Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Bone
Utility Patent
1996-05-06
2001-01-02
Millin, V. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Bone
C623S023580, C522S161000, C525S333800
Utility Patent
active
06168626
ABSTRACT:
TECHNICAL FIELD
The present invention relates to an ultra high molecular weight polyethylene molded article suitable for artificial joints having molecular orientation or crystal orientation and to a method of preparing the same.
BACKGROUND ART
Thirty years or more have passed since an artificial joint was developed and applied clinically to patients suffering from any diseases of arthritis. Since then, benefits given by the artificial joint have been great in the sense of social welfare because, for example, patients with chronic rheumatism have been able to walk again and to return to public life. On the other hand, however, serious problems have occurred, particularly late appearing complications caused by total joint arthroplasty, a high rate of “loosening” in the implant components, and the necessity of revision of the joint with a surgical operation due to osteolysis around the implanted artificial joint.
These artificial joints includes an artificial hip joint, an artificial knee joint, an artificial elbow joint, an artificial finger joint, artificial shoulder joint and the like. Among those joints, it is necessary for the artificial hip joint and artificial knee joint to have high mechanical strength because gravity corresponding to several times the patient's body weight is applied to them. Therefore, materials for the artificial joint at present are constituted of a hard material of metal or ceramic and a soft socket of an ultra high molecular weight polyethylene (UHMWPE). While the UHMWPE constituting such a socket is superior in abrasion resistance as compared with polymeric materials such as polytetrafluoroethylene and polycarbonate, the UHMWPE is inferior in properties such as low abrasion resistance and stress relaxation to impact load which are inherently possessed by articular cartilage of living body. Also, reaction caused by a foreign matter has been a serious problem wherein macrophages proliferate against wear debris of the UHMWPE socket, i.e. component and an abnormal granulation tissue generated thereby causes resorption of the bone.
After artificial joints were developed, though some improvements in qualities of material and design have been made, for example, a cementless artificial joint and the like with respect to the hard material, there has been no remarkable progress for about thirty years with respect to the soft socket portion except that the UHMWPE was employed. And if the artificial joint is used for a long period of time, numerous wear debris of polyethylene are produced because of friction between the hard material such as metal and the UHMWPE of the socket. By considering the osteolysis due to granulation tissue containing a foreign matter which is caused by the wear debris, further improvement of abrasion resistance is indispensable. As an attempt to reduce the abrasion of UHMWPE, it can be considered to select a material for the hard material and to improve the UHMWPE. Though the irradiation of an ultra high dose of &ggr;-ray was tried for improving the UHMWPE, it was made clear that coefficient of abrasion increases and abrasion loss does not decrease. Also, though the improvement to increase molecular weight of the UHMWPE was made and a weight-average molecular weight of the UHMWPE at present has been increased to approximately 5 to 8 million, it is difficult to make a UHMWPE having a far ultra high molecular weight. Further, considerable improvement in dynamic properties can scarcely be expected even if a UHMWPE having a weight-average molecular weight of 10 million could be synthesized. Thus, it is regarded that any improvement in dynamic properties of the UHMWPE by chemical modification reached its limitation, and it is regarded to be difficult to obtain a UHMWPE molded article having a more excellent abrasion resistance and lower friction.
It is well-known that Carothers of E.I. Du Pont developed, first all over the world, a synthetic fiber, i.e., Nylon, and greatly contributed industrially. As means for improving mechanical properties of this synthetic fiber, uniaxial stretching in the direction of fiber axis is carried out industrially. Also, to improve the strength of the film, biaxial stretching and rolling are carried out industrially. In accordance with these methods, mechanical properties can be increased considerably by giving uniaxial orientation or biaxial orientation to molecules or crystals.
From these points of view, there is an idea that orientation is given to molecules or crystals in the polymer structure to improve the mechanical properties. However, any technologies cannot endow molecules or crystals with orientation in a large molded article in the form of block, and it is not easy to consider enablement of a method.
Then, the present inventors tried to obtain a molded article of a low friction and to improve an abrasion resistance by introducing molecular orientation or crystal orientation into a finished product by means of, not a chemical modification method, but a physical modification method.
This approach has never been attempted, not only in Japan, but also in other countries. The idea to endow the polyethylene molded article for artificial joints with molecular orientation or crystal orientation is the very creative, and it is sure that this invention, if actually carried out, will be applied to artificial joints all over the world. Also, this invention will be revolutionary in terms of industrial innovation whereby disadvantages which have been problems for the past thirty years are improved.
DISCLOSURE OF THE INVENTION
The invention relates to an ultra high molecular weight polyethylene (UHMWPE) molded article for artificial joints and to an artificial join comprising the UHMWPE molded article.
This UHMWPE molded article having molecular orientation or crystal orientation can be obtained by irradiating a low dose of a high energy ray to a raw UHMWPE molded article to introduce a very small amount of crosslinking points in polymer chains so as to be crosslinked slightly, then by compression-deforming the crosslinked UHMWPE molded article after heating up to its compression-deformable temperature, and by cooling the molded article while keeping the deformed state.
The UHMWPE molded article having molecular orientation or crystal orientation (hereinafter referred to as “oriented UHMWPE molded article”) of the present invention has a low friction and remarkably improved abrasion resistance. And, the artificial joint comprising the oriented UHMWPE molded article has a smooth lubricity and reduced amount of abrasion loss.
BEST MODE FOR CARRYING OUT INVENTION
The oriented UHMWPE molded article of the invention has molecular orientation or crystal orientation within the molded article. The meaning of “to have molecular orientation within the molded article” is that polymer chains are oriented perpendicular to the direction of the compression, namely, oriented to the direction of the flow of the molecular chains. The meaning of “to have crystal orientation” is that the crystal planes in polyethylene such as (
200
) plane and (
110
) plane are oriented to the direction parallel to the compression plane, namely, that the crystal planes are oriented. Also, the presence of these orientations can be known by means of biefringence measurements, infrared spectra and X-ray diffraction. And, a coefficient of friction of the molded article decreases and abrasion loss also decreases by endowing with those orientations. Also, other functional properties, for example, tensile strength and tensile modulus are improved, and also density, thermal properties (melting point, heat of fusion) and the like are improved.
As described above, the oriented UHMWPE molded article can be obtained by irradiating a high energy ray to raw UHMWPE and then heating up and compression-deforming the UHMWPE, followed by cooling and solidifying.
As the raw UHMWPE, one having a weight-average molecular weight of 2 to 8 million, preferably 5 to 7 million is used. The melting point thereof is approximately 136° to 139° C. The raw UHMWPE is used u
Hyon Suong-Hyu
Oka Masanori
Armstrong, Westerman Hattori, McLeland & Naughton
BMG Incorporated
Millin V.
Nguyen Tram A.
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