Heart valve assembly

Abstract

A heart valve assembly including: a frame including a first portion and a second portion, the first portion configured to move from an undeployed position to a deployed position via self-expansion, the second portion configured to move from an undeployed position to a deployed position via actuation of a balloon; a valve coupled to the second portion; and a plurality of tines moveably coupled to the frame; wherein the first portion is configured to move from the undeployed position to the deployed position before the second portion is configured to move from the undeployed position to the deployed position.

Description

Attorney Docket No. 026389-0049- WOO 1HEART VALVE ASSEMBLY CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a non-provisional of and claims the benefit of U.S. Provisional Patent Application No. 63 / 742,672, filed on January 7, 2025, the entire contents of which are incorporated herein by reference.FIELD OF THE DISCLOSURE

[0002] The present disclosure relates to a heart valve assembly and replacement of a native heart valve, and more specifically to an aortic valve assembly and replacement of a native aortic valve.BACKGROUND OF THE DISCLOSURE

[0003] Transcatheter valve replacement, especially transcatheter aortic valve replacement (TAVR), is a medical procedure that has revolutionized the treatment of aortic stenosis. The use of the TAVR procedure for the treatment of aortic regurgitation (AR) remains investigational.

[0004] Valves used in TAVR are either balloon-expandable or self-expandable. In a balloon-expandable valve for TAVR, the valve is mounted on a balloon and is deployed by inflating the balloon to anchor the valve in the native aortic valve. For a self-expandable valve used in TAVR, the valve is mounted on a self-expanding frame and is deployed by unsheathing the valve to anchor in the native aortic valve.

[0005] Due to the lack of calcification around the native valve to anchor the new valve, the use for AR is associated with higher complications, such as valve embolization. This risk is exponentially higher in patients with a left ventricular assist device (LVAD) where the pressure from the LVAD pump causes the closure of the valve, which leads to valve embolization into the ventricle. Case reports have confirmed this complication with both balloon-expandable and selfexpandable valves. Patients with LVAD commonly have AR to varying degrees.Attorney Docket No. 026389-0049- WOO 1

[0006] Accordingly, a need exists for a device and method that uses TAVR to replace the native aortic valve in order to address AR to improve patient outcomes and reduce costs associated with complications.SUMMARY

[0007] In some aspects, the techniques described herein relate to a heart valve assembly including: a frame including a first portion and a second portion, the first portion configured to move from an undeployed position to a deployed position via self-expansion, the second portion configured to move from an undeployed position to a deployed position via actuation of a balloon; a valve coupled to the second portion; and a plurality of tines moveably coupled to the frame; wherein the first portion is configured to move from the undeployed position to the deployed position before the second portion is configured to move from the undeployed position to the deployed position.

[0008] In some aspects, the techniques described herein relate to a heart valve assembly, wherein the plurality of tines each include a first end coupled to the frame and a second end opposite the first end, the plurality of tines is movable from a collapsed position in which the second end of each of the plurality of tines contacts or is adjacent to the frame and an expanded position in which the second end of each of the plurality of tines is spaced apart from the frame.

[0009] In some aspects, the techniques described herein relate to a heart valve assembly, wherein at least a portion of the plurality of tines is coupled to the first portion, the at least a portion of the plurality of tines being movable from the collapsed position to the expanded position as the first portion moves from the undeployed position to the deployed position.

[0010] In some aspects, the techniques described herein relate to a heart valve assembly, wherein at least a portion of the plurality of tines is coupled to the second portion, the at least a portion of the plurality of tines being movable from the collapsed position to the expanded position as the second portion moves from the undeployed position to the deployed position.

[0011] In some aspects, the techniques described herein relate to a heart valve assembly, wherein the plurality of tines is coupled to the first portion and the second portion, the pluralityAttorney Docket No. 026389-0049- WOO 1of tines being movable from the collapsed position to the expanded position as the respective first portion and second portion move from the undeployed position to the deployed position.

[0012] In some aspects, the techniques described herein relate to a heart valve assembly, further including a skirt coupled to and extending from the second portion.

[0013] In some aspects, the techniques described herein relate to a heart valve assembly including: a frame including an anchor frame portion and a valve frame portion coupled to the anchor, the anchor frame portion is configured to move from an undeployed position to a deployed position via self-expansion; a valve coupled to the valve frame portion adjacent the anchor frame portion; and a plurality of tines moveably coupled to the frame; wherein the anchor frame portion is configured to move from the undeployed position to the deployed position before the valve frame portion is configured to move from the undeployed position to the deployed position.

[0014] In some aspects, the techniques described herein relate to a heart valve assembly, wherein the plurality of tines each include a first end coupled to the frame and a second end opposite the first end, the plurality of tines are movable from a collapsed position in which the second end of each of the plurality of tines contacts or is adjacent to the frame and an expanded position in which the second end of each of the plurality of tines is spaced apart from the frame.

[0015] In some aspects, the techniques described herein relate to a heart valve assembly, wherein at least a portion of the plurality of tines are coupled to the anchor frame portion, the at least a portion of the plurality of tines being movable from the collapsed position to the expanded position as the anchor frame portion moves from the undeployed position to the deployed position.

[0016] In some aspects, the techniques described herein relate to a heart valve assembly, wherein at least a portion of the plurality of tines are coupled to the valve frame portion, the at least a portion of the plurality of tines being movable from the collapsed position to the expanded position as the valve frame portion moves from the undeployed position to the deployed position.

[0017] In some aspects, the techniques described herein relate to a heart valve assembly, wherein the plurality of tines is coupled to the anchor frame portion and the valve frame portion,Attorney Docket No. 026389-0049- WOO 1the plurality of tines being movable from the collapsed position to the expanded position as the respective anchor frame portion and valve frame portion move from the undeployed position to the deployed position.

[0018] In some aspects, the techniques described herein relate to a heart valve assembly, further including a skirt coupled to and extending from the valve frame portion.

[0019] In some aspects, the techniques described herein relate to a heart valve assembly, wherein at least the anchor frame portion is formed from nitinol.

[0020] In some aspects, the techniques described herein relate to a heart valve assembly including: a frame including an anchor frame portion configured to move from an undeployed position to a deployed position via self-expansion and including a curved inner edge, and a valve frame portion configured to move from an undeployed position to a deployed position via actuation of a balloon, the valve frame portion positioned adjacent to and downstream from the curved inner edge; a valve coupled to the valve frame adjacent to the curved inner edge; and a plurality of tines moveably coupled to the frame; wherein the anchor frame portion is configured to move from the undeployed position to the deployed position before the valve frame portion is configured to move from the undeployed position to the deployed position.

[0021] In some aspects, the techniques described herein relate to a heart valve assembly, wherein the plurality of tines each include a first end coupled to the frame and a second end opposite the first end, the plurality of tines is movable from a collapsed position in which the second end of each of the plurality of tines contacts or is adjacent to the frame and an expanded position in which the second end of each of the plurality of tines is spaced apart from the frame.

[0022] In some aspects, the techniques described herein relate to a heart valve assembly, wherein at least a portion of the plurality of tines is coupled to the anchor frame portion, the at least a portion of the plurality of tines being movable from the collapsed position to the expanded position as the anchor frame portion moves from the undeployed position to the deployed position.

[0023] In some aspects, the techniques described herein relate to a heart valve assembly, wherein at least a portion of the plurality of tines is coupled to the valve frame portion, the atAttorney Docket No. 026389-0049- WOO 1least a portion of the plurality of tines being movable from the collapsed position to the expanded position as the valve frame portion moves from the undeployed position to the deployed position.

[0024] In some aspects, the techniques described herein relate to a heart valve assembly, wherein the plurality of tines is coupled to the anchor frame portion and the valve frame portion, the plurality of tines being movable from the collapsed position to the expanded position as the respective anchor frame portion and valve frame portion move from the undeployed position to the deployed position.

[0025] In some aspects, the techniques described herein relate to a heart valve assembly, further including a skirt coupled to and extending from the valve frame portion.

[0026] In some aspects, the techniques described herein relate to a heart valve assembly, wherein at the anchor frame portion is formed from nitinol.BRIEF DESCRIPTION OF THE DRAWINGS

[0027] FIG. l is a side view of a heart valve assembly according to an embodiment of the present disclosure including a first frame portion and a second frame portion, each in an undeployed position.

[0028] FIG. 2 is a side view of the heart valve assembly of FIG. 1 with the first portion in a deployed position and the second portion in the undeployed position.

[0029] FIG. 3 is a side view of the heart valve assembly of FIG. 1 with the first portion in the deployed position and the second portion in a deployed position.DETAILED DESCRIPTION

[0030] Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.Attorney Docket No. 026389-0049- WOO 1

[0031] Currently available self-expandable valves suffer from a lack of precision but have better anchoring features to prevent valve embolization in a patient with an LVAD. Currently available balloon-expandable valves have the precision and anatomically modifying force to attach to the native valve at an optimal position but lack anchoring properties in LVAD patients.

[0032] The present disclosure combines self-expanding properties and balloon-expanding properties to provide a heart valve for use in patients with AR and who have an LVAD.

[0033] FIGS. 1-3 illustrate a heart valve assembly 10 according to an embodiment of the present disclosure. The heart valve assembly 10 includes a frame 14, a valve 18 operably coupled within the frame 14, and expandable tines 22 supported by the frame 14.

[0034] The frame 14 includes a first end 26 and a second end 30 opposite the first end 26. The frame 14 includes a self-expandable portion 50 (e.g., a self-expandable anchor or anchor frame portion) and a balloon-expandable portion 60 (e.g., a balloon-expandable valve frame or valve frame portion). The self-expandable portion 50 extends from the first end 26 towards the second end 30. The balloon-expandable portion 60 extends form the self-expandable portion 50 toward the second end 30. In the illustrated embodiment, the self-expandable portion 50 and the balloon-expandable portion 60 are formed as a single piece. In other embodiments, the selfexpandable portion 50 and the balloon-expandable portion 60 may be coupled to one another via any suitable mechanism. The self-expandable portion 50 is formed from a first material (e.g., nitinol) such that it is capable of self-expansion. The balloon-expandable portion 60 is formed from another biologically suitable material and expandable by a balloon.

[0035] As illustrated, the self-expandable portion 50 has a curved inner edge 70 that is positioned at an intermediate location between the first end 26 and the second end 30. As shown, the curved inner edge 70 is positioned adjacent to the balloon-expandable portion 60. The curved inner edge 70 extends from or otherwise intersects the balloon-expandable portion 60. Also, as shown, the curved inner edge 70 circumscribes the balloon-expandable portion 60.

[0036] In the illustrated embodiment, the valve 18 is operably coupled to the balloonexpandable portion 60. That is, the valve 18 includes a plurality of leaflets that is coupled to an inner surface of the balloon-expandable portion 60 at a location adjacent to the self-expandableAttorney Docket No. 026389-0049- WOO 1portion 50. The valve 18 is coupled to the balloon-expandable portion 60 adjacent to the curved inner edge 70 of the self-expandable portion 50. The balloon-expandable portion 60 also includes a skirt 74 that is coupled at or adjacent to the second end of the frame 14. The skirt 74 extends beyond the second end and is configured to prevent leakage.

[0037] One or both of the self-expandable portion 50 and the balloon-expandable portion 60 may include expandable tines 22. The tines 22 are configured to expand away from the respective part of the frame 14 during deployment. Each of the tines 22 includes a first end coupled to the frame 14 and a second end opposite the first end. The tines 22 are movable from a collapsed position and an expanded position. In the collapsed position, the second ends of the tines 22 contact or are adjacent to the frame 14. In the expanded position, the second ends of the tines are spaced apart from the frame 14.

[0038] The self-expandable portion 50 is movable between an undeployed position and a deployed position. The self-expandable portion 50 is configured to move from the undeployed position to the deployed position via self-expansion. That is, the self-expandable portion 50, when unconstrained, is biased into its deployed position. Similarly, the balloon-expandable portion 60 is movable between an undeployed position and a deployed position. The balloonexpandable portion 60 is movable from the undeployed position to the deployed position via expansion of a balloon on which the balloon expandable portion and valve 18 coupled thereto are positioned. The valve assembly 10 is positioned within a delivery sheath 100 and is delivered to a site of deployment (e.g., a native aortic valve) via the delivery sheath.

[0039] In use, the surgeon uses a delivery sheath to deliver the valve assembly 10 to the location of the native aortic valve. Once the valve assembly 10 is appropriately positioned (as shown in FIG. 2) with the balloon-expandable portion 60 extending through a native aortic valve opening 104, the delivery sheath 100 can be retracted to allow the self-expandable portion 50 to move from the undeployed position to the deployed position. That is, the self-expandable portion 50 expands above the opening 104 of the native aortic valve. The self-expandable portion 50 is sized and shaped to be larger than the opening 104 of the aortic valve in the deployed position. Additionally, as the self-expandable portion 50 expands and is advanced, the tines 22 move from the collapsed position to the expanded position to engage the aortic root wallAttorney Docket No. 026389-0049- WOO 1108. With the self-expandable portion 50 in place, the surgeon can expand the balloonexpandable portion 60 using the balloon as shown in FIG. 3. If there are tines 22 on the balloonexpandable portion 60, they will move from the collapsed position to the expanded position to engage the aortic annulus 112. The balloon-expandable portion 60 enables sufficient anatomical modifying force to fully expand the valve 18 and prevent paravalvular leak. Once the respective portions of the frame 14 are deployed, the valve 18 is appropriately positioned in the opening 104 of the native aortic valve. The skirt 74 prevents leakage as noted above.

[0040] The valve assembly 10 is configured to provide anchoring (via the tines), precise positioning (via the balloon expandable portion), anatomical modifying anchoring force (via the balloon expandable portion), reduced paravalvular leak (via the balloon expandable portion), and minimize the risk of migration and embolization (via the self-expandable portion). More specifically, the valve assembly 10 provides stability in a non-calcified stenotic aortic valve (e.g., prevents migration / embolization) via the self-expandable portion. It can self-accommodate the aortic portion and provide anchoring without risk of rupturing the aorta. Further, the balloon expandable portion provides precision in positioning of the valve and stronger anchoring with a stronger radial force to modify the aortic annulus, which will result in less paravalvular leak. The balloon expandable valve has a stronger radial force than any self-expandable valve. It combines the technology of a controlled self-expanding anchor and the precision of a balloonexpanding valve to enhance the anchoring, as noted above.

[0041] The terms “substantially,” “essentially,” “approximately,” “about,” or any other version thereof, are defined as being close to as understood by one of ordinary skill in the art, and in one non-limiting embodiment the term is defined to be within 10%, in another embodiment within 5%, in another embodiment within 1% and in another embodiment within 0.5%. The term “one of,” without a more limiting modifier such as “only one of,” and when applied herein to two or more subsequently defined options such as “one of A and B” should be construed to mean an existence of any one of the options in the list alone (e.g., A alone or B alone) or any combination of two or more of the options in the list (e.g., A and B together).

[0042] Any numerical range recited herein includes all values from the lower value to the upper value. For example, if a range is stated as 1% to 50%, it is intended that the narrowerAttorney Docket No. 026389-0049- WOO 1ranges thereof, such as 2% to 40%, 10% to 30%, 1% to 3%, etc., are expressly enumerated by said statement. These specific examples represent only a limited subset of what is intended to be covered, and all possible combinations of numerical values between and including the lowest value and the highest value of the enumerated range are to be considered to be expressly stated in this application.

[0043] A device or structure that is “configured” in a certain way is configured in at least that way but may also be configured in ways that are not listed.

[0044] The terms “coupled,” “coupling,” or “connected” as used herein can have several different meanings depending on the context in which these terms are used. For example, the terms coupled, coupling, or connected can have a mechanical or electrical connotation. For example, as used herein, the terms coupled, coupling, or connected can indicate that two elements or devices are directly connected to one another or connected to one another through intermediate elements or devices via an electrical element, electrical signal or a mechanical element depending on the particular context.

[0045] In the foregoing specification, specific embodiments are described. However, one of ordinary skill in the art appreciates that various modifications and changes may be made without departing from the scope of the invention as set forth in the claims below. Accordingly, the specification and figures are to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope of present teachings.

[0046] One of ordinary skill in the art appreciates that various modifications and changes can be made without departing from the scope of the invention as set forth in the claims below. The benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential features or elements of any or all the claims. The invention is defined solely by the appended claims including any amendments made during the pendency of this application and all equivalents of those claims as issued.

[0047] Moreover, in this document, relational terms such as first and second, top and bottom, and the like may be used solely to distinguish one entity or action from another entity or actionAttorney Docket No. 026389-0049- WOO 1without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terms “comprises,” “comprising,” “has,” “having,” “includes,” “including,” “contains,” “containing,” or any other variation thereof, are intended to cover a nonexclusive inclusion, such that a process, method, article, or apparatus that comprises, has, includes, contains a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by “comprises ...a,” “has ...a,” “includes ... a,” or “contains ...a” does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises, has, includes, contains the element. Unless the context of their usage unambiguously indicates otherwise, the articles “a,” “an,” and “the” should not be interpreted as meaning “one” or “only one.” Rather these articles should be interpreted as meaning “at least one” or “one or more.” Likewise, when the terms “the” or “said” are used to refer to a noun previously introduced by the indefinite article “a” or “an,” “the” and “said” mean “at least one” or “one or more” unless the usage unambiguously indicates otherwise.

[0048] Various additional features and advantages of the invention are set forth in the following claims.

Claims

Attorney Docket No. 026389-0049- WOO 1CLAIMSWhat is claimed is:

1. A heart valve assembly comprising:a frame including a first portion and a second portion, the first portion configured to move from an undeployed position to a deployed position via self-expansion, the second portion configured to move from an undeployed position to a deployed position via actuation of a balloon;a valve coupled to the second portion; anda plurality of tines moveably coupled to the frame;wherein the first portion is configured to move from the undeployed position to the deployed position before the second portion is configured to move from the undeployed position to the deployed position.

2. The heart valve assembly of claim 1, wherein the plurality of tines each include a first end coupled to the frame and a second end opposite the first end, the plurality of tines is movable from a collapsed position in which the second end of each of the plurality of tines contacts or is adjacent to the frame and an expanded position in which the second end of each of the plurality of tines is spaced apart from the frame.

3. The heart valve assembly of claim 2, wherein at least a portion of the plurality of tines is coupled to the first portion, the at least a portion of the plurality of tines being movable from the collapsed position to the expanded position as the first portion moves from the undeployed position to the deployed position.

4. The heart valve assembly of claim 2, wherein at least a portion of the plurality of tines is coupled to the second portion, the at least a portion of the plurality of tines being movable from the collapsed position to the expanded position as the second portion moves from the undeployed position to the deployed position.Attorney Docket No. 026389-0049- WOO 15. The heart valve assembly of claim 2, wherein the plurality of tines is coupled to the first portion and the second portion, the plurality of tines being movable from the collapsed position to the expanded position as the respective first portion and second portion move from the undeployed position to the deployed position.

6. The heart valve assembly of claim 1, further comprising a skirt coupled to and extending from the second portion.

7. A heart valve assembly comprising:a frame including an anchor frame portion and a valve frame portion coupled to the anchor, the anchor frame portion is configured to move from an undeployed position to a deployed position via self-expansion;a valve coupled to the valve frame portion adjacent the anchor frame portion; anda plurality of tines moveably coupled to the frame;wherein the anchor frame portion is configured to move from the undeployed position to the deployed position before the valve frame portion is configured to move from the undeployed position to the deployed position.

8. The heart valve assembly of claim 7, wherein the plurality of tines each include a first end coupled to the frame and a second end opposite the first end, the plurality of tines are movable from a collapsed position in which the second end of each of the plurality of tines contacts or is adjacent to the frame and an expanded position in which the second end of each of the plurality of tines is spaced apart from the frame.

9. The heart valve assembly of claim 8, wherein at least a portion of the plurality of tines are coupled to the anchor frame portion, the at least a portion of the plurality of tines being movable from the collapsed position to the expanded position as the anchor frame portion moves from the undeployed position to the deployed position.

10. The heart valve assembly of claim 8, wherein at least a portion of the plurality of tines are coupled to the valve frame portion, the at least a portion of the plurality of tines being movableAttorney Docket No. 026389-0049- WOO 1from the collapsed position to the expanded position as the valve frame portion moves from the undeployed position to the deployed position.

11. The heart valve assembly of claim 8, wherein the plurality of tines is coupled to the anchor frame portion and the valve frame portion, the plurality of tines being movable from the collapsed position to the expanded position as the respective anchor frame portion and valve frame portion move from the undeployed position to the deployed position.

12. The heart valve assembly of claim 7, further comprising a skirt coupled to and extending from the valve frame portion.

13. The heart valve assembly of claim 7, wherein at least the anchor frame portion is formed from ni tinol.

14. A heart valve assembly comprising:a frame includingan anchor frame portion configured to move from an undeployed position to a deployed position via self-expansion and including a curved inner edge, anda valve frame portion configured to move from an undeployed position to a deployed position via actuation of a balloon, the valve frame portion positioned adjacent to and downstream from the curved inner edge;a valve coupled to the valve frame adjacent to the curved inner edge; anda plurality of tines moveably coupled to the frame;wherein the anchor frame portion is configured to move from the undeployed position to the deployed position before the valve frame portion is configured to move from the undeployed position to the deployed position.

15. The heart valve assembly of claim 14, wherein the plurality of tines each include a first end coupled to the frame and a second end opposite the first end, the plurality of tines is movable from a collapsed position in which the second end of each of the plurality of tines contacts or isAttorney Docket No. 026389-0049- WOO 1adjacent to the frame and an expanded position in which the second end of each of the plurality of tines is spaced apart from the frame.

16. The heart valve assembly of claim 15, wherein at least a portion of the plurality of tines is coupled to the anchor frame portion, the at least a portion of the plurality of tines being movable from the collapsed position to the expanded position as the anchor frame portion moves from the undeployed position to the deployed position.

17. The heart valve assembly of claim 15, wherein at least a portion of the plurality of tines is coupled to the valve frame portion, the at least a portion of the plurality of tines being movable from the collapsed position to the expanded position as the valve frame portion moves from the undeployed position to the deployed position.

18. The heart valve assembly of claim 15, wherein the plurality of tines is coupled to the anchor frame portion and the valve frame portion, the plurality of tines being movable from the collapsed position to the expanded position as the respective anchor frame portion and valve frame portion move from the undeployed position to the deployed position.

19. The heart valve assembly of claim 14, further comprising a skirt coupled to and extending from the valve frame portion.

20. The heart valve assembly of claim 14, wherein at the anchor frame portion is formed from ni tinol.

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