# US 9,517,100 B2 · Cryogenic treatment methods

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- Number: US 9,517,100 B2
- Document ID: US9517100B2
- Status: Granted
- Kind: B2
- Application number: 14/020,397
- Filed: 2013-09-06
- Published: 2014-01-09
- Granted: 2016-12-13
- Earliest claimed: 2011-02-01
- Assignees: Channel Medsystems, Inc.
- Applicants: Channel Medsystems, Inc.
- Inventors: Daniel R. Burnett; Ric Cote; William W. Malecki; Brian M. Neil; David Beaulieu; Benjamin D. Voiles
- Web page: https://patentgrep.com/patent/US9517100B2

## CPC

- A61F 7/123: {using a flexible balloon containing the thermal element}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 17/12022: {Occluding by internal devices, e.g. balloons or releasable wires (plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20)}
- A61B 18/02: by cooling, e.g. cryogenic techniques
- A61B 18/0218: {with open-end cryogenic probe, e.g. for spraying fluid directly on tissue or via a tissue-contacting porous tip}
- A61B 18/04: by heating (by applying electromagnetic radiation A61B18/18)
- A61B 5/6853: {with a balloon}
- A61B 2017/00539: {hydraulically}
- A61B 2018/00011: {with fluids}
- A61B 2018/00041: {Heating, e.g. defrosting}
- A61B 2018/0022: {Balloons}
- A61B 2018/00488: {Esophagus}
- A61B 2018/00553: {Sphincter}
- A61B 2018/00559: {Female reproductive organs}
- A61B 2018/00577: {Ablation}
- A61B 2018/00791: {Temperature}
- A61B 2018/00863: {Fluid flow}
- A61B 2018/00982: {combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes}
- A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter}
- A61B 2018/0262: {using a circulating cryogenic fluid}
- A61B 2018/046: {in liquid form}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## 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 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.

## Claims

### Claim 1

A method of ablating tissue, comprising:
positioning an elongate probe with an infusion lumen into a body lumen to be treated;
adjusting a number of one or more openings which remains unobstructed along a length of the infusion lumen, wherein adjustment of the number of one or more openings correspondingly adjusts an expandable length of a liner;
expanding the liner enclosing the probe into contact against a tissue surface of the body lumen by infusing one or more puffs of ambient air into the liner;
infusing a cryoablative fluid through the infusion lumen along the probe, after expanding the liner, and through the one or more openings defined along the length of the infusion lumen;
spraying the cryoablative fluid into the air contained within an interior of the liner and into contact against a wall of the liner; and
cooling the tissue in contact with the liner by absorbing heat from the tissue surface conducted through the liner and into the fluid such that the fluid evaporates into a gas form within the liner.

### Claim 2

The method of claim further comprising withdrawing the gas from the interior of the liner via the probe.

### Claim 3 (depends on 1)

The method of claim 1 wherein adjusting further comprises adjusting a position of a delivery lumen relative to the infusion lumen such that the one or more openings defined along the length of the infusion lumen remain unobstructed by the delivery lumen.

### Claim 4 (depends on 1)

The method of claim 1 wherein spraying further comprises reducing a temperature within the interior of the liner to about −89° C. within 6-7 seconds after spraying.

### Claim 5 (depends on 1)

The method of claim 1 wherein spraying further comprises spraying the fluid in a transverse or perpendicular direction relative to the probe.

### Claim 6 (depends on 1)

The method of claim 1 wherein spraying further comprises coating the wall of the liner with the sprayed fluid.

### Claim 7 (depends on 1)

The method of claim 1 further comprising withdrawing the gas from the interior of the liner.

### Claim 8 (depends on 7)

The method of claim 7 wherein withdrawing the gas comprises switching a valve in fluid communication between a pump and the interior of the liner.

### Claim 9 (depends on 1)

The method of claim 1 wherein spraying further comprises spraying the fluid for a period of time of up to 150 seconds.

### Claim 10 (depends on 1)

The method of claim 1 wherein the one or more puffs of air are infused into the liner until the liner conforms to the body lumen.

### Claim 11 (depends on 1)

The method of claim 1 wherein infusing a cryoablative fluid comprises infusing nitrous oxide or argon into the interior of the liner.

### Claim 12 (depends on 1)

The method of claim 1 further comprising ceasing infusion of the cryoablative fluid and evacuating the interior of the liner through the elongate probe.

### Claim 13 (depends on 1)

The method of claim 1 wherein infusing a cryoablative fluid comprises maintaining an insulative annular spacing between a sheath assembly and the interior of the elongate probe.

### Claim 14 (depends on 1)

The method of claim 1 further comprising monitoring a pressure of the interior of the liner while spraying the cryoablative fluid.

### Claim 15 (depends on 1)

The method of claim 1 further comprising monitoring a temperature of the body lumen while spraying the cryoablative fluid.

### Claim 16 (depends on 1)

The method of claim 1 further comprising monitoring a pressure within the interior of the liner for detecting a leak.