Implantable polymer for bone and vascular lesions
Inventors
D'Agostino, Jeffrey A. • Carter, Andrew J. • Jones, Craig M. • Watterson, Arthur C.
Assignees
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Publication Number
US-11850323-B2
Publication Date
2023-12-26
Expiration Date
Abstract
A solidifying prepolymeric implant composition comprising a biocompatible prepolymer and an optional filler. One such implant composition is a polyurethane implant composition comprising an isocyanate, such as hydroxymethylenediisocyanate (HMDI) and an alcohol, such as polycaprolactonediol (PCL diol). The compositions of the invention are useful for improving bone structure in patients by applying the solidifying implant composition to bone, reinforcing bone structure, improving load bearing capacity and/or aiding healing of microfractures.
Core Innovation
The invention relates to a solidifying injectable polymeric implant for bone augmentation or treatment of a bone fracture or lesion. The implant comprises a biocompatible prepolymer that is injectable and that solidifies at least in part by solvent absorption, solvent diffusion, or in situ polymerization. The implant forms pores and develops a scaffold for ingrowth and regeneration of bone tissue.
The implant includes a porogen and a polymeric matrix, where the porogen facilitates formation of pores. A surface having pores of less than 10 m is described for facilitating osteoblast ingrowth, and degradation of components forms interconnected pores having a pore size of 10 to 500 m. The document also describes mechanical-property targets, including compressive stiffness and strain-to-yield, and describes pore formation in terms of bulk and surface pore ranges.
The composition may further include fillers, radiopaque or contrast agents, and biologically active materials for site-specific delivery. Therapeutic agents include antibiotics, analgesics or NSAIDs, chemotherapeutics, gallium, bisphosphonates, and hydroxyapatite. Radiopacity is described as time-dependent, and solidification is associated with reduced heat during solidification.
Claims Coverage
The patent includes three independent claims directed to a biocompatible, biodegradable polymer implant and a method of forming a bone implant. The claims share a porogen that creates a porous surface for osteoblast ingrowth and a scaffold for ingrowth and regeneration of bone tissue, with two quantitative pore-size constraints and mechanical targets appearing in the method claim.
Porous surface enabling osteoblast ingrowth scaffold regeneration
A bone implant for bone augmentation or treatment of a bone fracture or lesion comprising a biocompatible, biodegradable polymer, having a surface having pores of <10 m for facilitating osteoblast ingrowth, and having or developing a scaffold for ingrowth and regeneration of bone tissue.
Porogen including fibers with pores <10 m scaffold regeneration
A bone implant for bone augmentation or treatment of a bone fracture or lesion comprising a biocompatible, biodegradable polymer and a porogen including fibers, wherein the bone implant has a surface having pores of <10 m for facilitating osteoblast ingrowth, and the bone implant has or develops a scaffold for ingrowth and regeneration of bone tissue.
Porogen including particles with pores <10 m scaffold regeneration
A bone implant for bone augmentation or treatment of a bone fracture or a lesion comprising a biocompatible, biodegradable polymer and a porogen including particles, wherein the bone implant has a surface having pores of <10 m for facilitating osteoblast ingrowth, and the bone implant has or develops a scaffold for ingrowth and regeneration of bone tissue.
Forming a porous implant by applying polymer porogen and solvent then removing solvent
A method for forming a bone implant comprising applying a composition comprising a polymer, a porogen, and a solvent to a bone; removing the solvent to form a porous surface characterized by a pore size of <10 m, wherein the porogen includes aligned fibers, the bone implant degrades to form interconnected pores having a pore size of 10 to 500 m, and the bone implant is characterized by a strain to yield of greater than 2.5% and a compressive stiffness of 14-20 GPa.
Overall, the independent claims are directed to a biodegradable polymer bone implant with a porogen to create a porous surface with pores of less than 10 m for osteoblast ingrowth and an implant scaffold for ingrowth and regeneration. The method claim further requires aligned-fiber porogen, interconnected degradation-formed pores of 10 to 500 m, and specified mechanical targets.
Stated Advantages
Reduced heat during solidification.
Time-dependent radiopacity.
Documented Applications
Bone fracture healing and bone augmentation / treatment of a bone fracture or lesion by an injectable solidifying polymeric implant.
Treatment of vascular lesions, including embolization, described as devascularizing a tumor or vascular lesion and treating an aneurysm or pseudoaneurysm.
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