Device and Method for Heart Valve Repair

• US 20140031926A1
• Filed: 04/04/2012
• Published: 01/30/2014
• Est. Priority Date: 04/04/2011
• Status: Active Grant

• Current Assignee: The Medical Research, Infrastructure And Health Services Fund Of The Tel Aviv Medical Center
• Original Assignee: The Medical Research, Infrastructure And Health Services Fund Of The Tel Aviv Medical Center
• Inventors: Kudlik, Nachman, Pevnay, Demitry
• Granted Patent: US 9,668,860 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2090/3912 Body cavities
• CPC Class Codes: A61B 2090/3925 ultrasonic
• 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 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

The invention provides a device (50) and system for treating a heart valve having an anchor (54, 56) and one or more sutures attached to the anchor. The anchor has an expanded deployed configuration and a low caliber undeployed configuration. A delivery in a heart includes catheter and a needle slidable in the lumen of the catheter. The distal end of the catheter is inserted through the myocardium of the heart until the catheter tip is juxtaposed to the underside of the valve leaflet to be treated. The leaflet is then pierced with tip of the needle. The needle is pushed until the anchor in its undeployed configuration passes through the needle tip and is released from the catheter. The anchor is then brought to its deployed configuration on one or both surfaces of the valve leaflet.

Claims

1. A device for treating a heart valve comprising:

(a) an anchor having an expanded deployed configuration and a low caliber undeployed configuration; and

(b) one or more sutures attached to the anchor.

2. The device according to claim 1 wherein the anchor portion comprises a central hub from which extend two or more wire loops.

3. The device according to claim 1 wherein the anchor in the deployed configuration comprises a first set of one or more wire loops lying in a first plane and a second set of one or more wire loops not lying in the first plane.

4. The device according to claim 3 wherein the second set of wire loops are curved towards the first plane.

5. The device according to claim 2 wherein, in the low caliber undeployed configuration, the first set of loops are collapsed away from the filaments and the second set of loops are collapsed towards the filaments.

6. The device according to claim 1 wherein the anchor comprises a resiliently flexible wire ring.

7. The device according to claim 6 wherein the anchor further comprises one or more cross elements in the wire ring.

8. The device according to claim 1 wherein the anchor comprises a wire rod and the sutures are attached to the wire rod.

9. A system for treating a heart valve comprising:

(a) A device for treating a heart valve comprising;

(i) an anchor having an expanded deployed configuration and a low caliber undeployed configuration; and

(ii) one or more sutures attached to the anchor;

(b) a delivery catheter having a catheter lumen having proximal end and a distal end; and

(c) a needle slidable in the catheter lumen, the needle having a needle lumen dimensioned to receive the device in the low caliber configuration of the device, the needle further having a sharp tip.

10. The system according to claim 9 further comprising a rod configured to push the device in the needle lumen towards the distal end of the catheter.

11. The system according to claim 9 wherein the distal end of the catheter is provided with a spiral wire.

12. The system according to claim 9 wherein the distal end of the catheter is provided with an inflatable balloon that is visible in echocardiography.

13. A method for treating a heart valve comprising:

(a) providing a system for treating a heart valve comprising;

i) A device for treating a heart valve comprising;

an anchor having an expanded deployed configuration and a low caliber undeployed configuration; and

one or more sutures attached to the anchor;

ii) a delivery catheter having a catheter lumen having proximal end and a distal end;

iii) a needle slidable in the catheter lumen, the needle having a needle lumen dimensioned to receive the device in the low caliber configuration of the device, the needle further having a sharp tip; and

iv) a rod configured to push the device in the needle lumen towards the distal end of the catheter.

(b) inserting the device into the delivery system;

(c) inserting the distal end of the catheter through myocardium of the heart, until the catheter tip is juxtaposed to the underside of the leaflet;

(d) piercing the leaflet with the sharp tip of the needle;

(e) pushing the rod towards the tip of the needle until the anchor in its undeployed configuration passes through the needle tip and is released from the catheter;

(f) bringing the anchor to it deployed configuration on one or both surfaces of the valve leaflet.