Mitral valve prosthesis

• US 10,588,741 B2
• Filed: 11/04/2016
• Issued: 03/17/2020
• Est. Priority Date: 11/06/2015
• Status: Active Grant

• Current Assignee: Micor Limited (Super Group Limited)
• Original Assignee: Micor Limited (Super Group Limited)
• Inventors: Zhang, Ji, Walsh, Brandon G., Yang, Cheng Y., Zhu, Jinhua
• Primary Examiner(s): Holwerda, Kathleen S
• Application Number:
  US15/344,486
• Publication Number:
  US 20170128203A1
• Time in Patent Office: 1,229 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A mitral valve prosthesis can be delivered within the native mitral annulus. The valve prosthesis has a valve component on which prosthetic valve leaflets are attached, and a lower support which anatomically and dynamically conforms to a native mitral valve annulus and which is flexibly attached to the valve component. The valve prosthesis can be delivered to the native mitral valve annulus in a collapsed configuration in which the valve component and anchoring element are serially rather than concentrically positioned to one another, thereby minimizing the diameter of the valve prosthesis during delivery. The devices and methods described are useful for treatment of various mitral valve disorders which result in, for example, mitral regurgitation.

Claims

1. A heart valve prosthesis comprising:

an upper support comprising a D-shaped ring component, the upper support being configured to be positioned adjacent to a native valve structure of a patient and comprising an anterior portion and a posterior portion;

a lower support, separate from the upper support, configured to engage the native valve structure from a ventricular side, comprising at least two engagement members, the upper support and the lower support collectively forming an anchoring element;

a flexible connector comprising an upper end portion coupled to the upper support and a lower end portion coupled to the lower support;

a valve component comprising an outer surface and a central orifice, the valve component being disposable intermediate the upper and lower supports, the valve component being radially expandable within the lower support to abut the native valve structure and to permit one-way flow therethrough along a central axis of the prosthesis upon expansion of the valve component; and

a coupler component having a first end portion attached to the anchoring element and a second end portion attached to the valve component, the coupler component providing a range of free relative movement between the valve component and the anchoring element, wherein the range of free relative movement includes (i) a range of free relative rotation between the valve component and the anchoring element, and (ii) a range of free relative longitudinal displacement between the valve component and the anchoring element,

wherein the lower support and the upper support are radially expandable from a collapsed configuration to an expanded configuration for delivery within the patient.

2. The valve prosthesis of claim 1, wherein the posterior portion of the upper support comprises a semicircular shape.

3. The valve prosthesis of claim 1, wherein the anterior portion of the upper support bends along an axis extending transverse relative to the central axis.

4. The valve prosthesis of claim 3, wherein the anterior portion of the upper support comprises a semicircular shape.

5. The valve prosthesis of claim 1, wherein in an expanded state, the posterior portion of the upper support extends within a first plane and the anterior portion of the upper support extends within a second plane, and wherein the first plane extends transversely relative to the second plane.

6. The valve prosthesis of claim 1, wherein the flexible connector comprises a tubular shape.

7. The valve prosthesis of claim 1, wherein the upper support is axially moveable within a fixed distance relative to the lower support, wherein the fixed distance is about equal to an axial length of the flexible connector.

8. The valve prosthesis of claim 1, wherein in an expanded state, the flexible connector comprises a tapering tubular shape.

9. The valve prosthesis of claim 1, wherein the lower support comprises a second ring-shaped component, the at least two engagement members being coupled to the second ring-shaped component.

10. The valve prosthesis of claim 1, further comprising a filler component coupled to a perimeter of the upper support.

11. The valve prosthesis of claim 10, wherein the filler component comprises a tubular shape and an upper end portion coupled to the perimeter of the upper support.

12. The valve prosthesis of claim 1, wherein the coupler component comprises a suture having a fixed length between the first end portion and the second end portion that determines the range of free relative movement and permits the valve component and the anchoring element to be longitudinally displaced from each other when interconnected.

13. The valve prosthesis of claim 1, wherein the coupler component comprises a tubular fabric sheet having a fixed length between the first end portion and the second end portion that determines the range of free relative movement and permits the valve component and the anchoring element to be longitudinally displaced from each other when interconnected.

14. The valve prosthesis of claim 1, wherein the upper support, the lower support, and the valve component are each independently expandable, rotatable, and longitudinally movable relative to each other when interconnected via the flexible connector and the coupler component.

15. The valve prosthesis of claim 1, wherein the first end portion of the coupler component is attached to a fixed position on the anchoring element and the second end portion of the coupler component is attached to a fixed position on the valve component.

16. The valve prosthesis of claim 1, wherein the range of free relative rotation is up to a limit of between about 180 degrees to 460 degrees of relative rotation between the valve component and the anchoring element, and wherein the range of free relative longitudinal displacement is up to a limit of between about 10% to 100% of a length of the valve component.

17. The valve prosthesis of claim 1, wherein the at least two engagement members comprise three hooks, the three hooks including first and second hooks positioned opposite each other, and a third hook positioned midway between the first and second hooks.

18. A heart valve prosthesis comprising:

an anchoring element comprising an upper support having a D-shaped ring component, a lower support separate from the upper support, and a flexible connector, the upper support being configured to be positioned adjacent to a native valve structure of a patient, the lower support being configured to engage a native valve structure from a ventricular side, the flexible connector comprising an upper end portion coupled to the upper support and a lower end portion coupled to the lower support; and

a valve component coupled to the lower support via a coupler component having a first end portion attached to the lower support and a second end portion attached to the valve component, the coupler component providing a range of free relative movement between the valve component and the lower support, the valve component being radially expandable within the lower support to abut the native valve structure wherein the range of free relative movement includes (i) a range of free relative rotation between the valve component and the anchoring element, and (ii) a range of free relative longitudinal displacement between the valve component and the anchoring element.

19. The valve prosthesis of claim 18, wherein an anterior portion of the upper support bends along an axis extending transverse relative to a central axis of the prosthesis.

20. The valve prosthesis of claim 18, wherein a posterior portion of the upper support extends within a first plane and an anterior portion of the upper support extends within a second plane, and wherein the first plane extends transversely relative to the second plane.

21. The valve prosthesis of claim 18, wherein the lower support comprises a plurality of arcuate sections, each arcuate section extending intermediate respective engagement members to form the lower support.

22. The valve prosthesis of claim 18, wherein the lower support comprises a second ring-shaped component and at least two engagement members coupled to the second ring-shaped component.

23. The valve prosthesis of claim 22, wherein the at least two engagement members comprise hooks.

24. The valve prosthesis of claim 18, further comprising a filler component coupled to a perimeter of the upper support.

25. The valve prosthesis of claim 18, wherein the coupler component has a flexible material of fixed length that restricts the range of free relative movement to a maximum longitudinal displacement between the anchoring element and the valve component.

26. The valve prosthesis of claim 18, wherein the lower support comprises a gathering arm extending radially outward from a central axis of the prosthesis, the gathering arm being configured to engage native tissue against the lower support.

27. A heart valve prosthesis delivery system comprising:

a heart valve prosthesis comprising an upper support having a D-shaped ring component, a lower support separate from the upper support, a flexible connector coupling the upper support to the lower support, and a valve component coupled to the lower support via a coupler component having a first end portion attached to the lower support and a second end portion attached to the valve component, the coupler component providing a range of free relative movement between the valve component and the lower support, the upper support being configured to be positioned adjacent to a native valve structure of a patient, the lower support being configured to engage the native valve structure from a ventricular side, the valve component being radially expandable within the lower support to abut the native valve structure wherein the range of free relative movement includes (i) a range of free relative rotation between the valve component and the lower support, and (ii) a range of free relative longitudinal displacement between the valve component and the lower support; and

a delivery device comprising a core member, a first sheath coupled to the core member, and a second sheath extending over the core member, proximal to the first sheath,

wherein the delivery device can maintain the valve prosthesis in a collapsed configuration with the first sheath enclosing at least a portion of the valve component and the second sheath enclosing at least a portion of the upper and lower supports, and

wherein the first and second sheath are movable to expose the upper and lower supports to anchor the valve prosthesis within the patient and thereafter release the valve component within the lower support.

28. The delivery system of claim 27, wherein a distal portion of the valve component is enclosed by a proximal portion of the first sheath and a proximal portion of the valve component is enclosed by a distal portion of the second sheath.

29. The delivery system of claim 27, wherein the lower support comprises a plurality of engagement members, and wherein the delivery device further comprises a plurality of anchor control components being releasably coupled to the engagement members when the valve prosthesis is in the collapsed configuration.

30. The delivery system of claim 29, wherein the plurality of anchor control components extends longitudinally within the second sheath.

31. The delivery system of claim 29, further comprising a gathering wire, the gathering wire being positionable and collapsible around the prosthesis to engage native tissue against the prosthesis.

32. A heart valve prosthesis comprising:

an upper support, configured to be positioned adjacent to a native valve structure of a patient, comprising a D-shaped ring component having an anterior portion and a posterior portion;

a lower support, separate from the upper support, configured to engage the native valve structure from a ventricular side, comprising at least two engagement members, the upper support and the lower support collectively forming an anchoring element;

a flexible connector comprising an upper end portion coupled to the upper support and a lower end portion coupled to the lower support;

a valve component comprising an outer surface and a central orifice, the valve component being disposable intermediate the upper and lower supports, the valve component being radially expandable within the lower support to abut the native valve structure and to permit one-way flow therethrough along a central axis of the prosthesis upon expansion of the valve component; and

a coupler component having a first end portion attached to the anchoring element and a second end portion attached to the valve component, the coupler component providing a range of free relative movement between the valve component and the anchoring element, wherein the coupler component comprises a suture having a fixed length between the first end portion and the second end portion that determines the range of free relative movement and permits the valve component and the anchoring element to be longitudinally displaced from each other when interconnected.

33. A heart valve prosthesis comprising:

an upper support, configured to be positioned adjacent to a native valve structure of a patient, comprising a D-shaped ring component having an anterior portion and a posterior portion;

a lower support, separate from the upper support, configured to engage the native valve structure from a ventricular side, comprising at least two engagement members, the upper support and the lower support collectively forming an anchoring element;

a flexible connector comprising an upper end portion coupled to the upper support and a lower end portion coupled to the lower support;

a valve component comprising an outer surface and a central orifice, the valve component being disposable intermediate the upper and lower supports, the valve component being radially expandable within the lower support to abut the native valve structure and to permit one-way flow therethrough along a central axis of the prosthesis upon expansion of the valve component; and

a coupler component having a first end portion attached to the anchoring element and a second end portion attached to the valve component, the coupler component providing a range of free relative movement between the valve component and the anchoring element, wherein the coupler component comprises a tubular fabric sheet having a fixed length between the first end portion and the second end portion that determines the range of free relative movement and permits the valve component and the anchoring element to be longitudinally displaced from each other when interconnected.

34. A heart valve prosthesis comprising:

an upper support, configured to be positioned adjacent to a native valve structure of a patient, comprising a D-shaped ring component having an anterior portion and a posterior portion;

a lower support, separate from the upper support, configured to engage the native valve structure from a ventricular side, comprising at least two engagement members, the upper support and the lower support collectively forming an anchoring element;

a flexible connector comprising an upper end portion coupled to the upper support and a lower end portion coupled to the lower support;

a valve component comprising an outer surface and a central orifice, the valve component being disposable intermediate the upper and lower supports, the valve component being radially expandable within the lower support to abut the native valve structure and to permit one-way flow therethrough along a central axis of the prosthesis upon expansion of the valve component; and

a coupler component having a first end portion attached to the anchoring element and a second end portion attached to the valve component, the coupler component providing a range of free relative movement between the valve component and the anchoring element, wherein the upper support, the lower support, and the valve component are each independently expandable, rotatable, and longitudinally movable relative to each other when interconnected via the flexible connector and the coupler component.

35. A heart valve prosthesis comprising:

an anchoring element comprising an upper support having a D-shaped ring component, a lower support separate from the upper support, and a flexible connector, the upper support being configured to be positioned adjacent to a native valve structure of a patient, the lower support being configured to engage a native valve structure from a ventricular side, the flexible connector comprising an upper end portion coupled to the upper support and a lower end portion coupled to the lower support; and

a valve component coupled to the anchoring element via a coupler component having a first end portion attached to the lower support and a second end portion attached to the valve component, the coupler component providing a range of free relative movement between the valve component and the lower support, the valve component being radially expandable within the lower support to abut the native valve structure wherein the range of free relative movement includes (i) a range of free relative rotation between the valve component and the anchoring element, and (ii) a range of free relative longitudinal displacement between the valve component and the anchoring element.