Granule made of biocompatible metallic material for vertebroplasty
Inventors
SORANO, Gaetano • DRAGO, Roberto
Assignees
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Publication Number
US-12226132-B2
Publication Date
2025-02-18
Expiration Date
Abstract
Disclosed is a granule made of biocompatible metallic material, in particular made of titanium or titanium alloys, for vertebroplasty operations. The granule has a spherical shape and includes a central core with a solid structure, also spherical, having an outer surface from which a first diametrical rib and a second diametrical rib also having a solid structure, protrude. The ribs are advantageously arranged according to two diameters orthogonal to each other. The granule also includes a portion having a trabeculated structure which extends between the outer surface of the central core and the outer surface of the granule itself.
Core Innovation
The invention relates to a biocompatible metallic granule for vertebroplasty operations, having a spherical shape. The granule comprises a spherical solid central core having an outer surface, from which a first diametrical rib and a second diametrical rib protrude, arranged according to two orthogonal diameters.
A portion of the granule comprises a trabeculated structure that extends between the outer surface of the central core and the outer surface of the granule itself. The trabeculated structure is configured to provide osseointegration by enhancing bone regrowth/osteogenesis while maintaining vertebroplasty granule geometry suitable for transcutaneous kyphoplasty applications.
The granule is made from titanium or titanium alloys and is described as being compatible with insertion through the same cannula used for balloon kyphoplasty. The granule is further specified with preferred external diameter and core dimensions, preferred rib width and trabecular pore size range, and is disclosed as being manufactured by electron beam melting (EBM) using a dode-thin mesh/software element to form the trabeculated structure.
Claims Coverage
The independent claim covers 1 biocompatible metallic, spherical vertebroplasty granule geometry and structure, including a solid spherical central core, two orthogonal solid diametrical ribs, and a trabeculated-structure portion extending between the core outer surface and the granule outer surface. Dependent claims further refine geometry and trabeculated pore size, and constrain production to EBM processing and EBM trabeculation formation using dode-thin elements.
Biocompatible metallic spherical granule with orthogonal solid ribs and trabeculated portion
A granule made of biocompatible metallic material for vertebroplasty operations, wherein the granule has a spherical shape and comprises a central core with a solid structure, also spherical, having an outer surface from which a first diametrical rib and a second diametrical rib also having a solid structure protrude, arranged according to two diameters orthogonal to each other, the granule comprising a portion having a trabeculated structure which extends between the outer surface of said central core and the outer surface of the granule itself.
External diameter and central core diameter constraints
The granule of the biocompatible metallic spherical granule has an external diameter of 3.3 mm and a central core diameter of 2.5 mm.
Rib width constraint
The granule of the biocompatible metallic spherical granule is characterized in that each of its first and second ribs has a width of 0.5 mm.
Trabeculated portion with average pore size range
The granule comprises a portion having a trabeculated structure whose average pore size is between 400 and 800 microns.
Manufacture using EBM rapid prototyping techniques
The granule is produced using EBM rapid prototyping techniques.
EBM trabeculation produced using dode-thin elements
The granule is characterized by a portion with a trabeculated structure whose trabeculation is produced by the EBM technique using dode-thin elements.
Overall, the claim set centers on a spherical biocompatible metallic vertebroplasty granule with a solid spherical central core, two orthogonal solid diametrical ribs, and an intervening trabeculated-structure portion. The dependent claims refine specific diameter, rib width, and average pore size ranges and further constrain production by EBM, including trabeculation formation using dode-thin elements.
Stated Advantages
Optimized primary stability under compressive loads.
Enhanced osseointegration/osteogenesis.
Compatibility with insertion through the same cannula used for balloon kyphoplasty.
Documented Applications
Vertebroplasty operations including transcutaneous kyphoplasty, with compatibility for insertion through the same cannula used for balloon kyphoplasty.
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