Cyrogenic treatment systems
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 and temperature sensing elements which may allow for control of the pressure and temperature 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, room temperature, or warmed fluid such as water may then be used to rapidly terminate the treatment session.
1. A tissue treatment system for treating a contoured tissue surface, comprising:
a handle having a housing;
an elongate probe extending from the housing and having a distal tip and a flexible length;
a liner expandably enclosing the probe and adapted to conform to the contoured tissue surface;
at least one infusion lumen positioned through or along the elongate probe, wherein the infusion lumen defines one or more openings along its length; and
a controller configured to:
deliver a non-ablative fluid into the interior of the liner at a pressure to expand the liner to conform to the contoured tissue surface without deforming the contoured tissue surface;
monitor a condition of the liner;
deliver an ablative fluid into an interior of the liner via the infusion lumen;
evacuate the ablative fluid from the liner.
2. The tissue treatment system of claim 1 , where the controller is configured to monitor the condition of the liner by monitoring a pressure in the liner for a period of time.
3. The system of claim 2 wherein the controller is further configured to monitor the condition of the liner by detecting whether the pressure within the interior of the liner remains above a set pressure over a pre-determined period to determine whether a leak is present within the liner.
4. The tissue treatment system of claim 1 , where ablative fluid comprises a cryoablative liquid.
5. The tissue treatment system of claim 4 , where the controller is configured to evacuate the ablative fluid from the liner after the cryoblative liquid changes to a gas.
6. The tissue treatment system of claim 1 , where delivering the ablative fluid into the interior of the liner occurs subsequent to monitoring the condition of the liner.
7. The system of claim 1 further comprising at least one delivery lumen slidingly positioned through or along the infusion lumen, wherein translation of the delivery lumen relative to the infusion lumen controls a number of unobstructed openings along the infusion lumen to control an ablative length of the liner.
8. The tissue treatment system of claim 1 , where the non-ablative fluid comprises an ambient air.
9. The system of claim 8 wherein the controller is further configured to deliver the ambient air into the interior of the liner at a pre-determined pressure for a pre-determined period prior to infusing the ablative fluid.
10. The system of claim 1 wherein the controller is further configured to cease delivering the ablative fluid into the interior of the liner.
11. The system of claim 10 wherein the controller is further configured to infuse air into the interior of the liner while the ablative fluid remains within the interior and then vent the liner to thaw tissue in contact with an exterior of the liner.
12. The tissue treatment system of claim 1 , where the liner comprises a tapered shape when expanded to conform to the contoured tissue surface to facilitate positioning in a tissue cavity.
13. A method of treating tissue, comprising:
positioning an elongate probe into a body lumen to be treated;
expanding a liner enclosing the probe into direct contact against the body lumen using a non-ablative fluid without deforming the body lumen;
monitoring a fluid condition of the liner; and
infusing an ablative fluid through a delivery lumen such that the fluid passes into an infusion lumen and into the liner to contact an interior of the liner.
14. The method of claim 13 , further comprising adjusting a position of the delivery lumen relative to the infusion lumen which is positioned through or along the elongate probe such that one or more openings defined along a length of the infusion lumen remain unobstructed by the delivery lumen.
15. The method of claim 14 , where infusing the ablative fluid through the delivery lumen further comprises maintaining the liner at a pressure of up to 150 mmHg and for a period of time of up to 150 seconds.
16. The method of claim 13 , where monitoring the fluid condition of the liner comprises monitoring a pressure in the liner for a period of time.
17. The method of claim 13 further comprising detecting whether the pressure within the interior of the liner remains above 40 mmHg over a period of 5 seconds to determine whether a leak is present within the liner.
18. The method of claim 13 wherein infusing the ablative fluid is controlled via a controller.
19. The method of claim 13 further comprising ceasing the infusion of the ablative fluid into the interior of the liner.
20. The method of claim 13 wherein prior to infusing the ablative fluid, infusing an air into the interior of the liner at a pre-determined pressure and for a period of time.
21. The method of claim 13 further comprising detecting whether the pressure within the interior of the liner deviates by at least pre-determined pressure over a pre-determined period of time to determine whether a leak is present within the liner.
22. The method of claim 13 further comprising infusing an air into the interior of the liner at a pre-determined pressure while the ablative fluid remains within the interior and then venting the liner for a pre-determined about 2 seconds to thaw tissue in contact with an exterior of the liner.