JPH03140163A - Balloon infuser - Google Patents

Abstract

PURPOSE:To inject liquid chemical in a balloon always at a specified discharge rate into a patient by consisting the balloon of a pipe made of a specific synthetic resin specific in the inside diameter, length and outside diameter of a flow rate control part. CONSTITUTION:The balloon part A, which is a part to be packed with the liquid chemical and is a driving part to move the liquid chemical to the injecting point of a human body, is constituted of a cylindrical outside shaft 1, an inside shaft 2, the balloon 3, a liquid chemical inflow part, and a liquid chemical outflow part. The flow rate control part is the part to control the flow rate of the liquid chemical and is constituted of a straight and extremely fine pipe 18. The synthetic resins, such as polyolefin, polyvinyl chloride and polyester, are used as the pipe material. The pipe has the shape of 10 to 500mu inside diameter, >=1cm length and the outside diameter of 5 to 500 times the inside diameter. The flow of the liquid chemical tends to stop if the inside diameter is below 10mu. The control of the liquid chemical flow rate is difficult if the inside diameter exceeds 500mu. The length of the pipe is preferably 50 to 1000cm. The control of the liquid chemical flow rate is difficult if the length is below 1cm while the size of the device increases excessively if the length is longer than the above- mentioned range. The connection to a liquid chemical outflow tube 11 is difficult if the ratio of the outside diameter to the inside diameter of the pipe exceeds 500 times.

Description

[Detailed Description of the Invention] [Industrial Application Field] The present invention relates to a balloon infuser for continuously injecting a predetermined amount of a medicinal solution into a blood vessel, bladder, subcutaneous tissue, etc. This invention relates to a balloon infuser in which the flow rate control section is made of an ultra-thin synthetic resin pipe for injecting a medicinal solution stored inside the balloon into a patient at a constant rate over a long period of time.

[Conventional technology]

Traditionally, as a method for injecting antibiotics, anticancer drugs, and other medicinal solutions little by little into blood vessels, bladders, etc., the medicinal solution is stored in a balloon made of elastic material, and the contraction force of the balloon is used to inject the medicinal solution into the blood vessel over a long period of time. As a device for continuous injection, etc.
Japanese Unexamined Patent Publication No. 50-108790 is known, and the flow rate control section for controlling the injection amount of the chemical liquid in such an apparatus includes at least one fine hole in the side wall in the middle of the chemical liquid outflow tube, A pipe with a closed end on the downstream side is introduced in Japanese Patent Application Laid-Open No. 170069.

(Problem to be Solved by the Invention) However, since this flow rate control method is configured to adjust the flow rate of the chemical solution depending on the cross-sectional area of the outflow hole and the number of outflow holes, it is difficult to adjust the flow rate. had a difficult problem.

One of the inventors of the present invention has developed an ultra-thin stainless steel pipe or synthetic resin pipe as a means for controlling the flow rate of a balloon infuser that solves the conventional drawbacks, and has already applied for a patent in Japanese Patent Application No. 160526/1983. There is.

However, stainless steel pipes need to be thoroughly cleaned as there is a risk that the chemical will cause the pipe to rust and the chemical will block the pipe, while synthetic resin pipes have the problem of fluctuations in the flow rate of the chemical due to temperature changes. .

[Means for Solving the Problems] In order to solve the problems, the present inventors conducted extensive research and arrived at the present invention.

That is, the present invention includes a balloon section made of an elastic material that stores a medical solution under pressure and injects and flows out the medical solution from an opening; In the balloon infuser, the balloon infuser includes a housing to which a liquid medicine is fixed, a liquid medicine flow passage extending from the liquid medicine outlet part, and a flow rate control part for controlling the amount of medicine/fIi disposed in the flow passage. It is a balloon infuser in which the control part is made of a synthetic resin pipe with an inner diameter of 10 to 500 μ, a length of 1 cm or more, and an outer diameter of 5 to 500 times the inner diameter.

Further, the present invention provides the balloon infuser as described above, in which the pipe of the flow rate control section has a crimped structure.

Furthermore, the present invention provides the balloon infuser,
This balloon infuser consists of a crimped pipe housed in a casing together with heat insulating material.

[Effect]

The present invention serves as a flow control section for a balloon infuser.
It uses an extremely thin pipe and controls the flow rate of the chemical solution by the resistance of the pipe. In addition, by making the outer diameter of the synthetic resin pipe a specific size relative to the inner diameter, the inner diameter of the pipe does not fluctuate under the outside air temperature, for example, in the temperature range of 15 to 40 degrees Celsius, and the balloon can be discharged at a constant rate at all times. The drug solution inside can be injected into the patient.

〔Example] The present invention will be explained in detail below with reference to Examples.

FIG. 1 is a plan view of an embodiment of the balloon infuser of the present invention, FIG. 2 is an enlarged cross-sectional view of the balloon portion of the balloon infuser shown in FIG. Figure 3 is a plan view of an example balloon infuser in which a pipe with a tank structure is used for the flow rate control section, Figure 4 is a cutaway explanatory diagram showing the internal structure of a pipe with a crimped structure, and Figure 5 is a FIG. 2 is a liquid volume discharge diagram when the balloon infuser shown in FIG. 1 is used.

In the figure, A is the balloon part, B is the flow control part, l is the outer shaft, 2 is the inner shaft, 3 is the balloon, 6 is the housing, 12 is the branch path,
Reference numeral 15 indicates a stopper for inflowing a chemical liquid, 17 a clamp, 18 a straight pipe, 21 a pipe having a crimped structure, 22 a heat insulating material, and 23 a casing.

In FIGS. 1 and 2, a balloon part A is a part filled with a medical solution and a driving part that moves the medical solution to an injection site in the human body. an inner shaft 2 slidably installed inside the shaft, a balloon 3 provided on the outside of both shafts, and one end of the outer shaft 1 opposite to the side where the inner shaft 2 is installed. It consists of a chemical liquid inflow part and a chemical liquid outlet part connected to the part. The outer shaft 1 and the inner shaft 12 are made of synthetic resin such as polycarbonate, polyethylene, polypropylene, etc. The balloon 3 has a cylindrical shape and is provided on the outside of both wheels so as to cover the outer shaft l and the inner shaft 2. One end of the balloon 3 is attached to the outer shaft l, and the other end is attached to an O-ring 5 or a metal. It is hermetically sealed and fixed by a sealing means such as a spiral stopper. The inside of the outer shaft 1 is the part on which the inner shaft 2 slides, and is also a flow path through which the medicinal solution filled in the balloon 3 gradually flows out into the human body. Therefore, it is preferable to provide a clearance of about 0.5 to 3 mm between the inner surface of the shaft 1 and the outer surface of the inner shaft 2. Various sizes and wall thicknesses can be used depending on the purpose, and the present invention is not limited to this, but as a general value, the outer diameter is 2 to 30 mm,
The wall thickness is between 0.1 and 2.0, and the length is between 3 and 30 cm.
It is m. The balloon 3 has a structure that can be expanded not only in the radial direction but also in the longitudinal direction by filling it with a medical solution. The inner shaft 2 moves in and out of the outer shaft 1 along with the movement of the balloon 3, and the relationship between its position and the amount of drug remaining in the balloon 3 is constant. By providing a scale, it is possible to check the amount of chemical solution flowing out.

The balloon 3 consists of a balloon portion made of an elastic material, such as an elastic polymer such as silicone rubber, butyl rubber, nitrile butadiene rubber, poly-1,4-butadiene, polyisoprene, polyurethane, or butadienstine copolymer. or natural rubber, mixtures of these polymers,
Examples include laminate.

The housing 6 prevents the balloon 3 from being damaged by contact with external objects, and also prevents liquid from leaking from the balloon due to defects such as pinholes in the balloon itself.
It has the function of sealing the chemical solution to prevent it from scattering to the outside. The housing 6 is preferably made of synthetic resin such as polyvinyl chloride, polypropylene, polycarbonate, or the like.

The housing 6 is preferably made of a transparent material so that the state of injection of the drug into the patient can be visually observed from the outside.

The housing 6 seals and covers the balloon part A to prevent the chemical solution from leaking outside even if the balloon 3 is damaged. However, if the inside is made completely airtight, the balloon 3
As the chemical liquid flows into the chamber, the air inside is compressed and the pressure increases, causing the inconvenience that the chemical liquid cannot flow beyond a certain level. Therefore, an air vent opening 7 is formed at an appropriate location in the housing 6, and the opening 7 is
A hydrophobic filter 8 is provided which allows air to pass through but not the chemical solution. Examples of the material for the hydrophobic filter 8 include polyester, fluororesin, or a laminate of both.

A chemical liquid inlet and a chemical liquid outlet (hereinafter referred to as a connecting part) 10 are connected to one end of the outer shaft 1, which is opposite to the side where the inner shaft 2 is installed. The connecting portion 10 is a passage for the medical solution to flow into the balloon or for the medical solution to flow out from the balloon.

At the opposite end of the housing 6 of the connection IO there is a branch 1
2 are connected. In this embodiment, this branch path 12 is constructed of a Y-shaped tube. The branch path 12 is a chemical liquid inflow path 13
and a chemical liquid outflow path 14, which contains polyolefin,
It is made of polyvinyl chloride, polycarbonate, etc. A drug solution inflow stopper 15 is provided at the tip of the drug solution inflow path 13 so that the drug solution can be injected into the balloon 3 using a syringe (not shown) or the like. Chemical solution inflow stopper 15
is made of a rubber-like elastic material such as silicone rubber, and has excellent penetration properties (a property that maintains liquid tightness even when punctured with a chemical liquid injection needle many times and prevents the internal chemical liquid from leaking). Can move around the body.

On the other hand, at the tip of the liquid outflow path 14, there is a chemical liquid outflow tube 1.
1 is connected to the tube 11, and the tube 11 has a clamp 17 that can stop the flow of the chemical solution at any time, and a flow rate control section B described later.

The flow rate control unit B is a part that controls the flow rate of the chemical liquid, and in this embodiment, it is composed of a straight, extremely thin pipe 18.

Pipe materials include polyolefin, polyvinyl chloride,
Synthetic resins such as polyester, polyamide, polyurethane, polyacrylate, polymethacrylate, and polycarbonate are used. The pipe has an inner diameter of 10 to 500 μ, a length of 1 cm or more, and an outer diameter of 5 to 500 times the inner diameter. The inner diameter of the pipe is 10-500μ, preferably 50μ
~300μ. If the inner diameter is less than 10μ, the flow of the chemical solution tends to stop due to air being mixed in the chemical solution, etc.
5 (If it exceeds 10 μ, it tends to be difficult to control the flow rate of the chemical liquid. The length of the pipe is IC111 or more, preferably 50 to 1000 α. If the length of the pipe is less than 11, it becomes difficult to control the flow rate of the chemical liquid. Also, as the length of the pipe becomes longer, the device tends to become too large, but when the length of the pipe exceeds 200C, it is difficult to The pipe with a crimped structure, which is preferably used, refers to a pipe with a spring-like or spiral shape, and is made to be able to expand and contract to some extent in the axial direction, and by storing the pipe in the casing 23, the flow rate control unit B can be made smaller. As shown in FIG. 4, the #JT heat material 22 is housed in the casing 23 along with the pipe 21 having a 141-fold structure, so that the pipe is not affected by the outside temperature. As the heat insulating material, porous plastic, short fibers, non-woven fabric, etc. are used.

The outer diameter of the pipe varies depending on the pipe material and the inner diameter of the pipe, but in general, when the inner diameter of the pipe is small, the ratio of the outer diameter to the inner diameter is large, and it is preferable to prevent the influence of outside temperature from reaching the inside of the pipe. When the ratio of the outer diameter to the inner diameter of the pipe exceeds 500 times, the diameter of the pipe becomes large and there is a tendency that connection with the chemical solution outflow tube 11 becomes difficult.

A synthetic resin pipe is manufactured by, for example, providing a metal wire corresponding to the inner diameter of the pipe in the center of a filament having a cylindrical cross section, melting and extruding the wire, cooling and solidifying the wire, and then removing the metal wire. It can also be manufactured by extruding a molten synthetic resin into a hollow linear shape from extrusion nozzles corresponding to the inner and outer diameters of the pipe, and cooling and solidifying the resin.

Medicine f1. A Luer tapered connector 19 is provided at the distal end of the outflow tube 11, and a venous needle, a Psv cent, or the like is connected through the connector 19.

The connector 19 may be provided with a check valve (not shown) to prevent the medical solution from flowing back due to venous pressure or the like.

Next, a method of using the balloon infuser of the present invention will be explained based on FIG.

To inject the drug solution, for example, the needle of a syringe is inserted into the drug solution injection stopper 15 to fill the balloon 3 with the drug solution. At this time, it is necessary to keep the clamp 17 in a stopped state so that the medicinal solution does not flow out toward the human body.

When a predetermined amount of the drug solution is filled, the injection needle is removed from the drug solution injection stopper 6. Thereafter, the medicinal solution is injected into the patient's body according to the actual medicinal solution injection location.

Examples 1 to 3, Comparative Example 1 Silicone balloon (inner diameter 6.8 m, outer diameter 8.4 m,
The meat ff 0.8 m) was assembled into the balloon injector shown in the MI diagram, and 60 te of physiological saline was filled into the balloon from the stopper 15 using a syringe. Then, an extremely thin metal wire was provided at the center of the cross section and melt extruded. After cooling and solidifying the polyvinyl chloride filament with a cylindrical cross section, the metal wire was removed and the polyvinyl chloride pipes having various outside diameters shown in Table 1 were flowed! It was used as a control unit. The pipe has an inner diameter of 100 μm and a length of 22 cm.

This balloon infuser was placed at a height of 3 cm, and the drug solution in the balloon was dripped from the intravenous needle attached to the connector 19 at the ambient temperature shown in Table 1.

The amount of drug solution discharged from the balloon after 24 hours, and the discharge rate of the drug solution from the balloon at that time (
a1/hour) are shown in Table 1.

In addition, using the balloon infuser of Example 3,
Figure 5 shows the change over time in the amount of the chemical solution discharged from the balloon at °C.

Table 1 As is clear from Table 1, the balloon infusers of Examples 1 to 3 of the present invention have less temperature dependence in the liquid discharge rate than the balloon infusers of the comparative example.

Example 4, Comparative Example 2 Natural rubber balloon manufactured by Kushiro Rubber Co., Ltd. (inner diameter 5 mm, outer diameter 7 mm)
, wall thickness 1. rm) was assembled into the balloon injector shown in FIG. 3, and 60 d of physiological saline was filled into the balloon through the stopper 15 with a syringe. Next, an ultra-fine metal wire was provided at the center of the cross-section, and the melt-extruded polypropylene filament with a cylindrical cross-section was cooled and solidified, and the metal wire was removed to obtain an ultra-fine polypropylene pipe (inner diameter 10
0μ, outer diameter 3000μ length 55CI, outer diameter/inner diameter = 30
) was crimped into a spiral shape as shown in FIG. 4, and was housed in a casing together with a heat insulating material made of 10 denier short polyester fibers to be used as a flow rate controller.

This balloon infuser was placed at a height of 3 cI11, and the drug solution inside the balloon was dripped from the intravenous needle attached to the connector 19 at the ambient temperature shown in Table 2.

The amount of drug solution discharged from the balloon after 24 hours, and the discharge rate of the drug solution from the balloon at that time (
i/hour) are shown in Table 2.

As Comparative Example 2, a stainless steel pipe (inner diameter 100μ, outer diameter 3000μ, length 55cm) was used for the flow rate control part, and the same balloon infuser as that used in Example 4 was used in other respects. A chemical discharge test was conducted in the same manner as above. The results are shown in Table 2.

Table 2 As is clear from Table 2, the balloon infuser of Example 4 of the present invention exhibited almost the same chemical liquid discharge performance as the balloon infuser of Comparative Example 2 using a stainless steel pipe. Therefore, it is clear that the difference in the liquid discharge rate due to temperature is due to the influence of the viscosity of the chemical liquid in the balloon.

(Effects) Since the balloon infuser of the present invention uses an ultra-thin pipe made of synthetic resin for the flow rate control section, there is no risk of the outflow of chemical solution being blocked due to the formation of rust that occurs in stainless steel pipes. Since there is no need to clean the inside, the number of steps has also been reduced.

Furthermore, by specifying the ratio of the outer diameter and inner diameter of the pipe,
The flow rate of chemical discharge can be controlled without the inner diameter of the pipe being affected by outside temperature at all.

[Brief explanation of the drawing]

FIG. 1 is a plan view of an embodiment of the balloon infuser of the present invention, FIG. 2 is an enlarged cross-sectional view of the balloon portion of the balloon infuser shown in FIG. Figure 3 is a plan view of an example balloon infuser that uses a pipe with a crimped structure for the flow rate control section.
FIG. 4 is a cutaway explanatory diagram showing the internal structure of a pipe having a crimped structure, and FIG. 5 is a liquid volume discharge diagram when the balloon infuser shown in FIG. 1 is used. In the figure, A is the balloon part, B is the flow control part, ■ is the outer ring, 2 is the inner sleeve, 3 is the balloon, 6 is the housing, 12 is the branch path,
15 is a stopper for injecting a chemical solution, 17 is a clamp, 18 is a straight pipe, 21 is a pipe with a collapsed structure, 22 is a heat insulating material, and 23 is a casing.

Claims (3)

[Claims] (1) A balloon section made of an elastic material that stores a medical solution under pressure and injects and flows out the medical solution from an opening; the balloon section is accommodated, and a medical solution injection part and a medical solution outflow part are fixed to the opening; In the balloon infuser, the balloon infuser includes a housing formed of a chemical liquid, a chemical liquid flow path extending from the chemical liquid outlet part, and a flow rate control part for controlling the amount of the chemical liquid disposed in the flow path, wherein the flow rate control part has an inner diameter of 10. A balloon infuser consisting of a synthetic resin pipe with a diameter of ~500μ, a length of 1cm or more, and an outer diameter 5 to 500 times the inner diameter. (2) The balloon infuser according to claim 1, wherein the pipe of the flow rate control section has a crimped structure. (3) The balloon infuser according to claim 2, wherein the crimped pipe is housed in a casing together with a heat insulating material.