Method and device for catheter based repair of cardiac valves

• US 20050216039A1
• Filed: 05/12/2005
• Published: 09/29/2005
• Est. Priority Date: 11/15/2002
• Status: Abandoned Application

• Current Assignee: Robert J. Lederman
• Original Assignee: Robert J. Lederman
• Inventors: Lederman, Robert J.
• Application Number:
  US11/127,112
• Publication Number:
  US 20050216039A1
• Time in Patent Office: Days
• US Class Current: 606/144
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00353 one mechanical instrument performing multiple functions, e.g. cutting and grasping channel for multiple instruments A61B2017/3445; instrument channel A61B2017/22072; replaceable heads A61B2017/2931; suction A61M1/00
• CPC Class Codes: A61B 2017/00853 low friction, hydrophobic and corrosion-resistant fluorocarbon resin coating (ptf, ptfe, polytetrafluoroethylene)
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/1142 Purse-string sutures
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus

Abstract

Disclosed is a system and method for catheter-based repair of cardiac valves, including transcatheter-mitral-valve-cerclage annuloplasty and transcatheter-mitral-valve reapposition. An exemplary embodiment of the system includes: a guiding cathether; one or more secondary catheters, such as a valve-manipulation catheter and one or more optional suture-clip-pledget assemblies; and/or a canalization-needle catheter. Imaging methods and devices can be used to assist the operator of the system in determining the placement and orientation of the system within a subject'"'"'s body. One exemplary imaging method is real-time magnetic-resonance imaging.

Claims

1. A method for applying a suture to a cardiac valve, comprising:

percutaneously inserting a guiding catheter into he vasculature of a subject, wherein the guiding catheter has a proximal end, a distal end, and a catheter lumen;

traversing the distal end of the guiding catheter through the vasculature to position the distal end of the guiding catheter in a first position adjacent the cardiac valve;

traversing a canalization-needle catheter through the catheter lumen, wherein the canalization-needle catheter has a proximal end and a distal end;

positioning the distal end of the canalization-needle catheter in second position adjacent the cardiac valve and in sufficient proximity to apply a suture to the cardiac valve; and

applying a suture to the cardiac valve.

2. The method according to claim 1, wherein the positioning of the distal end of the canalization-needle catheter includes puncturing the vasculature and traversing a region adjacent the cardiac valve.

3. The method according to claim 1, further comprising withdrawing the canalization-needle catheter after the suture is applied to the cardiac valve.

4. The method according to claim 1, wherein the suture comprises a cerclage suture.

5. The method according to claim 4, further comprising delivering a knot to the cerclage suture using a knot-delivery catheter.

6. The method according to claim 4, further comprising introducing tension to the cerclage suture to urge leaflets of the cardiac valve together.

7. The method according to claim 1, wherein the suture comprises a transverse-ligature portion.

8. The method according to claim 7, wherein the cardiac valve is the mitral valve, the suture extends at least partially through the coronary sinus, and the transverse-ligature portion extends from a posterolateral aspect of the coronary sinus to an anterior aspect of the coronary sinus.

9. The method according to claim 7, wherein the cardiac valve is the mitral valve, the suture extends at least partially through the coronary sinus, and the transverse-ligature portion extends from a septal aspect of the mitral-valve annulus to a lateral aspect of the mitral-valve annulus.

10. The method according to claim 1, wherein an imaging system is used to view the guiding catheter and the canalization-needle catheter in the vasculature of the subject.

11. A device for delivering a suture to a cardiac valve, comprising:

a flexible guiding catheter having a proximal end, a distal end, and a catheter lumen extending longitudinally through the guiding catheter, the guiding catheter being percutaneously insertable into the vasculature of a subject; and

a canalization-needle catheter having a proximal end and a distal end, the canalization-needle catheter being capable of sliding through the catheter lumen of the guiding catheter and extending beyond the distal end of the guiding catheter,

12. The device of claim 11, wherein the canalization-needle catheter is steerable.

13. The device of claim 11, wherein the canalization-needle catheter comprises a means for puncturing a vasculature wall.

14. The device of claim 11, wherein the canalization-needle catheter comprises a deflectable tip configured to penetrate and traverse through a vasculature wall in the subject.

15. The device of claim 11, wherein the suture is a cerclage suture.

16. The device of claim 11, wherein the guiding catheter further comprises a guide-wire lumen, and wherein the device further comprises a steerable guide wire along which the guide-wire lumen of the guiding catheter is capable of sliding.

17. The device of claim 16, wherein the guide wire comprises a portion adapted to puncture a vasculature wall.

18. The device of claim 16, wherein the guide wire comprises a deflectable tip configured to penetrate and traverse through a vasculature wall in a subject.

19. The device of claim 16, wherein the guide wire comprises a flexible tip having a moveable fulcrum.

20. The device of claim 11, wherein the guiding catheter and the canalization-needle catheter are manufactured at least partially of a material enhancing detectability of the guiding catheter and the canalization-needle catheter when they are viewed by an imaging system.

21. A device for applying a suture clip to a cardiac valve, comprising:

a flexible guiding catheter having a proximal end, a distal end, and a catheter lumen extending longitudinally through the guiding catheter, the guiding catheter being percutaneously insertable into the vasculature of a subject; and

a valve-manipulation catheter having a proximal end and a distal end, the valve-manipulation catheter being capable of sliding through the catheter lumen and extending beyond the distal end of the guiding catheter;

the valve manipulation catheter comprising a delivery system adapted to capture and apply a suture clip to a valve leaflet, wherein the delivery system comprises a spring loaded clip configured to grasp and apply a suture clip to the valve leaflet.