# Patent

## Title
Mitral spacer

## Abstract

A heart valve implant may include a shaft and an anchor configured to be coupled to an end of the shaft. A spacer may be coupled to a portion of the shaft and comprise a plurality of individual segments including a first and at least a second individual segment. The first segment may be coupled to the shaft. The second segment may be coupled to at least a portion of an exterior surface of the first segment and may have at least one cross-section dimension which is greater than an internal cross-sectional dimension of a delivery lumen. Additional segments may be coupled to an inner, adjacent segment. The segments may include a collapsible body portion to facilitate percutaneously delivery through a lumen. The segments may define an outer surface of the spacer 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.

## Background
CROSS-REFERENCE TO RELATED APPLICATION
The subject application is a continuation of U.S. patent application Ser. No. 11/940,674 which is a continuation-in-part of co-pending U.S. patent application Ser. No. 11/258,828, entitled “Heart Valve Implant” filed on Oct. 26, 2005, all of which are hereby incorporated by reference.


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.



BRIEF DESCRIPTION OF THE DRAWINGS
Features and advantage of the claimed subject matter will be apparent from the following description of embodiments consistent therewith, which description should be considered in conjunction with the accompanying drawings, wherein:
FIG. 1 is a perspective view of an embodiment of a mitral valve implant consistent with the present disclosure;
FIG. 2 depicts an embodiment mitral valve implant consistent with the present disclosure implanted within a heart in an open position;
FIG. 3 depicts an embodiment mitral valve implant consistent with the present disclosure implanted within a heart in a closed position;
FIG. 4 is a perspective view of the mitral valve implant shown in FIG. 1 in an unassembled state consistent with the present disclosure;
FIG. 5 is a cross-sectional view of another embodiment of the spacer segment consistent with the mitral valve implant according to the present disclosure;
FIG. 6 is a perspective view of another embodiment of the spacer segment and shaft consistent with the mitral valve implant according to the present disclosure;
FIG. 7 is a perspective view of another embodiment of the spacer consistent with the mitral valve implant according to the present disclosure;
FIG. 8 is a perspective view of one embodiment of a collapsed spacer segment partially disposed within a lumen of an implant delivery system;
FIG. 9 is an end view of the collapsed spacer segment within the lumen consistent with FIG. 8; and
FIG. 10 depicts one embodiment of a mitral valve implant including a plurality of individual segments disposed within an implant delivery system consistent with the present disclosure.



DESCRIPTION
Referring to FIG. 1, a perspective view of one embodiment of a mitral valve implant 10 is depicted. As shown, mitral valve implant 10 may generally include a spacer or valve body portion 12 which may be coupled to a shaft 14. The shaft 14 may be coupled to at least one anchor portion 16 configured to couple, attach, and/or otherwise secure the mitral valve implant 10 to native coronary tissue. In general, at least a portion of the spacer 12 may be configured to be disposed proximate a mitral valve 18 as generally shown in FIGS. 2 and 3 such that the mitral valve implant 10 may interact and/or cooperate with at least a portion of the native mitral valve 18 to reduce and/or eliminate excessive regurgitation through the mitral valve 18.
The spacer 12 of the mitral valve implant 10 shown in FIG. 1 may comprise at least two individual segments or components 20a-20n. As will be explained in greater detail hereinbelow, the plurality of segments 20a-20n may be configured to be individually delivered and assembled proximate an implant site of the mitral valve implant 10 to form a spacer 12 having an overall size and shape configured to accommodate, at least in part, a patient's anatomy, etiology of valve regurgitation, and/or the limitations of the implant delivery system. The plurality of segments 20a-20n may be configured to form a mitral valve implant 10 having a spacer 12 with at least one cross-sectional dimension that is larger than the internal cross-sectional dimensions of the implant delivery system used to deliver the mitral valve implant 10. The plurality of segments 20a-20n may also allow a mitral valve implant 10 to be constructed including a spacer 12 having an external size, contour, and shape based on, at least in part, the patient's anatomy and etiology of the regurgitate valve. As such, the mitral valve implant 10 according to one aspect of the present disclosure may provide an enhanced sealing surface for the leaflets 19 of the mitral valve 18 for reducing and/or eliminating excessive regurgitation.
As can be seen, the spacer 12 may be comprised of at least two segments 20a-20n that may be coupled to each other and, ultimately, to the shaft 14. Consequently, a mitral valve implant 10 according to one embodiment of the present disclosure may be built-up or constructed from multiple segments 20a-20n such that the resulting, constructed spacer 12 may have various cross-sectional shapes, sizes, configurations, or contours based on, at least in part, the patient's anatomy and etiology of the regurgitant valve. The cross-sectional shapes, sizes, configurations, or contours of the resulting spacer 12 may be varied by design and by quantity of the plurality of segments 20a-20n. Moreover, a mitral valve implant 10 may be constructed including a spacer 12 having at least one external cross-sectional dimension that may be larger than the internal cross-sectional dimensions of the implant delivery system.
According to one aspect, one embodiment of an exploded, unassembled mitral valve implant 10 and spacer 12 is shown in FIG. 4. In the illustrated embodiment, the plurality of segments 20a-20n are shown having a generally tubular or cylindrical shape. However, one or more of the segments 20a-20n may include other shapes and/or configurations. The overall shape/configuration of each of the segments 20a-20n may be varied such that the spacer 12, when constructed, provides a desired outer surface for interacting and/or cooperating with at least a portion of the native mitral valve 18 to reduce and/or eliminate excessive regurgitation through the mitral valve 18. Moreover, the overall shape/configuration of each of the segments 20a-20n may also be varied such to facilitate delivery of the plurality of segments 20a-20n through the implant delivery device to the implant site.
For example, one or more of the segments 20a-20n of the spacer 12 may include a symmetrical or non-symmetrical geometry. At least one segment 20a-20n may also have a tapered and/or a bell-like shape. In another aspect, one or more of the segments 20a-20n may be configured to be disposed substantially concentric with an adjacent segment 20 and/or the shaft 14. Alternatively, one or more of the segments 20a-20n may be configured to be non-concentric with an adjacent segment 20 and/or the shaft 14.
According to another aspect, one or more of the segments 20a-20n may be configured to be disposed substantially coextensively with one or more adjacent segments 20. Alternatively, at least one of the segments 20a-20n may be configured to be non-coextensive with one or more adjacent segments 20. For example, at least one segment 20 may be configured to be disposed about only a portion of an adjacent segment 20. In one instance, one or more of the segments 20a-20n may be configured such that a single surface of a segment 20 is in substantially direct contact with at least a portion of the surfaces of two or more adjacent segments 20. For example, a first segment 20a, FIG. 5, may include a surface 28 having a first portion 29 which is in substantially direct contact with at least a portion of the surface 31 of a first adjacent segment 20b and a second portion 31 which is in substantially direct contact with at least a portion of a surface 33 of a second adjacent segment 20c. As shown, the first segment 20a may include an outer or exterior surface 28 that substantially directly contacts two adjacent segments 20b and 20c. Those skilled in the art may now appreciate that the surface 28 may also include an inner or interior surface of the first segment 20a. 
According to one aspect, at least one of the plurality of segments 20a-20n, FIG. 4, may be coupled, mounted, or otherwise secured to at least a portion of the shaft 14 using any known technique and/or device. In the illustrated embodiment, a first segment 20a may be coupled to a distal end 13 of the shaft 14 generally opposite the anchor portion 16. However, other configurations are also possible. For example, the shaft 14 may extend longitudinally beyond the spacer 12 in both directions as generally shown in FIG. 1. For instance, one or more segments 20a-20n may be disposed proximate a central region of the shaft 14. Additionally, two or more segments 20a-20n may be coupled, mounted, or otherwise secured to at least a portion of the shaft 14.
One or more segments 20a-20n may be coupled to at least a portion of the shaft 14 by way of an adhesive or cement (for example, but not limited to, a biologically acceptable adhesive or cement), bonding/molding (for example, but not limited to, overmolding and the like), or welding (for example, but not limited to, ultrasonic welding or the like). The segments 20a-20n may also be coupled to at least a portion of the shaft 14 using a fastening mechanism. The fastening mechanism may substantially fix the position of one or more of the segments 20a-20n and the spacer 12 with respect to the mitral valve implant 10 (and specifically with respect to the shaft 14). According to another aspect, the fastening mechanism may allow one or more of the segments 20a-20n and the spacer 12 to move relative to the shaft 14. For example, the fastening mechanism may allow the one or more of the segments 20a-20n and spacer 12 to move generally along the longitudinal axis L and/or radially with respect to the shaft 14.
One example of a fastening mechanism may include one or more detents or protrusions 19 as shown in FIG. 6. The detents 19 may be provided as a spring-biased detent, a resilient/elastically deformable detent, or a substantially solid detent. As illustrated, the shaft 14 may be provided with one or more detents 19 extending generally outwardly from the shaft 14. Alternatively (or in addition), one or more of the segments 20a-20n may be provided with detents 19 for coupling with the shaft 14. One or more of the detents 19 may be integrally formed with the shaft 14 and/or segment 20. Furthermore, one or more of the detents 19 may be provided as a separate feature coupled to and/or formed on the shaft 14 and/or segment 20.
In an embodiment in which one or more of the detents 19 are formed as a spring-biased or resilient/elastically deformable detent coupled to the shaft 14, the segment 20a may be slidably coupled to the shaft 14 by pressing the segment 20a over at least one of the detents 19, which may at least partially retract or deform to permit passage of at least one of the detents 19 through an opening 21 and into a cavity 23 of the segment 20a. The spring-biased or resilient/elastically deformable detent 19 may at least partially expand and/or recover, thereby resisting passage of the one or more spring-biased detents 19 back through the opening 21. For example, the shaft 14 and/or the cavity 23 may be provided with a recessed region (not shown) configured to at least partially receive and engage the detent 19. The size and shape of the detent 19, the opening 21, cavity 23, and/or recessed region as well as the force provided by the spring-biased or resilient detent may be configured to engage each other such that the segment 20a may either permit movement of the segment 20a or substantially prevent movement of the segment 20a. 
In an embodiment in which one or more of the detents 19 are formed as a substantially solid detent coupled to the shaft 14, the segment 20a may be slidably coupled to the shaft 14 by pressing the segment 20a over at least one of the detents 19. The opening 21 of the segment 20a may at least partially elastically deform to permit passage of at least one of the detents 19 into the cavity 23. Once the detent 19 has been pressed through the opening 21, the opening 21 may at least partially elastically recover, thereby resisting passage of the detent 19 back through the opening 21. Again, the size and shape of the detent 19, the opening 21, and/or cavity 23, as well as the elastic properties, may be configured to engage each other such that the segment 20a may either permit movement of the segment 20a or substantially prevent movement of the segment 20a. Various other arrangements may be employed for providing detents on the shaft 14 and/or the segments 20a-20n for coupling, controlling and/or limiting translation of the spacer 12 along the shaft 14. It will be appreciated that the segments 20a-20n may be selectively removable from the shaft 14 by applying a force along the longitudinal axis L sufficient to overcome the holding force of the detents 19.
At least one segment 20b-20n may be configured to be at least partially disposed about and coupled to the first segment 20a as generally depicted in FIGS. 1 and 5. Additional segments 20n may also be configured to be at least partially disposed about and coupled to an inner, adjacent segment (for example, segment 20b). As discussed above, the number and configuration of segments 20a-20n may be based on, at least in part, the patient's anatomy and etiology of the regurgitant valve, as well as the physical limitations of the implant delivery system (such as, but not limited to, the internal cross-sectional dimensions of the implant delivery system).
According to one aspect, the additional segments 20b-20n may include an internal cavity 40, for example, as seen in FIG. 4, which may be configured to at least partially receive at least a portion of an inner, adjacent segment 20. As used herein, the term “inner, adjacent segment” or the like is intended to refer to a segment 20 which is at least partially disposed radially inwardly, e.g., generally towards the shaft 14. Additionally, the term “additional segments” and the like is intended to refer to segments which are at least partially coupled to at least one inner, adjacent segment. For example, in the embodiment illustrated in FIG. 4, a second segment 20b may include a cavity 40′ configured to at least partially receive the first segment 20a. Optionally, a third segment 20n may include a cavity 40′′ configured to at least partially receive the second segment 20b. While three segments 20 are shown, the spacer 12 may include a greater or less number of segments 20.
One or more of the cavities 40 may have an internal contour configured to substantially correspond to the outer surface 42 of one or more of the inner, adjacent segments 20 to be received therein. For example, the cavity 40 may include an inner surface 44 that is substantially coextensive with the outer surface 42 of one or more of the inner, adjacent segments 20 to be received therein. One or more of the cavities 40 and outer surfaces 44 may be configured to provide an interference and/or friction fit. For example, one or more of the cavities 40 may be deformable such that the cavity 40 stretches (either permanently or resiliently deformable) to receive at least a portion of the inner, adjacent segments 20 to be received therein.
One or more of the cavities 40 and/or segments 20a-20n may be configured to reduce or substantially eliminate the rotation of one segment 20 relative to an adjacent segment 20. For example, a cavity 40 and an inner, adjacent segment 20 may be provided with a non-cylindrical shape such that the inner, adjacent segment 20 may be received in the cavity 40 in substantially only a single orientation. Other configurations for reducing and/or eliminating the rotational movement of adjacent segments 20 are also possible.
While the illustrated cavities 40 are shown having a configuration which may substantially entirely circumscribe at least a portion of the outer surface 42 of an inner, adjacent segment 20 to be received therein, one or more of the cavities 42 may be configured to be disposed only about a portion of the outer surface 42 of the inner, adjacent segment 20 to be received therein. For example, one or more of the cavities 40 may be configured to be radially disposed about less than 360 degrees of the outer surface 42 of the inner, adjacent segment 20 to be received therein as shown in FIG. 7.
In any case, the additional segments 20b-20n may be coupled to an inner, adjacent segment 20 using any known technique and/or device. For example, the additional segments 20b-20n may be coupled to an inner, adjacent segment 20 using an interference fit between the cavity 40 and the outer surface 42 of the inner, adjacent segment 20 as discussed above. Alternatively (or in addition), one or more of the additional segments 20b-20n may be coupled to an inner, adjacent segment 20 using an adhesive or cement (for example, but not limited to, a biologically acceptable adhesive or cement), bonding/molding (for example, but not limited to, overmolding and the like), or welding (for example, but not limited to, ultrasonic welding or the like). The additional segments 20b-20n may also be coupled to at least a portion of an inner, adjacent segment 20 using a fastening mechanism. The fastening mechanism may substantially fix the position of one or more of the segments 20a-20n with respect to the mitral valve implant 10. According to another aspect, the fastening mechanism may allow one or more of the segments 20a-20n and the spacer 12 to move relative to the shaft 14. For example, the fastening mechanism may allow the one or more of the segments 20a-20n and spacer 12 to move generally along the longitudinal axis L and/or radially with respect to the shaft 14.
One example of a fastening mechanism may include one or more detents or protrusions 19 as shown in FIG. 4. The detents 19 may be disposed out the outer surface 42 of one or more of the segments 20a-20n and/or may be disposed at least partially within the cavity 40 of one or more of the segments 20a-20n. The detents 19 may include any of the various detent configurations discussed above such as, but not limited to, spring-biased detents, resilient/elastically deformable detents, or substantially solid detents.
According to one aspect, at least a portion of the body 24 of one or more of the plurality of segments 20a-20n may be expandable, retractable, collapsible and/or reducible in volume to facilitate percutaneous and/or transluminal delivery of the mitral valve implant 10. In such a manner, one or more of the segments 20a-20n of the mitral valve implant 10 may include a collapsible member, which may be reduced in volume and/or reduced in maximum cross-section during delivery to the heart and/or during placement and/or attachment of the anchor 16 to native coronary tissue. After delivery to the heart, the segments 20a-20n may be expanded, inflated, and/or otherwise increased in volume or size. Accordingly, the mitral valve implant 10 may be delivered to an implantation site via a smaller diameter catheter, and/or via smaller vessels, than would otherwise be required.
The deformable segments 20a-20n may be collapsed to a reduced size, which may, for example, facilitate loading the mitral valve implant 10 into a lumen 51 of a catheter delivery system 53 as generally shown in FIGS. 8 and 9. Such a catheter delivery system 53 may be suitable for transluminal delivery of a mitral valve implant 10, including the segments 20a-20n, to the heart as will be explained further below. In addition to being collapsed, the segments 20a-20n may be deformed to facilitate loading into a catheter delivery system 53. For example, the segments 20a-20n may be collapsed and may be rolled and/or folded to a generally cylindrical shape, allowing the segments 20a-20n to be loaded in a catheter having a generally circular lumen 51 as generally depicted in FIGS. 8 and 9.
A collapsed and/or rolled or folded segments 20a-20n may be inflated, restoring the segments 20a-20n to expanded configuration. For example, a collapsed and/or rolled or folded segments 20a-20n may be inflated and restored to an expanded configuration once the mitral valve implant 10 has been delivered to the heart and deployed from a catheter delivery system 53. Inflating the segments 20a-20n may be carried out by introducing a fluid, such as saline, into the at least one cavity of the segments 20a-20n. In addition to a liquid, such as saline, the segments 20a-20n may 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 segments 20a-20n. 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 segments 20a-20n may also be constructed from a shape-memory material. For example, at least a portion of the segments 20a-20n may 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 51 having a shape which does not exceed the interior dimensions of the delivery catheter lumen 51. For example, the segments 20a-20n may have a generally elongated or generally helical shape. Upon delivery to proximate the mitral valve 18, the shape-memory segments 20a-20n may be heated to cause the segments 20a-20n to deform into the desired shape for installation.
Alternatively (or in addition), one or more of the plurality of segments 20a-20n may have generally solid geometry. 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 segments 20a-20n does not substantially change before and after implantation of the mitral valve implant 10. A “generally solid geometry” may include, without limitation, a solid, semi-solid, or porous (e.g., micro- or nano-scale pores) material. The use a plurality of segments 20a-20n having a generally solid geometry may reduce the complexity and/or cost associated with the fabrication and/or implantation of the mitral valve implant 10. According to one embodiment, a segment 20 having a generally solid geometry may be provided having an outer cross-section which is no larger than the inner cross-section of the delivery lumen 51. For example, the first segment 20a may be provided having a generally solid geometry while additional segments 20n may be provided having a deformable geometry.
One or more of the segments 20a-20n may also be coupled to the shaft 14 prior to delivery of the mitral valve implant 10 to the heart. In such an embodiment, the segments 20a-20n coupled to the shaft 14 may be provided having external cross-sectional dimensions (when either expanded or collapsed) that are no larger than the internal cross-sectional dimensions of the implant delivery system.
At least a portion of the plurality of segments 20a-20n may be constructed from a synthetic and/or biological material depending on the application and the patient condition. The segments 20a-20n may include a plurality of layers. For example, the segments 20a-20n may include an open or closed cell foam substrate (for example, but not limited to, Invalon polyvinyl) and an outer layer of a material that is biologically acceptable. The outer layer may also include a material that is soft and/or deformable (either permanently or resiliently deformable) that may reduce and/or eliminate further scarring and/or damage to the leaflets 19 of the mitral valve 18. According to one aspect, the substrate of the segments 20a-20n may be coated with or formed substantially from a silicone urethane composite such as, but not limited to, Elasteon or the like.
The plurality of segments 20a-20n, when assembled as generally depicted in FIG. 1, may form a mitral valve implant 10 including a spacer 12 having an outer surface 27 that may be configured to interact and/or cooperate with at least a portion of the native mitral valve 18 (e.g., the leaflets 19) to reduce and/or eliminate excessive regurgitation as illustrated in FIGS. 2 and 3. According to one aspect, the mitral valve implant 10 (and in particular, the plurality of segments 20a-20n forming the spacer 12) may be selected from a range or set of sizes and shapes. For example, a “standard set” may be utilized where a set of “consensus” sizes and shapes of segments 20a-20n are pre-manufactured and provided to health care providers as a kit. This particular aspect has the advantage of being the most uniform and therefore the least expensive for the patient. Alternatively, a “custom design” may be fabricated where the exact size and shape of one or more of the segments 20a-20n is determined only after precise and/or detailed measurements of the dimensions of a patient's mitral valve 18 are obtained. As a result, the overall size and/or shape of the spacer 10 may be contoured to a specific patient if necessary.
In practice, the plurality of segments 20a-20n may be aligned serially along at least a portion of the shaft 14 (i.e., one segment 20a after another segment 20b) and inserted into the implant delivery system 53, a portion of which is generally depicted in FIG. 10. As mentioned above, the implant delivery system 53 may include a catheter 55 having a generally circular inner lumen 51. Those skilled in the art will recognize that the catheter 55 may include any catheter known to those skilled in art. While only a single lumen 51 is shown for clarity, the catheter 55 may include a plurality of lumens 51. According to one aspect, one or more of the segments 20a-20n may have an outer cross-section that is larger than the internal cross-section of the lumen 51. In such a case, the plurality of segments 20a-20n may be deformed or otherwise reduced in cross-section and/or volume such that each of the segments 20a-20n may fit within the lumen 51.
Once loaded into the delivery catheter system 53, the mitral valve implant 10 may be moved or delivered proximate the implant site using any device know to those skilled in the art. While moving the mitral valve implant 10 through the delivery catheter system 53, the plurality of segments 20a-20n may be individually rotated to facilitate movement of the plurality of segments 20a-20n. This may be particularly useful to facilitate navigating the plurality of segments 20a-20n about curves, bends or the like in the catheter 55. The shaft 14 may include a generally rigid shaft and/or a generally flexible shaft.
According to another aspect, shaft 14 and the plurality of segments 20a-20n may be separately loaded into the catheter delivery system 53 and delivered to the implant site. According to this aspect, the shaft 14 (which may optionally include the anchor portion 16) may be first loaded into the catheter delivery system 53 and the plurality of segments 20a-20n may be subsequently serially loaded into the catheter delivery system 53. Of course, the order of loading and/or delivering the shaft 14 and/or plurality of segments 20a-20 to the implant site may be changed.
Once the shaft 14 and the plurality of segments 20a-20n are proximate the implant site, the plurality of segments 20a-20n may be disposed or arranged about the shaft 14 and inner, adjacent segments 20b-20n to construct a spacer 12 having a desired size and shape. While the spacer 12 is illustrated having a generally cylindrical outer surface, the size and shape of the spacer 12 and each of the plurality of segments 20a-20n may be varied by design and by quantity to accommodate the patient anatomy, etiology, and limitations of the delivery system 100 (e.g., the internal dimensions of the catheter lumen).
According to an embodiment, a first segment 20a of the spacer 12, FIG. 1, may be slidably coupled to the shaft 14. The segment 20a may include an opening 46 extending from a first end 44 of the spacer 12, through the spacer 12, and to a second end 40. In one such embodiment, the opening 46 may extend generally axially through the spacer 12 and may be sized to slidably receive at least a portion of the shaft 14 therethrough. The shaft 14 may include one or more stops 48, 50. The stops 48, 50 may be sized and/or shaped to control and/or restrict translation of the spacer 12 along the shaft 14 beyond the respective stops 48, 50. In this manner, in the illustrated embodiment, translation of the spacer 12 along the shaft 14 may be restricted to the expanse of the shaft 14 between the stops 48, 50.
One or more of the stops 48, 50 may be integrally formed with the shaft 14. Furthermore, one or more of the stops 48, 50 (such as, but not limited to, stop 50) may be provided as a separate member coupled to and/or formed on the shaft 14. In an embodiment in which one or more of the stops 48, 50 are integrally formed with the shaft 14, the spacer 12 may be slidably coupled to the shaft 14 by pressing the spacer 12 over at least one of the stops 48, 50, which may at least partially elastically deform the opening 46 to permit passage of at least one of the stops 48, 50. Once the one or more of the stops 48, 50 have been pressed through the opening 46, the opening 46 may at least partially elastically recover, thereby resisting passage of the one or more stops 48, 50 back through the opening 46. Various other arrangements may be employed for providing stops on the shaft 14 and/or for controlling and/or limiting translation of the spacer 12 along the shaft 14.
The anchor portion 16 may include a helical member 52 coupled to the shaft 14. As shown, the helical member 52 may be loosely wound such that adjacent turns of the helical member 52 do not contact one another, for example resembling a corkscrew-type configuration. The anchor portion 16 may be engaged with tissue by rotating the anchor portion 16 about the axis of the helical member 52, thereby advancing the anchor portion 16 into tissue. Consistent with such an embodiment, the anchor portion 16 may resist pulling out from the tissue. The anchor portion 16 may be provided as an extension of the shaft 14 wound in a helical configuration. Consistent with related embodiments, the anchor portion 16 may be formed as a separate feature and may be coupled to the shaft 14, e.g., using mechanical fasteners, welding, adhesive, etc.
According to various alternative embodiments, the anchor portion 16 may include various configurations capable of being coupled to and/or otherwise attached to native coronary tissue. For example, the anchor portion 16 may include one or more prongs adapted to pierce coronary tissue and to alone, or in conjunction with other features, resist removal of the anchor portion 16 from tissue. For example, the anchor portion 16 may include a plurality of prongs which may engage native coronary tissue. According to various other embodiments, the anchor portion 16 may 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 portions 16 that may allow attachment or coupling to native coronary tissue may also suitably be employed in connection with the present disclosure.
Turning to FIGS. 2 and 3, the mitral valve implant 10 is shown implanted within a heart 102. The mitral valve implant 10 may be disposed at least partially within the left ventricle 64 of the heart 102. As shown, the anchor portion 16 may be engaged with native coronary tissue within and/or adjacent to the left ventricle 64. The shaft 14, coupled to the anchor portion 16, may extend into the left ventricle 64. The shaft 14 may further extend at least partially within the mitral valve 18, i.e., the shaft 14 may extend at least partially between the cusps or leaflets 19 of the mitral valve 18, and may also extend at least partially into the left atrium 62. The spacer 12 of the mitral valve implant 10 may be positioned at least partially within the left ventricle 64 with the bottom portion 44 within the left ventricle 64 and with the upper portion 40 positioned at least partially within and/or pointed towards the left atrium 62.
FIG. 2 depicts the heart 102 in a condition in which the pressure of blood within the left atrium 62 is at equal to, or higher than, the pressure of blood within the left ventricle 64, e.g., during contraction of the left atrium 62. As shown, when the pressure of blood within the left atrium 62 is greater than or equal to the pressure of blood within the left ventricle 64, blood may flow from the left atrium 62 into the left ventricle 64. The pressure differential and/or the flow of blood from the left atrium 62 to the left ventricle 64 may slidably translate the spacer 12 along the shaft 14 toward the left ventricle 64, in the direction of blood flow between the chambers.
Sliding translation of the spacer 12 along the shaft 14 may at least partially withdraw the spacer 12 from the mitral valve 18 to an open position, as shown. When the spacer 12 is at least partially withdrawn from the mitral valve 18, a passage may be opened between the spacer 12 and the mitral valve 18, allowing blood to flow from the left atrium 62 to the left ventricle 64. Translation of the spacer 12 away from the mitral valve 18 may be controlled and/or limited by the stop 48. In the open position, the stop 48 may maintain the spacer 12 in general proximity to the mitral valve 18 while still permitting sufficient clearance between the mitral valve 18 and the spacer 12 to permit adequate blood flow from the left atrium 62 to the left ventricle 64. Additionally, the flow of blood from left atrium 62 to the left ventricle 64 may cause the mitral valve 18 to flare and/or expand outwardly away from the mitral valve implant 10, permitting blood flow between the implant 10 and the cusps 19 of the mitral valve 19.
As the left ventricle 64 contracts, the pressure of blood in the left ventricle 64 may increase such that the blood pressure in the left ventricle 64 is greater than the blood pressure in the left atrium 62. Additionally, as the pressure of the blood in the left ventricle 64 initially increases above the pressure of the blood in the left atrium 62, blood may begin to flow towards and/or back into the left atrium 62. The pressure differential and/or initial flow of blood from the left ventricle 64 into the left atrium 62 may act against the spacer 12 and may translate the spacer 12 toward the left atrium 104. For example, pressurized blood within the left ventricle 64 may act against the bottom of the spacer 12 inducing sliding translation of the spacer 12 along the shaft 14 toward the left atrium 62.
In the closed position as shown in FIG. 3, the spacer 12 may be translated toward and/or at least partially into the left atrium 62. At least a portion of the spacer 12 may interact with, engage, and/or be positioned adjacent to at least a portion of the mitral valve 18. For example, at least a portion of at least one cusp 19 of the mitral valve 18 may contact at least a portion of the spacer 12. Engagement between the spacer 12 and the mitral valve 18 may restrict and/or prevent the flow of blood from the left ventricle 64 back into the left atrium 62.
In addition to the translation of the spacer 12, the mitral valve 18 may also at least partially close around the spacer 12, thereby also restricting and/or preventing the flow of blood from the left ventricle 64 to the left atrium 62. For example, as mentioned above, at least a portion of one or both of the cusps 19 of the mitral valve 18 may contact at least a portion of the spacer 12. In some embodiments, as the pressure of the blood in the left ventricle 64 increases, the pressure against the bottom 44 of the spacer 12 may increase. The increase in pressure against the bottom 44 of the spacer 12 may, in turn, increase the engagement between the spacer 12 and the mitral valve 18.
Sliding translation of the spacer 12 toward the left atrium 62 may at least partially be controlled and/or limited by the stop 50 coupled to the shaft 14. Additionally, translation of the spacer 12 toward the left atrium 62 may be at least partially limited and/or controlled by engagement between the spacer 12 and the mitral valve 18. One or both of these restrictions on the translation of the spacer 12 may, in some embodiments, prevent the spacer 12 from passing fully into the left atrium 62. Furthermore, the diameter and/or shape of the spacer 12 may limit and/or restrict the movement of the spacer 12 into the left atrium 62.
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, U.S. patent application Ser. No. 11/748,147, entitled “Safety for Mitral Valve Plug” filed on May 14, 2007, U.S. patent application Ser. No. 11/748,138, entitled “Solid Construct Mitral Spacer” filed on May 14, 2007, and U.S. patent application Ser. No. 11/748,121, entitled “Ballon Mitral Spacer” filed on May 14, 2007, all of which are hereby incorporated 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. The heart valve implant may include a shaft extending generally along a longitudinal axis of the heart valve implant. A spacer may comprise a plurality of individual segments including at least a first segment configured to be coupled to the shaft and at least a second segment configured to be coupled to a least a portion of an outer surface of the first segment. The plurality of individual segments may define an outer surface of the spacer 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. The heart valve implant may also include at least one anchor configured to be coupled to a first end region of the shaft.
According to another aspect, the present disclosure features a method of introducing a heart valve implant with respect to a heart valve. The method may include providing a heart valve implant comprising a shaft, at least one anchor configured to be coupled to the shaft, and a spacer including a plurality of individual segments including a first and at least a second segment. The plurality of individual segments may define an outer surface of the spacer 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. The plurality of individual segments may be serially aligned. The shaft and the first and the plurality of segments may be percutaneously delivered proximate the heart and the first segment may be coupled to the shaft. The second segment may be coupled to at least a portion of an outer surface of the first segment to define the spacer and the heart valve implant may be secured within the heart.
According to yet another aspect, the present disclosure features a heart valve implant system. The heart valve implant system may comprise a catheter including a lumen and a heart valve implant. The heart valve implant may comprise a shaft extending generally along a longitudinal axis of the heart valve implant. A spacer may comprise a plurality of individual segments including at least a first segment configured to be coupled to the shaft and at least a second segment configured to be coupled to a least a portion of an outer surface of the first segment. The second segment may include at least one cross-sectional dimension that is larger than an internal cross-section of the lumen. The plurality of individual segments may define an outer surface of the spacer 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 a first end region of the shaft.
As mentioned above, the present disclosure is not intended to be limited to a system or method which must satisfy one or more of any stated or implied object or feature of the present disclosure and should not be limited to the preferred, exemplary, or primary embodiment(s) described herein. The foregoing description of a preferred embodiment of the present disclosure has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the present disclosure to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The embodiment was chosen and described to provide the best illustration of the principles of the present disclosure and its practical application to thereby enable one of ordinary skill in the art to utilize the present disclosure in various embodiments and with various modifications as is suited to the particular use contemplated. All such modifications and variations are within the scope of the present disclosure as determined by the claims when interpreted in accordance with breadth to which they are fairly, legally and equitably entitled.

## Claims

1. A heart valve implant comprising:
a shaft extending generally along a longitudinal axis of said heart valve implant;
a spacer comprising a plurality of individual segments, wherein at least one of said plurality of individual segments is configured to be coupled to said shaft while disposed within a patient's heart, at least one of said plurality of individual segments includes a first fastener for coupling to an adjacent segment of said plurality of individual segments; at least one of said plurality of individual segments comprises an expendable portion to interact with at least a portion of at least one cusp of a patient's heart valve to at least partially restrict a flow of blood through said heart valve in a closed position; and
at least one anchor configured to be coupled to a first end region of said shaft.

2. A heart valve implant according to claim 1, wherein said plurality of individual segments includes a first segment, said heart valve implant further comprising a second fastener configured to couple said shaft with said first segment.

3. A heart valve implant according to claim 2, wherein said second fastener includes at least one detent.

4. A heart valve implant according to claim 3, wherein said at least one detent comprises a resilient detent configured to resiliently deform and at least partially recover.

5. A heart valve implant according to claim 4, wherein said at least one detent comprises a spring-biased detent.

6. A heart valve implant according to claim 4, wherein said at least one detent comprises a substantially solid detent.

7. A heart valve implant according to claim 1, wherein said plurality of individual segments including at least a first segment configured to be coupled to said shaft and at least a second segment configured to be coupled to at least a portion of an outer surface of said first segment.

8. A heart valve implant according to claim 1, wherein said expandable portion comprises an inflatable bladder.

9. A heart valve implant according to claim 1, wherein said expandable portion comprises a shape memory material configured to recoverably deform.

10. A heart valve implant according to claim 1, wherein said first fastener includes at least one detent configured to engage with said adjacent segment.

11. A heart valve implant system comprising:
a catheter including a lumen; and
a heart valve implant comprising:
a shaft extending generally along a longitudinal axis of said heart valve implant;
a spacer comprising a plurality of individual segments, wherein at least one of said plurality of individual segments is configured to be coupled to said shaft while disposed within a patient's heart, at least one of said plurality of individual segments includes a first fastener for coupling to an adjacent segment of said plurality of individual segments; and at least one of said plurality of individual segments comprises an expendable portion to interact with at least a portion of at least one cusp of a patient's heart valve to at least partially restrict a flow of blood through said heart valve in a closed position; and
at least one anchor configured to be coupled to a first end region of said shaft.

12. A heart valve implant system according to claim 11, wherein said plurality of individual segments includes a first segment, and said heart valve implant further comprises a second fastener configured to couple said shaft with said first segment.

13. A heart valve implant system according to claim 12, wherein said fastener includes at least one detent.

14. A heart valve implant according to claim 1, wherein said first fastener is chosen from an adhesive, a cement, a bonding, a molding, a weld, a detent, a protrusion, multiples thereof, and combinations thereof.

15. A heart valve implant comprising:
a shaft extending generally along a longitudinal axis of said heart valve implant;
a spacer configured to interact with at least a portion of at least one cusp of a patient's heart valve to at least partially restrict a flow of blood through said heart valve in a closed position, said spacer comprising a plurality of individual segments, wherein:
at least one of said plurality of individual segments is configured to be coupled to said shaft while disposed within a patient's heart, and at least one of said plurality of individual segments includes a first fastener for coupling to an adjacent segment of said plurality of individual segments;
said plurality of individual segments includes a first segment, said heart valve implant further comprising a second fastener configured to couple said shaft with said first segment, said second fastener comprising at least one detent, said at least one detent including a resilient detent configured to resiliently deform and at least partially recover; and
at least one anchor configured to be coupled to a first end region of said shaft.

16. A heart valve implant according to claim 15, wherein said at least one detent comprises a spring-biased detent.

17. A heart valve implant according to claim 15, wherein said at least one detent comprises a substantially solid detent.

18. A heart valve implant according to claim 15, wherein said first segment is configured to be coupled to said shaft, and said plurality of individual segments further comprises at least one second segment configured to be coupled to at least a portion of an outer surface of said first segment.

19. A heart valve implant according to claim 15, wherein at least one of said plurality of individual segments comprises an expandable portion.

20. A heart valve implant according to claim 19, wherein said expandable portion comprises an inflatable bladder.

21. A heart valve implant according to claim 19, wherein said expandable portion comprises a shape memory material configured to recoverably deform.

22. A heart valve implant according to claim 15, wherein said first fastener includes at least one detent configured to engage with said adjacent segment.

23. A heart valve implant system comprising:
a catheter including a lumen; and
a heart valve implant comprising:
a shaft extending generally along a longitudinal axis of said heart valve implant;
a spacer configured to interact with at least a portion of at least one cusp of a patient's heart valve to at least partially restrict a flow of blood through said heart valve in a closed position, said spacer comprising a plurality of individual segments, wherein:
at least one of said plurality of individual segments is configured to be coupled to said shaft while disposed within a patient's heart, and at least one of said plurality of individual segments includes a first fastener for coupling to an adjacent segment of said plurality of individual segments;
said plurality of individual segments includes a first segment, said heart valve implant further comprising a second fastener configured to couple said shaft with said first segment, said second fastener comprising at least one detent, said at least one detent including a resilient detent configured to resiliently deform and at least partially recover; and
at least one anchor configured to be coupled to a first end region of said shaft.

24. A heart valve implant according to claim 23, wherein said first fastener is chosen from an adhesive, a cement, a bonding, a molding, a weld, a detent, a protrusion, multiples thereof, and combinations thereof.

25. A heart valve implant system according to claim 24, wherein said first fastener includes at least one detent.