CA2615068A1 - Radiation and melt treated ultra high molecular weight polyethylene prosthetic devices - Google Patents
Radiation and melt treated ultra high molecular weight polyethylene prosthetic devices Download PDFInfo
- Publication number
- CA2615068A1 CA2615068A1 CA002615068A CA2615068A CA2615068A1 CA 2615068 A1 CA2615068 A1 CA 2615068A1 CA 002615068 A CA002615068 A CA 002615068A CA 2615068 A CA2615068 A CA 2615068A CA 2615068 A1 CA2615068 A1 CA 2615068A1
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- CA
- Canada
- Prior art keywords
- polyethylene
- preformed material
- consolidated
- mrad
- preformed
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Abstract
A medical prosthesis for use within the body which is formed of radiation treated ultra high molecular weight polyethylene having substantially no detectable free radicals, is described. Preferres prosthesis exhibit reduced production of particles from the prosthesis during wear of the prosthesis, and are substantially oxidation resistant. Methods of manufacture of such devices and material used therein are also provided.
Claims (25)
1. A preformed material for subsequent production of a wear resistant medical implant comprising a cross-linked consolidated polyethylene produced by a method comprising the steps of:
(a) irradiating consolidated polyethylene to cross-link polyethylene molecules;
(b) ceasing irradiation of the consolidated polyethylene, wherein the temperature of the consolidated polyethylene is above room temperature;
(c) repeating steps (a) and (b) at least once to obtain a total absorbed radiation dose of about 5 to about 100 MRad; and (d) allowing the cross-linked consolidated polyethylene to cool.
(a) irradiating consolidated polyethylene to cross-link polyethylene molecules;
(b) ceasing irradiation of the consolidated polyethylene, wherein the temperature of the consolidated polyethylene is above room temperature;
(c) repeating steps (a) and (b) at least once to obtain a total absorbed radiation dose of about 5 to about 100 MRad; and (d) allowing the cross-linked consolidated polyethylene to cool.
2. The preformed material of claim 1, wherein the step (c) is repeated at least twice.
3. The preformed material of claim 1, wherein the total absorbed radiation dose is about 10 to about 100 MRad.
4. The preformed material of claim 1, wherein the total absorbed radiation dose is from about 5 to about 10 MRad
5. The preformed material of claim 1, wherein three radiation doses are applied, and wherein the dose for each irradiation is from about 2 and about 5 MRad.
6. The preformed material of claim 1, wherein the polyethylene has a weight average molecular weight of greater than 400,000, wherein the weight average molecular weight is the weight average molecular weight of the polyethylene prior to cross-linking by irradiation.
7. The preformed material of claim 1, wherein the temperature of the consolidated polyethylene at step (b) is at a temperature lower than the melting point of the polyethylene.
8. The preformed material of claim 1, wherein the method is further comprising the step of fashioning an implantable bearing component from the polyethylene.
9. The preformed material of claim 1, wherein the irradiation step precedes the fashioning step.
10. The preformed material of claim 1, wherein the polyethylene has a crystallinity less than 50%.
11. The preformed material of claim 1, wherein the polyethylene has a tensile elastic modulus of less than 940 MPa.
12 The preformed material of claim 1, wherein the polyethylene has a lamellar thickness less than 290 .ANG..
13. The preformed material of claim 1, wherein the polyethylene has a hardness less than 65 on the Shore D scale.
14. The preformed material of claim 1, wherein the polyethylene has a hardness less than 55 on the Shore D scale.
15. The preformed material of claim 1, wherein the polyethylene has a hardness less than 50 on the Shore D scale.
16. The preformed material of claim 1, wherein at least 50% of the polyethylene does not dissolve in Decalin over a period of 24 hours.
17. The preformed material of claim 1, wherein the polyethylene has a gel content of 99% or greater.
18. A method for increasing the wear resistance of a preformed polyethylene comprising the steps of:
(a) irradiating the preformed polyethylene in the solid state to cross-link polyethylene molecules;
(b) ceasing irradiation of the consolidated polyethylene, wherein the temperature of the consolidated polyethylene is above room temperature;
(c) repeating steps (a) and (b) at least once to obtain a total absorbed dose of about 5 to about 100 MRad; and (d) allowing the consolidated polyethylene to cool.
(a) irradiating the preformed polyethylene in the solid state to cross-link polyethylene molecules;
(b) ceasing irradiation of the consolidated polyethylene, wherein the temperature of the consolidated polyethylene is above room temperature;
(c) repeating steps (a) and (b) at least once to obtain a total absorbed dose of about 5 to about 100 MRad; and (d) allowing the consolidated polyethylene to cool.
19. The method for increasing the wear resistance according to claim 18, wherein the total radiation dose is about 10 to about 100 MRad.
20. The method for increasing the wear resistance according to claim 18, wherein the total radiation dose is from about 5 to about 10 MRad.
21. The method for increasing the wear resistance according to claim 18, wherein the dose for each irradiation is from about 2 and about 5 MRad.
22. The method for increasing the wear resistance according to claim 18, wherein the total radiation dose is from about 5 to about 20 MRad.
23. The method for increasing the wear resistance as set forth in claim 18, wherein the weight average molecular weight of the polyethylene is greater than 400,000, wherein the weight average molecular weight is the weight average molecular weight of the polyethylene prior to cross-linking by irradiation.
24. The method for increasing the wear resistance according to claim 18, wherein the method is further including the step of machining the preformed polyethylene into a medical implant.
25. A medical device comprising a polyethylene material produced by a method comprising the steps of:
(a) irradiating consolidated polyethylene to cross-link polyethylene molecules;
(b) ceasing irradiation of the consolidated polyethylene, wherein the temperature of the consolidated polyethylene is lower than the melting point of the polyethylene material, (c) repeating steps (a) and (b) at least once to obtain a total absorbed radiation dose of about 5 to about 100 MRad; and (d) allowing the cross-linked consolidated polyethylene to cool.
(a) irradiating consolidated polyethylene to cross-link polyethylene molecules;
(b) ceasing irradiation of the consolidated polyethylene, wherein the temperature of the consolidated polyethylene is lower than the melting point of the polyethylene material, (c) repeating steps (a) and (b) at least once to obtain a total absorbed radiation dose of about 5 to about 100 MRad; and (d) allowing the cross-linked consolidated polyethylene to cool.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/600,744 | 1996-02-13 | ||
| US08/600,744 US5879400A (en) | 1996-02-13 | 1996-02-13 | Melt-irradiated ultra high molecular weight polyethylene prosthetic devices |
| US72631396A | 1996-10-02 | 1996-10-02 | |
| US08/726,313 | 1996-10-02 | ||
| CA002246342A CA2246342C (en) | 1996-02-13 | 1997-02-11 | Radiation and melt treated ultra high molecular weight polyethylene prosthetic devices |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002246342A Division CA2246342C (en) | 1996-02-13 | 1997-02-11 | Radiation and melt treated ultra high molecular weight polyethylene prosthetic devices |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2615068A1 true CA2615068A1 (en) | 1997-08-21 |
| CA2615068C CA2615068C (en) | 2012-08-21 |
Family
ID=39264246
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2615068A Expired - Lifetime CA2615068C (en) | 1996-02-13 | 1997-02-11 | Radiation and melt treated ultra high molecular weight polyethylene prosthetic devices |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2615068C (en) |
-
1997
- 1997-02-11 CA CA2615068A patent/CA2615068C/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| CA2615068C (en) | 2012-08-21 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKEX | Expiry |
Effective date: 20170213 |