WO2022146243A1 - Bone-like thermoplastic based composites - Google Patents
Bone-like thermoplastic based composites Download PDFInfo
- Publication number
- WO2022146243A1 WO2022146243A1 PCT/TR2020/051430 TR2020051430W WO2022146243A1 WO 2022146243 A1 WO2022146243 A1 WO 2022146243A1 TR 2020051430 W TR2020051430 W TR 2020051430W WO 2022146243 A1 WO2022146243 A1 WO 2022146243A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- composite material
- bone
- characterizing feature
- filling
- bioactive
- Prior art date
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- 239000002131 composite material Substances 0.000 title claims abstract description 71
- 229920001169 thermoplastic Polymers 0.000 title abstract description 9
- 239000004416 thermosoftening plastic Substances 0.000 title abstract description 9
- 210000000988 bone and bone Anatomy 0.000 claims abstract description 63
- 239000007943 implant Substances 0.000 claims abstract description 24
- 230000000975 bioactive effect Effects 0.000 claims abstract description 19
- 229920000642 polymer Polymers 0.000 claims description 22
- 239000004696 Poly ether ether ketone Substances 0.000 claims description 21
- 229920002530 polyetherether ketone Polymers 0.000 claims description 21
- 239000000654 additive Substances 0.000 claims description 16
- 230000000996 additive effect Effects 0.000 claims description 15
- 229910052588 hydroxylapatite Inorganic materials 0.000 claims description 13
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 claims description 13
- 229920003229 poly(methyl methacrylate) Polymers 0.000 claims description 13
- TZCXTZWJZNENPQ-UHFFFAOYSA-L barium sulfate Chemical compound [Ba+2].[O-]S([O-])(=O)=O TZCXTZWJZNENPQ-UHFFFAOYSA-L 0.000 claims description 12
- 239000004926 polymethyl methacrylate Substances 0.000 claims description 12
- 239000004626 polylactic acid Substances 0.000 claims description 10
- 239000002241 glass-ceramic Substances 0.000 claims description 6
- RVTZCBVAJQQJTK-UHFFFAOYSA-N oxygen(2-);zirconium(4+) Chemical compound [O-2].[O-2].[Zr+4] RVTZCBVAJQQJTK-UHFFFAOYSA-N 0.000 claims description 6
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims description 6
- 229910001928 zirconium oxide Inorganic materials 0.000 claims description 6
- 239000004417 polycarbonate Substances 0.000 claims description 5
- 229920000515 polycarbonate Polymers 0.000 claims description 5
- 210000003625 skull Anatomy 0.000 claims description 5
- 239000010936 titanium Substances 0.000 claims description 5
- 239000005313 bioactive glass Substances 0.000 claims description 4
- -1 HAPEx Substances 0.000 claims description 3
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 3
- 229910052719 titanium Inorganic materials 0.000 claims description 3
- 239000004609 Impact Modifier Substances 0.000 claims description 2
- 239000000378 calcium silicate Substances 0.000 claims description 2
- 229910052918 calcium silicate Inorganic materials 0.000 claims description 2
- OYACROKNLOSFPA-UHFFFAOYSA-N calcium;dioxido(oxo)silane Chemical compound [Ca+2].[O-][Si]([O-])=O OYACROKNLOSFPA-UHFFFAOYSA-N 0.000 claims description 2
- 239000012760 heat stabilizer Substances 0.000 claims description 2
- 229920000747 poly(lactic acid) Polymers 0.000 claims description 2
- 229910052712 strontium Inorganic materials 0.000 claims description 2
- CIOAGBVUUVVLOB-UHFFFAOYSA-N strontium atom Chemical compound [Sr] CIOAGBVUUVVLOB-UHFFFAOYSA-N 0.000 claims description 2
- 239000004605 External Lubricant Substances 0.000 claims 1
- 239000004610 Internal Lubricant Substances 0.000 claims 1
- 239000000463 material Substances 0.000 abstract description 50
- 238000004519 manufacturing process Methods 0.000 abstract description 39
- 238000001514 detection method Methods 0.000 abstract description 3
- 238000002591 computed tomography Methods 0.000 abstract description 2
- 238000000034 method Methods 0.000 description 9
- 239000000843 powder Substances 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- 230000002980 postoperative effect Effects 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- 238000005452 bending Methods 0.000 description 3
- 230000015556 catabolic process Effects 0.000 description 3
- 238000000576 coating method Methods 0.000 description 3
- 238000006731 degradation reaction Methods 0.000 description 3
- 238000001125 extrusion Methods 0.000 description 3
- 238000001746 injection moulding Methods 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 2
- 210000001124 body fluid Anatomy 0.000 description 2
- 239000010839 body fluid Substances 0.000 description 2
- 210000004027 cell Anatomy 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 230000006835 compression Effects 0.000 description 2
- 238000007906 compression Methods 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 239000000314 lubricant Substances 0.000 description 2
- 238000003754 machining Methods 0.000 description 2
- 239000007769 metal material Substances 0.000 description 2
- 210000005036 nerve Anatomy 0.000 description 2
- 230000002285 radioactive effect Effects 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 201000004569 Blindness Diseases 0.000 description 1
- 208000010392 Bone Fractures Diseases 0.000 description 1
- 206010065687 Bone loss Diseases 0.000 description 1
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 1
- 208000006670 Multiple fractures Diseases 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 150000001450 anions Chemical class 0.000 description 1
- 229920000249 biocompatible polymer Polymers 0.000 description 1
- 229920002988 biodegradable polymer Polymers 0.000 description 1
- 239000004621 biodegradable polymer Substances 0.000 description 1
- 239000005312 bioglass Substances 0.000 description 1
- 210000002449 bone cell Anatomy 0.000 description 1
- 239000001506 calcium phosphate Substances 0.000 description 1
- 210000000845 cartilage Anatomy 0.000 description 1
- 238000005266 casting Methods 0.000 description 1
- 150000001768 cations Chemical class 0.000 description 1
- 239000000919 ceramic Substances 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000005242 forging Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
- 231100000219 mutagenic Toxicity 0.000 description 1
- 230000003505 mutagenic effect Effects 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 238000006116 polymerization reaction Methods 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 230000035755 proliferation Effects 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 238000004381 surface treatment Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000009772 tissue formation Effects 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 229910000391 tricalcium phosphate Inorganic materials 0.000 description 1
- 229940078499 tricalcium phosphate Drugs 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L27/46—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with phosphorus-containing inorganic fillers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/54—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/44—Radioisotopes, radionuclides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
Definitions
- Beta tri calcium phosphate is used to optimize the degradation time of polylactic acid (PLA), which is used as a polymer (2) in the body.
- PLA polylactic acid
- polylactic acid (PLA) can be decomposed faster or slower.
- the composite material (1) degrades faster.
- 0 - 40% of beta tri calcium phosphate is used in composite material (1) depending on the requirement of the bone.
- beta tri calcium phosphate is used to optimize the degradation time of polylactic acid (PLA), it is also a bioactive filling (3.2). Depending on the need for use, 0 - 30% radiopaque filling (3.2) can be used in the composite material (1) prescription for long bones.
Abstract
The invention relates to a bioactive composite implant material that can adapt to any bone type and is biocompatible with the body structure. Subject of the invention is particularly related to the prescription and production method of thermoplastic-based composite material (1) that enables the bone and implant to be detected especially in X-rays post damage detection or repair, such as in computed tomography.
Description
DESCRIPTION
BONE-LIKE THERMOPLASTIC BASED COMPOSITES
Technical Field
This invention relates to a bioactive composite implant material that can adapt to any bone type and is biocompatible with the body structure. Subject of the invention is particularly related to the prescription and production method of thermoplastic-based composite material that enables the bone and implant to be detected especially in X-rays post damage detection or repair, such as in computed tomography.
Prior Art
Materials currently used are not suitable for the structure and properties of bone. Materials close to chemical and physical structure of the bone and its mechanical properties are not used. As a result, bone, which is a dynamic tissue, does not allow bone cells to attach, proliferate and grow. Implant material that can support this dynamic process of the bone is required.
Materials used in known applications of this technique consist of polymeric materials that can make monomeric release in the body or metallic materials that have been used since ancient times. Developing materials suitable for bone structure is of great importance in terms of compatibility of structure and characteristics. Although some of the materials used in current technique provide biocompatibility and bioactivity, these cannot meet the desired mechanical properties (tensile, bending, impact and compression). On the other hand, metallic materials used in current technique do not support cell attachment, growth and proliferation.
Considering the bone structure and characteristics that vary from person to person and even from region to region in the same human body, it is necessary to develop a personal and region-specific material prescription and production process.
Structure of the bone is divided into two as compact and spongy. Materials currently used cannot respond to bone that is both compact and spongy.
Development of bone-like materials using biocompatible and radiopaque materials is very important for the human body reaction and postoperative implant detection and monitoring on X-ray. Materials such as cartilage grafts, titanium, polyethylene, hydroxyapatite, methylmethacrylate, ceramics and alloplastic used in the current technique cannot meet all of the structure and characteristics of the bone, and postoperative patients experience serious problems related to compatibility with the body and bone tissue formation.
Problems arise because the shape of materials used in known applications of this technique are not designed individually. For example, bone damage, especially in the head area, is treated with currently used implant materials. Patients experience psychological problems and social life issues due to the deformity that occurs after surgery and the difference in appearance due to the formal incompatibility of implant materials used for the skull. It is necessary to develop implant materials not affecting the social life of the person, developed specifically for the relevant region and shaped exclusively for the person.
Methyl Methacrylate resins are cured and used to repair bone damage. These resins are expected to be poured and cured into the damaged bone area, freezing by polymerization. However, during the curing phase, all monomers in this solution are not able to polymerize and monomeric remnants are mixed with the body fluid. As these are non-compatible with the body, mixing of these monomeric structures into the body can create a body-wide reactive effect. As a solution, this problem can be eliminated by producing a bone-like material by using a fully polymerized polymethyl methacrylate (PMMA) thermoplastic composite material as a matrix material.
In applications where polymers such as PI_A, that can degrade over time due to its biodegradability when in contact with body fluid, are not desired to be degraded within the body, their interbody use is ensured by applying a special coating. Due to this coating, PI_A surface turns to be non-detectable on X-Ray and postoperative follow-up is made not possible. It is however possible to eliminate these
disadvantages using composite materials applicable in implant applications where intrabody dissolution is not desired, that can meet the need for post-operative follow-up and can eliminate the additional coating process, making it to be completely detectable on X-Ray. As a result, implant materials used today have made it necessary to perform and form material studies in order to eliminate above-mentioned disadvantages and to develop solutions to current problems.
Current production processes limit the production of implants specific to the structure and form of the bone. In the current technique; casting, machining, forging and similar production methods are used for the production of metallic implants.
Injection molding, extrusion, machining and similar production methods are used for the production of polymeric implants. Since the bones are spongy and compact, they contain pores. Due to these structures of the bones, none of the above production methods can provide a production of a compatible implant.
The currently used production methods are suitable for the production of bone implants with standard dimensions and features for mass production. Therefore, the cost of single-use implant production oriented to the form of bone to be applied to, increases due to current techniques.
In recent years, additive manufacturing methods have been used for the production of implants compatible to the structure and form of the bone to be applied. However, materials used in these additive manufacturing methods cannot provide bone-specific requirements of bioactivity, biocompatibility, radiopacity and mechanical properties.
Purpose of the Invention
The aim of the invention is to develop thermoplastic-based composite materials having below characteristics suitable to additive manufacturing technologies,
Compatible to the mechanical and physical properties (tensile, bending, impact, compression, porosity, density, etc.) of the bone to be applied,
Featuring radiopacity,
Featuring biocompatibility and bioactivity, suitable to be prescribed specific to the bone applied to with options in regards to fillers and additives in appropriate proportions,
Also suitable for injection and extrusion applications for the production of implants specific to the structure and form of the bone to be applied.
Detailed Description of the Invention
Reference numbers are given in order to better understand the invention of bonelike thermoplastic based composite material and the description will be indicated with these reference numbers in following sections. Accordingly;
1. Composite material
2. Polymer
3. Filling material
3.1. Bioactive filling
3.2. Radiopaque filling
4. Additive material
The invention is an implant material of thermoplastic-based composite substance (1) featuring bone-like characteristics. The composite material (1) prescriptions to be used in implant production mainly consist of three basic substances. These basic substances are polymer (2), filling material (3) and additive material (4).
The polymer (2) selected for the production of the composite material (1) must be suitable for interbody usage; ie biocompatible. When selecting the polymer (2) to be used in the production of composite material (1), it is important to choose a polymer (2) that will not cause any reactions to the body and will show biocompatibility. For this reason, polyetheretherketone (PEEK), polymethylmethacrylate (PMMA), polycarbonate (PC) and polylactic acid (PI_A) are materials that meet to the desired properties as polymer (2) types to be used in the production of composite materials (1).
Another important material used in the production of composite material (1) is the filling material (3). Filling materials (3) are used according to the desired characteristics in composite material (1) recipe. While bioactive filling (3.1) is used for composite material (1) to have bioactive characteristic, radiopaque filler (3.2) is used for featuring detectability under X-rays. Bioglasses, bioactive glassceramics (Cerabone), A/W glass ceramic, machinable glass ceramics, dense hydroxyapetite, HAPEx, p-tricalcium phosphate (p-TCP), titanium (Ti), calcium silicate (CS ), hydroxyapatite (HA), strontium containing hydroxyapatite (Sr-HA) and nano-fluorohydroxyapatite (nano-FHA) are being used as bioactive filling (3.1) in composite material (1) prescriptions. The difference of bioactive fillings (3.1) from bioinert materials is that thanks to their superior adhesiveness, they form a bond between the composite material (1) and bone tissue. Additionally, bioactive filling (3.1) is more resistant to mechanical forces. Barium sulphate and zirconium oxide are preferred as radiopaque filling (3.2).
The effect of filling materials (3) in regards to mechanical properties is very important. Due to insufficient use of filling material (3), bioactive or radiopacity effect aimed to be featured in the composite material (1) may not be achieved. However, excessive use of the filling material (3) both increases the cost and causes a decrease in the mechanical values. As a result, composite material (1) is not able to meet the desired bone properties. In addition, excessive filling material (3) used makes the production process of the composite material (1) difficult. One of the technical difficulties encountered during production is non-homogeneous distribution of filling material (3) in the polymer (2). Therefore, adjusting the ratio of used filling materials (3) is the part of production of composite material (1) that requires precise engineering calculations.
Each bone structure of the body is different from each other. As is the duty and function of each bone. When bone losses occur, it is necessary to fill the bone with a bone-like composite material (1). For this reason, composite material (1) prescriptions are specially made in regards to three different bone types.
• Production of polvetheretherketone (PEEK) based composite material (1) suitable for use in skull bones:
Polyetheretherketone (PEEK) is selected as the polymer (2) in bone applications such as skull. Polyetheretherketone (PEEK) is not mutagenic or toxic. Polyetheretherketone (PEEK), which is a type of polymer (2), is known as a bioinert material since it does not emit any anion and cation to human tissue. However, the polymer (2) can be given bioactive properties by using bioactive filling (3.1). On the other hand, polyetheretherketone (PEEK) is disadvantageous in terms of cell attachment due to its hydrophobic character. At the same time, the elasticity modulus of polyetheretherketone (PEEK) is approximately 3-4 GPa, which is less than the elasticity modulus of a bone. As polyetheretherketone (PEEK) is a type of biocompatible polymer (2), filling materials (3) were used to increase the low mechanical values and to add bioactivity and radiopacity.
The composite material prescription specially developed for use in skull bones (1) contains 0 - 60% polyetheretherketone (PEEK) as polymer (2), 0 - 40% bioactive filling (3.1) and 0 - 30% radiopaque filling (3.2). In this composite material (1) prescription, hydroxyapatite and/or bioactive glass can be used as bioactive filling (3.1), depending on the preference. Also depending on the preference, barium sulfate and/or zirconium oxide can be used to form the radiopaque filling (3.2) in the composite material (1) recipe.
Hydroxyapatite, which is used as a radioactive filling (3.1) in the composite material (1) recipe, adds radioactivity to the polyetheretherketone (PEEK) used as polymer (2) and increases its low elasticity modulus. The mechanical properties of hydroxyapatite used as radioactive filling (3.1) are as follows.
- Elasticity Modulus (GPa) 4-117
- Compressive Strength (MPa) 294
- Bending Strength (MPa) 147
- Hardness (Vickers, MPa) 3,43
- Poisson's Ratio 0,27
- Density (theoretical, g/cm3) 3,16
• Production of polymethylmethacrylate (PMMA) and/or polycarbonate (PC) based composite material (1) suitable for use in orbital bone:
A composite material (1) should be developed suitable for use in orbital bones not damaging surrounding tissues, organs and nerves upon breaking into small pieces with the impact it receives. If the composite material (1) used in the orbital bone does not break into small pieces upon receiving an impact, it puts pressure on the surrounding nerves. This pressure causes negative effects, up to the blindness of the user. For this reason, brittle polymethylmethacrylate (PMMA) and/or polycarbonate (PC) are used as polymer (2) in recipes of composite materials (1) specially developed for orbital bones. Polymethylmethacrylate (PMMA) and/or polycarbonate (PC) at 0 - 60%, bioactive filling (3.1) at 0 - 40% and radiopaque filling at 0 - 30% (3.2) are used. Hydroxyapatite can be used as bioactive filling (3.1) and/or barium sulfate and/or zirconium oxide in bioactive glass and radiopaque filling (3.2) in composite material (1) recipe suitable for orbital bone.
• Production of polylactic acid (PLA) based composite material (1) suitable for use in Iona bones:
Screws and plates are used as fasteners that keep the broken bones together and ensure bones to fuse together. In the production of these screws and plates, polylactic acid (PLA) based composite material (1) is preferred. Especially in long bones such as arms and legs, after the bone healing process is completed, these fasteners are required to be degraded and disposed from the body. Therefore, a biodegradable polymer (2) should be selected in the composite material (1) recipe of the fasteners. Biodegradable polylactic acid (PLA) is used as the polymer (2) in composite material (1) recipe of the invention. Polylactic acid (PLA) is used at a rate of 0-60% in the composite material (1) prescribed for long bones. The repair of young bones is performed faster than old bones. According to this, it is necessary to control the degradation time of the polymer (2) in the body, depending on whether the bone is young or old. Beta tri calcium phosphate is used to optimize the degradation time of polylactic acid (PLA), which is used as a polymer (2) in the body. Depending on the usage rate of beta tri calcium phosphate, polylactic acid (PLA) can be decomposed faster or slower. As the ratio of beta tri calcium phosphate in polylactic acid (PLA) increases, the composite material (1) degrades faster. 0 - 40% of beta tri calcium phosphate is used in composite material (1) depending on the requirement of the bone. While beta tri
calcium phosphate is used to optimize the degradation time of polylactic acid (PLA), it is also a bioactive filling (3.2). Depending on the need for use, 0 - 30% radiopaque filling (3.2) can be used in the composite material (1) prescription for long bones.
In addition to the use of polymer (2) and filling material (3) in composite material (1) recipes, additive material (4) is also used. As applicable to all composite material (1) recipes, heat stabilizer at the rate of 0.05 - 0.3%, inner lubricant at 0.3 - 2%, outer lubricant at 0.3 - 2% as additive material (4) 1 - 10% impact modifier and 3 - 10% compatibilizer are used. The compatibilizer, one of the additive materials (4), is used to ensure the compatibility (to increase the bonding) between the polymer (2) and filling materials (3). In order to increase the compatibility between the polymer (2) and the filling materials (3), various surface treatments can be applied optionally on the filling materials (3).
Bones consist of two separate structures namely as compact and spongy bones. The properties of both types of bones vary from person to person, from animal to animal, and even from region to region within the same body. This change in bone structures causes the need to develop a bone-specific recipe for composite material (1), as well as the requirement of production to be made specifically for the structure and form of the bone. Additive manufacturing technology is used to design implants and fasteners specially for the form of the bone. In order to use the additive manufacturing method, composite material (1) must be able to be formed into filament or powder form. In order for the composite material (1) to be turned into filament or powder form, the MFI (Melt Flow Index) value must be less than 7 g/10 min. In order for the composite material (1) to be turned into filament or powder form, granules must be produced by extrusion method beforehand. If the MFI value of the composite material (1) is greater than 7 g/10 min, the filament structure becomes too fluid and cannot be processed in powder form. In cases where the MFI value is higher than 7 g/10 min, the density and mechanical properties of the composite material (1) decrease and stop to be suitable for the additive manufacturing method. Therefore, while composite material (1) recipes were created, their optimum values were reached as a result of high-precision tests and calculations in the usage amounts of polymer (2), filling material (3) and additive material (4). While developing bone-specific composite material (1), both
biocompatibility, bioactivity and radiopacity properties and ability to be turned into filament and/or powder form suitable for layered production method has been ensured. If the radiopaque filling (3.2) is used more than 30% in the prescription, the MFI value of the composite material (1) exceeds 7 g/10 min. In this case, it is not possible to use the composite material (1) to be processed with the additive manufactiring method. Therefore, filling material (3) not only adds the desired feature for the composite material (1), but is also an important element for the additive manufacturing method. As a result of the tests, it has been observed that the MFI value of composite material (1) is less than 7 g/10 minutes, which allows the production of the implant by injection molding method. Bone-specific thermoplastic based composite material (1) may be produced optionally by injection molding method.
Claims
CLAIMS A composite material (1) developed for the implant compatible with mechanical properties of the bone and compact and spongy bone structure comprising; a. Biocompatible and 0-60% polymer (2), b. 0-40% bioactive filling (3.1) and c. 0-30% radiopaque filling (3.2). A composite material (1) suitable for use in skull bones, its characterizing feature is comprising; a. 0 - 60% polyetheretherketone (PEEK), b. 0 - 40% hydroxyapatite and/or bioactive glass and c. 0 - 30% barium sulfate and/or zirconium oxide. A composite material (1) suitable for use in orbital bone, its characterizing feature is comprising; a. 0 - 60% polymethylmethacrylate (PMMA) and/or polycarbonate (PC), b. 0 - 40% hydroxyapatite and/or bioactive glass and c. 0 - 30% barium sulfate and/or zirconium oxide. A composite material (1) suitable for use in long bones, its characterizing feature is comprising; a. 0 - 60% of polylactic acid (PI_A), b. 0 - 40% Beta tri calcium phosphate and c. 0 - 30% barium sulfate and/or zirconium oxide. A composite material (1) as in any of the claims 1 - 4 characterizing feature is MFI value to be less than 7 g/10 min. A composite material (1) as in any of the claims 1 - 4 characterizing feature is to contain 0.05 - 0.3% heat stabilizer as an additive (4). A composite material (1) as in any of the claims 1 - 4 characterizing feature is contains 0.3-2% internal lubricant. A composite material (1) as in any of the claims 1 - 4 characterizing feature is contains 0.3-2% external lubricant. A composite material (1) as in any of the claims 1 - 4 characterizing feature is it contains 1 - 10% impact modifier.
A composite material (1) as in any of the claims 1 - 4 characterizing feature is that 3 - 10% of compatibilizer is used. A composite material (1) in accordance with the Claim 1 comprising bioactive filling (3.1) contains glass-ceramics (Cerabone), A/W glass ceramic, machinable glass ceramics, HAPEx, titanium (Ti), calcium silicate
(CS), hydroxyapatite (HA), strontium containing hydroxyapatite (Sr-HA) and/or nano-fluorohydroxyapatite ( nano-FHA).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/TR2020/051430 WO2022146243A1 (en) | 2020-12-29 | 2020-12-29 | Bone-like thermoplastic based composites |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/TR2020/051430 WO2022146243A1 (en) | 2020-12-29 | 2020-12-29 | Bone-like thermoplastic based composites |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2022146243A1 true WO2022146243A1 (en) | 2022-07-07 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/TR2020/051430 WO2022146243A1 (en) | 2020-12-29 | 2020-12-29 | Bone-like thermoplastic based composites |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2022146243A1 (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007084609A2 (en) * | 2006-01-19 | 2007-07-26 | Osteotech, Inc. | Porous osteoimplant |
| US20150273751A1 (en) * | 2008-12-30 | 2015-10-01 | Orthovita, Inc. | Bioactive composites of polymer and glass and method for making same |
| US20160206786A1 (en) * | 2013-06-14 | 2016-07-21 | R & K Cad/Cam Technologie Gmbh & Co. Kg | Production of semifinished goods for implants based on plastic |
-
2020
- 2020-12-29 WO PCT/TR2020/051430 patent/WO2022146243A1/en active Application Filing
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007084609A2 (en) * | 2006-01-19 | 2007-07-26 | Osteotech, Inc. | Porous osteoimplant |
| US20150273751A1 (en) * | 2008-12-30 | 2015-10-01 | Orthovita, Inc. | Bioactive composites of polymer and glass and method for making same |
| US20160206786A1 (en) * | 2013-06-14 | 2016-07-21 | R & K Cad/Cam Technologie Gmbh & Co. Kg | Production of semifinished goods for implants based on plastic |
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