LINERS FOR MEDICAL JOINT IMPLANTS WITH IMPROVED WEAR-RESISTANCE
20170224872 · 2017-08-10
Inventors
Cpc classification
A61F2002/30067
HUMAN NECESSITIES
A61L31/128
HUMAN NECESSITIES
A61F2/30767
HUMAN NECESSITIES
A61F2/42
HUMAN NECESSITIES
A61L27/446
HUMAN NECESSITIES
A61F2/3609
HUMAN NECESSITIES
A61L2400/12
HUMAN NECESSITIES
A61F2002/30733
HUMAN NECESSITIES
A61L31/128
HUMAN NECESSITIES
A61L27/446
HUMAN NECESSITIES
International classification
Abstract
A polymeric liner for a medical joint implant constructed to be positioned in between a head (or a top plate) and a stem (or a base plate) of the medical joint implant. The polymeric liner is composed of at least one component. The at least one component includes a polymeric matrix having a polymeric material having a volume concentration of between 95%-99.9% v/v (volume per volume); and at least one metal chalcogenides or dichalcogenides nanotube nanoparticle having a volume concentration of between 0.1%-5% v/v. The at least one metal chalcogenides or dichalcogenides nanoparticle is distributed within the polymeric matrix, and selected from the group consisting of: TiS2, TiSe2, TiTe2, WS2, WSe2, WTe2, MoS2, MoSe2, MoTe2, SnS2, SnSe2, SnTe2, RuS2, RuSe2, RuTe2, GaS, GaSe, GaTe, InS, InSe, HfS2, ZrS2, VS2, ReS2, and NbS2.
Claims
1. A polymeric liner for a medical joint implant constructed to be positioned in between a head (or a top plate) and a stem (or a base plate) of said medical joint implant, said polymeric liner is composed of at least one component, said at least one component comprising: a polymeric matrix comprising a polymeric material having a volume concentration of between 95%-99.9% v/v (volume per volume); and at least one metal chalcogenides or dichalcogenides nanotube nanoparticle having a volume concentration of between 0.1%-5% v/v, 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: 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.
2. The polymeric liner according to claim 1, wherein said polymeric liner is composed of a single component.
3. The polymeric liner according to claim 1, wherein said polymeric matrix further comprises 0.05-2% additives and residues.
4. The polymeric liner according to claim 1, wherein said polymeric matrix further comprises at least one free radical scavenger (antioxidant).
5. The polymeric liner according to claim 1, wherein said polymeric material is selected from the list consisting of: UHMWPE, PEEK, Carbon fiber-reinforced PEEK or PI.
6. The polymeric liner according to claim 5, wherein said polymeric material is UHMWPE.
7. The polymeric liner according to claim 1, wherein said nanotube nanoparticles are substantially uniformly distributed within the polymeric matrix.
8. The polymeric liner according to claim 1, wherein said nanotube nanoparticles are distributed in the polymeric matrix in a variable concentration.
9. The polymeric liner according to claim 1, wherein said nanotube nanoparticles are distributed in the polymeric matrix such that the maximum concentration of said nanotube nanoparticles is present on surface areas of the liner.
10. The 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).
11. The polymeric liner according to claim 10, having a nanotubes nanoparticles volume concentration of between 0.5%-2% v/v.
12. The polymeric liner according to claim 1, wherein said polymeric liner is affixed to a head (or a top plate) and/or a stem (or a base plate) of a medical joint implant and wherein said medical joint implant is 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.
13. The polymeric liner according to claim 12, wherein said polymeric liner is affixed to a head (or a top plate) and/or a stem (or a base plate) of a medical joint implant by compression molding.
14. The polymeric liner according to claim 1, produced by compression molding.
15. The polymeric liner according to claim 1, produced by 3D printing.
16. The polymeric liner according to claim 1, produced by injection molding.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The disclosed technique will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:
[0019]
[0020]
[0021]
[0022]
[0023]
[0024]
[0025]
[0026]
[0027]
[0028]
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0029] 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.
[0030] A polymeric liner for a medical joint implant is constructed to be positioned 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 in very close proximity to the respective friction areas of the upper and lower portions of the joint, up to a point of full contact therewith. Since according to this embodiment, the contacting surfaces of the polymeric liner are not firmly attached (affixed) to the respective joint surfaces, these contacting surfaces are operative to move relative to the respective joint surfaces, in any direction permissible by mechanical design of the joint (e.g., laterally, radially, rotationally). For example, in reference to
[0031] 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 “component”, where used in connection with the polymeric liner disclosed herein, is referring to any element that constitutes part of the polymeric liner such as a friction reducing member and a body member. If the polymeric liner is composed of a single component, this component is the polymeric matrix (the friction reducing member). The term “polymeric matrix” herein refers to a mixture of a polymer material and at least one nanotube nanoparticle, both bind together (with heat or chemical reaction) into a rigid structure. This polymeric matrix which is a composite material is used as a liner or a bearing positioned 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.
[0032] 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.
[0033] 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.
[0034] 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 composite material 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
[0035] 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 comprises at least one component, at least one of said at least one component is prepared from a polymeric matrix. The polymeric matrix includes 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.
[0036] According to the disclosed technique, the polymeric matrix comprises a polymeric material having a volume concentration of between 95%-99.9% v/v (volume per volume) and at least one nanotube nanoparticle having a volume concentration of between 0.1%-5% v/v (volume per volume). For example, a polymeric matrix having a concentration of 99% v/v polymeric material further includes a volume concentration of 1% v/v of the at least one metal chalcogenides or dichalcogenides nanotube nanoparticle. Preferably, the volume concentration of the at least one nanotube nanoparticle in the polymeric matrix is 0.5%-2% v/v. The polymeric matrix can further comprise 0.05-2% additives and residues. In addition, the polymeric matrix can comprise a free radical scavenger (antioxidant).
[0037] Preferably, the nanoparticles are nanotube nanoparticles 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 nanotube nanoparticles are selected from WS.sub.2, MoS.sub.2 or any other organic or inorganic nanotube particle.
[0038] Reference is now made to
[0039] 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.
[0040] Body member 520 has at least one inner surface (referenced 522 in
[0041] Reference is now made to
[0042] Reference is now made to
[0043] Reference is now made to
[0044] Reference is now made to
[0045]
[0046]
[0047]
[0048] According to a further aspect of the disclosed technique, there is thus provided a method of production of a polymeric liner for joint implants. 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
[0049] 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. The polymeric material has a volume concentration of 95%-99% v/v and the at least one nanotube nanoparticle has a volume concentration of between 0.1%-5% 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, which refers to all above-disclosed methods, 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 0.1%-5% v/v.
[0050] 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 mixture of a polymeric material and at least one nanotube nanoparticle in the cavity of the mold, wherein the mixture contains a polymeric material having a volume concentration of between 95%-99.9% v/v and at least one nanotube nanoparticle having a volume concentration of between 0.1%-5% v/v. In an embodiment of the disclosed technique, the volume concentration of the at least one nanotube nanoparticle in the mixture is between 0.5%-2% v/v. The mold is closed and heated with the mixture of polymeric material and nanotube nanoparticles 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. A polymeric matrix is obtained 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.
[0051] 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. For example, the mixing procedure can be conducted by dispersing the nanotube nanoparticles in a solution in combination with stirring, sonication in a sonication bath, sonication with a sonication finger, for the required time until the desired mixture is obtained. 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.
EXAMPLES
[0052] APV Meyer Press was used for compression molding of UHMWPE GUR 1020. Four samples of medical liner were prepared:
Liner 1—Pure UHMWPE
[0053] Liner 2—UHMWPE with 0.5% nanotubes of SW.sub.2
Liner 3—UHMWPE with 1% nanotubes of SW.sub.2
Liner 4—UHMWPE with 1.5% nanotubes of SW.sub.2
[0054] Process Parameters:
[0055] The as received GUR1020 reactor powder (or each mixture with SW.sub.2) was directly sintered at 200° C. in air press (Model APV, Meyer) for 30 minutes with 20 MPa pressure. The samples were then quenched to ambient temperature using air flow. The sizes of the liners obtained were: Diameter=25 mm; Thickness: 1 and 3 mm; Weight: 480 gr+/−5%, 1440 gr+/−, 5% respectively.
[0056] Tribo-Meter Apparatus
[0057] A tribo-meter apparatus was used for studying the particular tribo-behavior of different nano-composite polymer liners in comparison with a pure polymeric liner. The focus of this equipment is to reach high accuracy measured signals for the sliding motion, load applied and frictional response of the rubbed material.
[0058] The Technical Specifications of the Study:
Normal load: up to 10N
Sliding speed: up to 500 mm/sec
Sliding amplitude: up to 25 mm
Counter body: 6 mm ceramic any type, mostly acidic/water environment.
[0059] The Results
[0060] Liner 1—Pure UHMWPE
400 g vertical load is applied on the tested sample. The sample is moving back and forth against the surface of the load in a velocity of 40 mm/sec and in a frequency of 3 Hz.
Measurements obtained: Coefficient of friction 0.16 for dry and Coefficient of friction 0.24 in water.
Higher coefficient of friction is observed under water lubricated condition.
Measurements of the depth of cracks in the liner revealed maximum depth of 10.9 μm (micrometer) and area of hole of 3595 μm.
[0061] Liner 2—UHMWPE with 0.5% Nanotubes of SW.sub.2
400 g vertical load is applied on the tested sample. The sample is moving back and forth against the surface of the load in a velocity of 40 mm/sec and in a frequency of 3 Hz.
Measurements obtained: Coefficient of friction 0.2 for dry
Coefficient of friction 0.28 in water
The coefficient of friction goes up and down in dry condition.
[0062] Liner 3—UHMWPE with 1% Nanotubes of SW.sub.2
Coefficient of friction 0.16 for dry
Coefficient of friction 0.24 in water
The warm surface is wrinkled with wavy morphology and the wrinkling is denser with small grooves for dry condition. This is due to the high temperature reaching the polymer surface and wrinkles present on the surface.
Measurements of the depth of cracks in the liner revealed maximum depth of 9.67 μm (micrometer) and area of hole of 3383 μm.
[0063] Liner 4—UHMWPE with 1.5% Nanotubes of SW.sub.2
400 g vertical load is applied on the tested sample. The sample is moving back and forth against the surface of the load in a velocity of 40 mm/sec and in a frequency of 3 Hz.
Measurements obtained: Coefficient of friction 0.15 for dry with lower rate and stable rate. In this liner the wear mechanism is different. The surface has no wavy morphology and exhibits only small grooves due to the low friction. This is a result of the low temperature reaching the polymer's surface.
Measurements of the depth of cracks in the liner revealed maximum depth of 9.23 μm (micrometer) and area of hole of 3131 μm.
[0064] Summary of Feasibility Results
[0065] The friction coefficient of the composite material of UHMWPE and nanotubes was reduced by a factor of 2 and more in comparison with the friction coefficient of pure UHMWPE. In addition the friction coefficient remained stable throughout duration of the test both in dry and aqueous media. The composite material of UHMWPE and nanotubes demonstrated lower surface temperature at the local area of the test during the complete duration of the test. Furthermore, observations of the behavior of liners with different thickness revealed that the liner thickness did not affect the test results.
[0066] 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.