MINIMALLY INVASIVE REPAIR OF HEART VALVE LEAFLETS

• US 20130035757A1
• Filed: 06/01/2012
• Published: 02/07/2013
• Est. Priority Date: 06/01/2011
• Status: Abandoned Application

• Current Assignee: NeoChord, Inc.
• Original Assignee: NeoChord, Inc.
• Inventors: Zentgraf, John, Parins, David Joseph, Saini, Arun
• Application Number:
  US13/486,632
• Publication Number:
  US 20130035757A1
• Time in Patent Office: Days
• US Class Current: 623/2.1
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/0456 Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2250/0012 for adjusting elasticity, flexibility, spring rate or mechanical tension

Abstract

A method of repairing a heart valve provides intravascular access for repair of a heart valve through a ventricular trans-septal approach. An external guide catheter can be inserted through a vein of a patient into the right ventricle via the right atrium. An internal guide catheter can be inserted through the external guide and can provide access to the septum for a puncture tool to create an opening through the septum to the left ventricle. The internal guide can then be advanced into the left ventricle and used to guide a deployment catheter that deploys a repair device onto the heart valve.

Claims

1. A method of repairing a heart valve in a beating heart of a patient, comprising:

inserting an external guide catheter through a vein of a patient and into a right atrium of a heart of a patient;

advancing the external guide catheter into a right ventricle of the patient'"'"'s heart;

inserting an internal guide catheter into the external guide catheter and advancing the internal guide catheter into the right ventricle;

puncturing a septum in the patient'"'"'s heart to create an opening between the right ventricle and a left ventricle;

advancing the internal guide catheter through the opening in the septum and into the left ventricle;

inserting a deployment catheter through the internal guide catheter and advancing the deployment catheter adjacent a heart valve in the left ventricle; and

deploying a repair device onto the heart valve with the deployment catheter.

2. The method of claim 1, further comprising:

advancing a sealing device through the internal guide catheter to the septum; and

positioning the sealing device within the opening in the septum to seal the opening.

3. The method of claim 1, wherein the repair device is a suture.

4. The method of claim 3, wherein deploying a repair device onto the heart valve with the deployment catheter includes:

capturing a heart valve leaflet with a clamping mechanism of the deployment catheter; and

inserting the suture through the heart valve leaflet with a needle of the deployment catheter.

5. The method of claim 3, further comprising:

advancing a sealing device through the internal guide catheter to the septum;

extending the suture through a lumen extending through the sealing device; and

positioning the sealing device within the opening in the septum to seal the opening, such that a proximal end of the suture extends from the heart valve through the septum.

6. The method of claim 5, further comprising:

threading the suture through an anchoring device;

advancing the anchoring device through the internal guide catheter to the septum;

interfacing the anchoring device with the sealing device to lock a position of the suture with respect to the sealing device;

advancing a cutting catheter having a cutting tool through the internal guide catheter to the septum; and

cutting the suture in the right ventricle adjacent the sealing device.

7. The method of claim 5, further comprising selectively tensioning the suture to have a desired tension through the septum.

8. The method of claim 7, wherein the suture tension is maintained by a seal within the sealing element that engages the suture, and further comprising:

releasing the tension on the suture by engaging the seal to cause the seal to release the suture; and

retensioning the suture.

9. The method of claim 3, wherein the deployment catheter deploys a plurality of sutures on the valve.

10. A method comprising:

providing a heart valve repair system, the system including an external guide catheter, an internal guide catheter adapted to be slidably inserted through the external guide catheter, a septal puncture tool and a deployment catheter; and

providing instructions for deploying a repair device onto a heart valve of a beating heart of a patient with the heart valve repair system, the instructions comprising;

inserting the external guide catheter through a vein of the patient and into a right atrium of a heart of the patient;

advancing the external guide catheter into a right ventricle of the patient'"'"'s heart;

inserting the internal guide catheter into the external guide catheter and advancing the internal guide catheter into the right ventricle;

inserting the septal puncture tool through the internal guide catheter and puncturing a septum of the patient with the septal puncture tool to create an opening through the septum between the right ventricle and a left ventricle;

advancing the internal guide catheter through the opening in the system and into the left ventricle;

inserting the deployment catheter through the internal guide catheter and advancing the deployment catheter adjacent the heart valve; and

deploying a repair device onto the heart valve with the deployment catheter.

11. The method of claim 10, wherein providing a heart valve repair system includes providing a sealing device, and the instructions further comprise:

advancing the sealing device through the internal guide catheter to the septum; and

positioning the sealing device within the opening in the septum to seal the opening.

12. The method of claim 10, wherein providing a heart valve repair system includes providing a suture as the repair device, wherein deploying a repair device onto the heart valve with the deployment catheter includes:

capturing a heart valve leaflet with a clamping mechanism of the deployment catheter; and

inserting the suture through the heart valve leaflet with a needle of the deployment catheter.

13. The method of claim 10, wherein providing a heart valve repair system includes providing a sealing device and providing a suture as the repair device and wherein the instructions further comprise:

advancing the sealing device through the internal guide catheter to the septum;

extending the suture through a lumen extending through the sealing device; and

positioning the sealing device within the opening in the septum to seal the opening, such that a proximal end of the suture extends from the heart valve through the septum.

14. The method of claim 13, wherein providing a heart valve repair system includes providing an anchoring device and a cutting catheter having a cutting tool, and the instructions further comprise:

threading the suture through the anchoring device;

advancing the anchoring device through the internal guide catheter to the septum;

interfacing the anchoring device with the sealing device to lock a position of the suture with respect to the sealing device;

advancing the cutting catheter through the internal guide catheter to the septum; and

cutting the suture in the right ventricle adjacent the sealing device with the cutting tool.

15. The method of claim 14, wherein the instructions further comprise selectively tensioning the suture to have a desired tension through the septum.

16. A system comprising:

means for intravenously accessing a right ventricle of a beating heart of a patient;

means for creating an opening through a septum of the patient'"'"'s heart between the right ventricle and a left ventricle;

means for deploying a repair device onto a heart valve;

means for positioning the means for deploying in the left ventricle; and

means for sealing the opening in the septum.

17. The system of claim 16, wherein the means for deploying a repair device includes a means for grasping a heart valve leaflet and a means for inserting a suture through the leaflet.

18. The system of claim 17, further comprising means for selectively tensioning the suture through the sealing device.

19. The system of claim 17, further comprising means for anchoring the suture at the sealing device.

20. The system of claim 18, further comprising means for selectively retensioning the suture.