CN113274078A

Movatterモバイル変換

Info

Publication number: CN113274078A
Application number: CN202110370935.9A
Authority: CN
Inventors: 马嘉丽; 崔立国; 高战团; 崔毅; 庄秀丽
Original assignee: CHANGCHUN SINOBIOMATERIALS CO LTD
Current assignee: CHANGCHUN SINOBIOMATERIALS CO LTD
Priority date: 2021-04-07
Filing date: 2021-04-07
Publication date: 2021-08-20

Abstract

The invention discloses a medical suture and a preparation method thereof, wherein the medical suture comprises the following components: a needle portion and a suture portion formed by integrally molding an absorbable material; the joint strength of the needle sewing part and the suture part is equal to the tensile strength of the suture part. The suture needle part and the suture part of the embodiment of the invention are made of absorbable materials, so that the biocompatibility of the medical suture can be effectively improved, and the problem of adverse reaction caused by the introduction of a suture needle in the suture process of the medical suture in the prior art is solved; the needle sewing part and the suture part are integrally formed, so that the problem that the needle sewing part and the suture part are connected in the prior art is solved, the convenience of operation is enhanced, and the use safety of the medical suture is improved.

Description

Medical suture and preparation method thereof

Technical Field

The invention relates to the technical field of medical materials, in particular to a medical suture and a preparation method thereof.

Background

The medical suture line refers to a special medical line used for ligation hemostasis, suture hemostasis and tissue suture in surgical operations. The ideal medical suture line is stable in vivo, is not easy to break and has small tissue reaction.

When the existing medical suture is used, the suture needs to be matched with a suture needle for use. In the preparatory phase prior to use, it is necessary to attach the suture to the needle. For operators, the connection operation between the two is inconvenient, and the time spent is long; and the connection between the suture line and the suture needle is not firm enough and is easy to break in the suture process, thereby bringing much inconvenience to the operation of doctors.

Most of the existing suture needles are stainless steel needles, the stainless steel belongs to non-absorbable materials, the biocompatibility is poor, inflammation is easy to occur to an organism in the using process, and then healing of the organism is affected. In addition, bacteria are easily introduced into the connection process of the suture and the suture, and the bacteria easily grow at the connection part of the suture and the suture, so that the suture is infected by the bacteria, and the problem of bacterial infection at the connection part is caused.

Disclosure of Invention

Aiming at the problems in the prior art, the invention provides a medical suture with integrally formed needles and threads and a preparation method thereof, which can effectively improve the safety of the medical suture.

The present invention provides, in a first aspect, a medical suture comprising: a needle portion and a suture portion formed by integrally molding an absorbable material; the joint strength of the needle sewing part and the suture part is equal to the tensile strength of the suture part.

The invention provides a method for preparing a medical suture in a second aspect, which comprises the following steps: integrally spinning the absorbable material to prepare a wire of the suture line; and forming a needle sewing part at the end of the thread material to obtain a needle and thread integrated suture.

Compared with the prior art, the embodiment of the invention at least has the following beneficial effects:

1. the suture needle part and the suture part of the embodiment of the invention are made of absorbable materials, so that the prepared medical suture has good biocompatibility, and adverse reactions of organisms caused by poor biocompatibility of a stainless steel suture needle in the prior art are overcome.

2. The medical suture line is manufactured by integrally forming the needle sewing part and the suture part, so that the problem that the needle sewing part and the suture part are not firmly connected in the prior art can be solved, and the infection risk caused by bacteria due to the connection of the needle sewing part and the suture part can be avoided; therefore, the convenience in the operation process of the medical suture is enhanced, and the use safety of the medical suture is improved.

3. The medical suture line provided by the embodiment of the invention is prepared by adopting a preparation method in the textile field, so that the preparation process is simplified, and the applicability of the medical suture line is improved.

Drawings

Fig. 1 is a schematic structural view of a suture for traditional Chinese medicine in example 1 of the present invention.

10, a sewing needle part, 20 and a sewing line part.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. It is to be understood that the embodiments described are only a few embodiments of the present invention, and not all embodiments. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, are within the scope of the present invention.

Embodiments of the present invention provide, in a first aspect, a medical suture, including: a needle portion and a suture portion formed by integrally molding an absorbable material; the joint strength of the needle sewing part and the suture part is equal to the tensile strength of the suture part. Therefore, the needle sewing part and the suture part of the embodiment of the invention are made of absorbable materials, so that the biocompatibility of the medical suture can be effectively improved, and the problem of adverse reaction caused by the introduction of a needle in the suture process of the medical suture in the prior art is solved; the needle sewing part and the suture part are integrally formed, so that the problem that the needle sewing part and the suture part are connected in the prior art is solved, the convenience of operation is enhanced, and the use safety of the medical suture is improved.

In a further embodiment, the absorbable material is a polymer formed from one or more of the monomers dioxanone, lactide, glycolide, and caprolactone. Therefore, the selected proper absorbable material not only can effectively improve the absorption stability and the connection mechanical strength of the medical suture, but also can realize the adjustment of the degradation period of the medical suture according to different tissue requirements.

In a further embodiment, the copolymer is a copolymer of p-dioxanone and caprolactone or a copolymer of lactide and glycolide.

In a further embodiment, the suture portion is a single strand suture. Therefore, the single-strand suture is used as the suture part, so that on one hand, the resistance of the suture part can be reduced in the suture process, and the adhesion of bacteria to the medical suture in the suture process due to too large resistance is avoided; on the other hand, the connecting strength of the sewing needle part and the sewing line part can be improved, and the problem that the connecting part of the sewing needle part and the sewing line part is broken is avoided.

In a further embodiment, the shape of the needle sewing part is a linear type or a bending type, and the shape of the needle point of the needle sewing part is a round needle or an angle needle.

Embodiments of the present invention provide, in a second aspect, a method of making a medical suture according to embodiments of the present invention, the method comprising the steps of: integrally spinning the absorbable material to prepare a wire of the suture line; and forming a needle sewing part at the end of the thread material to obtain a needle and thread integrated suture. Therefore, the preparation process of the medical suture is simplified.

In a further embodiment, the absorbable material is integrally spun to produce a suture strand, comprising: making absorbable nascent fiber from absorbable material; sequentially carrying out cooling treatment, hot water drawing treatment, hot air drawing treatment and heat setting treatment on the absorbable nascent fiber to obtain an absorbable wire; and cutting the absorbable wire to obtain the wire of the suture line with the preset length. Therefore, the thread of the suture can be prepared by the preparation method in the textile field, and the preparation process of the thread is simplified.

In a further embodiment, the method of making further comprises: and covering a coating on the needle part of the needle and thread integrated suture to obtain the suture with the coating. Thus, the strength of the needle portion of the medical suture can be improved, and the medical suture can smoothly pierce the tissue at the sutured site.

In a further embodiment, forming a stitch portion at the wire end includes: placing the end part of the wire rod in a heating area for heating treatment; rapidly transferring the heated end of the wire to a molding area, and performing molding treatment on the molding area, thereby forming a stitch portion intermediate body with a specific shape at the end of the wire; and machining the sewing needle part intermediate body to form a needle point, thereby obtaining the sewing needle part. From this, through carrying out heat treatment to the one end of wire rod to change the inside mode of arranging of absorbable material molecular structure of wire rod tip, and then improve the intensity of wire rod tip. In addition, the plasticity of the wire can be improved through heating treatment, so that the end parts of the wire can be formed into different shapes, and the diversity of the medical suture structure is improved.

In a further embodiment, the heating treatment of the wire ends in a heating zone comprises: coating a volatile glue solution on the end part of the wire rod, and forming a gluing section after a solvent of the volatile glue solution is volatilized; and placing the adhesive section of the wire rod in a heating area for heating treatment. Thereby forming a coating layer by applying a volatile glue solution to the end of the wire, thereby improving the strength of the end of the wire.

In a further embodiment, the heating treatment of the wire ends in a heating zone comprises: coating liquid reaction type glue on the end part of the wire rod, and forming a gluing section after the reaction type glue is reacted and cured; and placing the adhesive section of the wire rod in a heating area for heating treatment. Thus, the strength of the end of the wire is improved by applying the liquid reaction type glue to the end of the wire to form a coating.

In further embodiments, the temperature of the heat treatment is above the glass transition temperature of the absorbable material and below the viscous flow temperature or melting point; therefore, by adopting the temperature range, the plasticity of the wire can be improved while the original state of the wire is ensured.

In a further embodiment, the solute in the volatile gum solution is polylactic acid or polylactic acid-glycolic acid copolymer, and the solvent in the volatile gum solution is chloroform, dichloromethane or acetone. Therefore, the absorbable material is adopted as the solute in the volatile glue solution, and the biocompatibility of the medical suture can be effectively improved.

In a further embodiment, the reactive glue is a photosensitive reactive glue, an a and B component reactive glue, an oxygen catalyzed reactive glue, a moisture catalyzed reactive glue, or a heated reactive glue.

It is further noted that any range recited herein includes the endpoints and any values therebetween and any subranges subsumed therein or any values therebetween unless otherwise specified.

The following medical sutures were prepared in a sterile environment.

Example 1

A medical suture comprises aneedle sewing part 10 and asuture part 20, wherein the needle sewingpart 10 and thesuture part 20 are formed by integrally molding polylactic acid (polylactide); the joint strength of the needle portion and the stitch portion is equal to the tensile strength of the stitch portion.

The preparation method of the medical suture comprises the following steps: s101, preparing absorbable nascent fiber from polylactic acid, and sequentially carrying out cooling treatment, hot water drafting treatment, hot air drafting treatment and heat setting treatment on the absorbable nascent fiber to obtain an absorbable wire; and then cutting the absorbable wire to obtain the wire with the preset length of the suture. S102, dissolving polylactic acid in dichloromethane to obtain a volatile glue solution; coating a volatile glue solution on the end part of the wire rod, and forming a gluing section after dichloromethane in the volatile glue solution is volatilized; placing the adhesive section of the wire rod in a heating zone for heating operation, and ending the heating operation until the temperature of the end part of the wire rod is higher than the glass transition temperature of the polylactic acid and lower than the viscous flow temperature of the polylactic acid; then, quickly transferring the heated end of the wire to a die pressing area, and carrying out die pressing treatment on the die pressing area to form a bent stitch part; the curved needle portion is machined to form a needle tip of the needle portion.

And (3) performance testing:

while the needle-thread joining strength of the absorbable medical suture thread available on the market under USP0 No. (thread diameter of 0.400 to 0.499) was 17.25N, the joining strength of the needle portion and the suture portion of the medical suture thread of the same specification of this example was 105.0N, which was consistent with the thread tensile strength of the suture thread.

The needle-thread connecting strength of the medical suture line provided by the embodiment of the invention is far higher than that of the commercially available medical suture line.

Example 2

A medical suture comprises a needle sewing part and a suture part, wherein the needle sewing part and the suture part are formed by integrally molding polylactide glycolide; the joint strength of the needle portion and the stitch portion is equal to the tensile strength of the stitch portion. Wherein the polylactide glycolide is formed by polymerizing lactide monomers and glycolide monomers according to the proportion of 90: 10.

The preparation method of the medical suture comprises the following steps: s101, preparing absorbable nascent fibers from polylactide glycolide, and sequentially carrying out cooling treatment, hot water drafting treatment, hot air drafting treatment and heat setting treatment on the absorbable nascent fibers to obtain absorbable wire rods; and then cutting the absorbable wire to obtain the wire with the preset length of the suture. S102, placing the end part of the wire rod in a heating area for heating operation, and ending the heating operation until the temperature of the end part of the wire rod is higher than the glass transition temperature of the polylactide glycolide and lower than the viscous flow temperature of the polylactide glycolide; then, quickly transferring the heated end of the wire to a die pressing area, and carrying out die pressing treatment on the die pressing area to form a bent stitch part; the curved needle portion is machined to form a needle tip of the needle portion.

And (3) performance testing:

while the absorbable medical suture thread available on the market under USP0 No. (thread diameter of 0.400-0.499) was tested for the joint strength between the needle portion and the suture portion and was found to be 17.25N, the joint strength between the needle portion and the suture portion of the medical suture thread of the same specification of this example was found to be 98.3N, which is also found to be consistent with the tensile strength of the thread material.

Example 3

A medical suture comprises a needle sewing part and a suture part, wherein the needle sewing part and the suture part are integrally formed by polylactic acid; the joint strength of the needle portion and the stitch portion is equal to the tensile strength of the stitch portion.

The preparation method of the medical suture comprises the following steps: s101, preparing absorbable nascent fiber from polylactic acid, and sequentially carrying out cooling treatment, hot water drafting treatment, hot air drafting treatment and heat setting treatment on the absorbable nascent fiber to obtain an absorbable wire; and then cutting the absorbable wire to obtain the wire with the preset length of the suture. S102, coating liquid photosensitive reaction type glue on the end part of the wire rod, and forming a gluing section after the photosensitive reaction type glue reacts and solidifies; placing the adhesive section of the wire rod in a heating zone for heating operation, and ending the heating operation until the temperature of the end part of the wire rod is higher than the glass transition temperature of the polylactic acid and lower than the melting point of the polylactic acid; then, quickly transferring the heated end of the wire to a die pressing area, and carrying out die pressing treatment on the die pressing area to form a bent stitch part; the curved needle portion is machined to form a needle tip of the needle portion.

And (3) performance testing:

Example 4

A medical suture and a method for preparing the same, and performance tests were conducted as in example 3, except for the step S102 in the preparation method.

S102: placing the end part of the wire rod in a heating zone for heating operation, and ending the heating operation until the temperature of the end part of the wire rod is higher than the glass transition temperature of the polylactic acid and lower than the melting point of the polylactic acid; then, quickly transferring the heated end of the wire to a die pressing area, and carrying out die pressing treatment on the die pressing area to form a bent stitch part; the curved needle portion is machined to form a needle tip of the needle portion. The needle portion is coated with a coating of an absorbable material.

In the description herein, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, various embodiments or examples and features of different embodiments or examples described in this specification can be combined and combined by one skilled in the art without contradiction.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.

The above description is only for the specific embodiments of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art can easily conceive of the changes or substitutions within the technical scope of the present invention, and all the changes or substitutions should be covered within the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the appended claims.

Claims

1. A medical suture, comprising:

a needle portion and a suture portion formed by integrally molding an absorbable material; the joint strength of the needle sewing part and the suture part is equal to the tensile strength of the suture part.

2. The medical suture of claim 1, wherein the absorbable material is a polymer formed from one or more monomers selected from the group consisting of p-dioxanone, lactide, glycolide, and caprolactone; preferably, the copolymer is a copolymer of p-dioxanone and caprolactone or a copolymer of lactide and glycolide.

3. A method of preparing a medical suture according to any of claims 1 to 2, comprising the steps of:

integrally spinning the absorbable material to prepare a wire of the suture line;

and forming a needle sewing part at the end of the thread material to obtain a needle and thread integrated suture.

4. The method for preparing according to claim 3, further comprising; and covering a coating on the needle part of the needle and thread integrated suture to obtain the suture with the coating.

5. The manufacturing method according to claim 3, wherein forming a stitch portion at the wire end portion includes:

placing the end part of the wire rod in a heating area for heating treatment;

rapidly transferring the heated end of the wire to a molding area, and performing molding treatment on the molding area, so as to form a stitch intermediate body with a specific shape at the end of the wire;

and machining the sewing needle part intermediate body to form a needle point, thereby obtaining the sewing needle part.

6. The method according to claim 5, wherein the heating treatment of the wire end by placing the wire end in a heating zone comprises:

coating a volatile glue solution on the end part of the wire rod, and forming a gluing section after a solvent of the volatile glue solution is volatilized;

and placing the adhesive section of the wire rod in a heating area for heating treatment.

7. The method according to claim 5, wherein the heating treatment of the wire end by placing the wire end in a heating zone comprises:

coating liquid reaction type glue on the end part of the wire rod, and forming a gluing section after the reaction type glue is solidified;

8. The method of any one of claims 5 to 7, wherein the temperature of the heat treatment is above the glass transition temperature of the absorbable material and below the viscous flow temperature or melting point.

9. The method according to claim 6, wherein the solute in the volatile gum solution is polylactic acid or polylactic acid-glycolic acid copolymer, and the solvent in the volatile gum solution is chloroform, dichloromethane or acetone.