Layered surgical biocomposite material

• US 5,084,051 A
• Filed: 08/24/1988
• Issued: 01/28/1992
• Est. Priority Date: 11/03/1986
• Status: Expired due to Term

• Current Assignee: Biocon Oy
• Original Assignee: Biocon Oy
• Inventors: Tormala, Pertti, Rokkanen, Pentti, Helevirta, Pertti, Vainionpaa, Seppo, Pellinen, Marja
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): PREBILIC, PAUL B
• Application Number:
  US07/215,010
• Time in Patent Office: 1,252 Days
• Field of Search: 623/16, 623/11, 623/13, 128/92 YP, 128/92 YQ, 128/92 YR, 428/688, 428/704, 427/2, 606/76, 606/77
• US Class Current: 606/77
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/2803 for mandibular reconstruction temporo-mandibular joints A61F2/3099; bone plates for the jaw A61B17/8071
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30009 differing in fibre orientations
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30261 parallelepipedal
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30929 having at least two superposed coatings
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0082 parallelepipedal
• CPC Class Codes: A61F 2250/0023 differing in porosity
• CPC Class Codes: A61F 2250/0028 : differing in fibre orientations
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61L 27/10 : Ceramics or glasses
• CPC Class Codes: A61L 27/44 : having a macromolecular matrix
• CPC Class Codes: A61L 27/48 : with macromolecular fillers
• CPC Class Codes: A61L 31/129 : containing macromolecular fillers

Abstract

Biocomposite material that is especially suitable for bone surgical applications, containing:

at least one bioceramic piece (1) (bioceramic component) and

at least one material component (2).

The material component (2) comprises at least reinforcement elements which have been manufactured of essentially resorbable material like polymer, copolymer, polymer mixture and/or ceramic material.

Claims

1. Biocomposite material for bone surgical applications, which biocomposite comprises:

at least one bioceramic layered component and

at least one material component layer which has been manufactured of at least one polymer which material component has at least one common boundary surface with the bioceramic component;

wherein

the material component comprises at least reinforcement elements which have been manufactured of resorbable material selected from the group consisting of polymer, copolymer, polymer mixture, and ceramic material and mixtures thereof and that

the material component can include binding material which is manufactured of resorbable polymer, copolymer or polymer mixture and that

whereby the material component is porous at least in tissue conditions, and wherein

the bioceramic component is at least partially porous and that the material component has a surface contact connection with the bioceramic component in such a way that the part of the porosity of the bioceramic component, which is to be put against the bone tissue, is free of the material component.

2. A biocomposite material according to claim 1, wherein the reinforcement elements are fibres or film fibres or structures which have been constructed of them, which reinforcement elements have been manufactured from the resorbable polymers selected from the group consisting of polyglycolides (PGA), polyactides (PLA), glycolide/lactide copolymers (PGA/PLA), glycolide/trimethylenecarbonate copolymers (PGA/TMC), poly-β

-hydroxybutyric acid (PHBA), poly-β

-hydroxypropionic acid (PHPA), poly-β

-hydroxyvaleric acid (PHVA), PHBA/PHVA copolymers, poly-p-dioxanone (PDS), poly-1,4-dioxanone-2,5-diones, polyesteramides (PEA), poly-ε

-caprolactone, poly-δ

-valerolactone, polycarbonates, polyesters of oxalic acids, glycolic esters, dihydropyrane polymers, polyetheresters, cyanacrylates or chitine polymers.

3. A biocomposite material according to claim 1, wherein the binding material of the material component has been manufactured from resorbable polymers selected from the group consisting of polyglycolides (PGA), polylactides (PLA), glycolide/lactide copolymers (PGA/PLA), glycolide/timethylenecarbonate copolymers (PGA/TMC), poly-β

-hydroxybutyric acid (PHBA), poly-β

-hydroxypropionic acid (PHPA), poly-β

-hydroxyvaleric acid (PHVA), PHBA/PHVA copolymers, poly-p-dioxanone (PDS), poly-1,4-dioxanone-2,5-diones, polyesteramides (PEA), poly-ε

-caprolactone, poly-δ

-valerolactone, polycarbonates, polyesters of oxalic acid, glycolic esters, dihydropyrane polymers, polyetheresters, cyanoacrylates or chitine polymers.

4. A biocomposite material according to claim 1, wherein the bioceramic component has been manufactured bioceramics selected from the group consisting of calciumphosphates, dicalciumphosphates, apatites and magnesiumcalciumphosphates, mixtures of hydroxyapatite and tricalciumphosphate, aluminiumoxide ceramics, bioglasses, glass ceramics containing apatites or calciumcarbonate.

5. A biocomposite material according to claim 1, wherein the bioceramic component of the biocomposite is a plate, a rod, a prism, a cylinder, a tube or a chute or it has been designed to correspond anatomically some bone or some part of a bone and that the material component has been located on at least one surface of the bioceramic component.

6. A biocomposite material according to claim 1, wherein in that the biocompatible material comprises a bioceramic component in the form of a plate, whose upper-or lower surface or side surfaces have been coated with material component.

7. A biocomposite material according to claim 6, wherein the biocomposite material has been organized to a layered sample, where the bioceramic components and material components alternate.