Compositions, treatment systems and methods for improved cooling of lipid-rich tissue

• US 9,861,421 B2
• Filed: 01/30/2015
• Issued: 01/09/2018
• Est. Priority Date: 01/31/2014
• Status: Active Grant

• Current Assignee: ZELTIQ Aesthetics, Inc. (Abbvie Incorporated)
• Original Assignee: ZELTIQ Aesthetics, Inc. (Abbvie Incorporated)
• Inventors: O'Neil, Michael P., DeBenedictis, Leonard C., Frangineas, Jr., George
• Primary Examiner(s): Buckley, Audrea
• Application Number:
  US14/610,807
• Publication Number:
  US 20150216816A1
• Time in Patent Office: 1,075 Days
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/0206 ultrasonic, e.g. for destroying tissue or enhancing freezing
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00464 Subcutaneous fat, e.g. liposuction, lipolysis
• CPC Class Codes: A61B 2018/00714 Temperature
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00994 combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• CPC Class Codes: A61B 2018/0237 with a thermoelectric element in the probe for cooling purposes
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61B 2090/0463 against cooling or freezing
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 90/04 Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery protection of eyes against laser radiation A61F9/022
• CPC Class Codes: A61F 2007/0003 Face
• CPC Class Codes: A61F 2007/0004 Eyes or part of the face surrounding the eyes
• CPC Class Codes: A61F 2007/0019 Breast
• CPC Class Codes: A61F 2007/0036 Hand
• CPC Class Codes: A61F 2007/0045 Foot
• CPC Class Codes: A61F 2007/0047 Sole
• CPC Class Codes: A61F 2007/0052 for treatment of skin or hair
• CPC Class Codes: A61F 2007/0056 : for cooling
• CPC Class Codes: A61F 2007/0075 : using a Peltier element, e.g. near the spot to be heated or cooled
• CPC Class Codes: A61F 2007/0087 : Hand-held applicators
• CPC Class Codes: A61F 2007/0093 : programmed
• CPC Class Codes: A61F 2007/0096 : with a thermometer
• CPC Class Codes: A61F 7/00 : Heating or cooling appliances for medical or therapeutic treatment of the human body heating or cooling means in connection with bedsteads or mattresses A47C21/00 ; massage, therapeutic baths A61H; hyperthermia using electric or magnetic fields or ultrasound A61N; electric heating elements H05B
• CPC Class Codes: A61F 7/007 : characterised by electric heating
• CPC Class Codes: A61H 1/006 : Apparatus for applying pressure or blows for compressive stressing of a part of the skeletal structure, e.g. for preventing or alleviating osteoporosis
• CPC Class Codes: A61H 1/008 : Apparatus for applying pressure or blows almost perpendicular to the body or limb axis, e.g. chiropractic devices for repositioning vertebrae, correcting deformation
• CPC Class Codes: A61K 31/045 : Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
• CPC Class Codes: A61K 31/047 : having two or more hydroxy groups, e.g. sorbitol
• CPC Class Codes: 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

Abstract

Compositions and formulations for use with devices and systems that enable tissue cooling, such as cryotherapy applications, for alteration and reduction of adipose tissue are described. Aspects of the technology are further directed to methods, compositions and devices that provide protection of non-targeted cells (e.g., non-lipid-rich cells) from freeze damage during dermatological and related aesthetic procedures that require sustained exposure to cold temperatures. Further aspects of the technology include systems for enhancing sustained and/or replenishing release of cryoprotectant to a treatment site prior to and during cooling applications.

Claims

1. A system for non-invasive, transdermal removal of heat from lipid-rich cells of a subject'"'"'s body, comprising:

an applicator having a heat-exchanging element configured to reduce a temperature of a target region beneath the epidermis of the subject selectively to reduce the temperature of lipid-rich cells in the target region from a natural body temperature to a lower temperature in the target region; and

a first cryoprotectant having a viscosity greater than 10,000 centipose (cP) at 20°

C. to −

20°

C. that is configured to lower a freezing point of non-lipid-rich cells at the target region, the first cryoprotectant including a colligatively active adjuvant configured to increase absorption of the first cryoprotectant into an epidermal layer and/or dermal layer at the target region and one or more of a solute configured to raise an effective concentration of the solute in the epidermal layer and/or dermal layer, a hydrophilic molecule, and a lipophilic molecule;

wherein the first cryoprotectant protects non-lipid rich cells such that the lipid-rich cells in the target region are substantially affected while non-lipid rich cells in the target region are not substantially affected when the temperature is reduced.

2. The system of claim 1 wherein the first cryoprotectant has a freezing point in the range of −

40°

C. to 0°

C.

3. The system of claim 1, further comprising a cryoprotectant release structure between a surface of the applicator and a skin surface at the target region, the cryoprotectant release structure configured to retain and release the first cryoprotectant between the surface of the applicator and the skin surface, wherein the first cryoprotectant release structure comprises an absorbent material, a microporous pad, and/or an adhesive configured to adhere to the skin surface, and wherein the adhesive is configured to releasably retain the first cryoprotectant release structure at the skin surface at the target region.

4. The system of claim 1, further comprising a second cryoprotectant, and a cryoprotectant release structure between a surface of the applicator and a skin surface at the target region, the cryoprotectant release structure configured to retain and release the second cryoprotectant between the surface of the applicator and the skin surface, wherein the cryoprotectant release structure comprises either an absorbent material, a microporous pad, and/or an adhesive configured to adhere to the skin surface, and wherein the adhesive is configured to releasably retain the cryoprotectant release structure at the skin surface at the target region.

5. The system of claim 4 wherein the adhesive comprises at least one of a silicone gel, a wax, a hydrocarbon resin, a terpene-phenol resin, an natural resin and a synthetic resin.

6. The system of claim 4 wherein the cryoprotectant release structure provides sustained release of the second cryoprotectant to the skin surface at the lower temperature, and wherein lipid-rich cells in the target region are affected at the lower temperature while non-lipid-rich cells proximate the cryoprotectant release structure are preserved.

14. The system of claim 1, wherein the colligatively active adjuvant is glycolic acid.

15. The system of claim 1, wherein the solute comprises one or more of a calcium salt, a potassium salt, and a magnesium salt.

16. The system of claim 1, wherein the first cryoprotectant has a viscosity that is greater than 10,000 cP at 5°

C. to −

15°

C.

7. A system for removing heat from subcutaneous lipid-rich cells of a subject having skin, comprising:

a treatment unit;

an applicator having a cooling unit in communication with the treatment unit;

a pre-treatment composition configured to be applied to the skin to increase a permeability of the skin; and

a cryoprotectant composition including a colligatively active adjuvant and a solute, the cryoprotectant composition having a viscosity greater than 10,000 cP at a temperature greater than −

20°

C. and is configured to be applied to the skin to permeate into the skin to lower a freezing point of non-lipid-rich cells in the skin.

8. The system of claim 7 wherein the pre-treatment composition comprises an alpha-hydroxy acid, butylene glycol, a fatty acid, d-limonene, a terpene, a terpenoid, N-methyl-2-pyrrolidone, dimethylsulphoxide, 1,3-diphenylurea, dodecyl,N,N-dimethyl-aminoacetate, ethanol, alcohol, ethyl acetate, beta-cyclodextrin, alcohol, and/or isopropyl alcohol.

9. The system of claim 7, wherein the pre-treatment composition and the cryoprotectant composition are combined into a single composition and applied together onto the skin by rubbing the single composition into the skin with an abrasive cloth.

10. The system of claim 7, wherein the pre-treatment composition is first applied to the skin and thereafter the cryoprotectant composition is applied to the skin.

11. The system of claim 7, wherein the colligatively active adjuvant is configured to increase absorption of the cryoprotectant into an epidermal layer and/or dermal layer of the skin and a solute configured to raise an effective concentration of the solute in the epidermal layer and/or dermal layer of the skin.

12. The system of claim 7, wherein the solute is configured to raise an effective concentration of the solute in the epidermal layer and/or dermal layer of the skin.

13. The system of claim 7, wherein the cryoprotectant further comprises one or more of a hydrophilic molecule and a lipophilic molecule.

17. The system of claim 7, wherein the cryoprotectant composition has a viscosity that is greater than 10,000 cP at 5°

C. to −

15°

C.