METHOD AND APPARATUS FOR ADJUSTING A GASTROINTESTINAL RESTRICTION DEVICE

• US 20080097487A1
• Filed: 06/08/2007
• Published: 04/24/2008
• Est. Priority Date: 10/20/2006
• Status: Active Grant

• Current Assignee: Nuvasive Specialized Orthopedics, Inc. (Nuvasive Incorporated)
• Original Assignee: Ellipse Technologies, Inc. (Nuvasive Incorporated)
• Inventors: Chang, Arvin, McCoy, Jay R., Pool, Scott, Tran, Peter P., Walker, Blair, Quick, Richard L., Moaddeb, Shahram
• Granted Patent: US 7,862,502 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• 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 gastrointestinal implant system includes an adjustable restriction device having a contact surface configured for at least partially engaging a surface of a gastrointestinal tract of a mammal. The implant system further includes an implantable interface including a first driving element, the first driving element being moveable and operatively coupled to the adjustable restriction device by an actuator configured to change the dimension or configuration of the contact surface in response to movement of the first driving element. The system also includes an external adjustment device having a second driving element configured to non-invasively engage the first driving element of the implantable interface from a location external to the mammal. In the system, actuation of the second driving element of the external adjustment device produces movement in the first driving element of the implantable interface and results in a change in the dimension or configuration of the contact surface.

Claims

1. A gastrointestinal implant system, comprising:

an adjustable restriction device having a contact surface configured for at least partially engaging a surface of a gastrointestinal tract of a mammal;

an implantable interface including a first driving element, the first driving element being moveable and operatively coupled to the adjustable restriction device by an actuator configured to change the dimension or configuration of the contact surface in response to movement of the first driving element;

an external adjustment device having a second driving element configured to non-invasively engage the first driving element of the implantable interface from a location external to the mammal; and

wherein actuation of the second driving element of the external adjustment device produces movement in the first driving element of the implantable interface and results in a change in the dimension or configuration of the contact surface.

2. The system of claim 1, wherein the second driving element comprises at least one electromagnet.

3. The system of claim 1, wherein the second driving element comprises a moveable permanent magnet.

4. The system of claim 1, wherein the first driving element comprises a permanent magnet and said movement comprises rotational movement.

5. The system of claim 1, wherein the second driving element is configured to magnetically engage the first driving element of the implantable interface from a location external to the mammal.

6. The system of claim 1, further comprising a sensor configured to detect the movement of the first driving element.

7. The system of claim 1, further comprising a sensor configured to detect the direction of the movement of the first driving element.

8. The system of claim 1, wherein the external adjustment device includes a recessed portion configured to receive tissue overlying the first driving element.

9. The system of claim 1, wherein the first driving element of the implantable interface is coupled to the to the adjustable restriction device through a drive transmission.

10. The system of claim 9, wherein the drive transmission comprises a drive cable operatively connected to a rotatable lead screw, the rotatable lead screw having mounted thereon a nut affixed to an end of the actuator.

11. The system of claim 9, wherein the drive transmission comprises a rotatable lead screw, the rotatable lead screw having mounted thereon a nut affixed to an end of the actuator.

12. A gastrointestinal implant system, comprising:

an adjustable restriction device having a contact surface configured for at least partially engaging a surface of a gastrointestinal tract of a mammal; and

an implantable interface including a driving element, the driving element being moveable and operatively coupled to the adjustable restriction device by an actuator configured to change the dimension or configuration of the contact surface in response to movement of the driving element, wherein the movement of the driving element is effectuated by application of a moving magnetic field originating external to the mammal.

13. The gastrointestinal implant system of claim 12, wherein the moving magnetic field is created by one or more permanent magnets.

14. The gastrointestinal implant system of claim 12, wherein the moving magnetic field is created by one or more electromagnets.

15. The gastrointestinal implant system of claim 12, wherein the moving magnetic field comprises moving a static magnetic field.

16. A gastrointestinal implant, comprising:

an adjustable restriction device having a contact surface configured for at least partially engaging a surface of a gastrointestinal tract of a mammal;

an actuator configured to change the dimension or configuration of the contact surface in response to rotational movement of an implantable interface operatively coupled to the actuator via a drive transmission, the drive transmission comprising a rotatable lead screw, the rotatable lead screw having mounted thereon a nut affixed to an end of the actuator;

an external adjustment device configured to non-invasively couple to the implantable interface from a location external to the mammal; and

wherein rotational movement of the implantable interface results in a change in the dimension or configuration of the contact surface.

17. The gastrointestinal implant of claim 16, wherein the rotatable lead screw is operatively coupled to the implantable interface via a drive cable.

18. The gastrointestinal implant of claim 16, wherein the rotatable lead screw is operatively coupled to a magnetic element contained in the implantable interface.

19. A gastrointestinal implant system, comprising:

an adjustable restriction device having a contact surface configured for at least partially engaging a surface of a gastrointestinal tract of a mammal;

an implantable interface including a moveable magnetic element, the moveable magnetic element being operatively coupled to the adjustable restriction device by an actuator configured to change the dimension or configuration of the contact surface in response to movement of the moveable magnetic element of the implantable interface;

an external adjustment device having at least one moveable magnetic element configured to magnetically engage the moveable magnetic element of the implantable interface from a location external to the mammal; and

wherein when the at least one moveable magnetic element of the external adjustment device is magnetically engaged with the moveable magnetic element of the implantable interface, movement of the at least one moveable magnetic element of the external adjustment device produces corresponding movement in the moveable magnetic element of the implantable interface and results in a change in the dimension or configuration of the contact surface.

20. The implant system of claim 19, wherein the moveable magnetic element of the implantable interface comprises a plurality of permanent magnets.

21. The implant system of claim 19, wherein the moveable magnetic element of the implantable interface comprises a single permanent magnet.

22. The implant system of claim 19, wherein the moveable magnetic element of the implantable interface comprises a permanent magnet.

23. The implant system of claim 19, wherein the at least one moveable magnetic element of the external adjustment device comprises two permanent magnets.

24. The implant system of claim 19, wherein the moveable magnetic element of the implantable interface is rotatable about an axis.

25. The implant system of claim 24, wherein the at least one moveable magnetic element of the external adjustment device is rotatable about an axis.

26. The implant system of claim 23, wherein the two permanent magnets of the external adjustment device are mechanically coupled to one another and each permanent magnet is configured for rotation about a respective axis.

27. The implant system of claim 25, wherein rotation of the at least one moveable magnetic element of the external adjustment device in a first direction results in rotation of the moveable magnetic element of the implantable interface in a second, opposite direction.

28. The implant system of claim 25, wherein rotation of the at least one moveable magnetic element of the external adjustment device in a first direction results in rotation of the moveable magnetic element of the implantable interface in the first direction.

40. The system of claim 19, wherein the moveable magnetic element of the implantable interface is coupled to the adjustable restriction device through a drive transmission.

41. The system of claim 40, wherein the drive transmission comprises a drive cable operatively connected to a rotatable lead screw, the rotatable lead screw having mounted thereon a nut affixed to an end of the actuator.

42. The implant system of claim 40, wherein the drive transmission comprises a rotatable lead screw, the rotatable lead screw having mounted thereon a nut affixed to an end of the actuator.

29. A gastrointestinal implant system configured to be implanted within a mammal, the gastrointestinal implant system comprising:

an external drive assembly including at least one external magnet, the external drive assembly having a plurality of alternating magnetic poles rotationally arranged about an axis of rotation;

an internal drive assembly including at least one internal magnet, the internal drive assembly having a plurality of alternating magnetic poles rotationally arranged about an axis of rotation;

wherein the at least one external magnet and the at least one internal magnet are adapted for magnetic coupling and wherein rotation of the at least one external magnet in a first direction results in a corresponding rotation of the at least one internal magnet in a second direction.

30. The system of claim 29, wherein the external drive assembly comprises two external magnets.

31. The system of claim 29, wherein the at least one external magnet is a permanent magnet.

32. The system of claim 29, wherein the internal drive assembly comprises a single magnet.

33. The system of claim 29, wherein the internal drive assembly comprises a permanent magnet.

34. The system of claim 29, wherein the external drive assembly comprises a sensor configured to detect rotational movement of the at least one internal magnet.

35. The system of claim 34, wherein the sensor is configured to detect the rotational movement of the at least one internal magnet directly.

36. The system of claim 34, wherein the sensor is configured to detect the rotational movement of the at least one internal magnet indirectly.

37. The system of claim 29, further comprising torque sensing means configured to detect a loss of magnetic coupling between the at least one internal magnet and the at least one external magnet.

38. The system of claim 29, wherein the second direction is the same direction as the first direction.

39. The system of claim 29, wherein the second direction is the opposite direction of the first direction.

43. A gastrointestinal implant system comprising:

a restrictive band configured to at least partially engage a surface of a gastrointestinal tract of a mammal, the restrictive band having a first configuration and a second configuration, wherein the second configuration constricts the gastrointestinal tract more than does the first configuration;

an actuation element at least partially disposed on or in the restrictive band, wherein actuation of the actuation element results in movement of the restrictive band from the first configuration to the second configuration;

an implantable interface containing a first magnetic assembly coupled to the actuation element, the implantable interface being configured for implantation within the mammal; and

an external adjustment device containing a second magnetic assembly, wherein movement of the second magnetic assembly causes movement of the first magnetic assembly and actuation of the actuation element.

44. The system of claim 43, wherein the first magnetic assembly comprises a rotationally mounted permanent magnet.

45. The system of claim 43, wherein the second magnetic assembly comprises a rotationally mounted permanent magnet.

46. The system of claim 43, further comprising a sensor configured to detect the movement of the first magnetic assembly.

47. The system of claim 43, wherein the first magnetic assembly comprises a clutch.

48. A gastrointestinal implant device, comprising:

an adjustable restriction device comprising a flexible adjustable body having contact surface configured for at least partially engaging a surface of a gastrointestinal tract of a mammal, the flexible adjustable body including a moveable actuator anchored at a distal end to the flexible adjustable body, the moveable actuator being disposed within the flexible adjustable body about a plurality of ribs.

49. The device of claim 48, wherein the flexible adjustable body comprises a flexible jacket having a wavy configuration.

50. The device of claim 48, wherein the flexible adjustable body comprises a flexible jacket having a segmented configuration.

51. A method of treating obesity in a mammal comprising:

providing an adjustable restriction device configured for at least partially engaging a surface of a gastrointestinal tract of a mammal, the adjustable restriction device including an implantable interface comprising a first moveable driving element, the first moveable driving element being operatively coupled to the adjustable restriction device by an actuator configured to change the dimension or configuration of the adjustable restriction device in response to movement of the first moveable driving element;

providing an external adjustment device external to an abdominal region of the mammal, the external adjustment device having a second moveable driving element configured to non-invasively engage the first moveable driving element of the implantable interface from a location external to the mammal; and

moving the first moveable driving element of the implantable interface by moving the second moveable driving element of the external adjustment device.

52. The method of claim 51, wherein the movement of the first moveable driving element is rotational movement.

53. The method of claim 51, wherein the movement of the second moveable driving element is rotational movement.

54. The method of claim 51, wherein the second moveable driving element is configured to magnetically engage the first moveable driving element of the implantable interface from a location external to the mammal.

55. The method of claim 51, wherein movement of the first moveable driving element in a first direction results in tightening the adjustable restriction device and movement of the first moveable driving element in a second direction results in loosening the adjustable restriction device.

56. A method of treating obesity in a mammal comprising:

providing an adjustable restriction device configured for at least partially engaging a surface of a gastrointestinal tract of a mammal, the adjustable restriction device including an implantable interface including a moveable magnetic element, the moveable magnetic element being operatively coupled to the adjustable restriction device by an actuator configured to change the dimension or configuration of the adjustable restriction device in response to movement of the moveable magnetic element of the implantable interface;

providing an external adjustment device external to an abdominal region of the mammal, the external adjustment device having at least one moveable magnetic element configured to magnetically engage the moveable magnetic element of the implantable interface from a location external to the mammal; and

moving the moveable magnetic element of the implantable interface by moving the at least one moveable magnetic element of the external adjustment device.

57. The method of claim 56, wherein movement of the at least one moveable magnetic element of the external adjustment device is rotational movement.

58. The method of claim 56, wherein movement of the moveable magnetic element of the implantable interface is rotational movement.

59. The method of claim 58, wherein the at least one moveable magnetic element of the external adjustment device is magnetically coupled to the moveable magnetic element of the implantable interface via facing radial surfaces.

60. The method of claim 58, wherein the at least one moveable magnetic element of the external adjustment device is magnetically coupled to the moveable magnetic element of the implantable interface via facing axial surfaces.

61. The method of claim 56, further comprising moving the at least one moveable magnetic element of the external adjustment device a pre-determined amount.

62. The method of claim 56, further comprising sensing the degree of movement of the moveable magnetic element of the implantable interface.

63. The method of claim 62, wherein the sensing is performed by detecting an acoustic signal emitted from the implantable interface.

64. The method of claim 63, wherein the acoustic signal is generated by periodic movement of the moveable magnetic element of the implantable interface.

65. The method of claim 63, wherein the acoustic signal is generated by an impact between two objects.