Telemetrically controlled band for regulating functioning of a body organ or duct, and methods of making, implantation and use

• US 20050143766A1
• Filed: 10/12/2004
• Published: 06/30/2005
• Est. Priority Date: 09/04/2002
• Status: Active Grant

• Current Assignee: Apollo Endosurgery US, Inc. (Boston Scientific Corporation)
• Original Assignee: EndoArt SA (Abbvie Incorporated)
• Inventors: Bachmann, Michel, Fridez, Pierre, Montavon, Jean-Charles, Imbert, Christian, Jordan, Alain, Stergiopulos, Nikos
• Granted Patent: US 7,972,346 B2
• Time in Patent Office: Days
• US Class Current: 606/158
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61F 2/48 Operating or control means, e.g. from outside the body, control of sphincters
• CPC Class Codes: A61F 2002/30668 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2002/762 for measuring dimensions, e.g. a distance
• CPC Class Codes: A61F 2002/7625 for measuring angular position
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 5/0003 Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• CPC Class Codes: A61F 5/0053 remotely adjustable
• CPC Class Codes: A61F 5/0066 Closing devices for gastric bands

Abstract

Apparatus and methods are provided comprising an implantable non-hydraulic ring that encircles and provides a controllable degree of constriction to an organ or duct and an external control that powers and controls operation of the ring. The ring includes a rigid dorsal periphery that maintains a constant exterior diameter, and a compliant constriction system that reduces intolerance phenomena. A high precision, energy efficient mechanical actuator is employed that is telemetrically powered and controlled, and maintains the ring at a selected diameter when the device is unpowered, even for extended periods. The actuator provides a reversible degree of constriction of the organ or duct, which is readily ascertainable without the need for radiographic imaging. Methods of use and implantation also are provided.

Claims

1. Apparatus for regulating the functioning of a patient'"'"'s organ or duct, comprising:

an elongated member having first end and second ends, the elongated member having a compressible ventral surface and a substantially rigid dorsal periphery;

a clip disposed on the first end of the elongated member, the clip configured to engage the second end of the elongated member so that the elongated member forms a loop around the organ or duct;

a tension element slidably disposed within the elongated member, the tension element including a compliant portion that permits elastic extension of the tension element; and

a telemetrically-controlled actuator disposed on the second end of the elongated member, the actuator engaging the tension element, operation of the actuator causing the tension element to constrict the loop against a patient'"'"'s body organ or duct,

wherein the rigid dorsal periphery of the elongated element and the compliant portion of the tension element cooperate to permit straightening of the elongated element to facilitate passage into a patient'"'"'s abdomen laparoscopically.

2. The apparatus of claim 1 wherein the clip is configured to be engaged with the second end of the elongated member using laparoscopic instruments.

3. The apparatus of claim 1 wherein the apparatus is configured to be compatible with medical imaging modalities involving exposure to strong magnetic fields.

4. The apparatus of claim 1 wherein the clip further comprises a hinge configured to prevent inadvertent disengagement of the clip.

5. The apparatus of claim 1 wherein the loop creates a stoma within the patient'"'"'s body organ or duct, the stoma remaining substantially circular throughout a range of adjustment of the actuator.

6. The apparatus of claim 1 wherein a portion of the tension element further defines a helical screw thread.

7. The apparatus of claim 6 wherein the helical screw thread comprises a spring.

8. The apparatus of claim 1 wherein the tension element comprises:

a core wire having an end;

a cap affixed to the end of the core wire;

a first helical spring disposed on the core wire, the helical spring having a square transverse profile; and

a second helical spring interwound with the first helical spring to define a pitch of the first helical spring,

wherein the second helical spring has a first end fixed to the core wire and a second end free to slidably extend over the core wire for a predetermined length to permit flexion of the helical screw thread, the cap limiting extension of the second free end to maintain the pitch substantially constant.

9. The apparatus of claim 1 wherein the apparatus is configured to operate having an internal environment of up to 100% humidity.

10. The apparatus of claim 9 wherein the apparatus further comprises at least one of corrosion-resistant plating of metallic components, polymeric coating of electronic components and silicone or expoxy coverings disposed on electronic connections.

11. The apparatus of claim 1 where the elongated member encloses a skeleton that prevents diametral expansion of the dorsal periphery of the elongated member.

12. The apparatus of claim 11 wherein the skeleton imposes a circular arc shape on the elongated member in an undeformed state, the circular arc shape facilitating laparascopic implantation of the apparatus.

13. The apparatus of claim 11 wherein the skeleton further comprises a housing disposed at the second end of the elongated member, the actuator disposed within the housing.

14. The apparatus of claim 1 wherein the elongated member comprises an elongated tube of compressible material that renders the ventral surface of the elongated member compressible.

15. The apparatus of claim 14 wherein the elongated tube has a circular cross-section.

16. The apparatus of claim 14 wherein the elongated member further comprises an elastic membrane that prevents tissue ingrowth.

17. The apparatus of claim 16 wherein the elastic membrane is under tension when the loop is in a fully extended position, the elastic membrane contracting substantially without wrinkling when the loop is transitioned to a fully constricted position.

18. The apparatus of claim 16 wherein the elongated member is preconditioned for use in a preselected gas to reduce swelling of the elastic membrane.

19. The apparatus of claim 16 wherein the elongated member further comprises a valve or hole that facilitates gas exchange and reduces swelling of the elastic membrane.

20. The apparatus of claim 16 wherein the elastic membrane possesses diffusion characteristics that impede or enhance diffusion of the preselected gas to influence swelling of the elastic membrane when exposed to a preselected gas atmosphere.

21. The apparatus of claim 1 wherein the loop has a diameter, operation of the actuator varying the diameter in a range of between 15 mm to 35 mm.

22. The apparatus of claim 1 wherein the actuator and tension element are self-blocking in an unpowered state.

23. The apparatus of claim 1 wherein the telemetrically-controlled actuator further comprises:

an electric motor;

a nut disposed on the helical screw thread;

a gear transmission coupling the nut to the electric motor;

an antenna; and

a processing circuit electrically coupled between the antenna and electric motor.

24. The apparatus of claim 23 wherein the antenna and processing circuit are disposed within a pod.

25. The apparatus of claim 24 wherein the antenna is integrated with the processing circuit.

26. The apparatus of claim 24 wherein the pod has a substantially planar profile that facilitates placement between a patient'"'"'s sternum and skin.

27. The apparatus of claim 23 further comprising an external control that transmits commands to the processing circuit via the antenna.

28. The apparatus of claim 27 wherein the external control transmits power to the telemetrically-controlled actuator via electromagnetic induction.

29. The apparatus of claim 27 wherein the actuator is powered by a capacitor or implanted battery.

30. The apparatus of claim 27 wherein the external control receives feedback from the processing circuit comprising positional or operational data for the tension element.

31. The apparatus of claim 30 wherein the external control computes a metric corresponding to a degree of constriction of the loop based on the positional or operational data received from the processing circuit.

32. The apparatus of claim 31 wherein the external control displays variations in a diameter of the loop in fine increments.

33. The apparatus of claim 32 wherein the external control displays an absolute position of the diameter of the loop.

34. The apparatus of claim 23 further comprising a reference position switch.

35. The apparatus of claim 23 wherein the electric motor consumes 50 mW or less during operation.

36. The apparatus of claim 27 wherein the external control accepts a patient microchip card that stores positional data regarding previous adjustment of the tension flexible element.

37. The apparatus of claim 36 wherein the patient microchip card stores an implant serial number.

38. The apparatus of claim 24 wherein the pod is configured to be mounted subcutaneously near a patient'"'"'s sternum.

39. The apparatus of claim 1 wherein different portions of the apparatus are of different colors to facilitate laparoscopic manipulation and implantation of the apparatus.

40. The apparatus of claim 16 wherein the elastic membrane comprises a portion of a leak-proof encapsulation that prevents liquids from entering the apparatus.

41. Apparatus for gastric banding of a patient'"'"'s stomach, comprising:

an elongated member having first end and second ends, the elongated member having a compressible ventral surface and a substantially rigid dorsal periphery and configured to be formed into a loop around a portion of a patient'"'"'s stomach;

a housing disposed on the second end of the elongated member;

an electric motor disposed within the housing;

an actuator disposed within the housing and coupled to the electric motor;

a tension element slidably disposed within the elongated member, the tension element including a compliant portion and a portion defining a helical screw thread, the tension element having a fixed end coupled to the first end of the elongated member and a free end that engages and extends through the actuator,

wherein operation of the actuator causes the tension element to vary a diameter of the loop.

42. The apparatus of claim 41 wherein the apparatus is configured for laparoscopic introduction, and further comprising a clip configured to be engaged with the second end of the elongated member using laparoscopic instruments.

43. The apparatus of claim 42 wherein the clip further comprises a hinge configured to prevent inadvertent disengagement of the clip.

44. The apparatus of claim 41 wherein the apparatus is configured to be compatible with medical imaging modalities involving exposure to strong magnetic fields.

45. The apparatus of claim 41 wherein the loop creates a stoma within the patient'"'"'s body organ or duct, the stoma remaining substantially circular throughout a range of adjustment of the actuator.

46. The apparatus of claim 41 wherein the a compliant portion that selectively permits elastic extension of the tension element.

47. The apparatus of claim 46 wherein the compliant portion comprises a spring.

48. The apparatus of claim 41 wherein the helical screw thread comprises:

a core wire;

a first helical spring disposed on the core wire, the helical spring having rectangular or trapezoidal transverse profile; and

a second helical spring interwound with the first helical spring to define a pitch of the first helical spring, the second helical spring having first and second ends operatively associated with the core wire to permit flexion of the helical screw thread while maintaining the pitch substantially constant.

49. The apparatus of claim 41 wherein the apparatus is configured to operate having an internal environment of up to 100% humidity.

50. The apparatus of claim 49 wherein the apparatus further comprises at least one of corrosion-resistant plating of metallic components, polymeric coating of electronic components and silicone or epoxy coverings disposed on electronic connections.

51. The apparatus of claim 41 where the elongated member encloses a skeleton that prevents diametral expansion of the dorsal periphery of the elongated member.

52. The apparatus of claim 51 wherein the skeleton imposes a circular arc shape on the elongated member in an undeformed state, the circular arc shape facilitating laparascopic implantation of the apparatus.

53. The apparatus of claim 51 wherein the housing is coupled to an end of the skeleton.

54. The apparatus of claim 51 wherein the elongated member comprises an elongated tube of compressible material that renders the ventral surface of the elongated member compressible.

55. The apparatus of claim 54 wherein the elongated tube has a circular cross-section.

56. The apparatus of claim 54 wherein the elongated member further comprises an elastic membrane that prevents tissue ingrowth.

57. The apparatus of claim 56 wherein the elastic membrane is under tension when the loop is in a fully extended position, the elastic membrane contracting substantially without wrinkling when the loop is transitioned to a fully constricted position.

58. The apparatus of claim 56 wherein the elongated member is pre-conditioned for use in a preselected gas to reduce swelling of the elastic membrane.

59. The apparatus of claim 56 wherein the elongated member further comprises a valve or hole that facilitates gas exchange and reduces swelling of the elastic membrane.

60. The apparatus of claim 56 wherein the elastic membrane possesses diffusion characteristics that impede or enhance diffusion of the preselected gas to influence swelling of the elastic membrane when exposed to a preselected gas atmosphere.

61. The apparatus of claim 41 wherein operation of the actuator varies the diameter of the loop in a range of between 15 mm to 35 mm.

62. The apparatus of claim 41 wherein the actuator and tension element are self-blocking in an unpowered state.

63. The apparatus of claim 41 further comprising:

an antenna; and

a processing circuit electrically coupled between the antenna and electric motor.

64. The apparatus of claim 63 wherein the antenna and processing circuit are disposed within a pod.

65. The apparatus of claim 63 wherein the antenna is integrated with the processing circuit.

66. The apparatus of claim 64 wherein the pod has a substantially planar profile that facilitates placement between a patient'"'"'s sternum and skin.

67. The apparatus of claim 63 further comprising an external control that transmits commands to the processing circuit via the antenna.

68. The apparatus of claim 67 wherein the external control transmits power to the processing circuit via electromagnetic induction.

69. The apparatus of claim 67 wherein the actuator is powered by a capacitor or implanted battery.

70. The apparatus of claim 67 wherein the external control receives feedback from the processing circuit comprising positional or operational data for the tension element.

71. The apparatus of claim 70 wherein the external control computes a metric corresponding to a degree of constriction of the loop based on the positional or operational data received from the processing circuit.

72. The apparatus of claim 71 wherein the external control displays variations in the diameter of the loop in fine increments.

73. The apparatus of claim 72 wherein the external control displays an absolute position of the diameter of the loop.

74. The apparatus of claim 41 further comprising a reference position switch.

75. The apparatus of claim 41 wherein the electric motor consumes 50 mW or less during operation.

76. The apparatus of claim 67 wherein the external control accepts a patient microchip card that stores positional data regarding previous adjustment of the tension element.

77. The apparatus of claim 76 wherein the patient microchip card stores an implant serial number.

78. The apparatus of claim 64 wherein the pod is configured to be mounted subcutaneously near a patient'"'"'s sternum.

79. The apparatus of claim 41 wherein different portions of the apparatus are of different colors to facilitate laparoscopic manipulation and implantation of the apparatus.

80. The apparatus of claim 56 wherein the elastic membrane comprises a portion of a leak-proof encapsulation that prevents liquids from entering the apparatus.