Rod for intra-spinal fixation device in which fragments are difficult to disperse

Abstract

Provided is a rod for an internal fixation instrument, which reduces damage during screw fixation, has high rigidity and high durability against a deformation load, and greatly reduces the risk of dispersion of fragments even when fractured. A rod for a fastener according to one embodiment of the present invention is provided with: a core member containing a fiber-reinforced resin; and a coating resin layer that coats the core member, and a reinforcing member is provided inside the core member along the longitudinal direction of the core member.

Description

Technical Field

[0001] cross-reference

[0002] This application claims priority based on Japanese Patent Application 2023-058577 (filed on March 31, 2023), the contents of which are incorporated herein by reference in their entirety.

[0003] This invention relates to a rod for spinal fixation devices (referred to as a fixation rod in this specification for convenience) used in fixation devices for fixing the spine, which is designed to prevent the fragmentation of broken pieces from disintegrating. Background Technology

[0004] Previously, metal rods were known as fixation devices used to fix the spine.

[0005] In addition, as a type of fastener, a spinal pedicle rod is disclosed, for example, in Patent Document 1, which has an internally reinforced polymer core that is at least partially inserted into the polymer coating.

[0006] Existing technical documents

[0007] Patent documents

[0008] Patent Document 1: Japanese Patent Publication No. 2011-508623 Summary of the Invention

[0009] The problem that the invention aims to solve

[0010] Metal-based fasteners typically offer excellent fixing force and strength, but they suffer from several drawbacks. When using MRI or similar imaging techniques, the metal magnetizes in a magnetic field, affecting the magnetic field and causing image distortion, making diagnosis difficult. On the other hand, while the rod disclosed in Patent Document 1 does not have this problem, its lower fiber density makes it difficult to achieve the desired rigidity. This results in challenges in strength and durability, and the exposed spiny fibers upon breakage pose safety concerns.

[0011] One object of the present invention is to provide a rod for a spinal fixation device that reduces breakage during screw fixation, exhibits high rigidity and high durability under deformation loads, and significantly reduces the risk of fragmentation even in the event of fracture. Other objects of the present invention become apparent from reference to this specification in its entirety.

[0012] Methods for solving problems

[0013] A fastener rod according to one embodiment of the present invention has: a core component comprising fiber-reinforced resin; and a resin coating layer covering the core component, wherein a reinforcing member is disposed inside the core component along the length direction of the core component.

[0014] In a fastener rod according to one embodiment of the present invention, the reinforcing member is a high-elongation metal wire or fiber member. Furthermore, in a fastener rod according to one embodiment of the present invention, the tensile strength of the high-elongation metal wire or fiber member is 150 MPa or higher. Moreover, in a fastener rod according to one embodiment of the present invention, the elongation of the fiber member is higher than the elongation of the reinforcing fibers of the fiber-reinforced resin.

[0015] In a fastener rod according to one embodiment of the present invention, the diameter of the high elongation metal wire or fiber component is in the range of 0.1 mm to 1.0 mm.

[0016] In a fastener rod according to one embodiment of the present invention, when viewed in a cross section perpendicular to the length direction of the core component, the high elongation metal wire or fiber component is disposed within an imaginary circle centered at the center point of the core component, with a diameter equal to half the diameter of the fastener rod.

[0017] In a fastener rod according to one embodiment of the present invention, when viewed in a cross section perpendicular to the length direction of the core component, the core component is formed by stacking multiple layers.

[0018] In a fastener rod according to one embodiment of the present invention, the plurality of layers of the core component each comprise resin, and when viewed in a cross section perpendicular to the length direction of the core component, the reinforcing member is embedded in such a manner that it is surrounded by resin with a thickness ranging from 2 to 3 times the diameter of the reinforcing member.

[0019] In a fastener rod according to one embodiment of the present invention, when viewed in cross-section, the multiple layers of the core component are alternately formed in multiple layers, including a reinforcing fiber layer and a resin layer, a reinforcing fiber layer with fibers different from those of the reinforcing fiber layer, or a reinforcing fiber layer having fibers inclined relative to the fiber direction of the reinforcing fiber layer, and the reinforcing member is embedded in one or more of the multiple layers.

[0020] In a fastener rod according to one embodiment of the present invention, the reinforcing fiber layer is a fiber-reinforced resin. As the fiber, carbon, glass, boron, SiC or aromatic polyamide are used, and as the resin, epoxy resin, phenolic resin, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK or PEEK are used.

[0021] In a fastener rod according to one embodiment of the present invention, the resin of the resin layer is epoxy resin, phenolic resin, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK or PEEK.

[0022] In a fastener rod according to one embodiment of the present invention, the reinforcing fiber layer, which is different from the fiber of the reinforcing fiber layer, is a fiber-reinforcing resin. The fiber used is carbon, glass, boron, SiC or aromatic polyamide, and the resin used is epoxy resin, phenolic resin, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK or PEEK.

[0023] In a fastener rod according to one embodiment of the present invention, the fibers in the reinforcing fiber layer or a reinforcing fiber layer with fibers different from those in the reinforcing fiber layer are aligned in one direction, formed into a woven fabric, or randomly oriented. Furthermore, in a fastener rod according to another embodiment of the present invention, the fiber direction of the reinforcing fiber layer having fibers inclined relative to the fiber direction of the reinforcing fiber layer is inclined in the range of 10° to 90°.

[0024] In a fastener rod according to one embodiment of the present invention, when multiple layers are provided, including a resin layer, a reinforcing fiber layer with fibers different from those of the reinforcing fiber layer, or a reinforcing fiber layer having fibers inclined relative to the fiber direction of the reinforcing fiber layer, each layer may be the same layer or different layers.

[0025] In a fastener rod according to one embodiment of the present invention, the fibers of the reinforcing fiber layer are long fibers. In a fastener rod according to one embodiment of the present invention, the fiber content of the reinforcing fiber layer is 60% by weight or more. Furthermore, in a fastener rod according to one embodiment of the present invention, the fiber direction of the reinforcing fiber layer is aligned, and the thickness of the layer is in the range of 0.02 mm to 0.3 mm.

[0026] In a fixing rod according to one embodiment of the present invention, a mark is embedded in the core component.

[0027] In a fastener rod according to one embodiment of the present invention, the elongation of the reinforcing member is greater than the elongation of the fibers of the core member.

[0028] One embodiment of the present invention provides a fastener rod having a core component comprising fiber-reinforced resin, wherein a reinforcing member is provided inside the core component along its length.

[0029] Invention Effects

[0030] According to the above embodiments of the present invention, a fastener rod can be provided that reduces breakage during screw fastening, has high rigidity and high durability under deformation loads, and significantly reduces the risk of fragment dispersion even in the event of breakage. Attached Figure Description

[0031] Figure 1 This is a diagram showing a spinal fixation member 10 that includes a fixation rod according to one embodiment of the present invention.

[0032] Figure 2 This is a schematic diagram showing a cross-section of a fastener rod according to one embodiment of the present invention cut with a plane perpendicular to its central axis.

[0033] Figure 3 This is a schematic diagram showing a cross-section of the core component of the fixing rod according to one embodiment of the present invention, cut with a plane perpendicular to its central axis.

[0034] Figure 4 This is a schematic diagram showing a cross-section of the core component of the fixing rod according to one embodiment of the present invention, cut with a plane perpendicular to its central axis.

[0035] Figure 5 This is a schematic diagram showing a cross-section of the core component of the fixing rod according to one embodiment of the present invention, cut with a plane perpendicular to its central axis.

[0036] Figure 6 This is a diagram showing a cross-section of the core component of a fixing rod according to one embodiment of the present invention, cut with a plane perpendicular to its central axis. Detailed Implementation

[0037] Hereinafter, embodiments of the fixing rod of the present invention will be specifically described with reference to the accompanying drawings. Common components in the various drawings are labeled with the same reference numerals in those drawings. It should be noted that, for ease of explanation, the drawings are not necessarily shown at an exact scale.

[0038] Figure 1 This is a diagram illustrating a spinal fixation member 10 incorporating a fixation rod 1 according to an embodiment of the present invention. As shown, the spinal fixation member 10 includes: a plurality of screw members 18 (two screw members 18 in the illustrated example) fixed to the vertebrae; a plurality of rod fixing members 20 (two rod fixing members 20 in the illustrated example) mounted on the screw members 18 and having a recess 21 for receiving the fixation rod and a pressing member 22; and a fixation rod 1 inserted into the recess 21 of the plurality of rod fixing members 20 and fixed by the pressing member 22.

[0039] Next, refer to Figure 2The following describes a fixation rod 1 of one embodiment of the present invention used for a spinal fixation member 10. Figure 2 Therefore Figure 1 Observation of the XX section shown Figure 1 The figure shows a fastener rod 1. As shown, in one embodiment of the present invention, the fastener rod 1 is configured to have a core component 6 containing fiber-reinforced resin and a coating resin layer 7 covering the core component 6, with a reinforcing member 8 disposed inside the core component 6 along its length. Furthermore, in another embodiment of the present invention, the fastener rod 1 may also be configured to have a core component 6 containing fiber-reinforced resin, with a reinforcing member 8 disposed inside the core component 6 along its length, resulting in a structure without the coating resin layer 7 covering the core component 6.

[0040] According to one embodiment of the present invention, a fastener rod can be provided that reduces breakage during screw fastening, has high rigidity and high durability under deformation loads, and significantly reduces the risk of fragment dispersion even in the event of fracture.

[0041] In a fastener rod 1 according to one embodiment of the present invention, the reinforcing member 8 is a metal wire or fiber member with high elongation. Here, the metal wire refers to, for example, titanium alloy, SUS304, tantalum, or niobium. Furthermore, the fiber member refers to, for example, glass fiber, nylon fiber, polyimide fiber, or PEEK fiber, and is a fiber member with an elongation of 5% or more, preferably 10% or more. The fastener rod according to one embodiment of the present invention provides a fastener rod that reduces breakage during screw fastening, has high rigidity and high durability under deformation loads, and significantly reduces the risk of fragment dispersion even in the event of breakage. More specifically, the elongation of the reinforcing member is greater than the elongation of the fibers in the core member; therefore, even if the core member breaks, the reinforcing member is relatively difficult to break, and fragment dispersion is suppressed.

[0042] Furthermore, in the fastener rod 1 of one embodiment of the present invention, the tensile strength of the high-elongation metal wire or fiber component is 150 MPa or more. This makes it difficult for the reinforcing component to break due to impact when the core component breaks. Moreover, in the fastener rod of one embodiment of the present invention, the elongation of the fiber component is higher than the elongation of the reinforcing fibers of the fiber-reinforced resin included in the core component 6. This makes it difficult for the reinforcing component to break due to impact when the core component breaks. Furthermore, in the fastener rod of one embodiment of the present invention, the elongation of the reinforcing component is configured to be greater than the elongation of the fibers of the core component. This makes it difficult for the reinforcing component to break even when the core component breaks, and it is possible to suppress the dispersion of broken fragments.

[0043] In the fixing rod 1 of one embodiment of the present invention, the diameter of the high elongation metal wire or fiber component is in the range of 0.1 mm to 1.0 mm. When the diameter is less than 0.1 mm, it is known that the strength as a fixing core component is insufficient. On the other hand, when the diameter is greater than 1.0 mm, it not only causes MRI imaging to become disordered, but also easily leads to increased weight and fiber tangling. Therefore, it is known that within the above-mentioned numerical range, even in the event of breakage, the risk of fragment dispersion can be significantly reduced.

[0044] In a fastener rod 1 according to one embodiment of the present invention, when viewed in a cross-section perpendicular to the length direction of the core component 6, the high-elongation metal wire or fiber component is disposed within an imaginary circle (X) centered at the center point (O) of the core component 6, with a diameter (D / 2) equal to half the diameter (D) of the fastener rod. Thus, by providing a reinforcing component (high-elongation metal wire or fiber component) within the imaginary circle, where deformation due to bending of the core component is less, the stress generated in the reinforcing component is reduced, thereby reducing the load on the reinforcing component itself. Consequently, even in the event of fracture, the risk of fragmentation can be significantly reduced.

[0045] In the fixing rod 1 of one embodiment of the present invention, when viewed in a cross section perpendicular to the length direction of the core component 6, the core component 6 is formed by stacking multiple layers (details of the stacking of multiple layers will be described later). Furthermore, in Figure 6 The image shows a portion of a cross-section of the core component of a fastener rod according to one embodiment of the present invention, cut with a plane perpendicular to its central axis. However, in the fastener rod 1 of one embodiment of the present invention, multiple layers of the core component 6 each comprise resin, and when viewed in a cross-section perpendicular to the length direction of the core component 6, the reinforcing member 8 is embedded in a manner surrounded by resin with a thickness ranging from 2 to 3 times the diameter of the reinforcing member 8. Thus, in the event of significant stress near the reinforcing member, damage is easily caused along the resin or resin layer surrounding the reinforcing member (e.g., ...). Figure 6 The resin layer shown progresses, resulting in the reduction of stress applied to the reinforcing member, thereby preventing the reinforcing member from breaking.

[0046] Next, refer to Figure 3 , Figure 4 , Figure 5 The layer structure of the core component 6 of the fixation rod 1 of one embodiment of the present invention used in the spinal fixation member 10 will be described. Figure 3 , Figure 4 , Figure 5 Therefore Figure 1 Observation of the XX section shown Figure 1The diagram shows the core component 6 of the fixing rod 1. It should also be noted that, for ease of explanation, the aforementioned resin coating layer 7 has been omitted.

[0047] As shown in the figure, when viewed in cross-section, the multiple layers of the core component 6 of the fastener rod 1 according to one embodiment of the present invention are shown, with the reinforcing fiber layer 2 (in...) Figures 3 to 5 In the example, each of the 8 reinforcing fiber layers) and resin layer 3 (in Figure 3 In the example shown, each of the 7 resin layers 3), and the reinforcing fiber layer 4 having fibers different from those of the reinforcing fiber layer 2 (in... Figure 4 In the example shown, each of the 7 reinforcing fiber layers 4) or the reinforcing fiber layer 5 having fibers inclined relative to the fiber direction of the reinforcing fiber layer 2 (in) Figure 5 In the example shown, any one of the seven reinforcing fiber layers 5 is alternately formed into multiple layers, and the reinforcing member 8 is embedded in any one of these multiple layers or in any two or more layers (embedded across two or more layers). Here, the reinforcing fiber layer 2 and the resin layer 3 ( Figure 3 (Example shown), a reinforcing fiber layer 4 with fibers different from those of the reinforcing fiber layer. Figure 4 (Example shown) or a reinforcing fiber layer 5 having fibers inclined relative to the fiber direction of the reinforcing fiber layer. Figure 5 In the example shown, any layer is formed to have a thickness of 0.01 mm to 0.25 mm, but the thickness of the layer can also vary depending on the position of the layer (i.e., the thickness of the layer can also be formed to have both thin and thick parts). Moreover, the layer can also be formed intermittently (i.e., the thickness of the layer not only has both thin and thick parts, but also a part with a thickness of 0).

[0048] According to one embodiment of the present invention, the core component 6 of the fastener rod 1 provides a fastener rod that reduces breakage during screw fastening, exhibits high rigidity and high durability under deformation loads, and significantly reduces the risk of fragment dispersion even upon fracture. More specifically, the elongation of the reinforcing component is greater than the elongation of the fibers in the core component, thus the reinforcing component is relatively difficult to break even if the core component breaks, and fragment dispersion is suppressed. Furthermore, the layered structure of the fastener rod 1 according to one embodiment of the present invention, upon fracture, by concentrating stress in any layer among the resin layer sandwiched by the reinforcing fiber layer, the reinforcing fiber layer with fibers different from those of the reinforcing fiber layer, or the reinforcing fiber layer having fibers inclined relative to the fiber direction of the reinforcing fiber layer, reduces the likelihood of the reinforcing fiber layer becoming spiky upon rod fracture, resulting in a significant improvement in safety for the human body.

[0049] In the core component 6 of the fastener rod 1 according to one embodiment of the present invention, the reinforcing fiber layer 2 is a fiber-reinforced resin. The fibers used are carbon, glass, boron, SiC, or aromatic polyamide, and the resin used is epoxy resin, phenolic resin, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK, or PEEK. This allows for increased bending stiffness and higher strength of the fastener rod 1.

[0050] In the core component 6 of the fastener rod 1 according to one embodiment of the present invention, the resin of the resin layer 3 is epoxy resin, phenolic resin, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK or PEEK.

[0051] In the core component 6 of the fastener rod according to one embodiment of the present invention, the reinforcing fiber layer 4, which has fibers different from those of the reinforcing fiber layer 2, is a fiber-reinforced resin. The fibers used are carbon, glass, boron, SiC, or aromatic polyamide, and the resin used is epoxy resin, phenolic resin, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK, or PEEK. This allows for increased bending stiffness and higher strength of the fastener rod. Furthermore, the reason for using a reinforcing fiber layer with fibers different from those of the reinforcing fiber layer 2 is that by using different materials, different properties beyond rigidity and strength, such as flexibility and vibration absorption, can be imparted.

[0052] In the core component 6 of the fastener rod according to one embodiment of the present invention, the fibers in the reinforcing fiber layer 2 or the reinforcing fiber layer 4, which have fibers different from those in the reinforcing fiber layer 2, may be aligned in one direction, formed into a fabric, or randomly oriented. Furthermore, in the core component 6 of the fastener rod 1 according to one embodiment of the present invention, the fiber direction of the reinforcing fiber layer 5, which has fibers inclined relative to the fiber direction of the reinforcing fiber layer 2, may be inclined within a range of 10° to 90°. Thus, by configuring an appropriate laminated structure, the desired strength and rigidity can be achieved.

[0053] In the core component 6 of the fastener rod 1 according to one embodiment of the present invention, when multiple layers are provided, including resin layer 3, reinforcing fiber layer 4 with fibers different from those of the reinforcing fiber layer 2, or reinforcing fiber layer 5 with fibers inclined relative to the fiber direction of the reinforcing fiber layer 2, each layer may be the same or different (hereinafter the same). For example, when two layers are provided, there may be two resin layers 3 (in which case, each layer is the same), or there may be two different layers such as resin layer 3 and reinforcing fiber layer 4 with fibers different from those of the reinforcing fiber layer. When three or more layers are provided, a desired combination of the above layers may be selected. In this way, by configuring an appropriate layered structure, the desired strength and rigidity can be achieved.

[0054] In the core component 6 of the fastener rod 1 according to one embodiment of the present invention, the fibers constituting the reinforcing fiber layer 2 are long fibers. In this way, by making the fibers of the reinforcing fiber layer 2 long fibers, it is possible to further increase the bending rigidity and increase the strength.

[0055] Furthermore, in the core component 6 of the fastener rod 1 according to one embodiment of the present invention, the fiber content of the reinforcing fiber layer 2 is 60% by weight or more. Thus, by densely filling the fiber layer with long fibers, the fastener rod 1 with high rigidity and excellent durability can be formed.

[0056] In the core component 6 of the fastener rod 1 according to one embodiment of the present invention, the fiber direction of the reinforcing fiber layer 2 is aligned, and the thickness of the reinforcing fiber layer 2 is, for example, in the range of 0.02 mm to 0.3 mm. This homogenizes the resin density and reduces strength deviations caused by specific locations.

[0057] Next, a method for manufacturing a fastener rod 1 according to one embodiment of the present invention will be described. First, as step 1, any one of the following layers is cut to a predetermined size: reinforcing fiber layer 2, resin layer 3, reinforcing fiber layer 4 (different from the fibers of the reinforcing fiber layer), or reinforcing fiber layer 5 (having fibers inclined relative to the fiber direction of the reinforcing fiber layer) (layer cutting process). Then, as step 2, a high-elongation metal wire or fiber component for use as a reinforcing member 8 is prepared (reinforcing member selection process). Next, as step 3, the layers are stacked in a predetermined configuration, and the reinforcing member is placed between two adjacent layers while considering predetermined positions (layer stacking and reinforcing member placement process). Then, as step 4, the core member 6 is formed in a predetermined mold under predetermined conditions (e.g., temperature 380°C, pressure 5 MPa to 15 MPa) (forming process). Next, as step 5, the core member 6 is formed by processing to achieve the final shape and size (processing process). Finally, as step 6, a resin tube is melted, thereby forming a resin-coated layer 7 on the outer surface of the formed core member 6. Thus, a fixing rod 1 is formed according to one embodiment of the present invention.

[0058] According to one embodiment of the present invention, the fastener rod 1 formed in this way provides a fastener rod that reduces breakage during screw fastening, has high rigidity and high durability under deformation loads, and significantly reduces the risk of fragment dispersion even in the event of breakage. More specifically, the elongation of the reinforcing member is greater than the elongation of the fibers of the core member, so even if the core member breaks, the reinforcing member is relatively difficult to break, and fragment dispersion is suppressed.

[0059] Next, refer to again Figure 2 The following describes a fixation rod 1 of one embodiment of the present invention used in a spinal fixation member 10. Figure 2 Therefore Figure 1 Observation of the XX section shown Figure 1The diagram shows the fastener rod 1. In one embodiment of the present invention, the fastener rod 1 is configured to have a core component 6 comprising fiber-reinforced resin (details to be described later), a resin coating layer 7 covering the core component 6, and a reinforcing member 8 embedded in the core component 6. The resin coating layer 7 has a tensile strength of 50 MPa or more, an elongation of 30% or more, and a thickness ranging from 0.3 mm to 0.4 mm. By having such a resin coating layer 7, even if the internal core component 6 is damaged, the resin coating layer 7 will not break, ensuring that the core component 6 is covered. Therefore, it is possible to prevent the fibers of the core component 6 from being exposed to the outside, and even in the event of breakage, the risk of injury to the human body can be significantly reduced. More specifically, the elongation of the resin coating is sufficient to be approximately 2% relative to the standard elongation of carbon fiber, thus preventing damage caused by carbon fiber. Furthermore, if the resin coating has a certain thickness and strength, it can suppress the breakage of the resin coating against the impact force accompanying the breakage of carbon fiber. However, if the resin coating thickness exceeds 0.4 mm, coating breakage becomes difficult, but the outer diameter of the rod itself increases, leading to a greater impact on implantation. Furthermore, the core component described later reduces breakage during screw fixation, providing high rigidity and improved durability under deformation loads; however, the resin coating further enhances these technical effects. Here, in one embodiment of the fixing rod 1 of the present invention, a marker is embedded in the core component 6. It should be noted that the marker is made of a radiopaque material and serves to indicate the position of the implanted product within the body.

[0060] In a fastener rod 1 according to one embodiment of the present invention, the fiber volume fraction (VF) near the surface of the core component 6 is preferably in the range of 50% to 70%, more preferably in the range of 55% to 65%. Here, the area near the surface of the core component 6 refers to the region 0.2 mm inward from the surface of the core component towards the center. When the fiber volume fraction (VF) near the surface of the core component 6 is 50% or more, the bending stiffness can be effectively increased, and a rod that is difficult to break can be formed. In addition, when the volume fraction near the surface of the core component is 50% or more, the bonding with the coating resin is not completely integrated. That is, the resin on the surface of the core component and the coating resin easily and firmly integrate, but on the other hand, the carbon fibers on the surface of the core component and the coating resin have a relatively weak bond. In contrast, if the fiber volume fraction (VF) near the surface of the core component 6 exceeds 70%, there is too little resin on the surface, so sufficient bonding is not achieved between the coating resin and the resin of the core component. Because the core component and the coating resin are not completely integrated and form a weak bond, when the internal core component is damaged, cracks propagate between the core component surface and the coating resin layers to release stress, making it difficult for the coating resin to fracture.

[0061] In the fastener rod 1 of one embodiment of the present invention, the resin of the core component 6 and the resin of the covering resin layer 7 are the same thermoplastic resin. Examples of such thermoplastic resins include PEEK, nylon, PPSU, or PET. This allows for stable integration of the core component and the covering resin.

[0062] In a fastener rod according to one embodiment of the present invention, the resin coating layer is formed by melting and depositing a resin tube. In this way, by pre-forming the coating layer into a tubular shape, a coating layer with stable thickness and quality can be formed.

[0063] The dimensions, materials, and configurations of the constituent elements described in this specification are not limited to those explicitly stated in the embodiments. These constituent elements can be modified to have any dimensions, materials, and configurations that fall within the scope of this invention. Furthermore, constituent elements not explicitly stated in this specification can be added to the described embodiments, and some constituent elements described in each embodiment can be omitted.

[0064] Label Explanation

[0065] 1: Fixing rod; 2: Reinforcing fiber layer; 3: Resin layer; 4: Reinforcing fiber layer having fibers different from those in reinforcing fiber layer 2; 5: Reinforcing fiber layer having fibers inclined relative to the fiber direction of reinforcing fiber layer 2; 6: Core component; 7: Coating resin layer; 8: Reinforcing component; 10: Spine fixation component; 18: Screw component; 20: Rod fixing component; 21: Recess; 22: Pressing component.

Claims

1. A rod for fixing components, characterized in that, The fixing rod has the following characteristics: Core component, comprising fiber-reinforced resin; and A resin coating layer covers the core component. A reinforcing member is provided inside the core component along its length.

2. The rod for fixing according to claim 1, wherein, The reinforcing component is a high elongation metal wire or fiber component.

3. The rod for fixing according to claim 2, wherein, The tensile strength of the high elongation metal wire or fiber component is above 150 MPa.

4. The rod for fixing according to claim 2, wherein, The elongation of the fiber component is higher than that of the reinforcing fiber of the fiber-reinforced resin.

5. The rod for fixing according to claim 2, wherein, The diameter of the high elongation metal wire or fiber component ranges from 0.1 mm to 1.0 mm.

6. The rod for fixing according to claim 2, wherein, When viewed in a cross section perpendicular to the length direction of the core component, the high elongation metal wire or fiber component is disposed within an imaginary circle centered at the center point of the core component, with a diameter equal to half the diameter of the fixing rod.

7. The rod for fixing according to claim 1, wherein, When viewed in a cross section perpendicular to the length direction of the core component, the core component is formed by stacking multiple layers.

8. The rod for fixing according to claim 1, wherein, The multiple layers of the core component each comprise resin, and when viewed in a cross-section perpendicular to the length direction of the core component, the reinforcing member is embedded in such a manner that it is surrounded by resin with a thickness ranging from 2 to 3 times the diameter of the reinforcing member.

9. The rod for fixing according to claim 7, wherein, When viewed in cross-section, the multiple layers of the core component are alternately formed in multiple layers, including the reinforcing fiber layer and the resin layer, the reinforcing fiber layer with fibers different from those of the reinforcing fiber layer, or the reinforcing fiber layer with fibers inclined relative to the fiber direction of the reinforcing fiber layer, and the reinforcing component is embedded in one or more of the multiple layers.

10. The rod for fixing according to claim 9, wherein, The reinforcing fiber layer is a fiber-reinforcing resin. The fiber used is carbon, glass, boron, SiC or aromatic polyamide, and the resin used is epoxy resin, phenolic resin, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK or PEEK.

11. The rod for fixing according to claim 9, wherein, The resin in the resin layer is epoxy resin, phenolic resin, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK, or PEEK.

12. The rod for fixing according to claim 9, wherein, The reinforcing fiber layer, which is different from the fibers of the reinforcing fiber layer, is a fiber-reinforcing resin. The fibers used are carbon, glass, boron, SiC or aromatic polyamide, and the resin used is epoxy resin, phenolic resin, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK or PEEK.

13. The rod for fixing according to claim 9, wherein, In the reinforcing fiber layer or a reinforcing fiber layer with fibers different from those in the reinforcing fiber layer, the fibers are aligned in one direction, formed into a fabric-like structure, or randomly oriented.

14. The rod for fixing according to claim 9, wherein, The fiber direction of the reinforcing fiber layer, which has fibers that are tilted relative to the fiber direction of the reinforcing fiber layer, is tilted in the range of 10° to 90°.

15. The rod for fixing according to claim 9, wherein, In the case where multiple layers are provided, including the resin layer, the reinforcing fiber layer with fibers different from those of the reinforcing fiber layer, or the reinforcing fiber layer with fibers inclined relative to the fiber direction of the reinforcing fiber layer, each layer may be the same layer or different layers.

16. The rod for fixing according to claim 9, wherein, The fibers in the reinforcing fiber layer are long fibers.

17. The rod for fixing according to claim 9, wherein, The fiber content of the reinforced fiber layer is 50% or more by volume.

18. The rod for fixing according to claim 9, wherein, The fiber orientation of the reinforcing fiber layer is aligned, and the thickness of the reinforcing fiber layer is in the range of 0.02 mm to 0.3 mm.

19. The rod for fixing according to claim 1, wherein, Markings are provided on the reinforcing component.

20. The rod for fixing according to claim 1, wherein, The elongation of the reinforcing component is greater than the elongation of the fibers in the core component.

21. A rod for fixing a component, characterized in that, The fastener rod has a core component containing fiber-reinforced resin. A reinforcing member is provided inside the core component along its length.

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