# US 11,439,452 B2 · Systems and methods to treat wounds

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- Number: US 11,439,452 B2
- Document ID: US11439452B2
- Status: Granted
- Kind: B2
- Application number: 16/043,356
- Filed: 2018-07-24
- Published: 2019-01-31
- Granted: 2022-09-13
- Earliest claimed: 2017-07-25
- Assignees: CSA Medical, Inc.; United States Endoscopy Group, Inc.
- Applicants: United States Endoscopy Group, Inc.
- Inventors: John P. O'Connor
- Web page: https://patentgrep.com/patent/US11439452B2

## CPC

- A61B 18/0218: {with open-end cryogenic probe, e.g. for spraying fluid directly on tissue or via a tissue-contacting porous tip}
- A61B 2018/00005: {Cooling or heating of the probe or tissue immediately surrounding the probe}
- A61B 2018/00577: {Ablation}
- A61B 2018/00791: {Temperature}
- A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter}
- A61B 2018/0262: {using a circulating cryogenic fluid}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

The present disclosure relates generally to the field of cryoablation. In particular, the present disclosure relates to devices and methods for application of cryospray as a therapy to treat wounds.

## Claims

### Claim 1

A method of treating a wound comprising:
directing a distal tip of a cryospray catheter toward the wound;
orienting the distal tip of the catheter at an angle relative to a surface of the wound;
supplying cryogen to the distal tip of the catheter; and
spraying cryogen from the distal tip onto a tissue region of the wound at a distance from the wound, at a temperature of the cryogen, and for a duration of spraying, which are sufficient for effective treatment of the tissue region, until a temperature of an approximate square surface of the tissue region of the wound, about 2 cm long by about 2 cm wide, is about −20° C. to a depth from the surface of the wound,
wherein the duration is between about 20 seconds and about 60 seconds,
wherein the depth is more than 0.5 mm and up to about 1 mm.

### Claim 2 (depends on 1)

The method of claim 1, wherein the distance ranges from about 10 mm to about 15 mm.

### Claim 3 (depends on 1)

The method of claim 1, wherein the depth is about 1 mm.

### Claim 4 (depends on 1)

The method of claim 1, wherein the effective treatment of the tissue region comprises forming intracellular ice crystals within the tissue region of the wound.

### Claim 5 (depends on 1)

The method of claim 1, wherein the effective treatment of the tissue region comprises maintaining an extracellular matrix of tissue within the tissue region of the wound.

### Claim 6 (depends on 1)

The method of claim 1, wherein the effective treatment of the tissue region comprises flash freezing a portion of the tissue region of the wound.

### Claim 7 (depends on 1)

The method of claim 1, wherein the effective treatment of the tissue region comprises remodeling at least the tissue region of the wound.

### Claim 8 (depends on 1)

The method of claim 1, wherein the effective treatment of the tissue region comprises ablating injured or damaged tissue within the tissue region of the wound.

### Claim 9 (depends on 1)

The method of claim 1, further comprising the step of removing tissue from the tissue region of the wound that has been treated.

### Claim 10 (depends on 1)

The method of claim 1, wherein the cryogen is selected from the group consisting of liquid nitrogen, liquid argon, liquid oxygen, liquid nitrous oxide, and liquid carbon dioxide.

### Claim 11 (depends on 1)

The method of claim 1, wherein the angle is substantially perpendicular.

### Claim 12 (depends on 1)

The method of claim 1, wherein the wound is selected from the group consisting of a burn, an ulcer, a chronic wound, and a lesion.

### Claim 13 (depends on 1)

The method of claim 1, wherein the wound is on an external surface of a patient's body.

### Claim 14

A method of treating a wound comprising:
directing a distal tip of a cryospray catheter toward a wound;
orienting the distal tip of the catheter at an angle relative to at least one surface layer of the wound; and
spraying cryogen from the distal tip onto the at least one surface layer of the wound at a distance from the wound, at a temperature of the cryogen, and for a duration of spraying, which are sufficient for effective treatment of the at least one surface layer at a tissue temperature of about −20° C. up to a depth from a surface of the wound,
wherein the duration is between about 20 seconds and about 60 seconds,
wherein the depth is more than 0.5 mm and up to about 1 mm.

### Claim 15 (depends on 14)

The method of claim 14, wherein spraying cryogen further comprises spraying until a temperature of an approximate square region of the at least one surface layer, about 2 cm long by about 2 cm wide, is about −20° C. to a depth of more than 0.5 mm and up to about 1 mm.

### Claim 16 (depends on 14)

The method of claim 14, wherein the effective treatment of the tissue region comprises flash freezing the at least one surface layer.

### Claim 17 (depends on 14)

The method of claim 14, wherein the effective treatment of the tissue region comprises leaving a plurality of collagen fibers and an extra-cellular matrix of a region of the wound intact.

### Claim 18

A method of treating a wound comprising:
inserting a cryospray catheter within a body lumen;
orienting a distal tip of the catheter at an angle relative to a region of exposed tissue of a wound within the body lumen;
supplying cryogen to the distal tip of the catheter; and
spraying cryogen from the distal tip onto the exposed tissue region of the wound at a distance from the wound, at a temperature of the cryogen, and for a duration of spraying, which are sufficient for effective treatment of the tissue region, until a temperature of an approximate square surface of the tissue region of the wound, about 2 cm long by about 2 cm wide, is about −20° C. to a depth from a surface of the wound,
wherein the duration is between about 20 seconds and about 60 seconds,
wherein the depth is more than 0.5 mm and up to about 1 mm.

### Claim 19 (depends on 18)

The method of claim 18, wherein the effective treatment of the exposed tissue region comprises ablating injured or damaged tissue.

### Claim 20 (depends on 18)

The method of claim 18, wherein the spraying step includes one or both of spraying cryogen from the distal tip of the catheter parallel to a longitudinal axis of the catheter, and spraying cryogen from a plurality of radial apertures at the distal tip of the catheter perpendicular to the longitudinal axis.
