Multi-component material and process for its preparation

• US 6,080,801 A
• Filed: 07/14/1998
• Issued: 06/27/2000
• Est. Priority Date: 09/13/1990
• Status: Expired due to Fees

• Current Assignee: Klaus Draenert
• Original Assignee: Klaus Draenert
• Inventors: Draenert, Klaus, Wahlig, Helmut
• Primary Examiner(s): MERRIAM, ANDREW EDWIN
• Application Number:
  US09/115,323
• Time in Patent Office: 714 Days
• Field of Search: 523/115, 523/116, 523/117, 523/200, 523/205, 524/533, 524/560
• US Class Current: 523/115
• CPC Class Codes: A61L 24/0073 with a macromolecular matrix
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/44 having a macromolecular matrix
• CPC Class Codes: A61L 27/446 with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46
• CPC Class Codes: C08L 33/04 Homopolymers or copolymers of esters C08L43/04 takes precedence
• CPC Class Codes: C08L 33/12 Homopolymers or copolymers of methyl methacrylate

Abstract

A multiple component material, in particular a filler particle containing implantation material is produced and used to anchor prothesis components in bones, to strengthen bones, as dowel for bone screws and as implants for anchoring screws. The polymer component of the disclosed implantation material is preferably based on an acrylate or polymethacrylate basis, or on an acrylate and methacrylate copolymer or a mixture thereof. The polymer component encloses the filler particles at least in part. Preferably, the filler particles are 5 to 15 μm in size and have at least 50% void volume. The multiple component material is stored in a dry, stable particulate form ready for use by mixing with monomer liquid.

Claims

1. A polymerizable bone cement constituent material stored in dry, stable particulate form which is ready for use by mixing with monomer liquid to induce final polymerization into a bone cement implantation material, the bone cement constituent material comprising:

a prepolymerization component consisting of particles selected from the group consisting of an acrylate polymer, a methacrylate polymer, a methylmethacrylate polymer, and copolymers thereof, and

a filler component consisting of filler particles comprising at least one active substance;

wherein the bone cement constituent material is stored in dry, stable particulate form of particles no greater than 300 μ

m in size and having at least some of the filler particles at least partially embedded into individual particles of the prepolymerization component before the prepolymerization component reacts with the monomer liquid for final polymerization, said prepolymerization component being polymerizable by mixing the bone cement constituent material with monomer liquid into a bone cement implantation material which is biologically inert, said filler particles being accessible in the individual particles of the prepolymerization component for release from the bone cement implantation material by diffusion.

2. The bone cement constituent material according to claim 1, wherein at least some of the filler particles are completely embedded into individual particles of the prepolymerization component before the prepolymerization component reacts with monomer liquid for final polymerization, and the completely embedded filler particles are accessible for release by diffusion each through the individual particle of the prepolymerization component in which said filler particle is embedded.

3. The bone cement constituent material according to claim 1, wherein said filler particles are only partially embedded into individual polymer and/or copolymer particles.

4. The bone cement constituent material according to claim 1, wherein the filler particles are 1 to 250 μ

m in size.

5. The bone cement constituent material according to claim 4, wherein the filler particles are 5 to 15 μ

m in size.

6. The bone cement constituent material according to claim 1, wherein the active substance is an antibiotic.

13. The bone cement constituent material of claim 1, wherein the bone cement constituent material consists essentially of the filler particles and the individual polymer and/or copolymer particles, such that the filler particles directly contact the individual polymer and/or copolymer particles.

7. A polymerizable bone cement constituent material stored in dry, stable powder form which is ready for use by mixing with monomer liquid to induce final polymerization into a bone cement implantation material, the bone cement constituent material comprising:

a prepolymerization component consisting of particles selected from the group consisting of an acrylate polymer, a methacrylate polymer, a methylmethacrylate polymer, and copolymers thereof; and

a filler component consisting of filler particles comprising hydroxylapatite, tricalcium phosphate and/or another calcium phosphate or calcium carbonate compound, an aluminum or an aluminum oxide compound and/or a silicon compound;

wherein the bone cement constituent material is stored in dry, stable powder form having individual filler particles only partially embedded into individual polymer and/or copolymer particles before the prepolymerization component reacts with the monomer liquid for final polymerization, said prepolymerization component being polymerizable by mixing the bone cement constituent material with monomer liquid into a bone cement implantation material which is biologically inert, said partially embedded filler particles providing a free surface extending from the individual polymer and/or copolymer particles, said free surface being accessible to bone after final polymerization and upon implantation.

8. The bone cement constituent material according to claim 7 wherein the filler particles have a porosity of 20 to 80%.

14. The bone cement constituent material of claim 7, wherein the bone cement constituent particles are no greater than 300 μ

m in size.

15. The bone cement constituent material of claim 7, wherein the bone cement constituent material consists essentially of the filler particles and the individual polymer and/or copolymer particles, such that the filler particles directly contact the individual polymer and/or copolymer particles.

9. A material in particle form for subsequent use by combining with a liquid monomer to form a bone cement material, the material consisting essentially of:

50 to 99% by weight of polymer beads based on a plastics material selected from the group consisting of acrylate, methacrylate, methylmethacrylate, epoxy resin and copolymers thereof; and

1 to 50% by weight of irregularly shaped granules comprising polymer particles, the polymer particles based on a plastics material selected from the group consisting of acrylate, methacrylate, methylmethacrylate, epoxy resin and copolymers thereof.

10. The material of claim 9, consisting essentially of 80 to 95% by weight of the polymer beads and 5 to 25% by weight of the irregularly shaped granules.

16. The bone cement constituent material of claim 9, wherein the bone cement constituent particles are no greater than 300 μ

m in size.

11. A polymerizable bone cement constituent material stored in dry, stable particulate form which is ready for use by mixing with monomer liquid to induce final polymerization into a bone cement implantation material, the bone cement constituent material comprising a prepolymerization component and a filler component, said prepolymerization component consisting of particles selected from the group consisting of an acrylate polymer, a methacrylate polymer, a methylmethacrylate polymer, and copolymers thereof, said filler component consisting of filler particles of a material different from the material of the polymer and/or copolymer particles, wherein the bone cement constituent material is stored in dry, stable particulate form having at least some of the filler particles at least partially embedded into individual polymer and/or copolymer particles before the prepolymerization component is finally polymerized, and wherein the bone cement constituent material is in a crushed form having irregularly shaped granules.

17. The bone cement constituent material of claim 11, wherein the bone cement constituent particles are no greater than 300 μ

m in size.

18. The bone cement constituent material of claim 11, wherein the bone cement constituent material consists essentially of the filler particles and the individual polymer and/or copolymer particles, such that the filler particles directly contact the individual polymer and/or copolymer particles.

12. A polymerizable bone cement constituent material stored in dry, stable particulate form which is ready for use by mixing with monomer liquid to induce final polymerization into a bone cement implantation material, the bone cement constituent material comprising:

a prepolymerization component consisting of particles selected from the group consisting of an acrylate polymer, a methacrylate polymer, a methylmethacrylate polymer, and copolymers thereof, and

a filler component consisting of filler particles of a radiographic contrast agent;

wherein the bone cement constituent material is stored in dry, stable powder form having individual filler particles at least partially embedded into individual polymer and/or copolymer particles before the prepolymerization component reacts with the monomer liquid for final polymerization, said prepolymerization component being polymerizable by mixing the bone cement constituent material with monomer liquid into a bone cement implantation material which is biologically inert.

19. The bone cement constituent material of claim 12, wherein the bone cement constituent particles are no greater than 300 μ

m in size.

20. The bone cement constituent material of claim 12, packed with benzylperoxide.