System for mitral valve repair and replacement

• US 10,517,725 B2
• Filed: 08/28/2017
• Issued: 12/31/2019
• Est. Priority Date: 12/23/2010
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Gifford, III, Hanson S., Fann, James I., Morriss, John, Deem, Mark, Grainger, Jeffry J.
• Primary Examiner(s): Prebilic, Paul B
• Application Number:
  US15/687,774
• Publication Number:
  US 20180008413A1
• Time in Patent Office: 855 Days
• 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 heart valve device comprising:

a first assembly having a first pair of first arm members pivotally coupled to a second pair of second arm members at a first link and a second link, wherein the first arm members are coupled together at a first joint and the second arm members are coupled together at a second joint, the first assembly having a low-profile delivery configuration and an expanded deployed configuration such that the first and second links are spaced laterally apart from each other by lengths of the first and second arm members; and

a second assembly having a third pair of third arm members pivotally coupled to a fourth pair of fourth arm members at a third link and a fourth link, wherein the third arm members are coupled together at a third joint and the fourth arm members are coupled together at a fourth joint, the second assembly having a low-profile delivery configuration and an expanded deployed configuration such that the third and fourth links are spaced laterally apart from each other by lengths of the third and fourth arm members,

wherein the first and second assemblies in the deployed configuration are configured to clamp native valve leaflets and/or a native annulus therebetween,

wherein, in the expanded deployed configuration, the first arm members and second arm members together define an interior arcuate surface configured to face away from a heart wall and an exterior arcuate surface configured to face towards the heart wall such that the first assembly defines an arcuate element configured to approximate a periphery of a portion of the native annulus.

2. The device of claim 1 wherein the low-profile configuration of the first assembly is an axially-elongated configuration.

3. The device of claim 1 wherein the first assembly in the low-profile configuration is configured for placement within a delivery catheter lumen.

4. The device of claim 1 wherein the low-profile configuration of the second assembly is an axially-elongated configuration.

5. The device of claim 1 wherein the second assembly in the low-profile configuration is configured for placement within a delivery catheter lumen.

6. The device of claim 1 wherein reconfiguring the first assembly from the delivery configuration to the deployed configuration comprises urging a distal end of the first assembly proximally towards a proximal end of the first assembly.

7. The device of claim 1 wherein reconfiguring the second assembly from the delivery configuration to the deployed configuration comprises urging a distal end of the second assembly proximally towards a proximal end of the second assembly.

8. The device of claim 1 wherein the expanded deployed configuration of the first assembly is a laterally-elongated configuration.

9. The device of claim 1 wherein the expanded deployed configuration of the first assembly is an expanded curved configuration.

10. The device of claim 1 wherein the expanded deployed configuration of the second assembly is a laterally-elongated configuration.

11. The device of claim 1 wherein the expanded deployed configuration of the second assembly is an expanded curved configuration.

12. The device of claim 1 further comprising a locking mechanism for securing the first assembly in the deployed configuration.

13. The device of claim 1 further comprising a locking mechanism for securing the second assembly in the deployed configuration.

14. The device of claim 1 wherein the first assembly comprises a tissue engaging surface.

15. The device of claim 1 wherein the second assembly comprises a tissue engaging surface.

16. The device of claim 1 further comprising a stent assembly anchorable to the first and/or second assembly.

17. The device of claim 1 further comprising a valve assembly anchorable to the first and/or second assembly.

18. The device of claim 1, wherein, in the expanded deployed configuration, a first distance between the first link and the second link is greater than a second distance between the third link and the fourth link.

19. A heart valve device comprising:

a first assembly having a first pair of first arm members pivotally coupled to a second pair of second arm members at a first link and a second link, wherein the first arm members are coupled together at a first joint and the second arm members are coupled together at a second joint, the first assembly having a low-profile delivery configuration and an expanded deployed configuration such that the first and second links are spaced laterally apart from each other by lengths of the first and second arm members; and

a second assembly having a third pair of third arm members pivotally coupled to a fourth pair of fourth arm members at a third link and a fourth link, wherein the third arm members are coupled together at a third joint and the fourth arm members are coupled together at a fourth joint, the second assembly having a low-profile delivery configuration and an expanded deployed configuration such that the third and fourth links are spaced laterally apart from each other by lengths of the third and fourth arm members, wherein the first and second assemblies in the deployed configuration are configured to clamp native valve leaflets and/or a native annulus therebetween;

wherein each of the first arm members and each of the second arm members have a first curved edge and a second curved edge; and

wherein, in the expanded deployed configuration, the first assembly and the second assembly form a curved structure configured to approximate a peripheral portion of the native annulus.