Source: http://www.google.es/patents/US9277949
Timestamp: 2018-01-16 12:03:54
Document Index: 41065630

Matched Legal Cases: ['§119', 'Application No. 2', 'Application No. 2', 'Application No. 2', 'Application No. 10012589', 'Art. 94', 'Art. 94', 'Art. 94', 'Art. 94', 'Art. 94', 'Art. 94', 'Application No. 09013154', 'Art. 94', 'Art. 94', 'Art. 94']

Patente US9277949 - Antioxidant stabilized crosslinked ultra high molecular weight polyethylene ... - Google Patentes
An antioxidant combined with UHMWPE prior to subjecting the UHMWPE to crosslinking irradiation. In one exemplary embodiment, the antioxidant is tocopherol. After the antioxidant is combined with the UHMWPE, the resulting blend may be formed into slabs, bar stock, and/or incorporated into a substrate,...http://www.google.es/patents/US9277949?utm_source=gb-gplus-sharePatente US9277949 - Antioxidant stabilized crosslinked ultra high molecular weight polyethylene for medical device applications
Número de publicación US9277949 B2
Número de solicitud US 14/157,695
También publicado como US8664290, US20110028600, US20140194934, US20160108184
Número de publicación 14157695, 157695, US 9277949 B2, US 9277949B2, US-B2-9277949, US9277949 B2, US9277949B2
Inventores Alicia Rufner, John Knight, Toni Rowe, Dirk Pletcher, Ray Gsell, Werner Schneider, Hallie E Brinkerhuff
Citas de patentes (203), Otras citas (235), Clasificaciones (20)
US 9277949 B2
a consolidated blend of UHMWPE and an antioxidant which has been irradiated to crosslink the blend, wherein the consolidated and irradiated blend has a pin-on-disk wear rate of about 0.02 mg/Mc to about 0.69 mg/Mc,
wherein the bulk oxidation index of the blend is about zero after about 2 weeks of accelerated aging performed according to ASTM F1980.
2. The orthopedic implant of claim 1, wherein the consolidated blend is formed by consolidation of a mixture comprising UHMWPE powder and a solvent-dissolved antioxidant and evaporation of the solvent.
3. The orthopedic implant of claim 1, wherein the consolidated and irradiated blend has been irradiated with a total dose of about 100 kGy to about 1000 kGy to crosslink the blend.
4. The orthopedic implant of claim 1, wherein the consolidated and irradiated blend has an elongation-at-break of about 246.2% to about 411.2%.
5. The orthopedic implant of claim 1, wherein the consolidated and irradiated blend has a crosslink density of more than about 0.18 moles/dm3.
6. The orthopedic implant of claim 1, wherein at least some of the antioxidant remains in the crosslinked blend after the crosslinking irradiation.
7. The orthopedic implant of claim 1, wherein the antioxidant is tocopherol or a salt or ester thereof.
8. The orthopedic implant of claim 7, wherein about 0.011 wt % to about 0.882 wt % of the consolidated and irradiated blend is tocopherol or a salt or ester thereof that has reacted with the polyethylene to form a reaction product comprising the polyethylene and the tocopherol or salt or ester thereof, and remaining tocopherol or a salt or ester thereof that is not reacted with the polyethylene.
9. The orthopedic implant of claim 7, wherein about 0.016 wt % to about 0.575 wt % of the consolidated and irradiated blend is tocopherol or a salt or ester thereof that has reacted with the polyethylene to form a reaction product comprising the polyethylene and the tocopherol or salt or ester thereof.
10. The orthopedic implant of claim 1, wherein about 0.001 wt % to about 0.592 wt % of the consolidated and irradiated blend is remaining tocopherol or a salt or ester thereof that is not reacted with the polyethylene.
11. The orthopedic implant of claim 1, wherein the consolidated and irradiated blend has about no detectable oxidation after about 8 weeks of accelerated aging performed according to ASTM F2003.
12. The orthopedic implant of claim 1, wherein the consolidated and irradiated blend has about no detectable oxidation after about 24 weeks of accelerated aging performed according to ASTM F2003.
13. The orthopedic implant of claim 1, wherein the bulk oxidation index of the blend is about zero after about 1 week of accelerated aging performed according to ASTM F1980.
14. The orthopedic implant of claim 1, wherein the surface oxidation index of the blend is about zero after about 1 week of accelerated aging performed according to ASTM F1980.
15. The orthopedic implant of claim 1, wherein the consolidated and irradiated blend has a pin-on-disk wear rate of about 0.09 mg/Mc to about 0.62 mg/Mc.
16. The orthopedic implant of claim 1, wherein the consolidated and irradiated blend has been molded into at least one of a substrate, a polymeric article, and an antioxidant stabilized polymeric article.
17. The orthopedic implant of claim 1, wherein after about 50 days of immersion in deionized water at about 70° C., about none of the antioxidant remaining in the consolidated and irradiated blend has leached into the water.
18. The orthopedic implant of claim 1, wherein after subjecting a 1-cm cube of the consolidated and irradiated blend to soaking in an about 100-mL deionized water bath at a temperature of at least about 70° C. for at least about 53 days leaches a sufficiently small quantity of the antioxidant such that an absorbance reading of the water in an about 10 mm quartz tube at about 297 nm shows no greater than about 0.01 units of increase from a reference water absorbance.
a consolidated blend of UHMWPE and tocopherol or a salt or ester thereof which has been irradiated to crosslink the blend, wherein about 0.011 wt % to about 0.882 wt % of the consolidated and irradiated blend is tocopherol or a salt or ester thereof that has reacted with the polyethylene and remaining tocopherol or a salt or ester thereof to form a reaction product comprising the polyethylene and the tocopherol or salt or ester thereof, about 0.001 wt % to about 0.592 wt % of the consolidated and irradiated blend is remaining tocopherol or a salt or ester thereof that is not reacted with the polyethylene, and the consolidated and irradiated blend has a pin-on-disk wear rate of about 0.02 mg/Mc to about 0.69 mg/Mc,
This application is a continuation of U.S. patent application Ser. No. 12/847,741, filed Jul. 30, 2010, which is a continuation-in-part of U.S. patent application Ser. No. 12/579,094, filed Oct. 14, 2009, now issued as U.S. Pat. No. 8,129,440, which is a continuation of U.S. patent application Ser. No. 12/100,894, filed Apr. 10, 2008, now abandoned, which claims the benefit under Title 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No. 60/922,738, entitled AN ANTIOXIDANT STABILIZED CROSSLINKED ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE FOR MEDICAL DEVICE APPLICATIONS, filed on Apr. 10, 2007, the entire disclosures of which are expressly incorporated by reference herein.
FIG. 6 is a graph comparing TV1 in UHMWPE blend at different depths;
FIG. 8 is a graph illustrating the ration of IM peak at 1738 cm-1 to PE peak at 4322 cm-1 as a measure of IM absorption over aging time;
After processing, the UHMWPE blend may be heated to a temperature below the melting point of the UHMWPE blend to relieve any residual stresses that may have been formed during processing and to provide additional dimensional stability. In one exemplary embodiment, the melting point of the UHMWPE blend is determined according to standard methods using differential scanning calorimetry. Heating the UHMWPE blend below the melting point creates a more homogenous mixture and increases the final crystallinity. In one exemplary embodiment, the UHMWPE blend is heated to a temperature below its melting point, e.g., between 80° Celsius (C) and 140° C., and held isothermally for six hours. In other exemplary embodiments, the UHMWPE may be heated to a temperature as low as 80° C., 90° C., 95° C., or 100° C. or as high as 110° C., 115° C., 120° C., and 126° C. In other exemplary embodiments the temperature may be held for as short as 0.5 hours, 1.0 hours, 1.5 hours, or 2.0 hours or as long as 3.0 hours, 4.0 hours, 5.0 hours, or 6.0 hours. In another exemplary embodiment, the UHMWPE blend is heated after irradiation, described below, to provide similar benefits to the UHMWPE blend.
In some embodiments, the irradiated UHMWPE blend can have a pin-on-disk wear rate of about 0.02 mg/Mc to about 0.58 mg/Mc. In some embodiments, the irradiated UHMWPE blend can have a pin-on-disk wear rate of about 0.02 mg/Mc to about 0.69 mg/Mc. In some embodiments, the irradiated UHMWPE blend can have a pin-on-disk wear rate of about 0.09 mg/Mc to about 0.62 mg/Mc.
VE1 d/1-α-tocopherol index
Mc million cycles molecular weight between
Method of Water Calorimeter Aluminum Radiochromic
Dosimetry Calorimeter Film
tocopherol Dose, kGy Elongation, Yield, UTS,
Blended with d/1-α-tocopherol
VE VE VE %
VE % VE % Index Index (aged)
1370 nm 1900 nm 1370 nm 1900 nm 1370 nm
Run IR peak IR peak IR peak IR peak IR peak
VE % VE Index VE Index OI
(aged) (aged) (aged) (Extraction- TVI
1900 nm 1370 nm 1900 nm aged) TVI (aged)
Run IR peak IR peak IR peak FTIR FTIR FTIR
Oven to Free radicals
Preheat Dose Dose Rate Beam (spins/gram ×
Run Block (° C.) (kGy) VE % (kGy-m/min.) (minutes) E10-16)
Mechanical Properties of UHMWPE Blended with d/1-α-tocopherol
2 122.2 90 0.2 75 1050 74.8 348.8 50.338 21.72 6.12
8 100 150 1 75 1020 81.25 Not Tested 4.73
11 40 150 0.2 240 1020 87.53 293.1 56.19 26.87 5.96
12 100 150 0.2 240 1050 87.75 307.2 52.95 25.21 6.31
40 110 200 1 155 1050 69.42 329.7 49.54 23.12 6.27
Wear Properties of UHMWPE Mixed with d/1-α-tocopherol
Oven to POD
Preheat Dose Dose Rate Beam Wear
Run Block (° C.) (KGy) VE % (kGy-m/min.) (minutes) (mg/Mc)
In both of the monoblocks that were irradiated with the substrate facing the irradiation source, a band of discoloration, i.e., translucence, can be seen along the edge of the UHMWPE blend that interfaced with the substrate. As shown in FIG. 6 the FTIR analysis showed a substantial decline in the TVI of the UHMWPE blend at a point just past the interface between the UHMWPE blend and the substrate. Additionally, the percent crystallinity at a point in the center of the UHMWPE blend was approximately 59%. The percent crystallinity decreased as the UHMWPE blend approached the interface with the substrate, with the percent crystallinity reaching 48% in the translucent region near the UHMWPE blend/substrate interface, as shown in TABLE 9 below. In the preform that was irradiated with the substrate facing away from the irradiation source, the TVI of the UHMWPE blend was substantially more uniform throughout the UHMWPE blend and the percent crystallinity varied by only 2.2%. This may be a result of more uniform crosslinking occurring in the preform in which the substrate faced away from the irradiation source during irradiation.
Percent Crystallnity of UHMWPE Blend
% Crystallinity at % Crystallinity at
the center of the the UHMWPE Blend/
The pucks were preheated in a Grieve convection oven, available from The Grieve Corporation of Round Lake, Ill., to a preheat temperature. The preheat temperature was selected from 85° C. and 115° C. Once preheated, the pucks were then exposed to a selected total irradiation dose according to Method A, as set forth above in TABLE 2. The total irradiation dose was selected from 160 kGy and 190 kGy. One centimeter cubes were then machined from the pucks and placed in glass jars containing 100 ml of deionized water. The jars were then sealed using Teflon® seals and caps, available from E.I. DuPont Nemours and Company. Teflon® is a registered trademark of E. I. DuPont Nemours and Company of 1007 Market Street, Wilmington Del.
Elution of d/1-α-tocopherol in Deionized Water
Solvent 53 Day Water 53 Day Water
Temperature Wt (g) · Sample Raw A @ Net A @
Group # Solvent (° C.) Vol (mL) Weight (g) 297 nm 297 nm
Water −0.0016
The resulting UHMWPE blend cubes were then studied to investigate the polymer network parameters of the UHMWPE blend by measuring the materials' swell ratio (qs) with a Swell Ratio Tester (SRT), Cambridge Polymer Group (Boston, Mass.), in accordance with ASTM F-2214-02. Knowing qs, the Flory interaction parameter (χ1), the molar volume of the solvent (φ1), and the specific volume of the solvent ( ν), the crosslink density (νx) and the molecular weight between crosslinks (Mc) of the material were calculated according the following equations:
Additionally, it was found that under some conditions the crosslinked UHMWPE blend exhibited a crosslink density of less than 0.200 moles/dm3. Under other conditions, the crosslinked UHMWPE blend having at least 0.1 weight percent antioxidant exhibited a crosslink density of less than 0.190 moles/dm3. Further, under certain conditions, the crosslinked UHMWPE blend having at least 0.1 weight percent antioxidant exhibited a crosslink density of more than 0.200 moles/dm3 and had a molecular weight between cross links of less than 11,200 daltons.
SAMPLE PREHEAT DOSE
MATERIAL DOSE TEMP PERCENT RATE
RUN TYPE (kGy) (° C.) VITAMIN E (kGy-m/min)
POD WEAR Vx = XLD
mg/1M SWELL RATIO moles/ Mc = MWbXL
RUN CYCLES V/V0 = q(s) X dm{circumflex over ( )}3 Daltons
12 0.17 3.23 0.50 0.141 7135
The CT specimens were sent to Exova OCM Test Laboratories located in Anaheim, Calif. for testing per ASTM E647-08. A starter crack of length 3 mm was machined into the notch 202 (FIG. 4) prior to testing. Specimens were tested with an R-ratio of 0.1, a sinusoidal waveform, and a frequency of 3 Hz. All testing was performed at room temperature. Fatigue crack growth length was measured during the testing with an optical microscope. The number of cycles (n) for each growth period was recorded, and specimens were cycled until failure occurred.
GUR 1020 GUR 1050
185 kGy, 100 kGy,
0.14% VE Remelted
Exponent (m) 7.42 ± 0.39 6.89 ± 0.48
Coefficient (C) [×10−7] 0.17 ± 0.03 1.35 ± 0.42
ΔKinception, 1.73 ± 0.03 1.29 ± 0.01
Mpa-m0.5
OrthoPOD wear, 0.16 ± 0.06 0.33 ± 0.31
In this investigation, three different types of materials were tested, (1) gamma sterilized GUR 1050 (UHMWPE), (2) e-beam irradiated and post melted GUR 1050 (XLPE), and (3) an e-beam irradiated GUR 1050/Vitamin E blend (VE-XLPE). GUR 1050 medical grade UHMWPE powders were obtained from Ticona, having North American headquarters in Florence, Ky. d/l-α-tocopherol was obtained from DSM Nutritional Products, Ltd. of Geleen, Netherlands.
SOI AND BOI OF ACCELERATED AGE SAMPLES
SOI ASTM F1980 −0.08 −0.07 −0.06 −0.04 −0.07 −0.05 — —
ASTM F2003 −0.08 −0.06 −0.05 0.00 −0.01 −0.05 0.00 0.02
BSF −0.08 −0.01 0.01 0.07 −0.02 0.04 0.07 0.00
BOI ASTM F1980 −0.09 0.09 −0.08 −0.07 −0.07 −0.06 — —
ASTM F2003 −0.09 −0.05 −0.05 −0.04 −0.07 −0.03 −0.02  0.00
BSF −0.09 −0.02 0.00 0.04 0.01 0.03 0.05 −0.03
SOI ASTM F1980 −0.07 −0.08 −0.06 −0.05 0.13 0.05 — —
ASTM F2003 −0.07 −0.06 −0.05 0.04 0.62 1.59 4.15 *
BSF −0.07 −0.06 0.00 −0.07 −0.06 −0.05 −0.06  −0.05
BOI ASTM F1980 −0.06 −0.07 −0.06 −0.05 0.03 0.19 — —
ASTM F2003 −0.06 −0.06 −0.04 0.07 0.78 1.84 4.26 *
BSF −0.06 −0.05 0.00 −0.08 −0.06 −0.05 −0.05  −0.04
SOI ASTM F1980 −0.03 −0.02 0.09 0.02 0.22 0.33 — —
ASTM F2003 −0.03 0.03 0.04 0.61 3.85 * * *
BSF −0.03 0.02 0.06 0.08 0.14 0.10 0.53 *
BSF extracted — — — — — — 0.62 *
BOI ASTM F1980 −0.03 −0.04 −0.02 0.01 0.03 0.05 — —
ASTM F2003 −0.03 0.02 0.20 0.72 2.53 * * *
BSF −0.03 0.01 0.07 0.12 0.31 0.42 1.27 *
BSF extracted — — — — — — 1.40 *
Portions of each of the materials (UHMWPE, XLPE, VE-PE, VE-XLPE and Extracted) were machined into 3 mm cubes. Three cubes of each of the materials were analyzed for crosslink density by swell ratio testing according to ASTM F2214-02 by Cambridge Polymer Group located in Boston, Mass. Additionally, prior to absorptivity testing, crystallinity of each of the materials was measured in according to ASTM D 2625 and using a Q1000 available from TA Instruments of New Castle, Del.
Portions of each of the materials were machined into 10 mm cubes. Five 10 mm cubes of each of the materials were aged in 100% isopropyl myristate solution available from Sigma-Aldrich, St. Louis, Mo. at 60° C. Care was taken to make sure that all surfaces of the cubes were equally exposed to the aging environment by submerging the cubes in the isopropyl myristate and placing the cubes on a wire mesh. One cube of each of the materials was removed at 1, 2, 3, 5, and 6 weeks. After being removed from the aging environment, 200 μm thick films were microtomed from the center of each cube. The films then underwent FT-IR analysis using an Excalibur FTS 3000 FTIR available from Digilab located in Randolph, Mass. The height of the IM peak at 1738 cm−1 was ratioed to the polyethylene peak representing C-H overtones at 4322 cm−1. The IM index was reported in the bulk of the material (center 4.8 mm of the cube).
It will be understood that the methods, compositions, devices and embodiments described above are illustrative of the applications of the principles of the subject matter disclosed herein. It will also be understood that certain modifications may be made by those skilled in the art without departing from the spirit and scope of the subject matter disclosed and/or claimed herein. Thus, the scope of the invention is not limited to the above description, but is set forth in the following claims and/or any future claims made in any application that claims the benefit of this application.
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US20050125074 * 4 Nov 2004 9 Jun 2005 Ronald Salovey Crosslinking of polyethylene for low wear using radiation and thermal treatments
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Clasificación internacional C08K9/10, C08K5/00, C08K5/1545, A61L27/50, C08L23/06, A61L27/16, A61B17/80
Clasificación cooperativa C08J2323/26, C08J3/28, C08J3/247, A61B17/8085, Y10T428/315, C08K5/005, Y10T428/31, C08L23/06, C08K5/1545, C08K9/10, C08L2312/06, A61L27/16, A61L27/505