Devices and methods for treatment of obesity

• US 8,342,183 B2
• Filed: 03/10/2007
• Issued: 01/01/2013
• Est. Priority Date: 04/19/2006
• Status: Expired due to Fees

• Current Assignee: Vibrynt, Inc.
• Original Assignee: Vibrynt, Inc.
• Inventors: Makower, Joshua, Bender, Theodore M., Shiu, Brian K., Acosta, Pablo G., Uemura, Shuji, Friedmann, Josef L., Lee, Crystine
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): MENDOZA, MICHAEL G
• Application Number:
  US11/716,985
• Publication Number:
  US 20070250102A1
• Time in Patent Office: 2,124 Days
• Field of Search: 606/119, 606/151, 606/192, 606/200, 606/202, 606/203, 600/37, 128/898
• US Class Current: 128/898
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/00876 magnetic
• 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 5/003 inflatable
• CPC Class Codes: A61F 5/0073 in the abdominal cavity, e.g. not attached to the stomach

Abstract

Methods, devices, tools, instruments and systems for treating a patient to induce weight loss. In one method embodiment, a device, including an expandable member in a collapsed configuration, is passed through an opening in the skin of the patient, and into the abdominal cavity of the patient. At least a portion of the expandable member is anchored relative to at least one structure in the abdominal cavity, without piercing the stomach. The expandable member is expanded to an expanded configuration 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.

Claims

1. A method of implanting a weight-loss treatment device by connecting the device to an anchoring frame, said method comprising:

passing the anchoring frame into the abdominal cavity of the patient;

anchoring the anchoring frame to at least one structure in the abdominal cavity, without piercing the stomach;

passing the device, including an expandable member in a compressed configuration, into the abdominal cavity of the patient; and

passing the device over the anchoring frame to anchor the device to the anchoring frame.

2. The method of claim 1, wherein said anchoring comprises anchoring the anchoring frame to the abdominal wall.

3. The method of claim 1, wherein said anchoring comprises driving a deployment member through a channel of the anchoring frame to drive anchors through a contact surface of the anchoring frame, while the contact surface contacts the at least one structure.

4. The method of claim 1, wherein said passing the anchoring frame comprises passing the anchoring frame over a guidewire.

5. The method of claim 1, wherein said passing the device comprises passing the device over a guidewire.

6. The method of claim 1, wherein said passing the device over the anchoring frame to mechanically lock the device to the anchoring frame comprises sliding keys on the device though a channel provided in the anchoring frame.

7. The method of claim 6, wherein the channel is slotted.

8. The method of claim 3, wherein said anchoring of the anchoring frame is reversible, and the anchors are retractable from the at least one structure and back through the contact surface by driving the deployment member through the channel in a direction opposite to the direction driven to effect the anchoring.

9. The method of claim 1, wherein said passing the device over the anchoring frame to mechanically lock the device to the anchoring frame comprises a channel provided in the device over a rail provided on the anchoring frame.

10. The method of claim 1, further comprising loading the anchoring frame in a distal end portion of an anchoring frame deployment tool, wherein said passing the anchoring frame is performed by passing the distal end portion of the anchoring frame deployment tool and into the abdominal cavity.

11. The method of claim 10, wherein the distal end portion is delivered over a guidewire to perform said passing the anchoring frame.

12. The method of claim 10, further comprising visualizing the at least one structure via an endoscope provided in the anchoring frame deployment tool, prior to said anchoring the anchoring frame.

13. The method of claim 10, further comprising rotating the distal end portion of the anchoring frame deployment tool, relative to the remainder of the anchoring frame deployment tool, to position the distal end portion up against the at least one structure, and then performing said anchoring of the anchoring frame.

14. The method of claim 13, wherein the at least one structure comprises the anterior abdominal wall.

15. The method of claim 1, wherein the device is mechanically locked to the anchoring frame.

16. The method of claim 15 wherein said mechanical locking is performed by an automatic locking mechanism on the anchoring frame.

17. The method of claim 16, further comprising removing the device from anchoring to the anchoring frame, said removing comprising:

inserting an anchoring frame unlocking tool against the automatic locking mechanism to unlock the mechanism; and

sliding the device out of contact with the anchoring frame.

18. The method of claim 17, wherein the anchoring frame unlocking tool includes a lock depressor on a distal end portion thereof, and wherein sliding the lock depressor over the automatic locking mechanism depresses locking features of the automatic locking mechanism.

19. The method of claim 17, whereby the anchoring frame unlocking tool and the device are retracted together for removal from the anchoring frame.

20. A method of implanting a weight-loss treatment device by connecting the device to an anchoring frame, said method comprising:

passing the anchoring frame into the abdominal cavity of the patient;

passing the device, including an expandable member in a collapsed configuration, into the abdominal cavity of the patient; and

passing the device over the anchoring frame to mechanically lock the device to the anchoring frame and to anchor the anchoring frame to at least one structure in the abdominal cavity, without piercing the stomach.

21. A method of treating a patient, said method comprising:

passing a device including an expandable member in a collapsed configuration through an opening in the skin of the patient, and into the abdominal cavity of the patient;

anchoring at least one attachment tab which is attached to and extending from the expandable member, relative to at least one structure in the abdominal cavity, without piercing the stomach, wherein said anchoring comprises engaging a portion of said device with an anchoring frame mounted on an internal structure in the abdominal cavity; and

expanding the expandable member to an expanded configuration 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.

22. The method of claim 21, wherein said method is performed as a mini-laparoscopic procedure.

23. The method of claim 21, wherein a guidewire is passed through the skin of the patient, and into the abdominal cavity, and wherein the device is passed over the guidewire to guide the device to an intended location in the abdominal cavity;

said method further comprising inserting a flexible endoscope through the skin and into the abdominal cavity, to view placement of the guidewire prior to passing the device over the guidewire.

24. The method of claim 21, wherein a guidewire is passed through the skin of the patient, and into the abdominal cavity, and wherein the device is passed over the guidewire to guide the device to an intended location in the abdominal cavity, said method further comprising visualizing placement of the guidewire using at least one of:

fluoroscopy, three-dimensional RF visualization, and three-dimensional magnetic visualization.

25. The method of claim 21, wherein a guidewire is passed through the skin of the patient, and into the abdominal cavity, and wherein the device is passed over the guidewire to guide the device to an intended location in the abdominal cavity, said method further comprising inserting a trocar through the sheath and advancing the trocar to establish a pathway into the abdominal cavity.

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

passing a device including an expandable member through a minimally invasive opening through the skin of the patient and the abdominal wall of the patient, and into the abdominal cavity of the patient;

accessing a tether looped through a positioning member on the expandable member from a second minimally invasive opening; and

drawing the tether through the second minimally invasive opening and drawing on the positioning member to reorient the expandable member.

27. The method of claim 26, further comprising expanding the expandable 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.

28. The method of claim 26, further comprising anchoring the expanded expandable member against the abdominal wall of the patient in the location of the first opening.

29. The method of claim 28, wherein the reorientation of the expandable member includes drawing an attachment tab, extending from the expandable member, into contact with the inner surface of the abdominal wall, said method further comprising attaching the attachment tab to the abdominal wall.

30. The method of claim 29, further comprising anchoring at least a portion of the expandable member, relative to at least one additional location in the abdominal cavity, without piercing the stomach.

31. The method of claim 28, further comprising anchoring at least a portion of the expandable member, relative to at least one additional location in the abdominal cavity, without piercing the stomach.

32. The method of claim 26, wherein the reorientation of the expandable member includes drawing an attachment tab, extending from the expandable member, into contact with the inner surface of the abdominal wall, said method further comprising attaching the attachment tab to the abdominal wall.

33. The method of claim 26, further comprising anchoring at least a portion of the expandable member, relative to at least one structure in the abdominal cavity, without piercing the stomach.

34. A method of treating a patient, said method comprising:

passing a device including an expandable member in a collapsed configuration through an opening in the skin of the patient, and into the abdominal cavity of the patient;

anchoring at least one attachment tab extending from the expandable member, relative to at least one structure in the abdominal cavity, without piercing the stomach; and

expanding the expandable member to an expanded configuration 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;

wherein the device is passed in a compact configuration via an introducer that maintains the device in the compact configuration during said passing, said method further comprising opening splittable jaws of the introducer, once the device has been placed in the space in the abdominal cavity.

35. A method of treating a patient, said method comprising:

passing a device including an expandable member in a collapsed configuration through an opening in the skin of the patient, and into the abdominal cavity of the patient;

anchoring at least one attachment tab extending from the expandable member, relative to at least one structure in the abdominal cavity, without piercing the stomach; and

expanding the expandable member to an expanded configuration 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;

wherein the expandable member comprises an elongated tube, said anchoring at least a portion of the expandable member comprises anchoring a distal end portion of the tube, said method further comprising incrementally advancing an additional portion of the tube and placing the additional portion into a desired location;

anchoring the additional portion; and

repeating the incrementally advancing, placing and anchoring the additional portion steps until all of the elongated tube has been placed and anchored in the abdominal cavity.

36. A method of treating a patient, said method comprising:

passing a device including an expandable member in a collapsed configuration through an opening in the skin of the patient, and into the abdominal cavity of the patient;

anchoring at least one attachment tab extending from the expandable member, relative to at least one structure in the abdominal cavity, without piercing the stomach; and

expanding the expandable member to an expanded configuration 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;

wherein the device is passed in a compact configuration, the device being provided with looped tabs, the compact configuration being achieved by rolling the device to align opposite sets of the looped tabs, and inserting a rod or wire through the aligned sets of looped tabs.

37. A method of treating a patient, said method comprising:

passing a device including an expandable member in a collapsed configuration through an opening in the skin of the patient, and into the abdominal cavity of the patient;

anchoring at least one attachment tab which is attached to and extending from the expandable member, relative to at least one structure in the abdominal cavity, without piercing the stomach; and

expanding the expandable member to an expanded configuration 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;

wherein the device is passed in a compact configuration, the compact configuration being achieved by providing an expandable compaction member that is preformed to roll up when inflated;

placing the expandable member on the expandable compaction member while said compaction member is in a spread apart, non-inflated state; and

inflating said expandable compaction member to assume a rolled up configuration substantially surrounding the expandable member and maintaining the expandable member in the compact configuration.

38. The method of claim 37, further comprising deflating the expandable compaction member once the expandable member has been positioned in a desired location in the abdominal cavity;

and retracting the deflated compaction member to remove it from the expandable member prior to said expanding the expandable member.

39. The method of claim 38, wherein said anchoring at least a portion of the expandable member is performed prior to said deflating the expandable compaction member.

40. A method of treating a patient, said method comprising:

passing a device including an expandable member in a collapsed configuration through an opening in the skin of the patient, and into the abdominal cavity of the patient, wherein the device is passed in a compact configuration, the compact configuration being achieved by providing a rigid exoskeleton; and

placing the expandable member in the rigid exoskeleton, wherein the rigid exoskeleton maintains the expandable member in the compact configuration;

anchoring at least one attachment tab which is attached to and extending from the expandable member, relative to at least one structure in the abdominal cavity, without piercing the stomach; and

expanding the expandable member to an expanded configuration 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; and

extracting the expandable member from the rigid exoskeleton once the expandable member has been positioned in a desired location in the abdominal cavity;

wherein a distal portion of the expandable member, at least one attachment tab or flange extending from a distal portion of the expandable member, or a distal portion of the expandable member and at least one attachment tab or flange extending from the expandable member extends out of the rigid exoskeleton prior to said extracting, and wherein said anchoring at least a portion of the expandable member is performed prior to said extracting and assists in said extracting by retracting the rigid exoskeleton against the force provided by said anchoring.

41. The method of claim 40, wherein said extracting comprises rotating the rigid exoskeleton.

42. The method of claim 40, wherein said extracting comprises moving the rigid exoskeleton linearly away from an anchored portion of the expandable member.

43. A method of treating a patient, said method comprising:

passing a device including an expandable member in a collapsed configuration through an opening in the skin of the patient, and into the abdominal cavity of the patient, wherein the device is passed in a compact configuration, the compact configuration being achieved by providing a rigid exoskeleton; and

placing the expandable member in the rigid exoskeleton, wherein the rigid exoskeleton maintains the expandable member in the compact configuration;

anchoring at least one attachment tab which is attached to and extending from the expandable member, relative to at least one structure in the abdominal cavity, without piercing the stomach;

expanding the expandable member to an expanded configuration 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; and

extracting the expandable member from the rigid exoskeleton once the expandable member has been positioned in a desired location in the abdominal cavity;

wherein said extracting is performed incrementally, said method further comprising anchoring additional portions of the expandable member in steps between incremental extraction steps performed.