Polymeric acrylic prothesis

• US 4,535,485 A
• Filed: 03/12/1982
• Issued: 08/20/1985
• Est. Priority Date: 03/12/1982
• Status: Expired due to Term

• Current Assignee: United States Surgical Corporation (Medtronic Plc)
• Original Assignee: Medical Biological Sciences Inc.
• Inventors: Ashman, Arthur, Bruins, Paul F.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): Isabella, David J.
• Application Number:
  US06/357,739
• Time in Patent Office: 1,257 Days
• Field of Search: 427/2, 433/201, 3/1, 3/1.9, 3/1.911, 3/1.912, 3/1.913, 128/92 C, 128/92 CA, 128/92 G
• US Class Current: 623/23.72
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Abstract

This invention relates to implantable porous prostheses for use as bone or hard tissue replacements anywhere in the body. The porous implants comprise loose, individual polymeric particles of a specified size, coated with a hydrophilic material and barium sulfate particles. The prostheses are biologically compatible in the body and promote bone and tissue ingrowth and attachment. This invention also relates to a method for producing the novel prosthetic devices disclosed herein.

Claims

1. A packing material for forming in vivo prosthetic implants for hard tissue, the packing material comprising disjoint micron sized particles, each particle having an inner core comprised of a first biologically-compatible polymeric material and having an outer coating generally surrounding the inner core, the outer coating being comprised of a second biologically-compatible polymeric material, the second polymeric material being hydrophilic and having a composition different from the composition of the first polymeric material, each particle incorporating a sufficient quantity of barium sulfate to render a prosthetic implant formed of a compacted mass of the particles visible in an X-ray radiograph, the particles being of a size to permit a mass of the disjoint particles to be packed in a body cavity having at least one surface comprised of a hard tissue to form a prosthetic implant for the hard tissue with interstices between compacted particles of the prosthetic implant forming pores into which tissue can grow.

2. The packing material of claim 1 in which the diameter of the particles is in the range of from about 590 microns to about 840 microns.

3. The packing material of claim 2 in which the cores of the particles are composed of an acrylic polymeric material.

4. The packing material of claim 3 in which the cores of the particles are polymethylmethacrylate beads.

5. The packing material of claim 4 in which the polymethylmethacrylate beads include a plasticizer.

6. The packing material of claim 3 in which the cores of the particles are composed of a copolymer of methylmethacrylate and a comonomer.

7. The packing material of claim 3 in which the hydrophilic polymeric material is a polymeric hydroxyethylmethacrylate.

8. A packing material for forming in vivo prosthetic implants for hard tissue, the packaging material comprising disjoint particles, having a diameter in the range of from about 590 microns to about 840 microns, each particle having an inner core comprised of a biologically-compatible acrylic polymeric material and having an outer coating generally surrounding the inner core, the outer coating being comprised of a biologically-compatible hydrophilic polymeric hydroxyethylmethacrylate material, the ratio of the weight of the polymeric hydroxyethylmethacrylate to the weight of the cores of the particles is in the range of from about 0.04 to about 0.07, each particle incorporating a sufficient quantity of barium sulfate to render a prosthetic implant formed of a compacted mass of the particles visible in an X-ray radiograph, the particles being of a size to permit a mass of the disjoint particles to be packed in a body cavity having a least one surface comprised of a hard tissue to form a prosthetic implant for the hard tissue with interstices between compacted particles of the prosthetic implant forming pores into which tissue can grow.

9. The packing material of claim 8 in which the polymeric hydroxyethylmethacrylate comprises a copolymer of monomeric hydroxyethylmethacrylate and a cross-linking agent.

10. The packing material of claim 9 in which the cross-linking agent is triethyleneglycol dimethacrylate.

11. The packing material of claim 10 in which the ratio of the weight of the triethyleneglycol dimethacrylate to the weight of the monomeric hydroxyethylmethacrylate is in the range of from about 0.01 to about 0.05.

12. The packing material of claim 8 in which the barium sulfate is located in the coating of hydrophilic polymeric material.

13. The packing material of claim 12 in which the ratio of the weight of the barium sulfate to the weight of the cores of the particles is in the range of from about 0.25 to about 0.43.

14. The packing material of claim 13 in which the barium sulfate is in the form of particles having a diameter of less than about one micron.

15. A packing material for forming in vivo prosthetic implants for hard tissue, the packing material comprising disjoint micron sized particles, each particle having an inner core comprised of a first biologically-compatible polymeric material and having an outer coating generally surrounding the inner core, the outer coating being comprised of a second biologically-compatible polymeric material, the second polymeric material being hydrophilic and having a composition different from the composition of the first polymeric material, each particle incorporating a radio-opaque material, the particles being of a size to permit a mass of the disjoint particles to be packed in a body cavity having at least one surface comprised of a hard tissue to form a prosthetic implant for the hard tissue with interstices between compacted particles of the prosthetic implant forming pores into which tissue can grow.

16. The packing material of claim 15 in which the diameter of the particles is in the range of from about 590 microns to about 840 microns.

17. The packing material of claim 16 in which the cores of the particles are composed of an acrylic polymeric material.

18. The packing material of claim 17 in which the cores of the particles are polymethylmethacrylate beads.

19. The packing material of claim 18 in which the polymethylmethacrylate beads include a plasticizer.

20. The packing material of claim 17 in which the cores of the particles are composed of a copolymer of methylmethacrylate and a comonomer.

21. The packing material of claim 17 in which the hydrophilic polymeric material is a polymeric hydroxyethylmethacrylate.

22. The packing material of claim 21 in which the ratio of the weight of the polymeric hydroxyethylmethacrylate to the weight of the cores of the particles is in the range of from about 0.04 to about 0.07.

23. The packing material of claim 22 in which the polymeric hydroxyethylmethacrylate comprises a copolymer of monomeric hydroxyethylmethacrylate and a cross-linking agent.

24. The packing material of claim 23 in which the cross-linking agent is triethyleneglycol dimethacrylate.

25. The packing material of claim 24 in which the ratio of the weight of the triethyleneglycol dimethacrylate to the weight of the monomeric hydroxyethylmethacrylate is in the range of from about 0.01 to about 0.05.

26. The packing material of claim 21 in which the radio-opaque material is barium sulfate.

27. The packing material of claim 26 in which the barium sulfate is located in the coating of hydrophilic polymeric material.

28. The packing material of claim 27 in which the ratio of the weight of the barium sulfate to the weight of the cores of the particles is in the range of from about 0.25 to about 0.43.

29. The packing material of claim 28 in which the barium sulfate is in the form of particles having a diameter of less than about one micron.

30. A packing material for forming in vivo prosthetic implants for hard tissue, the packing material comprising disjoint micron sized particles, each particle having an inner core comprised of a first biologically-compatible polymeric material and having an outer coating generally surrounding the inner core, the outer coating being comprised of a second biologically-compatible polymeric material, the second polymeric material being hydrophilic and having a composition different from the composition of the first polymeric material, each particle incorporating a sufficient quantity of barium sulfate to prevent bonding between the particles, the particles being of a size to permit a mass of the disjoint particles to be packed in a body cavity having at least one surface comprised of a hard tissue to form a prosthetic implant for the hard tissue with interstices between compacted particles of the prosthetic implant forming pores into which tissue can grow.