WO2020168652A1

WO2020168652A1 - Hollow porous partially absorbable suture and preparation method

Info

Publication number: WO2020168652A1
Application number: PCT/CN2019/089241
Authority: WO
Inventors: 王璐; 张倩; 林婧; 王富军; 高晶; 关国平; 刘晓凤
Original assignee: 东华大学
Priority date: 2019-02-20
Filing date: 2019-05-30
Publication date: 2020-08-27
Also published as: CN109770982A

Abstract

Provided are a hollow porous partially absorbable suture and a preparation method therefor. The hollow porous partially absorbable suture is prepared from non-absorbable braiding yarn (1) and absorbable axial yarn (2) by means of a two-dimensional triaxial braiding process and a thermal treatment process. The preparation method therefor comprises: first pre-forming the braiding yarn (1) and the axial yarn (2) on the surface of a lining tube (3), so as to obtain a suture with a porous surface, wherein the pore diameter is adjustable in the axial direction; then, after the thermal treatment process is carried out, the axial yarn (2) being partially fused to fix braid points of the braiding yarn (1); and finally, removing the lining tube (3), and obtaining a hollow porous suture with a stable structure. The suture is partially absorbable, and can guarantee mechanical support and also reduce the non-absorbable ratio; and a hollow porous structure facilitates tissue ingrowth, and promotes tissue regeneration, and when in use, the suture is stressed to be tape-shaped, thereby reducing the cutting of tissue. An integral forming technique combining braiding with thermal setting is used in the preparation method, and no after-treatment technique, such as welding and bonding, is needed, thus achieving simple procedures and convenient processing.

Description

Hollow porous part absorbable suture thread and preparation method

Technical field

The invention belongs to the technical field of biomedical textile products, and particularly relates to a hollow porous part absorbable orthopedic suture and a preparation method thereof.

Background technique

Tendon and ligament injuries are very common. Due to its special tissue structure and biological characteristics, self-healing ability is poor. Effective surgery is the main method to repair damaged tendons and ligaments. Suture is an important material for tendon and ligament repair, and its material, structure, mechanics and biological properties have an important impact on tendon and ligament repair, healing and regeneration. Due to the long repair time of tendons and ligaments, the mechanical properties of sutures are required to be high. Although absorbable sutures have better biological performance, due to hydrolysis and enzymatic hydrolysis in the body, their strength is easily reduced and the tendons/ligaments are lost. It is difficult to meet the repair requirements due to its mechanical support. At present, clinical orthopedic sutures are still dominated by non-absorbable sutures. Although non-absorbable sutures have good mechanical strength, they are beneficial to reduce the incidence of surgical failure caused by suture rupture during the repair and healing of tendons and ligaments. However, the long-term clinical use of non-absorbable sutures is not good, which is not conducive to tissue healing and regeneration. On the basis of meeting mechanical requirements, some absorbable sutures are prepared to reduce the proportion of non-absorbable materials and improve biological performance. Become a development trend. Scholars at home and abroad have done a lot of research on the effect of suture materials, but they have not paid enough attention to the structure. The cross-section of traditional sutures is mostly thin and round and compact. There are reports in the literature that thinner round sutures are easy to damage the organization. Cuts are produced, which leads to repair failure, and the tight structure is not conducive to tissue growth, which prolongs the healing time of the tissue and limits the healing effect. Therefore, further optimizing the suture material and structure, preparing a partially absorbable suture with a more excellent structure, reducing the cutting of the tissue and the poor long-term repair effect are still key problems to be solved.

The existing products and patents related to the new type of suture include: ① The Orthocord suture developed by Depuy and the patents with grant numbers US20050149118A1 and US008940018B2 reported that the sutures are high-strength partially absorbable sutures, although they effectively reduce non-absorbable components , But it is still a traditional round and compact structure, which is not conducive to tissue growth; ②The FiberTape suture developed by Arthrex is similar in shape to shoelaces and is flat ribbon-like. The cross section is different from the traditional round shape. -The tissue interface can better disperse the force, reduce the stress concentration, and reduce the cutting of the tissue. However, this kind of suture is also a compact structure, and its long-term use effect needs to be further verified; ③The publication number is US2018/0000480A1, CN107405145A 'S patent reported on the mesh suture thread and its application. The suture thread is composed of a tubular suture thread and an anti-twist rope element. However, the preparation of the tubular suture first and then the introduction of the anti-twist rope element increases the complexity of the preparation process. The introduction of the anti-twist rope The tubular suture may be damaged during the process.

Summary of the invention

The purpose of the present invention is to provide a new type of absorbable orthopedic suture with a hollow porous part that has excellent mechanical properties, reduces foreign body reactions, reduces the effect of sutures on tissue cutting, promotes tissue ingrowth, and accelerates tissue healing and regeneration, and a preparation method thereof.

In order to achieve the above objective, the present invention provides a hollow porous part absorbable suture, which is characterized in that its preparation method comprises: lining the non-absorbable woven yarn and the absorbable shaft yarn through a two-dimensional triaxial weaving process. The outer surface of the tube is preformed to obtain the surface porous suture. The obtained surface porous suture and the inner tube are heat-treated to melt the absorbable shaft yarn part, bond the knitting points of the non-absorbable braided yarn, and then remove the inner surface. The liner is obtained with a hollow porous part that can absorb sutures.

Preferably, the non-absorbable woven yarn can be made of non-absorbable materials such as polyester, polyethylene, polypropylene, etc., and the structure can be monofilament or multifilament.

Preferably, the absorbable shaft yarn is a covered yarn, wherein the outer yarn is absorbable polycaprolactone fiber, and the core yarn may be absorbable poly(p-dioxanone, poly(p-dioxanone) or poly(p-dioxanone) with a higher melting point than polycaprolactone). Lactic acid, poly(4-hydroxybutyrate) homopolymer or copolymer fiber material.

Preferably, the two-dimensional triaxial weaving process includes: preforming the outer surface of the non-absorbable knitting yarn and the absorbable shaft yarn on the inner lining tube by adjusting the knitting parameters to obtain the surface porous suture with the aperture on the suture spool Adjustable direction, absorbable shaft yarn does not participate in weaving.

More preferably, the heat treatment process includes: partially melting the outer covering yarn of the absorbable shaft yarn to make the knitting points of the non-absorbable knitting yarn adhere firmly, and finally removing the inner liner tube to obtain a hollow porous suture with a stable structure.

Preferably, the lining tube is made of polytetrafluoroethylene material, and the cross section can be round, square or racetrack-shaped.

Preferably, the holes are rhombus or triangles, with adjustable size, and the pore diameter is greater than 75 μm.

The present invention also provides a method for preparing the above-mentioned hollow porous part absorbable suture, which is characterized in that it comprises the following steps:

Step 1): Select the non-absorbable woven yarn material and the core yarn material of the absorbable shaft yarn, and select polycaprolactone as the outer yarn material of the absorbable shaft yarn;

Step 2): Wrap the outer yarn material that can absorb the shaft yarn on the core yarn material through a covering process to prepare the absorbable shaft yarn;

Step 3): Place the non-absorbable braided yarn material in step 1) on the knitting machine spindle, draw the absorbable shaft yarn prepared in step 2) through the center through hole of the angle gear bolt of the yarn carrier, and then use two Three-dimensional three-axis knitting process, by adjusting the knitting parameters, the non-absorbable knitting yarn and the absorbable shaft yarn are preformed on the outer surface of the inner lining tube to obtain the absorbable suture with the porous part of the surface;

Step 4): Put the surface porous suture thread in step 3) together with the inner lining tube in an oven for heat treatment. The heat treatment temperature is higher than the melting point of the absorbable shaft yarn and outer yarn polycaprolactone, and lower than the non-absorbable woven yarn and the Absorb the core yarn melting point of the shaft yarn, melt the outer covering yarn of the absorbable shaft yarn, and evenly melt the outer surface of the core yarn of the absorbable shaft yarn, bond the non-absorbable braided yarn weaving points, and then cool at room temperature to extract the inner lining Tube to obtain a hollow and porous part that can absorb sutures.

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

(1) The hollow porous part prepared by the present invention can absorb the suture thread. It is prepared by introducing a shaft yarn that does not participate in weaving, preferably a braided yarn and a shaft yarn, and adjusting the shape and size of the inner lining tube, weaving process parameters, heat treatment temperature and time The hollow porous part absorbable suture with adjustable size and pore size and stable structure can be obtained. This suture can maintain mechanical support, reduce foreign body reaction, facilitate tissue growth and regeneration, and accelerate repair and healing.

(2) The hollow porous part prepared by the present invention absorbs the suture thread. When the hollow structure is used, the suture thread is stressed in a belt shape, which reduces the cutting of the tissue; the bonded knitting point is beneficial to restrict fiber slippage and achieve high strength and low elongation.

(3) It adopts the integrated molding technology that combines weaving and heat setting, without welding, bonding and other finishing technologies, the process is simple and the processing is convenient.

(4) The hollow porous part absorbable suture of the present invention is particularly suitable for use as an orthopedic suture.

Description of the drawings

Figure 1 is a light micrograph of the hollow and porous part of the absorbable orthopedic suture;

Description of reference signs: 1 is a non-absorbable woven yarn, 2 is an absorbable shaft yarn, and 3 is an inner lining tube.

detailed description

The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope of the present invention. In addition, it should be understood that after reading the teachings of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the appended claims of the present application.

Example 1

As shown in Figure 1, this embodiment provides a hollow porous part absorbable suture. The preparation method includes: lining the non-absorbable woven yarn 1 and the absorbable shaft yarn 2 through a two-dimensional triaxial weaving process. The outer surface of the tube 3 is preformed to obtain a surface porous suture. The obtained surface porous suture and the inner tube 3 are heat-treated to melt the absorbable shaft yarn 2 and bond the knitting points of the non-absorbable knitting yarn 1 , And then remove the inner liner 3 to obtain a hollow and porous part absorbable suture.

The specific preparation steps of the hollow porous part absorbable orthopedic suture are as follows:

Step 1): Select FDA approved polypropylene monofilament (

Ethicon) is a non-absorbable woven yarn material, with a diameter of 0.15mm; polydioxanone monofilament (prepared by melt spinning) is selected as the core yarn material of absorbable shaft yarn, with a diameter of 0.10mm; Caprolactone multifilament (prepared by melt spinning) is an outer yarn material that can absorb a shaft yarn, with a diameter of 0.15mm;

Step 2): Using polydioxanone monofilament as the core yarn, the principle of hollow spindle is used to wrap the polycaprolactone multifilament on the outer layer of polydioxanone, and the coating twist is 450T/m ；

Step 3): Place the polypropylene monofilament in step 1) on the spindle of an 8-spindle knitting machine, and draw the two absorbable shaft yarns prepared in step 2) through the central through hole of the angle gear bolt of the yarn carrier, and then Using two-dimensional triaxial weaving process, by adjusting the weaving parameters, the non-absorbable woven yarn and the absorbable shaft yarn are racetrack-shaped in cross section, and the outer surface of the PTFE-lined tube is preformed. The length of the straight side of the raceway is 2mm, the radius of the semicircle is 0.25mm, and the porous part of the surface can be absorbed suture;

Step 4): Put the absorbable suture thread on the surface of the porous part in step 3) together with the inner lining tube in an oven for heat treatment. Set the heat treatment temperature to 80°C and the heat treatment time for 10 minutes. The melting point of caprolactone is lower than the melting point of non-absorbable woven yarn polyethylene and core yarn of absorbable shaft yarn poly-dioxanone, so that the outer yarn of absorbable shaft yarn is melted, and polycaprolactone is evenly melted and distributed On the surface of polydioxanone, bond the knitting points of non-absorbable braided yarn. After setting, cool at room temperature and extract the inner lining tube to obtain a uniform and stable hollow porous part absorbable suture.

The hollow porous part absorbs the suture thread. The part of the surface of the suture thread without shaft yarn is diamond-shaped, and the part with shaft yarn is triangular, with a hole diameter of 450 μm, and a breaking strength of 158N. It penetrates the tissue and is under a small tension. The shape of the belt is helpful to reduce the cutting of the tissue. Tests show that the force required for the suture to cut the pig's hindlimb tendon to fail is 49.4N.

Example 2

Step 1): Select FDA approved polypropylene monofilament (

Step 3): Place the polypropylene monofilament in step 1) on a 12-spindle knitting machine spindle, and draw the 3 absorbable shaft yarns prepared in step 2) through the center through hole of the angle gear bolt of the yarn carrier, and then Using two-dimensional triaxial weaving process, by adjusting the weaving parameters, the non-absorbable braided yarn and the absorbable shaft yarn are preformed on the outer surface of the PTFE lined tube with a diameter of 1.2mm and a circular cross section to obtain the surface The porous part can absorb sutures;

The hollow porous part can absorb sutures. The part of the surface of the suture thread without shaft yarn is diamond-shaped, and the part with shaft yarn is triangular. The hole diameter is 1.1mm. The breaking force is 269N. It penetrates the tissue and is under the action of small tension. , Has a ribbon shape, which is beneficial to reduce the cutting of tissues. Tests show that the force required for sutures to cut the pig's hindlimb tendons to fail is 52.8N.

Example 3

Step 1): Select FDA approved polypropylene monofilament (

Ethicon) is a non-absorbable woven yarn material with a diameter of 0.15mm; poly(4-hydroxybutyrate) monofilament (

Tepha) is the core yarn material that can absorb the shaft yarn, with a diameter of 0.10mm; polycaprolactone multifilament (prepared by melt spinning) is selected as the outer yarn material of the absorbable shaft yarn, with a diameter of 0.15mm;

Step 2): Take poly(4-hydroxybutyrate) monofilament as the core yarn, and apply the principle of hollow spindle to wrap the polycaprolactone multifilament on the outer layer of poly(4-hydroxybutyrate) monofilament. The twisting degree is 500T/m;

Step 3): Place the polypropylene monofilament in step 1) on a 12-spindle knitting machine spindle, and draw the 3 absorbable shaft yarns prepared in step 2) through the center through hole of the angle gear bolt of the yarn carrier, and then Using two-dimensional triaxial weaving process, by adjusting the weaving parameters, the non-absorbable braided yarn and the absorbable shaft yarn are pre-shaped on the outer surface of the PTFE lined tube with a diameter of 1.6mm and a circular cross section to obtain the surface The porous part can absorb sutures;

Step 4): Put the absorbable suture thread on the surface of the porous part in step 3) together with the inner lining tube in an oven for heat treatment. Set the heat treatment temperature to 80°C and the heat treatment time for 10 minutes. The melting point of caprolactone is lower than the melting point of non-absorbable woven yarn polyethylene and core yarn poly(4-hydroxybutyrate) of absorbable shaft yarn, so that the outer covering yarn of absorbable shaft yarn melts and the polycaprolactone is uniform It melts and distributes on the surface of poly(4-hydroxybutyrate) to bond the knitting points of non-absorbable braided yarn. After setting, it is cooled at room temperature and the inner lining tube is extracted to obtain a uniform and stable hollow porous part absorbable suture.

Said hollow porous part absorbs sutures. The part of the surface of the suture thread without shaft yarn is diamond-shaped, and the part with shaft yarn is triangular. The hole diameter is 1.8mm and the breaking force is 276N. It penetrates the tissue and is under the action of small tension. , In the shape of a ribbon, it is helpful to reduce the cutting of the tissue. The test shows that the force required for the suture to cut the pig's hindlimb tendon to fail is 58.7N.

Claims

A hollow and porous part absorbable suture is characterized in that the preparation method comprises: preforming the non-absorbable braided yarn and the absorbable shaft yarn through a two-dimensional triaxial weaving process on the outer surface of the inner liner to obtain a porous surface. Suture thread, heat treatment of the obtained surface porous suture thread together with the inner lining tube, so that the absorbable shaft yarn part is melted, the knitting points of the non-absorbable woven yarn are bonded, and then the inner liner tube is removed to obtain the hollow porous part absorbable Suture.
The hollow porous part absorbable suture thread according to claim 1, wherein the non-absorbable woven yarn can be made of polyester, polyethylene or polypropylene non-absorbable materials, and the structure can be monofilament or multifilament.
The hollow porous part absorbable suture thread of claim 1, wherein the absorbable shaft yarn is a covered yarn, wherein the outer yarn is absorbable polycaprolactone fiber, and the core yarn may have a melting point higher than that of polycaprolactone. Caprolactone absorbable polydioxanone, polylactic acid, poly(4-hydroxybutyrate) homopolymer or copolymer fiber material.
The hollow porous part absorbable suture according to claim 1, wherein the two-dimensional triaxial knitting process comprises: adjusting the knitting parameters to make the non-absorbable knitting yarn and the absorbable shaft yarn outside the inner lining tube The surface is pre-formed to obtain a porous suture on the surface, and the pore diameter is adjustable in the axial direction of the suture, and the absorbable shaft yarn does not participate in weaving.
The hollow porous part absorbable suture according to claim 1, wherein the inner liner tube is made of polytetrafluoroethylene material, and the cross section can be round, square or racetrack-shaped.
The hollow porous part absorbable suture according to claim 3, wherein the heat treatment process comprises: melting the outer part of the absorbable shaft yarn to make the knitting points of the non-absorbable knitting yarn adhere firmly, and finally remove the inner The liner obtains a structurally stable hollow porous suture.
The hollow porous part absorbable suture according to claim 1, wherein the hole is rhombus or triangle, the size is adjustable, and the pore diameter is greater than 75 μm.
The method for preparing the hollow porous part absorbable suture according to any one of claims 1 to 7, characterized in that it comprises the following steps:

Step 1): Select the non-absorbable woven yarn material and the core yarn material of the absorbable shaft yarn, and select polycaprolactone as the outer yarn material of the absorbable shaft yarn;

Step 2): Wrap the outer yarn material that can absorb the shaft yarn on the core yarn material through a covering process to prepare the absorbable shaft yarn;

Step 3): Place the non-absorbable braided yarn material in step 1) on the knitting machine spindle, draw the absorbable shaft yarn prepared in step 2) through the center through hole of the angle gear bolt of the yarn carrier, and then use two Three-dimensional three-axis knitting process, by adjusting the knitting parameters, the non-absorbable knitting yarn and the absorbable shaft yarn are preformed on the outer surface of the inner lining tube to obtain the absorbable suture with the porous part of the surface;

Step 4): Put the surface porous suture thread in step 3) together with the inner lining tube in an oven for heat treatment. The heat treatment temperature is higher than the melting point of the absorbable shaft yarn and outer yarn polycaprolactone, and lower than the non-absorbable woven yarn and the Absorb the core yarn melting point of the shaft yarn, melt the outer covering yarn of the absorbable shaft yarn, and evenly melt the outer surface of the core yarn of the absorbable shaft yarn, bond the non-absorbable braided yarn weaving points, and then cool at room temperature to extract the inner lining Tube to obtain a hollow and porous part that can absorb sutures.