This relates to the field of medical devices and more particular to a compressive-shear wear joint replacement.
Arthritis of the thumb basal joint (or alternatively refered to as the thumb carpometacarpal (CMC) joint) or the trapeziometacarpal joint (TMJ) joint is a disabling disorder of the thumb axis. Similarly, arthritis of the metatarsophalangeal joint (MTPJ) is a disabling disorder of the toe axis. Similarly, arthritis of the tarsometatarsal joints (TMT) is a disabling disorder of the feet. Similarly, arthritis and instability of the radiocapitellar joint is a disabling disorder of the elbow joint.
Since the early 1960s, various solutions have been introduced for reconstruction of these joints to try to alievate the pain and discomfort. Silicone replacement arthroplasty of the thumb CMC was first advocated by Swanson in the early 1960s, however, such silicone joint replacements have essentially fell out of favor mainly because of the complications associated with wear of the silicone implant, and silicone synovitis. Silicone synovitis is essentially a recurrence of pain, swelling, and instability at the site of the original silicone replacement arthroplasty. It is characterized by bony destruction, and soft tissue swelling and inflammation.
Another problem associated with silicone implants is silicone elastomer transfer wear which causes a spackling effect against the bone wherein pores of the bone are filled with the silicone.
Subsequently various metallic, ceramic, absorbable polymeric, and pyro carbon implants have been introduced to serve either as spacers or hemiarthroplasty in order to provide for pain relief at the CMC, TMJ, MTPJ and radiocapitellar joints.
Biomechanically, the prior art implants are either too stiff, or too soft to provide for a durable arthroplasty. For example, the stiffness of the trapezium generally is essentially similar to that of the scaphoid at approximately 150 Megapascals. The silicone implants initially advocated in the 1960s display a stiffness of less than 4 megapascals in vivo, where as the titanium implants are in general more than 100 Gigapascals. The cobalt chrome trapezial implants display a high stiffness at 200 GigaPascals while the zirconia ceramic implants are even stiffer at approximately 400 GigaPascals. The more recent pyrocarbon introduction is an attempt to use materials which are less stiff, however, the pyrocarbon stiffness nevertheless approaches that of cortical bone at approximately 15-20 GigaPascals (3 orders of magnitude more stiff than the native trapezium). Accordingly, these materials do not provide a biomechanically appropriate implant.
Looking at the CMC, for example, the ideal material for joint replacement arthroplasty would not only be mechanically and materially less stiff than the trapezium to provide for a stable spacer to prevent collapse of the thumb, but also would be less in stiffness to that of the cortico-cancellus bone of the thumb metacarpal medullary shaft in order to prevent thumb metacarpal subsidence over the implant. In addition, an ideal material would have superior wear qualities so that microscopic wear particles would not create polymeric synovitis. In short, material that is slightly stiffer than silicone elastomer yet resistant to in vivo degradation with superior wear properties would be an ideal candidate to serve as a sound CMC, TMJ, MTPJ or radiocapitellar joint implant.
The inventor has recognized that polycarbonate urethanes (PCU), which are a class of thermoplastic polyurethanes (TPU), allow for desired elastomeric properties to be maintained in vivo, while at the same time provide for adequate protection against environmental stress cracking and breakdown in vivo.
The present invention provides in at least one embodiment a compressive force and compressive-shear force joint implant including a head defining a wear contact surface and a stem extending from the head opposite of the wear contact surface. At least the wear contact surface is manufactured from a polycarbonate urethane material.
In at least one embodiment, the present invention provides a compressive force and compressive-shear force joint implant including a head defining at least two wear contact surfaces with at least the wear contact surfaces manufactured from a polycarbonate urethane material.
The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings:
Although the invention is illustrated and described herein with reference to specific embodiments, the invention is not intended to be limited to the details shown. Rather, various modifications may be made in the details within the scope and range of equivalents of the claims and without departing from the invention.
Referring to
In the present embodiment, the head 52, including the wear contact surface 53, the stem 54 and the collar 56 are formed as a unitary structure of PCU material. While the present embodiment is illustrated as a unitary structure, the invention is not limited to such. For example, the implant 100 illustrated in
In the implant 50 of
The implant 50 of
The implant 120 of
The implants 130, 130′ of
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While the present invention is described herein in relation to CMC, TMJ, MTPJ and radiocapitellar joint arthroplasty, the invention is not limited to such. Implants in accordance with the invention may be utilized in other applications wherein the implant wear contact surface is subject to compressive contact. Additionally, while various embodiments of the implant are described herein, the invention is not limited to such. The implants may have various configurations with a head having a wear contact surface manufactured from PCU material. As explained in more detail below, the use of such PCU material provides unexpected favorable results for a compressive implant having a head with a wear surface on one side and a stem extending from the opposite side. Such an implant meets the need for a reliable implant that has existed since the 1960s.
To confirm the viability of the implants of the present invention, a wear test was performed on an exemplary PCU implant and a prior art silicone implant. In general, post reconstruction of the thumb basal joint, the maximum key pinch strength obtained is approximately 5±2.5 kilograms; activities of daily living require a pinch force no more than 2 kilograms. Therefore a normal force of 8 pounds was chosen to be applied to the prosthetic stem against synthetic bone #40 (Pacific research labs) to study wear characteristics.
Tests were performed on both silicone implants from Wright medical technology (flexspan) and the PCU implants of the present invention. Testing was performed utilizing a wear test assembly 150 as illustrated in
Table 1 below provides a summary of the weight loss during the wear test results while Table 2 shows the normalized percentage of weight loss results of the test. As can be seen, there was significantly more weight loss in the silicone group when compared to the PCU implant group.
The above clearly demonstrates that PCU implants of the current invention are significantly more durable than silicone elastomer in conditions of abrasive wear against a rough counter face which is the expected situation in vivo. More specifically, as shown in Table 2, the current silicone specimens wear 4 times more than the PCU implant specimens under uniform testing conditions for both groups.
Furthermore,
It was clear from the wear tests that the PCU implant showed significantly less wear against an artificial bone counter face. Volumetric wear is significantly less and is demonstrated by significantly less weight loss from the PCU implant sample when compared to that of the silicone elastomer implant.
In light of the fact that there is less volumetric wear of the PCU implants, and no electron microscopic evidence evidence for transfer wear as demonstrated by the scanning electron microscopy, it is believed that particulate synovitis can be avoided with the use of a more biomechanically and biomaterially sound elastomeric implant material of the present invention.
To further confirm the viability of the implants of the present invention, a thermal dynamic mechanical analysis of the silicone elastomer and the PCU implant samples were carried out at 37° C. and the results are charted in
As a further confirmation, the PCU implants specimens were subjected to a cyclic compressive fatigue test using a fatigue testing assembly 170 as shown in
The assembly 170 was on the LOAD control, half sine wave form (sine wave, only compression force−half sine). For example—the system was run from minus 0.5 Kg to minus 60 Kg. Frequency was set at 10 Hz. For stability of the wave form and force we used a special mode of amplitude control. Five different loads were tested at 10 kg, 15 kg, 25 kg, 50 kg, and 60 kg. At each load the testing took approximately 14 days to achieve 10 million cycles of compressive fatigue. As shown in