Cryoprotectant for use with a cooling device for improved cooling of subcutaneous lipid-rich cells

Abstract

A cryoprotectant for use with a treatment device for improved removal of heat from subcutaneous lipid-rich cells of a subject having skin is provided. The cryoprotectant is a non-freezing liquid, gel, or paste for allowing pre-cooling of the treatment device below 0° C. while preventing the formation of ice thereon. The cryoprotectant may also prevent freezing of the treatment device to the skin or ice from forming from moisture seeping out from the skin. The cryoprotectant may further be hygroscopic, thermally conductive, and biocompatible.

1 . A system for removing heat from subcutaneous lipid rich cells of a subject having skin, comprising:
 a treatment device having a heat exchanging element having a first side in thermal communication with a heat exchanging surface and a second side opposite the first side, the heat exchanging element being configured to reduce a temperature of the target region such that lipid rich cells in the region are affected while preserving non-lipid rich cells proximate to the heat exchanging surface; and   a cryoprotectant with a freezing point in the range of about −40° C. to about 0° C. applied to an interface between the heat exchanging surface and the skin of the subject, the cryoprotectant being in contact with at least one of the skin of the subject at a target region and the heat exchanging surface.   
     
     
         2 . The cooling system of  claim 1  wherein the cryoprotectant further comprises a pH buffer to maintain a pH in the cryoprotectant in the range of about 6 to about 7.5. 
     
     
         3 . The cooling system of  claim 1  wherein the cryoprotectant contains polypropylene glycol. 
     
     
         4 . The cooling system of  claim 1  wherein the cryoprotectant is water-soluble. 
     
     
         5 . The cooling system of  claim 1  wherein the cryoprotectant is a hydrogel. 
     
     
         6 . The cooling system of  claim 1  wherein the cryoprotectant further comprises a thickening agent to provide a viscosity of the cryoprotectant in the range of about 1 cP to about 10,000 cP. 
     
     
         7 . The cooling system of  claim 1  wherein the cryoprotectant further comprises a humectant. 
     
     
         8 . The cooling system of  claim 1  wherein the cryoprotectant freezing point is below about −10° C. 
     
     
         9 . The cooling system of  claim 1  further comprising a coupling device containing the cryoprotectant, the coupling device being releasably coupled to the treatment device and proximate to the heat exchanging surface. 
     
     
         10 . The cooling system of  claim 9  wherein the coupling device includes a backside portion proximate to the heat exchanging surface, a front side portion spaced apart from the backside portion, and an intermediate portion between the backside portion and the front side portion for holding the cryoprotectant. 
     
     
         11 . The cooling system of  claim 10  wherein the front side portion includes at least one aperture in fluid communication with the intermediate portion. 
     
     
         12 . The cooling system of  claim 10  wherein the intermediate portion is constructed from a mesh, foam, a porous plastic material and/or a porous metal material. 
     
     
         13 . The cooling system of  claim 10  further comprising a supply device in fluid communication with the intermediate portion via a conduit and a pressure sensor operatively coupled to one of the intermediate portion, the supply device, and the conduit for monitoring a pressure in the intermediate portion. 
     
     
         14 . The cooling system of  claim 10  wherein the intermediate portion contains the thermally conductive cryoprotectant before treatment. 
     
     
         15 . The cooling system of  claim 1  further comprising an absorbent pre-loaded with the cryoprotectant, the absorbent being at least partially between the heat exchanging surface and target region. 
     
     
         16 . The system of  claim 1  wherein the cryoprotectant includes at least one of a polypropylene glycol, glycol, polyethylene glycol, ethylene glycol, dimethyl sulfoxide, polyvinyl pyridine, calcium magnesium acetate, sodium acetate, ethanol, propanol, and sodium formate. 
     
     
         17 . A system for removing heat from subcutaneous lipid rich cells of a subject having skin, comprising:
 a treatment device having a housing and a thermal mass in thermal communication with a heat exchanging surface, the thermal mass being configured to reduce a temperature of a region of the skin such that lipid rich cells in the region are affected while preserving non-lipid rich cells proximate to the heat exchanging surface; and   a hygroscopic cryoprotectant configured to substantially cover an interface between the treatment device and the skin, wherein the cryoprotectant is configured to contact at least one of the treatment device and the skin.   
     
     
         18 . The cooling system of  claim 17  further comprising a coupling device releasably coupled to the treatment device, wherein the coupling device includes a backside portion proximate to the heat exchanging surface, a front side portion spaced apart from the backside portion, and an intermediate portion between the backside portion and the front side portion for holding the cryoprotectant. 
     
     
         19 . The cooling system of  claim 17 , wherein the cryoprotectant further comprises a pH buffer to maintain the pH in the range of about 3 to about 11. 
     
     
         20 . The cooling system of  claim 19  wherein the pH buffer maintains a pH in the range of about 6 to about 7.5. 
     
     
         21 . The cooling system of  claim 17  wherein the cryoprotectant contains polypropylene glycol. 
     
     
         22 . The cooling system of  claim 17  wherein the cryoprotectant is water-soluble. 
     
     
         23 . The cooling system of  claim 17  wherein the cryoprotectant is a hydrogel. 
     
     
         24 . The cooling system of  claim 17  wherein the cryoprotectant further comprises a thickening agent to provide a viscosity of the cryoprotectant in the range of about 1 cP to about 10,000 cP. 
     
     
         25 . The cooling system of  claim 17  wherein the cryoprotectant further comprises a humectant. 
     
     
         26 . The treatment device of  claim 17  wherein the cryoprotectant has a freezing point below about −10° C. 
     
     
         27 . A method of applying to skin of a subject a treatment device having a heat exchanging element, a cryoprotectant applied to a heat exchanging surface in thermal communication with the heat exchanging element, comprising:
 (i) applying the cryoprotectant to an interface between the treatment device and the skin;   (ii) reducing a temperature of the heat exchanging element to a treatment temperature;   (iii) placing the heat exchanging element with respect to the skin at a treatment region; and   (iv) achieving a desired temperature in the region such that lipid rich cells in the region are affected while preserving non-lipid rich cells in the epidermis.   
     
     
         28 . The method of  claim 27  wherein applying the cryoprotectant includes applying the cryoprotectant to the heat exchanging surface, and wherein the method further includes preventing ice formation on the heat exchanging surface when reducing the temperature of the heat exchanging element to the treatment temperature. 
     
     
         29 . The method of  claim 27  wherein applying the cryoprotectant includes applying the cryoprotectant to the skin, and the method further includes reducing a freezing point of the skin of the subject. 
     
     
         30 . The method of  claim 29  further comprising continually supplying the cryoprotectant to the skin of the subject and maintaining a sufficient concentration of the cryoprotectant in the skin of the subject. 
     
     
         31 . The method of  claim 29  wherein applying the cryoprotectant includes applying the cryoprotectant using a coupling device having a backside portion proximate to the heat exchanging surface, a front side portion spaced apart from the backside portion, and an intermediate portion between the backside portion and the front side portion for holding the cryoprotectant. 
     
     
         32 . The method of  claim 31 , further comprising maintaining a constant cryoprotectant pressure in the intermediate portion. 
     
     
         33 . The method of  claim 31 , further comprising pre-charging the intermediate portion with the cryoprotectant before treatment. 
     
     
         34 . The method of  claim 27  wherein applying the cryoprotectant includes applying a cryoprotectant including at least one of a polypropylene glycol, glycol, polyethylene glycol, ethylene glycol, dimethyl sulfoxide, polyvinyl pyridine, calcium magnesium acetate, sodium acetate, ethanol, propanol, methanol and sodium formate. 
     
     
         35 . A kit for removing heat from subcutaneous lipid rich cells of a subject having skin, comprising:
 a treatment device having a heat exchanging element with a heat exchanging surface, the heat exchanging element being configured to reduce a temperature of a target region such that lipid rich cells in the region are affected while preserving non-lipid rich cells proximate to the heat exchanging surface; and   a cryoprotectant with a freezing point in the range of about −40° C. to about 0° C. and configured to be applied to an interface between the heat exchanging surface and the target region;   instruction documentation containing information regarding how to (i) apply the cryoprotectant to the target region and/or the heat exchanging surface of the treatment device and (ii) reduce a temperature of the target region such that lipid rich cells in the region are affected while preserving non-lipid rich cells proximate to the heat exchanging surface.   
     
     
         36 . The kit of  claim 35  wherein the cryoprotectant contains at least one of polypropylene glycol, polyethylene glycol, propylene glycol, ethylene glycol, glycerin, ethanol, propanol, iso-propanol, and butanol. 
     
     
         37 . The kit of  claim 35  further comprising a coupling device configured to contain the cryoprotectant, the coupling device being releasably couplable to the treatment device. 
     
     
         38 . The kit of  claim 37  wherein the coupling device includes a backside portion, a front side portion spaced apart from the backside portion, and an intermediate portion between the backside portion and the front side portion for holding the cryoprotectant. 
     
     
         39 . The kit of  claim 37  wherein the front side portion includes at least one aperture in fluid communication with the intermediate portion. 
     
     
         40 . The cooling system of  claim 35  further comprising an absorbent pre-loaded with the cryoprotectant.