Disposable provisional instrument component for evaluating the fit of an orthopaedic implant

• US 5,522,897 A
• Filed: 04/13/1995
• Issued: 06/04/1996
• Est. Priority Date: 04/26/1994
• Status: Expired due to Term

• Current Assignee: Zimmer Technology Incorporated (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Incorporated (Zimmer Biomet Holdings, Inc.)
• Inventors: Rohr, William L., King, Richard S., Lin, Steve T., Swarts, Dale F., Devanathan, Thirumalai N. C.
• Primary Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US08/422,193
• Time in Patent Office: 418 Days
• Field of Search: 623/11, 623/16, 623/18, 604/110, 604/111, 604/199, 606/102, 524/88
• US Class Current: 606/102
• CPC Class Codes: A61B 2090/0814 Preventing re-use
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/461 of knees
• CPC Class Codes: A61F 2/468 Testing instruments for artificial joints for testing non-implantable prostheses A61F2/76
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2002/30716 for single use, e.g. having means for preventing re-use
• CPC Class Codes: A61F 2240/008 Means for testing implantable prostheses
• CPC Class Codes: A61F 2250/009 for single use, e.g. having means for preventing re-use
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: Y10S 623/914 Bone

Abstract

A provisional instrument component 1 for evaluating the fit of a corresponding orthopaedic implant. The component 1 is intended and designed to be a disposable, single use provisional instrument component. The provisional instrument component 1 is made of a material which can be sterilized by gamma irradiation, but which provides a visible indicator, such as visible deformation 10, upon resterilization by exposure to a heated environment, thereby discouraging or preventing re-use of the component 1.

Claims

1. A provisional instrument component for evaluating the fit of a corresponding orthopaedic implant, wherein the component is intended and designed to be a disposable, single use provisional surgical instrument component, and wherein the provisional instrument component is comprised of a material which can be sterilized by gamma irradiation, but which provides a visible indicator upon resterilization by exposure to a heated environment to discourage or prevent reuse of the component, and wherein the provisional component includes performance characteristics which are not suitable or strong enough for implant use in a static or dynamic loaded environment, but which are suitable for provisional use for evaluating the fit of the corresponding implant.

2. The component of claim 1 wherein the visible indicator is visible deformation of the component upon resterilization by exposure to a heated environment.

3. The component of claim 2 wherein the component is comprised of a material which will visibly deform upon exposure to temperatures of about 250°

F. or greater.

4. The component of claim 2 wherein the component is comprised of a material which will visibly deform upon exposure to the heated environment of steam sterilization.

5. The component of claim 2 wherein the component is comprised of an acrylic material which is designed to soften or melt, or otherwise visibly deform, when exposed to the heated environment.

6. The component of claim 5 wherein the acrylic material is comprised of poly methyl methacrylate.

7. The component of claim 5 wherein the acrylic material is comprised of a combination of poly methyl methacrylate and methyl methacrylate.

8. The component of claim 5 wherein the acrylic material is a liquid molding compound including poly methyl methacrylate, methyl methacrylate, benzoyl peroxide and N,N-Dimethyl-P-Toluidine.

9. The component of claim 5 wherein the acrylic material further includes a fiber reinforcement or filler.

10. The component of claim 1 wherein the component further includes a reinforcement portion.

11. The component of claim 1 wherein the material includes a temperature sensitive color indicator which will change color upon exposure to the heated environment.

12. A provisional instrument component for evaluating the fit of a corresponding orthopaedic implant, wherein the component is intended and designed to be a disposable, single use provisional surgical instrument component, and wherein the provisional instrument component is comprised of a material which can be sterilized by gamma irradiation, but which provides a visible indicator upon resterilization by exposure to a heated environment to discourage or prevent reuse of the component, and wherein the material includes a mineral which will release gas and cause visible deformation in the form of bumps or bubbles on the component upon exposure to the heated environment.

13. A provisional instrument component for evaluating the fit of a corresponding orthopaedic implant, wherein the component is intended and designed to be a disposable, single use provisional surgical instrument component, and wherein the provisional instrument component is comprised of a material which provides a visible indicator upon resterilization by exposure to a heated environment to discourage or prevent reuse of the component, and wherein the material includes a mineral which will release gas and cause visible deformation in the form of bumps or bubbles on the component upon exposure to the heated environment.

14. A provisional instrument component for evaluating the fit of a corresponding orthopaedic implant, wherein the component is intended and designed to be a disposable, single use provisional surgical instrument component, and wherein the provisional instrument component is comprised of a material which can be initially sterilized in a nonheated environment, but which provides a visible indicator upon resterilization by exposure to a heated environment to discourage or prevent reuse of the component, and wherein the provisional component includes performance characteristics which are not suitable or strong enough for implant use in a static or dynamic loaded environment, but which are suitable for provisional use for evaluating the fit of the corresponding implant.