JP3485472B2 - Medical device for diagnosis and treatment of intestinal obstruction - Google Patents

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a tube and a guide wire which are inserted into the intestinal tract from the nose or mouth by a guide wire and used for diagnosis or treatment at the time of intestinal obstruction.

[0002]

2. Description of the Related Art Intestinal obstruction is diagnosed and treated by inserting a tube having a balloon at the tip from the nose or mouth into the pylorus with a guide wire, removing the guide wire, and then inflating the balloon to obstruct the tube by peristaltic movement of the intestine. It is carried out by guiding to the occlusion, sending the contrast agent to the occlusion site through the hole of the tube, and sucking the occlusion matter, gas, etc. out of the body. Since the tube is inserted over a long distance in the bent digestive tract from the nose or mouth to the intestinal tract, the friction between the living tissue and the tube is large and a large force is required to insert the tube, and at the same time the patient also complains of pain. There is. Also, after inserting the tube to the pylorus, the guide wire is removed from the tube, but since the tube is in a bent state, friction between the tube lumen and the guide wire is large and a large force is required to remove the guide wire. Sometimes, there is a problem that the guide wire cannot be removed.

Several attempts have been made to reduce the friction between a tube and a living tissue by using a hydrogel. In all of these, the hydrogel is applied to the outer surface of the tube, and the hydrogel is bonded to the base material of the tube. However, there is a problem in that the hydrogel is easily detached and the sufficient effect cannot be obtained. In addition, there are some reports that try to reduce the friction between the tube and the guide wire by using hydrogel, but these apply hydrogel to the surface of the guide wire or hydrogel to the inner surface of the tube. In the former case, the hydrogel applied by the guide wire is likely to fall off due to contact with the tube when the guide wire is inserted, and the guide wire itself slips when it is removed, which makes it difficult to handle. Further, the latter has a problem that the hydrogel applied to the tube is easily scraped off by contact with the guide wire, and the effect of sufficiently reducing the withdrawal resistance cannot be obtained.

[0004]

SUMMARY OF THE INVENTION The present invention is intended to solve the above-mentioned conventional problems. Therefore, focusing on the fact that a compound having a photoreactive azido group or a photoreactive arylketone group is inserted between C—H bonds on the surface of a synthetic resin by irradiation of ultraviolet rays and a covalent bond is possible on the surface of the synthetic resin, One functional group that can be selected from a photoreactive azido group or a photoreactive arylketone group and a succinimide group, an isocyanate group, an aldehyde group, an amino group, a carpoxyl group, an epoxy group, a hydroxyl group, or an acid anhydride in the molecule. That the hydrogel having an amino group or a carboxyl group can be covalently bonded to the surface of any synthetic resin having a C—H bond by the bifunctional reagent having, and the desorption resistance to friction of the hydrogel is improved relative to coating. Furthermore, by fixing the hydrogel to the lumen of the tube and coating the surface of the guide wire with synthetic resin elastomer, It found that it is possible to prevent scraping Dorogeru led to Zukui study present invention.

[0005]

DISCLOSURE OF THE INVENTION The present invention comprises a tube in which a hydrogel is fixed to the outer surface and inner surface of the tube and a guide wire or a guide wire covered with a synthetic resin elastomer. A medical device for diagnosing intestinal obstruction, which reduces friction between a tube and a guide wire, and is less likely to cause detachment of the hydrogel or scraping off by the guide wire even after repeated use, thereby reducing friction resistance satisfactorily. It is about.

[0006]

BEST MODE FOR CARRYING OUT THE INVENTION A tube that can be used in the present invention comprises a lumen having a balloon at or near the tip thereof and capable of delivering liquid or gas to the balloon, and a lumen capable of passing liquid or solid. A tube shaped with multiple lumens is desirable. The material of the tube that can be used in the present invention is not particularly limited, but a polyurethane resin, polyvinyl chloride resin, silicone resin, polyamide resin, or a composite material based on a synthetic resin that can be selected from these is used. it can.

As the balloon material usable in the present invention, silicone rubber, polyurethane rubber, synthetic rubber, natural rubber, polyvinyl chloride, etc. can be used. Further, the guide wire that can be used in the present invention, such as a metal wire or a metal core rod wound with a metal wire in a coil shape, can be used, but the hydrogel fixed to the tube lumen is scraped off by the guide wire. Since it is easy, a metal core rod coated with a synthetic resin elastomer or a metal core rod wound with a metal wire in a coil shape and coated with a synthetic resin elastomer is preferable.

The metal that can be used for the guide wire in the present invention is not particularly limited, but stainless steel, Ni
-Ti alloy etc. can be used. Further, the synthetic resin that can be used for coating the guide wire in the present invention may be a styrene elastomer, a urethane elastomer, an olefin elastomer, a polyester elastomer, a polyamide elastomer, a vinyl chloride elastomer, a silicone resin, etc. Even if the elastomers and silicone resins are flexible and coated, they do not significantly affect the physical properties of the guide wire and they are not toxic, which is desirable.
Further, examples of the hydrogel that can be used in the present invention include polyvinyl alcohol, hyaluronic acid, poly (N-vinylpyrrolidone), gelatin, collagen and the like. Among them, poly (N-vinylpyrrolidone) is preferable because it has no reactivity with living tissues.

The photoreactive reagent that can be used for immobilizing the hydrogel in the present invention includes a photoreactive arylketone group, a succinimide group, an isocyanate group in one molecule,
It has one functional group that can be selected from an aldehyde group, an amino group, a carboxyl group, an epoxy group, a hydroxyl group, and an acid anhydride, and is not particularly limited, but as the one having a photoreactive aryl ketone, benzoyl Benzoic acid, benzoylbenzoic N-oxysuccinimide, benzoylbenzoic-polyethylene glycol, benzoylbenzoic-polyethyleneglycol-amine and the like are desirable, and particularly for fixing poly (N-vinylpyrrolidone), benzoylbenzoic N-oxysuccinic acid Acid imide and benzoylbenzoic-polyethylene glycol-amine are more desirable. The effects of the present invention will be described below with reference to examples.

[0010]

【Example】

(Examples and Comparative Examples) 1) Preparation of Tube Base Material Polyvinyl chloride resin (manufactured by Sumitomo Bakelite Co., Ltd.) was extruded to have an outer diameter of 6 mm, an inner diameter of 3 mm, 2 mm, and 1.
It was a 3 lumen tube having a length of 5 mm and a length of 300 cm.
One tube stump closes the lumen of these tube stumps by placing an adhesive in the lumen of 2 mm and 1.5 mm inner diameter, and 5 cm and 12 cm from this stump, 14 cm
A hole having an inner diameter of 2 mm was provided at a position of cm, 16 cm, 18 cm, 20 cm, and 22 cm, which penetrates the outer surface of the tube and the lumen having an inner diameter of 3 mm. Next, an adhesive tape made of Teflon was attached to the outer surface of the tube at a position 7 cm to 10 cm from the stump that closed the two lumens, and masking was performed so that the rehydrogel was not fixed and a tube base material was prepared.

[0011]

[0012]

3) Preparation of poly (N-vinylpyrrolidone) fixed tube (2) 500 ml of a dry dioxane solution of 6 g of ethylenediamine (manufactured by Wako Pure Chemical Industries, Ltd.) in a light-shielded three-necked flask.
10 g of benzoylbenzoic N-oxysuccinimide (manufactured by SIGMA) was added thereto, and the mixture was stirred overnight at room temperature to obtain a benzophenone derivative of ethylenediamine.
Then, in a light-shielded state, the molecular weight of 36 was added to 300 ml of dioxane.
36 g of 10,000 poly (N-vinylpyrrolidone) (manufactured by Wako Pure Chemical Industries, Ltd., for cosmetics) and 3.8 g of a benzophenone derivative of ethylenediamine and 1 g of dicyclohexylcarbodiimide (manufactured by Wako Pure Chemical Industries, Ltd.) were added. Then, the mixture was stirred at room temperature for 8 hours, and poly (N-vinylpyrrolidone) was bound to the benzophenone derivative of ethylenediamine to obtain poly (N-vinylpyrrolidone) bound with photoreactive benzophenone.

Next, 6 g of poly (N-vinylpyrrolidone) bound with photoreactive benzophenone was dissolved in 200 ml of a 1: 1 mixed solution of isopropyl alcohol and pure water,
The entire outer surface and inner diameter of the masked tube base material 3m
It was applied to the entire lumen of the m lumen. After the tube was dried, the masking tape was removed, the tube was irradiated with light from a high pressure mercury lamp overnight, and the unreacted material was washed by ultrasonic cleaning with a neutral detergent. After drying the tube, a lumen with an inner diameter of 1.5 mm and a hole with an outer diameter of 1.5 mm that penetrates the outer surface of the tube are opened in the center of the masking section, and 7c from the stump on the sealed side.
A silicone balloon with a volume of 30 ml is bonded to the part from 10 m to 10 cm, and a luer connector that can be connected to a syringe is bonded to the tube stump with an inner diameter of 2 mm and a lumen of 1.5 mm on the side of the tube that has not been sealed. Then
The poly (N-vinylpyrrolidone) -fixed ileus tube (2) of the present invention was produced.

[0015]

5) Preparation of comparative tube Polyvinyl chloride resin (manufactured by Sumitomo Bakelite Co., Ltd.) was extruded to have an outer diameter of 6 mm, an inner diameter of 3 mm, 2 mm, and 1.
It was a 3 lumen tube having a length of 5 mm and a length of 300 cm.
One tube stump closes the lumen of these tube stumps by placing an adhesive in the lumen with an inner diameter of 2 mm and 1.5 mm, and 5 cm and 12 cm from this stump
A hole having an inner diameter of 2 mm was provided at a position of cm, 16 cm, 18 cm, 20 cm, and 22 cm, which penetrates the outer surface of the tube and the lumen having an inner diameter of 3 mm. Next, a hole with an outer diameter of 1.5 mm that penetrates the lumen with an inner diameter of 1.5 mm and the outer surface of the tube is opened at a position 8.5 cm from the stump that closed the two lumens.
A silicone balloon with a volume of 30 ml is adhered to a place 7 cm to 10 cm from the stump on the block side, and the tube stump on the non-blocked side has a tube stump with an inner diameter of 2 mm and a lumen of 1.5 mm. A lure connector to which a syringe can be connected was adhered to manufacture a comparative ileus tube.

6) Preparation of Polyurethane-Coated Guide Wire Stainless steel wire wound around a stainless cored bar in a coil shape with an outer diameter of 1.3 mm and a length of 3 m and 50 cm is 10% TH of medical polyurethane (Tecoflex 85A).
The polyurethane solution-coated guide wire of the present invention was produced by applying the F solution and vacuum drying at 60 ° C. for 5 hours.

7) Measurement of tube lubricity A lump of pork is cut out into a cylindrical shape having a diameter of 50 mm and a length of 120 mm (about 350 g), a polyethylene film is wrapped around the side surface of the cylinder, and fixed with tape to fix the pork. I made a simulated living tissue. Next, the pork was fixed to the desk with a clamp, and the poly (N
-Vinylpyrrolidone) fixed tube (2) and the tube of the comparative example are penetrated into the pork from the tube stumps of the side where the balloons are attached at 1 cm intervals, and when each tube is 12 cm out of the surface of the pork, the tip of each tube And Digital Force Gauge (Sympo Industry Co., Ltd., DFGO2)
K type) was connected with a stainless wire, and the pork and the whole tube were immersed in pure water. Next, the digital force gauge connected to the tube was moved at a constant speed of 10 mm / sec to pull out the tube straight from the pork for 30 cm, and the withdrawal resistance of each tube was measured.

8) Measurement of pull-out resistance of guide wire The poly (N 1-vinylpyrrolidone) fixed tube (2) prepared above and the tube of the comparative example were injected with a syringe 20
Then, 300 ml of the polyurethane-coated guide wire and the polyurethane-uncoated guide wire prepared above were inserted into a lumen having an inner diameter of 3 mm, and each tube was wound around a cylinder having a diameter of 10 cm once.
Next, the tip of the guide wire coming out of the tube 5 cm
B is bent into a U shape and connected to a digital force gauge (DFGO2K type manufactured by Shinpo Industry Co., Ltd.), and the digital force gauge is moved 30 cm at a constant speed of 10 mm / S to guide the wire from inside the tube. Was pulled out, and the average pulling load was taken as the resistance value, and the resistance was measured in each tube.

[0020]

[0021]

10) Results of measuring the lubricity of the tube The pulling resistance of the poly (N-vinylpyrrolidone) fixed tube (2) and the tube of the comparative example from the pork was as shown in FIG. 11) Measurement result of pull-out resistance of guide wire The pull-out resistance value obtained by pulling out the polyurethane-coated guide wire and the uncoated guide wire from the poly (N-vinylpyrrolidone) fixed tube (2) and the tube of the comparative example is as shown in FIG. became.

[0023]

[0024]

As described above, it has been clarified that the ileus tube in which the hydrogel is fixed by the photofunctional reagent can reduce the friction with the living tissue and the pull-out resistance of the guide wire.

[Brief description of drawings]

FIG. 1 is a polyvinyl chloride tube of a comparative example and a poly (N-vinylpyrrolidone) fixing tube of the present invention (2).
Was inserted into pork with a puncture needle, and the withdrawal resistance value of each tube when each tube was pulled out at a constant speed was shown by the load (g).

[Fig. 2] A polyvinyl chloride tube of Comparative Example and a tube (2) of the present invention on which poly (N-vinylpyrrolidone) is fixed, in which a polyurethane-coated guide wire and an uncoated guide wire in the presence of pure water are kept constant. The pull-out resistance value when pulling out at a speed is shown by the load (g).

─────────────────────────────────────────────────── --- Continuation of the front page (56) References JP-A-9-103481 (JP, A) JP-A-5-285217 (JP, A) JP-A-8-19599 (JP, A) JP-A-9- 51941 (JP, A) JP 10-179722 (JP, A) JP 6-7426 (JP, A) JP 5-156203 (JP, A) JP 3-184557 (JP, A) JP-A-2-211167 (JP, A) (58) Fields investigated (Int.Cl. ⁷ , DB name) A61L 29/00 A61L 31/00

Claims (3)

(57) [Claims] 1. A two officer hydrogel outer surface and an inner luminal surface
A bifunctional reagent that consists of a tube fixed with a functional reagent and a guide wire to fix the hydrogel.
One functional group is a photoreactive aryl ketone group,
One functional group is succinimide group, isocyanate group,
Aldehyde group, amino group, carboxyl group, epoxy
A medical device for diagnosing and treating intestinal obstruction, which is a functional group that can be selected from a group and an acid anhydride . 2. The medical device for diagnosis and treatment of intestinal obstruction according to claim 1, wherein the guide wire is covered with a thermoplastic elastomer. 3. The hydrogel is hyaluronic acid, poly (N
-Vinylpyrrolidone), polyvinyl alcohol, gelatin, collagen at least 1
The medical device for diagnosing and treating intestinal obstruction according to claim 1 or 2, which is one hydrogel.