LINERS FOR MEDICAL JOINT IMPLANTS WITH IMPROVED WEAR-RESISTANCE

Abstract

An uncoated polymeric liner for a medical joint implant constructed to be engaged in between a head (or a top plate) and a stem (or a base plate) of said medical joint implant. The uncoated polymeric liner is prepared from a polymeric matrix comprising a polymeric material and at least one metal chalcogenides or dichalcogenides nanoparticle which is distributed within said polymeric matrix.

Claims

1. An uncoated polymeric liner for a medical joint implant constructed to be engaged in between a head (or a top plate) and a stem (or a base plate) of said medical joint implant, said uncoated polymeric liner comprising: a polymeric matrix comprising a polymeric material and at least one metal chalcogenides or dichalcogenides nanoparticle, wherein said at least one metal chalcogenides or dichalcogenides nanoparticle is distributed within said polymeric matrix, and wherein said at least one metal chalcogenides or dichalcogenides nanoparticle is selected from the group consisting of: a. TiS.sub.2, b. TiSe.sub.2, c. TiTe.sub.2, d. WS.sub.2, e. WSe.sub.2, f. WTe.sub.2, g. MoS.sub.2, h. MoSe.sub.2, i. MoTe.sub.2, j. SnS.sub.2, k. SnSe.sub.2, l. SnTe.sub.2, m. RuS.sub.2, n. RuSe.sub.2, o. RuTe.sub.2, p. GaS, q. GaSe, r. GaTe, s. InS, t. InSe, u. HfS.sub.2, v. ZrS.sub.2, w. VS.sub.2, x. ReS.sub.2, and y. NbS.sub.2.

2. The uncoated polymeric liner according to claim 1, wherein said at least one metal chalcogenides or dichalcogenides nanoparticle is selected from the group consisting of nanotubes nanoparticles of tungsten disulfide (WS.sub.2); and molybdenum disulfide (MoS.sub.2).

3. The uncoated polymeric liner according to claim 1, wherein said polymeric material is selected from the list consisting of: i. UHMWPE; ii. PEEK; iii. Carbon fiber-reinforced PEEK; or iv. PI.

4. The uncoated polymeric liner according to claim 1, wherein said polymeric material is UHMWPE.

5. The uncoated polymeric liner according to claim 1, wherein said polymeric matrix having a volume concentration of between 5%-99% volume per volume (v/v) of said polymeric material.

6. The uncoated polymeric liner according to claim 1, wherein said polymeric matrix having a volume concentration of between 1%-5% volume per volume (v/v) of said at least one metal chalcogenides or dichalcogenides nanoparticle.

7. The uncoated polymeric liner according to claim 1, for use in medical joint implants selected from: a hip joint, a knee joint, an ankle joint, an intervertebral disc, a shoulder joint, an elbow joint, a wrist joint, a finger joint, a finger metacarpal joint, a toe joint, a toe-metatarsal joint, a carpometacarpal joint.

8. The uncoated polymeric liner according to claim 1, produced by compression molding.

9. The uncoated polymeric liner according to claim 1, produced by 3D printing.

10. The uncoated polymeric liner according to claim 1, produced by injection molding.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The disclosed technique will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:

[0018] FIG. 1 is an exploded side perspective view of a total hip replacement implant, as is known in the prior art;

[0019] FIG. 2 is a side perspective view of a total knee replacement implant, as is known in the prior art;

[0020] FIG. 3 is a side perspective view of a total disc replacement implant, as is known in the prior art;

[0021] FIG. 4 is a side perspective view of a total ankle replacement implant, as is known in the prior art;

[0022] FIG. 5 is a cross-sectional side view of a first polymeric liner, constructed and operative in accordance with an embodiment of the disclosed technique;

[0023] FIG. 6 is a cross-sectional side view of a second polymeric liner, constructed and operative in accordance with another embodiment of the disclosed technique;

[0024] FIG. 7 is a cross-sectional side view of a third polymeric liner, constructed and operative in accordance with a further embodiment of the disclosed technique;

[0025] FIG. 8 is a cross-sectional side view of a fourth polymeric liner, constructed and operative in accordance with another embodiment of the disclosed technique; and

[0026] FIG. 9 is a cross-sectional side view of a fifth polymeric liner, constructed and operative in accordance with a further embodiment of the disclosed technique.

[0027] FIG. 10 is a cross-sectional side view of a sixth polymeric liner, constructed and operative in accordance with a further embodiment of the disclosed technique.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0028] The disclosed technique overcomes the disadvantages of the prior art by providing a wear resistant polymeric liner for joint implants. The polymeric liner disclosed herein can be manufactured for use in medical joint implants such as a hip joint, a knee joint, an ankle joint, an intervertebral disc, a shoulder joint, an elbow joint, a wrist joint, a finger joint, a finger metacarpal joint, a toe joint, a toe-metatarsal joint, a carpometacarpal joint and the like. In addition, the polymeric liner of the disclosed technique can also be used in other types of medical implants (such as, intramedullary nails, where UHMWPE washers are used to eliminate interlocking screw movement relative to the nail implant) where an enhanced wear resistance and long durability of the implant is required. The description herein of the disclosed technique as it relates to polymeric liners for joint implants such as hip and knee implants should be viewed as merely an example of the uses of the disclosed technique. The disclosed technique relates to any situation where artificial joints are used and is not limited to artificial joints used in humans.

[0029] A polymeric liner for a medical joint implant is constructed to be engaged in between a head (or a top plate) and a stem (or a base plate) of a medical joint implant. The polymeric liner has two contacting surfaces constructed to closely contact the bottom surface of the head (or top plate) from one side and the upper surface of the stem (or base plate) from the other side. In particular, the two contacting surfaces of the polymeric liner are located at the friction areas. For example, in reference to FIG. 1, polymeric liner 12 is positioned between the bottom surface of head 11 and the upper surface of stem 14 thus reducing the friction between the contacting surfaces of head 11 and stem 14, if positioned one (head) in contact with the other (stem) without a liner.

[0030] The terms medical implant, prosthesis, artificial implant, polymeric implant, replacement implant, joint implant and medical joint are used interchangeably throughout the description and refer to artificial joints. The term polymeric matrix herein refers to a polymer material composed of at least one nanotube nanoparticle, which is used as a liner or a bearing between two hard surfaces such as metals and/or ceramics to reduce friction between two adjacent moving components. The term nanoparticle within the context of the disclosed technique refers to a microscopic particle with at least one dimension (length, width and/or thickness) less than 100 nanometers (herein abbreviated nm). The term nanotube refers to a nanometer-scale tube-like structure. Examples of nanoparticles having a nanotube configuration which are useful in the disclosed technique are fullerene-like (IF) nanoparticles which are either organic or inorganic and organic nanotubes such as carbon nanotubes. Terms such as inorganic fullerene-like (IF) particles and inorganic fullerene-like (IF) nanoparticles used within the context of the specification of the disclosed technique include hollow and non-hollow nanoparticles of transition metal chalcogenides and dichalcogenides, made up of single layers or multi-layers and having structures such as spheres, tubes, nested polyhedra, onion-like and the like. A chalcogen as used herein refers to any one of the following elements: S (sulfur), Se (selenium) or Te (tellurium). The metal chalcogenides and dichalcogenides are preferably selected from TiS.sub.2, TiSe.sub.2, TiTe.sub.2, WS.sub.2, WSe.sub.2, WTe.sub.2, MoS.sub.2, MoSe.sub.2, MoTe.sub.2, SnS.sub.2, SnSe.sub.2, SnTe.sub.2, RuS.sub.2, RuSe.sub.2, RuTe.sub.2, GaS, GaSe, GaTe, InS, InSe, HfS.sub.2, ZrS.sub.2, VS.sub.2, ReS.sub.2 and NbS.sub.2. More preferably, the metal chalcogenides and dichalcogenides are selected from WS.sub.2 and MoS.sub.2.

[0031] Molybdenum disulfide, tungsten disulfide and graphite are currently used in industrial, manufacturing, mining, marine, agriculture and automotive applications to reduce friction and wear. Tungsten disulfide (WS.sub.2) is a dry-film lubricant that was developed for NASA by Stanford University in the 1960s. Following its initial debut, tungsten disulfide found its way into industrial applications, primarily in aerospace and defense applications. Tungsten disulfide is known to improve wear properties and to enhance lubricity. When applied to a substrate material, tungsten disulfide forms a very thin layer due to the fact that it does not bond to itself. As a result, the dimensions and tolerances of treated parts are not compromised or appreciably affected when a substrate is treated with tungsten disulfide.

[0032] U.S. Pat. No. 6,390,992 to Morris et al., entitled Intraluminal device with lubricious surface describes a guidewire with a tenacious lubricious coating on its surface comprising finely divided lubricious particulate selected from the group consisting of tungsten disulfide, molybdenum disulfide and the like. Tungsten disulfide or molybdenum disulfide are applied as a surface treatment in order to provide lubricious properties to the guidewire. As stated above, surface treatment provides a film that tends to be unstable and break off from the joint implant.

[0033] According to the disclosed technique a matrix prepared from a polymer such as UHMWPE with nanotube nanoparticles of tungsten disulfide (WS.sub.2), for example, forms a matrix possessing superior wear resistant properties. The mechanism of such a matrix formed from polymer and nanotube nanoparticles appears to be somewhat similar to that of high tin bronze alloys which are stronger and have a high wear resistance and low friction resistance than plain bronze. The rolling friction is the force resisting the motion when a body (such as a ball, tire, or wheel) rolls on a surface. With respect to joint implants such as hip replacement implant 10 (shown in FIG. 1), head 14 moves within a cup-shaped depression of liner 12 which fits into cup 11. If, for example, liner 12 is replaced with a polymeric liner according to the disclosed technique, the circular/rotational movement of the nanoparticles within the matrix in response to the forces transmitted in hip replacement implant 10, will reduce the rolling friction in the implant, thereby enhancing the wear resistance of the prosthesis.

[0034] The disclosed technique provides a polymeric liner for use in joint implants such as a hip joint, a knee joint, an ankle joint, an intervertebral disc, a shoulder joint, an elbow joint, a wrist joint, a finger joint, a finger metacarpal joint, a toe joint, a toe-metatarsal joint, a carpometacarpal joint and the like. The polymeric liner is prepared from a polymeric matrix including a polymeric material and at least one nanotube nanoparticle. The polymeric material may be selected from crosslinked or uncrosslinked UHMWPE, PEEK, carbon fiber-reinforced PEEK or polyimides (PI). However, any other known polymeric material currently used in the production of liners can be used in the preparation of the polymeric liner disclosed herein.

[0035] According to the disclosed technique, the polymeric matrix comprises at least one nanotube nanoparticle having a volume concentration of between 5%-99% volume per volume. Preferably, the nanotube nanoparticles are selected from organic or inorganic fullerenes. An embodiment of the disclosed technique includes nanotube nanoparticles such as inorganic IF particles and inorganic IF nanoparticles selected from the list consisting of: TiS.sub.2, TiSe.sub.2, TiTe.sub.2, WS.sub.2, WSe.sub.2, WTe.sub.2, MoS.sub.2, MoSe.sub.2, MoTe.sub.2, SnS.sub.2, SnSe.sub.2, SnTe.sub.2, RuS.sub.2, RuSe.sub.2, RuTe.sub.2, GaS, GaSe, GaTe, InS, InSe, HfS.sub.2, ZrS.sub.2, VS.sub.2, ReS.sub.2 and NbS.sub.2. More preferably, the nanoparticles are selected from WS.sub.2, MoS.sub.2 or any other organic or inorganic nanotube particle.

[0036] Reference is now made to FIG. 5 which is a cross-sectional side view of a first polymeric liner, generally referenced 500, constructed and operative in accordance with an embodiment of the disclosed technique. Polymeric liner 500 includes a friction reducing member 510 and a body member 520. For example, polymeric liner 500 can be applied instead of prior art liners, such as liners 12, 22, 32 and 42 (see FIGS. 1-4). Friction reducing member 510 comprises an outer surface 512 and an inner surface 514. Friction reducing member 510 is produced from a polymeric matrix including a polymeric material and at least one nanotube nanoparticle having a volume concentration of between 5%-99% v/v. Preferably, the polymeric material is selected from UHMWPE, PEEK, carbon fiber-reinforced PEEK or PI. However, any other known polymeric material currently used in the production of liners can be used. The polymeric matrix in several embodiments of the disclosed technique may include at least one nanotube nanoparticle in different volumes of concentration, such as 70%-90% v/v, 60%-90% v/v, 40%-70% v/v or 5%-50% v/v. In these embodiments, the nanotube nanoparticle should have a volume concentration of 10%-80% v/v, however other volume concentrations are possible as listed above. Preferable nanotube nanoparticles are inorganic fullerene-like (IF) particles and inorganic fullerene-like (IF) nanoparticles selected from TiS.sub.2, TiSe.sub.2, TiTe.sub.2, WS.sub.2, WSe.sub.2, WTe.sub.2, MoS.sub.2, MoSe.sub.2, MoTe.sub.2, SnS.sub.2, SnSe.sub.2, SnTe.sub.2, RuS.sub.2, RuSe.sub.2, RuTe.sub.2, GaS, GaSe, GaTe, InS, InSe, HfS.sub.2, ZrS.sub.2, VS.sub.2, ReS.sub.2 and NbS.sub.2. More preferably, the nanotube nanoparticles are selected from WS.sub.2 and MoS.sub.2. Friction reducing member 510 may have a mean depth or thickness in the range 0.2 to 1.0 millimeters (herein abbreviated mm) although other mean depths or thicknesses are possible.

[0037] Preferably the dimensions of the friction reducing member are 3%-50% of the total mean depth (i.e., thickness) of the polymeric liner. More preferably, the mean depth of the friction reducing member is about 5% of the total mean depth of the polymeric liner. For example, a polymeric liner for a total hip replacement will have a friction reducing member having a mean depth or thickness in the range of 24-28 mm and a body member with a mean depth or thickness in the range of 38-50 mm.

[0038] Body member 520 has at least one inner surface (referenced 522 in FIG. 5). Inner surface 522 of body member 520 is conjoined with inner surface 514 of friction reduction member 510. Body member 520 can be manufactured from any polymeric material currently used in the production of liners. Preferably, body member 520 is produced from a polymer selected from UHMWPE, PEEK, carbon fiber-reinforced PEEK or PI.

[0039] Reference is now made to FIG. 6 which is a cross-sectional side view of a second polymeric liner, generally referenced 600, constructed and operative in accordance with another embodiment of the disclosed technique. Polymeric liner 600 includes three layers: a first friction reducing member 610, a body member 620 and a second friction reducing member 630. To ease understanding reducing member 610 may be referred to as a first layer or layer one, body member 620 may be referred to as a second layer or layer two and friction reducing member 630 may be referred to as a third layer or layer three. First and second friction reducing members 610 and 630 are produced from the same polymeric matrix as friction reducing member 510 (FIG. 5). Body member 620 is produced from the same material used for the preparation of body member 520. First friction reducing member 610 comprises an outer surface 612 and an inner surface 614. Second friction reducing member 630 comprises an inner surface 632. Body member 620 includes first inner surface 622 and second inner surface 624. When all layers are conjoined, body member 620 is sandwiched between first friction reducing member 610 and second friction reducing member 630 such that first inner surface 622 of body member 620 is conjoined with inner surface 614 of friction reduction member 610. Similarly, second inner surface 624 is conjoined with inner surface 632 of second friction reducing member 630.

[0040] Reference is now made to FIG. 7 which is a cross-sectional side view of a third polymeric liner, generally referenced 700, constructed and operative in accordance with a further embodiment of the disclosed technique. Polymeric liner 700 includes a friction reducing member 710 and a body member 720, both made of a polymeric material and at least one nanotube nanoparticle having a volume concentration of between 5%-99% v/v. Being made of the same composition it is not possible to differentiate in FIG. 7 between the two members. The resulting polymeric liner is composed of substantially uniformly distributed nanotube nanoparticles in a polymeric matrix. Alternatively, it is also possible to produce a liner having a varying distribution of the nanotube nanoparticles by applying magnetic and/or electric fields to the polymeric liner during production. For example, in an embodiment of the disclosed technique, the polymeric liner is manufactured such that the density of the nanotube nanoparticles is higher on the outer surface of polymeric liner 700 than the density in body member 720, i.e., density decreases with depth. This can be achieved similarly with the embodiments shown in FIGS. 5 and 6, with the density of the nanoparticles in friction reducing members 510 (FIG. 5), 610 and 630 (both from FIG. 6) being higher than the density of nanoparticles in the body members 520 (FIG. 5) and 620 (FIG. 6). Optionally, the density of the nanoparticles can vary as a function of the distance from the center of the polymeric liner. For example, the density of the nanoparticles on the outer surface of the liner can be around 99% whereas the density in the center of the liner can vary between 5%-50%.

[0041] Reference is now made to FIG. 8 which is a cross-sectional side view of a fourth polymeric liner, generally referenced 800, constructed and operative in accordance with another embodiment of the disclosed technique. Polymeric liner 800 includes a plurality of friction reducing members 810, 812, 814, 816 and 818 and a plurality of body members 820, 828 and 824. The body members are placed one on top of the other such that friction reducing member 810 forms one (outer skin) contacting surface and friction reducing member 818 forms another (inner skin) contacting surface of polymeric liner 800. Friction reducing members 812-816 are interspersed between body members 820-824 as shown in FIG. 8. It would be appreciated that the plurality of friction reducing members and the plurality of body members are conjoined in a similar manner as illustrated in detail with respect of FIGS. 5 and 6 whereas an inner surface of one member is conjoined with an outer surface of another member.

[0042] Reference is now made to FIG. 9 which is a cross-sectional side view of a fifth polymeric liner, generally referenced 900, constructed and operative in accordance with a further embodiment of the disclosed technique. As shown, polymeric liner 900 is assembled from vertically positioned friction reducing members 910 and body members 920. In this specific embodiment the body members and friction reducing members are made of pre-preg carbon fiber-reinforced PEEK which undergo compression molding so that all members are conjoined.

[0043] FIG. 10 is a cross-sectional side view of a sixth polymeric liner, generally referenced 1000, constructed and operative in accordance with a further embodiment of the disclosed technique. Polymeric liner 1000 is assembled from a plurality of L-shaped sections of friction reducing members 1010 constructed to be interjoined with a plurality of body members 1020 to result in the desired structure of the polymeric liner.

[0044] It will be appreciated that any other combination of complementing structures can be used for the construction of the polymeric liner and that the embodiment shown in FIG. 10 is only one example for a combination of a plurality of different possible structural constructions of the friction reducing members, body members and a combination thereof which can form the polymeric liner.

[0045] As stated above, the friction reducing member and the body member are conjoined preferably by compression molding. However, any other method of coupling such as mold injection, 3D printing, adhesion or any other suitable method can be applied. By way of example, the following is a method for preparing a polymeric liner for medical joint implants by compression molding in accordance with an embodiment of the disclosed technique. The method comprises the following: providing a mold with a cavity in a shape of the polymeric liner. For example, the cavity in the mold can be designed to form the polymeric liner shown in FIG. 1 as liner 12. Then, applying a first layer made of a polymeric matrix in the cavity of the mold, wherein the first layer contains a polymeric material and at least one nanotube nanoparticle having a volume concentration of between 5-99% V/V. This first layer forms the friction reducing member, referenced as 510 in FIG. 5. Thereafter, a second layer of a polymeric material is applied on the first layer of the polymeric matrix. The second layer forms a body member made of a polymeric material, referenced as 520 in FIG. 5. The mold is closed and heated with the polymeric material to a temperature below the melting point of the polymeric material. Pressure is applied to the mold such that air contained in the mold is sucked out and the polymeric material forms in the shape of the polymeric liner. The final procedure is opening the mold and removing the polymeric liner from the mold. The resulting polymeric liner comprises a friction reducing member and a body member which are conjoined by compression molding.

[0046] In an embodiment of the disclosed method of production, before the procedure of closing the mold, a third layer of polymeric matrix is applied to the second layer. This third layer contains a polymeric material and at least one nanotube nanoparticle having a volume concentration of between 5%-99% v/v. The resulting polymeric liner according to this embodiment is composed of a skin made of homogeneously distributed nanoparticles in a polymeric matrix and a body member made of a polymeric material. Preferably, the resulting skin substantially covers the body member. In an additional embodiment of the disclosed method of production, the nanotube nanoparticle is selected from nanoparticles of tungsten disulfide (WS.sub.2) and molybdenum disulfide (MoS.sub.2) having a volume concentration of between 5%-99% v/v.

[0047] A further embodiment of the disclosed method of production includes the procedures of providing a mold with a cavity in a shape of the polymeric liner and thereafter, loading a required amount of a polymeric matrix into the cavity, wherein the polymeric matrix includes a polymeric material and a nanotube nanoparticle having a volume concentration of between 5%-99% v/v. The mold with the polymeric matrix is then heated to a temperature below the melting point of the polymeric material. Pressure is applied to the mold such that air contained in the mold is sucked out and the polymeric material forms in the shape of the polymeric liner. The final procedure is opening the mold and removing the polymeric liner from the mold. The resulting polymeric liner is composed of substantially uniformly distributed nanotube nanoparticles in a polymeric matrix.

[0048] The polymer is provided as a powder or grinded material. The polymer is then mixed with the nanotube nanoparticles and the mixture is transferred into a mold. The temperature and pressure of the mold determine the melting and cooling of the polymeric material in the mold. Both temperature and pressure can be controlled and revised to accord with the specific melting temperature and solidification time required for the specific material. With respect to the concentration gradient of the nanoparticles, this can be controlled by an electric or magnetic field which can be formed during the stages of preparation of the polymeric liner. The electric or magnetic field will determine the concentration of the nanoparticle on a specific surface/layer and the viscosity of the polymer is determined by temperature and time.

[0049] It will be appreciated by persons skilled in the art that the disclosed technique is not limited to what has been particularly shown and described hereinabove. Rather the scope of the disclosed technique is defined only by the claims, which follow.