Method and apparatus for circulatory valve repair

• US 6,269,819 B1
• Filed: 02/25/1999
• Issued: 08/07/2001
• Est. Priority Date: 06/27/1997
• Status: Expired due to Term

• Current Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Original Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Inventors: Allen, William, Levin, Howard P., Lemole, Gerald M., Umana, Juan P., Lotvin, Alan, Oz, Mehmet C.
• Primary Examiner(s): Thaler, Michael H.
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US09/254,111
• Time in Patent Office: 894 Days
• Field of Search: 606/139, 606/142, 606/143, 606/151, 606/205-207, 606/216, 606/217, 606/219-221
• US Class Current: 128/898
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0686 having a forming anvil staying below the tissue during stapling
• 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 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

An apparatus for the repair of a cardiovascular valve having leaflets comprises a grasper capable of grabbing and co-apting the leaflets of the valve. Preferably, the grasper has jaw that grasp, immobilize the leaflets, and then a fastener is inserted to co-apt the leaflets. The apparatus is particularly useful for repairing mitral valves to cure mitral regurgitation.

Claims

1. A method of repairing a heart valve having leaflets in a patient suffering from regurgitation or insufficiency wherein an apparatus comprising a grasper capable of grasping and coapting the leaflets of the valve is inserted into a patient'"'"'s heart, the grasper is used to grasp and immobilize the leaflets of the valve, and a fastener is inserted to coapt the leaflets, and wherein the heart is not stopped.

2. The method of claim 1, wherein the apparatus is inserted into the heart through the chest via a thorascope.

3. The method of claim 1, wherein the apparatus is inserted through the jugular vein.

4. The method of claim 1, wherein the apparatus is inserted through the femoral artery and advanced percutaneously.

5. The method of claim 1, wherein the heart valve is a mitral valve or an aortic valve.

6. The method of claim 5, wherein the heart valve is a mitral valve.

7. The method of claim 5, wherein the heart valve is an aortic valve.

8. The method of claim 1 for repairing a mitral valve in a patient suffering from mitral valve regurgitation wherein the leaflets of the mitral valve are grasped and immobilized by jaws of the grasper and a fastener is inserted into the immobilized mitral valve leaflets to coapt the leaflets.

9. The method of claim 1 for repairing an aortic valve in a patient suffering from aortic valve insufficiency wherein the leaflets of the aortic valve are grasped and immoblized by jaws of the grasper and a fastener is inserted into the immobolized aortic valve leaflets to coapt the leaflets.

18. The method of claim 1, 10, 13, 15, or 16, wherein the heart is slowed.

19. The method of claim 1, 10, 13, 15, or 16, wherein grasping comprises grasping two leaflets with an apparatus inserted into the heart through the chest via a port.

20. The method of claim 1, 10, 13, 15, or 16, wherein grasping comprises grasping two leaflets with an apparatus inserted through a vein and advanced therethrough.

21. The method of claim 1, 10, 13, 15, or 16, wherein grasping comprises grasping two leaflets with an apparatus inserted through an artery and advanced therethrough.

24. The method of claim 1, 10, 13, 15, or 16, wherein fastening the leaflets together comprises inserting a fastener into the immobilized leaflets.

25. The method of claim 24, wherein the fastener is selected from the group consisting of clips, staples, coils, sutures, dual button fasteners, and cufflink-like fasteners.

26. The method of claim 1, 10, 13, 15, or 16, wherein grasping comprises applying a suction to capture the valve leaflet.

27. The method of claim 1, 10, 13, 15, or 16, further comprising visualizing the leaflets.

28. The method of claim 27, wherein visualizing comprises echocardiographic visualization.

29. The method of claim 1, 10, 13, 15, or 16, wherein grasping comprises grasping two leaflets with an apparatus inserted into the heart via a means that controls bleeding around the entry site.

30. The method of claim 1, 10, 13, 15, or 16, wherein grasping comprises grasping two leaflets with an apparatus inserted into the heart via a transvenous approach, where the left atrium is entered through the interatrial septum.

31. The method of claim 1, 10, 13, 15, or 16, wherein an apparatus enters the heart transarterially through the aortic valve.

10. A method of repairing a heart valve having leaflets in a patient suffering from regurgitation or insufficiency comprising:

inserting an apparatus comprising a grasper capable of grasping and coapting the leaflets of the valve into a patient'"'"'s heart;

grasping the leaflets of the heart valve;

immobilizing said leaflets of the heart valve;

inserting a fastener into the patient'"'"'s heart in proximity to the grasped valve leaflets;

coapting the leaflets of the said heart valve together by affixing the fastener; and

removing the grasper while leaving the fastener in place, wherein the heart is not stopped.

11. The method of claim 10, wherein the patient suffers from mitral regurgitation and a mitral valve is repaired.

12. The method of claim 10, wherein the patient suffers from aortic insufficiency and an aortic valve is repaired.

13. A method for repairing a heart valve having leaflets in a patient suffering from regurgitation, said method comprising:

grasping two leaflets to immobilize said leaflets, wherein the patient'"'"'s heart is not stopped;

observing if regurgitation persists to determine if the leaflets are immobilized in a position which resolves the regurgitation; and

fastening the leaflets together after it has been determined that the leaflets are immobilized in a position which adequately resolves the regurgitation.

14. The method of claim 13, which further comprises adjusting or regrasping the valve leaflets if necessary until the leaflets are in a position which resolves the regurgitation.

22. The method of claim 13, 15, or 16, wherein the heart valve is a mitral valve or an aortic valve.

23. The method of claim 22, wherein the heart valve is the mitral valve.

15. A method for repairing a heart valve having leaflets in a patient suffering from regurgitation, said method comprising:

grasping two leaflets to immobilize said leaflets, wherein the patient'"'"'s heart is not stopped;

adjusting or regrasping the valve leaflets if necessary until the leaflets are in a position which resolves the regurgitation; and

fastening the leaflets together after the leaflets are immobilized in a position which adequately resolves the regurgitation.

16. The method of claim 15, which further comprises observing if regurgitation persists to determine if the leaflets are immobilized in a position which resolves the regurgitation.

17. A method for repairing a heart valve having leaflets in a patient suffering from regurgitation, said method comprising:

grasping two leaflets to immobilize said leaflets, wherein the heart is not stopped;

observing if regurgitation persists to determine if the leaflets are immobilized in a position which resolves the regurgitation;

adjusting or regrasping the valve leaflets if necessary until the leaflets are in a position which resolves the regurgitation; and

fastening the leaflets together after it has been determined that the leaflets are immobilized in a position which adequately resolves the regurgitation.