KR100316200B1 - Non-adhesion fabric band for surgical operation and it's manufacturing process - Google Patents

Abstract

PURPOSE: An adhesion inhibitor for a surgical operation is provided, thereby the adhesion inhibitor having an improved adhesion inhibiting activity can be cheaply produced. CONSTITUTION: The adhesion inhibitor for a surgical operation characteristically consists of an adhesion inhibiting fabric(1) which contains an adhesion inhibiting means in a biodegradable reproduced cellulose non-woven fabric, and a hemostatic fabric(2) which contains a hemostatic means in the biodegradable reproduced cellulose non-woven fabric, wherein the adhesion inhibiting fabric(1) and the hemostatic fabric(2) are pasted by using a biodegradable adhesive(3).

Description

NON-ADHESION FABRIC BAND FOR SURGICAL OPERATION AND IT'S MANUFACTURING PROCESS}

The present invention relates to an anti-adhesion agent attached to a surgical site to prevent adhesion of tissue during a surgical operation, and to a method of manufacturing a nonwoven fabric constituting it.

During surgery, due to the adhesion of the surgical site, the intestine is attached and requires reoperation, or in the obstetrics and gynecology area, internal organ adhesion occurs after pelvic cavity surgery, resulting in infertility due to fallopian tubes and peritoneal factors. Is required.

In the gynecological area, for example, anti-histamines, corticosteroids, nonsteroidal anti-inflammatory drugs, etc. may be administered systemically in an effort to prevent adhesion after surgery, or substances such as dextran or sodium carboxyl methyl cellulose may be left in the abdominal cavity or these methods. Attempts have been made to achieve postoperative adhesions in parallel, but have not yet achieved a complete prevention of adhesions.

Recently, Johnson & Johnson marketed an anti-adhesion agent under the trade name Interceed, which prevents adhesion from the surgical site by attaching an anti-adhesion agent made of oxidized regenerated cellulose fiber to the surgical site to separate the surgical site from the internal organs. Since the adhesion of the anti-adhesion agent is made in a state in which hemostasis is not sufficiently performed after the operation, there was a problem in that a perfect anti-adhesion effect cannot be obtained by the blood cut out to the anti-adhesion surface.

In order to solve this problem, sufficient hemostasis must be made after the incision of the surgical site, but the operation time is long for the hemostasis, and due to side effects causing a dangerous situation depending on the patient, there is a situation in which sufficient hemostasis cannot be achieved.

On the other hand, the anti-adhesion agent is produced oxidized regenerated cellulose fibers and is produced in the form of knitted fabrics through knitting or weaving looms, so the manufacturing process is complicated, and because the production of fibers by solution spinning, it is difficult to control the physical properties of the fibers and equipment costs I had a problem.

The present invention is proposed to solve the problems associated with hemostasis when using conventional anti-adhesion agents, to present an anti-adhesion agent that exhibits a hemostatic function and an anti-adhesion function at the same time, constituting the anti-adhesion agent. will be.

To this end, the present invention is attached to the anti-adhesion fabric including the anti-adhesion means on the biodegradable regenerated cellulose nonwoven fabric and the hemostatic cell including the hemostatic means included in the biodegradable regenerated cellulose nonwoven fabric with a biodegradable adhesive to prevent the cohesion and at the same time prevent adhesion An anti-adhesion agent for surgical surgery having an effect and a method of manufacturing the same are provided.

Hereinafter, the configuration and operation of the present invention will be described in detail.

1 is a structural diagram of the anti-adhesion agent according to the present invention

Figure 2 is a manufacturing method of the nonwoven fabric for anti-adhesion according to the present invention

Figure 3 is a partially enlarged view of the nonwoven fabric for anti-adhesion according to the present invention

* Description of the major symbols

1. Anti-adhesion cloth 2. Hemostatic 3. Adhesive

4.Radiator 5.Integrator

The present invention attaches the anti-adhesion fabric (1) including the anti-adhesion means to the biodegradable regenerated cellulose nonwoven fabric and the hemostatic cell (2) including the hemostatic means to the biodegradable regenerated cellulose nonwoven fabric with a biodegradable adhesive (3). It is made up.

1 is an enlarged view of the basic shape of the anti-adhesion agent for surgery of the above configuration.

The biodegradable regenerated cellulose is naturally decomposed and absorbed in vivo, and the anti-adhesion function is given by partially substituting the -OH group to the -COOH group in the cellulose group, and the carboxyl group content of the biodegradable oxidized regenerated cellulose substituted by the carboxyl group is 5 to 40wt%. % Is preferred.

Below 5wt%, the degree of adhesion prevention by Gary Holtz's classification method is Grade 2 or above, and the adhesion prevention effect is reduced, and when it is 40wt% or above, it cannot be used.

Preferred carboxyl group content is in the range from 15 to 35 wt%, thus the pH in the range from 6.5 to 7.5.

The carboxyl group content of oxidized regenerated cellulose was determined by adding 50 ml of CO2 -free water and 30 ml of 0.5N calcium acetate to 0.5 g of oxidized regenerated cellulose. Obtain

The present invention provides a method of adding calcium to a nonwoven fabric as a hemostatic means.

The role of calcium in the hemostasis stage is well known, and it promotes coagulation when converting protothrombin to thrombin in one stage of blood coagulation.

The present invention is to enhance the hemostatic effect by containing a calcium content of 0.5 ~ 10t% in the nonwoven fabric in order to enhance the hemostatic effect and the hemostatic effect by the shielding action of the surgical site by the nonwoven fabric.

If the calcium content is less than 0.5wt%, the hemostatic effect is reduced, and if more than 10wt%, the blood coagulates, and the range of the good calcium content is 2 to 6.5wt%.

The adhesive 3 uses a biodegradable adhesive that is harmless to the human body as a component for attaching an anti-adhesion cloth having an anti-adhesion function and a hemostatic cell having a hemostatic effect after dissolving a natural or synthetic biodegradable polymer in a solvent.

As the adhesive, synthetic degradable polymers such as glycolide, lactide, glycolic acid, lactic acid, dioxane source, trimethylene carbonate, caprolactone, copolymers and blends thereof, or natural degradable polymers such as chitosan and cellulose And copolymers and blends thereof, and by adhering the anti-adhesion cloth and the hemostatic cell using such an adhesive, the identity of the anti-adhesion agent can be maintained, and the biodegradation rate can be maintained.

The present invention includes a configuration for varying the color of the anti-adhesion cloth and hemostatic cells of the composition of the anti-adhesion agent.

The anti-adhesion agent according to the present invention achieves a hemostatic effect and an anti-adhesion effect by attaching the anti-adhesion cloth so that the anti-adhesion cloth is directed to the outside and the hemostatic cell is in direct contact with the surgical site. It is not easy to cause confusion and raises concern about misuse.

By distinguishing the anti-adhesion cloth and hemostatic cells by their respective colors, they are easy to distinguish when handling and can be used without any confusion, and can prevent misuse due to confusion.

In order to impart color, pigments that are harmless to the human body are added or dyed using dyes. In the present invention, Color Index Solvent Violet 13 or Solvent Green 6 is used, and the amount of addition is 0.01 to 1 wt%, so that hemostasis and anti-adhesion effects are achieved. It has good color separation ability without offsetting.

Oxidized regenerated cellulose nonwoven fabric is manufactured by dissolving regenerated cellulose in N-metylmorpholine N-oxide (MMNO), discharging it through spinneret and collecting fiber with solvent. This excellent nonwoven fabric is used, and the fiber diameter has the best hemostatic effect and anti-adhesion effect at 0.001 to 0.01 μm.

If the fiber diameter of the nonwoven fabric is 0.1 μm or more, the porosity is large, and thus, the anti-adhesion effect is reduced since the blood or the bleed is cut out through the hemostatic or anti-adhesion cloth after the operation.

In order to effectively obtain a fiber diameter in the above range and to simplify the manufacturing process significantly, the present invention also provides a method for producing a nonwoven fabric constituting the anti-adhesion agent.

The manufacturing method of the nonwoven fabric which is a component of the anti-adhesion agent by this invention is as follows.

Regenerated cellulose is dissolved in N-metylmorpholine N-oxide (MMNO), discharged through spinneret (4), high voltage of 10-100 kV to concentrator (5) by roller or conveyer belt that collects solvent-attached fibers. It is a method of producing a nonwoven fabric by distributing thin and uniform fibers by applying a high voltage.

Figure 2 shows the manufacturing principle of the nonwoven fabric by the method described above, 6 is a winding roll for winding the nonwoven fabric in the form of a roll to enable continuous production, 7 is an extension roller, 8 is a solution tank. .

N-metylmorpholine N-oxide (MMNO) contained in the regenerated cellulose and the electric attraction due to the high voltage applied to the concentrator can distribute the fiber very thin and uniformly, and control the voltage and MMNO concentration applied to the concentrator, respectively. By doing so, it is possible to easily and simply produce a nonwoven fabric having a desired diameter.

Therefore, in order to prepare the anti-adhesion agent, oxidized regenerated cellulose fibers are manufactured and manufactured in the form of woven or knitted fabric using a loom or knitting machine, which makes the manufacturing process very complicated and makes the fiber by solution spinning, thus making it difficult to control the physical properties of the fibers. It is possible to solve the disadvantage that the equipment cost is expensive, it is possible to continuously produce a non-woven fabric excellent in the touch as shown in FIG.

Specific embodiments of the present invention by the above configuration are as follows.

Example 1

The MMNO solvent was melted at 90 ° C., and 8 wt% of pulp having a polymerization degree of 1120 was added to prepare a spinning stock solution.

To the prepared stock solution was added 0.03wt% of Color Index Solvent Violet 13 to prepare a purple stock solution.

This stock solution is placed in a nonwoven fabric manufacturing tank and placed in a hot air dryer at 85 ° C. for one day to remove bubbles.

The stock solution is discharged through a spinneret having a diameter of 0.1 mm using a nonwoven fabric manufacturing apparatus.

In order to remove the discharged solvent, a non-woven fabric having an average thickness of 0.006 μm, a thickness of 10 μm, and a width of 8 cm was manufactured by concentrating a fiber having a solvent attached thereon in a roller subjected to a 50 kV high voltage.

Using this regenerated cellulose nonwoven fabric, a carboxyl group having 25 wt% was used as the anti-adhesion fabric having anti-adhesion function.

In addition, the MMNO solvent was melted at 90 ° C., and 8 wt% of pulp having a polymerization degree of 1120 was added thereto, and 0.04 wt% of Color Index Solvent Green 6 was added to the spinning stock solution to prepare a green stock solution.

Using this stock solution, a nonwoven fabric was prepared in the same manner as a nonwoven fabric having an anti-adhesion function.

Using this green nonwoven fabric, a carboxyl group having 30 wt% was separately prepared, and calcium was introduced into the carboxyl group to produce a nonwoven fabric having a content of 4.5 wt% to impart a hemostatic function.

Glycolide-lactide (molar ratio 90/10) copolymer was dissolved with methylene chloride solvent to attach a purple nonwoven fabric having anti-adhesion function and a green nonwoven fabric having a hemostatic effect.

This was dried and dried under vacuum at 0.1 tor at 100 ° C. so that the residual amount of methylene chloride was 10 ppm or less.

The anti-adhesion prepared as described above was sterilized with ethylene oxide (ethylene oxide) and animal experiments were performed using 10 rabbits.

Artificially damaged Gato uterus was covered with 3.8cm × 5.1cm adhesion agent.

Sixty days after surgery, the degree of adhesion prevention was evaluated. Grade 0.1 ± 0.05 showed almost perfect adhesion prevention effect.

The hemostatic effect was measured by using a swine splenic incision model, and as a result of the hemostasis function containing 4.5 wt% calcium, the oxidized regenerative cellulose nonwoven fabric containing no calcium was 12 ± 0.5 minutes. The nonwoven fabric retained was very effective at 3.2 ± 0.2 minutes.

Example 2

The spinning stock solution was prepared by melting the MMNO solvent at 90 ° C. and adding 6 wt% of pulp having a degree of polymerization of 720.

To the prepared stock solution was added 0.03wt% of Color Index Solvent Violet 13 to prepare a purple stock solution.

This stock solution is placed in a nonwoven fabric manufacturing tank and placed in a hot air dryer at 85 ° C. for one day to remove bubbles.

The stock solution is discharged through a spinneret having a diameter of 0.12 mm using a nonwoven fabric manufacturing apparatus.

In order to remove the discharged solvent, a non-woven fabric having a fiber gap with a solvent attached to the bottom was focused in a roller subjected to a high voltage of 30 kV, and an average fiber diameter of 0.08 μm, a thickness of 15 μm, and a width of 8 cm were prepared.

Using this regenerated cellulose nonwoven fabric, a carboxyl group having 35 wt% was used and used as an anti-adhesion fabric having an anti-adhesion function.

In addition, MMNO solvent was melted at 90 ° C., and 6 wt% of pulp having a degree of polymerization of 720 was added to prepare a green stock solution by adding 0.035 wt% of Color Index Solvent Green 6 to the spinning stock solution.

Using this stock solution, a nonwoven fabric was prepared in the same manner as the purple nonwoven fabric showing anti-adhesion function.

Using this green nonwoven fabric, a carboxyl group of 40 wt% was separately prepared, and calcium was introduced into the carboxyl group to produce a nonwoven fabric of 5.5 wt%, thereby imparting a hemostatic effect.

The glycolide-lactide (molar ratio 90/10) copolymer was dissolved in a methylene chloride solvent to adhere a purple anti-adhesion cloth having anti-adhesion function and a green hemostatic cell having a hemostatic effect.

This was dried and dried under vacuum at 0.1 tor at 100 ° C. so that the residual amount of methylene chloride was 10 ppm or less.

The anti-adhesion prepared as described above was sterilized with ethylene oxide (ethylene oxide) and animal experiments were performed using 10 rabbits.

The artificially damaged Gato uterus was covered with a 3.8cm × 5.1cm adhesion agent and removed 60 days after surgery to evaluate the degree of adhesion prevention.

As a result, grade 0.1 ± 0.08 showed almost perfect anti-adhesion effect.

The hemostatic effect was measured by using a swine splenic incision model, and as a result of measurement of hemostatic time, oxidized and regenerated cellulose nonwoven fabric containing 40 wt% of carboxyl group containing no calcium was 11 ± 0.8 minutes, whereas calcium was 5.5wt%. Non-woven fabric with hemostatic effect was found to be 2.6 ± 0.1 minutes, which was very effective.

Example 3

The MMNO solvent was melted at 90 ° C., and 7 wt% of pulp having a degree of polymerization of 1050 was added thereto to prepare a spinning stock solution.

Green Index was prepared by adding 0.03wt% of Color Index Solvent Green 6 to the prepared stock solution.

This stock solution is placed in a nonwoven fabric manufacturing tank and placed in a hot air dryer at 85 ° C. for one day to remove bubbles.

The stock solution is discharged through a spinneret having a diameter of 0.08 mm using a nonwoven fabric manufacturing apparatus.

In order to remove the discharged solvent, a non-woven fabric having a fiber gap with a solvent attached to the bottom was focused in a roller subjected to a high voltage of 80 kV, and an average fiber diameter of 0.003 μm, a thickness of 8 μm, and a width of 8 cm were prepared.

Using this regenerated cellulose nonwoven fabric, a carboxyl group having 35 wt% was used and used as an anti-adhesion fabric having an anti-adhesion function.

In addition, the MMNO solvent was melted at 90 ° C., and 6 wt% of pulp having a polymerization degree of 1050 was added thereto, and 0.03 wt% of Color Index Violet 13 was added to the spinning stock solution to prepare a purple stock solution.

Using this stock solution, a nonwoven fabric was prepared in the same manner as in the green anti-adhesion fabric showing anti-adhesion function.

Using this purple nonwoven fabric, a carboxyl group of 40 wt% was separately prepared, and calcium was introduced to the carboxyl group to produce a nonwoven fabric of 5.5 wt%, thereby imparting a hemostatic effect.

The glycolide-lactide (molar ratio 90/10) copolymer was dissolved in a methylene chloride solvent, and the anti-adhesion agent was prepared by attaching a purple anti-adhesion cloth and a green hemostatic cell that provided a hemostatic effect.

This was dried and dried under vacuum at 0.1 tor at 100 ° C. so that the residual amount of methylene chloride was 10 ppm or less.

The anti-adhesion prepared as described above was sterilized with ethylene oxide (ethylene oxide) and animal experiments were performed using 10 rabbits.

The artificially damaged Gato uterus was covered with 3.8cm × 5.1cm size adhesion inhibitor and then taken out 60 days after surgery to evaluate the degree of adhesion prevention.

As a result, grade 0.05 ± 0.05 showed almost perfect anti-adhesion effect.

The hemostatic effect was measured by using a swine splenic incision model, and as a result, 10 ± 0.8 minutes of oxidized and regenerated cellulose nonwoven fabric containing 40 wt% of carboxyl group containing no calcium was 5.5 wt% Non-woven fabric with hemostatic effect was found to be very effective at 2.3 ± 0.2 minutes.

Each embodiment described above is intended to show that the present invention can be implemented in various forms, the basic idea of the present invention is not limited to the above embodiments.

In the above embodiment, the degree of adhesion of the tissue was determined by dividing the grade into grade 0, 1, 2, 3. 4 by Gary Holtz's classification method

Grade 0: No adhesion

Grade 1: single filmy adhesion

Grade 2: Extensive Filmy Adhesion

Grade 3: Single dense adhesion

Grade 4: Very strong dense adhesion.

The hemostatic effect was defined as Factor IV, one of 13 blood clotting factors in the International Committee on Nomenclature of Blood Clotting Factors. Hemostatic time was measured using a swine splenic incision model.

The present invention is composed of a biodegradable anti-adhesion agent having both anti-adhesion function and hemostatic effect at the same time, even if the anti-adhesion agent is attached at the same time with surgery to achieve a perfect hemostatic effect, thereby maximizing the adhesion prevention function, It has the effect of reducing the operation time by the required time.

Also, to avoid confusion when handling, the color of one side showing anti-adhesion effect and the other side showing hemostatic effect function is very convenient for the procedure, and it can be designed and used by the doctor as needed for the surgical site during the operation. The ease of procedure and the loss of sample can be minimized.

In addition, since the fiber diameter of the nonwoven fabric is 0.001 to 0.01 μm, it has maximum flexibility and softness, so there is no restriction on the treatment site or foreign object after the procedure, and the manufacturing process is simpler compared to the case of manufacturing existing knitted fabrics. Can be reduced.

The present invention is very excellent in the prevention of intestinal adhesions in the general surgical area, and can reduce the mental pain of women suffering from infertility, especially in the obstetrics and gynecology area, as well as the convenience of the procedure, resulting in shortening of the operation time. Can be.

Claims (9)

Adhesion prevention cloth (1) including the anti-adhesion means in the biodegradable regenerated cellulose nonwoven fabric and hemostatic cells (2) including the hemostatic means in the biodegradable regenerated cellulose nonwoven fabric are attached to the biodegradable adhesive (3), Anti-adhesion agent for surgical operation, characterized in that different colors are assigned to the anti-adhesion cloth and hemostatic cells. The surgical anti-adhesion agent according to claim 1, wherein the anti-adhesion means has a adhesion prevention function by partially replacing the hydroxyl group (-OH) with a carboxyl group (-COOH) in the cellulose groups constituting the regenerated cellulose nonwoven fabric. The surgical anti-adhesion agent according to claim 2, wherein the content of the carboxyl group of the biodegradable oxidized regenerated cellulose is 5-40 wt% and the pH range is 6.5-7.5. The anti-adhesion agent according to claim 1, wherein the hemostatic means is configured to introduce calcium into the carboxyl group constituting the biodegradable oxidized regenerated cellulose nonwoven fabric so as to contain a calcium content of 0.5-4.5 wt%. The method according to claim 1, wherein the adhesive (3) comprises a synthetic degradable polymer such as glycolide, lactide, glycolic acid, lactic acid, dioxane source, trimethylene carbonate, caprolactone, copolymers and blends thereof; Natural degradable polymers such as chitosan, cellulose and the like and copolymers and blends thereof; A surgical anti-adhesion agent characterized in that it comprises one of a biodegradable adhesive harmless to the human body. The thickness of the fibers constituting the nonwoven fabric is 0.1 to 0.001 μm, and preferably 0.01 to 0.001 μm. delete According to claim 1, Pigment for imparting color is dyed using a pigment or dye that is harmless to the human body, such as Color Index Solvent Violet 13 or Solvent Green 6, Surgical, characterized in that the addition amount is in the range of 0.01 to 1wt% Surgical anti-adhesion agents. When the regenerated cellulose is dissolved in N-methylmorpholine N-oxide (MMNO) solvent and the solution is discharged through the spinneret (4), the solvent-attached fibers are focused on the concentrator (5) by roller or conveyer belt. A method for producing a non-woven fabric for surgical anti-adhesion preparation, characterized in that for producing a non-woven fabric for surgical anti-adhesion preparation by applying a high voltage in the range of 10 to 100 kV in a thin and uniform dispersion.