Methods, Devices, Kits and Systems for Defunctionalizing the Gallbladder

• US 20090143760A1
• Filed: 11/25/2008
• Published: 06/04/2009
• Est. Priority Date: 11/30/2007
• Status: Abandoned Application

• Current Assignee: Treus Medical, Inc.
• Original Assignee: Treus Medical, Inc.
• Inventors: Milroy, J. Craig, Van Dam, Jacques, Ohline, R. Matthew
• Application Number:
  US12/277,443
• Publication Number:
  US 20090143760A1
• Time in Patent Office: Days
• US Class Current: 604/500
• 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 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2002/041 Bile ducts
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

The application discloses devices, systems, kits and methods for treating biliary disease. Device comprise, for example, a component configured for deployment to a lumen of a gallbladder or gallbladder duct which has a proximal end and a distal end with a lumen extending therethrough and a fluid or gas delivery apparatus at its distal end.

Claims

1. A device for treating biliary disease comprising:

a component configured for defunctionalizing a gallbladder of a patient which has a proximal end and a distal end with a lumen extending therethrough and one or more apertures at a distal end adaptable to deliver a material to a lumen within the gallbladder or a gallbladder duct.

2. The device of claim 1 wherein the distal end has an angular orientation relative to a length of the component.

3. The device of claim 1 wherein the distal end is adapted to deliver a material with at least one of a 360 degree radial pattern, a sharp stream, and a cone shape.

4. The device of claim 1 wherein the distal end has an articulating member.

5. The device of claim 1 further is adapted to apply a vacuum.

6. The device of claim 1 wherein the distal end is adapted to apply an adhesive to a lumen of the gallbladder.

7. The device of claim 1 wherein the device is configured for deployment by an endoscope.

8. The device of claim 1 wherein the device is configured for deployment using at least one of a needle, guidewire, or guidance catheter.

9. The device of claim 1 wherein the lumen is configurable to provide restrictable fluid flow.

10. The device of claim 9 further comprising one or more fluid control components.

11. The device of claim 1 further comprising a valve.

12. The device of claim 11 wherein the valve is at least one of a flow-restrictor or one-way valve.

13. The device of claim 1 wherein the device is flexible.

14. The device of claim 1 wherein the device is an elongate tube adapted and configured to extend into the gastrointestinal tract.

15. A method of treating biliary disease comprising:

a. accessing a lumen associated with a gallbladder or a gallbladder duct;

b. defunctionalizing at least one of the gallbladder duct or the gallbladder; and

c. leaving the gallbladder in situ.

16. The method of claim 15 wherein the step of defunctionalizing the gallbladder further comprising the step of delivering a substance to at least one of the gallbladder duct or the gallbladder.

17. The method of claim 16 wherein the substance occupies, or substantially occupies, a lumen of at least one of the gallbladder duct or the gallbladder.

18. The method of claim 16 wherein the substance is one or more of antibiotics, inflammatory agents, and anti-inflammatory agents.

19. The method of claim 15 further comprising the step of preventing bile from entering the gallbladder lumen.

20. The method of claim 15 further comprising the step of localizing the gallbladder via endoscopic ultrasound.

21. The method of claim 15 further comprising the step of accessing the gallbladder via the gastrointestinal tract.

22. The method of claim 21 wherein the step of accessing is performed in the gastrointestinal tract at a duodenum.

23. The method of claim 15 wherein the step of defunctionalizing at least one of the gallbladder duct or the gallbladder further comprises one or more of sclerosing, necrotizing or ablating tissue.

24. The method of claim 23 wherein an ablation technique is selected from the group comprising cryoablation, thermal ablation, chemical ablation, radio frequency ablation, microwave ablation, and ultrasound ablation.

25. The method of claim 15 further comprising the step of delivering a fluid with an angular orientation relative to a length of body of a fluid delivery device.

26. The method of claim 15 further comprising the step of delivering a fluid with at least one of a 360 degree radial pattern, a sharp stream, and a cone shape.

27. The method of claim 15 further comprising the step of delivering a fluid with a device comprising an articulating member.

28. The method of claim 15 wherein the step of defunctionalizing at least one of the cystic duct or the gallbladder further comprises applying a vacuum to a lumen of the cystic duct or the gallbladder.

29. The method of claim 28 further comprising the step of applying an adhesive to the lumen of the gallbladder duct or the gallbladder.

30. The method of claim 15 wherein the step of defunctionalizing at least one of the gallbladder duct or the gallbladder further comprises physically blocking a lumen of the gallbladder duct or the gallbladder.

31. The method of claim 15 further comprising the step of removing gallstones.

32. The method of claim 15 further comprising the step of altering gallstones.

33. The method of claim 32 further comprising the step of removing the altered gallstones.

34. The method of claim 15 further comprising the step of clearing obstructions within the gallbladder.

35. The method of claim 15 further comprising the step of visualizing a treatment area.

36. The method of claim 15 further comprising the step of delivering a device via an endoscope.

37. The method of claim 15 further comprising the step of delivering a device via a needle, guidewire or guidance catheter.

38. The method of claim 15 further comprising the step of restricting fluid flow from the gallbladder lumen to the gastrointestinal tract.

39. The method of claim 38 further comprising the step of operating a valve to restrict fluid flow.

40. The method of claim 15 further comprising the step of defunctionalizing the gallbladder in situ.

41. The method of claim 40 wherein the step of defunctionalizing is achieved by delivering a substance into a space within the gallbladder.

42. The method of claim 41 wherein the delivered substance is selected from the group consisting of gel and foam.

43. The method of claim 41 further comprising the step of activating the delivered substance in situ.

44. The method of claim 41 further comprising delivering an amount of substance sufficient to fill or substantially fill the gallbladder lumen.

45. The method of claim 15 wherein the step of defunctionalizing is achieved by one or more of sclerosing or necrotizing a tissue within the gallbladder.

46. The method of claim 45 wherein the step of sclerosing or necrotizing can be achieved by an ablation technique.

47. The method of claim 45 wherein the ablation technique is selected from cryoablation, thermal ablation, chemical ablation, radio frequency ablation, ultrasound ablation, and microwave ablation.

48. A kit for treating biliary disease comprising:

(a) a device adaptable to deliver to a lumen of a gallbladder or gallbladder duct; and

optionally (b) a compound for delivery to a tissue.

49. The kit of claim 48 further comprising a catheter.

50. The kit of claim 48 further comprising one or more of a needle, a guidewire, and a guidance catheter.

51. The kit of claim 48 further comprising an ablation device.

52. The kit of claim 48 wherein the compound comprises a sclerosing agent.

53. The kit of claim 48 wherein the compound comprises antibiotics.

54. The kit of claim 48 wherein the compound comprises one or more of inflammatory agents and anti-inflammatory agents.

55. The kit of claim 48 further comprising one or more biocompatible gels and biocompatible foams.

56. The kit of claim 48 further comprising one or more of a pair of scissors, a scalpel, a swab, a syringe, a hemostat, a lubricant, a needle, a snare, an antiseptic, and an anesthetic.