METHODS, SYSTEMS AND DEVICES FOR CARDIAC VALVE REPAIR

• US 20100298929A1
• Filed: 01/19/2010
• Published: 11/25/2010
• Est. Priority Date: 02/07/2005
• Status: Abandoned Application

• Current Assignee: Abbott Vascular Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Vascular Incorporated (Abbott Laboratories Incorporated)
• Inventors: Erickson, Sylvia, Valencia, Francisco J., Madden, John P., Lucatero, Pedro B., Srinivasan, Murli, Goodgion, Roger A., Lucatero, Sylvester B., Saenz, Sandra, Sarabia, Jaime E., Komtebedde, Jan, Thornton, Troy L., Dell, Kent D., Goldfarb, Eric A., Powell, Ferolyn T., Liao, Yen C.
• Application Number:
  US12/690,027
• Publication Number:
  US 20100298929A1
• Time in Patent Office: Days
• US Class Current: 623/2.1
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/295 combined with cutting implements
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0427 : having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0435 : the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/0441 : the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0445 : cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0454 : the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/048 : for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/0647 : having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/12018 : Elastic band ligators
• CPC Class Codes: A61B 2017/22044 : with a pointed tip
• 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 2/2445 : 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 2/2457 : Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 : Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2463 : Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/249 : Device completely embedded in the heart wall
• CPC Class Codes: A61F 2002/30079 : magnetic
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0007 : for adjusting length

Abstract

Disclosed are methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction. The procedures described herein can be performed with interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient'"'"'s arterial or venous vasculature remote from the heart. The interventional tools and other equipment may be introduced percutaneously or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart.

Claims

1. A device for treating heart valve regurgitation comprising:

an expandable, fluid-tight bladder configured to be deployed between valve leaflets of the heart valve, the bladder comprising;

a middle portion positionable within a line of valve leaflet coaptation, wherein the middle portion provides a sealing surface for one or more of the leaflets;

an upper expandable portion that extends into an atrium; and

a lower expandable portion that extends into a ventricle,

wherein the upper portion and lower portions expand and contract passively upon changes in heart chamber pressure differential.

2. The device of claim 1, wherein the bladder is formed on a cage to position the bladder within the line of valve leaflet coaptation.

3. The device of claim 1, wherein the upper expandable portion of the bladder blocks a valve leaflet from flailing into the atrium.

4. The device of claim 1, wherein the bladder is fluid-filled.

5. The device of claim 1, wherein the bladder further comprises one or more anchors securing the bladder to a location in the heart that is proximal to, distal to or at the level of an annulus of the valve.

6. The device of claim 1, wherein the bladder further comprises one or more anchors securing the bladder to an annulus of the valve.

7. The device of claim 6, wherein the one or more anchors secure the middle portion in a stationary position to the annulus of the valve.

8. The device of claim 1, wherein the bladder further comprises one or more anchors securing the bladder to the valve at opposite edges of a gap in the line of coaptation causing valve regurgitation.

9. The device of claim 1, wherein the valve is the mitral valve and the bladder is coaxially positioned through the mitral valve.

10. A method for treating regurgitation through a valve in a heart, the heart having an atrium fluidically coupled to a ventricle by the valve, the valve including at least two leaflets which coapt along a line of coaptation, the method comprising:

introducing percutaneously a medical device system into a patient'"'"'s heart to a vicinity of a gap within the line of coaptation of the valve, the medical device system comprising;

a steerable guide catheter configured for delivery through the patient'"'"'s vasculature to the vicinity of the gap;

a retractable sheath selectively housing a blocker comprising an expandable, fluid-tight bladder configured to be compressed by the sheath into a delivery configuration;

using the guide catheter to position a middle portion of the blocker within the gap along the line of coaptation, an upper portion of the blocker extending into the atrium of the heart; and

a lower portion of the blocker extending into the ventricle of the heart;

retracting the sheath to release the expandable region of the blocker from compressive forces maintaining the blocker in the delivery configuration;

expanding the expandable region of the blocker such that the middle portion of the blocker provides a sealing surface for one or more of the valve leaflets;

detaching the blocker from the catheter; and

retracting the catheter and the sheath from the heart.

11. The method of claim 10, wherein the upper portion blocks a valve leaflet from flailing into the atrium.

12. The method of claim 10, wherein retracting the sheath to release the expandable region of the blocker expands the expandable region.

13. The method of claim 10, wherein expanding the expandable portion comprises filling the blocker with a fluid.

14. The method of claim 10, wherein the upper portion and lower portions expand and contract passively upon changes in heart chamber pressure differential.

15. An implant device for treating heart valve regurgitation comprising:

a body comprising an atrial portion extending proximally into an atrium;

a ventricular portion extending distally into a ventricle; and

an annular portion positioned at a level of a valve annulus having a sealing surface, wherein the body is releasably implantable in a coaxial orientation within a gap between valve leaflets, and wherein at least a portion of the valve leaflets coapts against the sealing surface when in a closed configuration.

16. The implant device of claim 15, wherein the body occludes the gap between the valve leaflets.

17. The implant device of claim 15, wherein the atrial portion blocks one or more of the valve leaflets from flailing into the atrium.

18. The implant device of claim 15, wherein the atrial portion and ventricular portion are reversibly compressible.

19. The implant device of claim 15, wherein the body further comprises an anchor configured to attach to a location adjacent the heart valve to prevent the body from being dislodged from between the valve leaflets.

20. The implant device of claim 15, wherein the atrial portion has a volume substantially equivalent to the atrium and wherein the ventricular portion has a volume that is less than the ventricle.