System and method for delivering a mitral valve repair device

• US 20070073391A1
• Filed: 09/28/2005
• Published: 03/29/2007
• Est. Priority Date: 09/28/2005
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Pintor, Rafael, Bourang, Henry, Fariabi, Sepehr, Solem, Jan, Kimblad, Per, Harnek, Jan
• Application Number:
  US11/238,853
• Publication Number:
  US 20070073391A1
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0004 bioabsorbable

Abstract

A system and method is provided for treating a mitral valve. The method preferably includes advancing a guide catheter to an ostium of the coronary sinus and advancing a delivery catheter containing a medical implant through the guide catheter and into the coronary sinus. The delivery catheter has an inner member on which the medical implant is held and an outer sheath which is retractable for deploying and releasing the medical implant. In one embodiment, the medical implant has proximal and distal anchors and a bridge containing resorbable material. The inner member may have a flexible sleeve for gripping and holding a portion of the outer sheath, thereby providing a releasable attachment mechanism. In another embodiment, the inner member may include an inflatable balloon having a tapered distal region which extends from the outer sheath for providing an atraumatic tip. The inflatable balloon may also be used to expand the medical implant and to grip the outer sheath.

Claims

1. A method of repairing a mitral valve, comprising:

inserting a guidewire into a coronary sinus;

advancing a distal end of a guide catheter along the guidewire to an ostium of the coronary sinus;

advancing a delivery catheter through the guide catheter and into the coronary sinus, the delivery catheter including an inner tubing and an outer sheath and a releasable attachment mechanism connecting the inner tubing and the outer sheath, the delivery catheter being configured to deliver a medical implant including a self-expanding proximal anchor, a self-expanding distal anchor and a bridge connecting the proximal and distal anchors;

releasing the releasable attachment mechanism;

retracting the outer sheath relative to the inner tubing to deploy the self-expanding distal anchor;

retracting the delivery catheter to remove slack in the bridge of the medical implant; and

retracting the outer sheath relative to the inner tubing to deploy the self-expanding proximal anchor.

2. The method of claim 1, wherein the distal anchor of the medical implant is deployed in the anterior interventricular vein.

3. The method of claim 1, wherein the outer sheath is retracted by proximally sliding a sliding button on a handle of the delivery catheter, the sliding button and the outer sheath being attached.

4. The method of claim 1, wherein the distal end of the guide catheter is provided with an inflatable balloon.

5. The method of claim 4, wherein the inflatable balloon on the distal end of the guide catheter is sized for placement in the ostium of the coronary sinus.

6. The method of claim 5, wherein the inflatable balloon provides a sealing member and wherein a radiopaque fluid is injected into the coronary sinus before advancing the delivery catheter into the coronary sinus.

7. The method of claim 4, wherein the inflatable balloon on the distal end of the guide catheter increases a diameter of the coronary sinus before advancing the delivery catheter into the coronary sinus.

8. The method of claim 4, wherein the inflatable balloon on the distal end of the guide catheter is inflated with a radiopaque fluid.

9. The method of claim 1, wherein the bridge of the medical implant is positioned along an anterior wall of the coronary sinus before retracting the outer sheath to deploy the self-expanding distal anchor.

10. The method of claim 1, wherein the inner tubing of the delivery catheter includes at least one radiopaque marker band.

11. The method of claim 1, wherein the releasable attachment mechanism comprises a plurality of fingers along a distal end of the outer sheath and a flexible sleeve along a distal end of the inner tubing and wherein the flexible sleeve is contractible over the plurality of fingers for holding the fingers in a friction-fit relationship, thereby releasably attaching the outer sheath to the inner tubing.

12. The method of claim 1, wherein the inner tubing of the delivery catheter further comprises an inflatable balloon along a distal end region.

13. The method of claim 12, wherein the inflatable balloon along the distal end region of the inner tubing is inflatable for engaging an inner wall of the outer sheath and contractible for disengaging an inner wall of the outer sheath, thereby releasably attaching the outer sheath to the inner tubing.

14. The method of claim 12, wherein the inflatable balloon along the distal end region of the inner tubing is configured to seat the distal anchor of the medical implant within the coronary sinus.

15. The method of claim 12, wherein the inflatable balloon along the distal end region of the inner tubing partially extends from a distal end of the outer sheath during advancement of the delivery catheter into the coronary sinus and wherein a distal end portion of the inflatable balloon has a tapered shape for facilitating advancement of the delivery catheter.

16. The method of claim 1, wherein the bridge of the medical implant is made of a shape memory material and wherein a resorbable material is disposed along the bridge for maintaining the bridge in an extended condition during advancement of the delivery catheter into the coronary sinus and wherein the length of the bridge contracts as the resorbable material is resorbed after deploying the proximal and distal anchors of the medical implant.

17. A method of repairing a mitral valve, comprising:

providing a delivery catheter including an inner member and an outer sheath, the inner member having an inflatable balloon disposed along a distal end region, the delivery catheter being configured to deliver a medical implant into a coronary sinus, the medical implant having proximal and distal anchors and a bridge connecting the proximal and distal anchors;

advancing a distal end of a guide catheter through a patient'"'"'s vasculature and toward a coronary sinus;

advancing a distal end portion of the delivery catheter through the guide catheter and into the coronary sinus;

retracting the outer sheath relative to the inner member to expose the distal anchor;

inflating the inflatable balloon along the distal end region of the inner member to radially expand the distal anchor; and

retracting the outer sheath relative to the inner member to expose the proximal anchor.

18. A method of repairing a mitral valve, comprising:

providing a delivery catheter having an inner member and an outer sheath, the delivery catheter being configured to deliver a medical implant into a blood vessel, the medical implant including a proximal anchor, a distal anchor and a bridge connecting the proximal and distal anchors;

advancing a distal end of the delivery catheter into an anterior interventricular vein;

retracting the outer sheath relative to the inner member to deploy the distal anchor in the anterior interventricular vein; and

retracting the outer sheath relative to the inner member to deploy the proximal anchor in a coronary sinus;

wherein the implant reshapes a mitral valve annulus for repairing the mitral valve.

19. The method of claim 18, further comprising deploying a stent in a circumflex artery and/or left anterior descending artery before repairing the mitral valve

20. An apparatus for treating a mitral valve, comprising:

a delivery catheter including an inner tubing and an outer sheath, the inner tubing having an inflatable balloon disposed along a distal end region; and

a handle attached to a proximal end of the delivery catheter, the handle including a sliding button attached to the outer sheath;

wherein a self-expanding medical implant is located on the inner tubing in a contracted condition and covered by the outer sheath and wherein the sliding button is retractable for withdrawing the outer sheath and deploying the medical implant.

21. The apparatus of claim 20, wherein the inflatable balloon has a tapered distal end portion configured to extend from the outer sheath for facilitating advancement of the delivery catheter through a patient'"'"'s vasculature and into a coronary sinus.

22. The apparatus of claim 21, wherein the tapered distal end portion of the inflatable balloon is coated with a lubricious coating.

23. The apparatus of claim 20, wherein at least a portion of the medical implant is disposed over the inflatable balloon and wherein inflation of the inflatable balloon assists in the deployment of the medical implant.

24. A delivery system for deploying a medical implant in a coronary sinus, comprising:

a guide catheter;

a delivery catheter including an inner tubing and an outer sheath surrounding at least a portion of the inner tubing, the inner tubing having an attachment mechanism for engaging the outer sheath; and

a handle attached to a proximal end of the delivery catheter;

wherein the medical implant is mounted on the inner tubing and covered by the outer sheath during delivery to the coronary sinus and the handle is configured to withdraw the outer sheath relative to the inner tubing for deploying the medical implant.

25. The delivery system of claim 24, wherein the attachment mechanism comprises a flexible sleeve on the distal end of the inner tubing, the flexible sleeve sized to constrict around a distal end of the outer sheath.

26. The delivery system of claim 24, wherein the attachment mechanism comprises an inflatable balloon disposed along a distal end of the inner tubing for engaging an inner wall of the outer sheath.