Laparoscopic adjustable gastric banding device and method for implantation and removal thereof

• US 5,449,368 A
• Filed: 05/12/1993
• Issued: 09/12/1995
• Est. Priority Date: 02/18/1993
• Status: Expired

• Current Assignee: Lubomyr I. Kuzmak
• Original Assignee: Lubomyr I. Kuzmak
• Inventors: Kuzmak, Lubomyr I.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): MULCARE, NANCY C
• Application Number:
  US08/059,592
• Time in Patent Office: 853 Days
• Field of Search: 606/151, 606/157, 606/201-203, 600/29, 600/30, 600/31, 128/899, 128/DIG. 25
• US Class Current: 606/157
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• CPC Class Codes: A61F 5/0056 using injection ports
• CPC Class Codes: A61F 5/0066 Closing devices for gastric bands

Abstract

An adjustable gastric banding device for regulating the size of a stoma opening in the stomach of a patient includes an elongate band portion that encircles the stomach so as to limit the food intake by the digestive portion of the stomach. The device can be readily implanted and removed using laparoscopic procedures. A locking element protruding from a location near the distal end of the encircling band portion is inserted into a slot formed in a receiving segment at an intermediate location along the encircling band portion so as to form a circle or loop of fixed diameter. The receiving segment has a thickness which is greater than the thickness of the encircling band portion and of the rear portion of the band. A moveable bolt secures the locking element in the slot. The bolt can be displaced remotely, thus releasing the locking element and allowing easy laparoscopic removal of the banding device. The entire circumference of the stomach encircling band portion is covered by an expandable section in contact with the surface of the stomach. The size of the stoma opening can be adjusted by injecting into or removing fluid from the expandable section.

Claims

1. A gastric banding device for forming a stoma opening in a stomach so as to restrict food intake to the lower digestive portion of the stomach, said device comprising:

an elongate band member including a band portion for, in use, encircling a stomach to form a stoma opening in the stomach, said band member including a free end and an intermediate portion having a thickness greater than the thickness of the remainder of said band member;

an expandable section secured to said band portion of said band member for varying the size of the stoma opening;

a securing member located near said free end of said band member and protruding outwardly therefrom;

a recess, formed in said intermediate portion of said band member, for receiving said securing member therein; and

means, including a movable control member separate from said securing member, for positively retaining said securing member in said recess so that said band portion forms a circle of a predetermined fixed diameter around said stoma opening.

2. A gastric banding device as claimed in claim 1, wherein said central member comprises a moveable bolt for releasably retaining said securing member in said recess.

3. A gastric banding device as claimed in claim 2, wherein said securing member includes a threaded hole therein in which said bolt is received.

4. A gastric banding device as claimed in claim 2, wherein said bolt comprises a distal part of an elongate control element located within said band member and extending longitudinally thereof.

5. A gastric banding device as claimed in claim 2, wherein said control element includes a proximal end which extends beyond said band member for allowing remotely controlled release of securing member from said recess by movement of said bolt.

6. A gastric banding device as claimed in claim 2, further comprising a guiding plate, located within said band member of on one side of said recess, for guiding the movement of said bolt, and a holding plate located within said band member on the other side of said recess, for retaining the free end of said bolt.

7. A gastric banding device as recited in claim 1, wherein said expandable section comprises an expandable member extending around substantially the entire circumference of said band portion that, in use, encircles the stomach wall.

8. A gastric banding device as claimed in claim 1, wherein said expandable section includes reinforcement in the sidewalls thereof.

9. A gastric banding device as recited in claim 1, further comprising a remotely disposed fluid injection unit in fluid connection with said expandable section through said band member such that the size of the stoma opening can be altered by adding or withdrawing fluid to cause expansion and retraction of said expandable section.

10. A gastric banding device as claimed in claim 1, further comprising barrier means for preventing tissue from growing around said securing member.

11. A gastric banding device as claimed in claim 10, wherein said barrier means comprises a soft sponge-like silicone barrier element.

12. A gastric banding device as claimed in claim 1, further comprising a thin loop extending around a peripheral surface of said securing member which is received in said recess for ensuring a secure fit between said securing member and said recess.

13. A method for removing a gastric band device including an encircling band portion encircling a stomach so as to form a restricted stoma opening for limiting food intake to the lower digestive portion of the stomach, said gastric band device including an expandable section secured to said encircling band portion for varying the size of the stomach opening, an elongate band portion incorporating a remotely operable securing means for retaining a locking element projecting from said gastric band device at a location near the distal end of said encircling band portion in a locking position wherein said locking element is received in a recess formed at an intermediate location along said gastric banding device so that said encircling band portion forms a circle of a predetermined fixed diameter around said stoma opening, and expansion control means, located in the abdominal muscle wall at the proximal end of said gastric band device, for controlling expansion and contraction of said expandable section, said method comprising the steps of:

providing an incision in the abdominal muscle wall at the location of said expansion control means;

retracting said securing means so as to release said locking element from said recess;

cutting said elongate band portion close to said recess on a side of said recess opposite said expandable section, with said securing means sufficiently retracted such that the securing means is not severed by said cutting, so as to produce a cut portion of said elongate band portion;

removing both said expansion control means and said cut portion of said elongate band portion through said incision; and

laparoscopically removing the remainder of said gastric band device containing said recess and said expandable section at the location of said stoma opening.

14. A method for removing a gastric band device including an encircling band portion encircling a stomach so as to form a restricted stoma opening for limiting food intake to the lower digestive portion of the stomach, said gastric band device including an expandable section secured to said encircling band portion for varying the size of the stomach opening, an elongate band portion incorporating a remotely operable securing means for retaining an outwardly projecting locking element formed integral with and projecting from said gastric band device at a location at least near the distal end of said encircling band portion in a locking position wherein said locking element is received in a recess formed at an intermediate fixed distance along said gastric banding device from said locking element so that said encircling band portion forms a circle of a predetermined fixed diameter around said stoma opening, and expansion control means, located in the abdominal muscle wall at the proximal end of said gastric band device, for controlling expansion and contraction of said expandable section, said method comprising the steps of:

providing an incision in the abdominal muscle wall at the location of said expansion control means;

removing said expansion control means through said incision;

releasing said outwardly projecting locking element from said recess and completely removing said securing means from said gastric band device through said incision; and

laparoscopically removing said gastric band device at the location of said stoma opening.

15. A method for laparoscopically implanting a gastric band device including an encircling band portion which, in use, encircles a stomach so as to form a restricted stoma opening for limiting food intake to the lower digestive portion of the stomach, said gastric band device including an expandable section secured to said encircling band portion for varying the size of the stomach opening, an elongate band portion incorporating a remotely operable securing means for, when the device is implanted, retaining an outwardly projecting locking element formed integral with and projecting from said gastric band device at a location at least near the distal end of said encircling band portion in a locking position wherein said locking element is received in a recess formed at an intermediate fixed distance along said gastric banding device from said locking element so that, when the band is implanted, said encircling band portion forms a circle of a predetermined fixed diameter around said stoma opening, and expansion control means, communicating with said expandable section through a channel formed in said elongate band portion, for controlling expansion and contraction of said expandable section, said method comprising the steps of:

using an endoscope introduced into an cannula to dissect tissue surrounding the stomach to provide a path for the elongate band portion of the gastric band device;

laparoscopically introducing the gastric band into the abdominal cavity such that said encircling band portion encircles the stomach and said locking element is inserted in said recess so that said encircling band portion forms a circle of a fixed diameter around said stoma opening of the stomach which is predetermined prior to insertion of the locking element into the recess by said fixed distance between the locking element and the recess;

operating said securing means to lock said locking element in said recess; and

implanting said expansion control means in the abdominal muscle wall.

16. A gastric banding device for forming a stoma opening in a stomach so as to restrict food intake to the lower digestive portion of the stomach, said device comprising:

a band member including encircling band means for, in use, encircling a stomach in a single loop so as to form a stoma opening in the stomach;

an expandable section extending completely around the entire length of said encircling band means so that, in use, the expandable section fully encircles the stoma opening; and

means for controlling expansion and contraction of said expandable section so as to control the size of the stoma opening;

said band means having a free end and said device further comprising a first interlocking securing means disposed at a first predetermined fixed position at least close to said free end and a second interlocking securing means, disposed at a second predetermined fixed position located at an intermediate portion along said band, for interlocking with said first interlocking securing means to provide securing of said free end of said band means to said intermediate portion of said band means at said second position so that the band means forms a single loop circle of predetermined fixed diameter around the stoma opening.

17. A gastric banding device as claimed in claim 16, wherein said expandable section comprises an elongate inflatable element having reinforced walls.

18. A gastric banding device as recited in claim 16, further comprising releasing means for remotely releasing said securing means.

19. A gastric banding device for forming a stoma opening in a stomach so as to restrict food intake to the lower digestive portion of the stomach, said device comprising:

an elongate band member including a band portion for, in use, encircling a stomach to form a stoma opening in the stomach, said band member including a free end, and securing means for securing the free end of said band member to an intermediate portion of said band member so that said band portion forms a circle of a predetermined fixed diameter around said stoma opening, said securing means comprising first and second fixed interlocking means formed integrally with the band member for, when interlocked, forming said band portion into said circle of predetermined diameter; and

an expandable section secured to said band portion of said band member for varying the size of the stoma opening;

said first interlocking means comprising a securing member located near the free end of said band member and protruding outwardly therefrom and said second interlocking means comprising a recess formed in said band member at said intermediate portion thereof for receiving said securing member therein.

20. A gastric banding device as claimed in claim 19, wherein said securing means further comprises retaining means separate from said securing member for positively retaining said securing member in said recess.

21. A gastric banding device as claimed in claim 20, wherein said retaining means comprises a moveable bolt.

22. A gastric banding device as claimed in claim 20, wherein said retaining means comprises a distal part of an elongate control element located within said band member and extending longitudinally thereof.

23. A gastric banding devices as claimed in claim 22, wherein said control element includes a proximal end which extends beyond said band member for allowing remotely controlled release of securing member from said recess by movement of said retaining means.

24. A gastric banding device as claimed in claim 21, wherein said bolt has a free end, said device further comprising a guiding plate, located within said band member of on one side of said recess, for guiding the movement of said bolt, and a holding plate located within said band member on the other side of the recess, for retaining the free end of said bolt.

25. A gastric banding device as recited in claim 19, wherein expandable section comprises an expandable member extending around the entire circumference of said band portion that, in use, encircles the stomach wall in a single loop.

26. A gastric banding device as claimed in claim 19, wherein said band portion of said band member is of a first thickness and the remainder of the band member is of a second, greater thickness.

27. A gastric banding device as claimed in claim 19, wherein said expandable section includes reinforcement in the sidewalls thereof.

28. A gastric banding device as recited in claim 19, further comprising a remotely disposed fluid injection unit in fluid connection with said expandable section through said band member such that the size of the stoma opening can be altered by adding or withdrawing fluid to cause expansion and retraction of said expandable section.

29. A gastric banding device as claimed in claim 19, further comprising barrier means on said band member for preventing tissue from growing around said securing member.

30. A gastric banding device as claimed in claim 29 wherein said barrier means comprises a soft sponge-like silicone barrier element.

31. A gastric banding device as claimed in claim 19, further comprising a thin loop formed around the securing member for ensuring a secure fit between said securing member and said recess.

32. A device as claimed in claim 19, wherein said securing means further comprises retaining means separate from said securing member for positively retaining said securing member in said recess.

33. A method for controlling the size of a stoma opening in a stomach so as to provide the restriction of food intake to the digestive portion of the stomach, said method comprising the steps of:

placing an elongate band around an exterior surface of a stomach so that a portion of the band encircles the stomach;

inserting a locking element formed integrally with and projecting outwardly from said band at a location near the distal end of the band into a recess formed at an intermediate location along the said band so as to form said band into a complete circle of fixed diameter around the stomach; and

positively securing said locking element in said recess using a retaining member separate from said locking element.

34. The method as recited in claim 33, further comprising varying the amount of fluid contained in an expandable section located on a surface of said band in contact with the exterior surface of the stomach so as to vary the size of the stoma opening.

35. The method as claimed in claim 33 wherein securing of said locking element in said recess comprises using a remotely located control member connected to said retaining member by a connector element extending along the length of said band to move said retaining member so as to lock said locking element in said recess.

36. The method as claimed in claim 33 further comprising using a remotely located control member connected to said retaining member by a connector element extending along the length of said band to move said retaining member so as to release said locking member from said recess.

37. A gastric banding device for forming a stoma opening in a stomach so as to restrict food intake to the lower digestive portion of the stomach, said device comprising:

an elongate band member including a band portion for, in use, encircling a stomach to form a stoma opening in the stomach, said band member including a free end, and securing means for securing the free end of said band member to an intermediate portion of said band member so that said band portion forms a circle of a predetermined fixed diameter around said stoma opening, said securing means comprising first and second fixed interlocking means formed integrally with the band member for, when interlocked, forming said band portion into said circle of predetermined diameter; and

a retaining member separate from said first and second interlocking means for positively securing said first and second interlocking means together so as to prevent unlocking thereof; and

an expandable section secured to said band portion of said band member for varying the size of the stoma opening.

38. A device as claimed in claim 37 further comprising a control member located at the proximal end of said band member and connected to said retaining member by a connector element extending along the length of said band member for controlling movement of said retaining member.

39. A device as claimed in claim 37 wherein one of said first and second interlocking means comprises a projection and the other of said first and second interlocking means comprises a recess and wherein said retaining member engages said projection in said recess to provide locking of said projection in said recess.

40. The device as claimed in claim 39 wherein said retaining member comprises a movable bolt.