Title of Invention	A METHOD OF MANUFACTURING ARTIFICIAL BONE AMPLANT
Abstract	A METHOD OF MANUFACTURING ARTIFICIAL BONE AMPLANT

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FORM 2 THE PATENTS ACT, 1970 (39 of 1970) COMPLETE SPECIFICATION [See section 10] A METHOD OF MANUFACTURING ARTIFICIAL BONE IMPLANT; TADPHALE KESHAV BALKRISHNA AN INDIAN NATIONAL OF BHAWANI BAUG, GAT NO. 16, ARVI, TALUKA HAVELI, DIST PUNE, 412 205, IN THE STATE OF MAHARASHTRA, WITHIN THE UNION OF INDIA AND DR. MODAK MILTND BATTATRAYA AN INDIAN NATIONAL OF 1188 SADASHIV PETH, GOPAL DHAM, LIMAYEWADI, PUNE 411 030, IN THE STATE OF MAHARASHTRA, WITHIN THE UNION OF INDIA THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE NATURE OF THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFOMED 2 Medicine and Surgery have evolved over the ages. Surgery and especially Orthopaedic surgery has developed by leaps and bounds-hand in hand with the progress, research and development in various other branches of science and engineering. Progress in Orthopaedic management fracture treatment and joint replacement is multidisciplinary approach. Other than Orthopaedic, knowledge of bio -engineering, instrument/ prosthetic designing is necessary to achieve a good implant or a prosthetic design. The past three decades have witnessed a number of changes in synthetic bio -material device -designs, surgical treatment and clinical longevities. Continuous improvement, change and evolution have been observed and are anticipated. In some situations this was achieved by the use of mechanically and chemically anisotropic fiber reinforced components, whereas in other cases metallic alloys were coated with bioactive ceramics based on calcium phosphate or glass ceramic systems. There are a number of materials, which have been used, in the human body for the past decades. As the search for the most ideal bio-material goes on, there are a number of factors, which are to be considered. Inertness in the human body would be the top priority consideration. Neither undergoing any change in the human body nor eliciting a foreign body response is the primary criteria towards development of a synthetic biomaterial. The other factors to be considered are, modulus of elasticity, tensile strength and elongation to fracture. 3 Electrochemical properties, especially for metallic systems, bio-chemical features (materials of highest possible strength, ductility, bio-degradation resistance and wear resistance) are considered for processing and development of implant. Finally the selection of a material includes the important considerations of availability, fabricability and cost. Some of the patents granted to date are sited below for the elaboration of the above. U.S. Patent No. 6,253,225: Okada, et al, describes process for producing biocompatible implants material. "A process for producing a biocompatible implant material which can be suitably shaped into variety of forms, A binder is added to a mixture of hydroxylapatite powder and calcium phosphate glass frit (5 wt.%), to thereby prepare a slurry, and the resultant slurry is granulated, to prepare spherical raw material granules. Separately, spherical polyisobutyl methacrylate particles are prepared, and the particles are dry-mixed with the above -prepared granules, to thereby obtain a powder mixture. The Powder mixture is compacted using a mold press, to thereby form a cuboid sample. The resultant compant is heated in a drier at 170. degree. C. for three hours, to thereby melt spherical polyisobutyl methacryylate particles. Thereafter, the compact is allowed to cool, to thereby bind the raw material granules together via the polyisobutyl methacrylate that solidifies after melting. After the compact is allowed to cool, the compact is subjected to shaping by use of a copy-machining machine and also to drilling. Thereafter, the compact is heated at a rate of 300.degree. C. hour, and fired at 1,250. degree. C. for three hours, to thereby produce a biocompatible implant material." 4 U.S. Patent No. 5,855,612; Ohthuki, et al describes Biocompatible titanium implant "A biocompatible titanium implant with a modified exterior surface having a covering layer that comprises a hydrated titania gel. The exterior surface of the titanium implant is processed by a hydrogen peroxide aqueous solution that contains metal irons which not only promotes a reaction between the titanium implant and the hydrogen peroxide aqueous solution but also provides a high apatite formation ability to the hydrated titania gel on the surface of the implant". United States Patent No. 5,849, 417; Sawada, et al, describes Titanium implantation materials for the living body "Implantation materials for the living body comprising: 10 to 4000 ppm of gaseous ingredients combined, mainly composed of oxygen; up to 100 ppm of ingredients other than the gaseous ingredients such as iron; and the balance titanium. An oxide film is formed on the surface, where necessary, by anodizing or the like. Titanium fixation wires for implanting in the living body composing: up to 300 ppm oxygen, up to 50 ppm hydrogen, up to 200 ppm nitrogen, and up to 400 ppm described as preferred embodiments in concrete and polymer based shaped articles". U.S. Patent No. 5,639, 402 Barlow, et al Method for fabricating artificial bone implant green parts. "Bone implants are made from calcium phosphate powders by selectively fusing layers of calcium powders that have been coated or mixed with polymer binders. A 5 The calcium powder mixture may be formed into layers and the polymer fused with a laser. Complex three-dimensional geometrical shapes can be automatically replicated or modified using this approach". U.S .Patent No. 5,462,722 Liu, et al describes Calcium phosphate calcium sulfate composite implant material. "This invention provides new inorganic composite materials for hard tissue replacement. The new composite material comprises solid material of calcium sulfate, which is fully or partially converted to calcium phosphate from aqueous solution. This composite material has good biocompatibility and controllable restoration, and will be very useful for bone substitute material in orthopedic and dental applications. The fully converted material, which comprises mainly appetite calcium phosphate, is also useful for chromatography application. A process to prepare these new composite materials is also described". U.S. Patent No.5,204,319 Enomoto, et al describes, Fiber reinforced ceramics of calcium phosphate series compounds "Calcium phosphate series compound ceramics are provided in which heat resistant inorganic short fibers such as flawless SiC or Si.sub.3 N.sub.4 are three -dimensionally dispersed in a matrix composed of calcium phosphate series compound and entangled with each other to form a high strength shaped body as well as a method of producing the same. Also, a high-density silicon carbide ceramic is provided in which biological glass is impregnated and filled in a porous shaped body. These composite ceramics have high strength and high toughness 6 and are suitable as a heat-resistant structural material or a material for bio hard texture". U.S. Patent No. 5,192,325 ; Kijima, et al describes Ceramic implant "A ceramic implant comprising a sintered body of zirconia and a coated layer of a porous sintered body of mixture comprising, alpha-tricalcium phosphate and zirconia, or hydroxyapatite and zirconia formed on the surface of the sintered body of zirconia" U. S. Patent No. 5,141,576 Shimamune, et al. describes, Titanium composite materials coated with calcium phosphate compound and process for production thereof "A titanium composite material is disclosed which comprises a titanium or titanium alloy substrate, a base layer formed thereon of a calcium phosphate compound resulting from calcinations of a hydrochloric or nitric acid aqueous solution of the calcium phosphate compound, and a covering layer thereon of a calcium phosphate compound formed by sintering a suspension of the calcium phosphate compound applied to the base layer. The composite material is useful as biological implant. It is produced by activating the surface of the substrate, forming the base layer by coalmining the solution coated in the substrate and then forming the covering layer by sintering the suspension coated on the base layer. The covering layer may be hydro thermallytreated to increase its crystallinity". 7 U. S. Patent No. 4,336,617 Shikita, et al describes Prosthetic substituted member for living body and a method for the surgical treatment by use thereof, "The invention provides and artificial prosthetic member for bone substitute with a novel structure comprising a core, an outer layer covering the core made of metallic aluminium, preferably, formed by electrolytic plating, and a surface layer on the outer layer formed of an anodically oxidized aluminium oxide. The prosthetic member of the invention is very advantageous with high affinity to the living tissues and absence of elution of poisonous metallic ions". General characteristics limitation of bio materials used are discussed below Synthetic origin biomaterials broadly categorized into: i) Metal: alloys of iron, cobalt or titanium single element Compositions Titanium (Ti) or Zirconium (Zr) ii) Ceramics & Carbons: those based on Aluminium (AI203) or Zirconium oxide (Zro2) Calcium aluminates & Phosphate glass & glass Ceramics & carbon silicon compounds, iii) Polymer : PMMA, GHMWPE, PTFE, PET, PDS, polyurethane, Polypropylene, poly sulfones iv) Composites Metals, ceramics, carbons or polymers are bonded to one another to form new structures with specific properties that are different from the independent Components. 8 The limitations for use of the above for use as a biomaterials are given below 1. METALS & ALLOYS ■ Stainless steel can"t be used for porous implants because of its susceptibility to crevice corrosion. ■ Alloys passivated (oxidized) surface conditions provide increased resistance to biodegradation however a high incidence of breakdown of this surface layer is found. ■ Biologic aspects: Metallic ion release and tissue responses can be categorized into : I) local tissue reactions (toxicity) ii) allergy or hypersensitivity iii) carcinogenicity a small but significant portion of the population will react to Nickel or cobalt based alloys. CERAMICS Porosity : Which results from incomplete sintering has a deleterious affects on mechanical prospects. (Sintering is a process dependant on time & temperature, which must be carefully controlled to prevent large grain size & to achieve 100% density) Full density can be achieved through single crystal technology- however it has extremely high cost of production. Most ceramic materials are poly crystalline & behave like metal in that very fine grain size produces high strength whereas large grain results in poor strength & fatique resistance. 9 Problems of fracture with alumina -alumina head socket combination have been noted. Mechanical properties of alumina are quite sensitive to impurities (typically cao, Mgo, sio2) Hydroxylapetite and its composites are extremely costly. Overall processing is difficult and requires stringent specific manufacturing process. The present invention comprises of using fluoropolymer with suitable reinforcement. A layer of substantial thickness of fluoropolymer is used in final embodiment of the bone implant or prosthetic over the reinforcement member where ever required. PTFE, PCTFE, FEP, PFA, RULON constitute a group of fluoropolymers. They are available in Powder form. They are moulded by methods of compression and / or injection in a specially designed die or mould as per required specifications. Depending on the required features of the final product, PEFE, PCTFE, FEP, PFA, RULON™ or the like are reinforced by various materials like metals, carbon, etc and various additional ingredients are addedlike carbon, ceramics, and glass fibre. These moulded forms are ejected from the die and processed suitably, after which post machining is done to achieve required shape as per design. This reinforced PTFE, PCTFE, FEP, PFA, RULON have enhanced physical properties suitable for use for medical purpose such as joint surgery, instrumentatipn^ndiptal replacement of bone segment. These materials have tremendous, potential for custom-made implant and prosthetic, including any bone in Human and Veterinary. 10 The invention now will be described with the help of following figures Fig 1- Shows the process of manufacturing the basic shape of the implant material with reinforcement. Fig. 2 - Shows the bones of foot according to present invention with the reinforcement Fig 3 - Shows the bones of elbow in normal embodiment Fig 4- Shows the bones of elbow as per th present invention with reinforcement Fig 5- Shows the bones of humerus & scapula as per present invention with reinforcement Fig 6- Shows the bones Tibia & Fibula in embodiment as per the present invention Fig 7 - Shows the metacarpal bones as per the present invention Fig 8 - Shows the embodiment of patella as per the present invention Fig 9- Shows femur as reinforced and replaced fully & partly and joint of a created bone with plate screw as per the inventions I Referring to the above figures, insert reinforcement (121) is placed in a molding die having at least two parts (101) & (102) and the fluoropolymer material is : injected in molten form or compression molded in the said cavity forming parts (101) & (102) , so that the cavity is filled with the fluraocarbon material (111).Then the mold is opened & the .basic-shape (130) haviing reinfefeement (121)and tiuoropolymer layer (111)over it is taken out. Depending on the type of material e.g. PTFE it is sintered in a fumance to get basic raw material for rnanufacturing the artificial bones implant or prosthetic. The final shapes shown in subsequent figures 2 to fig. 8 are machined forms that basic shape. The basis 11 shape is designed to suit the final shape so that minimum amount of machining required to achieve final shape. Some of the final shapes are shown are as follows : Fig 2 metatarsat & tarsal bones. Tarsal bones (211) with reinforcing insert (221), metatarsal bones showing fluoropolymer part (212), (213), (214) with reinforcement (222), (223) & (224) Fig 3 shows a normal elbow joint in the human bones while fig 4 shows the same joint with outer layer of fluoropolymer (411), (412) & (413) while the reinforcement (421), (422) & (423) in the same. Fig 5 shows bones Humerus & scapula in present embodiment where (511), (512) are the fluoropolymer layer while (521) & (522) are th reinforcement members. Fig 6 shows the bones tibia and Fibula in which fluoropolymer part is shown as (611), (612) while reinforcement is shown in as (621), (622). Fig 7 shows the bones of phalanges i,e, metacarpal bones where one of the bone is shown replaced with the artificial bone as per present invention showing fluorocarban layer as (711) while the reinforcement as (721) Fig 8 shows the patella as per present invention with (811) as an outer fluorocarbon layer while the reinforcement is shown as (821) Fig 9 shows femur in case where it is totally replaced showing the outer layer of fluorocarbon (911) and reinforcement (921) while second part of figure shows part of the femur replaced thus the replaced portion (912) is made up of fluoropolymer with reinforcement (922) which also extends in to the original bone part (914) for anchoring into it. While a bone fractured at (916) can be joined by a plate made of outer fluorocarbon layer (913) and reinforcement (923) with screws (924) made of fluorocarbon material to secure both parts of the cracked bone together. 12 In all the above examples the embodiment comprises of having a layer of substantial thickness of the fluropolymer material over the reinforcement member. The desired shape of an orthotic can also be given to the material. Depending on the stresses - it is appropriately reinforced. The examples cited above are just representative examples as to how the artificial bone implant as prosthetic can be manufactured, in fact any of the human or veterinary requirement for artificial bone implant or prosthetic can be met with above method. WE CLAIM 1. A method of manufacturing artificial bone implant containing fluropolymer comprising the steps of: (a), molding a fluropolymer with a reinforcement to a shape (b). sintering the mold at a high temperature; and (c). machining the mold to form a fluropolymer implant wherein the implant comprises a substantially thick layer of fluropolymer material over the reinforcement member. 2. A method as claimed in claim 1 wherein fluropolymer is selecte from the group of PTFE, PCTFE, FEP, PFA, RULON or the like. 3. A method as claimed in claim 1 wherein molding is by injectir molten fluropolymer with reinforcement in a molding die. 4. A method as claimed in claim 1 wherein molding is by compressir the fluropolymer with reinforcement in a molding die. 5. A method as claimed in claim 1 wherein the implant is bones of legs, hands, joints, or the like. Dated this 3rd day of August, 2001. FOR TADPHALE KESHAV BALKRISHNA & DR. MODAK MILIND DATTATRAYA By their Agent (MANISH SAURASTRI) KRISHNA & SAURASTRI

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