Compressive Device For Percutaneous Treatment of Obesity

• US 20080167647A1
• Filed: 01/15/2008
• Published: 07/10/2008
• Est. Priority Date: 03/23/2004
• Status: Abandoned Application

• Current Assignee: Michael Gertner
• Original Assignee: Michael Gertner
• Inventors: Gertner, Michael
• Application Number:
  US12/014,106
• Publication Number:
  US 20080167647A1
• Time in Patent Office: Days
• US Class Current: 606/41
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/00871 polymeric
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0456 Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0086 : using clamps, folding means or the like

Abstract

Disclosed are methods and apparatus for implantation into the walls of an organ such as the stomach. Deformable or inflatable anchors with a connector between are used to pull the walls of the organ together, or to implant devices in the wall of the organ. Also disclosed are surgical instruments useful in practicing the disclosed methods.

Claims

1. A method for reducing the interior volume of an organ, comprising:

passing a first end of a first surgical instrument through the patient'"'"'s skin, through a first exterior surface of the organ, through the interior of the organ, and thence through a second exterior surface of the organ, so that the surgical instrument traverses the organ;

deploying a first anchor from the surgical instrument wherein the first anchor is located adjacent to the second exterior surface of the organ;

partially or completely withdrawing the surgical instrument;

deploying a second anchor wherein the second anchor is located adjacent to the first exterior surface of the organ;

providing a connector between the first and second anchors, wherein the length of the connector between the first and second anchors is such that the first and second anchors urge the first and second exterior surfaces of the organ toward each other, thereby reducing the volume of the organ.

2. The method of claim 1, wherein said first and second anchors are deployed from the same surgical instrument.

3. A method of reversing the volume reducing procedure of claim 1 comprising:

providing a patient having one or more connectors in an organ, wherein the connectors have been implanted utilizing the method of claim 1; and

cutting or otherwise dividing said one or more connectors between the first and second anchors.

4. The method of claim 1, wherein the organ is a gastrointestinal organ.

5. The method of claim 1, further comprising creating a space outside the organ adjacent to the second exterior surface thereof by introducing a volume-filling substance into a potential space adjoining said second exterior surface.

6. The method of claim 5, wherein said potential space is expanded by the injection of a gas, liquid, gel, foam, or solid, into the potential space.

7. The method of claim 4, wherein said potential space is expanded by the inflation of a balloon placed in the potential space.

8. The method of claim 4, wherein said potential space is expanded by blunt dissection.

9. The method of claim 4, further comprising insufflating the organ prior to said passing of said first end of a surgical instrument through a first exterior surface of the organ.

10. The method of claim 4, wherein said patient'"'"'s skin is overlying the patient'"'"'s stomach, said organ is the patient'"'"'s stomach, said first exterior surface is the anterior wall of the stomach, said second exterior surface is the posterior wall of the stomach, and said potential space is the lesser sac of the peritoneum.

11. The method of claim 10, further comprising urging the anterior and posterior walls of the stomach closer together by shortening the length of the connector between the first and the second anchors.

12. The method of claim 10, wherein the surgical instrument is inserted into the patient'"'"'s abdomen by directly penetrating the patient'"'"'s skin and abdominal wall, by passing the surgical instrument through a laparoscopic port, or by passing the surgical instrument through an incision in the patient'"'"'s skin and abdominal wall.

65. The method of claim 10, wherein mucosa of said anterior and posterior walls contact one another.

13. A method for reducing the volume of a patient'"'"'s stomach, comprising:

passing a first anchor through a patient'"'"'s abdominal skin, and through the patient'"'"'s anterior and posterior stomach walls, wherein the first anchor is in a reduced profile configuration;

deploying said first anchor within the patient;

passing a second anchor through the skin of a patient'"'"'s abdominal wall;

deploying the second anchor within the patient;

connecting the first and second anchors by means of a connector that passes through the stomach;

urging the first and second anchors toward each other; and

holding the anterior and posterior walls of the stomach close together with said first and second anchors.

14. The method of claim 13 wherein said second anchor is deployed within the peritoneal cavity.

16. The method of claim 13, wherein passing said second anchor through the patient'"'"'s abdominal skin is done while said second anchor is in a reduced profile configuration, further comprising said second anchor subsequently being in a deployed configuration.

17. The method of claim 13 wherein said reduced profile configuration of said first anchor is substantially folded, and/or compressed, and/or uninflated, and said deployed configuration is substantially unfolded and/or uncompressed and/or inflated.

18. The method of claim 16 wherein said reduced profile of said second anchor is substantially folded, and/or compressed, and/or uninflated, and said deployed configuration is substantially unfolded and/or uncompressed and/or inflated.

19. The method of claim 14, wherein mucosa of said anterior and posterior walls of the stomach do not contact one another

20. The method of claim 14, wherein mucosa of said anterior and posterior walls contact one another.

21. The method of claim 14, wherein said holding step is performed by adjusting the relative position of the connector and the second anchor, and then configuring the second anchor to engage the connector in a manner that prevents a change in the distance between the first and second anchors.

22. The method of claim 13 further comprising delivering an electrical signal to said anterior stomach wall through said second anchor.

23. The method of claim 13 further comprising delivering an electrical signal to said posterior stomach wall through said first anchor.

24. The method of claim 14 wherein the method is performed without the use of a general pneumoperitoneum;

and wherein an endoscope is not used for mechanical manipulation.

25. The method of claim 14 further comprising imaging of the patient'"'"'s abdomen using fluoroscope, MRI, CAT scan, or ultrasound, during insertion of either of said first or second anchors into the patient'"'"'s abdomen.

15. The method of 13 wherein said second anchor is deployed between the abdominal skin and the outermost peritoneum of the abdominal cavity.

26. A fastening assembly, comprising:

a first anchor, a second anchor, and a connector;

wherein said first anchor comprises a relatively planar body attached to said connector;

said body of said first anchor having a relatively planar deployed profile and a reduced profile configuration;

wherein said second anchor comprises a relatively planar body, a hole or other passageway approximately in the center of the body of sufficient diameter to allow passage of the connector through said hole or other passageway, and one or more gripping elements within said hole or other passageway;

said body of said second anchor having a relatively planar deployed profile and a reduced profile configuration; and

wherein said gripping elements prevent movement of said second anchor along the longitudinal axis of the connector in the direction away from said first anchor when the connector is disposed in said hole or other passageway and when said second anchor is in its deployed configuration.

27. The fastening assembly of claim 26 wherein said body has two or more attachment structures accessible from a top surface of said body.

28. The fastening assembly of claim 26, wherein said reduced profile configuration is substantially folded, and/or compressed, and/or uninflated, and said deployed configuration is substantially unfolded, and/or uncompressed, and/or inflated.

29. The fastening assembly of claim 28, wherein said gripping elements do not prevent movement of said second anchor along the longitudinal axis in either direction when said connector is disposed in said hole or other passageway and when said second anchor is in its reduced profile configuration.

30. The fastening assembly of claim 26, wherein said body of said first anchor is inflatable;

wherein said first anchor has a relatively planar deployed profile when inflated and a reduced profile configuration when uninflated;

wherein said first anchor is readily deformable when uninflated; and

wherein said connector is hollow and configured to allow inflation of said first anchor by delivery of a filling substance through said connector to said first anchor.

31. The fastening assembly of claim 26, wherein said body of said second anchor is inflatable;

wherein said second anchor has a relatively planar deployed profile when inflated and a reduced profile configuration when uninflated; and

wherein said second anchor is readily deformable when uninflated.

32. The fastening assembly of claim 31, wherein said gripping elements do not prevent movement of said second anchor along the longitudinal axis in either direction when said connector is disposed in said hole or other passageway when said second anchor is in its reduced profile configuration.

33. The fastening assembly of claim 31, wherein said second anchor has an inflation tube connected to said second anchor body configured to allow inflation of said second anchor by delivery of a filling substance through said inflation tube to said second anchor body.

34. The fastening assembly of claim 30, wherein said filling substance hardens, cures, polymerizes, or become a gel over time.

35. The fastening assembly of claim 33, wherein said filling substance hardens, cures, polymerizes, or become a gel over time.

36. The fastening assembly of claim 26, wherein said first anchor, said second anchor, or both said first and said second anchors, can deliver an electrical signal to tissue when placed in contact with said tissue.

37. A surgical instrument comprising:

a proximal end, a distal end, and a shaft with a channel;

said distal end comprising a tissue penetrator adapted to penetrate a wall of a hollow organ, and a tissue grasper adapted to grasp a wall of a hollow organ;

an expander within the channel of the surgical instrument;

wherein the expander can be deployed from within the channel of the instrument and extend through a wall of the hollow organ while the wall is being grasped by the tissue grasper, and is adapted to introduce a volume-filling material or device beyond the hollow organ.

38. A surgical instrument comprising:

a proximal end, a distal end, and a channel;

wherein said distal end comprises a tip which has an open configuration and a closed configuration;

wherein in said closed configuration, said tip is adapted to penetrate a wall of a hollow organ;

wherein in said open configuration, said tip can grasp the wall of the hollow organ.

39. The surgical instrument of claim 38 wherein said channel comprises a diameter of about 2 mm to 12 mm.

40. An anchor implantation instrument comprising:

an outer sheath, a middle sleeve disposed within the outer sheath, an inner member disposed within the middle sleeve, and a channel within the inner member;

wherein said middle sleeve has an outer diameter and a longitudinal axis, and the outer diameter of said middle sleeve is such that it can slide within the outer sheath along the longitudinal axis of the middle sleeve;

wherein the inner member has an outer diameter, and the outer diameter of said inner member is such that it can slide within the middle sleeve along the longitudinal axis of the middle sleeve;

wherein said inner member has a grasper suitable for grasping a foldable anchor and wherein said outer sheath has a distal portion which has an inner diameter sufficient to hold a foldable anchor in its folded configuration.

41. A biocompatible surgical anchor adapted for use in connecting the walls of a hollow organ or anchoring a device to the wall of a hollow organ, comprising:

a body portion, wherein said body portion is foldable and can assume a relatively planar deployed configuration and a reduced-profile folded configuration, wherein the body portion has an opening extending therethrough; and

a gripper on the body portion adapted to grip an elongated connector as such a connector extends through the opening, wherein the gripper engages such a connector when the anchor is in the deployed configuration, and releases such a connector when the anchor is in the folded configuration.

42. The surgical anchor of claim 41, wherein the gripper, when engaging a connector, allows movement of the connector in one direction relative to the anchor but prevents movement of the connector in an opposite direction relative to the anchor.

43. A biocompatible surgical anchor adapted for use in connecting the walls of a hollow organ, comprising:

a body portion, wherein said body portion is inflatable and can assume a relatively planar deployed configuration when inflated and a reduced-profile configuration when uninflated, wherein the body portion has an opening extending therethrough; and

a gripper on the body portion adapted to grip an elongated connector as such a connector extends through the opening, wherein the gripper engages such a connector when the anchor is inflated, and releases such a connector when the anchor is uninflated.

44. The surgical anchor of claim 43, wherein the gripper, when engaging a connector, allows movement of the connector in one direction relative to the anchor but prevents movement of the connector in an opposite direction relative to the anchor.

45. The surgical anchor of claim 43, wherein said anchor has an inflation tube connected to said body portion configured to allow inflation of said body portion by delivery of a filling substance through said inflation tube to said body portion.

46. The surgical anchor of claim 45, wherein said filling substance hardens, cures, polymerizes, or become a gel over time.

47. The surgical anchor of claim 43, wherein said anchor has one or more attachment structures accessible from a top surface of said body.

48. A fastening assembly, comprising:

a first anchor, a second anchor, and a connector;

wherein said first anchor comprises an inflatable body attached to said connector;

said body of said first anchor having a deployed configuration when inflated that is relatively spherical and a reduced profile configuration when uninflated wherein it is readily deformable;

wherein said connector is hollow and configured to allow inflation of said first anchor by delivery of a filling substance through said connector to said first anchor;

wherein said second anchor comprises a relatively planar body, a hole or other passageway approximately in the center of the body of sufficient diameter to allow passage of the connector through said hole or other passageway, one or more gripping elements projecting into said hole or other passageway, and one or more attachment structures accessible from a top surface of said body;

said body of said second anchor having a relatively planar deployed profile and a reduced profile configuration wherein it is substantially folded; and

wherein said gripping elements prevent movement of said second anchor along the longitudinal axis of the connector in the direction away from said first anchor when the connector is disposed in said hole or other passageway when said second anchor is in its deployed configuration.

49. The fastening assembly of claim 48, wherein said gripping elements do not prevent movement of said second anchor along the longitudinal axis in either direction when said connector is disposed in said hole or other passageway when said second anchor is in its reduced profile configuration.

50. The fastening assembly of claim 48, wherein said filling substance hardens, cures, polymerizes, or become a gel over time.

51. The fastening assembly of claim 48, wherein said body of said second anchor is inflatable;

wherein said second anchor has a relatively planar deployed profile when inflated and a reduced profile configuration when uninflated; and

wherein said second anchor is readily deformable when uninflated.

52. The fastening assembly of claim 51, wherein said gripping elements do not prevent movement of said second anchor along the longitudinal axis in either direction when said connector is disposed in said hole or other passageway when said second anchor is in its reduced profile configuration.

53. The fastening assembly of claim 52, wherein said second anchor has an inflation tube connected to said second anchor body configured to allow inflation of said second anchor by delivery of a filling substance through said inflation tube to said first anchor body.

54. The fastening assembly of claim 53, wherein said filling substance hardens, cures, polymerizes, or become a gel over time.

55. A method of fastening a device to one wall of a gastrointestinal organ comprising;

passing said device through a patient'"'"'s abdominal skin, and through the one wall of a gastrointestinal organ, wherein the device is in a undeployed configuration;

passing an anchor through a patient'"'"'s abdominal skin wherein said anchor is in an undeployed configuration;

deploying said device;

connecting said device and said anchor by means of a connector that passes through the wall of said gastrointestinal organ;

wherein said connector prevents said device and second anchor from moving apart;

and deploying said anchor to its deployed configuration.

56. The method of claim 55 wherein said device comprises an inflatable body attached to said connector;

said body of said device having a deployed configuration when inflated that is relatively spherical and a reduced profile configuration when uninflated wherein it is readily deformable;

wherein said connector is hollow and configured to allow inflation of said device by delivery of a filling substance through said connector to said device;

wherein said anchor comprises a relatively planar body, a hole or other passageway approximately in the center of the body of sufficient diameter to allow passage of the connector through said hole or other passageway, one or more gripping elements associated with said hole or other passageway, and one or more attachment structures accessible from a top surface of said body;

said body of said second anchor having a relatively planar deployed profile and a reduced profile configuration wherein it is substantially compressed; and

wherein said gripping elements prevent movement of said anchor along the longitudinal axis of the connector in the either direction away from said device when the connector is disposed in said hole or other passageway and when said anchor is in its deployed configuration.

57. The method of claim 56, wherein said filling substance hardens, cures, polymerizes, or become a gel over time

58. The method of claim 56 wherein said body of said anchor is inflatable;

wherein said second anchor has a relatively planar deployed profile when inflated and a reduced profile configuration when uninflated; and

wherein said second anchor is readily deformable when uninflated.

59. The method of claim 58, wherein said gripping elements do not prevent movement of said second anchor along the longitudinal axis in either direction when said connector is disposed in said hole or other passageway when said second anchor is in its reduced profile configuration.

60. The method of claim 59, wherein said anchor has an inflation tube connected to said anchor body configured to allow inflation of said anchor by delivery of a filling substance through said inflation tube to said anchor body.

61. The method of claim 60, wherein said filling substance hardens, cures, polymerizes, or become a gel over time.

62. The method of claim 55 wherein said device is an electrical stimulator.

63. The method of claim 62 further comprising delivering an electrical signal to the wall of said gastrointestinal organ through said electrical stimulator.

64. The method of claim 55 wherein said device is adapted to deliver a medicine.