KR20190032675A - Suture having a long degrading rate, and method for preparing the same - Google Patents

Abstract

The present invention relates to a barbed suture using conjugate spinning and a manufacturing method thereof. More particularly, the present invention relates to a barbed suture that simultaneously satisfies suitable physical properties and a long-term maintenance period in vivo, and a manufacturing method thereof, wherein the barbed suture is manufactured by spinning monofilament composite yarn of a sheath/core structure, comprising a core which is a lactic acid, polylactic acid (PLA) or a polycaprolactone (PCL) and a sheath which is a biodegradable polymer used in a conventional surgical suture, followed by barbing.

Description

BACKGROUND OF THE INVENTION 1. Field of the Invention [0001] The present invention relates to a suture having a long degradation rate,

The present invention relates to a barbed suture and a method for preparing the same, and more particularly to a barbed suture used for a core which is lactic acid or lactide polymer (PLA) or a caprolactone polymer (PCL) A monofilament composite yarn having a sheath / core structure including a sheath, which is a biodegradable polymer, is prepared by barbing the monofilament composite yarn, The present invention relates to a barbed suture that simultaneously satisfies a sustaining period and appropriate physical properties, and a method for producing the same.

A barbed suture with a sloping spine on its surface (ie, barb) has the advantage of shortening the operation time and reducing wounds, because it does not slip without knotting and maintains the sutured condition of the wound or tissue . This has increased the use of minimally invasive surgery since FDA approval in 2004.

In addition, barbed sutures have attracted greater attention not only for surgical operations but also for lifting procedures because of their ability to pass through tissues in one direction with visible protrusions, but to inhibit movement in the opposite direction. The improvement of facial wrinkles, sagging, and skin depression caused by reduction of skin elasticity or collagen loss is the most popular field in the plastic surgery, and therefore, a barbed suture made of the same material as a conventional absorbable suture Has taken its place in the market as a representative medical lifting device for a short time.

In this way, the lifting procedure case of the absorbable barbed suture is soaring that the unsatisfactory aspect has begun to appear. In the case of barbed sutures made of the same polydioxanone (PDO) as the conventional absorbable suture, the in vivo maintenance period is only about six months. Short in vivo maintenance time means that the number of re-operations increases, which leads to reduced patient convenience and increased costs. Therefore, there is a strong demand for an absorbable barbed suture having a longer in vivo maintenance period.

To solve this problem, attempts have been made to manufacture barbed sutures using lactic acid or lactide polymer (PLA) or caprolactone polymer (PCL), which have a long lifetime in vivo among biodegradable and biocompatible polymers. However, PLA There is a problem that the flexibility of the yarn is low and the surface hardness is so high that the barbing is not performed well and the PCL has a problem that the mechanical properties of the yarn are insufficient to be suitable as a suture.

Therefore, the need for a barbed suture with both a long maintenance period and suitable physical properties in vivo has not been met, and further research and development is required to overcome it.

Disclosure of Invention Technical Problem [8] The present invention has been made to solve the above-mentioned problems of the prior art, and it is a technical object of the present invention to provide a barbed suture that satisfies both a long sustain period and appropriate physical properties in vivo.

In order to solve the above-mentioned technical problems, the present invention provides a sheath / core structure comprising a core which is a homopolymer or copolymer of lactic acid, lactide or caprolactone, and a sheath which is a biodegradable polymer Wherein at least one barb is formed on the surface of the monofilament composite yarn.

According to another aspect of the present invention, there is provided a method for producing a monofilament composite yarn, comprising: preparing a monofilament composite yarn of sheath / core structure by co-spinning a biodegradable polymer as a homopolymer or copolymer of lactic acid, lactide or caprolactone as a core and a sheath; And forming at least one barb on the surface of the composite yarn.

The barbed suture according to the present invention can be easily barbed in the conventional manner because the sheath portion is an existing biodegradable polymer material and the core portion of the lactic acid, lactide or caprolactone polymer material can be used for lifting It is possible to improve the convenience of the patient and reduce the cost by increasing the maintenance period.

Although the terms used in the present invention have been selected as general terms that are widely used at present, there are some terms selected arbitrarily by the applicant in a specific case. In this case, the meaning described or used in the detailed description part of the invention The meaning must be grasped.

Hereinafter, the technical structure of the present invention will be described in detail with reference to preferred embodiments shown in the accompanying drawings.

However, the present invention is not limited to the embodiments described herein but may be embodied in other forms. Like reference numerals designate like elements throughout the specification.

The barbed suture of the present invention is a monofilament composite yarn of sheath / core structure, which comprises a homopolymer or copolymer of lactic acid, lactide or caprolactone as the core.

More specifically, the core may comprise a lactide homopolymer, a lactic acid homopolymer, and a caprolactone (epsilon-caprolactone) homopolymer, a copolymer of lactide and caprolactone, a lactic acid and a caprolactone And a combination thereof. More preferably, a lactide homopolymer, a caprolactone homopolymer, a copolymer of lactide and caprolactone, and a combination thereof can be used.

In addition, the barbed suture of the present invention includes a biodegradable polymer as the sheath.

Examples of the biodegradable polymer that can be used as a sheath in the barbed suture of the present invention include glycolide, glycolic acid, p-dioxanone, trimethylene carbonate, poly Homopolymers of those selected from unhydrides and polyhydroxyalkanoates; Or at least two kinds of copolymers selected from glycolide, glycolic acid, dioxanone, trimethylene carbonate, polyanhydride and polyhydroxyalkanoate; Or a copolymer of at least one selected from the group consisting of glycolide, glycolic acid, dioxanone, trimethylene carbonate, polyanhydride and polyhydroxyalkanoate, and at least one selected from lactide, lactic acid and caprolactone; Preferably a copolymer of a dioxanone homopolymer, a copolymer of glycolide and caprolactone, a copolymer of glycolide and trimethylene carbonate, a copolymer of dioxanone and trimethylene carbonate and caprolactone, or a copolymer of dioxanone and tri Copolymers of methylene carbonate and glycolide may be used.

According to one embodiment, in the barbed suture of the present invention, the content of the sheath is preferably 30 to 70% by volume, more preferably 40 to 60% by volume based on 100% by volume of the suture, The content of the core is preferably 30 to 70% by volume, more preferably 40 to 60% by volume. When the core content in the barbed suture of the present invention is less than 30% by volume, the fibers of the polymer component constituting the core may become too thin when irradiated, so that the effect of extending the in vivo maintenance period may be difficult. On the contrary, when the sheath content in the barbed suture of the present invention is less than 30% by volume, the thickness of the sheath portion becomes too thin and barbing may become difficult.

The barbed suture of the present invention may further comprise a dye to easily distinguish it from the procedure. D & C Violet No. 2, D & C Green No. 6, FD & C Blue No. 2 and Phthalocyanine Blue, which are conventionally used in the production of sutures, may be used as the dyes usable in the present invention.

Monofilaments by composite radiation are structurally similar to sea / islands type, segmented pie type, side-by-side type, sheath / core type sheath / core type), and the barbed suture of the present invention has a sheath / core structure. In the sheath / core structure of the barbed suture of the present invention, since the seizure is a commercially available absorbable biodegradable suture material, it is easy to barbing the barb, which is a protrusion of visible form, while the core is made of PLA, PCL It is possible to exhibit a longer in vivo maintenance period than a conventional barbed suture.

According to another aspect of the present invention, there is provided a method for producing a monofilament composite yarn, comprising: preparing a monofilament composite yarn of sheath / core structure by co-spinning a biodegradable polymer as a homopolymer or copolymer of lactic acid, lactide or caprolactone as a core and a sheath; And forming at least one barb on the surface of the composite yarn.

In the method of manufacturing a barbed suture of the present invention, a conventional complex radiator can be used. According to one embodiment of the present invention, though not limited thereto, two extruders are used to melt the core and the polymer corresponding to the sheath, respectively. The molten polymer through the extruder can be discharged by a desired amount through each metering pump to adjust the content ratio of each component. The molten polymer discharged from each metering pump is combined in a distribution plate in a composite spinning block, passed through a nozzle and made into a monofilament of sheath / core structure, and the composite spinning yarn is solidified and crystallized in a cooling bath. At this time, the air gap between the discharge port of the radiation block and the water surface of the cooling bath is preferably 0.5 to 100 cm, more preferably 1 to 30 cm. The solidified yarn is stretched through a conventional multi-stage stretching device and wound around a winding machine to obtain improved physical properties by orientation.

In order to produce a homogeneous and stable sheath / core structure monofilament in the spinning process, the melt index (MI) and spinning conditions of the polymer component forming the core and the polymer component forming the sheath need to be adjusted . In the case of the melt index, the melt index difference between the polymer component forming the core and the polymer component forming the sheath is preferably 10 or less. When the difference in melt index of these polymers is larger than 10, phase separation easily occurs inside the fibers, and curling of the fibers may occur. In order to prevent such a phenomenon, the spinning temperature can be adjusted so that the physical properties and melting behavior of the polymer such as melting point, crystallization degree and heat shrinkage can be harmonized. Further, in order to suppress the component separation phenomenon, a stress relaxation of 10% or more, preferably 10 to 30%, more preferably 10 to 20% in consideration of the heat shrinkage ratio of the two components in the final drawing oven So as to stabilize the structure.

The method of manufacturing a barbed suture of the present invention includes the step of forming at least one barb on the surface of the composite yarn produced as described above.

The barb forming step may be performed using a conventional barbing process and apparatus. The composite yarn according to the present invention has an advantage that there is no restriction on the barb cutting conditions due to the physical properties of the polymer forming each part of the sheath / core structure.

The barbed suture of the present invention produced as described above exhibits excellent effects such as excellent barb processability and improved ease of use due to a long in-vivo maintenance period.

The present invention will be described in more detail with reference to the following examples, but the present invention is not limited thereto.

(Example)

Example 1

45% by volume of polydioxanone and 55% by volume of polylactic acid as a core polymer were combined to prepare a monofilament of sheath / core structure, and the prepared monofilament of sheath / To make a barbed suture. The squeezing workability and the in-vivo degradation rate of the suture manufactured were measured during suture production and are shown in Table 1 below.

Example 2

Except that 55 vol% of a copolymer of glycolide (75) / caprolactone (25) as a biodegradable polymer for use in the present invention and 45 vol% of polycaprolactone as a core polymer were used. To obtain a barbed suture. The squeezing workability and the in-vivo degradation rate of the suture manufactured were measured during suture production and are shown in Table 1 below.

Comparative Example 1

Only barbed polydioxanone monofilaments were barbed to produce barbed sutures. The squeezing workability and the in-vivo degradation rate of the suture manufactured were measured during suture production and are shown in Table 1 below.

Comparative Example 2

Only a polylactic acid monofilament was barbed to produce a barbed suture. The squeezing workability and the in-vivo degradation rate of the suture manufactured were measured during suture production and are shown in Table 1 below.

Example 1 Example 2 Comparative Example 1 Comparative Example 2 Barbed workability Great Great Great impossible In-vivo degradation rate 18 months 24 months 6 months -

While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it is clearly understood that the same is by way of illustration and example only and is not to be taken by way of limitation, Various changes and modifications will be possible.

Claims (6)

Wherein at least one barb is formed on the surface of a monofilament composite yarn of a sheath / core structure comprising a core which is a homopolymer or copolymer of lactic acid, lactide or caprolactone and a sheath which is a biodegradable polymer.
The method according to claim 1,
Wherein the core is selected from a lactide homopolymer, a lactic acid homopolymer, and a caprolactone homopolymer, a copolymer of lactide and caprolactone, a copolymer of lactic acid and caprolactone, and combinations thereof.
The method according to claim 1,
A homopolymer of a biodegradable polymer used as a sheath selected from glycolide, glycolic acid, dioxanone, trimethylene carbonate, polyanhydride and polyhydroxyalkanoate; or
At least two copolymers selected from glycolide, glycolic acid, dioxanone, trimethylene carbonate, polyanhydride and polyhydroxyalkanoate; or
A copolymer of at least one member selected from the group consisting of glycolide, glycolic acid, dioxanone, trimethylene carbonate, polyanhydride and polyhydroxyalkanoate and at least one selected from lactide, lactic acid and caprolactone; Wherein the barbed suture is a barbed suture.
The method according to claim 1,
The biodegradable polymer used as a sheath is selected from the group consisting of a dioxanone homopolymer, a copolymer of glycolide and caprolactone, a copolymer of glycolide and trimethylene carbonate, a copolymer of dioxanone, trimethylene carbonate and caprolactone, or a mixture of dioxanone and tri A barbed suture characterized by being a copolymer of methylene carbonate and glycolide.
The method according to claim 1,
Wherein the suture content is 30 to 70% by volume and the core content is 30 to 70% by volume based on 100% by volume of the suture.
Preparing a monofilament composite yarn of a sheath / core structure by co-spinning a biodegradable polymer as a homopolymer or copolymer of lactic acid, lactide or caprolactone as a core and a sheath; And
And forming at least one barb on the surface of the composite yarn.