or third wires74a,74b,74cmay facilitate deployment of the anchor15and/or capture of the chordae as described herein.

In some embodiments, the one or more core wires74(e.g., wires74a,74b,74c) may comprise a proximal pusher section73proximal to the proximal curved section76which extends from the proximal curved section76to a proximal end of the delivery device30. The proximal pusher section73may act as an actuation mechanism and facilitate longitudinal translation of the one or more core wires74within the lumen71of the anchor15. For example, the proximal end of the proximal pusher section73may be coupled to an actuation mechanism in/on the delivery device30in order to translate the one or more core wires74. Alternatively, the proximal end of the proximal pusher section73may be manually manipulated by at or near a proximal end of the delivery device in order to translate the one or more core wires74. The proximal pusher section73of the first and second wires74a,74b74b(and the third wire74c, a fourth wire, etc.) may or may not be disposed within the housing. For example, the proximal pusher portion73be disposed within the housing between the proximal end of the anchor and the distal end of the frame structure12.

The core wires74a,74b,74cmay extend through and towards a proximal end of the delivery device30. The wires74a,74b.74cmay be coupled to one or more actuation mechanisms in/on the delivery device in order to translate the wires74a.74b,74crelative to one another and/or the anchor15. Alternatively, the wires74a,74b,74cmay be manually manipulated by at or near a proximal end of the delivery device in order to translate the core wires74a.74b,74c. The wires74a,74b,74cmay be independently translated in order to generate additive curvatures. The wires74a,74b,74cmay be pulled/pushed distally or proximally relative to one another to cause the distal tip portion77to deflect in any number and manner of shapes or curvatures desired.

In some embodiments, the first wire74aand the second wire74b(and the third wire74c, a fourth wire, etc.) may be coupled to one another at the distal tip75. Translation of the first and second wires74a.74brelative to one another may change the curvature of the distal section77, thereby deflecting the distal tip75of the core wires74in order to facilitate anchor deployment and/or wrapping of the anchor15around one or more structures of the native valve as described herein. By providing two or more wires74a,74bcoupled to one another at a distal tip75, the distal tip75of the core wire74may be deflected into more complex and/or varying shapes than may be possible with a deflection feature disposed on or along the one or more core wires74or a single wire as described herein. The two wires74a.74bmay be independently translated in order to generate additive curvatures. The wires74a,74bmay be pulled/pushed distally or proximally relative to one another to cause the entire “grabber arm” of the distal section77to deflect in any number and manner of shapes or curvatures desired. In this way, the wires74a.74bmay act as pull wires for the grabber arm of the distal section77and alter the shape thereof.

For example, the distal tip75may be deflected proximally or distally as shown inFIGS. 79 and 80, respectively, by relative translation of the wires74a,74b.74c, which may be coupled to one another at the distal tip75or along the distal section77as described herein. In some embodiments, one or more of the wires74may remain untranslated. It will be understood by one of ordinary skill in the art that the number, complexity, and manner of the shapes or curvatures of the distal tip portion77may be adjusted by changing the location(s) at which the wires74are coupled to one another, changing the number of wires74, and/or changing the shape of the wires74(e.g., by adding deflecting features, curvatures, etc. as described herein).

In some embodiments, the first wire74aand the second wire74b(and the third wire74c, a fourth wire, etc.) may be disposed within a housing. The housing may comprise a flexible material. Translation of the first and second wires74a,74brelative to one another may change the curvature of the housing, thereby deflecting the distal tip75of the core wires74in order to facilitate anchor deployment and/or wrapping of the anchor15around one or more structures of the native valve as described herein. By providing two or more wires74a,74bwithin a housing, the distal tip75of the core wire74may be deflected into more complex and/or varying shapes than may be possible with a deflection features disposed on or along the one or more core wires74described herein. The two wires74a,74bmay be independently translated in order to generate additive curvatures. The wires74a,74bmay be pulled/pushed distally or proximally relative to one another to cause the housing of the distal tip portion77to deflect in any number and manner of shapes or curvatures desired. In some embodiments, the entire “grabber arm” of the distal tip portion77may be made up of wires.

Alternatively, or in combination, at least a portion of the anchor15may include a support covering and/or band material disposed on or around the anchor15. The anchor15material may comprise a permeable, semi-permeable, or impermeable material while the support covering or band material may be flexible, semi-flexible, or rigid. In some embodiments, the anchor15material may be relatively soft so as to reduce the risk of injury to the one or more structures during rotation of the anchor15. The anchor15material may, for example, comprise a webbing material, a fabric, a polymeric material, an elastomeric material, or the like. The anchor15material may fully span the support covering so as to reduce leakage therethrough. Alternatively, or in combination, the anchor15material may be configured to improve alignment of the support covering. It will be understood by one of ordinary skill in the art from the description herein that any of the anchors15described herein may comprise a support covering and/or a material disposed therein or thereon.

In some embodiments, the support covering may comprise one or more channels or lumens disposed therein. The support covering may comprise a hollow, tubular cross-section.

In some embodiments, the support covering may, for example, comprise a hypotube. The lumen of the support covering may be configured to pass another component (e.g. a wire, guidewire, etc.) therethrough. The support covering may, for example, comprise an upper (proximal) wire and a lower (distal) wire. The upper and lower wires may be coupled to one another at a proximal attachment point and/or a distal attachment point. The wires may be round wires or have other cross-sectional shapes. In various embodiments, the support covering may comprise a scaffold such as a laser-etched Nitinol scaffold or a mesh. The anchor15may be tapered such that subsequent turns of the anchor15and support covering nest into each other so as to reduce a radial footprint of the anchor15. The upper and lower wires of the support covering may be configured to nest with one another when the in the deployed configuration.

In some embodiments, the upper wire and lower wires of the support covering may be bundled together during deployment from an undeployed configuration to an intermediate deployed configuration. The intermediate configuration may be configured to reduce the size the size of the lumen and/or aperture in or through which, respectively, the anchor15may travel (for example, a lumen or aperture of the delivery device) during deployment. The anchor15may be maintained in the intermediate configuration during rotation around the one or more native valve structures as described herein. In at least some instances, coupling the upper and lower wires of the support covering together into an intermediate configuration may facilitate alignment of the wires of the support covering. After delivery from the delivery device30and/or rotation around one or more native valve structures, the anchor15may be fully deployed into the deployed configuration by releasing the bundle and allowing the upper and lower wires to “spring out” into the deployed configuration. In some embodiments the anchor and/or upper and lower wires “spring out” or expand into the deployed configuration. In some embodiments, the anchor15is pushed out of the delivery device into the deployed configuration. The support covering may have a band material disposed therein or thereon as described herein. The band material may span the distance between upper and lower wires in order to couple the wires to one another. The band material may span the structural support so as to reduce leakage therethrough as described herein. Alternatively, or in combination, the band material may be configured to improve alignment of the support covering upper and lower wires such that they maintain a desired relative position to one another.

In some embodiments, the support covering may comprise one or more channels or lumens disposed therein. For example, one or more of the wires may comprise one or more channels or lumens. One or more of the wires may comprise a hollow, tubular cross-section. The support covering or anchor15may, for example, comprise a hypotube. The lumen of the spiral band may be configured to pass another component (e.g. a wire, guidewire, etc.) therethrough. The channels or lumens may for example be left as open lumens. Alternatively, or in combination, the channels or lumens may be filled, for example with one or more stiffening members.

Any of the free ends22of the anchors15described herein can include a “grabber” arm extending therefrom. The grabber arm can be configured to extend radially outwards from the rest of the anchor15to help capture one or more native valve structures as the anchor15is rotated. For example,FIG. 85shows an exemplary anchor15with a grabber arm91extending from the free end22. The grabber arm91can be continuous with the anchor15and can spiral in the same direction (e.g., clockwise or counterclockwise). However, as shown inFIGS. 85A-85B, the grabber arm91can extend in a wider arc or angle that the loops of the anchor15, thereby providing a larger space with which to grab the structures of the native valve. In some embodiments, the distal tip of the grabber arm91can hook or bend radially inwards to further aid in grabbing of native valve structure. Once implanted, the grabber arm91may not engage or anchor against native valve structures.

Referring toFIG. 86A, the grabber arm91can, in some embodiments, be configured to lie in the same plane93as the anchor15. When the anchor15is implanted, the plane93can be positioned mid-leaflet relative to the native valve or aligned with the leaflet free edge of the native valve. Referring toFIG. 86B, the grabber arm91can, in some embodiments, be configured such that the grabber arm91inclines from the plane93towards a more proximal plane94. When the anchor15is implanted, the proximal plane94can be substantially parallel with the subannular plane. Referring toFIG. 86C, the grabber arm91can, in some embodiments, be configured such that the grabber arm91inclines towards and plateaus along the plane94. In some embodiments, having the grabber91extend proximally towards the plane94(e.g., the subannular plane) can help move the anchor15towards the annulus and prevent paravalvular leakage upon implantation.

In some embodiments, the anchor15may comprise one or more locking mechanisms configured to maintain the anchor15in the deployed configuration. The one or more locking mechanisms may be any of the locking mechanisms described herein or understood by one of ordinary skill in the art from the description herein. In various embodiments, one or more loops may be nested with each other when the anchor is in the deployed configuration.

Referring toFIGS. 3A-3AC, at least a portion of the valve prosthesis10may be expanded within the native valve. For example, the valve prosthesis10may be deployed such that it captures one or more structures therein, for example one or more chordae tendineae and/or one or more valve leaflets. Expansion of the valve prosthesis10, or a portion thereof, may compress the captured structures therein to anchor the valve prosthesis10in place.

The valve prosthesis10may comprise first and second opposite ends, the first end extending above a native valve and the second end extending below the native valve when the valve prosthesis10is anchored to the native valve. Alternatively, the valve prosthesis10may be configured to sit entirely below the native valve when the valve prosthesis10is anchored to the native valve.

In some embodiments, the valve prosthesis10may comprise an expanded outer periphery in the expanded configuration and a compressed outer periphery when subject to an external radial force in the unexpanded configuration. The compressed outer periphery may be smaller in diameter than the expanded outer periphery.

In some embodiments, at least a portion of the valve prosthesis10may be actuated from the unexpanded configuration to the expanded configuration on a first side of the native valve prior to being advanced to a second side of the native valve. For example, the valve prosthesis10may be expanded in a left atrium of a heart prior to being advanced to a left ventricle of the heart as described herein.

Alternatively, or in combination, at least a portion of the valve prosthesis10may be actuated from the unexpanded configuration to the expanded configuration on a second side of the native valve after being advanced to the second side from a first side of the native valve. For example, valve prosthesis10may be advanced from a left atrium of a heart prior to being expanded in a left ventricle of the heart.

Delivery device30may refer to various components in certain embodiments. For example, delivery device30may refer to a steerable catheter for transseptal delivery. Delivery device30may refer to a catheter for delivery of the replacement valve, frame structure, and/or anchor. In some embodiments, delivery device30may refer to a first delivery device component detachably coupled to the anchor and a second delivery device component detachably coupled to the frame structure. In some embodiments, one or more valve prosthesis components may be different delivery devices or different components of a delivery device system.

Referring toFIGS. 3A-3AC, the delivery device30may include an outer sheath (e.g., an outer catheter), an inner shaft52(e.g., a delivery tube) disposed within a lumen of the outer sheath50, and an optional guidewire54disposed within a lumen of the inner shaft52. As described further below, a tether78(see, e.g.,FIGS. 89A-89C) may also be used. The guidewire54may optionally comprise a nosecone55to facilitate guidance of the guidewire54to the native valve. The proximal end57of the anchor15may be detachably coupled to the inner shaft52(or tether78) during delivery to the native valve as described herein. The outer sheath50may be steerable.

The valve prosthesis10may be operably coupled to the delivery device30as described herein. In some embodiments, at least a portion of the valve prosthesis10may be directly coupled to the inner shaft52(or tether78). Alternatively, or in combination, at least a portion of the valve prosthesis10may be indirectly coupled to the inner shaft52(or tether78). For example, at least a portion of the valve prosthesis10may be coupled to a torque hub or other connector, which may be coupled to the inner shaft52.

The valve prosthesis10may be detachably coupled to the delivery device30in the unexpanded configuration during delivery to the native valve. Expansion of the valve prosthesis10to the expanded configuration may detach (i.e. release) the valve prosthesis10from the delivery device30.

The valve prosthesis10may be balloon-expandable, self-expanding, or otherwise expansible as will be understood to one of ordinary skill in the art from the description herein.

For example, the delivery system30may comprise an inflatable balloon (for example, as shown inFIGS. 3V-3AA) disposed within the valve prosthesis10. Inflation of the balloon may cause expansion of the valve prosthesis10.

Alternatively, or in combination, the valve prosthesis10may be self-expandable. The valve prosthesis10may be maintained in the unexpanded configuration by radial constriction from the outer sheath of the delivery device30when disposed in a lumen of the outer sheath. Advancement of the inner shaft52out of the lumen of the outer sheath may actuate the valve prosthesis10into the expanded configuration. Stated another way, retraction of the outer sheath away from the valve prosthesis10may actuate the valve prosthesis10into the expanded configuration.

The anchor15of the prosthesis10may be directly coupled to the frame structure12(or tether78), for example at a proximal or distal end thereof. Alternatively, or in combination, the anchor15may be detachably coupled to the delivery device30prior to deployment at the native valve. For example, a proximal end57(seeFIG. 2) of the anchor15may be detachably coupled to the inner shaft52during delivery to the native valve. The proximal end57may be configured to remain engaged with the inner shaft52after being actuated from the elongated configuration to the deployed configuration adjacent the native valve. Alternatively, or in combination, a proximal end57of the anchor15may be coupled to a distal end of the frame structure12or a proximal end of the frame structure12. The anchor15is shown in a deployed configuration.

The frame structure12may have an unexpanded configuration (for example, as shown inFIGS. 1, 2 and 3F-3V) when the valve prosthesis10is in its unexpanded configuration and an expanded configuration (for example, as shown inFIGS. 3W-3AC & 58A-B) when the valve prosthesis10is in its expanded configuration. As shown inFIG. 2, the frame structure12in the expanded configuration may have a generally tubular expanded shape. The frame structure12may be configured for expanding within the native valve of the patient. In some embodiments, the unexpanded configuration may be sized and dimensioned for percutaneous insertion and the expanded configuration may be sized and dimensioned for implantation in the native valve of the patient. The frame structure12may be configured to remain in its unexpanded configuration while the anchor15is in the deployed configuration.

The frame structure12may comprise a first and second opposite ends, the first end extending above a native valve and the second end extending below the native valve when the frame structure12is anchored to the native valve. Alternatively, the frame structure12may be configured to sit entirely below the native valve when the frame structure12is anchored to the native valve.

In some embodiments, the frame structure12may comprise an expanded outer periphery in the expanded configuration and a compressed outer periphery when subject to an external radial force in the unexpanded configuration. The compressed outer periphery may be smaller in diameter than the expanded outer periphery.

The frame structure12may be balloon-expandable, self-expanding, or otherwise expansible as will be understood by one of ordinary skill in the art. The frame structure12may, for example, comprise an expandable stent.

The delivery system30may comprise an inflatable balloon (for example as shown inFIGS. 3V-3AA) disposed within the frame structure12and inflation of the balloon may cause expansion of the frame structure12as described herein.

In some embodiments, the delivery device30may be configured to carry the anchor15in an undeployed configuration and deploy the anchor15into a deployed configuration as the desired location as described herein.

The delivery device30may additionally or alternatively include any of the features of the delivery devices described in PCT/US2019/047542, PCT/US2019/055049. PCT/US2019/057082, and PCT/US2019/068088, the entireties of which are incorporated by reference herein.

In use, a valve prosthesis10may be loaded onto the delivery device30. The valve system may optionally be primed before or after loading onto the delivery device30. The delivery device30may be inserted through an introducer into a vessel. The delivery device30can be guided over a guidewire to a target location using the Seldinger technique.

The distal end of the delivery device30may be configured to be advanced from a first side of a native valve to a second side of the native valve. For example, the distal end of the delivery device30may be advanced from a left atrial side of a mitral valve to a left ventricular side of a mitral valve. In some instances, the distal end of the delivery device30may be transseptally inserted into the left atrium of the heart prior to advancement into the left ventricle. Alternatively. or in combination, the distal end of the delivery device30may be steerable such that it is positionable to point towards the first side of the native valve before being advanced to the second side of the native valve.

After advancing to the second side of the native valve, the anchor15may be fully deployed on the second side of the native valve. Fully deploying the anchor15may comprise actuating the anchor15from an elongated delivery configuration as shown inFIG. 1to a deployed configuration as shown inFIG. 2.

In some embodiments, fully deploying the anchor15may comprise actuating the anchor15from an elongated delivery configuration to a deployed configuration on the first side of the native valve and advancing the anchor15in the deployed configuration through the native valve to the second side of the native valve. Advancing the anchor15may comprise pushing the anchor through the native valve. Advancing the anchor15may further comprise rotating the anchor15through the native valve.

In some embodiments, fully deploying the anchor15may comprise positioning the anchor15such that it is located only on the second side of the native valve.

In some embodiments, the anchor15may be actuated from the delivery configuration to the deployed configuration on a first side of the native valve prior to being advanced to a second side of the native valve. For example, the anchor15may be deployed in a left atrium of a heart prior to being advanced to a left ventricle of the heart as described herein.

Alternatively, the anchor15may be actuated from the delivery configuration to the deployed configuration on a second side of the native valve after being advanced to the second side from a first side of the native valve. For example, anchor15may be advanced from a left atrium of a heart prior to being deployed in a left ventricle of the heart.

The free end22of the deployed anchor15may optionally be rotated around one or more structures on the second side of the native valve. The one or more structures may comprise one or more valve leaflets of the native valve. Alternatively, or in combination, the one or more structures may comprise one or more chordae of the left ventricle.

The free end22of the deployed anchor15may optionally rotated around one or more structures on the second side of the native valve such that the one or more structures (e.g., chordae, leaflets, or annulus) are pulled radially inwards towards the longitudinal axis of the anchor15and/or towards the longitudinal axis of the delivery device30. The anchor15and/or free end22may be configured such that minimal torque is applied to the one or more structures. Alternatively, or in combination, the anchor15and/or free end22may be configured such that the one or more structures are not rotated, or are minimally rotated, during rotation of the anchor15.

In some embodiments, the valve prosthesis10, for example anchor15, may be counter-rotated in order to reposition the anchor15with respect to the one or more structures of the native valve before continuing the rotation in the first direction. For example, counter-rotation may be applied if the one or more structures are caught by the free end of the anchor15(or another part of the valve prosthesis10or delivery device30) during the initial rotation. In such instances, counter-rotation may enable to the clinician to disengage some or all of the one or more structures to reduce the stress or torque on the one or more structures (e.g., by adjusting the position of the valve prosthesis10) before resuming rotation. Rotation and counter-rotation may be applied as many times as desired by the clinician in order to properly position the anchor15around the one or more structures of the native valve.

The anchor15may then be released from the distal end of the delivery device30. The anchor15may be released from the distal end of the delivery device30on the second side of the native valve.

The frame structure12may be expanded within the native valve from an unexpanded configuration to an expanded configuration. The valve prosthesis10is finally anchored when the frame structure12is expanded within the native valve4. The frame structure12dilates the valve leaflets14and the compressive force fixes the valve prosthesis10into position. Thereafter tissue ingrowth ensures the valve prosthesis10remains seated and does not migrate.

The frame structure12may be released from the distal end of the delivery device30. In some embodiments, at least a portion the frame structure may be expanded within at least a portion of the deployed anchor to anchor the frame structure to the native valve.

In some embodiments, expanding the frame structure and releasing the frame structure may occur simultaneously.

Finally, the delivery device30may be retracted from the native valve.

The valve devices described herein in accordance with the present disclosure provides several advantages over conventional valve systems. Embodiments described herein provide an easy-to-use, repositionable device. Unlike conventional valve systems, the valve prosthesis described herein reduces the risk of injuring or tearing chordac. Typical mitral valve replacement systems involve implanting a prosthetic annulus or ring around the valve. The ring increases the circumference of the valve and risks occluding the entry to the aortic valve. The valve device described herein overcomes these and other problems.

FIGS. 3A-3AC and 58A-58Bshow sequential views of a method of implanting a valve prosthesis10using a delivery device30. The valve prosthesis10may be similar to any of the valve prostheses described herein or understood by one of ordinary skill in the art from the description herein. Similarly, the delivery device30may be substantially similar to any of the delivery devices described herein or understood by one of ordinary skill in the art from the description herein. Not all prosthesis10or delivery device30elements are labeled in each ofFIGS. 3A-3AC and 58A-B in order to make the illustrations less cluttered and easier to see.

While the method shown inFIGS. 3A-3AC and 58A-B is described in relation to a mitral valve replacement procedure, it will be understood by one of ordinary skill in the art that the methods described herein may be applied to a variety of procedures or anatomical areas, for example other atrioventricular valves of the heart or the like. For example, the methods described herein may be applied to replacement of a diseased aortic valve or tricuspid valve.

FIGS. 3A-3Cshows various cross-sectional views of a heart2having a diseased mitral valve4which may be treated using the devices, systems, and methods described herein. The mitral valve4sits between the left atrium25and the left ventricle26and, when functioning properly, allows blood to flow from the left atrium25to the left ventricle26while preventing backflow or regurgitation in the reverse direction. As shown inFIG. 3A, the native valve leaflets42of the diseased mitral valve4do not fully prolapse and the patient experiences regurgitation.FIG. 3Bshows a cross-sectional view of the heart2taken along line A-A, shown inFIG. 3A, which shows the native valve leaflets42of the mitral valve4from the viewpoint of the left atrium25.FIG. 3Cshows a cross-sectional view of the heart2taken along line B-B, shown inFIG. 3A, which shows the chordae tendineae40of the left ventricle26.

As shown inFIG. 3D, a distal end of the delivery device30may be inserted into the left atrium25of the heart2via a transseptal puncture as described herein. For example, the distal ends of inner shaft52and/or outer sheath50may be advanced into the left atrium25of the heart2. The inner shaft52may optionally be advanced distally into the left atrium25away from the distal end of the outer sheath50. In some embodiments, advancing the inner shaft52relative to the outer sheath50may aid in deployment and/or placement of the valve prosthesis10as described herein. Alternatively, both the inner shaft52and the outer sheath50may be advanced distally into the left atrium25through the transseptal puncture.

FIGS. 3E-3Hshow deployment of the anchor15from the distal end of the delivery device30. As described herein, at least a portion of the valve prosthesis10may be deployed from an undeployed (for example, compressed or unexpanded) configuration to an expanded configuration within the left atrium25. At least a portion of the anchor15may be deployed from a delivery and/or elongated configuration to a deployed configuration within the heart. For example anchor15may be actuated from an elongated configuration (e.g., from a straightened shaped) to a deployed configuration (e.g., a pre-formed shape for implantation, such as a spiral, helical, or conical shape) within the left atrium25as described herein. In some embodiments, the anchor15may be deployed from the inner shaft52by pushing the anchor15out of the inner shaft52, releasing the anchor15from radial constraint by retracting the outer sheath50, or the like as described herein. In some embodiments, the anchor15may be pushed out of the inner shaft52using a pusher on a proximal handle (not shown) located outside the body). After the anchor15has been deployed from the delivery device30, the frame structure12may be at least partially deployed from the delivery device30as shown inFIG. 3Hso as to place the frame structure12within the anchor15. The frame structure12may be deployed from the delivery device30in either the unexpanded configuration or the expanded configuration, depending on the location of deployment, as will be understood by one of ordinary skill in the art based on the teachings herein.

FIGS. 3I-3Kshow advancement of the valve prosthesis10, with anchor15deployed around the unexpanded frame structure12, towards the native valve4requiring treatment. The distal end of the delivery device30(for example, the distal end of the inner shaft52and/or the outer sheath50) may be steered such that the distal end of the delivery device30points toward the atrial side of the native valve4. Such steering may occur prior to, during, or after deployment of at least a portion (for example deployment of an anchor15) of the valve prosthesis10. In some embodiments, the distal end of the outer sheath50may be steerable. Alternatively, or in combination, the inner shaft52may comprise a joint configured to change an angle of the distal portion of the inner shaft52relative to a proximal portion of the inner shaft52. The inner shaft52may be steered by changing the angle of the distal portion of the inner shaft52relative to the proximal portion of the inner shaft52. The angle of the joint may be changed passively or actively. In various embodiments, the angle may be selectively controlled by a proximal handle. For example, pull wires or other mechanisms may connect to the joint to controls on the handle.

FIGS. 3L-30show the valve prosthesis10being advanced through the native valve4by the delivery device30from the left atrium25to the left ventricle26. Advancement of the valve prosthesis10and optionally delivery device30through the mitral valve4may be facilitated by the natural opening and closing of the valve4during the cardiac cycle. The distal end of the delivery device30and/or valve prosthesis10may be configured to be advanced from a first side of a native valve to a second side of the native valve. For example, the distal end of the delivery device30and/or valve prosthesis10may be advanced from a left atrial side of a mitral valve4to a left ventricular side of a mitral valve4. Advancing the anchor15may comprise pushing the anchor15through the native valve4. Alternatively, or in combination, advancing the anchor15may comprise rotating the anchor15through the native valve4. In some instance, the combination of rotational motion and pushing may facilitate advancement of the device from the first side of the native valve4to the second side of the native valve4. Rotation of the valve prosthesis10, for example rotation of the anchor15and/or frame structure12, may be facilitated by the inner shaft52described herein. For example, the inner shaft52may transmit rotational motion to the valve prosthesis10in order to rotate the valve prosthesis10during advancement through the native valve4.

In some instances, advancing the anchor15through the native valve4may cause the anchor15to be stretched or elongated as shown inFIG. 3M. Rotation of the anchor15during advancement may assist with the stretching process by aiding in unwinding the anchor15. Additionally, the rotational motion may reduce the risk of the free end22of the anchor15undesirably engaging other anatomy during insertion through the native valve leaflets42. The anchor15may be sufficiently elastic so as to enable relatively easy insertion through the native valve4and/or reduce the risk of injury to the native leaflets43. At the same time, the anchor15may be sufficiently rigid to for guiding through and anchoring to the structures in the heart. After the anchor15has stretched through the native valve4it may return to the deployed configuration as shown inFIG. 3N.FIG. 3Oshows the position of the valve prosthesis10within the ventricle26and, in particular, the position of the anchor15relative to the native chordae tendineae40and native valve annulus.

In some embodiments, the anchor15may be advanced into the ventricle after being fully deployed from the delivery (e.g., elongated) configuration to the deployed configuration.

In some embodiments, the anchor15may be advanced into the ventricle before being deployed from the delivery (e.g., elongated) configuration to the deployed configuration.

FIGS. 3P-3Sshow rotation of the valve prosthesis10around one or more native valve structures on the ventricular side of the mitral valve4. The one or more structures may comprise one or more valve leaflets43and/or one or more chordae tendineae40. After the anchor15has been at least partially deployed within the left ventricle26adjacent one or more chordae tendineae40, the valve prosthesis10may be rotated to capture and anchor the native chordae40and/or native leaflets42. The free end22of the anchor15may extend radially outward from the rest of the anchor15to facilitate capture of the native structures. The free end22of the anchor15may be rotated around one or more of the chordae tendineae40as shown inFIGS. 3P-3Q. Additional rotation of the valve anchor15may gradually capture additional chordae tendineae40as shown inFIGS. 3R-3S.

Rotation of the valve prosthesis10, for example, rotation of the anchor15and/or frame structure12, may be facilitated by the delivery device30described herein. For example, the inner shaft52may be rotated and rotational motion may be transmitted from the inner shaft52to the valve prosthesis10in order to rotate the valve prosthesis10around one or more of the structures on the ventricle side of the mitral valve4as described herein.

In some embodiments, the valve prosthesis10, for example anchor15, may be counter-rotated in order to reposition the anchor15with respect to the chordae tendineae40before continuing the rotation in the first direction. For example, counter-rotation may be applied if the chordae tendineae40are caught by the free end of the anchor15(or another part of the valve prosthesis10or delivery device30) during the initial rotation. In such instances, counter-rotation may enable to the clinician to disengage some or all of the chordae tendineae40to reduce the stress or torque on the chordae tendineae40(e.g., by adjusting the position of the valve prosthesis10) before resuming rotation. As another example, the anchor15may encounter friction or other resistance to rotation. In this case the clinician may counter-rotate the anchor15to return to the original position and then begin rotating the anchor15to re-start and/or continue encircling chordae tendineae40. Rotation and counter-rotation may be applied as many times as desired by the clinician in order to properly position the anchor15around the valve structures.

FIGS. 3T-3Ushow the valve prosthesis10wrapped around the captured chordae tendineae40. The valve prosthesis10may be rotated around the chordae tendineae40such that the chordae tendineae40are pulled inwardly into bunches. As shown inFIG. 3T, the native valve leaflets42may also be in communication with the valve prosthesis10. The valve prosthesis10may be rotated to capture enough chordae tendineae40and/or valve leaflets42to rigidly anchor the anchor15adjacent the native valve annulus. The valve prosthesis10may be anchored by wrapping around only a portion of the chordae40. Although it may be possible to capture all or substantially all the chordae40, this may not be necessary to provide sufficient anchoring of the valve prosthesis10. As described further herein, the prosthesis may be further anchored by expansion of the frame structure12within the native valve4and against the anchor15. Alternatively. or in combination, the anchor may be sufficiently anchored after winding around some or only a portion of the chordae. It is believed that only a portion of the chordae are necessary for anchoring.

In some embodiments, the anchor15may be deployed such that at least a portion of the anchor15resides within a subvalvular plane. For example, at least 50%, 60%, 70%, 80%, 90%, 100% of the anchor15may reside within the subvalvular plane after being deployed. The subvalvular plane may be located at the posterior valve annulus, below the valve annulus and around the native valve leaflets42, and/or parallel to a plane within at least three points of the plane in which the valve annulus resides. In some instances, the anchor15may be rotated in the subvalvular plane around the chordae tendineae40. In some instances, the anchor15may be rotated in a plane below to the subvalvular plane in order to encircle the chordae tendineae40before the anchor15is moved into the subvalvular plane (e.g., by pulling the anchor15into the sub-annular space).

Once the anchor15has been anchored adjacent to the native valve4, the frame structure12and prosthetic valve segment14may be expanded at least partially within the anchor15as described herein. The frame structure12and the valve segment14may be deployed (e.g., expanded) simultaneously. Alternatively, or in combination, the frame structure12and the valve segment14may be deployed sequentially, for example by first expanding the frame structure12and then receiving the prosthetic valve segment14therein.

FIGS. 3V-3Zshow expansion of the frame structure12within the native valve4. The frame structure12may be expanded within the native valve4from an unexpanded configuration to an expanded configuration. In some embodiments, at least a portion the frame structure12may be expanded within at least a portion of the deployed anchor15to anchor the frame structure12to the native valve4. In some embodiments, the frame structure12may comprise an expandable stent. In some embodiments, the frame structure12of valve prosthesis10may be self-expandable. In some embodiments, the frame structure12of valve prosthesis10may be balloon-expandable. The delivery device30may comprise a balloon48which may be disposed within the valve prosthesis10in order to expand the valve prosthesis10. The balloon48may be positioned within at least a portion of the valve prosthesis10, for example within at least a portion of frame structure12in an uninflated configuration, as shown inFIG. 3V, prior to being inflated. The inflatable balloon48may, for example, be disposed within the inner shaft52or outer sheath50while the anchor15is being positioned adjacent the native valve4and then advanced therefrom (or the inner shaft52or outer sheath50is retracted therefrom) to be positioned within the frame structure12. Alternatively, the inflatable balloon48may be disposed within the frame structure12during placement of the valve prosthesis10.FIGS. 3W-3Xshow the frame structure12partially expanded by partially-inflated balloon48. As shown inFIG. 3X, the frame structure12may be partially expanded towards the anchor15in order to capture the chordae tendineae40therebetween. As the frame structure12continues to be expanded to a fully expanded state, as shown inFIGS. 3Y-3Z, the chordae tendineae40may be sandwiched between the anchor15and the frame structure12. The frame structure12and anchor15may thus be anchored to the chordae tendineae40.

The valve prosthesis10may then be released from the delivery device30. In some embodiments, releasing the valve prosthesis10may comprise releasing the anchor15and/or the frame structure12. Releasing the valve prosthesis10from the delivery device30may comprise expanding the valve prosthesis10from the unexpanded configuration to the expanded configuration. For example, expanding the frame structure12and releasing the frame structure12may occur simultaneously as described herein. Alternatively, the frame structure12may be released prior to or after being expanded.

FIGS. 3AA-3ACshow deflation of the balloon48(FIG. 3AA), retraction of the balloon48into inner shaft52(FIG. 3AB), and removal of the delivery device30from the heart2(FIG. 3AC). After the frame structure12has been expanded and anchored to the native valve4as described herein, the inflatable balloon48may be deflated. The balloon48may optionally be retracted back into the delivery device30, for example into inner shaft52. The delivery device30may then be removed from the heart2.

FIGS. 58A-58Bshow the valve prosthesis10fully expanded with the native valve leaflets42and chordae tendineae40captured between the frame structure12and the anchor15. As described herein, the valve prosthesis10may comprise one or more valve segments14disposed therein to replace the native valve leaflets42.

Although the steps above show a method of deploying a valve prosthesis10within a native valve4in accordance with embodiments, a person of ordinary skill in the art will recognize many variations based on the teaching described herein. The steps may be completed in a different order. Steps may be added or deleted. Some of the steps may comprise sub-steps. Many of the steps may be repeated as often as necessary to assemble at least a part of an article.

For example, in some embodiments, deploying the valve prosthesis10may occur in multiple steps such that a portion of the valve prosthesis10(e.g., anchor15) may be deployed before another portion the valve prosthesis10(e.g., frame structure12). Alternatively, or in combination, in some embodiments, deploying the anchor15may occur in multiple steps such that a portion of the anchor15may be deployed before being advanced through the native valve4and another portion of the anchor15may be deployed after being advanced through the native valve4. Alternatively. or in combination, the delivery device30may be advanced from the left atrium25to the left ventricle26with the valve prosthesis10undeployed. In many embodiments, the frame structure12may be self-expanding and the balloon48may not be necessary for expansion of the frame structure12. Alternatively, or in combination, the anchor15may be released after the frame structure12has been expanded within it.

Although shown and described with respect to a mitral valve, one of ordinary skill in the art will understand that the principles described herein may be applied equally to other atrioventricular valves. Aspects of the procedure, delivery tool and implanted valve prosthesis are similar to those described in U.S. Pat. Nos. 9,034,032; 9,005,273; 8,323,336; 8,075,615; 7,621,948; and 7,175,656 and U.S. Pub. No. 2011/0288637, which are incorporated herein for all purposes in their entirety.

In some embodiments, any of the valve prostheses10described herein may be deployed to replace a diseased mitral valve. The first side of the native valve may comprise a left atrium and the second side of the native valve may comprise a left ventricle.

In some embodiments, any of the valve prostheses10described herein may be deployed to replace a diseased tricuspid valve. The first side of the native valve may comprise a right atrium and the second side of the native valve may comprise a right ventricle.

In some embodiments, any of the valve prostheses10described herein may be deployed to replace a diseased aortic valve. The first side of the native valve may comprise a left ventricle and the second side of the native valve may comprise an aorta.

The valve prosthesis device and implant method described herein in accordance with the present disclosure may provide many advantages as will be understood by one of ordinary skill in the art. The overall device and method may provide a simpler way to approach the native valve compared to existing devices. The system may enable a transcatheter approach through the septal wall compared to more invasive transapical approaches. The device may provide a consistent and relatively easy mechanism for anchoring to the native valve. Clinicians need only use the common technique of inserting the device through the valve and then rotating the anchor. The coil may provide preliminary anchoring in the native valve. If desired, the clinician can readjust the anchor and/or retrieve the anchor (e.g. by counterrotation). The device is then easily set by expanding within the native valve leaflets. The device and methods in accordance with the present disclosure may also address unmet clinical needs with atrioventricular repair and replacement. Existing devices face challenges with the complex anatomy of the mitral and tricuspid valves, for example. The present disclosures address these complications by reshaping the native valve annulus to a conventional round shape and providing a robust, yet simple, anchoring mechanism.

FIGS. 4A-4Hshow sequential views of an exemplary deployment of an anchor15from the distal end of a delivery device30. The anchor15and delivery device30may be substantially similar to any of the anchors and delivery devices described herein, respectively. The anchor15may be detachably coupled to the delivery device30and/or a frame structure12(not shown inFIGS. 4A-4H) as described herein. As described herein, the anchor15may be actuated from an elongated configuration to a deployed configuration adjacent a native valve of patient. In some embodiments, the anchor15may be deployed from the inner shaft52by pushing the anchor15out of the inner shaft52(if disposed within the inner shaft52in the elongated configuration), releasing the anchor15from radial constraint by retracting the outer sheath50(if disposed within the outer sheath50in the elongated configuration), or the like as described herein. When correctly deployed from the delivery device30, the anchor15may wrap at least partially around a distal portion of the delivery device30(e.g., around the inner shaft52if disposed within the inner shaft52or around the outer sheath50if disposed within the outer sheath50). A central axis of the curved anchor15may be co-axial with a longitudinal axis of the delivery device30when the curved anchor15is in the deployed configuration.

FIG. 4Ashows the free end22of the anchor15being advanced out of a lumen of the delivery device30via aperture31(also referred to herein as an opening or hole).FIG. 4Bshows a 90° rotated view ofFIG. 4A. The aperture31may be disposed at a distal end of the delivery device as shown. Alternatively, the aperture31may be disposed at a location proximal to the distal end of the delivery device30.

FIG. 4Cshows the free end22of the anchor15being further advanced through the opening31such that it begins to wrap around the distal end of the delivery device30.FIG. 4Dshows a 90° rotated view ofFIG. 4C. As the first loop of the anchor15is deployed, the free end22may be positioned to the right side of the delivery device30. It will be understood by one of skill in the art that the position of the free end22with respect to the delivery device30at this stage (i.e. positioned along the right side or the left side) needed for correct deployment of the anchor15may be dependent on the handedness of the loops (also referred to herein as coils or turns) of the anchor15.

FIG. 4Eshows the free end22of the anchor15being further advanced through the opening31such that a second turn of the anchor15wraps around the delivery device30.FIG. 4Fshows a 90° rotated view ofFIG. 4E. The free end22may again be positioned to the right side of the delivery device30as the anchor15continues to loop around the delivery device30.

FIG. 4Gshows the anchor15in the final deployed configuration.FIG. 4Hshows a 90° rotated view ofFIG. 4G. The remainder of the anchor15may be advanced out of the opening31in order to deploy the anchor15as described herein. While three loops of the anchor15have been shown wrapped around the distal end of the delivery device30, one of ordinary skill in the art will understand that the anchor15may comprise any number of loops desired, for example, one, two, three, four, five, or six loops, and may be configured such that at least a portion of the anchor is wrapped around the delivery device30when deployed. A central axis of the anchor15may be co-axial or concentric with a longitudinal axis of the delivery device30when the anchor15is in the deployed configuration.

After the anchor15has been deployed from the delivery device30, the frame structure12may be at least partially deployed from the delivery device30(for example as shown inFIG. 3H) so as to place the frame structure12within the anchor15. The anchor15may then be used to capture one or more structures as described herein.

FIGS. 5A-5Hshow sequential views of a different and possibly less preferable deployment of an anchor15from the distal end of a delivery device30in accordance with embodiments. The anchor15and delivery device30may be substantially similar to any of the anchors15and delivery devices30described herein, respectively. When deployed from the delivery device30, the anchor15one or more loops of the anchor15may not wrap around a distal portion of the delivery device30(e.g., around the inner shaft52if disposed within the inner shaft52or around the outer sheath50if disposed within the outer sheath50). A central axis of the curved anchor15may not be co-axial with a longitudinal axis of the delivery device30when the curved anchor15is in this deployed configuration. In this configuration, the anchor15may not sit coplanar with the valve annulus and/or may not wrap around native valve structures, such as the chordae tendinae.

FIG. 5Ashows the free end22of the anchor15being advanced out of a lumen of the delivery device30via aperture31.FIG. 5Bshows a900rotated view ofFIG. 5A.

FIG. 5Cshows the free end22of the anchor15being further advanced through the opening31such that it begins to form a loop adjacent the distal end of the delivery device30.FIG. 5Dshows a 90° rotated view ofFIG. 5C. As the first loop of the anchor15is deployed, the free end22may be positioned to the left side of the delivery device30.

FIG. 5Eshows the free end22of the anchor15being further advanced through the opening31such that a second turn of the anchor14deploys adjacent the delivery device30.FIG. 5Fshows a 90° rotated view ofFIG. 5E. The free end22may again be positioned to the left side of the delivery device30as the anchor15continues form loops next to, but not around, the delivery device30.

FIG. 5Gshows the anchor15in the final deployed configuration.FIG. 5Hshows a 90° rotated view ofFIG. 5G. The remainder of the anchor15may be advanced out of the opening31in order to deploy the anchor15. When deployed in this manner, the anchor15may not be wrapped around the delivery device30. The anchor15may instead sit to the side of the delivery device30. A central axis of the anchor15may not be co-axial or concentric with a longitudinal axis of the delivery device30when the anchor15is in the deployed configuration. Instead, the central axis (e.g., helical axis) of the anchor15may be at an angle relative to the longitudinal axis of the delivery device30.

After the anchor15has been deployed from the delivery device30in the configuration shown inFIGS. 5A-5H, the frame structure12may, in some embodiments, be unable to be deployed from the delivery device30to sit within the anchor15, which may subsequently make capturing of the one or more structures and/or anchoring of the frame structure12to the anchor12more difficult or impossible.

FIGS. 6A-6Bshow close-up views of the distal end of a delivery device30during another (possibly more preferable) deployment of an anchor15therefrom.FIGS. 6C-6Dshow close-up views of the distal end of a delivery device30during deployment of the anchor15therefrom. In this deployment method, the anchor15wraps concentrically or coaxially around a longitudinal axis32of the delivery device30. Such wrapping may be directed, at least in part, by the positioning of the free end22relative to the delivery device30. Correctly positioning the free end22relative to the delivery device30may result is proper deployment. If the free end22is positioned on the right side of the delivery device30as it loops towards the delivery device30, the free end22may be able to wrap around the delivery device30and encircle it as indicated by the arrows inFIGS. 6A-6B. If the free end22is instead positioned on the left side of the delivery device30, the free end22may be unable to wrap around the delivery device30and will continue to loop towards the left as indicated by the arrows inFIGS. 6C-6D. It would therefore be desirable to provide an anchor15which may be reliably deflected towards the correct side of the delivery device30to ensure wrapping and deployment of the anchor15.

FIG. 26shows a perspective view of an exemplary anchor delivery system30coupled to an anchor15. The delivery device30may comprise an inner shaft52as described herein, an outer sheath50, and an anchor guide153. In some embodiments, the outer sheath50may be delivered through an introducer or itself act as an introducer. In some embodiments, the inner shaft52and the outer sheath50may be separate sub-assemblies of the delivery device30and may be translatable relative to one another. The anchor15may be detachably coupled to the delivery device30and/or a frame structure12as described herein. The anchor15may be detachably coupled to a retention wire or tether78(seeFIG. 28) that may be translatable within the delivery device30(e.g., within the inner shaft52) relative to the other components of the delivery device30. As described herein, the anchor15may be actuated from an elongated configuration to a deployed configuration adjacent a native valve of patient. In some embodiments, the anchor15may be deployed from the inner shaft52by pushing the anchor15out of the inner shaft52(e.g., with a tether78). When correctly deployed from the delivery device30, the anchor15may wrap at least partially around a distal portion of the delivery device30and/or a central axis of the anchor15may be co-axial with a longitudinal axis of the distal end of the delivery device30when the anchor15is in the deployed configuration.

FIG. 27shows a perspective view of an inner shaft52of the delivery device30ofFIG. 26. The inner shaft52may be substantially similar to any of the inner shafts described herein. The anchor15may be configured to rotate with the inner shaft52when the inner shaft52is rotated. A distal end of the inner shaft52may comprise a curved anchor delivery sheath or anchor guide153(also referred to herein as a “throwdown arm”) at the distal end thereof. The anchor guide153may be configured to deliver the anchor15to the native valve as described herein.

Referring toFIGS. 87A-87C, the anchor guide153can include a proximal section161and a distal section162. The proximal section161can be substantially straight and/or axially aligned with the inner shaft52. The distal section162, in contrast, can be curved, bent, or looped, such that it forms a tapered spiral (or tapered corkscrew) about the same axis as the proximal section161and/or the inner shaft52. The tapered spiral can transition continuously from a high-pitch, low-radius curve at the proximal end to a low-pitch, high-radius curve at the distal end. The distal-most plane of the tapered spiral of the distal section162can be orthogonal to the central axis of the proximal section161and/or inner shaft52. Having the distal-most plane of the distal section162be orthogonal to the central axis of the proximal section161and/or inner shaft52can advantageously ensure that the anchor15is stable (e.g., does not wobble) during deployment. Further, the distal-most portion of the tapered spiral of the distal section162can have a curvature that substantially matches the curvature of the spiral of the anchor15. Having matching curvatures can advantageously ensure that the anchor15rotates on-axis with the proximal section161of the guide153and the inner shaft52as the inner shaft52is rotated and/or as the anchor15is released.

In some embodiments (as best shown inFIG. 87C), the curved distal section162can form a spiral or tapered spiral that extends approximately 360°. In other embodiments, the curved section can extend less than 180° (e.g., 90°-120°) 180°-360°, or greater than 360°. In one specific embodiment, the height h of the distal section162can be 10-20 mm, such as approximately 15 mm. In one specific embodiment, the radius r of the distal portion of the tapered spiral can be 7-12 mm, such as approximately 9 mm.

The distal section162of the anchor guide153may direct the anchor15out of the guide153in an initial direction that is transverse to the longitudinal axis of the inner shaft52and/or proximal section161. As the anchor15is rotated, however, the spiral can form about the longitudinal axis of the inner shaft52and/or proximal section161. The anchor guide153may thus be shaped to act as a throwdown arm and may be configured to correctly orient the anchor15relative to the chordae tendineae and/or prevent twisting of the anchor15during deployment and/or rotation, as well as ensure that the anchor15will self-assemble around the inner shaft52and/or frame structure12, after the outer sheath50is advanced through the native valve. During anchor deployment, translation and/or rotation of the inner shaft52and anchor guide153may provide control over the direction and orientation of anchor self-assembly. During encircling of the chordae tendineae, the axial position of the inner shaft52and anchor guide153may control the height of the anchor relative to the valve annulus, and rotation of the inner shaft52and anchor guide153may be translated to the anchor15to provide encircling motion thereto as described herein.

In some embodiments, the anchor guide153may be held in a relatively straight collapsed configuration when positioned within the lumen of the outer sheath50(e.g., by radial constriction from the sheath50). The anchor guide153may be shape-set such that distal translation of the anchor guide153relative to the distal tip of the outer sheath50, and release of radial constriction therefrom, allows the anchor guide153to bend at the distal section162. In some embodiments, the anchor guide153can be retracted into the outer sheath50(i.e., return to the collapsed configuration) after deployment of the anchor15. The anchor guide153can thus be an extendable and retractable anchor guide153.

In some embodiments, the anchor guide153may comprise one or more deflection features, similar to as described herein for other elements, in order to facilitate delivery of the anchor15to the native valve. The one or more deflection features may help provide the anchor guide153with a shape configured to correctly orient the anchor15relative the longitudinal axis of the inner shaft52in order to facilitate concentric wrapping of the anchor15around the inner shaft52as the anchor15is deployed from the delivery configuration to the deployed configuration.

Referring toFIG. 87D, in some embodiments, the anchor guide153can be shape-set. The anchor guide153can include a portion with a laser cut pattern configured to provide the spiraled or tapered spiral formation. The laser cut pattern can advantageously create a rigid, fixed shape when deployed, but allow for straightening of the anchor15during delivery and/or retraction. The anchor guide153can further be designed to have the maximum curvature possible (e.g., to reduce deployment forces) while maintaining a minimum footprint. The stiffness of the anchor15can also be designed so as to maintain stability as the anchor15is deployed and/or as the anchor guide153is translated and/or rotated within and/or about native valve structures.

In some embodiments, the anchor guide153can be designed such that the distal end thereof overlaps with a proximal end of the anchor15even when the anchor15is fully deployed, thereby increasing torsional and bending stiffness of the anchor. Further, in some embodiments, the distal end of the anchor guide153can be tapered to minimize the step size between the anchor guide153and the anchor15, thereby reducing the chances of the anchor guide153getting stuck on native valve structures during deployment.

The anchor guide153can advantageously ensure deployment of the anchor15in a concentric direction with the delivery device30, avoiding tangling of the anchor15with the delivery device30. Additionally, the anchor guide153can advantageously provide a stable support for the anchor15after the anchor15has been advanced and as the anchor15is rotated about the native valve structures.

In some embodiments, the inner shaft52and anchor guide153may be translated (or “wiggled”) within the outer sheath50prior to, during, or after deployment of the anchor15in order to actively or reactively move the distal tip156of the anchor guide153. Translating the inner shaft52and anchor guide153back-and-forth during deployment of the anchor15may correspondingly adjust the angle of the anchor15and/or free end22of the anchor15as it deploys. This may facilitate deployment of the anchor15in tight spaces and/or facilitate encircling of the chordae tendineae (e.g., by adjusting the orientation and/or location of the free end22). In some embodiments, the anchor guide153can be moved with respect to the sheath50to change the shape or length of the anchor guide153during deployment of the anchor15.

In some embodiments, the anchor guide153is a unitary construct with the distal end of the inner shaft52. Referring toFIG. 88A, in other embodiments, the anchor guide153can be a separate component from the distal end of the inner shaft52and can be bonded at bond region163or otherwise coupled to distal end of the inner shaft52.

Referring toFIGS. 88A-88B, in some embodiments, the anchor guide153may be formed from a shape memory (e.g., NiTi) layer171. In some embodiments, the guide153can further include an inner layer172(e.g., PTFE liner) to reduce friction as the anchor15is moved through the guide153. In some embodiments, the anchor guide153can include an outer jacket layer173(e.g., Pebax® (i.e., a polyether block amide) or urethane). The outer jacket layer173can advantageously help reduce friction with the outer sheath50(which may be steerable) and can advantageously remain flexible as the shape memory layer171takes shape. Further, the outer jacket layer173can advantageously help maintain the integrity of the inner layer172.

Referring toFIGS. 88A and 88C, in some embodiments, the shaft52can include a braided layer, such as a stainless steel braid. The inner layer175can be similar to the inner layer172of the anchor guide153. Likewise, the outer layer176can be similar to the outer layer173of the anchor guide153. In some embodiments, the inner layers172/175can be continuous with one another. Similarly, the outer layers173/176can be continuous with one another.

FIG. 28shows a perspective view of an exemplary anchor15of the system ofFIG. 26. The anchor15may be substantially similar to any of the anchors described herein. The proximal end57of the anchor15may be detachably coupled to a tether78, which may be disposed within the lumen of the inner shaft52(and anchor guide153) and extend towards a proximal end of the delivery device30. The anchor15may comprise a body having a coiled shape (e.g., a spiral shape) as described herein. The body of the anchor15may comprise a plurality of turns or loops as described herein. The body of the anchor15may, for example, comprise a spiral shape having one or more loops as described herein. In various embodiments, the anchor15may comprise a flat spiral shape. Loops of the flat spiral shaped anchor may be generally positioned within the same plane (the plane being perpendicular to a longitudinal axis of a delivery device) as described herein. The anchor15may comprise a free end22configured to act as a “grabber” arm as described herein. The free end22may be disposed proximally, distally, and/or radially outward from the rest of the anchor body. In some embodiments, the free end22may be “L”-shaped relative to the body of the anchor15. In some embodiments, the free end22may be unitary construct with the body of the anchor15. In some embodiments, the free end22may be formed as a separate component from the coiled body of the anchor15and bonded or otherwise coupled to the anchor body prior to deployment.

The anchor15may comprise a delivery (e.g., elongated, radially collapsed, or unexpanded) configuration and a deployed configuration. In various embodiments, the anchor15may be self-expanding and may move to the deployed configuration as it is deployed (e.g., pushed out from the anchor guide153by the tether78). In various embodiments, the anchor15may be configured to self-assemble when it is deployed in the heart cavity (e.g., left ventricle or left atrium). The anchor15may be actuated from the delivery configuration to the deployed configuration adjacent the native valve using any method or mechanism understood by one of ordinary skill in the art from the description herein. Advancement of the inner shaft52and guide153out of the lumen of the outer sheath50may actuate the anchor15into the deployed configuration as described herein.

Referring toFIGS. 89A-89C, the tether78can be detachably coupled to the anchor15, such as via connection mechanism300. Further, as shown inFIGS. 89A-89B, the tether78can, in some embodiments, include a distal portion89and a proximal portion87. The distal portion89can be more flexible than the proximal portion87so as to fit, and easily flex and/or translate, within the anchor guide153. The proximal portion88, in contrast, may be stiffer and ensure that push/pull force is transmitted to the anchor15to deploy and/or retract the anchor from/into the inner shaft52and anchor153. The proximal portion87may be substantially similar to the proximal pushers described herein.

In some embodiments, and as shown inFIG. 89B, the distal portion89of the tether78may be shaped to correspond to the shape of the anchor guide153. The anchor15may self-assemble around the inner shaft52and/or outer sheath50as it is pushed from the lumen of the anchor guide153by the tether78as described herein.

A proximal end of the anchor15may be detachably coupled to the tether78. The tether78may be disposed within a lumen of the delivery device30(e.g., within a lumen of the inner shaft52and anchor guide153) and may operably couple the anchor15to the delivery device30. The tether78may act as an actuation mechanism and facilitate longitudinal translation of the anchor15through the delivery device30during deployment. For example, a proximal end of the tether78may be coupled to an actuation mechanism in/on the delivery device30in order to translate the anchor15. Alternatively, the proximal end of tether78may be manually manipulated by, at, or near a proximal end of the delivery device30in order to translate the anchor15.

The tether78may comprise a flexible advancement member housed and translatable within the inner shaft52. The tether78may comprise a flexible shaft or stylet, for example, in the form of a wire or a metal wire, and/or flexible hypotube with a lumen to accommodate a guidewire. The tether78may be sufficiently flexible to allow for easy rotation within the deflectable delivery device30. The tether78may be comprise a release actuation mechanism (e.g., retention wire88).

In various embodiments, the anchor15may be self-expanding and may move to the deployed configuration as it is deployed (e.g., pushed out) from the anchor guide153by the tether78. The anchor15may be rotated by the rotating the inner shaft52(and anchor guide153) and/or the tether78. In some embodiments, the tether78may be rotated, and rotational motion may be translated from the tether78to the anchor15. Rotation of the anchor15via the anchor guide153and/or tether78can enable the anchor15to wrap around the one or more native valve structures on the ventricle side of the mitral valve as described herein.

The anchor15may be disposed in the inner shaft52(and anchor guide153) and maintained in the delivery configuration by radial constriction from the inner shaft52and anchor guide153. Advancement of the anchor15out of the inner shaft52may actuate the anchor15into the deployed configuration. The proximal end57of the anchor15may be detachably coupled to the tether78within the lumen of the inner shaft52as described herein. Although the anchor15is described as being pushed out of the inner shaft52in some embodiments, one will appreciate from the description herein that different mechanisms may be employed to deploy the anchor depending on the anchor15and/or inner shaft52design. In some respects, pushing is used somewhat interchangeably with rotation in reference to deployment of the anchor15. For example, the anchor15can be rotated out of a lateral opening with a rotational action.

FIGS. 29-30show various views of an anchor15coupled to a tether78at with connection mechanism300.FIG. 29is a side view.FIG. 30is a side cross-sectional view. The tether78may comprise a round wire housed in a tubular housing301. The housing301may, for example, comprise a mesh. The mesh may comprise a wire or polymer mesh. A distal end of the tether78may comprise a hypotube302bonded to the housing301(e.g., mesh). The hypotube end302of the housing301may provide support to the connection point300between the anchor15and the tether78. The coupling hypotube302may comprise a lubricous liner306therein to facilitate de-coupling of the anchor15and the pusher arm78. The wire (or wires) of the tether78may be substantially similar in cross-section and structure to the anchor15in order to facilitate overlap of the layers and provide support.

The tether78may be coupled to the anchor15by a retention wire88. The retention wire88may run the length of the tether78from the connection point300to the proximal end. A distal end of the retention wire88may be threaded through a hole304spanning at least a portion of both the anchor15and the tether wire78when aligned in the delivery configuration. When threaded as such, the retention wire88may act as an engagement pin to keep the anchor15and tether wire78together during deployment of the anchor15. Once the anchor15is deployed, the proximal end of the retention wire88may be translated proximally in order to disengage the retention wire88from the anchor15and release the anchor15from the tether78. The proximal end of the retention wire88may be coupled to an actuation mechanism in/on the delivery device in order to translate the retention wire88. Alternatively, the proximal end of the retention wire88may be manually manipulated by, at, or near a proximal end of the delivery device in order to translate the retention wire88. Once disengaged, the tether78may be retracted from the body, leaving the deployed anchor15adjacent the native valve as described herein.

FIGS. 31-33show sequential views of the release of the anchor15from the tether78.FIG. 31shows the anchor15coupled to the tether78(e.g., during deployment of the anchor15to the heart). After the anchor15has encircled the one or more structures of the native valve, the inner shaft52has been retracted (e.g., as shown inFIG. 43), the frame structure12has been deployed, valve positioning has been confirmed, and/or hemodynamics have been assessed, the anchor15may be decoupled from the proximal pusher78. As shown inFIG. 32, actuation of the release mechanism (e.g., proximal translation of the retention wire88) may disengage the retention wire88from the hole304. As shown inFIG. 33, the tether78may then be retracted into the delivery device30and de-coupled from the anchor15.

FIG. 34shows a side view of an exemplary tether78.FIG. 35shows a side view of an exemplary anchor15.FIG. 36shows a perspective view of the tether78coupled to the anchor15with an inset showing a magnified view of the connection mechanism300between the two elements. The anchor15and the tether78may be substantially similar to any of the anchor and tethers, respectively, described herein. In some embodiments, the free end22of the anchor may comprise a loop. The loop may comprise the same or a different material as the body of the anchor15. The loop may be configured to provide a different stiffness to the free end22compared to the body of the anchor15(e.g., by varying the shape, thickness, size, etc.). In some embodiments, the loop may be secured to the distal portion of the free end22with a collar or other retaining mechanism. In some embodiments, the loop may comprise a wire loop. In some embodiments, the loop may be flat wire or a round wire. The loop may have a diameter within a range of about 2 mm to about 10 mm. A flat, for example rectangular, wire loop may have a cross-section of about 0.1 mm to about 0.5 mm wide and about 0.2 mm to about 1.5 mm tall. A round, for example circular, wire loop may have a diameter of about 0.25 mm to about 1 mm. In some embodiments, the tip (e.g., loop) of the anchor15may be unitary construct with the free end22. In some embodiments, the tip (e.g., loop) may be formed as a separate component from the free end22and bonded or otherwise coupled to the free end22prior to deployment.

FIGS. 90A-90Gshow sequential views of a method of implanting a valve prosthesis10using the delivery system30ofFIGS. 26-28 and 87A-89C. AtFIG. 90A, a transseptal puncture is made. The guidewire54is then routed through the puncture site and left either in the left atrium25or across the mitral valve into the left ventricle26. AtFIG. 90B, the outer sheath50(optionally with an inner dilator51) is tracked over the guidewire54until the distal end of the outer sheath50protrudes into the left atrium25. The guidewire54and inner dilator51are then removed from the outer sheath50. AtFIG. 90C, the inner sheath and anchor guide153are inserted through the outer sheath50until the distal tip of the anchor guide153extends into the left atrium25. The anchor guide153can be positioned and/or oriented as desired by steering the distal end of the sheath50and/or rotating the inner shaft and anchor guide153within the sheath50. AtFIG. 90D, once the anchor guide153is in the correct orientation, the anchor15can be pushed out through distal tip of the anchor guide153. AtFIG. 90E, the curvature of the anchor guide153can cause torsion on the anchor15, causing the anchor15to deploy concentrically with the outer sheath50into the atrium25. AtFIG. 90F, the entire delivery system30can be pushed and steered (for example, via steering mechanisms in the outer sheath50) towards an apex of the ventricle26, crossing through the mitral valve. In some embodiments, counter-rotation of the anchor15(via counter-rotation of the inner shaft and guide153) may aid in getting the anchor across the mitral valve without tangling. Once the anchor15is at the correct depth within the ventricle26, forward rotation of the anchor15(via forward rotation of the inner shaft and guide153) will allow the anchor15to encircle the mitral leaflets and chordae. In some embodiments, the anchor15can be deployed towards the apex to avoid interference with mitral leaflet motion. AtFIG. 90G, the outer sheath40, inner sheath, and anchor guide153are removed, leaving the tether78in place (and still attached to the anchor15). The frame structure12can then be delivered over the tether78and into place within the mitral valve.

FIGS. 37-44also show sequential views of a method of implanting a valve prosthesis10using the delivery system30ofFIG. 26. Thus.FIG. 37shows advancement of the delivery device30over a guidewire54. The guidewire54may be advanced into the heart of a patient, for example, through a transseptal puncture. The guidewire54may be routed through the puncture side and left either in the left atrial appendage or positioned across the mitral valve in the left ventricle as desired. The delivery device30may comprise an outer sheath50, an inner shaft52, an anchor guide153, and a proximal pusher78as described herein. The delivery device30may be configured to deliver a valve prosthesis10comprising an anchor15and a frame structure12as described herein.

FIG. 38shows removal of the guidewire54(and optional introducer) from the heart.

FIG. 39shows advancement of the inner shaft52distally into the left atrium25away from the distal end of the outer sheath50. In some embodiments, advancing the inner shaft52relative to the outer sheath50may aid in deployment and/or placement of the valve prosthesis10as described herein. For example, advancement of the inner shaft52may expose the anchor guide153from the distal end of the outer sheath50, freeing it from radial constriction and allowing the anchor guide153to take on its pre-set shape.

FIGS. 40-41show deployment of the anchor15out of the anchor guide153. The anchor guide153may be shaped and configured to facilitate deployment of the anchor15in the correct orientation relative to the delivery device30as described herein. For example, the curvature of the anchor guide153may cause torsion on the anchor15, which may cause the anchor15to be deployed concentrically with the longitudinal axis of the distal end of the inner shaft. The anchor15may be deployed from an elongated delivery configuration to a spiral deployed configuration. The anchor15may be fully deployed in the left atrium25. In some embodiments, the anchor15may be deployed relatively aligned to the apex of the ventricle26in order to maximize the amount of space in which the anchor15deploys within the left atrium25.

FIG. 42shows advancement of the delivery device30and anchor15from the left atrial side25of the mitral valve4to the left ventricle side26of the mitral valve4. The distal end of the delivery device30may be steerable such that it is positionable to point towards the first side of the native valve before being advanced to the second side of the native valve as described herein. The delivery system30may be advanced distally and deflected towards the apex of the ventricle26(so that the anchor15is relatively perpendicular to the apex) before crossing the mitral valve4.

Advancing the anchor15may comprise pushing the anchor15through the native valve4. Advancing the anchor15may further comprise rotating the anchor15through the native valve4.

The free end22of the deployed anchor15may optionally be rotated around one or more structures on the second side of the native valve4. The one or more structures may comprise one or more valve leaflets42of the native valve4. Alternatively, or in combination, the one or more structures may comprise one or more chordae tendineae40of the left ventricle23.

The free end22of the deployed anchor15may optionally rotated around one or more structures on the second side of the native valve such that the one or more structures (e.g., chordae, leaflets, or annulus) are pulled radially inwards towards the longitudinal axis of the anchor15and/or towards the longitudinal axis of the delivery device30. The anchor15and/or free end22may be configured such that minimal torque is applied to the one or more structures. Alternatively, or in combination, the anchor15and/or free end22may be configured such that the one or more structures are not rotated, or are minimally rotated, during rotation of the anchor15.

In some embodiments, the anchor15may be counter-rotated in order to reposition the anchor15with respect to the one or more structures of the native valve before continuing the rotation in the first direction. For example, counter-rotation may be applied if the one or more structures are caught by the free end of the anchor15(or another part of the valve prosthesis10or delivery device30) during the initial rotation. In such instances, counter-rotation may enable to the clinician to disengage some or all of the one or more structures to reduce the stress or torque on the one or more structures (e.g., by adjusting the position of the valve prosthesis10) before resuming rotation. Rotation and counter-rotation may be applied as many times as desired by the clinician in order to properly position the anchor15around the one or more structures of the native valve.

In some embodiments, the anchor15may be deployed towards the apex of the ventricle26in order to avoid interference with motion of the native leaflets42during positioning. In some embodiments, the anchor15may then be pulled upwards to seat the anchor15adjacent the native leaflets42.

FIG. 43shows retraction of the anchor guide153into the outer sheath50following positioning of the anchor15around the one or more structures of the native valve4.

FIG. 44shows retraction of the outer sheath50from the heart, leaving the anchor retention wire78and anchor15in place. An engagement wire (e.g., engagement wire88shown inFIGS. 29-33) may then be actuated to de-couple the proximal pusher78from the anchor15as shown inFIGS. 31-33. The anchor retention wire78may be disengaged from the anchor15and pulled back into the delivery device30.

The frame structure12may deployed before, during, or after retraction of the anchor guide153and/or outer sheath50.

Referring toFIGS. 59-62B, in some embodiments, the delivery device30may comprise an outer sheath assembly155, an inner shaft52disposed within a lumen of the outer sheath50, and an optional guidewire54disposed within a lumen of the inner shaft52. The outer sheath assembly155can include an outer sheath50and a valve capsule154.

The valve capsule154may comprise a flexible material or a rigid material. The valve capsule154may be relatively rigid such that it can exert a compression force on a frame structure12delivered within the valve capsule154while still retaining flexibility to deform under an external force. The valve capsule154may comprise a soft or flexible material.

As described herein, the inner shaft52may be disposed within a lumen of the outer sheath assembly155, and a guidewire54may be disposed adjacent to the inner shaft52within a lumen of the outer sheath assembly155. Alternatively, the guidewire54may be disposed in a lumen of inner shaft54. The guidewire54may optionally comprise a nosecone to facilitate guidance of the guidewire54to the native valve. A proximal end of the valve prosthesis10may be operably coupled to the inner shaft52(or tether78, such as described with respect toFIGS. 89A-89C) during delivery to the native valve as described herein. The outer sheath50may be steerable. The outer sheath50may be guided by a guidewire54. The outer sheath50may be guided by a guidewire54in conjunction with an anchor guide153. The outer sheath50may likewise be guided by the anchor guide153.

FIGS. 59-62Bshow various steps of an exemplary method of delivering a valve prosthesis10to a native valve of a patient using the delivery device30.

FIG. 59is a section view of a heart2with a diseased valve4. A guidewire54of a delivery device30may be guided to the left atrium25and left ventricle26through a transseptal puncture27.

FIG. 60Ais a section view of the delivery device30being guided into over the guidewire54into the left atrium25of the heart2. The guidewire54may be located in a lumen of the outer sheath assembly155. The delivery device30can be steered by movement of the guidewire54. The outer sheath50can be steered by an advancement of the anchor guide153through the lumen of the outer sheath50as described herein.

FIG. 60Bis a section view of the delivery device30comprising the outer sheath assembly155. As the delivery device30is advanced further into the left atrium, the valve capsule154of the outer sheath assembly155may be separated from the outer sheath50to expose an inner shaft52disposed within a lumen of the outer sheath assembly155. The inner shaft52may comprise a tight bend configured align the inner shaft52and/or distal tip154with the mitral valve. Correct alignment of the distal tip154with the mitral valve may facilitate deployment of the anchor15around the inner shaft52and/or frame structure12as described herein. The outer sheath50and the valve capsule154may be translated relative to one another; for example, the valve capsule154may be advanced relative to the outer sheath50to separate the two components, forming an opening between the two components and exposing the lumens of the outer sheath50and the valve capsule154to the exterior.

In some embodiments, the valve capsule154of the outer sheath assembly155may be steerable. The valve capsule154of the outer sheath assembly155may be steered prior to or after separation of the valve capsule154from the outer sheath50such that the valve capsule154points towards the native valve.

The valve prosthesis10may be operably coupled to the delivery device30as described herein. In some embodiments, at least a portion of the valve prosthesis10may be directly coupled to the inner shaft52(or tether78). Alternatively, or in combination, at least a portion of the valve prosthesis10may be indirectly coupled to the inner shaft52. For example, at least a portion of the valve prosthesis10may be coupled to a torque hub or other connector, which may be coupled to the inner shaft52.

FIG. 60Cis a section view of the delivery device30after the anchor guide153has been pushed through a lumen of the outer sheath50into the left atrium25. The anchor guide153may be configured to deliver an anchor15of the valve prosthesis10to the native valve4. The inner shaft52can form a tight bend (e.g., a 90 degree angle), thereby centering the valve capsule154of the delivery device to the center of the mitral valve. The anchor guide153can then push the anchor15through the outer sheath50and around the bent the inner shaft52. The anchor guide153(also referred to herein as a throwdown arm or anchor guide sheath) may be configured to correctly orient the anchor15relative to the bent inner shaft52in order to facilitate wrapping of the anchor15around the inner shaft52as the anchor15is deployed from the delivery configuration to the deployed configuration.

In some embodiments, the anchor15may be partially deployed to an intermediate deployed configuration in the left atrium before being advanced through the native valve into the left ventricle. In the intermediate deployed configuration, the anchor15may be wrapped at least partially around the inner shaft52.

In some embodiments, the anchor15may be fully deployed from the anchor guide153into a deployed configuration within the left atrium prior to being advanced into the left ventricle.

The anchor15may comprise a delivery (e.g., elongated, radially collapsed, or unexpanded) configuration and a deployed configuration. A frame structure of the valve prosthesis (e.g., frame structure12shown inFIGS. 62A-62B) may remain in its unexpanded configuration while the anchor15is in the deployed configuration. In various embodiments, the anchor15may be self-expanding and may move to the deployed configuration as it is deployed (e.g., pushed out) from the anchor guide153by a proximal pusher arm or a tether. In various embodiments, the anchor15may be configured to self-assemble when it is deployed in the heart cavity (e.g., left ventricle or left atrium). The anchor15may be actuated from the delivery configuration to the deployed configuration adjacent the native valve using any method or mechanism understood by one of ordinary skill in the art from the description herein. For example, retraction of the guidewire54into the lumen of the inner shaft52may actuate the anchor15into the deployed configuration. Alternatively, or in combination, the anchor15may be maintained in the delivery configuration by radial constriction from one or more of the outer sheath50or the valve capsule154of the outer sheath assembly155. Advancement of the inner shaft52out of the lumen of the outer sheath50may actuate the anchor15into the deployed configuration as described herein.

In some embodiments, the anchor15may be actuated from the delivery configuration to the deployed configuration (or intermediate configuration) on a first side of the native valve prior to being advanced to a second side of the native valve. For example, the anchor15may be deployed in a left atrium of a heart prior to being advanced to a left ventricle of the heart as described herein (e.g. as shown inFIGS. 60A-62B). The anchor15may be fully advanced from a first side of a native valve in a patient (e.g., an atrial side) to a second side of the native valve (e.g., into a ventricle of the heart) and anchor a frame structure (e.g., frame structure12shown inFIGS. 62A-62B) to the native valve when the frame structure is in the expanded configuration adjacent the native valve.

FIG. 61Ashows a section view of the delivery device30after the anchor15in the intermediate deployed configuration has been pushed through the diseased valve into the left ventricle26, adjacent to the native chordae tendineae40. As the anchor guide153is pushed through the outer sheath50, the tight bend of the inner shaft52may be pulled straighter (e.g., towards 180 degrees) by the guidewire54. The outer sheath50may then be further directed to a (e.g., by the rigid shape of a proximal pusher arm within the) anchor guide153as it is advanced through a lumen of the outer sheath50.

Advancement of the anchor guide153as the outer sheath50is brought into alignment with the mitral valve and/or advanced through the mitral valve may expose a bend in the anchor guide153. The bend in the anchor guide153can act as a throwdown arm and may be configured to correctly orient the anchor15relative to the chordae tendineae40and/or prevent twisting of the anchor15during deployment and/or rotation, as well as ensure that the anchor15will self-assemble around the inner shaft52and/or frame structure12, after the outer sheath50is straightened.

FIG. 61Bshows a section view of the delivery device30with the anchor15being wrapped around the native chordae tendineae40. The anchor15may, for example, be wrapped around the chordae tendineae40by further advancing the anchor15through the anchor guide153. The anchor15may be wrapped around the native chordae tendineae40by being urged out of the anchor guide153positioned radially offset from the longitudinal axis of the outer sheath50. Alternatively, or in combination, the anchor15may be wrapped around the native chordae tendineae40by rotating the inner shaft52, outer sheath50, and/or anchor guide153, thereby rotating the anchor15around the chordae tendineae40. In some embodiments, advancement of the anchor guide153may facilitate wrapping of the anchor15around the chordae tendineae. The anchor guide153may direct the anchor to a direction transverse to the longitudinal axis of the outer sheath50while centered about the longitudinal axis of the outer sheath50.

FIG. 62Ais a section view showing expansion of a frame structure12of the valve prosthesis10from an opening created by separation of the valve capsule154of the outer sheath assembly155from the outer sheath50. The valve capsule154may be advanced distally into the left ventricle in order to unsheathe and expose the frame structure12by expanding the opening of the outer sheath assembly155. The valve capsule154may be collapsible upon removal of the frame structure12. The valve capsule154may comprise a pliable material configured not to cause damage to anatomical structures. The guidewire54may comprise an element at a fixed position on the guidewire54to prevent movement of the valve capsule154past a certain point. The element may be. For example, a bend or a fixed structure with a diameter greater than that of the lumen of the valve capsule154.

In some embodiments, the valve capsule154of the outer sheath assembly155may comprise a soft valve capsule as described herein.

FIG. 62Bis a section view showing the final position of the valve prosthesis10following retraction of the anchor guide153. The anchor15may be wrapped around the native chordae tendineae40in order to lock the valve prosthesis10in place as described herein. The frame structure10may be released from the delivery device30as described herein. The delivery device30may then be retracted to leave the valve prosthesis10in place (e.g., as shown inFIG. 65).

The separation of the valve capsule154of the outer sheath assembly155from the outer sheath50may be facilitated by advancement of an inner shaft52through the lumen of the outer sheath50. In some embodiments, the frame structure12may be housed within the valve capsule154of the outer sheath assembly155and can be maintained in the delivery configuration by radial constriction from one or more of the valve capsule154or by the outer sheath50.

FIGS.6A3-64C sequentially describe a method of deploying a valve prosthesis within the native valve, in accordance with many embodiments.

FIGS. 63A-63Csequentially describe a method of delivering a valve prosthesis10directly to a left ventricle of the heart.FIG. 63Ais a section view of a delivery device30which has been steered to an edge of the native valve prior to deployment of the anchor12. The delivery device30may be configured to be delivered into the heart over a guidewire54through a transseptal puncture in a manner substantially similar to that described herein (e.g., as shown inFIGS. 59-60A). The delivery device30may comprise an outer sheath assembly155which may be substantially similar to any of the outer sheath assemblies described herein. For example, the outer sheath assembly153may comprise an outer sheath50and a valve capsule154as described herein.

The outer sheath assembly155may be steerable as described herein. The outer sheath assembly155may be steered through the native valve such that the valve capsule154is positioned on below the native valve and the outer sheath50is positioned above the native valve. Steering of the valve capsule154of the outer sheath assembly155may be accomplished by a guidewire54with a deflection element such as a rigid bend. The anchor guide153may also position the anchor15for attachment to the chordae tendineae40as described herein. A proximal pusher arm or tether within the anchor guide153may position the anchor15for attachment to the chordae tendineae40as described herein. Alternatively, or in combination, the distal end of the anchor15may comprise a deflection element to steer the anchor15as it is released from the radial constriction of the anchor guide153. The outer sheath50and the valve capsule154may be separated to form an opening therebetween and expose an inner shaft52of the delivery device30as described herein. The outer sheath50and the valve capsule154may be separated from one another such that the opening spans the native valve. The outer sheath50and the valve capsule154may be separated from one another such that the opening entirely on the second side of the native valve (e.g., on a ventricular side of the native valve).

FIG. 63Bis a side section view of the delivery device30after an anchor guide153has been pushed through a lumen of the outer sheath50into the left ventricle. The opening formed by the separation of the outer sheath50and the valve capsule154may enable the anchor guide153to be delivered directly into the left ventricle. The anchor guide153may be substantially similar to any of the anchor delivery sheaths described herein.

FIG. 63Cis a side section view of the delivery device30after an anchor15has been partially pushed through the anchor guide153, thereby partially deploying the anchor15from the delivery conformation directly into the deployed conformation while simultaneously wrapping the anchor15around the native chordae tendineae40. The anchor15may be pushed through the anchor guide153(e.g., with a proximal pusher arm or tether78disposed within the lumen of the anchor guide153. The anchor15may be substantially similar to any of the anchors described herein.

FIG. 64Ais a section view of the repositioning of the delivery device30to the center of the diseased valve and the continued deployment of the anchor15from the anchor guide153. The anchor15may be wrapped around one or more structures of the native valve (e.g., chordae tendineae), as described herein. For example, direct deployment of the anchor15from the anchor guide153in the left ventricle may facilitate wrapping as the anchor15transitions from the delivery configuration to the deployed configuration. Alternatively, or in combination, the anchor15may be rotated during or after deployment as described herein.

FIG. 64Bis a section views of the deployment of the frame structure12of the valve prosthesis10from an opening created by the separation of the distal end of the valve capsule154from the outer sheath50. The frame structure12may be substantially similar to any of the frame structures described herein. The frame structure12may be expanded from an unexpanded configuration to an expanded configuration as described herein. Separation of the valve capsule154from the outer sheath50may be facilitated by the advancement of an inner shaft52through the lumen of the outer sheath50such that the valve capsule154is pushed away from the outer sheath50by the inner shaft52. The frame structure12can be maintained in the delivery configuration by radial constriction from one or more of the valve capsule154or the outer sheath50.

The anchor15may be detachably coupled to a proximal or distal portion of the frame structure12as described herein. Alternatively, or in combination, the frame structure12may be detachably coupled to the delivery device30in the delivery configuration during delivery to the native valve. For example, the proximal end of the frame structure12may be detachably coupled to the inner shaft52of the delivery device30by radial constriction from the outer sheath50or the valve capsule154. Retraction of the outer sheath50away from the proximal end of the frame structure12(or, similarly, extrusion of the distal end of the frame structure12out of an opening in the outer sheath) may detach the frame structure12from the delivery device30. Alternatively, or in combination, the proximal end of the frame structure12may be detachably coupled to the inner shaft52of the delivery device30by an attachment element. Alternatively, or in combination, the proximal end of the frame structure12may be detachably coupled to the inner shaft52of the delivery device30by a weak adhesive.

FIG. 64Cis a section view showing the final position of the valve prosthesis10following retraction of the anchor guide153. The anchor15may be wrapped around the native chordae tendineae40in order to lock the valve prosthesis10in place as described herein. The frame structure12may be released from the delivery device30as described herein. The delivery device30may then be retracted to leave the valve prosthesis10in place (e.g., as shown inFIG. 65).

FIG. 65shows a cross-section of the heart following delivery of the valve prosthesis10by any of the methods described herein. The valve prosthesis10may be positioned within the native valve as described herein. The valve prosthesis10may allow blood to flow from the left atrium25to the left ventricle26while preventing backflow or regurgitation in the reverse direction.

FIG. 68Ashows a side view of an embodiment of a valve capsule154of an exemplary outer sheath assembly155prior to deployment of a frame structure12. The outer sheath assembly155may be substantially similar to any of the outer sheath assemblies described herein and may comprise an outer sheath50and a valve capsule154. The valve capsule154of the outer sheath assembly155may be configured to hold at least a portion of a valve prosthesis10, for example at least a portion of a frame structure12. In some embodiments, the outer sheath50may comprise a side port214through which the anchor15can be deployed prior to separation of the valve capsule154from the outer sheath50. Alternatively, or in combination, deployment of the anchor15may be facilitated by separation of the valve capsule154and the outer sheath50. Prior to its deployment adjacent a native valve as described herein, the frame structure12may be fully enclosed within the valve capsule154. In some embodiments, the frame structure12may be disposed around an inner shaft52of the delivery device. In some embodiments, the frame structure12may be disposed around a distal tip of the outer sheath50which is covered by the valve capsule154of the outer sheath assembly155prior to separation of the valve capsule154and the outer sheath50.

The valve capsule154may comprise a cylindrical proximal section220and a tapered distal section219. In some embodiments, the valve capsule154may comprise a single unitary construction (i.e., the cylindrical proximal section220and a tapered distal section219can be of single unitary construction). In some embodiments, the cylindrical section220and the tapered distal section219may comprise different structural features or elements (for example, as shown inFIGS. 69A-69C). Alternatively, or in combination, the cylindrical section220and the tapered distal section219may comprise two separate pieces which may be coupled and uncoupled (for example, as shown inFIGS. 72A-73C). It will be understood by one of ordinary skill in the art that any of the cylindrical sections220described herein may be combined with any of the tapered tip sections219described herein to form the valve capsule154, and any of the valve capsules154described herein may be combined with any of the outer sheaths50described herein to form an outer sheath assembly155.

FIG. 68Bshows a side view of the outer sheath assembly155ofFIG. 68Aas the valve capsule154begins to separate from the outer sheath50.FIG. 68Cshows a side view of the outer sheath assembly155ofFIG. 68Afollowing the separation of the valve capsule154of the outer sheath assembly155from the outer sheath50. The valve capsule154of the outer sheath assembly155may be distally away from the outer sheath50to expose the frame structure12. In some embodiments, a distal end of the inner shaft52may extend through a lumen of the outer sheath50and the valve capsule154as described herein and may be connected to an internal surface of the tapered distal section219of the valve capsule154of the outer sheath assembly155. Distal translation of the inner shaft52relative to the outer sheath50may push the valve capsule154away from the outer sheath50to expose the frame structure12. Translation of the valve capsule154away from the outer sheath50may release the frame structure12from radial constriction provided by the valve capsule154and allow the frame structure12to expand (e.g., self-expand or with the aid of a balloon as described herein) as described herein.

FIG. 69Ashows a side view of an embodiment of the valve capsule154including a cylindrical proximal section220and a tapered distal section219.FIGS. 69B-69Cshow side views of the separation of the valve capsule154from the outer sheath50, exposing the frame structure12wherein the cylindrical section220comprises a collapsing mechanism by which the cylindrical proximal section220may collapse during separation to expose the frame structure12. The mechanism can comprise a pull wire to actuate the collapse of the cylindrical proximal section220of the valve capsule154or a coil spring in a compressed state wherein separation from the frame structure12releases tension on the coil spring, thereby allowing the cylindrical section220of the valve capsule154to collapse.

FIG. 70Ashows a side view of an embodiment of the valve capsule154including a cylindrical proximal section220and a tapered distal section219, wherein the cylindrical proximal section220includes a helically wound wire226and a ring227.FIGS. 70B-70Cshow side views of the separation of the valve capsule154from the outer sheath50, exposing the frame structure12wherein the helically wound wire226of the cylindrical proximal section220comprises a releasing mechanism by which the ring227of the cylindrical proximal section220is released from the outer sheath50. The mechanism can comprise a pull wire to actuate the collapse of the helically wound wire226. Advancement of the inner shaft52relative to the outer sheath50may transmit force to the ring227in order slide the ring227off of the outer sheath50. Release of the ring227from the outer sheath can enable the helically wound wire226to release to an actuated height. In some embodiments, the helically wound wire226can have has a delivery height greater than an actuated height. In some embodiments, the helically wound wire226can have an actuated height less than a delivery height. The helically wound wire226can be a round wire, a flat wire, a square wire, an oval wire, a triangular wire, etc. Further, the valve capsule154can comprise nitinol.

FIG. 71Ashows a side view of an embodiment of the valve capsule154including a cylindrical proximal section220and a tapered distal section219, wherein the cylindrical proximal section220includes a plurality of rings227connected by a wire228.FIGS. 71B-71Cshow side views of the separation of the distal end of the valve capsule154from the outer sheath50, exposing the frame structure12. The cylindrical proximal section220includes mechanism by which the rings227of the cylindrical section are released from the outer sheath50. The mechanism can include a pull wire to actuate the collapse of the series of rings227connected by a wire228of the cylindrical section. The mechanism can include a force from the advancement of an inner shaft52relative to the outer sheath50to slide the ring227off of the outer sheath50. Release of the rings227from the outer sheath50can enable the series of rings227connected by a wire228to release to an actuated height. In some embodiments, the series of rings227connected by a wire228can have a delivery height greater than an actuated height. In some embodiments, the series of rings227connected by a wire228can have an actuated height less than a delivery height. Further, the valve capsule154may comprise nitinol.

FIG. 72Ashows a side view of an embodiment of the valve capsule154wherein the valve capsule154includes a cylindrical proximal section220and a tapered lowered section219wherein the cylindrical proximal section220and the tapered distal section219are releasably attached.FIG. 72Bshows a side view of the separation of tapered distal section219of the valve capsule154from the cylindrical proximal section220of the outer sheath assembly155, attached to the outer sheath50, exposing the frame structure12.FIG. 72Bshows an embodiment wherein the cylindrical section220comprises a mechanism by which it collapses to during separation to expose the frame structure12, while the tapered distal section219, attached to an inner shaft52, remains stationary relative to the frame structure12. The mechanism can include a wire223within a spiral lumen221of the cylindrical section220which can be pulled to actuate the collapse of the cylindrical section220of the valve capsule. The mechanism can comprise a balloon within a spiral lumen221of the cylindrical section220which can be deflated (e.g., by a vacuum) to actuate the collapse of the cylindrical section220of the valve capsule.

FIG. 73Ashows a side view of another embodiment of the valve capsule154wherein the valve capsule154includes a cylindrical proximal section220and a tapered distal section219wherein the cylindrical proximal section220and the tapered distal section219are releasably attached.FIGS. 73B-73Cshow side views of the separation of tapered distal section219of the valve capsule154from the cylindrical proximal section220of the valve capsule154, attached to the outer sheath50, exposing the frame structure12.FIG. 73Bshows an embodiment wherein the cylindrical proximal section220and the tapered distal section219both move away from each other to expose the frame structure12.

During use of any of the delivery devices30ofFIGS. 59-73CA, a guidewire may be advanced into the heart of a patient, for example, through a transseptal puncture (e.g., as shown inFIG. 59). A distal end of the guidewire may be advanced from a first side of a native valve to a second side of the native valve. For example, the distal end of the guidewire may be advanced from a left atrial side of a mitral valve to a left ventricular side of a mitral valve.

The delivery device30may be advanced into the heart over the guidewire54(e.g., as shown inFIG. 60A). The distal end of the delivery device30may be configured to be advanced from a first side of a native valve to a second side of the native valve. For example, the distal end of the delivery device30may be advanced from a left atrial side of a mitral valve to a left ventricular side of a mitral valve. The distal end of the delivery device30(e.g., the sheath50) may be steerable such that it is positionable to point towards the first side of the native valve before being advanced to the second side of the native valve.

The valve capsule154may be separated from the outer sheath50adjacent the native valve to form the opening and expose the inner shaft52and anchor guide153. The opening may be formed prior to, during, or after advancing the distal end of the delivery device30from the first side of the native valve to the second side of the native valve.

In some embodiments, the distal end of delivery device30may be advanced from the first side of the native valve to the second side of the native valve after at least partially deploying the anchor15(e.g., as shown inFIG. 61A). In some embodiments, the distal end of the delivery device30may be advanced from the first side of the native valve to the second side of the native valve prior to deploying the anchor15(e.g., as shown inFIG. 63A).

After advancing to the second side of the native valve, the anchor15may be fully deployed from the anchor guide153on the second side of the native valve (e.g., as shown inFIGS. 61B and 7A). Fully deploying the anchor15may comprise actuating the anchor15from an elongated delivery configuration.

In some embodiments, fully deploying the anchor15from the anchor guide153may comprise actuating the anchor15from an elongated delivery configuration to a deployed configuration on the first side of the native valve (e.g., as shown inFIG. 60C) and advancing the anchor15in the deployed configuration through the native valve to the second side of the native valve (e.g., as shown inFIG. 61A). Advancing the anchor15may comprise pushing the anchor15through the native valve. Advancing the anchor15may further comprise rotating the anchor15through the native valve.

In some embodiments, fully deploying the anchor15from the anchor guide153may comprise positioning the anchor15such that it is located only on the second side of the native valve as can be seen inFIGS. 61B and 64A.

In some embodiments, the anchor15may be actuated from the delivery configuration to the deployed configuration on a first side of the native valve prior to being advanced to a second side of the native valve (e.g., as shown inFIG. 60C). For example, the anchor15may be deployed in a left atrium of a heart prior to being advanced to a left ventricle of the heart as described herein.

Alternatively, the anchor15may be actuated from the delivery configuration to the deployed configuration on a second side of the native valve after being advanced to the second side from a first side of the native valve (e.g., as shown inFIG. 63C). For example, anchor15may be advanced from a left atrium of a heart prior to being deployed in a left ventricle of the heart.

The free end of the deployed anchor15may optionally be rotated around one or more native valve structures on the second side of the native valve. The one or more native valve structures may comprise one or more valve leaflets of the native valve. Alternatively. or in combination, the one or more native valve structures may comprise one or more chordae of the left ventricle.

The free end of the deployed anchor15may optionally rotated around one or more native valve structures on the second side of the native valve such that the one or more native valve structures (e.g., chordae, leaflets, or annulus) are pulled radially inwards towards the longitudinal axis of the anchor and/or towards the longitudinal axis of the delivery device. The anchor and/or free end may be configured such that minimal torque is applied to the one or more native valve structures. Alternatively, or in combination, the anchor15and/or free end may be configured such that the one or more native valve structures are not rotated, or are minimally rotated, during rotation of the anchor.

In some embodiments, rotation of the free end may occur simultaneously with deployment of the anchor15from the anchor delivery sheath.

The anchor15may then be released from the anchor guide153. The anchor15may be released from the anchor guide153on the second side of the native valve.

The frame structure12may be expanded within the native valve from an unexpanded configuration to an expanded configuration (e.g., as shown inFIGS. 62A and 64B).

The frame structure12may be released from the distal end of the delivery device.

The frame structure12may be held within the valve capsule154. In some embodiments, the cylindrical proximal section220and the tapered distal section219of the valve capsule154may be permanently attached to one another (e.g., as shown inFIGS. 68A-68C, 69A-69C, 70A-70C, and 71A-71C). Release of the frame structure12may comprise distal translation of the valve capsule154away from the outer sheath50and frame structure12held thereon (e.g., as shown in FIGS.68A-68C). Release of the frame structure12may comprise collapse of the valve capsule154into an actuated position (e.g., as shown inFIGS. 69A-69C.70A-70C,71A-71C). In some embodiments, the cylindrical section220and the tapered section219may be releasably attached to one another (e.g., as shown inFIGS. 72A-72B, 73A-73C). Release of the frame structure12may comprise proximal translation of the cylindrical proximal section220of the valve capsule away from the tapered distal section219(e.g., as shown inFIG. 72B). Release of the frame structure12may comprise translation of both the cylindrical proximal section220(e.g., proximal translation) and the tapered distal section219(e.g., distal translation) to separate the cylindrical proximal section220from the tapered distal section219(e.g., as shown inFIG. 73B-73C).

In some embodiments, at least a portion the frame structure12may be expanded within at least a portion of the deployed anchor15to anchor the frame structure12to the native valve.

In some embodiments, expanding the frame structure12and releasing the frame structure12may occur simultaneously.

In some embodiments, the frame structure12may be self-expanding and may be maintained in the unexpanded configuration by radial constriction from one or more of the outer sheath50of the delivery device30or by the valve capsule154of the outer sheath assembly155. Advancement of the inner shaft52out of the lumen of the outer sheath50may actuate the frame structure12into the expanded configuration. Advancement of the inner shaft52out of the lumen of the outer sheath assembly155may actuate the frame structure12into the expanded configuration by the separation of the valve capsule154of the outer sheath assembly155from the outer sheath50.

Finally, the delivery device30may be retracted from the native valve as shown inFIG. 65.

WhileFIGS. 3E-3H and 4A-8Dshow deployment of the anchor15from an opening in the distal tip of the delivery device30(e.g., a distal tip of the inner shaft52or a distal tip of the outer sheath50), it will be understood by one of ordinary skill in the art that the anchor15may be deployed from an opening in a distal end of the delivery device30that is proximal to the distal tip, for example from an opening in a side wall of the delivery device30(e.g., a side opening in the inner shaft52or a side opening in the outer sheath50).

FIGS. 81A-81I and 82A-G show sequential views of a method of implanting a valve prosthesis10using a delivery device30with a lateral or side opening215.FIG. 83shows a magnified side view of the delivery device30highlighting the start of deployment of the anchor15from the side opening215in the delivery device30.FIG. 81Ashows a cross section view of a heart having a diseased mitral valve4which may be treated using the devices, systems, and methods described herein. The mitral valve4sits between the left atrium25and the left ventricle26and, when functioning properly, allows blood to flow from the left atrium25to the left ventricle26while preventing backflow or regurgitation in the reverse direction. As shown inFIG. 81A, the native valve leaflets42of the diseased mitral valve4do not fully prolapse and the patient experiences regurgitation. The native chordae tendineae40of the heart2are shown. A guide wire54may be inserted into the left atrium25of the heart2via a transseptal puncture as described herein. The distal end or nosecone55of the guidewire54may be placed in the left ventricle26.

The delivery device30may comprise an optional outer sheath50(e.g., an outer catheter) and an inner shaft52(e.g., a delivery tube) disposed within a lumen of the outer sheath5-. A proximal end of the valve prosthesis10may be operably coupled to the inner shaft52during delivery to the native valve as described herein. The outer sheath50may be steerable. The inner shaft52may be steerable and may include the side opening215.

The valve prosthesis10may be similar to any of the valve prostheses described herein. For example, the valve prosthesis may include a frame structure12and an anchor15. The anchor15may be directly coupled to the frame structure12, for example at a proximal or distal end thereof. Alternatively, or in combination, the anchor15may be detachably coupled to the delivery device30prior to deployment at the native valve. The anchor15may comprise a deployed configuration (for example, as shown inFIGS. 81I and 84D). The frame structure12may have an unexpanded configuration (for example, as shown inFIGS. 81B-81I and 82A), for example when the valve prosthesis10is in its unexpanded configuration, and an expanded configuration (for example, as shown inFIGS. 82B-82G), for example when the valve prosthesis10is in its expanded configuration. The frame structure12is shown in the unexpanded configuration. The expanded configuration may have a generally tubular expanded shape. The frame structure12may be configured for expanding within the native valve of the patient. In some embodiments, the unexpanded configuration may be sized and dimensioned for percutaneous insertion and the expanded configuration may be sized and dimensioned for implantation in the native valve of the patient.

The frame structure12may comprise a first and second opposite ends, the first end extending above a native valve and the second end extending below the native valve when the frame structure12mis anchored to the native valve. Alternatively, the frame structure12may be configured to sit entirely below the native valve when the frame structure12is anchored to the native valve.

The frame structure12may be self-expanding and may be maintained in the unexpanded configuration by radial constriction from the outer shaft54or inner shaft52of the delivery device30. In some embodiments, advancement of the inner shaft52out of the lumen of the outer shaft may actuate the frame structure12into the expanded configuration. In some embodiments, advancement of the frame structure12out of the lumen of the inner shaft52, for example with the aid of a proximal pusher78(seeFIG. 83) and/or balloon as described herein, may actuate the frame structure12into the expanded configuration. In some embodiments, the frame structure12may be detachably coupled to and/or disposed within the delivery device30at a location proximal to the anchor15. In some embodiments, the frame structure12may be detachably coupled to and/or disposed within the delivery device30at a location distal to the anchor15. In some embodiments, at least a portion of the frame structure12may be detachably coupled to and/or disposed within the delivery device30at a location adjacent (e.g., within) the anchor15.

In some embodiments, the anchor15may be detachably coupled to and/or disposed within the delivery device30at a location proximal to the frame structure12. In some embodiments, the anchor15may be detachably coupled to and/or disposed within the delivery device30at a location distal to the frame structure12. In some embodiments, at least a portion of the anchor15may be detachably coupled to and/or disposed within the delivery device30at a location adjacent (e.g., around) the frame structure12. In some embodiments, the anchor15may be disposed in a lumen of the inner shaft52. The anchor15may or may not be coupled to the inner shaft52. The anchor15may be maintained in the delivery configuration by radial constriction from the inner shaft52. Advancement of the anchor15out of the inner shaft52, for example out of the side port215of the inner shaft52, may actuate the anchor15into the deployed configuration. The proximal end57of the anchor15may be detachably coupled to an actuation arm (e.g., proximal pusher78shown inFIG. 83) which may be disposed within the lumen of the inner shaft52and extend towards a proximal end of the delivery device30.

The anchor15may comprise a curved wire in the deployed configuration, for example a coiled wire or band, a helical wire or band, or a spiral wire or band as described herein. In various embodiments, the anchor15may have a curved shape in the deployed configuration. In various embodiments, the anchor may be elongated-rather than curved—in the delivery configuration. For example, the anchor15may be elongated into a straight shape within the delivery device30. In various embodiments, a portion of the anchor15may have a curved shape. In various embodiments, a substantial portion of the anchor15may have a curved shape. In various embodiments, the anchor15may be formed as a flat curve (in the deployed configuration) whereby the loops generally are positioned within the same plane (the plane being perpendicular to a longitudinal axis). In various embodiments, the anchor15may be formed as a three-dimensional curve (in the deployed configuration) whereby the loops generally are positioned out of plane with one another.

The anchor15may comprise a spiral wire or band in the deployed configuration. As used herein, a spiral or spiral shape may comprise a curve which emanates from a point (e.g., a central point) having a continuously increasing or decreasing distance from the point. The spiral or spiral shape may be two-dimensional (e.g., planar) or three-dimensional. In some embodiments, the anchor15may comprise one or more spiral portions as described herein. In various embodiments, the anchor15may have a spiral-shaped deployed configuration. In various embodiments, spiral refers to a shape with windings about a central axis. The spiral may be continuous. The windings may gradually widen (or tighten) along the length. The spiral may be formed in a flat plane perpendicular to the central axis. In various embodiments, the anchor15may have a deployed configuration that is not formed in a flat plane, or in other words the deployed shape is formed in a three-dimensional and/or non-degenerate space. In various embodiments, the anchor15may have a conical-shaped deployed configuration including, but not limited to, tubular, conical, frustoconical and/or helical shapes.

The anchor15may comprise one or more loops. For example, the anchor15may comprise a plurality of loops, which may increase the radial strength of the anchor by increasing friction and addition structural support. The one or more loops of the anchor15may be spiral radially outward from a central point or central axis of the spiral, for example along an axis which is coaxial with a longitudinal axis of a delivery device30such that the anchor15lies approximately along a plane perpendicular to the longitudinal axis of a delivery device. In some embodiments, the one or more loops of the anchor15may comprise one or more spaces therebetween. The spaces may facilitate movement of the captured tissue (e.g. chordae and/or leaflets) from the free end22to the center of the anchor15during rotation of the anchor15as described herein.

The free end22of the anchor15may extend radially outward from the frame12, and in particular from the remainder of the spiral band or wire20. The other end of the anchor15may be coupled to the top or bottom of the frame structure12as described herein. Alternatively, or in combination, the other end of the anchor15may not be attached to the frame structure12as described herein. The free end22of the anchor15may facilitate capturing of the valve leaflets and/or chordal tendineae within the sweep of the free end during rotation as described herein. During rotation of the anchor15, the leaflets and/or chordae tendineae may be captured by the free end22and trapped between the valve frame structure12and an interior surface of the anchor15.

The anchor15(e.g., including a tapered spiral band) may comprise a delivery (e.g., elongated) configuration and a deployed configuration (and optional intermediate configurations) as described herein. The anchor15may be configured to be actuated from the elongated configuration to the deployed configuration adjacent a native valve in a patient. The anchor15may be delivered to the native valve by a delivery device in the elongated configuration as described herein. The anchor15may be coupled to the delivery device and/or a frame structure of a valve prosthesis as described herein, for example at a proximal portion (e.g. adjacent proximal attachment point on an interior of the spiral) or distal portion (e.g. adjacent distal attachment point on an exterior of the spiral) thereof. The anchor15may be deployed adjacent the native valve substantially similarly to other anchor embodiments as described herein.

After extending out of the side opening215, the free end22of the anchor15may optionally rotated around one or more native valve structures on the second side of the native valve such that the one or more native valve structures (e.g., chordae, leaflets, or annulus) are pulled radially inwards towards the longitudinal axis of the anchor15and/or towards the longitudinal axis of the delivery device30. The anchor15may be configured such that minimal torque is applied to the one or more structures. Alternatively, or in combination, the anchor15may be configured such that the one or more native valve structures are not rotated, or are minimally rotated, during rotation of the anchor15. For example, the anchor15may comprise one or more spaces between loops of the anchor15which facilitate movement of the captured tissue (e.g. chordae and/or leaflets) from the free end22to the center of the spiral structure with little or no torque and/or rotation of the native valve structures during rotation of the tapered spiral band as described herein. Alternatively or in combination, the anchor15may be configured such that, when fully deployed, none of the native valve structures reside between the loops of the spiral. Instead, the one or more native valve structures may sit radially inward of the loops in order to facilitate capture of the one or more structures between anchor15and the expanded frame structure12as described herein. The one or more native valve structures may retain or nearly retain their normal anatomical position when the spiral band is fully deployed. The free end22may be disposed radially outwards from the remainder of the anchor15. Disposing the free end22radially outward from the remainder of the anchor15may, for example, aid in deployment of the anchor15from the delivery device and/or capture of the one or more native valve structures as described herein. The free end22may be angled proximally (e.g., towards a proximal portion of the anchor15and a distal end of the delivery device30) or distally (e.g., away from a proximal portion of the anchor15and towards a proximal portion of the delivery device30) from the rest of the anchor15. Angling the free end22proximally or distally towards or away from the delivery device30may, for example, aid in deployment of the anchor15from the side opening215delivery device and/or capture of the one or more native valve structures as described herein.

The distal end of the delivery device30may be configured to be advanced from a first side of a native valve to a second side of the native valve. For example, the distal end of the delivery device30may be advanced from a left atrial side of a mitral valve to a left ventricular side of a mitral valve. In some instances, the distal end of the delivery device30may be transseptally inserted into the left atrium of the heart prior to advancement into the left ventricle. Alternatively, or in combination, the distal end of the delivery device30may be steerable such that it is positionable to point towards the first side of the native valve before being advanced to the second side of the native valve.

After advancing to the second side of the native valve, the anchor15may be fully deployed on the second side of the native valve. In some embodiments, fully deploying the anchor15may comprise positioning the anchor15such that it is located only on the second side of the native valve. One will appreciate from the description here, that alternatively the anchor may be deployed on the first side of the valve (e.g., in one of the atria) and then pushed through the respective valve and subsequently rotated to anchor to the chordae and/or native valve.

Advancing the anchor15may comprise pushing the anchor through the native valve. Advancing the anchor15may further comprise rotating the anchor15through the native valve.

In some embodiments, the anchor15may be actuated from the delivery configuration to the deployed configuration on a first side of the native valve prior to being advanced to a second side of the native valve. For example, the anchor15may be deployed in a left atrium of a heart prior to being advanced to a left ventricle of the heart as described herein.

Alternatively, the anchor15may be actuated from the delivery configuration to the deployed configuration on a second side of the native valve after being advanced to the second side from a first side of the native valve. For example, anchor15may be advanced from a left atrium of a heart prior to being deployed in a left ventricle of the heart by the retreat of an outer sheath50or advancement out of an inner shaft52.

The free end22of the deployed anchor15may optionally be rotated around one or more structures on the second side of the native valve. The one or more structures may comprise one or more valve leaflets of the native valve. Alternatively, or in combination, the one or more structures may comprise one or more chordae of the left ventricle.

The free end22of the deployed anchor15may optionally rotated around one or more structures on the second side of the native valve such that the one or more structures (e.g., chordae, leaflets, or annulus) are pulled radially inwards towards the longitudinal axis of the anchor15mand/or towards the longitudinal axis of the delivery device30. The anchor15and/or free end22may be configured such that minimal torque is applied to the one or more structures. Alternatively, or in combination, the anchor15and/or free end22may be configured such that the one or more structures are not rotated, or are minimally rotated, during rotation of the anchor15.

The anchor15may then be released from the distal end of the delivery device30. The anchor15may be released from the distal end of the delivery device30on the second side of the native valve.

The frame structure12may be expanded within the native valve from an unexpanded configuration to an expanded configuration.

The frame structure12may be released from the distal end of the delivery device30. In some embodiments, at least a portion the frame structure12may be expanded within at least a portion of the deployed anchor15to anchor the frame structure12to the native valve.

In some embodiments, expanding the frame structure12and releasing the frame structure12may occur simultaneously.

Finally, the delivery device30may be retracted from the native valve.

As noted,FIGS. 81A-81I, 82A-82Gshow sequential views of a specific exemplary method of implanting a valve prosthesis10using a delivery device30with a side opening215.FIG. 83shows a magnified side view of the delivery device30highlighting the start of deployment of the anchor15from the side opening215in the delivery device30. The valve prosthesis10may be similar to any of the valve prostheses described herein or understood by one of ordinary skill in the art from the description herein. For example, valve prosthesis10may be substantially similar to any of the valve prostheses10may comprise a frame structure12and anchor15as described herein. The delivery device30may comprise an inner shaft52as described herein. The delivery device30may optionally comprise an outer sheath50, a guidewire54, a proximal pusher72and/or a tether78, in any combination thereof as desired by one of ordinary skill in the art. The proximal pusher72may comprise a flexible advancement member housed and advancable within the inner shaft52. The proximal pusher72may comprise a flexible shaft or stylet, for example, in the form of a wire or a metal wire, and/or flexible hypotube with a lumen to accommodate the guidewire54. Not all elements are labeled in each ofFIGS. 81A-81I.82A-82G in order to make the illustrations less cluttered and easier to see.

While the method shown inFIGS. 81A-84is described in relation to a mitral valve replacement procedure, it will be understood by one of ordinary skill in the art that the methods described herein may be applied to a variety of procedures or anatomical areas, for example other atrioventricular valves of the heart or the like.

Returning toFIG. 81A, a distal end of the delivery device30may be inserted into the left atrium25of the heart2via a transseptal puncture as described herein. For example, the nosecone55of guidewire54may be advanced into the left atrium25of the heart2. As shown inFIG. 81B, the inner shaft52may be advanced distally into the left atrium25following the distal end of the guidewire54. In some embodiments, advancing the inner shaft52relative to the guidewire54may aid in deployment and/or placement of the valve prosthesis10as described herein. Both the guidewire54and the inner shaft52may be advanced distally into the left atrium25through the transseptal puncture.

FIGS. 81B-81Eshow advancement of the valve prosthesis10, with anchor15deployed around the compressed or unexpanded frame structure12, towards the native valve4requiring treatment. The distal end of the delivery device30(for example, the distal end of the outer sheath50, the inner shaft52, and/or the guidewire54) may be steered such that the distal end of the delivery device30points toward the atrial side of the native valve4. Such steering may occur prior to, during, or after deployment of at least a portion (for example deployment of an anchor15) of the valve prosthesis10. In some embodiments, the distal end of the guidewire54may be steerable. Alternatively, or in combination, the inner shaft52may comprise a joint configured to change an angle of the distal portion of the inner shaft52relative to a proximal portion of the inner shaft52. The inner shaft52may be steered by changing the angle of the distal portion of the inner shaft52relative to the proximal portion of the inner shaft52. The angle of the joint may be changed passively or actively. In various embodiments, the angle may be selectively controlled by a proximal handle. For example, pull wires or other mechanisms may connect to the joint to controls on the handle.

FIGS. 81C-81E(as well asFIG. 83) also show deployment of the anchor15from the lateral or side opening215of the inner shaft52of the delivery device30. The side opening215may, for example, comprise a side port. Alternatively, or in combination, the side opening215may comprise an opening which exposes the distal end of the anchor15resultant of a retraction of the outer sheath. As described herein, at least a portion of the valve prosthesis10may be deployed from an undeployed (for example, compressed or unexpanded) configuration to an expanded configuration within the left atrium25. At least a portion of the anchor15may be deployed from a delivery and/or elongated configuration to a deployed configuration within the heart. For example anchor15, may be actuated from an elongated configuration to a deployed configuration within the left atrium25as described herein. In some embodiments, the anchor15may be deployed from the inner shaft52by pushing the anchor15out of the side port215of the inner shaft52(e.g., with a the proximal pusher72or the tether78as described herein), releasing the anchor15from radial constraint by retracting the outer sheath50, or the like as described herein. After the anchor15has been deployed from the delivery device30, the valve prosthesis10comprising frame structure12may be at least partially deployed from the delivery device30(e.g., as shown inFIG. 82B) so as to place the frame structure12within the anchor15. The valve prosthesis10comprising frame structure12may be deployed from the inner shaft52of the delivery device30in either the unexpanded configuration or the expanded configuration, depending on the location of deployment, as will be understood by one of ordinary skill in the art.

FIGS. 81E-81Fshow the partially deployed anchor15being advanced through the native valve4by the delivery device30from the left atrium25to the left ventricle26. Advancement of the anchor15and optionally delivery device30through the mitral valve4may be facilitated by the natural opening and closing of the valve4during the cardiac cycle. The deployed anchor15may be optionally wrapped around the distal end of the inner shaft52. After the anchor15has been deployed to the distal end of the inner shaft52, the inner shaft52may be moved or steered further along the guidewire54so as to place the anchor15above the native leaflets42of the diseased mitral valve4, as shown inFIG. 81E.FIGS. 81G-81Ishow the securing of the anchor15to the native chordae tendinae. The anchor15may be rotated by the rotating of the inner shaft52, the anchor guide153, and/or the proximal pusher72. Advancing the anchor15may comprise pushing the anchor15through the native valve4. Alternatively, or in combination, advancing the anchor15may comprise rotating the anchor15through the native valve4. In some instance, the combination of rotational motion and pushing may facilitate advancement of the device from the first side of the native valve4to the second side of the native valve4. Rotation of the anchor15may be facilitated by the inner shaft52as described herein. For example, the inner shaft52or the anchor guide153may transmit rotational motion to the anchor15in order to rotate the anchor15to secure the anchor15to the tendinae chordae as shown inFIGS. 81G-81I.

The distal end of the delivery device30and/or valve prosthesis10may be configured to be advanced from a first side of a native valve to a second side of the native valve. For example, the distal end of the delivery device30and/or valve prosthesis10may be advanced from a left atrial side of a mitral valve4to a left ventricular side of a mitral valve4.

FIGS. 81G-81Ishow rotation of the valve prosthesis10around one or more native valve structures on the ventricular side of the mitral valve4. The one or more native valve structures may comprise one or more valve leaflets43and/or one or more chordae tendineae40(e.g., as shown inFIGS. 85A-85C). After the anchor15has been placed within the left ventricle26adjacent one or more chordac tendineae40, the valve prosthesis10(e.g., the anchor15and, optionally, the frame structure12) may be rotated to capture and anchor the native chordae40and/or native leaflets43. The free end22of the anchor15may extend radially outward from the rest of the anchor15to facilitate capture of the native structures. The free end22of the anchor15may be rotated around one or more of the chordae tendineae40as shown inFIG. 81G. Additional rotation of the valve coil15may gradually capture additional chordae tendineae40as shown inFIGS. 81H-81I.

Rotation of the valve prosthesis10, for example, rotation of the anchor15and/or frame structure12, may be facilitated by the delivery device30described herein. For example, the inner shaft52may be rotated and rotational motion may be transmitted from the inner shaft52or the anchor guide153to the valve prosthesis10in order to rotate the valve prosthesis10around one or more of the structures on the ventricle side of the mitral valve4as described herein. Alternatively, or in combination, a proximal portion of the anchor15may be detachably coupled to a tether78that extends through a lumen of the inner shaft52to a distal end thereof. The tether78may be rotated and rotational motion may be translated from the tether78to the anchor15in order to rotate the anchor15around the one or more structures on the ventricle side of the mitral valve4as described herein.

FIGS. 82A-82Gshow the valve prosthesis10wrapped around the captured chordae tendineae40. The valve prosthesis10may be rotated around the chordae tendineae40such that the chordae tendineae40are pulled inwardly into bunches. As shown inFIG. 82G, the native valve leaflets43may also be in communication with the valve prosthesis10. The valve prosthesis10may be rotated to capture enough chordae tendineae40and/or valve leaflets43to rigidly anchor the anchor15adjacent the native valve annulus. The valve prosthesis10may be anchored by wrapping around only a portion of the chordae40. Although it may be possible to capture all or substantially all the chordae40, this may not be necessary to provide sufficient anchoring of the valve prosthesis10. As described further herein, the prosthesis10may be further anchored by expansion of the frame structure12within the native valve4and against the anchor15.

Once the anchor15has been anchored adjacent to the native valve4, the valve prosthesis10comprising the frame structure12and prosthetic valve segment14may be expanded at least partially within the anchor15as described herein. The frame structure12and the valve segment14may be deployed (e.g., expanded) simultaneously. Alternatively, or in combination, the frame structure12and the valve segment14may be deployed sequentially, for example by first expanding the frame structure12and then receiving the prosthetic valve segment14therein.

FIGS. 82A-82Dshow expansion of the valve prosthesis comprising the frame structure12within the native valve4. The frame structure12may be expanded within the native valve4from an unexpanded configuration to an expanded configuration. In some embodiments, at least a portion the frame structure12may be expanded within at least a portion of the deployed anchor15to anchor the frame structure12to the native valve4. In some embodiments, the frame structure12may comprise an expandable stent. In some embodiments, the frame structure12of valve prosthesis10may be balloon-expandable. In some embodiments, the frame structure12of valve prosthesis10may be self-expandable. The delivery device30may comprise a proximal pusher72which may be disposed within the valve prosthesis10in order to expand the valve prosthesis10. The proximal pusher72may be positioned proximal to the valve prosthesis10as shown inFIG. 82A-82D. The proximal pusher72may be configured to operably couple to a proximal portion of the frame structure12, for example, in order to longitudinally translate the frame structure12within the lumen of the inner shaft52. Alternatively, if the proximal pusher72is expandable (e.g., an expandable balloon-like element), the proximal pusher72may be positioned within at least a portion of the valve prosthesis10, for example within at least a portion of frame structure12in an unexpanded configuration, prior to being expanded. The proximal pusher72may, for example, be disposed within a proximal portion of the inner shaft52or outer sheath50while the anchor15is being positioned adjacent the native valve4and then advanced therefrom (or the inner shaft52or outer sheath50is retracted therefrom) to be positioned proximal to or within the frame structure12. Alternatively, the proximal pusher72may be disposed within the frame structure12during placement of the valve prosthesis10.

FIG. 82Ashows advancement of the proximal pusher72within the inner shaft52towards a proximal end of the frame structure12.FIG. 82Bshows the frame structure12partially expanded following engagement with the proximal pusher72, for example self-expanded after being partially pushed by the pusher72out of a distal end of the inner shaft52. The frame structure12may be deployed from a distal end of the delivery device30. The frame structure12may be at least partially expanded towards the anchor15in order to capture the chordae tendineae40therebetween. As the frame structure12continues to be expanded to a fully expanded state, for example by continued advancement of the proximal pusher72as shown inFIG. 82C, the chordae tendineae40may be sandwiched between the anchor15and the frame structure12. The frame structure12and anchor15may thus be anchored to the chordae tendineae40.

In some embodiments, the frame structure12and the anchor15may be located within the same lumen of the delivery device30prior to deployment. In some embodiments, the frame structure12and the anchor15may be located within different lumens of the delivery device30.

In some embodiments, the frame structure12and the anchor15may be deployed from the same opening (e.g., the side port215) in the delivery device30. In some embodiments, the frame structure12and the anchor15may be deployed from different openings in the delivery device30.

The valve prosthesis10may then be released from the delivery device30. Releasing the valve prosthesis10from the delivery device30may comprise expanding the valve prosthesis10from the unexpanded configuration to the expanded configuration. For example, expanding the frame structure12and releasing the frame structure12may occur simultaneously as described herein. Alternatively, the frame structure12may be released prior to or after being expanded.

After the frame structure12has been expanded and anchored to the native valve4as described herein, the proximal pusher72may be retracted. The delivery device30, comprising the guidewire54, may then be removed from the heart2.

FIG. 82Dshows retraction of the proximal pusher72towards the proximal end of the delivery device30.FIG. 82Eshows removal of the delivery device30, proximal pusher72, tether78, and inner shaft52from the heart2.FIG. 82Fshows removal of the guidewire54from the heart2.

FIG. 82Gshows the valve prosthesis10fully expanded with the native valve leaflets42and chordae tendineae40captured between the frame structure12and the anchor15. As described herein, the valve prosthesis10may comprise one or more valve segments14disposed therein to replace the native valve leaflets42.

Although the steps above show a method of deploying a valve prosthesis10within a native valve4in accordance with embodiments, a person of ordinary skill in the art will recognize many variations based on the teaching described herein. The steps may be completed in a different order. Steps may be added or deleted. Some of the steps may comprise sub-steps. Many of the steps may be repeated as often as necessary to assemble at least a part of an article.

For example, in some embodiments deploying the valve prosthesis10may occur in multiple steps such that a portion of the valve prosthesis10(e.g., anchor15) may be deployed before another portion the valve prosthesis10(e.g., frame structure12). Alternatively. or in combination, in some embodiments, deploying the anchor15may occur in multiple steps such that a portion of the anchor15may be deployed before being advanced through the native valve4and another portion of the anchor15may be deployed after being advanced through the native valve4. Alternatively. or in combination, the delivery device30may be advanced from the left atrium25to the left ventricle26with the valve prosthesis10undeployed. In many embodiments, the frame structure may12be balloon-expandable and the delivery device may comprise a balloon instead of or in addition to the proximal pusher72in order to expand the frame structure12. Alternatively, or in combination, the anchor15may be released after the frame structure12has been expanded within it.

As shown inFIG. 83, the anchor15may be disposed in the inner shaft52and maintained in the delivery configuration by radial constriction from the inner shaft52. Advancement of the anchor15out of the side port215of the inner shaft52may actuate the anchor15into the deployed configuration. The proximal end57of the anchor15may be detachably coupled to a tether78within the lumen of the inner shaft52as described herein. Although the anchor15is described as being pushed out of the delivery catheter in some embodiments, one will appreciate from the description herein that different mechanisms may be employed to deploy the anchor15depending on the anchor15and/or shaft52design. In some respects, pushing is used somewhat interchangeably with rotation in reference to deployment of the anchor15. For example, the anchor15can be rotated out of the side opening215with a rotational action.

FIGS. 84A-84Dshow an exemplary delivery device30including a rotatable anchor drive shaft82. The delivery device30is configured to deploy the anchor15with a “flat screw deployment” mechanism. The anchor15may be substantially similar to any of the anchors described herein. In some embodiments, the anchor15may be coupled to the delivery device30and/or a frame structure12as described herein. The frame structure12may be substantially similar to any of the frame structures described herein. The delivery device30may comprise an inner shaft52and an outer sheath50. The inner shaft52may be substantially similar to any of the inner shafts described herein. The outer sheath50may be substantially similar to any of the outer shafts described herein. The anchor15may be coupled to the inner shaft52as described herein. The frame structure12may be coupled to the inner shaft52, for example around the inner shaft52or at a distal end of the inner shaft52, as described herein.

The delivery device30may further comprise the anchor drive shaft82. The anchor15may be disposed on or around the anchor drive shaft82in a screw-like undeployed configuration.FIG. 84Bshows an exemplary anchor15disposed around anchor drive shaft82in a screw-like undeployed configuration with the outer sheath50removed in order to show the internal components of the delivery device30in relation to the undeployed valve prosthesis10. At least a portion of the anchor drive shaft82, for example a distal end (e.g., deployment drive83), may be operably coupled to the anchor15. The anchor drive shaft82may be rotatable relative to the outer shaft15. The anchor drive shaft82may be configured to transmit rotational motion and/or torque to the anchor15in order to rotate the anchor out of the delivery device30and/or around the one or more native valve structures.

Deployment of the anchor15from the delivery device30may be facilitated by combined retraction of at least a portion of the outer sheath50relative to the inner shaft52to form or expose a lateral opening in the delivery device30and rotation of an anchor drive shaft82relative to the outer sheath50and/or inner shaft52. The anchor15may be actuated from a delivery configuration (shown inFIG. 84B) to a deployed configuration (shown inFIG. 84C). The delivery configuration may be substantially similar to any of the delivery configurations described herein. For example, the anchor15may comprise a compact screw-like spiral shape when disposed around the inner shaft52in the delivery configuration. The deployed configuration may be substantially similar to any of the deployed configurations described herein. For example, the anchor15may comprise a flat spiral shape in the deployed configuration and at least a portion of the anchor15may be disposed about or proximal to a distal end of the inner shaft in the deployed configuration. The outer sheath50may be retracted such that a lateral opening is formed and the distal end22of the anchor15is exposed. Continued rotation of the anchor drive shaft82may actuate the anchor15out of the opening into the deployed configuration through its coupling with deployment drive83.

In some embodiments, the outer sheath50may be moved back and forth over the anchor drive shaft82prior to, during, or after rotation of the anchor drive shaft82in order to “ratchet” incremental portions of the anchor15out of the delivery device30and away from the inner shaft52. For example, the anchor15may be deployed by a retraction of the inner shaft52followed by a series of rotations of the anchor drive shaft82followed by an advancement of the anchor drive shaft82, which may be repeated as needed to deploy the full anchor15.

The anchor15may be releasably coupled to the deployment drive83. Once the anchor15is in the deployed configuration, the deployment drive83may remain connected until the anchor15is fully secured around the diseased valve and fully deployed implant valve. The deployment drive83may be used to translate the anchor15distally such that it sits at least partially around the frame structure12(as shown inFIG. 84D). The anchor15may then be advanced through the native valve and rotated around one or more native structures as described herein. Alternatively, the deployment drive83may be disconnected from the anchor15prior to the anchor15being secured to the one or more native structures of the diseased valve.

The anchor15may be deployed from the delivery device30in the left atrium of the heart and advanced into the left ventricle through the diseased mitral valve as described herein. Alternatively, the anchor15may be deployed from the delivery device30in the left ventricle of the heart as described herein. Alternatively, the anchor15may be partially deployed in the left atrium, advanced into the left ventricle, and then fully deployed in the left ventricle as described herein.

In some embodiments, deployment of the anchor15and capture of the one or more structure of the native valve may occur in a stepwise fashion. For example, the anchor15may be deployed before being rotated to capture the one or more structures.

In some embodiments, deployment of the anchor15and capture of the one or more structure of the native valve may occur simultaneously. For example, rotation of the anchor drive shaft82may rotate the anchor15out of the delivery device30. If deployed in the left ventricle, the free end22of anchor15may be rotated around the one or more native valve structures as the anchor15is rotated out of the delivery device.

The distal free end22of the anchor may comprise a key84configured to slide into a complementary lock85located on the band of the anchor15. When the anchor15is fully deployed and wrapped around the frame structure12and the diseased valve, the key84may slide over the band of the anchor15until it falls into place within the lock85. Once engaged, the key84and lock85may hold the anchor15in place against the one or more structures of the native valve. The respective locations of key84and lock85may be configured to lock the anchor15into the fully deployed configuration, the fully undeployed configuration, or any intermediate configuration therebetween. Any number of key84and lock85elements may be placed on the anchor15in order to allow for one or more locked configurations as desired. The key84and lock85may be replaced with or combined with other locking mechanisms. For example, a frictional band may replace or be added to the key84and lock85locking mechanism.

Referring toFIGS. 45-54, any of the anchors15described herein may include one or more deflecting features23disposed on or along the anchor body in order to cause the free end22of the anchor15to “wiggle” or deflect away from the longitudinal axis of the delivery device30as it is exits the delivery device, thereby causing a change in the deployment angle of the free end22. The deflecting feature23may be positioned at a location along the anchor15such that deflection of the free end22is “timed” to occur with the free end22wrapping back towards the delivery device30(for example as shown inFIG. 6A) such that the free end22deflects towards the preferred side of the delivery device30as described herein. The free end22may, for example, be deflected each time it wraps back towards the delivery device30.

FIG. 45shows an anchor15comprising a plurality of deflection features23disposed therealong. The anchor15may be substantially similar to any of the anchors described herein. For example, the anchor15can be a helical or spiral wire anchor in the deployed configuration as shown. The plurality of deflection features23may be disposed at a plurality of locations along the length of the anchor15. In some embodiments, the plurality of deflection features23may be positioned along the length of the anchor15at locations along the anchor15such that deflection of the free end22is “timed” to occur with the free end22wrapping back towards the delivery device as described herein. The free end22may, for example, be deflected each time it wraps back towards the delivery device as described herein. The plurality of deflection features23may, for example comprise a plurality of wave-like features (e.g., similar toFIGS. 9A-9D). Alternatively, or in combination, one or more of the plurality of deflection features23may comprise a bend, a hump, or the like. In some embodiments, the plurality of deflection features23may have the same shape. In some embodiments, at least one of the plurality of deflection features23may have a different shape from one or more of the other deflection features23. The anchor15may comprise a plurality of loops as described herein. In some embodiments, one or more of the plurality of loops may comprise a deflection feature23. In some embodiments, one or more of the plurality of loops may comprise a plurality deflection features23. Alternatively, or in combination, one or more of the loops may not comprise a deflection feature23. In some embodiments, a plurality of deflection features23may be disposed along the plurality of loops such that each loop comprise a single deflection feature23.

In some embodiments, the anchor15may comprise a helical or spiral shape in the deployed configuration as described herein. The deflection feature23may be comprise one or more bends or kinks along the helical anchor which are discontinuous with the helical shape. In some embodiments, the deflection features23may be attached (fixedly or detachably) to the helical or spiral shape, for example in the form of a tab or a wing or the like. Alternatively or in combination, the deflection features23may comprise discontinuities in the helical or spiral shape, for example in the form of bends, kinks, waves, humps, bumps, or the like in the helical wire itself. In some embodiments, the deflection features23may position a portion of the wire inside, outside, above, below, or at an angle to the otherwise relatively continuous helical or spiral shape of the anchor15.

FIGS. 46-47show various views of an anchor15comprising a plurality of deflection features23. The anchor15may be substantially similar to any of the anchors described herein, for example a spiral wire anchor as shown. The plurality of deflection features23may be disposed at a plurality of locations along the length of the anchor15as described herein. The anchor15may be deployed from an aperture31at or proximate to the distal end of a delivery device30as described herein. Interaction of the plurality of deflection feature23with the aperture31may cause free end22to deflect during deployment from the elongated configuration to the deployed configuration in order to facilitate wrapping of the anchor15around the delivery device30as described herein.

The one or more deflection features23may be configured so as to resist straightening of the bends when the anchor15is in the elongated configuration. The one or more deflection features23may be configured interact with the frame structure12to facilitate anchoring. The one or more deflection features23may be configured not to interact with the frame structure12in order to facilitate anchoring. The one or more deflection features may be introduced to the anchor15without adding substantial circumferential compliance into the coil.

FIGS. 48-49show various views of another anchor15comprising a plurality of deflection features23. The anchor15may be substantially similar to any of the anchors described herein, for example a spiral wire anchor as shown. The plurality of deflection features23may be disposed at a plurality of locations along the length of the anchor15as described herein. The plurality of deflection features23may comprise a plurality of waves, bends, humps, or the like as described herein.

FIG. 50shows an anchor15having an optional tip22orientation determined by a single deflection feature near free end22. The anchor15may be substantially similar to any of the anchors described herein, for example a helical anchor as shown. The anchor15may be detachably coupled to a delivery device30as described herein. The anchor15may comprise a single deflection feature23near the free end22. The anchor15may be deployed from an aperture31of a delivery device30as described herein. Interaction of the deflection feature23with the aperture31may cause free end22to deflect during deployment from the elongated configuration to the deployed configuration in order to facilitate wrapping of the anchor15around the delivery device30as described herein. The free end22may be deflected to overlap the next turn in order to ensure that the free end wraps back around the delivery device30. The single deflection feature23may, for example, comprise a bend configured to deflect the free end22proximally (e.g., towards a proximal portion of the anchor15and a distal end of the delivery device30), distally (e.g., away from a proximal portion of the anchor15and towards a proximal portion of the delivery device30), and/or radially (e.g., radially outwards or inwards from the main body of the anchor15and away from or towards the delivery device30, respectively). In some embodiments, for example, the single deflection feature23may be configured to position the free end22adjacent one or more loops of the anchor15(i.e. the main body of the anchor15) when the anchor15is in the deployed configuration. Alternatively, or in combination, the single deflection feature23may be configured to position the free end22such that it angles towards a proximal end of the anchor15when the anchor15is in the deployed configuration. Alternatively, or in combination, the single deflection feature23may be configured to position the free end22such that it angles towards a distal end of the delivery device30when the anchor15is in the deployed configuration.

In at least some instances, it may be sufficient to initially deflect the free end22during wrapping as described herein in order to form the first loop around the delivery device30. Once the first loop as wrapped around the delivery device30, the remaining loops may be more inclined or biased to wrap correctly around the delivery device30without additional deflection or manipulation.

In at least some instances, deflection (e.g., angling proximally, distally, and/or radially outward) of the free end22away from the loops of the proximal portion of the anchor15may aid in capture of the one or more structures by forming a “grabber” arm.

In at least some instances, the absence of additional deflection features23on the loops of the anchor15may facilitate rotation of the loops around the one or more structures as described herein. Alternatively, or in combination, the absence of additional deflection features23on the loops may enhance the circumferential strength of the loops of the anchor15.

FIGS. 51-53show various view of an anchor15having an optional tip22orientation determined by a single deflection feature23near free end22. Anchor15may be substantially similar to the anchor15shown inFIG. 50except that the handedness of the anchor may be reversed. The deflection feature23may deflect the free end22of the anchor15towards a distal end of the delivery device30and a proximal end of the anchor15such that it may be positioned adjacent the loops of the anchor15as described herein.

FIG. 54shows a clockwise anchor15having an optional tip22orientation determined by a single deflection feature23near free end22.FIG. 55shows an anchor15substantially similar to the anchor inFIG. 54but with a counter-clockwise spiral.FIG. 56shows a clockwise anchor15having an optional tip22orientation determined by a single deflection feature23near free end22.FIG. 57shows an anchor15substantially similar to the anchor inFIG. 56but with a counter-clockwise spiral. The anchor15may be substantially similar to any of the anchors described herein, for example a spiral band anchor as shown. The anchor15may be detachably coupled to a delivery device30as described herein. The anchor15may comprise a single deflection feature23near the free end22. The anchor15may be deployed from an aperture31of a delivery device30as described herein. Interaction of the deflection feature23with the aperture31may cause free end22to deflect during deployment from the elongated configuration to the deployed configuration as described herein. In some embodiments, the anchor15may be configured not to wrap around the distal end of the delivery device30in the deployed configuration. The loops of the anchor15may instead lie entirely distal of the distal end of the delivery device30as shown. The single deflection feature23may, for example, comprise a bend configured to deflect the free end22proximally (for example, as shown inFIGS. 55 and 57), distally (for example, as shown inFIGS. 54 and 46), and/or radially (for example, as shown inFIG. 53). In at least some instances, deflection (e.g., angling proximally, distally, and/or radially outward) of the free end22away from the loops of the proximal portion of the anchor15may aid in capture of the one or more structures by forming a “grabber” arm.

In some embodiments, the anchor15may comprise a flat spiral shape in the deployed configuration as described herein. The deflection feature23may be comprise one or more bends or kinks along the spiral anchor which are discontinuous with the spiral shape. In some embodiments, the deflection features23may be attached (fixedly or detachably) to the spiral shape, for example in the form of a tab or a wing or the like. Alternatively or in combination, the deflection features23may comprise discontinuities in the spiral shape, for example in the form of bends, kinks, waves, humps, bumps, or the like in the spiral wire itself. In some embodiments, the deflection features23may position a portion of the wire radially inside, radially outside, above, below, or at an angle to the otherwise relatively continuous spiral shape of the anchor15.

In at least some instances, the absence of additional deflection features23on the loops of the anchor15may facilitate rotation of the loops around the one or more structures as described herein. Alternatively, or in combination, the absence of additional deflection features23on the loops may enhance the circumferential strength of the loops of the anchor15.

While the one or more deflection features have been described herein with reference to changing the angle of a free end of an anchor of a valve prosthesis during deployment from a delivery device, it will be understood by one of ordinary skill in the art that such features may be used in a variety of settings.

Alternatively, or in combination with, the deflection feature(s)23built into the anchor15, the anchor15may include a movable core wire (e.g., wire or rod) therein configured to change the shape of the distal portion of the anchor assembly. For example,FIGS. 7A-25show a movable or translatable core wire74configured to be translated longitudinally within and relative to the anchor15in order to change the shape of the distal portion of the anchor15. The movable core element may include one or more deflecting features33such that, when advanced distally past the free end22of the anchor15, a distal tip of the core wire74may be caused to “wiggle” or deflect away from the curvature of the anchor body15and change the deployment angle of the distal tip out of the anchor body15in order to facilitate wrapping of the anchor15around the delivery device30as described herein. The movable core wire74may be translated within the anchor15before, during, or after deployment of the anchor from the undeployed configuration to the deployed configuration. For example, the movable core element74may be translated within the anchor15before deployment of the anchor into a self-assembly state in order to facilitate wrapping of the anchor15around the delivery device (e.g., by extending past the free end22of the anchor and acting similarly to the anchor deflecting features23described herein). Alternatively, or in combination, the movable core wire74may be translated within the anchor15during deployment of the anchor15in order to actively or reactively “wiggle” or deflect the angle of the distal tip22of the anchor15as it deploys as described herein. Alternatively, or in combination, the movable core wire74may be translated with the anchor15into an encircling state in order to facilitate grasping of and rotation of the anchor around the one or more native structures as described herein. By utilizing a movable core wire74comprising one or more deflecting features33, the anchor15may comprise a relatively simpler shape compared to an anchor15having one or more deflecting features23itself, which may facilitate design and fabrication of the anchor15. For example, the anchor15may have a shape with a substantially continuous curvilinear shape and/or the reduction of complex bends. Alternatively, or in combination, the behavior of the free end22of the anchor15and/or core wire74may be optimized to facilitate various deployment and/or implantation steps of the anchor15. The anchor15may be relatively stiffer than the movable core wire74in order to prevent or reduce deflection of the body of the anchor15when the movable core wire74is disposed in a lumen thereof. In some embodiments, the movable core wire74may comprise a relatively more complex shape compared to the anchor15in order to guide and the free end22of the relatively stiffer anchor15.

In various embodiments, the anchor15and/or core wire74may have a spiral-shaped deployed configuration. In various embodiments, spiral refers to a shape with windings about a central axis. The spiral may be continuous. The windings may gradually widen (or tighten) along the length. The spiral may be formed in a flat plane perpendicular to the central axis. In various embodiments, the anchor15and/or core wire74may have a deployed configuration that is not formed in a flat plane, or in other words the deployed shape is formed in a three-dimensional and/or non-degenerate space. In various embodiments, the anchor15and/or core wire74may have a conical-shaped deployed configuration including, but not limited to, tubular, conical, frustoconical, and/or helical shapes.

In various embodiments, the core wire74may be configured to be removed from the valve prosthesis (e.g., translated proximally out of the body) after the anchor15has been deployed. The core wire74may be removed with the delivery device as will be understood by one of ordinary skill in the art based on the disclosure herein.

In various embodiments, the core wire74may be configured to remain within the anchor15after the anchor15has been deployed. A proximal end of the core wire74may be released from the delivery device30as will be understood by one of ordinary skill in the art based on the disclosure herein.

In various embodiments, a proximal end of the core wire74may be directly manipulated by a user outside the body in order to translate the core wire74within the anchor15. In various embodiments, a proximal end of the core wire74may be indirectly manipulated by a user, for example, with a translatable pusher section73(as described elsewhere herein) disposed within the delivery device and coupled to the proximal end of the core wire74adjacent the anchor15, in order to translate the core wire within the anchor.

FIG. 7Ashows an exemplary straight anchor15core wire74configured to translate therethrough. The anchor15may comprise a lumen or channel71in which the core wire74may be disposed. The anchor15is shown as a straight anchor with a central channel71, however it will be understood by one of ordinary skill in the art that the anchor15may have any of the configurations described herein. The core wire74is shown as a straight wire, however it will be understood by one of ordinary skill in the art that the core wire74may have any of the configurations described herein. Advancement of the distal tip75of the straight core wire74through an aperture at the free end22of the anchor15may result in the core wire74being deployed such that the free end22and/or distal tip75experiences no deflection and moves co-axially with the longitudinal axis of the anchor15. When subsequently deployed out of the delivery device, the free end22and/or distal tip75may similarly experience no deflection and instead may move co-axially with the longitudinal axis of the delivery device.

FIG. 7Bshows a core wire74comprising a deflecting feature33. The deflecting feature33may, for example, comprise a pre-formed wave, bend, hump, or the like in the wire74(e.g., in a distal tip portion of the core wire74). By adding a deflecting feature33to the core wire74, the distal tip75may “wiggle” or deflect away from the longitudinal axis of the anchor15and/or delivery device as it exits the lumen71of the anchor15and change the deployment angle of the distal tip75beyond the free end22. Deflection of the distal tip75of the core wire74may be caused by interaction of one or more changes in angle (shown here as A, B, C. and D) making up the deflecting feature33with the sides of lumen71(e.g., with an opening or aperture through which the core wire74is extruded). It will be understood by one of ordinary skill in the art from the teachings herein that the angle(s) of the deflecting feature33may be configured to deflect the distal tip75to any angle desired in any direction desired. The deflecting feature33may be positioned at a location along the core wire74such that deflection of the distal tip75is “timed” to occur with the distal tip75and/or free end22wrapping back towards the delivery device (for example as shown inFIG. 6A) such that the distal tip75and/or free end22deflects towards the correct side of the delivery device30as described herein. The lumen71of the anchor15may be sized and dimensioned to match or be slightly larger than the diameter of the core wire74in order to enable such interactions. In some embodiments, the core wire74may be made of a shape memory material such as nitinol in order to allow shaping of the deflection feature33. In some embodiments, the core wire74may be made of a heat treatable material in order to allow shaping of the deflection feature33.

The anchor15may be relatively stiffer than the core wire74. The anchor15may be sufficiently stiffer than the core wire74such that the core wire74anchor15experiences little or no deflection itself when the core wire74is disposed therein.

FIGS. 8A-8Dshow sequential cross-sectional views of a core wire74comprising a deflecting feature33during deployment from the free end22of an anchor15.FIG. 8Ashows the distal tip75as it begins advancing out of the opening in the free end22of the anchor15up to first change in angle A. As the distal tip75continues to be deployed (up to change in angle B), the deflection feature33may move past the opening in the free end22, releasing the radial constriction of change in angle A and allowing the distal tip75of the core wire74to deflect in a first direction (shown inFIG. 8Bas a deflection towards the right side of the anchor15). Continued advancement of the core wire74out the opening in the free end22(up to change in angle C) may further deflect the distal tip75in second direction (shown inFIG. 8Cas shown as a deflection towards the left side of the anchor15) as change in able B is released from radially constriction. Continued advancement of the distal tip75out the opening of the free end22(up to change in angle D) may further deflect the distal tip75again as change in angle C is released from radial constriction, for example co-axially with the longitudinal axis of the anchor15(shown inFIG. 8D). Advancing the remainder of the distal tip75out of the anchor15may result in no further deflection unless and until a second deflection feature33is encountered at the opening to the lumen71.

In some embodiments, the distal tip75may comprise an elongated delivery configuration as described herein. The deflection feature33may comprise one or more bends or kinks along the length of the elongated distal tip75. The elongated distal tip75may be substantially straight along a longitudinal axis thereof (for example, substantially co-axial with a longitudinal axis of the delivery device30as described herein). The deflection feature33may comprise one or more bends that position at least a portion of the core wire74discontinuous with the rest of the core wire74, for example along an axis other than the longitudinal axis. For example, the deflection feature33may comprise a bend at an angle relative to the longitudinal axis or a plurality of bends to form a portion (for example, a wave, bump, hump, or the like) which starts and ends along the longitudinal axis but which is disposed off-axis (e.g., parallel to or at an angle to the longitudinal axis) along at least a portion of the deflection feature33. In some embodiments, the deflection features33may be attached (fixedly or detachably) to the distal tip75, for example in the form of a tab or a wing or the like.

In some embodiments, at least a portion of the core wire74may comprise a curved shape when the anchor15is in the deployed configuration. The curved shape may, for example, comprise a coil a helix, or a spiral as described herein. The curved shape may be configured to encircle one or more structures of the native valve. The curved shape may correspond to the curved shape of the anchor15in the deployed configuration. The deflection feature33may be comprise one or more bends or kinks along the core wire74which are discontinuous with the curved shape. In some embodiments, the deflection features33may be attached (fixedly or detachably) or adjacent to the curved shape, for example in the form of a tab or a wing or the like. Alternatively or in combination, the deflection features33may comprise discontinuities in the curved shape, for example in the form of bends, kinks, waves, humps, bumps, or the like in the curved wire itself. In some embodiments, the deflection features33may position a portion of the wire inside, outside, above, below, or at an angle to the otherwise relatively continuous curved shape of the core wire74.

FIGS. 9A-9Dshow various optional, non-limiting configurations of a deflection feature33.FIG. 9Ashows a deflection feature33which may bend away from a longitudinal axis of the anchor15and/or delivery device30at a primary bend P and bend towards the longitudinal axis at a secondary bend S. The deflection feature33may comprise a height H which may correspond to the maximum orthogonal distance of the deflection feature33away from the longitudinal axis.FIG. 9Bshows a deflection feature33which may be substantially similar to the deflection feature33shown inFIG. 9Abut with a longer distance between the primary bend P and secondary bend S.FIG. 9Cshows a deflection feature33having a primary bend P and two secondary bends S which for an “s”-like configuration about the longitudinal axis. The deflection feature33may comprise a maximum orthogonal distance H extending on either side of the longitudinal axis.FIG. 9Dshows a deflection feature33substantially similar to the deflection feature33ofFIG. 9Abut the direction of deflection is down instead of up.

It will be understood by one of ordinary skill in the art that the number of bends, the angle of each bend, the length, the shape, the location, and/or the orientation of the deflection feature33, the number of deflection features33, and/or the diameter and/or material of the core wire74and/or anchor15may be adjusted in order to effect a desired amount and orientation of the deflection of the distal tip75of the core wire74and/or free end22of the anchor15.

FIG. 10shows a perspective bottom view of an exemplary anchor15comprising a translatable core wire74disposed therein, the core wire74having a deflection feature33disposed thereon and being in a nominal state relative to the anchor15.FIG. 11shows a top view of the anchor15ofFIG. 10. The anchor15may be substantially similar to any of the anchors described herein, for example a helical anchor comprising a lumen or channel71in the deployed configuration as shown. The anchor15may be directly coupled to a frame structure12, for example at a proximal or distal end thereof, as described herein. Alternatively, or in combination, the anchor15may be detachably coupled to the delivery device30prior to deployment at the native valve. The delivery device30may be substantially similar to any of the delivery devices described herein. For example, a proximal end57of the anchor15may be detachably coupled to the inner shaft52during delivery to the native valve. Alternatively, or in combination, a proximal end57of the anchor15may be coupled to a distal end of the frame structure12or a proximal end of the frame structure12. The anchor15is shown in a deployed configuration. The anchor15may comprise a delivery (e.g., elongated) configuration (e.g., as shown inFIG. 1) and a deployed configuration (e.g., as shown inFIG. 2). In various embodiments, the anchor may be self-expanding and may move to the deployed configuration as it is removed from the delivery sheath as described herein. The anchor15may be configured to wrap at least partially around the frame structure12in the deployed configuration.

In various embodiments, the anchor15may have a generally helical shape in the deployed configuration. In various embodiments, the anchor15may be elongated—rather than helix-shaped—in the delivery configuration. For example, the anchor15may be elongated into a straight shape within the delivery device. In various embodiments, a portion of the anchor15may have a helical shape. In various embodiments, a substantial portion of the anchor15may have a helical shape. In various embodiments, the helical anchor15may be formed as a three-dimensional helix (in the deployed configuration) whereby the loops generally are positioned around the same axis (for example, a longitudinal axis of the delivery device30).

Optionally, the anchor15may comprise a first portion comprising the helical shape and another portion. Alternatively, or in combination, the anchor15may comprise a plurality of helical portions. For example, the anchor15may comprise at least two helical portions having the same or different diameters. Alternatively, or in combination, the anchor15may comprise at least two helical portions having the same or different winding pitches.

The free end22of the anchor15may extend radially outward from the frame structure12, and in particular from the remainder of the anchor15(for example, as shown inFIG. 11). In some embodiments, the anchor15may have a generally tubular shape. The free end22of the anchor1520may extend radially outward from the tubular shape. In some embodiments, the anchor15may have a generally frustoconical shape. The free end22of the anchor15may extend radially outward from the frustoconical shape. In some embodiments, the anchor15may have a generally cylindrical shape. The free end22of the anchor15may extend radially outward from the cylindrical shape. The free end22may be configured to encircle a larger radius than the main loops of the anchor15. The larger diameter may facilitate capturing of one or more structures, for example the valve leaflets of the chordal tendineae within the sweep of the free end22when rotated as described herein.

The anchor15may comprise a movable core wire74disposed within a lumen or channel of the anchor15as described herein. A distal tip portion of the core wire74may comprise one or more deflection features33disposed thereon or therealong as described herein. For example the distal tip portion may comprise a single deflection feature33. The core wire74may be translatable. The core wire74may translate distally and proximally within the lumen71of the anchor15. Translation of the core wire74within the lumen71of the anchor15may cause the one or more deflection features33to deflect the distal tip75of the core wire74as it moves in or out of the anchor15. For example, when advanced distally past the free end22of the anchor15, a distal tip75of the core element74may be caused to “wiggle” or deflect away from the curvature of the curved anchor body15and change the deployment angle of the distal tip75of the core wire74out of the anchor body15in order to facilitate wrapping of the anchor15around the delivery device30as described herein.

The movable core wire74may be translated within the anchor15before, during, or after deployment of the anchor15from the undeployed configuration to the deployed configuration. For example, the movable core wire15may be translated within the anchor15before deployment of the anchor15into a self-assembly state (e.g., as shown inFIG. 12) in order to facilitate wrapping of the anchor15around the delivery device (e.g., by extending past the free end22of the anchor15and acting similarly to the deflecting feature(s)23of the anchor15). Alternatively, or in combination, the movable core wire74may be translated within the anchor15during deployment of the anchor15in order to actively or reactively “wiggle” or deflect the angle of the distal tip75as it deploys as described herein. Alternatively, or in combination, the movable core wire74may be translated with the anchor15into an encircling state (e.g., as shown inFIGS. 13 and/or 14) in order to facilitate grasping of and rotation of the anchor15around the one or more native valve structures as described herein.

FIG. 12shows a side view of the anchor15ofFIG. 10with the core wire74in a self-assembly state. The core wire74may comprise a deflecting feature33configured to change the angle of distal tip75of the core wire74as the core wire74is translated distally or proximally within the lumen71of the anchor15as described herein. For example, the deflecting feature33may comprise a wave, bump, hump, or the like made up of a plurality of angle changes similar to the deflecting feature33shown inFIGS. 7A-7D. As shown inFIGS. 7A-7D, the distal tip75may be deflected to multiple positions (discretely or continuously) as the core wire74is translated out of the anchor body15.

Deflection of the core wire74and distal tip75may be adjusted and/or optimized for various steps during deployment of the valve prosthesis10as described herein. For example, the distal tip75may be advanced into a self-assembly state prior to or during deployment of the anchor15from the delivery device30in order to facilitate wrapping of the core wire74and anchor15around the delivery device30into the correctly deployed configuration as described herein. In the self-assembly state, the distal tip75may be deflected prior to or during deployment of the anchor15such that the distal tip75overlaps with one or more turns of the anchor15in order to ensure that the free end22wraps back around the delivery device30.

The deflection feature33in the self-assembly state may, for example, be configured to deflect the distal tip15proximally (e.g., towards a proximal portion of the anchor15and a distal end of the delivery device30), distally (e.g., away from a proximal portion of the anchor15and towards a proximal portion of the delivery device30), and/or radially (e.g., radially outwards or inwards from the main body of the anchor15and away from or towards the delivery device30, respectively). In some embodiments, for example, the deflection feature33may be configured to position the distal tip75adjacent one or more loops of the anchor15when the anchor15is in the deployed configuration. Alternatively, or in combination, the deflection feature33may be configured to position the distal tip75such that it angles towards a proximal end of the anchor15when the anchor15is in the deployed configuration. Alternatively, or in combination, the deflection feature33may be configured to position the distal tip75such that it angles towards a distal end of the delivery device30when the anchor15is in the deployed configuration.

In at least some instances, it may be sufficient to initially deflect the distal tip75during wrapping as described herein in order to form the first loop of the anchor15around the delivery device30. Once the first loop as wrapped around the delivery device30, the remaining loops may be more inclined or biased to wrap correctly around the delivery device30without additional deflection or manipulation. The core wire74may remain in the self-assembly for the entirety of the deployment of the anchor15from the delivery device30. Alternatively, once the free end22of the anchor15has made a first loop around the delivery device30facilitated by the distal tip75of the core wire74, the distal tip75of the core wire74may be translated proximally and retracted at least partially back into the anchor15for the remainder of the deployment of the anchor15.

FIG. 13shows a side view of the anchor ofFIG. 10with the core wire74in an exemplary encircling state, in accordance with embodiments. The distal tip75may be advanced into an encircling state following (or during) deployment of the anchor15from the delivery device30in order to facilitate capture of the one or more structures by the anchor15. In the encircling state, the one or more deflection features33of the core wire74may deflect the distal tip75such that the distal tip75angles away from the anchor15.

The deflection feature33in the encircling state may, for example, be configured to deflect the distal tip15proximally (e.g., towards a proximal portion of the anchor15and a distal end of the delivery device30), distally (e.g., away from a proximal portion of the anchor15and towards a proximal portion of the delivery device30), and/or radially (e.g., radially outwards or inwards from the main body of the anchor15and away from or towards the delivery device30, respectively).

In at least some instances, deflection (e.g., angling proximally, distally, and/or radially outward) of the distal tip75of the core wire74away from the loops of the anchor15may aid in capture of the one or more native valve structures by forming a “grabber” arm. For example, during rotation of the anchor15, the grabber arm distal tip75of the core wire74may be rotated as shown to capture the one or more structures of the native valve.

The distal tip75of the core wire74may optionally rotated around one or more structures on the second side of the native valve such that the one or more structures (e.g., chordae, leaflets, and/or annulus) are pulled radially inwards towards the longitudinal axis of the anchor15and/or towards the longitudinal axis of the delivery device30. The core wire74, distal tip75, anchor15, and/or free end22may be configured such that minimal torque is applied to the one or more native valve structures. Alternatively, or in combination, the core wire74, distal tip75, anchor15, and/or free end22may be configured such that the one or more structures are not rotated, or are minimally rotated, during rotation of the anchor15.

FIG. 14shows a side view of the anchor ofFIG. 10with the core wire74in another exemplary encircling state, in accordance with embodiments. The distal tip75may be advanced into an encircling state following (or during) deployment of the anchor15from the delivery device30in order to facilitate capture of the one or more structures by the anchor15. In the encircling state, the one or more deflection features33of the core wire74may not deflect the distal tip75of the core wire74, and the distal tip75may be coaxial the anchor15.

The distal tip75of the core wire74may optionally rotated around one or more structures on the second side of the native valve such that the one or more structures (e.g., chordae, leaflets, or annulus) are pulled radially inwards towards the longitudinal axis of the anchor15and/or towards the longitudinal axis of the delivery device30. The core wire74, distal tip75, anchor15, and/or free end22may be configured such that minimal torque is applied to the one or more native valve structures. Alternatively, or in combination, the core wire74, distal tip75, anchor15, and/or free end22may be configured such that the one or more native valve structures are not rotated, or are minimally rotated, during rotation of the anchor15.

FIG. 15shows a perspective view of an exemplary anchor15comprising a lumen71disposed therethrough, in accordance with embodiments. The anchor15may be substantially similar to any of the anchors described herein, for example a helical anchor as shown. The anchor15may be detachably coupled to a delivery device30as described herein. The anchor15may comprise one or more lumens or channels71as described herein. The anchor15may, for example, comprise a hypotube. The anchor15may comprise a hollow, tubular cross-section. The one or more lumens or channels71may be configured to pass another component (e.g., a core wire74, guidewire, etc.) therethrough. For example, the one or more lumens71may be configured to pass a core wire comprising one or more deflection features therethrough.

The anchor15may comprise a single lumen or channel71. The anchor15may comprise a plurality of lumens or channels71. For example, the anchor15may comprise one, two, three, four, five, six, seven, eight, nine, or ten lumens of channels71disposed therethrough. It will be understood to one of ordinary skill in the art based on the teachings herein that any number of channels may be utilized as desired. The channels71may for example be left as open lumens (e.g., for placement of one or more core wires74therethrough). Alternatively, or in combination, the channels may be filled, for example with one or more stiffening members.

The anchor15may comprise a round cross-section. The anchor15may comprise a non-round cross section. The anchor15may have a cross-section of any shape desired, for example a circular, tubular, hollow, square, elongated, ovoid, triangular, or any other shaped cross-section. The cross-sectional shape of the anchor15may, for example, be selected to facilitate deployment from the delivery device. Alternatively, or in combination, the shape of the anchor15may be selected to reduce pulling, torqueing, or otherwise damaging the one or more native valve structures as it is rotated therearound. Alternatively, or in combination, the shape of the anchor15may be selected to provide sufficient radial strength when a frame structure12is expanded therein to anchor the frame structure12to the one or more native valve structures therebetween.

The anchor15may comprise or more loops. For example, the anchor15may comprise a plurality of loops, which may increase the radial strength of the anchor by increasing friction and addition structural support. The one or more loops of the anchor15may be substantially cylindrical around a central axis of the anchor15, for example along an axis which is coaxial with a longitudinal axis of a delivery device30. The one or more loops of the anchor15may be substantially helical around a central axis or helical axis of the anchor15, for example along an axis which is coaxial with a longitudinal axis of a delivery device. The one or more loops (also referred to herein as coils or turns) of the anchor15may comprise a curved shape that bends around back towards its origin (for example, an arc, ellipsoid, circle, or the like). In some embodiments, a loop may comprise a curved shape that bends back towards its origin but does not cross itself, making a rotation within a range of about 180 degrees to about 360 degrees, as described herein. In some embodiments, a loop may comprise a shape that bends back towards and crosses itself, making at least a 360 degree rotation, as described herein. The one or more loops may comprise any number of loops desired, for example, one, two, three, four, five, six, seven, eight, nine, or ten loops. The one or more loops may comprise a rotation within a range of about 180 degrees to about 3600 degrees as described herein. The one or more loops may comprise a rotation within a range bounded by any of the following values: 180 degrees, 270 degrees, 360 degrees, 450 degrees, 540 degrees, 630 degrees, 720 degrees, 810 degrees, 900 degrees, 990 degrees, 1080 degrees, 1170 degrees, 1260 degrees, 1350 degrees, 1440 degrees, 1530 degrees, 1620 degrees, 1710 degrees, 1800 degrees, 1890 degrees, 1980 degrees, 2070 degrees, 2160 degrees, 2250 degrees, 2340 degrees, 2430 degrees, 2520 degrees, 2610 degrees, 2700 degrees, 2790 degrees, 2880 degrees, 2970 degrees, 3060 degrees, 3150 degrees, 3240 degrees, 3330 degrees, 3420 degrees, 3510 degrees, or 3600 degrees.

Interaction of the frame structure12with the one or more loops of the anchor15may create opposing forces therebetween that provide mechanical leverage for anchoring the frame structure12to the one or more anatomical structures as described herein. In some embodiments, the one or more loops may comprise at least 360 degrees of rotation when deployed such that the loops wrap around one another and provide additional mechanical leverage against the frame structure12in order to facilitate anchoring of the frame structure as described herein. Additional loops or partial loops may provide additional mechanical strength and/or leverage.

FIG. 16shows a side view of an exemplary core wire74comprising a deflection feature33in a distal tip section77of the core wire74. The core wire74may comprise one or more sections of wire having the same or different pre-formed shapes to facilitate deployment within the lumen of the anchor. For example, the core wire74may comprise a distal tip section77comprising the distal tip75and one or more deflection features33. The core wire74may also comprise a proximal curved section76proximal to the distal section77which comprises a curved shape. The curved shape may be substantially similar to the curved shape of the anchor15in order to provide robust rotational constraint to the core wire74so that the distal tip75does not rotate relative to the anchor as it is translated. Alternatively, the curved shape may be configured with a different shape or curvature that the anchor in order to induce rotation in the distal tip75during translation as desired. In some embodiments, the core wire74may comprise a proximal pusher section (e.g., proximal pusher section73) proximal to the proximal curved section76which extends from the proximal curved portion76to a proximal end of the delivery device. The proximal pusher section may act as an actuation mechanism and facilitate longitudinal translation of the core wire74within the lumen71of the anchor15. For example, a proximal end of the proximal pusher section may be coupled to an actuation mechanism on the delivery device in order to translate the core wire74. Alternatively, the proximal end of the proximal pusher section may be manually manipulated by at or near a proximal end of the delivery device in order to translate the core wire74.

In some embodiments, the core wire74may comprise a helical shape in the deployed configuration as described herein. The deflection feature33may be comprise one or more bends or kinks along the distal section77which are discontinuous with the helical shape of the proximal curved section76. In some embodiments, the deflection feature33may be attached (fixedly or detachably) to the distal section77, for example in the form of a tab or a wing or the like. Alternatively or in combination, the deflection feature33may comprise a discontinuity in the helical shape, for example in the form of bends, kinks, waves, humps, bumps, or the like in the wire itself.

In some embodiments, the core wire74may comprise a spiral shape in the deployed configuration as described herein (e.g., as shown inFIGS. 20-21). The deflection feature33may be comprise one or more bends or kinks along the distal section77which are discontinuous with the spiral shape of the proximal curved section76. In some embodiments, the deflection feature33may be attached (fixedly or detachably) to the distal section77, for example in the form of a tab or a wing or the like. Alternatively or in combination, the deflection feature33may comprise a discontinuity in the spiral shape, for example in the form of bends, kinks, waves, humps, bumps, or the like in the wire itself.

In some embodiments, one or more deflection features33may be positioned along the length of the distal section77at one or more locations such that deflection of the distal tip75is “timed” to occur with the distal tip75and/or free end22wrapping back towards the delivery device30as described herein. The distal tip75may, for example, be deflected each time it wraps back towards the delivery device30as described herein. In some embodiments, the deflection features33may position the distal tip portion77of the core wire74inside, outside, above, below, or at an angle to the otherwise relatively continuous curved shape of the proximal curved section76.

The one or more deflection features33may be configured so as to resist straightening of the bends when the anchor is in the elongated configuration. The one or more deflection features33may be configured interact with the frame structure12to facilitate anchoring. The one or more deflection features33may be configured not to interact with the frame structure in order to facilitate anchoring. The one or more deflection features33may advantageously avoid a need for substantial circumferential compliance into the curved shape of the anchor15.

The core wire74may be formed of a material having sufficient rigidity to hold a predetermined shape. The core wire74may, for example, be formed of a shape memory material (e.g., NiTi). It may be desirable for at least an end portion (e.g., a distal section77as described herein) to be relatively rigid such that it can exert a force to move chordal tendineae, while still retaining flexibility to be collapsed within the anchor15and/or a delivery device30. In various embodiments, the distal section77only needs sufficient rigidity to hold its shape and will deform under a load. For example, the distal section77may be configured with a similar rigidity to a guidewire, or slightly stiffer.

FIGS. 17A-17Bshow side views of various optional, non-limiting configurations of a deflection feature33of a core wire74. The distal section77of the core wire74may comprise one or more bends, kinks, waves, humps, bumps, or the like as described herein. For example, the distal section77may comprise a single bend in order to angle and deflect the distal tip75(e.g., distally away towards the anchor body15and away from the delivery device30or proximally away from the anchor body15and towards the delivery device30) as shown inFIG. 17A. In some embodiments, the distal section77of the core wire74may comprise two bends to produce a wave-like shape in order to angle and deflect the distal tip75of the core wire74as shown inFIG. 17B. In some embodiments, the distal section77of the core wire74may comprise three bends to produce a bump-like shape in order to angle and deflect the distal tip75of the core wire74as shown inFIG. 17C. It will be understood by one of ordinary skill in the art from the teachings herein that the distal section77may comprise any number or shape of deflection features33in order to deflect the distal tip75as described herein.

The distal tip75of the core wire74may be sized and dimensioned for insertion through the native valve, for example through tissue at or near a commissure of the native valve or through the valve opening itself. In some embodiments, the distal tip75may comprise an atraumatic tip to avoid reduce risk of injury to the native valve tissue and leaflets. For example, the distal tip75may comprise a blunt end, a ball tip, a curved tip (e.g., J-tip or pigtail), or other atraumatic shapes. Alternatively, the distal tip75may be configured for piercing tissue.

In various embodiments, the distal tip75may be shaped and configured to reduce the risk of counter-rotation. For example, the distal tip75may have a curled end to cause the distal tip75to snag chordae if it is rotated in a direction opposite the anchoring rotation.

The distal tip75may optionally rotated around one or more native valve structures on the second side of the native valve such that the one or more structures (e.g., chordae, leaflets, or annulus) are pulled radially inwards towards the longitudinal axis of the anchor15and/or towards the longitudinal axis of the delivery device30. The distal tip75and/or free end22may be configured such that minimal torque is applied to the one or more structures. Alternatively. or in combination, the distal tip75and/or free end22may be configured such that the one or more structures are not rotated, or are minimally rotated, during rotation of the anchor15. For example, the anchor15may comprise one or more spaces between loops of the curved shape of the anchor15which facilitate movement of the captured tissue (e.g. chordae and/or leaflets) from the distal tip75and/or free end22to the center of the curved structure with little or no torque and/or rotation of the structures during rotation of the anchor15as described herein. The one or more native valve structures may sit radially inward of the loops in order to facilitate capture of the one or more native valve structures between the distal tip75and/or anchor15and the expanded frame structure12. The one or more native valve structures may retain or nearly retain their normal anatomical position when the anchor15is fully deployed.

FIG. 18shows a perspective view of another exemplary anchor15comprising a lumen71disposed therethrough.FIG. 19shows a side view of the anchor15ofFIG. 18. The anchor15may be substantially similar to the anchor shown inFIG. 15, except that the anchor may comprise a spiral shape instead of a helical shape. The anchor15may be detachably coupled to a delivery device as described herein. The anchor15may comprise one or more lumens or channels71as described herein. The anchor15may, for example, comprise a hypotube. The anchor15may comprise a hollow, tubular cross-section. The one or more lumens or channels71may be configured to pass another component (e.g., a wire, guidewire, etc.) therethrough. For example, the one or more lumens71may be configured to pass a core wire comprising one or more deflection features therethrough as described herein. The anchor15may comprise or more loops as described herein. The one or more loops of the anchor15may spiral radially outward from a central point or central axis of the anchor15, for example along an axis which is coaxial with a longitudinal axis of a delivery device30such that the anchor15lies approximately along a plane perpendicular to the longitudinal axis of the delivery device30.

The free end22of the anchor15may extend radially outward from the frame structure, and in particular from the remainder of the anchor15. The other end of the spiral band or wire20may be coupled to the top or bottom of the frame structure as described herein. Alternatively, or in combination, the other end of the anchor15may not be attached to the frame structure12as described herein. The free end22of the anchor15may facilitate capturing of the valve leaflets and/or chordal tendineae within the sweep of the free end during rotation as described herein. During rotation of the anchor15, the leaflets and/or chordae tendineae may be captured by the free end22and trapped between the valve frame structure and an interior surface of the anchor15.

In various embodiments, the anchor15may have a generally spiral shape in the deployed configuration. In various embodiments, the anchor15may be elongated—rather than spiral-shaped—in the delivery configuration. For example, the anchor15may be elongated into a straight shape within the delivery device. In various embodiments, a portion of the anchor15may have a spiral shape. In various embodiments, a substantial portion of the anchor15may have a spiral shape. In various embodiments, the anchor15may be formed as a flat spiral (in the deployed configuration) whereby the loops generally are positioned within the same plane (the plane being perpendicular to a longitudinal axis).

Optionally, the anchor15may comprise a first portion comprising the spiral portion and another portion. Alternatively, or in combination, the anchor15may comprise a plurality of spiral portions. For example, the anchor15may comprise at least two spiral portions having the same or different diameters. Alternatively. or in combination, the anchor15may comprise at least two spiral portions having the same or different winding pitches.

FIGS. 20-22show various views of the anchor15ofFIG. 18loaded on a delivery device30and having a translatable core wire74disposed within the its lumen71, the core wire74having a deflection feature33disposed thereon and being in a nominal state relative to the anchor15.FIG. 20shows a side view.FIG. 21shows a perspective top view.FIG. 22shows a top view. The anchor15may be substantially similar to any of the anchors15described herein, for example a spiral-shaped anchor having a lumen or channel71in the deployed configuration as shown. The anchor15may be detachably coupled to a delivery device30as described herein. The anchor15may be directly coupled to a frame structure12, for example at a proximal or distal end thereof, as described herein. Alternatively. or in combination, the anchor15may be detachably coupled to the delivery device30prior to deployment at the native valve. The delivery device30may be substantially similar to any of the delivery devices described herein. For example, a proximal end of the anchor15may be detachably coupled to the inner shaft52and/or anchor guide153during delivery to the native valve. Alternatively, or in combination, a proximal end of the anchor15may be coupled to a distal end of the frame structure12or a proximal end of the frame structure12. The anchor15is shown in a deployed configuration. The anchor15may comprise a delivery (e.g., elongated) configuration (e.g., as shown inFIG. 1) and a deployed configuration (e.g., as shown inFIG. 2). In various embodiments, the anchor may be self-expanding and may move to the deployed configuration as it is removed from the delivery sheath as described herein. The anchor15may be configured to wrap at least partially around the frame structure12in the deployed configuration. In some embodiments, the anchor15may be configured not to wrap around the distal end of the delivery device30in the deployed configuration. The loops of the anchor15may instead lie entirely distal of the distal end of the delivery device30as shown.

The anchor15may comprise a movable core element74disposed within a lumen or channel71of the anchor15as described herein. A distal section77of the core wire74may comprise one or more deflection features33disposed thereon or therealong as described herein. For example the distal tip portion may comprise a single deflection feature33. The core wire74may be translatable. The core wire74may translate distally and proximally within the lumen71of the anchor15. Translation of the core wire74within the lumen71of the anchor15may cause the one or more deflection features33to deflect the distal tip75of the core wire74as it moves in or out of the anchor15. For example, when advanced distally past the free end22of the anchor15, a distal tip75of the core element74may be caused to “wiggle” or deflect away from the curvature of the curved anchor body15and change the deployment angle of the distal tip75out of the anchor body15in order to facilitate wrapping of the anchor15around the delivery device30as described herein.

The movable core wire74may be translated within the anchor15before, during, or after deployment of the anchor15from the undeployed configuration to the deployed configuration. For example, the movable core wire74be translated within the anchor15before deployment of the anchor15into a self-assembly state (e.g., as shown inFIG. 12) in order to facilitate wrapping of the anchor15around the delivery device30(e.g., by extending past the free end22of the anchor and acting similarly to the free end22comprising the deflecting feature(s)23described herein). Alternatively. or in combination, the movable core wire74may be translated within the anchor15during deployment of the anchor15in order to actively or reactively “wiggle” or deflect the angle of the distal tip as it deploys as described herein. Alternatively, or in combination, the movable core wire74may be translated with the anchor15into an encircling state (e.g., as shown inFIGS. 13 and/or 14) in order to facilitate grasping of and rotation of the anchor15around the one or more native valve structures as described herein. In at least some instances, deflection (e.g., angling proximally, distally, and/or radially outward) of the distal tip75away from the loops of the anchor15may aid in capture of the one or more native valve structures by forming a “grabber” arm as described herein.

While the one or more deflection features23,33have been described herein with reference to changing the angle of a distal tip75of a core wire74and/or free end22of an anchor14of a valve prosthesis10during deployment from a delivery device30, it will be understood by one of ordinary skill in the art that such deflection features23,33may be used in a variety of settings.

FIG. 23shows a side view of another exemplary anchor15comprising multiple translatable core wires74disposed therein. The anchor15may be substantially similar to any of the anchors15described herein, for example a helix-shaped anchor15having a lumen or channel71in the deployed configuration as shown. The anchor15may be detachably coupled to a delivery device30as described herein. The anchor15may be directly coupled to a frame structure12, for example at a proximal or distal end thereof, as described herein. Alternatively, or in combination, the anchor15may be detachably coupled to the delivery device30prior to deployment at the native valve. Alternatively, or in combination, the anchor15may be coupled to the frame structure12and/or delivery device30by a tether78or by a proximal pusher of the core wire74as described herein. The delivery device30may be substantially similar to any of the delivery devices30described herein. For example, a proximal end of the anchor15may be detachably coupled to the inner shaft52during delivery to the native valve. Alternatively, or in combination, a proximal end of the anchor15may be coupled to a distal end of the frame structure12or a proximal end of the frame structure. Alternatively, or in combination, a proximal end of the anchor15may be coupled to a tether78or a proximal pusher of the core wire74, thereby operably coupling the anchor15to the delivery device30. The anchor15is shown in a deployed configuration. The anchor15may comprise a delivery (e.g., elongated) configuration (e.g., as shown inFIG. 1) and a deployed configuration (e.g., as shown inFIG. 2). In various embodiments, the anchor15may be self-expanding and may move to the deployed configuration as it is removed from the delivery sheath50as described herein. The anchor15may be configured to wrap at least partially around the frame structure in the deployed configuration. The anchor15may be configured to wrap at least partially around a distal end of the delivery device30in the deployed configuration.

The core wire74may comprise one or more sections of wire having the same or different pre-formed shapes to facilitate deployment within the lumen of the anchor. For example, the core wire74may comprise a distal wire section77comprising the distal tip75and one or more deflection features as described herein. The core wire74may also comprise a proximal curved section76proximal to the distal section77which comprises a curved shape. The curved shape may be substantially similar to the curved shape of the anchor in order to provide robust rotational constraint to the core wire74so that the distal tip75does not rotate relative to the anchor as it is translated. Alternatively, the curved shape may be configured with a different shape or curvature that the anchor in order to induce rotation in the distal tip75during translation as desired. In some embodiments, the core wire74may comprise a tether78or proximal pusher section proximal to the proximal curved section76which extends from the proximal curved portion76to a proximal end of the delivery device. The proximal pusher section or tether78may act as an actuation mechanism and facilitate longitudinal translation of the core wire74within the lumen71of the anchor74. For example, a proximal end of the proximal pusher section or tether78may be coupled to an actuation mechanism in/on the delivery device30in order to translate the core wire74. Alternatively, the proximal end of the proximal pusher section or tether78may be manually manipulated by at or near a proximal end of the delivery device in order to translate the core wire74.

Rather than providing a core wire74comprising a single wire and one or more deflection features33disposed thereon or therealong (e.g., as shown inFIGS. 10-22), the core wire74may comprise a plurality of wires which may be translated relative to one another in order to change the shape of a distal tip portion and deflect the distal tip75of the core wire to facilitate wrapping of the core wire74and/or anchor15around the delivery device30and/or one or more native valve structures as described herein. For example, the core wire74may comprise a first wire74aand a second wire74b. The first and second wires74a.74bmay be longitudinally translatable independent of one another within the lumen71of the anchor15.

In some embodiments, the first wire74aand the second wire74bmay be disposed within a housing79. The housing79may comprise a flexible material. Translation of the first and second wires74a,74brelative to one another may change the curvature of the housing79, thereby deflecting the distal tip75of the core wire74in order to facilitate anchor deployment and/or wrapping of the anchor15around one or more structures of the native valve in a manner substantially similar to that described with respect to the deflecting features described herein. By providing two or more wires74a,74bwithin a housing79, the distal tip75of the core wire74may be deflecting into more complex and/or varying shapes than may be possible with a deflection features disposed on or along the core wire74. In some embodiments, the entire “grabber arm” of the distal section77may be made up of wires.

FIG. 24shows a side view of a distal tip of the anchor and core wires74a,74bofFIG. 23.FIG. 25shows a side view of a proximal end of the anchor and core wires74a,74b, ofFIG. 23. The distal portions (which may include a distal tip portion77and, optionally, a proximal curved portion76) of the first and second wires74a,74bmay be disposed within a housing79as described herein. A proximal pusher section of the first and second wires74a,74bmay or may not be disposed within a housing79. For example, the proximal pusher section may be disposed within the housing79between the proximal end of the anchor15and the distal end of the frame structure12. The frame structure12is shown dispose around the wires74a,74bin the unexpanded configuration. The wires74a.74bmay extend through and towards a proximal end of the delivery device. The wires74a,74bmay be coupled to one or more actuations mechanisms in/on the delivery device30in order to the translate the wires74a,74brelative to one another and/or the anchor15. Alternatively, the wires74a,74bmay be manually manipulated by at or near a proximal end of the delivery device in order to translate the core wires74a.74b. The two wires74a.74bmay be independently translated in order to generate additive curvatures. The wires74a,74bmay be pulled/pushed distally or proximally relative to one another to cause the housing of the distal section77to deflect in any number and manner of shapes or curvatures desired.

It should be understood that any feature described with respect to one embodiment may be combined with or substituted for any feature described with respect to another embodiment.

Although the method steps described herein are described sequentially in accordance with certain embodiments, a person of ordinary skill in the art will recognize many variations based on the teaching described herein. The steps may be completed in a different order. Steps may be added or deleted. Some of the steps may comprise sub-steps. Many of the steps may be repeated as often as necessary ensure correct placement of the delivery device and deployment of the valve prosthesis components.

Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.