Methods and apparatus for treatment of a body cavity or lumen

• US 10,849,673 B2
• Filed: 06/14/2018
• Issued: 12/01/2020
• Est. Priority Date: 06/01/2009
• Status: Active Grant

• Current Assignee: Channel Medsystems, Inc.
• Original Assignee: Channel Medsystems, Inc.
• Inventors: Burnett, Daniel R.
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US16/008,251
• Publication Number:
  US 20180289411A1
• Time in Patent Office: 901 Days
• 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 system for treating a condition in a body lumen, comprising:

a first catheter having a first retaining member and a second catheter having a second retaining member, wherein the first and second retaining members are configured for positioning within the body lumen and wherein a position of the first and second retaining members are adjustable relative to one another so as to define a treatment area between the retaining members;

a cryoablative agent in fluid communication with the treatment area; and

a controller in communication with the first and second retaining members and configured to monitor a first pressure of the cryoablative agent within the treatment area for comparison against a second pressure within the first and second retaining members, wherein the controller is further configured to adjust the first pressure to be below the second pressure such that the first pressure is maintained below the second pressure.

2. The system of claim 1 wherein the first and second retaining members are configured for positioning within an esophagus, uterus, respiratory tract, or bladder.

3. The system of claim 1 wherein the first and second retaining members are inflatable via a fluid.

4. The system of claim 1 wherein the first or second catheter is linearly translatable relative to one another to adjust a size of the treatment area.

5. The system of claim 1 wherein the cryoablative agent comprises a heated or cooled agent.

6. The system of claim 1 further comprising an endoscope configured to visualize the treatment area.

7. The system of claim 1 wherein the cryoablative agent is less than −

5 degrees C.

8. The system of claim 1 further comprising an additional fluid in fluid communication with the treatment area, the additional fluid having a temperature for warming the treatment area.

9. The system of claim 1 further comprising an agent having an active compound in fluid communication with the treatment area.

10. A method for treating a body lumen, comprising:

positioning a first catheter having a first retaining member relative to a second catheter having a second retaining member within the body lumen so as to define a treatment area between the first and second retaining members;

introducing a cryoablative agent into the treatment area such that a tissue region within the treatment area is thermally ablated;

monitoring a first pressure of the cryoablative agent introduced into the treatment area via a controller;

monitoring a second pressure within the first or second retaining members via the controller;

comparing the first pressure against the second pressure via the controller; and

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

11. The method of claim 10 wherein positioning comprises positioning the first catheter and second catheter within an esophagus, uterus, respiratory tract, or bladder.

12. The method of claim 10 wherein positioning further comprises positioning the first and second retaining members so that a lesion is contained within the treatment area.

13. The method of claim 10 wherein positioning further comprises inflating the first and second retaining members via a fluid.

14. The method of claim 10 wherein introducing a cryoablative agent comprises heating or cooling the cryoablative agent prior to introducing into the treatment area.

15. The method of claim 10 further comprising visualizing via an endoscope while forming the treatment area.

16. The method of claim 10 wherein the cryoablative agent is less than −

5 degrees C.

17. The method of claim 10 further comprising introducing an additional fluid into the treatment area where the additional has a temperature which warms the treatment area.

18. The method of claim 10 further comprising introducing an agent having an active compound within the treatment area.