Adjustable implant and method of use

• US 10,039,661 B2
• Filed: 10/22/2015
• Issued: 08/07/2018
• Est. Priority Date: 10/20/2006
• Status: Active Grant

• Current Assignee: Nuvasive Specialized Orthopedics, Inc. (Nuvasive Incorporated)
• Original Assignee: Nuvasive Specialized Orthopedics, Inc. (Nuvasive Incorporated)
• Inventors: Pool, Scott, Walker, Blair, McCoy, Jay R., Tran, Peter P., Quick, Richard L., Moaddeb, Shahram, Chang, Arvin
• Primary Examiner(s): KUHLMAN, CATHERINE BURK
• Application Number:
  US14/920,709
• Publication Number:
  US 20160038324A1
• Time in Patent Office: 1,020 Days
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2005/002 for sensing mechanical parameters
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0053 remotely adjustable
• CPC Class Codes: A61F 5/0059 with wireless means
• CPC Class Codes: A61F 5/0066 Closing devices for gastric bands

Abstract

A system includes an adjustable implant configured for implantation internally within a subject and includes a permanent magnet configured for rotation about an axis of rotation, the permanent magnet operatively coupled to a drive transmission configured to alter a dimension of the adjustable implant. The system includes an external adjustment device configured for placement on or adjacent to the skin of the subject having at least one magnet configured for rotation, the external adjustment device further comprising a motor configured to rotate the at least one magnet and an encoder. Rotation of the at least one magnet of the external adjustment device effectuates rotational movement of the permanent magnet of the adjustable implant and alters the dimension of the adjustable implant. Drive control circuitry is configured to receive an input signal from the encoder.

Claims

1. A restriction device for implantation within a subject, comprising:

an adjustable body having an inner volume extending along a length of the adjustable body and comprising a contact surface configured to engage an outer surface of a lumen of the subject, the adjustable body having a substantially linear configuration and a non-linear configuration;

a connector comprising a first connector portion and a second connector portion, the first and second connector portions configured for attachment to one another;

an elongated actuating member having a first and second end and extending through the inner volume of the adjustable body, the actuating member secured at its first end to the adjustable body;

an actuator comprising a first permanent magnet having a first axis of rotation, the first permanent magnet operatively coupled to the second end of the actuating member, and configured to apply a tension to the actuating member to change the configuration of the contact surface; and

an external adjustment device configured to be located outside the subject, the external adjustment device comprising at least a second permanent magnet and a third permanent magnet;

wherein the second permanent magnet has a second axis of rotation, and the third permanent magnet has a third axis of rotation, and wherein the first axis of rotation, the second axis of rotation, and the third axis of rotation are spaced apart; and

wherein cooperative rotation of the second permanent magnet about the second axis and rotation of the third permanent magnet about the third axis result in rotation of the first permanent magnet about the first axis.

2. The restriction device of claim 1, wherein the substantially linear configuration is for insertion into the subject.

3. The restriction device of claim 1, wherein the non-linear configuration is for securement with respect to the lumen.

4. The restriction device of claim 1, wherein the connector is located on a surface of the adjustable body.

5. The restriction device of claim 1, wherein the first connector portion is located on a first location of the adjustable body and wherein the second connector portion is located on a second location of the adjustable body.

6. The restriction device of claim 5, wherein the first location is at one of substantially the end of the adjustable body and substantially the beginning of the adjustable body, and wherein the second location is at the other of substantially the end of the adjustable body and substantially the beginning of the adjustable body.

7. The restriction device of claim 1, further comprising a sheath extending between the adjustable body and the actuator and having a lumen extending therethrough, the lumen configured to slidingly house at least a portion of the actuating member.

8. The restriction device of claim 7, wherein the sheath comprises a metallic coil surrounded by a polymeric material.

9. The restriction device of claim 7, wherein the sheath is sealed to substantially prevent the entrance of fluids.

10. The restriction device of claim 1, wherein the actuating member comprises a filament.

11. The restriction device of claim 1, wherein the actuating member comprises a tape.

12. The restriction device of claim 1, wherein the actuating member comprises a belt.

13. The restriction device of claim 1, wherein the adjustable body comprises at least one of silicone, polyurethane or a silicone-urethane copolymer.

14. The restriction device of claim 1, wherein the actuator is configured for securement to an internal structure of the subject.

15. The restriction device of claim 14, wherein the actuator is configured for securement by suture.

16. The restriction device of claim 1, wherein the lumen of the subject comprises at least one of an esophagus and a stomach.

17. The restriction device of claim 1, wherein the lumen of the subject comprises a sphincter.

18. The restriction device of claim 17, wherein the sphincter is associated with an anus.

19. The restriction device of claim 17, wherein the sphincter is associated with a urethra.

20. The restriction device of claim 1, wherein the actuator is configured to cause an incremental change which results in partial occlusion of the lumen of the subject.

21. The restriction device of claim 1, wherein the actuator is configured to cause an incremental change which results in complete occlusion of the lumen of the subject.

22. The restriction device of claim 1, wherein the adjustable body is configured to completely encircle the lumen of the subject when the adjustable body is secured to the lumen of the subject.

23. An occlusive member for an occlusive device comprising

an outer sheath having an inner space that is configured to retain a fluid, the outer sheath being water tight and having a first end and a second end, at least a portion of the outer sheath configured to at least partially encircle a fluid conveying body vessel;

and

an inner tape disposed through the inner space of the outer sheath, the inner tape having a first end and a second end, wherein the first end of the inner tape is fixed to the first end of the outer sheath, and the second end of the inner tape is movable relative to the outer sheath and configured to receive a tension, wherein when the second end of the inner tape is under tension the inner tape applies a pressure to the portion of the outer sheath encircling the fluid conveying body vessel, and the inner tape is configured to increase or decrease the pressure on the fluid conveying body vessel;

wherein the tension received by the second end is created by rotation of a first magnet having a first axis of rotation, the first magnet operatively connected to the inner tape; and

an external adjustment device, the external adjustment device comprising a second permanent magnet having a second axis of rotation, and a third permanent magnet having a third axis of rotation, wherein the first axis of rotation, the second axis of rotation, and the third axis of rotation are spaced apart; and

wherein the rotation of the first magnet about the first axis of rotation occurs in response to a rotating magnetic field generated by the cooperative rotation of the second permanent magnet about the second axis and the rotation of the third permanent magnet about the third axis.