Application of Zinc or Zinc Alloy Wire as Medical Suture and Medical Braided Suture

Abstract

The present invention provides an application of zinc or zinc alloy wire as a medical suture and a medical braided suture. The zinc or zinc alloy wire is a drawn wire with a diameter of 0.25 to 0.35 mm. It can be directly used as a pure metal suture or used as an inner core to prepare a braided suture. Both types of sutures can be directly used for suturing or as a supporting suture for suture anchors, and are applied to the suture repair of tendons, labrum, and ligaments. The degradation time of zinc metal and the suture strength can meet the suture requirements of tendon-bone insertion points. The degradation products can induce bone formation, exhibit good osteoinductive properties, and promote osteogenic differentiation and healing of tendon-bone insertion points.

Description

Technical Field

[0001] The present invention relates to the technical field of biomedical applications, and particularly relates to the application of zinc or zinc alloy wire as a medical suture and a medical braided suture. Background Art

[0002] In glenoid labrum repair, reconstruction, and ligament and tendon suture surgeries, suture - attached anchors are the most commonly used direct fixation devices at present. During surgery, suture - attached anchors are routinely used to connect soft tissues (such as ligaments and tendons) to bones. The anchor is used for fixation, providing a press - fit between the bone, the graft / tendon, and the anchor; the suture is used to suture ligaments, tendons, etc. and fix them in their proper positions in the human body, also playing a crucial role.

[0003] Current sutures mainly include absorbable sutures and non - absorbable sutures. The latter includes three categories: natural materials, metal materials, and synthetic materials. Among them, pure metal sutures have high strength and minimal tissue reaction, do not change their properties in tissues, and are easy to disinfect and sterilize. However, they have disadvantages such as being time - consuming and difficult to tie knots, which also limit their popularization and application to a certain extent.

[0004] Degradable metal materials represented by Mg have certain advantages due to their good biocompatibility and the need not for a second operation to remove them. However, due to the active chemical properties of Mg element, its degradation rate in the body is very fast and hydrogen gas (H2) is generated, forming a layer of magnesium hydroxide (Mg(OH)2) protective film on the surface. High - concentration chloride ions (Cl - ) in the physiological environment can further dissolve Mg(OH)2, thus exacerbating its corrosion degree and accelerating the degradation rate. On the other hand, the relatively limited mechanical strength of Mg alloys often causes the suture - attached anchor to rupture during implantation, affecting its application. Summary of the Invention

[0005] Aiming at the deficiencies in the prior art, the main purpose of the present invention is to provide the application of zinc or zinc alloy wire as a medical suture and a medical braided suture. Zinc or zinc alloy wire with a diameter of 0.25 - 0.35 mm can be directly used as a pure - metal suture, can be directly used for suturing or as a supporting suture for suture - attached anchors, and is applied to the suture repair of tendons, glenoid labrum, and ligaments. The degradation time of zinc metal and the suture strength can meet the suture requirements at the tendon - bone insertion point. The degradation products can induce bone formation, exhibit good osteoinductive properties, and promote osteogenic differentiation and healing at the tendon - bone insertion point.

[0006] To achieve the above - mentioned purpose, according to the first aspect of the present invention, a medical suture zinc or zinc alloy wire is provided.

[0007] The medical suture zinc or zinc alloy wire is a drawn wire with a diameter of 0.25 - 0.35 mm.

[0008] Further, the breaking strength of the zinc or zinc alloy wire is 130 N.

[0009] To achieve the above object, according to the second aspect of the present invention, a medical braided suture is provided.

[0010] The medical braided suture includes a metal inner core and a yarn layer coated on the outer side of the metal inner core; wherein, the metal inner core is a zinc or zinc alloy wire, and the zinc or zinc alloy wire is a drawn wire with a diameter of 0.25 - 0.35 mm.

[0011] Further, the material of the yarn layer is ultra-high molecular weight polyethylene or cellulose fiber filaments;

[0012] Preferably, the breaking strength of the zinc or zinc alloy wire is 130 N;

[0013] Preferably, the weight percentage of the yarn layer is 30 - 70%.

[0014] Preferably, the weight percentage of the yarn layer is 40%, 55% or 64%.

[0015] Further, the diameter of the medical braided suture is 0.5 - 0.6 mm, and the breaking strength ≥ 223.76 N.

[0016] To achieve the above object, according to the third aspect of the present invention, a method for preparing a medical braided suture is provided.

[0017] The method for preparing the medical braided suture includes the following steps:

[0018] Prepare a metal inner core;

[0019] Use a braiding method to wind and braid multiple yarns on the outer side of the metal inner core to form a yarn layer.

[0020] Further, 16 yarns are wound and braided on the outer side of the metal inner core to form the yarn layer, and the thickness of each yarn is 100 - 110 dtex.

[0021] Further, the metal inner core is prepared by a drawing process; the specific process of the drawing process is: a billet with a diameter of 10 mm is repeatedly drawn and heat-treated to obtain a zinc or zinc alloy wire.

[0022] To achieve the above object, according to the fourth aspect of the present invention, a specific application of a zinc or zinc alloy wire as a medical suture is provided.

[0023] The application of the zinc or zinc alloy wire as a medical suture in tendon-bone insertion suture.

[0024] The application of the zinc or zinc alloy wire as a medical suture in tendon, glenoid labrum, and ligament suture.

[0025] To achieve the above object, according to the fifth aspect of the present invention, there is provided an application of a medical braided suture.

[0026] The application of the medical braided suture in tendon-bone insertion suture.

[0027] The application of the medical braided suture in tendon, glenoid labrum, and ligament suture.

[0028] The zinc or zinc alloy wire in the present invention can be directly used as a pure metal suture, and can be directly used for suture or as a supporting suture for suture anchors. It is applied to the suture repair of tendons, glenoid labrums, and ligaments. The degradation time of zinc metal and the strength of the suture can meet the suture requirements of tendon-bone insertion. The degradation products can induce bone formation, exhibit good osteoinductive properties, and promote osteogenic differentiation and healing of tendon-bone insertion.

[0029] The breaking strength of the zinc or zinc alloy wire used as a pure metal suture in the present invention is 130 N, with high strength.

[0030] The medical braided suture in the present invention uses a high-strength zinc or zinc alloy wire as its inner core part, which can not only utilize the degradable metal to accelerate tendon-bone healing, but also further improve the overall strength of the suture to adapt to higher breaking forces.

[0031] The present invention combines a metal inner core with a braiding process to obtain a braided suture with a zinc wire inside and a yarn layer outside, which can not only make up for the disadvantage that pure metal sutures are difficult to knot, but also take into account the advantage of the degradable metal to accelerate tendon-bone healing.

[0032] The zinc or zinc alloy wire and the medical braided suture in the present invention can both be applied to the suture at tendon-bone insertion sites such as tendons, ligaments, and glenoid labrums. As a supporting suture for suture anchors, they can also be further extended and used for sutures in other fields. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] By reading the following detailed description of the preferred embodiments, various other advantages and benefits will become clear to those of ordinary skill in the art. The drawings are only for the purpose of showing the preferred embodiments and are not considered to be a limitation of the present invention. Moreover, throughout the drawings, the same reference numerals are used to represent the same components. In the drawings:

[0034] Figure 1 is a side view of the medical braided suture provided in the embodiment of the present invention;

[0035] Figure 2 is a longitudinal sectional view of the medical braided suture provided in the embodiment of the present invention.

[0036] In the figure:

[0037] 1. Metal inner core; 2. Yarn layer. Detailed implementation mode

[0038] The exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided so that the present disclosure can be more thoroughly understood and the scope of the present disclosure can be completely conveyed to those skilled in the art.

[0039] Zinc is the second most abundant trace element in organisms, with high biological safety, and is the basis for cell physiology and human anatomy; at the same time, it participates in hundreds of enzymatic reactions, affecting human development, maturation, and the regulation of immune function. The average daily zinc intake of humans is 4 - 14 mg / day. As an implant material, the degradation rate of Zn is slower than that of Mg and faster than that of Fe, and it takes about two years to completely degrade, which is more suitable for the clinical needs of orthopedic implants and can meet the time required for suture degradation.

[0040] Therefore, the present invention provides a zinc or zinc alloy wire that can be used as a medical suture, has high mechanical properties, can be directly used for suturing or as a supporting suture for suture anchors, is applied to the suture repair of tendons, glenoid labrum, and ligaments, and the degradation products can induce bone formation, exert good osteoinductive properties, and promote osteogenic differentiation and healing at the tendon-bone insertion site.

[0041] The diameter of the zinc or zinc alloy wire medical suture in the present invention is 0.25 - 0.35 mm, preferably 0.3 mm, and this suture is a zinc wire or zinc alloy wire obtained by drawing a metal zinc or zinc alloy ingot.

[0042] At the same time, the present invention uses a conventional mechanical tester to measure the mechanical strength of this suture, and its breaking strength is 130 N, which is much better than the mechanical strength of current products on the market. For example, the breaking strength of the No. 2 suture with a polyester core from Arthrex is 120 N, and the breaking strength of some absorbable PE and PDO blended sutures from Johnson & Johnson is 110 N.

[0043] In view of the fact that the supporting sutures for suture anchors currently widely used in the fields of orthopedics and sports medicine for suturing tendon-bone insertion sites such as tendons, glenoid labrum, and ligaments are mostly composed of a single material and cannot fully take into account both the strength and biological effects of the suture, and the existing pure metal sutures also have the drawback of being difficult to knot, the present invention continues to innovate on the basis of the above-mentioned zinc or zinc alloy wire medical suture and provides a medical braided-like suture.

[0044] This medical braided-like suture can be directly used for suturing or as a supporting suture for suture anchors and is applied to the suturing of tendons, glenoid labrum, and ligaments.

[0045] As Figure 1 and Figure 2 shown, for the convenience of description, part of the metal inner core 1 in Figure 2 is exposed. The medical braided suture in the present invention comprises a metal inner core 1 and a yarn layer 2 coated on the outer side of the metal inner core 1; wherein, the metal inner core 1 is the above-mentioned zinc or zinc alloy wire.

[0046] For the first time, the suture of the present invention is composed of two parts, and the metal inner core 1 and the yarn layer 2 are fused. Of course, the metal inner core 1 can also be fused into a conventional suture. In actual use, it not only serves the purpose of suturing, but also can further enhance the strength of the suture, and can also utilize the characteristics of zinc metal as the metal inner core 1 to play a specific role at the sutured site, such as osteogenesis, promoting tendon-bone healing, reducing inflammatory reactions, etc.

[0047] In some embodiments of the present invention, the material of the yarn layer 2 can be ultra-high molecular weight polyethylene or cellulose fiber filaments.

[0048] In some embodiments of the present invention, the weight percentage of the yarn layer 2 is 30-70%.

[0049] For example, the weight percentage of the yarn layer 2 is 64%, and the weight percentage of the metal inner core 1 is 36%.

[0050] The weight percentage of the yarn layer 2 is 55%, and the weight percentage of the metal inner core 1 is 45%.

[0051] The weight percentage of the yarn layer 2 is 40%, and the weight percentage of the metal inner core 1 is 60%.

[0052] In some embodiments of the present invention, the diameter of the above-mentioned medical braided suture is 0.5-0.6 mm, and the breaking strength ≥ 223.76 N, which is much better than the mechanical strength of current products on the market. For example, the breaking strength of the German-American No. 2 UHMWPE suture is 170 N, the breaking strength of the Arthrex company's No. 2 suture with a polyester core is 120 N, and the breaking strength of some absorbable PE and PDO blended sutures of Johnson & Johnson is 110 N.

[0053] The medical braided suture in the present invention can not only make up for the shortcoming that metal sutures are difficult to knot, but also take into account high strength and good biological properties. It can not only be applied to the fields of orthopedics and sports medicine, but can also be further extended to sutures for other fields.

[0054] It is worth mentioning that the metal inner core 1 of the medical braided suture in the present invention is not limited to pure zinc wire and zinc alloy wire, and of course, other metal materials can also be tried for replacement.

[0055] To further illustrate the suture in the present invention, the present invention provides a method for preparing a medical braided suture.

[0056] The method for preparing the medical braided suture in the present invention includes the following steps:

[0057] (1) Prepare the metal inner core 1.

[0058] In an embodiment of the present invention, the metal inner core 1 is prepared by a drawing process. The specific process of the drawing process is as follows: A billet with a diameter of about 10 mm, which is made by forging and rolling after conventional heat treatment annealing, is repeatedly drawn and heat-treated to obtain a zinc wire with a diameter of 0.25 - 0.35 mm as the metal inner core 1. Of course, this metal inner core 1 can also be directly used as the suture of a suture anchor.

[0059] (2) Use a braiding method to wind and braid multiple strands of yarns on the outside of the metal inner core 1 to form a yarn layer 2.

[0060] In an embodiment of the present invention, a thread roller wrapped with the metal inner core 1, such as pure zinc wire, is installed on a braiding machine. The rotation speed is adjusted to 1000 - 1300 r / min and the pitch is adjusted to 2 - 4 mm. The spindles equipped with yarns, such as ultra-high molecular weight polyethylene with a fineness of 110 dtex, are driven by the motor on the braiding machine to move crosswise around the pure zinc wire, and the yarns are braided around the pure zinc wire to form a yarn layer 2, obtaining a medical braided suture. During the braiding process, as the braiding progresses, the thread roller wrapped with the medical braided suture is synchronously wound to complete the overall preparation of the medical braided suture (with a diameter of 0.5 - 0.6 mm).

[0061] In an embodiment of the present invention, 16 strands of yarns are wound and braided on the outside of the metal inner core 1, such as 16 strands of ultra-high molecular weight polyethylene are wound and braided to form a yarn layer 2, and the fineness of each strand of yarn is 110 dtex.

[0062] As mentioned above, the above is only a preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims

1. Application of a medical braided suture in the preparation of a braided suture product for tendon-bone insertion suture, characterized in that The medical imitation braided suture comprises a metal inner core and a yarn layer coated on the outer side of the metal inner core; wherein, the metal inner core is a zinc or zinc alloy wire, the zinc or zinc alloy wire is a drawn wire with a diameter of 0.25-0.35 mm; the breaking strength of the zinc or zinc alloy wire is 130 N; the material of the yarn layer is ultra-high molecular weight polyethylene or cellulose fiber filaments, and the weight percentage of the yarn layer is 30-70%; The preparation of the medical imitation braided suture comprises the following steps: Preparing a metal inner core; Using a braiding method to wind and braid multiple yarns on the outer side of the metal inner core to form a yarn layer.

2. The application according to claim 1, characterized in that, The diameter of the medical imitation braided suture is 0.5-0.6 mm, and the breaking strength ≥ 223.76 N.

3. The application according to claim 1, characterized in that, In the preparation of the medical imitation braided suture, 16 yarns are wound and braided on the outer side of the metal inner core to form the yarn layer, and the thickness of each yarn is 110 dtex.

4. The application according to claim 1, characterized in that, In the preparation of the medical imitation braided suture, the metal inner core is prepared by a drawing process; the specific process of the drawing process is: a blank ingot with a diameter of 10 mm is subjected to repeated drawing and heat treatment to obtain a zinc or zinc alloy wire.

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