A biological composite high-strength ligament graft capable of inducing regeneration

Abstract

The present invention relates to a biocomposite, regenerative, high-strength ligament graft, the ligament graft being woven from at least four types of ligament fiber bundles; the ligament fiber bundles being woven from different proportions of porcine small intestinal submucosal fibers and composite fibers; wherein the porcine small intestinal submucosal fibers are made by curling the porcine small intestinal submucosal layer; and the composite fibers are made by wrapping the porcine small intestinal submucosal layer around the surface of the high-strength fibers. The ligament graft of the present invention is woven from porcine small intestinal submucosal fibers and porcine small intestinal submucosal composite high-strength fibers. The porcine small intestinal submucosal layer retains extracellular matrix components and microstructures, facilitating cell migration, adhesion, and proliferation. The composite high-strength fibers are prepared by combining the composite high-strength fibers with a degradable polymer material, which serves as a mechanical support component. The complementary advantages of the degradable polymer material give the ligament graft of the present invention both good biocompatibility and strength.

Description

Technical Field

[0001] The present invention relates to the field of surgical repair, and in particular to a biological composite high-strength ligament graft capable of inducing regeneration. Background Art

[0002] With the continuous improvement of my country's material living standards and the continuous strengthening of people's fitness awareness, the sports industry has developed rapidly, the number of people participating in sports has continued to grow, and the resulting sports injuries have also increased year by year, including joint ligament injuries. Ligaments play a role in strengthening joints and maintaining the stability of joints during exercise. When subjected to violence, the ligaments are overstretched and exceed their tolerance, and injuries occur. Among them, the anterior cruciate ligament (ACL) injury has the highest incidence rate. In recent years, there have been 350,000 cases of ACL injury in the United States each year, and the related treatment costs have reached $6 billion. Because the anterior cruciate ligament is difficult to heal on its own after injury, reconstructive surgery has become the gold standard for treating anterior cruciate ligament injuries.

[0003] In reconstructive surgery, the selection of ACL reconstruction grafts has always been a hot topic and difficulty in sports medicine research at home and abroad. Currently, the commonly used grafts for clinical reconstruction of ACL injuries are: autologous grafts, allogeneic grafts, and artificial grafts. Although autologous grafts and allogeneic grafts are widely used in clinical practice, there are risks of donor site damage, insufficient sources, immunogenicity, and disease transmission. In addition, the artificial grafts available clinically are all non-degradable artificial ligaments, which cannot induce ligament regeneration in the joint cavity in vivo, and the bone channel and host bone scar heal, and have poor mechanical strength. Therefore, new ligament grafts are currently a hot topic in clinical research and development. Summary of the Invention

[0004] The purpose of the present invention is to provide a bio-composite high-strength ligament graft that can be induced to regenerate, which combines the porcine small intestinal submucosa and high-strength fibers to complement each other's advantages. The ligament graft can be used in clinical anterior cruciate ligament injury reconstruction surgery, and is also suitable for repair of tendon injuries in the human limbs.

[0005] In order to achieve the above-mentioned purpose, the present invention adopts the following technical solutions:

[0006] The present invention provides a biocomposite, regenerative, high-strength ligament graft, wherein the ligament graft is woven from at least four types of ligament fiber bundles; the ligament fiber bundles are woven from porcine small intestinal submucosal fibers and composite fibers in different proportions;

[0007] The pig small intestinal submucosa fiber is made by curling the pig small intestinal submucosa; and the composite fiber is made by wrapping the pig small intestinal submucosa on the surface of a high-strength fiber.

[0008] Furthermore, the ligament graft comprises 3-100 ligament fiber bundles.

[0009] Further preferably, the ligament graft comprises 4-50 ligament fiber bundles.

[0010] Furthermore, the ligament fiber bundle contains 3-12 fibers.

[0011] Further preferably, the ligament fiber bundle comprises 3-8 fibers.

[0012] Furthermore, the high-strength fiber is a degradable polymer material.

[0013] Further preferably, the degradable polymer material is PLA, PCL, PPDO, PHA or P4HB.

[0014] Furthermore, the ligament graft has a length of 5-40 cm and a diameter of 1-10 mm.

[0015] More preferably, the ligament graft has a length of 10-30 cm and a diameter of 2.5-6 mm.

[0016] Compared with the prior art, the present invention has the following advantages:

[0017] The ligament graft of the present invention is woven from porcine small intestinal submucosa fibers and porcine small intestinal submucosa composite high-strength fibers. The porcine small intestinal submucosa retains the extracellular matrix components and microstructure, which is conducive to cell migration, adhesion, and proliferation. The composite high-strength fibers are prepared by combining the fibers with degradable polymer materials. The degradable polymer materials serve as mechanical support components, and the advantages complement each other, so that the ligament graft of the present invention has both good biocompatibility and strength. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 This is a schematic diagram of the preparation process of the porcine small intestinal submucosa fiber of the present invention;

[0019] Figure 2 This is a schematic diagram of the preparation process of the composite fiber of the present invention;

[0020] Figure 3 is a schematic diagram of the preparation process of a ligament graft in one embodiment of the present invention;

[0021] Figure 4 is a schematic diagram of the preparation process of a ligament graft according to another embodiment of the present invention;

[0022] Figure 5 This is a scanning electron microscope image of the porcine small intestinal submucosa tissue of the present invention. DETAILED DESCRIPTION

[0023] The present invention provides a bio-composite, regenerative, high-strength ligament graft, which is woven from at least four types of ligament fiber bundles; the ligament fiber bundles are woven from porcine small intestinal submucosal fibers and composite fibers in different proportions; wherein the porcine small intestinal submucosal fibers are made by curling the porcine small intestinal submucosal layer; and the composite fibers are made by wrapping the porcine small intestinal submucosal layer on the surface of the high-strength fibers.

[0024] The porcine small intestinal submucosa retains extracellular matrix components and microstructures, which are beneficial to cell migration, adhesion, and proliferation. The porcine small intestinal submucosa is compounded with a degradable polymer material to prepare a composite high-strength fiber. The degradable polymer material serves as a mechanical support component, and the advantages complement each other, so that the ligament graft of the present invention has both good biocompatibility and strength.

[0025] In one embodiment of the present invention, the ligament fiber bundle comprises 3-12 fibers, preferably, the ligament fiber bundle comprises 3-8 fibers.

[0026] In one embodiment of the present invention, the ligament graft comprises 3-100 ligament fiber bundles, preferably, the ligament graft comprises 4-50 ligament fiber bundles.

[0027] In one embodiment of the present invention, the high-strength fiber is a degradable polymer material. Preferably, the degradable polymer material is PLA, PCL, PPDO, PHA or P4HB.

[0028] In one embodiment of the present invention, the ligament graft has a length of 5-40 cm, preferably 10-30 cm, and a diameter of 1 mm-10 mm, preferably 2.5 mm-6 mm.

[0029] The present invention will be described in detail and specifically below through specific examples to provide a better understanding of the present invention, but the following examples do not limit the scope of the present invention.

[0030] Example 1

[0031] Preparation of a biocomposite high-strength ligament graft capable of inducing regeneration:

[0032] like Figure 1 As shown, the pig small intestinal submucosa fiber 1 is prepared by curling the pig small intestinal submucosa 4;

[0033] like Figure 2 As shown, the composite fiber 2 is prepared by wrapping the pig small intestine submucosa 4 on the surface of the high-strength fiber 3;

[0034] like Figure 3As shown, three composite fibers 2; two composite fibers 2 and one porcine small intestinal submucosal fiber 1; one composite fiber 2 and two porcine small intestinal submucosal fibers 1; and three porcine small intestinal submucosal fibers 1 are woven into four types of ligament fiber bundles 5 respectively;

[0035] Then the four ligament fiber bundles 5 are woven into a ligament graft.

[0036] Example 2

[0037] Preparation of a biocomposite high-strength ligament graft capable of inducing regeneration:

[0038] like Figure 1 As shown, the pig small intestinal submucosa fiber 1 is prepared by curling the pig small intestinal submucosa 4;

[0039] like Figure 2 As shown, the composite fiber 2 is prepared by wrapping the pig small intestine submucosa 4 on the surface of the high-strength fiber 3;

[0040] like Figure 4 As shown, four composite fibers 2; three composite fibers 2 and one porcine small intestinal submucosal fiber 1; two composite fibers 2 and two porcine small intestinal submucosal fibers 1; one composite fiber 2 and three porcine small intestinal submucosal fibers 1; and four porcine small intestinal submucosal fibers 1 are woven into five kinds of ligament fiber bundles 5 respectively;

[0041] Then the five ligament fiber bundles 5 are braided into a ligament graft.

[0042] Verification Example 1

[0043] like Figure 5 As shown, the porcine small intestinal submucosa tissue used in the present invention has collagen fibers arranged in a crisscross pattern. The fibers on the surface of the material are obvious, with a fiber diameter of about 1 μm. The collagen fibers are well preserved and have a length of more than 50 μm. No obvious broken fibers are found. There are connecting holes leading to the interior of the material, which is conducive to the growth, adhesion and proliferation of new cells and tissues.

[0044] Verification Example 2

[0045] Biomechanical properties are key properties of artificial ligament grafts. This verification example conducted biomechanical tests on different ligament fiber bundles, where ligament fiber bundle (1) consisted of 4 porcine small intestinal submucosal fibers; fiber bundle (2) consisted of 3 porcine small intestinal submucosal fibers and 1 composite fiber; fiber bundle (3) consisted of 2 porcine small intestinal submucosal fibers and 2 composite fibers; and fiber bundle (4) consisted of 1 porcine small intestinal submucosal fiber and 3 composite fibers. The tensile breaking strength of four samples of each ligament fiber bundle was measured, and the results are shown in Table 1 below:

[0046] Table 1

[0047] project Sample 1 (N) Sample 2 (N) Sample 3 (N) Sample 4 (N) Fiber bundle (1) 9.1 9.6 10.3 10.7 Fiber bundles (2) 13.7 15.6 15.6 14.3 Fiber bundles (3) 21.3 25 22.1 22.7 Fiber bundles (4) 30 29.2 31.9 32.4

[0048] As shown in Table 1, the biomechanical strength of the composite fiber is significantly higher than that of the porcine small intestinal submucosa fiber. The addition of high-strength degradable polymer fibers can significantly improve the biomechanical properties of the ligament fiber bundle, thereby improving the biomechanics of the ligament graft.

[0049] The above description is only a preferred embodiment of the present invention and does not limit the implementation mode and protection scope of the present invention. For those skilled in the art, it should be aware that all solutions obtained by equivalent substitutions and obvious changes made using the description and illustrations of the present invention should be included in the protection scope of the present invention.

Claims

1. A biocomposite high-strength ligament graft capable of inducible regeneration, characterized in that: The pig small intestinal submucosa layer 4 is curled to prepare the pig small intestinal submucosa fiber 1; the pig small intestinal submucosa layer 4 is wrapped on the surface of the high-strength fiber 3 to prepare the composite fiber 2; Weaving four types of ligament fiber bundles 5, respectively, by weaving three composite fibers 2, two composite fibers 2 and one porcine small intestinal submucosal fiber 1, one composite fiber 2 and two porcine small intestinal submucosal fibers 1, and three porcine small intestinal submucosal fibers 1; and then weaving the four types of ligament fiber bundles 5 into a ligament graft; Alternatively, four composite fibers 2, three composite fibers 2 and one porcine small intestinal submucosal fiber 1, two composite fibers 2 and two porcine small intestinal submucosal fibers 1, one composite fiber 2 and three porcine small intestinal submucosal fibers 1, and four porcine small intestinal submucosal fibers 1 are respectively woven into five types of ligament fiber bundles 5; and then the above five types of ligament fiber bundles 5 are woven into a ligament graft.

2. The high-strength ligament graft according to claim 1, characterized in that: The high-strength fiber is a degradable polymer material.

3. The high-strength ligament graft according to claim 2, characterized in that: The degradable polymer material is PLA, PCL, PPDO, PHA or P4HB.

4. The high-strength ligament graft according to claim 1, characterized in that: The ligament graft has a length of 5-40 cm and a diameter of 1-10 mm.

5. The high-strength ligament graft according to claim 4, characterized in that: The ligament graft has a length of 10-30 cm and a diameter of 2.5-6 mm.

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