Artificial ligament and method for its production

Abstract

The present disclosure describes an artificial ligament including a braided tissue and an artificial bone material, which is formed by coating or infiltrating a solution containing the artificial bone material to the braided tissue and drying, the artificial bone material being mixed of inorganic particles and a polymer material, the inorganic particles being composed of a calcium-phosphorous compound, the mass fraction of the inorganic particles being 10% to 60%, the polymer material being caprolactone or a copolymer of p-dioxanone and lactide or glycolide, the artificial bone material being gradually degraded, the gradual degradation including that the polymer material is rapidly degraded in preference to the inorganic particles, and after the artificial ligament is implanted, bone tissue grows into the braided tissue along the artificial bone material. According to the present disclosure, an artificial ligament improving the tendon-bone healing ability and a method of manufacturing the same can be provided.

Description

[0001] This application is a divisional application of the patent application filed on December 21, 2020, with application number 2020115219407, entitled "Artificial Ligament with Healing Function and Method for Preparing the Same". Technical Field

[0002] This disclosure generally relates to an artificial ligament and a method for its preparation. Background Technology

[0003] Ligament injuries are a common sports injury with a high incidence rate, especially among young people, and this trend is increasing year by year as people's awareness of sports improves. Currently, the main clinical treatment for ligament injuries is ligament reconstruction using grafts. Clinically, there are three main types of grafts: autologous, allogeneic, and artificial. Autologous grafts have drawbacks such as significant surgical trauma, impaired donor site function, numerous complications, slow recovery, and the risk of multiple knee injuries. Allogeneic grafts present challenges such as donor scarcity, infection risk, disease transmission, and immune rejection. Therefore, given the aforementioned problems with autologous and allogeneic grafts, most surgeries opt for artificial grafts, such as artificial ligaments.

[0004] However, artificial grafts often fail to achieve tendon-bone healing in clinical practice. Typically, after a certain period of time in the body, problems such as ligament and joint bone tunnel loosening, decreased joint stability, and repair failure occur. Therefore, research and development to address the insufficient tendon-bone healing capacity of artificial grafts in vivo is imperative. Summary of the Invention

[0005] This disclosure was made in view of the above-mentioned state of the prior art, and its purpose is to provide an artificial ligament with healing function that improves tendon-bone healing ability and a method for preparing the same.

[0006] Therefore, the first aspect of this disclosure provides an artificial ligament with healing function, which is formed by coating or impregnating a biocompatible woven fabric with a solution containing absorbable artificial bone material and then drying it. The woven fabric is formed of polymer fibers and has a first woven portion for implantation into a first bone tunnel, a second woven portion for implantation 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 the polymer fibers, and the artificial bone material is at least distributed in the mesh structure of the first woven portion and the connecting portion. In the mesh structure of the second braided portion, the artificial bone material is composed of inorganic particles and polymer materials. The inorganic particles are composed of calcium phosphate compounds, with a mass fraction of 10% to 60%. The polymer material is a copolymer of caprolactone or p-dioxanone with lactide or glycolide, with an average molecular weight of 1000 Da to 20000 Da. The artificial bone material is malleable. After the artificial ligament is implanted into the first and second bone tunnels, bone tissue grows along the artificial bone material into the mesh structure to fix the first and second braided portions. In this disclosure, the artificial ligament is composed of a biocompatible braid and absorbable artificial bone material, with the artificial bone material distributed in the mesh structure of the braid. In this case, the artificial bone material can promote osteoblast formation and induce bone tissue ingrowth into the braid, thus improving the tendon-bone healing ability of the artificial ligament.

[0007] Additionally, in the artificial ligament disclosed herein, optionally, the first and second braided portions are woven from warp and weft threads, and the connecting portion is composed of the warp threads, which are polymer fibers extending along the length direction of the artificial ligament, and the weft threads are polymer fibers extending along the width direction of the artificial ligament. This facilitates the formation of a mesh structure.

[0008] Additionally, in the artificial ligaments disclosed herein, optionally, the woven fabric has a first surface and a second surface opposite to the first surface, with the artificial bone material distributed on the first surface. The artificial ligament is formed by wrapping and suturing the woven fabric along the second surface and the weft direction. This can improve the tendon-bone healing ability of the artificial ligament.

[0009] Furthermore, in the artificial ligaments disclosed herein, optionally, the tensile strength of the connecting portion is not less than 1000N. This enables the artificial ligament to possess good mechanical properties.

[0010] Additionally, in the artificial ligaments disclosed herein, the polymer fibers may optionally be made of a non-degradable material selected from at least one of polyethylene terephthalate and ultra-high molecular weight polyethylene. This provides long-term mechanical strength support.

[0011] Furthermore, in the artificial ligaments disclosed herein, optionally, the mesh structure of the first braided portion and the mesh structure of the second braided portion are filled with the artificial bone material. This enhances the promoting effect of the artificial ligament on tendon-bone healing.

[0012] Additionally, in the artificial ligaments disclosed herein, optionally, the artificial ligament is elongated and has a first implanted segment including the first woven portion, a connecting segment including the connecting portion, and a second implanted segment including the second woven portion. This facilitates its application in ligament reconstruction within the joint cavity.

[0013] Additionally, in the artificial ligaments disclosed herein, optionally, the first implanted segment is connected to a first traction wire, through which the first implanted segment is implanted and fixed to the first bone tunnel; the second implanted segment is connected to a second traction wire, through which the second implanted segment is implanted and fixed to the second bone tunnel. This facilitates the implantation and fixation of the artificial ligament.

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

[0015] This disclosure provides a third aspect of a method for preparing an artificial ligament with healing function, comprising: preparing a woven fabric having a braided portion and an absorbable artificial bone material; dissolving the artificial bone material in an organic solvent to obtain a paste; immersing the woven fabric in the paste; and then drying to obtain the artificial ligament. The artificial bone material is composed of inorganic particles and a polymer material. The inorganic particles are composed of calcium phosphate compounds and have a mass fraction of 10% to 60%. The polymer material is a copolymer of caprolactone or p-dioxanone with lactide or glycolide, and has an average molecular weight of 1000 Da to 20000 Da. The artificial bone material is malleable. The woven fabric is formed of polymer fibers. The braided portion is for implantation into a bone tunnel and has a mesh structure. In the artificial ligament, the artificial bone material is at least distributed in the mesh structure of the braided portion. In this disclosure, an artificial ligament with artificial bone material distributed in the mesh structure is formed by infiltration method to combine artificial bone material with a woven fabric having a mesh structure. Since the artificial bone material can promote the generation of osteocytes 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 this disclosure, an artificial ligament with healing function that improves tendon-bone healing ability and a method for preparing the same can be provided. Attached Figure Description

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

[0018] Figure 1 This is a schematic diagram illustrating an example of an application scenario of an artificial ligament involved in this disclosure.

[0019] Figure 2 This is a schematic diagram illustrating the structure of an artificial ligament involved in one example of this disclosure.

[0020] Figure 3 This is a schematic diagram illustrating the structure of a woven fabric involved in one example of this disclosure.

[0021] Figure 4 This is a schematic diagram illustrating the structure of a woven fabric involved in another example of this disclosure.

[0022] Figure 5 This is a schematic diagram illustrating the structure of a woven fabric as described in yet another example of this disclosure.

[0023] Figure 6 This is a schematic diagram illustrating an example of artificial ligament wrapping involved in this disclosure.

[0024] Figure 7This is a schematic diagram illustrating the structure of an artificial ligament involved in another example of this disclosure.

[0025] Figure 8 This is a flowchart illustrating a method for preparing an artificial ligament as described in one example of this disclosure.

[0026] Figure 9 This is a flowchart illustrating another example of a method for preparing an artificial ligament according to this disclosure.

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

[0028] Figure 11 This is a MicroCT result image related to Embodiment 2 of this disclosure.

[0029] Figure 12 This is a diagram of the MicroCT results involved in the comparative example of this disclosure. Detailed Implementation

[0030] The present disclosure will now be described in further detail with reference to the accompanying drawings and specific embodiments. In the drawings, the same components or components having the same function are denoted by the same symbols, and repeated descriptions of them are omitted.

[0031] The artificial ligament 1 with healing function disclosed herein (hereinafter referred to as "artificial ligament 1") can be used for ligament reconstruction. In clinical applications, artificial ligament 1 can be implanted into the body (e.g., into the joint cavity).

[0032] For example, artificial ligaments can be used for shoulder ligament reconstruction (such as coracoclavicular ligament reconstruction), elbow ligament reconstruction (such as medial collateral ligament reconstruction of the elbow), knee ligament reconstruction (such as cruciate ligament reconstruction), etc.

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

[0034] The following description uses the reconstruction of the cruciate ligament of the knee as an example to illustrate the application of artificial ligament 1. In the reconstruction of the cruciate ligament of the knee, such as... Figure 1 As shown, the artificial ligament 1 (single bundle) can be implanted into the knee joint cavity by inserting its two ends into bone tunnels in different bones (i.e., the femur and tibia) and fixing them in place. The middle segment of the artificial ligament 1 can be located within the joint cavity. The bone tunnel can be a channel drilled into the bone. Furthermore, the two ends of the artificial ligament 1 can be fixed using fixation devices such as compression pins, suspension plates, or button plates. These fixation devices can be absorbable or non-absorbable.

[0035] Furthermore, the shape of the artificial ligament 1 disclosed herein is not particularly limited. For example, the artificial ligament 1 can be formed into a strip shape (such as columnar or tubular), a membrane shape, etc. In addition, the artificial ligament 1 can be a single-bundle or 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 This is a schematic diagram illustrating the structure of an artificial ligament 1 as described in one example of this disclosure.

[0037] In some examples, the artificial ligament 1 may include woven tissue (not shown) and artificial bone material 20 (see [reference]). Figure 2 The woven tissue and artificial bone material 20 can be composited by coating, soaking, or hot pressing. For example, a solution containing artificial bone material 20 can be used to coat or impregnate the woven tissue and then dried.

[0038] In some examples, the artificial ligament 1 can use woven tissue as a mechanical support scaffold. In other examples, the woven tissue can be biocompatible. This reduces the occurrence of immune rejection, thereby facilitating cell (tissue) ingrowth into the artificial ligament 1. In other words, the woven tissue can be formed from biocompatible materials.

[0039] In some examples, the woven structure may consist of one or more woven fabrics 10. For example, in Figure 2 In the examples shown, the woven structure may consist of one woven fabric 10. In other examples, the woven structure may consist of 2 to 10 woven fabrics 10. In other examples, the woven structure may also consist of more than 10 woven fabrics 10. Additionally, in some examples, multiple woven fabrics 10 may be identical. In other examples, at least one of the multiple woven fabrics 10 may be different.

[0040] In some examples, the woven structure may consist of multiple layers of woven fabric 10 stacked (layered) and joined together by weaving or sewing. Additionally, the size and structure of the multiple woven fabrics 10 may be matched. For example, the multiple woven fabrics 10 may be identical in size and structure. In other examples, the woven structure may have an upper surface and a lower surface opposite to the upper surface.

[0041] Figure 3 This is a schematic diagram illustrating the structure of the woven fabric 10 involved in one example of this disclosure.

[0042] In some examples, such as Figure 3As shown, the woven fabric 10 can be formed from polymer fibers 11. More specifically, the woven fabric 10 can be formed by weaving polymer fibers 11. In other examples, the woven fabric 10 can be formed from metal wires.

[0043] In some examples, the woven fabric 10 can be formed using weaving techniques such as plain weave, twill weave, and satin weave. That is, the weave structure of the woven fabric 10 can be plain weave, twill weave, satin weave, etc. In other examples, the woven fabric 10 can be in sheet form.

[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. Alternatively, the woven fabric 10 can be woven from multiple warp threads 11b and multiple weft threads 11a. In other examples, such as... Figure 3 As shown, the warp 11b can be a polymer fiber 11 extending along the length of the braid 10 (or artificial ligament 1), and the weft 11a can be a polymer fiber 11 extending along the width of the braid 10 (or artificial ligament 1).

[0045] In some examples, the woven fabric 10 has a first surface A and a second surface B opposite to the first surface A (see [reference]). Figure 6 In other examples, the woven fabric 10 may have a woven section. Additionally, the woven section may have a mesh structure.

[0046] In some examples, the mesh size of the braided portion can be from 0.1 mm to 2 mm. For example, the mesh size of the braided portion can 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 woven portion can be formed by weaving. In other examples, the woven fabric 10 can be composed of the woven portion. In still other examples, the woven portion can be formed by weaving the weft yarn 11a and the warp yarn 11b. This facilitates the formation of a mesh structure.

[0048] In some examples, the woven section can be formed using weaving techniques such as plain weave, twill weave, and satin weave. That is to say, the weave structure of the woven section can be plain weave, twill weave, or satin weave.

[0049] In some examples, the fabric 10 may have multiple braids, at least one of which can be used for implanting a bone tunnel. Additionally, in some examples, different braids are used for implanting different bone tunnels.

[0050] In some examples, multiple weave sections can be formed by weaving different weft threads 11a with the same warp threads 11b. Additionally, the weave structures of multiple weave sections can be identical, or at least one weave section can have a different weave structure.

[0051] In some examples, the woven fabric 10 may also have a non-woven portion. Furthermore, the non-woven portion may consist of multiple polymer fibers 11. Specifically, the non-woven portion may be formed by multiple polymer fibers 11 arranged in parallel.

[0052] In some examples, the non-woven portion may consist of warp yarns 11b (see...) Figure 3 The non-woven section can be composed of multiple warp threads 11b. In other examples, the warp threads 11b arranged in the non-woven section and the warp threads 11b woven in the woven section can be the same. That is, in the woven fabric 10, the same warp thread 11b can simultaneously serve as a warp thread 11b in the woven section and a warp thread 11b in the non-woven section. In other words, the same warp thread 11b can be used to weave with the weft threads 11a to form a woven section, and to arrange with the warp threads 11b to form a non-woven section. In other words, the multiple warp threads 11b of the woven section can extend to form the non-woven section.

[0053] In some examples, the non-woven portion may include a transition portion for connecting the woven portion. Furthermore, the tensile strength of the transition portion may be not less than 1000 N. This enables the artificial ligament 1 to possess good mechanical properties. For example, the tensile strength of the transition portion may be 1000 N, 1500 N, 2000 N, 2500 N, or 1000 N.

[0054] Figure 4 This is a schematic diagram illustrating the structure of the woven fabric 10 involved in another example of this disclosure.

[0055] In some examples, such as Figure 4 As shown, the braided fabric 10 may have a first end D1 and a second end D2. Furthermore, the first end D1 and the second end D2 may be located along the length of the braided fabric 10. In some examples, the first end D1 and the second end D2 may be located at both ends of the braided fabric 10 along its length. In some examples, the first end D1 and the second end D2 may belong to a non-woven portion. In other words, the non-woven portion may include the first end D1 and the second end D2. This facilitates the formation and fixation of the traction wire. For example, in... Figure 4 In the example shown, the first end D1 and the second end D2 can be formed by multiple warp threads 11b extending through the weave along the length of the fabric 10.

[0056] In some examples, the non-woven portion may include a folding section Z for folding (see...). Figure 5Thus, an artificial ligament 1 with two bundles can be formed by folding. For example, the woven fabric 10 can be folded along the fold line L to form the artificial ligament 1 with two bundles. In addition, the turning part Z can be formed by extending multiple warp threads 11b of the woven part.

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

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

[0059] In some examples, the mesh size of the mesh structure of the first braided portion 10a and the second braided portion 10b can be from 0.1 mm to 2 mm. For example, the mesh size of the mesh structure of the first braided portion 10a and the second braided portion 10b can 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 weaving section 10a and the second weaving section 10b can be woven from warp threads 11b and weft threads 11a, and the connecting section 10c can be composed of warp threads 11b. This facilitates the formation of a mesh structure. In other examples, the weaving structures of the first weaving section 10a and the second weaving section 10b can be the same or different.

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

[0062] In some examples, the tensile strength of the connecting portion 10c can be no less than 1000N. This allows the artificial ligament 1 to possess good mechanical properties. For example, the tensile strength of the connecting portion 10c can be 1000N, 1500N, 2000N, 2500N, or 1000N.

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

[0064] Figure 5 This is a schematic diagram illustrating the structure of the woven fabric 10 involved in yet another example of this disclosure.

[0065] In some examples, such as Figure 5 As shown, the braided fabric 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 can be used for implanting bone tunnels. Alternatively, the third braided portion 10d and the fourth braided portion 10e can be used for implanting different bone tunnels, and the connecting portion 10f can connect the third braided portion 10d and the fourth braided portion 10e. For example, the first braided portion 10a can be used for implanting a third bone tunnel, and the second braided portion 10b can be used for implanting a fourth bone tunnel. In some examples, the first braided portion 10a and the second braided portion 10b can be used for implanting bone tunnels of adjacent bones.

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

[0067] In some examples, the mesh size of the mesh structure of the third braid 10d and the fourth braid 10e can be from 0.1 mm to 2 mm. For example, the mesh size of the mesh structure of the third braid 10d and the fourth braid 10e can 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 weave section 10d and the fourth weave section 10e can be woven from warp threads 11b and weft threads 11a, and the connecting section 10f can be composed of warp threads 11b (see [reference]). Figure 5 Thus, a woven fabric 10 with a mesh structure can be formed.

[0069] In some examples, the tensile strength of the connector 10f can be no less than 1000N. This enables the artificial ligament 1 to have good mechanical properties. For example, the tensile strength of the connector 10f can be 1000N, 1500N, 2000N, 2500N, or 1000N.

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

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

[0072] In some examples, the third weaving portion 10d, the fourth weaving 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 via a turning portion Z.

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

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

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

[0076] In some examples, the woven fabric 10 can be semi-degradable. Specifically, the woven fabric 10 can be formed from both degradable and non-degradable polymer fibers 11, thus the woven fabric 10 can be partially degradable and partially non-degradable. In this case, the artificial ligament 1 can provide both good mechanical properties and promote ligament tissue growth and attachment. Furthermore, the degradation rate of the degradable portion of the woven fabric 10 can be lower than the degradation rate of the artificial bone material 20.

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

[0078] In some examples, the woven fabric 10 can be biodegradable. In this case, it can promote the growth of ligament tissue. Additionally, the degradation rate of the biodegradable woven fabric 10 can be lower than the degradation rate of the artificial bone material 20.

[0079] As described above, the woven fabric 10 can be formed from polymer fibers 11. In some examples, the polymer fibers 11 can be made from non-degradable materials. This provides long-term mechanical strength support, enabling the artificial ligament 1 to be used for an extended period. The polymer fibers 11 formed from non-degradable materials can be non-degradable. In other examples, the polymer fibers 11 can be made from at least one selected from polyethylene terephthalate and ultra-high molecular weight polyethylene. This provides long-term mechanical strength support and good biocompatibility.

[0080] In some examples, the polymer fiber 11 can be made of a biodegradable material. This facilitates the growth and attachment of ligament tissue. The polymer fiber 11 formed using a biodegradable material can be biodegradable. Additionally, in some examples, the polymer fiber 11 can be made of at least one selected from collagen, silk, starch, polyglycolic acid, polylactic acid, and polyvinylpyrrolidone.

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

[0082] In some examples, the woven fabric 10 may be made of commercially available artificial ligaments.

[0083] As mentioned above, such as Figure 2 As shown, the artificial ligament 1 may include artificial bone material 20. In some examples, the artificial bone material 20 may be distributed at least within the woven tissue. In other examples, the artificial bone material 20 may be distributed within the gaps of the woven tissue. Additionally, 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 weft 11a woven in the fabric 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 and / or lower surfaces of the woven tissue.

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

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

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

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

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

[0090] As mentioned above, such as Figure 4 As shown, the woven 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 can be filled with artificial bone material 20. This improves the tendon-bone healing ability of the artificial ligament 1. 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 woven fabric 10.

[0091] In some examples, after the artificial ligament 1 is implanted, bone tissue can grow into the woven tissue along the artificial bone material 20. This allows the artificial ligament 1 to be secured. In other examples, after the artificial ligament 1 is implanted, bone tissue can grow into the woven fabric 10 along the artificial bone material 20. Furthermore, after the artificial ligament 1 is implanted, bone tissue can grow into the woven portion along the artificial bone material 20. More specifically, after the artificial ligament 1 is implanted, bone tissue can grow into the mesh structure of the woven portion along the artificial bone material 20.

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

[0093] In some examples, the artificial bone material 20 can be bonded to the woven structure (or woven fabric 10) by coating or impregnation. Specifically, a solution containing the artificial bone material 20 can be coated or impregnated to bond the artificial bone material 20 to the woven structure (or woven fabric 10). Alternatively, the artificial bone material 20 can also be bonded to the woven structure (or woven fabric 10) by hot pressing.

[0094] In some examples, the solution containing artificial bone material 20 can be obtained by dissolving the artificial bone material 20 in an organic solvent. The organic solvent can be dichloromethane, trichloromethane, or tetrahydrofuran. Additionally, the solution containing artificial bone material 20 can be viscous. This improves the bonding strength between the artificial bone material 20 and the fabric 10.

[0095] In some examples, the artificial bone material 20 can be malleable. Specifically, the artificial bone material 20 can be malleable within a predetermined temperature range. In some examples, within the predetermined temperature range, the artificial bone material 20 can be molded into a clay-like form. In other words, within the predetermined temperature range, the artificial bone material 20 can be freely shaped. Additionally, in some examples, the predetermined temperature range can be from 25°C to 40°C. In this case, it is convenient to apply the artificial bone material 20 in a real clinical setting. For example, the predetermined temperature can 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. Furthermore, the artificial bone material 20 can exhibit 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 osteocyte formation, thus helping to improve the tendon-bone healing ability of the artificial ligament 1 and enabling the tendon-bone interface to heal firmly.

[0097] In some examples, the artificial bone material 20 may include inorganic particles and polymer materials. Additionally, the inorganic particles may be distributed within the polymer material. Furthermore, in some examples, the inorganic particles in the artificial bone material 20 may be uniformly distributed within the polymer material. In other examples, the inorganic particles may be randomly distributed within the polymer material. Moreover, in some examples, the inorganic particles may be distributed within the polymer material with a stepped density or a pattern of denser particles in the middle and sparser particles at the edges.

[0098] In some examples, the inorganic particles may be composed of calcium phosphate compounds. In some examples, the inorganic particles may contain 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, promoting bone tissue growth.

[0099] Furthermore, in this embodiment, the inorganic particles are not limited to the aforementioned hydroxyapatite, calcium polyphosphate, tricalcium phosphate, etc. In this embodiment, the inorganic particles may also contain other substances similar to the composition of human bone tissue, thereby also enhancing the repair effect of the artificial bone material 20 on human bone tissue.

[0100] In some examples, the mass fraction of inorganic particles in the artificial bone material 20 can be from 10% to 60%. This allows for improved bone repair by the artificial bone material 20 while maintaining its plasticity. For example, the mass fraction of inorganic particles can be 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, or 60%.

[0101] Furthermore, in some examples, preferably, the inorganic particles can be rigid particles. In some examples, the inorganic particles can have a Young's modulus greater than 2 × 10⁻⁶. 11 Pa rigid particles. In this case, the mechanical strength of artificial bone material 20 can be improved.

[0102] Furthermore, the shape of the inorganic particles is not particularly limited in this embodiment. For example, in some examples, the inorganic particles can be spherical. However, this embodiment is not limited to this; in other examples, the inorganic particles can be ellipsoidal, irregular three-dimensional, etc.

[0103] Furthermore, in this 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 from 5 nm to 200 nm. For example, the average particle size of the inorganic particles can be 5 nm, 10 nm, 30 nm, 50 nm, 100 nm, 200 nm, 500 nm, 100 nm, 200 nm, 500 nm, 100 nm, 200 nm, 300 nm, 500 nm, 800 nm, 100 nm, 130 nm, 150 nm, 180 nm, or 200 nm. The average particle size of the inorganic particles can be selected according to different application scenarios.

[0104] In some examples, the surface of inorganic particles can be physically or chemically modified. For instance, an adhesive layer (such as polyethyleneimine) that readily bonds to polymer materials can be coated onto the surface of the inorganic particles; or active groups can be modified on the surface of the inorganic particles to facilitate bonding with polymer materials. In such cases, the bonding force between the inorganic particles and the polymer materials can be increased, thereby allowing the inorganic particles to be better bonded together.

[0105] In some examples, the polymer material can exhibit flowability and viscosity at temperatures ranging from 20°C to 60°C. Additionally, in some examples, the polymer material can be biodegradable.

[0106] In some examples, the average molecular weight of the polymer material can be from 1,000 Da to 20,000 Da. For example, the average molecular weight of the polymer material can be 1,000 Da, 2,000 Da, 3,000 Da, 4,000 Da, 6,000 Da, 8,000 Da, 9,000 Da, 10,000 Da, 12,000 Da, 15,000 Da, 18,000 Da, or 20,000 Da.

[0107] In this embodiment, the average molecular weight of the polymer material can refer to its number-average molecular weight. In other words, the number-average molecular weight of the polymer material can be between 1000 Da and 20000 Da. Additionally, in some examples, the average molecular weight of the polymer material can be determined by time-of-flight mass spectrometry, nuclear magnetic resonance (NMR) spectroscopy, or gel permeation chromatography.

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

[0109] In some examples, the polymeric material can be a copolymer of caprolactone or p-dioxanone with lactide or glycolide. In this case, a biodegradable polymeric material can be formed, which is beneficial for the application of artificial bone material 20 in the orthopedic field, especially in the field of absorbable orthopedic materials. For example, the polymeric material can 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 can be a copolymer of caprolactone and lactide, and the molar ratio of caprolactone to lactide in the polymer material is from 1:1 to 2.5:1. This allows for the formation of a biodegradable polymer material with suitable viscosity and flowability. For example, the molar ratio of caprolactone to lactide in the polymer material can 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 polymer material in artificial bone material 20 can be from 40% to 90%. In this case, the plasticity of artificial bone material 20 can be improved. For example, the mass fraction of polymer material can be 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, or 90%.

[0112] In some examples, the artificial bone material 20 may include growth factors. In this case, the artificial bone material 20 can better promote bone tissue regeneration, thereby further improving the tendon-bone healing capacity 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 consist of a polymer material and inorganic particles. Specifically, the artificial bone material 20 may be a composition consisting of a biodegradable polymer material and inorganic particles distributed within the polymer material.

[0114] In some examples, the artificial bone material 20 can degrade in a gradient manner within the human body. In other examples, polymeric materials can preferentially and rapidly degrade to provide sufficient space for bone ingrowth, while inorganic particles degrade more slowly, enabling them to continue to promote osteoblast growth and induce bone tissue ingrowth 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 antimicrobial substance. This reduces the likelihood of infection. Additionally, in some examples, the antimicrobial substance may be mixed into the artificial bone material 20. In other words, the artificial bone material 20 may include an antimicrobial substance.

[0116] In some examples, antimicrobial substances may be added to the polymer fibers 11 (e.g., the warp 11b and weft 11a of the woven fabric 10). Alternatively, antimicrobial substances may be distributed on the polymer fibers 11.

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

[0118] In some examples, the antibacterial ion can be at least one of silver ions, gallium ions, copper ions, and zinc ions. Additionally, the sulfonamide can be one or more of trimethoprim, sulfadiazine, sulfamethoxazole, trimethoprim-sulfamethoxazole, and sulfadiazine. Furthermore, in some examples, the quinolone can be one or more of norfloxacin, ofloxacin, ciprofloxacin, and fleroxacin. Additionally, the nitroimidazole can be one or more of metronidazole, dimetridazole, isonitroazole, secnidazole, ornidazole, tinidazole, and lonidazole.

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

[0120] Figure 6 This is a schematic diagram illustrating an example of the coiling of an artificial ligament 1 as described in this 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 and suturing along the weft direction 11a. Furthermore, after winding, the artificial bone material 20 in the artificial ligament 1 can be exposed to the outside, allowing the artificial bone material 20 to contact the bone tunnel. This can improve the tendon-bone healing ability of the artificial ligament 1. In other words, the artificial ligament 1 can be wound to allow the artificial bone material 20 to contact the bone tunnel.

[0122] For example, taking the artificial ligament 1 formed by the braided fabric 10 and the artificial bone material 20 as an example, the winding is illustrated. The braided fabric 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 braided fabric 10 along the second surface B and the direction of the weft thread 11a and then suturing it (see...). Figure 6 In this case, the artificial bone material 20 in the artificial ligament 1 faces outward, allowing the artificial bone material 20 to 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 after being wound to form a double-bundle structure. In other examples, the artificial ligament 1 can be bent at the turning point Z after being wound to form a double-bundle structure.

[0124] For example, taking the artificial ligament 1 formed by the woven fabric 10 having a first braided portion 10a, a second braided portion 10b, a third braided portion 10d and a fourth braided portion 10e and the artificial bone material 20 as an example, the artificial ligament 1 can be bent at the turning point Z after being wound so that the first braided portion 10a and the fourth braided portion 10e are arranged side by side, and the second braided portion 10b and the third braided portion 10d are arranged side by side, thereby forming a double bundle structure.

[0125] In some examples, the artificial ligament 1 may have an implanted segment and a free segment. Alternatively, the implanted segment may be used for implantation into a bone tunnel, and the free segment may be positioned within the joint cavity. Additionally, the artificial ligament 1 may have multiple implanted segments. In other examples, the artificial ligament 1 may have multiple free segments.

[0126] In some examples, the implanted segment may include a woven portion. That is, the implanted segment may be formed from a portion including a woven portion. In other examples, the free segment may include a non-woven portion. That is, the free segment may be formed from a portion including a non-woven portion. For example, the free segment may include a connecting segment 1c. Additionally, the connecting segment 1c may include a connecting portion 10c.

[0127] For example, let's take an artificial ligament 1 formed by a woven fabric 10 having a first braided portion 10a and a second braided portion 10b and an artificial bone material 20 as an example to explain in detail. Figure 6 As shown, the artificial ligament 1 may have a first implanted segment 1a including a first braided portion 10a, a connecting segment 1c including a connecting portion 10c, and a second implanted segment 1b including a second braided portion 10b. This facilitates the reconstruction of ligaments (e.g., the cruciate ligament of the knee) within the joint cavity. For example, the first implanted segment 1a can be implanted into a tibial tunnel, the second implanted segment 1b can be implanted into a femoral tunnel, and the connecting segment 1c can be positioned within the knee joint cavity.

[0128] Figure 7 This is a schematic diagram illustrating the structure of an artificial ligament 1 as described in another example of this disclosure.

[0129] In some examples, traction wires may be provided at both ends of the artificial ligament 1 (see...). Figure 7 This facilitates the implantation and fixation of the artificial ligament 1. In other examples, the traction suture can be placed after the artificial ligament 1 has been coiled. Additionally, the traction suture can be absorbable or non-absorbable.

[0130] In some examples, the traction suture can be attached to the implanted segment of the artificial ligament 1. Additionally, the traction suture can be used for implantation of the implanted segment. That is, the implanted segment can be inserted into the bone tunnel using the traction suture. Specifically, the traction suture can guide the implanted segment of the artificial ligament 1 through the bone tunnel.

[0131] In some examples, traction cables can be used to fix the implant segment. That is, the implant segment can be fixed to the bone tunnel using traction cables. Specifically, the implant segment can be fixed to the bone tunnel using traction cables in conjunction with fixation devices (such as button plates or suspension plates), thereby fixing the artificial ligament 1 in the body. For example, the artificial ligament 1 can be fixed by binding the traction cables to a suspension plate.

[0132] For example, let's take an artificial ligament 1 formed by a woven fabric 10 having a first braided portion 10a and a second braided portion 10b and an artificial bone material 20 as an example to explain in detail. Figure 7As shown, the first implant segment 1a can be connected to a first traction wire Q1, through which the first implant segment 1a can be implanted and fixed in the first bone tunnel. The second implant segment 1b can be connected to a second traction wire Q2, through which the second implant segment 1b can be implanted and fixed in the second bone tunnel. This facilitates the implantation and fixation of the artificial ligament 1.

[0133] In this embodiment, the artificial ligament 1 is composed 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 osteocytes 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 (i.e., the artificial ligament 1 is firmly bonded to the bone interface). Thus, the artificial ligament 1 can provide effective mechanical strength.

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

[0135] As described above, the method for preparing the artificial ligament 1 may include preparing woven tissue and artificial bone material 20. The woven tissue and artificial bone material 20 can be referred to the description above.

[0136] Figure 8 This is a flowchart illustrating a method for preparing an artificial ligament 1 according to an example of this disclosure. Figure 9 This is a flowchart illustrating a method for preparing an artificial ligament 1 according to another example of this disclosure.

[0137] The following example illustrates how an artificial ligament 1 is obtained using a woven fabric 10 (i.e., the woven tissue consists of a single woven fabric 10) and artificial bone material 20. Figure 8 and Figure 9 The preparation method of artificial ligament 1 is described in detail. Among other things, Figure 8 This is a flowchart of the preparation process using a coating method. Figure 9 This is a flowchart of the preparation process using the infiltration method.

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

[0139] In some examples, such as Figure 8 and Figure 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). Furthermore, the paste may be viscous. This facilitates the bonding between the artificial bone material 20 and the woven fabric 10, improves the strength of the bond between the artificial bone material 20 and the woven fabric 10, and thus enhances the tendon-bone healing ability of the artificial ligament 1.

[0140] In some examples, in step S20, the organic solvent can be dichloromethane, trichloromethane, or tetrahydrofuran. Additionally, in step S20, the mass-to-volume ratio (g:ml) of the artificial bone material 20 to the organic solvent can be from 1:30 to 1:1. For example, the mass-to-volume ratio (g:ml) of the artificial bone material 20 to the organic solvent can 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 preparation method of the artificial ligament 1 may include contacting the woven fabric 10 with a paste (step S30). This allows the artificial bone material 20 to be combined with the woven fabric 10 to obtain the artificial ligament 1. In some examples, step S30 may be performed by coating or impregnation. In other words, step S30 may be performed as 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 coating a paste onto the woven fabric 10 (step S30A). That is, the artificial bone material 20 and the woven fabric 10 are combined by coating. In addition, before step S30A, the woven fabric 10 can be laid flat or suspended. This facilitates coating.

[0143] In some examples, in step S30A, the paste can be uniformly applied to the woven fabric 10. In other examples, in step S30A, the paste can be applied to at least the woven portion (mesh structure) of the woven fabric 10. Alternatively, in step S30A, the paste can be applied to the entire woven portion (mesh structure) of the woven fabric 10.

[0144] In some examples, in step S30A, the paste may also be applied to the non-woven portion of the woven fabric 10 (e.g., the connecting portion 10c). Alternatively, 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 can be applied to one side of the woven fabric 10. For example, the paste can be applied to either the first surface A or the second surface B of the woven fabric 10. In other examples, in step S30A, the paste can be applied to both sides of the woven fabric 10. For example, the paste can be applied to both the first surface A and the second surface B of the woven fabric 10.

[0146] In some examples, such as Figure 9 As shown, the method for preparing the artificial ligament 1 may include impregnating the woven fabric 10 with a paste (step S30B). That is, the artificial bone material 20 and the woven fabric 10 are composited by impregnation.

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

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

[0149] In some examples, the preparation method of the artificial ligament 1 may include drying to obtain the artificial ligament 1 (step S40). In step S40, 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 woven fabric 10 (mesh structure or gaps) is not filled by the artificial bone material 20, steps S30 and S40 can be repeated until the woven fabric 10 (mesh structure or gaps) is filled by the artificial bone material 20.

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

[0152] In this embodiment, by coating or impregnating the artificial bone material 20 and the woven fabric 10 with a mesh structure, an artificial ligament 1 with the artificial bone material 20 distributed in the mesh structure can be formed. Since the artificial bone material 20 can promote the generation of osteocytes 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 this disclosure, an artificial ligament 1 with healing function that improves tendon-bone healing ability and a method for preparing the same can be provided.

[0154] To further illustrate this disclosure, the following describes in detail the artificial ligament 1 with healing function and its preparation method provided by this disclosure in conjunction with embodiments, and fully explains the beneficial effects achieved by this disclosure in conjunction with comparative examples.

[0155] Figure 10 This is a diagram showing the results of methylene blue-basic fuchsin staining according to Example 1 of this disclosure. Figure 11 This is a MicroCT result image related to Embodiment 2 of this disclosure. Figure 12 This is a diagram of the MicroCT results involved in the comparative example of this 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 woven fabric was laid flat, and the paste was evenly coated onto both sides. After air drying and vacuum drying, an artificial ligament was obtained. The artificial ligament was then rolled and sutured to form a cylindrical shape with a diameter of 2.0mm. The cylindrical artificial ligament was then implanted into the femoral condyle of a New Zealand white rabbit. The pre-drilled bone tunnel in the femoral condyle had a diameter of 1.8mm. The artificial ligament was inserted into the bone tunnel without any evidence of the artificial bone being scraped off by the bone tunnel, demonstrating a strong bond between the artificial bone and the woven fabric.

[0159] Tissue samples were taken 8 months post-surgery and stained with methylene blue-basic fuchsin. Results are shown below. Figure 10 Among them, the white dots are cross-sections of the ligament weave, and a large amount of bone tissue (red tissue) has been formed in the weave, indicating that the tendon-bone healing effect is obvious.

[0160] [Example 2]

[0161] The woven fabric was soaked in the paste from Example 1, air-dried, and then vacuum-dried to obtain an artificial ligament. The artificial ligament was then rolled and sutured to form a cylindrical shape. The diameter of the cylindrical artificial ligament was 2.5 mm. The cylindrical artificial ligament was then implanted into the femoral condyle of a New Zealand white rabbit. The pre-drilled bone tunnel in the femoral condyle had a diameter of 2.2 mm. The artificial ligament was inserted into the bone tunnel, and no artificial bone was scraped off by the bone tunnel, demonstrating a strong bond between the artificial bone and the woven fabric.

[0162] Tissue samples were taken 8 months post-surgery and subjected to MicroCT scans. Results are shown below. Figure 11 Among them, the woven material has been removed, and there is obvious new bone tissue growing into the bone tunnel, that is, the tendon-bone healing effect is obvious.

[0163] [Comparative Example]

[0164] The French LARS artificial ligament was implanted into the femoral condyle of New Zealand white rabbits. Tissue samples were taken 8 months post-surgery and subjected to MicroCT scanning. Results are shown below. Figure 12 In some cases, there was no obvious bone ingrowth within the bone tunnel, and the tendon-bone healing effect was not ideal.

[0165] While the present disclosure has been 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 way. Those skilled in the art can make modifications and variations to the present disclosure as needed without departing from its essential spirit and scope, and all such modifications and variations fall within the scope of the present disclosure.

Claims

1. An artificial ligament, characterized in that, The artificial ligament comprises a woven tissue and an artificial bone material, formed by coating or impregnating the woven tissue with a solution containing the artificial bone material and then drying it. The artificial bone material is a mixture of inorganic particles and polymeric materials. The inorganic particles are composed of calcium-phosphorus compounds, with a mass fraction of 10% to 60%. The polymeric material is a copolymer of caprolactone and p-dioxanone with lactide or glycolide. The artificial bone material undergoes gradient degradation, which includes the rapid degradation of the polymeric material prior to the inorganic particles. After implantation of the artificial ligament, bone tissue grows into the woven tissue along the artificial bone material. The polymeric material has an average molecular weight of 1000 Da to 20000 Da, giving it fluidity and viscosity at temperatures between 20°C and 60°C.

2. The artificial ligament as described in claim 1, characterized in that, The polymer material has a mass fraction of 40% to 90%.

3. The artificial ligament as described in claim 1, characterized in that, The artificial bone material includes growth factors and antibacterial substances.

4. The artificial ligament as described in claim 1, characterized in that, The surface of the inorganic particles is physically or chemically modified to increase the bonding force between the inorganic particles and the polymer material.

5. The artificial ligament as described in claim 1, characterized in that, The inorganic particles are uniformly distributed in the polymer material; or The inorganic particles are randomly distributed in the polymer material; or The inorganic particles are distributed in the polymer material according to a stepped arrangement or a pattern of denser particles in the middle and sparser particles at the edges.

6. The artificial ligament as described in claim 1, characterized in that, The woven structure consists of one or more woven fabrics formed of polymer fibers, which are made of at least one selected from polyethylene terephthalate and ultra-high molecular weight polyethylene.

7. The artificial ligament as described in claim 6, characterized in that, The woven fabric is non-degradable; or The woven fabric is semi-degradable, and is formed from degradable and non-degradable polymer fibers; or The woven fabric is biodegradable, and the degradation rate of the woven fabric is less than that of the artificial bone material.

8. The artificial ligament as described in claim 1, characterized in that, The woven tissue consists of one or more woven fabrics having a first woven portion for implantation in a first bone tunnel, a second woven portion for implantation in 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 at least distributed in the mesh structure of the first woven portion and the mesh structure of the second woven portion. After the artificial ligament is implanted in the first bone tunnel and the second bone tunnel, bone tissue grows along the artificial bone material into the mesh structure to fix the first woven portion and the second woven portion.

9. A method for preparing an artificial ligament, characterized in that, include: A woven fabric with a braided portion and an absorbable artificial bone material are prepared. The artificial bone material is dissolved in an organic solvent to obtain a paste, and the paste is coated onto the woven fabric or the woven fabric is immersed in the paste. The mixture is then dried to obtain the artificial ligament. The artificial bone material is a mixture of inorganic particles and a polymer material. The inorganic particles are composed of calcium phosphate compounds, with a mass fraction of 10% to 60%. The polymer material is a copolymer of caprolactone and p-dioxanone with lactide or glycolide. The artificial bone material undergoes gradient degradation, including rapid degradation of the polymer material prior to the inorganic particles. The braided portion has a mesh structure, and the artificial bone material is at least distributed within the mesh structure of the braided portion in the artificial ligament. The polymer material has an average molecular weight of 1000 Da to 20000 Da, giving it fluidity and viscosity at temperatures between 20°C and 60°C.

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