Precoated polymeric prosthesis and process for making same

• US 6,558,428 B2
• Filed: 01/30/2001
• Issued: 05/06/2003
• Est. Priority Date: 04/01/1999
• Status: Expired due to Fees

• Current Assignee: Joon B. Park
• Original Assignee: Joon B. Park
• Inventors: Park, Joon B.
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US09/772,795
• Publication Number:
  US 20010011190A1
• Time in Patent Office: 826 Days
• Field of Search: 623/16.11, 623/17.11, 623/23.59, 623/23.37, 623/23.11, 606/76, 606/213, 427/2.26, 427/2.24, 427/379, 427/393.5, 428/170, 428/218
• US Class Current: 623/23.59
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/32 for the hip
• CPC Class Codes: A61F 2/34 Acetabular cups
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/3662 Femoral shafts
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/30878 with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/30929 having at least two superposed coatings
• CPC Class Codes: A61F 2002/30934 Special articulating surfaces
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2002/3611 Heads or epiphyseal parts of femur
• 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 2230/0019 rectangular
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: A61F 2310/00952 : Coating, pre-coating or prosthesis-covering structure made of bone cement, e.g. pre-applied PMMA cement mantle
• CPC Class Codes: A61L 2420/02 : Methods for coating medical devices
• CPC Class Codes: A61L 27/26 : Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/34 : Macromolecular materials
• CPC Class Codes: C08L 23/06 : Polyethene
• CPC Class Codes: C08L 2666/04 : Macromolecular compounds according to groups C08L7/00 - C08L49/00, or C08L55/00 - C08L57/00; Derivatives thereof
• CPC Class Codes: C08L 33/12 : Homopolymers or copolymers of methyl methacrylate
• CPC Class Codes: C09D 133/12 : Homopolymers or copolymers of methyl methacrylate
• CPC Class Codes: Y10S 623/923 : Bone

Abstract

The present invention is directed to a polymeric prosthesis precoated with a bone cement compatible polymer. The bone cement compatible polymer coating, is provided by an activated powder mixture of polymethyl methacrylate and ultra high molecular weight polyethylene which is bonded to the outer surface of the prosthesis by sintering. Once bonded to a polymeric prosthesis in accordance with the present invention, the precoat strengthens the interface between a bone cement and a prosthesis when the prosthesis is later implanted. The inner layer of the prosthesis may be provided of cross-linked UHMWPE powder sintered with virgin UHMWPE powder or fibers to provide a intermediate layer(s) of the coating present on the prosthesis. The precoat also decreases the likelihood that the prosthesis will loosen and break away from the cement over time. The polymeric implant product of the present invention is particularly well suited for use as an acetabular cup or a tibia plateau in replacing hip joints and knee joints respectively.

Claims

1. An implant product for implantation into the body comprising:

a prosthetic member having a shape configured to be implanted into a prepared area of the body, said prosthetic member defining a polymer surface adapted to be attached to an adjoining bone with a bone cement composition;

a coating covering said polymer surface of said prosthetic member, said coating being made from a bone cement compatible polymer comprising an activated mixture of UHMWPE and polymethyl methacrylate; and

an interfacial layer between said surface of said prosthetic member and said coating, said coating being bonded to said surface across said interfacial layer, said interfacial layer being made from a mixture of cross-linked polyethylene, virgin polyethylene, and polyethylene fibers.

2. An implant product as defined in claim 1, wherein said polymer used to make said prosthetic member comprises polyethylene.

3. An Implant product as defined in claim 1, wherein said coating is applied to said polymer surface as a sintered layer.

4. An implant product as defined in claim 1, wherein said interfacial layer is at least 1 millimeter thick.

5. An implant product as defined in claim 1, wherein said coating of said bone cement compatible polymer is up to about 2 millimeters thick and has a substantially pore free outer surface.

6. An implant product as defined in claim 1, wherein said implant product comprises an acetabular cup or a tibia plateau.

7. A method of orthopedic implantation of a polymeric prosthesis with a bone cement composition comprising the steps of:

providing a polymeric prosthesis to be implanted;

contacting said prosthesis with an activated powder mixture of UHMWPE and PMMA;

sintering said activated powder mixture to said prosthesis, thereby providing a precoated prosthesis;

preparing an area within a patient to receive the precoated polymeric prosthesis;

inserting a quantity of a bone cement composition into the prepared area;

immediately positioning said precoated polymeric prosthesis in the prepared area; and

permitting said bone cement composition to cure for bonding said precoated polymeric prosthesis with said prepared area.

8. A method as defined in claim 7, wherein said polymeric prosthesis is made from a polymer comprising UHMWPE and said bone cement compatible polymer comprises a melted mixture of polymethyl methacrylate and UHMWPE.

9. A method as defined in claim 7, wherein said sintering step further comprises sintering under an inert atmosphere.

10. A coating composition for a polymeric member comprising:

a sinterable mixture of an adhesive polymer and a structural polymer.

11. The coating composition according to claim 10 wherein said adhesive polymer is PMMA.

12. The coating composition according to claim 10 wherein said structural polymer is polyethylene.

13. The coating composition according to claim 10 wherein said sinterable mixture comprises a bone cement compatible polymer of PMMA and a structural polymer of UHMWPE.

14. The coating composition according to claim 10 wherein said sinterable mixture further comprises MMA.

15. The coating composition according to claim 13 wherein said sinterable mixture further comprises MMA.

16. The coating composition according to claim 15 wherein said MMA reacts under sintering conditions to form PMMA.