Methods, Devices, Kits and Systems for Defunctionalizing the Cystic Duct

• US 20090143759A1
• 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:
  US12/277,338
• Publication Number:
  US 20090143759A1
• 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. Devices comprise, for example, a component configurable for deployment between within a cystic duct of a patient which has a proximal end and a distal end. In some embodiments, a lumen may also extend therethrough.

Claims

1. A device for treating biliary disease comprising:

a component configurable for placement within a cystic duct of a biliary system of a patient which has a proximal end and a distal end.

2. The device of claim 1 further comprising a delivery mechanism for delivering a substance.

3. The device of claim 1 wherein the device is formed from at least one of a bioresorbable material or an activatable material.

4. The device of claim 1 wherein the device is removable.

5. The device of claim 1 wherein the device is expandable.

6. The device of claim 1 further comprising one or more configurations selected from a deployment configuration, a delivery configuration and a final configuration.

7. The device of claim 6 further comprising a variable profile.

8. The device of claim 1 wherein a cross-sectional area of the device is variable along a length.

9. The device of claim 1 wherein the device is configurable for deployment by an endoscope.

10. The device of claim 1 wherein the device is configurable for deployment by a guidance element.

11. The device of claim 1 wherein a lumen is provided that is configurable to provide restrictable fluid flow.

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

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

13. (canceled)

14. (canceled)

16. A biliary disease treatment device comprising:

an implant adapted to be delivered by an endoscope, guidance element to a gastrointestinal site in proximity to a gallbladder, and further adapted to form a conduit between the gastrointestinal site and the gallbladder.

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28. A method of delivering a device to treat biliary disease comprising:

a. using an endoscope to place a guidance element between an access lumen and a gallbladder;

b. inserting a delivery catheter over the guidance element and into the gallbladder;

c. delivering a cystic duct defunctionalizing device on the guidance element; and

d. positioning the cystic duct defunctionalizing device within a cystic duct.

34. The method of claim 28 further comprising the step of localizing the gallbladder via endoscopic ultrasound.

35. The method of claim 28 further comprising the step of removing gallstones.

36. The method of claim 28 further comprising the step of altering gallstones.

37. The method of claim 36 further comprising the step of removing the altered gallstones.

39. The method of claim 28 wherein the biliary disease is treated without removal of the gallbladder.

40. The method of claim 28 wherein the biliary disease is treated without removal of the cystic duct.

42. The method of claim 28 further comprising the step of forming a biological duct in situ from a patient'"'"'s tissue.

43. The method of claim 28 further comprising the step of changing the cystic duct defunctionalizing device from a delivery configuration to a deployment configuration.

44. The method of claim 28 further comprising the step of changing the cystic duct defunctionalizing device from a delivery configuration to a final configuration.

45. The method of claim 28 further comprising the step of changing the cystic duct defunctionalizing device from a deployment configuration to a final configuration.

46. The method of claim 28 further comprising the step of reducing a cross-sectional profile of the cystic duct defunctionalizing device.

48. The method of claim 28 further comprising the step of defunctionalizing the cystic duct in situ.

49. The method of claim 48 wherein the step of defunctionalizing is achieved by delivering a substance into a space within the cystic duct.

50. The method of claim 49 wherein the delivered substance is selected from the group consisting of gel and foam.

51. The method of claim 49 further comprising the step of activating the delivered substance in situ.

52. The method of claim 49 further comprising delivering an amount of substance sufficient to fill, or substantially fill, the cystic duct lumen.

53. The method of claim 48 wherein the step of defunctionalizing is achieved by delivering a plug into a space within the cystic duct.

54. The method of claim 53 wherein the plug is configurable either internally or externally to seat within the lumen.

55. The method of claim 53 wherein the plug further comprises one or more thread profiles, ridges or steps about its exterior surface.

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57. A kit for treating biliary disease comprising:

a. a device configurable to be positioned within a cystic duct; and

optionally

b. a compound for delivery to a tissue.

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66. A method of treating biliary disease comprising:

a. accessing a lumen associated with a gallbladder;

b. defunctionalizing a cystic duct.

71. The method of claim 66 further comprising the step of preventing bile from entering the gallbladder lumen.

73. The method of claim 66 further comprising the step of accessing the gallbladder via the gastrointestinal tract.

74. The method of claim 73 wherein the step of accessing is performed in the gastrointestinal tract at a duodenum.

75. The method of claim 73 wherein the step of defunctionalizing the cystic duct further comprises one or more of sclerosing, necrotizing or ablating tissue.

76. The method of claim 75 wherein an ablation technique is selected from the group comprising cryoablation, thermal ablation, chemical ablation, radio frequency ablation, ultrasound ablation, and microwave ablation.

77. The method of claim 73 further comprising the step of delivering a fluid with an angular orientation.

78. The method of claim 73 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.

79. The method of claim 73 further comprising the step of delivering a fluid with a device comprising an articulating member.

80. The method of claim 73 wherein the step of defunctionalizing the cystic duct further comprises applying a vacuum to a lumen of the cystic duct or the gallbladder.

81. The method of claim 80 further comprising the step of applying all adhesive to the lumen of the cystic duct.

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70. The method of claim 69 wherein the substance is one or more of antibiotics, inflammatory agents, and anti-inflammatory agents.

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83. A device for treating biliary disease comprising a plug adapted and configurable to be positioned within a lumen of a cystic duct of a patient having a proximal end and a distal end and is configurable either internally or externally to seat within the lumen after deployment.

84. The device of claim 83 wherein the external configuration is one or more of threads, ridges and steps.

87. The device of claim 83 wherein the plug is positioned within or proximal to a cystic duct.

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