# US 12,004,797 B2 · Medical systems, methods, and devices for hypopigmentation cooling treatments

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- Number: US 12,004,797 B2
- Document ID: US12004797B2
- Status: Granted
- Kind: B2
- Application number: 16/986,780
- Filed: 2020-08-06
- Published: 2021-01-21
- Granted: 2024-06-11
- Earliest claimed: 2015-09-04
- Assignees: R2 Technologies, Inc.
- Applicants: R2 Technologies, Inc.
- Inventors: Jesse Rosen; Kevin Springer; Kristine Tatsutani; Michael O'Neil
- Web page: https://patentgrep.com/patent/US12004797B2

## CPC

- A61B 18/0206: {ultrasonic, e.g. for destroying tissue or enhancing freezing}
- A61B 18/203: {applying laser energy to the outside of the body}
- A61B 2018/00458: {Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains}
- A61B 2018/00994: {combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound}
- A61B 2018/0237: {with a thermoelectric element in the probe for cooling purposes}
- A61B 2018/2023: {Self-contained devices, i.e. with power supply in the hand-piece}
- A61F 2007/0052: {for treatment of skin or hair}
- A61N 7/00: Ultrasound therapy (lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 {; using ultrasound for introducing media into the body A61M37/0092})
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

Embodiments of the present invention generally relate to methods, devices, and systems for reducing a pigmentation of a skin of a patient. In some embodiments, freezing of the skin may be desirable to effect the hypopigmentation of the skin of the patient. Generally, embodiments may limit supercooling (or promote freezing) of the skin of the patient during a cooling treatment. In some embodiments, coupling fluids are provided to reduce a thermal contact resistance between a cooling treatment probe and the skin of the patient to improve cooling treatment. Optionally, a fluid carrier may be provided to help retain the coupling fluid at the treatment site. In some embodiments, the coupling fluid may include ice nucleating agents to promote ice crystal formation in the coupling fluid during cooling treatment. The ice crystal formation in the coupling fluid may progress into the skin to limit supercooling of the skin during treatment.

## Claims

### Claim 1

A method of altering pigmentation in a skin of a patient, the method comprising:
generating seed crystals on a contact surface of a cooling treatment probe;
applying a coupling fluid to a treatment area on the skin of the patient; and
applying the contact surface of the cooling treatment probe to the treatment area with the applied coupling fluid present, wherein the applying the contact surface of the cooling treatment probe to the treatment area with the applied coupling fluid present introduces an ice nucleating agent to the coupling fluid, the ice nucleating agent configured to promote ice formation in the coupling fluid and to limit supercooling of the skin in the treatment area, and wherein applying the contact surface of the cooling treatment probe to the treatment area with the applied coupling fluid present promotes ice crystal formation in the coupling fluid and wherein the ice crystal formation in the coupling fluid propagates into the skin of the patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein generating seed crystals on the contact surface of the cooling treatment probe comprises pre-cooling the contact surface of the cooling treatment probe to between −20° C. to 0° C. for a period of time before applying the contact surface of the cooling treatment probe to the treatment area with the applied coupling fluid present.

### Claim 3 (depends on 2)

The method of claim 2, wherein the period of time comprises between 20 seconds and 2 minutes.

### Claim 4 (depends on 2)

The method of claim 2, wherein pre-cooling the contact surface of the cooling treatment probe to between −20° C. to 0° C. comprises cooling the temperature of the contact surface of the cooling treatment probe to a temperature of approximately −10° C. for the period of time before applying the contact surface of the cooling treatment probe to the treatment area with the applied coupling fluid present.

### Claim 5 (depends on 2)

The method of claim 2, wherein generating seed crystals on the contact surface of the cooling treatment probe further comprises applying water to the contact surface of the cooling treatment probe before applying the contact surface of the cooling treatment probe to the treatment area with the applied coupling fluid present.

### Claim 6 (depends on 5)

The method of claim 5, wherein applying water to the contact surface of the cooling treatment probe comprises misting water onto the contact surface of the cooling treatment probe.

### Claim 7 (depends on 2)

The method of claim 2, wherein the contact surface of the cooling treatment probe comprises an aluminum plate.

### Claim 8 (depends on 1)

The method of claim 1, wherein the contact surface of the cooling treatment probe comprises a roughened surface comprising recessed areas configured to retain the seed crystals.

### Claim 9 (depends on 8)

The method of claim 8, wherein the roughened surface is configured to promote formation of ice crystals from moisture in the air.

### Claim 10 (depends on 8)

The method of claim 8, wherein the roughened surface comprises a knurled surface.

### Claim 11 (depends on 8)

The method of claim 8, wherein the roughened surface has a roughness between 32-256 μin.

### Claim 12 (depends on 8)

The method of claim 8, wherein the roughened surface has a roughness between 1000-2000 μm.

### Claim 13 (depends on 1)

The method of claim 1, wherein the ice nucleating agent comprises the seed crystals.

### Claim 14 (depends on 1)

The method of claim 1, wherein the coupling fluid comprises an aqueous fluid and a thickening agent to increase a viscosity of the aqueous fluid.

### Claim 15 (depends on 1)

The method of claim 1, wherein applying the coupling fluid to the treatment area on the skin of the patient comprises applying a fluid carrier to the treatment area of the skin, the fluid carrier configured to retain the coupling fluid at the treatment area.

### Claim 16

A method of altering pigmentation in a skin of a patient, the method comprising:
applying a coupling fluid to a treatment area on the skin of the patient, the coupling fluid configured to limit supercooling of the skin, and the coupling fluid comprising a thickening agent increasing a viscosity of the coupling fluid to retain the coupling fluid at the treatment area; and
applying a cooling treatment to the treatment area with the coupling fluid present, wherein applying the cooling treatment to the treatment area with the coupling fluid present promotes ice crystal formation in the coupling fluid and wherein the ice crystal formation in the coupling fluid propagates into the skin of the patient.

### Claim 17 (depends on 16)

The method of claim 16, wherein the coupling fluid comprises an aqueous fluid.

### Claim 18 (depends on 17)

The method of claim 17, wherein the coupling fluid freezes near 0 de. C.

### Claim 19 (depends on 16)

The method of claim 16, further comprising abrading or piercing the treatment area prior to applying the cooling treatment.

### Claim 20 (depends on 16)

The method of claim 16, wherein applying the cooling treatment comprises contacting a treatment surface of a cooling probe with the coupling fluid at the treatment area.

### Claim 21 (depends on 20)

The method of claim 20, wherein the treatment surface of the cooling probe comprises a smooth surface.

### Claim 22 (depends on 20)

The method of claim 20, wherein the treatment surface of the cooling probe comprises a textured surface.