JP3245841B2 - Chemical injection device - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a drug solution injection device for injecting a predetermined amount of a drug solution into a body, and more particularly to a drug solution stored under pressure in a balloon to a patient at a constant speed. The present invention relates to a drug solution injector that can be injected.

[0002]

2. Description of the Related Art Conventionally, as a means for injecting a drug solution such as an antibiotic, an anticancer drug, an anesthetic, etc. little by little into a blood vessel, a bladder or the like, the drug solution is stored in a balloon made of an elastic material.
An instrument for continuously injecting a drug solution into a human body by utilizing the contraction force of a pump (Japanese Patent Laid-Open No. 4-67873) is known. FIGS. 5 and 6 show the drug solution injector described in the publication. FIG. 5 is an overall explanatory view of the drug solution injection device, showing a state in which the puncture needle has not punctured the stopper of the housing, and FIG. 6 shows the balloon of the housing shown in FIG. 5 filled with the drug solution. It is an expanded sectional view showing a state at the time. 5 and FIG. 6 show a chemical liquid injection tube having a balloon section e comprising a housing 43 for accommodating a balloon 42 and a chemical liquid flow tube section f having a flow rate control section 44 for adjusting the flow rate of the chemical liquid. It consists of
The balloon 42 has a rod-shaped inner shaft 45 shown in FIG. 6, a cylindrical outer shaft 46 slidably mounted on the inner shaft 45, and an outer shaft 46 at one end of the inner shaft 45. An inner bearing 47 formed integrally with the inner shaft at an end opposite to the side, and provided outside the two shafts so as to cover the inner shaft 45 and the outer shaft 46, one end of which is provided on the inner shaft 45. The balloon 42 is made of an elastic material and is tightly fixed and the other end is closely fixed to the outer shaft 46. At one end of the housing 43, an adapter, which is a chemical liquid inflow / outflow part, is provided.
48 is formed and communicates with the chemical solution passage 51 via the inside of the inner shaft 45. At the end of the chemical solution passage 51, a stopper 49 is installed. When the chemical solution flows into the balloon 42, the medical solution is injected with the injection needle 50, and when the drug solution flows out of the balloon 42, the injection needle 50 of FIG. By puncturing the stopper 49, the drug solution flows through the tube.
Puncture needle (not shown) provided on connector 52 at the end of ridge f
Has a structure that is injected into the human body.

[0003]

In such a liquid injector, the inner shaft and the outer shaft are provided inside the balloon so that the balloon can be discharged at a constant pressure without causing significant deformation of the balloon. So that it deforms along the central axis in the long axis direction,
Further, by providing an inner bearing at the end inside the balloon, the balloon is configured to be deformed along the inner wall of the housing. However, such a drug solution injecting device is
The provision of such a mechanism in the interior of the device limits the downsizing of the drug solution injector naturally, and presents a problem when the patient injects the drug solution while carrying the device. In addition, since this chemical solution injection device causes the chemical solution to flow only by the internal pressure of the balloon, if the chemical solution in the balloon decreases, there is a problem that the outflow speed of the chemical solution decreases when the internal pressure of the balloon decreases. The present inventors have conducted intensive studies in order to solve such a problem, and as a result, the conventional technique of injecting a drug solution into a human body only by the contraction force of a balloon filled with a drug solution, by further applying a spring pressure. The present inventors have found that a chemical solution can be injected into a human body with a simple mechanism, and have reached the present invention.

[0004]

That is, the present invention relates to a balloon for storing a drug solution in a pressurized state and for allowing a drug solution to flow in and out of an opening, a balloon, and a balloon filled with a drug solution outside the balloon. A housing containing a constant load spring that compresses the balloon at a pressure higher than the pressure, a drug solution inflow portion and a drug solution outflow portion connected to an opening of the balloon, a drug solution flow tube extending from the drug solution outflow portion, and the drug solution. This is a drug solution injector comprising a flow rate control unit for controlling the amount of drug solution disposed in the flow tube. Further, the present invention is the above-mentioned drug solution injector, wherein the balloon material is made of elastic rubber or thermoplastic resin. Further, the present invention is the chemical injection device, wherein a metering valve is provided on the chemical liquid upstream side of the flow control unit in the chemical injection device. Still further, the present invention provides the liquid medicine injection device, wherein the metering valve comprises an orifice body made of a rubber-like elastic body having a valve hole whose inner diameter is deformable, and an adjusting means for adjusting the inner diameter of the valve hole. It is an injection device. Also,
The present invention is the chemical injection device, wherein the flow control unit is a fine inner diameter pipe having an inner diameter of 10 to 500 μm.

[0005]

According to the present invention, the balloon is compressed from the outside of the balloon which has been filled with a chemical solution and expanded by the compression force of a spring greater than the contraction force of the balloon.
The drug solution in the chamber is injected into the patient via a drug solution distribution tube. In addition, the flow rate of the chemical in the balloon is controlled at a constant infusion rate by a flow rate control unit provided in the chemical flow tube to be injected into the patient.

[0006]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of the present invention will be described below with reference to the accompanying drawings. FIG. 1 is an explanatory view of an embodiment of the chemical injection device of the present invention, FIG. 2 is an enlarged sectional view of a balloon portion when the balloon of FIG. 1 is filled with a chemical, and FIG. FIG. 4 is an enlarged cross-sectional view of a balloon portion when a balloon is filled with a drug solution in another embodiment of the device. FIG. FIG. 5 is an explanatory view of the vicinity of the control unit, FIG. 5 is an overall explanatory view of a chemical liquid injector described in Japanese Patent Application Laid-Open No. 4-67873, and FIG. 6 is a state when a chemical liquid is filled into a balloon of a housing shown in FIG. FIG.

In the drawing, a is a balloon portion, b is a chemical solution flow tube portion, 1 and 58 are balloons, 2 is a housing, 3 is a chemical solution outlet portion, 4 is a chemical solution inlet portion, and 5 is a flow rate control. , 6 is a connector part, 7 is a chemical outflow tube, 8 is a connector, 9 and 59 are springs, 10 is a metering valve, 12 and 60 are pressing members, 13
Is a clamp, 14 and 61 are chemical liquid outlets, 15 is a branch,
37 is a filter, 30 is an orifice body, 31 is a valve hole, 32 is a cylindrical body, 33 is a plug body, 34 is a female screw part, 35 is a male screw part, 36
Indicates a cap body.

In FIG. 1, the drug solution injection device comprises a balloon portion a and a drug solution flowing tube portion b. As shown in FIG. 2, the balloon portion a includes a balloon 1 in which a medical solution is accommodated in a housing 2 and a spring 9 having a compressive force larger than the contraction force of the balloon 1 , and moves the medical solution to an injection point of a human body. It is a driving part. The balloon 1 has an opening is secured to the liquid-tight and chemical outflow inlet 14 of the housing 2, one end closed cylindrical, has a flat or spherical shape, chemical branch portion 15 connected to the connector section 6 It expands by filling the liquid medicine from the inflow part 4. The cylindrical balloon has a structure that can be inflated in the longitudinal direction as well as in the radial direction. The balloon 1 can be of various sizes and thicknesses depending on the amount of the drug solution injected into the patient, the injection time, and the like, and is not particularly limited in the present invention.

The material of the balloon 1 includes an elastic rubber or a thermoplastic resin. Silicone rubber as an elastic rubber, butyl rubber, acrylonitrile butadienyl et Ngomu, butadiene et Ngomu, isoprene rubber, urethane rubber,
Suchirenbutaji et Ngomu, Pelprene, elastomer or natural rubber, such as Kraton rubber, these polymer mixtures or processed material was added harmless antioxidant body after removing the additives of these substances, or laminate, etc., Is mentioned. Examples of the thermoplastic resin include unstretched, uniaxially stretched and biaxially stretched films of polyethylene, polypropylene, polyvinyl chloride, polyester, polyamide and the like.

The opening of the balloon 1 is fixed in a liquid-tight manner by an O-ring 16 and a liquid outflow port 14 fixedly formed on the wall of the cap 21 of the housing 2. consists of a male connector 17 formed in the outer wall portion branching portion 15 of the base end formed male connector 18., has both connector to communicate with the medical liquid flow tube portion b by screwing . The spring 9 is housed in the chamber of the housing 2 on the opposite side of the chemical solution outlet 14 and is separated from the balloon 1 by the pressing member 12. The pressing member 12 is driven by the compressive force of the spring 9 to discharge the chemical solution.
It moves in 14 directions and presses the balloon 1 filled with the drug solution. As a result, the drug solution in the balloon 1 is almost completely branched.
Injected into the human body from the drug solution outflow portion 3 via the drug solution flow tube portion b.

As the spring 9, a coil spring, a constant load spring or the like is used. In FIG. 1, a constant load spring having a constant tension or pushing force is used. In the constant load spring, the tip of the spring from the drum around which the spring body is wound is locked by, for example, a bolt 27 provided in a wall near the opening of the housing 2. The spring coming out of the drum is fixed by bolts 27 through a longitudinal groove 28 provided in the wall of the housing 2, and the spring is wound around the drum with a constant tensile force so that the pressing member 12 causes the inner wall of the housing 2 to move. The balloon 1 is moved while compressing the balloon 1 in the direction of the chemical solution outflow / inlet 14 along the path. As the constant load spring, for example, there is a tension conston (trade name, manufactured by Sanko Hakko Co., Ltd.). A cap 21 formed on one end surface of the housing 2 is connected to an end of the housing 2 by screwing.

In FIG. 1, a chemical solution flow tube portion b includes a connector portion 6 connected to the chemical solution outflow / inlet port 14, a branch portion 15 connected to the connector portion 6, a flow rate control portion 5 for controlling the amount of the chemical solution, It comprises a chemical outflow tube 7, a clamp 13 for manually opening and closing the inside of the chemical outflow tube 7, and a connector 8. The branch portion 15 is formed of a Y-shaped tube as shown in FIG. 2, and one end of the branch portion 15 is formed of a female connector 18 which is screwed with a male connector 17 formed at the chemical solution outlet 14 of the housing 2. . The branch part 15 is composed of the chemical liquid outlet 3 and the chemical liquid inlet 4. The drug solution inflow portion 4 is provided with a drug solution injecting plug 22 made of a rubber-like elastic body in an inner cavity, and allows the drug solution to flow into the balloon 1 by piercing with a puncture needle of a syringe containing the drug solution. It is preferable that the end face of the medical fluid injecting plug 22 on the side of the chemical liquid inflow is formed in a concave shape in order to prevent the chemical liquid attached to the surface of the plug 22 from touching the hand or the like after the chemical liquid flows. Examples of the stopper 22 for chemical liquid injection include synthetic rubber such as silicone rubber and butyl rubber, and natural rubber, and those having excellent puncture resistance of the puncture needle are preferable. The drug solution outlet 3 is connected to a drug solution outlet tube 7, and injects the drug solution flowing out of the balloon 1 into the human body via the flow rate controller 5.
In FIG. 2, the branch portion 15 is described as a Y-shaped tube, but may be a V-shaped tube.

The flow rate control section 5 is a section for controlling the flow rate of the chemical solution. For example, when a pipe having a fine inner diameter of 10 to 500 μm as shown in FIG. In other words, the time for injecting the drug solution into the human body can be lengthened. The pipe length is 1cm or more and the outer diameter is 5
It is 500 times larger. When the length of the pipe exceeds 30 mm, a fine inner diameter pipe 25 having a crimped structure as shown in FIG.
It is preferable to use the case 26 in which the chemical solution outflow tube 7 is shortened. As the flow control unit 5, a metal pipe, a synthetic resin pipe, a glass pipe, or the like described in JP-A-2-11160 or JP-A-3-140163 already filed by the present applicant may be used. Can be. The flow control unit 5 can be installed at an arbitrary position of the chemical solution outflow tube 7, but is preferably installed at a position away from the connector 8 for operation. The chemical solution downstream tube d from the flow control unit 5 to the connector 8 located downstream thereof has a chemical solution outlet 3 whose inner diameter is located upstream of the flow control unit 5.
It is smaller than the inner diameter of the chemical solution upstream tube c extending in the direction. The inner diameter of the chemical solution downstream tube d is the chemical solution upstream tube.
15% to 85%, preferably 30% to 70% of the inner diameter of the bush
It is. Chemical solution upstream tube c and chemical solution downstream tube d
The ratio of the inner diameters varies depending on the length of the chemical solution downstream tube d.

A filter for removing minute substances contained in the chemical solution in the balloon 1 may be provided between the branch portion 15 and the flow control portion 5. The filter is preferably installed at the tip of the flow control unit 5, and a fibrous material, a sintered product, or the like is used. The clamp 13 has a function of stopping or flowing the chemical solution flowing through the inner cavity of the chemical solution outflow tube 7 as needed. The clamp 13 can be installed at any position of the chemical outflow tube 7, but is preferably provided at the position of the chemical outflow tube 7 between the branch portion 15 and the flow control unit 5. Examples of the chemical outflow tube 7 include soft polyvinyl chloride, polypropylene, and polyester.
At the other end, a luer-taper-like connecting tool 8 is provided.
A venous needle, a PSV set, and the like are connected via the connection tool 8. The connector 8 may be provided with a check valve (not shown) for preventing the chemical solution from flowing backward due to venous pressure or the like.

The method of using the drug solution injection device shown in FIG.
After connecting the chemical outflow / inlet port 14 of the pump 1 to the base end of the chemical flow tube b by the connector 6, the balloon is inserted from the chemical inlet 4 of the branch 15 of the chemical flow tube b with a syringe needle. The chemical solution is caused to flow into 1 and then the chemical solution outflow tube 7 is closed by the clamp 13 to prevent the chemical solution from flowing out to the human body. Next, one end of the spring 9 is fixed by the locking portion 27, and when the rod of the drum of the spring 9 is removed, the spring 9 is operated and the pressing member 12 moves forward to press the balloon 1 filled with the chemical. At the same time, by opening the clamp 13 which has been closed, the chemical solution in the balloon 1 is injected into the human body through the chemical solution outflow portion 3 of the branch portion 15, the flow rate control portion 5, and the connecting device 8.

FIG. 3 is an enlarged sectional view of a balloon portion when a balloon is filled with a drug solution in another embodiment of the drug solution injector of the present invention. The housing 2 includes an upper lid 55 and a lower lid 56, and when injecting a drug solution into a human body, the upper lid 55 and the lower lid
Reference numeral 56 denotes a closed state in which a male screw and a female screw provided in each opening are screwed together. The upper lid 55 accommodates a coil spring 59 and a pressing member 60 for pressing the balloon 58. The base end of the spring 59 is fixed by a locking portion 62 on the inner wall of the upper lid portion 55, and the other end of the spring 59 is fixed by a locking portion 63 on the inner wall of the pressing member 60. A flat balloon 58 is accommodated in the lower lid portion 56, and a chemical solution outflow / inlet port which is an opening portion thereof is provided.
Reference numeral 61 denotes a structure in which the tube at the base end of the chemical solution distribution tube portion b is directly bonded with an adhesive or the like. Since the balloon 58 and the chemical solution tube portion b are integrated, the lower lid portion 56
An insertion hole 57 for inserting the chemical solution circulation tube portion b is provided on the side wall. The method of using the chemical injection device shown in FIG. 3 is as follows. -Closing the valve 7 to prevent the chemical solution from flowing out to the human body side. Next, by screwing the upper lid 55 and the lower lid 56, the upper lid 55 and the lower lid 56 are closed, and the coil spring 59 presses the balloon 58 filled with the chemical solution via the pressing member 60. I do. Subsequently, by opening the clamp 13, the chemical solution flows out into the chemical solution outflow tube 7,
The drug solution is injected into the human body via the flow control unit 5 and the connection tool 8.

FIG. 4 shows a metering valve upstream of the chemical solution of the flow control unit 5.
FIG. 4 is an explanatory diagram around a flow control unit 5 provided with 10. By providing the fixed amount valve 10 at the inlet of the chemical liquid upstream of the flow control unit 5, the amount of the chemical liquid flowing into the flow control unit 5 can be made substantially constant, so that the flow rate can be controlled more accurately. The metering valve 10 in FIG. 4 is an example, but a plug 33 is attached to the upstream side of the chemical solution of the cylindrical body 32 to which the orifice body 30 made of a deformable rubber-like elastic body is fixed, and a cap body 36 is attached to the downstream side of the chemical solution. A chemical solution tubes 38, 39 and chemical solution passages 40, 41 are arranged coaxially before and after the valve hole 31 of the orifice body 30. The orifice body 30 has a valve hole 31 communicating from the chemical liquid upstream side to the chemical liquid downstream side, and the inside diameter of the valve hole 31 is minimized on the way from the valve hole inlet, and gradually decreases from the minimum position toward the chemical liquid downstream side. It has a shape with a larger inside diameter. The inner diameter of the valve hole 31 can be arbitrarily changed depending on a desired chemical outflow speed. The orifice body 30 is fixed to the inner wall of the cylindrical body 32. A female screw part 34 is formed on the inner wall of the cylindrical body 32 on the side of the chemical solution inflow, and is screwed with a male screw part 35 of the plug 33 to form a plug.
Pressing the orifice body 30 by rotating 33,
The inner diameter of the valve hole 31 is adjusted. Between the valve hole 31 and the chemical solution upstream tube c, a filter 37 for removing minute substances contained in the chemical solution in the balloon 1 may be provided. The filter 37 is preferably installed at the tip of the tube c on the upstream side of the chemical solution.

The stopper 33 is provided with a chemical solution upstream passage 40 for communicating with the inlet of the valve hole 31 of the orifice body 30, and a chemical solution upstream passage.
A chemical solution upstream tube c connected to 40 is mounted,
The tip of the plug 33 is in contact with the orifice body 30, and the outlet of the chemical liquid upstream passage 40 and the inlet of the valve hole 31 of the orifice body 30 are communicated coaxially. A male screw portion 35 that is screwed with the female screw portion 34 of the cylindrical body 32 is formed on the tip side surface portion of the plug 33, and the male screw portion 35 is turned into a female type by rotating the plug 33. By moving the screw portion 34, the size of the inner diameter of the valve hole 31 of the orifice body 30 is adjusted, and the outflow speed of the chemical solution is adjusted. Cap body
Reference numeral 36 denotes a chemical solution downstream passage 41 for communicating with the outlet of the valve hole 31 of the orifice body 30, and a chemical solution downstream tube d connected to the chemical solution downstream passage 41. One end of the cap body 36 is in contact with the orifice body 30 and is fitted into the inner cavity of the cylindrical body 32, and the inlet of the chemical solution downstream passage 41 and the valve hole 31 of the orifice body 30 are provided.
Communicates coaxially with the outlet.

In the metering valve 10 shown in FIG.
A valve hole 31 is formed at a substantially central portion of the valve body, and by rotating the plug body 33, the tip of the plug body 33 presses the annular foot of the orifice body 30 made of a rubber-like elastic body. The liquid outflow speed is set slightly. The valve hole 31 has such a shape that the inside diameter becomes minimum while entering from the valve hole entrance, and gradually increases from the minimum position toward the downstream side of the chemical solution. In this state, the chemical supplied from the chemical upstream tube c through the chemical upstream passage 40 reaches the inlet of the valve hole 31 through the concave space formed at the inlet of the orifice body 31 and is given to the inlet. The minimum position of the inner diameter of the valve hole 31 is slightly changed by the pressure. As a result, the pressure of the drug solution flowing out of the outlet of the valve hole 31 is always kept substantially constant.

The orifice body 30 is made of a deformable rubber-like elastic body. Examples of the rubber-like elastic material include synthetic rubbers such as styrene / butadiene rubber, isoprene rubber, acrylonitrile / butadiene rubber, butadiene rubber, olefin rubber, fluorine rubber, silicone rubber, urethane rubber, clayton rubber, perprene, and natural rubber. And the like. The hardness of the elastic body is a hardness measured by a JIS-A type spring hardness tester of 25 to 70 degrees, preferably 35 to 60 degrees.
Degrees. If the hardness is less than 25 degrees, the orifice body 30 tends to be easily deformed due to the pressure of the chemical solution, it is difficult to adjust the inner diameter of the valve hole 31, and if the hardness exceeds 70 degrees, there is a slight chemical outflow pressure. The orifice body 30 does not respond to the change of the diameter, and the inner diameter of the valve hole 31 does not change. Valve hole 31
Can be arbitrarily changed depending on the desired chemical outflow rate, but usually 100 to 1000 μm is preferable.

[0021]

The liquid injector according to the present invention fills a balloon with a liquid medicine and compresses the balloon from the outside of the expanded balloon with a spring pressure larger than the contraction force of the balloon. Since this is a mechanism for injecting the liquid medicine in the balloon into the patient, the operation mechanism of the balloon in the housing is simplified compared to the conventional liquid injector, and the liquid liquid in the balloon is almost completely discharged to the end. Can be injected into the patient. In addition, by installing a metering valve at the upstream of the liquid medicine of the flow control unit, the amount of the liquid medicine flowing into the flow control unit can be made substantially constant, and the amount of the liquid medicine can be controlled more accurately, and the liquid medicine can be supplied to the patient. For a long time at a constant rate.

[Brief description of the drawings]

FIG. 1 is an explanatory view of one embodiment of a drug solution injector according to the present invention.

FIG. 2 is a perspective view of a balloon when a chemical solution is filled in the balloon of FIG. 1;
FIG.

FIG. 3 is another embodiment of the drug solution injector according to the present invention,
FIG. 4 is an enlarged sectional view of a balloon portion when the balloon is filled with a chemical solution.

FIG. 4 is an explanatory view showing the vicinity of a flow rate control unit in which a metering valve is provided in a tube on a chemical liquid upstream side of the flow rate control unit.

FIG. 5 is an overall explanatory view of a drug solution injector described in Japanese Patent Application Laid-Open No. 4-67873.

FIG. 6 is an enlarged cross-sectional view showing a state when a chemical solution is filled in a balloon of the housing shown in FIG. 5;

[Explanation of symbols]

 a balloon part b chemical liquid distribution tube part 1, 58 balloon 2 housing 5 flow control part 7 chemical liquid outflow tube 8 connector 9, 59 spring 10 metering valve 12, 60 pressing member 13 clamp 14, 61 Chemical outflow inlet 15 Branch

──────────────────────────────────────────────────続 き Continuation of the front page (56) References JP-A-6-296688 (JP, A) JP-A-4-67873 (JP, A) JP-A-1-135359 (JP, A) JP-A-2- 11160 (JP, A) JP-A-3-140163 (JP, A) JP-A-3-80741 (JP, U) JP-A-7-503162 (JP, A) (58) Fields investigated (Int. Cl. ⁷ , DB name) A61M 31/00 A61M 5/142 A61M 25/00

Claims (5)

(57) [Claims] 1. A balloon for storing a medicinal solution in a pressurized state and flowing a medicinal solution in and out of an opening, and compressing the balloon at a pressure higher than the pressure of the balloon and the balloon filled with the medicinal solution outside the balloon. A housing containing a constant load spring , a drug solution inflow portion and a drug solution outflow portion connected to the opening of the balloon, a drug solution flow tube extending from the drug solution outflow portion, and a drug solution amount arranged in the drug solution flow tube. A chemical injection device comprising a flow control unit for controlling. 2. The liquid injector according to claim 1, wherein the balloon material is made of an elastic rubber or a thermoplastic resin. 3. The chemical injection device according to claim 1, wherein a metering valve is provided upstream of the chemical liquid in the flow control unit. 4. The liquid injector according to claim 3, wherein the metering valve comprises an orifice body made of a rubber-like elastic body having a valve hole whose inner diameter is deformable, and adjusting means for adjusting the inner diameter of the valve hole. . 5. The chemical injection device according to claim 1, wherein the flow rate control unit comprises a pipe having a fine inner diameter of 10 to 500 μm.