# US 12,109,330 B2 · Shapeable scaffold material and uses thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,109,330 B2 - Document ID: US12109330B2 - Status: Granted - Kind: B2 - Application number: 17/570,549 - Filed: 2022-01-07 - Published: 2022-10-06 - Granted: 2024-10-08 - Earliest claimed: 2015-08-20 - Assignees: Ecole Polytechnique Federale De Lausanne (Epfl) - Applicants: Ecole Polytechnique Federale de Lausanne (EPFL) - Inventors: Amelie Barbara Hildegarde Beduer; Thomas Braschler; Philippe Renaud; Giorgio Pietramaggiori; Saja Scherer - Web page: https://patentgrep.com/patent/US12109330B2 ## CPC - A61L 27/56: Porous materials, {e.g. foams or sponges} - A61L 27/227: {Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24} - A61L 27/3616: {Blood, e.g. platelet-rich plasma} - A61L 27/38: {containing added animal cells (organs or tissue containing native cells A61L27/36)} - A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials} - A61L 27/52: Hydrogels or hydrocolloids - A61L 27/505: {Stabilizers} - 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) ## Abstract The invention relates to a scaffold material comprising a plurality of particles of a highly porous polymeric material, characterized in that said scaffold material becomes a shapeable paste once hydrated. The specific features of the particle material impart a special behavior to the scaffold, which can be easily shaped and even highly reversibly compressed, so that in certain aspects it can, if needed, be injected, said capacity to be shaped being maintained over a high range of hydration conditions. A particular aspect of the invention relates, therefore, to the use of such scaffold material for the manufacturing of shapeable body implants, such as breast implants, to the shapeable body implants themselves as well as to non-invasive methods for using thereof in creating or reconstructing a three-dimensional volume in a subject's body part. ## Claims ### Claim 1 A scaffold material for use in manufacturing shapeable three-dimensional body implants, wherein: the scaffold material consists essentially of a plurality of elastically compressible particles; the particles have a plurality of interconnected pores in their core and on their surface that are connected to an environment external to the particles; non-pore space of the particles is wall material; the wall material comprises a macromolecular polymer gel constructed of a network of hydrogel forming materials; the pores have a mean pore diameter between 1 μm and 2 mm; the particles have a ratio of mean pore diameter to wall material thickness of at least 3; and the scaffold material is a shapeable paste, or becomes a shapeable paste when contacted with a liquid, wherein the shapeable paste has a reversible compressibility volume ratio between a hydrated state and a dehydrated state of between 1.2 and 50. ### Claim 2 (depends on 1) The scaffold material of claim 1, wherein the scaffold material is configured to create or reconstruct a three-dimensional volume in a subject's body part. ### Claim 3 (depends on 1) The scaffold material of claim 1, wherein the particles are hydrated to a w/w ratio between the liquid and the particles of between 1000 and 1. ### Claim 4 (depends on 1) The scaffold material of claim 1, wherein the shapeable paste is flowable and injectable. ### Claim 5 (depends on 1) The scaffold material of claim 1, wherein the scaffold material further comprises a bioactive molecule. ### Claim 6 (depends on 5) The scaffold material of claim 5, wherein the bioactive molecule is coated on or embedded in the particles. ### Claim 7 (depends on 5) The scaffold material of claim 5, wherein the bioactive molecule is a protein, a peptide, a polypeptide, a polysaccharide, a lipid molecule, or a nucleic acid, or a combination thereof. ### Claim 8 (depends on 1) The scaffold material of claim 1, wherein the scaffold material further comprises cells or tissue suspensions. ### Claim 9 (depends on 1) The scaffold material of claim 1, wherein the hydrogel forming materials comprise polysaccharides, polypeptides, or a copolymer thereof, or a mixture thereof. ### Claim 10 (depends on 9) The scaffold material of claim 9, wherein the hydrogel forming materials comprise a polysaccharide selected from the group consisting of cellulose, modified cellulose, agarose, alginate, starch, modified starch, chitosan, hyaluronic acid, chondroitinsulfate, dermatansulfate, heparansulfate, heparinsulfate, and keratansulfate, or a copolymer thereof, or a mixture thereof. ### Claim 11 (depends on 9) The scaffold material of claim 9, wherein the hydrogel forming materials comprise a polypeptide selected from the group consisting of silk, collagen, and gelatin, or a copolymer thereof, or a mixture thereof. ### Claim 12 (depends on 1) The scaffold material of claim 1, wherein the hydrogel forming materials comprises glycosaminoglycan, proteoglycan, or a copolymer thereof, or a mixture thereof. ### Claim 13 (depends on 1) The scaffold material of claim 1, wherein the scaffold material is sterile. ### Claim 14 (depends on 1) The scaffold material of claim 1, wherein upon hydration the particles display a non-linear compression behavior with a plateau region localized in compression ranges between 5% and 95% of a fully hydrated state. ### Claim 15 (depends on 1) A shapeable paste comprising the scaffold material of claim 1 and a liquid. ### Claim 16 (depends on 15) The shapeable paste of claim 15, wherein the shapeable paste further comprises a bioactive molecule. ### Claim 17 (depends on 16) The shapeable paste of claim 16, wherein the bioactive molecule is a protein, a peptide, a polypeptide, a polysaccharide, a lipid molecule, or a nucleic acid, or a combination thereof. ### Claim 18 (depends on 1) An injectable material comprising the scaffold material of claim 1 and a liquid containing material, optionally wherein the liquid containing material is an aqueous solution or a water-containing biological material. ### Claim 19 (depends on 18) The injectable material of claim 18, wherein the liquid containing material is a tissue extract or a cell suspension. ### Claim 20 (depends on 1) A shapeable tissue or organ body implant consisting essentially of a hydrated form of the scaffold material of claim 1. ### Claim 21 (depends on 20) The shapeable tissue or organ body implant of claim 20, wherein the scaffold material is at least partially hydrated through liquid absorption from a target tissue or organ upon insertion therein, or is at least partially hydrated through ex vivo liquid absorption from a liquid solution or a water-containing biological material mixed therewith. ### Claim 22 (depends on 1) A medical delivery device comprising at least one container filled with the scaffold material of claim 1.