Mitral valve repair system and method for use

• US 7,381,210 B2
• Filed: 03/14/2003
• Issued: 06/03/2008
• Est. Priority Date: 03/14/2003
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Buchbinder, Maurice, Krumme, John, Zarbatany, David, Tieu, Tai, Pung, Ponaka, Perry, Ken, Videll, Joseph
• Primary Examiner(s): Sonnet; Kathleen
• Assistant Examiner(s): SONNETT, KATHLEEN C
• Application Number:
  US10/389,721
• Publication Number:
  US 20040181238A1
• Time in Patent Office: 1,908 Days
• Field of Search: 606/108, 606/194, 606/139, 606144-151, 606/217, 606/222, 606228-233, 128/898
• US Class Current: 606/108
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00371 Multiple actuation, e.g. pushing of two buttons, or two working tips becoming operational
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0451 Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/22052 eccentric
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve

Abstract

The present invention is directed to various systems for repairing tissue within the heart of a patient. The mitral valve repair system of the present invention comprises a guide catheter having a proximal end, a distal end, and at least one internal lumen formed therein, a therapy catheter capable of applying a suture to the tissue, and a fastener catheter capable of attaching a fastener to the suture. The therapy catheter and the fastener catheter are capable of traversing the internal lumen of the guide catheter. In addition, the present invention discloses various methods for repairing tissue within the heart of a patient.

Claims

1. A system for repairing tissue within the heart of a patient comprising:

a guide catheter having a proximal end, a distal end, and an internal lumen formed therein, the internal lumen in fluid communication with the proximal end and the distal end;

a therapy catheter having a proximal end and a distal end, the distal end having a suction recess disposed thereon, a first needle port and at least one co-aligned and opposing first receiving port thereon, a first needle lumen in communication with the first needle port, the first needle lumen having a first needle therein, a first needle deployment member detachably coupled to the first needle, the first needle and the first needle deployment member positioned within the first needle lumen, the first needle connected to a source of suture material, a first needle trap positioned within the first receiving port, and a first actuator attached to the first needle, the therapy catheter sized to be received axially within the guide catheter wherein the therapy catheter is configured to deploy one or more lines of suture; and

a fastener catheter having a suture fastener detachably coupled thereto and a cutting member positioned thereon, the fastener catheter sized to be received within the guide catheter, wherein the suture fastener is configured to receive and secure one or more lines of suture, the fastener catheter further comprising a fastener actuator, wherein the fastener actuator is configured to be moved from a first position to a second position and to a third position, wherein the fastener actuator in the first position causes the suture fastener to be maintained securely to the fastener catheter, the fastener actuator in the second position causes deployment of the suture fastener, and the fastener actuator in the third position causes cutting of the one or more lines of suture.

2. The system of claim 1 wherein the therapy catheter further comprises a second needle port and at least one co-aligned and opposing second receiving port thereon, a second needle lumen in communication with the second needle port, the second needle lumen having a second needle therein.

3. The system of claim 2 further comprising a first actuator member in communication with the first needle, and a second actuator member in communication with the second needle, wherein the first actuator member and second actuator member are independently operable.

4. The system of claim 2 wherein the second receiving port further comprises a second needle trap, the second needle trap capable of engaging and retaining the second needle therein.

5. The system of claim 1 wherein the first needle is in communication with a source of suture material.

6. The system of claim 1 wherein the fastener catheter further comprises a fastener lumen formed therein, the fastener lumen capable of receiving a fastener attached to suture material therein.

7. The system of claim 1 wherein the fastener catheter includes a cutting member thereon, the cutting member capable of engaging and cutting suture material.

8. A system for repairing tissue within the heart of a patient, comprising:

a guide catheter having a proximal end, a distal end, and an internal lumen formed therein, the internal lumen in fluid communication with the proximal end and the distal end;

a therapy catheter having a proximal end and a distal end, the distal end having a suction recess disposed on a first side thereof whereby the distal end is configured with a suction recess-free surface on an opposite side thereof, a first needle port and at least one co-aligned and opposing first receiving port thereon, a first needle lumen in communication with the first needle port, the first needle lumen having a first needle therein, wherein the first receiving port further comprises a first needle catch, the first needle catch capable of engaging and coupling to the first needle, the therapy catheter sized to be received axially within the guide catheter, wherein the therapy catheter is configured to deploy one or more lines of suture; and

a fastener catheter having a suture fastener detachably coupled thereto and a cutting member positioned thereon, the fastener catheter sized to be received within the guide catheter, wherein the suture fastener is configured to receive and secure one or more lines of suture, the fastener catheter further comprising a fastener actuator, wherein the fastener actuator is configured to be moved from a first position to a second position and to a third position, wherein the fastener actuator in the first position causes the suture fastener to be maintained securely tote fastener catheter, the fastener actuator in the second position causes deployment of the suture fastener, and the fastener actuator in the third position causes cutting of the one or more lines of suture.

9. The system of claim 8, wherein the suture fastener comprises a fastener inner lumen configured to receive one or more suture lines therein, the suture fastener further comprising one or more fastener engagement elements configured to engage against suture passing through the fastener inner lumen.

10. The system of claim 9, wherein the fastener catheter comprises a generally cylindrical distal end configured to pass within the fastener inner lumen and configured to be engaged against by one or more of the fastener engagement elements.