# US 11,898,138 B2 · Tissue processing apparatus and method for processing adipose tissue > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,898,138 B2 - Document ID: US11898138B2 - Status: Granted - Kind: B2 - Application number: 18/077,947 - Filed: 2022-12-08 - Published: 2023-04-13 - Granted: 2024-02-13 - Earliest claimed: 2013-09-05 - Assignees: The GID Group, Inc. - Applicants: GID Bio, Inc. - Inventors: William W. Cimino; Ramon Llull; Adam J. Katz - Web page: https://patentgrep.com/patent/US11898138B2 ## CPC - C12M 47/04: {Cell isolation or sorting (purging biological preparations of unwanted cells C12N5/0081, determining the presence or kind of microorganism C12Q1/04)} - A61K 35/32: Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane - A61L 27/00: Materials for {grafts or} prostheses or for coating {grafts or} prostheses (dental prostheses A61C13/00; shape or structure of prostheses A61F2/00; use of preparations for artificial teeth A61K6/80; artificial kidneys A61M1/14) - C12M 45/02: {by mechanical forces; Stirring; Trituration; Comminuting (crushing, pulverizing, disintegrating in general B02C)} - C12M 45/05: {by centrifugation (centrifuges in general B04B)} - C12N 5/0653: {Adipocytes; Adipose tissue} - A61M 1/88: {Draining devices having means for processing the drained fluid, e.g. an absorber (for liposuction A61M1/892)} - A61M 1/892: {with treatment of the collected fat} - A61M 2202/08: Lipoids - C12M: APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; {APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract Harvested adipose tissue is processed in a single-use portable processing container to prepare a centrifuges pellet phase of stromal vascular fraction concentrate, which is selectively removed and disposed in a syringe dispersed in a dispersion medium to prepare an osteoarthritis treatment product. ## Claims ### Claim 1 A method for preparing a product for treatment of osteoarthritis in a human patient with uncultured stromal vascular fraction cells derived from harvested adipose tissue from the patient, the method comprising: washing a volume of harvested adipose tissue from the patient within a single-use, portable processing container to remove blood components from the harvested adipose tissue and prepare washed adipose tissue; after the washing, enzymatically digesting the washed adipose tissue within the processing container, the enzymatically digesting comprising combining the washed adipose tissue and an enzyme-containing digestion medium in a mixture and agitating the mixture for a digestion retention time to release stromal vascular fraction cells from the washed adipose tissue; after the enzymatically digesting, centrifuging the processing container to form in the processing container a density-separated pellet phase of stromal vascular fraction cell concentrate comprising stromal vascular fraction cells released from the washed adipose tissue during the enzymatically digesting; after the centrifuging, selectively removing at least a portion of the stromal vascular fraction cell concentrate from the processing container; and disposing in a syringe an osteoarthritis treatment formulation comprising a quantity of the stromal vascular fraction cell concentrate removed from the processing container dispersed in a liquid dispersion medium, wherein the syringe is configured to administer by injection the osteoarthritis treatment formulation to the patient in one or more injections for treatment of the osteoarthritis at one or more joints of the patient; and the osteoarthritis treatment formulation in the syringe comprises a volume of from 0.25 milliliter to 1.5 milliliters of the stromal vascular fraction cell concentrate. ### Claim 2 (depends on 1) The method of claim 1, wherein the volume of the harvested adipose tissue is at least 10 cubic centimeters. ### Claim 3 (depends on 2) The method of claim 2, wherein the volume of the harvested adipose tissue is not larger than 250 cubic centimeters. ### Claim 4 (depends on 3) The method of claim 3, wherein the volume of the harvested adipose tissue is at least 25 cubic centimeters. ### Claim 5 (depends on 1) The method of claim 1, wherein the centrifuging comprises centrifuging the processing container until the pellet phase of the stromal vascular fraction cell concentrate has a volume in a range of from 0.2 percent to 2 percent of the volume of the harvested adipose tissue. ### Claim 6 (depends on 1) The method of claim 1, wherein: the volume of the harvested adipose tissue is in a range of from 20 cubic centimeters to 175 cubic centimeters; and the centrifuging comprises centrifuging the processing container until the pellet phase of the stromal vascular fraction cell concentrate has a volume in a range of from 0.2 percent to 2 percent of the volume of the harvested adipose tissue. ### Claim 7 (depends on 6) The method of claim 6, wherein the digestion retention time is in a range of from 20 minutes to 50 minutes. ### Claim 8 (depends on 1) The method of claim 1, wherein the agitating comprises mixing contents of the processing container during the digestion retention time. ### Claim 9 (depends on 8) The method of claim 8, wherein the mixing comprises rotation of a mixer in the processing container during the enzymatically digesting. ### Claim 10 (depends on 1) The method of claim 1, wherein the agitating comprises continuous agitation for a duration of the digestion retention time. ### Claim 11 (depends on 1) The method of claim 1, wherein the centrifuging comprises preparing multiple density-separated phases in the processing container, the multiple density-separated phases including lower-density material phases, having a lower density than the pellet phase, comprising an aqueous layer, a disaggregated adipose layer and an oil layer. ### Claim 12 (depends on 11) The method of claim 11, wherein the selectively removing comprises removing at least the volume of the stromal vascular fraction cell concentrate from the processing container without first removing the lower-density material phases. ### Claim 13 (depends on 1) The method of claim 1, wherein the selectively removing comprises aspirating at least the volume of the stromal vascular fraction cell concentrate directly from the pellet phase into a fluid receptacle located outside of the processing container. ### Claim 14 (depends on 13) The method of claim 13, wherein the selectively removing comprises: inserting an aspiration tube from outside to inside of the processing container downwardly inside the processing container into the pellet phase. ### Claim 15 (depends on 14) The method of claim 14, wherein: the processing container comprises a pellet well in which the pellet phase forms during the centrifuging and from which at least the volume of the stromal vascular fraction cell concentrate is removed during the aspirating; during the aspirating the aspiration tube extends through a vertical portion of the pellet well, with the vertical portion of the pellet well having a vertical length of at least 0.5 centimeter, a maximum horizontal cross-dimension of no larger than 10 millimeters and a minimum horizontal cross-dimension of no smaller than 1.5 millimeters; and at commencement of the aspirating at least a portion of the pellet phase is disposed in the vertical portion of the pellet well. ### Claim 16 (depends on 13) The method of claim 13, wherein prior to the aspirating the fluid receptacle contains a pre-loaded quantity of the dispersion medium, wherein a volume ratio of the pre-loaded quantity of the dispersion medium to a quantity of the stromal vascular fraction cell concentrate introduced into the fluid receptacle during the aspirating is in a range of from 1:1 to 10:1. ### Claim 17 (depends on 1) The method of claim 1, wherein the washing comprises at least two wash cycles, wherein each said wash cycle comprises: adding a volume of wash liquid to the processing container to contact adipose tissue within the processing container; mixing the wash liquid and the adipose tissue within the processing container; and removing at least a majority of the wash liquid from the processing container; and wherein a volume ratio of the wash liquid to the harvested adipose tissue is at least 1:1. ### Claim 18 (depends on 17) The method of claim 17, wherein the enzymatically digesting comprises adding a volume of the digestion medium to the processing container, wherein a volume ratio of the digestion medium to the washed adipose tissue in the processing container is at least 1:1. ### Claim 19 (depends on 18) The method of claim 18 wherein the digestion medium contains collagenase enzyme in an amount to provide at least 150 collagen digestion units (CDU) per milliliter of catalytic volume, wherein the catalytic volume is a total volume of the digestion medium and the washed adipose tissue in the processing container. ### Claim 20 (depends on 19) The method of claim 19, wherein the amount of the collagenase enzyme provides not more than 300 collagen digestion units (CDU) per milliliter of the catalytic volume. ### Claim 21 (depends on 18) The method of claim 18, wherein during the digestion retention time the processing container is disposed in a temperature-controlled environment maintained at a temperature of at least 32° C. ### Claim 22 (depends on 21) The method of claim 21, wherein during the digestion retention time the processing container is disposed in the temperature-controlled environment maintained at a temperature of up to 38° C. ### Claim 23 (depends on 1) The method of claim 1, wherein the processing container comprises: an internal containment volume including a tissue retention volume and a filtrate volume; a filter disposed within an internal containment volume with the tissue retention volume on one side of the filter and the filtrate volume on another side of the filter, with the tissue retention volume and the filtrate volume being in fluid communication through the filter; and a rotatable mixer disposed in the tissue retention volume; and wherein: at commencement of the washing the harvested adipose tissue is disposed in the tissue retention volume and following the washing and at commencement of the enzymatically digesting, the washed adipose tissue is disposed in the tissue retention volume; and each said wash cycle comprises rotating the rotatable mixer in the tissue retention volume to mix adipose tissue and wash liquid in the tissue retention volume. ### Claim 24 (depends on 23) The method of claim 23, wherein the internal containment volume comprises an available processing volume with from 40 percent to 60 percent of an available processing volume in the tissue retention volume and from 60 percent to 40 percent of the available processing volume in the filtrate volume. ### Claim 25 (depends on 23) The method of claim 23, wherein the selectively removing comprises aspirating at least the volume of the stromal vascular fraction cell concentrate directly from the pellet phase into a fluid receptacle located outside of the processing container. ### Claim 26 (depends on 25) The method of claim 25, wherein the selectively removing comprises: inserting an aspiration tube from outside to inside of the processing container downwardly inside the processing container into the pellet phase. ### Claim 27 (depends on 26) The method of claim 26, wherein: the processing container comprises a pellet well in which the pellet phase forms during the centrifuging and from which at least the volume of the stromal vascular fraction cell concentrate is removed during the aspirating; during the aspirating the aspiration tube extends through a vertical portion of the pellet well, with the vertical portion of the pellet well having a vertical length of at least 0.5 centimeter, a maximum horizontal cross-dimension of no larger than 10 millimeters and a minimum horizontal cross-dimension of no smaller than 1.5 millimeters; and at commencement of the aspirating at least a portion of the pellet phase is disposed in the vertical portion of the pellet well. ### Claim 28 (depends on 27) The method of claim 27, wherein prior to the aspirating the fluid receptacle contains a pre-loaded quantity of the dispersion medium, wherein a volume ratio of the pre-loaded quantity of the dispersion medium to a quantity of the stromal vascular fraction cell concentrate introduced into the fluid receptacle during the aspirating is in a range of from 1:1 to 10:1. ### Claim 29 (depends on 1) The method of claim 1, wherein the osteoarthritis treatment formulation comprises a volume ratio of a volume of the dispersion medium to the volume of the stromal vascular fraction cell concentrate in a range of from 1:1 to 10:1. ### Claim 30 (depends on 29) The method of claim 29, wherein the osteoarthritis treatment formulation comprises a total volume in a range of from 0.5 milliliter to 5 milliliters. ### Claim 31 (depends on 30) The method of claim 30, wherein the total volume is in an amount for a single injection treatment of osteoarthritis at a joint of the patient.