System for mitral valve repair and replacement

• US 9,421,098 B2
• Filed: 12/16/2011
• Issued: 08/23/2016
• Est. Priority Date: 12/23/2010
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Gifford, Hanson S. III, Fann, James I., Morriss, John, Deem, Mark, Grainger, Jeffry J.
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US13/329,083
• Publication Number:
  US 20120165930A1
• Time in Patent Office: 1,712 Days
• Field of Search: 623/2.36, 623/2.37, 623/2.17, 623/2.18, 623/1.24, 623/1.26, 623/1.16
• US Class Current: 1/1
• 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 a native mitral valve, the native mitral valve having a native annulus and native leaflets, and the system comprising:

a proximal stabilizing structure having a first pair of first arm members pivotally coupled to a second pair of second arm members at joints between individual first arm members and individual second arm members to move between a low-profile axially-elongated configuration positionable in the lumen of the catheter and a laterally-elongated configuration in which the proximal stabilizing structure is configured to engage tissue of a native valve, wherein, in the laterally-elongated configuration, (a) the joints are spaced laterally apart from each other by lengths of the first and second arm members, and (b) each second arm member has a lower surface configured to extend along and engage a periphery of an atrial surface of the native mitral valve annulus; and

a

distal stabilizing structure having a third pair of third arm members pivotally coupled to a fourth pair of fourth arm members at joints between individual third arm members and individual fourth arm members to move between the low-profile axially-elongated configuration and the laterally-elongated configuration in which the distal stabilizing structure is configured to engage tissue of the native valve, wherein, in the laterally-elongated configuration, (a) the joints are spaced laterally apart from each other by lengths of the third and fourth arm members, and (b) each third arm member has an upper surface configured to extend along and engage a periphery of a ventricular surface of the mitral valve annulus behind the leaflet;

wherein the lower surfaces face the upper surfaces so as to clamp the mitral valve annulus therebetween in the laterally-elongated configuration.

2. The system of claim 1 further comprising a catheter within which the apparatus is positionable in its axially-elongated 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 further comprising a valve prosthesis positionable against or along the distal and/or proximal stabilizing structures.

13. The system of claim 1 wherein:

the first and second arm members terminate proximate to the joints where the first and second arm members are pivotally coupled; and

the third and fourth arm members terminate proximate to the joints where the third and fourth arm members are pivotally coupled.

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

a proximal stabilizing structure having a first pair of first arm members pivotably coupled to a second pair of second arm members, wherein the first and second arm members have a length; and

a distal stabilizing structure having a third pair of third arm members pivotably coupled to a fourth pair of fourth arm members, wherein the third and fourth arm members have a length;

wherein the distal and proximal stabilizing structures are pivotably coupled via at least one link configured to pass through the commissure of the native valve such that the distal and proximal stabilizing structures are configurable between an axially-elongated configuration positionable in a lumen of a catheter having a longitudinal axis and a laterally-elongated configuration, wherein the lengths of each of the first, second, third and fourth arm members are aligned with the longitudinal axis in the axially-elongated configuration and transverse to the longitudinal axis in the laterally-elongated configuration in which the first and second arm members pivot closer to each other along the length of the first and second arm members such that the first arm members and second arm members are configured to extend along an atrial surface of the native annulus and the third and fourth arm members pivot closer to each other along the length of the third and fourth arm members such that the third arm members and fourth arm members are configured to extend along a ventricular surface of the native annulus and engage an underside of the native leaflets;

wherein at least one of the arm members in the distal stabilizing structure or the proximal stabilizing structure comprises a link or segment.

10. The system of claim 8 wherein the second pair of arm members have supra-annular tissue engaging surfaces and the third pair of arm members have sub-annular tissue engaging surfaces, and wherein the supra-annular tissue engaging surfaces extend in the same direction as the sub-annular tissue engaging surfaces in the laterally-elongated configurations.

11. The system of claim 8 wherein:

the first and second arm members are closer to each other in the laterally-elongated configuration than in the axially-elongated configuration; and

the third and fourth arm members are closer to each other in the laterally-elongated configuration than in the axially-elongated configuration.

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

a proximal stabilizing structure having a pair of first arm members pivotally coupled to a pair of second arm members, the first arm members each have a proximal end pivotally coupled to a proximal member and a distal end, the second arm members each have a distal end pivotally coupled at a middle member and a proximal end, and the distal end of one first arm member is pivotally coupled to the proximal end of a corresponding one of the second arm members separately from the distal end of the other first arm member being pivotally coupled to the proximal end of the other second arm member;

a distal stabilizing structure having a pair of third arm members pivotally coupled to a pair of fourth arm members, the third arm members each have a proximal end pivotally coupled to the middle member and a distal end, the fourth arm members each have a distal end pivotally coupled to a distal member and a proximal end, and the distal end of one third arm member is pivotally coupled to the proximal end of a corresponding one of the fourth arm members separately from the distal end of the other third arm member being pivotally coupled to the proximal end of the other fourth arm member; and

wherein the proximal and distal stabilizing structures are configured to move from an axially-elongated configuration to a laterally-elongated configuration in which the native mitral valve annulus is clamped between the proximal and distal stabilizing structures.

12. The system of claim 9 wherein:

the first and second arm members pivot toward each other from the axially-elongated configuration to the laterally-elongated configuration such that the first and second arm members are closer to each other in the laterally-elongated configuration than in the axially-elongated configuration; and

the third and fourth arm members pivot toward each other from the axially-elongated configuration to the laterally-elongated configuration such that the third and fourth arm members are closer to each other in the laterally-elongated configuration than in the axially-elongated configuration.