IP Library Granted Patent US 12,178,702
Granted Patent B2
US 12,178,702 · App. 18/154,804 · Granted Dec 31, 2024

System for mitral valve repair and replacement

Inventors: Hanson S. Gifford, III (Woodside, CA); James I Fann (Portola Valley, CA); John Morriss (Emerald Hills, CA); Mark E. Deem (Mountain View, CA); Jeffry J. Grainger (Portola Valley, CA)
Assignee: Twelve, Inc.
A61F2/2454A61F2/2418A61F2/2445A61F2/2466A61F2/243A61F2220/0016A61F2220/0075A61F2230/0008A61F2250/0003A61F2250/0004A61F2250/0008A61F2250/006
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Quick Facts
Patent No.
US 12,178,702
App. No.
18/154,804
Granted
Dec 31, 2024
Kind
B2
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 (31)

1. A method for the treatment of conditions affecting a heart valve, comprising:

deploying a first interventional device adjacent a first commissure of the heart valve such that the first interventional device spans from a first leaflet of the heart valve to a second leaflet of the heart valve, wherein deploying the first interventional device comprises deploying a first stabilizing structure on a subannular side of the first and second leaflets and deploying a second stabilizing structure on a supra-annular side of the first and second leaflets; and

deploying a second interventional device adjacent a second commissure of the heart valve such that the second interventional device spans from the first leaflet of the heart valve to the second leaflet of the heart valve, wherein deploying the second interventional device comprises deploying a third stabilizing structure on a subannular side of the first and second leaflets and deploying a fourth stabilizing structure on a supra-annular side of the first and second leaflets.

2. The method of claim 1 , wherein the first stabilizing structure is pivotably coupled to the second stabilizing structure at a joint.

3. The method of claim 2 , wherein each of the first stabilizing structure and the second stabilizing structure comprises a plurality of arms pivotably coupled at joints,

wherein deploying the first interventional device comprises the plurality of arms of each of the first stabilizing structure and the second stabilizing structure pivoting to reconfigure from a low-profile, axially elongated configuration to a laterally-elongated deployed configuration.

4. The method of claim 1 ,

wherein the first stabilizing structure and the second stabilizing structure are curved such that when deployed, the first stabilizing structure and the second stabilizing structure follow along a periphery of an annulus of the heart valve adjacent the first commissure, and

wherein the third stabilizing structure and the fourth stabilizing structure are curved such that when deployed, the third stabilizing structure and the fourth stabilizing structure follow along the periphery of the annulus of the heart valve adjacent the second commissure.

5. A method for the treatment of conditions affecting a heart valve, comprising:

deploying a first interventional device adjacent a first commissure of the heart valve, the first interventional device spanning from a first leaflet of the heart valve to a second leaflet of the heart valve; and

deploying a second interventional device adjacent a second commissure of the heart valve, the second interventional device spanning from the first leaflet of the heart valve to the second leaflet of the heart valve,

wherein the first and second interventional devices are deployed such that a central region of the heart valve between the first commissure and the second commissure is uninhibited such that the first and second leaflets may be supported by the first and second interventional devices to facilitate coaptation of the first and second leaflets.

6. The method of claim 5 ,

wherein deploying the first interventional device comprises deploying a first stabilizing structure on a subannular side of the first and second leaflets and deploying a second stabilizing structure on a supra-annular side of the first and second leaflets, and

wherein deploying the second interventional device comprises deploying a third stabilizing structure on a subannular side of the first and second leaflets and deploying a fourth stabilizing structure on a supra-annular side of the first and second leaflets.

7. The method of claim 6 ,

wherein the first and second stabilizing structures compress the first and second leaflets therebetween, and

wherein the third and fourth stabilizing structures compress the first and second leaflets therebetween.

8. The method of claim 6 , wherein the first stabilizing structure and the second stabilizing structure are curved such that when deployed, the first stabilizing structure and the second stabilizing structure follow along a periphery of an annulus of the heart valve adjacent the first commissure.

9. The method of claim 8 , wherein the third stabilizing structure and the fourth stabilizing structure are curved such that when deployed, the third stabilizing structure and the fourth stabilizing structure follow along the periphery of the annulus of the heart valve adjacent the second commissure.

10. The method of claim 5 ,

wherein the heart valve is a mitral heart valve,

wherein, when deployed, the first interventional device comprises a first portion extending along an anterior leaflet of the mitral valve and a second portion extending along a posterior leaflet of the mitral valve, wherein the first portion is longer than the first second portion,

wherein, when deployed, the second interventional device comprises a third portion extending along the anterior leaflet of the mitral valve and a fourth portion extending along the posterior leaflet of the mitral valve, wherein the third portion is longer than the fourth portion.

11. The method of claim 10 , wherein, when deployed, the first interventional device and the second interventional device cover at least 60% of a circumference of the mitral valve.

12. The method of claim 5 , further comprising delivering the first interventional device to heart valve prior to deploying the first interventional device and delivering the second interventional device to the heart valve prior to deploying the second interventional device.

13. The method of claim 12 ,

wherein delivering the first interventional device comprises delivering the first interventional device in a low-profile, axially elongated delivery configuration within a catheter, wherein in the low-profile, axially elongated delivery configuration a longitudinal axis of the first interventional device extends co-axially within the catheter,

wherein deploying the first interventional device comprises deploying the first interventional device from a distal end of the catheter such that the first interventional device reconfigures to a laterally-elongated deployed configuration, wherein in the laterally-elongated deployed configuration the longitudinal axis of the first interventional device extends circumferentially relative to the heart valve.

14. The method of claim 5 , further comprising deploying a prosthetic heart valve at the heart valve within the first interventional device and the second interventional device.

Assignments (3)
CHANGE OF NAME Recorded Jan 14, 2023
From: FOUNDRY NEWCO XII, INC.
To: TWELVE, INC.
Reel/Frame 062389/0682 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 14, 2023
From: GIFFORD, HANSON S., III; FANN, JAMES I.; MORRISS, JOHN; DEEM, MARK; GRAINGER, JEFFRY J.
To: THE FOUNDRY, LLC
Reel/Frame 062378/0137 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 14, 2023
From: THE FOUNDRY, LLC
To: FOUNDRY NEWCO XII, INC.
Reel/Frame 062378/0146 →
Continuity (7)
Continuation 16685867 · Nov 15, 2019
Continuation 15687774 · Aug 28, 2017
Continuation 15211940 · Jul 15, 2016
Division 13329083 · Dec 16, 2011
Provisional Application 61499630 · Jun 21, 2011
Provisional Application 61460041 · Dec 23, 2010
Related Publication 20230172717A1 · Jun 8, 2023