Biocompatible material in granules made of metal material or metal alloys and use of said granules for vertebroplasty
Inventors
FRANCAVIGLIA, Natale • SORANO, Gaetano • DRAGO, Roberto
Assignees
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Publication Number
US-10478522-B2
Publication Date
2019-11-19
Expiration Date
Abstract
More specifically, granules made of biocompatible metal material, preferably osteoinductive metal, for use in vertebroplasty surgery, as well as the use of these granules for this purpose, are the object of the present invention.
Core Innovation
The invention relates to transcutaneous vertebroplasty/kyphoplasty using non-PMMA biocompatible, preferably osteoinductive, metal granules. The granules are solid or hollow spheres made from biocompatible metal material or alloys, with an outer surface having a trabeculated porous structure designed for osseointegration.
The granules are engineered to provide a trabeculated porous outer surface, including trabeculated pores having a defined diameter range. The outer diameter of the solid spherical granule is between 3 and 4 millimeters in claim form, and the trabeculated pores have a diameter between 400 and 800 microns.
The document further describes manufacturing that produces the granules with the engineered porous surface. Localized precision casting of powders via high-energy electron beam melting (EBM) is described as a manufacturing approach for creating the trabeculated porous metal granules, including alternatives involving localized micro-fusion of powders using high energy electron beams (EBM) or laser.
Claims Coverage
The independent claim covers a specific granule geometry and porosity, and the claim set includes dependent claim refinements that add material selection, manufacturing route, vertebroplasty delivery into vertebral internal cavities, and optional granule-to-granule connecting means. The main inventive features described across the independent claim and its dependents are summarized below.
Biocompatible metal spherical granule with trabeculated porous outer surface
A granule made of biocompatible metal material or alloys of said metal material, wherein the granule comprises a solid spherical structure with an outer diameter of between 3 and 4 millimeters, and an outer surface having a trabeculated porous structure, wherein the trabeculated pores of the outer surface have a diameter of between 400 and 800 microns.
Titanium or titanium alloy granule
The granule is made of titanium or titanium alloys.
Trabeculated porous structure with pore diameter about 600 microns
The granule further includes a trabeculated porous structure characterized by a pore diameter of about 600 microns.
Manufacture by localized micro-fusion of powders using EBM or laser
The granule is manufactured using production techniques involving localized micro-fusion of powders using high energy electron beams (EBM) or laser.
Vertebroplasty method by depositing a granule composition into vertebral internal cavities
A method for performing vertebroplasty by selecting a subject needing the surgery, providing a granule composition, and depositing that composition into an internal cavity of one or more vertebra of the selected subject.
Connecting means for connecting granules
The granule further includes a connecting means that allows it to be connected to at least one other granule.
Overall, the claims cover a biocompatible metal spherical granule with a trabeculated porous outer surface having defined pore dimensions, material options including titanium/titanium alloys, manufacturing via localized micro-fusion using EBM and/or laser, and vertebroplasty delivery by depositing the granule composition into vertebral internal cavities, with optional connecting means to connect granules.
Stated Advantages
Elimination of cement polymerization heat.
Reduction of risk from cement particle escape.
Enable load transfer and bone regeneration/osseointegration.
Documented Applications
Transcutaneous vertebroplasty/kyphoplasty for vertebral compression fractures by depositing a granule composition into vertebral internal cavities using cannula delivery concepts.
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