WO2022070834A1 - 脊椎固定具用ロッド - Google Patents

脊椎固定具用ロッド Download PDF

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Publication number
WO2022070834A1
WO2022070834A1 PCT/JP2021/033268 JP2021033268W WO2022070834A1 WO 2022070834 A1 WO2022070834 A1 WO 2022070834A1 JP 2021033268 W JP2021033268 W JP 2021033268W WO 2022070834 A1 WO2022070834 A1 WO 2022070834A1
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WO
WIPO (PCT)
Prior art keywords
reinforcing fiber
fiber
layer
rod
fiber layer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2021/033268
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English (en)
French (fr)
Inventor
勝広 及川
拓司 川村
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Globeride Inc
Original Assignee
Globeride Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Globeride Inc filed Critical Globeride Inc
Priority to KR1020237006589A priority Critical patent/KR102825578B1/ko
Priority to US18/027,818 priority patent/US12599411B2/en
Priority to CN202180053600.2A priority patent/CN115996837A/zh
Priority to EP21875136.0A priority patent/EP4223502B1/en
Publication of WO2022070834A1 publication Critical patent/WO2022070834A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L31/125—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L31/126—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing carbon fillers
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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Definitions

  • the present invention relates to a fixture rod used as a fixative for fixing the spine.
  • a fixture rod using metal has been known as a fixative for fixing the spine.
  • Patent Document 1 discloses a spinal vertebral arch rod having an internally reinforced polymer core at least partially inserted in a polymer coating.
  • Fixture rods made of metal are generally excellent in fixing force and strength, but when imaged by MRI etc., the magnetic field is affected by the magnetization of the metal in the magnetic field, causing image distortion and the captured image. There was a problem that it was difficult to make a diagnosis. On the other hand, although the rod disclosed in Patent Document 1 does not have such a problem, it is difficult to impart the desired rigidity due to the low fiber density, and the strength and durability are difficult. I know.
  • One of the objects of the present invention is to provide a fixing rod having high rigidity and high durability due to a deformation load while reducing damage at the time of screw fixing.
  • Other objects of the invention will become apparent by reference to the entire specification.
  • the fixing rod according to the embodiment of the present invention is configured to include a core member and a reinforcing fiber layer provided on the core member.
  • the fixing rod according to the embodiment of the present invention is configured to include a coating layer provided on the reinforcing fiber layer.
  • the core member is made of a resin containing fibers.
  • the fiber is any of carbon, glass, aramid, boron or SiC
  • the resin is epoxy, phenol, unsaturated polyester, PA, PC, PPSU. , POM, PP, PE, ABS, PS, PAEK or PEEK.
  • the reinforcing fiber layer is a fiber reinforced resin, carbon, glass, boron, SiC or aramid is used as the fiber, and epoxy, phenol and unsaturated as the resin.
  • Polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK or PEEK are used.
  • the fibers of the reinforcing fiber layer are configured to be long fibers.
  • the fiber content of the reinforcing fiber layer is configured to be 60% by weight or more.
  • the reinforcing fiber layer includes a plurality of reinforcing fiber layers, and at least one layer is an oblique fiber layer whose fiber direction is inclined with respect to the axial length direction. ..
  • the oblique fiber layer has a fiber angle in the range of 5 ° to 85 ° or ⁇ 5 ° to ⁇ 85 °.
  • the fiber directions of the reinforcing fiber layers are aligned, and the thickness of the layers is in the range of 0.02 mm to 0.25 mm.
  • the reinforcing fiber layer includes a plurality of reinforcing fiber layers
  • the fibers used in at least one or more reinforcing fiber layers of the plurality of reinforcing fiber layers are used.
  • the flexural modulus is larger than the flexural modulus of the core member.
  • FIG. 1 is a diagram showing a spinal fixture 10 including a fixture rod 1 according to an embodiment of the present invention.
  • the fixture 10 has a plurality of screw members 18 (two screw members 18 in the illustrated example) fixed to the bones of the spine, and a fixture rod attached to the screw members 18.
  • a plurality of rod fixing members 20 having a receiving recess 21 and a pressing member 22 (two rod fixing members 20 in the illustrated example), and being inserted into the recesses 21 of the plurality of rod fixing members 20 and fixed by the pressing member 22.
  • a rod 1 for a fixture is provided.
  • FIG. 2 is a view of the fixing rod 1 shown in FIG. 1 in an XX cross section shown in the figure.
  • the fixing rod 1 according to the embodiment of the present invention is configured to include a core member 2 and a reinforcing fiber layer 3 provided on the core member 2.
  • the fixing rod 1 it is possible to provide a fixing rod having high rigidity and high durability due to a deformation load while reducing damage at the time of screw fixing. More specifically, because it adopts a solid double structure and uses a material with a large average flexural modulus for the outer layer as described later, it is a fixture with excellent bending rigidity and crushing strength of the entire rod. It becomes possible to provide a rod for use.
  • the average flexural modulus refers to a value calculated by dividing the flexural rigidity of the entire corresponding portion by the secondary moment of the relevant portion.
  • the fixing rod 1 is configured to include a coating layer provided on the reinforcing fiber layer 3.
  • the coating layer can be formed of, for example, epoxy, phenol, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK or PEEK, but is not limited thereto.
  • the core member 2 is made of a resin containing fibers.
  • the fiber is any of carbon, glass, aramid, boron or SiC
  • the resin is a thermosetting resin (for example, epoxy, phenol). , Unsaturated polyester, etc.), or a thermoplastic resin (eg, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK, PEEK, etc.). In this way, it is possible to increase the bending rigidity and the strength of the core member.
  • the reinforcing fiber layer 3 is a fiber reinforced resin, carbon, glass, boron, SiC or aramid is used as the fiber, and the thermosetting resin is used as the resin.
  • the thermosetting resin is used as the resin.
  • thermoplastic resin eg, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK, PEEK, etc.
  • the fibers of the reinforcing fiber layer 3 are configured to be long fibers. Since the fibers of the reinforcing fiber layer 3 are long fibers, it is possible to further increase the bending rigidity and the strength.
  • the fiber content of the reinforcing fiber layer 3 is configured to be 60% by weight or more.
  • the fiber layer in which the long fibers are emphasized at a high density makes it possible to form the fixing rod 1 having high rigidity and excellent durability.
  • the fixing rod 1 according to the embodiment of the present invention includes a core member 2 and a reinforcing fiber layer 3 provided on the core member 2, and the reinforcing fiber layer 3 is a fiber. It is configured to include an axial length fiber layer 4 whose direction is oriented in the axial length direction (front-back direction of the paper surface) and an oblique fiber layer 5 whose fiber direction is oblique from the axial length direction.
  • the axial length fiber layer 4 has advantages in terms of flexural rigidity and bending strength, and the oblique fiber layer 5 has advantages in terms of torsional rigidity and torsional strength, so that the core member 2 and the reinforcing fiber layer 3 have advantages. This makes it possible to provide a fixing rod having high rigidity and high durability due to a deformation load while reducing damage during screw fixing.
  • the reinforcing fiber layer 3 includes a plurality of reinforcing fiber layers, and at least one layer has an oblique direction in which the fiber direction is inclined with respect to the axial length direction. It can be configured to be a fiber layer.
  • the oblique fiber layer 5 has advantages in terms of torsional rigidity and torsional strength, the core member 2 and the reinforced fiber layer 3 reduce damage during screw fixing, and are deformed with high rigidity. It is possible to provide a fixing rod having high durability due to a load.
  • the oblique fiber layer has a fiber angle in the range of 5 ° to 85 ° or ⁇ 5 ° to ⁇ 85 °.
  • the most effective fiber angle of the oblique fiber layer is about ⁇ 45 °. The reason is that the shear modulus at ⁇ 45 ° is the maximum and the torsional rigidity is also the maximum.
  • the fiber directions of the reinforcing fiber layers are aligned, and the thickness of the layers is, for example, in the range of 0.02 mm to 0.25 mm. .. In this way, the density of the resin is made uniform, and it is possible to reduce the variation in strength depending on the site.
  • the reinforcing fiber layer includes a plurality of reinforcing fiber layers, it is used for at least one or more reinforcing fiber layers of the plurality of reinforcing fiber layers.
  • the flexural modulus of the fiber is larger than the flexural modulus of the core member. In this way, by combining the reinforcing fiber layer with the core member while giving it a certain elasticity, it is possible to maintain high bending rigidity and crushing strength of the entire rod.
  • the fixing rod 1 according to the embodiment of the present invention is configured to include a core member 2 and a reinforcing fiber layer 3 provided on the core member 2.
  • the core member 2 is formed of PEEK / CF (short fibers) and has an outer shape of about 3.0 mm.
  • the reinforcing fiber layer 3 is formed of a first laminated layer 6, a second laminated layer 7, and a third laminated layer 8.
  • the first laminated layer 6 is formed by laminating a glass scrim on a UD.
  • the UD has a fiber elastic modulus of 30 tons, a resin content of RC 24%, and a thickness of about 0.103 mm, and the scrim has a fiber elasticity.
  • the modulus is 7 tons, the resin content is 28%, and the thickness is 0.012 mm.
  • the second laminated layer 7 is obtained by laminating two diagonal layers, and the diagonal layer has a fiber elastic modulus of 30 tons, a resin content of RC 30%, and a thickness of about 0.051 mm.
  • the tilt angle is configured to be + 45 ° or ⁇ 45 °.
  • the third laminated layer 8 is formed by laminating a glass scrim on a UD.
  • the UD has a fiber elastic modulus of 30 tons, a resin content of RC 24%, and a thickness of about 0.103 mm, and the scrim has a fiber elasticity.
  • the modulus is 7 tons, the resin content is 28%, and the thickness is 0.012 mm.
  • FIG. 5 is a view of the fixture rod 1 according to the embodiment of the present invention in which each layer is formed as shown in FIG. 4 in the XX cross section shown in FIG.
  • the fixing rod 1 according to the embodiment of the present invention includes a core member 2 and a reinforcing fiber layer 3 provided on the core member 2, and the reinforcing fiber layer 3 is described above. It is formed by the first laminated layer 6, the second laminated layer 7, and the third laminated layer 8.
  • the fixing rod 1 it is possible to provide a fixing rod having high rigidity and high durability due to a deformation load while reducing damage at the time of screw fixing. More specifically, because it adopts a solid double structure and uses a material with a large average flexural modulus for the outer layer as described later, it is a fixture with excellent bending rigidity and crushing strength of the entire rod. It becomes possible to provide a rod for use.
  • the average flexural modulus refers to a value calculated by dividing the flexural rigidity of the entire corresponding portion by the secondary moment of the relevant portion.
  • step 1 the prepreg is cut (cutting the prepreg). Then, as step 2, a core material (for example, carbon solid (long fiber)) is prepared. As a step 3, since the core material is not stiff, the V-groove rail shown in FIG. 6A is used, and a temporary fixing resin is applied to temporarily fix the core material (temporary fixing). As step 4, the prepreg is wound.
  • a core material for example, carbon solid (long fiber)
  • step 3 since the core material is not stiff, the V-groove rail shown in FIG. 6A is used, and a temporary fixing resin is applied to temporarily fix the core material (temporary fixing).
  • step 4 the prepreg is wound.
  • step 5 curing is performed using the grooved orthodontic mold shown in FIG. 6 (b).
  • the reason for using the straightening die is that it may be slightly bent at the time of winding in step 4 described above, and it is necessary to correct this.
  • cutting is performed in step 6, the tape is removed in step 7, and finally, centerless is performed in step 8 for adjusting the outer diameter.
  • the fixing rod 1 that reduces damage during screw fixing, has high rigidity, and is highly durable due to a deformation load. It becomes possible to do. More specifically, because it adopts a solid double structure and uses a material with a large average flexural modulus for the outer layer as described later, it is a fixture with excellent bending rigidity and crushing strength of the entire rod. It becomes possible to provide a rod for use.
  • the average flexural modulus refers to a value calculated by dividing the flexural rigidity of the entire corresponding portion by the secondary moment of the relevant portion.
  • each component described herein is not limited to those expressly described in the embodiments, and each component may be included in the scope of the present invention. Can be modified to have the dimensions, materials, and arrangement of.
  • components not explicitly described in the present specification may be added to the described embodiments, or some of the components described in each embodiment may be omitted.

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Abstract

スクリュー固定時の破損を低減し、かつ高剛性で変形荷重による耐久性も高い固定具用ロッドを提供することにある。本発明の一実施形態に係る固定具用ロッドは、コア部材と、該コア部材上に設けられた強化繊維層とを含むように構成される。

Description

脊椎固定具用ロッド
相互参照
　本出願は、日本国特許出願２０２０－１６３９６４（２０２０年９月２９日出願）に基づく優先権を主張し、その内容は参照により全体として本明細書に組み込まれる。
　本発明は、脊椎を固定するための固定具に用いる固定具用ロッドに関する。
　従来より、脊椎を固定するための固定具として金属を用いた固定具用ロッドが知られている。
　また、このような固定具用ロッドとして、例えば、特許文献１にポリマーコーティング内に少なくとも部分的に入れられた内部補強されたポリマーコアを備える脊柱椎弓根ロッドが開示されている。
特表２０１１－５０８６２３号公報
　金属を用いた固定具用ロッドは、一般に固定力や強度に優れるものの、ＭＲＩ等による撮像の際、磁場中で金属が磁化することで磁場が影響を受け、画像の乱れが発生し、撮影画像による診断が難しいという問題があった。他方で、特許文献１に開示のロッドでは、そのような問題はないものの、繊維密度が低くなってしまうために所望の剛性を付与することが難しく、強度や耐久性に難があるということが判っている。
　本発明の目的の一つは、スクリュー固定時の破損を低減し、かつ高剛性で変形荷重による耐久性も高い固定具用ロッドを提供することにある。本発明のこれら以外の目的は、本明細書全体を参照することにより明らかとなる。
　本発明の一実施形態に係る固定具用ロッドは、コア部材と、該コア部材上に設けられた強化繊維層とを含むように構成される。
　本発明の一実施形態に係る固定具用ロッドは、前記強化繊維層上に設けられた被覆層を含むように構成される。
　本発明の一実施形態に係る固定具用ロッドにおいて、前記コア部材は、繊維を含む樹脂で形成されている。
　本発明の一実施形態に係る固定具用ロッドにおいて、前記繊維は、カーボン、ガラス、アラミド、ボロン又はＳｉＣのいずれかであり、前記樹脂は、エポキシ、フェノール、不飽和ポリエステル、ＰＡ、ＰＣ、ＰＰＳＵ、ＰＯＭ、ＰＰ、ＰＥ、ＡＢＳ、ＰＳ、ＰＡＥＫ又はＰＥＥＫのいずれかである。
　本発明の一実施形態に係る固定具用ロッドにおいて、前記強化繊維層は、繊維強化樹脂であり、繊維として、カーボン、ガラス、ボロン、ＳｉＣ又はアラミドが用いられ、樹脂としてエポキシ、フェノール、不飽和ポリエステル、ＰＡ、ＰＣ、ＰＰＳＵ、ＰＯＭ、ＰＰ、ＰＥ、ＡＢＳ、ＰＳ、ＰＡＥＫ又はＰＥＥＫが用いられる。
　本発明の一実施形態に係る固定具用ロッドにおいて、前記強化繊維層の繊維は長繊維であるように構成される。
　本発明の一実施形態に係る固定具用ロッドにおいて、前記強化繊維層の繊維含有率は、６０重量％以上であるように構成される。
　本発明の一実施形態に係る固定具用ロッドにおいて、前記強化繊維層は、複数の強化繊維層を含み、少なくとも１層は繊維方向が、軸長方向に対して傾斜する斜向繊維層である。
　本発明の一実施形態に係る固定具用ロッドにおいて、前記斜向繊維層は、繊維角度が、５°から８５°又は－５°から－８５°の範囲の角度である。
　本発明の一実施形態に係る固定具用ロッドにおいて、前記強化繊維層の繊維方向は引き揃えられており、該層の厚みは、０．０２ｍｍから０．２５ｍｍの範囲にある。
　本発明の一実施形態に係る固定具用ロッドにおいて、前記強化繊維層が複数の強化繊維層を含む場合、該複数の強化繊維層の少なくとも１つ以上の強化繊維層に使用されている繊維の曲げ弾性率は、前記コア部材の曲げ弾性率よりも大きい。
　本発明の上記各実施形態によれば、スクリュー固定時の破損を低減し、かつ高剛性で変形荷重による耐久性も高い固定具用ロッドを提供することが可能となる。
本発明の一実施形態に係る固定具用ロッドを含む脊椎用固定具１０を示す図である。 本発明の一実施形態に係る固定具用ロッドをその中心軸に垂直な面で切断した断面を模式的に示す図である。 本発明の一実施形態に係る固定具用ロッドをその中心軸に垂直な面で切断した断面を模式的に示す図である。 本発明の一実施形態に係る固定具用ロッドの各層を示す図である。 本発明の一実施形態に係る固定具用ロッドをその中心軸に垂直な面で切断した断面を模式的に示す図である。 本発明の一実施形態に係る固定具用ロッドの製造に用いる部材を示す図である。
　以下、本発明に係る固定具用ロッドの実施形態について、添付図面を参照しながら具体的に説明する。複数の図面において共通する構素には当該複数の図面を通じて同一の参照符号が付されている。各図面は、説明の便宜上、必ずしも正確な縮尺で記載されているとは限らない点に留意されたい。
　図１は、本発明の一実施形態に係る固定具用ロッド１を含む脊椎用固定具１０を示す図である。図示のように、脊椎用固定具１０は、脊椎の骨に固定される複数のスクリュー部材１８（図示の例では２つのスクリュー部材１８）と、該スクリュー部材１８に取付けられ、固定具用ロッドを受け入れる凹部２１及び押圧部材２２を備える複数のロッド固定部材２０（図示の例では２つのロッド固定部材２０）と、該複数のロッド固定部材２０の凹部２１に挿入されかつ押圧部材２２により固定される固定具用ロッド１と、を備える。
　次に、図２を参照して、脊椎用固定具１０に用いる本発明の一実施形態に係る固定具用ロッド１について説明する。図２は、図１に示す固定具用ロッド１を同図に示すＸ－Ｘ断面でみたものである。図示のように、本発明の一実施形態に係る固定具用ロッド１は、コア部材２と、該コア部材２上に設けられた強化繊維層３とを含むように構成される。
　本発明の一実施形態に係る固定具用ロッド１によれば、スクリュー固定時の破損を低減し、かつ高剛性で変形荷重による耐久性も高い固定具用ロッドを提供することが可能となる。より具体的には、中実の二重構造を採用し、後述するように外側層に平均曲げ弾性率の大きい材料を使用しているため、ロッド全体の曲げ剛性やつぶれ強度の優れた固定具用ロッドを提供することが可能となる。ここで、平均曲げ弾性率とは該当する部位全体の曲げ剛性を、該当する部位の二次モーメントで割って算出した値を指す。
　また、本発明の一実施形態に係る固定具用ロッド１は、当該強化繊維層３上に設けられた被覆層を含むように構成される。当該被覆層は、例えば、エポキシ、フェノール、不飽和ポリエステル、ＰＡ、ＰＣ、ＰＰＳＵ、ＰＯＭ、ＰＰ、ＰＥ、ＡＢＳ、ＰＳ、ＰＡＥＫ又はＰＥＥＫにより形成されることができるが、これらに限られない。
　本発明の一実施形態に係る固定具用ロッド１において、当該コア部材２は、繊維を含む樹脂で形成されている。また、本発明の一実施形態に係る固定具用ロッド１において、当該繊維は、カーボン、ガラス、アラミド、ボロン又はＳｉＣのいずれかであり、当該樹脂は、熱硬化性樹脂（例えば、エポキシ、フェノール、不飽和ポリエステル等）、又は熱可塑性樹脂（例えば、ＰＡ、ＰＣ、ＰＰＳＵ、ＰＯＭ、ＰＰ、ＰＥ、ＡＢＳ、ＰＳ、ＰＡＥＫ又はＰＥＥＫ等）であるように構成される。このようにして、コア部材の曲げ剛性の増大化や高強度化が可能となる。
　本発明の一実施形態に係る固定具用ロッド１において、当該強化繊維層３は、繊維強化樹脂であり、繊維として、カーボン、ガラス、ボロン、ＳｉＣ又はアラミドが用いられ、樹脂として熱硬化性樹脂（例えば、エポキシ、フェノール、不飽和ポリエステル等）、又は熱可塑性樹脂（例えば、ＰＡ、ＰＣ、ＰＰＳＵ、ＰＯＭ、ＰＰ、ＰＥ、ＡＢＳ、ＰＳ、ＰＡＥＫ又はＰＥＥＫ等）が用いられる。このようにして、強化繊維層の曲げ剛性の増大化や高強度化が可能となる。
　本発明の一実施形態に係る固定具用ロッド１において、当該強化繊維層３の繊維は長繊維であるように構成される。強化繊維層３の繊維が長繊維であることにより、さらに曲げ剛性の増大化や高強度化が可能となる。
　また、本発明の一実施形態に係る固定具用ロッド１において、当該強化繊維層３の繊維含有率は、６０重量％以上であるように構成される。このように、長繊維が高密度に重点された繊維層により、剛性が高く、耐久性に優れた固定具用ロッド１を形成することが可能となる。
　次に図３を参照して、本発明の一実施形態に係る固定具用ロッド１について説明する。図示のように、本発明の一実施形態に係る固定具用ロッド１は、コア部材２と、該コア部材２上に設けられた強化繊維層３とを含み、該強化繊維層３は、繊維方向が軸長方向（紙面の前後方向）を指向する軸長繊維層４と、繊維方向が当該軸長方向から斜向した斜向繊維層５とを備えるように構成される。軸長繊維層４は、曲げ剛性や曲げ強度の点で利点を有し、斜向繊維層５は、ねじれ剛性やねじれ強度の点で利点を有することで、コア部材２と強化繊維層３とにより、スクリュー固定時の破損を低減し、かつ高剛性で変形荷重による耐久性も高い固定具用ロッドを提供することが可能となる。
　また、本発明の一実施形態に係る固定具用ロッド１において、当該強化繊維層３は、複数の強化繊維層を含み、少なくとも１層は繊維方向が、軸長方向に対して傾斜する斜向繊維層であるように構成することができる。このようにして、斜向繊維層５がねじれ剛性やねじれ強度の点で利点を有することで、コア部材２と強化繊維層３とにより、スクリュー固定時の破損を低減し、かつ高剛性で変形荷重による耐久性も高い固定具用ロッドを提供することが可能となる。
　本発明の一実施形態に係る固定具用ロッド１において、当該斜向繊維層は、繊維角度が、５°から８５°又は－５°から－８５°の範囲の角度である。ねじれ剛性やねじれ強度を考慮すると、最も効果的な斜向繊維層の繊維角度は、±４５°程度である。その理由は、±４５°におけるせん断弾性率が最大となり、かつねじれ剛性も最大となるためである。
　また、本発明の一実施形態に係る固定具用ロッド１において、前記強化繊維層の繊維方向は引き揃えられており、該層の厚みは、例えば、０．０２ｍｍから０．２５ｍｍの範囲にある。このようにして、樹脂の密度が均一化され、部位による強度のばらつきを低減することが可能となる。また、本発明の一実施形態に係る固定具用ロッドにおいて、前記強化繊維層が複数の強化繊維層を含む場合、該複数の強化繊維層の少なくとも１つ以上の強化繊維層に使用されている繊維の曲げ弾性率は、前記コア部材の曲げ弾性率よりも大きい。このようにして、当該強化繊維層に一定の弾性を持たせながら当該コア部材と組み合わせることで、ロッド全体の曲げ剛性やつぶれ強度を高く保持することが可能となる。
　次に、図４、５を参照して、本発明の一実施形態に係る固定具用ロッド１について説明する。図示のように、本発明の一実施形態に係る固定具用ロッド１は、コア部材２と、該コア部材２上に設けられた強化繊維層３とを含むように構成される。当該コア部材２は、ＰＥＥＫ／ＣＦ（短繊維）により形成され、外形は約３．０ｍｍ程度である。
　図示のように、当該強化繊維層３は、第１の積層層６と、第２の積層層７と、第３の積層層８とから形成されている。当該第１の積層層６は、ＵＤにガラススクリムを貼り合わせたものであり、ＵＤは、繊維弾性率が３０ｔ、レジンコンテントがＲＣ２４％、厚みは約０．１０３ｍｍであり、スクリムは、繊維弾性率が７ｔ、レジンコンテントが２８％、厚みが０．０１２ｍｍであるように構成される。
　また、当該第２の積層層７は、２つの斜向層を貼り合わせたものであり、斜向層は、繊維弾性率が３０ｔ、レジンコンテントがＲＣ３０％、厚みは約０．０５１ｍｍであり、斜向角度は、＋４５°又は－４５°であるように構成される。
　当該第３の積層層８は、ＵＤにガラススクリムを貼り合わせたものであり、ＵＤは、繊維弾性率が３０ｔ、レジンコンテントがＲＣ２４％、厚みは約０．１０３ｍｍであり、スクリムは、繊維弾性率が７ｔ、レジンコンテントが２８％、厚みが０．０１２ｍｍであるように構成される。
　図５は、図４に示すような各層が形成された本発明の一実施形態に係る固定具用ロッド１を、図１に示すＸ－Ｘ断面でみたものである。図示のように、本発明の一実施形態に係る固定具用ロッド１は、コア部材２と、該コア部材２上に設けられた強化繊維層３とを含み、該強化繊維層３は、上述の、第１の積層層６と、第２の積層層７と、第３の積層層８とにより形成されている。
　本発明の一実施形態に係る固定具用ロッド１によれば、スクリュー固定時の破損を低減し、かつ高剛性で変形荷重による耐久性も高い固定具用ロッドを提供することが可能となる。より具体的には、中実の二重構造を採用し、後述するように外側層に平均曲げ弾性率の大きい材料を使用しているため、ロッド全体の曲げ剛性やつぶれ強度の優れた固定具用ロッドを提供することが可能となる。ここで、平均曲げ弾性率とは該当する部位全体の曲げ剛性を、該当する部位の二次モーメントで割って算出した値を指す。
　次に、本発明の一実施形態に係る固定具用ロッド１の製造方法について説明する。まず、ステップ１として、プリプレグを切断する（プリプレグのカット）。そして、ステップ２として、芯材（例えば、カーボンソリッド（長繊維））を用意する。ステップ３として、該芯材にはコシがないため、図６（ａ）に示すＶ溝レールを使用し、仮止めレジンを塗布して仮止めを行う（仮止め）。ステップ４として、プリプレグの巻き付けを行う。
　次に、ステップ５において、図６（ｂ）に示す溝付き矯正型を使用し、キュアを行う。当該矯正型を使用する理由は、上述のステップ４の巻き付け時に僅かに曲がっていることがあるため、これを矯正する必要があるからである。そして、ステップ６において切断を行い、ステップ７においてテープを除去し、最後に、ステップ８において、外径調整のためセンタレスを実施する。
　このようにして形成された本発明の一実施形態に係る固定具用ロッド１によれば、スクリュー固定時の破損を低減し、かつ高剛性で変形荷重による耐久性も高い固定具用ロッドを提供することが可能となる。より具体的には、中実の二重構造を採用し、後述するように外側層に平均曲げ弾性率の大きい材料を使用しているため、ロッド全体の曲げ剛性やつぶれ強度の優れた固定具用ロッドを提供することが可能となる。ここで、平均曲げ弾性率とは該当する部位全体の曲げ剛性を、該当する部位の二次モーメントで割って算出した値を指す。
　本明細書で説明された各構成要素の寸法、材料、及び配置は、実施形態中で明示的に説明されたものに限定されず、この各構成要素は、本発明の範囲に含まれうる任意の寸法、材料、及び配置を有するように変形することができる。また、本明細書において明示的に説明していない構成要素を、説明した実施形態に付加することもできるし、各実施形態において説明した構成要素の一部を省略することもできる。
１　固定具用ロッド
２　コア部材
３　強化繊維層
４　軸長繊維層
５　斜向繊維層
６　第１の積層層
７　第２の積層層
８　第３の積層層
１０　脊椎用固定具
１８　スクリュー部材
２０　ロッド固定部材
２１　凹部
２２　押圧部材

 

Claims (11)

  1. 　固定具用ロッドであって、
    　コア部材と、該コア部材上に設けられた強化繊維層とを含むことを特徴とする、固定具用ロッド。
  2. 　前記強化繊維層上に設けられた被覆層を含む、請求項１に記載の固定具用ロッド。
  3. 　前記コア部材は、繊維を含む樹脂で形成されている、請求項１又は２に記載の固定具用ロッド。
  4. 　前記繊維は、カーボン、ガラス、アラミド、ボロン又はＳｉＣのいずれかであり、前記樹脂は、エポキシ、フェノール、不飽和ポリエステル、ＰＡ、ＰＣ、ＰＰＳＵ、ＰＯＭ、ＰＰ、ＰＥ、ＡＢＳ、ＰＳ、ＰＡＥＫ又はＰＥＥＫのいずれかである、請求項３に記載の固定具用ロッド。
  5. 　前記強化繊維層は、繊維強化樹脂であり、繊維として、カーボン、ガラス、ボロン、ＳｉＣ又はアラミドを用い、樹脂としてエポキシ、フェノール、不飽和ポリエステル、ＰＡ、ＰＣ、ＰＰＳＵ、ＰＯＭ、ＰＰ、ＰＥ、ＡＢＳ、ＰＳ、ＰＡＥＫ又はＰＥＥＫを用いる、請求項１から４までのいずれか１項に記載の固定具用ロッド。
  6. 　前記強化繊維層の繊維は長繊維である、請求項１から５までのいずれか１項に記載の固定具用ロッド。
  7. 　前記強化繊維層の繊維含有率は、６０重量％以上である、請求項１から６までのいずれか１項に記載の固定具用ロッド。
  8. 　前記強化繊維層は、複数の強化繊維層を含み、少なくとも１層は繊維方向が、軸長方向に対して傾斜する斜向繊維層である、請求項１から７までのいずれか１項に記載の固定具用ロッド。
  9. 　前記斜向繊維層は、その繊維角度が、５°から８５°又は－５°から－８５°の範囲の角度である、請求項８に記載の固定具用ロッド。
  10. 　前記強化繊維層の繊維方向は引き揃えられており、該層の厚みは、０．０２ｍｍから０．２５ｍｍの範囲にある、請求項１から９までのいずれか１項に記載の固定具用ロッド。
  11. 　前記強化繊維層が複数の強化繊維層を含む場合、該複数の強化繊維層の少なくとも１つ以上の強化繊維層に使用されている繊維の曲げ弾性率は、前記コア部材の曲げ弾性率よりも大きい、請求項１から１０までのいずれか１項に記載の固定具用ロッド。

     
PCT/JP2021/033268 2020-09-29 2021-09-10 脊椎固定具用ロッド Ceased WO2022070834A1 (ja)

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