Apparatus and method for treating gastroesophageal reflux disease

• US 20030120289A1
• Filed: 12/09/2002
• Published: 06/26/2003
• Est. Priority Date: 12/20/2001
• Status: Active Grant

• Current Assignee: REX Medical LP
• Original Assignee: REX Medical LP
• Inventors: Hinchliffe, Peter W.J., McGuckin, James F. Jr.
• Granted Patent: US 7,261,722 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• 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 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• 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 2017/308 with suction cups

Abstract

A minimally invasive surgical procedure is disclosed which includes the steps forming a fold of tissue, extending one or more needles through the fold of tissue, deploying a tissue fastener from an interior lumen of each of the needles, and retracting each of the needles from the fold of tissue such that the tissue fasteners remain deployed in the fold of tissue.

Claims

1. A method of treating gastroesophageal reflux disease comprising the steps of:

a) forming a fold of esophageal tissue proximate to the lower esophageal sphincter;

b) extending a needle through the fold of esophageal tissue, the needle having an interior lumen containing a tissue fastener;

c) ejecting a distal portion of the tissue fastener from the interior lumen of the needle such that the distal portion of the tissue fastener is disposed against a distal surface of the fold of esophageal tissue; and

d) retracting the needle from the fold of esophageal tissue such that a proximal portion of tissue fastener is deployed from the interior lumen of the needle and is disposed against a proximal surface of the fold of esophageal tissue.

2. A method according to claim 1, further comprising the step of providing an endoscopic device having a tissue reception cavity formed in a distal end portion thereof and the step of forming the fold of esophageal tissue includes the step of drawing esophageal tissue into the tissue reception cavity of the endoscopic device.

3. A method according to claim 2, wherein the step drawing esophageal tissue into the tissue reception cavity of the endoscopic device is performed under suction.

4. A method according to claim 2, wherein the step of drawing esophageal tissue into the tissue reception cavity of the endoscopic device is performed with a tissue grasping device.

5. A method according to claim 2, further comprising the step of guiding the endoscopic device through the esophagus to a location wherein the tissue reception cavity is disposed proximate to the lower esophageal sphincter.

6. A method according to claim 2, further comprising the step of providing the needle within an interior lumen of the endoscopic device.

7. A method according to claim 6, further comprising the step of providing the tissue fastener within the interior lumen of the needle in an initial condition wherein the fastener is in a generally elongate orientation and wherein the step of ejecting the staple from the interior lumen of the needle includes permitting the distal portion of the tissue fastener to move to a normal condition wherein the distal portion of the tissue fastener is in a curved orientation.

8. A method according to claim 7, wherein the step of retracting the needle from the fold of esophageal tissue includes permitting the proximal portion of the tissue fastener to move to a normal condition wherein the proximal portion of the tissue fastener is-in a curved orientation.

9. A method according to claim 1, further comprising the step of providing an endoscope for performing the steps of the method under vision.

10. A method according to claim 9, wherein the endoscope is provided as an integral part of the endoscopic device.

11. A method according to claim 1, further comprising the steps of extending at least one other needle containing a tissue fastener through the fold of esophageal tissue, and deploying the distal and proximal portions of the tissue fastener against respective surfaces of the fold of esophageal tissue.

12. A method according to claim 11, wherein the needles are extended through the fold of esophageal tissue simultaneously and the tissue fasteners are ejected from the needles simultaneously.

13. A method according to claim 11, wherein the needles are extended through the fold of esophageal tissue in seriatim and the tissue fasteners are ejected from the needles in seriatim.

14. A method of applying a surgical fastener to gastro-esophageal tissue comprising the steps of:

a) forming a fold of gastro-esophageal tissue;

b) extending at least one needle through the fold of tissue, the at least one needle having an interior lumen containing a tissue fastener formed from shape memory metal disposed in an initial condition;

c) ejecting a distal portion of the tissue fastener from the interior lumen of the needle such that the distal portion of the tissue fastener moves to a normally curved condition against a distal surface of the fold of tissue; and

d) retracting the needle from the fold of tissue such that a proximal portion of tissue fastener is deployed from the interior lumen of the needle and moves to a normally curved condition against a proximal surface of the fold of tissue.

15. A method according to claim 14, further comprising the step of providing an endoscopic device having a tissue reception cavity formed in a distal end portion thereof and the step of forming the fold of gastro-esophageal tissue includes the step of drawing tissue into the tissue reception cavity of the endoscopic device.

16. A method according to claim 15, wherein the step of drawing tissue into the tissue reception cavity of the endoscopic device is performed under suction.

17. A method according to claim 15, wherein the step of drawing tissue into the tissue reception cavity of the endoscopic device is performed with a tissue grasping device.

18. An endoscopic surgical apparatus comprising:

a) an elongated tubular body having opposed proximal and distal end portions and an interior lumen extending therethrough;

b) a needle disposed within the elongated tubular body and mounted for reciprocal movement therein between a retracted position and a protracted position, the needle having an interior lumen extending therethrough;

c) a tissue fastener configured for movement between an initial position within the interior lumen of the needle and a normal position ejected from the interior lumen of the needle;

d) means for effectuating reciprocal movement of the needle within the interior bore of the elongated tubular body; and

e) means for ejecting the tissue fastener from the interior lumen of the needle.

22. An apparatus as recited in claim 18, wherein the tissue fastener has a generally elongate configuration in the initial position, and in the normal position, opposed end portions of the fastener have a generally curved configuration.

23. An apparatus as recited in claim 18, wherein the means for ejecting the tissue fastener from the interior lumen of the needle includes a pusher extending through the interior lumen of the needle.

24. An apparatus as recited in claim 18, wherein the tissue fastener is formed from a shape memory metal alloy.

25. An apparatus as recited in claim 18, wherein the elongated tubular body is flexible along the length thereof.

26. An apparatus as recited in claim 18, wherein the means for effectuating reciprocal longitudinal movement of the elongated needle within the interior bore of the elongated tubular body includes an axial drive member.

19. An apparatus as recited in claim 19, wherein a tissue receiving window is formed within the distal end portion of the elongated tubular body.

20. An apparatus as recited in claim 19, wherein the retracted position of the needle is proximal of the tissue receiving window and the protracted position of the needle is distal of the tissue receiving window.

21. An apparatus as recited in claim 19, wherein the retracted position of the needle is lateral to the tissue receiving window and the protracted position of the needle is distal of the tissue receiving window.

28. An apparatus as recited in claim 19, wherein the needle has a tapered leading end portion.

29. An apparatus as recited in claim 19, wherein an angioplasty balloon is operatively associated with a distal portion of the tubular body for esophageal expansion.