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

• US 20040236357A1
• Filed: 06/10/2004
• Published: 11/25/2004
• Est. Priority Date: 05/17/2002
• Status: Abandoned Application

• Current Assignee: EsophyX, Inc.
• Original Assignee: EsophyX, Inc.
• Inventors: Vincent, Stephen T., Adams, John M., Kraemer, Stefan J.M.
• Application Number:
  US10/864,954
• Publication Number:
  US 20040236357A1
• Time in Patent Office: Days
• US Class Current: 606/151
• 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
• 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. -3. Canceled.

4. A tissue fixation 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 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. A tissue fixation 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 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. -45. Canceled.

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

a first end portion and a second end portion, the first end portion having a tissue-piercing end; and

a connecting portion extending between the first and second end portions, the device having an initial configuration before deployment and a final configuration after deployment that holds together tissue between the first and second portions.

47. The device of claim 46, further comprising an elongated member including the first and second end portions arranged to steer itself through a fold of tissue and into a 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. -70. Canceled.

71. A tissue fixation assembly comprising:

a tissue fixation device comprising a tissue fixation device for effecting tissue geometry, the device comprising a first end portion and a second end portion, the first end portion having a tissue-piercing end, and a connecting portion extending between the first and second end portions, the device having an initial configuration before deployment and a final configuration after deployment that holds together tissue between the first and second portions; and

a tissue fixation device director including a lumen that slidingly receives the tissue fixation device and guides the tissue fixation device into tissue layers to be fixated.

72. The assembly of claim 71 wherein the tissue fixation device director comprises a tissue shaper having a tissue engaging surface communicating with the lumen, the tissue shaper being configured to shape the tissue layers into a shape that restores a gastroesophageal flap valve.

73. The assembly of claim 71 further comprising a pusher that pushes the tissue fixation device through the lumen and into the tissue layers.

74. The assembly of claim 71 wherein the lumen has a longitudinal axis and wherein the tissue fixation device enters the tissue in a direction substantially transverse to the longitudinal axis.