Minimally Invasive Procedure for Implanting an Annuloplasty Device

• US 20070244557A1
• Filed: 04/12/2007
• Published: 10/18/2007
• Est. Priority Date: 04/12/2006
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Douk, Nareak, Rafiee, Nasser, Finney, Michael, Mas, Juan-Pablo, House, Morgan, Mac Donald, Stuart, Barone, David, Bloom, Eliot, Huynh, Rany
• Granted Patent: US 7,699,892 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2448 D-shaped rings

Abstract

A method for modifying a heart valve annulus includes placing a purse string suture at a puncture site adjacent a heart valve, inserting at least one delivery member through the puncture site, positioning a distal end of the at least one delivery member adjacent a portion of a valve annulus, deploying an annuloplasty device carried within the at least one delivery member and implanting the annuloplasty device into the valve annulus. The method also includes reshaping the heart valve annulus after implantation of the at least one annuloplasty device.

Claims

1. A method for modifying a heart valve annulus, comprising:

accessing a heart via a passage made through a patient'"'"'s skin into the thoracic cavity;

placing a continuous circular suture around a puncture site in the wall of the patient'"'"'s heart adjacent a heart valve;

puncturing the heart at the puncture site;

inserting a distal end of at least one elongated delivery member for an annuloplasty device through the puncture site;

positioning the distal end of the at least one delivery member adjacent a portion of a valve annulus;

deploying an annuloplasty device comprising at least one helical anchor and an elongated flexible tether, the helical anchor having a long axis, a distal end with a sharpened tip portion, a proximal end, and a plurality of coils defining an inner channel that communicates along the length of the helical anchor and the tether having a first end and a second end;

implanting the annuloplasty device by rotating the helical anchor into the valve annulus such that the long axis of the helical anchor extends along the valve annulus and the tether is routed through the inner channel such that one end of the tether extends from the distal end of the helical anchor and the other end of the tether extends from the proximal end of the helical anchor; and

withdrawing the delivery member from the puncture site.

5. The method of claim 1 comprising the additional steps of:

creating a loop in the tether by securing the first end of the tether to the second end of the tether with a locking device that can be moved along the tether away from the second end when a force is applied to move the locking device away from the second end but cannot be moved back toward the second end of the tether if the loop is tightened to the point that it is subjected to tension;

making the loop smaller by moving the locking device away from the second end of the tether until the locking device passes through the puncture site and the shape of the heart valve annulus begins to be modified;

monitoring the modification of the shape of the heart valve annulus while continuing to make the loop smaller until a desired level of modification is reached;

inserting a cutting device into the puncture site;

cutting the tether at a location that is adjacent the locking device but between the locking device and the second end of the tether;

withdrawing the cutting device from the puncture site; and

tightening the suture to close the puncture site.

6. The method of claim 5 wherein the locking device is a snell knot made by tying the first end of the tether to a portion of the tether adjacent the second end.

7. The method of claim 5 wherein the locking device is at least one stop member that has a size and shape such that it cannot pass through the inner channel of the at least one helical anchor;

the at least one stop member having at least one tether channel passing therethrough, and the tether further comprising a plurality of locking members spaced along at least a portion of the tether adjacent the first end of the tether; and

wherein the locking members are configured to allow them to pass through the tether cannel in one direction and not pass through the tether channel in the opposite direction.

8. The method of claim 7 wherein the at least one stop member having at least one tether channel is a single stop member having two tether channels;

and

wherein the first end of the tether is secured in one of the tether channels and the second end of the tether can be slidably inserted in the other tether channel.

9. The method of claim 7 wherein the at least one stop member having at least one tether channel is two stop members, each having a single tether channel.

10. The method of claim 5 wherein the method is performed on a beating heart and the step of monitoring the modification of the shape of the heart valve annulus while continuing to make the loop smaller until a desired level of modification is reached, is accomplished by using fluoroscopic imaging techniques to monitor the function of the heart valve.

11. The method of claim 1 wherein the delivery member includes an anchor guide and the step of positioning the distal end of the at least one delivery member adjacent a portion of a valve annulus comprises placing the anchor guide into contact with at least a portion of the valve annulus.

12. The method of claim 1 wherein positioning the distal end of the at least one delivery member adjacent a portion of a valve annulus comprises articulating a portion of the distal end.

13. The method of claim 1 wherein implanting the annuloplasty device into the valve annulus comprises rotating and translating a helical anchor through the valve annulus in response to rotation and translation of a drive member operably connected to the helical anchor.

14. The method of claim 1 wherein the method is performed while the heart is beating.

2. The method of claim wherein multiple elongated delivery members are used, and the annuloplasty device comprises a plurality of helical anchors and the elongated flexible tether.

3. The method of claim 2 comprising the additional steps of:

inserting a distal end of an elongated delivery member through the puncture site;

positioning the distal end of the delivery member adjacent a portion of a valve annulus;

deploying an additional helical anchor having a long axis, a distal end with a sharpened tip portion, a proximal end, and a plurality of coils defining an inner channel that communicates along the length of the helical anchor;

implanting the helical anchor by rotating the helical anchor into the valve annulus such the long axis of the helical anchor extends along the valve annulus and the tether is routed through the inner channel such that one end of the tether extends from the distal end of the helical anchor and the other end of the tether extends from the proximal end of the helical anchor;

withdrawing the delivery member from the puncture site; and

repeating the steps of inserting and positioning the distal end of a delivery member, deploying and implanting a helical anchor, and withdrawing the delivery member until a predetermined number of helical anchors has been implanted.

4. The method of claim 3 wherein the number of helical anchors implanted is in the range of two to six.

15. A method for modifying a heart valve annulus, comprising:

inserting a delivery member for an annuloplasty device through the puncture site in the wall of a heart adjacent a heart valve, the puncture site being surrounded by a continuous circular suture placed in the wall of the heart;

positioning a distal end the delivery member adjacent at least a portion of a valve annulus;

deploying an annuloplasty device comprising at least one helical anchor and an elongated flexible tether, the helical anchor having a long axis, a distal end with a sharpened tip portion, a proximal end, and a plurality of coils defining an inner channel that communicates along the length of the helical anchor and the tether having a first end and a second end;

implanting the annuloplasty device by rotating the helical anchor into a portion of the valve annulus such that the long axis of the helical anchor extends along the valve annulus and the tether is routed through the inner channel such that one end of the tether extends from the distal end of the helical anchor and the other end of the tether extends from the proximal end of the helical anchor; and

removing the delivery member.

16. The method of claim 15 wherein the steps are repeated until a desired number of helical anchors are implanted in the heart valve annulus.

17. The method of claim 15 further comprising the steps of comprising the additional steps of:

creating a loop in the tether by securing the first end of the tether to the second end of the tether with a locking device that can be moved along the tether away from the second end when a force is applied to move the locking device away from the second end but cannot be moved back toward the second end of the tether if the loop is tightened to the point that it is subjected to tension;

making the loop smaller by moving the locking device away from the second end of the tether until the locking device passes through the puncture site and the shape of the heart valve annulus begins to be modified;

monitoring the modification of the shape of the heart valve annulus while continuing to make the loop smaller until a desired level of modification is reached;

inserting a cutting device into the puncture site;

cutting the tether at a location that is adjacent the locking device but between the locking device and the second end of the tether;

withdrawing the cutting device from the puncture site; and

tightening the suture to close the puncture site.

18. The method of claim 15 wherein implanting the annuloplasty device into a portion of the valve annulus comprises rotating and translating the helical anchor through the portion of the valve annulus in response to rotation and translation of a drive member operably connected to the helical anchor.

19. The method of claim 15 wherein the method is performed while the heart is beating.

20. A method for modifying a heart valve annulus, comprising:

inserting a delivery member for an annuloplasty device through the puncture site in the wall of a heart adjacent a heart valve, the puncture site being surrounded by a continuous circular suture placed in the wall of the heart;

positioning a distal end the delivery member adjacent a first portion of a valve annulus;

deploying an annuloplasty device comprising a helical anchor and an elongated flexible tether, the helical anchor having a long axis, a distal end with a sharpened tip portion, a proximal end, and a plurality of coils defining an inner channel that communicates along the length of the helical anchor and the tether having a first end and a second end;

implanting the annuloplasty device by rotating the helical anchor into a portion of the valve annulus such that the long axis of the helical anchor extends along the valve annulus and the tether is routed through the inner channel such that one end of the tether extends from the distal end of the helical anchor and the other end of the tether extends from the proximal end of the helical anchor;

removing the delivery member;

configuring the tether to shorten the long axis of the helical anchor;

shortening the long axis of the helical anchor to modify the shape of the heart valve annulus;

monitoring the modification of the shape of the heart valve annulus while continuing to make the loop smaller until a desired level of modification is reached;

inserting a cutting device into the puncture site;

cutting the tether at a location that is adjacent the locking device but between the locking device and the second end of the tether;

withdrawing the cutting device from the puncture site; and

tightening the suture to close the puncture site.

21. The method of claim 20 wherein implanting the annuloplasty device into a portion of the valve annulus comprises rotating and translating the helical anchor through the portion of the valve annulus in response to rotation and translation of a drive member operably connected to the helical anchor.

22. The method of claim 20 wherein the method is performed while the heart is beating.

23. The method of claim 20 wherein the step of configuring the tether comprises creating a loop in the tether by securing the first end of the tether to the second end of the tether with a locking device that can be moved along the tether away from the second end when a force is applied to move the locking device away from the second end but cannot be moved back toward the second end of the tether if the loop is tightened to the point that it is subjected to tension;

making the loop smaller by moving the locking device away from the second end of the tether until the locking device passes through the puncture site; and

the long axis of the helical anchor is shortened by continuing to make the loop smaller.

24. The method of claim 20 wherein the step of configuring the tether comprises securing the first end of the tether to the distal end of the helical anchor;

placing a tether stop on the second end of the tether, the tether stop having a size and shape such that it cannot pass through the inner channel of the helical anchor;

advancing the tether stop away from the second end of the tether until it enters the puncture site and makes contact with the proximal end of the helical anchor; and

the long axis of the helical anchor is shortened by continuing to advance the tether stop away from the second end of the tether.

25. The method of claim 24 wherein the first end of the tether is secured to a tether stop having a size and shape that it cannot pass through the inner channel of the helical anchor and the tether stop is positioned directly adjacent the distal end of the anchor.

26. The method of claim 24 wherein the first end of the tether is tied to the distal end of the anchor.