Mitral valve repair system and method for use

• US 20040181238A1
• Filed: 03/14/2003
• Published: 09/16/2004
• 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
• Granted Patent: US 7,381,210 B2
• Time in Patent Office: Days
• 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. In one embodiment, the method of repairing heart valve tissue includes advancing a guide catheter through a circulatory pathway to a location in the heart proximate to a heart valve, advancing a therapy catheter through the guide catheter to the heart valve, stabilizing a first leaflet with the therapy catheter, deploying a first suture into the stabilized first leaflet, disengaging the first leaflet from the therapy catheter while leaving the first suture attached thereto, stabilizing a second leaflet with the therapy catheter, deploying a second suture into the second leaflet, disengaging the second leaflet from the therapy catheter while leaving the second suture attached thereto, and joining the first and second leaflets by reducing the distance between the first and second sutures.

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 communication with the proximal end and the distal end of the guide catheter;

a therapy catheter capable of applying a suture to the tissue, the therapy catheter capable of traversing the internal lumen of the guide catheter; and

a fastener catheter capable of attaching a fastener to the suture, the fastener catheter capable of traversing the internal lumen of the guide catheter.

2. The system of claim 1 wherein the guide catheter is capable of receiving a guide wire therein.

3. The system of claim 2 wherein the guide catheter further includes a guide wire lumen formed therein.

4. The system of claim 1 wherein the therapy catheter comprises:

an elongated body having a proximal end and a distal end and a suction lumen formed therein;

a suction recess formed on the distal portion of the elongated body, wherein the suction recess is in fluid communication with the suction lumen;

a needle lumen formed in the elongated body, the needle lumen having a needle positioned therein;

a needle port positioned on the distal end of the elongated body proximate to the suction recess, the needle port in communication with the needle lumen;

a suture lumen formed within the elongated body;

a receiving port in communication with the suture lumen and positioned proximate to the suction recess, wherein the receiving port is co-aligned with and opposing the needle port; and

an actuator attached to the needle.

5. The system of claim 4 further comprising a needle catch positioned within the suture lumen, the needle catch capable of being attached to the needle.

6. The system of claim 4 wherein the elongated body further comprises a guide wire lumen formed therein.

7. The system of claim 1 wherein the therapy catheter comprises:

an elongated body having a proximal end and a distal end, the elongated body having a suction lumen formed therein;

a suction recess formed on the distal portion of the elongated body, the suction recess in communication with the suction lumen;

a needle lumen formed in the elongated body;

a needle port positioned on the distal end of the elongated body and located proximate to the suction recess, the needle port in communication with the needle lumen;

a detachable needle coupled to a needle deployment member, the detachable needle and the needle deployment member positioned within the needle lumen, the detachable needle connected to a source of suture material;

a needle trap port positioned proximate to said suction recess, wherein the needle trap port is co-aligned with and opposite to the needle port;

a needle trap positioned within the needle trap port; and

an actuator attached to the needle.

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 thereon a needle port and at least one co-aligned and opposing receiving port thereon, a needle lumen in communication with the needle port, the needle lumen having a needle therein, the therapy catheter sized to be received axially within the guide catheter; and

a fastener catheter having a fastener detachably coupled thereto and a cutting member positioned thereon, the fastener catheter sized to be received within the guide catheter.

9. The system of claim 8 wherein the guide catheter is steerable.

10. The system of claim 8 wherein the guide catheter is capable of receiving a guidewire therein.

11. The system of claim 8 wherein the needle is in communication with a source of suture material.

12. The system of claim 8 wherein the receiving port further comprises a needle catch, the needle catch capable of engaging and coupling to the needle.

13. The system of claim 8 wherein the receiving port further comprises a needle trap, the needle trap capable of engaging and retaining a detachable needle therein.

14. The system of claim 8 wherein the fastener catheter further comprises a fastener lumen formed therein, the fastener lumen capable of receiving a fastener attached to suture material therein.

15. The system of claim 8 wherein the fastener catheter includes a cutting member thereon, the cutting member capable of engaging and cutting suture material.

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

a guide wire capable of being inserted into the patient and advanced through a circulatory pathway;

a therapy catheter attachable to the guide wire and capable of applying a suture to the tissue; and

a fastener catheter attachable to the guide wire and capable of attaching a fastener to the suture.

17. A catheter for delivering a suture to tissue within the heart of a patient, comprising:

an elongated body having a proximal end and a distal end, the distal end having a suction recess formed thereon;

a needle port located proximate to the suction recess;

a needle lumen in communication with the needle port, the needle lumen having a needle positioned therein;

a receiving port located proximate to the suction recess, the receiving port co-aligned with and opposing the needle port, the receiving port having a needle catch capable of receiving and retaining the needle therein, the needle catch attached to a source of suture material; and

at least one actuator member in communication with the needle.

18. A catheter for delivering a suture to tissue within the heart of a patient, comprising:

an elongated body having a proximal end and a distal end, the distal end having a suction recess formed thereon;

a needle port located proximate to the suction recess;

a needle lumen in communication with the needle port, the needle lumen having a detachable needle attached to suture material positioned in the needle lumen;

a receiving port located proximate to the suction recess, the needle receiving port co-aligned with and opposing the needle port, the needle receiving port having a needle trap capable of receiving the detachable needle therein, the needle trap attached to a source of suture material; and

an actuator member in communication with the needle.

19. A catheter for delivering a suture to tissue within the heart of a patient, comprising:

an elongated body having a proximal end and a distal end, the distal end having a suction recess formed thereon;

an inflation lumen positioned within the elongated body;

an inflatable positioning balloon positioned on the distal end of the elongated body, the inflatable positioning balloon in fluid communication with the inflation lumen;

a needle port located proximate to the suction recess;

a needle lumen in communication with the needle port, the needle lumen having a detachable needle attached to suture material positioned therein;

a needle receiving port located proximate to the suction recess, the needle receiving port co-aligned with and opposing the needle port, the receiving port having a needle trap capable of receiving the detachable needle therein, the needle trap attached to a source of suture material; and

an actuator member in communication with the needle.

20. A suture fastener attachable to suture material, comprising:

a fastener body having an attachment lumen formed therein, the attachment lumen capable of receiving a suture therein; and

an engagement member attached to the fastener body, the engagement member capable of engaging and retaining the suture material, the engagement member defining an engagement aperture, the engagement aperture in communication with the attachment lumen.

21. The device of claim 20 wherein the fastener is manufactured from a shape memory alloy.

22. A method of repairing tissue within the heart of a patient, comprising;

advancing a guide catheter through a circulatory pathway to a location in the heart proximate to a heart valve;

advancing a therapy catheter through the guide catheter to the heart valve;

stabilizing a first leaflet with the therapy catheter;

deploying a first suture material into the stabilized first leaflet;

disengaging the first leaflet from the therapy catheter while leaving the first suture material attached thereto;

stabilizing a second leaflet with the therapy catheter;

deploying a second suture material into the second leaflet;

disengaging the second leaflet from the therapy catheter while leaving the second suture material attached thereto;

removing the therapy catheter from the guide catheter;

advancing a fastener catheter along the first and second suture material through the guide catheter to the heart valve; and

joining the first and second leaflets by reducing a distance between the first and second sutures with a fastener deployed from the fastener catheter.

23. A method of repairing tissue within the heart of a patient, comprising;

advancing a guide catheter through a circulatory pathway to a location in the heart proximate to a heart valve;

advancing a therapy catheter through the guide catheter to the heart valve;

inflating an inflatable positioning balloon on the therapy catheter;

engaging a second leaflet with the inflatable positioning balloon thereby directing the therapy catheter to a first leaflet;

stabilizing the first leaflet with the therapy catheter;

deploying a first suture material into the stabilized first leaflet;

disengaging the first leaflet from the therapy catheter while leaving the first suture material attached thereto;

engaging the first leaflet with the inflatable positioning balloon thereby directing the therapy catheter to the second leaflet;

stabilizing a second leaflet with the therapy catheter;

deploying a second suture material into the second leaflet;

disengaging the second leaflet from the therapy catheter while leaving the second suture material attached thereto;

deflating the inflatable positioning balloon;

removing the therapy catheter from the guide catheter;

advancing a fastener catheter along the first and second suture material through the guide catheter to the heart valve; and

joining the first and second leaflets by reducing a distance between the first and second sutures with a fastener deployed from the fastener catheter.