Methods for treatment of a body cavity or lumen

• US 9,427,556 B2
• Filed: 11/29/2011
• Issued: 08/30/2016
• Est. Priority Date: 06/01/2009
• Status: Active Grant

• Current Assignee: Channel Medsystems, Inc.
• Original Assignee: Channel Medsystems, Inc.
• Inventors: Burnett, Daniel Rogers
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US13/306,076
• Publication Number:
  US 20120136343A1
• Time in Patent Office: 1,736 Days
• Field of Search: 606/21, 606/27, 607/96, 607/105
• US Class Current: 1/1
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/105 Oesophagus
• CPC Class Codes: A61M 2210/1433 Uterus
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

Methods and apparatus for the treatment of a body cavity or lumen are described where a heated fluid and/or gas may be introduced through a catheter and into treatment area within the body contained between one or more inflatable/expandable members. The catheter may also have optional pressure sensing elements which may allow for control of the pressure within the treatment zone and also prevent the pressure from exceeding a pressure of the inflatable/expandable members to thereby contain the treatment area between these inflatable/expandable members. Optionally, a chilled or room temperature fluid such as water may then be used to rapidly terminate the treatment session.

Claims

1. A method for treating a body cavity or lumen, comprising:

positioning a tissue region of interest between a distal occlusion member and a proximal occlusion member which are adjustably movable relative to one another via adjustment of a catheter;

occluding the tissue region to be treated between the occlusion members such that a treatment area is defined therebetween;

introducing a hyperthermic or hypothermic fluid and/or gas into the treatment area such that the tissue region is treated by thermal ablation with the hyperthermic or hypothermic fluid and/or gas contacting the tissue region;

monitoring a first pressure of the hyperthermic or hypothermic fluid and/or was introduced into the treatment area;

comparing the first pressure against a second pressure within the occlusion members; and

adjusting the first pressure to be below the second pressure if the first pressure exceeds the second pressure.

2. The method of claim 1 wherein positioning comprises positioning the catheter within a body lumen selected from the group consisting of an esophagus, uterus, respiratory tract, and bladder.

3. The method of claim 1 wherein occluding the tissue region comprises inflating the occlusion members via a fluid.

4. The method of claim 1 wherein occluding the tissue region comprises expanding the occlusion members via a self-expanding or shape-memory material.

5. The method of claim 1 wherein introducing a hyperthermic or hypothermic fluid and/or gas comprises heating or cooling the fluid and/or gas prior to introduction into the treatment area.

6. The method of claim 1 further comprising visualizing via an endoscope while at least positioning.

8. The method of claim 1 further comprising stirring, or circulating the fluid and/or gas within the treatment area such that temperature of the fluid and/or gas is even.

9. The method of claim 1 further comprising introducing, an additional fluid into the treatment area having a temperature which cools or warms the fluid and/or gas.

10. The method of claim 1 wherein the fluid and/or gas comprises water.

11. The method of claim 1, wherein the hyperthermic fluid and/or gas is between 42 degrees Celsius and 100 degrees Celsius.

12. The method of claim 1, wherein the hypothermic fluid and/or gas is between −

2 degrees Celsius and −

40 degrees Celsius.

13. The method of claim 1, wherein the treatment area is exposed to the hyperthermic fluid and/or gas for a period between 15 seconds and 15 minutes.

14. The method of claim 1, wherein the hypothermic fluid and/or was is between −

5 degrees Celsius and −

20 degrees Celsius.

7. The method of claim wherein the fluid and/or gas is chilled to less than −

5 degrees C.

15. A method for treating a body cavity or lumen, comprising:

positioning a tissue region of interest between a distal occlusion member and a proximal occlusion member which are adjustably movable relative to one another via adjustment of a catheter;

occluding the tissue region to be treated between the occlusion members such that a treatment area is defined therebetween;

introducing a hyperthermic or hypothermic gel or colloidal suspension into the treatment area such that the tissue region is treated by thermal ablation with the hyperthermic or hypothermic gel or colloidal suspension contacting the tissue region;

monitoring a first pressure of the hyperthermic or hypothermic gel or colloidal suspension introduced into the treatment area;

comparing the first pressure against a second pressure within the occlusion members; and

adjusting the first pressure to be below the second pressure if the first pressure exceeds the second pressure.

16. The method of claim 15 wherein the gel or colloidal suspension comprises a suspension of metal particles, fibers or ions.

17. The method of claim 15 wherein positioning comprises positioning the catheter within a body lumen selected from the group consisting of an esophagus, uterus, respiratory tract, and bladder.

18. The method of claim 15 wherein occluding the tissue region comprises inflating the occlusion members via a fluid.

19. The method of claim 15 wherein introducing a hyperthermic or hypothermic gel or colloidal suspension comprises heating or cooling the gel or colloidal suspension prior to introduction into the treatment area.

20. The method of claim 15 further comprising visualizing via an endoscope while at least positioning.

21. The method of claim 15 wherein the gel or colloidal suspension is chilled to less than −

5 degrees C.

22. The method of claim 15 further comprising stirring or circulating the gel or colloidal suspension within the treatment area such that temperature of the gel or colloidal suspension is even.

23. The method of claim 15 further comprising introducing an additional fluid into the treatment area having a temperature which cools or warms the gel or colloidal suspension.

24. The method of claim 15, wherein the hyperthermic gel or colloidal suspension is between 42 degrees Celsius and 100 degrees Celsius.

25. The method of claim 15, wherein the hypothermic gel or colloidal suspension is between −

2 degrees Celsius and −

40 degrees Celsius.

26. The method of claim 15, wherein the treatment area is exposed to the hyperthermic gel or colloidal suspension for a period between 15 seconds and 15 minutes.

27. The method of claim 15, wherein the hypothermic gel or colloidal suspension is between −

5 degrees Celsius and −

20 degrees Celsius.

28. A method for treating a body cavity or lumen, comprising:

positioning a distal end of a treatment catheter within an opening of a body cavity or lumen;

occluding the opening such that fluid communication is inhibited between an outer surface of the catheter and the opening such that a treatment area is defined within the body cavity or lumen;

introducing a hyperthermic or hypothermic fluid and/or gas into the treatment area such that a tissue region in the treatment area is treated by thermal ablation with the hyperthermic or hypothermic fluid and/or gas contacting the tissue region;

monitoring a treatment pressure of the hyperthermic or hypothermic fluid and/or gas introduced into the body cavity or lumen;

comparing the treatment pressure against an occluding pressure between the catheter and opening; and

adjusting the treatment pressure to be below the occluding pressure if the treatment pressure exceeds the occluding pressure.

29. The method of claim 28 wherein positioning comprises positioning the catheter distal end within a uterus or bladder.

30. The method of claim 28 wherein occluding comprises inflating an occlusion member via a fluid in proximity to the opening.

31. The method of claim 28 wherein occluding comprises expanding an occlusion members via a self-expanding or shape-memory material.

32. The method of claim 28 wherein introducing a hyperthermic or hypothermic fluid and/or gas comprises heating or cooling the fluid and/or gas prior to introduction into the body cavity or lumen.

33. The method of claim 28 further comprising visualizing via an endoscope while at least positioning.

34. The method of claim 28 wherein the fluid and/or gas is chilled to less than −

5 degrees C.

35. The method of claim 28 further comprising stirring or circulating the fluid and/or gas within the body cavity or lumen such that temperature of the fluid and/or gas is even.

36. The method of claim 28 further comprising introducing an additional fluid into the treatment area having a temperature which cools or warms the fluid and/or gas.

37. The method of claim 28 wherein the fluid and/or gas comprises water.

38. The method of claim 28, wherein the hyperthermic fluid and/or gas is between 42 degrees Celsius and 100 degrees Celsius.

39. The method of claim 28, wherein the hypothermic fluid and/or gas is between −

2 degrees Celsius and −

40 degrees Celsius.

40. The method of claim 28, wherein the treatment area is exposed to the hyperthermic fluid and/or gas for a period between 15 seconds and 15 minutes.

41. The method of claim 28, wherein the hypothermic fluid and/or was is between −

5 degrees Celsius and −

20 degrees Celsius.