Particle suitable for the manufacture of an implantable soft tissue engineering material
The particle ( 1 ) is suitable for the manufacture of an implantable soft tissue engineering material and comprises a three-dimensionally warped and branched sheet ( 2 ) where: (i) the three-dimensionally warped and branched sheet ( 2 ) is made from a biocompatible material having a Young's modulus of 1 kPa to 1 GPa; (ii) the three-dimensionally warped and branched sheet ( 2 ) has an irregular shape which is encompassed in a virtual three-dimensional envelope ( 3 ) having a volume VE; (iii) the three-dimensionally warped and branched sheet ( 2 ) has a mean sheet thickness T; (iv) the three-dimensionally warped and branched sheet ( 2 ) has a volume VS; (v) the particle ( 1 ) has a Young's modulus of 100 Pa to 15 kPa; and (vi) the particle ( 1 ) further comprises a number of protrusions ( 4 ) where the three-dimensionally warped and branched sheet ( 2 ) reaches the envelope ( 3 ); (vii) the particle ( 1 ) has a number of interconnected channel-type conduits ( 5 ) defined by the branching of the sheet ( 2 ) and/or by voids in the sheet ( 2 ); and (viii) where the conduits ( 5 ) have (a) a mean diameter DC; and (b) an anisotropicity index of 1.01 to 5.00.
1 . Implantable soft tissue engineering material comprising:
(i) multitude of particles, and
(ii) a physiologically acceptable fluid, wherein the implantable soft tissue engineering material is in the form of a malleable paste,
wherein particles in the multitude of particles are formed from a three-dimensionally warped and branched sheet that has a mean sheet thickness (T), wherein the sheet comprises a biocompatible material,
wherein the particles in the multitude of particles have irregular shapes and comprise a number of protrusions, wherein the particles in the multitude of particles have a number of interconnected channel-type conduits;
wherein the conduits have a mean diameter (DC); and
wherein the ratio of DC/T is larger than 1.
2 . The implantable soft tissue engineering material according to claim 1 , further comprising one or more of the following substances:
living aspirates, lipoaspirate, pharmaceutically active agents, lidocaine, adrenaline, cell suspensions, biological tissues, stem cells, virus, bacteria, fungi, transfecting agents, antibodies, genetically modified cells, extracellular matrices, co-cultures of cells, growth factors, platelet rich plasma, cell differentiation factors, lipids, and high density lipoprotein (HDL).
3 . The implantable soft tissue engineering material according to claim 1 , characterized in that the multitude of particles is admixed with adipose tissue, engineered tissue, autologous tissues, heterologous tissues, and/or xenologous tissues.
4 . The implantable soft tissue engineering material according to claim 1 , characterized in that it is reversibly compressible after injection into a patient by uptaking liquid from its surrounding tissues.
5 . The implantable soft tissue engineering material according to claim 1 , characterized in that it exhibits a Young's modulus between 100 Pa and 15 kPa.
6 . The implantable soft tissue engineering material according to claim 1 , wherein the implantable soft tissue engineering material has a deployment pressure of at least 100 Pa.
7 . The implantable soft tissue engineering material according to claim 1 , wherein the biocompatible material of the sheet is selected from the group consisting of poly-ethyleneglycol (PEG), poly-acrylamide, poly-(hydroxyethyl)methacrylate, gelatin, and polysaccharides.
8 . The implantable soft tissue engineering material according to claim 1 , wherein the biocompatible material of the sheet is a polysaccharide selected from the group consisting of hyaluronic acid, alginate, agarose, chitosan, cellulose, methylcellulose, carboxymethylcellulose, agarose, polysucrose, and dextran.
9 . The implantable soft tissue engineering material according to claim 1 , wherein the biocompatible material of the sheet is a material selected from the group consisting of carbohydrates, collagens, peptides, and extracellular matrices.
10 . The implantable soft tissue engineering material according to claim 1 , wherein the biocompatible material of the sheet is a hydrogel.
11 . The implantable soft tissue engineering material according to claim 1 , wherein the implantable soft tissue engineering material deploys up to a predefinable and controllable volume via the control of its hydration level.
12 . The implantable soft tissue engineering material of claim 1 , wherein the multitude of particles comprise between 0.05 weight % and 15 weight % of the implantable soft tissue engineering material.
13 . The implantable soft tissue engineering material of claim 1 , wherein the multitude of particles comprise a composite of collagen and a polysaccharide, optionally wherein the collagen is covalently attached to the polysaccharide.
14 . A shapeable tissue or organ body implant comprising the implantable soft tissue engineering material of claim 1 .
15 . The shapeable tissue or organ body implant of claim 14 in a form suitable for breast tissue reconstruction.
16 . The shapeable tissue or organ body implant of claim 14 in a form suitable for treating tissue defects.
17 . The shapeable tissue or organ body implant of claim 14 in a form suitable for lipofilling.
18 . The shapeable tissue or organ body implant of claim 14 in a form suitable for aesthetic restoration in a patient's face or part of a patient's body, optionally wherein the part of the body is the breast.
19 . A method of implanting the implantable soft tissue engineering material of claim 1 in a patient, comprising (i) placing the material in contact with a biological material to form a mixture, and (ii) subsequently injecting the mixture in a target area in a patient.
20 . The method of claim 19 , wherein the biological material is adipose tissue, and wherein the method further comprises prior to step (ii), (iii) mixing the material with the adipose tissue using two syringes and a connector.
21 . The method of claim 20 , wherein the adipose tissue is harvested from the patient.
22 . The method of claim 19 , wherein following step (ii), (iii) the implant is manually shaped from outside the patient to create a desired shape.
23 . The implantable soft tissue engineering material according to claim 1 , having a non-zero yield stress and strain.
24 . The implantable soft tissue engineering material according to claim 1 , wherein the physiologically acceptable fluid is selected from the group consisting of physiological saline, phosphate buffered saline, blood plasma, water, aqueous solution, blood, serum, or a combination thereof.
25 . The implantable soft tissue engineering material according to claim 1 , wherein the conduits have a mean diameter (DC) between 20 μm and 600 μm.
26 . The implantable soft tissue engineering material according to claim 1 , wherein the ratio of DC/T is greater than 1 and less than 30.