Transoral endoscopic gastroesophageal flap valve restoration device, assembly, system and method

• US 20030216754A1
• Filed: 05/17/2002
• Published: 11/20/2003
• Est. Priority Date: 05/17/2002
• Status: Active Grant

• Current Assignee: Endogastric Solutions
• Original Assignee: Scout Medical Technologies LLC (Mpm Capital LLC)
• Inventors: Vincent, Stephen T., Adams, John M., Kraemer, Stefan J.M.
• Granted Patent: US 6,790,214 B2
• Time in Patent Office: Days
• US Class Current: 606/142
• 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 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/07214 Stapler heads
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61B 2017/2926 Details of heads or jaws
• CPC Class Codes: A61B 2017/306 holding by means of suction

Abstract

The invention provides a device, assembly, and method for transoral endoscopic restoration of a gastroesophageal flap valve. The invention also provides a self-steering and self-closing tissue fixation device for tissue fixation, and an invaginator device for gripping and maneuvering tissue. The restoration device includes a longitudinal member arranged for transoral placement into a stomach, a tissue shaper carried on the longitudinal member that causes stomach tissue to assume a shape related to a gastroesophageal flap, and a tissue fixation device that maintains the shaped stomach tissue in a shape approximating a gastroesophageal flap. The tissue shaper may include a mold. The device may include the invaginator device for gripping and maneuvering esophageal tissue to aid restoration of the gastroesophageal flap, and may include the tissue fixation device.

Claims

1. A transoral endoscopic gastroesophageal flap valve restoration device, the device comprising:

a longitudinal member, a portion of which is-arranged for—

transoral placement into a stomach;

a tissue shaper carried on the longitudinal member that causes stomach tissue to assume a shape related to a gastroesophageal flap; and

a tissue fixation device that maintains the shaped stomach tissue in a shape approximating a gastroesophageal flap.

2. The device of claim 1, wherein the longitudinal member is a tubular member.

3. The device of claim 1, wherein the tissue shaper includes a tissue gripper.

4. The device of claim 1, wherein the tissue fixation device comprises an elongated member having a first end portion and a second end portion, the first end portion terminating in a tissue-piercing end, and a connecting portion extending between the first and second end portions, the elongated member having an initial configuration before deployment and a final configuration after deployment that forms an interior perimeter holding together a fold of tissue enclosed within the perimeter, and the properties of the elongated member cause it to move from the initial configuration to the final configuration.

5. The device of claim 1, wherein the tissue fixation device comprises an elongated member having a first end portion and a second end portion, the first end portion terminating in a tissue-piercing end, and a connecting portion extending between the first and second end portions, the elongated member having an initial stressed and distorted configuration that, as the portions beginning with the first end portion are deployed from a lumen by a force pushing on the second end portion, steers the elongated member into and through tissue proximate to the lumen and assumes a final configuration, wherein the elongated member forms an interior perimeter holding together tissue enclosed within the perimeter.

6. A transoral endoscopic gastroesophageal flap valve restoration assembly, the assembly comprising:

a longitudinal member, a portion of which is arranged for transoral placement into a stomach, and that carries a mold having a shape related to a gastroesophageal flap;

a tissue shaper that non-invasively grips and urges tissue into the mold; and

a tissue fixation device that maintains the molded stomach tissue in a shape approximating a gastroesophageal flap.

7. The assembly of claim 6, wherein the mold has a first configuration for transoral placement in proximity to the esophageal-gastric junction, and a second configuration having the shape related to the gastroesophageal flap valve.

8. The assembly of claim 6, wherein the mold is further arranged to move from the first configuration to the second configuration in vivo.

9. The assembly of claim 6, wherein the mold is arranged to move from the first configuration to the second configuration in response to a change in pressure in a portion of the mold.

10. The assembly of claim 6, wherein the mold has a first configuration for transoral placement in proximity to the esophageal-gastric junction, a second configuration having the shape related to the gastroesophageal flap valve, and a third configuration for transoral removal.

11. The assembly of claim 10, wherein the first configuration and third configuration are substantially the same.

12. The assembly of claim 6, wherein the portion of the mold having a shape related to a gastroesophageal flap that is transparent.

13. The assembly of claim 6, wherein the mold comprises a material that may be passed “

per vias naturales.”

14. The assembly of claim 6, wherein the mold comprises a biocompatible material.

15. The device of claim 6, wherein the molded stomach tissue forms an approximately 180-degree, semicircular structure.

16. The device of claim 6, wherein the molded stomach tissue forms a semicircular structure having an arc of at least 120 degrees.

17. The device of claim 6, wherein the molded stomach tissue forms a semicircular structure having an arc of not more than 330 degrees.

18. The assembly of claim 6, wherein the longitudinal member includes a channel arranged to maintain an orientation with the endoscope.

19. The assembly of claim 6, wherein the longitudinal member is arranged to at least partially surround a length of an endoscopic device, and be moveable relative to the length of the endoscopic device.

20. The assembly of claim 6, wherein the longitudinal member is arranged to engage an extracorporeal portion of a shaft of an endoscopic device when a distal portion of the endoscopic device is in vivo, and be moveable relative to the shaft of the endoscopic device.

21. The assembly of claim 6, wherein the longitudinal member includes at least one lumen arranged to carry at least one tissue fixation device.

22. The assembly of claim 6, wherein the longitudinal member includes at least one chamber arranged to carry at least one tissue fixation device.

23. The assembly of claim 6, wherein the longitudinal member further comprises an extracorporeal member providing movement control.

24. The assembly of claim 6, wherein the longitudinal member carries the tissue shaper.

25. The assembly of claim 6, wherein the tissue shaper grips tissue with a vacuum.

26. The assembly of claim 6, wherein the tissue shaper includes a plurality of vacuum orifices on at least a portion of a molding surface of the mold arranged to draw tissue into the mold and hold the tissue proximate to the molding surface.

27. The assembly of claim 6, wherein the tissue shaper comprises:

a structure that moves from a first position arranged to grip tissue to a second position arranged to urge tissue into the mold; and

a member carried on the structure and having a plurality of vacuum orifices on a surface arranged to grip tissue.

28. The assembly of claim 6, wherein the tissue shaper is movable with respect to the mold.

29. The assembly of claim 6, wherein the tissue fixation device comprises an elongated member having a first end portion and a second end portion, the first end portion terminating in a tissue-piercing end, and a connecting portion extending between the first and second end portions, the elongated member having an initial stressed and distorted configuration that, as portions beginning with the first end portion are deployed from a lumen by a force pushing on the second end portion, steers the elongated member into and through tissue proximate to the lumen and assumes a final configuration, wherein the elongated member forms an interior perimeter holding together a fold of tissue enclosed within the perimeter.

30. The assembly of claim 6, wherein the elongated member forms a substantially enclosed interior perimeter in the final configuration.

31. The device of claim 6, wherein the tissue fixation device comprises an elongated member having a first end portion and a-second-end-portion, the first end portion-terminating in a tissue-piercing end, and a connecting portion extending between the first and second end portions, the elongated member having an initial configuration before deployment and a final configuration after deployment that forms an interior perimeter holding together a fold of tissue enclosed within the perimeter, and the properties of the elongated member cause it to move from the initial configuration to the final configuration.

32. A transoral endoscopic gastroesophageal flap valve restoration assembly, comprising:

a longitudinal member, a portion of which is arranged for transoral placement into a stomach, and that carries a mold having a shape related to a gastroesophageal flap;

a tissue gripper that non-invasively grips with a vacuum and urges tissue to take a shape related to the mold;

an invaginator having a tissue gripper to vacuum grip esophageal tissue and allow a force to be imparted to the vacuum gripped esophageal tissue; and

a tissue fixation device that maintains the molded stomach tissue in a shape approximating a gastroesophageal flap.

33. The assembly of claim 32, wherein the invaginator has a first configuration for transoral placement in the esophagus, and a second configuration for vacuum engagement with the esophageal tissue.

34. The assembly of claim 33, wherein the invaginator is further arranged to move from the first configuration to the second configuration in vivo.

35. The assembly of claim 33, wherein the invaginator is arranged to move from the first configuration to the second configuration in response to a change in pressure in a portion of the invaginator.

36. The assembly of claim 32, wherein the invaginator includes an extracorporeal member providing movement control.

37. The assembly of claim 32, wherein the invaginator is arranged to be carried on an endoscopic device.

38. The assembly of claim 32, wherein the invaginator has a channel arranged to maintain an orientation with an endoscopic device.

39. The assembly of claim 32, wherein the invaginator has a channel arranged to maintain an orientation with the mold.

40. The assembly of claim 32, wherein the invaginator comprises a biocompatible material.

41. The assembly of claim 32, wherein the invaginator further comprises a plurality of vacuum orifices opening on at least a portion of the peripheral surface of the invaginator and arranged to hold tissue proximate to the at least a portion of the peripheral surface.

42. The assembly of claim 32, wherein the invaginator allows a force to be imparted to the vacuum gripped esophageal tissue sufficient to move stomach tissue into an improved position for restoration of a gastroesophageal flap.

43. A transoral endoscopic gastroesophageal flap valve restoration assembly, comprising:

a longitudinal member, a portion of which is arranged for transoral placement into a stomach, that carries a mold having a shape related to a gastroesophageal flap, and that has a channel arranged to maintain an orientation with an endoscopic device and a lumen arranged to carry a tissue fixation device;

a tissue gripper that non-invasively grips with a vacuum and urges tissue to take a shape related to the mold, the tissue gripper including a member carried on the longitudinal member that has a plurality of vacuum orifices on a surface arranged to grip tissue and hold the tissue proximate to a molding surface of the mold; and

a tissue fixation device that maintains the molded stomach tissue in a shape approximating a gastroesophageal flap.

44. The assembly of claim 43, wherein the tissue fixation device comprises an elongated member having a first end portion and a second end portion, the first end portion terminating in a tissue-piercing end, and a connecting portion extending between the first and second end portions, the elongated member having an initial configuration before deployment and a final configuration after deployment that forms an interior perimeter holding together tissue enclosed within the perimeter, and the properties of the elongated member cause it to move from the initial configuration to the final configuration.

45. The assembly of claim 43, the tissue fixation device including an elongated member having a first end portion and a second end portion, the first end portion terminating in a tissue-piercing end, and a connecting portion extending between the first and second end portions, the elongated member having an initial stressed and distorted configuration that, as portions beginning with the first end portion are deployed from a lumen by a force pushing on the second end portion, steers the elongated member into and through tissue proximate to the lumen and assumes a final configuration, wherein the elongated member forms an interior perimeter holding together tissue enclosed within the perimeter.

46. A self-closing tissue fixation device for effecting tissue geometry, the device comprising:

an elongated member having a first end portion and a second end portion, the first end portion terminating in a tissue-piercing end; and

a connecting portion extending between the first and second end portions, the elongated member having an initial configuration before deployment and a final configuration after deployment that forms an interior perimeter holding together tissue enclosed within the perimeter, and the properties of the elongated member cause it to move from the initial configuration to the final configuration.

47. The device of claim 46, wherein the elongated member is arranged to steer itself through the fold of tissue and into the final configuration.

48. A self-closing tissue fixation device for effecting tissue geometry, the device comprising:

an elongated member having a first end portion and a second end portion, the first end portion terminating in a tissue-piercing end; and

a connecting portion extending between the first and second end portions, the connecting portion having a first and second joining portions separated by a pressure portion,

the elongated member having an initial stressed and distorted configuration that, as portions beginning with the first end portion are deployed from a lumen by a force pushing on the second end portion, steers the elongated member into and through tissue proximate to the lumen and assumes a final configuration, wherein the elongated member forms an interior perimeter holding together the tissue enclosed within the perimeter.

49. The device of claim 48, wherein the elongated member is arranged to steer itself through tissue and into the final configuration.

50. The device of claim 48, wherein the elongated member forms a substantially enclosed interior perimeter when the elongated member is in the final configuration.

51. The device of claim 48, wherein the first end portion is proximate to the second end portion when the elongated member is in the final configuration.

52. The device of claim 48, wherein the elongated member forms an approximately rectangular interior perimeter in the final configuration.

53. The device of claim 48, wherein the elongated member forms an approximately round interior perimeter in the final configuration.

54. The device of claim 48, wherein the elongated member is formed from material having superelastic properties.

55. The device of claim 54, wherein the elongated member is formed from Nitinol.

56. The device of claim 48, wherein the elongated member is formed from material having shape memory properties.

57. An invaginator device comprising a member arranged to vacuum grip interior tissue of a hollow body structure and allow a force to be imparted on the hollow body structure.

58. The device of claim 57, wherein the member has a first configuration for placement in the hollow body structure, and a second configuration for vacuum gripping of the hollow body structure.

59. The device of claim 57, wherein the member is further arranged to move from the first configuration to the second configuration in vivo.

60. The device of claim 57, wherein the member is arranged to move from the first configuration to the second configuration in response to a change in pressure in a portion of the device.

61. The device of claim 57, wherein the invaginator further comprises a plurality of vacuum orifices opening on at least a portion of the peripheral surface of the invaginator and arranged to hold tissue proximate to at least a portion of the peripheral surface.

62. The device of claim 57, wherein the invaginator allows a force to be imparted to the vacuum gripped esophageal tissue sufficient to move stomach tissue into an improved position for restoration of a gastroesophageal flap.

63. The device of claim 57, wherein the invaginator includes an extracorporeal portion providing movement control.

64. The device of claim 57, wherein the invaginator is arranged to be carried on an endoscopic device.

65. The device of claim 57, wherein the member includes a channel arranged to maintain an orientation with an endoscopic device.

66. A method of transoral restoration of a gastroesophageal flap valve, the method including the steps of:

selecting a portion of intraluminal fundus tissue that is proximate to the cardiac notch;

shaping the tissue into a shape resembling a gastroesophageal flap; and

fixating the shaped tissue into a shape approximating a gastroesophageal flap.

67. The method of claim 66, where the shaping step includes molding the tissue into a shape resembling a gastroesophageal flap.

68. The method of claim 66, where the fixating step includes deploying a self-closing tissue fixation device.

69. A method of transoral restoration of a gastroesophageal flap valve, the method including the steps of:

providing at least one self-closing tissue fixation device for effecting gastroesophageal geometry;

providing a longitudinal member carrying a mold having a shape related to a gastroesophageal flap valve, and a tissue shaper that urges gastric tissue to take a shape related to the mold, the tissue gripper including a member having a plurality of vacuum orifices on a surface arranged to grip tissue and to hold the tissue proximate to a molding surface of the mold;

gripping-gastric-tissue-from the fundus region of the stomach proximate to the cardiac notch with the tissue shaper and urging the gastric tissue into a shape related to a gastroesophageal flap; and

deploying at least one tissue fixation device into the gastric tissue to maintain the gastric tissue in a shape approximating a gastroesophageal flap.

70. The method of claim 69, further including the further step of applying a force with an invaginator to the vacuum gripped esophageal tissue sufficient to move stomach tissue into an improved position for restoration of a gastroesophageal flap.