Devices and methods for treatment of obesity

• US 20090099588A1
• Filed: 10/11/2007
• Published: 04/16/2009
• Est. Priority Date: 10/11/2007
• Status: Active Grant

• Current Assignee: Reshape Medical, Inc. (ReShape LifeSciences, Inc.)
• Original Assignee: Reshape Medical, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Bender, Theodore M., Makower, Joshua, Uemura, Shuji, Friedmann, Josef L., Acosta, Pablo G., Shiu, Brian K., Lee, Crystine
• Granted Patent: US 8,556,925 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• CPC Class Codes: A61F 5/0073 in the abdominal cavity, e.g. not attached to the stomach

Abstract

Implantable devices, methods of implantation and tools for performing the implantations. A device includes a volume occupying member having a working configuration such that, when the device is implanted into the abdominal cavity of the patient, the device performs at least one of: prevention of expansion of the stomach of the patient into a space occupied by the volume occupying member in the abdominal cavity; and compression of a portion of the stomach. A device is configured to have substantially neutral buoyancy or a slightly positive buoyancy when implanted in the abdominal cavity external of the stomach. An attachment member is connected to the volume occupying member, and at least a portion of the attachment member is configured to encourage tissue ingrowth from at least one internal abdominal structure when held in contact therewith.

Claims

1. An implantable device for treatment of a patient to assist weight loss, said device comprising:

a fillable member configured to be positioned exteriorly of the stomach in an abdominal cavity of the patient, said fillable member configured to be filled after placement of said device in the abdominal cavity, wherein said device, with said fillable member in a filled configuration, has a buoyancy characteristic comprising a density of about 900 kg/m3 to about 1100 kg/m3.

5. The device of claim 1, wherein said device is substantially neutrally buoyant in the abdominal cavity.

6. The device of claim 1, wherein said device is slightly positively buoyant in the abdominal cavity.

14. The device of claim 1, wherein said fillable member has a non-spherical configuration when in said filled configuration and, when implanted in the abdominal cavity outside of the stomach, takes up a first volume adjacent the fundus of the stomach and a second volume adjacent the body of the stomach, wherein said first volume is larger than said second volume.

15. The device of claim 1, further comprising a reinforcement layer extending over a majority of a length of at least one side of said fillable member.

16. The device of claim 1, further comprising at least one attachment structure extending medially, laterally and inferiorly of said fillable member.

17. The device of claim 16, further comprising tissue ingrowth-enhancing material on at least one of said at least one attachment structure.

18. The device of claim 16, wherein a portion of at least one of said at least one attachment structure comprises a porous material configured to encourage tissue ingrowth.

19. The device of claim 1, further comprising a positioning loop attached to said fillable member and extending therefrom.

20. The device of claim 1, further comprising a positioning tab on said fillable member.

21. The device of claim 20, wherein said positioning tab includes a pointer oriented so that said fillable member is oriented correctly in the abdominal cavity when said pointer points toward the Angle of His.

22. The device of claim 19, further comprising at least one suture extending through said positioning loop, said suture having at least one length extending from said positioning loop that is longer than said positioning loop.

23. The device of claim 16, further comprising at least one suture extending through said at least one attachment member, each said suture having a length sufficient to extend through an abdominal wall of the patient, when the attachment member is positioned against an internal wall surface of the abdominal wall.

24. The device of claim 23, wherein at least one of said at least one sutures is folded back and forth upon itself to form a bundle, said bundle temporarily retained in a loop extending through said at least one attachment member, a free end of said at least one suture extending from said bundle, wherein upon grasping said free end and pulling, said suture is pulled free from said loop and unbundled.

25. The device of claim 23, comprising at least one bundle having a pair of sutures folded back and forth upon themselves and temporarily retained in one of said loops.

2. The device of claim 2, further comprising a buoyancy member exhibiting substantially uniform density throughout, wherein said density of said buoyancy member is less than a density of said fillable member when said fillable member is filled with a liquid, such that, when said buoyancy member is combined with said fillable member in said filled configuration, said density of said device is less than said density of said fillable member when filled with a liquid and not combined with said buoyancy member.

3. The device of claim 2, wherein said buoyancy member is non-expandable.

4. The device of claim 2, wherein said buoyancy member comprises porous silicone.

7. The device of claim 2, wherein said buoyancy member is contained within said fillable member.

8. The device of claim 2, wherein said buoyancy member is fixed to an internal surface of said fillable member.

9. The device of claim 2, wherein said buoyancy member extends along an elongated internal surface of said fillable member and increases structural integrity of said fillable member.

10. The device of claim 2, wherein said buoyancy member is elongated and substantially proportional in shape to a shape of said fillable member in said filled configuration.

11. The device of claim 2, wherein said buoyancy member is elongated and has a curvature that corresponds to a curvature of said fillable member when filled to a filled configuration.

12. The device of claim 2, wherein said buoyancy member is resilient.

13. The device of claim 2, wherein said fillable member is substantially stomach-shaped in said filled configuration, and said buoyancy member is substantially stomach-shaped.

26. A method of treating a patient, said method comprising the steps of:

taking at least one internal measurement in an abdominal space of the patient; and

selecting an appropriately sized device for implantation into the abdominal cavity of the patient, based on the internal measurements taken.

27. The method of claim 26, wherein the at least one internal measurement is afe taken with the aid of a visualization apparatus, and said at least one internal measurement includes at least one of:

measurement of the stomach of the patient while the stomach is substantially empty;

measurement of the stomach while the stomach is substantially full, Lateral measurement or AP measurement.

28. The method of claim 27, wherein the visualization apparatus provides two-dimensional visualization of the abdominal cavity and rib cage of the patient.

29. The method of claim 27, wherein the visualization apparatus provides three-dimensional visualization of the abdominal cavity and rib cage of the patient.

30. The method of claim 27, wherein the visualization apparatus is selected form at least one of CT and MRI.

31. The method of claim 26, wherein said selecting comprises:

referencing a chart that correlates internal measurements with device sizes; and

selecting a device size from the chart based on the internal measurements taken.

32. The method of claim 26, wherein said selecting comprises:

ordering a custom-sized device sized specifically for the internal measurements taken.

33. The method of claim 26, wherein the appropriately sized device is selected from a plurality of devices having a plurality of different sizes, each said device comprising a fillable member, wherein each said fillable member, when filled to a filled configuration has at least a different length or diameter dimension different from those of the other fillable members.

34. The method of claim 33, wherein each said fillable member has a unique combination of said length and said diameter dimensions.

35. The method of claim 26, wherein said internal measurements are Lateral and AP measurements.

36. The method of claim 35, wherein said AP measurement is taken by measuring a distance from a posterior inside surface of a rib of the patient at a level of and through the center of the gastroesophageal junction to an anterior inside surface of the rib at the level of the gastroesophageal junction;

and the Lateral measurement is taken from midline to a left lateral inside surface of the rib, through the center of the location of the gastroesophageal junction, at the level of the gastroesophageal junction.

37. The method of claim 26, further comprising:

passing the selected device into the abdominal cavity of the patient, wherein the device includes at least one attachment member extending from a main body portion thereof; and

at least temporarily attaching the at least one attachment member to an internal abdominal structure, without attachment to the stomach.

38. The method of claim 37, further comprising at least partially filling the main body portion with a fluid, using an adjustment aid tool that does not require a pushing pressure against the hand of the user to deliver fluid out of a syringe.

39. The method of claim 37, wherein the selected device includes a fillable member, the fillable member is in a compressed configuration during said passing of the device, and the method further comprises filling the fillable member in a space in the abdominal cavity to perform at least one of:

prevention of expansion of the stomach of the patient into the space; and

compression of a portion of the stomach.

40. The method of claim 26, wherein the device has a volume occupying member, said method further comprising:

placing the volume occupying member exteriorly of the stomach and into the abdominal cavity of the patient adjacent the stomach to prevent expansion of the stomach into a volume occupied by the placed device; and

attaching an attachment member connected to the volume occupying member to at least one internal abdominal structure, without attachment to the stomach;

wherein at least a portion of the attachment member is configured to encourage tissue ingrowth from the at least one internal abdominal structure that it is attached to.

41. The method of claim 40, wherein the attachment member is attached to the abdominal wall of the patient.

42. The method of claim 40, wherein said attaching comprises passing at least one suture through the abdominal wall, and fixing said at least one suture externally of an external surface of the abdominal wall.

43. The method of claim 42, wherein said attaching comprises puncturing through a location of the abdominal wall above a location of at least one said suture and inserting an instrument into the abdominal cavity;

capturing the suture; and

wherein said passing at least one suture through the abdominal wall comprises pulling a portion of the at least one suture through the abdominal wall;

applying tension to the at least one suture to draw the at least one attachment tab against an internal surface of the abdominal wall; and

fixing the at least one suture externally of the abdominal wall.

44. The method of claim 43, further comprising placing a suture placement template over the skin of the patient in an orientation to align at least one location over the abdominal wall through which said puncturing through a location of the abdominal wall is conducted, prior to said puncturing through the location of the abdominal wall.

45. The method of claim 40, wherein said placing comprises passing the device through a small opening in the patient'"'"'s abdominal wall, wherein the fillable member is in a collapsed configuration during said passing, and wherein the fillable member is filled to a fill configuration in a space in the abdominal cavity external of the stomach to perform at least one of:

prevention of expansion of the stomach of the patient into the space; and

compression of a portion of the stomach.

46. The method of claim 45, wherein the fillable member is filled to a mini volume fill configuration upon said placing, where the fillable member in the mini volume fill configuration has no wrinkles upon said placing, said method further comprising subsequently filling the fillable member to a target volume fill configuration.

47. The method of claim 46, wherein the fillable member is left in the mini volume fill configuration upon completion of implantation of the device, and wherein the fillable member is filled to the target volume fill configuration after a period of time has elapsed to allow tissue ingrowth into the attachment member.

48. The method of claim 40, wherein said attaching comprises puncturing through a location of the abdominal wall above a location of at least one suture, having been preinstalled through said attachment member, and inserting an instrument into the abdominal cavity;

capturing the at least one suture;

pulling a portion of the at least one suture through the abdominal wall;

applying tension to the at least one suture to draw the attachment member against an internal surface of the abdominal wall; and

fixing the at least one suture externally of the abdominal wall.

49. The method of claim 40, wherein said placing the volume occupying member is performed using a tool comprising:

a delivery tube dimensioned to receive the volume occupying member in a compact configuration with the volume occupying member in a compressed configuration;

a plunger configured to be received in an annulus of said tube;

a plunger shaft extending proximally from said plunger, said plunger shaft having a length sufficient to extend a handle at a proximal end of said plunger shaft out of a proximal end of said tube when said plunger is flush or nearly flush with a distal end of said tube; and

a mandrel fixed relative to said plunger shaft and extending distally of said plunger, said mandrel being receivable through said annulus along with said plunger.

50. The method of claim 49, wherein said tool further includes a tether fixed with respect to said plunger shaft, said tether having sufficient length to extend distally of a distal end of said mandrel;

and a sheath dimensioned to wrap around the volume occupying member the volume occupying member is in the compact configuration.