WO2017151714A1 - System and method for reinforced polymer composites in medical devices and instrumentation - Google Patents

Abstract

A medical device fabricated from a polymeric base material and a reinforcing material is described. Suitable materials include natural polymers, semi-synthetic polymers, synthetic polymers, metal, ceramic, glass, carbon fiber, carbon nanotubes, and combinations thereof. In one aspect, the medical device is an internal or external fixation device.

Description

SYSTEM AMD METHOD FOR REINFORCED POLYMER COMPOSITES IN MEDICAL

DEVICES AMD INSTRUMENTATION

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of and herein incorporates by reference in its entirety, U.S. Provisional Patent Application Serial No. 62/302,068, filed on March 1, 2016, and entitled "SYSTEM AND METHOD FOR REINFORCED POLYMER COMPOSITES IN MEDICAL DEVICES AND INSTRUMENTATION."

BACKGROUND

[0002] The disclosure relates, in general, to systems and methods for creating and using medical devices and instrumentation fabricated from a reinforced composite material, such as a fiber reinforced polymer composite.

[0003] Many modern medical procedures rely on the use of medical devices and instrumentation such as pins, screws, rods, plates, targeting guides and the like. These devices and instruments are useful for procedures including the repair or replacement of bones and joints. For example, pins, screws, and rods are used to construct external fixators, such as frames and rings. Although they are outside the body, the screws and pins go through the skin and muscle to connect to the bone. In this way, they differ from casts and splints, which rely solely on external support. Alternatively, internal fixation often involves wires, plates, rods, pins, nails, and screws used inside the body to support the bone directly. In some bone fractures, alignment of the bone ends is achieved by inserting a rod or nail through the hollow center of the bone.

[0004] Other examples of procedures that rely on internal or external hardware include partial or total joint arthroplasty (surgical repair of a joint). Joint replacements, such as for the hip or knee, typically involve a prosthesis composed of a metal piece that fits closely into a matching sturdy plastic piece. The metal and plastic components are selected from materials designed to enable the joint to move just like a normal joint. Reconstructive surgeries, such as knee surgery to repair the anterior cruciate ligament (ACL) rely on interference screws to hold a graft in place. Various other screw types include dynamic hip, cortical, cancellous, cannulated, Acutrak and Herbert screws.

[0005] In each of the examples above, the medical devices and instrumentation are selected from materials such as stainless steel, cobalt-base alloys, bioceramics, titanium alloys, pure titanium, and polymers. Currently, there are several recognized problems associated with materials used in medical devices and instrumentation including cost, weight, and unfavorable or unwanted material properties. For example, stainless steel is one of the most preferred materials for bone-plates, because of its mechanical properties and cost-effectiveness in comparison with other metals. However, stainless steel has a lower corrosion resistance compared with other metals, and an immune system reaction to nickel metal present in the steel could result in a potential complication for a patient using such a device. Metallic alloys, like cobalt-base alloys, offer beneficial material properties including wear, corrosion, and heat resistances, but are often not suitable for use due to difficulties in fabrication and high cost. Titanium metal is one of the most widely chosen materials for permanent bone plates due to its excellent biocompatibility and corrosion resistance, but it is less ductile and more expensive when compared with other materials such as stainless steel, such that its use is still limited.

[0006] In summary, drawbacks of currently available medical devices and instrumentation include high cost, poor functionality, increased weight, lack of strength and decreased ability to visualize a fracture when being viewed on a medical imaging apparatus (radio-opaque). Given the aforementioned disadvantages of current materials used in the production of medical devices and instrumentation, there is a need to significantly decrease cost and improve patient outcome through the selection of a new class of materials.

SUMMARY OF THE DISCLOSURE

[0007] The present disclosure provides apparatuses and methods to overcome the aforementioned drawbacks by providing medical devices and instrumentation fabricated from reinforced polymer composites. In the current healthcare environment, reduction in cost associated with polymers would provide a significant advantage to patients. Fiber reinforced polymers can be molded to produce medical products that are lighter in weight and stronger than their metallic counterparts. The radiolucent nature of the materials, as well as the opportunity to produce smaller devices and instrumentation with improved functionality are some potential advantages of using polymers in medical devices. Thermoplastics also present a true opportunity to customize implants for individual patients.

[0008] In particular, reinforced polymer composites are especially promising and have the potential to be applied in the fabrication of external fixators, plates for fracture fixation, and intramedullary rods. Multiple other additional applications include, but are not limited to, total joint arthroplasty, suture anchors, and interference screws. In addition, these polymers may be custom designed and coated to help prevent infection.

[0009] In one aspect of the present disclosure, a medical device for supporting a bone structure in a patient is disclosed. For example, the medical device may be an internal or external fixation device. The medical device comprises a polymeric base material and a reinforcing material, and the polymeric base material is at least partially radiolucent. In some embodiments, the polymeric base material comprises a natural polymer, semisynthetic polymers, synthetic polymers or combinations thereof. In some aspects the natural polymer is cellulose or silk. In some aspects, semi-synthetic polymers such as nitrocellulose, cellulose acetate, or rayon could be used. Examples of synthetic polymers that can be used in embodiments of the present disclosure include polyester, aromatic polyester, polyamide, aramid, polyimide, polyolefin, polyethylene, polyurethane, polyuria, polyvinyl chloride, polyvinylidene chloride, polyether amide, poly ether urethane, polyacrylate, polyacrylonitrile, acrylic, polyphenylene sulfide, polylactic acid, poly(diimidazopyridinylene-dihydroxyphenylene, poly(p-phenyIene-2, 6-benzobisoxazole), and liquid crystal polymer fiber,

[0010] In some aspects of the present disclosure, the reinforcing material comprises fibers, such as continuous filament reinforcing fiber. The reinforcing material may also comprise metal, ceramic, glass, carbon fiber, carbon nanotubes, or combinations of those materials. The fibers may have many different lengths, and in some aspects, at least one fiber has a length greater than 20 mm. In some embodiments, the medical device comprises fibers having lengths between about 25 mm and about 50 mm. The reinforcing material fibers may be dispersed and distributed throughout the polymeric base material. In some aspects, the medical device comprises a woven fabric.

[0011] In some aspects, the medical device comprises a plurality of layers, and each of the plurality of layers comprises a polymeric base material and a reinforcing material. The polymeric base material can comprise a resin and the reinforcing material can comprise fibers. In some aspects, at least one layer comprises a directional fiber and at least one layer comprises a non-directional fiber. The medical device may comprise at least one layer comprising fabric, and at least one layer comprising a polymeric film. In some aspects, the at least one fabric layer is sandwiched between two polymeric film layers.

[0012] In some aspects, the medical device comprises a coating. The coating may comprise polyurethane, polyether, polyvinyl chloride, polyvinyiidene chloride, silicone, styrene-butadiene, polyethylene, polypropylene, ethylene-propylene copolymer, polyisoprene, ethylene vinyl acetate, ethylene-proplyene-diene monomer, polyamide, polyether block amide, and polyether urethane. In some aspects, the coating has a selectively permeable quality, and could be comprised of polyvinyl chloride. In other aspects, the coating may comprise an antibacterial agent. The antibacterial agent may be one of iodine, antibiotics, silver, triclosan, biocides, or other antibacterial agents.

[0013] Additionally, a method for producing a medical device for supporting a bone structure in a patient is disclosed. The method comprises forming a fiber-reinforced resin core, covering the fiber-reinforced resin core with a fiber material, enclosing the fiber- reinforced resin core in a mold shaped to conform to the shape of the fiber-covered core, and injecting resin into the mold under pressure to impregnate the fiber material and bond it to the fiber-reinforced resin core. In some aspects, the fiber-reinforced core comprises a polymeric base material that could be comprised of natural polymers, semi-synthetic polymers, synthetic polymers or combinations thereof. The fiber material could be metal, glass, ceramic, carbon fiber, carbon nanotubes, or combinations thereof. The fiber material could also comprise at least one fiber having a length of greater than 20 mm.

[0014] Additionally, the method could further comprise coating at least a portion of the medical device with a laminate. The laminate could comprise polyurethane, polyether, polyvinyl chloride, polyvinyiidene chloride, silicone, styrene-butadiene, polyethylene, polypropylene, ethylene-propylene copolymer, polyisoprene, ethylene vinyl acetate, ethylene-proplyene-diene monomer, polyamide, polyether block amide, and polyether urethane, or combinations of those materials. In some aspects, the laminate is at least partially antibacterial. Such laminates could comprise an antibacterial agent comprising iodine, antibiotics, silver, triclosan, biocides, or other possible antibacterial agents.

[0015] The foregoing and other aspects and advantages of the invention will appear from the following description. In the description, reference is made to the accompanying drawings which form a part hereof, and in which there is shown by way of illustration a preferred embodiment of the invention. Such embodiment does not necessarily represent the full scope of the invention, however, and reference is made therefore to the claims and herein for interpreting the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1A is an illustration of straight and angled posts;

Fig. IB is a photographic depiction of an angled post as illustrated in Fig. 1A; Fig. 2A is a is an illustration of different rod to rod and pin to rod connectors; Fig. 2B is a is a photographic depiction of a rod to rod connector as illustrated in Fig. 2A;

[0020] Fig. 3A is an illustration of different configurations of multi-pin clamps;

[0021] Fig. 3B is a photographic depiction of a multi-pin clamp as illustrated in Fig.

3A;

[0022] Fig. 4A is an illustration of different lengths of connecting rods;

[0023] Fig. 4B is a photographic depiction of a connecting rod as illustrated in Fig.

4A;

[0024] Fig. 5 is an illustration of different configurations of partial rings and plates for internal and external fixation.

[0025] Fig. 6 is a diagrammatic perspective view of a prior art fixator including different variants of connectors mounted on a bone;

[0026] Fig. 7 is a diagrammatic perspective view of a fixator including various connectors mounted on a bone;

[0027] Fig. 8 is an X-ray image of a fixator made of radio-opaque materials mounted on a human subject;

[0028] Fig. 9 is an enlarge partial view of the fixator of Fig. 7 detailing a portion of the ring and a rod to rod connector; [0029] Fig. 10A shows a proximal targeting guide for use in intramedullary nailing.

[0030] Fig. 1GB shows front views of a bone fitted with an intramedullary nail and screws.

[0031] Fig. IOC shows perspective views of a bone fitted with an intramedullary nail and screws.

[0032] Fig. 11A shows a proximal targeting guide for use in application of the fixator.

[0033] Fig. 11B shows the fixator in isolation.

[0034] Fig. IIC shows the fixator mounted on a bone.

[0035] Like reference numerals will be used to refer to like parts from figure to figure in the following detailed description.

DETAILED DESCRIPTION

[0036] The present disclosure describes varying embodiments in the following description with reference to the Figures, in which like numbers represent the same or similar elements. Reference throughout this specification to "one embodiment," "an embodiment," or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases "in one embodiment," "in an embodiment," and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment.

[0037] The described features, structures, or characteristics described in the present disclosure may be combined in any suitable manner in one or more embodiments. In the following description, numerous specific details are recited to provide a thorough understanding of embodiments of the system. One skilled in the relevant art will recognize, however, that the system and method may both be practiced without one or more of the specific details, or with other methods, components, materials, and so forth. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obscuring aspects of the invention.

[0038] In one aspect of the present disclosure, medical devices and instrumentation, such as for internal and external fixation, can be replaced with reinforced polymer composites, Current devices and instrumentation for the internal fixation of fractures are fabricated from metal plates, screws, and metal intramedullary rods, Similarly, external fixators used to align fractures, lengthen and straighten bones, and angulate or rotate the position of bone and soft tissue are made of stainless steel, titanium and aluminum, which are radio-opaque (i.e., able to absorb X-ray photons). Therefore, the components made out of these materials ma obscure the healing bone, hindering evaluation of progress, status, etc. Moreover, external fixators tend to be bulky and uncomfortable for the patient

[0039] The use of reinforced polymer composites represents a significant opportunity to decrease cost, improve functionality, and decrease weight, while increasing the strength of both internal and external fixators, In order to achieve the required material properties, it is necessary to select composite materials having the requisite strength, elasticity, biocompatibility, bending stiffness and so forth, Furthermore, many reinforced polymer composites are also radiolucent, Therefore, manufacturing the parts of an internal or external fixator with a reinforced polymer composite provides for the opportunity to better visualize the fracture and monitor healing. This same technology could be applied to halos used in spinal surgery. Examples of medical devices and instrumentation that can be fabricated from reinforced polymer composites are depicted in the Figures.

[0040] Referring to Figs, lA- i lC, a number of medical device are shown that can be fabricated from composites of the present disclosure. Examples of suitable devices include posts 10 (Figs. 1Α-1ΒΊ, rod-to-rod and rod-to-pin connectors 12 (Figs, 2A-2B), multi-pin clamps 14 (Figs. 3A-3B), connecting rods 16 (Figs. 4A-4B), and partial rings and plates 18 (Fig. 5), Figures 6 and 7 illustrate examples of fixators including different variants of connectors mounted on a bone 20 including rod-to-rod connectors 12, pin clamps 14, connecting rods 16 and rings 18. Figure 9 provides an enlarged partial view of Fig, 7 showing a ring 18 with rod to rod connector 12 and connecting rod 16, When the devices and instrumentation are made of traditional materials, such as stainless steel and titanium, the devices and instrumentation are radio-opaque as shown in the X-ray image in Fig, 8. By contrast, the present disclosure enables the fabrication of radiolucent devices and instrumentation for improved imaging. The use of the composite materials of the present disclosure also reduces the weight of the fixator without sacrificing mechanical strength, thereby preventing potential deformation.

[0041] The present disclosure also contemplates the fabrication of other radiolucent medical devices and instrumentation including internal proximal targeting guides 22, intramedullary rods 24 screws 26 and fixator plates 28. Figures 10A and 11A show two examples of proximal targeting guides 22 that can be fabricated from composite materials according to the present disclosure. The targeting guide 22 of Fig. 10A enables accurate positioning of screws 26 for securing the intramedullary rod 24 (Figs. 10B-10C), whereas targeting guide 22 in Fig. 11A enables accurate positioning and attachment of the internal fixator plate 28 on the bone 20. Each of the aforementioned parts can be made of radiolucent composites to enable optimized viewing during and after the procedures.

[0042] A more complete, but not comprehensive list of parts suitable for fabrication according to the present disclosure includes: external fixator components such as rod (bar) to rod (bar) couplings/clamps, pin to rod couplings/clamps, multi pin clamps, posts, pins, dynamization/distraction rods and compression/distraction rods; external fixator instruments such as wrenches, thumb wheels, drill guides, soft tissue protectors, and trocars; external fixator with wires such as olives for wires, pin posts, foot rings and threaded posts; and external fixators with wires, such as bolts/nuts, hinges, wire posts, washer couplers and oblique supports.

[0043] Composites with customized and tailored properties can be used for the production of medical devices and instrumentation for specific tasks. Known processes of forming reinforced plastic composites from fiber strands and thermoplastic resins include the embedding of thermoplastic resin in reinforcing fiber strands as they are drawn through a forming die in the presence of molten thermoplastic resin introduced from an extruder. The extrusion product of that process is an elongated bar or rod having a continuous length of reinforcing fiber encased within thermoplastic resin. The preformed composite may be inserted into a die of an injection molding machine and utilized as an insert in a compound, composite product with an additional layer of thermoplastic resin molded over the insert The extrudate rod can also be cut from the forming die into short lengths for use as molding pellets. The extruded fiber/resin composite rod is immediately cooled, prior to final forming and cutting to desired lengths,

[0044] In some embodiments, the medical devices and instrumentation are made of a composite material such as a polymer and a reinforcing material. Suitable reinforced polymer composites include natural polymers, semi-synthetic polymers, synthetic polymers, metal, ceramic, glass, carbon fiber, carbon nano tubes, and the like.

[0045] Examples of suitable reinforcing materials include fibers, fabrics, and the like, which can include at least one of polymer, metal, glass, ceramic, and the like and blends, copolymers, composites, and mixtures thereof. Where high strength and stiffness are required, carbon-fiber reinforced epoxy resins are advantageous. Other fibers including araniid, glass, or nylon may be also used. Preferably, continuous filament reinforcing fibers are used.

[0046] A variety of short and long fibers can be used in the formation of reinforced polymer composites. The choice of longer fibers [e.g., 25-50 mm and greater) provides advantages such as an improved modulus, strength and impact resistance as compared with shorter fibers. Related to fiber length is the dispersion and distribution of individual fibers in the polymer. Fully dispersing and distributing individual fibers without breaking is highly advantageous and provides an exceptional reinforcing matrix. Moreover, fuller dispersion of the fiber bundles results in fewer visual defects.

[0047] Medical devices and instrumentation of the present disclosure can be fabricated from one or more polymers including flexible engineering plastics. Suitable natural polymers include cellulose, silk, and the like. Semi-synthetic fibers include nitrocellulose, cellulose acetate, rayon, and the like. Suitable synthetic fibers include polyester, aromatic polyester, polyamide (NYLON®, DACRON®), aramid iKEVLAR®), polyimide, polyoiefin, polyethylene (SPECTRA®), polyurethane, polyurea, polyvinyl chloride (PVC), polyvinylidene chloride, polyether amide (PEBAX®), polyether urethane (PELLETHANE®), polyacrylate, polyacrylonitrile, acrylic, polyphenylene sulfide (PPS), polylactic acid (PLA), poly(diimidazopyridinylene-dihydroxyphenylene) (M-5); poiy(p- phenylene-2,6-benzobisoxazole) (ZYLON®), liquid crystal polymer fiber (VECTRAN®), and the like, and blends, copolymers, composites, and mixtures thereof. Thermoset or thermoplastic matrices may be used, including polyester, nylon, or bismaleimide resins. [0048] In addition to the aforementioned polymers and fibers, the medical devices and instrumentation can also include a suitable metal, such as stainless steel, spring steel, nitinoi, super elastic materials, amorphous metal alloys, and the like,

[0049] An example medical device can include a plurality of layers of directional or non-directional fibers and a resin, which can impregnate the fibers. In some embodiments, the fibers are sandwiched between polymer film layers. Some embodiments comprise a plurality of layers, for example, a fabric layer and a polymer film layer, or a fabric layer sandwiched between polymer film layers.

[0050] In some embodiments, coatings and/or laminations are disposed on one or more portions of the medical devices and instrumentation. Suitable coatings and laminating materials include polymers such as poiyurethane, poiyether, PVC, polyvinylidene chloride, silicone, styrene-butadiene, polyethylene, polypropylene, ethylene-propylene copolymer, polyisoprene, ethylene vinyl acetate (EVA), ethyiene- propylene-diene monomer (EPDM), polyamide (MYLAR®), poiyether block amide (PEBAX®), poiyether urethane (PELLETHANE®), composites, blends, mixtures, and the like.

[0051] Some embodiments of the coating or lamination modify gas and/or moisture permeability, for example, by controlling the size of pores in the coating and/or device. For example, decreasing moisture permeability creates a barrier to pathogens such as bacteria. Some materials are selectively permeable to certain fluids. For example, some embodiments of PVC are oxygen permeable and moisture impermeable. Some embodiments of the coating or lamination comprise an antibacterial or antimicrobial agent. In some embodiments, the antibacterial or antimicrobial agent is a surface agent or is integral to the material. Examples of suitable antibacterial or antimicrobial agents include iodine, antibiotics, silver, triclosan, biocides, and the like. Some embodiments of the coating or lamination provide a smoother and/or lower friction inside surface.

[0052] In some embodiments, the medical device is comprised of an abrasion and/or puncture resistant material. The abrasion and/or puncture resistance is beneficial for performance and reliability for applications involving sharp or pointed instruments such as chisels, drills, rasps, scalpels, and the like. Example applications include procedures involving arthroscopic surgery, abdominal surgery, and procedures involving prosthetic devices including hip procedures, hip replacement, and spinal procedures.

[0053] In yet other embodiments, woven and braided fabrics are advantageously used in the construction of parts having substantial thickness, as such fabrics are generally available in greater thicknesses and contain more fiber ends than commercially available unidirectional ply materials.

[0054] One aspect of the present disclosure relates to a process for the formation of reinforced composite polymer medical devices and instrumentation. For example, international application WO 1997/030651 describes methods and devices involving fiber- reinforced composite structures having improved performance under shear, bending, and torsional stresses. The composite materials and process described therein can be utilized in the practice of the present disclosure, and the application is hereby incorporated by reference in its entirety.

[0055] One process for forming a fiber-reinforced composite according to the present disclosure can include components that are molded and/or extruded as a single piece or as a plurality of pieces that can then be assembled into a single device. Alternatively, the process can include the formation of a fiber-reinforced resin core. Once formed, the core can be covered with a fiber material, and enclosed in a mold shaped to conform to the shape of the fiber-covered core. Resin can then be injected into the closed mold under pressure to impregnate the fiber material and bond it to the core. In yet another example process, a material containing unidirectional fibers and resin can be placed in a moid. In one aspect, a reinforced polymer composite comprises a long fiber thermoplastic (LFT) composite. LFT are bulk molding materials that feature continuous fiber filaments running the full length of the pellet allowing these materials to exhibit simultaneous improvements in strength, stiffness, and impact resistance over a wide temperature range, LFT composites can be substituted for traditional reinforced thermoplastics and metals. LFT pellets can be produced generally in a number of lengths and more particularly in lengths from about 5 to about 15 mm. The fiber is the structural component of the LFT composite with longer fibers providing increased structural support to the composite. Suitable fibers include glass, aramid, stainless steel, and carbon fiber reinforcement from about 20% to about 60% by weight,

[0056] In another aspect, devices and instrumentation of the present disclosure are manufactured at least in part with injection molding techniques, Injection molding processes transfer unreinforced or short-fiber reinforced liquid resin into a closed mold where it cross-links before being demolded. The process is capable of producing net or near-net shape components with good dimensional tolerances and characterized by cost- effectiveness. Net shape manufacturing is a technique where the initial production of the item is very close to the final (net) shape, reducing the need for additional finishing such as machining or grinding in order to reduce production costs. Advantages of the injection molding process include design flexibility; intricate features such as dovetails, slots, undercuts, threads, and complex curved surfaces; and lower production costs. Two or more simple shapes can be combined into a single, more complex component to minimize assembly costs.

[0057] Injection molding can be used to manufacture continuous-fiber reinforced composites, short-fiber-reinforced composites, thermoplastics, and thermosets. Injection molded parts often contain no reinforcement at all, but short-fiber reinforcement may be used. However, injection molding for the production of composites with fibers of any appreciable length presents a greater challenge.

[0058] Injection molding processes designed to accommodate the use of LFT enable the consolidation of metal and/or polymer components. Generally, metal parts and 2D composites cannot form complex shape and assembly of these parts requires the use of fasteners. Injection molded LFT composites can be manufactured as complex shapes without the need for fasteners or secondary machining.

[0059] In another aspect, reinforcement fibers can be placed in a three-dimensional

(3D) pattern or weave for fabrication of medical devices and instrumentation. Successful 3D fiber placement can translate the physical and mechanical properties of the fabric or preform into structural and thermal properties of the final composite. To achieve a high quality design, fiber damage must be minimized while maximizing accuracy of fiber placement Examples of 3D preform construction techniques include biaxial 3D, triaxial 3D, 3D Cartesian coordinate and 3D polar coordinate weaves. In some embodiments, the medical device fabrication process is capable of tailoring fiber orientation and judicious fiber placement automaticall and not manually as with other fiber reinforced composites.

[0060] In yet another aspect, recyclability and life cycle assessment (LCA) are a component of the present disclosure. Medical devices and instrumentation manufactured from reinforced polymer composites can be designed from recycled and/or recyclable plastics. Examples of plastics which can be recycled include polyethylene terephthaiate (PET or PETE), polyvinyl chloride (PVC), high-density polyethylene (HOPE), polystyrene (PS) low-density polyethylene (LDPE), polypropylene (PP) and mixtures thereof. In one aspect, a life cycle analysis (LCA) is performed to inform the selection of materials for the device and/or determine the impact of the device on the environment. LCA is a technique to assess environmental impacts associated with all stages of a product's life from raw material extraction through materials processing, manufacture, distribution, use, repair and maintenance, and disposal or recycling. In one aspect, the reinforced polymer composites are at least in part, "green" composites.

[0061] In general, all of the processes described herein can be subject to automation.

Automated manufacturing of medical devices and instrumentation fabricated from reinforced polymer composites can include automated fiber placement, tape laying, thermoplastic processing, thermoset processing, and so forth.

[0062] The present disclosure has described one or more preferred embodiments, and it should be appreciated that many equivalents, alternatives, variations, and modifications, aside from those expressly stated, are possible and within the scope of the invention.

[0063] Each reference identified in the present application is herein incorporated by reference in its entirety.

[0064] While present inventive concepts have been described with reference to particular embodiments, those of ordinary skill in the art will appreciate that various substitutions and/or other alterations may be made to the embodiments without departing from the spirit of present inventive concepts. Accordingly, the foregoing description is meant to be exemplary, and does not limit the scope of present inventive concepts.

[0065] A number of examples have been described herein. Nevertheless, it should be understood that various modifications may be made. For example, suitable results may be achieved if the described techniques are performed in a different order and/or if components in a described system, architecture, device, or circuit are combined in a different manner and/or replaced or supplemented by other components or their equivalents. Accordingly, other implementations are within the scope of the present inventive concepts.

Claims

CLAIMS What is claimed is:

1. A medical device for supporting a bone structure in a patient, the medical device comprising:

a polymeric base material; and

a reinforcing material, wherein the polymeric base material is at least partially radiolucent.

2. The medical device of claim 1, wherein the polymeric base material is selected from the group consisting of natural polymers, semi -synthetic polymers, synthetic polymers and combinations thereof.

3. The medical device of claim 2, wherein the natural polymer comprises cellulose,

4. The medical device of claim 2, wherein the natural polymer comprises silk,

5. The medical device of claim 2, wherein the semi-synthetic polymer is chosen from the group consisting of nitrocellulose, cellulose acetate, and rayon,

6. The medical device of claim 2, wherein the synthetic polymer is chosen from the group consisting of polyester, aromatic polyester, polyamide, aramid, polyimide, polyolefin, polyethylene, polyurethane, polyuria, polyvinyl chloride, polyvinylidene chloride, polyether amide, polyether urethane, polvacrylate, polvacrylonitrile, acrylic, polyphenvlene sulfide, polylactic acid, polyfdiimidazopyridinylene-dihydroxyphenylene, poly(p-phenylene~2, 6- benzobisoxazole), and liquid crystal polymer fiber.

7. The medical device of claim 1, wherein the reinforcing material is a continuous filament reinforcing fiber.

8. The medical device of claim 1, wherein the reinforcing material comprises fibers.

9. The medical device of claim 8, wherein at least one of the fibers has a length of greater than 20 mm.

10. The medical device of claim 9, comprising fibers having a length of between 25 mm and 50 mm.

11. The medical device of claim 8, wherein the reinforcing material fibers are dispersed and distributed throughout the polymeric base material.

12. The medical device of claim 1, wherein the medical device comprises a plurality of layers, wherein each of the plurality of layers comprises a polymeric base material and a reinforcing material, and the polymeric base material comprises a resin and the reinforcing material comprises fibers.

13. The medical device of claim 1, wherein at least one layer comprises a directional fiber and at least one layer comprises a non-directional fiber.

14. The medical device of claim 1, wherein the medical device comprises a plurality of layers, wherein at least one layer comprises a fabric and at least one layer comprises a polymer film,

15. The medical device of claim 14, wherein the at least one fabric layer is sandwiched between two polymer film layers.

16. The medical device of claim 1, wherein at least a portion of the medical device comprises a coating.

17. The medical device of claim 16, wherein the coating comprises a material chosen from the group consisting of polyurethane, polyether, polyvinyl chloride, polyvinylidene chloride, silicone, styrene-butadiene, polyethylene, polypropylene, ethylene-propylene copolymer, polyisoprene, ethylene vinyl acetate, ethylene-proplyene-diene monomer, polyamide, polyether block amide, and polyether urethane.

18. The medical device of claim 16, wherein the coating of the medical device comprises a selectively permeable material.

19. The medical device of claim 18, wherein the coating comprises polyvinyl chloride.

20. The medical device of claim 16, wherein the coating comprises an antibacterial agent

21. The medical device of claim 20, wherein the antibacterial agent is chosen from the group consisting of iodine, antibiotics, silver, triclosan, and biocides.

22. The medical device of claim 1, further comprising a woven fabric.

23. The medical device of claim 1, wherein the reinforcing material is selected from the group consisting of metal, ceramic, glass, carbon fiber, carbon nanotubes, and combinations thereof.

24. The medical device of claim 1, wherein the medical device is selected from the group consisting of an internal or external fixation device.

25. A method of producing a medical device for supporting a bone structure in a patient, the method comprising:

forming a fiber-reinforced resin core;

covering the fiber-reinforced resin core with a fiber material;

enclosing the fiber-reinforced resin core in a mold shaped to conform to the shape of the fiber-covered core; and

injecting resin into the mold under pressure to impregnate the fiber material and bond it to the fiber-reinforced resin core.

26. The method of claim 25, wherein the fiber-reinforced core comprises a polymeric base material is selected from the group consisting of natural polymers, semi-synthetic polymers, synthetic polymers and combinations thereof.

27. The method of claim 25, wherein the fiber material is selected from the group consisting of metal, ceramic, glass, carbon fiber, carbon nanotubes, and combinations thereof.

28. The method of claim 25, wherein the fiber material comprises at least one fiber having a length of greater than 20 mm.

29. The method of claim 25, wherein the method further comprises coating at least a portion of the medical device with a laminate,

30. The method of claim 29, wherein the laminate comprises a material chosen from the group consisting of polyurethane, poly ether, polyvinyl chloride, polyvinylidene chloride, silicone, styrene-butadiene, polyethylene, polypropylene, ethylene-propylene copolymer, polyisoprene, ethylene vinyl acetate, ethylene-proplyene-diene monomer, polyamide, polyether block amide, and polyether urethane.

31. The method of claim 29, wherein the laminate is at least partially antibacterial.

32. The method of claim 31, wherein the laminate comprises an antibacterial agent chosen from the group consisting of iodine, antibiotics, silver, triclosan, and biocides.