Method and device for treatment of mitral insufficiency

• US 8,109,984 B2
• Filed: 01/04/2006
• Issued: 02/07/2012
• Est. Priority Date: 06/30/1999
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Solem, Jan Otto, Kimblad, Per-Ola, von Oepen, Randolf, Quint, Bodo, Seibold, Gerd, Michlitsch, Kenneth J., Ha, Suk-Woo, Eckert, Karl-Ludwig, Joergensen, Ib, Nielsen, Stevan
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US11/326,546
• Publication Number:
  US 20060116756A1
• Time in Patent Office: 2,225 Days
• Field of Search: 623 111- 154
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2210/0004 bioabsorbable

Abstract

A device for treatment of mitral annulus dilation is disclosed, wherein the device comprises two states. In a first of these states the device is insertable into the coronary sinus and has a shape of the coronary sinus. When positioned in the coronary sinus, the device is transferable to the second state assuming a reduced radius of curvature, whereby the radius of curvature of the coronary sinus and the radius of curvature as well as the circumference of the mitral annulus is reduced.

Claims

1. A method of treating dilatation of the mitral valve annulus, comprising:

advancing a balloon catheter through a coronary ostium and into a coronary sinus, the balloon catheter including a balloon disposed near a distal region and a balloon expandable stent mounted on the balloon, wherein the balloon and the stent are in a radially collapsed configuration during the advancement, the stent having a length extending from a proximal end to a distal end of the stent;

positioning the stent in a desired location in the coronary sinus;

inflating the balloon to expand the stent in the coronary sinus; and

reducing a circumference of the mitral valve annulus by decreasing the length of the stent, thereby bending the coronary sinus.

2. The method of claim 1, wherein the balloon assumes a predetermined curved shape when inflated.

3. The method of claim 1, wherein the stent is tapered along a longitudinal axis.

4. The method of claim 1, wherein the location of the stent in the coronary sinus is determined using fluoroscopy.

5. The method of claim 1, wherein inflation of the balloon caused the stent to be plastically deformed.

6. The method of claim 1, wherein a degree of mitral valve regurgitation is monitored while inflating the balloon.

7. The method of claim 1, wherein the balloon comprises an anchor element on one side for causing the balloon to assume a predetermined shape.

8. The method of claim 7, wherein the anchor element is formed of a radiopaque material.

9. The method of claim 1, wherein the balloon is preshrunk on one side for causing the balloon to assume a predetermined shape.

10. The method of claim 1, wherein the stent expands to a greater degree on one side for providing the stent with a curved shape.

11. The method of claim 1, wherein an intravascular ultrasound transducer is used to align the correct side of the stent adjacent the mitral valve annulus.

12. The method of claim 1, wherein the stent comprises a proximal stent section, a distal stent section, and a central section extending between the proximal and distal stent sections.

13. The method of claim 12, further comprising expanding the distal stent section within the coronary sinus before expanding the proximal stent section within the coronary sinus.

14. The method of claim 12, wherein the central section is retained in a contracted state by a biodegradable structure.

15. The method of claim 14, wherein the biodegradable structure comprises a suture.

16. A method of treating dilatation of the mitral valve annulus, comprising:

advancing a balloon catheter through a coronary ostium and into a coronary sinus, the balloon catheter including a balloon disposed near a distal region, the balloon being formed to expand to a predetermined curved shape, the balloon catheter further including a plastically deformable stent mounted on the balloon, wherein the balloon and the stent are in a radially collapsed configuration during the advancement, the stent having a length extending from a proximal end to a distal end of the stent;

positioning the stent in a desired location in the coronary sinus under fluoroscopy;

inflating the balloon while monitoring mitral regurgitation to plastically expand the stent into a curved shape; and

reducing a circumference of the mitral valve annulus by decreasing the length of the stent, thereby causing the coronary sinus to bend.

17. The method of claim 16, wherein the stent comprises a proximal stent section, a distal stent section, and a central section extending between the proximal and distal stent sections.

18. The method of claim 17, further comprising expanding the distal stent section within the coronary sinus before expanding the proximal stent section within the coronary sinus.

19. The method of claim 17, wherein the central section is retained in a contracted state by a biodegradable structure.

20. The method of claim 19, wherein the biodegradable structure comprises a suture.

21. A method of treating dilatation of a mitral valve annulus, comprising:

advancing a balloon catheter into a coronary sinus, the balloon catheter including a balloon disposed near a distal region and a balloon expandable implant mounted on the balloon, wherein the balloon and the implant are in a radially collapsed configuration during the advancing, the implant having a length extending from a proximal end to a distal end of the implant;

positioning the implant in a desired location in the coronary sinus;

inflating the balloon to expand the implant in the coronary sinus; and

reshaping the mitral valve annulus by decreasing the length of the implant, thereby altering a shape of the coronary sinus and reducing a circumference of the mitral valve annulus.

22. The method of claim 21, wherein the implant comprises a proximal implant section, a distal implant section, and a central section extending between the proximal and distal implant sections.

23. The method of claim 22, further comprising expanding the distal implant section within the coronary sinus before expanding the proximal implant section within the coronary sinus.

24. The method of claim 22, wherein the central section is retained in a contracted state by a biodegradable structure.

25. The method of claim 24, wherein the biodegradable structure comprises a suture.

26. A method of treating dilatation of a mitral valve annulus, comprising:

advancing a catheter into a coronary sinus, the catheter carrying an expandable implant that is in a radially collapsed configuration during the advancing, the implant having a length extending from a proximal end to a distal end of the implant;

positioning the implant in a desired location in the coronary sinus;

expanding the implant in the coronary sinus; and

altering a shape of the coronary sinus by decreasing the length of the implant, thereby reducing a circumference of the mitral valve annulus.

27. The method of claim 26, wherein the implant comprises a proximal implant section, a distal implant section, and a central section extending between the proximal and distal implant sections.

28. The method of claim 27, further comprising expanding the distal implant section within the coronary sinus before expanding the proximal implant section within the coronary sinus.

29. The method of claim 27, wherein the central section is retained in a contracted state by a biodegradable structure.

30. The method of claim 29, wherein the biodegradable structure comprises a suture.

31. A method of treating dilatation of a mitral valve annulus, comprising:

advancing a catheter into a coronary sinus, the catheter carrying an expandable implant that is in a radially collapsed configuration during the advancing, the implant having a length extending from a proximal portion to a distal portion of the implant;

positioning the implant in the coronary sinus;

expanding the implant in the coronary sinus; and

changing a shape of the mitral valve annulus by decreasing the length of the implant, thereby altering a shape of the coronary sinus,

wherein the implant comprises a proximal implant section, a distal implant section, and a central section extending between the proximal and distal implant sections, the central section being retained in a contracted state during the advancing by a biodegradable structure,

wherein the central section is retained in the contracted state by the biodegradable structure after expansion, within the coronary sinus, of both the proximal and distal implant sections, and the central section is configured to, upon expansion, draw the proximal and distal implant sections together and to decrease the length of the implant.

32. The method of claim 31, wherein the biodegradable structure comprises a suture.