JP2021023760A - Blocking material for medical treatment - Google Patents

Abstract

To provide a blocking material for medical treatment, safely usable without overflowing into the blood vessel.SOLUTION: A blocking material for medical treatment comprises a swellable member capable of being buckling-deformed, and a biocompatible thread having a thread cast-off prevention part at one side, and the other side of the biocompatible thread penetrates into at least a part of the swellable member.SELECTED DRAWING: Figure 1

Description

The present invention relates to a medical occlusion material.

When performing treatment or examination using a catheter or the like without performing thoracotomy, it is necessary to occlude the puncture hole after the procedure, and a hemostatic device applied to a puncture hole having a relatively small diameter has been proposed so far. There is.

Patent Document 1 discloses an instrument for sealing a penetrating portion of a blood vessel wall, in which a hydrogel made of reactive PEG is used as a hemostatic implant.

Patent Document 2 discloses a tissue puncture site closing device, the closing device including a sealing plug and an anchor.

JP-A-2017-164531 Japanese Unexamined Patent Publication No. 2016-73678

In the device for sealing the penetrating portion of the wall of the blood vessel described in Patent Document 1, the hydrogel for occluding may be excessively expanded due to water absorption, and there is a risk of overflowing into the blood vessel. Further, in the tissue puncture portion closing device described in Patent Document 2, since the anchor is seated in the blood vessel, there is a risk of overflowing into the blood vessel.

Therefore, an object of the present invention is to provide a medical occlusion material that can be safely used without the occlusion material overflowing into the blood vessel when the puncture hole of the blood vessel is closed.

As a result of intensive research to solve the above problems, the present inventor has made a swellable member capable of buckling deformation or a swellable member having a spiral shape, and a biocompatible thread having a thread removal prevention portion on one side. By using a medical occlusion material in which the other side of the biocompatible thread penetrates at least one part of the swelling member by pushing it out with a plunger or the like, the occlusion material becomes lumpy and any place. It was found that a hole such as a puncture hole can be closed, and the present invention has been completed. That is, the present invention includes the following inventions.

[1] A medical obstructive material, wherein the obstructive material is composed of a swellable member capable of buckling deformation and a biocompatible yarn having a thread pull-out prevention portion on one side, and the other of the biocompatible yarns , A medical occlusion material that penetrates at least one of the swellable members.
[2] The closing material according to [1], wherein the buckling deformable swelling member has a cylindrical shape.
[3] A medical obstructive material, wherein the obstructive material is composed of a swellable member having a spiral shape and a biocompatible yarn having a thread pull-out prevention portion on one side, and the other of the biocompatible yarns. A medical occlusion material that penetrates at least one of the swellable members.
[4] The closing material has yet another thread pull-out preventing portion, and is connected by a biocompatible thread in the order of the thread pull-out preventing portion, the swelling member, and the thread pull-out preventing portion, [1] to The blocking material according to any one of [3].
[5] The blocking material according to any one of [1] to [4], wherein the swelling member comprises at least one selected from the group consisting of gelatin, collagen, polyethylene glycol and polyethylene glycol-based derivatives.
[6] The closing material according to any one of [1] to [5], wherein the swellable member is a sponge, a non-woven fabric, or a woven or knitted fabric.
[7] The closing material according to any one of [1] to [6], wherein the thread removal prevention portion is a non-swelling member.
[8] The thread loss prevention portion comprises at least one selected from the group consisting of polyglycolic acid, polylactic acid, polycaprolactone and a copolymer of two or more kinds of monomers constituting them [1] to [ 7] The blocking material according to any one of.
[9] The closing material according to any one of [1] to [8], wherein the thread removal prevention portion is a non-woven fabric, a woven or knitted fabric, or a sponge.
[10] The biocompatible yarn comprises at least one selected from the group consisting of polyglycolic acid, polylactic acid, polycaprolactone, a copolymer of two or more kinds of monomers constituting them, and a mixture thereof. The blocking material according to any one of [1] to [9].
[11] The blocking material according to any one of [1] to [10], wherein the blocking material is mounted on a hemostatic device having a delivery mechanism.
[12] The closing material according to any one of [1] to [11], wherein the closing material is mounted on a hemostatic device having a positioning mechanism.
[13] The blocking material according to any one of [1] to [12], wherein the blocking material is a hemostatic material.

When the medical occlusion material of the present invention is used, a hole such as a puncture hole formed in a blood vessel or the like can be closed at an arbitrary place in the living body, and at that time, the thread removal prevention portion can be used without entering the blood vessel or the like. , Can be used safely without overflowing into blood vessels.

FIG. 1 (A) shows the spiral-shaped medical occlusion material of the present invention. FIG. 1B is an overall view showing a hemostatic device on which the medical occlusion material is mounted. FIG. 2A is a diagram showing a first step of a hemostatic procedure using the hemostatic device of FIG. FIG. 2B is a diagram showing a second step following FIG. 2A. FIG. 2C is a diagram showing a third step following FIG. 2B. FIG. 2D-1 is a diagram showing a fourth step following FIG. 2C. FIG. 2D-2 is a diagram showing the state of only the closing material from the upper part in the fourth step of FIG. 2D. FIG. 2E-1 is a diagram showing a fifth step following FIG. 2D. FIG. 2E-2 is a diagram showing the state of only the closing material from the upper part in the fifth step of FIG. 2E. FIG. 2F is a diagram showing a sixth step following FIG. 2E. FIG. 3A is a diagram of the closing material used in Example 1. FIG. 3B is a diagram of the closing material used in Example 2. FIG. 3C is a diagram of the closing material used in Comparative Example 1. FIG. 3D is a diagram of the closing material used in Comparative Example 2. (A) and (B) in FIG. 4 are schematic views regarding the evaluation system of the closing material of the present invention in Examples. FIG. 5A is a photograph of an obstructing material in which a suture is sewn through a spiral gelatin sponge. (B) is a photograph immediately after the obstructing material was placed in the gel. The spiral hole has not been closed yet. (C) is a photograph of a closing material in which a suture is pulled and a spiral hole is filled to form a lump. (A) and (B) in FIG. 6 are examples of "buckling deformation" in the present invention, and show a state in which the material can be bent at a plurality of points and reversibly deformed. (C-1) and (C-2) in FIG. 6 show a state in which the material is bent at one place instead of a plurality of places, and (C-3) in FIG. 6 is like cement. The state in which the shape changes irreversibly when the material is compressed is shown, and these deformations are not included in the "buckling deformation" in the present invention.

The first embodiment of the present invention comprises a buckling deformable swellable member and a biocompatible yarn having a thread pull-out prevention portion on one side, and the other side of the biocompatible yarn is at least the swellable member. Regarding medical occlusion material that penetrates one place. Such an obstruction material typically uses a delivery member to push the obstruction material, in which the swelling member and the thread pull-out prevention portion are connected by a biocompatible thread, into the puncture hole and pull the biocompatible thread. Then, the blocking material becomes lumpy and the puncture hole can be closed. As described above, since the obstructing material of the present invention can adjust the size of the mass, it is also possible to obstruct a large-diameter puncture hole, which has been a conventional problem, and the time required for hemostasis is significantly longer than that of the prior art. It can be shortened to, and minimally invasive treatment can be expected.

The "buckling deformation" of the swellable member that can be buckled and deformed in the present invention refers to a deformation in which bending deformation occurs at a plurality of points during compression and no fracture or irreversible deformation occurs at the bent portion. The "bending deformation" includes a deformation having a curved surface and bending (Fig. 6 (A)) and a deformation that bends at an acute angle (Fig. 6 (B)), and twisting deformation when bending at a plurality of places. You can also have. In order to cause such deformation, it is preferable to use a member made of a flexible material and having a thin shape. From this point of view, the "buckling deformation" in the present invention does not include deformation in which only elastic deformation occurs when the member is compressed, and as shown in FIG. 6 (C-3), a material such as cement. Does not include deformation that changes shape irreversibly. The shape of the member that can be buckled and deformed includes a cylindrical shape, a strip shape, a columnar shape, a cubic shape, and a polyhedral shape, and these may be used in one or a plurality to the extent that the buckling deformable member. From the viewpoint of ease of buckling deformation, a member long in the longitudinal direction when viewed from the puncture hole side is preferable, and a hollow cylindrical shape or a spiral shape described later is more preferable.

The obstructing material of the present invention swells when the swelling member comes into contact with blood or body fluid, and can efficiently occlude the puncture hole. Here, in the present invention, "swellability" means ((mass after swelling)-(mass before swelling)) based on the mass of the member measured at room temperature and normal pressure when the member swells with distilled water. ) × 100 / (mass before swelling) means that the swelling rate is 10% or more. Materials that are completely soluble in water are excluded. Further, in the swellable member of the present invention, the swelling rate is preferably 20% or more, and particularly preferably 100% or more. In the present invention, "non-swelling" means a state in which the swelling rate is less than 10%. Further, the swelling rate of the non-swelling member is preferably 3% or less, and particularly preferably 1% or less. As the swellable member, a bioabsorbable material composed of gelatin, collagen, polyethylene glycol, polyethylene glycol derivative, carboxymethyl cellulose, oxidized cellulose, alginate, alginic acid, polyvinyl alcohol, fibrin and the like is preferable. Among them, gelatin, collagen, polyethylene glycol or polyethylene glycol-based derivative is preferable. These materials can be used alone or in combination. Further, thrombin or the like can be contained as a hemostatic promoting material. Examples of the form of the swellable member include sponges, non-woven fabrics, woven fabrics, and woven and knitted fabrics, but sponges are more preferable. The sponge in the present invention is a soft porous material usually called a sponge, and includes a naturally-derived sponge such as gelatin and a sponge made of a synthetic resin or the like.

The type of gelatin used as a raw material for the gelatin sponge in the present invention is not particularly limited and may be generally available. For example, crude collagen obtained by treating bones, ligaments, tendons or skin of cattle, pigs, chickens or salmon with acid or alkali and heat-extracting with water can be mentioned. The gelatin is not limited to one type, and may be used by appropriately mixing raw materials and those having different physical properties such as solubility, molecular weight or isoelectric point. Examples of the average molecular weight of gelatin that can be used in the present invention include those having a low molecular weight of about 3,000 or more and less than 10,000, those having a medium molecular weight of 10,000 or more and less than 100,000, and those having a high molecular weight. Any of the above 100,000 or more and less than 500,000 can be used. The average molecular weight of gelatin can be obtained from the molecular weight distribution obtained by the Paggy Method 9th Edition (2002).

The gelatin sponge in the present invention may be crosslinked to increase water resistance so that it can serve as a blocking material. The cross-linking method is not particularly limited, and examples thereof include a method using a cross-linking agent, a vacuum thermal dehydration method, a dry heat method, a γ-ray irradiation method, an ultraviolet irradiation method, an electron beam irradiation method, and an X-ray irradiation method. In the vacuum thermal dehydration method, the cross-linking method can be carried out by treating at 100 ° C. to 200 ° C. under the condition of 50 Pa or less for 1 hour to 48 hours. Further, in the dry heat method, cross-linking can be performed by treating at 100 to 200 ° C. for 1 hour to 48 hours.

In the gelatin sponge of the present invention, for example, an aqueous gelatin solution is poured into a mold of a predetermined size, pre-cooled or foamed in a refrigerator at −5 ° C. to 20 ° C., and then at −40 ° C. to −120 ° C. After freezing, this frozen product can be produced by freezing and drying under the conditions of 50 Pa or less. It can also be used by pressing a gelatin sponge.

As the gelatin sponge in the present invention, commercially available gelatin sponges for hemostasis, for example, Sponzel (registered trademark) and Zelfoam (registered trademark) can also be used.

The above-mentioned collagen is any conventionally known collagen obtained from animal tissues such as bone, skin and tendon, for example, insoluble collagen such as acid-insoluble collagen and neutral salt-insoluble collagen; acid-solubilized collagen and neutral. Solubilized collagen such as salt-solubilized collagen, enzyme-solubilized collagen, and alkali-solubilized collagen; chemically modified these insolubilized or solubilized collagen (eg, acetylated, saccharified, maleylated, phthalylated, benzoylated, esterified). , Amidation, guanizinization, etc.); Examples thereof include regenerated collagen obtained by regenerating collagen fibers from solubilized collagen.

The molecular species of the collagen is not particularly limited, but specifically, for example, type I collagen derived from pig skin, type I collagen derived from pig tendon, type II collagen derived from cow nose cartilage, type I collagen extracted from fish, and the like are preferable. Can be mentioned.

A collagen solution can be prepared for a collagen sponge and produced in the same manner as a gelatin sponge.

The thread pull-out prevention portion in the present invention may be any form and material that can compress the swelling member in a lump shape so that the thread does not come off when the biocompatible thread is pulled, and has the thread pull-out prevention portion. As a result, the puncture hole can be efficiently closed. A biocompatible material is preferable for the thread pull-out prevention part, and an insoluble material and a sparingly soluble material can be mentioned, but a non-swelling member is more preferable. Non-swellable materials include aliphatic polyesters such as polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polycaprolactone, lactic acid-caprolactone copolymer, polyglycerol sebacic acid, polyhydroxyalkanoic acid, and polybutylene. Succinates and derivatives thereof can be exemplified and preferably have bioabsorbability. Among these, a group consisting of polyglycolic acid, polylactic acid, polycaprolactone, a copolymer of two or more kinds of monomers constituting them (regardless of the combination of monomers and the copolymerization ratio), and a mixture thereof. More selected and most preferred are polylactic acid or lactic acid-glycolic acid copolymers. As the polylactic acid, for example, stereocomplex polylactic acid composed of poly L lactic acid and poly D lactic acid may be used. As the form of the thread removal prevention portion, a non-woven fabric, a woven or knitted fabric, a sponge made of fibers, a foam sponge, or the like can be processed into a strip shape, a cylinder shape, a columnar shape, a cube shape, or a polyhedron shape as necessary. , These are also referred to as thread pull-out prevention members in the present specification. In addition, the biocompatible thread itself may be tied to form a thread stopper, but the size must be such that the thread does not come off in consideration of the material and properties of the swellable member. To attach this thread removal prevention member to the biocompatible thread, it can be fixed with an adhesive or the like, but typically, a biocompatible thread having a ball knot at the tip thereof is sewn to the thread removal prevention member. Passing through is preferable from the viewpoint of manufacturing and biocompatibility. It is more preferable to use a non-woven fabric from the viewpoint of surely preventing the thread from coming off. The method for producing a non-woven fabric in the present invention is spun by, for example, a melt blow (MB) method, a dry spinning (DSP) method, or an electrospinning (EB) method. Here, the dry spinning method is described in, for example, as described in Japanese Patent Application Laid-Open No. 2013-534978, in which a polymer is dissolved in a volatile solvent and this is injected into a high-speed gas stream using compressed air or the like to form a polymer strand. A method of forming and further stretching this by a high-speed gas flow.

The biocompatible thread is a biocompatible thread, and the swellable member can be agglomerated by connecting the swelling member and the thread pull-out prevention portion and pulling the biocompatible thread after placing the closing material. , The puncture hole can be efficiently closed. The biocompatible thread may be monofilament or multifilament, but a commercially available suture is preferable from the viewpoint of handleability. Examples of the material of the biocompatible yarn include polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polycaprolactone, lactic acid-caprolactone copolymer, polyglycerol sebacic acid, polyhydroxyalkanoic acid, and polybutylene succinate. , Nylon, Teflon®, enteric line, silk, polypropylene and derivatives thereof can be exemplified, and preferably have bioabsorbability. Among these, the material of the biocompatible yarn is preferably a copolymer of polyglycolic acid, polylactic acid, polycaprolactone, and two or more kinds of monomers constituting them (regardless of the combination of monomers and the copolymerization ratio). , As well as mixtures thereof, with polylactic acid or lactic acid-glycolic acid copolymers being the most preferred. In addition, for example, stereocomplex polylactic acid composed of poly L lactic acid and poly D lactic acid may be used. The thickness of the biocompatible yarn is preferably 0.02 mm to 0.8 mm in diameter.

The obstructing material of the present invention penetrates through the biocompatible thread in the order of the thread removal prevention portion and the swelling member when viewed from the side of the puncture hole to be placed. In order to bend and form a lump, it is preferable that there is at least one penetration point proximal to the puncture hole side of the swelling member, and a plurality of other penetration points toward the distal direction when viewed from the puncture hole side. If it is, it tends to become more lumpy. Further, when the swelling member has a cylindrical shape or a spiral shape, if the plurality of penetrating points are located at positions separated from each other, for example, on opposite sides in the radial direction of the circle, the central hole is likely to be closed when the thread is pulled. .. Further, if the thread pull-out prevention parts are arranged on both sides of the swellable member in the order of the thread pull-out prevention part, the swellable member, and the thread pull-out prevention part, and they are connected by the biocompatible thread, it is more reliably lumpy. Can be.

A second embodiment of the present invention comprises a swellable member having a spiral shape and a biocompatible yarn having a thread pull-out prevention portion on one side, and the other side of the biocompatible yarn is at least the swellable member. Regarding medical occlusion material that penetrates one place. In such a closing material, a member having a spiral shape can be lumped by buckling deformation as described above, or the central hole of the spiral can be made small and lumpy without buckling deformation. Further, such a swellable member may have a spiral shape in all or a partial spiral shape. As the swelling member, the thread pull-out prevention part, and the biocompatible thread in the present embodiment, the above-mentioned ones can be used. The spiral shape may be wound at least one round or more, and more preferably two turns or more. The biocompatible yarn penetrates at least one place of the swelling member, more preferably two or more places, and particularly preferably two or more times per spiral of the swelling member. .. Further, it is preferable that the biocompatible thread penetrates along the spiral shape. The diameter of the outer diameter of the spiral can be adjusted according to the diameter of the puncture hole. The swellable member can be divided into a plurality of pieces to form a spiral shape.

The occlusive material of the present invention is not limited to the puncture hole, but can also be used to occlude a hole generated in a living body, and typically, to puncture a puncture hole of a blood vessel generated by catheter surgery or the like. It can be stored or mounted in a hemostatic device or hemostatic device for use. The hemostatic device is not particularly limited as long as it has a positioning mechanism, and for example, a device having a balloon in the positioning structure, a device having an anchor mechanism, or a device having a backflow mechanism can be used. The hemostatic device may include a passage through which the guide wire is inserted. With such a configuration, the insertion end of the tube can be smoothly introduced into the puncture hole by using the guide wire.

By storing the blocking material of the present invention in the tube of the hemostatic device, it can be operated without touching blood, body fluid, or the like. Also, a device having an extrusion mechanism is preferable. The puncture hole can be efficiently closed by extruding the closing material into the puncture hole portion by the extrusion mechanism. The obstructing material is typically stored in the device in a spiral or cylindrical shape, preferably in a spiral shape.

Hereinafter, the blocking material of the present invention will be described with reference to the drawings of the hemostatic device containing the closing material. An example of this occlusive material is an instrument used for a procedure for puncturing a puncture hole formed into a blood vessel percutaneously, and in the following, a procedure using a sheath introducer percutaneously punctured in the femoral artery. The case where the puncture hole from the body surface to the inside of the blood vessel formed by the removal of the sheath introducer is occluded will be described as an example. Although the wire is shown as the positioning mechanism in the drawing, other positioning mechanisms can also be used.

First, refer to FIG. The occlusive material 1 of the present embodiment is mounted on a hemostatic device 2 including a catheter tube. The closing material 1 is sewn and connected by the biocompatible thread 5 in the order of the thread removal prevention portion 4 and the swelling member 3 when viewed from the puncture hole side. The closing material 1 is spirally stored inside the outer sheath 6. Further, a plunger 7 for extruding the closing material is configured inside the outer sheath 6.

The swellable member 3 of the closing material 1 is sewn at least once by the biocompatible thread 5, and may be sewn a plurality of times. The thread removal prevention portion 4 is sewn and fixed at least once, and may be sewn a plurality of times. Further, when the biocompatible thread 5 forms the thread removal prevention portion on the distal end side when viewed from the puncture hole side, the closing material 1 can be more reliably agglomerated.

As a positioning mechanism, the wire 8 is housed inside the catheter tube.

Examples of the material constituting the catheter tube include polyvinyl chloride resin, urethane resin such as polyurethane, polyolefin resin such as polyethylene, polypropylene and ethylene-propylene copolymer, polyamide resin, polytetrafluoroethylene and tetrafluoroethylene-per. Examples thereof include various synthetic resin materials such as a fluoroalkyl vinyl ether copolymer, a tetrafluoroethylene-hexafluoropropylene copolymer, a fluororesin such as polyvinylidene fluoride, and an ethylene-vinyl acetate copolymer.

The size of the catheter tube is not particularly limited, but the length of the outer sheath 6 can be, for example, 20 to 300 mm. The outer diameter of the outer sheath 6 is set to the same or smaller diameter in relation to the inner diameter of the puncture hole to be blocked (hemostatic) or the outer diameter of the sheath introducer used to form the puncture hole. For example, it can be set within the range of 0.5 to 20.0 mm. The plunger 7 is set to have the same or smaller diameter than the inner diameter of the outer sheath 6, and can be set within the range of 0.3 to 19.0 mm.

The swellable member 3 can have, for example, a strip-shaped, cylindrical, cylindrical, cubic or polyhedral structure, and is formed by spirally winding. The thread pull-out prevention portion 4 may have, for example, a strip-shaped, cylindrical, cylindrical, cubic or polyhedral structure, or may form a part of a spiral structure. The mass of the swellable member 3 is set to 1 to 200 mg, and the mass of the thread removal prevention portion 4 is set to 1 to 100 mg.

The length of the biocompatible yarn 5 can be 30-2000 mm and is connected to a manual spool, an automatic spool or a member having a tension mechanism through the inside of the outer sheath 6 or the lumen of the plunger 7. ..

The wire 8 is housed inside the catheter tube. By extruding from the catheter tube, it serves as an inflated positioning within the blood vessel.

Next, using the above-mentioned hemostatic device, the puncture hole from the body surface to the inside of the blood vessel, which is formed by removing the sheath introducer punctured into the blood vessel (femoral artery) percutaneously, is occluded (hemostatic). The procedure of the procedure to be performed will be described with reference to FIGS. 2A to 2F.

First, as shown in FIG. 2A, the insertion end 9 of the hemostatic device 1 is inserted into the puncture hole 10 from a state in which the skin tissue 11 and the blood vessel wall 12 are percutaneously punctured. In addition, in FIGS. 2A to 2F, the drawing of blood is omitted.

From this state, the wire 8 is then discharged from the catheter tube into the blood vessel, and the wire 8 locates and positions the blood vessel wall as shown in FIG. 2B.

Then, as shown in FIG. 2C, the spirally wound obstructive material 1 containing the biocompatible thread is extruded into the puncture hole by the plunger 7. As a result, the spirally wound obstructive material is discharged into the puncture hole, and the swellable member of the obstructive material expands due to blood or body fluid. In this state, the wire is pulled back and collected. As shown in FIG. 2D-1, when only the wire 8 is pulled out, the through hole of the wire 8 is opened as shown in FIG. 2D-2.

Then, by winding or pulling the biocompatible thread 5 while maintaining the extruded state of the plunger portion, the occlusion material becomes lumpy as shown in FIG. 2E, and is shown in FIG. 2E-2. The puncture hole is occluded as shown in the above, and hemostasis is completed by finally collecting the hemostatic device as shown in FIG. 2F. If there is no thread pull-out prevention part and only the swelling member is used, the thread stopper of the biocompatible thread does not function and cannot be closed. In the occlusion material of the present invention, the biocompatible thread is sewn through the swelling member, so that the through hole is closed and the excessive expansion of the occlusion material is suppressed, so that the puncture hole of the blood vessel is more efficiently performed. Can be detained in. Further, since the occlusive material of the present invention can be placed outside the blood vessel, it can be prevented from overflowing into the blood vessel, and a serious defect can be prevented. Further, the occlusion material of the present invention can be left as it is even after the operation by using a bioabsorbable material.

Hereinafter, the present invention will be specifically described with reference to Examples and Comparative Examples, but the scope of the present invention is not limited thereto.

[Example 1]
To prepare a gelatin sponge, first, 60 mL of pure water was added to 1.2 g of gelatin (LS-H, manufactured by Nitta Gelatin Co., Ltd.), and the dispersion was heated to 60 ° C. until it was completely dissolved. Next, 30 mL of gelatin solution was poured into a plastic petri dish having a diameter of 10 cm and cooled at 4 ° C. for 2 hours. It was then frozen at −80 ° C. and lyophilized under 1 Pa conditions. The obtained gelatin sponge was heat-treated at 130 ° C. for 6 hours to obtain a crosslinked gelatin sponge, which was cut out to a length of about 60 mm, a width of about 6 mm, and a thickness of about 2 mm. Next, in order to prepare a thread loss prevention portion, a glycolic acid-lactic acid copolymer (Purasorb PDLG5010, manufactured by Purac) was dissolved in dichloromethane to prepare an 8% by weight polymer solution. Spinning distance 80 cm, liquid feeding speed 3 mL / min (per nozzle hole. 4 holes were used for preparation), air flow rate 60 L / min, spinning by dry spinning method equipped with collector transfer system, non-swelling A sheet-shaped non-woven fabric was obtained as a member. A sheet-shaped non-woven fabric having a thickness of about 2 mm was cut out to a length of about 4 mm and a width of about 4 mm. Subsequently, 30 mg of the prepared gelatin sponge and 5 mg of the non-woven fabric of the lactic acid-glycolic acid copolymer were sewn together with a polyglycomer suture (Polysove, manufactured by Covidien) as shown in FIG. 3 (A). The tip of the polyglycomer suture was tied to a diameter of about 1 mm to prepare a thread removal prevention portion. Subsequently, an acrylic pipe having a partition plate having an inner diameter of 5.5 mm and a through hole having a diameter of 2.7 mm is provided at the center of the pipe as shown in FIG. 4 (A), and an evaluation simulating the through hole in the living body is provided. A tube 13 was prepared, and the obstructing material was spirally stored in the tube 13 as shown in FIG. 4 (B), and physiological saline was immersed from the lower part of the pipe so that the obstructing material was moistened. Further, the suture was pulled from the upper part of the obstructing material while being pressed by the plunger 14 having a diameter of 5 mm, and it was confirmed as indwellability whether the obstructing material became lumpy and could be indwelled. Those that could be placed in a lump were marked with 〇, and those that could not be placed in a lump due to the suture coming off were marked with x. Further, as shown in FIG. 4B, water pressure was applied from the lower part of the acrylic pipe having the pressure gauge 15, and the water resistance was evaluated in a state where the blocking material was suppressed by the plunger. Those that did not leak even at 220 mmHg or more were evaluated as 〇, and those that leaked at 220 mmHg or less were evaluated as ×. The results are shown in Table 1. As shown in the table, this blocking material could be placed in a lump and had water resistance.

[Example 2]
30 mg of gelatin sponge was prepared by the procedure of Example 1, and two 5 mg non-woven fabrics of the lactic acid-glycolic acid copolymer similarly prepared by the procedure of Example 1 were prepared, and polyglycomer suture was performed so that the sponge was sandwiched from above and below. It was sewn with a thread (polysorbe, manufactured by Covidien) as shown in FIG. 3 (B). The closing material was stored in the acrylic pipe in the same manner as in Example 1, and the suture was pulled in the same manner as in Example 1 to evaluate the closing material. The results are shown in Table 1. As shown in the table, this blocking material could be placed in a lump and had water resistance.

[Comparative Example 1]
As shown in FIG. 3C, 30 mg of gelatin sponge prepared in the procedure of Example 1 was sewn through with a polyglycomer suture (Polysove, manufactured by Covidien), and the tip of the polyglycomer suture was ball-tied to a diameter of about 1 mm. A thread removal prevention part was produced. Similar to Example 1, such a closing material was stored in a pipe so as to have a spiral shape, and the indwellability and water resistance were evaluated. As a result, in the case of the closing material containing only the ball knot without the non-woven fabric of the lactic acid-glycolic acid copolymer as in Example 1, the suture thread does not come off from the swelling member and does not become lumpy, and the water resistance is sufficient. It wasn't something like that.

[Comparative Example 2]
The non-woven fabric of the lactic acid-glycolic acid copolymer of the non-swelling member produced in the procedure of Example 1 was cut out to a length of about 60 mm × a width of about 6 mm × a thickness of about 2 mm, and was sutured with polyglycomer as shown in FIG. 3 (D). A thread (polyzove, manufactured by Covidien) was sewn through, and the tip of the polyglycomer suture was ball-tied to a diameter of about 1 mm to prepare a thread removal prevention portion. When such a blocking material was stored in a pipe in a spiral shape and evaluated for indwellability and water resistance in the same manner as in Example 1, it became lumpy, but the water resistance was not sufficient.

The embodiments described above are described for facilitating the understanding of the present invention, and are not described for limiting the present invention. Therefore, each element disclosed in the above-described embodiment is intended to include all design changes and equivalents belonging to the technical scope of the present invention.

1 Occlusion material 2 Hemostatic device (hemostatic device)
3 Swellable member or biocompatible member 4 Thread loss prevention part 5 Biocompatible thread 6 Outer sheath 7 Plunger 8 Wire 9 Insertion end of hemostatic device 1 10 Puncture hole 11 Skin tissue 12 Blood vessel wall 13 Evaluation tube 14 Evaluation Plunger 15 pressure gauge

Claims (13)

A medical occlusion material, the occlusion material is composed of a swellable member capable of buckling deformation and a biocompatible yarn having a thread pull-out prevention portion on one side, and the other side of the biocompatible yarn is the swelling material. A medical occlusion material that penetrates at least one part of a sex member. The closing material according to claim 1, wherein the buckling-deformable swellable member has a cylindrical shape. A medical occlusion material, wherein the occlusion material is composed of a swellable member having a spiral shape and a biocompatible thread having a thread pull-out prevention portion on one side, and the other side of the biocompatible thread is the swelling property. A medical occlusion material that penetrates at least one part of the member. Any of claims 1 to 3, wherein the closing material has yet another thread pull-out prevention portion, and is connected by a biocompatible thread in the order of the thread pull-out prevention portion, the swelling member, and the thread pull-out prevention portion. The blocking material according to item 1. The occlusion material according to any one of claims 1 to 4, wherein the swelling member comprises at least one selected from the group consisting of gelatin, collagen, polyethylene glycol and polyethylene glycol-based derivatives. The closing material according to any one of claims 1 to 5, wherein the swelling member is a sponge, a non-woven fabric, or a woven or knitted fabric. The closing material according to any one of claims 1 to 6, wherein the thread removal prevention portion is a non-swelling member. Any one of claims 1 to 7, wherein the thread removal prevention portion comprises at least one selected from the group consisting of polyglycolic acid, polylactic acid, polycaprolactone, and a copolymer of two or more kinds of monomers constituting them. The blocking material according to item 1. The closing material according to any one of claims 1 to 8, wherein the thread removal prevention portion is a non-woven fabric, a woven knit, or a sponge. 1. The biocompatible yarn comprises at least one selected from the group consisting of polyglycolic acid, polylactic acid, polycaprolactone, a copolymer of two or more kinds of monomers constituting them, and a mixture thereof. The blocking material according to any one of 9 to 9. The obstruction material according to any one of claims 1 to 10, wherein the obstruction material is mounted on a hemostatic device having a delivery mechanism. The closing material according to any one of claims 1 to 11, wherein the closing material is mounted on a hemostatic device having a positioning mechanism. The blocking material according to any one of claims 1 to 12, wherein the blocking material is a hemostatic material.