Methods and apparatus for performing malabsorptive bypass procedures within a patient's gastro-intestinal lumen

• US 20060036267A1
• Filed: 08/11/2004
• Published: 02/16/2006
• Est. Priority Date: 08/11/2004
• Status: Abandoned Application

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Saadat, Vahid, Ewers, Richard C., Peh, Ruey-Feng
• Application Number:
  US10/916,768
• Publication Number:
  US 20060036267A1
• Time in Patent Office: Days
• US Class Current: 606/153
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/1103 Approximator
• CPC Class Codes: A61B 2017/1117 adapted for discharge after necrotisation, e.g. by evacuation, expulsion or excretion

Abstract

Methods and apparatus for performing malabsorptive bypass procedures within a patient'"'"'s gastrointestinal lumen are described comprising, for example, gastroenterostomy procedures that are preferably performed in an endoscopic or laparoscopic fashion. Anastomosis between the patient'"'"'s stomach and intestine allows food to bypass at least a portion of the patient'"'"'s stomach and/or intestine, thereby providing a malabsorptive region. The malabsorptive procedure may be accompanied by additional procedures, for example, pyloric occlusion, pyloroplasty, gastroplasty, gastric tissue destruction and/or intestinal pleating.

Claims

1. Apparatus for performing malabsorptive bypass procedures within a patient'"'"'s gastro-intestinal lumen, the apparatus comprising:

a steerable or shape-lockable overtube configured for advancement into the patient'"'"'s small intestine;

an anastomosis instrument having proximal and distal regions, and an elongate body extending therebetween, the anastomosis instrument configured for advancement through the overtube into the patient'"'"'s small intestine to join a portion of the patient'"'"'s small intestine to the patient'"'"'s stomach, and to form an ostomy therebetween; and

an alignment mechanism for aligning the portion of the patient'"'"'s small intestine with the patient'"'"'s stomach.

2. The apparatus of claim 1, wherein the overtube is configured for advancement into the patient'"'"'s small intestine via an approach chosen from the group consisting of endoluminal, laparoscopic, per-oral, per-anal, transluminal, transgastric, trans-intestinal, trans-colonic, per-pyloric, endo-pyloric, trans-pyloric and combinations thereof.

3. The apparatus of claim 1, wherein the alignment mechanism is configured for endoluminal or laparoscopic advancement into the patient'"'"'s stomach.

4. The apparatus of claim 1, wherein the alignment mechanism is chosen from the group consisting of light, telemetry, imaging, sensing, steering, mechanical steering, shape-locking, rigidizing, magnetism and combinations thereof.

5. The apparatus of claim 1, wherein the anastomosis instrument comprises a piercing element for forming the ostomy.

6. The apparatus of claim 1, wherein the anastomosis instrument comprises at least one securing element for joining the portion of the patient'"'"'s small intestine to the patient'"'"'s stomach.

7. The apparatus of claim 6, wherein the securing element is configured to form the ostomy through pressure necrosis of joined tissue.

8. The apparatus of claim 7, wherein the securing element comprises a weight configured for disposal within the patient'"'"'s small intestine to facilitate pressure necrosis.

9. The apparatus of claim 6, wherein the securing element comprises a first portion disposed in the patient'"'"'s intestine and a second portion disposed in the patient'"'"'s stomach.

10. The apparatus of claim 9, wherein the first and second portions are magnetic, and wherein the alignment mechanism comprises magnetic attraction between the first and second portions.

11. The apparatus of claim 9, wherein the first and second portions of the securing element comprise central openings through which the ostomy may be formed.

12. The apparatus of claim 1 further comprising an occlusive element for at least partially occluding the patient'"'"'s pylorus.

13. The apparatus of claim 12, wherein the occlusive element is chosen from the group consisting of hydrogels, adhesives, inflatable balloons, barbed devices, inflammatory agents, chemical irritants, radiofrequency irradiators, heating elements, burning elements, bulking agents, suture, securing elements and combinations thereof.

14. The apparatus of claim 1 further comprising a gastroplasty instrument configured for partitioning a patient'"'"'s stomach.

15. The apparatus of claim 14, wherein the gastroplasty instrument is configured for advancement through the overtube.

16. The apparatus of claim 1 further comprising a tissue destruction instrument for destroying tissue within the patient'"'"'s gastrointestinal lumen.

17. The apparatus of claim 16, wherein the tissue destruction instrument is configured for advancement through the overtube.

18. The apparatus of claim 16, wherein the tissue destruction instrument is chosen from the group consisting of radiofrequency instruments, plasma instruments, electrocautery instruments, cryoablation instruments, Argon plasma coagulation instruments, mechanical abrasion instruments, energy instruments and combinations thereof.

19. The apparatus of claim 16, wherein the tissue destruction instrument is configured to destroy tissue within an excluded portion of the patient'"'"'s stomach.

20. The apparatus of claim 1, further comprising a pleating instrument for pleating tissue within the patient'"'"'s gastro-intestinal lumen.

21. The apparatus of claim 20, wherein the pleating instrument is configured to pleat a section of the patient'"'"'s small intestine, and wherein the anastomosis instrument is configured to join the portion of the patient'"'"'s small intestine to the patient'"'"'s stomach distal of the pleated section of the patient'"'"'s small intestine.

22. The apparatus of claim 1, wherein the anastomosis instrument further comprises a plication instrument configured to form and secure tissue folds.

23. The apparatus of claim 1, wherein the overtube is both steerable and shape-lockable.

24. The apparatus of claim 1, wherein the overtube is configured for advancement through the patient'"'"'s pylorus.

25. The apparatus of claim 6, wherein the securing element is bioabsorbable or bioresorbable.

26. A method for performing malabsorptive bypass procedures within a patient'"'"'s gastro-intestinal lumen, the method comprising:

steering an overtube into the patient'"'"'s small intestine;

advancing an anastomosis instrument through the overtube into the patient'"'"'s small intestine;

aligning the anastomosis instrument with the patient'"'"'s stomach; and

joining a portion of the patient'"'"'s small intestine to the patient'"'"'s stomach with the anastomosis instrument.

27. The method of claim 26, wherein joining a portion of the patient'"'"'s small intestine to the patient'"'"'s stomach further comprises forming an ostomy therebetween.

28. The method of claim 27, wherein forming an ostomy further comprises piercing tissue at the joining to form the ostomy.

29. The method of claim 27, wherein forming an ostomy further comprises forming the ostomy through pressure necrosis of tissue at the joining.

30. The method of claim 27 further comprising at least partially occluding the patient'"'"'s pylorus.

31. The method of claim 27 further comprising performing pyloroplasty to render the patient'"'"'s pyloric sphincter at least temporarily incompetent.

32. The method of claim 27 further comprising performing gastroplasty within the patient'"'"'s stomach.

33. The method of claim 27 further comprising locally destroying tissue within the patient'"'"'s gastro-intestinal lumen.

34. The method of claim 26 further comprising shape-locking or rigidizing the overtube.

35. The method of claim 26, wherein steering the overtube further comprises endoluminally steering the overtube.

36. The method of claim 26, wherein steering the overtube further comprises laparoscopically steering the overtube.

37. The method of claim 26, wherein aligning the anastomosis instrument with the patient'"'"'s stomach further comprises retroflexing the overtube to a pre-determined configuration.

38. The method of claim 26, wherein joining a portion of the patient'"'"'s small intestine to the patient'"'"'s stomach further comprises forming and securing tissue folds encompassing the walls of the patient'"'"'s small intestine and stomach.

39. The method of claim 26 further comprising pleating a section of the patient'"'"'s small intestine,

wherein joining a portion of the patient'"'"'s small intestine to the patient'"'"'s stomach further comprises joining a portion of the patient'"'"'s small intestine disposed distal of the pleated section of the small intestine.

40. A method for performing malabsorptive bypass procedures within a patient'"'"'s gastro-intestinal lumen, the method comprising:

performing gastroenterostomy within the patient'"'"'s gastro-intestinal lumen;

altering the patient'"'"'s pylorus;

performing gastroplasty within the patient'"'"'s stomach; and

destroying tissue within the patient'"'"'s stomach.

41. The method of claim 40, wherein altering the patient'"'"'s pylorus comprises at least partially occluding the pylorus.

42. The method of claim 40, wherein altering the patient'"'"'s pylorus comprises performing pyloroplasty.

43. The method of claim 40 further comprising performing the method endoluminally.

44. The method of claim 40 further comprising performing the method laparoscopically.

45. The method of claim 40 further comprising pleating a portion of the patient'"'"'s small intestine.