# US 10,864,112 B2 · Pain management using cryogenic remodeling

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- Number: US 10,864,112 B2
- Document ID: US10864112B2
- Status: Granted
- Kind: B2
- Application number: 16/796,078
- Filed: 2020-02-20
- Published: 2020-07-09
- Granted: 2020-12-15
- Earliest claimed: 2007-11-14
- Assignees: Pacira CryoTech, Inc.
- Applicants: Pacira CryoTech, Inc.
- Inventors: Keith Burger; Lisa Elkins; Ronald Williams
- Web page: https://patentgrep.com/patent/US10864112B2

## CPC

- A61F 7/12: Devices for heating or cooling internal body cavities
- A61B 18/0218: {with open-end cryogenic probe, e.g. for spraying fluid directly on tissue or via a tissue-contacting porous tip}
- A61F 7/00: Heating or cooling appliances for medical or therapeutic treatment of the human body (hyperthermia using electric or magnetic fields or ultrasound A61N)
- A61B 2018/00452: {Skin}
- A61B 2018/0293: {using an instrument interstitially inserted into the body, e.g. needle}
- A61F 2007/0056: {for cooling}
- A61F 2007/0063: {for cooling}
- A61F 2007/0087: {Hand-held applicators}
- A61F 2007/0094: {using a remote control}
- A61F 2007/0285: {Local anaesthetic effect}
- A61F 2007/126: {for invasive application, e.g. for introducing into blood vessels}
- 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

Embodiments include methods and systems for treating back pain associated with a nerve. A needle of a cryogenic system may be inserted beneath a skin surface. The needle may include an electrically conducting structure at least partially surrounded by an electrical insulator for conducting electrical energy. The needle may include an outer lumen and an inner lumen extending distally within the outer lumen, the inner lumen include a distal opening open to the outer lumen. The needle may be positioned at a desired location in proximity to the nerve, and a cooling therapy including cooling cycles and thawing periods may be performed to cool tissue at the desired location. The cooling therapy may sufficiently reduce the back pain.

## Claims

### Claim 1

A method for treating a back pain associated with a target nerve of a patient, the method comprising:
inserting a distal end of a needle of a cryogenic system into a tissue beneath a skin surface of the patient, wherein the needle comprises an electrically conducting structure at least partially surrounded by an electrical insulator, and wherein the distal end of the needle comprises an electrically conductive surface configured to be able to conduct electrical energy from an electrical source, wherein the needle comprises:
an outer lumen extending distally toward the distal end of the needle, and
an inner lumen extending distally within the outer lumen, the inner lumen comprising a distal opening that is open to the outer lumen;
positioning a distal portion of the needle at a desired location in proximity to the target nerve associated with the back pain; and
performing a first cooling cycle via the distal portion of the needle at the desired location in proximity to the target nerve associated with the back pain so that the needle cools tissue at the desired location;
causing at least a portion of the tissue at the desired location to be thawed over a thawing period; and
performing a second cooling cycle via the distal portion of the needle;
wherein the cooling cycles are configured to reach temperatures less than −19 degrees Celsius, and wherein the cooling cycles sufficiently reduce back pain.

### Claim 2 (depends on 1)

The method of claim 1, wherein the back pain comprises a lower back pain.

### Claim 3 (depends on 1)

The method of claim 1, further comprising:
stimulating the target nerve via the electrically conductive surface to locate the target nerve.

### Claim 4 (depends on 1)

The method of claim 1, wherein performing the first cooling cycle via the distal portion of the needle comprises:
directing a cooling fluid from a cooling fluid source to the distal portion of the needle via a fluidic pathway, the fluidic pathway comprising the cooling fluid source, the inner lumen, and the outer lumen;
wherein a flow of the cooling fluid cools the needle so that the needle cools the tissue at the desired location.

### Claim 5 (depends on 4)

The method of claim 4, wherein the cooling fluid flows from the cooling fluid source to the outer lumen via the inner lumen.

### Claim 6 (depends on 4)

The method of claim 4, further comprising venting the cooling fluid proximally from the distal end of the needle.

### Claim 7 (depends on 4)

The method of claim 4, wherein the cooling fluid is in a liquid state when in the cooling fluid source.

### Claim 8 (depends on 4)

The method of claim 4, wherein the cooling fluid comprises nitrous oxide or carbon dioxide.

### Claim 9 (depends on 4)

The method of claim 4, wherein at least some of the cooling fluid is caused to vaporize into a gaseous state within the needle.

### Claim 10 (depends on 4)

The method of claim 4, further comprising venting the cooling fluid proximally as a gas from the distal end of the needle via the fluidic pathway.

### Claim 11 (depends on 1)

The method of claim 1, wherein the inner lumen comprises a cooling fluid supply tube configured to extend distally of the skin surface when the distal portion of the needle is positioned at the desired location.

### Claim 12 (depends on 1)

The method of claim 1, wherein the second cooling cycle is performed at the desired location in proximity to the target nerve associated with the back pain.

### Claim 13 (depends on 1)

The method of claim 1, wherein causing at least a portion of the tissue at the desired location to be thawed comprises applying a warming energy or injecting a warming fluid to speed thawing of the tissue at the desired location.

### Claim 14 (depends on 1)

The method of claim 1, wherein the needle comprises a 16 gauge or smaller needle.

### Claim 15

A method for treating a back pain associated with a target nerve of a patient, the method comprising:
inserting a sharpened distal end of a needle of a cryogenic system into a tissue beneath a skin surface of the patient, wherein the needle comprises a 16 gauge or smaller needle, and wherein the needle includes:
an outer lumen extending distally toward the distal end of the needle, and
an inner lumen extending distally within the outer lumen, the inner lumen comprising a distal opening that is open to the outer lumen;
positioning a distal portion of the needle beneath the skin surface at a desired location in proximity to the target nerve associated with the back pain; and
performing a first cooling cycle via the distal portion of the needle at the desired location in proximity to the target nerve associated with the back pain so that the needle cools tissue at the desired location;
causing at least a portion of the tissue at the desired location to be thawed over a thawing period; and
performing a second cooling cycle via the distal portion of the needle;
wherein the cooling cycles are configured to reach temperatures less than −19 degrees Celsius, and wherein the cooling cycles sufficiently reduce back pain.

### Claim 16 (depends on 15)

The method of claim 15, wherein the back pain comprises a lower back pain.

### Claim 17 (depends on 15)

The method of claim 15, wherein the needle comprises an 18 gauge or smaller needle.

### Claim 18 (depends on 15)

The method of claim 15, wherein performing the first cooling cycle via the distal portion of the needle comprises:
directing a cooling fluid from a cooling fluid source to the distal portion of the needle via a fluidic pathway, the fluidic pathway comprising the cooling fluid source, the inner lumen, and the outer lumen;
wherein a flow of the cooling fluid cools the needle so that the needle cools the tissue at the desired location.

### Claim 19 (depends on 18)

The method of claim 18, further comprising venting the cooling fluid proximally from the distal end of the needle.

### Claim 20 (depends on 18)

The method of claim 18, wherein the cooling fluid flows from the cooling fluid source to the outer lumen via the inner lumen.

### Claim 21 (depends on 18)

The method of claim 18, wherein the cooling fluid comprises nitrous oxide (N2O) or carbon dioxide (CO2).

### Claim 22 (depends on 18)

The method of claim 18, wherein the cooling fluid is in a liquid state when in the cooling fluid source.

### Claim 23 (depends on 22)

The method of claim 22, wherein at least some of the cooling fluid is caused to vaporize into a gaseous state within the needle.

### Claim 24 (depends on 18)

The method of claim 18, further comprising venting the cooling fluid proximally as a gas from the distal end of the needle via the fluidic pathway.

### Claim 25 (depends on 15)

The method of claim 15, wherein causing at least a portion of the tissue at the desired location to be thawed comprises applying a warming energy or injecting a warming fluid to speed thawing of the tissue at the desired location.

### Claim 26 (depends on 15)

The method of claim 15, wherein the inner lumen comprises a cooling fluid supply tube configured to extend distally of the skin surface when the distal portion of the needle is positioned at the desired location.

### Claim 27 (depends on 15)

The method of claim 15, further comprising stimulating the target nerve to locate the target nerve.

### Claim 28 (depends on 15)

The method of claim 15, wherein the second cooling cycle is performed at the desired location in proximity to the target nerve associated with the back pain.