Artificial ligament and preparation method thereof

Abstract

The invention discloses an artificial ligament and a preparation method thereof, the artificial ligament comprises a woven tissue and an artificial bone material, the artificial ligament is formed by coating or infiltrating the woven tissue with a solution containing the artificial bone material and drying, the artificial bone material is formed by mixing inorganic particles and a polymer material, the inorganic particles are composed of calcium-phosphorus compounds, and the polymer material is composed of calcium-phosphorus compounds. The mass fraction of the inorganic particles is 10%-60%, the polymer material is a copolymer formed by caprolactone or p-dioxanone and lactide or glycolide, the artificial bone material is subjected to gradient degradation, and the gradient degradation includes that the polymer material is rapidly degraded prior to the inorganic particles, and after the artificial ligament is implanted, the polymer material can be rapidly degraded. The bone tissue grows into the woven tissue along the artificial bone material. According to the present invention, the artificial ligament capable of improving the tendon-bone healing ability and the preparation method thereof can be provided.

Description

[0001] This application is a divisional application of a patent application with an application date of December 21, 2020, application number 2020115219407, and invention name "Artificial ligament with healing function and preparation method thereof". Technical Field

[0002] The present disclosure generally relates to an artificial ligament and a method for making the same. Background Art

[0003] Ligament injury is a common sports injury with a high incidence rate, especially among young people, and it is increasing year by year as people's awareness of sports increases. At present, the main method for treating ligament injuries in clinical practice is to reconstruct the ligament using graft surgery. There are three main types of grafts commonly used in clinical practice: autologous, allogeneic and artificial grafts. Among them, autologous grafts have problems such as large surgical trauma, impaired donor site function, many complications, slow recovery and multiple knee joint injuries; allogeneic grafts have problems such as lack of sources, infection risks, disease transmission and immune rejection. Therefore, in view of the above-mentioned problems of autologous and allogeneic grafts, most surgeries choose to use artificial grafts, such as artificial ligaments.

[0004] However, since artificial grafts are often difficult to form tendon-bone healing in clinical practice, they usually experience problems such as loosening of ligament joints, decreased joint stability, and repair failure after being implanted in the body for a certain period of time. Therefore, research and development to address the problem of insufficient tendon-bone healing ability of artificial grafts in vivo is imperative. Summary of the invention

[0005] The present disclosure is made in view of the above-mentioned prior art conditions, and its purpose is to provide an artificial ligament with healing function that improves the tendon-bone healing ability and a preparation method thereof.

[0006] To this end, the first aspect of the present disclosure provides an artificial ligament with a healing function, which is formed by coating or infiltrating a solution containing an absorbable artificial bone material with a biocompatible braided fabric and drying it, wherein the braided fabric is formed of polymer fibers, and the braided fabric has a first braided portion for implanting into a first bone tunnel, a second braided portion for implanting into a second bone tunnel, and a connecting portion connecting the first braided portion and the second braided portion, wherein the first braided portion and the second braided portion have a mesh structure woven by the polymer fibers, and the artificial bone material is at least distributed in the mesh structure of the first braided portion and the second braided portion. In the mesh structure of the second braided part, the artificial bone material is a mixture of inorganic particles and polymer materials, the inorganic particles are composed of calcium-phosphorus compounds, the mass fraction of the inorganic particles is 10% to 60%, the polymer material is a copolymer formed by caprolactone or p-dioxanone and lactide or glycolide, the average molecular weight of the polymer material is 1000Da to 20000Da, the artificial bone material has plasticity, and after the artificial ligament is implanted into the first bone tunnel and the second bone tunnel, bone tissue grows into the mesh structure along the artificial bone material to fix the first braided part and the second braided part. In the present disclosure, the artificial ligament is composited by a biocompatible braid and an absorbable artificial bone material, and the artificial bone material is distributed in the mesh structure of the braid. In this case, the artificial bone material can promote the generation of bone cells and induce bone tissue to grow into the braid, so the artificial ligament can improve the tendon-bone healing ability.

[0007] In addition, in the artificial ligament of the present disclosure, optionally, the first braided portion and the second braided portion are braided by warp and weft, the connecting portion is composed of the warp, the warp is a polymer fiber extending along the length direction of the artificial ligament, and the weft is a polymer fiber extending along the width direction of the artificial ligament. Thus, it is easy to form a mesh structure.

[0008] In addition, in the artificial ligament involved in the present disclosure, optionally, the braid has a first surface and a second surface opposite to the first surface, the artificial bone material is distributed on the first surface, and the artificial ligament is formed by winding the braid along the second surface and the weft direction and suturing. This can help improve the tendon-bone healing ability of the artificial ligament.

[0009] In addition, in the artificial ligament involved in the present disclosure, optionally, the breaking force of the connecting portion is not less than 1000 N. Thus, the artificial ligament can have good mechanical properties.

[0010] In addition, in the artificial ligament of the present disclosure, optionally, the polymer fiber is made of at least one non-degradable material selected from polyethylene terephthalate and ultra-high molecular weight polyethylene, thereby providing long-term mechanical strength support.

[0011] In addition, in the artificial ligament of the present disclosure, optionally, the mesh structure of the first braided part and the mesh structure of the second braided part are filled with the artificial bone material, thereby improving the promoting effect of the artificial ligament on tendon-bone healing.

[0012] In addition, in the artificial ligament involved in the present disclosure, optionally, the artificial ligament is in the shape of a long strip, and the artificial ligament has a first implantation segment including the first braided portion, a connection segment including the connection portion, and a second implantation segment including the second braided portion. Thus, it can be convenient to be applied to the reconstruction of the ligament in the joint cavity.

[0013] In addition, in the artificial ligament involved in the present disclosure, optionally, the first implant segment is connected to a first traction line, through which the first implant segment is implanted and fixed in the first bone tunnel, and the second implant segment is connected to a second traction line, through which the second implant segment is implanted and fixed in the second bone tunnel. This can facilitate the implantation and fixation of the artificial ligament.

[0014] The second aspect of the present disclosure provides a method for preparing an artificial ligament with a healing function, which comprises: preparing a woven fabric having a woven portion and an absorbable artificial bone material, dissolving the artificial bone material in an organic solvent to obtain a paste, applying the paste to the woven fabric, and then drying to obtain the artificial ligament, wherein the artificial bone material is a mixture of inorganic particles and polymer materials, the inorganic particles are composed of calcium-phosphorus compounds, the mass fraction of the inorganic particles is 10% to 60%, the polymer material is a copolymer formed by caprolactone or p-dioxanone and lactide or glycolide, the average molecular weight of the polymer material is 1000Da to 20000Da, the artificial bone material has plasticity, the woven fabric is formed by polymer fibers, the woven portion is used for implantation in a bone tunnel and has a mesh structure, and in the artificial ligament, the artificial bone material is at least distributed in the mesh structure of the woven portion. In the present disclosure, artificial bone material and a woven fabric with a mesh structure are compounded by a coating method to form an artificial ligament having artificial bone material distributed in the mesh structure, and because the artificial bone material can promote the generation of bone cells and induce bone tissue to grow into the woven fabric, an artificial ligament with improved tendon-bone healing ability can be obtained.

[0015] The third aspect of the present disclosure provides a method for preparing an artificial ligament with a healing function, which comprises: preparing a woven fabric having a woven portion and an absorbable artificial bone material, dissolving the artificial bone material in an organic solvent to obtain a paste, and soaking the woven fabric in the paste, and then drying to obtain the artificial ligament, wherein the artificial bone material is a mixture of inorganic particles and polymer materials, the inorganic particles are composed of calcium-phosphorus compounds, the mass fraction of the inorganic particles is 10% to 60%, the polymer material is a copolymer formed by caprolactone or p-dioxanone and lactide or glycolide, the average molecular weight of the polymer material is 1000Da to 20000Da, the artificial bone material has plasticity, the woven fabric is formed by polymer fibers, the woven portion is used for implantation in a bone tunnel and has a mesh structure, and in the artificial ligament, the artificial bone material is at least distributed in the mesh structure of the woven portion. In the present disclosure, artificial bone material and a woven fabric with a mesh structure are compounded by an infiltration method to form an artificial ligament having artificial bone material distributed in the mesh structure, and because the artificial bone material can promote the generation of bone cells and induce bone tissue to grow into the woven fabric, an artificial ligament with improved tendon-bone healing ability can be obtained.

[0016] According to the present disclosure, an artificial ligament with healing function and a preparation method thereof that improves tendon-bone healing ability can be provided. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Embodiments of the present disclosure will now be explained in further detail, by way of example only, with reference to the accompanying drawings, in which:

[0018] Figure 1 is a schematic diagram showing an example of an application scenario of an artificial ligament involved in an example of the present disclosure.

[0019] Figure 2 is a schematic diagram showing the structure of an artificial ligament involved in an example of the present disclosure.

[0020] Figure 3 Schematic diagram showing the structure of a braided fabric according to an example of the present disclosure.

[0021] Figure 4 2 is a schematic structural diagram showing a braided fabric according to another example of the present disclosure.

[0022] Figure 5 is a schematic structural diagram showing a braided fabric according to yet another example of the present disclosure.

[0023] Figure 6 is a schematic diagram showing the winding of an artificial ligament according to an example of the present disclosure.

[0024] Figure 7is a schematic structural diagram showing an artificial ligament involved in another example of the present disclosure.

[0025] Figure 8 is a flow chart showing a method for preparing an artificial ligament according to an example of the present disclosure.

[0026] Fig. 9 is a flow chart showing a method for preparing an artificial ligament according to another example of the present disclosure.

[0027] Fig.10 This is a diagram showing the results of methylene blue-basic fuchsin staining according to Example 1 of the present disclosure.

[0028] Fig.11 2 is a diagram showing the MicroCT result according to Example 2 of the present disclosure.

[0029] Fig.12 2 is a diagram showing the MicroCT results of the comparative example of the present disclosure. DETAILED DESCRIPTION

[0030] The present disclosure is further described in detail below in conjunction with the accompanying drawings and specific embodiments. In the accompanying drawings, the same components or components with the same functions are marked with the same symbols, and repeated descriptions thereof are omitted.

[0031] The artificial ligament 1 with healing function (hereinafter referred to as "artificial ligament 1") of the present disclosure can be applied to ligament reconstruction. In clinical applications, the artificial ligament 1 can be implanted into the body (eg, a bone joint cavity).

[0032] For example, the artificial ligament 1 can be applied to shoulder joint ligament reconstruction (such as coracoclavicular ligament reconstruction), elbow joint ligament reconstruction (such as medial collateral ligament reconstruction of the elbow joint), knee joint ligament reconstruction (such as cruciate ligament reconstruction), etc.

[0033] Figure 1 is a schematic diagram showing an example of an application scenario of the artificial ligament 1 involved in an example of the present disclosure.

[0034] The following describes the application of the artificial ligament 1 by taking the reconstruction of the cruciate ligament of the knee as an example. Figure 1 As shown, the artificial ligament 1 (single bundle) can be implanted into the knee joint cavity by implanting the two ends of the artificial ligament 1 (single bundle) into the bone tunnels of different bones (i.e., femur and tibia) and fixing them, and the middle section of the artificial ligament 1 can be located in the joint cavity. The bone tunnel can be a channel drilled in the bone. In addition, the two ends of the artificial ligament 1 can be fixed by using fixings such as extrusion nails, suspension plates, button plates, etc. In addition, the fixings can be absorbable or non-absorbable.

[0035] In addition, the shape of the artificial ligament 1 involved in the present disclosure is not particularly limited. For example, the artificial ligament 1 can be formed into a long strip (such as a columnar, tubular), a membrane, etc. In addition, the artificial ligament 1 can be a single-bundle ligament or a double-bundle ligament. In some examples, the size of the artificial ligament 1 is not particularly limited and can be selected according to actual needs.

[0036] Figure 2 is a schematic structural diagram showing an artificial ligament 1 involved in an example of the present disclosure.

[0037] In some examples, the artificial ligament 1 may include a braided tissue (not shown) and an artificial bone material 20 (see Figure 2 ). The braided tissue and the artificial bone material 20 can be compounded by coating, soaking or hot pressing. For example, the braided tissue can be coated or infiltrated with a solution containing the artificial bone material 20 and then dried.

[0038] In some examples, the artificial ligament 1 can use braided tissue as a mechanical support. In other examples, the braided tissue can be biocompatible. Thus, the occurrence of immune rejection can be reduced, thereby facilitating the growth of cells (tissues) into the artificial ligament 1. In other words, the braided tissue can be formed of a biocompatible material.

[0039] In some examples, the braided structure may be composed of one or more braids 10. For example, in Figure 2 In the example shown, the braided tissue can be composed of one braid 10. In other examples, the braided tissue can be composed of 2 to 10 braids 10. In other examples, the braided tissue can also be composed of more than 10 braids 10. In addition, in some examples, in the braided tissue, multiple braids 10 can be the same. In other examples, at least one braid 10 can be different among the multiple braids 10.

[0040] In some examples, the braided tissue can be stacked (stacked up and down) by multiple braids 10 and joined by braiding or suturing. In addition, the size and structure of multiple braids 10 can match. For example, the size and structure of multiple braids 10 can be the same. In other examples, the braided tissue can have an upper surface and a lower surface relative to the upper surface.

[0041] Figure 3 1 is a schematic structural diagram showing a braided fabric 10 according to an example of the present disclosure.

[0042] In some examples, such as Figure 3As shown, the braid 10 may be formed of polymer fibers 11. In other words, the braid 10 may be braided from the polymer fibers 11. In other examples, the braid 10 may be formed from metal wires.

[0043] In some examples, the braid 10 may be formed by a weaving process such as plain weave, twill weave, satin weave, etc. That is, the weaving structure of the braid 10 may be plain weave, twill weave, satin weave, etc. In other examples, the braid 10 may be in a sheet shape.

[0044] In some examples, such as Figure 3 As shown, the woven fabric 10 can be woven from warp threads 11b and weft threads 11a. That is, the polymer fiber 11 can include warp threads 11b and weft threads 11a. In addition, the woven fabric 10 can be woven from a plurality of warp threads 11b and a plurality of weft threads 11a. In other examples, such as Figure 3 As shown, the warp threads 11b may be polymer fibers 11 extending along the length direction of the woven fabric 10 (or the artificial ligament 1), and the weft threads 11a may be polymer fibers 11 extending along the width direction of the woven fabric 10 (or the artificial ligament 1).

[0045] In some examples, the braid 10 has a first surface A and a second surface B opposite the first surface A (see Figure 6 In some other examples, the braided fabric 10 may have a braided portion. In addition, the braided portion may have a mesh structure.

[0046] In some examples, the mesh size of the mesh structure of the woven portion may be 0.1 mm to 2 mm. For example, the mesh size of the mesh structure of the woven portion may be 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 1.2 mm, 1.5 mm, 1.8 mm, or 2 mm.

[0047] In some examples, the braided portion may be formed by braiding. In addition, in some examples, the braided fabric 10 may be composed of the braided portion. In other examples, the braided portion may be formed by braiding the weft 11a and the warp 11b. Thus, it is easy to form a mesh structure.

[0048] In some examples, the woven portion may be formed by a weaving process such as plain weaving, twill weaving, satin weaving, etc. That is, the weaving structure of the woven portion may be plain weave, twill weave, or satin weave.

[0049] In some examples, the braid 10 may have a plurality of braided portions, at least one of which may be used for implantation in a bone tunnel. In addition, in some examples, different braided portions may be used for implantation in different bone tunnels.

[0050] In some examples, the plurality of woven parts may be respectively woven by weaving different pluralities of weft threads 11a with the same pluralities of warp threads 11b. In addition, the woven structures of the plurality of woven parts may be the same, or the woven structure of at least one woven part may be different.

[0051] In some examples, the woven fabric 10 may further include a non-woven portion. In addition, the non-woven portion may be composed of a plurality of polymer fibers 11. Specifically, the non-woven portion may be formed by a plurality of polymer fibers 11 arranged in parallel.

[0052] In some examples, the nonwoven portion may be composed of warp yarns 11b (see Figure 3 ). The non-woven portion may be composed of a plurality of warp threads 11b. In other examples, the warp threads 11b arranged in the non-woven portion may be the same as the warp threads 11b woven in the woven portion. That is, in the woven fabric 10, the same warp thread 11b may be used as both the warp thread 11b in the woven portion and the warp thread 11b in the non-woven portion. That is, the same warp thread 11b may be used to weave with the weft threads 11a to form the woven portion, and to be arranged with the warp threads 11b to form the non-woven portion. In other words, the plurality of warp threads 11b of the woven portion may be extended to form the non-woven portion.

[0053] In some examples, the non-woven portion may include a transition portion for connecting the woven portion. In addition, the breaking force of the transition portion may be not less than 1000N. Thus, the artificial ligament 1 can have good mechanical properties. For example, the breaking force of the transition portion may be 1000N, 1500N, 2000N, 2500N or 1000N.

[0054] Figure 4 1 is a schematic structural diagram showing a braided fabric 10 according to another example of the present disclosure.

[0055] In some examples, such as Figure 4 As shown, the braid 10 may have a first end D1 and a second end D2. In addition, the first end D1 and the second end D2 may be located in the length direction of the braid 10. In some examples, the first end D1 and the second end D2 may be located at both ends of the braid 10 along the length direction of the braid 10. In some examples, the first end D1 and the second end D2 may belong to the non-woven portion. In other words, the non-woven portion may include the first end D1 and the second end D2. This can facilitate the formation and fixing of the traction line. For example, in Figure 4 In the example shown, the first end portion D1 and the second end portion D2 may be formed by a plurality of warp threads 11 b extending through the woven portion along the length direction of the woven fabric 10 .

[0056] In some examples, the nonwoven portion may include a transition portion Z for folding in half (see Figure 5). Thus, the double-bundle artificial ligament 1 can be folded in half. For example, the braided fabric 10 can be folded in half along the folding line L to form the double-bundle artificial ligament 1. In addition, the turning portion Z can be formed by extending a plurality of warp threads 11b of the braided portion.

[0057] In some examples, such as Figure 3 As shown, the braid 10 may have a first braided portion 10a, a second braided portion 10b and a connecting portion 10c. The first braided portion 10a and the second braided portion 10b may be used for implantation into a bone tunnel, and the connecting portion 10c may connect the first braided portion 10a and the second braided portion 10b. In addition, the first braided portion 10a and the second braided portion 10b may be used for implantation into different bone tunnels. For example, the first braided portion 10a may be used for implantation into a first bone tunnel, and the second braided portion 10b may be used for implantation into a second bone tunnel. In some examples, the first braided portion 10a and the second braided portion 10b may be used for implantation into bone tunnels of adjacent bones.

[0058] In some examples, the first woven portion 10a and the second woven portion 10b may have a mesh structure woven from polymer fibers 11. In addition, the mesh sizes of the mesh structures of the first woven portion 10a and the second woven portion 10b may be the same or different.

[0059] In some examples, the mesh size of the mesh structure of the first woven portion 10a and the second woven portion 10b may be 0.1 mm to 2 mm. For example, the mesh size of the mesh structure of the first woven portion 10a and the second woven portion 10b may be 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 1.2 mm, 1.5 mm, 1.8 mm or 2 mm.

[0060] In some examples, such as Figure 3 As shown, the first woven portion 10a and the second woven portion 10b can be woven from warp threads 11b and weft threads 11a, and the connecting portion 10c can be composed of warp threads 11b. Thus, it is easy to form a mesh structure. In other examples, the woven structures of the first woven portion 10a and the second woven portion 10b can be the same or different.

[0061] In some examples, such as Figure 3 As shown, the first woven portion 10a and the second woven portion 10b can be formed by weaving different multiple weft threads 11a and the same multiple warp threads 11b, respectively, and the connecting portion 10c can be composed of the multiple warp threads 11b (arranged in parallel). That is, the multiple weft threads 11a of the first woven portion 10a can be different from the multiple weft threads 11a of the second woven portion 10b, and the multiple warp threads 11b of the first woven portion 10a, the multiple warp threads 11b of the second woven portion 10b, and the multiple warp threads 11b of the connecting portion 10c can be the same.

[0062] In some examples, the breaking force of the connecting portion 10c may be no less than 1000 N. Thus, the artificial ligament 1 can have good mechanical properties. For example, the breaking force of the connecting portion 10c may be 1000N, 1500N, 2000N, 2500N or 1000N.

[0063] In some examples, such as Figure 3 As shown, the braided fabric 10 may be formed with a first braided portion 10a, a connecting portion 10c, and a second braided portion 10b in sequence. In other examples, the braided fabric 10 may be formed with a first end portion D1, a first braided portion 10a, a connecting portion 10c, a second braided portion 10b, and a second end portion D2 in sequence (see Figure 4 ). In addition, the first woven portion 10a, the connecting portion 10c, and the second woven portion 10b may be sequentially connected to form a first woven fabric.

[0064] Figure 5 1 is a schematic structural diagram showing a braided fabric 10 according to yet another example of the present disclosure.

[0065] In some examples, such as Figure 5 As shown, the braid 10 may have a third braided portion 10d, a fourth braided portion 10e and a connecting portion 10f. The third braided portion 10d and the fourth braided portion 10e may be used for implantation in a bone tunnel. In addition, the third braided portion 10d and the fourth braided portion 10e may be used for implantation in different bone tunnels, and the connecting portion 10f may connect the third braided portion 10d and the fourth braided portion 10e. For example, the first braided portion 10a may be used for implantation in a third bone tunnel, and the second braided portion 10b may be used for implantation in a fourth bone tunnel. In some examples, the first braided portion 10a and the second braided portion 10b may be used for implantation in bone tunnels of adjacent bones.

[0066] In some examples, the third braided portion 10d and the fourth braided portion 10e may have a mesh structure woven from polymer fibers 11. In addition, the mesh sizes of the mesh structures of the third braided portion 10d and the fourth braided portion 10e may be the same or different. In addition, the mesh sizes of the mesh structures of the third braided portion 10d and the fourth braided portion 10e and the first braided portion 10a (or the second braided portion 10b) may be the same or different.

[0067] In some examples, the mesh size of the mesh structure of the third braided portion 10d and the fourth braided portion 10e may be 0.1 mm to 2 mm. For example, the mesh size of the mesh structure of the third braided portion 10d and the fourth braided portion 10e may be 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 1.2 mm, 1.5 mm, 1.8 mm or 2 mm.

[0068] In some examples, the third woven portion 10d and the fourth woven portion 10e may be woven from warp threads 11b and weft threads 11a, and the connecting portion 10f may be composed of warp threads 11b (see Figure 5 ). Thus, a braided fabric 10 having a mesh structure can be formed.

[0069] In some examples, the breaking force of the connecting portion 10f may be no less than 1000 N. Thus, the artificial ligament 1 can have good mechanical properties. For example, the breaking force of the connecting portion 10f may be 1000N, 1500N, 2000N, 2500N or 1000N.

[0070] In some examples, such as Figure 5 As shown, the first woven portion 10a, the second woven portion 10b, the third woven portion 10d and the fourth woven portion 10e can be respectively formed by weaving different multiple weft threads 11a with the same multiple warp threads 11b, and the connecting portion 10c and the connecting portion 10f are composed of the same multiple warp threads 11b (arranged in parallel).

[0071] In some examples, the weaving structures of the third and fourth weaving portions 10d and 10e may be the same or different. In other examples, the weaving structures of the third and fourth weaving portions 10d and 10e may be the same or different from those of the first weaving portion 10a (or the second weaving portion 10b).

[0072] In some examples, the third woven portion 10d, the fourth woven portion 10e and the connecting portion 10f are sequentially connected to form a second woven fabric. In other examples, the second woven fabric can be connected to the first woven fabric through a turning portion Z.

[0073] In some examples, the braided fabric 10 may be formed with a first braided fabric, a transition portion Z, and a second braided fabric in sequence. That is, the braided fabric 10 may be formed with a first braided portion 10a, a connecting portion 10c, a second braided portion 10b, a transition portion Z, a third braided portion 10d, a connecting portion 10f, and a fourth braided portion 10e in sequence (see Figure 5 ).

[0074] In some examples, the braided fabric 10 may be sequentially formed with a first end D1, a first braided cloth, a transition portion Z, a second braided cloth, and a second end D2. That is, the braided fabric 10 may be sequentially formed with a first end D1, a first braided portion 10a, a connecting portion 10c, a second braided portion 10b, a transition portion Z, a third braided portion 10d, a connecting portion 10f, a fourth braided portion 10e, and a second end D2.

[0075] In some examples, the braid 10 may be non-degradable. In this case, the non-degradable braid 10 can provide long-term mechanical strength support, thereby providing long-term mechanical support for the artificial ligament 1, so that the artificial ligament 1 can be used for a long time.

[0076] In some examples, the braid 10 can be semi-degradable. Specifically, the braid 10 can be formed by degradable polymer fibers 11 and non-degradable polymer fibers 11, so that the braid 10 can be partially degradable and partially non-degradable. In this case, the artificial ligament 1 can provide better mechanical properties and promote the growth and attachment of ligament tissue. In addition, the degradation rate of the degradable part of the braid 10 can be less than the degradation rate of the artificial bone material 20.

[0077] In some examples, in the woven fabric 10, the warp yarn 11b may be non-degradable, and the weft yarn 11a may be degradable. In addition, in some examples, in the woven fabric 10, the warp yarn 11b may be degradable, and the weft yarn 11a may be non-degradable. In other examples, in the woven fabric 10, both the warp yarn 11b and the weft yarn 11a may contain degradable polymer fibers 11 and non-degradable polymer fibers 11.

[0078] In some examples, the braid 10 may be degradable. In this case, the growth of ligament tissue can be promoted. In addition, the degradation rate of the degradable braid 10 may be lower than the degradation rate of the artificial bone material 20.

[0079] As described above, the braid 10 can be formed of polymer fibers 11. In some examples, the polymer fibers 11 can be made of non-degradable materials. Thus, long-term mechanical strength support can be provided, so that the artificial ligament 1 can be used for a long time. The polymer fibers 11 formed using non-degradable materials can be non-degradable. In other examples, the polymer fibers 11 can be made of at least one selected from polyethylene terephthalate and ultra-high molecular weight polyethylene. Thus, long-term mechanical strength support and good biocompatibility can be provided.

[0080] In some examples, the polymer fiber 11 may be made of a degradable material. Thus, it is possible to facilitate the growth and attachment of ligament tissue. The polymer fiber 11 may be formed using a degradable material. In addition, in some examples, the polymer fiber 11 may be made of at least one selected from collagen, silk, starch, polyglycolic acid, polylactic acid, and polyvinyl pyrrolidone.

[0081] In some examples, polymer fibers 11 may be cylindrical, tubular, flat, etc. Additionally, the shapes of polymer fibers 11 used to form braid 10 may be the same or different.

[0082] In some examples, braid 10 may employ commercially available artificial ligaments.

[0083] As mentioned above, Figure 2 As shown, the artificial ligament 1 may include an artificial bone material 20. In some examples, the artificial bone material 20 may be distributed at least in the woven tissue. In other examples, the artificial bone material 20 may be distributed in the gaps of the woven tissue. In addition, the artificial bone material 20 may fill the gaps of the woven tissue. In some examples, the artificial bone material 20 may also be attached to the polymer fibers 11 of the woven tissue (e.g., the warp 11b and the weft 11a woven in the braid 10).

[0084] In some examples, the artificial bone material 20 may be distributed at least on the surface of the woven tissue. For example, the artificial bone material 20 may be distributed at least on the upper surface and / or the lower surface of the woven tissue.

[0085] In some examples, such as Figure 2 As shown, the artificial bone material 20 can be distributed in the braid 10. In addition, in some examples, the artificial bone material 20 can be distributed at least on the surface of the braid 10. For example, the artificial bone material 20 can be distributed at least on the first surface A and / or the second surface B of the braid 10.

[0086] In some examples, the artificial bone material 20 may be distributed in the gaps of the braided fabric 10. In addition, the artificial bone material 20 may fill the gaps of the braided fabric 10. In other examples, the artificial bone material 20 may be distributed in the braided portion of the braided fabric 10.

[0087] In some examples, the artificial bone material 20 may be distributed at least in the mesh structure of the woven portion. In addition, in some examples, the artificial bone material 20 may be distributed at least in the mesh structure of the first woven portion 10a and the mesh structure of the second woven portion 10b of the woven fabric 10 (see Figure 2 In some other examples, the artificial bone material 20 may be distributed at least in the mesh structure of the third braided portion 10d and the mesh structure of the fourth braided portion 10e of the braided fabric 10.

[0088] In some examples, the artificial bone material 20 can fill the mesh structure of the braided part. Thus, the tendon-bone healing ability of the artificial ligament 1 can be improved. For example, the artificial bone material 20 can fill the mesh structure of the first braided part 10a, the artificial bone material 20 can fill the mesh structure of the second braided part 10b, the artificial bone material 20 can fill the mesh structure of the third braided part 10d, and the artificial bone material 20 can fill the mesh structure of the fourth braided part 10e.

[0089] As mentioned above, Figure 3As shown, the braided fabric 10 may include a first braided portion 10a and a second braided portion 10b. In this case, the mesh structure of the first braided portion 10a and the mesh structure of the second braided portion 10b may be filled with an artificial bone material 20 (see Figure 2 ). Thus, the promoting effect of the artificial ligament 1 on tendon-bone healing can be improved. In addition, in some examples, the artificial bone material 20 can fill the mesh structure of the first braided portion 10a and the mesh structure of the second braided portion 10b of the braided fabric 10.

[0090] As mentioned above, Figure 4 As shown, the braided fabric 10 may further include a third braided portion 10d and a fourth braided portion 10e, in which case the mesh structure of the third braided portion 10d and the mesh structure of the fourth braided portion 10e may be filled with the artificial bone material 20. Thus, the tendon-bone healing ability of the artificial ligament 1 can be improved. In other examples, the artificial bone material 20 may fill the mesh structure of the third braided portion 10d and the mesh structure of the fourth braided portion 10e of the braided fabric 10.

[0091] In some examples, after the artificial ligament 1 is implanted, bone tissue can grow into the braided tissue along the artificial bone material 20. Thus, the artificial ligament 1 can be fixed. In other examples, after the artificial ligament 1 is implanted, bone tissue can grow into the braided fabric 10 along the artificial bone material 20. In addition, after the artificial ligament 1 is implanted, bone tissue can grow into the braided part along the artificial bone material 20. Further, after the artificial ligament 1 is implanted, bone tissue can grow into the mesh structure of the braided part along the artificial bone material 20.

[0092] For example, an artificial ligament 1 formed by a woven fabric 10 having a first woven portion 10a and a second woven portion 10b and an artificial bone material 20 is explained in detail. As described above, the first woven portion 10a can be implanted into the first bone tunnel, and the second woven portion 10b can be implanted into the second bone tunnel. After the artificial ligament 1 is implanted into the first bone tunnel and the second bone tunnel, bone tissue can grow into the mesh structure (the mesh structure of the first woven portion 10a and the second woven portion 10b) along the artificial bone material 20 to fix the first woven portion 10a and the second woven portion 10b, thereby fixing the artificial ligament 1.

[0093] In some examples, the artificial bone material 20 can be combined with the braided structure (or braided fabric 10) by coating or infiltration. Specifically, the braided structure (or braided fabric 10) can be coated or infiltrated with a solution containing the artificial bone material 20 to combine the artificial bone material 20 with the braided structure (or braided fabric 10). In addition, the artificial bone material 20 can also be combined with the braided structure (or braided fabric 10) by hot pressing.

[0094] In some examples, the solution containing the artificial bone material 20 can be obtained by dissolving the artificial bone material 20 in an organic solvent. The organic solvent can be dichloromethane, chloroform or tetrahydrofuran. In addition, the solution containing the artificial bone material 20 can be viscous. Thus, the firmness of the combination of the artificial bone material 20 and the braided fabric 10 can be improved.

[0095] In some examples, the artificial bone material 20 may have plasticity. Specifically, the artificial bone material 20 may have plasticity within a predetermined temperature range. In some examples, within a predetermined temperature range, the artificial bone material 20 may be in the shape of a plasticine. In other words, within the range of a predetermined temperature, the artificial bone material 20 may be freely shaped. In addition, in some examples, the range of the predetermined temperature may be 25°C to 40°C. In this case, it is possible to facilitate the application of the artificial bone material 20 in an actual clinical environment. For example, the predetermined temperature may be 25°C, 26°C, 27°C, 28°C, 29°C, 30°C, 31°C, 32°C, 33°C, 34°C, 35°C, 36°C, 37°C, 38°C, 39°C or 40°C. In addition, the artificial bone material 20 may have fluidity and viscosity after heating.

[0096] In some examples, the artificial bone material 20 is absorbable. In this case, the artificial bone material 20 can promote the generation of bone cells, thereby helping to improve the tendon-bone healing ability of the artificial ligament 1 and make the tendon-bone interface heal firmly.

[0097] In some examples, the artificial bone material 20 may include inorganic particles and polymer materials. In addition, the inorganic particles may be distributed in the polymer material. In addition, in some examples, in the artificial bone material 20, the inorganic particles may be uniformly distributed in the polymer material. In other examples, the inorganic particles may also be randomly distributed in the polymer material. In addition, in some examples, the inorganic particles may be distributed in the polymer material in a stepped arrangement density or a pattern of dense in the middle and sparse on both sides.

[0098] In some examples, the inorganic particles may be composed of calcium-phosphorus compounds. In some examples, the inorganic particles may include at least one selected from hydroxyapatite, calcium polyphosphate, and tricalcium phosphate. In this case, since the composition of the inorganic particles is similar to that of human bone tissue, the bioactivity and biocompatibility of the artificial bone material 20 can be improved, and bone tissue growth can be promoted.

[0099] In addition, in this embodiment, the inorganic particles are not limited to the above-mentioned hydroxyapatite, calcium polyphosphate, tricalcium phosphate, etc. In this embodiment, the inorganic particles may also include other substances similar to the composition of human bone tissue, thereby also being able to improve the repair effect of the artificial bone material 20 on human bone tissue.

[0100] In some examples, the mass fraction of the inorganic particles in the artificial bone material 20 may be 10% to 60%. Thus, the repair effect of the artificial bone material 20 on bones can be improved while taking into account the plasticity of the artificial bone material 20. For example, the mass fraction of the inorganic particles may be 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55% or 60%.

[0101] In addition, in some examples, preferably, the inorganic particles may be rigid particles. In some examples, the inorganic particles may have a Young's modulus greater than 2×10 11 In this case, the mechanical strength of the artificial bone material 20 can be improved.

[0102] In addition, in this embodiment, the shape of the inorganic particles is not particularly limited. For example, in some examples, the inorganic particles may be spherical. However, this embodiment is not limited thereto, and in other examples, the inorganic particles may be ellipsoidal, irregular solid, etc.

[0103] In addition, in the present embodiment, the average particle size of the inorganic particles is not particularly limited. In some examples, the average particle size of the inorganic particles can be 5nm to 200nm, for example, the average particle size of the inorganic particles can be 5nm, 10nm, 30nm, 50nm, 100nm, 200nm, 500nm, 100nm, 200nm, 500nm, 100nm, 200nm, 300nm, 500nm, 800nm, 100nm, 130nm, 150nm, 180nm or 200nm. The average particle size of the above-mentioned inorganic particles can be selected according to different usage scenarios.

[0104] In some examples, the surface of the inorganic particles can be physically or chemically modified. For example, an adhesive layer (such as polyethyleneimine) that is easy to combine with the polymer material is covered on the surface of the inorganic particles; the surface of the inorganic particles is modified with active groups to facilitate the combination with the polymer material. In this case, the binding force between the inorganic particles and the polymer material can be increased, so that the inorganic particles can be better bonded together.

[0105] In some examples, the polymer material may be fluid and viscous at a temperature of 20° C. to 60° C. Additionally, in some examples, the polymer material may be degradable.

[0106] In some examples, the average molecular weight of the polymer material can be 1000Da to 20000Da. For example, the average molecular weight of the polymer material can be 1000Da, 2000Da, 3000Da, 4000Da, 6000Da, 8000Da, 9000Da, 10000Da, 12000Da, 15000Da, 18000Da or 20000Da.

[0107] In the present embodiment, the average molecular weight of the polymer material may refer to the number average molecular weight of the polymer material. In other words, the number average molecular weight of the polymer material may be 1000Da to 20000Da. In addition, in some examples, the average molecular weight of the polymer material may be measured by a time-of-flight mass spectrometer, a nuclear magnetic resonance spectroscopy, or a gel permeation chromatography. In addition, in some examples, the number average molecular weight of the polymer material may be measured by a time-of-flight mass spectrometer, a nuclear magnetic resonance spectroscopy, or a gel permeation chromatography.

[0108] In some examples, in gel permeation chromatography, for example, tetrahydrofuran (THF) can be used as a solvent to dissolve a polymer material to form a sample solution to be tested, and tetrahydrofuran is used as a mobile phase, and polystyrene is used as a reference standard for molecular weight. The sample solution to be tested is subjected to gel permeation chromatography measurement, thereby obtaining the average molecular weight (number average molecular weight) of the polymer material.

[0109] In some examples, the polymer material may be a copolymer formed by caprolactone or p-dioxanone and lactide or glycolide. In this case, a degradable polymer material can be formed, which is beneficial to the application of the artificial bone material 20 in the field of orthopedics, especially in the field of absorbable orthopedic materials. For example, the polymer material may be a copolymer of caprolactone and lactide, a copolymer of caprolactone and glycolide, a copolymer of p-dioxanone and lactide, or a copolymer of p-dioxanone and glycolide.

[0110] In some examples, the polymer material may be a copolymer of caprolactone and lactide, and in the polymer material, the molar ratio of caprolactone to lactide is 1:1 to 2.5:1. Thus, a degradable polymer material with suitable viscosity and fluidity can be formed. For example, in the polymer material, the molar ratio of caprolactone to lactide may be 1:1, 1.2:1, 1.5:1, 1.8:1, 2:1, 2.3:1 or 2.5:1.

[0111] In some examples, the mass fraction of the polymer material in the artificial bone material 20 may be 40% to 90%. In this case, it is possible to improve the plasticity of the artificial bone material 20. For example, the mass fraction of the polymer material may be 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85% or 90%.

[0112] In some examples, the artificial bone material 20 may include a growth factor. In this case, the artificial bone material 20 can better promote bone tissue regeneration, thereby further improving the tendon-bone healing ability of the artificial ligament 1. In some examples, the growth factor may be at least one selected from collagen, bone morphogenetic protein-2, fibroblast growth factor-2, transforming growth factor-β, insulin-like growth factor-1, and platelet-derived growth factor.

[0113] In some examples, the artificial bone material 20 may be composed of a polymer material and inorganic particles. Specifically, the artificial bone material 20 may be a composition formed by mixing a degradable polymer material and inorganic particles distributed in the polymer material.

[0114] In some examples, the artificial bone material 20 can be degraded in a gradient manner in the human body. In addition, in some examples, the polymer material can be preferentially degraded quickly to provide sufficient space for bone growth, while the inorganic particles degrade more slowly, and can continue to promote bone cell growth and induce bone tissue to grow into the artificial ligament 1 (e.g., the mesh structure of the braid 10).

[0115] In some examples, the artificial ligament 1 may include an antibacterial substance. Thus, the occurrence of infection can be reduced. In addition, in some examples, the antibacterial substance may be mixed in the artificial bone material 20. In other words, the artificial bone material 20 may include an antibacterial substance.

[0116] In some examples, the antibacterial substance may be added to the polymer fibers 11 (eg, the warp yarns 11 b and the weft yarns 11 a of the woven fabric 10 ). In addition, the antibacterial substance may be distributed on the polymer fibers 11 .

[0117] In some examples, the antibacterial substance can be antibacterial ions, sulfonamides, quinolones, nitroimidazoles, and the like.

[0118] In some examples, the antibacterial ion can be at least one of silver ions, gallium ions, copper ions and zinc ions. In addition, the sulfonamide can be one or more of trimethoprim, sulfadiazine, sulfamethoxazole, cotrimoxazole, and sulfamethoxazole. In addition, in some examples, the quinolone can be one or more of norfloxacin, ofloxacin, ciprofloxacin, and fleroxacin. In addition, the nitromidine can be one or more of metronidazole, dimetridazole, isopronidazole, seconidazole, ornidazole, tinidazole, and ronidazole.

[0119] In some examples, such as Figure 2As shown, the artificial ligament 1 can be formed by combining the artificial bone material 20 and the braid 10. In other words, the artificial ligament 1 can be a composite of the artificial bone material 20 and the braid 10. Specifically, the artificial ligament 1 can be formed by coating or impregnating the biocompatible braid 10 with a solution containing the absorbable artificial bone material 20 and drying it.

[0120] Figure 6 is a schematic diagram showing the winding of an artificial ligament 1 according to an example of the present disclosure.

[0121] In some examples, such as Figure 6 As shown, the artificial ligament 1 can be formed into a long strip by winding. In other examples, the artificial ligament 1 can be formed by winding along the latitude 11a and suturing. In addition, after winding, the artificial bone material 20 in the artificial ligament 1 can be exposed to the outside world so that the artificial bone material 20 can contact the bone tunnel. Thereby, it can be helpful to improve the tendon-bone healing ability of the artificial ligament 1. In other words, the artificial ligament 1 can be wound so that the artificial bone material 20 can contact the bone tunnel.

[0122] For example, an artificial ligament 1 formed by a braid 10 and an artificial bone material 20 is used as an example to explain winding. The braid 10 has a first surface A and a second surface B. The artificial bone material 20 is distributed on the first surface A. The artificial ligament 1 can be formed by winding the braid 10 along the second surface B and the weft 11a and suturing them (see Figure 6 In this case, the artificial bone material 20 in the artificial ligament 1 faces the outside, so that the artificial bone material 20 can contact the bone tunnel, which can help improve the tendon-bone healing ability of the artificial ligament 1.

[0123] In some examples, the artificial ligament 1 can be bent to form a double bundle structure after being wound. In addition, in some examples, the artificial ligament 1 can be bent at the turning portion Z to form a double bundle structure after being wound.

[0124] For example, an artificial ligament 1 formed by a woven fabric 10 having a first woven portion 10a, a second woven portion 10b, a third woven portion 10d and a fourth woven portion 10e and an artificial bone material 20 is explained in detail. After winding, the artificial ligament 1 can be bent at a turning portion Z so that the first woven portion 10a and the fourth woven portion 10e are relatively parallel, and the second woven portion 10b and the third woven portion 10d are relatively parallel, thereby forming a double-bundle structure.

[0125] In some examples, the artificial ligament 1 may have an implantation segment and a free segment. In addition, the implantation segment may be used for implantation in a bone tunnel, and the free segment may be arranged in a joint cavity. In addition, the artificial ligament 1 may have a plurality of implantation segments. In other examples, the artificial ligament 1 may have a plurality of free segments.

[0126] In some examples, the implant segment may include a braided portion. That is, the implant segment may be formed by a portion including a braided portion. In other examples, the free segment may include a non-braided portion. That is, the free segment may be formed by a portion including a non-braided portion. For example, the free segment may include a connecting segment 1c. In addition, the connecting segment 1c may include a connecting portion 10c.

[0127] For example, an artificial ligament 1 formed by a braided fabric 10 having a first braided portion 10a and a second braided portion 10b and an artificial bone material 20 is described in detail. Figure 6 As shown, the artificial ligament 1 can have a first implant segment 1a including a first braided portion 10a, a connecting segment 1c including a connecting portion 10c, and a second implant segment 1b including a second braided portion 10b. Thus, it is convenient to apply to the reconstruction of ligaments (such as the cruciate ligament of the knee joint) in the joint cavity. For example, the first implant segment 1a can be implanted in the tibial tunnel, the second implant segment 1b can be implanted in the femoral tunnel, and the connecting segment 1c can be arranged in the knee joint cavity.

[0128] Figure 7 is a schematic structural diagram showing an artificial ligament 1 involved in another example of the present disclosure.

[0129] In some examples, traction wires may be provided at both ends of the artificial ligament 1 (see Figure 7 ). Thus, it can help implantation and fixation of the artificial ligament 1. In other examples, the traction line can be set after the artificial ligament 1 is wound. In addition, the traction line can be absorbable or non-absorbable.

[0130] In some examples, the traction line can be connected to the implantation segment of the artificial ligament 1. In addition, the traction line can be used for implantation of the implantation segment. That is, the implantation segment can be implanted into the bone tunnel through the traction line. Specifically, the implantation segment of the artificial ligament 1 can be guided through the bone tunnel through the traction line.

[0131] In some examples, the traction wire can be used to fix the implant segment. That is, the implant segment can be fixed to the bone tunnel by the traction wire. Specifically, the implant segment can be fixed to the bone tunnel by the traction wire in combination with a fixing member (such as a button plate, a suspension plate), thereby fixing the artificial ligament 1 in the body. For example, the traction wire can be tied to the suspension plate to fix the artificial ligament 1.

[0132] For example, an artificial ligament 1 formed by a braided fabric 10 having a first braided portion 10a and a second braided portion 10b and an artificial bone material 20 is described in detail. Figure 7As shown, the first implant segment 1a can be connected to a first traction line Q1, through which the first implant segment 1a can be implanted and fixed in the first bone tunnel, and the second implant segment 1b can be connected to a second traction line Q2, through which the second implant segment 1b can be implanted and fixed in the second bone tunnel. This can help the implantation and fixation of the artificial ligament 1.

[0133] In this embodiment, the artificial ligament 1 is composed of a composite of a biocompatible woven fabric 10 and an absorbable artificial bone material 20. The artificial bone material 20 is distributed in the mesh structure of the woven fabric 10. In this case, the artificial bone material 20 can promote the generation of bone cells and induce bone tissue to grow into the woven fabric 10. Therefore, the artificial ligament 1 can improve the tendon-bone healing ability, thereby enabling the tendon-bone interface to heal firmly (that is, the artificial ligament 1 is firmly bonded to the bone interface), thereby enabling the artificial ligament 1 to provide effective mechanical strength.

[0134] As described above, the artificial ligament 1 can be obtained by a coating method or a soaking method. In some examples, the preparation method of the artificial ligament 1 may include preparing a braided tissue and an artificial bone material 20, and compounding them by a coating method or a soaking method.

[0135] As described above, the method for preparing the artificial ligament 1 may include preparing a braided tissue and an artificial bone material 20. The braided tissue and the artificial bone material 20 may refer to the above description.

[0136] Figure 8 is a flow chart showing a method for preparing an artificial ligament 1 according to an example of the present disclosure. Fig. 9 is a flow chart showing a method for preparing an artificial ligament 1 according to another example of the present disclosure.

[0137] In the following, the artificial ligament 1 is obtained by combining a braided fabric 10 (i.e., the braided tissue is composed of a braided fabric 10) and an artificial bone material 20 as an example. Figure 8 and Fig. 9 , the preparation method of the artificial ligament 1 is described in detail. Figure 8 The flow chart of the preparation using the coating method is as follows: Fig. 9 Flow chart of the preparation using the infiltration method.

[0138] In some examples, such as Figure 8 and Fig. 9 The method for preparing the artificial ligament 1 may include preparing a braided fabric 10 having a braided portion and an absorbable artificial bone material 20 (step S10). In step S10, the braided fabric 10 and the artificial bone material 20 may refer to the above description.

[0139] In some examples, such as Figure 8 and Fig. 9 The preparation method of the artificial ligament 1 may include dissolving the artificial bone material 20 in an organic solvent to obtain a paste (step S20). In addition, the paste may be viscous. Thus, it is beneficial to combine the artificial bone material 20 with the braid 10, improve the firmness of the combination of the artificial bone material 20 and the braid 10, and further help improve the tendon-bone healing ability of the artificial ligament 1.

[0140] In some examples, in step S20, the organic solvent may be dichloromethane, chloroform or tetrahydrofuran. In addition, in step S20, the mass volume ratio (g: ml) of the artificial bone material 20 to the organic solvent may be 1:30 to 1:1. For example, the mass volume ratio (g: ml) of the artificial bone material 20 to the organic solvent may be 1:30, 1:25, 1:20, 1:18, 1:15, 1:12, 1:10, 1:8, 1:5, 1:4, 1:3, 1:2 or 1:1.

[0141] In some examples, the method for preparing the artificial ligament 1 may include contacting the braid 10 with the paste (step S30). Thus, the artificial bone material 20 and the braid 10 can be combined to obtain the artificial ligament 1. In some examples, in step S30, it can be performed by coating or infiltration. In other words, step S30 can be performed by step S30A or step S30B.

[0142] In some examples, such as Figure 8 As shown, the method for preparing the artificial ligament 1 may include applying a paste to the braid 10 (step S30A). That is, the artificial bone material 20 and the braid 10 are composited by a coating method. In addition, before step S30A, the braid 10 may be laid or hung. Thus, coating can be facilitated.

[0143] In some examples, in step S30A, the paste may be evenly applied to the braided fabric 10. In other examples, in step S30A, the paste may be applied to at least the braided portion (net structure) of the braided fabric 10. In addition, in step S30A, the paste may completely cover the braided portion (net structure) of the braided fabric 10.

[0144] In some examples, in step S30A, the paste may also be applied to the non-woven portion (eg, the connecting portion 10c) of the woven fabric 10. In addition, in some examples, in step S30A, the paste may be applied to the entire woven fabric 10.

[0145] In some examples, in step S30A, the paste may be applied to one side of the braid 10. For example, the paste may be applied to the first surface A or the second surface B of the braid 10. In other examples, in step S30A, the paste may be applied to both sides of the braid 10. For example, the paste may be applied to the first surface A and the second surface B of the braid 10.

[0146] In some examples, such as Fig. 9 As shown, the method for preparing the artificial ligament 1 may include infiltrating the braided fabric 10 into a paste (step S30B). That is, the artificial bone material 20 and the braided fabric 10 are compounded by an infiltration method.

[0147] In some examples, in step S30B, at least the woven portion (net structure) of the woven fabric 10 may be soaked in the paste. In addition, in step S30B, the entire woven fabric 10 may be soaked in the paste.

[0148] In some examples, in step S30B, the soaking time may be 0.5 s to 10 s. For example, the soaking time may be 0.5 s, 1 s, 1.5 s, 2 s, 3 s, 4 s, 5 s, 6 s, 7 s, 8 s, 9 s, or 10 s.

[0149] In some examples, the method for preparing the artificial ligament 1 may include drying to obtain the artificial ligament 1 (step S40). In step S40, the drying may be performed by at least one of air drying, oven drying, and vacuum drying.

[0150] In some examples, in step S40 , after drying, if the braided fabric 10 (the mesh structure or the gaps) is not fully filled with the artificial bone material 20 , steps S30 and S40 may be repeated until the braided fabric 10 (the mesh structure or the gaps) is fully filled with the artificial bone material 20 .

[0151] In some examples, after step S40, the artificial ligament 1 may be wound and sutured to form a long strip. In other examples, a traction line may be set on the artificial ligament 1 after winding.

[0152] In this embodiment, the artificial bone material 20 and the woven fabric 10 having a mesh structure are compounded by a coating method or an infiltration method to form an artificial ligament 1 having the artificial bone material 20 distributed in the mesh structure. Moreover, since the artificial bone material 20 can promote the generation of bone cells and induce bone tissue to grow into the woven fabric 10, an artificial ligament 1 with improved tendon-bone healing ability can be obtained.

[0153] According to the present disclosure, an artificial ligament 1 with a healing function and a preparation method thereof that improves the tendon-bone healing ability can be provided.

[0154] In order to further illustrate the present disclosure, the artificial ligament 1 with healing function and the preparation method thereof provided by the present disclosure are described in detail below in combination with the embodiments, and the beneficial effects achieved by the present disclosure are fully illustrated in combination with the comparative examples.

[0155] Fig.10 This is a diagram showing the results of methylene blue-basic fuchsin staining according to Example 1 of the present disclosure. Fig.11 2 is a diagram showing the MicroCT result according to Example 2 of the present disclosure. Fig.12 2 is a diagram showing the MicroCT results of the comparative example of the present disclosure.

[0156] In this embodiment, French LARS artificial ligament braid is used as the braid, and a mixture of 50 wt % hydroxyapatite and 50 wt % lactide-caprolactone copolymer is used as the artificial bone material 20 .

[0157] [Example 1]

[0158] 5g of artificial bone material was dissolved in 10ml of dichloromethane to obtain a viscous paste, the braid was spread flat, the paste was evenly applied to both sides of the braid, and the artificial ligament was obtained after air drying and vacuum drying. Then the artificial ligament was wound and sutured to form a cylinder, and the diameter of the cylindrical artificial ligament was 2.0mm. Then the cylindrical artificial ligament was implanted into the femoral condyle of New Zealand white rabbits, the femoral condyle pre-drilled bone tunnel had a diameter of 1.8mm, and the artificial ligament was inserted into the bone tunnel. No artificial bone was scraped off by the bone tunnel, which proved that the artificial bone and the braid were firmly combined.

[0159] 8 months after surgery, tissue samples were obtained and stained with methylene blue-basic fuchsin. Fig.10 Among them, the white dots are the cross-section of the ligament fabric. It can be seen that a large amount of bone tissue (red tissue) has been formed in the fabric, that is, the tendon-bone healing effect is obvious.

[0160] [Example 2]

[0161] The braid is soaked in the paste in Example 1, air-dried and vacuum-dried to obtain an artificial ligament, which is then wound and sutured to form a cylindrical shape. The diameter of the cylindrical artificial ligament is 2.5 mm. The cylindrical artificial ligament is then implanted into the femoral condyle of New Zealand white rabbits. The diameter of the pre-drilled bone tunnel of the femoral condyle is 2.2 mm. The artificial ligament is inserted into the bone tunnel, and no artificial bone is scraped off by the bone tunnel, proving that the artificial bone is firmly combined with the braid.

[0162] 8 months after surgery, the specimens were taken and scanned with MicroCT. Fig.11 , in which the braided material has been removed, and there is obvious new bone growth in the bone tunnel, that is, the tendon-bone healing effect is obvious.

[0163] [Comparative Example]

[0164] French LARS artificial ligament was implanted into the femoral condyle of New Zealand white rabbits. 8 months after surgery, the specimens were obtained and scanned by MicroCT. Fig.12 , among which, there was no obvious bone ingrowth in the bone tunnel, and the tendon-bone healing effect was not ideal.

[0165] Although the present disclosure is specifically described above in conjunction with the accompanying drawings and embodiments, it is to be understood that the above description does not limit the present disclosure in any form. Those skilled in the art may modify and change the present disclosure as needed without departing from the essential spirit and scope of the present disclosure, and these modifications and changes all fall within the scope of the present disclosure.

Claims

1. An artificial ligament, characterized in that: The invention comprises a woven tissue and an artificial bone material, which is formed by coating or infiltrating the woven tissue with a solution containing the artificial bone material and drying the woven tissue. The artificial bone material is formed by mixing inorganic particles and polymer materials. The inorganic particles are composed of calcium-phosphorus compounds, and the mass fraction of the inorganic particles is 10% to 60%. The polymer material is a copolymer formed by caprolactone or p-dioxanone and lactide or glycolide. The artificial bone material degrades in a gradient manner, and the gradient degradation includes that the polymer material degrades rapidly before the inorganic particles. After the artificial ligament is implanted, bone tissue grows into the woven tissue along the artificial bone material.

2. The artificial ligament according to claim 1, characterized in that The average molecular weight of the polymer material is 1000Da to 20000Da.

3. The artificial ligament according to claim 1, characterized in that: The mass fraction of the polymer material is 40% to 90%.

4. The artificial ligament according to claim 1, characterized in that: The artificial bone material comprises growth factors and antibacterial substances.

5. The artificial ligament according to claim 1, characterized in that: The surfaces of the inorganic particles are physically or chemically modified to increase the binding force between the inorganic particles and the polymer material.

6. The artificial ligament according to claim 1, characterized in that: The inorganic particles are uniformly distributed in the polymer material; The inorganic particles are randomly distributed in the polymer material; or The inorganic particles are distributed in the polymer material in a stepped arrangement density or in a pattern of dense in the middle and sparse on both sides.

7. The artificial ligament according to claim 1, characterized in that: The braided structure is composed of one or more braids, and the braids are formed of polymer fibers, and the polymer fibers are made of at least one selected from polyethylene terephthalate and ultra-high molecular weight polyethylene.

8. The artificial ligament according to claim 7, characterized in that: The braid is non-degradable; The woven fabric is semi-degradable, the woven fabric being formed of degradable polymer fibers and non-degradable polymer fibers; or The braided fabric is degradable, and the degradation rate of the degradable braided fabric is lower than the degradation rate of the artificial bone material.

9. The artificial ligament according to claim 1, characterized in that: The woven tissue is composed of one or more woven fabrics, which have a first woven portion for implanting into a first bone tunnel, a second woven portion for implanting into a second bone tunnel, and a connecting portion connecting the first woven portion and the second woven portion, the first woven portion and the second woven portion have a mesh structure woven from polymer fibers, the artificial bone material is distributed at least in the mesh structure of the first woven portion and the mesh structure of the second woven portion, and after the artificial ligament is implanted into the first bone tunnel and the second bone tunnel, bone tissue grows into the mesh structure along the artificial bone material to fix the first woven portion and the second woven portion.

10. A method for preparing an artificial ligament, characterized in that: include: A woven fabric with a woven portion and an absorbable artificial bone material are prepared, the artificial bone material is dissolved in an organic solvent to obtain a paste, the paste is applied to the woven fabric or the woven fabric is immersed in the paste, and then dried to obtain the artificial ligament, wherein the artificial bone material is a mixture of inorganic particles and polymer materials, the inorganic particles are composed of calcium-phosphorus compounds, the mass fraction of the inorganic particles is 10% to 60%, the polymer material is a copolymer formed by caprolactone or p-dioxanone and lactide or glycolide, the artificial bone material is gradiently degraded, and the gradient degradation includes that the polymer material is rapidly degraded before the inorganic particles, the woven portion has a mesh structure, and in the artificial ligament, the artificial bone material is at least distributed in the mesh structure of the woven portion.

Images