Devices, systems, and methods for reshaping a heat valve annulus

• US 20090306622A1
• Filed: 08/12/2009
• Published: 12/10/2009
• Est. Priority Date: 09/20/2000
• Status: Active Grant

• Current Assignee: MVRx, Inc.
• Original Assignee: Ample Medical, Inc. (MVRx, Inc.)
• Inventors: Machold, Timothy R., Rahdert, David A., Chang, Robert T., Macoviak, John A., Soss, Rick A.
• Granted Patent: US 9,861,475 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61B 90/50 Supports for surgical instruments, e.g. articulated arms
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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: Y10S 623/904 Heart

Abstract

Devices, systems, and methods employ an implant that is sized and configured to attach to the annulus of a dysfunctional heart valve annulus. In use, the implant extends across the major axis of the annulus above and/or along the valve annulus. The implant reshapes the major axis dimension and/or other surrounding anatomic structures. The implant restores to the heart valve annulus and leaflets a more functional anatomic shape and tension. The more functional anatomic shape and tension are conducive to coaptation of the leaflets during systole, which, in turn, reduces regurgitation. The implant improves function to the valve, without surgically cinching, resecting, and/or fixing in position large portions of a dilated annulus, or without the surgical fixation of ring-like structures.

Claims

1. A method comprising

(i) identifying for treatment a mitral heart valve in a left atrium having a native mitral heart valve annulus, a pair of native mitral valve leaflets on the mitral valve annulus, and native first and second mitral valve leaflet commissures positioned on opposite sides of the native mitral heart valve annulus, defining between the first and second native mitral valve leaflet commissures a major axis of the native mitral heart valve annulus,

(ii) providing an implant comprising an elastic body sized and configured to extend between the native first and second mitral valve leaflet commissures at or above the native mitral heart valve annulus within the left atrium, the elastic body having a spring constant capable of being elastically compressed out of a normal unloaded condition into an elastically loaded state of net compression, and spaced-apart first and second struts appended to the elastic body to contact tissue at or near the native first and second mitral valve leaflet commissures, respectively,

(iii) introducing the implant into the left atrium where the mitral heart valve identified in (i) is located comprising establishing an intravascular path that extends from a right atrium through a septum into the left atrium and deploying the implant through the intravascular path while in the normal unloaded condition, and

(iv) displacing and stretching tissue along the major axis of the native mitral heart valve annulus by placing the first strut into contact with tissue at or near the native first mitral valve leaflet commisure and maintaining force on the first strut to elastically compress the elastic body while placing the second strut into contact with tissue at or near the native second mitral valve commissure to place the elastic body in the state of net compression within the left atrium between the native first and second mitral valve leaflet commissures at or above the native mitral heart valve annulus without removal of any native mitral valve leaflet, the state of net compression thereby reshaping the native mitral heart valve annulus to affect coaptation of all the native mitral valve leaflets.

2. A method according to claim 1

wherein, during (iii), the implant is carried within a sheath, and

wherein, during (iv), the sheath is withdrawn from the implant.

3. A method according to claim 1

wherein, during (iii), a catheter advances the implant through the intravascular path, the catheter having a column strength to maintain force on the first strut during (iv).