Annuloplasty Device Having a Helical Anchor and Methods for its Use

• US 20070244556A1
• Filed: 04/12/2007
• Published: 10/18/2007
• Est. Priority Date: 04/12/2006
• Status: Abandoned Application

• 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
• Application Number:
  US11/734,566
• Publication Number:
  US 20070244556A1
• 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

Abstract

A system for modifying a heart valve annulus includes a helically helical anchored annuloplasty device delivered to the annulus via an elongated delivery member. The helical anchors of the devices disclosed herein are rotated into the valve annulus along an anchor guide by using a driver that is movably disposed in the delivery member. A tether is disposed within an inner channel of the helical anchor and a locking device is used to secure the annuloplasty device after the valve annulus has been modified. The annuloplasty device can be delivered to the annulus using, traditional surgical approach or a minimally invasive or catheter based methods.

Claims

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

accessing a patient'"'"'s heart chamber having the heart valve annulus;

visually examining the valve annulus to determine the appropriate size and shape for an annuloplasty device delivery member to use for modifying the heart valve annulus;

selecting at least an annuloplasty device comprising at least one helical anchor and an elongated flexible tether, the at least one 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 at least one helical anchor and the tether having a first end and a second end;

selecting at least one annuloplasty device delivery member with a distal end having an anchor guide with a shape that matches the curvature of the valve annulus;

placing the at least one anchor guide on the valve annulus;

implanting the annuloplasty device by rotating the at least one helical anchor into the valve annulus such that the long axis of the at least one 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 at least one delivery device from the valve annulus.

2. The method of claim 1 wherein multiple delivery devices 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:

selecting an additional helical anchor, 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;

selecting an additional annuloplasty device delivery member with a distal end having an anchor guide with a shape that matches the curvature of the valve annulus;

placing the anchor guide on the valve annulus;

implanting the helical anchor 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

removing the delivery member from the valve annulus.

repeating the steps of selecting a helical anchor, selecting a delivery member, placing the anchor guide on the valve annulus, implanting the helical anchor, and removing 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.

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

creating a loop in the tether;

making the loop smaller until the shape of the heart valve annulus reaches a desired state of modification;

tying a knot in the tether such that the shape of the heart valve annulus maintains the desired state of modification; and

cutting the excess length from the ends of the tether.

6. The method of claim 1 wherein implanting the annuloplasty device into the heart 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.

7. A method for modifying a mitral valve annulus, comprising:

accessing a patient'"'"'s left atrium;

visually examining the mitral valve annulus to determine the appropriate size and shape for an annuloplasty device delivery member to use for modifying the valve annulus;

selecting 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;

selecting at least one annuloplasty device delivery member with a distal end having an anchor guide with a shape that matches the curvature of the valve annulus;

placing the anchor guide on the valve annulus;

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

removing the delivery device from the valve annulus.

8. The method of claim 7 comprising the additional steps of:

selecting an additional helical anchor, 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 anchor;

selecting an additional annuloplasty device delivery member with a distal end having an anchor guide with a shape that matches the curvature of the valve annulus;

placing the anchor guide on the valve annulus;

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

removing the delivery member from the valve annulus. repeating the steps of selecting an annuloplasty device, selecting a delivery member, placing the anchor guide on the valve annulus, implanting the annuloplasty device, and removing the delivery member until a predetermined number of helical anchors has been implanted.

9. The method of claim 7 comprising the additional steps of:

creating a loop in the tether;

making the loop smaller until the shape of the heart valve annulus reaches a desired state of modification;

tying a knot in the tether such that the shape of the heart valve annulus maintains the desired state of modification; and

cutting any excess length from the ends of the tether.

10. The method of claim 7 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.

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

accessing a patient'"'"'s heart chamber having the heart valve annulus;

visually examining the valve annulus to determine the appropriate size and shape for an annuloplasty device delivery member to use for modifying the heart valve annulus;

selecting 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;

selecting an annuloplasty device delivery member with a distal end having an anchor guide with a shape that matches the curvature of the valve annulus;

placing the anchor guide on the valve annulus;

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;

removing the delivery device from the valve annulus; and

shortening the length of the long axis of the implanted helical anchor.

12. The method of claim 11 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.

13. The method of claim 11 wherein the step of shortening the length of the long axis of the implanted helical anchor is accomplished by forming the tether into a loop and making the loop smaller until the helical anchor is shortened to a desired length.

14. The method of claim 13 comprising the additional step of securing the loop such that it maintains the helical anchor at the desired length.

15. The method of claim 14 wherein the step of securing the loop is accomplished by tying a knot in the tether.

16. The method of claim 14 comprising the additional step of removing any excess length from the ends of the tether.

17. The method of claim 11 wherein the step of configuring the tether comprises securing the first end of the tether to the distal end of the helical anchor and applying tension to the tether by pulling on the portion of tether that extends from the proximal end of the helical anchor until the helical anchor is shortened to a desired length and securing the tether to the proximal end of the helical anchor to maintain the helical anchor at the desired length.

18. The method of claim 17 wherein the first end of the tether is tied to the distal end of the anchor, the helical anchor is shortened, and the tether is then tied to the proximal end of the helical anchor.

19. The method of claim 17 comprising the additional step of removing any excess length from the ends of the tether.