System for mitral valve repair and replacement

• US 9,770,331 B2
• Filed: 07/15/2016
• Issued: 09/26/2017
• 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:
  US15/211,940
• Publication Number:
  US 20160324640A1
• Time in Patent Office: 438 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 method for the treatment of conditions affecting a heart valve, comprising:

positioning a first assembly having a first pair of first arm members pivotally coupled to a second pair of second arm members adjacent to the heart valve, wherein the individual first arm members are coupled together at first joint and the individual second arm members are coupled together at a second joint;

reconfiguring the first assembly from a low-profile delivery configuration to an expanded curved configuration against a first surface of the heart valve such that the first and second joints are spaced laterally apart from each other by lengths of the individual first and second arm members;

positioning a second assembly having a third pair of third arm members pivotally coupled to a fourth pair of fourth arm members adjacent to the heart valve, wherein the individual third arm members are coupled together at a third joint and the individual fourth arm members are coupled together at a fourth joint; and

reconfiguring the second assembly from a low-profile delivery configuration to an expanded curved configuration against a second surface of the heart valve such that the third and fourth joints are spaced laterally apart from each other by lengths of the individual third and fourth arm members and native valve leaflets and/or a native annulus are compressed between the first and second assemblies.

2. The method of claim 1 wherein positioning a first assembly comprises advancing the first assembly intravascularly into an atrial chamber.

3. The method of claim 1 wherein positioning a first assembly comprises deploying the first assembly from the low-profile delivery configuration from within a catheter lumen.

4. The method of claim 1 wherein reconfiguring the first assembly comprises urging a distal end of the first assembly proximally towards a proximal end of the first assembly.

5. The method of claim 1 wherein positioning a second assembly comprises deploying the second assembly from the low-profile delivery configuration from within a catheter lumen.

6. The method or claim 1 wherein reconfiguring the second assembly comprises urging a distal end of the second assembly towards a proximal end of the second assembly.

7. The method of claim 1 further comprising locking the first and second assemblies in the compressed configuration.

8. The method of claim 1 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 heart valve.

9. The method of claim 1 further comprising anchoring a valve prosthesis against or along the first and second assemblies and through the heart valve.

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

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

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

pivoting the individual first arm members and second arm members about corresponding first and second joints to move the first assembly from a low-profile delivery configuration to an expanded curved configuration to extend along and engage a ventricular surface of a mitral valve annulas, wherein the first and second joints are spaced laterally apart from each other by lengths of the first and second arms in the expanded curved configuration; and

pivoting the individual third arm members and fourth arm members about corresponding third and fourth joints to move the second assembly from a low-profile delivery configuration to an expanded curved configuration such that the second assembly extends along and engages an atrial surface of the mitral valve annulus, wherein the third and fourth joints are spaced laterally apart from each other by lengths of the third and fourth arms in the expanded curved configuration, and wherein the mitral valve annulus is compressed between the first and second assemblies when the first and second assemblies are in the expanded curved configuration.