Implantable polymer for bone and vascular lesions

Abstract

A solidifying implant composition of a polymer mixed with a bioabsorbable solvent. A method of treating a patient, by implanting the solidifying implant composition into bone, and solidifying the implant composition. A method of improving bone structure in patients by applying the solidifying implant composition to bone, shoring up bone structure, and improving load bearing capacity and aiding healing of microfractures. A method of fixing an implant, by applying the solidifying implant composition to an implant, and shoring up the implant. A method of devascularizing and treating a tumor or vascular lesion. A method of treating a vascular disease. A method of treating aneurysms/pseudoaneurysms.

1 . A solidifying implant composition, comprising a polymeric material mixed with a biocompatible solvent. 
     
     
         2 . The solidifying implant composition of  claim 1 , wherein said composition is in a form chosen from the group consisting of an injectable fluid, a malleable paste, a hydrogel, and an aerosol gel. 
     
     
         3 . The solidifying implant composition of  claim 1 , wherein said polymeric material is chosen from the group consisting of polymethylmethacrylate (PMMA), polyethylene UHMW (ultra-high-molecular-weight), cross-linked polyethylene PEX, polypropylene, polyesters, polybutylene terephtalate (PBT), polyetherekketone (PEEK-Optima), polystyrene mono- and copolymer, polybutadiene mono- and copolymer, polyvinyl alcohol mono- and copolymer, polyamides (nylon), polyglycolic acid (PGA), polylactic acid (PLA), polyglycolic-lactic acid (PGLA), polyurethanes, calcium phosphates, calcium sulphates, hydroxyapatite, silicates, bioactive glasses, diacetonylacrylamide, polylactides, polydioxannones, polycarbonates, polyalkene oxylates, polyanhydrides, polyamides, polyesteramides, polyurethanes, polyacetals, polyketals, polyorthocarbonates, polyphosphazenes, polyhydroxyvalerates, polyalkylene succinates, poly(malic acid), poly(amino acids), Chitin, Chitosan, polyorthoesters, polyhydroxybutyrates, polyethylene glycol, porous silicon, collagen, hyaluronic acid, and copolymers, terpolymers, and combinations thereof. 
     
     
         4 . The solidifying implant composition of  claim 1 , wherein said solvent is chosen from the group consisting of dimethyl sulfoxide (DMSO), acetone, 2-butanol, ethanol, ethyl acetate, methyl acetate, dimethylformamide, caprolactam, oleic acid, 1 propanol, 2-propanol, propyl acetate, propylene glycol, glycerol, any solvent analogous or homologous to dimethyl sulfoxide, and combinations thereof. 
     
     
         5 . The solidifying implant composition of  claim 1 , wherein said solvent is in excess. 
     
     
         6 . The solidifying implant composition of  claim 1 , further including a radiopaque metal particle chosen from the group consisting of Tantalum, Platinum, Barium, Titanium, Silver, Gold, Palladium, Iridium, Osmium, Copper, Niobium, Molybdenum, Strontium, Gallium, Nickel-Titanium, Nickel-Manganese-Gallium, Platinum-Iridium, Platinum-Osmium, and combinations thereof. 
     
     
         7 . The solidifying implant composition of  claim 1 , further including a catalyst chosen from the group consisting of Platinum, Palladium, peroxide, metal salts, Zinc, redox couples, enzymes, and combinations thereof. 
     
     
         8 . The solidifying implant composition of  claim 1 , further including suspended particles of biologically active material chosen from the group consisting of antibiotics, therapeutic agents that stimulate bone healing, pain relief therapeutics, cancer treatments, and combinations thereof. 
     
     
         9 . The solidifying implant composition of  claim 1 , further including biodegradable polymers chosen from the group consisting of polyglycolic acid (PGA), polylactic acid (PLA), polyglycolic-lactic acid (PGLA), polycaprolactone (PCL), ε-poly-L-lysine (EPA), glycosaminoglycans (GAGs, polyalcohols, heparinoids, and combinations thereof. 
     
     
         10 . The solidifying implant composition of  claim 1 , further including a material chosen from the group consisting of polymeric fibers, ceramic fibers, metal fibers, polymeric filaments, ceramic filaments, metal filaments, polymeric coils, ceramic coils, metal coils, polymeric particles, ceramic particles, metal particles, and combinations thereof. 
     
     
         11 . The solidifying implant composition of  claim 1 , further including a liquid contrast agent chosen from the group consisting of Ethiodol, Tantalum, Barium Sulfate, and Nickel-Titanium. 
     
     
         12 . The solidifying implant composition of  claim 1 , wherein said implant composition when solidified possesses compressive strength within the range of 10-500 MPa, possesses elastic modulus between 0.1-100 GPa, and possesses yield strength within 0.5-10 MPa. 
     
     
         13 . The solidifying implant composition of  claim 1 , wherein said implant composition when solidified includes pores in a size of 1-1000 μm within said composition and less than 10 μum on a surface of said composition. 
     
     
         14 . The solidifying implant composition of  claim 1 , wherein said composition is radiopaque and opacity of said composition diminishes over time. 
     
     
         15 . The solidifying implant composition of  claim 1 , wherein said composition is chosen from the group consisting of PLA-PGA co-polymer with a triol cross-linker in a DMSO solvent, PLA-PGA co-polymer with a triol cross-linker in a DMSO solvent with a polyHEMA (hydroxyethylmethacrylate) hydrogel, PLA-co-PGA and HEMA monomer in DMSO solvent, PLA and PCL in DMSO with an AA (acrylic acid) monomer, PLA and PCL in DMSO with HEMA and AA monomers, PLA-co-PGA in DMSO with AA monomer, PLA and PCL in DMSO with polyHEMA hydrogel and PEG, and PLA and PCL in DMSO with polyAA hydrogel and PEG. 
     
     
         16 . A method of treating a patient, including the steps of:
 implanting a solidifying implant composition comprising a polymeric material mixed with a biocompatible solvent into bone; and   solidifying the implant composition.   
     
     
         17 . The method of  claim 16 , wherein said implanting step is further defined as injecting the implant composition into the bone. 
     
     
         18 . The method of  claim 17 , wherein said injecting step further includes the step of mixing the implant composition before entry into the bone. 
     
     
         19 . The method of  claim 16 , further including the step, prior to said implanting step, of mixing the implant composition. 
     
     
         20 . The method of  claim 18 , wherein said implanting step is performed during a procedure chosen from the group consisting of vertebroplasty, kyphoplasty, void filling, bone stabilization, and stabilization of nonresorbable materials in contact with bone. 
     
     
         21 . The method of  claim 16 , wherein said implanting step is further defined as treating a fracture is chosen from the group consisting of bone fractures, osteoporotic bone fractures, compression fractures, stress fractures, pathological fractures, non-union fractures, complex fractures, displaced fractures, and poor-healing fractures. 
     
     
         22 . The method of  claim 16 , wherein said solidifying step is further defined as solidifying the implant composition upon contact with surrounding tissue or liquid by absorbing and diffusing the solvent into the surrounding tissue or liquid. 
     
     
         23 . The method of  claim 22 , further including the step of forming pores within the implant composition and on the implant composition in place of the solvent. 
     
     
         24 . The method of  claim 16 , further including the step of allowing controlled movement of bone with the implant composition. 
     
     
         25 . The method of  claim 16 , further including the step of absorbing and distributing stress and preventing fatigue and fracture of adjacent bone with the implant composition. 
     
     
         26 . The method of  claim 16 , wherein the implant is chosen from the group consisting of permanent, biodegradable, and bioabsorbable. 
     
     
         27 . A method of improving bone structure in patients, including the steps of:
 applying a solidifying implant composition comprising a polymeric material mixed with a biocompatible solvent to bone;   shoring up bone structure; and   improving load bearing capacity and aiding healing of microfractures.   
     
     
         28 . The method of  claim 27 , wherein said applying step is further defined as a method chosen from the group consisting of injecting the implant composition into the bone, and coating the composition on the bone. 
     
     
         29 . The method of  claim 27 , wherein the patients are suffering from a disease chosen from the group consisting of severe osteoporosis, metastases, and bone lesions at risk of catastrophic failure. 
     
     
         30 . The method of  claim 27 , further including the step of temporarily stabilzing the implant composition after said shoring up step. 
     
     
         31 . The method of  claim 30 , further including the step of making subsequent procedures less difficult. 
     
     
         32 . The method of  claim 27 , wherein the solidifying implant composition is chosen from the group consisting of permanent, biodegradable, and bioabsorbable. 
     
     
         33 . A method of fixing an implant, including the steps of:
 applying a solidifying implant composition comprising a polymeric material mixed with a biocompatible solvent to an implant; and   shoring up the implant.   
     
     
         34 . The method of  claim 33 , wherein the solidifying implant composition is chosen from the group consisting of permanent, biodegradable, and bioabsorbable. 
     
     
         35 . A method of devascularizing a tumor or vascular lesion, including the step of:
 applying a solidifying implant composition comprising a polymeric material mixed with a biocompatible solvent to a tumor or vascular lesion.   
     
     
         36 . The method of  claim 35 , further including the step of treating the tumor or vascular lesion with a therapeutic. 
     
     
         37 . A method of treating a vascular disease, including the step of:
 applying a solidifying implant composition comprising a polymeric material mixed with a biocompatible solvent to vascular site in need of treatment.   
     
     
         38 . The method of  claim 37 , wherein the vascular disease is chosen from the group consisting of an endoleak that occurs following endovascular repair of aortic aneurysms, aneurysms, spinal and body arteriovenous malformations and fistulae, cerebral and spinal dural arteriovenous fistulae, traumatic vessel injury (traumatic vascular lesion), venous varices, visceral and/or viscerocutaneous fistulae, vascular tumors, and cerebral arteriovenous malformations. 
     
     
         39 . The method of  claim 37 , wherein said applying step is further defined as delivering the composition into space that is filled by blood or body fluids, tracking the composition along the space, and filling in a vascular site. radiopacity 
     
     
         40 . A method of treating aneurysms/pseudoaneurysms, including the step of:
 applying a solidifying implant composition comprising a polymeric material mixed with a biocompatible solvent to an aneurysm/pseudoaneurysm.