HYDROGEL MICROPARTICLE-BASED LUBRICANT
Methods for viscosupplementation in a joint or surgical site of a human or animal subject are disclosed along with unique materials for achieving such beneficial outcomes. The methods generally comprise introducing into the joint or surgical site a plurality of porous viscoelastic solid hydrogel microparticles having a size of greater than about 30 pm, and substantially free of any cells, tissue, or therapeutic compounds. Kits for viscosupplementation in a joint or surgical site of a human or animal subject are also disclosed. The kits comprise the plurality of porous viscoelastic solid hydrogel microparticles having a size of greater than about 30 pm, and substantially free of any cells, tissue, or therapeutic compounds, and instructions for administering the same.
1 . A method for viscosupplementation in a joint or surgical site of a human or animal subject, said method comprising: introducing into the joint or surgical site a plurality of porous viscoelastic solid hydrogel microparticles having a size of greater than about 30 μm, and substantially free of any cells, tissue, or therapeutic compounds.
2 . The method of claim 1 , wherein said hydrogel microparticles are injected at or near the joint or surgical site.
3 . The method of any one of the foregoing claims, wherein said hydrogel microparticles are characterized as self-sustaining bodies having a 3-dimensional matrix of covalently or ionically crosslinked polymer compounds.
4 . The method of any one of the foregoing claims, wherein said plurality of porous viscoelastic solid hydrogel microparticles comprise at least two different populations of microparticles, wherein a first population of microparticles comprises a plurality of microparticles having a first characteristic, and a second population of microparticles comprises a plurality of microparticles having a second characteristic, wherein said first characteristic is different from said second characteristic.
5 . The method of any one of the foregoing claims, wherein said hydrogel microparticles provide cushioning and/or reduce friction between tissues at or near the joint or surgical site.
6 . The method of any one of the foregoing claims, wherein said hydrogel microparticles induce a favorable physiological response in the subject at the site of implantation.
7 . The method of any one of the foregoing claims, wherein said hydrogel microparticles do not induce inflammation.
8 . The method of any one of the foregoing claims, wherein said hydrogel microparticles increase amount or quality of cartilage produced in a joint at the site of implantation.
9 . The method of any one of the foregoing claims, wherein said hydrogel microparticles provide a resilient response to load-bearing for cushion and reduce friction within a joint at the site of implantation.
10 . The method of any one of the foregoing claims, wherein said hydrogel microparticles are introduced into a joint of the knees, hips, ankles, wrists, elbows, shoulders, toes, fingers, or spine.
11 . The method of any one of the foregoing claims, wherein said hydrogel microparticles are injected into an intraarticular space of a joint.
12 . The method of any one of the foregoing claims, wherein said hydrogel microparticles are introduced into a synovial capsule portion of said joint.
13 . The method of any one of the foregoing claims, wherein said hydrogel microparticles are introduced in and/or around a site of implantation of a surgical device in said subject.
14 . The method of claim 13 , wherein said surgical device is surgical mesh.
15 . The method of any one of the foregoing claims, wherein said hydrogel microparticles are introduced subdermally as a dermal filler.
16 . The method of any one of the foregoing claims, wherein said hydrogel microparticles are introduced between organs of said subject.
17 . The method of any one of the foregoing claims, wherein said hydrogel microparticles are suspended or dispersed in a suitable delivery vehicle.
18 . The method of claim 16 , wherein said delivery vehicle is a buffered saline solution, viscous solution, putty, paste, or gel.
19 . The method of any one of the foregoing claims, wherein said hydrogel microparticles are directly injected into the site of implantation.
20 . The method of any one of the foregoing claims, wherein said hydrogel microparticles are provided in a composition in a pre-loaded syringe for injecting into the joint or surgical site.
21 . The method of any one of the foregoing claims, wherein said hydrogel microparticles are confined to said site of implantation for a therapeutically effective period of time.
22 . The method of any one of the foregoing claims, wherein said hydrogel microparticles remain at said site of implantation without degradation under normal physiological conditions for at least 3 months.
23 . The method of any one of the foregoing claims, wherein said hydrogel microparticles remain at said site of implantation without degradation under normal physiological conditions for at least 6 months.
24 . The method of any one of the foregoing claims, wherein said human or animal subject received recurring dosages of said hydrogel microparticles administered at an interval of every 3 months, preferably every 3-6 months, preferably every 6-12 months.
25 . A kit for viscosupplementation in a joint or surgical site of a human or animal subject, comprising a plurality of porous viscoelastic solid hydrogel microparticles having a size of greater than about 30 μm, and substantially free of any cells, tissue, or therapeutic compounds, and instructions for administering the same.
26 . The kit of claim 25 , wherein said plurality of porous viscoelastic solid hydrogel microparticles are lyophilized, said kit further comprising a biologically compatible vehicle in a separate container for reconstituting said hydrogel microparticles or instructions for reconstituting said hydrogel microparticles prior to administration.
27 . The kit of claim 26 , further comprising an empty syringe and instructions for loading said syringe with said hydrogel microparticles after reconstitution.
28 . The kit of claim 25 , wherein said plurality of porous viscoelastic solid hydrogel microparticles are packaged in solution, wherein said solution is pre-loaded into a syringe for administration and instructions for the same.
29 . The kit of claim 25 , wherein said plurality of porous viscoelastic solid hydrogel microparticles are packaged in solution wherein said kit comprises an empty syringe and said hydrogel microparticles in a separate container configured to permit withdrawal of the solution from the container to load said syringe prior to said administration, and instructions for the same.
30 . A viscosupplement for use in treating a joint or surgical site of a human or animal subject such as by lubricating and cushioning intra-articular joint surfaces and tissues, comprising a plurality of porous viscoelastic solid hydrogel microparticles having a size of greater than about 30 μm, and substantially free of any cells, tissue, or therapeutic compounds, wherein said viscosupplement is configured for introduction into a joint or surgical site of the human or animal subject.
31 . A viscosupplement for use according to claim 30 , wherein the plurality of porous viscoelastic solid hydrogel microparticles are dispersed in a pharmaceutically-acceptable vehicle.
32 . Use of a viscosupplement in treating a joint or surgical site of a human or animal subject such as by lubricating and cushioning intra-articular joint surfaces and tissues, comprising a plurality of porous viscoelastic solid hydrogel microparticles having a size of greater than about 30 μm, and substantially free of any cells, tissue, or therapeutic compounds.