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

• US 20050143765A1
• 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 7,901,419 B2
• Time in Patent Office: Days
• US Class Current: 606/157
• CPC Class Codes: A61F 5/0053 remotely adjustable
• CPC Class Codes: A61F 5/0063 wrapping the stomach
• 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. A method of laparoscopically implanting a gastric band comprising a telemetrically-driven mechanical actuator within a patient'"'"'s abdominal cavity to control passage of food through the patient'"'"'s stomach, the method comprising:

providing a gastric band comprising an elongated member having a flexible element defining a helical screw thread and a telemetrically-driven mechanical actuator that engages the helical screw thread to selectively constrict the elongated member against the patient'"'"'s stomach;

inserting a plurality of cannulae into the abdominal cavity;

insufflating of the abdominal cavity to create a pneumoperitoneum;

dissecting tissue surrounding the stomach to create a path for the elongated member using a first tool inserted into one of the cannulae;

introducing the gastric band into the abdominal cavity;

grasping the gastric band with a second tool placed through a cannula; and

manipulating the elongated member to encircle the patient'"'"'s stomach and form a stoma opening within the stomach.

2. The method of claim 1 wherein grasping the gastric band with a second tool placed through a cannula comprises grasping the gastric band using laparoscopic instruments.

3. The method of claim 1 wherein manipulating the elongated member to encircle the patient'"'"'s stomach comprises manipulating the elongated member using laparoscopic instruments.

4. The method of claim 1 wherein introducing the gastric band into the abdominal cavity comprises introducing the gastric band via a laparoscopic cannula.

5. The method of claim 1 wherein introducing the gastric band into the abdominal cavity comprises introducing the gastric band via a laparotomy.

6. The method of claim 1 further comprising preconditioning the gastric band in a preselected gas.

7. The method of claim 6, wherein the preconditioning comprises placing the gastric band within a container having a preselected gas atmosphere for a sufficient duration so that the preselected gas diffuses into and replaces pre-existing gases located within the gastric band.

8. The method of claim 7 wherein the gastric band is sealed within sterile packaging prior to preconditioning.

9. The method of claim 6 wherein preconditioning the gastric band comprises packaging the gastric band in a sealed container having a preselected gas atmosphere.

10. The method of claim 1 wherein the gastric band further comprises an antenna coupled to the telemetrically-driven mechanical actuator, the method further comprising manipulating the antenna using laparscopic instruments to locate the antenna subcutaneously atop the patient'"'"'s sternum.

11. The method of claim 10 further comprising suturing the antenna in position.

12. The method of claim 1 wherein the elongated member comprises first and second ends and a clip disposed on the first end, wherein manipulating the elongated member to encircle the patient'"'"'s stomach comprises manipulating the elongated member so that the clip engages the second end.

13. The method of claim 12 wherein the clip comprises an aperture configured to receive the second end, the method further comprising manipulating the second end of the elongated member to insert it through the clip.

14. The method of claim 12 wherein the elongated member further comprises a compressible ventral surface and a substantially rigid dorsal periphery, the method further comprising straightening the elongated member to permit passage into the abdominal cavity.

15. The method of claim 12 further comprising:

providing a remote control; and

telemetrically operating the telemetrically-driven actuator to confirm proper operation of the gastric band.

16. The method of claim 15 wherein telemetrically operating the telemetrically-driven actuator comprises transmitting power to the telemetrically-controlled actuator via electromagnetic induction.

17. The method of claim 15 further comprising assessing a coupling strength between the remote control and the telemetrically-driven actuator.

18. The method of claim 15 wherein telemetrically operating the telemetrically-driven actuator comprises operating the telemetrically-driven actuator to adjust a diameter of the stoma opening in fine increments.

19. The method of claim 15 wherein telemetrically operating the telemetrically-driven actuator further comprises telemetrically operating the telemetrically-driven actuator so that the remote control receives feedback indicating positional data for the flexible element.

20. The method of claim 1 wherein portions of the gastric band are different colors, wherein manipulating the elongated member to encircle the patient'"'"'s stomach further comprises manipulating selected portions of the gastric band in accordance with colors of the selected portions of the gastric band.

21. A method of laparoscopically removing a gastric ring comprising a telemetrically-driven mechanical actuator from within a patient'"'"'s abdominal cavity, the gastric ring including an elongated member having first and second ends and a clip disposed on the first end that engages the second end, the method comprising:

inserting a plurality of cannulae into the abdominal cavity;

insufflating of the abdominal cavity to create a pneumoperitoneum;

unclipping the clip from the second end of the elongated member;

removing the elongated member from a position encircling the patient'"'"'s stomach; and

removing the gastric ring from the patient'"'"'s abdominal cavity.

22. The method of claim 21 wherein unclipping the clip comprises using a laparoscopic instrument placed through a cannula to grasp the gastric ring.

23. The method of claim 21 further comprising straightening the elongated member after removing the elongate member from a position encircling the patient'"'"'s stomach.

24. The method of claim 21 wherein removing the gastric ring from the patient'"'"'s abdominal cavity comprises withdrawing the gastric ring through one of the plurality of cannulae.

25. The method of claim 21 wherein removing the gastric ring from the patient'"'"'s abdominal cavity comprises withdrawing the gastric ring through a laparotomy.

26. A method of laparoscopically implanting a gastric ring comprising a telemetrically-driven actuator within a patient'"'"'s abdominal cavity to control passage of food through the patient'"'"'s stomach, the method comprising:

providing a gastric ring comprising an elongated member having first end and second ends, 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 flexible element slidably disposed within the elongated member, the flexible element defining a helical screw thread that engages the actuator;

placing at least one laparoscopic cannula within the abdominal cavity;

insufflating the abdominal cavity to create a pneumoperitoneum;

placing at least two additional laparoscopic cannulae within the abdominal cavity;

dissecting tissue surrounding the stomach to create a path for the gastric ring;

introducing the gastric ring into the abdominal cavity;

grasping the gastric ring with a tool placed through one of the cannulae;

pulling the gastric ring into an encircling position around the stomach; and

securing the gastric ring in the encircling position around the stomach.

27. The method of claim 26 wherein grasping the gastric ring with a tool placed through one of the cannulae comprises grasping the gastric ring using a laparoscopic instrument.

28. The method of claim 26 wherein pulling the elongated member to encircle the patient'"'"'s stomach comprises manipulating the elongated member using laparoscopic instruments.

29. The method of claim 26 further comprising pre-conditioning the gastric ring in a preselected gas atmosphere.

30. The method of claim 29, wherein the preconditioning comprises placing the gastric ring within a container having a preselected gas atmosphere for a sufficient duration so that the preselected gas diffuses into and replaces pre-existing gases located within the gastric ring.

31. The method of claim 30 wherein the gastric ring is sealed within sterile packaging prior to preconditioning.

32. The method of claim 30 wherein preconditioning the gastric ring comprises packaging the gastric ring in a sealed container having a preselected gas atmosphere.

33. The method of claim 26 wherein the gastric ring further comprises an antenna coupled to the actuator, the method further comprising:

manipulating the antenna using laparscopic instruments to locate the antenna subcutaneously atop the patient'"'"'s sternum.

34. The method of claim 33 further comprising suturing the antenna in position.

35. The method of claim 26 wherein the elongated member comprises a clip disposed on the first end, wherein securing the gastric ring in the encircling position around the stomach comprises manipulating the elongated member so that the clip engages the second end.

36. The method of claim 35 wherein the clip comprises an aperture configured to receive the second end, the method further comprising manipulating the second end of the elongated member to insert it through the clip.

37. The method of claim 35 further comprising straightening the elongated member to permit passage through the laparoscopic cannula into the abdominal cavity.

38. The method of claim 26 further comprising:

providing a remote control; and

telemetrically operating the actuator to confirm proper operation of the gastric ring.

39. The method of claim 38 wherein telemetrically operating the telemetrically-driven actuator comprises transmitting power to the actuator via electromagnetic induction.

40. The method of claim 38 further comprising assessing a coupling strength between the remote control and the actuator.

41. The method of claim 38 wherein telemetrically operating the actuator comprises operating the actuator to adjust a length of the flexible element in predetermined increments.

42. The method of claim 38 wherein telemetrically operating the actuator further comprises receiving feedback indicating positional data for the flexible element.

43. The method of claim 26 wherein portions of the gastric ring are different colors, wherein pulling the gastric ring into an encircling position around the stomach further comprises manipulating selected portions of the gastric ring in accordance with colors of the selected portions of the gastric ring.

44. The method of claim 26 wherein introducing the gastric ring into the abdominal cavity comprises introducing the gastric ring via a laparoscopic cannula.

45. The method of claim 26 wherein introducing the gastric ring into the abdominal cavity comprises introducing the gastric ring via a laparotomy.