# US 11,441,994 B2 · Method and system for in-silico design of skin electroporation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,441,994 B2 - Document ID: US11441994B2 - Status: Granted - Kind: B2 - Application number: 16/046,239 - Filed: 2018-07-26 - Published: 2019-01-31 - Granted: 2022-09-13 - Earliest claimed: 2017-07-27 - Assignees: Tata Consultancy Services Limited - Applicants: Tata Consultancy Services Limited - Inventors: Rakesh Gupta; Beena Rai - Web page: https://patentgrep.com/patent/US11441994B2 ## CPC - G01N 15/0806: {Details, e.g. sample holders, mounting samples for testing} - A61N 1/327: {for enhancing the absorption properties of tissue, e.g. by electroporation} - G01N 15/088: {Investigating volume, surface area, size or distribution of pores; Porosimetry} - G16H 50/50: for simulation or modelling of medical disorders - A61N 1/0412: {Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs} - G01N 2015/0833: {Pore surface area} - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - 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) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## Abstract A system and method for testing of skin electroporation using simulations of human skin has been described. The system is using a simulation protocol to provide an in-silico design of skin's upper layer stratum-corneum (SC) at molecular level. This model is then further used to design the skin electroporation strategy. An external electric field was applied across the lipid bilayer to form a pore in the lipid bilayer. The pore size and pore growth rate was calculated depending on the applied external electric field. The generated pore was then stabilized by varying the external electric field. Further, on removing the external electric field, the reformation of lipid bilayer and self-healing of human skin was also achieved. In another embodiment, the system is also configured to perform the virtual testing of a drug permeation through skin in presence of external electric field. ## Claims ### Claim 1 A method for testing of skin electroporation using simulations of human skin, the method comprises a processor implemented steps of: providing a molecular model of stratum corneum layer of the human skin, wherein the stratum corneum layer comprises a lipid bilayer; setting a plurality of parameters for creating an equilibrium environment for the simulations; applying an external electric field across the lipid bilayer, wherein the application of the external electric field results in the generation of a pore inside the lipid bilayer; measuring a radius of the pore across the lipid bilayer based on the applied external electric field; stabilizing the radius of the pore by varying the applied external electric field; and removing the external electric field, wherein the removal of external electric field results in the reformation of the lipid bilayer and self-healing of the human skin. ### Claim 2 (depends on 1) The method of claim 1, further comprising the step of testing of a drug permeation through the pore in the presence of the external electric field. ### Claim 3 (depends on 1) The method of claim 1 further comprising the step of measuring a pore growth rate based on the applied external electric field, wherein the pore growth rate represents change in the radius of the pore in a predefined time interval. ### Claim 4 (depends on 1) The method of claim 1, wherein the radius of the pore is calculated using geometric mean of the radius of pore in the x-direction and the y-direction. ### Claim 5 (depends on 1) The method of claim 1, wherein the plurality of parameters comprises one or more of a skin temperature, pressure, force field parameters of skin lipid interaction, applied electric field or temperature coupling. ### Claim 6 (depends on 1) The method of claim 1, wherein the external electric field is applied across the bilayer of the human skin. ### Claim 7 (depends on 1) The method of claim 1, wherein the molecular model of stratum corneum layer of the skin membrane is made up of Ceramide, cholesterol and free fatty acids. ### Claim 8 (depends on 1) The method of claim 1 wherein the pore formation starts after the external electric field crosses a threshold electric field value, wherein the threshold electric field value is depending on the composition of the human skin. ### Claim 9 (depends on 1) The method of claim 1, wherein the external electric field is between 30 volts to 1500 volts. ### Claim 10 (depends on 1) The method of claim 1 further comprising the step of measuring a poration time based on the applied external electric field, wherein the poration time represents the time required for the formation of pore for the applied external electric field. ### Claim 11 (depends on 1) The method of claim 1 further comprises the step of determining an optimum value of the applied external electric field and the poration time to ensure safety of the human skin. ### Claim 12 A system for testing of skin electroporation using simulations of human skin, the system comprises: a first input module for providing a molecular model of stratum corneum layer of the human skin, wherein the stratum corneum layer comprises a lipid bilayer; a second input module for setting a plurality of parameters for creating an equilibrium environment for the simulations; a memory; and a processor in communication with the memory, the processor further configured to perform the steps of: applying an external electric field across the lipid bilayer, wherein the application of the external electric field results in the generation of a pore inside the lipid bilayer; measuring a radius of the pore along across the lipid bilayer based on the applied external electric field; stabilizing the radius of the pore by varying the applied external electric field; and removing the external electric field, wherein the removal of external electric field results in the reformation of the lipid bilayer and self-healing of the human skin. ### Claim 13 One or more non-transitory computer readable information medium having embodied thereon a computer program for executing a method for testing of skin electroporation using simulations of human skin, the method comprising: providing a molecular model of stratum corneum layer of the human skin, wherein the stratum corneum layer comprises a lipid bilayer; setting a plurality of parameters for creating an equilibrium environment for the simulations; applying an external electric field across the lipid bilayer, wherein the application of the external electric field results in the generation of a pore inside the lipid bilayer; measuring a radius of the pore across the lipid bilayer based on the applied external electric field; stabilizing the radius of the pore by varying the applied external electric field; and removing the external electric field, wherein the removal of external electric field results in the reformation of the lipid bilayer and self-healing of the human skin.