Methods and devices for endovascular mitral valve correction from the left coronary sinus

• US 20040254600A1
• Filed: 02/25/2004
• Published: 12/16/2004
• Est. Priority Date: 02/26/2003
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Schreck, Stefan, Zarbatany, David
• Application Number:
  US10/787,574
• Publication Number:
  US 20040254600A1
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

Apparatuses and methods for reshaping a mitral valve annulus to correct for mitral regurgitation. The apparatuses include one or more balloons in a balloon assembly that are delivered in a deflated state and inflated within the left coronary sinus adjacent mitral annulus. The balloon or balloon assembly may be linear and have one or both ends more flexible than a mid-section, or may be curvilinear. A single balloon having differently constructed end sections may be used. Alternatively, a balloon assembly may include two concentrically arranged balloons with an inner, shorter balloon and an outer, longer balloon. The outer balloon defines the ends of the balloon assembly and is inflated to a lesser pressure than the inner balloon so as to result in the flexible ends. Two or more balloons in series may be mounted on a catheter with gaps therebetween to permit relative flexing or bending. The inflation fluid may be saline or other biocompatible inflation fluid, or may be a fluid that can be subsequently hardened by curing or cross-linking. In either case, a one-way valve is typically utilized to prevent deflation of the balloon once implanted, and structure for decoupling the delivery catheter from the balloon or balloon assembly may be included.

Claims

1. A method for endovascular mitral valve correction of a patient, comprising:

providing a catheter having a balloon assembly including a first balloon having a length and a second balloon also having a length, the catheter having separate lumens connected to inflate the first and second balloons, the balloon assembly including the first and second balloons having a total length and opposed ends, wherein at least a first opposed end of the balloon assembly is flexible so as to permit bending relative to an adjacent portion of the balloon assembly;

inserting the catheter into the vasculature system of the patient;

advancing the catheter such that the balloon assembly is located within the left coronary sinus; and

inflating the first and second balloons.

2. The method of claim 1, wherein the second balloon is arranged concentrically around the first balloon and has a length that is greater than the first balloon, the second balloon being mounted such that opposed ends thereof extend beyond opposed ends of the first balloon and define the opposed ends of the balloon assembly.

3. The method of claim 2, further including:

inflating the first balloon to a first pressure; and

inflating the second balloon to a second pressure less than the first such that the opposed ends of the second balloon that extend beyond the opposed ends of the first balloon render the opposed ends of the balloon assembly relatively more flexible than a mid-portion thereof.

4. The method of claim 1, wherein the first and second balloons are arranged in series along the balloon assembly and are connected to each other by a portion of the catheter that permits relative bending therebetween so that the second balloon defines the first opposed end of the balloon assembly that is flexible.

5. The method of claim 4, further including a third balloon arranged in series adjacent the first balloon along the balloon assembly such that the first balloon is between the second and third balloons, the third balloon being connected to the first balloon by a portion of the catheter that permits relative bending therebetween so as to define a second opposed end of the balloon assembly that is flexible.

6. The method of claim 5, wherein the second and third balloons each have a length that is shorter than the length of the first balloon.

7. The method of claim 1, wherein prior to inserting the catheter into the vasculature system of the patient the balloon assembly is deflated and wrapped and heat set within a tube to create a low delivery profile.

8. A method for endovascular mitral valve correction of a patient, comprising:

providing a catheter having a balloon on a distal end thereof;

inserting the catheter into the vasculature system of the patient;

advancing the catheter such that the balloon is located within the left coronary sinus;

inflating the balloon with a fluid; and

causing the fluid to harden.

9. The method of claim 8, wherein the step of causing the fluid to harden comprises cross-linking the fluid.

10. The method of claim 9, wherein the step of cross-linking the fluid is accomplished by an action selected from the group consisting of:

injecting a cross-linking agent into the balloon; and

applying energy to the fluid.

11. The method of Claim 8, wherein the step of causing the fluid to harden comprises curing the fluid.

12. The method of claim 8, wherein the balloon after being inflated with the fluid has a non-linear shape.

13. The method of claim 8, wherein prior to inserting the catheter into the vasculature system of the patient the balloon assembly is deflated and wrapped and heat set within a tube to create a low delivery profile.

14. A system for endovascular mitral valve correction, comprising:

a catheter having a balloon assembly including a first balloon having a length and a second balloon also having a length, the catheter having separate lumens connected to inflate the first and second balloons, the balloon assembly including the first and second balloons having a total length and opposed ends, wherein at least a first opposed end of the balloon assembly is flexible so as to permit bending relative to an adjacent portion of the balloon assembly.

15. The system of claim 14, wherein the second balloon is arranged concentrically around the first balloon and has a length that is greater than the first balloon, the second balloon being mounted such that opposed ends thereof extend beyond opposed ends of the first balloon and define the opposed ends of the balloon assembly.

16. The system of claim 14, wherein the first and second balloons are arranged in series along the balloon assembly and are connected to each other by a portion of the catheter that permits relative bending therebetween so that the second balloon defines the first opposed end of the balloon assembly that is flexible.

17. The system of claim 14, further including a third balloon arranged in series adjacent the first balloon along the balloon assembly such that the first balloon is between the second and third balloons, the third balloon being connected to the first balloon by a portion of the catheter that permits relative bending therebetween so as to define a second opposed end of the balloon assembly that is flexible.

18. The system of claim 17, wherein the second and third balloon each has a length that is shorter than the length of the first balloon.

19. The system of claim 14, wherein the first opposed end that is flexible has a length that is between about 8-17% of the total length of the balloon assembly.

20. The system of claim 14, wherein the balloon assembly is tapered when inflated such that a proximal end has a greater outer diameter than a distal end thereof.

27. The system of claim 14, wherein the catheter includes at least one inflation lumen and one-way valve into an interior of the first and second balloons.

21. A system for endovascular mitral valve correction, comprising:

a catheter having a balloon thereon having a length, the balloon having a balloon wall including a mid-section contiguous with opposed end sections, the mid-section being formed differently than at least a first end section so as to be more rigid than the first end section when the balloon is inflated.

22. The system of claim 21, wherein the mid-section has a greater wall thickness than the first end section.

23. The system of claim 21, wherein the mid-section is impregnated with a tubular matrix.

24. The system of claim 21, wherein the mid-section is formed of a different material than the first end section and joined thereto at bond lines.

25. The system of claim 21, wherein the first end section has a length that is between about 8-17% of the total length of the balloon.

26. The system of claim 21, wherein the balloon is tapered when inflated such that a proximal end has a greater outer diameter than a distal end thereof.

28. The system of claim 21, wherein the catheter includes an inflation lumen and one-way valve into an interior of the balloon.

29. A system for endovascular mitral valve correction comprising:

a catheter having a balloon thereon, the balloon adapted to be positioned within a coronary sinus and adapted to remodel a mitral valve annulus adjacent to the coronary sinus, the balloon containing a hardenable material to maintain the balloon in an inflated condition in the coronary sinus.

30. The system of claim 29 wherein the hardenable material is at least one of an acrylic resin, a silicone resin and an ultraviolet light curable material.