Patent ID: 12201521

DETAILED DESCRIPTION

Described herein are systems, devices, or methods for treatment or replacement of a diseased native valve of the heart, for example a mitral valve.

FIGS.1A-1Bshow an exemplary valve prosthesis10(also referred to herein as “valve device”) for replacement of a valve, such as a mitral valve. The illustrated valve prosthesis10comprises a frame structure12, leaflets14, and an anchor15. The anchor15includes a wire20formed in a spiral shape around the frame structure12.

The exemplary frame structure12is configured like a stent. The frame structure12has an expanded state and an unexpanded (e.g., collapsed or compressed) state. The compressed state is sized and dimensioned for percutaneous insertion and the expanded state is sized and dimensioned for implantation in a native valve of a patient, such as a mitral valve.

The anchor15can include a spiral member, such as wire20, having a proximal end21and a distal end22. The anchor15can be configured to engage with the frame structure12via a compression fit. The wire20can be formed of a material having sufficient rigidity to hold a predetermined shape. In an exemplary embodiment, the wire20can be formed of a shape memory material (e.g. NiTi). Further, the anchor15prior to implantation may comprise a flat spiral shape such that loops of the anchor are generally positioned within the same plane (the plane being perpendicular to a longitudinal axis of a delivery device). Additionally, in some embodiments, the distal end22can be rounded and/or atraumatic.

The valve prosthesis10can be configured for replacing a mitral valve with the distal end22configured for insertion through a commissure.

FIGS.2A-2Hshow sequential views of an exemplary method of implanting a valve prosthesis10. AtFIG.2A, a transseptal puncture is made. A guidewire54is then routed through the puncture site and left either in the left atrium25or across the mitral valve into the left ventricle26. AtFIG.2B, 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.2C, an inner shaft and attached distal 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 guide153relative to the sheath50. AtFIG.2D, once the anchor guide153is in the correct orientation, the anchor15can be pushed out through distal tip of the anchor guide153(with the distal tip22extending out of the guide153first). AtFIG.2E, the anchor15can fully deploy into the atrium25. AtFIG.2F, 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 anchor15may aid in getting the anchor15across 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 (i.e., with the distal end22leading the encircling). AtFIG.2G, the outer sheath40, inner sheath, and anchor guide153are removed, leaving a tether78in place (and attached to the proximal end21of the anchor15). Next, the frame structure12can then be delivered over the tether78and into place within the anchor15. AtFIG.2H, the frame structure12has been delivered, the tether78has been released from the proximal end21of the anchor15to leave the prosthesis10in place in the mitral valve4. As shown in the exemplaryFIG.2H, the anchor15is positioned to encircle substantially all of the chordae42and is “high” in the ventricle26. An anchor15that has a high position can be adjacent the inferior surface of the annulus of mitral valve4.

In some embodiments, an anchor15is adapted to transport and deliver a biocompatible contrast agent that can enhance an imaging modality image during and/or following delivery of the anchor. The imaging modality can be any modality that is compatible with minimally invasive procedures, such as fluoroscopy and/or echocardiography. Examples of contrast agents (e.g., media) comprise iodine, iodine-based compounds, barium-sulfate, or saline. Without being bound by theory, regarding an x-ray imagining modality, the contrast agent can block or limit the passage of x-rays therethrough. Regarding an ultrasound imaging modality, the contrast agent may possess an increased echogenicity. An anchor15that delivers such a contrast agent during and/or following its deployment can alter the appearance of the heart anatomy and/or of the circulation therein, for example of one or more chambers or vessels of the heart.

Referring toFIGS.3A-3C, in some embodiments, the anchor15can include one or more structures that are adapted to transport and deliver a contrast agent120from a contrast agent source135through the anchor and into or near a target tissue or anatomy of the patient (such as a heart).FIG.3Adepicts an entirety of the anchor15, including a distal tip (further illustrated inFIG.3B) and portions of the anchor proximal to the tip (further illustrated inFIG.3C). It should be noted that in the illustrated embodiment, the distal portion of the anchor15can have a larger radius of curvature compared to other, more proximal portions of the anchor, causing the distal portion to extend or “stick out” from the rest of the anchor. It should be understood that other embodiments of the anchor may not have this distal portion that extends outwards, and can instead comprise an anchor that has only a single radius of curvature (such as the anchor depicted inFIG.1A).

The contrast agent source135can be a vessel, container, or volume either disposed within the anchor15or remote from the anchor. The contrast agent source135is fluidly coupled with the lumen130of the anchor. In some embodiments, the contrast agent source can be a syringe exterior to the anchor and to the patient. In other embodiments, the lumen of the anchor can be fluidly coupled to another lumen within a delivery catheter, and the contrast agent source can be either fluidly coupled to the delivery catheter lumen or remote from (but fluidly coupled to) the delivery catheter. The contrast agent source can further include a mechanism for delivering contrast agent from the source into the lumen(s) and out through the port(s) of the anchor. For example, in one embodiment the contrast agent can be delivered by deploying a syringe. In other embodiments, pumps or other ways of pressurizing and/or creating a flow of the contrast agent can be implemented.

As depicted in the exampleFIG.3B, in some embodiments, the contrast agent120is delivered from a tip of the anchor15, which comprises a lumen130and one or more ports125. In some embodiments, the lumen130is formed by an inner wall of the anchor15that is located within an outer perimeter of the anchor (e.g., is substantially centrally located). In some embodiments, the lumen130is formed by an outer wall of the anchor15(e.g., as a monorail). The lumen130can traverse from a proximal portion to a distal portion of the anchor15. In some embodiments that comprise a monorail construction, the lumen may traverse less than the entirety of the length of the anchor15. For example, a proximal end of the lumen130may terminate distal to a proximal end of the anchor15, and/or a distal end of the lumen130may terminate proximal to a distal end of the anchor15.

As depicted in the exampleFIG.3C, in some embodiments, the contrast agent120is delivered from one or more portions of the anchor15that are proximal to the tip, where the proximal portions include a lumen110and one or more ports115. In some embodiments, the one or more ports115are positioned on the body of the anchor15such that, when delivered in a selected orientation and/or position in the heart, the one or more ports115are at least partially obstructed by one or more portions of the native heart. For example, an obstruction can comprise a leaflet of the native valve, one or more chordae, an inferior surface of the valve annulus, or a portion of the ventricular heart wall. In some embodiments, the one or more ports115are oriented to be generally radially-outward, generally radially-inward, and/or generally along a superior aspect of the anchor15(e.g., superior when implanted in the ventricle of the heart).

In some embodiments, feedback regarding an orientation and/or position of the anchor15with respect to the native heart anatomy can be provided according to one or more characteristics of the blood flow, visualized in the presence of the contrast agent that is delivered via the anchor15. Within a ventricle of the heart, blood flow velocity is often reduced in a region that is inferior and peripheral to the valve annulus. In contrast, blood flow velocity within the ventricle is increased within a central region of the chamber, moving toward the apex of the heart. Referring now toFIGS.4A-4B, in some embodiments an anchor15that is position “low” with respect to the sub-annular tissue (e.g., anchor140seen in cross-section,FIG.4B) may release contrast agent120into a space having a relatively high blood flow velocity, such that the contrast agent120dilutes and/or disperses relatively quickly. The contrast agent120may appear to have a reduced or diminished intensity in such a condition, and/or to occupy a greater region of space within the heart. Referring now toFIGS.4C-D, in some embodiments, an anchor15that is positioned in a preferred “high” near the sub-annular tissue (e.g., anchor150seen in cross-section,FIG.4D) may release contrast agent120into a space having a relatively low blood flow velocity, such that the contrast agent120gathers in the space with little dilution and/or dispersion. The contrast agent120may appear to have a greater intensity with the given imaging modality in such a condition. In combination with an appropriate imaging modality, the position of the anchor15can be (e.g., indirectly) measured or confirmed by the intensity and/or dispersion of a contrast agent120.

FIG.5is a flowchart that describes a method of delivering a valve prosthesis including delivering a contrast agent with an anchor of a valve prosthesis. In some embodiments, at step502, the method can include advancing a distal end of a delivery device to a first side of a native valve (FIG.2C). At step504, the method can further include deploying an anchor from a delivery configuration to a deployed configuration on the first side of the native valve (FIG.2D-FIG.2E). In some embodiments, the anchor can comprise at least one port for delivering a contrast agent therefrom. At step506, the method can further include advancing the anchor in the deployed configuration from the first side of the native valve to a second side of the native valve and at step508, rotating the anchor in the deployed configuration around one or more structures on the second side of the native valve (FIG.2F). At step510, the method can include delivering the contrast agent through the at least one port (as shown inFIGS.3A-3C). Finally, the method can include identifying a characteristic of the contrast agent in an image to confirm that the anchor has been rotated around the one or more structures.

In some embodiments, the method ofFIG.5can further include releasing the anchor from the distal end of the delivery device.

In some embodiments, delivering the contrast agent comprises delivering into a blood flow path of the heart. In other embodiments, delivering the contrast agent comprises delivering following the step of advancing to the second side of the native valve.

In some examples, the characteristic of the contrast agent comprises an extent of dispersion. In one implementation, confirming that the anchor has been fully rotated comprises confirming that dispersion of the contrast agent is substantially confined to a selected region.

In some examples, the selected region comprises a sub-annular space of the native valve.

In some implementations of the method, the method further includes repeating at least one of the rotating, delivering, and identifying steps until the extent of dispersion is within the selected region.

In some examples, the image comprises a fluoroscopic image.

In other embodiments, the anchor comprises any of the anchors described in this disclosure.

Additional elements of valve prostheses, anchors, and methods of delivery are described in PCT Application No. PCT/US2019/047542 filed on Aug. 21, 2019, PCT Application No. PCT/US2019/057082 filed on Mar. 19, 2019, PCT Application No. PCT/US2019/068088 filed on Dec. 20, 2019, and PCT Application No. PCT/US2020/23671, the entireties of which are incorporated by reference herein in their entireties.

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

When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.

Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.

Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.