ADJUSTABLE IMPLANT SYSTEM

• US 20160143734A1
• Filed: 10/16/2015
• Published: 05/26/2016
• Est. Priority Date: 03/25/2008
• Status: Active Grant

• Current Assignee: Nuvasive Specialized Orthopedics, Inc. (Nuvasive Incorporated)
• Original Assignee: Ellipse Technologies, Inc. (Nuvasive Incorporated)
• Inventors: Anderson, Daniel, Shaolian, Samuel, Pool, Scott, Tsukashima, Ross
• Granted Patent: US 10,076,413 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0004 adjustable

Abstract

Systems and methods treat a heart valve using a magnetically adjustable annuloplasty ring attached to or near a cardiac valve annulus. A changing magnetic field may be used to selectively increase or decrease a circumference of, or otherwise modify the shape of, the implanted annuloplasty ring. The adjustable annuloplasty ring includes a tubular body member, one or more adjustable members, and an internal magnet within the tubular body member. The tubular body member and the one or more adjustable members form a ring shape. The internal magnet is configured to rotate in response to a rotating external magnetic field. The internal magnet is coupled to the one or more adjustable members to change a dimension of the ring shape as the internal magnet rotates. A system for treating a heart valve may include an external adjustment device having one or more external magnets to generate the rotating external magnetic field.

Claims

1. A system for treating a heart valve, the system comprising:

an adjustable annuloplasty ring configured to be attached to or near a cardiac valve annulus, the adjustable annuloplasty ring comprising;

a tubular body member;

one or more adjustable members, the tubular body member and the one or more adjustable members forming a ring shape; and

an internal magnet within the tubular body member, the internal magnet configured to rotate in response to a rotating external magnetic field;

wherein the internal magnet is coupled to the one or more adjustable members to change a dimension of the ring shape as the internal magnet rotates.

2. The system of claim 1, wherein the internal magnet comprises a cylindrical magnet having magnetic poles divided along a plane running the length of the cylinder.

3. The system of claim 2, wherein the internal magnet is a permanent magnet.

4. The system of claim 1, wherein the adjustable annuloplasty ring further comprises a magnet housing attached to the internal magnet, the magnet housing rotating with the rotation of the internal magnet, the magnet housing coupling the internal magnet to the one or more adjustable members.

5. The system of claim 1, wherein the adjustable annuloplasty ring further comprises:

a first lead screw coupled to a first end of the internal magnet, wherein the first lead screw rotates with the rotating internal magnet; and

a drive nut coupled to the one or more adjustable members, wherein threads of the drive nut engage threads of the first lead screw, and wherein rotation of the first lead screw advances the first lead screw through the drive nut to pull or push the one or more adjustable members to change the dimension of the ring shape.

6. The system of claim 5, wherein the one or more adjustable members comprise a wire.

7. The system of claim 6, wherein the wire comprises nitinol.

8. The system of claim 5, wherein the adjustable annuloplasty ring further comprises a first drive cable to couple a first end of the internal magnet to the first lead screw.

9. The system of claim 8, wherein the adjustable annuloplasty ring further comprises:

a first fixed arm coupled to a first end of the tubular body member; and

a second fixed arm coupled to a second end of the tubular body member;

wherein the one or more adjustable members comprise a first swivel arm hinged to the first fixed arm at a first pivot point, and wherein rotation of the first lead screw results in the first swivel arm rotating around the first pivot point.

10. The system of claim 9, wherein the one or more adjustable members further comprise a second swivel arm having a first end hinged to the second fixed arm at a second pivot point, and the second swivel arm having a second end hinged to the first drive nut at a third pivot point, wherein rotation of the first lead screw results in the second swivel arm rotating around the second pivot point and the drive nut rotating around the third pivot point.

11. The system of claim 9, wherein the one or more adjustable members further comprise:

a second swivel arm having a first end hinged to the second fixed arm at a second pivot point;

a second lead screw; and

a second drive cable to couple a second end of the internal magnet to the second lead screw;

wherein rotation of the internal magnet results in rotation of the second lead screw;

wherein the drive nut includes a first set of threads to engage the threads of the first lead screw and a second set of threads to engage the threads of the second lead screw;

and wherein rotation of the second lead screw results in the second swivel arm rotating around the second pivot point.

12. The system of claim 1, wherein the internal magnet includes a hollow opening therein for coupling the internal magnet to the one or more adjustable members.

13. The system of claim 12, wherein at least a portion of the hollow opening is threaded, and wherein the adjustable annuloplasty ring further comprises a lead screw interfacing with the threads of the hollow opening to draw the lead screw into or out of the hollow opening as the internal magnet rotates.

14. The system of claim 13, wherein the lead screw comprises a flexible wire comprising threads cut or formed in a first end of the flexible wire, wherein the first end of the flexible wire is coupled to a first end of the internal magnet.

15. The system of claim 14, wherein the flexible wire further comprises threads cut or formed in a second end of the flexible wire, wherein the second end of the flexible wire is coupled to a second end of the internal magnet.

16. The system of claim 13, wherein the adjustable annuloplasty ring further comprises:

a drive cable having a first end coupled to the lead screw;

wherein the adjustable annuloplasty ring further comprises;

a first fixed arm coupled to a first end of the tubular body member; and

a second fixed arm coupled to a second end of the tubular body member;

wherein the one or more adjustable members comprise;

a first swivel arm hinged to the first fixed arm at a first pivot point;

a second swivel arm having a first end hinged to the second fixed arm at a second pivot point; and

a push rod having a first end coupled to a second end of the drive cable within a passage way in the second swivel arm, the push rod having a second end hinged to a second end of the first fixed arm at a third pivot point.

17. The system of claim 12, wherein the adjustable annuloplasty ring further comprises:

a drive cable having a first end coupled within the hollow opening in the internal magnet, wherein rotation of the internal magnet results in rotation of the drive cable; and

a lead screw coupled to a second end of the drive cable, wherein rotation of the drive cable results in rotation of the lead screw;

wherein the adjustable annuloplasty ring further comprises;

a first fixed arm coupled to a first end of the tubular body member; and

a second fixed arm coupled to a second end of the tubular body member;

wherein the one or more adjustable members comprise;

a first swivel arm hinged to the first fixed arm at a first pivot point;

a second swivel arm having a first end hinged to the second fixed arm at a second pivot point, wherein a second end of the second fixed arm comprises a drive nut that interfaces the lead screw.

18. The system of claim 17, wherein the first swivel arm comprises a jewel bearing coupled to the lead screw.

19. The system of claim 1, wherein the adjustable annuloplasty ring is sized and configured to be placed into a heart through a catheter or trocar.

20. The system of claim 19, wherein the size of the adjustable annuloplasty ring in any direction is less than approximately 10 mm when inserted into the catheter or trocar and greater than approximately 20 mm when attached to or near the cardiac valve annulus.