METHODS AND DEVICES FOR ACCESS ACROSS ADJACENT TISSUE LAYERS

• US 20130310833A1
• Filed: 04/26/2013
• Published: 11/21/2013
• Est. Priority Date: 04/21/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Brown, Peter, Lepulu, Keke, Donovan, Ryan, Binmoeller, Kenneth F., Khoune, Sith
• Granted Patent: US 9,381,041 B2
• Time in Patent Office: Days
• US Class Current: 606/45
• 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 from the first cutting feature towards an outer diameter of the distal tip;

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 releasing a proximal flange of the stent into the first body lumen.

10. 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.

11. 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.

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

13. 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.

14. The method of claim 13, wherein the first and second patterned holes have a diameter that is less than the maximum diameter of the distal tip.

15. The method of claim 13, wherein the first and second patterned holes each include a central hole with one or more projections radiating from the central hole.

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

17. The method of claim 16, wherein the first body lumen is selected from the group consisting of:

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

18. The method of claim 17, wherein the second body lumen is part of the digestive tract or biliary tree.

19. 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.

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

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

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

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

24. The method of claim 23, further comprising removing the stent after forming the anastomosis.

25. A catheter assembly, comprising:

a catheter body having a proximal end, a distal end, and a central passage therethrough; and

a tip positioned near the distal end of the catheter body, the tip having a conductive portion including a first cutting feature and one or more projections outwardly extending from the first cutting feature towards an outer diameter of the tip, the conductive portion configured to be electrically coupled to an electrosurgical generator.

26. The method of claim 25, wherein the first cutting feature and one or more projections comprises an arced configuration.

27. The method of claim 25, wherein the tip does not have a guidewire lumen.

28. The catheter assembly of claim 25, wherein the first cutting feature comprises a concentric ring.

29. The catheter assembly of claim 28, the catheter further comprising a guidewire lumen, wherein the concentric ring is configured to be disposed about and insulated from the guidewire lumen.

30. The catheter assembly of claim 29, wherein the one or more outwardly extending projections extend from the first cutting feature to a maximum radial position, the maximum radial position defining a length between the radial position and a center point of the distal tip, wherein the length is less than 50% of the outer diameter of the tip.

31. The catheter assembly of claim 25, wherein the conductive portion includes an exterior portion made of stainless steel and an interior portion comprising copper electrically coupled to the exterior portion and configured to be electrically coupled to an electrosurgical generator.

32. The catheter assembly of claim 25, wherein the one or more projections outwardly extending from the first cutting feature towards the outer diameter of the tip include a covered portion adjacent to a maximum diameter of the tip.

33. The catheter assembly of claim 25, wherein electrosurgical generator is configured to supply about 50 watts to about 100 watts of power to the conductive portion of the tip.

34. The catheter assembly of claim 25, the conductive portion including two projections.

35. The catheter assembly of claim 25, the conductive portion including four projections.

36. The catheter assembly of claim 25, further comprising a compartment within the catheter body configured to hold a stent.

37. The catheter of claim 36, further comprising a stent within the compartment within the catheter body, wherein the stent is a self-expanding stent and the self-expanding stent is radially restrained by a movable sheath.

38. The catheter of claim 37, wherein the stent is configured to expand to form distal and proximal double-walled flanges.

39. The catheter of claim 38, wherein the stent has a pull-out strength of greater than about 400 grams.

40. The catheter of claim 25, wherein the catheter is configured to be attached to an endoscope.

41. The catheter of claim 25, further comprising a control handle configured to control the energy provided by the electrosurgical generator to the first cutting feature and the one or more projections.

42. The catheter of claim 25, the catheter assembly further comprising an inner catheter shaft engaged with the distal tip and configured to move relative to the catheter body within the central passage of the catheter body, wherein the inner catheter shaft and distal tip are configured to be removable from the catheter body.

43. A method for advancing a catheter distally through a luminal wall of a first body lumen, the method comprising:

positioning a catheter comprising an outer tubular body and inner body with a distal tip proximal to the luminal wall of the first body lumen;

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

advancing distally the distal tip of the catheter through the first luminal wall along with a portion of the outer tubular body 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 an outer diameter of the distal tip; and

withdrawing the inner body and distal tip through the outer tubular body leaving a portion of the outer tubular body in the passage in the luminal wall of the first body lumen.

44. The method of claim 43, wherein the first luminal wall is a transgastric wall or transduodenal wall.

45. The method of claim 44, further comprising foaming a hole in a pseudocyst during advancing distally.

46. The method of claim 45, further comprising passing a catheter, stent, or drainage device through the outer tubular body and into the hole in the pseudocyst.

47. The method of claim 43, wherein positioning includes following a guidewire to a target location of the luminal wall of the first body lumen.

48. The method of claim 46, further comprising deploying a distal flange of the stent in the pseudocyst and deploying a proximal flange of the stent in contact with the transgastric wall or transduodenal wall.

49. The method of claim 43, wherein the first cutting feature and one or more projections comprises an arced configuration.

50. The method of claim 43, wherein the first cutting feature comprises a concentric ring that is concentric to a lumen in the distal tip of the catheter.