Self-locking all-suture anchor

Abstract

The application provides a self-locking full-suture anchor, which comprises a suture, a self-locking tube and an anchoring tube; one end of the suture passes through the self-locking tube and the anchoring tube in sequence and then passes out of the self-locking tube again; the self-locking tube holds the suture to avoid the movement of the suture relative to the self-locking tube; the anchoring tube is a first tubular body which is woven by one or more rigid yarns and a plurality of fibers; in use, the anchoring tube is placed into an anchoring hole, and by pulling one end or both ends of the suture, the anchoring tube is tightened to form a thread ball, and then the suture is anchored. In the application, when the anchoring tube is tightened to form a thread ball, the rigid yarns form a support structure in the thread ball, and the thread ball abuts against the inner wall of the anchoring hole or blocks the anchoring hole from inside, and then the suture is anchored and locked. The self-locking tube holds the suture, which can prevent the movement of the suture relative to the self-locking tube, and then the anchoring state of the anchoring tube can be maintained for a long time.

Description

Technical Field

[0001] This invention relates to the field of full-suture anchor technology, and in particular to a self-locking full-suture anchor. Background Technology

[0002] In orthopedic surgery, soft tissue fixation to bone remains a crucial component of orthopedic surgical practice. The development of suture anchors has revolutionized soft tissue fixation of bone, providing a simple and effective way to secure bone and soft tissues (such as tendons and ligaments) in open and arthroscopic surgeries of the elbow, wrist, and lower extremities. Suture anchors provide pressure fit between the bone, graft / tendon, and screw, while sutures bind the soft tissue to the implant embedded in the bone.

[0003] These suture anchors are typically made of metals, polymers, and composite materials, including steel or titanium alloys, non-biodegradable polyetheretherketone (PEEK), biodegradable polylactic acid (PLA) or polyglycolic acid (PGA) copolymers, or other polymers. These suture anchors resemble screws in appearance and have drawbacks such as large implantation tunnels, significant bone removal, and difficulties in postoperative revision and repair. Metals and non-biodegradable polymers offer high mechanical stability, but post-implantation inflammation can lead to osteolysis, causing the anchor to loosen and fall out, resulting in fixation failure. Biodegradable anchors, due to uncontrollable degradation rates, may not provide sufficient strength after implantation, and the accumulation of acidic byproducts and debris from the degradation material can lead to adverse reactions in patients, such as sinus infections, inflammation, and cyst formation.

[0004] The continuous evolution of suture anchors has resulted in various types, with fully sutured anchors representing a new generation. These anchors are characterized by both the anchor and suture components being made of a soft, woven material. Due to the soft suture material, they can be used with curved guides to access confined areas, and MRI imaging is distortion-free. Furthermore, fully sutured anchors have a smaller diameter, resulting in less bone removal during insertion. However, fully sutured anchors also have certain shortcomings and defects. Due to their inherent structure, insufficient deformation of the anchor area and inadequate knotting can lead to insufficient anchor stability and a tendency for them to detach. Summary of the Invention

[0005] The purpose of this invention is to provide a self-locking full-stitch anchor to solve at least one of the aforementioned technical problems in the prior art.

[0006] To solve the above-mentioned technical problems, the present invention provides a self-locking full-stitch anchor, comprising: suture, self-locking suture tube and anchoring suture tube; One end of the suture passes through the self-locking tube and the anchoring tube in sequence, and then comes out of the self-locking tube again. The self-locking suture tube holds the suture tightly, preventing the suture from moving relative to the self-locking suture tube; The anchoring tube is a first tubular body woven from one or more rigid yarns and multiple fibers (bundles); in use, the anchoring tube is placed into the anchoring hole of the bone tissue, and by pulling one or both ends of the suture, the anchoring tube is tightened to form a ball of thread, thereby anchoring the suture to the bone tissue.

[0007] In this application, the rigid yarn has a certain rigidity. When the anchoring tube is stretched to form a ball, the rigid yarn forms a support structure inside the ball. The ball abuts against the inner wall of the anchoring hole or seals the anchoring hole from the inside, thereby anchoring and locking the thread. The self-locking tube holds the thread tightly, preventing the thread from moving relative to it, thus maintaining the anchoring state of the anchoring tube for a long time.

[0008] Furthermore, the self-locking tube is a second tubular body woven from one or more rigid yarns and multiple fibers.

[0009] Furthermore, the self-locking tubing and the anchoring tubing are integrally woven from one or more rigid yarns and multiple fibers; the lumen of the first tubular body is connected to the lumen of the second tubular body, and at the same time, the lumen of the first tubular body is provided with an opening on the outside of the second tubular body for the re-passing of the suture.

[0010] Furthermore, the bending moment of the rigid yarn is 0.3 to 0.5 cN·cm.

[0011] The bending moment of the fiber is not higher than 0.25 cN·cm.

[0012] Furthermore, the fineness of the fiber is 5-100D.

[0013] Preferably, the fiber has a fineness of 75D.

[0014] Furthermore, the anchoring conduit is woven from 1-3 rigid yarns and 5-20 strands of the aforementioned fiber.

[0015] Furthermore, the anchoring conduit is woven from a rigid yarn and 10-15 strands of the aforementioned fiber.

[0016] Furthermore, before and after the anchoring conduit is tightened, the anchoring conduit holds the seam tightly to prevent the seam from moving relative to the anchoring conduit.

[0017] Both the anchoring tube and the self-locking tube tightly hold the suture, effectively preventing the suture from moving relative to either of them, thus maintaining a long-term anchored and locked state. During anchoring, external force can be used to pull the suture, overcoming the clamping force of both tubes and forcing the suture to move relative to either of them, thereby tightening the anchoring tube.

[0018] Furthermore, the suture is a single-layer braided thread made of multiple strands of fibers (bundles).

[0019] When preparing single-layer braided yarn, a spindle-type braiding machine is used. Multiple spindles with fibers wound on them are loaded onto the braiding machine. The main operating part of the machine is a stable working platform (vertical). Multiple strands of fibers pass through the small holes at the weave point and are wound onto the drum.

[0020] The platform surface has figure-eight shaped grooves connected by intersecting tangents. The spindle is placed in the groove and divided into two equal parts, which intersect each other evenly and move in opposite directions at the same speed. This process is repeated, and the machine rotates the spindle back and forth to weave a single layer of braided yarn.

[0021] Preferably, the suture is a single-layer braided thread made of 10-30 strands of fiber (bundle). More preferably, it is made of 15-18 strands of fiber (bundle).

[0022] Furthermore, the stitching is a double-layered braided thread with axial lining; Multiple spindles with fibers wound around them are mounted on a braiding machine, and a single-layer braiding thread is placed between multiple sets of spindles for synchronous braiding, so that multiple bundles of fibers are woven on the surface of the single-layer braiding thread to form a braided layer, thereby forming the axially backing double-layer braided thread.

[0023] Furthermore, the fiber is ultra-high molecular weight polyethylene fiber; the molecular weight of the ultra-high molecular weight polyethylene fiber is 1 million to 5 million.

[0024] Furthermore, the anchoring conduit, or the anchoring conduit and the self-locking conduit, are made of polypyrrole (PPy) and hydroxyapatite (Ca). 10 Anchor parts modified with (PO4)6(OH)2, HA, and polydopamine (PDA).

[0025] The anchor part is the portion that is inserted into the bone tissue installation hole (positioning hole).

[0026] The second aspect of this application discloses a method for modifying an anchor portion, which includes the following steps: S10. Immerse the anchor bolt portion in ferric chloride solution and ultrasonically soak for 10-30 minutes. S20. At 0℃, the anchor part is immersed in a 0.5~1M pyrrole solution. After the reaction is complete, a PPy nanofilm (black film) is formed on the surface of the anchor part, thereby obtaining a PPy anchor.

[0027] S30. Rinse the PPy anchor repeatedly with ethanol and / or deionized water to remove unreacted pyrrole monomers and ferric chloride from the surface of the PPy anchor, and then dry it. S40. Immerse the dried PPy anchors in a 0.1~0.5 M ferric chloride hexahydrate solution and soak them thoroughly (generally for more than 15 minutes) before taking them out. S50. (Using dipping or spraying) Coat the pyrrole dopamine mixed solution onto the surface of the PPy anchor. After sufficient polymerization, (using dipping or spraying) coat the surface of the PPy anchor with a Tris-HCl solution of pH 8.5. After sufficient polymerization again, PDA / PPy anchor is obtained. S60. Rinse the PDA / PPy anchors repeatedly with ethanol and / or deionized water to remove unreacted monomers and ferric chloride; then dry them under vacuum. S70. HA is deposited on PDA / PPy anchors using an electrodeposition method; wherein, the PDA / PPy anchors are used as the substrate for electrochemical deposition, and the electrolyte solution is a mixed solution containing 0.02~0.06M CaCl2, 0.015~0.04M KH2PO4 and 0.5~1M H2O2, and after sufficient deposition, the PDA / PPy / HA modified anchor portion is formed.

[0028] Furthermore, the molar ratio of calcium to phosphorus in the electrolyte solution is 1.67.

[0029] Furthermore, in step S70, a constant current mode is used, with a deposition current density of 2.5~5 mA / cm². 2 The temperature of the electrolyte solution is 40-60℃, more preferably 50℃; the deposition time is 1-2h.

[0030] Furthermore, the pyrrole-dopamine mixed solution contains 0.05~0.3M pyrrole and 0.05~0.3M dopamine.

[0031] Further, in step S20, the reaction time is 10-60 min; more preferably, the reaction time is 20-40 min.

[0032] Further, in step S10, the concentration of ferric chloride in the ferric chloride solution is 0.5~1 M.

[0033] Further, in step S10, the anchor pin portion is placed in a ferric chloride solution and ultrasonically soaked for 15 minutes.

[0034] Furthermore, in step S10, before immersing the anchor part in the ferric chloride solution, the anchor part is ultrasonically cleaned with anhydrous ethanol, acetone and / or deionized water to remove surface oil and impurities, and then dried at 70°C.

[0035] The ultra-high molecular weight polyethylene fiber has a molecular weight of 1 million to 5 million and has advantages such as high specific strength, high specific modulus, wear resistance, corrosion resistance, and outstanding impact resistance and cut resistance, which ensures the strength of the self-locking structural full-seam anchor.

[0036] By adopting the above technical solution, the present invention has the following beneficial effects: The present invention provides a self-locking full-suture anchor, which is made of soft fiber material, has a simple structure, and requires a small diameter positioning hole. When it is inserted into the positioning hole, the two ends of the suture are pulled tight. The contraction part of the suture tube will expand due to the volume difference between the suture and the fiber, forming a sealing structure with a large deformation. Furthermore, the self-locking part of the suture tube can fix the sealing structure, thereby forming the self-locking full-suture anchor into a ball of thread, which is firmly fixed in the positioning hole, thus improving the firmness of the self-locking full-suture anchor in the positioning hole. Attached Figure Description

[0037] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0038] Figure 1 This is a schematic diagram of the structure of the self-locking full-stitch anchor provided in Embodiment 1 of the present invention; Figure 2 for Figure 1 A schematic diagram showing the self-locking full-suture anchor after it has been inserted into the positioning hole; Figure 3 for Figure 1 The diagram shown illustrates the working principle of the self-locking full-stitch anchor. Figure 4 This is a bar chart showing the survival rate of osteoblasts from MC3T3-E1 mouse embryos in Example 6. Figure 5 Comparison of mineralization quality before and after mineralization for unmodified anchor samples, PDA-modified anchor samples, PDA / PPy-modified anchor samples, and PDA / PPy / HA-modified anchor samples; Figure 6 A comparative graph showing the mineralization quality growth rate of unmodified anchor samples, PDA-modified anchor samples, PDA / PPy-modified anchor samples, and PDA / PPy / HA-modified anchor samples; Figure 7 This is a schematic diagram of the structure of the self-locking full-stitch anchor provided in Embodiment 7 of the present invention; Figure 8This is a cross-sectional view of the self-locking full-stitch anchor provided in Embodiment 7 of the present invention.

[0039] Figure label: 1- Rigid yarn; 2- Multiple bundles of fibers; 10- Suture; 20- Self-locking suture tube; 21- Opening; 22- Threading port; 23- Side opening; 30- Anchoring suture tube; 40- Bone tissue; 41- Anchoring hole. Detailed Implementation

[0040] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0041] To facilitate understanding of the embodiments of this application, the main inventive concept of this application is first introduced as follows: To address the problems in existing technologies, such as insufficient deformation and inadequate knotting of fully sewn anchors, leading to insufficient anchor strength and easy detachment, this application divides the suture tube into a contraction section and a self-locking section. The suture tube is woven from sewn thread and fiber. The contraction section of the suture tube expands due to the volume difference between the sewn thread and fiber, forming a sealing structure with large deformation. The self-locking section of the suture tube forms a self-locking structure by pulling the sewn thread to tighten and fold, thus fixing the sealing structure and making the self-locking fully sewn anchor form a ball of thread, firmly fixed in the positioning hole, thereby improving the firmness of the self-locking fully sewn anchor in the positioning hole. In view of the problem that existing technologies require drilling large positioning holes in the bone tissue to be repaired, resulting in a large amount of bone removal, this application sets the diameter of the suture tube contraction section to be equal to the diameter of the traction suture, and sets the cross-sectional area of ​​the suture tube self-locking section to be twice the cross-sectional area of ​​the suture tube contraction section. This makes the size of the self-locking full suture anchor smaller, and therefore the diameter of the positioning hole required in the bone tissue to be repaired is smaller, thereby reducing the amount of bone removal and reducing damage to the human skeleton.

[0042] The present invention will be further explained below with reference to specific embodiments.

[0043] Example 1 like Figure 1-3 As shown, this embodiment provides a self-locking full-suture anchor, comprising: a suture 10, a self-locking suture tube 20, and an anchoring suture tube 30; one end of the suture 10 passes sequentially through the self-locking suture tube 20 and the anchoring suture tube 30 and then exits again from the self-locking suture tube 20; the self-locking suture tube 20 holds the suture 10 tightly to prevent the suture 10 from moving relative to the self-locking suture tube 20.

[0044] The anchoring conduit 30 is a first tubular body woven from one or more rigid yarns 1 and multiple bundles of fibers 2; see also Figure 2 and 3 As shown, in use, the anchoring tube 30, or the anchoring tube 30 and the self-locking tube 20, is placed into the anchoring hole 41 of the bone tissue 40. By pulling one or both ends of the suture 10, the anchoring tube 30 is tightened to form a ball of thread, thereby anchoring the suture 10 to the anchoring hole 41 of the bone tissue 40 together.

[0045] In this application, the rigid yarn 1 has a certain stiffness (or bending moment value). When the anchoring tube 30 is tightened to form a ball, the rigid yarn 1 forms a support structure inside the ball. The ball abuts against the inner wall of the anchoring hole 41 or seals the anchoring hole 41 from the inside, thereby anchoring and locking the thread 10. The self-locking tube 20 holds the thread 10 tightly, preventing the thread 10 from moving relative to it, thus maintaining the anchoring state of the anchoring tube 30 for a long time.

[0046] Preferably, the self-locking tube 20 is a second tubular body woven from one or more rigid yarns 1 and multiple bundles of fibers 2. The self-locking tube 20 and the anchoring tube 30 are separately provided. More preferably, the self-locking tube 20 and the anchoring tube 30 are integrally woven from one or more rigid yarns 1 and multiple bundles of fibers 2. The cavity of the first tubular body of the self-locking tube 20 is connected to the cavity of the second tubular body of the anchoring tube 30. At the same time, the cavity of the first tubular body is provided with an opening 21 on the outside of the second tubular body for the re-passing of the suture 10.

[0047] In this embodiment, the rigidity of the rigid yarn 1 is limited by the bending moment value. Specifically, the bending moment value of the rigid yarn 1 is 0.3 to 0.5 cN·cm.

[0048] To form the aforementioned rigid yarn, a twisting device (such as a doubling twister or a ring spinning machine) can be used to twist one or more of ultra-high molecular weight polyethylene fibers, polyester fibers, polyaramid fibers, or other fibers to obtain a twisted yarn with a twist of 50-200 twists / meter; wherein, the bending moment value of the rigid yarn is controlled by adjusting the twist.

[0049] During production or testing, the bending moment value of the twisted yarn is measured, and the twist is adjusted according to the measurement results until the rigid yarn 1 with a bending moment value of 0.3 to 0.5 cN·cm is obtained. For example, when the bending moment value of the twisted yarn is less than the above-mentioned bending moment threshold, its stiffness can be increased by increasing the twist; when the bending moment value of the twisted yarn is greater than the above-mentioned bending moment threshold, its bending moment value or stiffness can be reduced by decreasing the twist.

[0050] In numerous experiments with 2mm diameter anchor holes 41 in bone tissue 40, when the bending moment of the rigid yarn 1 is 0.3–0.5 cN·cm, the anchor tube 30 can withstand a maximum tensile force of 500–630 N after being inserted into the anchor hole 41. Most preferably, when the bending moment of the rigid yarn 1 is approximately 0.4 cN·cm, the anchor tube 30 can withstand a maximum tensile force of 630 N after being inserted into the anchor hole 41. In contrast, existing anchors with 2mm diameter anchor holes typically only have an anchoring force of 230–400 N.

[0051] Meanwhile, the applicant’s extensive testing has demonstrated that when the bending moment value of the stiffness of the rigid yarn 1 is less than 0.3 cN·cm, the anchoring force of the spherical anchoring tube 30 decreases rapidly, with a maximum of no more than 150 N, because the rigid yarn 1 cannot provide effective support.

[0052] When the bending moment of the rigid yarn 1 exceeds 0.5 cN·cm, due to the excessive stiffness of the rigid yarn 1, it is difficult to force the anchor tube 30 to tighten into a ball by normal tensioning one or both ends of the seam 10, thus causing its anchoring force to decrease rapidly. At the same time, due to the excessive stiffness or bending moment of the rigid yarn 1, the recovery force of the anchor tube 30 after being contracted exceeds the clamping force (or locking force) of the anchor tube 30 and the self-locking tube 20 on the gap 10, thus causing the spherical anchor tube 30 to quickly recover and unfold, thereby losing its anchoring ability.

[0053] The design diameter of the anchoring conduit 30 during braiding is 0.3~0.8 times the design outer diameter of the sewing thread 10 during braiding; the self-locking conduit 20 can be provided with a single hole (one cavity), through which both the inlet and outlet of the sewing thread 10 pass. The design diameter of the single hole of the self-locking conduit 20 during braiding is 0.5~1.5 times the design outer diameter of the sewing thread 10 during braiding; the self-locking conduit 20 can also be provided with a double hole structure, including two through holes, through which both the inlet and outlet of the sewing thread 10 pass. The design diameter of the through holes of the self-locking conduit 20 during braiding is 0.3~0.8 times the design outer diameter of the sewing thread 10 during braiding.

[0054] In summary, given a fixed material for the self-locking full-suture anchor, by controlling the diameters of the self-locking tube 20 and the anchoring tube 30, as well as the thickness of the suture 10, the clamping force of the anchoring tube 30 and the self-locking tube 20 on the gap 10 can be made greater than the self-restoring force of the spherical anchoring tube 30.

[0055] In this embodiment, the bending moment value of the fiber 2 is no higher than 0.2 cN·cm. Preferably, the bending moment value of the fiber 2 is 0.1-0.2 cN·cm. If the stiffness or bending moment value of the fiber 2 is too large, it will be impossible to force the anchor tube 30 to tighten into a ball by stretching one or both ends of the sewing thread 10 under normal human force, thereby causing its anchoring force to decrease rapidly. Also, if the stiffness of the fiber 2 is too large, the recovery force of the anchor tube 30 after being contracted will exceed the clamping force (or locking force) of the anchor tube 30 and the self-locking tube 20 on the gap 10, thereby causing the spherical anchor tube 30 to quickly recover and unfold, thus losing its anchoring ability. Of course, if the stiffness or bending moment value of the fiber 2 is too small, it will also lead to a decrease in the supporting force of the spherical anchor tube 30.

[0056] In this embodiment, the fiber 2 is an ultra-high molecular weight polyethylene fiber. The fineness of the fiber 2 is 5-100D; more preferably 75D.

[0057] The anchoring conduit 30 can be woven from 1-3 rigid yarns 1 and 5-20 strands of the fiber 2. In this embodiment, the anchoring conduit 30 is woven from 1 rigid yarn 1 and 10-15 strands of the fiber 2.

[0058] Before and after the anchoring conduit 30 is tightened, it holds the suture 10 tightly, preventing the suture 10 from moving relative to the anchoring conduit 30. Both the anchoring conduit 30 and the self-locking conduit 20 hold the suture 10 tightly, effectively preventing the suture 10 from moving relative to either of them, thus maintaining a long-term anchored and locked state. During anchoring, external force can be used to pull the suture 10, overcoming the holding forces of both, thereby forcing the suture 10 to move relative to either of them, and thus tightening the anchoring conduit 30.

[0059] The present invention provides a self-locking full-suture anchor, which is woven from soft fiber 2 material, has a simple structure, and requires a small diameter positioning hole. When it is inserted into the positioning hole, the two ends of the suture 10 are pulled tight. The contraction part of the suture tube will expand due to the volume difference between the suture 10 and the fiber 2, forming a sealing structure with a large deformation. Furthermore, the self-locking part of the suture tube can fix the sealing structure, thereby forming the self-locking full-suture anchor into a ball of thread, which is firmly fixed in the positioning hole, thus improving the firmness of the self-locking full-suture anchor in the positioning hole.

[0060] Example 2 This embodiment is basically the same as embodiment 1, except that: In this embodiment, the stitch 10 is a single-layer braided thread made of multiple strands of fiber 2.

[0061] The fiber 2 is ultra-high molecular weight polyethylene fiber. The molecular weight of the ultra-high molecular weight polyethylene fiber is 1 million to 5 million.

[0062] When preparing single-layer braided yarn, a spindle-type braiding machine is used. Multiple spindles with fibers 2 wound on them are loaded onto the braiding machine. The main operating part of the machine is a stable working platform (vertical). Multiple strands of fibers 2 pass through the small holes at the weave opening and are wound onto the roll.

[0063] The platform surface has figure-eight shaped grooves connected by intersecting tangents. A spindle is placed in these grooves and divided into two equal parts, which intersect each other evenly and move in opposite directions at the same rate. This process is repeated continuously, causing the machine to rotate the spindle back and forth to weave a single layer of braided yarn. Preferably, the thread 10 is a single layer of ultra-high molecular weight polyethylene braided yarn made of 10-30 strands of fiber 2 (bundles). More preferably, the thread 10 is made of 15-18 strands of fiber 2 (bundles).

[0064] Example 3 This embodiment is basically the same as embodiment 2, except that: In this embodiment, the stitch 10 is a double-layered braided thread with axial lining; the fiber 2 is ultra-high molecular weight polyethylene fiber. The molecular weight of the ultra-high molecular weight polyethylene fiber is 1 million to 5 million.

[0065] Multiple spindles with fibers 2 wound around them are mounted on a braiding machine, and a single-layer braiding thread is placed between multiple sets of spindles for synchronous braiding, so that multiple bundles of fibers 2 are braided on the surface of the single-layer braiding thread to form a braided layer, thereby forming a double-layer braided thread with axial lining of ultra-high molecular weight polyethylene.

[0066] Example 4 This embodiment is basically the same as embodiment 2, except that: In this embodiment, fiber 2 is polyarylate fiber, and a polyarylate single-layer braided suture is obtained.

[0067] Example 5 This embodiment is basically the same as embodiment 3, except that: In this embodiment, the fiber 2 is a polyaryl ester fiber, resulting in a polyaryl ester axially lining double-layer braided yarn.

[0068] According to the national standard GB / T 19975-2005, a computer-controlled tensile testing machine was used to test the sutures. The test conditions were: clamping distance of 200 mm; tensile speed of 250 mm / min. The breaking strength of the single-layer braided suture of Example 2, the axially liningd double-layer braided suture of Example 3, and the single-layer braided suture and axially liningd double-layer braided suture of Example 4 were measured respectively.

[0069] The test results are shown in Table 3 below.

[0070] Table 3 Comparison of breaking strength of sutures Note: The data comes from test results in publicly available literature. All sutures are of the United States Pharmacopeia standard size (No. 2) and the suture diameter is 2mm.

[0071] As shown in Table 3, the strength of the single-layer braided suture made of ultra-high molecular weight polyethylene fiber is 299.8 N, and the strength of the double-layer braided suture with axial lining is as high as 393 N, both of which are greater than the strength of the medical sutures described in the published literature.

[0072] Furthermore, comparisons between Examples 2 and 3, and between Examples 4 and 5, showed that the suture strength increased by 30-65% after axial yarn backing double-layer weaving treatment. Among these, polyaryl fiber, due to its low-cost advantage, has greater potential for promotion after double-layer weaving treatment.

[0073] Example 6 This embodiment is basically the same as embodiments 1-5, except that: In this embodiment, the anchoring conduit 30, or the anchoring conduit 30 and the self-locking conduit 20, is made of polypyrrole (PPy) and hydroxyapatite (Ca). 10 The anchor portion is modified with (PO4)6(OH)2, HA, and polydopamine (PDA). The anchor portion is inserted into the mounting hole (positioning hole) in the bone tissue.

[0074] This embodiment also discloses a method for modifying the anchor portion, which includes the following steps: S10. Immerse the anchor bolt portion in ferric chloride solution and ultrasonically soak for 10-30 minutes. S20. At 0℃, the anchor part is immersed in a 0.5~1M pyrrole solution. After the reaction is complete, a PPy nanofilm (black film) is formed on the surface of the anchor part, thereby obtaining a PPy anchor.

[0075] S30. Rinse the PPy anchor repeatedly with ethanol and / or deionized water to remove unreacted pyrrole monomers and ferric chloride from the surface of the PPy anchor, and then dry it. S40. Immerse the dried PPy anchors in a 0.1~0.5 M ferric chloride hexahydrate solution and soak them thoroughly (generally for more than 15 minutes) before taking them out. S50. (Using dipping or spraying) Coat the pyrrole dopamine mixed solution onto the surface of the PPy anchor. After sufficient polymerization, (using dipping or spraying) coat the surface of the PPy anchor with a Tris-HCl solution of pH 8.5. After sufficient polymerization again, PDA / PPy anchor is obtained. S60. Rinse the PDA / PPy anchors repeatedly with ethanol and / or deionized water to remove unreacted monomers and ferric chloride; then dry them under vacuum. S70. HA is deposited on PDA / PPy anchors using an electrodeposition method; wherein, the PDA / PPy anchors are used as the substrate for electrochemical deposition, and the electrolyte solution is a mixed solution containing 0.02~0.06M CaCl2, 0.015~0.04M KH2PO4 and 0.5~1M H2O2, and after sufficient deposition, the PDA / PPy / HA modified anchor portion is formed.

[0076] Furthermore, the molar ratio of calcium to phosphorus in the electrolyte solution is 1.67.

[0077] Furthermore, in step S70, a constant current mode is used, with a deposition current density of 2.5~5 mA / cm². 2 The temperature of the electrolyte solution is 40-60℃, more preferably 50℃; the deposition time is 1-2h.

[0078] Furthermore, the pyrrole-dopamine mixed solution contains 0.05~0.3M pyrrole and 0.05~0.3M dopamine.

[0079] Further, in step S20, the reaction time is 10-60 min; more preferably, the reaction time is 20-40 min.

[0080] Further, in step S10, the concentration of ferric chloride in the ferric chloride solution is 0.5~1 M.

[0081] Further, in step S10, the anchor pin portion is placed in a ferric chloride solution and ultrasonically soaked for 15 minutes.

[0082] Furthermore, in step S10, before immersing the anchor part in the ferric chloride solution, the anchor part is ultrasonically cleaned with anhydrous ethanol, acetone and / or deionized water to remove surface oil and impurities, and then dried at 70°C.

[0083] The ultra-high molecular weight polyethylene fiber 2 has a molecular weight of 1 million to 5 million and has advantages such as high specific strength, high specific modulus, wear resistance, corrosion resistance, and outstanding impact resistance and cut resistance, which ensures the strength of the self-locking structural full-seam anchor.

[0084] Test 1. CCK-8 cell proliferation and cytotoxicity detection 1) Using MC3T3-E1 mouse embryonic osteoblasts as the research object, Transwell permeable cell culture chambers were used for culture. 1 mL of cell suspension was seeded into each well of a 24-well plate, with a seeding quantity of 20,000 cells per well. (The specific number of cells per well needs to be determined based on factors such as cell size and cell proliferation rate).

[0085] 2) After the cells have adhered (about 24 hours), place the anchor material to be tested in each group into the upper chamber, add culture medium to cover the anchor material, and gently place the chamber into the well for co-culture with the cells.

[0086] 3) After culturing for 1 day, perform CCK8 detection. Replace 4.5 mL of fresh culture medium in each well and add 50 μL of CCK8 solution. Use wells with the corresponding amount of cell culture medium and wells without CCK8 as blank controls.

[0087] 4) Continue incubation in the cell culture incubator for 1-4 hours, and select a time point with a suitable absorbance value for subsequent detection.

[0088] 5) Measure the absorbance at 450 nm using an ELISA reader. The formula for calculating the relative cell proliferation rate (R) is: .

[0089] Among them, OD 490样 The average optical density of the sample at a wavelength of 490 nm is OD. 490对照 This represents the average optical density of the anchor portion at a wavelength of 490 nm.

[0090] 2. Biomineralization Experiment To investigate the biomineralization capacity of full-suture anchors, four groups of anchor samples—unmodified, PDA-modified, PDA / PPy-modified, and PDA / PPy / HA-modified—were first sterilized and dried in an autoclave. They were numbered according to the testing sequence, and their initial weights (W0) were recorded. Then, each group of samples was placed in a petri dish containing 10 mL of sterile simulated body fluid (SBF), with the pH controlled to approximately 7.4 according to testing requirements. The soaked petri dishes were then placed in a 37°C incubator containing 5% carbon dioxide for 10 days of mineralization deposition. After each deposition period, the samples were removed, cleaned, dried, and weighed, and the weights (W0) after mineralization at different times were recorded. d The mineralization quality proliferation rate (B) of the printed polyetheretherketone bone scaffold samples in different experimental groups was calculated.

[0091] The calculation method for the mineralization quality growth rate (B) is shown in the following formula: Mineralization quality growth rate B (%) = (W d -W0)×100 / W0 Among them, W d The measurement and weighing of the test samples in each experimental group after the number of days of biomineralization, and W0 is the initial weight of the samples in each experimental group before biomineralization.

[0092] 3. Results 3.1 Results of Cytotoxicity Experiments Figure 4 The survival rate of MC3T3-E1 mouse embryonic osteoblasts was measured. The MTT assay was used to analyze the survival rate of MC3T3-E1 cells cultured on different anchor samples for one day. After one day of culture with PDA / PPy / HA anchor samples, cell viability was 95.197%, indicating that cells could grow on PDA / PPy / HA anchor samples. Generally, cell viability exceeding 80% is considered to indicate that the material is non-toxic. The results demonstrate that the prepared PDA / PPy / HA modified anchor samples possess excellent bioactivity and biocompatibility.

[0093] 3.2 Results of Biomineralization Performance Test Figure 5 This is a comparison chart showing the mineralization quality of unmodified anchor samples, PDA-modified anchor samples, PDA / PPy-modified anchor samples, and PDA / PPy / HA-modified anchor samples before and after mineralization. Figure 6 The growth rate of mineralization quality is given for unmodified anchor samples, PDA-modified anchor samples, PDA / PPy-modified anchor samples, and PDA / PPy / HA-modified anchor samples.

[0094] pass Figure 5 and Figure 6 It can be seen that the weight gain rate of the unmodified anchor sample was 14.5%, the weight gain rate of the PDA-modified anchor sample was 16.39%, the weight gain rate of the PDA / PPy-modified anchor sample was 20.97%, and the weight gain rate of the PDA / PPy / HA-modified anchor sample was 22.34%. The mineralization quality growth rate showed an increasing trend, and the surface PDA / PPy / HA modified anchor sample exhibited the best biomineralization performance.

[0095] Example 7 This embodiment is basically the same as embodiments 1-6, except that: like Figure 7-8 As shown, in this embodiment, the self-locking conduit 20 has a threading port 22 at one end away from the anchoring conduit 30 for threading the suture 10 in and out.

[0096] Two side openings 23 are provided on both sides of the self-locking suture tube 20, connecting the inside and outside of the cavity of the self-locking suture tube 20; one end of the suture 10 passes through the two side openings 23 on one side of the self-locking suture tube 20 and then extends out of the threading opening 22, and the other end of the suture 10 passes through the two side openings 23 on the other side of the self-locking suture tube 20 and then extends out of the threading opening 22.

[0097] In this embodiment, two side openings 23 are respectively provided on both sides of the wall of the self-locking suture tube 20; each end of the suture 10 is bent and laid in the passage of the two side openings 23, the cavity and the threading opening 22, thereby greatly improving the locking ability of the suture tube 20 to lock the suture 10.

[0098] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A self-locking full-stitch anchor, characterized in that, include: Sutures, self-locking sutures, and anchoring sutures; One end of the suture passes through the self-locking tube and the anchoring tube in sequence, and then comes out of the self-locking tube again. The self-locking suture tube holds the suture tightly, preventing the suture from moving relative to the self-locking suture tube; The anchoring tube is a first tubular body woven from one or more rigid yarns and multiple fibers. In use, the anchoring tube is placed into the anchoring hole of the bone tissue. By pulling one or both ends of the suture, the anchoring tube is tightened to form a ball of thread, thereby anchoring the suture to the bone tissue.

2. The self-locking full-stitch anchor pin according to claim 1, characterized in that, The self-locking tube is a second tubular body woven from one or more rigid yarns and multiple fibers.

3. The self-locking full-stitch anchor according to claim 2, characterized in that, The self-locking tubing and the anchoring tubing are integrally woven from one or more rigid yarns and multiple fibers; the lumen of the first tubular body is connected to the lumen of the second tubular body, and the lumen of the first tubular body has an opening on the outside of the second tubular body for the re-passing of the suture.

4. The self-locking full-stitch anchor according to claim 1, characterized in that, The bending moment of the rigid yarn is 0.3 to 0.5 cN·cm.

5. The self-locking full-stitch anchor according to claim 1, characterized in that, The fiber has a fineness of 5-100D.

6. The self-locking full-stitch anchor according to claim 1, characterized in that, The anchoring conduit is woven from 1-3 rigid yarns and 5-20 strands of the aforementioned fiber.

7. The self-locking full-stitch anchor according to claim 1, characterized in that, Before and after the anchoring conduit is tightened, the anchoring conduit holds the seam tightly to prevent the seam from moving relative to the anchoring conduit.

8. The self-locking full-stitch anchor according to claim 1, characterized in that, The suture is a single-layer braided thread made of multiple strands of fiber.

9. The self-locking full-stitch anchor according to claim 1, characterized in that, The stitching is a double-layered braided thread with axial lining; Multiple spindles with fibers wound around them are mounted on a braiding machine, and a single-layer braiding thread is placed between the multiple sets of spindles for synchronous braiding, so that multiple bundles of fibers are woven on the surface of the single-layer braiding thread to form a braided layer, thereby forming the axially backing double-layer braided thread.

10. The self-locking full-stitch anchor according to claim 1, characterized in that, The fiber is ultra-high molecular weight polyethylene fiber or polyarylate fiber.

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