WO2022149326A1 - 脊椎固定具用ロッド及びこれを備える脊椎用固定具 - Google Patents
脊椎固定具用ロッド及びこれを備える脊椎用固定具 Download PDFInfo
- Publication number
- WO2022149326A1 WO2022149326A1 PCT/JP2021/037720 JP2021037720W WO2022149326A1 WO 2022149326 A1 WO2022149326 A1 WO 2022149326A1 JP 2021037720 W JP2021037720 W JP 2021037720W WO 2022149326 A1 WO2022149326 A1 WO 2022149326A1
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- WIPO (PCT)
- Prior art keywords
- core member
- fixture
- fiber
- rod according
- fixing rod
- Prior art date
Links
- 239000000835 fiber Substances 0.000 claims abstract description 82
- 239000012783 reinforcing fiber Substances 0.000 claims description 28
- 229920005989 resin Polymers 0.000 claims description 19
- 239000011347 resin Substances 0.000 claims description 19
- 239000000834 fixative Substances 0.000 claims description 7
- 239000004593 Epoxy Substances 0.000 claims description 6
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims description 6
- 229920006305 unsaturated polyester Polymers 0.000 claims description 6
- 239000004696 Poly ether ether ketone Substances 0.000 claims description 5
- 229920000491 Polyphenylsulfone Polymers 0.000 claims description 5
- JUPQTSLXMOCDHR-UHFFFAOYSA-N benzene-1,4-diol;bis(4-fluorophenyl)methanone Chemical compound OC1=CC=C(O)C=C1.C1=CC(F)=CC=C1C(=O)C1=CC=C(F)C=C1 JUPQTSLXMOCDHR-UHFFFAOYSA-N 0.000 claims description 5
- 229920006260 polyaryletherketone Polymers 0.000 claims description 5
- 229920002530 polyetherether ketone Polymers 0.000 claims description 5
- ZOXJGFHDIHLPTG-UHFFFAOYSA-N Boron Chemical compound [B] ZOXJGFHDIHLPTG-UHFFFAOYSA-N 0.000 claims description 4
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical group [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 4
- 239000004760 aramid Substances 0.000 claims description 4
- 229920003235 aromatic polyamide Polymers 0.000 claims description 4
- 229910052796 boron Inorganic materials 0.000 claims description 4
- 229910052799 carbon Inorganic materials 0.000 claims description 4
- 239000011521 glass Substances 0.000 claims description 4
- 230000004323 axial length Effects 0.000 claims description 2
- 239000000853 adhesive Substances 0.000 abstract description 12
- 230000001070 adhesive effect Effects 0.000 abstract description 12
- 230000002787 reinforcement Effects 0.000 abstract 3
- 239000011162 core material Substances 0.000 description 97
- 239000010410 layer Substances 0.000 description 29
- 239000000463 material Substances 0.000 description 11
- 238000005452 bending Methods 0.000 description 5
- 239000011247 coating layer Substances 0.000 description 3
- 238000006073 displacement reaction Methods 0.000 description 3
- 239000002184 metal Substances 0.000 description 3
- 229920000642 polymer Polymers 0.000 description 3
- 238000003825 pressing Methods 0.000 description 3
- 238000000034 method Methods 0.000 description 2
- 238000000465 moulding Methods 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 229920005992 thermoplastic resin Polymers 0.000 description 2
- 210000000988 bone and bone Anatomy 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000010304 firing Methods 0.000 description 1
- 238000003384 imaging method Methods 0.000 description 1
- 230000005415 magnetization Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 229920001187 thermosetting polymer Polymers 0.000 description 1
Images
Classifications
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- 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, setting implements or the like
- 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 ; Bone stabilisers comprising fluid filler in an implant
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- 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 ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
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- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
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Definitions
- the present invention relates to a fixture rod used as a fixative for fixing the spine and a spinal fixator provided with the rod.
- a fixture rod using metal has been known as a fixative for fixing the spine.
- Patent Document 1 discloses a spinal pedicle rod having an internally reinforced polymer core which is at least partially inserted in a polymer coating.
- One of the objects of the present invention is to provide a fixture rod having high rigidity and high durability under a deformation load, which has significantly improved adhesive force between a core member and a reinforcing fiber layer, and a spinal fixture provided with the rod. To do. Other objects of the invention will become apparent by reference to the entire specification.
- the fixture rod according to an embodiment of the present invention includes a core member containing fibers and a reinforcing fiber layer provided on the core member, and the fibers of the core member are a part thereof from the core member. Is exposed, and an exposed portion of the fiber is embedded in the reinforcing fiber layer.
- the fibers of the core member are long fibers.
- the fibers of the core member are short fibers.
- the fibers of the core member include long fibers and short fibers.
- the fibers of the core member are configured so that the end portion thereof viewed in the longitudinal direction is exposed from the core member.
- the fibers of the core member are configured so that the end portion thereof viewed in the radial direction is exposed from the core member.
- the fiber of the core member is carbon, glass, aramid, boron or SiC.
- one or a plurality of recesses are formed on the outer surface of the core member.
- the recess is formed in the circumferential direction of the core member.
- the recess is formed in the axial length direction of the core member.
- the recess is formed in a direction inclined with respect to the circumferential direction of the core member.
- the recesses are configured to include two or more recesses formed in different directions.
- the depth of the recess is configured to be in the range of 3 ⁇ m to 200 ⁇ m.
- the core member contains a resin, and the resin includes epoxy, phenol, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, and the like. It is configured to be either PAEK or PEEK.
- the fixture for the spine according to the embodiment of the present invention includes any of the above-mentioned fixture rods.
- a fixture rod having high rigidity and high durability due to a deformation load which has significantly improved adhesive force between the core member and the reinforcing fiber layer, and a spinal fixture provided with the rod. Can be provided.
- 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 includes a core member 2 including the fiber 4 and a reinforcing fiber layer 3 provided on the core member, and the fiber of the core member. Part 4 is exposed from the core member 2, and the exposed part of the fiber 4 is embedded in the reinforcing fiber layer 3.
- the fiber 4 of the core member will be described in more detail below.
- the fixing rod 1 there is provided a fixing rod having high rigidity and high durability due to a deformation load, in which the adhesive force between the core member and the reinforcing fiber layer is significantly improved. It becomes possible to do. More specifically, by allowing the fibers 4 of the core member to be exposed and penetrate into the reinforcing fiber layer, the adhesion between the core member and the reinforcing fiber layer is strengthened, and a solid double structure is adopted.
- a material having a large average flexural modulus is used for the outer layer, it is possible to provide a rod for a fixture having excellent bending rigidity and crushing strength of the entire rod.
- 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 core member 2 can be formed of a resin containing the fiber 4, but the fiber 4 of the core member is configured to be a short fiber. Will be done. As described above, by using the staple fibers, the fiber directions can be randomly oriented, so that the fibers can be strengthened in all directions.
- the core member 2 can be formed of a resin containing fibers, but the fibers 4 of the core member are configured to be long fibers. .. In this way, the bending rigidity can be effectively improved.
- the fiber 4 of the core member 2 is a staple fiber 15, and a part thereof is exposed from the surface of the core member.
- the staple fiber 15 of the core member 2 is configured such that the end portion (1-10 ⁇ m) seen in the longitudinal direction thereof is exposed from the core member 2.
- the fiber 4 of the core member 2 is a long fiber 16, and a part thereof is exposed from the surface of the core member.
- the staple fiber 15 of the core member 2 is configured such that the end portion (1-10 ⁇ m) seen in the radial direction thereof is exposed from the core member 2.
- the fiber 4 of the core member 2 includes the long fiber 16 and the short fiber 15. Further, although not shown, in the fixing rod 1 according to the embodiment of the present invention, the fiber 4 of the core member 2 contains the above-mentioned short fibers 15 and long fibers 16 from the surface of the core member 2. A part of it may be exposed. By exposing the short fibers 15 and the long fibers 16 in this way, minute irregularities are generated on the surface of the core member 2, and the displacement between the core member 2 and the reinforcing fiber layer 3 can be suppressed.
- the fiber 4 of the core member 2 is, for example, carbon, glass, aramid, boron or SiC. Fibers other than these can be used and are not limited to specific fibers.
- the core member 2 contains a resin
- the resin includes a thermosetting resin (for example, epoxy, phenol, unsaturated polyester, etc.) or a thermoplastic resin (for example, epoxy, phenol, unsaturated polyester, etc.).
- a thermosetting resin for example, epoxy, phenol, unsaturated polyester, etc.
- a thermoplastic resin for example, epoxy, phenol, unsaturated polyester, etc.
- PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK, PEEK, etc. can be used.
- the reinforcing fiber layer 3 is a fiber reinforced resin, carbon, glass, boron, SiC or aramid is used as the fiber, and the heat-curable resin is used as the resin.
- the resin for example, epoxy, phenol, unsaturated polyester, etc.
- thermoplastic resin for example, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK, PEEK, etc.
- 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 of the fixture rod 1 according to the embodiment of the present invention used for the spinal fixative 10 will be described.
- the fixing rod 1 according to the embodiment of the present invention one or a plurality of recesses are formed on the outer surface of the core member 2.
- the fiber 4 of the core member 2 is partially exposed from the outer surface of the core member 2, but may be exposed from the concave portion, or may be exposed from the other core member 2. It may be exposed from the surface (the same applies hereinafter). In this way, since the contact surface area between the core member 2 and the reinforcing fiber layer 3 becomes large during molding, it is possible to further significantly improve the adhesive strength between the core member and the reinforcing fiber layer. It becomes. This will be described in more detail below.
- the recess (circumferential recess) 11 is formed in the circumferential direction of the core member 2 having the fiber 4 which is partially exposed. Will be done. In the illustrated example, seven recesses 11 are formed, but a desired number can be provided and the number is not limited to a specific number. Further, it can be formed on all or a part of the core member 2 in the circumferential direction. Alternatively, the recess 11 may be intermittently formed in all or a part of the core member 2 in the circumferential direction. By providing the recesses in the circumferential direction of the core member in this way, it is possible to increase the adhesive area and suppress the axial deviation between the core member 2 and the reinforcing fiber layer 3.
- the recess (axial recess) 12 is the shaft of the core member 2 having the fiber 4 partially exposed. Formed in the long direction.
- eight recesses 12 are formed, but a desired number can be provided and the number is not limited to a specific number. Further, it can be formed on all or a part of the core member 2 in the axial direction. Alternatively, the recess 12 may be intermittently formed in all or a part of the core member 2 in the axial direction.
- the recess (inclined recess) 13 is the circumference of the core member 2 having the fiber 4 partially exposed. It is formed so as to be inclined with respect to a direction.
- seven recesses 13 are formed, but a desired number can be provided and the number is not limited to a specific number. Further, it can be formed on the entire circumference of the core member 2 or a part thereof. Alternatively, the recess 13 may be intermittently formed on the entire circumference of the core member 2 or a part thereof.
- the recess (different direction recess) 14 includes two or more recesses formed in different directions. , Formed on the surface of the core member 2 having the partially exposed fibers 4. In the illustrated example, a large number of recesses 14 are formed, but a desired number can be provided and the number is not limited to a specific number. Further, when there are three or more recesses 14, two or more recesses 14 may be formed in the same direction. Further, it can be formed on the entire surface of the core member 2 or a part thereof. Alternatively, the recess 11 may be intermittently formed on the entire surface of the core member 2 or a part thereof. By providing the recesses in different directions in this way, it is possible to suppress deviation in a plurality of different directions.
- the depth of the recess is in the range of 3 ⁇ m to 200 ⁇ m.
- the spine fixative 10 includes any of the above fixture rods 1. In this way, it becomes possible to provide a spinal fixture having a fixture rod having high rigidity and high durability due to a deformation load, which greatly improves the adhesive force between the core member and the reinforcing fiber layer. ..
- a core member also referred to as a core material (including each aspect of FIG. 3-8 described above) is prepared (FIG. 9a).
- a fiber-reinforced resin material is prepared (FIG. 9b).
- step 3 the fiber reinforced resin material is wound around the core member to form the fiber reinforced material integrated member (FIG. 9c).
- step 4 a tape is wound around the outer surface of the fiber-reinforced resin material integrated member as an outer mold (FIG. 9d).
- step 5 the fiber-reinforced resin material integrated member around which the tape is wound is fired (molded) (FIG. 9e).
- step 6 the fiber-reinforced resin material integrated member after firing is taken out, and the unnecessary portion is cut (FIG. 9f).
- step 7 the fixing rod 1 according to the embodiment of the present invention provided with the core member and the fiber reinforced resin layer by removing the tape of the fiber reinforced resin material integrated member from which the unnecessary portion has been cut. Can be obtained (Fig. 9 g).
- the adhesive strength between the core member and the reinforcing fiber layer is significantly improved, and the rigidity is high and the durability due to the deformation load is increased. It also makes it possible to provide high fixture rods. More specifically, by allowing the fibers of the core material to be exposed and penetrate into the reinforcing fiber layer, the adhesion between the core member and the reinforcing fiber layer is strengthened, and a solid double structure is adopted. As will be described later, since a material having a large average flexural modulus is used for the outer layer, it is possible to provide a rod for a fixture having excellent bending rigidity and crushing strength of the entire rod.
- 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
Description
2 コア部材
3 強化繊維層
4 繊維
10 脊椎用固定具
11 凹部(周方向凹部)
12 凹部(軸方向凹部)
13 凹部(傾斜方向凹部)
14 凹部(異方向凹部)
15 繊維(短繊維)
16 繊維(長繊維)
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 (15)
- 固定具用ロッドであって、
繊維を含むコア部材と、該コア部材上に設けられた強化繊維層とを含み、
該コア部材の繊維は、該コア部材からその一部が露出し、該繊維の露出する一部は該強化繊維層内に埋設されていることを特徴とする、固定具用ロッド。 - 前記コア部材の繊維は長繊維である、請求項1に記載の固定具用ロッド。
- 前記コア部材の繊維は短繊維である、請求項1に記載の固定具用ロッド。
- 前記コア部材の繊維は長繊維と短繊維とを含む、請求項1に記載の固定具用ロッド。
- 前記コア部材の繊維は、その長手方向でみた端部が該コア部材から露出する、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。
- 前記コア部材の繊維は、その径方向でみた端部が該コア部材から露出する、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。
- 前記コア部材の繊維は、カーボン、ガラス、アラミド、ボロン又はSiC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。
- 前記コア部材の外表面には、1又は複数の凹部が形成される、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。
- 前記凹部は、前記コア部材の周方向に形成される、請求項8に記載の固定具用ロッド。
- 前記凹部は、前記コア部材の軸長方向に形成される、請求項8に記載の固定具用ロッド。
- 前記凹部は、前記コア部材の周方向に対して傾斜する方向に形成される、請求項8に記載の固定具用ロッド。
- 前記凹部は、それぞれ異なる方向に形成された2以上の凹部を含む、請求項8に記載の固定具用ロッド。
- 前記凹部の深さは、3μmから200μmの範囲である、請求項8から12までのいずれか1項に記載の固定具用ロッド。
- 前記コア部材は樹脂を含み、該樹脂は、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1から13までのいずれか1項に記載の固定具用ロッド。
- 請求項1から14までのいずれか1項に記載の固定具用ロッドを備える脊椎用固定具。
Priority Applications (4)
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KR1020237023502A KR20230118647A (ko) | 2021-01-05 | 2021-10-12 | 척추 고정구용 로드 및 이것을 구비하는 척추용 고정구 |
US18/269,488 US20240058038A1 (en) | 2021-01-05 | 2021-10-12 | Rod for spinal fixture, and spinal fixture comprising same |
CN202180088813.9A CN116669662A (zh) | 2021-01-05 | 2021-10-12 | 脊椎固定器用杆和具有该脊椎固定器用杆的脊椎用固定器 |
EP21917551.0A EP4275630A1 (en) | 2021-01-05 | 2021-10-12 | Rod for spinal fixture, and spinal fixture comprising same |
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JP2021000613A JP7432538B2 (ja) | 2021-01-05 | 2021-01-05 | 脊椎固定具用ロッド及びこれを備える脊椎用固定具 |
JP2021-000613 | 2021-01-05 |
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EP (1) | EP4275630A1 (ja) |
JP (1) | JP7432538B2 (ja) |
KR (1) | KR20230118647A (ja) |
CN (1) | CN116669662A (ja) |
WO (1) | WO2022149326A1 (ja) |
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US20110106162A1 (en) * | 2009-10-30 | 2011-05-05 | Warsaw Orthopedic, Inc. | Composite Connecting Elements for Spinal Stabilization Systems |
DE102013013024A1 (de) * | 2012-08-03 | 2014-02-06 | Orthobion Gmbh | Verfahren zum Herrstellen eines Pedikelstabs, Pedikelstab für ein System zur Fixierung und Stabilisierung einer Wirbelsäule und zugehöriges System |
WO2014162873A1 (ja) * | 2013-04-02 | 2014-10-09 | 東レ株式会社 | サンドイッチ積層体、サンドイッチ構造体とそれを用いた一体化成形品およびそれらの製造方法 |
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US20050136764A1 (en) | 2003-12-18 | 2005-06-23 | Sherman Michael C. | Designed composite degradation for spinal implants |
FR2867057B1 (fr) | 2004-03-02 | 2007-06-01 | Spinevision | Element de liaison dynamique pour un systeme de fixation rachidien et systeme de fixation comprenant un tel element de liaison |
EP2389883B1 (en) | 2006-09-20 | 2016-09-14 | Woodwelding AG | Device to be implanted in human or animal tissue and method for implanting and assembling the device |
US9232968B2 (en) | 2007-12-19 | 2016-01-12 | DePuy Synthes Products, Inc. | Polymeric pedicle rods and methods of manufacturing |
CN102548759B (zh) | 2009-10-06 | 2014-10-29 | 横滨橡胶株式会社 | 橡胶叠层体 |
US20110152937A1 (en) | 2009-12-22 | 2011-06-23 | Warsaw Orthopedic, Inc. | Surgical Implants for Selectively Controlling Spinal Motion Segments |
US20170165077A1 (en) | 2015-12-09 | 2017-06-15 | Woven Orthopedic Technologies, Llc | Retention devices, lattices and related systems and methods |
US10617458B2 (en) | 2015-12-23 | 2020-04-14 | Carbofix In Orthopedics Llc | Multi-layer composite material bone screw |
EP3551105A4 (en) | 2016-12-09 | 2020-07-29 | Woven Orthopedic Technologies, LLC | RESTRAINT DEVICES, GRIDS AND RELATED SYSTEMS AND METHODS |
-
2021
- 2021-01-05 JP JP2021000613A patent/JP7432538B2/ja active Active
- 2021-10-12 KR KR1020237023502A patent/KR20230118647A/ko unknown
- 2021-10-12 US US18/269,488 patent/US20240058038A1/en active Pending
- 2021-10-12 CN CN202180088813.9A patent/CN116669662A/zh active Pending
- 2021-10-12 EP EP21917551.0A patent/EP4275630A1/en active Pending
- 2021-10-12 WO PCT/JP2021/037720 patent/WO2022149326A1/ja active Application Filing
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20110106162A1 (en) * | 2009-10-30 | 2011-05-05 | Warsaw Orthopedic, Inc. | Composite Connecting Elements for Spinal Stabilization Systems |
DE102013013024A1 (de) * | 2012-08-03 | 2014-02-06 | Orthobion Gmbh | Verfahren zum Herrstellen eines Pedikelstabs, Pedikelstab für ein System zur Fixierung und Stabilisierung einer Wirbelsäule und zugehöriges System |
WO2014162873A1 (ja) * | 2013-04-02 | 2014-10-09 | 東レ株式会社 | サンドイッチ積層体、サンドイッチ構造体とそれを用いた一体化成形品およびそれらの製造方法 |
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US20240058038A1 (en) | 2024-02-22 |
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CN116669662A (zh) | 2023-08-29 |
EP4275630A1 (en) | 2023-11-15 |
JP7432538B2 (ja) | 2024-02-16 |
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