Single catheter mitral valve repair device and method for use

• US 8,241,304 B2
• Filed: 02/14/2011
• Issued: 08/14/2012
• Est. Priority Date: 09/03/2002
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Bachman, Alan B.
• Primary Examiner(s): WOO, JULIAN W
• Application Number:
  US13/027,045
• Publication Number:
  US 20110137326A1
• Time in Patent Office: 547 Days
• Field of Search: 606/139, 606/142, 606/144, 606/153, 606/213, 227/175.1, 227/179.1, 227/181.1
• US Class Current: 606/139
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• 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 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00991 Telescopic means
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/306 holding by means of suction

Abstract

A single catheter mitral valve repair device for stabilizing a tissue portion and selectively applying a tissue fastener thereto. The single catheter mitral valve repair device of the present invention includes an extendable engagement tip having at least one vacuum port formed thereon, at least one deployable fastener in communication with the engagement tip, and at least one actuator member in communication with the port. The deployable fastener is capable of controllably engaging and fastening a tissue segment located proximal to the engagement tip.

Claims

1. A method of repairing a heart valve of a heart, the method comprising:

providing a catheter having a proximal portion and a distal portion, wherein the distal portion comprises a distal portion main body and an extendable engagement tip, wherein the distal portion main body has a width, wherein the extendable engagement tip is telescopically connected to the distal portion main body by a sliding connecting rod, wherein the sliding connecting rod is connected to the distal portion main body at a first side of the distal portion main body and wherein the sliding connecting rod is radially displaced away from a central longitudinal axis of the main body, wherein the extendable tip is configured to be telescopically and distally extended away from and retracted back towards the distal portion main body, and wherein the distal portion has an open configuration and a closed configuration, wherein in the closed configuration the extendable tip is positioned against the distal portion main body, and in the open configuration the extendable tip is telescopically extended distally away from the distal portion main body to create a tissue-receiving opening bordered by the extendable tip, connecting rod, and distal portion main body, wherein the tissue-receiving opening is open on a second side of the elongate body distal portion and closed on the first side of the distal portion, wherein the second side of the elongate body distal portion is generally opposite to the first side of the distal portion, and the tissue-receiving opening extends across most of the width of the distal portion, across the central longitudinal axis of the main body, and from the second side of the distal portion main body to the connecting rod, wherein the catheter distal portion further comprises a first tissue fastener;

advancing the catheter distal portion into the heart;

positioning the catheter distal portion at a position adjacent a first tissue portion, wherein the first tissue portion comprises a portion of a first heart valve leaflet;

extending the extendable engagement tip away from the distal portion main body to thereby form the tissue-receiving opening;

positioning the first tissue portion within the tissue-receiving opening;

retracting the extendable engagement tip toward the distal portion main body to thereby grasp the first tissue portion between the extendable engagement tip and the distal portion main body;

deploying the first tissue fastener into the first tissue portion; and

re-extending the extendable engagement tip away from the distal portion main body to thereby release the first tissue portion, wherein said re-extending the extendable engagement tip away from the distal portion main body occurs after advancing the first suture line through deployment of the first tissue fastener into the first tissue portion.

2. The method of claim 1, comprising:

deploying a second tissue fastener into a second tissue portion.

3. The method of claim 2, wherein the second tissue portion comprises a portion of a second valve leaflet.

4. The method of claim 2, wherein the first tissue fastener comprises a first suture portion, the second tissue fastener comprises a second suture portion, and the first and second suture portions comprise portions of a common suture line, and wherein the method further comprises:

tightening the common suture line to secure the first tissue portion to the second tissue portion via the common suture line.

5. The method of claim 4, wherein the second tissue portion is a portion of a second valve leaflet, and the method further comprises:

coapting the first tissue portion and the second tissue portion by drawing together the first and second tissue fasteners until the first tissue portion is in contact with the second tissue portion.

6. The method of claim 1, wherein the first tissue fastener comprises a first suture portion, the catheter distal portion comprises a first needle and a first needle catch, wherein the first needle catch is secured to the first suture portion, and the first needle catch is configured to be secured to the first needle when the first needle engages against the first needle catch, and

wherein deploying the first tissue fastener into the first tissue portion comprises advancing the first needle through the first tissue portion, engaging the first needle against the first needle catch to thereby secure the first needle catch to the first needle, and retracting the first needle, with the first needle catch secured thereto, back through the first tissue portion to thereby pull the first needle catch and first suture portion through the first tissue portion.

7. The method of claim 6, wherein the catheter further comprises a second tissue fastener, wherein the second tissue fastener comprises a second suture portion, the catheter distal portion comprises a second needle and a second needle catch, wherein the second needle catch is secured to the second suture portion, and the second needle catch is configured to be secured to the second needle when the second needle engages against the second needle catch, wherein the method further comprises:

positioning the catheter distal portion at a position adjacent a second tissue portion, wherein the second tissue portion comprises a portion of a second heart valve leaflet;

extending the extendable engagement tip away from the distal portion main body to thereby form the tissue-receiving opening;

positioning the second tissue portion within the tissue-receiving opening;

retracting the extendable engagement tip toward the distal portion main body to thereby grasp the second tissue portion between the extendable engagement tip and the distal portion main body;

deploying the second tissue fastener into the second tissue portion by advancing the second needle through the second tissue portion, engaging the second needle against the second needle catch to thereby secure the second needle catch to the second needle, and retracting the second needle, with the second needle catch secured thereto, back through the second tissue portion to thereby pull the second needle catch and second suture portion through the second tissue portion; and

re-extending the extendable engagement tip away from the distal portion main body to thereby release the second tissue portion, wherein said re-extending the extendable engagement tip away from the distal portion main body occurs after advancing the second suture line through deployment of the second tissue fastener into the second tissue portion.

8. The method of claim 7, wherein positioning the catheter distal portion at a position adjacent a second tissue portion comprises rotating the catheter after securing the first tissue portion.

9. A method of securing suture to a mitral valve of a heart, the method comprising:

advancing a catheter into the heart, the catheter having a generally cylindrical elongate body having a proximal end and a distal end and a longitudinal axis, an extendable engagement tip capable of moving in telescopic relation to the elongate body distal end, an extendable support slidingly extending from the elongate body distal end at a first side thereof, wherein the extendable support is radially displaced away from the longitudinal axis of the elongate body, wherein the extendable engagement tip is secured to the extendable support, wherein when the extendable support is slidingly extended from the elongate body distal end, a tissue-receiving opening is formed which is defined by the elongate body distal end, the extendable engagement tip, and the extendable support, and wherein the tissue-receiving opening extends from the extendable support at the first side of the elongate body distal end, across the longitudinal axis of the elongate body, and to a second side of the elongate body distal end, wherein the second side of the elongate body distal end is radially opposite to the first side of the elongate body distal end, the catheter further comprising a first suture portion and a first needle;

advancing the elongate body distal end to a position adjacent a first tissue portion, wherein the first tissue portion is a first valve leaflet of the mitral valve;

extending the extendable engagement tip and the extendable support distally of the elongate body distal end to thereby create the tissue-receiving opening;

positioning the first valve leaflet within the tissue-receiving opening;

retracting the extendable engagement tip and the extendable support back toward the elongate body distal end to thereby mechanically retain and stabilize the first valve leaflet;

passing the first needle through the first valve leaflet, wherein the first suture portion is pulled through the first valve leaflet by the first needle;

releasing the first valve leaflet by extending the extendable engagement tip and the extendable support distally from the elongate body distal end; and

withdrawing the catheter from the heart.

10. The method of claim 9, further comprising:

passing a second suture portion through a second tissue portion, wherein the first suture portion and the second tissue portion are portions of a single suture line.

11. The method of claim 10, wherein the second tissue portion is a second valve leaflet of the mitral valve.

12. The method of claim 9, wherein the catheter further includes a second needle and a second suture portion, the method further comprising:

after releasing the first valve leaflet but before withdrawing the catheter from the heart, positioning the elongate body distal end adjacent a second valve leaflet of the mitral valve;

positioning the second valve leaflet within the tissue-receiving opening;

retracting the extendable engagement tip and the extendable support back toward the elongate body distal end to thereby mechanically retain and stabilize the second valve leaflet;

passing the second needle through the second valve leaflet, wherein the second suture portion is pulled through the second valve leaflet by the second needle; and

releasing the second valve leaflet by extending the extendable engagement tip and the extendable support distally from the elongate body distal end.

13. The method of claim 12, wherein positioning the elongate body distal end adjacent the second valve leaflet comprises rotating the catheter.

14. The method of claim 9, wherein advancing the catheter into the heart comprises advancing the elongate body distal end to a position antegrade of the mitral valve, and wherein advancing the elongate body distal end to a position adjacent a first tissue portion comprises advancing the elongate body distal end from the position antegrade of the first tissue portion to the position adjacent the first tissue portion.

15. The method of claim 9, wherein advancing the catheter into the heart comprises advancing the elongate body distal end to a position retrograde of the mitral valve, and wherein advancing the elongate body distal end to a position adjacent a first tissue portion comprises advancing the elongate body distal end from the position retrograde of the first tissue portion to the position adjacent the first tissue portion.

16. A method of repairing a mitral valve of a heart, comprising:

providing a catheter comprising;

a main catheter body distal portion having a width and a distal end and a central longitudinal axis, the distal end having a first side and a second side, wherein the first side is on an opposite side of the central longitudinal axis from the second side, the distal end having a generally circular shape;

a main catheter body proximal portion;

an extendable engagement tip at the main catheter body distal portion, the extendable engagement tip configured to extend distally from the main catheter body distal portion to thereby form a tissue-receiving recess between the main catheter body distal portion and the extendable engagement tip, wherein the extendable engagement tip comprises a proximal end having a generally circular shape which matches the shape of the distal end of the main catheter body;

an extendable support configured to distally extend from the distal end of the main catheter body from a position adjacent the first side of the distal end of the main catheter body, wherein the extendable support is positioned radially away from the central longitudinal axis of the main catheter body distal portion and radially away from a central axis of the extendable engagement tip, the extendable support having a distal end with the extendable engagement tip positioned thereon, whereby when the extendable engagement tip is extended distally, the tissue-receiving recess between the main catheter body distal portion and the extendable tip extends across the entire width of the main catheter body distal portion except for the area at the first side of the distal end of the main catheter body, and wherein the tissue-receiving recess extends across the central longitudinal axis of the main catheter body distal portion;

a first tissue fastener positioned at or adjacent the main catheter body distal end and configured to be advanced across the tissue-receiving recess between the main catheter body distal portion and the extendable engagement tip; and

an actuation device positioned at the main catheter body proximal portion, wherein the actuation device is configured to selectively extend and retract the extendable engagement tip from the main catheter body distal portion;

advancing the main catheter body distal portion to a position wherein the distal end thereof is within the heart adjacent a first valve leaflet of the mitral valve;

activating the actuation device to extend the extendable engagement tip distally from the main catheter body distal portion to thereby form the tissue-receiving recess;

positioning the first valve leaflet within the tissue-receiving recess;

retaining and stabilizing the first valve leaflet by retracting the extendable engagement tip toward the main catheter body distal portion to thereby mechanically hold the first valve leaflet between the extendable engagement tip and the main catheter body;

advancing the first tissue fastener across the tissue-receiving recess between the main catheter body distal portion and the extendable engagement tip, whereby the first tissue fastener passes through the first valve leaflet; and

releasing the first valve leaflet from the main catheter body by extending the extendable engagement tip distally from the main catheter body distal portion.

17. The method of claim 16, wherein the catheter comprises a second tissue fastener positioned at or adjacent the main catheter body distal end and configured to be advanced across the tissue-receiving recess between the main catheter body distal portion and the extendable engagement tip, the method further comprising:

after releasing the first valve leaflet from the main catheter body, positioning the main catheter body distal portion with the distal end thereof adjacent a second valve leaflet of the mitral valve;

positioning the second valve leaflet within the tissue-receiving recess;

retaining and stabilizing the second valve leaflet by retracting the extendable engagement tip toward the main catheter body distal portion to thereby mechanically hold the second valve leaflet between the extendable engagement tip and the main catheter body;

advancing the second tissue fastener across the tissue-receiving recess between the main catheter body distal portion and the extendable engagement tip, whereby the second tissue fastener passes through the second valve leaflet;

releasing the second valve leaflet from the main catheter body by extending the extendable engagement tip distally from the main catheter body distal portion; and

withdrawing the catheter from the heart.

18. The method of claim 17, wherein positioning the main catheter body distal portion with the distal end thereof adjacent the second valve leaflet of the mitral valve comprises rotating the catheter.

19. The method of claim 17, wherein the first tissue fastener comprises a first suture portion, the second tissue fastener comprises a second suture portion, the catheter comprises a first suture needle positioned at or adjacent the main catheter body distal end and configured to be advanced across the tissue-receiving recess between the main catheter body distal portion and the extendable engagement tip and to thereby pull the first suture portion across the tissue-receiving recess, the catheter comprises a second suture needle positioned at or adjacent the main catheter body distal end and configured to be advanced across the tissue-receiving recess between the main catheter body distal portion and the extendable engagement tip and to thereby pull the second suture portion across the tissue-receiving recess, wherein the first suture portion and the second suture portion are portions of a single suture line, and wherein advancing the first tissue fastener across the tissue-receiving recess comprises advancing the first suture needle across the tissue-receiving recess, and advancing the second tissue fastener across the tissue-receiving recess comprises advancing the second suture needle across the tissue-receiving recess.

20. The method of claim 16, wherein the first tissue fastener comprises a first suture portion, the catheter comprises a first suture needle positioned at or adjacent the main catheter body distal end and configured to be advanced across the tissue-receiving recess between the main catheter body distal portion and the extendable engagement tip and to thereby pull the first suture portion across the tissue-receiving recess, and wherein advancing the first tissue fastener across the tissue-receiving recess comprises advancing the first suture needle across the tissue-receiving recess.