JPH0446588B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Field of Application] The present invention relates to a surgical suture and a sustained drug release suture related to drug administration techniques.

[Prior Art] Medications to be taken, poultices, and the like have been known as sustained drug release materials, which are materials that gradually release drugs while adjusting the concentration.

On the other hand, conventional surgical sutures that are commonly used as means for suturing incisions are only sterilized or coated with antiseptic agents, and do not release the drugs themselves required for the procedure in a sustained manner. There was no composition.

[Problems to be Solved by the Invention] Therefore, when the treated area is sutured with sutures in a surgical operation, it is necessary to apply an anti-rejection agent or an anti-pyogenic agent to make the sutures compatible with the living body. Or, treatment such as taking medication was required.

The present invention has been made in view of the above-mentioned suturing treatment, and is designed to gradually administer a portion of the drug required for the suture treatment directly to the affected area through the suture used in the treatment at the same time as the suture treatment using suture threads. The object of the present invention is to provide a sustained drug release suture.

[Means for Solving the Problems] The sustained drug release suture according to the present invention is such that a slowly releasing drug is present in a dissipating or non-dissolving suture for surgical treatment so as to have a sustained release effect. The gist is as follows.

Disappearance type drug sustained release sutures are made of a polymer compound coating (hereinafter referred to as "temporal decomposition coating") that has the property of dissolving the fine powder of the drug in the body over time through hydrolysis, etc. The gist is that coated sustained-release drug particles are present on at least the surface of the synthetic suture.

A sustained drug release suture made by spinning a kneaded composition of a drug and a synthetic resin polymer.

In addition, the above-mentioned drug sustained-release suture has a fine powder of the drug present in the synthetic suture, and the synthetic suture itself is transformed into a synthetic absorbable suture made of a polymer compound that has the property of disappearing in the body over time. It can also be implemented by configuring accordingly.

Alternatively, the fiber may have a core-sheath structure in which the drug is unevenly distributed in the core or periphery of the fiber.

Non-degradable drug sustained release sutures are made by coating a drug on the circumferential surface of a filament made of a synthetic resin that is insoluble in the body, and then covering the coating layer of the drug with a decomposition film over time. This is a summary.

Furthermore, the layer of the drug and the time-degradable coating can be formed into a multilayer structure in which a plurality of different types of drugs are alternately laminated from the outside with the time-degradable coating to regulate sustained release.

[Function] The sustained drug release suture having the above structure is obtained by spinning a kneaded composition of a drug coated with a film that decomposes over time and a synthetic resin polymer suture material into a suture shape. The resin polymer is stretched into an extremely thin thread-like shape, and forms a large number of fine pores extending toward the inside of the suture thread.
Therefore, the drug present in the thread gradually oozes out from the fine pores, and as a result, it is transferred into the living body over time via the film that degrades over time.

In addition, when the suture itself is made of a synthetic absorbable suture made of a polymer compound that has the property of disappearing in the body over time, the drug present in the suture can be released by the disappearance of the suture. It is gradually released in the body.

Furthermore, sutures with a structure in which drug and time-degradable coating layers are alternately laminated from the outside of the thread make it possible to regulate and control the administered sustained-release drug over time, making long-term medication management possible. It becomes like this.

[Example] Examples of the sustained drug release suture according to the present invention will be described below with reference to the drawings.

Disappearance system suture (1) The one in Figure 1 is a synthetic absorbable suture made of polydioxanone (polydioxanone) containing fine particles 1 (particle size 2 μm or less) of a drug (described later).
After the drug is pulverized to a predetermined size, the fine powder is blended into a suture base material made of molten polydioxanone at an addition rate of 10% by weight, and then thoroughly A uniformly dispersed kneaded composition is prepared by kneading, and this kneaded composition is melt-drawn to form a predetermined wire diameter (0.01 to 2 mm) to obtain a sustained drug release suture.

Disappearance system suture (2) The one in Figure 2 is a drug particle 1 (particle size 2 μm or less)
A time-degradable coating 3 made of a bioabsorbable synthetic material made of polydioxanone.
In addition, the sustained-release drug particles are coated with 10% by weight of the fine powder is added to the suture base material made of polydioxanone melted.
The kneaded composition is blended at an addition rate of 1.0 to 1.0 mm, thoroughly kneaded to prepare a uniformly dispersed kneaded composition, and this kneaded composition is melt-drawn to form a predetermined wire diameter (0.01 to 2 mm) to achieve sustained drug release. Use as a suture.

In addition to polydioxanone, the absorbable suture 1 material for the extinguishing suture includes polygratin (glycolide/lactide copolymer), synthetic fibers such as polydionisanone, sheep small intestine submucosa, and Animal protein fibers such as bovine small intestine serosa tissue are used.

Non-absorbable suture thread (3) In Fig. 3, a drug 1 is coated on the outer periphery of a non-absorbable suture thread 4 made of a polymer or a copolymer, and the thread body is coated with polygratatin 3 from the outside of the drug 1.
70 and calcium stearate to form a core-sheath structure.

Non-absorbable suture (4) The suture shown in FIG. 4 has a second drug layer 6 coated on the outer periphery of the non-absorbable suture 4, and a suitably controlled thickness on the outer periphery of the second drug layer 6. A second time-degradable coating layer 7 is formed on the periphery of the second time-degradable coating layer 7, and a first drug layer 8 is coated on the outer periphery of the second time-degradable coating layer 7, and a controlled thickness is coated on the outer periphery of the first drug layer 8. It has a multilayer structure in which a first time-degradable coating layer 9 having the following properties is formed.

Conventional suture threads can be used as the material for the non-absorbable suture thread 4 of the non-disappearing suture thread, including synthetic fibers made of high molecular weight polymers or copolymers such as polypropylene, polyester, and nylon. Sutures such as sutures and animal sutures such as silk can be used.

Examples of drugs that can be used as drug particles or drug layers (1) Anti-pyogenic agents (2) Hemostatic agents (3) Anti-inflammatory and analgesic salicylic acid preparations, steroid preparations, non-steroid preparations (4) Antitumor agents (5) Circulation Instrumental agents Coronary vasodilators (6) Hormonal agents (7) Antipyretic, analgesic, anti-inflammatory, and antipruritic steroid preparations, non-steroid preparations, antihistamine preparations These drugs can be used in liquid form as well as powder. can.

[Effects of the Invention] As described above, according to the sustained drug release suture according to the present invention, the drug mixed in the sustained drug release suture is released after a pre-adjusted period of time due to the resolution of the decomposition film over time. It is a sustained release drug that allows for direct administration through the suture to the sutured site. Furthermore, since the release rate of the drug can be freely controlled by adjusting the coating, it has the advantage of allowing highly safe administration and long-term continuous administration. Therefore, the impact on the pharmaceutical industry after implementation of the present invention will be extremely large.

[Brief explanation of drawings]

1, 2, 3, and 4 are microscopic cross-sectional views of sutures showing examples of sustained drug release sutures according to the present invention, respectively. 1... Drug fine particles, 2... Synthetic absorbable suture thread, 3...
Degradable coating over time, 4... Non-absorbable suture, 5... Absorbable coating, 6... Second degraded coating layer over time, 7... Second drug layer, 8... First drug layer, 9... First The film layer decomposes over time.

Claims (1)

[Scope of Claims] 1. A sustained drug release suture made by spinning a kneaded composition of a drug and a synthetic resin polymer. 2. A sustained drug release suture having a core-sheath structure, which is obtained by spinning a kneaded composition of a drug and a synthetic resin polymer so that it is located in the core of a synthetic resin polymer fiber. 3. A sustained drug release suture having a core-sheath structure, which is obtained by spinning a kneaded composition of a drug and a synthetic resin polymer so that it is located around the periphery of synthetic resin polymer fibers. 4. The drug according to claim 1, 2 or 3, wherein the drug is a sustained release drug particle obtained by coating fine powder of the drug with a polymeric compound coating that has the property of disappearing in the living body over time by hydrolysis or the like. Drug-controlled suture. 5. A sustained drug release suture comprising one or more drug layers and a polymer compound coating layer having a property of disappearing in the body over time, which are alternately coated around the outer periphery of the suture. 6. The sustained drug release suture according to claims 1 to 5, wherein the suture itself is a synthetic absorbable suture made of a polymer compound that disappears in the body over time.