JPS58188463A - Balloon type cathetel and production thereof - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION 1. Background of the Invention (Technical Field) The present invention relates to a balloon-type catheter for introducing anesthetic gas, oxygen gas, etc. into the airways.

(Prior Art) As a balloon-type catheter for anesthesia or Vi breathing, a soft film is provided near the tip of the catheter tube body so as to surround the outer circumferential surface thereof in a ring shape, and the soft film and the catheter tube body are connected to each other. It is conventionally known that an inflation lumen is opened between the flexible film and the outer circumferential surface of the flexible film, and the flexible film is expanded and contracted through the inflation lumen.

This balloon-type catheter is used for the purpose of sealing the airway in front of the bronchus by inflating the balloon part (or cuff) made of this soft film, and preventing anesthesia gas from escaping from the body. .

(Problems with the prior art) However, the balloon part (also known as the 0-ring) of this conventional sleeve balloon type catheter uses soft 2J adhesive vinyl, polyvinyl acetate, latex rubber, silicone rubber, etc. as the material. The tube has a shape that is equal to the outside diameter of the tube body, and is used by injecting air into it and inflating it like a balloon. It was used. Therefore, attention has been drawn to the fact that peripheral circulation failure in the tracheal mucosa caused by this high pressure causes damage. Subsequently, an improved cuff was devised and put into practice that minimizes pressure on the tracheal wall.

This is the inner diameter of the trachea to be sealed in advance and t'
4 uses a cuff of the same size or larger, and attempts to seal the trachea without increasing the internal pressure of the cuff, or with a phantom low pressure. This type of cuff prevents pressure on the tracheal mucosa due to increased awareness of damage to the tracheal mucosa, and these types of cuffs are currently the most commonly used.

However, although it was more effective than previous cuffs for tracheal mucosal damage, in recent years there have been reports that even with such soft cuffs, the internal pressure of the cuff increases due to the permeation of anesthetic gas into the cuff, and in such cases, the above-mentioned Similarly, many proposals have been made, such as injecting anesthetic gas into the cuff with an anesthetic gas of the same composition, since it is undesirable because it compresses the tracheal wall at high pressure.

However, the above-mentioned proposal for self-injection of anesthetic gas through the cuff has practical problems, such as the need for the person to prepare a separate syringe or the like filled with anesthetic gas for injection.

Therefore, during use of conventional balloon catheters, gas is periodically vented from the balloon to adjust the volume and internal pressure of the balloon. However, there are problems in that adjustment of such a balloon is often difficult and complicated.

■Purpose of the invention This invention was made in view of the above circumstances, and its purpose is to improve the weight and weight of the balloon during use.
It is an object of the present invention to provide a balloon-type catheter that can eliminate the need to adjust the internal pressure and thus prevent damage caused by airway compression caused by the balloon.

That is, the present invention includes a catheter tube body, a balloon portion made of a film that is expandable and deflated so as to annularly surround a portion of the outer peripheral surface of the tube body;
3. A balloon-type catheter comprising an inflation lumen disposed in parallel with the tube body and for inflating and deflating the balloon part so as to communicate with the inside of the balloon part, wherein the film forming the balloon part is soft. The present invention provides a balloon-type catheter comprising at least two layers: a synthetic resin layer and a polyvinylidene chloride layer or a polyvinylidene alcohol layer.

Further, in the above catheter, the soft synthetic resin is selected from polyvinyl chloride, polyvinyl acetate, latex rubber, polyurethane, silicone rubber, polyester, polyethylene, and nylon, and the thickness of the layer of polyvinylidene chloride or polyvinyl alcohol is is 5 to 50μ, and the thickness of the film forming the balloon part]
The object of the present invention is to provide the above-mentioned 9 rune type catheter, which has an elementary permeability coefficient of 3 x 10-9 m1·crn/crn2·sec·mHg or less.

Furthermore, this invention involves forming a soft synthetic resin into a balloon shape in advance, applying a hydrophilic adhesive such as a polyurethane adhesive to the balloon part, drying it, and then applying liquid polyvinylidene chloride or polyvinyl alcohol to the adhesive. The present invention provides a method for manufacturing a balloon-type catheter, characterized in that the agent is applied onto a layer of the agent, then heated and dried, and then attached to the catheter body.

Furthermore, the present invention provides the method for manufacturing a catheter described above, in which the soft synthetic resin is selected from polyvinyl chloride, polyvinyl acetate, latex rubber, polyurethane, silicone rubber, polyester, polyethylene, and nylon. The present invention provides a method for producing the above-mentioned balloon-type catheter, characterized in that the layer of polyvinylidene chloride or 7-pole vinyl alcohol is coated to a thickness of 5 to 50 μm after drying.

■Detailed description of the invention The present invention will be described below with reference to illustrated embodiments.

In the figure, reference numeral 1 denotes a catheter tube body made of soft nolastic material, which has a lumen 2 at its axis for introducing anesthetic gas, oxygen gas, etc., and its tip 30 has a smooth shape in order to be suitable for insertion into the body. It has a bevel shape. Further, the other end (not shown) can communicate with a gas supply device into the body, as in the conventional case.

As shown in FIG. 2 or 3, a thin inflation lumen 4 is embedded in the tube wall of the catheter chest body 1 along the axial direction of the tube body 1. As shown in FIG. This inflation lumen 4 is closed near the beveled tip 3 as shown in FIG. This inflation lumen 4 communicates with the interior space of the balloon part 5 via the part IIL. The inflation lumen 4 further communicates with an inflation tube 7 through a tube wall notch 6 of the tube body 1 at a position rearward of the balloon portion 5, as shown in FIG.

FIG. 3 shows an example of the connection between the inflation lumen 4 and the inflation cheep 7. As shown in FIG. That is, a connector 8 is connected to the distal end of the inflation tube 7, and the distal end of the connector 8 is pushed into the inflation lumen 4 (9-) and is fitted into the inflation lumen 4 airtightly. This connector 8 is made of hard glass such as polystyrene, has a cylindrical shape whose outer diameter is slightly larger than the inner diameter of the inflation lumen 4, and has a stopper 9 formed in its middle portion. Note that the connection between the inflation tube 7 and the inflation lumen 4 can be made by simply press-fitting as described above, or by inserting a pre-heated mandrel into the inflation lumen, and simultaneously inserting the connector 8 into the inflation lumen when the mandrel is removed. It may be fixed. The use of such a connector 8 is preferable since the connection part of the inflation lumen is hard to bend, so that the connection state is smooth, and it is also preferable in terms of work efficiency. Further, an adapter 11 with a cage and a groove is attached to the rear end of the inflation tube 2 via a mother pilot balloon 10 for recognizing the degree of inflation of the balloon portion. In addition, the diameter reference mark -10
Reference numeral 12 denotes an X-ray opaque line, which is provided over the entire length of the catheter chest body 1 in the longitudinal direction so that the position of the catheter chest body 1 can be easily confirmed with X-rays.

A balloon portion 5 is provided in the vicinity of the distal end of the catheter tube body 1 so as to be inflatable and deflated so as to annularly surround the outer peripheral surface of the catheter tube body 1 . As shown in the figure, this balloon portion 5 is made of polyvinylidene chloride, polyvinyl alcohol, etc. on the upper surface of a soft plastic film 13 made of soft polyvinyl chloride, polyurethane, vinyl acetate, latex rubber, silicone rubber, nylon, polyurethane, polyester, polyethylene, etc. For example, it may have a 2/# structure having a gas permeation prevention layer 14 coated with a coating of about 0005 to 0.05 m1+, or it may have three or more layers of two or more gas permeation prevention layers 14 as required. Moreover, this gas permeation prevention layer 14 is a soft glass film layer 1.
The inner surface of 3 may be coated. but,
In either case, the permeability coefficient of laughing gas (nitrous oxide gas) of the Norono Lune portion 5 is 3×10 ml-c.
It is preferable to select a flexible abrasive material that is below m/an”・sec・mHg (room temperature) and that does not easily expand and contract and damage the tracheal mucosa.Thickness of the film of the balloon part 5 Although there is no particular restriction on the length, in consideration of air permeability and flexibility, a length of about 0.03 to 0.30 ms is generally used.

- Any known method can be used to form the groove portion 5. For example, glass, ceramic, and metal balloon molds are immersed in polyvinyl chloride plastisol to obtain even deposition of the polyvinyl chloride plastisol. Next 14
The plastisol is melted and caerified in a heated oven at 0 to 220°C to form a polyvinyl chloride film. Until room temperature
After cooling, it is immersed in a urethane adhesive dissolved in an organic solvent such as Inglobil alcohol or toluene to form a polyurethane adhesive layer on the polyvinyl chloride film. After drying and volatilizing the solvent, it is immersed in a polyvinylidene chloride emulsion liquid to obtain a coating layer of polyvinylidene chloride that is heated and dried at 100 to 220°C.

If it is desired to obtain an even thicker coating layer, the film is immersed in the polyvinylidene chloride emulsion solution again and the same operation is repeated.

The viscosity of polyvinylidene chloride emulsion liquid is 3 to 7.
The thickness of the coating layer obtained by one immersion operation can be changed by adjusting the viscosity.

In the case of a polyvinyl alcohol layer, after forming a polyurethane adhesive layer in the same manner as described above, it is immersed in a polyvinyl alcohol solution and dried at room temperature to 160° C. to obtain a polyvinyl alcohol laminated layer.

Although the thickness of the coating layer can be obtained by multiple immersions, it is easier to adjust the solution concentration.

Note that since polyvinyl alcohol is water-soluble, when used as a balloon, it is preferable that the polyvinyl alcohol layer be on the inside. Therefore, after releasing the balloon from the mold, an inversion operation 13- is performed.

The balloon portion 5 can be attached to the tube body 1 by a method of fitting a balloon formed into a predetermined balloon shape into the tube body 1 as described above, and airtightly sealing both ends of the balloon with adhesive. It may be appropriately attached by any conventionally known method. Further, if the balloon portion 5 is made of two or more layers, it can be easily manufactured by repeating the depping process several times. When the balloon portion 5 is constructed from two or more layers of film in this way, it is more preferable in terms of preventing the occurrence of bottle balls.

There is no particular difference in the method of using the balloon-type catheter according to the present invention from that of conventional balloon-type catheters.

Experimental Examples As shown in the table below, a rubber cuffed endotracheal tube and a polyvinyl chloride cuffed endotracheal tube were used as comparative examples (conventional products), and as examples of the present invention, polyvinyl chloride and polyvinyl chloride 14- Using a cuffed endotracheal tube consisting of two layers: gas permeability and compliance (volume that expands at a constant pressure, which is an index of elasticity), etc. of the balloon section were measured. Measurement conditions were exposure time 1 hour, partial pressure difference 76
The temperature was set at room temperature of cm Hg.

The results of these experiments are shown in the table below.

15- As is clear from this table, the compliance of Examples A and H is almost the same as Comparative Example 1 and ■ (conventional product), but the amount of laughing gas permeation is that of Example A.

Both B are significantly smaller than conventional products.

Further, the balloon internal pressure at this time was significantly lower than that of Comparative Example (1), which was 100 inches. Therefore, it can be said that the balloon internal pressure of the present invention is effective in suppressing the increase in balloon internal pressure.

■Specific effects of the invention As detailed above, according to the invention, the balloon part (can) has two or more layers of a soft glass layer and a gas permeation prevention layer, which prevents defective products due to pinholes. In addition, it can significantly suppress the permeation of laughing gas, nitrogen gas, oxygen gas, etc., so the increase in balloon volume and internal pressure during use is suppressed, preventing damage to the airways. In addition, it is possible to eliminate the trouble of adjusting the internal pressure of the balloon part as in the conventional method, and has a remarkable effect in practical use.

17-

[Brief explanation of the drawing]

The drawings show a balloon-type catheter according to an embodiment of the present invention. FIG. 1 is a perspective view of the main parts thereof, FIG. 2 is an enlarged cross-sectional view of the balloon part, and FIG. 13 is a diagram showing an inflation tube and an inflation tube. It is a sectional view showing a connection part with a lumen. In the figure, 1... Catheter tube body, 2... Lumen, 3... Tube body tip, 4... Inflation lumen, 5... Balloon, 6... Tube wall notch, 7...・Inflation tube, 8... Connect fi-11o... Mother pilot balloon, 1...
・Adapter, 13... Soft plastic film,
14... Gas permeation prevention layer. Applicant's agent Patent attorney Takehiko Suzue = 18-

Claims (7)

[Claims] (1) A catheter tip main body, a balloon portion made of a film that is provided to be expandable and contractible so as to annularly surround a portion of the outer peripheral surface of the tube main body, and communicate with the inside of the balloon portion. In the balloon type catheter, the film forming the balloon part includes a soft synthetic resin layer and a polyvinylidene chloride layer or a polyvinylidene chloride layer. A balloon-type catheter comprising at least two layers including a polyvinyl alcohol layer. (2) The soft synthetic resin is polyvinyl chloride, polyvinyl acetate, latex rubber, polyurethane, silicone rubber,
The balloon-type catheter according to claim 1, which is selected from polyester, polyethylene, and nylon. (3) The balloon type catheter according to claim 1, wherein the polyvinylidene chloride or polyvinyl alcohol layer has a thickness of 5 to 50 μm. (4) The nitrous oxide permeability coefficient of the film forming the balloon part is 3XIQ me-(,,〆crn2・sec・
The balloon type catheter according to claim 1.2 or 3, which has a crnHg or less. (5) After molding the soft synthetic resin into a balloon shape,
A hydrophilic adhesive is applied to this balloon part and dried, then liquid polyvinylidene chloride or polyvinyl alcohol is applied onto the adhesive coating layer and dried, and then this is attached to the Kabutil main body. Features: ・Method for manufacturing maroon-shaped catheters. (6) The manufacturing method according to claim 5, wherein the soft synthetic resin is selected from polyvinyl chloride, polyvinyl acetate, latex rubber, polyurethane, silicone rubber, ester, polyethylene, and nylon. (7) The manufacturing method according to claim 5 or 6, wherein the vinylidene chloride or polyvinyl alcohol layer is coated to have a thickness of 5 to 50 μm after drying.