Methods and devices for access across adjacent tissue layers

• US 9,381,041 B2
• Filed: 04/26/2013
• Issued: 07/05/2016
• Est. Priority Date: 04/21/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Xlumena, Inc. (Boston Scientific Corporation)
• Inventors: Brown, Peter, Khoune, Sith, Lepulu, Keke, Donovan, Ryan, Binmoeller, Kenneth F
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): GIULIANI, THOMAS ANTHONY
• Application Number:
  US13/871,978
• Publication Number:
  US 20130310833A1
• Time in Patent Office: 1,166 Days
• Field of Search: 606/45, 606/39, 606/41, 606/46
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3476 Powered trocars, e.g. electrosurgical cutting, lasers, powered knives
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3454 Details of tips
• CPC Class Codes: A61B 2017/346 with wings
• CPC Class Codes: A61B 2018/00345 Vascular system
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2018/1412 Blade
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/144 Wire

Abstract

Adjacent tissue layers can be accessed using a catheter device with a distal tip having a conductive portion including a first cutting feature and one or more projections extending from the first cutting feature towards an outer diameter of the distal tip. Electrical energy can be supplied to the conductive portion of the device to cut tissue. A stent can be delivered to form a fluid communication between the adjacent tissue layers.

Claims

1. A method for advancing a catheter distally through opposed first and second luminal walls of first and second body lumens, the method comprising:

positioning a catheter with a distal tip proximal to the first luminal wall, the catheter including a stent;

providing an electrical current to a conductive portion of the distal tip;

advancing distally the distal tip of the catheter through the first and second luminal walls to create a passage therethrough, wherein the conductive portion of the distal tip includes a first cutting feature and one or more projections extending proximally from the first cutting feature towards a region of the distal tip having a larger outer diameter than that of the first cutting feature;

deploying a distal flange of the stent in the second body lumen; and

drawing proximally on the distal flange to pull the first and second luminal walls towards each other.

2. The method of claim 1, further comprising forming a hole in the first and second body lumens using a needle prior to positioning the catheter.

3. The method of claim 1, wherein the first cutting feature and one or more projections comprises an arced configuration.

4. The method of claim 1, wherein a guidewire is not used for positioning the catheter and the distal tip does not have a guidewire lumen.

5. The method of claim 1, wherein the first cutting feature comprises a concentric ring that is concentric to a lumen in the distal tip of the catheter.

6. The method of claim 5, wherein the catheter is disposed about a guidewire and positioning includes advancing the catheter along the guidewire, wherein the concentric ring is configured to be disposed about the guidewire.

7. The method of claim 1, further comprising verifying the deployment of the distal flange prior to drawing proximally.

8. The method of claim 7, wherein verifying the deployment of the distal flange is done using ultrasound.

9. The method of claim 1, further comprising deploying a proximal flange of the stent into the first body lumen.

10. The method of claim 9, wherein the catheter includes a sheath radially constraining the stent, the stent being a self-expanding stent, and deploying the proximal flange includes retracting the sheath to allow the proximal flange of the stent to expand.

11. The method of claim 9, further comprising forming an anastomosis between the first and second body lumens.

12. The method of claim 11, further comprising removing the stent after forming the anastomosis.

13. The method of claim 12, wherein removing the stent includes retrieving the stent with a snare.

14. The method of claim 1, wherein the catheter includes a sheath radially constraining the stent, the stent being a self-expanding stent, and deploying the distal flange includes retracting the sheath to allow the distal flange of the stent to expand.

15. The method of claim 1, further comprising attaching the catheter to an endoscope prior to positioning the catheter.

16. The method of claim 1, wherein advancing the distal tip through the first and second luminal walls to create the passage therethrough forms a first patterned hole in the first luminal wall and a second patterned hole in the second luminal wall.

17. The method of claim 16, wherein the first and second patterned holes have a diameter that is less than the maximum diameter of the distal tip.

18. The method of claim 16, wherein the first and second patterned holes each include a central hole with one or more cuts radiating from the central hole.

19. The method of claim 1, wherein the first body lumen is within the digestive tract.

20. The method of claim 19, wherein the first body lumen is selected from the group consisting of:

esophagus, stomach, duodenum, jejunum, small intestine, large intestine, colon, and rectum.

21. The method of claim 20, wherein the second body lumen is part of the digestive tract or biliary tree.

22. The method of claim 1, wherein the second body lumen is selected from the group consisting of:

esophagus, stomach, duodenum, jejunum, small intestine, large intestine, colon, bile duct, pancreatic duct, gallbladder, and pancreas.

23. The method of claim 1, wherein the first and second body lumens are sections of the colon.

24. The method of claim 1, wherein the first body lumen is the stomach or duodenum and the second body lumen is the gallbladder.

25. The method of claim 1, wherein the first and second body lumens are a fundal pouch and a section of the duodenum or jejunum.

26. A method for advancing a catheter distally through adjacent first and second tissue layers, the method comprising:

positioning a catheter with a distal tip proximal to the first tissue layer, the catheter including a stent;

providing an electrical current to a conductive portion of the distal tip;

advancing the distal tip of the catheter through the first and second tissue layers to create a passage therethrough, wherein the conductive portion of the distal tip includes a first cutting feature and one or more projections extending from the first cutting feature towards a region of the distal tip having a larger outer diameter than that of the first cutting feature;

deploying a distal flange of the stent distal to the second tissue layer; and

drawing on the distal flange to pull the first and second tissue layers towards each other.

27. The method of claim 26, further comprising forming a hole in the first and second tissue layers using a needle prior to positioning the catheter.

28. The method of claim 26, wherein the first cutting feature and one or more projections comprises an arced configuration.

29. The method of claim 26, wherein a guidewire is not used for positioning the catheter and the distal tip does not have a guidewire lumen.

30. The method of claim 26, wherein the first cutting feature comprises a concentric ring that is concentric to a lumen in the distal tip of the catheter.

31. The method of claim 30, wherein the catheter is disposed about a guidewire and positioning includes advancing the catheter along the guidewire, wherein the concentric ring is configured to be disposed about the guidewire.

32. The method of claim 26, further comprising verifying the deployment of the distal flange prior to drawing on the distal flange.

33. The method of claim 32, wherein verifying the deployment of the distal flange is done using ultrasound.

34. The method of claim 26, further comprising deploying a proximal flange of the stent proximal to the first tissue layer.

35. The method of claim 34, wherein the catheter includes a sheath radially constraining the stent, the stent being a self-expanding stent, and deploying the proximal flange includes retracting the sheath to allow the proximal flange of the stent to expand.

36. The method of claim 34, further comprising forming an anastomosis between the first and second tissue layers.

37. The method of claim 36, further comprising removing the stent after forming the anastomosis.

38. The method of claim 26, wherein the catheter includes a sheath radially constraining the stent, the stent being a self-expanding stent, and deploying the distal flange includes retracting the sheath to allow the distal flange of the stent to expand.

39. The method of claim 26, further comprising attaching the catheter to an endoscope prior to positioning the catheter.

40. The method of claim 26, wherein advancing the distal tip through the first and second tissue layers to create the passage therethrough forms a first patterned hole in the first tissue layer and a second patterned hole in the second tissue layer.

41. The method of claim 40, wherein the first and second patterned holes have a diameter that is less than the maximum diameter of the distal tip.

42. The method of claim 40, wherein the first and second patterned holes each include a central hole with one or more cuts radiating from the central hole.

43. The method of claim 26, wherein the first tissue layer is within a digestive tract.

44. The method of claim 43, wherein the first tissue layer is selected from the group consisting of:

a wall of the esophagus, a wall of the stomach, a wall of the duodenum, a wall of the jejunum, a wall of the small intestine, a wall of the large intestine, a wall of the colon, and a wall of the rectum.

45. The method of claim 44, wherein the second tissue layer is part of the digestive tract or biliary tree.

46. The method of claim 26, wherein the second tissue layer is selected from the group consisting of:

a wall of an esophagus, a wall of a stomach, a wall of a duodenum, a wall of a jejunum, a wall of a small intestine, a wall of a large intestine, a wall of a colon, a wall of a bile duct, a wall of a pancreatic duct, a wall of a gallbladder, and a wall of a pancreas.

47. The method of claim 26, wherein the first and second tissue layers are sections of colon.

48. The method of claim 26, wherein the first tissue layer is a wall of a stomach or a wall of a duodenum and the second tissue layer is a wall of a gallbladder.

49. The method of claim 26, wherein the first and second tissue layers are a wall of a fundal pouch and a section of a wall of a duodenum or jejunum.