KR101705854B1 - Bone connection material - Google Patents

Abstract

The present invention relates to a bone connecting member, wherein the bone connecting member includes a plurality of fibers and a covering layer, and the plurality of fibers are alternately knitted with each other to form a fiber knitting structure. Wherein the single fiber is a multi-layered fiber and the coefficient of thermal expansion of each layer of the multi-layered fiber is the same or gradually smaller from the inner layer to the outer layer, and at least one of the multi-layered fibers is made of an X-ray impermeable material, Increase strength and bioavailability and provide discrimination on medical examinations.

Description

BONE CONNECTION MATERIAL

The present invention relates to a bone connecting member, and more particularly to a bone connecting member having a fiber knitting structure.

In surgical operation, most of the joint members that connect parts such as teeth, skulls, facial, and limb fractures are mostly implanted with bone nails and bone fixation plates to join the affected parts. Generally, bone nails and bone fixation plates are manufactured using materials such as titanium metal and steel since stress occurs in these bone nails and bone fixation plates as a joint member when the patient's body moves.

Clinically, bone nails and bone fixation plates made of materials such as titanium metal and steel are implanted in the patient's joints, and after the material is hard and rigid, elasticity, etc., (References: TWM483771, CN102256557B patents). Also, there is a bone connecting member (TWI368633, CN202113157U patent) manufactured by using polylactic acid in the past, but it has a disadvantage that it is easily broken when it receives force due to its weak characteristic of material. It is not suitable as a connecting member to be always moved.

The main object of the present invention is to provide a bone connecting member.

The bone connecting member according to the present invention includes a plurality of fibers and a covering layer, and the plurality of fibers are alternately knitted with each other to form a fiber knitting structure. Wherein the single fiber is a multi-layered fiber, wherein the coefficient of thermal expansion of each layer of the multi-layered fiber is the same or smaller than the inner layer to the outer layer, and at least one of the multi-layered fibers is made of an X-ray impermeable material.

Preferably, the covering layer is for covering the fiber knitting structure, and the covering layer comprises the resin.

Preferably, the fiber knitting structure comprises a central fiber axis and a plurality of cannulated fiber axes, wherein the central fiber axis passes straight through the fiber knitting structure and the plurality of cannulated fiber axes alternately surround the central fiber axis.

Preferably, the multi-layered fiber comprises a core layer and a housing layer, and the housing layer surrounds the peripheral surface of the core layer. Or the multilayered fiber includes a core layer, an intermediate layer and a housing layer, the intermediate layer surrounding the peripheral surface of the core layer, and the housing layer surrounding the peripheral surface of the intermediate layer.

Preferably, a dot-like coating layer is provided on the outer surface of the housing layer.

Preferably, at least one of the multilayer fibers is made of a bioinert material, and at least one of the multilayer fibers is made of a bioactive material.

Preferably, the bioactive material is a bioactive glass, collagen protein, hydroxyapatite (HA), or tricalcium phosphate (TCP).

Preferably, each layer and each layer of the multilayer fiber are integrally formed.

Preferably, each layer of the multi-layered fiber is formed of a circular long-fiber yarn, a hexagonal long-fiber yarn, or a bar-like long fiber yarn.

Preferably, the coating layer further comprises bioactive glass, collagen protein, hydroxyapatite, and / or tricalcium phosphate.

Preferably, the resin has bioavailability.

Preferably, the resin is biodegradable.

Preferably, the resin is thermosetting.

Preferably, the resin is thermoplastic.

The present invention can generate flexibility by resisting the shear force in the lateral direction by the fiber knitting structure and has a wide range of applicability. Therefore, it is more suitable for a part that is always active compared with a conventional rigid material, and does not easily cause a rejection phenomenon by the human body as compared with a conventional metal material. The present invention eliminates the disadvantage that the conventional metal material is too hard and not elastic, and the polylactic acid material is too weak. Therefore, the bone member according to the present invention is closer to the natural bone, and thus is more suitable for the bone marrow and the stem cell. Further, the single fiber is a multi-layered fiber, and the tensile strength of the single fiber is increased by the same or increasingly smaller thermal expansion coefficient of each layer of the multi-layered fiber from the inner layer to the outer layer. Moreover, at least one of the multilayer fibers is made of an X-ray impermeable material to provide discrimination on medical examinations.

1 is a schematic view of a bone connecting member according to a comprehensive embodiment of the present invention;
2A to 2D are schematic views of a single fiber for a bone connecting member according to the first to fourth embodiments of the present invention.
Figs. 3A to 3E are schematic views of a single fiber for a bone connecting member according to fifth to ninth embodiments of the present invention. Fig.
Figures 4A and 4B are schematic views of a single fiber for a bone connecting member according to a tenth embodiment and an eleventh embodiment of the present invention.
5 is a schematic view of a bone connecting member according to another general embodiment of the present invention;
Figure 6 is a schematic view of a bone connecting member according to yet another general embodiment of the present invention.
7A is a side schematic view of a bolt formed in an embodiment of the present invention.
7B is a schematic view of a bolt with internal threads formed in an embodiment of the present invention.
7C is a cross-sectional schematic view of a bolt with internal threads formed in an embodiment of the present invention.
8A is a perspective view of a bone-bonded plate formed in an embodiment of the present invention.
8B is a schematic plan view of the bone formed in an embodiment of the present invention.
8C is a schematic plan view of a lever type formed in an embodiment of the present invention.

Referring to FIG. 1, a bone connecting member 100 according to an embodiment of the present invention includes a plurality of fibers F and a covering layer R. The plurality of fibers (F) are alternately knitted together to form a fiber knitting structure (W). The covering layer (R) is for covering the fiber knitting structure (W), and the covering layer (R) comprises a resin.

1 is a plan view of the bone connecting member 100. FIG. From the sub drawing A, it can be seen that the fibers F are fixed to the coating layer R. 1, the fibers F are knitted to form a fiber knitting structure W, and the plurality of fibers F are knitted and bound together by the forces of the fibers F, It can be seen that flexibility can be generated by resisting the shearing force. The resin of the coating layer (R) and the fiber knitting structure (W) are advantageous in that the bone connecting member (100) is provided with elastic force and high tensile strength at the same time. In other words, with respect to the concentrated stress in the bone connecting member 100, it is more preferable to provide the covering layer R and the fiber knitting structure W than the conventional structure, It is suitable for use as a bone member connection or as a stem cell skeleton. Preferably, the textile knitting structure W comprises a central fiber axis 10 and a plurality of spoken fiber axes 20. The central fiber shaft 10 passes straight through the fiber knitting structure W and a plurality of spoken fiber axes 20 alternately surround the central fiber shaft 10. [ The figure " * " in subdivision B provides a separate fixed and vertical intrinsic strength for the castable fiber shaft 20, thereby forming a structure that is stronger than the conventional figure "x".

The resin of the coating layer (R) may be made of a biologically inert or biodegradable material to facilitate the osseointegration process, and may be determined according to actual practice, and the resin may be thermosetting or thermoplastic. In a preferred embodiment, the coating layer (R) may further include or additionally contain the additive (R1) as shown in Fig. The additive R1 may be a material such as bioactive glass, collagen protein, hydroxyapatite, and / or tricalcium phosphate. Hydroxyapatite is the main component of human skeletal tissues. After implantation in the body, calcium and phosphorus are released into the surface of the material and absorbed into the body tissues. In general, the body itself generates related or similar elements such as hydroxyapatite to carry out the basic process of skeletal reconstruction, but the length of time required is determined by individual constitution. The coating layer (R) of the present invention can include these materials for skeletal reconstruction, thereby making it possible for the body to be used for the reconstruction and for promoting rehabilitation, which is quite convenient.

The single fiber F of the bone connecting member 100 according to the present invention is a multi-layered fiber, and the coefficient of thermal expansion of each layer of the multi-layered fiber is the same or gradually decreases from the inner layer to the outer layer. At least one layer of the multi- Transmissive material. The details will be described below.

Referring now simultaneously to Figures 2A-2D, these drawings are schematic views of multi-layer fibers for a bone connecting member 100, according to first through fourth embodiments of the present invention, respectively. In these embodiments, the single fiber F is a multi-layered fiber, the multi-layered fiber comprises a core layer 2 and a housing layer 1, and the housing layer 1 surrounds the peripheral surface of the core layer 2 . 3A to 3E, these drawings are schematic views of the multi-layer fibers for a bone connecting member 100 according to fifth to ninth embodiments of the present invention, respectively. In these embodiments, the single fiber F is a multi-layered fiber, the multi-layered fiber comprises a core layer 2, an intermediate layer 3, and a housing layer 1, Surrounds the peripheral surface, and the housing layer (1) surrounds the peripheral surface of the intermediate layer (3).

As can be seen from Figures 2A to 2D and 3A to 3E, in each of the different embodiments, each layer of the multi-layer fibers constituting the single fiber F is formed of a circular long fiber yarn, a hexagonal long filament yarn, . Referring to FIG. 3D, for example, the core layer 2 of the single multilayer fiber is hexagonal long fiber, the intermediate layer 3 is circular long fiber yarn, and the housing layer 1 is a bar type long fiber yarn. The purpose of forming the hexagonal long filament yarn is to provide the stress intensity of the fiber knitting structure W and the purpose of forming the bar long filament yarn is to prevent the fibers F between the fibers F of the fiber knitting structure W, And a high coefficient of friction between the bone and the bone to increase the fixation force. 4A and 4B, a separate dot-type coating layer 11 is provided on the outer surface of the housing layer 1, and the function of the dot-type coating layer 11 is also formed on the fibers F of the fiber knitting structure W ) Or between the fibers (F) and the bones.

The coefficient of thermal expansion of each layer of the multilayered fiber is the same or gradually decreases from the inner layer to the outer layer. For example, in Figures 2A-2D, the housing layer 1 has a coefficient of thermal expansion equal to or less than the core layer 2. 3A to 3E, the thermal expansion coefficient of the intermediate layer 3 is equal to or smaller than the thermal expansion coefficient of the intermediate layer 3, and the thermal expansion coefficient of the intermediate layer 3 is equal to or smaller than the thermal expansion coefficient of the core layer 2 . By such an installation, the tensile strength in the radial direction of the single multilayer fiber is increased. High tensile strength is important in bone connecting members. The reason for this is that the bone connecting member is always subjected to the force and the direction of the external force applied thereto does not coincide.

In a preferred embodiment, each layer and each layer of a single multilayer fiber are integrally molded. For example, the intermediate layer 3, the core layer 2, and the housing layer 1 are integrally formed, or some layers are integrally formed. The integral molding can be made, for example, in the manner of fusion bonding to improve the structural strength of a single multi-layered fiber.

In addition, for ease of medical examination, the present invention manufactures at least one layer of multilayer fibers from an X-ray impermeable material, thereby allowing the bone connecting member 100 to appear in an X-ray scan.

In a preferred embodiment, at least one of the multilayer fibers is made of a bioactive material, and at least one of the multilayer fibers is made of a bioactive material. The biologically active material can be bioactive glass, collagen protein, hydroxyapatite, or tricalcium phosphate, and the interaction of these biological materials and the body tissues can improve bone growth and rehabilitation speed. Therefore, when the bone connecting member 100 is implanted, the fibers F begin to osseointegrate to the bone. And the other layer may be made of a bioactive material to maintain the structure of the bone connecting member 100. The biologically inactive material may also be a bioactive material having X-ray impermeability, for example, a bioactive glass fiber having X-ray impermeability. Since the fibers F of the bone connecting member 100 include a biologically active material, a more dense osseointegration can be achieved by using a multilayer fiber knitting method as compared with the conventional coating method.

For example, in Figure 2A-2D, the housing layer 1 is made of bioactive material. When the bone is in contact with the housing layer 1, the biologically active material is released from the housing layer 1 to contact the osteoblasts in the bone, thereby causing bone adhesion. The core layer 2 is made of a bioactive material, for example, bioactive inactive glass fiber, to maintain the structure of the bone connecting member 100. Of course, the present invention is not limited to this, and the housing layer 1 may be made of a bioactive material and the core layer 2 may be made of a bioactive material. For example, in FIG. 3A to FIG. 3E, the core layer 2 and / or the intermediate layer 3 is made of a bioactive glass fiber or bioactive material having X-ray impermeability and the housing layer 1 is made of a bioactive material , Such as bioactive glass, collagen protein, hydroxyapatite, or tricalcium phosphate. The purpose of forming the three layers is to maintain the two-layer structure composed of the housing layer 1 and the remaining core layer 2 and the intermediate layer 3 when the bone is osseointegrated. It is needless to say that the formation of the three-layer structure can provide a greater stress than the formation of the two-layer structure. The core layer 2 and / or the intermediate layer 3 may be made of a bioactive material such as bioactive glass, collagen protein, hydroxyapatite, or tricalcium phosphate, in an alternative embodiment. And the housing layer 1 can be made of bio-inert glass fiber or bio-inert material having X-ray impermeability. Thereby, the biologically active material is released from the core layer 2 or the intermediate layer 3 to make contact with the osteoblasts in the bone to proceed osseointegration. Further, each layer of the single multilayer fiber may be a glass fiber material or a ceramic material, all of which can be arranged correspondingly to the needs of the subject, and have superior ability to the adhesion assisting of the bone member. In the bone connecting member constructed using multi-layered fibers, the bioactive material can cooperate with the growth of the skeleton and remains in the body and does not cause any adverse effect, so that the bioactive material may not be separately removed and removed. In addition, since it is not made of materials such as titanium metal or steel, the patient does not develop a sensitive reaction. Since the conventional bone connecting member can not be placed in the human body for a long period of time, when the affected part is partially rehabilitated, the doctor has to perform a so-called secondary operation on the patient to remove the bone connecting member from the patient's body. Then, the patient must again bear the risk of anesthesia and the risk of postoperative infection during surgery, which causes the patient's economic, physiological and psychological burden. However, since the bone connecting member according to the present invention uses a material that can be placed for a long time in the body, it is not necessary to take out the bone connecting member through a secondary operation, thereby reducing the burden on the patient.

It should be noted that the above-described embodiments are used for illustrative purposes only and are not intended to limit the present invention. In another embodiment, the bone connecting member 100 may have a structure of three or more layers. For example, the single fibers F used in the bone connecting member 100 may be ten layers of fibers, And at least one of the layers may be made of a material having X-ray impermeability so long as the bone connecting member 100 can appear in X-ray scanning.

Referring to FIG. 6, the bone connecting member 100 may be manufactured in a double threaded structure according to actual practice. It can be seen from the subdrawing C that the fibers F are fixed to the covering layer R and provided to the bone connecting member 100 of the double threaded structure. 6, it can be seen that the fibers F are knitted to form a fiber knitting structure W. Sub-drawing E shows a cross-sectional view of a textile knitting structure (W).

The covering layer R or the plurality of fibers F may be formed into a bone nail shape as shown in Figs. 7 to 7C or a bone nail shape as shown in Figs. 8A to 8C, which is previously set to correspond to the bone connecting member 100 after being knitted. It can be composed of a bone plate (for connection). Of course, a substrate such as, for example, a bone nail, a bone connecting sheet / block, or the like may be produced through knitting in this embodiment. On the other hand, there are many kinds of knitting methods. For example, a knitting method in which one fiber (F) is used as a main axis and another fiber (F) is wound, or a proximity knitting method in which two or three fibers (F) (F) is re-knitted again with other fibers (F) which are already knitted or not knitted. All of the above-described methods have a knitting method according to the present embodiment, and many knitting methods are not described one by one in this specification. It will be explained in advance that any knitting method is included in the " knitting "

100 bone connecting member
1 housing layer
11 dot type coating layer
2 core layer
3 middle layer
10 central fiber shaft
20 spatula type fiber shaft
F fiber
R coating layer
R1 Additive
W Textile Knitting Structure

Claims (6)

In the bone connecting member,
A plurality of fibers alternately knitted to form a fiber knitting structure,
Wherein the fiber knitting structure includes a central fiber shaft that straightly passes through the fiber knitting structure, and a cannon-type fiber shaft that alternately surrounds the central fiber shaft,
Wherein the fiber is a multi-layer fiber comprising a core layer and a housing layer surrounding the periphery of the core layer, wherein the coefficient of thermal expansion of each layer of the multi-layer fiber gradually decreases from the inner layer to the outer layer, A bone connecting member made of an X-ray impermeable material. The method according to claim 1,
And a covering layer for covering the fiber knitting structure, wherein the covering layer comprises a resin. 3. The method of claim 2,
Wherein said coating layer further comprises bioactive glass, collagen protein, hydroxyapatite and / or tricalcium phosphate. The method according to claim 1,
And a dot-like coating layer on the outer surface of the multilayer fiber. The method according to claim 1,
At least one layer of the multi-layer fibers is made of a bioactive material, and at least one layer of the multi-layer fibers is made of a bioactive material. The method according to claim 1,
Wherein each layer of the multi-layer fibers is formed of a circular long-fiber yarn, a hexagonal long-fiber yarn, or a bar-like long fiber yarn.

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