SYSTEM FOR MITRAL VALVE REPAIR AND REPLACEMENT

• US 20120165930A1
• Filed: 12/16/2011
• Published: 06/28/2012
• Est. Priority Date: 12/23/2010
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: The Foundy LLC
• Inventors: GIFFORD, Hanson S. III, FANN, James I., MORRISS, John, DEEM, Mark, GRAINGER, Jeffry J.
• Granted Patent: US 9,421,098 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0008 for adjusting a position by translation along an axis or two perpendicular axes
• CPC Class Codes: A61F 2250/006 modular

Abstract

Systems for mitral valve repair are disclosed where one or more mitral valve interventional devices may be advanced intravascularly into the heart of a patient and deployed upon or along the mitral valve to stabilize the valve leaflets. The interventional device may also facilitate the placement or anchoring of a prosthetic mitral valve implant. The interventional device may generally comprise a distal set of arms pivotably and/or rotating coupled to a proximal set of arms which are also pivotably and/or rotating coupled. The distal set of arms may be advanced past the catheter opening to a subannular position (e.g., below the mitral valve) and reconfigured from a low-profile delivery configuration to a deployed securement configuration. The proximal arm members may then be deployed such that the distal and proximal arm members may grip the leaflets between the two sets of arms to stabilize the leaflets.

Claims

1. A system for the treatment of conditions affecting the mitral valve, comprising:

a proximal stabilizing structure having a first pair of arm members pivotably coupled to a second pair of arm members; and

a distal stabilizing structure having a third pair of arm members-pivotably coupled to a fourth pair of arm members;

wherein the distal and proximal stabilizing structures arc pivotably coupled via at least one link such that the distal and proximal stabilizing structures are configurable between an axially-elongated configuration and a laterally-elongated configuration.

2. The system of claim 1 further comprising a catheter within which the apparatus is positionable in its axially-elongated delivery configuration.

3. The system of claim 1 further comprising a stent, scaffold, or valve implant which is anchorable to the apparatus.

4. The system of claim 1 further comprising one or more locking mechanisms along the apparatus for securing a configuration of the apparatus.

5. The system of claim 1 wherein at least one of the arm members in the distal stabilizing structure or the proximal stabilizing structure is comprised of a plurality of links or segments.

6. The system of claim 1 wherein at least one of the arm members further comprise one or more projections or protrusions along a surface of the arm members.

7. The system of claim 1 wherein a length of the third and/or fourth pair of arm members are shorter than a length of the first and/or second arm members.

8. The system of claim 1 in which the proximal and distal stabilizing structures are radially offset from one another.

9. The system of claim 1 further comprising an extension arm member attached to the first or second pair of arm members, the extension arm member having a length which extends beyond the first or second pair of arm members.

10. The system of claim 1 wherein the distal stabilizing structure comprises at least one pair of telescoping arm members which are reconfigurable between an axially-elongated configuration and an extended configuration.

11. The system of claim 1 further comprising a valve prosthesis positionable against or along the distal and/or proximal stabilizing structures.

12. A system for the treatment of conditions affecting the mitral valve, comprising:

a proximal stabilizing structure having a first pair of arm members pivotably coupled to a second pair of arm members; and

a distal stabilizing structure having a third pair of arm members pivotably coupled to a fourth pair of arm members;

wherein the distal and proximal stabilizing structures are pivotably coupled via at least one link such that the distal and proximal stabilizing structures are configurable between an axially-elongated configuration and a laterally-elongated configuration.

wherein at least one of the arm members in the distal stabilizing structure or the proximal stabilizing structure is comprised of a plurality of links or segments.

13. A system for the treatment of conditions affecting the mitral valve, comprising:

a proximal stabilizing structure having a first pair of arm members pivotably coupled to a second pair of arm members; and

a distal stabilizing structure having a third pair of arm members pivotably coupled to a fourth pair of arm members;

wherein the distal and proximal stabilizing structures are pivotably coupled via at least one link such that the distal and proximal stabilizing structures are configurable between an axially-elongated configuration and a laterally-elongated configuration.

wherein at least one of the arm members further comprise one or more projections or protrusions along a surface of the arm members.

14. A system for the treatment of conditions affecting the mitral valve, comprising:

a proximal stabilizing structure having a first pair of arm members pivotably coupled to a second pair of arm members; and

a distal stabilizing structure having a third pair of arm members pivotably coupled to a fourth pair of arm members wherein a length of the third and/or fourth pair of arm members are shorter than a length of the first and/or second arm members;

wherein the distal and proximal stabilizing structures are pivotably coupled via at least one link such that the distal and proximal stabilizing structures are configurable between an axially-elongated configuration and a laterally-elongated configuration.

15. A system the treatment of conditions affecting the mitral valve, comprising:

a proximal stabilizing structure having a first pair of arm members pivotably coupled to a second pair of arm members; and

a distal stabilizing structure having a third pair of arm members pivotably coupled to a fourth pair of arm members;

wherein the distal and proximal stabilizing structures are pivotably coupled via at least one link such that the distal and proximal stabilizing structures are configurable between an axially-elongated configuration and a laterally-elongated configuration in which the first and second assemblies are radially offset from one another.

16. A system for the treatment of conditions affecting the mitral valve, comprising:

a proximal stabilizing structure having a first pair of arm members pivotably coupled to a second pair of arm members;

a distal stabilizing structure having a third pair of arm members pivotably coupled to a fourth pair of arm members; and

,

an extension arm member attached to the first or second pair of arm members, the extension arm member having an length which extends beyond the first or second pair of arm members;

wherein the distal and proximal stabilizing structures are pivotably coupled via at least one link such that the distal and proximal stabilizing structures are configurable between an axially-elongated configuration and a laterally-elongated configuration.

17. A system the treatment of conditions affecting the mitral valve, comprising:

a proximal stabilizing structure having a first pair of arm members pivotably coupled to a second pair of arm members;

a distal stabilizing structure having at least one pair of telescoping arm members which are reconfigurable between a axially-elongated configuration and an extended configuration; and

,

wherein the proximal stabilizing structure is pivotably coupled via at least one link to the distal stabilizing structure such that the proximal stabilizing structure is configurable between an axially-elongated configuration and a laterally-elongated configuration.

18. A system for the treatment of conditions affecting the mitral valve, comprising:

a support ring positionable within or above an annulus of the mitral valve;

a reconfigurable retaining member positionable in a subannular space of the mitral valve; and

a coupling mechanism for coupling the retaining member to the support ring.

19. The system of claim 18 wherein the support ring is reconfigurable between a low-profile compressed configuration for delivery within a catheter and a deployed expanded configuration.

20. The system of claim 19 wherein the support ring approximates a shape of the mitral valve when deployed.

21. The system of claim 18 wherein the reconfigurable retaining member comprises a distal stabilizing structure having a first pair of arm members pivotably coupled to a second pair of arm members such that the assembly is configurable between an axially-elongated configuration and a laterally-elongated configuration.

22. The system of claim 18 wherein the coupling mechanism is attached to a proximal portion of the retaining member.

23. The system of claim 22 wherein the support ring defines at least one opening sized to receive the coupling member in a locking configuration.

24. The system of claim 18 wherein the coupling mechanism comprises a locking member unidirectionally connectable to the support ring.

25. A system for the treatment of conditions affecting the mitral valve, comprising:

a support ring positionable within or above an annulus of the mitral valve; and

a distal stabilizing structure having a first pair of arm members pivotably coupled to a second pair of arm members such that the assembly is configurable between an axially-elongated configuration and a laterally-elongated configuration.

26. A system for the treatment of conditions affecting the mitral valve, comprising:

an elongate catheter having a detachable connector at a distal end of the catheter, the connector defining two or more openings in apposition relative to one another about a circumference of the connector;

a first pair of arm members reconfigurable between a straightened configuration for delivery and a curved configuration when advanced through at least one of the openings, wherein the first pair of arm member in the straightened configuration define an angle relative to the catheter; and

a second pair of arm members reconfigurable between a straightened configuration for delivery and a curved configuration when advanced through at least one of the openings, wherein the second pair of arm member in the straightened configuration define an angle relative to the catheter and adjacent to the first pair of arm members.

27. The system of claim 26 wherein each of the arm members define an atraumatic distal tip.

28. The system of claim 26 wherein the arm members are inflatable.

29. The system of claim 26 further comprising an inner catheter which is longitudinally translatable relative to the catheter, the inner catheter having a second detachable connector defining two or more openings through which the second pair of arm members are advanced.

30. A method for the treatment of conditions affecting the mitral valve, comprising:

positioning a first assembly having a first pair of arm members pivotably coupled to a second pair of arm members in a subannular position;

reconfiguring the first assembly from a low-profile delivery configuration to an expanded curved configuration against a subannular surface of the mitral valve;

positioning a second assembly having a third pair of arm members pivotably coupled to a fourth pair of arm members in a supra-annular position; and

reconfiguring the second assembly from a low-profile delivery configuration to an expanded curved configuration against a supra-annular leaflet surface such that valve leaflets and/or annulus are compressed between the first and second assemblies.

31. The method of claim 30 wherein positioning a first assembly comprises advancing the first assembly intravascularly into a left atrial chamber.

32. The method of claim 30 wherein positioning a first assembly comprises deploying the first assembly from the low-profile delivery configuration from within a catheter lumen.

33. The method of claim 30 wherein reconfiguring the first assembly comprises urging a distal end of the first assembly proximally towards a proximal end of the first assembly.

34. The method of claim 30 wherein positioning a second assembly comprises deploying the second assembly from the low-profile delivery configuration from within a catheter lumen.

35. The method of claim 30 wherein reconfiguration the second assembly comprises urging a distal end of the second assembly towards a proximal end of the second assembly.

36. The method of claim 30 further comprising locking the first and second assemblies in the compressed configuration.

37. The method of claim 30 further comprising positioning a third assembly and a fourth assembly coupled to the third assembly into apposition relative to the first and second assemblies along the mitral valve.

38. The method of claim 30 further comprising anchoring a valve prosthesis against or along the first and second assemblies and through the mitral valve.

39. A method for the treatment of conditions affecting the mitral valve, comprising:

positioning a first assembly having a first pair of arm members pivotably coupled to a second pair of arm members along a subannular position;

positioning a second assembly haying a third pair of arm members pivotably coupled to a fourth pair of arm members along a supra-annular position; and

reconfiguring the first assembly and second assembly from a low-profile delivery configuration to an expanded curved configuration against respective subannular and supra-annular leaflet surfaces such that valve leaflets and/or annulus are compressed between the first and second assemblies.

40. A medical device for treating conditions affecting the mitral valve comprising:

at least two independently deployable stabilizing structures positionable in a sub-annular space and configured to engage a subannular surface of the mitral valve when deployed.

41. The device of claim 40 wherein the at least structures are positioned on opposing sides of the valve.

42. The device of claim 40 wherein the at least two structures are positioned in the valve commissures.

43. The device of claim 40 further comprising an interconnecting structure, wherein the interconnecting structure connects the at least two stabilizing structures.

44. The device of claim 40 further comprising a prosthetic valve coupleable between the at least two structures.

45. A percutaneous device for treating conditions affecting the mitral valve, comprising:

an stabilizing structure movable between a first configuration and a second configuration;

wherein in the first configuration the stabilizing structure is positionable between leaflets of the mitral valve into a subannular space; and

wherein in the second configuration the stabilizing structure engages a ventricular surface of the valve.

46. The device of claim 45 wherein the first configuration is linear and the second configuration is curved to approximate the shape of the native valve annulus.

47. The device of claim 45 wherein the first configuration is axially-elongated and the second configuration is laterally-elongated.

48. The device of claim 45 wherein in the second configuration the stabilizing structure engages the ventricular and atrial surfaces of the valve leaflets.

49. The device of claim 45 further comprising a prosthetic valve coupleable to the stabilizing structure.

50. A system for treatment of a heart valve comprising:

first and second stabilizing structures independently positionable in a subannular space of the heart valve; and

a prosthetic valve coupleable to the stabilizing structures.

51. A medical device for treating conditions affecting the mitral valve, comprising:

a first portion positionable in a subannular space;

a second portion positionable in a supra-annular space; and

wherein the first portion and the second portion are configured to compress a mitral leaflet and/or annulus therebetween.

52. The device of claim 51 further comprising a flexible tether coupled to the subannular portion.

53. A medical device for treating conditions affecting the mitral valve comprising:

a first portion positionable in a subannular space;

a second portion detached from the first portion, wherein the second portion is positionable within a supra-annular space; and

a coupling mechanism for coupling the first portion to the second portion at the native valve site when the second portion is positioned in the subannular space.

54. The device of claim 53 further comprising two laterally extending wings positionable in the subannular space, wherein the laterally extending wings are capable of collapsing to a linear, flexible configuration and also a laterally-elongated, rigid configuration.