KR19990010319A - Two-component surgical suture with strong retention and biodegradability - Google Patents

Abstract

The present invention relates to a two-component surgical suture with a strong retention rate and biodegradability, more specifically, 5 to 95% of the first component of the polymer by weight relative to the total polymer component by weight 5 It relates to a two-component surgical suture having a cross-section of the second component to form one or more segments on the matrix of the first component by wrapping the polymer of the second component from 95%.

The two-component surgical suture according to the present invention has a cross-section of two kinds of polymers having different strength retention rates and biodegradability, each of which comprises a first component as a sea component and a second component as a island component. Since it has a combination of each component and the ratio of the components can be easily adjusted for the strong retention and biodegradability of the surgical suture, it is flexible and has excellent knot stability. Therefore, according to the present invention, it is possible to manufacture a surgical suture suitable for the site and the intended use.

Suture according to the present invention can be used as a soft tissue patch, surgical mesh, thin-film dressing, surgical felt, artificial blood vessels, neurotherapy aid, artificial skin, pleural effusion in addition to surgical suture.

Description

Two-component surgical suture with strong retention and biodegradability

The present invention relates to a two-component surgical suture that has a strong retention and biodegradability is adjustable, more specifically the control of biodegradability and strong retention of two different polymer components to form a separate one or more segments on the fiber cross-section This easy surgical suture relates.

Sutures used as surgical sutures can be divided into natural sutures and synthetic sutures according to the raw materials. Alternatively, absorbent sutures and tissues that are naturally decomposed and absorbed into the body after a certain period of time, depending on the absorbency in vivo. It can be classified as a nonabsorbable suture that remains undecomposed even after the bonding and must be removed by reoperation. In addition, according to the structure of the suture can be divided into monofilament and multifilament, multifilament suture is produced by spinning radially dozens of monofilament strands of about 1 to 5 denier thickness.

In the case of absorbent sutures, the strength deteriorates with time since the biodegradation is absorbed into the body after the suture treatment. The tissue must be maintained at a certain strength or more until the tissue is regenerated and bonded. Conventional sutures, however, are usually reduced to 60% of initial strength after two weeks of suture and to 10% after four weeks.

In addition, the characteristics of the suture required also vary depending on the suture area, for example, because the eye area does not require a high-strength suture, thin sutures can be used, but in the case of the heart area, the suture area is caused by the beating of the heart. Is susceptible to fall again, so sutures with very high initial strength should be used. It is possible to increase the initial strength of the suture by using a suture that is thick, but when the suture becomes thick, knot formation and / or knot fastening becomes poor during the procedure.

Therefore, there has been a demand for surgical sutures which can arbitrarily control biodegradability and strong retention according to in vivo characteristics and have excellent flexibility.

In the production of surgical sutures, a single component suture has been conventionally produced by one extruder by polymerizing a single component or a copolymer. The sutures thus prepared have only the properties of a single component as it is, making it difficult to produce a suture having optimal properties satisfying the properties required for supplementation.

The present inventors have solved the above-mentioned problems of the prior art and studied to manufacture a suture which can control the strong retention and biodegradability, and have excellent flexibility. By producing a suture by spinning to form a segment, the surgical suture can be easily adjusted to compensate for the physical properties that the one-component system does not have and maintain a strong retention rate and biodegradability.

SUMMARY OF THE INVENTION An object of the present invention is to provide a bicomponent surgical suture that can arbitrarily control biodegradability and potency retention, and is suitable for in vivo characteristics and ensures the stability of the procedure.

1 shows a cross section of a fiber consisting of 16 radial segments in accordance with one embodiment of the present invention,

FIG. 2 shows a distribution plate for producing the fiber having the cross section shown in FIG.

The present invention is the second component on the matrix of the first component by wrapping 5 to 95% of the first component of the polymer by weight relative to the total polymer component by weight of 5 to 95% of the second component It is a bicomponent surgical suture which has a cross section which forms this one or more segments.

Hereinafter, the present invention will be described in more detail.

Surgical suture according to the present invention is composed of two different polymer components having biocompatibility and one component has a form that completely wraps the other components, so that the two-component polymer in the cross section of the fiber to form at least one segment each do.

The polymer that can be used for the two-component suture of the present invention is not particularly limited, but the polymers that can be combined include glycolide, glycolic acid, lactide, lactic acid, caprolactone, dioxanone, trimethylene carbonate, or dimethyl trimethylene carbonate. Homopolymers, copolymers, blend compositions, and the like, may be used. Preferred are polylactide, glycolide / lactide copolymer, polydioxanone and the like. In addition, collagen, chitin, chitin derivatives, amino acids (gelatin), polysaccharides and the like can also be used.

The two-component polymers that can be used in the present invention are each selected from among polymers having biocompatibility and complementary physical properties, and preferably, polyglycolic acid / polylactide, polyglycolic acid / polydioxanone , Polylactide / polydioxanone and polydioxanone / polycaprolactone.

The two-component suture according to the present invention may be manufactured in various colors by adding pigments such as D C green No. 6 and D C violet No. 13 to the first component and / or the second component through different distribution plates.

In the production of the two-component suture of the present invention, each of the molten first and second polymer melts are extruded from two extruders in a bungee spinning pack and flow without being mixed to the distribution plate of the present invention attached to the spinning block. To come out. One or more slits and / or circular holes are formed in the distribution plate so that each component can form a separate segment within the fiber cross section.

1 is a cross-sectional view of a fiber according to a preferred embodiment of the present invention in which the first component is eight segments and the second component is eight segments in total of 16 segments. As shown in FIG. 1, the surgical suture according to the present invention may be manufactured in a form in which the first component completely surrounds the second component having a radial slit form.

FIG. 2 shows a distribution plate for manufacturing the fiber according to the sphere of FIG. 1, wherein the melt from two extruders flows through a separate conduit from the two extruders to the top of the nozzle face and is combined at the nozzle face to show the fiber cross section shown in FIG. 1. To form. Referring to FIG. 2 showing the distribution plate according to the above embodiment, eight slit grooves are formed in the distribution plate, and eight circular holes are formed between the slit grooves. Thus, the first component flows through the eight circular holes of the distribution plate and the second component flows through the eight slits and then through the spinneret, resulting in a cross section comprising 16 segments.

The distribution plate must be appropriately designed according to the ratio of the first component and the second component in the fiber cross section. For example, in the above embodiment, rational design of the distribution plate is possible from the following equation.

The discharge rate Q ₁ when using a circular nozzle is as follows:

Wherein R is the diameter of the circular nozzle, ΔP is the pressure difference, μ ₁ is the melt viscosity of the first component, and L ₁ is the length of the circular nozzle.

In the case of a slit nozzle, the discharge amount Q ₂ is as follows:

Where W is the width of the slit, B is the depth of the slit, ΔP represents the pressure difference, μ ₂ is the melt viscosity of the second component, L ₂ is the length of the slit, and F _P is B and W It is the shape deformation ratio according to the ratio of.

In the above equation, when the quantity of Q ₁ and Q ₂ is constantly measured, the diameter R of the circular nozzle, the width W of the slit, and the depth B of the slit can be obtained in the design of the nozzle.

In the above embodiment, the diameter of the spinneret inlet is larger than the diameter of the distribution plate hole consisting of the slit and the circular hole so that the first component completely covers the second component appearing in the slit form on the fiber cross section, so that the two components are bladed. The workability in the suture manufacturing process is improved by preventing the segment of.

The fiber having a sea island-shaped cross section according to the present invention has the island component in the middle, while the polymer of the first component and the polymer of the second component which flow out from the two extruders of the spin pack pass through the distribution plate. Is divided into island components to form sea components. In order to divide the polymer of the first component and the second component into the island component and the sea component, one or more distribution plates may be used. The final distribution plate used in this process is attached with a plurality of pins that divide the polymer into island components. . The attached pins should extend slightly longer than the interface between the spinneret and the distribution plate, otherwise the molten polymer of the sea component interrupts the flow of the molten polymer of the island component and continues in the longitudinal direction of the fiber axis. It is not possible to obtain a non-uniform distribution of the island component on the fiber cross-section, it is impossible to control the strength retention and biodegradability.

The number of pins of the distribution plate may vary depending on the mono fineness of the island components. For example, when a sea island-type suture of USP standard 3/0 is prepared using polylactide as a sea component and polyglycolide as a sea component, if the mono fineness of the island component is 0.13 denier, 127 pieces per hole A total of 36 holes made of pins in two arrays can produce a multi-type suture made of 4572 degrees in total.

In the present invention, the composition ratio of the first component or the second component to the total polymer component is 5 to 95% by weight, preferably 20 to 80%. When the composition ratio of the first component or the second component is 5% or less or 95% or more, the components discharged to the slit part or the circular part in the distribution plate of the present invention cannot form the desired fiber cross section, and the extreme In this case, the flowability of the polymer melt is lost, making the fiber impossible.

The biodegradability and / or strength retention of the two-component suture according to the present invention can be arbitrarily adjusted according to the combination and component ratio of the first component and the second component, the thickness of the first component surrounding the second component, and the number of segments of each component. Can be.

According to one preferred embodiment of the present invention, a polymer having low hydrolysis property, i.e., having excellent strength retention, is used as the first component (sea component) of FIG. A two-component sutures can be produced as a (component). Thus prepared two-component suture can be biodegradable at a high speed while maintaining the desired degree of strength for a desired period of time can significantly shorten the period of existence as a foreign body when used in the human body.

In addition, it is possible to manufacture a two-component suture comprising a polymer having excellent strength retention as a second component and a polymer having a low retention strength as a first component. Compared with the two-component suture described above, flexibility and knot stability can be improved.

According to the present invention, not only multifilament but also monofilament can be produced, and the degree of mono fineness of the island component is 0.5 denier and the degree of fineness of the island-in-the-sea monofilament can also be produced from several tens to hundreds of daiers.

In addition, in the case of monofilament, monofilaments having a sea island-shaped cross section may be prepared in order to improve flexibility, and treated with an appropriate solvent according to a combination of polymers to produce monofilaments having excellent flexibility and controlling strong retention. .

As the treating solvent, a solvent having solubility with respect to a polymer used as a sealing yarn may be used. Ethyl acetate, acetone, ethyl alcohol, acetic anhydride, methylene chloride, methanol, benzene, xylene, tetrahydrofuran, formic acid, and the like may be used. Can be used.

The two-component suture according to the present invention prepared as in the embodiment described above can be adjusted in accordance with the intended use, because the conventional suture can be strongly opposed to each other and strong maintenance period and biodegradability at the same time Can be used.

EXAMPLE

Hereinafter, the present invention will be described in more detail with reference to Examples.

(Example 1)

With polyglycolic acid as the first component and polylactic acid as the second component, the first component is discharged into the circular hole of the distribution plate and the second component is discharged into the slit of the distribution plate so that the first component completely surrounds the second component A bicomponent fiber was produced having a radial cross section. Spin stretching was carried out using two extruders at a weight ratio of 30% polylactic acid and 70% polyglycolic acid. Polyglycolic acid had a viscosity of 10,000 poise at 250 ° C. and a shear rate of 10 rad / sec, and polylactide was used at 15,000 poise at 200 ° C. and a shear rate of 10 rad / sec.

As a distribution plate, a distribution plate consisting of a radial slit having a width of 0.3 mm, a depth of 0.6 mm, and a length of 2 mm, and a circular hole having a diameter of 0.3 mm and a length of 1 mm were alternately positioned with a total of 16 segments. The diameter of the distribution plate hole was 4 mm, the inlet diameter of the spinneret was 4.2 mm, the diameter of the spinneret was 0.34 mm, and the length was 0.7 mm.

By using the above-described distribution plate and spinneret, a drawn yarn having a strength of 7.6 g / d and an elongation of 28% at 90 denier 36 filaments was prepared.

This stretched yarn was bladed using a 16-blader to prepare absorbent surgical sutures having a diameter of 0.589 mm, knot strength of 8.9 kg, and USP standard 2.

The suture was heat-treated for 4 hours under a nitrogen atmosphere of 110 ℃ and coated with a methylene chloride dispersion of polycaprolactone and calcium stearyl to measure the strong retention, 90% after two weeks in a buffer solution of pH 7.4, 37 ℃, 65% after 3 weeks.

(Example 2)

The strength of 85 denier 36 filaments in the same manner as in Example 1, except that polylactic acid was used as the first component, polyglycolic acid was used as the second component, and 30% polyglycolic acid and 70% polylactic acid were used by weight. Was drawn at 7.2 g / d and elongation was 35%.

The drawn yarn was bladed using a 16-blader to prepare an absorbent surgical suture of 0.590 mm in diameter and 8.5 kg in knot strength and USP standard 2.

The sutures were heat-treated under a nitrogen atmosphere at 100 ° C. for 3 hours and 30 minutes, and coated with a methylene chloride dispersion of polycaprolactone and calcium stearyl, and the strong retention was measured. As a result, 90 weeks after 4 weeks in a buffer solution of pH 7.4 and 37 ° C. %, 55% after 6 weeks.

(Example 3)

Polyglycolic acid having a viscosity of 13,000 poise at 250 ° C. and shear rate of 10 rad / sec was used as the first component, and polydioxanone having 18,000 poise at 170 ° C. and 10 rad / sec was used as the second component. A stretch yarn of 83 denier 36 filaments having a strength of 7.2 g / d and an elongation of 30% was prepared in the same manner as in Example 1, except that 25% and 75% of polyglycolic acid were used.

The drawn yarn was bladed using a 16-blader to prepare an absorbent surgical suture of 0.585 mm in diameter and 8.3 kg in knot strength and USP standard 2.

The sutures were heat-treated for 8 hours under a nitrogen atmosphere of 90 ° C. and coated with a methylene chloride dispersion of polycaprolactone and calcium stearyl, and the strong retention was measured. After 2 weeks in a buffer solution of pH 7.4 and 37 ° C., 95%, 65% after 4 weeks.

(Example 4)

With polydioxanone as the first component and polyglycolic acid as the second component, the first component is discharged into the circular hole of the distribution plate and the second component is discharged into the slit of the distribution plate so that the second component has a radial cross section. Fibers were prepared. Spun stretching was carried out using two extruders with 75% polydioxanone and 25% polyglycolic acid by weight. Polyglycolic acid had a viscosity of 13,000 poise at 250 ° C. and a shear rate of 10 rad / sec, and polydioxanone had a viscosity of 18,000 poise at 170 ° C. and a shear rate of 10 rad / sec.

As a distribution plate, a distribution plate consisting of a slit having a width of 0.28 mm, a depth of 0.56 mm, and a length of 3 mm, and a circular hole having a diameter of 0.28 mm and a length of 1 mm were alternately positioned with a total of 16 segments. The diameter of the distribution plate hole was 3.8 mm, the inlet diameter of the spinneret was 4.0 mm, the diameter of the spinneret was 0.48 mm, and the length was 1.0 mm.

Cool the fibers discharged from the spinneret with water at 7cm away from the spinneret and use rollers. Stretch the 1st and 2nd stages with water, relax at 3rd stage and heat it at 90 ℃ to store at room temperature. This was made possible and the spin-drawing was carried out simultaneously.

According to the above-mentioned distribution plate and spinneret, a stretched yarn of 70 denier monofilament having a strength of 6.0 g / d, an elongation of 45%, and a diameter of 0.079 mm was manufactured, and then the knot strength was 0.23 kg and the USP standard 7/0. Absorbent surgical sutures were prepared.

The sutures were heat-treated under 100 ° C. nitrogen atmosphere for 2 hours, and the strong retention was measured. The results showed 95% after 2 weeks, 87% after 3 weeks, and 80% after 4 weeks in a buffer solution of pH 7.4 and 37 ° C. .

(Example 5)

The first component (sea component) is polyglycolide having a viscosity of 10,000 poise at 250 ° C. and a shear rate of 10 rad / sec as the second component. By discharging with a distribution plate, a fiber having an island-in-the-sea cross section was produced. 70% polyglycolide and 30% polylactide by weight were spin-drawn using two extruders.

As a distribution plate, a distribution plate having 36 holes with 127 pins was used, and the total number of pins was 4572. The spinneret has a diameter of 0.55 mm and a ratio of diameter to length of four.

A stretched yarn of 40 denier / 14 filaments was prepared by the above-described distribution plate and spinneret.

The drawn yarn was bladed using a 16-blader to prepare absorbent surgical sutures of USP standard 3/0 and modulus of elasticity of 56 g / d.

As a result of treating the obtained suture with methylene chloride, the elastic modulus after the treatment was 12 g / d, showing excellent flexibility.

The sutures were heat-treated and the strong retention was measured in 37 ℃ buffer solution of pH 7.4, it was 95% after 3 weeks, 85% after 4 weeks.

(Example 6)

In Example 5, except that the weight ratio of polyglycolide and polylactide was set to 30 to 70, a stretched yarn was prepared in the same manner as in Example 5 to produce 88 denier / 36 filaments, and then stretched to the core during blading. Surgical sutures of USP standard 2, knot strength 11.8 kg were prepared using 8 drawn yarns and 16 drawn yarns.

In the spinning and stretching step, 36 holes consisting of 127 pins and 4572 pins in total were used for dividing the island components.The 36 holes consisted of two rows of 0.34mm in diameter and the ratio of diameter and length was 2 Detention was used.

The suture was heat-treated and strong retention in 37 ℃ buffer solution of pH 7.4, 98.7% after 3 weeks, 87.5% after 4 weeks.

(Example 7)

USP standard 3/0, by the same method as Example 5, except that polydioxanone as the first component and polylactide as the second component were used at a ratio of 75/25, and spinnerets having a diameter of 0.58 mm were used. A surgical suture of 45 g / d modulus of elasticity and 2.35 kg of knot strength was prepared.

Polydioxanone was used at a viscosity of 10,000 poise at 170 ℃, shear rate 10rad / sec and polylactide was used at 7,500poise at 200 ℃.

As a result of treating the obtained suture with ethyl acetate, the knot strength after the treatment was 2.15 kg.

(Example 8)

USP standard 3/0, modulus of elasticity 45g / d, knot strength 2.25kg in the same manner as in Example 7, except that polycaprolactone as the first component and polydioxanone as the second component were used at a ratio of 75/25 Surgical suture was prepared.

Polydioxanone was used at a viscosity of 10,000 poise at 170 ℃, shear rate 10rad / sec and polycaprolactone was used at 10,000poise at 90 ℃.

As a result of treating the obtained suture with ethyl acetate, the knot strength after the treatment was 1.95 kg.

The two-component surgical suture according to the present invention has a cross-section in which the second component is composed of one or more segments, with the first component as the sea component and the second component as the island component, respectively, of two kinds of polymers having different strong retention and biodegradability. Therefore, the strength and biodegradability of the surgical suture can be easily adjusted by the combination and ratio of each component, and it is flexible and has excellent knot stability. Therefore, according to the present invention, it is possible to manufacture a surgical suture suitable for the site and the intended use.

Suture according to the present invention can be used as a soft tissue patch, surgical mesh, thin-film dressing, surgical felt, artificial blood vessels, neurotherapy aid, artificial skin, pleural effusion in addition to surgical suture.

Claims (3)

5 to 95% of the first component of the polymer by weight relative to the total polymer component wraps between 5 to 95% of the second component of the polymer by weight relative to the total polymer component and the second component is one or more on the matrix of the first component. A two-component surgical suture having a cross section forming a segment. 2. A combination according to claim 1, wherein the combination of two components is selected from the group consisting of polyglycolic acid / polylactide, polyglycolic acid / polydioxanone, polylactide / polydioxanone and polydioxanone / polycaprolactone It will be a two-component surgical suture. The two-component surgical suture according to claim 1, wherein the two-component surgical suture has a cross-section of the island-in-the-sea type or a second component in the form of a radial slit.