Implantable metallic open-celled lattice/polyethylene composite material and devices

• US 6,087,553 A
• Filed: 11/06/1997
• Issued: 07/11/2000
• Est. Priority Date: 02/26/1996
• Status: Expired due to Term

• Current Assignee: Zimmer Trabecular Metal Technology, Inc. (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Implex Corp. (Consorteum Holdings, Inc.)
• Inventors: Takeuchi, Makoto, Cohen, Robert C.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/968,917
• Time in Patent Office: 978 Days
• Field of Search: 623/11, 623/16, 623/18, 623/19, 623/20, 623/22, 623/23, 427/2.26, 427/2.27
• US Class Current: 623/22.21
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/32 for the hip
• CPC Class Codes: A61F 2/34 Acetabular cups
• CPC Class Codes: A61F 2/3662 Femoral shafts
• CPC Class Codes: A61F 2002/30004 the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
• CPC Class Codes: A61F 2002/30199 Three-dimensional shapes
• CPC Class Codes: A61F 2002/30685 Means for reducing or preventing the generation of wear particulates
• CPC Class Codes: A61F 2002/30894 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/3092 having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/3412 with pins or protrusions, e.g. non-sharp pins or protrusions projecting from a shell surface
• CPC Class Codes: A61F 2002/3443 with an anti-luxation elevated rim portion, e.g. on the inner shell
• CPC Class Codes: A61F 2002/3448 Multiple cups made of three or more concentric shells fitted or nested into one another
• CPC Class Codes: A61F 2002/3456 ellipsoidal or having a flattened polar region
• CPC Class Codes: A61F 2002/3611 Heads or epiphyseal parts of femur
• CPC Class Codes: A61F 2002/3625 Necks
• CPC Class Codes: A61F 2002/365 Connections of heads to necks
• CPC Class Codes: A61F 2002/4631 the prosthesis being specially adapted for being cemented
• CPC Class Codes: A61F 2230/0063 Three-dimensional shapes
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0014 : having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00161 : Carbon; Graphite
• CPC Class Codes: A61F 2310/00544 : Coating made of tantalum or Ta-based alloys
• CPC Class Codes: A61L 27/04 : Metals or alloys
• CPC Class Codes: A61L 27/40 : Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 23/06 : Polyethene

Abstract

A method for making a composite material for implantation in the body which is able to act as a matrix for the biological ingrowth of bone and is suitable as a bearing surface. The method consists of compression molding the implant by forming to net shape the first material to its desired end device and inserting it into a mold cavity. Polyethylene in is then placed onto the first material, and the mold is subjected to heat and pressure for specific time durations. The end result is polyethylene which is fully interdigitated into the first material to a desired depth which is controlled by temperature, pressure and time constraints. The present method creates an interface between the first material and the polyethylene which is securely fixed and does not allow micro and macro motion between the two materials. The compression molding process optimizes the mechanical and wear properties of the polyethylene, and enables the new material to provide a smooth and frictionless bearing surface on one side of the composite material. The opposite side of the composite material is porous and thus allows for biological ingrowth of new bone or cement interdigitation. The first material provides structural stability, yet allows flexibility and load transfer to improve biological interface characteristics and a more normal bony remodeling that are lacking in other acetabular cups. An acetabular cup constructed with the composite material is also disclosed.

Claims

1. A composite material suitable for implantation in the body comprising:

a first foam portion defining a plurality of pores, said first foam portion having a bulk volume porosity between 50-90%, useful for bone fixation;

a second biocompatible wear resistant portion which is capable of defining an implant bearing surface; and

an interface between said first portion and said second portion, said interface comprising a region wherein said second portion is interdigitated into said first portion to a depth between 1-3 mm.

2. The composite material according to claim 1, wherein said pores of said first portion are defined by an open-celled lattice structure of interconnecting continuous channels.

3. The composite material according to claim 2, wherein said open-celled lattice structure is covered by a metallic layer.

4. The composite material according to claim 3, wherein said metallic layer comprises a biocompatible metal.

5. The composite material according to claim 4, wherein said biocompatible metal is tantalum.

6. The composite material according to claim 2, wherein said second biocompatible wear resistant portion is polyethylene.

7. The composite material according to claim 1, wherein said interface between said first portion and said second portion is formed by compression molding.

8. The composite material according to claim 7, wherein said interface eliminates motion between said first portion and said second portion.

9. An articulating joint implant for implantation in the body comprising a composite material, said composite material comprising:

a first foam portion defining a plurality of pores, said first foam portion having a bulk volume porosity between 50-90%, useful for bone fixation;

a second biocompatible wear resistant portion which is capable of defining an implant bearing surface; and

an interface between said first portion and said second portion, said interface comprising a region wherein said second portion is interdigitated into said first portion to a depth between 1-3 mm.

10. The implant comprising a composite material according to claim 9, wherein said pores of said first portion are defined by an open-celled lattice structure of interconnecting continuous channels.

11. The implant comprising a composite material according to claim 10, wherein said open-celled lattice structure is covered by a metallic layer.

12. The implant comprising a composite material according to claim 11, wherein said metallic layer comprises a biocompatible metal.

13. The implant comprising a composite material according to claim 12, wherein said biocompatible metal is tantalum.

14. The implant comprising a composite material according to claim 13, wherein said biocompatible wear resistant material is polyethylene.

15. The implant comprising a composite material according to claim 9, wherein said interface between said first portion and said second portion is formed by compression molding.

16. The implant comprising a composite material according to claim 15, wherein said interface eliminates motion between said first portion and said second portion.