Safety for mitral valve implant

A heart valve implant may include a shaft extending generally along a longitudinal axis of the heart valve implant. A spacer may be coupled to the shaft between a first and a second end region of the shaft. The spacer may be configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position and at least one anchor may be configured to be coupled to the first end region of the shaft. At least one safety stop may extend generally radially outwardly from the longitudinal axis of the heart valve implant beyond at least a portion of an outer perimeter of the spacer. The safety stop may include a cross-section which is greater than a cross-section of the heart valve in at least one dimension. The safety stop may also be configured to at least partially restrict a movement of the heart valve implant with respect to the heart valve in at least one direction.

FIELD

The present disclosure relates to the repair and/or correction of dysfunctional heart valves, and more particularly pertains to heart valve implants and systems and methods for delivery and implementation of the same.

BACKGROUND

A human heart has four chambers, the left and right atrium and the left and right ventricles. The chambers of the heart alternately expand and contract to pump blood through the vessels of the body. The cycle of the heart includes the simultaneous contraction of the left and right atria, passing blood from the atria to the left and right ventricles. The left and right ventricles then simultaneously contract forcing blood from the heart and through the vessels of the body. In addition to the four chambers, the heart also includes a check valve at the upstream end of each chamber to ensure that blood flows in the correct direction through the body as the heart chambers expand and contract. These valves may become damaged, or otherwise fail to function properly, resulting in their inability to properly close when the downstream chamber contracts. Failure of the valves to properly close may allow blood to flow backward through the valve resulting in decreased blood flow and lower blood pressure.

Mitral regurgitation is a common variety of heart valve dysfunction or insufficiency. Mitral regurgitation occurs when the mitral valve separating the left coronary atrium and the left ventricle fails to properly close. As a result, upon contraction of the left ventricle blood may leak or flow from the left ventricle back into the left atrium, rather than being forced through the aorta. Any disorder that weakens or damages the mitral valve can prevent it from closing properly, thereby causing leakage or regurgitation. Mitral regurgitation is considered to be chronic when the condition persists rather than occurring for only a short period of time.

Regardless of the cause, mitral regurgitation may result in a decrease in blood flow through the body (cardiac output). Correction of mitral regurgitation typically requires surgical intervention. Surgical valve repair or replacement is carried out as an open heart procedure. The repair or replacement surgery may last in the range of about three to five hours, and is carried out with the patient under general anesthesia. The nature of the surgical procedure requires the patient to be placed on a heart-lung machine. Because of the severity/complexity/danger associated with open heart surgical procedures, corrective surgery for mitral regurgitation is typically not recommended until the patient's ejection fraction drops below 60% and/or the left ventricle is larger than 45 mm at rest.

DESCRIPTION

Referring toFIG. 1, a perspective view of one embodiment of a mitral valve implant10is depicted. As shown, mitral valve implant10may generally include a spacer or valve body portion12which may be coupled to a shaft14. The shaft14may be coupled to at least one anchor portion16configured to couple, attach, and/or otherwise secure the mitral valve implant10to native coronary tissue. In general, at least a portion of the spacer12may be configured to be disposed proximate a mitral valve such that the mitral valve implant10may interact and/or cooperate with at least a portion of the native mitral valve18to reduce and/or eliminate excessive regurgitation as illustrated inFIG. 2.

The mitral valve implant10,FIG. 1, may also include one or more safety stops20. The safety stops20may at least partially reduce, restrict and/or prevent the mitral valve implant10from moving away from the mitral valve18area in at least one direction should the anchor portion16become dislodged or allows excessive movement of the mitral valve implant10. The safety stops20may be configured to extend generally radially outwardly from the longitudinal axis L of mitral valve implant10beyond at least a portion of an outer perimeter of the spacer12such that the safety stops20may at least partially reduce, restrict and/or prevent the mitral valve implant10from moving away from the mitral valve18area in at least one direction. According to one aspect, the safety stops20may define an outer perimeter and/or cross-section that is larger in at least one direction than the mitral valve18. For example, the safety stops20may define an outer perimeter and/or cross-section that is larger in at least one direction than the perimeter and/or cross-section of the spacer14.

For example, the safety stops20may be configured to reduce and/or prevent the mitral valve implant10from moving through the mitral valve18in at least one direction. According to this embodiment, the safety stop20may allow a portion of the mitral valve implant10to move with respect to the mitral valve18; however, the safety stop20may prevent, restrict and/or reduce the ability of the entire mitral valve implant10from passing through the mitral valve18. It should be noted that the safety stops20need only prevent, restrict and/or reduce the mitral valve implant10from passing through the mitral valve18. The safety stop20does not necessarily have to restrict the movement of the mitral valve implant10sufficiently to allow the mitral valve implant may to continue to interact and/or cooperate with the mitral valve leaflets19and reduce and/or eliminate excessive regurgitation. In other words, the safety stop20may allow the mitral valve implant10to move such that the mitral valve implant10no longer interacts and/or cooperates with the mitral valve leaflets19and no longer reduces and/or eliminates excessive regurgitation. The safety stop20according to this aspect need only prevent, restrict and/or reduce the mitral valve implant10from passing through the mitral valve18.

Additionally (or alternatively), the safety stops20may be configured to sufficiently reduce, restrict and/or prevent the movement of the mitral valve implant10(and in particular, the spacer12) such that the spacer12may continue to interact and/or cooperate with at least a portion of the mitral valve18to reduce and/or eliminate excessive regurgitation. It should be noted that the safety stops20do not necessarily have to be configured to prevent the mitral valve implant10from moving at all or from moving away from an original, preferred, or optimized position with respect to the mitral valve18. As such, the safety stops20may allow the mitral valve implant10to move with respect to the mitral valve18as long as a minimum degree of interaction and/or cooperation exists between the mitral valve implant10and at least a portion of the mitral valve leaflets19. The minimum degree of interaction and/or cooperation between the mitral valve implant10and at least a portion of the mitral valve leaflets19may vary and may be determined experimentally.

As shown inFIG. 1, the mitral valve implant10may include at least one safety stop20disposed generally above the spacer12. For example, the mitral valve implant10may include a safety stop20aextending generally radially outwardly from the longitudinal axis L of mitral valve implant10along at least a portion of the shaft14. As used herein, the term “above” the spacer12refers to a portion of the mitral valve implant10between spacer12and a first end23of the mitral valve implant10which is intended to be disposed proximate the atrium (e.g., the left atrium22). The safety stop20amay be disposed proximate the distal portion of the first end23of the shaft14as shown, however, the safety stop20amay be disposed anywhere along the portion of the mitral valve implant10between spacer12and the distal portion of the first end23of the shaft14. For example, the safety stop20amay be disposed proximate the spacer12. As shown inFIG. 2, the safety stop20amay be configured to be disposed generally within the left ventricle24.

Referring toFIG. 3, the mitral valve implant10may include at least one safety stop20disposed generally below the spacer12. As used herein, the term “below” the spacer12refers to a portion of the mitral valve implant10between spacer12and a second end24of the mitral valve implant10which is intended to be disposed proximate the ventricle (e.g., the left ventricle24). For example, the mitral valve implant10may include a safety stop20bextending generally radially outwardly from the longitudinal axis L of mitral valve implant10along at least a portion of the shaft14. As shown inFIG. 4, the safety stop20bmay be configured to be disposed generally within the left atrium22. While the mitral valve implant10is shown having safety stops20a,20bdisposed above and below the spacer12, the mitral valve implant10may include only the safety stop20b.

Alternatively (or in addition), the mitral valve implant10may include a safety stop20c,FIG. 5, extending generally radially outwardly from the longitudinal axis L of mitral valve implant10about the anchor portion16. The safety stop20cmay be disposed proximate the shaft14, however, one or more safety stops20cmay be disposed along other positions of the anchor portion16. Again, while the mitral valve implant10is shown having safety stops20a,20bdisposed above and below the spacer12, the mitral valve implant10may include only the safety stop20c.

Referring toFIG. 6, the mitral valve implant10may include at least one safety stop20dextending generally radially outwardly from the longitudinal axis L of mitral valve implant10along the spacer12. According to one embodiment, the safety stop20dmay be disposed proximate either the first or the second ends23,24of the mitral valve implant10. Placing the safety stop20dproximate either the first or second ends23,24of the mitral valve implant10may increase the surface available to the spacer12to interact and/or cooperate with the mitral valve leaflets19to reduce and/or eliminate excessive regurgitation and may reduce the likelihood of the safety stop20dfrom preventing the spacer12from interacting and/or cooperating with the mitral valve leaflets19to reduce and/or eliminate excessive regurgitation.

Those skilled in the art will recognize that while the mitral valve implant10inFIGS. 2-6are shown in combination with the safety stop20adisposed above the spacer12, the mitral valve implant10does not necessarily have to include the safety stop20a. The mitral valve implant10may include one or more or a combination of two or more of the safety stops20a-20d.

As discussed above, the safety stops20may reduce and/or prevent the mitral valve implant10from moving away from the mitral valve18area should the anchor portion16become dislodged or allows excessive movement of the mitral valve implant10. For example, the safety stops20may define an outer perimeter and/or cross-section that is larger in at least one direction than the mitral valve18. As such, the safety stop20may include a variety a configurations and/or geometries depending on the intended application. The safety stop20may be shaped to facilitate the flow of blood from the left atrium22to the left ventricle24when the mitral valve18is open. The safety stop20may have a generally streamlined shape, allowing the smooth flow of blood around the safety stop20. Other embodiments of the mitral valve implant10may provide less consideration for the flow characteristics of blood flowing around the safety stop20.

According to one aspect, the safety stop20may have a generally annular, ring-like shape and may define an outer perimeter extending approximately 360 degrees around the radius of the mitral valve implant10. For example, the safety stop20may include a generally circular, oval, or elliptical outer perimeter as generally shown inFIGS. 1-6. In any event, the outer perimeter of the safety stop20may be configured to restrict the movement of the mitral valve implant10through the mitral valve18. The safety stop20may be configured to be mounted, attached, coupled, or otherwise secured to the mitral valve implant10using one or more spokes, ribs, stringers, or supports26. As such, the safety stop20may form a generally open, frame-like structure. Alternatively (or in addition), the safety stop20may be configured as a substantially solid geometry or shape. According to one embodiment, the safety stop20may include a generally solid, disc-like structure. The substantially solid geometry safety stop20may optionally include one or more apertures or openings that allow fluid to pass through the safety stop20.

The safety stop20may also include one or more segments or components30extending generally radially outwardly from the mitral valve implant10as shown inFIGS. 7-9. Each segment30may extend generally outwardly less than 360 degrees along the radius of the mitral valve implant10. For example, the safety stop20may include a single segment30aas shown inFIG. 7. The single segment30amay extend generally radially outwardly less than 360 degrees along the radius of the mitral valve implant10. The single segment30amay extend outwardly from mitral valve implant10in at least one direction such that an outer perimeter and/or cross-section of the mitral valve implant10is larger in at least one direction than the cross-section of the mitral valve18. Alternatively, the safety stop20may include a plurality of segments30a-30nas shown inFIGS. 8 and 9. The plurality of segments30a-30nmay be spaced evenly and/or unevenly about the radial direction of the mitral valve implant10. While each segment30a-30nmay extend less than 360 degrees along the radius of the mitral valve implant10, the sum of the segments30a-30nmay be equal, less than, or greater than 360 degrees. Again, the plurality of segments30a-30nmay extend outwardly from mitral valve implant10in at least one direction such that an outer perimeter and/or cross-section of the mitral valve implant10is larger in at least one direction than the cross-section of the mitral valve18.

According to one embodiment, the segments30may have a generally tear-drop like shape. However, the segments30may include other shapes such as, but not limited to, circles, ovals, rectangles, triangles, and the like. The segments30may form a generally wire-like frame as shown inFIGS. 7 and 8. The wire-like frame may facilitate the flow of fluid past the safety stop20.

The segments30may also have a generally solid geometry or shape as shown inFIG. 9. The solid segments30may optionally include one or more openings, apertures, or passageways32configured to allow fluid to pass through the solid segment30. As used herein, the phrases “generally solid geometry”, “substantially solid geometry”, or the like are intended to mean a geometry having an outer surface that defines a substantially fixed or constant volume. That is, a volume of the segments30does not substantially change before and after implantation of the mitral valve implant10. A “generally solid geometry” may include, without limitation, a solid, semi-solid, or porous (e.g., micro- or nano-scale pores) material.

At least a portion of the safety stop20may be collapsible and/or reducible in volume to facilitate percutaneous and/or transluminal delivery of the mitral valve implant10. In such a manner, the safety stop20of the mitral valve implant10may be a collapsible member, which can be reduced in volume and/or reduced in maximum diameter during delivery to the heart and/or during placement and/or attachment of the anchor to native coronary tissue. After delivery to the heart, the safety stop20may be expanded, inflated, and/or otherwise increased in volume or size. Accordingly, the mitral valve implant10may be delivered to an implantation site via a smaller diameter catheter, and/or via smaller vessels, than would otherwise be required.

The at least partially deformable safety stop20may be collapsed to a reduced size, which may, for example, allow the mitral valve implant10to be loaded into a catheter delivery system. Such a catheter delivery system may be suitable for transluminal delivery of a mitral valve implant10, including the safety stop20, to the heart. In addition to being collapsed, the safety stop20may be deformed to facilitate loading into a catheter delivery system. For example, the safety stop20may be collapsed and may be rolled and/or folded to a generally cylindrical shape, allowing the safety stop20to be loaded in a catheter having a circular lumen.

A collapsed and/or rolled or folded safety stop20may be inflated, restoring the safety stop20to expanded configuration. For example, a collapsed and/or rolled or folded safety stop20may be inflated and restored to an expanded configuration once the mitral valve implant10has been delivered to the heart and deployed from a catheter delivery system. Inflating the safety stop20may be carried out by introducing a fluid, such as saline, into the at least one cavity of the safety stop20. In addition to a liquid, such as saline, the safety stop20may be inflated with a setting or curable fluid. The setting or curable fluid may set and/or be cured to a solid and/or semi-solid state within the cavity of the safety stop20. An example of such a material may be a thermoset polymer resin, a gel material, such as silicone gel, etc.

At least a portion of the safety stop20may also be constructed from a shape-memory material. For example, at least a portion of the safety stop20may include a shape-memory alloy such as, but not limited to, copper-zinc-aluminum, copper-aluminum-nickel, and nickel-titanium (NiTi) alloys. The shape-memory alloy may include either one-way or two-way shape memory and may be introduced in to the delivery catheter lumen having a shape which does not exceed the interior dimensions of the delivery catheter lumen. For example, the safety stop20may have a generally elongated or generally helical shape. Upon delivery to proximate the mitral valve, the shape-memory safety stop20may be heated to cause the safety stop20to deform into the desired shape for installation.

According to another embodiment, the safety stop20may be formed from one or more separate segments30which are each no larger than the interior, radial dimensions of the delivery catheter lumen in at least one direction. The segments30do not need to be expanded/inflated, but rather may be configured to be mounted, coupled, attached, or otherwise secured to the mitral valve implant10once delivered proximate the mitral valve. The size and shape of the segments30may be varied by design and quantity such that the constructed safety stop20accommodates the patient's anatomy, etiology of valve regurgitation, as well as the physical limitations of the implant delivery system.

At least a portion of the safety stop20may also be coated or encapsulated with various compliant materials such as, but not limited to, porous synthetic materials (for example, polyesters) that promote cell growth to improve biocompatibility and improve attachment between the safety stop20and the native coronary tissue. Other coating materials include non-reactive synthetics (for example, silicone/urethane composites) and xenograft (animal pericardium or collagen) materials.

While the safety stop20has been shown extending generally 90 degrees radially outwardly from the mitral valve implant10, one or more of the safety stops20may extend generally radially outwardly at one or more angles greater than or less than 90 degrees from the longitudinal axis L of the mitral valve implant10. Additionally, the safety stops20may be located at a fixed position along the mitral valve implant10or may be movable along the longitudinal axis L of the mitral valve implant10. Accordingly, the safety stop20may be positioned along the longitudinal axis L of the mitral valve implant10to minimize possible movement of the mitral valve insert10and/or to position the safety stop20to minimize potential interference with the surrounding tissue. For example, the safety stop20may include a ratchet-like mechanism. The safety stops20may also be located about a common, radial plane of the mitral valve implant10and/or may be located about two or more radial planes of the mitral valve implant10.

It should be noted that while the mitral valve implant10has been described in combination with a spacer12, the mitral valve implant10may optionally include only the shaft14, the anchor portion16, and one or more safety stops20as generally shown inFIG. 10. Additionally, at least a portion of the shaft14may include a substantially rigid shaft which is configured to be substantially self-supporting. Alternatively (or in addition), at least a portion of the shaft14may include a wire-like shaft. According to this aspect, the first and second ends23,24of the shaft14may each include anchor portions16.

The spacer12of the mitral valve implant10shown inFIGS. 1-9may have any shape known to those skilled in the art. For example, as shown inFIG. 1, the spacer12may have a generally tapered shape, including a sidewall17tapering outwardly from a narrow portion40adjacent to one or more of the ends of the spacer12to an enlarged portion42. The taper of the sidewall17may have a flared or belled shape, providing an at least partially concave geometry. In various other embodiments, the spacer12may include a sidewall17having a generally uniform taper, providing a straight profile. In still other embodiments, the sidewall17of the spacer12may exhibit a convex taper, producing an at least somewhat bulging tapered profile.

The enlarged portion42of the spacer12may have an arcuate profile around the circumference of the proximal region of the enlarged portion42. The bottom44of the enlarged portion42may be provided having a flat and/or arcuate shape. Furthermore, the bottom44of the proximal region may include convex and/or concave contours.

According to an embodiment, the spacer12may be slidably coupled to the shaft14. The spacer12may include an opening46extending from the bottom44of the enlarged portion42, through the spacer12, and to the narrow portion40. In one such embodiment, the opening46may extend generally axially through the spacer12. The opening46may be sized to slidably receive at least a portion of the shaft14therethrough. The shaft14may include one or more stops48,50. The stops48,50may be sized and/or shaped to control and/or restrict translation of the spacer12along the shaft14beyond the respective stops48,50. In this manner, in the illustrated embodiment, translation of the spacer12along the shaft14may be restricted to the expanse of the shaft14between the stops48,50.

One or more of the stops48,50may be integrally formed with the shaft14. Furthermore, one or more of the stops48,50may be provided as a separate member coupled to and/or formed on the shaft14. In an embodiment in which one or more of the stops48,50are integrally formed with the shaft14, the spacer12may be slidably coupled to the shaft14by pressing the spacer12over at least one of the stops48,50, which may at least partially elastically deform the opening46to permit passage of at least one of the stops48,50. Once the one or more of the stops48,50have been pressed through the opening46, the opening46may at least partially elastically recover, thereby resisting passage of the one or more stops48,50back through the opening46. Various other arrangements may be employed for providing stops on the shaft and/or for controlling and/or limiting translation of the spacer along the shaft.

The anchor portion16may include a helical member52coupled to the shaft14. As shown, the helical member52may be loosely wound such that adjacent turns of the helical member52do not contact one another, for example resembling a corkscrew-type configuration. The anchor portion16may be engaged with tissue by rotating the anchor portion16about the axis of the helical member52, thereby advancing the anchor portion16into tissue. Consistent with such an embodiment, the anchor portion16may resist pulling out from the tissue. The anchor portion16may be provided as an extension of the shaft14wound in a helical configuration. Consistent with related embodiments, the anchor portion16may be formed as a separate feature and may be coupled to the shaft14, e.g., using mechanical fasteners, welding, adhesive, etc.

According to various alternative embodiments, the anchor portion16may include various configurations capable of being coupled to and/or otherwise attached to native coronary tissue. For example, the anchor portion16may include one or more prongs adapted to pierce coronary tissue and to alone, or in conjunction with other features, resist removal of the anchor portion16from tissue. For example, the anchor portion16may include a plurality of prongs which may engage native coronary tissue. According to various other embodiments, the anchor portion16may include features that may facilitate attachment by suturing. Exemplary features to facilitate suturing may include rings or openings, suture penetrable tabs, etc. Various other anchor portions16that may allow attachment or coupling to native coronary tissue may also suitably be employed in connection with the present disclosure.

Turning toFIGS. 2 and 4, the mitral valve implant10is shown implanted within a heart102. The mitral valve implant10may be disposed at least partially within the left ventricle24of the heart102. As shown, the anchor portion16may be engaged with native coronary tissue within and/or adjacent to the left ventricle24. The shaft14, coupled to the anchor portion16, may extend into the left ventricle24. The shaft14may further extend at least partially within the mitral valve18, i.e., the shaft14may extend at least partially between the cusps or leaflets19of the mitral valve18, and may also extend at least partially into the left atrium22. The spacer12of the mitral valve implant10may be positioned at least partially within the left ventricle24with the enlarged portion42within the left ventricle24and with the narrow portion48positioned at least partially within and/or pointed towards the left atrium22.

FIGS. 2aand4depict the heart102in a condition in which the pressure of blood within the left atrium22is at equal to, or higher than, the pressure of blood within the left ventricle24, e.g., during contraction of the left atrium22. As shown, when the pressure of blood within the left atrium22is greater than or equal to the pressure of blood within the left ventricle24, blood may flow from the left atrium22into the left ventricle24. The pressure differential and/or the flow of blood from the left atrium22to the left ventricle24may slidably translate the spacer12along the shaft14toward the left ventricle24, in the direction of blood flow between the chambers.

Sliding translation of the spacer12along the shaft14may at least partially withdraw the spacer12from the mitral valve18to an open position, as shown. When the spacer12is at least partially withdrawn from the mitral valve18, a passage may be opened between the spacer12and the mitral valve18, allowing blood to flow from the left atrium22to the left ventricle24. Translation of the spacer12away from the mitral valve18may be controlled and/or limited by the stop50. In the open position, the stop50may maintain the spacer12in general proximity to the mitral valve18while still permitting sufficient clearance between the mitral valve18and the spacer12to permit adequate blood flow from the left atrium22to the left ventricle24. Additionally, the flow of blood from left atrium22to the left ventricle24may cause the mitral valve18to flare and/or expand outwardly away from the mitral valve implant10, permitting blood flow between the implant10and the cusps19of the mitral valve19.

As the left ventricle24contracts, the pressure of blood in the left ventricle24may increase such that the blood pressure in the left ventricle24is greater than the blood pressure in the left atrium22. Additionally, as the pressure of the blood in the left ventricle24initially increases above the pressure of the blood in the left atrium22, blood may begin to flow towards and/or back into the left atrium22. The pressure differential and/or initial flow of blood from the left ventricle24into the left atrium22may act against the spacer12and may translate the spacer12toward the left atrium104. For example, pressurized blood within the left ventricle24may act against the bottom24of the spacer12inducing sliding translation of the spacer12along the shaft14toward the left atrium22.

In the closed position as shown inFIG. 2b, the spacer12may be translated toward and/or at least partially into the left atrium22. At least a portion of the spacer12may interact with, engage, and/or be positioned adjacent to at least a portion of the mitral valve18. For example, at least a portion of at least one cusp19of the mitral valve18may contact at least a portion of the spacer12. Engagement between the spacer12and the mitral valve18may restrict and/or prevent the flow of blood from the left ventricle24back into the left atrium22.

In addition to the translation of the spacer12, the mitral valve18may also at least partially close around the spacer12, thereby also restricting and/or preventing the flow of blood from the left ventricle24to the left atrium22. For example, as mentioned above, at least a portion of one or both of the cusps19of the mitral valve18may contact at least a portion of the spacer12. In some embodiments, as the pressure of the blood in the left ventricle24increases, the pressure against the bottom44of the spacer12may increase. The increase in pressure against the bottom44of the spacer12may, in turn, increase the engagement between the spacer12and the mitral valve18.

Sliding translation of the spacer12toward the left atrium22may at least partially be controlled and/or limited by the stop48coupled to the shaft14. Additionally, translation of the spacer12toward the left atrium22may be at least partially limited and/or controlled by engagement between the spacer12and the mitral valve18. One or both of these restrictions on the translation of the spacer12may, in some embodiments, prevent the spacer12from passing fully into the left atrium22. Furthermore, the diameter of the enlarged portion20of the spacer12may limit and/or restrict the movement of the spacer12into the left atrium22.

The preceding embodiment may, therefore, provide a mitral valve implant that is slidably translatable relative to the mitral valve to reduce and/or eliminate regurgitation. Additional embodiments of a mitral valve implant are described in co-pending U.S. patent application Ser. No. 11/258,828, entitled “Heart Valve Implant” filed on Oct. 26, 2005, which is fully incorporated herein by reference. For example, the mitral valve implant may include a generally stationary spacer and may include more than one anchoring portions.

The implant herein has been disclosed above in the context of a mitral valve implant. An implant consistent with the present disclosure may also suitably be employed in other applications, e.g., as an implant associated with one of the other valves of the heart, etc. The present invention should not, therefore, be construed as being limited to use for reducing and/or preventing regurgitation of the mitral valve.

According to one aspect, the present disclosure features a heart valve implant comprising a shaft extending generally along a longitudinal axis of the heart valve implant and a spacer coupled to the shaft between a first and a second end region of the shaft. The spacer may be configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position. At least one anchor may be configured to be coupled to the first end region of the shaft and at least one safety stop may extend generally radially outwardly from the longitudinal axis of the heart valve implant beyond at least a portion of an outer perimeter of the spacer. The safety stop may be configured to at least partially restrict a movement of the heart valve implant with respect to the heart valve in at least one direction.

According to another aspect, the present disclosure features a method of restricting movement of a heart valve implant with respect to a heart valve. The method may comprise providing a heart valve implant comprising a shaft, a spacer coupled to the shaft between a first and a second end region of the shaft, at least one anchor configured to be coupled to the first end region of the shaft, and at least one safety stop extending generally radially outwardly from the heart valve implant beyond at least a portion of an outer perimeter of the spacer. The heart valve implant may be at least partially collapsed and may be percutaneously inserted into a heart where it may be secured. At least a portion of the collapsed heart valve implant may be expanded and the safety stop may be configured to at least partially restrict a movement of the heart valve implant with respect to the heart valve in at least one direction.

According to yet another aspect, the present disclosure features a method of restricting the movement of a heart valve implant. The method may comprise engaging an anchor into coronary tissue, providing a shaft coupled to the anchor and a spacer coupled to the shaft. The spacer may be configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position. At least one safety stop may be provided that extends generally radially outwardly from the heart valve implant beyond at least a portion of an outer perimeter of the spacer. The safety stop may be configured to at least partially restrict a movement of the heart valve implant with respect to the heart valve in at least one direction.

While the depicted embodiments including expandable and/or recoverably deformable as well as solid safety stops have generally been shown configured as a safety stop consistent with a translating spacer, an expandable and/or recoverably or solid safety stop may be configured for use as part of a valve implant including a stationary spacer. Similarly, while the valve implant embodiments including an expandable spacer and/or safety stops have been discussed in connection with transluminal and/or percutaneous delivery systems and/or procedures, such embodiments may also suitably be employed in connection with surgical delivery systems and/or methods. Additionally, other features and aspects of the various embodiments may also suitably be combined and/or modified consistent with the present disclosure. The present disclosure herein should not, therefore, be limited to any particular disclosed embodiment, and should be given full scope of the appended claims.