Delivery systems for delivering prosthetic heart valve devices and associated methods

Systems for delivering prosthetic heart valve devices can include, for example, an elongated catheter body, a deliver capsule carried by the catheter body, and an expandable atraumatic member. The delivery capsule includes a platform and a housing having an outer wall and a proximal rim, and the platform is configured to be releasably coupled to a prosthetic heart valve device. The housing is configured to slide along the platform from a containment configuration to a deployment configuration. The expandable atraumatic member has an atraumatic surface and a peripheral portion. The atraumatic member has a compacted configuration and an expanded configuration in which the peripheral portion extends laterally outward over the proximal rim of the housing to protect tissue of the heart and the vasculature from potentially being damaged by the proximal rim of the housing as the delivery system is withdrawn in a proximal direction through the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

TECHNICAL FIELD

The present technology relates generally to systems for delivering prosthetic heart valve devices. In particular, several embodiments of the present technology are related to hydraulic systems for percutaneously delivering prosthetic heart valve devices into mitral valves and associated methods.

BACKGROUND

Heart valves can be affected by several conditions. For example, mitral valves can be affected by mitral valve regurgitation, mitral valve prolapse and mitral valve stenosis. Mitral valve regurgitation is abnormal leaking of blood from the left ventricle into the left atrium caused by a disorder of the heart in which the leaflets of the mitral valve fail to coapt into apposition at peak contraction pressures. The mitral valve leaflets may not coapt sufficiently because heart diseases often cause dilation of the heart muscle, which in turn enlarges the native mitral valve annulus to the extent that the leaflets do not coapt during systole. Abnormal backflow can also occur when the papillary muscles are functionally compromised due to ischemia or other conditions. More specifically, as the left ventricle contracts during systole, the affected papillary muscles do not contract sufficiently to effect proper closure of the leaflets.

Mitral valve prolapse is a condition when the mitral leaflets bulge abnormally up in to the left atrium. This can cause irregular behavior of the mitral valve and lead to mitral valve regurgitation. The leaflets may prolapse and fail to coapt because the tendons connecting the papillary muscles to the inferior side of the mitral valve leaflets (chordae tendineae) may tear or stretch. Mitral valve stenosis is a narrowing of the mitral valve orifice that impedes filling of the left ventricle in diastole.

Mitral valve regurgitation is often treated using diuretics and/or vasodilators to reduce the amount of blood flowing back into the left atrium. Surgical approaches (open and intravascular) for either the repair or replacement of the valve have also been used to treat mitral valve regurgitation. For example, typical repair techniques involve cinching or resecting portions of the dilated annulus. Cinching, for example, includes implanting annular or peri-annular rings that are generally secured to the annulus or surrounding tissue. Other repair procedures suture or clip the valve leaflets into partial apposition with one another.

Alternatively, more invasive procedures replace the entire valve itself by implanting mechanical valves or biological tissue into the heart in place of the native mitral valve. These invasive procedures conventionally require large open thoracotomies and are thus very painful, have significant morbidity, and require long recovery periods. Moreover, with many repair and replacement procedures, the durability of the devices or improper sizing of annuloplasty rings or replacement valves may cause additional problems for the patient. Repair procedures also require a highly skilled cardiac surgeon because poorly or inaccurately placed sutures may affect the success of procedures.

Less invasive approaches to aortic valve replacement have been implemented in recent years. Examples of pre-assembled, percutaneous prosthetic valves include, e.g., the CoreValve Revalving® System from Medtronic/Corevalve Inc. (Irvine, Calif., USA) and the EdwardsSapien® Valve from Edwards Lifesciences (Irvine, Calif., USA). Both valve systems include an expandable frame and a tri-leaflet bioprosthetic valve attached to the expandable frame. The aortic valve is substantially symmetric, circular, and has a muscular annulus. The expandable frames in aortic applications have a symmetric, circular shape at the aortic valve annulus to match the native anatomy, but also because tri-leaflet prosthetic valves require circular symmetry for proper coaptation of the prosthetic leaflets. Thus, aortic valve anatomy lends itself to an expandable frame housing a replacement valve since the aortic valve anatomy is substantially uniform, symmetric, and fairly muscular. Other heart valve anatomies, however, are not uniform, symmetric or sufficiently muscular, and thus transvascular aortic valve replacement devises may not be well suited for other types of heart valves.

DETAILED DESCRIPTION

The present technology is generally directed to hydraulic systems for delivering prosthetic heart valve devices and associated methods. Specific details of several embodiments of the present technology are described herein with reference toFIGS. 1-25. Although many of the embodiments are described with respect to devices, systems, and methods for delivering prosthetic heart valve devices to a native mitral valve, other applications and other embodiments in addition to those described herein are within the scope of the present technology. For example, at least some embodiments of the present technology may be useful for delivering prosthetics to other valves, such as the tricuspid valve or the aortic valve. It should be noted that other embodiments in addition to those disclosed herein are within the scope of the present technology. Further, embodiments of the present technology can have different configurations, components, and/or procedures than those shown or described herein. Moreover, a person of ordinary skill in the art will understand that embodiments of the present technology can have configurations, components, and/or procedures in addition to those shown or described herein, and that these and many embodiments can be without several of the configurations, components, and/or procedures shown or described herein without deviating from the present technology.

With regard to the terms “distal” and “proximal” within this description, unless otherwise specified, the terms can reference relative positions of portions of a prosthetic valve device and/or an associated delivery device with reference to an operator and/or a location in the vasculature or heart. For example, in referring to a delivery catheter suitable to deliver and position various prosthetic valve devices described herein, “proximal” can refer to a position closer to the operator of the device or an incision into the vasculature, and “distal” can refer to a position that is more distant from the operator of the device or further from the incision along the vasculature (e.g., the end of the catheter). With respect to a prosthetic heart valve device, the terms “proximal” and “distal” can refer to the location of portions of the device with respect to the direction of blood flow. For example, proximal can refer to an upstream position or a location where blood flows into the device (e.g., inflow region), and distal can refer to a downstream position or a location where blood flows out of the device (e.g., outflow region).

Overview

Several embodiments of the present technology are directed to delivery systems and mitral valve replacement devices that address the unique challenges of percutaneously replacing native mitral valves. The delivery systems and implantable devices are well-suited to be recaptured in a percutaneous delivery device after being partially deployed for repositioning or removing the device. The delivery systems are also well-suited for deploying self-expanding prosthetic heart valve replacement devices and withdrawing the delivery systems from the patient. Compared to replacing aortic valves, percutaneous mitral valve replacement faces unique anatomical obstacles that render percutaneous mitral valve replacement significantly more challenging than aortic valve replacement. First, unlike relatively symmetric and uniform aortic valves, the mitral valve annulus has a non-circular D-shape or kidney-like shape, with a non-planar, saddle-like geometry often lacking symmetry. The complex and highly variable anatomy of mitral valves makes it difficult to design a mitral valve prosthesis that conforms well to the native mitral annulus of specific patients. As a result, the prosthesis may not fit well with the native leaflets and/or annulus, which can leave gaps that allows backflow of blood to occur. For example, placement of a cylindrical valve prosthesis in a native mitral valve may leave gaps in commissural regions of the native valve through which perivalvular leaks may occur.

Current prosthetic valves developed for percutaneous aortic valve replacement are unsuitable for use in mitral valves. First, many of these devices require a direct, structural connection between the stent-like structure that contacts the annulus and/or leaflets and the prosthetic valve. In several devices, the stent posts which support the prosthetic valve also contact the annulus or other surrounding tissue. These types of devices directly transfer the forces exerted by the tissue and blood as the heart contracts to the valve support and the prosthetic leaflets, which in turn distorts the valve support from its desired cylindrical shape. This is a concern because most cardiac replacement devices use tri-leaflet valves, which require a substantially symmetric, cylindrical support around the prosthetic valve for proper opening and closing of the three leaflets over years of life. As a result, when these devices are subject to movement and forces from the annulus and other surrounding tissues, the prostheses may be compressed and/or distorted causing the prosthetic leaflets to malfunction. Moreover, a diseased mitral annulus is much larger than any available prosthetic aortic valve. As the size of the valve increases, the forces on the valve leaflets increase dramatically, so simply increasing the size of an aortic prosthesis to the size of a dilated mitral valve annulus would require dramatically thicker, taller leaflets, and might not be feasible.

In addition to its irregular, complex shape, which changes size over the course of each heartbeat, the mitral valve annulus lacks a significant amount of radial support from surrounding tissue. Compared to aortic valves, which are completely surrounded by fibro-elastic tissue that provides sufficient support for anchoring a prosthetic valve, mitral valves are bound by muscular tissue on the outer wall only. The inner wall of the mitral valve anatomy is bound by a thin vessel wall separating the mitral valve annulus from the inferior portion of the aortic outflow tract. As a result, significant radial forces on the mitral annulus, such as those imparted by an expanding stent prostheses, could lead to collapse of the inferior portion of the aortic tract. Moreover, larger prostheses exert more force and expand to larger dimensions, which exacerbates this problem for mitral valve replacement applications.

The chordae tendineae of the left ventricle may also present an obstacle in deploying a mitral valve prosthesis. Unlike aortic valves, mitral valves have a maze of cordage under the leaflets in the left ventricle that restrict the movement and position of a deployment catheter and the replacement device during implantation. As a result, deploying, positioning and anchoring a valve replacement device on the ventricular side of the native mitral valve annulus is complicated.

The present technology provides systems, methods and apparatus to treat heart valves of the body, such as the mitral valve, that address the challenges associated with the anatomy of the mitral valve. The present technology provides for repositioning and/or removal of a partially deployed device, and/or for atraumatic removal of the delivery system from the patient. The apparatus and methods enable a percutaneous approach using a catheter delivered intravascularly through a vein or artery into the heart, or through a cannula inserted through the heart wall. For example, the apparatus and methods are particularly well-suited for trans-septal and trans-apical approaches, but can also be trans-atrial and direct aortic delivery of a prosthetic replacement valve to a target location in the heart. Additionally, several embodiments of the devices and methods as described herein can be combined with many known surgeries and procedures, such as known methods of accessing the valves of the heart (e.g., the mitral valve or triscuspid valve) with antegrade or retrograde approaches, and combinations thereof.

The systems and methods described herein facilitate controlled delivery of a prosthetic heart valve device using trans-apical or trans-septal delivery approaches, allow resheathing of the prosthetic heart valve device after partial deployment of the device to reposition and/or remove the device, and/or provide for atraumatic removal of the delivery systems from the patient. Systems in accordance with several embodiments of the present technology comprise an elongated catheter body, a delivery capsule carried by the catheter body, and an expandable atraumatic member. The delivery capsule includes a platform and a housing having a sidewall and a proximal rim, and the capsule is configured to releasably contain a prosthetic heart valve device. The housing is configured to slide along the platform from a containment configuration to a deployment configuration. The expandable atraumatic member is carried by the capsule (e.g., in the capsule), and the atraumatic member has an opening through which a portion of a support member extends, an atraumatic surface, and a peripheral portion. In some embodiments, the atraumatic member has (a) a compacted configuration in which the atraumatic member is configured to be located within at least a portion of an implantable device while constrained with the capsule, and (b) an expanded configuration in which the peripheral portion extends laterally outward beyond the proximal rim of the housing (e.g., radially outward of the diameter of the proximal rim). In the expanded configuration, the implantable device is spaced apart from the atraumatic member, and the atraumatic member is configured to protect tissue of the heart and the vasculature from potentially being damaged by the proximal rim of the housing as the delivery system is withdrawn in a proximal direction through the patient. Additionally, the atraumatic member can expand outwardly against the implantable device during deployment to assist in disengaging the implantable device from the capsule.

Access to the Mitral Valve

To better understand the structure and operation of valve replacement devices in accordance with the present technology, it is helpful to first understand approaches for implanting the devices. The mitral valve or other type of atrioventricular valve can be accessed through the patient's vasculature in a percutaneous manner. By percutaneous it is meant that a location of the vasculature remote from the heart is accessed through the skin, typically using a surgical cut down procedure or a minimally invasive procedure, such as using needle access through, for example, the Seldinger technique. The ability to percutaneously access the remote vasculature is well known and described in the patent and medical literature. Depending on the point of vascular access, access to the mitral valve may be antegrade and may rely on entry into the left atrium by crossing the inter-atrial septum (e.g., a trans-septal approach). Alternatively, access to the mitral valve can be retrograde where the left ventricle is entered through the aortic valve. Access to the mitral valve may also be achieved using a cannula via a trans-apical approach. Depending on the approach, the interventional tools and supporting catheter(s) may be advanced to the heart intravascularly and positioned adjacent the target cardiac valve in a variety of manners, as described herein.

FIG. 1illustrates a stage of a trans-septal approach for implanting a valve replacement device. In a trans-septal approach, access is via the inferior vena cava IVC or superior vena cava SVC, through the right atrium RA, across the inter-atrial septum IAS, and into the left atrium LA above the mitral valve MV. As shown inFIG. 1, a catheter1having a needle2moves from the inferior vena cava IVC into the right atrium RA. Once the catheter1reaches the anterior side of the inter-atrial septum IAS, the needle2advances so that it penetrates through the septum, for example at the fossa ovalis FO or the foramen ovale into the left atrium LA. At this point, a guidewire replaces the needle2and the catheter1is withdrawn.

FIG. 2illustrates a subsequent stage of a trans-septal approach in which guidewire6and guide catheter4pass through the inter-atrial septum IAS. The guide catheter4provides access to the mitral valve for implanting a valve replacement device in accordance with the technology.

In an alternative antegrade approach (not shown), surgical access may be obtained through an intercostal incision, preferably without removing ribs, and a small puncture or incision may be made in the left atrial wall. A guide catheter passes through this puncture or incision directly into the left atrium, sealed by a purse string-suture.

The antegrade or trans-septal approach to the mitral valve, as described above, can be advantageous in many respects. For example, antegrade approaches will usually enable more precise and effective centering and stabilization of the guide catheter and/or prosthetic valve device. The antegrade approach may also reduce the risk of damaging the chordae tendineae or other subvalvular structures with a catheter or other interventional tool. Additionally, the antegrade approach may decrease risks associated with crossing the aortic valve as in retrograde approaches. This can be particularly relevant to patients with prosthetic aortic valves, which cannot be crossed at all or without substantial risk of damage.

FIGS. 3 and 4show examples of a retrograde approaches to access the mitral valve. Access to the mitral valve MV may be achieved from the aortic arch AA, across the aortic valve AV, and into the left ventricle LV below the mitral valve MV. The aortic arch AA may be accessed through a conventional femoral artery access route or through more direct approaches via the brachial artery, axillary artery, radial artery, or carotid artery. Such access may be achieved with the use of a guidewire6. Once in place, a guide catheter4may be tracked over the guidewire6. Alternatively, a surgical approach may be taken through an incision in the chest, preferably intercostally without removing ribs, and placing a guide catheter through a puncture in the aorta itself. The guide catheter4affords subsequent access to permit placement of the prosthetic valve device, as described in more detail herein. Retrograde approaches advantageously do not need a trans-septal puncture. Cardiologists also more commonly use retrograde approaches, and thus retrograde approaches are more familiar.

FIG. 5shows a trans-apical approach via a trans-apical puncture. In this approach, access to the heart is via a thoracic incision, which can be a conventional open thoracotomy or sternotomy, or a smaller intercostal or sub-xyphoid incision or puncture. An access cannula is then placed through a puncture in the wall of the left ventricle at or near the apex of the heart. The catheters and prosthetic devices of the invention may then be introduced into the left ventricle through this access cannula. The trans-apical approach provides a shorter, straighter, and more direct path to the mitral or aortic valve. Further, because it does not involve intravascular access, the trans-apical approach does not require training in interventional cardiology to perform the catheterizations required in other percutaneous approaches.

Selected Embodiments of Delivery Systems for Prosthetic Heart Valve Devices

FIG. 6is an isometric view of a hydraulic system100(“system100”) for delivering a prosthetic heart valve device configured in accordance with at least some embodiments of the present technology. The system100includes a catheter102having an elongated catheter body108(“catheter body108”) and a delivery capsule106. The catheter body108can include a proximal portion108acoupled to a hand held control unit104(“control unit104”) and a distal portion108bcarrying the delivery capsule106. The delivery capsule106can be configured to contain a prosthetic heart valve device110(shown schematically in broken lines). The control unit104can provide steering capability (e.g., 360 degree rotation of the delivery capsule106, 180 degree rotation of the delivery capsule106, 3-axis steering, 2-axis steering, etc.) used to deliver the delivery capsule106to a target site (e.g., to a native mitral valve) and deploy the prosthetic heart valve device110at the target site. The catheter102can be configured to travel over a guidewire120, which can be used to guide the delivery capsule106into the native heart valve. The system100can also include a fluid assembly112configured to supply fluid to and receive fluid from the catheter102for hydraulically moving the delivery capsule106to deploy the prosthetic heart valve device110.

The fluid assembly112includes a fluid source114and a fluid line116fluidically coupling the fluid source114to the catheter102. The fluid source114may contain a flowable substance (e.g., water, saline, etc.) in one or more reservoirs. The fluid line116can include one or more hoses, tubes, or other components (e.g., connectors, valves, etc.) through which the flowable substance can pass from the fluid source114to the catheter102and/or through which the flowable substance can drain from the catheter102to the fluid source114. In other embodiments, the fluid line116can deliver the flowable substance to the catheter102from a first reservoir of the fluid source114and drain the flowable substance from the catheter102to a separate reservoir. The fluid assembly112can also include one or more pressurization devices (e.g., a pump), fluid connectors, fittings, valves, and/or other fluidic components that facilitate moving the fluid to and/or from the fluid source114. As explained in further detail below, the movement of the flowable substance to and from the fluid assembly112can be used to deploy the prosthetic heart valve device110from the delivery capsule106and/or resheathe the prosthetic heart valve device110after at least partial deployment.

In certain embodiments, the fluid assembly112may comprise a controller118that controls the movement of fluid to and from the catheter102. The controller118can include, without limitation, one or more computers, central processing units, processing devices, microprocessors, digital signal processors (DSPs), and/or application-specific integrated circuits (ASICs). To store information, for example, the controller118can include one or more storage elements, such as volatile memory, non-volatile memory, read-only memory (ROM), and/or random access memory (RAM). The stored information can include, pumping programs, patient information, and/or other executable programs. The controller118can further include a manual input device (e.g., a keyboard, a touch screen, etc.) and/or an automated input device (e.g., a computer, a data storage device, servers, network, etc.). In still other embodiments, the controller118may include different features and/or have a different arrangement for controlling the flow of fluid into and out of the fluid source114.

The control unit104can include a control assembly122and a steering mechanism124. For example, the control assembly122can include rotational elements, such as a knob, that can be rotated to rotate the delivery capsule106about its longitudinal axis107. The control assembly122can also include features that allow a clinician to control the hydraulic deployment mechanisms of the delivery capsule106and/or the fluid assembly112. For example, the control assembly122can include buttons, levers, and/or other actuators that initiate unsheathing and/or resheathing the prosthetic heart valve device110. The steering mechanism124can be used to steer the catheter102through the anatomy by bending the distal portion108bof the catheter body108about a transverse axis. In other embodiments, the control unit104may include additional and/or different features that facilitate delivering the prosthetic heart valve device110to the target site.

The delivery capsule106includes a housing126configured to carry the prosthetic heart valve device110in the containment configuration and, optionally, an end cap128. The end cap128can have an opening130at its distal end through which the guidewire120can be threaded to allow for guidewire delivery to the target site. As shown inFIG. 6, the end cap128can also have an atraumatic shape (e.g., a partially spherical shape, a frusto-conical shape, blunt configuration, rounded configuration, etc.) to facilitate atraumatic delivery of the delivery capsule106to the target site. In certain embodiments, the end cap128can also house a portion of the prosthetic heart valve device110. The housing126and/or the end cap128can be made of metal, polymers, plastic, composites, combinations thereof, or other materials capable of holding the prosthetic heart valve device110. The delivery capsule106is hydraulically driven via the control unit104and/or the fluid assembly112between a containment configuration for holding the prosthetic heart valve device110and a deployment configuration for at least partially deploying the prosthetic heart valve device110at the target site. The delivery capsule106also allows for resheathing of the prosthetic heart valve device110after it has been partially deployed.

FIG. 7Ais a cross-sectional view of at least some embodiments of the capsule106in a containment configuration, andFIG. 7Bis a cross-sectional view of the capsule106in a deployment configuration. The capsule106can be actuated hydraulically and capable of resheathing the device110to either reposition or remove the device110from a patient after being partially deployed. In several embodiments, the capsule106includes a support710within the housing126. The support710can have a central member711, a platform712extending radially outward from a medial portion of the central member711, and an end plate714extending radially outward from an end portion of the central member711. The central member711can be an extension of the catheter102or a separate component attached to the distal end108bof the catheter body108. The platform712and the end plate714can be shoulders or flanges having a disk-like shape or other suitable shapes. The support710can further include a first orifice721, a first fluid line723coupled to the first orifice721, a second orifice722, and a second fluid line724coupled to the second orifice722.

The housing126of the capsule106in this embodiment includes a side wall730having a proximal rim732and a distal terminus734. The sidewall730is size to be slightly larger than the outer perimeter of the platform712and the end plate714such that seals750(e.g., O-rings) can fluidically seal against the inner surface of the sidewall730. The housing126can further include a flange740extending radially inwardly from the sidewall730, and the flange740can have an opening742through which the central member711of the support710passes. The flange740is configured to carry a seal752(e.g., an O-ring) that seals against the central member711of the support710. The capsule106of this embodiment is configured to have a first fluid chamber761between the platform712and the flange740, and a second fluid chamber762between the flange740and the end plate714. The first fluid chamber761is open to the first orifice721, and a second fluid chamber762is open to the second orifice722. The upper portion of the sidewall730shown inFIG. 7Adefines a chamber770in the containment configuration in which the prosthetic heart valve device110(shown schematically as an annular box) is retained during delivery to a target site.

In operation, the housing126of the capsule106moves between the containment and deployment configurations by delivering or draining a flowable substance (e.g., water, saline, etc.) to or from the first and second fluid chambers761and762via the first and second orifices721and722, respectively. For example, the housing126moves from the containment configuration (FIG. 7A) to the deployment configuration (FIG. 7B) by delivering the flowable substance to the first fluid chamber761via the first orifice721while draining the flowable substance from the second fluid chamber762via the second orifice722. Conversely, the housing moves from the deployment configuration (FIG. 7B) to the containment configuration (FIG. 7A) by delivering the flowable substance to the second fluid chamber762via the second orifice722while draining the flowable substance from the first fluid chamber761via the first orifice721.

The system100can further include an expandable atraumatic member780(“atraumatic member780”) carried by the capsule106. As best shown inFIG. 7B, the atraumatic member780can include an atraumatic surface782and a peripheral portion784. The atraumatic member780is configured to be retained within the capsule106in the containment configuration (FIG. 7A) and expand radially outward in the deployment configuration (FIG. 7B) such that at least a peripheral portion of the atraumatic member780extends over at least a portion of the proximal rim732of the capsule106(e.g., radially beyond the diameter of the proximal rim732). Referring toFIG. 7A, at least some embodiments of the atraumatic member780can be compacted and positioned between a distal portion of the device110and the central member711of the support710such that the atraumatic member780can, if necessary, drive the distal portion of the device110outward to disengage the device110from the platform712. In many embodiments, the atraumatic member780does not need be positioned between the device110and the central member711of the support710, but rather the atraumatic member780can be located distal of the distal-most portion of the device110.

In the deployment configuration shown inFIG. 7B, the proximal rim732of the housing126is positioned distally beyond the distal-most portions of the device110and the atraumatic member780. The device110accordingly expands radially outward beyond the housing126, and the atraumatic member780expands such that at least the peripheral portion784of the atraumatic member780is laterally (e.g., radially) outward with respect to the proximal rim732of the housing126. For example, the atraumatic member780covers the proximal rim732in a proximal direction. The atraumatic member780accordingly protects tissue of the heart and vasculature as the catheter102is withdrawn proximally to remove the delivery device after deploying the device110.

Several embodiments of the atraumatic member780are shown inFIGS. 8A-11.FIG. 8Ais an isometric view an expandable atraumatic member800(“atraumatic member800”) comprising a truncated conical member having a proximal surface810, a distal surface820, an atraumatic surface822between the proximal surface810and the distal surface820, and a peripheral region830. At least a portion of the atraumatic surface822can slope outwardly in the distal direction. The atraumatic surface822, for example, inclines (e.g., flares) outwardly with increasing distance distally. As a result, the atraumatic surface800directs the capsule106through openings and the lumens of the vasculature as the catheter102(FIG. 1) is withdrawn from the patient. The peripheral portion830of the atraumatic member800is configured to cover the proximal rim732of the housing126(FIG. 7B) and thereby prevent the proximal rim732from damaging the tissue as the catheter102is withdrawn. The atraumatic member800further includes an opening840configured to receive the central member711of the support710.

The atraumatic member800can be a polymeric material, a braided material, or a structure formed from individual struts. In the case of a polymeric material, the atraumatic member800can be a porous material, such as an open cell foam or closed cell foam. Other polymeric materials that expand when unconstrained, such as Silicone, can also be used. The atraumatic member800can alternatively be a cage other structure formed from struts or a braid of shape-memory wires or other types of wires that have a truncated conical shape in a fully-expanded unbiased state. The wires of the braid can comprises one or more of nitinol, stainless steel, drawn filled tubes (e.g., nitinol and platinum), and cobalt-chromium alloy.

FIG. 8Bis a side cross-sectional view of some embodiments of the atraumatic member800that further include a hub850and a disc860extending distally and radialy outward from the hub850in an unconstrained state. The atraumatic member800shown inFIG. 8Bcan be made from Silicone or some other suitable polymeric material, and the hub850and the disc860can be formed integrally with each other. For example, the hub850and the disc860can be molded or three-dimensionally printed from Silicone or another suitable material. The opening840can extend through the hub850. The disc860can flex inwardly at the hub850to be loaded into a delivery capsule and then self-expand radially outwardly with respect to the hub when unconstrained (i.e., released from the delivery capsule). The atraumatic member800shown inFIG. 8Bcan further include supports862(e.g., arms) on the inner surface of the disc860. The supports862can be formed integrally with the disc860, such as by molding or three-dimensional printing, or the supports862can be separate components (e.g., metal rods) attached to or molded within the disc860.

FIGS. 9A and 9Bare side views of some embodiments of the atraumatic member800and the housing126of the capsule106when the housing126is in different positions.FIG. 9A, more specifically, shows the atraumatic member800when the housing126is in the fully extended position ofFIG. 7Bafter the implantable device and the atraumatic member800have fully expanded. At this stage, the peripheral portion830of the atraumatic member800extends outwardly beyond the radius of the proximal rim732of the housing126.FIG. 9Bshows the system after the housing126has been retracted to its original position shown inFIG. 7Acausing the atraumatic member800to slide proximally along the central member711(FIG. 9A) of the support. At this stage, the peripheral portion830of the atraumatic member800remains over the proximal rim732of the housing126to protect tissue of the heart and vasculature of the patient as the delivery system is withdrawn.

FIG. 10Ais a side view illustrating an atraumatic member900ain accordance with several embodiments of the present technology. The atraumatic member900ahas hub910with a proximal surface911, an opening912to receive the central member711of the support710, and a distal end913. The hub910can be a short tubular member. The atraumatic member900afurther includes a plurality of arms930extending distally from the distal end913of the hub910.FIG. 10Ashows the atraumatic member900ain an expanded state in which the arms930flare radially outwardly in the distal direction. In this embodiment, the arms930have a semi-hyperboloid shape. The arms930have outer surfaces932that together define the atraumatic surface of the atraumatic member900a.

FIG. 10Bis a side view andFIG. 10Cis a top view illustrating an atraumatic member900bin accordance with several embodiments of the present technology. The atraumatic member900bis formed from a cut hypo-tube having a plurality of first sections920held together by a casing922to form a proximal hub924(FIG. 10B) and a plurality of second sections926that extends distally from the proximal hub924to define a plurality of arms930(FIG. 10B). The first sections926can be arranged to form an opening940(FIG. 10C) configured to receive the central member711(FIG. 7A) of the support710(FIG. 7A). As with the atraumatic member900ashown inFIG. 10A, the arms930of the atraumatic member900bflare radially outwardly in the distal direction when the atraumatic member900bis in the expanded state. Both of the atraumatic members900aand900bcan be formed from a shape memory material, such as nitinol, or other materials (e.g., stainless steel or polymeric materials). Additionally, the arms930of both of the atraumatic members900aand900bhave outer surfaces932that together define an atraumatic surface.

FIG. 11is a side view illustrating the atraumatic members900aor900bmounted to the central member711in an expanded state in which the arms930extend radially outwardly such that the distal peripheral portions of the arms930are radially outward of the proximal rim732of the housing126. The distal portions of the arms930accordingly define a peripheral portion of the atraumatic members900aor900bthat extend laterally (e.g., radially) outward of the proximal rim732to cover the proximal rim732of the housing126in the proximally facing direction. In operation, the arms930of either of the atraumatic members900aand900bsufficiently cover the proximal rim732of the housing126in the proximally facing direction to protect the tissue of the heart and/or the vasculature of the patient as the catheter102is withdrawn. Additionally, the radial expansion of the arms930can assist in disengaging an implantable device from the capsule by pushing radially outward against a distal portion of the implantable device.

Additional embodiments of the atraumatic members900aand900bcan optionally include a covering950(FIG. 11) over the arms930. For example, a fabric covering made from Dacron®, a braided wire mesh, or another suitable material can be placed over the outer surface of the arms930and/or line the inner surface of the arms930to further enhance the protective nature of the arms930. In alternative embodiments, instead of separate arms930, the atraumatic members900aand900bcan have a fluted skirt made from a fabric, braided mesh of metal wires, or a thin sheet of metal that self-expands radially outwardly when not constricted by the housing126of the capsule106.

In addition to protecting heart and vasculature tissue, atraumatic members of the present technology enable the housing126to have an open proximal end. Referring toFIG. 7A, for example, the capsule106does not need a proximal cap that seals to or otherwise covers the proximal rim732in the containment configuration. This reduces the length of the capsule106, which is desirable to enable the capsule106to pass through turns and corners of the vasculature.

Selected Embodiments of Prosthetic Heart Valve Devices

The delivery systems with atraumatic member described above with reference toFIGS. 6-11can be configured to deliver various prosthetic heart valve devices, such as prosthetic valve devices for replacement of the mitral valve and/or other valves (e.g., a bicuspid or tricuspid valve) in the heart of the patient. Examples of these prosthetic heart valve devices, system components, and associated methods are described in this section with reference toFIGS. 12A-25. Specific elements, substructures, advantages, uses, and/or other features of the embodiments described with reference toFIGS. 12A-25can be suitably interchanged, substituted or otherwise configured with one another. Furthermore, suitable elements of the embodiments described with reference toFIGS. 12A-25can be used as stand-alone and/or self-contained devices.

FIG. 12Ais a side cross-sectional view andFIG. 12Bis a top plan view of a prosthetic heart valve device (“device”)1100in accordance with an embodiment of the present technology. The device1100includes a valve support1110, an anchoring member1120attached to the valve support1110, and a prosthetic valve assembly1150within the valve support1110. Referring toFIG. 12A, the valve support1110has an inflow region1112and an outflow region1114. The prosthetic valve assembly1150is arranged within the valve support1110to allow blood to flow from the inflow region1112through the outflow region1114(arrows BF), but prevent blood from flowing in a direction from the outflow region1114through the inflow region1112.

In the embodiment shown inFIG. 12A, the anchoring member1120includes a base1122attached to the outflow region1114of the valve support1110and a plurality of arms1124projecting laterally outward from the base1122. The anchoring member1120also includes a fixation structure1130extending from the arms1124. The fixation structure1130can include a first portion1132and a second portion1134. The first portion1132of the fixation structure1130, for example, can be an upstream region of the fixation structure1130that, in a deployed configuration as shown inFIG. 12A, is spaced laterally outward apart from the inflow region1112of the valve support1110by a gap G. The second portion1134of the fixation structure1130can be a downstream-most portion of the fixation structure1130. The fixation structure1130can be a cylindrical ring (e.g., straight cylinder or conical), and the outer surface of the fixation structure1130can define an annular engagement surface configured to press outwardly against a native annulus of a heart valve (e.g., a mitral valve). The fixation structure1130can further include a plurality of fixation elements1136that project radially outward and are inclined toward an upstream direction. The fixation elements1136, for example, can be barbs, hooks, or other elements that are inclined only in the upstream direction (e.g., a direction extending away from the downstream portion of the device1100).

Referring still toFIG. 12A, the anchoring member1120has a smooth bend1140between the arms1124and the fixation structure1130. For example, the second portion1134of the fixation structure1130extends from the arms1124at the smooth bend1140. The arms1124and the fixation structure1130can be formed integrally from a continuous strut or support element such that the smooth bend1140is a bent portion of the continuous strut. In other embodiments, the smooth bend1140can be a separate component with respect to either the arms1124or the fixation structure1130. For example, the smooth bend1140can be attached to the arms1124and/or the fixation structure1130using a weld, adhesive or other technique that forms a smooth connection. The smooth bend1140is configured such that the device1100can be recaptured in a capsule or other container after the device1100has been at least partially deployed.

The device1100can further include a first sealing member1162on the valve support1110and a second sealing member1164on the anchoring member1120. The first and second sealing members1162,1164can be made from a flexible material, such as Dacron® or another type of polymeric material. The first sealing member1162can cover the interior and/or exterior surfaces of the valve support1110. In the embodiment illustrated inFIG. 12A, the first sealing member1162is attached to the interior surface of the valve support1110, and the prosthetic valve assembly1150is attached to the first sealing member1162and commissure portions of the valve support1110. The second sealing member1164is attached to the inner surface of the anchoring member1120. As a result, the outer annular engagement surface of the fixation structure1130is not covered by the second sealing member1164so that the outer annular engagement surface of the fixation structure1130directly contacts the tissue of the native annulus.

The device1100can further include an extension member1170. The extension member1170can be an extension of the second sealing member1164, or it can be a separate component attached to the second sealing member1164and/or the first portion1132of the fixation structure1130. The extension member1170can be a flexible member that, in a deployed state (FIG. 12A), flexes relative to the first portion1132of the fixation structure1130. In operation, the extension member1170provides tactile feedback or a visual indicator (e.g., on echocardiographic or fluoroscopic imaging systems) to guide the device1100during implantation such that the device1100is located at a desired elevation and centered relative to the native annulus. As described below, the extension member1170can include a support member, such as a metal wire or other structure, that can be visualized via fluoroscopy or other imaging techniques during implantation. For example, the support member can be a radiopaque wire.

FIGS. 13A and 13Bare cross-sectional views illustrating an example of the operation of the smooth bend1140between the arms1124and the fixation structure1130in the recapturing of the device1100after partial deployment.FIG. 13Aschematically shows the device1100loaded into a capsule1700of a delivery system in a delivery state, andFIG. 13Bschematically shows the device1100in a partially deployed state. Referring toFIG. 13A, the capsule1700has a housing1702, a pedestal or support1704, and a top1706. In the delivery state shown inFIG. 13A, the device1100is in a low-profile configuration suitable for delivery through a catheter or cannula to a target implant site at a native heart valve.

Referring toFIG. 13B, the housing1702of the capsule1700has been moved distally such that the extension member1170, fixation structure1130and a portion of the arms1124have been released from the housing1702in a partially deployed state. This is useful for locating the fixation structure1130at the proper elevation relative to the native valve annulus A such that the fixation structure1130expands radially outward into contact the inner surface of the native annulus A. However, the device1100may need to be repositioned and/or removed from the patient after being partially deployed. To do this, the housing1702is retracted (arrow R) back toward the fixation structure1130. As the housing1702slides along the arms1124, the smooth bend1140between the arms1124and the fixation structure1130allows the edge1708of the housing1702to slide over the smooth bend1140and thereby recapture the fixation structure1130and the extension member1170within the housing1702. The device1100can then be removed from the patient or repositioned for redeployment at a better location relative to the native annulus A. Further aspects of prosthetic heart valve devices in accordance with the present technology and their interaction with corresponding delivery devices are described below with reference toFIGS. 14-25.

FIG. 14is a top isometric view of an example of the device1100. In this embodiment, the valve support1110defines a first frame (e.g., an inner frame) and fixation structure1130of the anchoring member1120defines a second frame (e.g., an outer frame) that each include a plurality of structural elements. The fixation structure1130, more specifically, includes structural elements1137arranged in diamond-shaped cells1138that together form at least a substantially cylindrical ring when freely and fully expanded as shown inFIG. 14. The structural elements1137can be struts or other structural features formed from metal, polymers, or other suitable materials that can self-expand or be expanded by a balloon or other type of mechanical expander.

In several embodiments, the fixation structure1130can be a generally cylindrical fixation ring having an outwardly facing engagement surface. For example, in the embodiment shown inFIG. 14, the outer surfaces of the structural elements1137define an annular engagement surface configured to press outwardly against the native annulus in the deployed state. In a fully expanded state without any restrictions, the walls of the fixation structure1130are at least substantially parallel to those of the valve support1110. However, the fixation structure1130can flex inwardly (arrow I) in the deployed state when it presses radially outwardly against the inner surface of the native annulus of a heart valve.

The embodiment of the device1100shown inFIG. 14includes the first sealing member1162lining the interior surface of the valve support1110, and the second sealing member1164along the inner surface of the fixation structure1130. The extension member1170has a flexible web1172(e.g., a fabric) and a support member1174(e.g., metal or polymeric strands) attached to the flexible web1172. The flexible web1172can extend from the second sealing member1164without a metal-to-metal connection between the fixation structure1130and the support member1174. For example, the extension member1170can be a continuation of the material of the second sealing member1164. Several embodiments of the extension member1170are thus a malleable or floppy structure that can readily flex with respect to the fixation structure1130. The support member1174can have a variety of configurations and be made from a variety of materials, such as a double-serpentine structure made from Nitinol.

FIG. 15is a side view andFIG. 16is a bottom isometric view of the device1100shown inFIG. 14. Referring toFIG. 15, the arms1124extend radially outward from the base portion1122at an angle α selected to position the fixation structure1130radially outward from the valve support1110(FIG. 14) by a desired distance in a deployed state. The angle α is also selected to allow the edge1708of the delivery system housing1702(FIG. 13B) to slide from the base portion1122toward the fixation structure1130during recapture. In many embodiments, the angle α is 15°-75°, or more specifically 15°-60°, or still more specifically 30°-45°. The arms1124and the structural elements1137of the fixation structure1130can be formed from the same struts (i.e., formed integrally with each other) such that the smooth bend1140is a continuous, smooth transition from the arms1124to the structural elements1137. This is expected to enable the edge1708of the housing1702to more readily slide over the smooth bend1140in a manner that allows the fixation structure1130to be recaptured in the housing1702of the capsule1700(FIG. 13B). Additionally, by integrally forming the arms1124and the structural elements1137with each other, it inhibits damage to the device1100at a junction between the arms1124and the structural elements1137compared to a configuration in which the arms1124and structural elements1137are separate components and welded or otherwise fastened to each other.

Referring toFIGS. 15 and 16, the arms1124are also separated from each other along their entire length from where they are connected to the base portion1122through the smooth bend1140(FIG. 15) to the structural elements1137of the fixation structure1130. The individual arms1124are thus able to readily flex as the edge1708of the housing1702(FIG. 13B) slides along the arms1124during recapture. This is expected to reduce the likelihood that the edge1708of the housing1702will catch on the arms1124and prevent the device1100from being recaptured in the housing1702.

In one embodiment, the arms1124have a first length from the base1122to the smooth bend1140, and the structural elements1137of the fixation structure1130at each side of a cell1138(FIG. 14) have a second length that is less than the first length of the arms1124. The fixation structure1130is accordingly less flexible than the arms1124. As a result, the fixation structure1130is able to press outwardly against the native annulus with sufficient force to secure the device1100to the native annulus, while the arms1124are sufficiently flexible to fold inwardly when the device is recaptured in a delivery device.

In the embodiment illustrated inFIGS. 14-16, the arms1124and the structural elements1137are configured such that each arm1124and the two structural elements1137extending from each arm1124formed a Y-shaped portion1142(FIG. 16) of the anchoring member1120. Additionally, the right-hand structural element1137of each Y-shaped portion1142is coupled directly to a left-hand structural element1137of an immediately adjacent Y-shaped portion1142. The Y-shaped portions1142and the smooth bends1140are expected to further enhance the ability to slide the housing1702along the arms1124and the fixation structure1130during recapture.

FIG. 17is a side view andFIG. 18is a bottom isometric view of a prosthetic heart valve device (“device”)1200in accordance with another embodiment of the present technology. The device1200is shown without the extension member1170(FIGS. 14-16), but the device1200can further include the extension member1170described above. The device1200further includes extended connectors1210projecting from the base1122of the anchoring member1120. Alternatively, the extended connectors1210can extend from the valve support1110(FIGS. 12A-16) in addition to or in lieu of extending from the base1122of the anchoring member1120. The extended connectors1210can include a first strut1212aattached to one portion of the base1122and a second strut1212battached to another portion of the base1122. The first and second struts1212a-bare configured to form a V-shaped structure in which they extend toward each other in a downstream direction and are connected to each other at the bottom of the V-shaped structure. The V-shaped structure of the first and second struts1212a-bcauses the extension connector1210to elongate when the device1200is in a low-profile configuration within the capsule1700(FIG. 13A) during delivery or partial deployment. When the device1200is fully released from the capsule1700(FIG. 13A) the extension connectors1210foreshorten to avoid interfering with blood flow along the left ventricular outflow tract.

The extended connectors1210further include an attachment element1214configured to releasably engage a delivery device. The attachment element1214can be a T-bar or other element that prevents the device1200from being released from the capsule1700(FIG. 13A) of a delivery device until desired. For example, a T-bar type attachment element1214can prevent the device1200from moving axially during deployment or partial deployment until the housing1702(FIG. 13A) moves beyond the portion of the delivery device engaged with the attachment elements1214. This causes the attachment elements1214to disengage from the capsule1700(FIG. 13A) as the outflow region of the valve support1110and the base1122of the anchoring member1120fully expand to allow for full deployment of the device1200.

FIG. 19is a side view andFIG. 20is a bottom isometric view of the device1200in a partially deployed state in which the device1200is still capable of being recaptured in the housing1702of the delivery device1700. Referring toFIG. 19, the device1200is partially deployed with the fixation structure1130substantially expanded but the attachment elements1214(FIG. 17) still retained within the capsule1700. This is useful for determining the accuracy of the position of the device1200and allowing blood to flow through the functioning replacement valve during implantation while retaining the ability to recapture the device1200in case it needs to be repositioned or removed from the patient. In this state of partial deployment, the elongated first and second struts1212a-bof the extended connectors1210space the base1122of the anchoring member1120and the outflow region of the valve support1110(FIG. 12A) apart from the edge1708of the capsule1700by a gap G.

Referring toFIG. 20, the gap G enables blood to flow through the prosthetic valve assembly1150while the device1200is only partially deployed. As a result, the device1200can be partially deployed to determine (a) whether the device1200is positioned correctly with respect to the native heart valve anatomy and (b) whether proper blood flow passes through the prosthetic valve assembly1150while the device1200is still retained by the delivery system1700. As such, the device1200can be recaptured if it is not in the desired location and/or if the prosthetic valve is not functioning properly. This additional functionality is expected to significantly enhance the ability to properly position the device1200and assess, in vivo, whether the device1200will operate as intended, while retaining the ability to reposition the device1200for redeployment or remove the device1200from the patient.

FIG. 21is an isometric view of a valve support1300in accordance with an embodiment of the present technology. The valve support1300can be an embodiment of the valve support1110described above with respect toFIGS. 12A-20. The valve support1300has an outflow region1302, an inflow region1304, a first row1310of first hexagonal cells1312at the outflow region1302, and a second row1320of second hexagonal cells1322at the inflow region1304. For purposes of illustration, the valve support shown inFIG. 21is inverted compared to the valve support1110shown inFIGS. 12A-20such that the blood flows through the valve support1300in the direction of arrow BF. In mitral valve applications, the valve support1300would be positioned within the anchoring member1120(FIG. 12A) such that the inflow region1304would correspond to orientation of the inflow region1112inFIG. 12Aand the outflow region1302would correspond to the orientation of the outflow region1114inFIG. 12A.

Each of the first hexagonal cells1312includes a pair of first longitudinal supports1314, a downstream apex1315, and an upstream apex1316. Each of the second hexagonal cells1322can include a pair of second longitudinal supports1324, a downstream apex1325, and an upstream apex1326. The first and second rows1310and1312of the first and second hexagonal cells1312and1322are directly adjacent to each other. In the illustrated embodiment, the first longitudinal supports1314extend directly from the downstream apexes1325of the second hexagonal cells1322, and the second longitudinal supports1324extend directly from the upstream apexes1316of the first hexagonal cells1312. As a result, the first hexagonal cells1312are offset from the second hexagonal cells1322around the circumference of the valve support1300by half of the cell width.

In the embodiment illustrated inFIG. 21, the valve support1300includes a plurality of first struts1331at the outflow region1302, a plurality of second struts1332at the inflow region1304, and a plurality of third struts1333between the first and second struts1331and1332. Each of the first struts1331extends from a downstream end of the first longitudinal supports1314, and pairs of the first struts1331are connected together to form first downstream V-struts defining the downstream apexes1315of the first hexagonal cells1312. In a related sense, each of the second struts1332extends from an upstream end of the second longitudinal supports1324, and pairs of the second struts1332are connected together to form second upstream V-struts defining the upstream apexes1326of the second hexagonal cells1322. Each of the third struts1333has a downstream end connected to an upstream end of the first longitudinal supports1314, and each of the third struts1333has an upstream end connected to a downstream end of one of the second longitudinal supports1324. The downstream ends of the third struts1333accordingly define a second downstream V-strut arrangement that forms the downstream apexes1325of the second hexagonal cells1322, and the upstream ends of the third struts1333define a first upstream V-strut arrangement that forms the upstream apexes1316of the first hexagonal cells1312. The third struts1333, therefore, define both the first upstream V-struts of the first hexagonal cells1312and the second downstream V-struts of the second hexagonal cells1322.

The first longitudinal supports1314can include a plurality of holes1336through which sutures can pass to attach a prosthetic valve assembly and/or a sealing member. In the embodiment illustrated inFIG. 21, only the first longitudinal supports1314have holes1336. However, in other embodiments the second longitudinal supports1324can also include holes either in addition to or in lieu of the holes1336in the first longitudinal supports1314.

FIG. 22is a side view andFIG. 23is a bottom isometric view of the valve support1300with a first sealing member1162attached to the valve support1300and a prosthetic valve1150within the valve support1300. The first sealing member1162can be attached to the valve support1300by a plurality of sutures1360coupled to the first longitudinal supports1314and the second longitudinal supports1324. At least some of the sutures1360coupled to the first longitudinal supports1314pass through the holes1336to further secure the first sealing member1162to the valve support1300.

Referring toFIG. 23, the prosthetic valve1150can be attached to the first sealing member1162and/or the first longitudinal supports1314of the valve support1300. For example, the commissure portions of the prosthetic valve1150can be aligned with the first longitudinal supports1314, and the sutures1360can pass through both the commissure portions of the prosthetic valve1150and the first sealing member1162where the commissure portions of the prosthetic valve1150are aligned with a first longitudinal support1314. The inflow portion of the prosthetic valve1150can be sewn to the first sealing member1162.

The valve support1300illustrated inFIGS. 21-23is expected to be well suited for use with the device1200described above with reference toFIGS. 17-20. More specifically, the first struts1331cooperate with the extended connectors1210(FIGS. 17-20) of the device1200to separate the outflow portion of the prosthetic valve1150from the capsule1700(FIGS. 19-20) when the device1200is in a partially deployed state. The first struts1331, for example, elongate when the valve support1300is not fully expanded (e.g., at least partially contained within the capsule1700) and foreshorten when the valve support is fully expanded. This allows the outflow portion of the prosthetic valve1150to be spaced further apart from the capsule1700in a partially deployed state so that the prosthetic valve1150can at least partially function when the device1200(FIGS. 17-20) is in the partially deployed state. Therefore, the valve support1300is expected to enhance the ability to assess whether the prosthetic valve1150is fully operational in a partially deployed state.

FIGS. 24 and 25are schematic side views of valve supports1400and1500, respectively, in accordance with other embodiments of the present technology. Referring toFIG. 24, the valve support1400includes a first row1410of first of hexagonal cells1412and a second row1420of second hexagonal cells1422. The valve1400can further include a first row1430of diamond-shaped cells extending from the first hexagonal cells1412and a second row1440of diamond-shaped cells extending from the second hexagonal cells1422. The additional diamond-shaped cells elongate in the low-profile state, and thus they can further space the prosthetic valve1150(shown schematically) apart from a capsule of a delivery device. Referring toFIG. 25, the valve support1500includes a first row1510of first hexagonal cells1512at an outflow region1502and a second row1520of second hexagonal cells1522at an inflow region1504. The valve support1500is shaped such that an intermediate region1506(between the inflow and outflow regions1502and1504) has a smaller cross-sectional area than that of the outflow region1502and/or the inflow region1504. As such, the first row1510of first hexagonal cells1512flares outwardly in the downstream direction and the second row1520of second hexagonal cells1522flares outwardly in the upstream direction.

Examples

Several aspects of the present technology are set forth in the following examples.

1. A system for delivering a prosthetic heart valve device into a heart of a patient, the system comprising:an elongated catheter body;a delivery capsule carried by the elongated catheter body, the delivery capsule including a platform and a housing having a sidewall and a proximal rim, the housing being configured to slide along the platform from a containment configuration to a deployment configuration, and the platform and the sidewall defining a chamber for retaining a prosthetic heart valve device in the containment configuration; andan expandable atraumatic member associated with the capsule, the atraumatic member having an opening, an atraumatic surface, and a peripheral portion, wherein the atraumatic member is configured to be in (a) a compacted configuration in which the atraumatic member is within the chamber in the containment configuration and (b) an expanded configuration in which the peripheral portion extends laterally outward over the proximal rim of the housing in the deployment configuration.

2. The system of example 1 wherein the housing is open at the proximal rim such that the chamber is open facing proximally in the containment configuration.

3. The system of any of the foregoing examples wherein the atraumatic member comprises a truncated conical member.

4. The system of any of the foregoing examples wherein the truncated conical member comprises foam, an elastomer, or a braided wire.

5. The system of any of the foregoing examples wherein the atraumatic member comprises a hub and arms that flare outwardly in the expanded configuration.

6. The system of example 5 wherein the arms comprise a shape memory material.

7. The system of any of the foregoing examples wherein the atraumatic member comprises arms having distal portions that flare radially outward in a distal direction in the expanded configuration.

8. The system of any of the foregoing examples wherein the atraumatic surface is an inclined surface that flares outwardly in a distal direction.

9. The system of example 8 wherein the inclined surface is defined by an outwardly flared arm.

10. The system of any of the foregoing examples, further comprising a prosthetic heart valve device in a low-profile state in the chamber in the containment configuration, and wherein the atraumatic member is within a distal portion of the prosthetic heart valve device in the compacted configuration.

11. A system for treating a native heart valve, comprising:an elongated catheter body;a delivery capsule carried by the elongated catheter body, the delivery capsule including a support and a housing, the support having a platform, the housing having a sidewall and a proximal rim, and the housing being configured to slide along the platform from a containment configuration to a deployment configuration, and wherein the housing and the platform define a chamber in the containment configuration;an expandable prosthetic heart valve device at least partially within the chamber of the housing in the containment configuration; andan expandable atraumatic member carried by the capsule, the atraumatic member having an opening through which the support extends, a proximal atraumatic surface, and a peripheral portion, wherein the atraumatic member is configured to (a) have a first diameter in a compacted configuration and (b) expand outwardly to a second diameter greater than the first diameter in an expanded configuration when the prosthetic heart valve device is released from the chamber such that the peripheral portion extends laterally outward of the proximal rim of the housing.

12. The system of example 11 wherein, when the atraumatic member is in the compacted configuration, the atraumatic member is between the support of the capsule and the prosthetic heart valve device.

13. The system of any of examples 11-12 wherein the atraumatic member comprises a truncated conical member.

14. The system of example 13 wherein the truncated conical member comprises foam, an elastomer, or a braided wire.

15. The system of any of examples 11-14 wherein the atraumatic member comprises a hub and arms that flare outwardly in the expanded configuration.

16. The system of example 15 wherein the arms comprise a shape memory material.

17. The system of any of examples 11-16 wherein the atraumatic member comprises a hub and an expandable member attached to the hub, and wherein the expandable member flares radially outward in a distal direction in the expanded configuration.

18. The system of any of examples 11-17 wherein the atraumatic surface is an inclined surface that flares outwardly in a distal direction.

19. The system of example 18 wherein the inclined surface is a foam surface.

20. The system of example 18 wherein the inclined surface is defined by an outwardly flared arm.

21. A method of delivering a prosthetic heart valve device, comprising:positioning a delivery capsule carrying a prosthetic heart valve at a native heart valve within a heart of a human, wherein the capsule is in a containment configuration;moving a housing of the capsule from the containment configuration to a deployed configuration whereby the prosthetic heart valve self-expands and releases from the capsule; andcausing an atraumatic member to expand from a compacted configuration in which the atraumatic member has a first diameter to an expanded configuration in which the atraumatic member has a second diameter greater than the first diameter such that a peripheral portion of the atraumatic member extends laterally outward relative to a proximal rim of the housing.

CONCLUSION

The above detailed descriptions of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. Additionally, various features of several embodiments of the atraumatic members shown and described with reference toFIGS. 7A-11can be interchanged with each other. For example, all of the atraumatic member can optionally include a fabric or wire-braided covering. The various embodiments described herein may also be combined to provide further embodiments.