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-10857261-B2
Publication Date
2020-12-08
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 hydroxymetbylenediisocyanate (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 composition that solidifies into a biocompatible implant having a surface. The composition includes polymeric materials comprising biodegradable groups and biodegradable porogens configured to create pores within the implant upon degradation, and in one form a first porogen is provided in the form of filaments comprising silicates and a second porogen is provided in the form of particulates.
Degradation of the porogen forms pores having size and connectivity, and the implant degradation rate is defined as a function of the size and connectivity of the pores formed by degradation of the first porogen. The biocompatible implant also includes a strain-to-yield greater than 2.5%, and the surface of the biocompatible implant comprises pores having a pore size of less than 10 µm before degradation of either the first porogen or the second porogen.
In a narrower form, the invention provides a composition that solidifies into a biocompatible implant having a surface, where a polymeric material comprising biodegradable groups is combined with biodegradable porogen filaments comprising silicates. Degradation of the porogen filaments forms pores having size and connectivity, and the rate of degradation is a function of the pore size and connectivity.
Claims Coverage
The document includes two independent claims, with inventive features centered on forming pores in a solidified biocompatible implant via degradation of biodegradable silicate porogen(s), making the degradation rate a function of pore size and connectivity, and enforcing mechanical and structural thresholds for strain-to-yield and surface pore size.
Biodegradable silicate porogens forming pores with size and connectivity
A composition that solidifies into a biocompatible implant having a surface, comprising biodegradable polymeric materials and biodegradable porogens, where degradation of the porogen forms pores within the biocompatible implant and the pores have a size and connectivity.
Degradation rate determined by pore size and connectivity
The rate of degradation of the biocompatible implant is a function of the size and connectivity of the pores formed by degradation of the first porogen.
Strain-to-yield constraint for the biocompatible implant
A strain-to-yield of the biocompatible implant is greater than 2.5%.
Surface pores smaller than 10 µm before porogen degradation
The surface of the biocompatible implant comprises pores having a pore size of less than 10 µm before degradation of either the first porogen or the second porogen.
Dual biodegradable porogens including silicate filaments and biodegradable particulates
The composition comprises a first polymeric material and a second polymeric material, a biodegradable first porogen in the form of filaments comprising silicates, and a biodegradable second porogen in the form of particulates, with the first and second polymeric materials comprising biodegradable groups.
Silicate porogen filaments with a single biodegradable porogen architecture
A composition that solidifies into a biocompatible implant having a surface, the composition comprising a polymeric material and a biodegradable porogen in the form of filaments comprising silicates, where the polymeric material comprises biodegradable groups.
Across the independent claims, the core coverage is a solidifying composition that creates pores in a biocompatible implant by degradation of biodegradable silicate porogen(s), where pore size and connectivity govern degradation rate, and the implant exhibits strain-to-yield greater than 2.5% with surface pores of less than 10 µm prior to porogen degradation.
Stated Advantages
Improved visualization for endovascular use.
Stress dampening to reduce stress shielding.
Documented Applications
Bone applications including bone augmentation/fixation and void filling/bone stabilization/microfracture healing.
Vascular applications including embolization and devascularizing tumors or vascular lesions, including aneurysms and pseudoaneurysms.
Use as an injectable polymer implant that solidifies in vivo.
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