US 12,453,805 B2
Cryoprotective compositions, surgical kits, and methods for protection of a surgical site during cryosurgery
Franz Schmidlin, Geneva (CH); John Bischof, St. Paul, MN (US); Paul A. Iaizzo, White Bear Lake, MN (US); Qi Shao, Plymouth, MN (US); Pegah Ranjbartehrani, Falcon Heights, MN (US); David A. Ramirez, St. Paul, MN (US); and Alexandre Porcello, Belmont-sur Yverdon (CH)
Assigned to Everest Medical Innovation GmbH, Zug (CH); and Regents of the University of Minnesota, Minneapolis, MN (US)
Filed by Everest Medical Innovation GmbH, Baar (CH); and Regents of the University of Minnesota, Minneapolis, MN (US)
Filed on Mar. 22, 2022, as Appl. No. 17/700,950.
Application 17/700,950 is a continuation in part of application No. 17/482,898, filed on Sep. 23, 2021.
Claims priority of provisional application 63/082,790, filed on Sep. 24, 2020.
Prior Publication US 2022/0211923 A1, Jul. 7, 2022
Int. Cl. A61B 18/02 (2006.01); A61L 31/02 (2006.01); A61L 31/04 (2006.01); A61L 31/16 (2006.01); A61M 5/32 (2006.01); A61B 18/00 (2006.01)
CPC A61L 31/16 (2013.01) [A61B 18/02 (2013.01); A61L 31/028 (2013.01); A61L 31/042 (2013.01); A61M 5/3294 (2013.01); A61B 2018/00101 (2013.01); A61B 2018/00547 (2013.01); A61L 2300/216 (2013.01); A61L 2300/232 (2013.01); A61L 2400/06 (2013.01)] 29 Claims
 
1. A surgical kit for providing a cryoprotective composition configured to be applied during cryotreatment of a patient, the kit comprising:
at least one first container containing a predetermined amount or volume of at least one biodegradable and/or bioerodible fluid agent comprising a gel and a saline buffer solution; and
at least one second container containing a predetermined amount or volume of at least one non-toxic cryoprotectant agent, the at least one non-toxic cryoprotectant agent comprising a sugar cryoprotectant agent and Dimethyl sulfoxide (DMSO),
wherein the predetermined amount or volume of the of at least one biodegradable and/or bioerodible fluid agent and the predetermined amount or volume of at least one non-toxic cryoprotectant agent are configured to be mixed together to form the cryoprotective composition in which a therapeutically effective amount of the cryoprotective composition deposited in a body space of the patient in proximity to the cryotreatment remains within at least a portion of the body space for a duration of the cryotreatment, does not cause substantial nerve damage when positioned in the body space for the duration of the cryotreatment, and at least a portion of a body tissue proximate to the body space is viable after the cryotreatment, and
wherein, when mixed together, the gel comprises from about 1 weight percent to about 10 weight percent of the cryoprotective composition, the sugar cryoprotectant agent comprises from about 5 weight percent to about 10 weight percent of the cryoprotective composition, and the DMSO comprises from about 1 weight percent to about 5 weight percent of the cryoprotective composition.