Method for treatment of mitral insufficiency

• US 20030069636A1
• Filed: 11/26/2002
• Published: 04/10/2003
• Est. Priority Date: 06/30/1999
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: JOMED NV
• Inventors: Solem, Jan Otto, Kimblad, Per Ola
• Granted Patent: US 7,090,695 B2
• Time in Patent Office: Days
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

A method for treatment of mitral annulus dilatation comprises reducing the circumference of the mitral valve annulus. The method further comprises inserting an elongate body into the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, fixing the position of the elongate body relative to the coronary sinus, and changing the shape of the elongate body in order to remodel the mitral valve annulus.

Claims

1. A method of reducing the circumference of the mitral valve annulus, comprising

providing an elongate body having a proximal stent section, a distal stent section and means for reducing the distance therebetween,

inserting the elongate body into the coronary sinus in the vicinity of the posterior leaflet of the mitral valve,

fixing the positions of the proximal and distal stents relative to the coronary sinus, and

reducing the distance between the proximal and distal stent sections of the elongate body.

2. The method of claim 1, wherein the distance between the proximal and distal stent sections is reduced by means of wires.

3. The method of claim 1, wherein the distance between the proximal and distal stent sections is reduced by means of a central stent section, the length of which is reduced when it is expanded.

4. A method for providing a medical device for use in treating a patient from within a vein that is associated with the patient'"'"'s heart, comprising:

providing an array of medical devices, each medical device having an elongate body that is adjustable in-situ from a first configuration having a first shape to a second configuration having a second shape, and each elongate body of each medical device of the array being constructed to have a unique size relative to the elongate bodies of the other medical devices of the array; and

choosing the medical device from the array at least in part based upon a known measurement for a vein that is associated with the patient'"'"'s heart,

wherein the elongate body of the chosen medical device is adapted to be delivered in the first configuration into the vein and is adjustable within the vein from the first configuration to the second configuration such that the unique size is appropriate in order to remodel the mitral valve annulus from within the vein.

5. The method of claim 4, further comprising choosing the medical device at least in part based upon comparing the measurement for the vein with the unique size of the elongate body.

6. The method of claim 4, wherein the medical device is chosen at least in part based upon a known measurement for a coronary sinus.

7. The method of claim 4, wherein the vein has a central axis, and the known measurement comprises at least one of a length of at least a portion of the vein, a radius of curvature of the vein along the central axis, and a diameter of the vein across the central axis.

8. The method of claim 4, further comprising:

providing the array of medical devices such that the elongated bodies have a graduated array of respective sizes.

9. A method for providing a medical device for use in treating a patient comprising:

providing an array of medical devices, each medical device having an elongate body that is adjustable in-situ from a first configuration having a first shape to a second configuration having a second shape, and each elongate body of each medical device of the array being constructed to have a unique geometry relative to the elongate bodies of the other medical devices; and

choosing the medical device from the array at least in part based upon a known measurement for a parameter associated with at least one of (i) a valve associated with the patient'"'"'s heart, and (ii) a vessel associated with the patient'"'"'s heart,

wherein the elongate body of the chosen medical device is adapted to be delivered in the first configuration into the vessel and is adjustable within the vessel from the first configuration to the second configuration such that the unique geometry is appropriate in order to remodel the valve from within the vessel.

10. The method of claim 9, further comprising:

choosing the medical device from the array at least in part based upon a known measurement for a geometric parameter associated with at least one of the mitral valve and the coronary sinus.

11. The method of claim 10, further comprising choosing the medical device at least in part based upon a known measurement for a geometric parameter associated with the coronary sinus.

12. The method of claim 11, wherein the coronary sinus has a central axis and the geometric parameter comprises at least one of:

a length of at least a portion of the coronary sinus, a radius of curvature of the coronary sinus along the central axis, and a diameter of the coronary sinus across the central axis.

13. The method of claim 9, further comprising choosing the medical device at least in part based upon a known measurement for a geometric parameter associated with the mitral valve.

14. The method of claim 13, wherein the geometric parameter is associated with a mitral valve annulus of the mitral valve.

15. The method of claim 12, wherein the geometric parameter comprises a diameter of the mitral valve annulus.

16. A method of reducing mitral annulus diameter, comprising:

transluminally advancing a prosthesis into the coronary sinus; and

deploying at least a portion of the prosthesis within the coronary sinus to restrain expansion of the mitral annulus.

17. A method of reducing mitral annulus diameter as in claim 16, further comprising the step of percutaneously accessing the venous system prior to the transluminally advancing step.

18. A method of reducing mitral annulus diameter as in claim 17, wherein the accessing step is accomplished by accessing one of the internal jugular, subclavian and femoral veins.

19. A method of reducing mitral annulus diameter as in claim 16, further comprising the step of advancing the prosthesis from a first configuration to a second configuration to reduce the diameter of the mitral annulus.

20. A method of reducing mitral annulus diameter as in claim 16, further comprising the step of limiting diastolic expansion of the left ventricle.

21. A method of reducing mitral valve annulus diameter as in claim 16, wherein the transluminally advancing step is accomplished using a catheter.

22. A method of reducing mitral annulus diameter as in claim 16, further comprising the step of monitoring the degree of mitral regurgitation.

23. A method of performing transluminal mitral annuloplasty, comprising:

providing a catheter, having a proximal end and a distal end and a prosthesis therein;

inserting the catheter into the venous system such that the distal end of the catheter is proximate the coronary sinus;

transluminally advancing the prosthesis into the coronary sinus; and

deploying the prosthesis to influence the size of the mitral valve annulus.

24. A method of performing transluminal mitral annuloplasty as in claim 23, further comprising the step of causing the prosthesis to exert a compressive force on the adjacent atrial musculature.

25. A method of performing transluminal mitral annuloplasty as in claim 24, wherein the compressive force is generated by a bias in the prosthesis.

26. A method of performing transluminal mitral annuloplasty as in claim 24, wherein the compressive force is generated by tightening the prosthesis around the mitral valve annulus following the transluminally advancing step.

27. A method of performing transluminal mitral annuloplasty as in claim 26, wherein the tightening step is accomplished by axial movement of a tightening element within the prosthesis.

28. A method of providing a therapeutic compressive force against a tissue structure which is adjacent to a vessel wall, comprising positioning a device in the vessel and exerting a force against the wall of the vessel to exert a force against the tissue structure.

29. A method as in claim 28, wherein the positioning is accomplished percutaneously.

30. A method as in claim 28, wherein the tissue structure comprises the mitral valve annulus.

31. A method as in claim 28, wherein the tissue structure comprises the left ventricle.

32. A method as in claim 28, further comprising deploying the device within the vessel.

33. A method as in claim 28, wherein the vessel comprises a vein.

34. A method of performing annuloplasty of the mitral valve comprising positioning a prosthesis in the coronary sinus.

35. A method of limiting diastolic expansion of the left ventricle, comprising positioning a prosthesis in a coronary vein.