JP2003299732A - Medicine solution injection apparatus and medicine solution container - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a small, lightweight and carriable medicine solution injection apparatus capable of using up the medicine solution without waste and setting and controlling the injection volume and time arbitrarily, and also to provide a medicine solution container for use in the same. <P>SOLUTION: The medicine solution container comprises a container body made of flexible and deformable material, a casing member and an elastic member containing air layers. The medicine solution injection apparatus comprises the medicine solution container, a pump for generating a negative pressure in the medicine solution container, an internal control unit for controlling the operation of the pump, and a liquid supply channel. <P>COPYRIGHT: (C)2004,JPO

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention is for injecting a medicinal solution into epidural, arteriovenous blood vessel, subcutaneous, muscle, various organs, etc., and is compact and lightweight and portable. The present invention relates to a chemical injection device that can set and control the injection amount and injection time arbitrarily and can use up the chemical liquid without waste, and a chemical liquid container for such a chemical injection device.

[0002]

2. Description of the Related Art Conventionally, in order to continuously administer hormones such as insulin, narcotics for pain relief, anticancer agents, antibiotics or heparin, these drug solutions are subcutaneously, blood vessels, muscles, The method of injecting into epidural, various organs, etc. is general. In this case, it is possible to administer a small amount by an electric circuit or a computer, or while finely controlling according to the condition of the patient.

A pump mechanism for making the above-mentioned chemical liquid injection system portable has been developed, and for example, a chemical liquid pump of a type in which a syringe filled with a chemical liquid is driven under pressure by a battery is known. However, there are limits to size reduction and weight reduction of mechanical members such as syringes and driving power sources such as batteries. In addition, driving parts such as syringe motors that can be carried around are expensive because they are required to be small in size and have high performance. In addition, they generally have a short service life and have difficulty in durability, requiring frequent maintenance. Is.

On the other hand, pumps of the type for sucking a chemical solution are also known, for example, a peristaltic pump using an electric motor as a power source, or a liquid delivery pump using a smaller and lighter vibration plate than this. These suction type pumps can be made smaller and lighter than the pressurized syringe pump type. Further, if the container body is made of a soft plastic material that is easily deformed, the volume itself changes and the space occupied by the container body can be reduced, and the weight can be reduced. When combined with the suction pump described above, the chemical injection device can be made smaller and lighter.

[0005]

Generally, when a container body can be hung on an infusion stand or the like to create a differential pressure state, even if a suction pump such as the above-mentioned peristaltic pump is used, a liquid solution is delivered without leaving a chemical solution. can do. However, the portable drug solution injector is used while worn on the patient's body for a long time, and the orientation of the container body differs depending on the patient's wearing position or activity state, and the drug solution discharge direction is always oriented in the gravity direction. It is difficult to keep it in the open state. In such a state, it becomes difficult for the drug solution to be sucked out, and the easily deformable container body changes in volume from the easily deformable portion to cause blocking, that is, the inner surfaces of the container body stick to each other and the flow path is blocked. , The chemical may remain in the container body. Further, in the case of a drug solution container that is not as easily deformable as a soft material or a container body that does not deform even when the volume is reduced, the suction pressure becomes insufficient as the drug solution volume is reduced, and the drug solution in the container cannot be sufficiently sucked.

The present invention has been made in view of the circumstances of the prior art as described above, and is a small-sized and light-weight chemical liquid container that can be used up without waste, and a chemical liquid container including this chemical liquid container. It is an object of the present invention to provide a portable liquid medicine injecting device capable of arbitrarily setting and controlling the amount and injecting time, and particularly to provide a liquid medicine injecting device with a small amount of the drug remaining in the container body after the completion of liquid feeding. .

[0007]

The above-mentioned problems can be solved by the present invention as described below. (1) Includes a container body made of a soft material that is easily deformable, a casing member made of a hard material that is spaced apart from the container body, and an air layer compressed and held by the casing member and the container body. A drug solution container composed of an elastic member, a pump that is connected to the downstream of the container body and generates a negative pressure in the container body, and an internal control that is connected to the pump and controls the operation of the pump. A chemical liquid injector having a device and a liquid supply path provided downstream of the pump for supplying the chemical liquid discharged from the pump.

In the present invention, the elastic member does not include a metallic material. (2) The chemical liquid injector according to (1) above, in which the elastic member is made of a soft, low-rebound elastic urethane foam is a preferred embodiment of the present invention.

(3) The casing member is a container,
The drug solution container is integrally configured by accommodating the container body and the elastic member inside (1)
Alternatively, the drug solution injector of (2). (4) The drug solution injector according to (3), wherein the drug solution container is a prefilled preparation in which a drug solution is filled in the container body. A mode in which the liquid medicine container has a liquid medicine filling port may be adopted.

(5) The chemical liquid injector according to any one of the above (1) and (4), wherein the casing member constitutes a part of the housing of the chemical liquid injector.

(6) The above-mentioned (1), wherein the drug solution is insulin or an insulin analogue having insulin-like activity.
The drug solution injector according to any one of (5) to (5). (7) The chemical liquid injector according to any one of (1) to (6), wherein the pump is a diaphragm pump.

(8) A container body made of a soft material that is easily deformable, a casing member made of a hard material arranged apart from the container body, and air compressed and held by the casing member and the container body. A chemical solution container for a chemical solution injection device, which is integrally configured with an elastic member including a layer.

(9) The internal liquid control device further comprises an input means for inputting a liquid chemical injection instruction in the device, wherein the liquid chemical injection device is any one of the above (1) to (8). The operation of the pump can be controlled by the chemical liquid injection instruction input to the input means.

(10) The chemical liquid injector according to any one of (1) to (9), wherein the chemical liquid injector further includes an external control device capable of transmitting and receiving information to and from the internal control device. (11) The chemical liquid injection device according to (10), wherein the external control device includes a program in which a chemical liquid injection instruction to be transmitted to the internal control device is set. The operation of the pump can be controlled by transmitting a drug solution injection instruction based on the program set in the external control device to the internal control device.

(12) The above-mentioned internal control device further comprises means for recording the operating state of the pump and / or the liquid injection amount, and transmission means for displaying the record on the external control device or separately storing it. The chemical injection device according to (10) or (11).

(13) The above-mentioned (1) wherein the external control device and the internal control device are wirelessly connected to each other.
The liquid medicine injector according to any one of 0) to (12).

[0017]

BEST MODE FOR CARRYING OUT THE INVENTION Preferred embodiments of the chemical liquid injector 1 according to the present invention will be specifically described below with reference to the drawings. FIG. 1 is a partial cross-sectional view showing a schematic configuration of a chemical injection device 1 of the present invention. The chemical liquid injector 1 of the present invention is provided with a chemical liquid container 2 including a container body 20, a pump 3 connected to the downstream of the container body 20, and a downstream of the pump 3.
It has a tube-shaped liquid supply path 5 for supplying the chemical liquid 6 discharged from the pump 3 whose operation is controlled by the internal control device 4.

The liquid medicine container 2 is compressed by a container body 20 made of a soft material that is easily deformable, a casing member 8 made of a hard material arranged apart from the container body 20, and a casing member 8 and the container body 20. The elastic member 7 is held. FIG. 1 shows an aspect in which the casing member 8 is a container (case), and the container body 20 and the elastic member 7 are housed inside the casing member 8 to integrally configure the chemical liquid container 2.

The container body 20 of the present invention is made of a soft material that is easily deformable. In the case where the container body 20 itself does not have to have the gas barrier property, for example, by providing the casing member 8 with the gas barrier property, the material of the container body 20 is selected from the materials whose stability to the drug has already been guaranteed. It suffices to select a soft material that can be deformed following the reduced volume of the drug solution 6 sucked out by the action of the pump 3 connected to the container body 20. Also cresol (preservative)
A chemical resistant material that does not adsorb oily chemicals such as is selected.

Such a soft material can be easily deformed following the volume reduction of the internal volume. For example, olefin polymers such as polypropylene and polyethylene, and polymer materials such as polyvinyl chloride can be used. A combination of two or more of these may be used. In addition, elasticity and flexibility can be improved by appropriately adding an elastomeric polymer such as a styrene elastomer or an olefin elastomer to these. The soft material is usually transparent or translucent.

Further, by using a material obtained by laminating a hard material layer on the soft material layer, the container body 20 itself has a gas barrier property,
It can also have a water vapor barrier property. Specific examples of such hard material include polyethylene terephthalate (PET), polyethylene naphthalate (PEN),
Polymeric materials such as polyacrylonitrile (PAN), hard olefin-based polymers, polycarbonate, and acrylic resins can be mentioned. It may be a mixture or a mixture of two or more of these. In the case of a laminate having the hard material layer, the hard material layer may be laminated in any of an inner layer or an outer layer of the soft material layer and an inner or outer layer sandwiching the soft material layer, but the inner layer is usually a soft material. And

The shape of the container body 20 is not particularly limited as long as it can be easily deformed in accordance with the decrease of the internal volume, but normally, the main body portion 21 is deformed in accordance with the decrease of the contained drug solution 6. A bag-shaped body having a mouth portion 22 that is not deformed by sucking out the chemical liquid 6. The main body portion 21 does not need to have a shape-retaining property capable of standing by itself,
A shape in which the inner volume of the main body portion 21 is close to zero when the inner surface of the main body portion 21 is in close contact with each other when the liquid volume can be easily deformed following the volume reduction and the liquid can no longer be delivered, that is, at the end of the liquid delivery. Is desirable.

A preferred shape of the main body portion 21 has a cross section as shown in FIG.
The shape is symmetrical with respect to the vertical axis from. Specifically, a bag-shaped main body portion 21 in which two symmetrically cut sheets are bonded together can be used. A plan view of a preferred embodiment is shown in FIG. If the main body 21 is a laminated bag made of a sheet made of a soft material, it is possible to make the internal space almost zero by the close contact between the inner surfaces of the main body 21 when the liquid feeding is completed (FIG. 4). (See (b)), almost all the filled chemical liquid 6 can be sent.

As shown in FIG. 2 (b), the tubular film has a gusset-free bag-like body having open ends excluding the mouth 22 bonded by fusion or the like, or a bottom material attached to the bag-like body for sealing. It is also preferable that the bag-shaped body (not shown) formed by the above-mentioned process has a fold (crease) parallel to the perpendicular axis on the tubular main body portion 21 (not shown). The bag-shaped body can be formed by a method such as blow molding or inflation molding of the above material.

The mouth portion 22 can be formed by injection molding of the above soft material. The mouth portion 22 and the main body portion 21 are
They may be integrally molded, or they may be molded separately and then integrated by fusion or an adhesive. It should be noted that the following description will be given based on a preferred example of the main body portion 1 shown in FIGS. 1 and 2, but the main body portion 21 of the present invention is not limited to the shapes shown in these drawings.

The thickness of the main body portion 21 is not particularly limited as long as it does not impair the above purpose, but when it is made of only a soft material, it is usually about 10 μm to 1000 μm. Further, in the case of a laminate having a hard material layer, the thickness of each layer is not particularly limited as long as it does not impair the object of the present invention that deforms following volume reduction, but usually the soft material layer is about 10 to 1000 μm. , The hard material layer is 5-100 μm
It is a degree. The inner volume of the container body is usually about 1 to 100 mL, although it varies depending on the medicine to be filled.

The elastic member 7 is compressed and held by the container body 20 and the casing member 8 so that the deformation of the main body portion 21 due to the volume reduction of the liquid medicine is uniform and uniform. It is for auxiliary pressing of the outer surface. Such an elastic member 7 may be a member that is resilient to compression, but it is shock-absorbing, lightweight, and has low resilience, and particularly, the container body 20 is continuously pressed by a low resilience force. It is desirable that the material consist of continuous materials. In the present invention, as the elastic member, it is difficult to reduce the size and weight, and an elastic member made of a metal material such as a coil spring that damages the container body 20 made of a soft material is not usually used.

As the elastic member 7 as described above, a member including an air layer as an elastic spring, for example, a soft foam can be mentioned. Specific examples thereof include flexible polyurethane foam such as polyether polyurethane foam and polyester polyurethane foam. In particular, these flexible polyurethane foams are manufactured according to JIS K640.
The hardness measured according to 1 (Test method for flexible urethane foam) is preferably 300 N or less, and more preferably 80 N or less. Density is about 1 to 140 kg / m ³ ,
Further, it is desirable that the pressure is about 5 to 80 kg / m ³ . The impact resilience is preferably 40% or less, more preferably 10% or less, still more preferably 5% or less.

The flexible polyurethane foam can be adjusted to have the above-mentioned hardness, impact resilience and density by selecting a combination of raw materials and a usage ratio according to a known production method. In the present invention, as the flexible polyurethane foam as described above, a general-purpose urethane foam FL,
Soft everlite products (DLN, FHN, FX-B, R
KW, etc.) (Each of them is made by Bridgestone), EGR
Commercially available products such as series (EGR2, EGR6, etc .: manufactured by INOAC CORPORATION) and the like may be used. Among these, low-resilience urethane foams such as soft everlite products and E
GR series products are preferred.

Further, in the present invention, as the low-resilience and lightweight elastic member 7, a cushion in which wool or feathers are packed in a lightweight bag of polyethylene or cloth that does not impair the low-resilience and lightness of the contents. Can also be used.

The shape and size of the elastic member 7 are not particularly limited as long as the above-mentioned object can be achieved, but it is usually a substantially plate-like body having a thickness and contacting at least a part of the outer surface of the container body 20, usually 25% or more. Preferably. Specifically, a form of covering the entire outer surface of the main body 21, a form of covering both sides (see FIG. 1) or a single side of the main body 21 to which a sheet is attached may be used. The elastic member 7 is
At least a part of the elastic member 7 may be fixed to the container body 20 and / or the casing member 8 with an adhesive or the like, if the effect is not impaired, or simply sandwiched between the container body 20 and the casing member 8. May be held by. The bonding method and the bonding site are not limited at all.

The method of holding the elastic member 7 is arranged on one side of the container body 20 in a mode in which the casing member 8 of the chemical liquid container 2 constitutes a part of the housing 10 as a lid of the accommodating portion 10a of the chemical liquid injection device 1. A specific example of this is shown in FIG. FIG. 3A shows a casing member (lid) 8 on which an elastic member 7 is attached.
FIG. 3B shows an example in which the elastic member 7 is bonded and fixed.
It is an example of a mode in which the is adhered and fixed to the container body 20. Figure 3 (c)
Is an example of a mode in which the elastic member 7 is simply placed on the container body 20 and sandwiched between the casing member (lid) 8 and the container body 20.

The thickness of the elastic member 7 varies depending on the shape and material of the elastic member 7 and the size and shape of the container body 20. The elastic member 7 is compressed and sandwiched between the container body 20 and the casing member 8 so that the elastic member 7 is compressed. Is selected so that the container main body 20 is not destroyed by the restoring force and the desired pressing force is obtained. The elastic member 7 is set in a compressed state (compared to its natural volume) by the container body 20 of the maximum volume filled with the chemical liquid 6 and the casing member 8 before the start of liquid delivery. At the time of setting, the elastic member 7 may be previously compressed with a palm or the like. The compressibility of the elastic member 7 before the start of liquid feeding is usually about 30 to 70% with respect to the natural volume. Further, at the end of liquid feeding, the elastic member 7 is released from compression as compared with the start of liquid feeding, but it is preferable that the elastic member 7 is compressed more than its natural volume. Specifically, the compression rate at the end of liquid feeding is 8 to 4
It is preferably about 0%.

Due to the elastic member 7 as described above, when the main body portion 21 of the container main body 20 made of a soft material is deformed following the volume reduction of the chemical liquid 6, it is difficult to move toward the mouth portion 22. It is possible to prevent formation of wrinkles or partial occlusions. That is, by the pressing assistance of the elastic member 7, the main body portion 21 does not cause blocking, and finally the inner surfaces of the main body portion 21 are brought into close contact with each other so that the internal volume of the main body portion 21 can be substantially zero. . In the present invention, the container body 20 is pressed by the elastic member 7, but the chemical liquid 6 is not discharged unless the pump 3 sucks.

The casing member 8 is made of a hard material which is hard to be deformed regardless of deformation of the container body 20 or external force. The casing member 8 includes the elastic member 7 and the container body 2.
It is desirable that the strength is high enough to protect 0, and it is preferable to have gas barrier properties and water vapor barrier properties.
However, when the container body 20 itself has gas barrier properties and water vapor barrier properties, the elastic member 7 is particularly gas barrier properties,
It does not have to have a steam barrier property. Further, the casing member 8 preferably has chemical resistance to an oil-based drug such as cresol, and is also preferably transparent or translucent. As such a hard material, specifically,
Polyethylene terephthalate (PET), polyethylene naphthalate (PEN), polyacrylonitrile (PA
Polymer materials such as N), hard olefin-based polymers, polycarbonate, and acrylic resins can be mentioned. It may be a mixture or a mixture of two or more of these.

If the casing member 8 made of the above-mentioned material has a thickness of usually about 0.1 to 2 mm, the casing member 8 does not lose its lightness, and cooperates with the container body 20 to have a strength for compressing and holding the elastic member 7. Can be secured. The casing material, its shape and size are not particularly limited. In the present invention, as described above, the casing member 8 may have a container shape (see FIG. 1) that houses the container body 20 and the elastic member 7 therein and integrally configures the drug solution container 2,
It may be a member shared with the housing 10 that constitutes a part of the housing 10 of the chemical liquid injector 1 (see FIG. 3).
When the casing member 8 is a container, the housing 1
The case may be independent of 0 and may be incorporated in the housing portion 10a in the housing.

FIG. 4 shows a drug solution container 2 provided by the present invention, in which the container body 20 and the elastic member 7 are housed in a casing member 8 which is a container, preferably a closed container, and the elastic member 7 is provided. Shows a mode integrally formed by being compressed and held by the casing member 8 and the container body 20. If the liquid medicine container 2 is such an integrated independent type, the liquid medicine container 2 can be taken out of the housing 10 of the liquid medicine injection device 1 and replaced after the liquid feeding is completed (FIG. 4 (b)). Further, the casing member 8 is the housing 1 of the chemical liquid injector 1.
In the case of configuring a part (lid) of 0, the container body 20 or the container body 20 and the elastic member 7 can be taken out of the housing portion 10a of the housing 10 and exchanged after the completion of the liquid feeding.

In the present invention, in the case where the drug solution container 2 is of the above-mentioned hermetically sealed type, it may be a so-called prefilled preparation containing the drug solution 6 pre-filled in the container body 20. When the prefilled preparation is used, it may be integrated with the pump 3. Further, the container body 20 is the liquid medicine container 2
Alternatively, it may have a liquid medicine filling port (not shown) for filling the liquid medicine 6 after configuring the liquid medicine injector 2.
For example, the chemical solution 6 may be filled just before use or refilled after use. The chemical liquid 6 is filled in the container body 20 in an aseptic environment, or is sterilized by an autoclave or the like after filling the chemical liquid.

The drug solution 6 filled in the container body 20 as described above is not particularly limited, but hormone agents such as pancreatic hormone, gonadotropin, and gonadotropin-releasing hormone such as insulin, insulin analogue having insulin-like activity, and the like. , Other than hormonal agents, narcotics such as morphine for pain relief, anti-cancer agents, antibiotics,
Heparin etc. can be mentioned. If the container body 20 is made of a drug-resistant olefin polymer, it can be used for infusion of insulin or the like containing an oil-based preservative such as cresol.

FIG. 4 is a partially enlarged sectional view of FIG. 1 for explaining the operation of the chemical liquid container 2 configured as described above. Before the start of liquid delivery (FIG. 4 (a)), the elastic member 7 is held in a compressed state by the container body 20 filled with the drug solution 6 and the casing member 8. When the liquid cannot be further sent, that is, at the end of the liquid transfer (FIG. 4 (b)), the inner surfaces of the main body 21 come into close contact with each other due to the deformability of the main body 21 and the restoring force of the elastic member 7, and the main body 21 The space inside is almost zero. As a result, only a small amount of the chemical liquid 6 is left in the mouth portion 22, and it is possible to avoid the chemical liquid 6 remaining in the main body portion 21. When the liquid feeding is completed, the elastic member 7 in contact with the outer surface of the container body 20 is more compressed than when the liquid feeding is started, but is preferably compressed rather than the natural volume.

Further, in the case where the casing member 8 as shown in FIG. 4 is an independent container in which the chemical liquid container 2 is integrated, when the casing member 8 has gas barrier property and water vapor barrier property, the casing member 8 is , Usually elastic member 7
Has one or a plurality of openings 8a for communicating with the atmosphere. This opening 8a can be sealed when the tank is not used until the start of liquid transfer, and the casing member 8 can be made into a closed container (FIG. 4 (a)). In particular, when the container body 2 is a prefilled preparation, a structure for sealing the opening 8a is indispensable until just before the start of use in order to prevent reduction of moisture and additive components such as preservatives during storage and to secure gas barrier property. . The sealing method, the shape and material of the seal are not particularly limited.

In FIG. 4, the film 1 covering the opening 8a is shown.
1 is fused to the casing member 8 to form the opening 8a.
The mode which sealed is shown. Further, as shown in FIG. 5, the opening 8a may be formed by removing the tag 12 formed integrally with the casing member 8. In addition, when the container body 20 is not a prefilled formulation but is filled with a drug solution at the time of use, the structure for sealing the opening 8a is not always necessary.

A system for generating a negative pressure in the container body 20, that is, a pump 3 for sucking out the drug solution 6 is connected to the downstream side of the container body 20 through a port 23 fitted in the mouth portion 22. . The liquid medicine inside the container body 20 is sucked out by the suction of the suction pump 3. The suction pump 3 causes the inside of the container body 20 to become a negative pressure, but in the present invention, the pressing force of the elastic member 7 maintains the internal pressure at which the body body portion 21 does not cause blocking. The discharge pressure of the container body 20 may be atmospheric pressure, that is, up to about 100 kPa (760 mmHg). Specifically, the suction force of the pump 3 that can generate such a negative pressure may be about 0.1 to 50 mL / h in terms of the amount of liquid delivered per hour. If the amount of liquid to be fed is about this amount, the amount of liquid to be fed can be adjusted to a minute amount up to about 0.1 μL / h by intermittently feeding the liquid.

The pump 3 used in the present invention is of a type that sucks out a chemical liquid, and is not particularly limited as long as it can be made small and lightweight, but a diaphragm type pump can be cited as a preferred embodiment. The structure and operating principle of the diaphragm type pump are shown in FIGS. The diaphragm pump 300 shown in FIG. 5 has a vibrating plate 303 arranged between the flow passage 301 and the housing space 306, and one side of the vibrating plate 303 located downstream of the vibration plate 303 of the flow passage 301. Valve 304, which allows only fluid to flow
And a chamber 302 formed by 305. The upstream side of the flow path 301 is connected to the container body 20 side, and the downstream side is connected to the liquid feeding path 5.

The diaphragm 303 normally vibrates due to a change in voltage or current. For example, when a periodic voltage or current is applied (not shown) to the diaphragm 303, the diaphragm 303 vibrates in synchronization with the frequency, and the vibration causes a pressure change in the chamber 302. As a result, the upstream and downstream valves 304 and 305 are alternately opened and closed, and the pump 3
Negative pressure is generated in the container body 20 connected to the upstream side of
The sucked chemical liquid 6 flows into the flow path 31. The upstream and downstream valves 304 and 305 may be opened and closed automatically in synchronization with the diaphragm 303.

Although the example of the diaphragm type pump having the valve (open / close valve) has been described above, the above drawings are for explaining the operation principle, and the shape of each constituent member is not limited to the above. It goes without saying that this is not the case. As a type based on another liquid feeding principle using a vibrating plate, for example, a type in which a liquid flow direction is determined by a flow channel shape without using a valve can be cited. Specifically, by making the inlet flow path and the outlet flow path into the chamber tapered so as to increase the resistance in the upstream direction, it is possible to direct the inflow into the chamber and the outflow from the chamber. .

Other Principles of Liquid Delivery Using Vibration Plate The vibration frequency of the vibration plate can be from several Hz to several 100 kHz. Among these, a so-called ultrasonic vibration type diaphragm that utilizes the frequency of the ultrasonic wave region can be preferably used. Even if it is of a type having a valve, the frequency is not particularly limited as long as the valve can follow it.

The principle itself of the diaphragm pump is known, and in the present invention, any structure and shape can be used as long as it is a system for sucking the chemical solution from the connected container body 20. From various diaphragms, a type and performance suitable for the flow rate suitable for the drug to be administered may be selected. For example, in the type having the above-mentioned valve, the diaphragm 33
Since it follows the gentle vibration of, it is suitable for use at a slow liquid transfer rate. Further, a type that does not have a valve and determines the flow path direction according to the flow path shape is suitable for use at a high liquid transfer rate.

In the above description, the structure of the pump 3 is described as a diaphragm type. However, in the present invention, a diaphragm without a diaphragm may be used as long as it is a system for sucking the chemical liquid. For example, a roller pump, a cylinder pump, an axial flow pump, a centrifugal pump, etc. can be used. However, in the present invention, the internal pressure that does not cause blocking of the container body 20 made of a soft material that is easily deformed by the pressing force of the elastic member 7 is always maintained, and the liquid medicine can be sucked out while uniformly deforming. In order to
As a pump to be combined with such a container body 20, a diaphragm pump that is smaller and lighter than a mechanical pump is suitable.

In the present invention, the pump 3 is the container body 2
0, and may be integrated with the liquid supply path tube 5. If the container body 20 and the pump 3 are integrated,
The operator does not need to connect the container body 20 and the pump 3 and can be handled cleanly and easily. Further, after the liquid feeding is completed, the container body 20 may be disposed of together with the integrated pump 3 and further the liquid feeding passage tube 5. The drug solution container 2, the pump 3 and the internal control device 4 are preferably housed in the housing 10 of 1.

FIG. 7 is a block diagram showing a preferred embodiment of the chemical liquid injector 1 of the present invention including the chemical liquid container 2, the pump 3, the internal control device 4 and the liquid feeding passage 5 as described above. The other end of the liquid supply path 5 whose one end is connected to the pump 3 is connected to the injection needle 52 via the connector 51 as needed during use. The pump 3 has a power source 4 built in the internal control device 4.
0 can be used as a power source, and the power source can be controlled by the internal control device 4. Further, the pump 3 includes a control circuit 41 connected to a power source 40 in the internal control device 4,
The operation is controllable via an electrical contact 8 such as a connector. The injection amount of the chemical liquid 6 is controlled by controlling the operation of the pump 3 by the internal control device 4. Further, the internal control device 4 may have an input means 42 such as a switch.

The internal control device 4 preferably includes a recording means (memory) 43 for recording the operating condition of the pump 3 and / or the amount of chemical liquid injected. Further, it may have a display device 44 such as a liquid crystal display for confirming the input of the medication program, a liquid feeding state, an alarm, an error, and the like. You can

It is also preferable that the chemical liquid injector 1 of the present invention includes an external control device 100 capable of transmitting information to the internal control device 4. Further, it is also preferable that the external control device 100 has a transmitting means for displaying the record recorded in the memory 43 of the internal control device 4 or separately storing the record. The control circuit 41 can be used as this transmitting means (communication circuit 41). The external control device 100 and the internal control device 4 can be wirelessly connected to each other, and any method can be used as long as digital transmission and reception can be performed.

An administration program instructed by a doctor may be preset in the control circuit 41. Alternatively, in a mode including the external control device 100, the external control device 1
It is also possible to arbitrarily control the operation of the pump 3 by arbitrarily setting a medication program to 00 and transmitting (transferring) a drug solution injection instruction based on the set program to the internal control device 4. Further, by connecting to the external control device 100, information can be read out, and detailed confirmation and analysis of information can be performed. Further, the external control device 100
If the memory 101 is installed in the, the long-term history information can be managed.

At the same time that the pump 3 is connected to the internal control device 4, it is connected to the control circuit 41, and the control signal and electric power for driving the pump are supplied from the control circuit 41 by the operation of starting the medication by pressing the switch 42 or the like. Supplied. As a result, the pump operation can be controlled according to the preset chemical injection program.

When the operation control of the pump 3 is instructed and a negative pressure is generated in the container body 20 to suck the chemical liquid 6, the chemical liquid 6 is sucked from the container body 20. In the present invention, the body barrel 21 is uniformly deformed while always maintaining the internal pressure that does not cause blocking when the volume of the body barrel 21 made of a soft material that is easily deformed by pressing the elastic member 7 is changed. Finally, as shown in FIG. 4 (b), the internal volume of the main body 21 becomes almost zero, and the filled chemical solution 6 can be sucked out almost completely. Therefore, the drug solution can be used up without waste, which is a great advantage especially when expensive insulin or the like is used. In the present invention, even if the mouth portion 22 faces upward, the pump 3 described later will be used.
Thus, the chemical liquid 6 can be sucked out without leaving the main body 21.

The drug solution injection using the drug solution injector of the present invention as described above may be performed via any of epidural, arteriovenous blood vessel, subcutaneous, muscle, various organs and the like. The chemical liquid injector of the present invention as described above is not only compact and lightweight and easy to carry, but also can utilize the chemical liquid to the end without waste by utilizing the spring characteristic of the elastic member. Further, the administration can be arbitrarily controlled according to the drug, and if it is programmed in the internal or external control device, the administration can be performed at an appropriate time, and even a person who cannot control the administration by himself / herself can easily perform the administration.

Insulin used in the treatment of diabetes is conventionally generally administered by a syringe or a dedicated injector, which is administered once to four times a day before each meal or at a predetermined time. But
In this method, blood glucose rises in the morning (dawn phenomenon: dawn p due to an increase in physiological insulin resistance due to the control of blood glucose when meal times are irregular and secretion of growth hormone in the early morning).
henomenon) is often difficult to prevent.
Therefore, instead of the conventional frequent injection, there is a tendency to administer a small amount at a high concentration only when necessary such as when the blood glucose level is lowered or after meal, but if the drug solution injection device of the present invention suitable for carrying is Such an administration method can be easily performed.

[0059]

EXAMPLES The present invention will now be specifically described with reference to examples, but the present invention is not limited to these examples. [Example 1] A liquid feeding test was conducted on the following chemical liquid containers to measure changes in the internal pressure of the container body and the residual liquid amount. FIG. 8 shows a schematic diagram of the test circuit. 2 with the shape shown in Fig. 2 (a)
A container body 20 having a mouth 22 formed by adhering a port 23 with an epoxy adhesive to a bag (width 16.5 mm × length 52 mm) in which polyethylene sheets (thickness 75 μm) were attached was used. 2.99 mL of water in the container body 20
And both sides of the container 20 are made of a flexible low-resilience urethane foam (DLN manufactured by Bridgestone Co., Ltd.) having an elastic resilience of 5% or less (length 60 mm × width 20 mm × thickness 15).
mm), and the elastic member 7 is further covered with two acrylic plates (length 60 mm × width 6) with a distance between the plates of 20 mm.
0 mm × thickness 6 mm) (casing member 7) to hold the liquid medicine container 2. The thickness of the container body 20 when filled with the chemical liquid 6 is about 6.5 mm, and the elastic member 7
Was compressed to 13.5 mm with two sheets (30 mm). Therefore, the compression rate of the elastic member 7 in this state is 55.
%Met.

The mouth 22 of the container body 20 was set upward, and the drug solution 6 was sucked out by the roller pump 3 (10 mL / hr). The pressure inside the container body 20 at the start of liquid feeding was a positive pressure of 21.7 mmHg in gauge pressure. The liquid medicine 6 was sucked out by the roller pump 3 (10 mL / hr), and when the inside of the container body 20 became a negative pressure of −100 mmHg due to the gauge pressure (at the completion of liquid feeding), the residual liquid amount in the main body portion 21 was 0. 12m
The residual liquid amount in the entire container body 20 including the mouth portion 22 was 0.21 mL. The compressibility of the elastic member 7 at this time was 33.3%. The results are shown in Table 1.
FIG. 8 shows a change in pressure with time in the container body 20 due to the suction of the roller pump 3.

[Embodiment 2] In Embodiment 1, the material of the elastic member 7 is made of soft urethane foam (F made by Bridgestone Corporation).
A liquid sending test was conducted in the same manner as in Example 1 except that the solution was changed to L). The results are shown in Table 1. FIG. 8 shows a time-dependent pressure change in the container body 20 due to the suction of the roller pump 3.

[Examples 3 to 6] A liquid sending test was conducted in the same manner as in Example 1 except that the number of elastic members 7 used or the material thereof was changed as shown in Table 1. The results are shown in Table 1. In Table 1, the soft low-resilience urethane foam of Example 4 is EGR6 manufactured by INOAC.

Reference Example 1 A liquid feeding test is performed in the same manner as in Example 1 except that the elastic member 7 and the acrylic plate 8 are not used and the chemical liquid container is composed of only the container body 20. It was The results are shown in Table 1. Roller pump 3
FIG. 9 shows the time-dependent pressure change in the container body 20 due to the sucking out of the.

[Examples 7 to 9] In Example 1, the main body body portion 21 was made of polypropylene (PP) (with a thickness of 50).
μm), polyethylene terephthalate (PET) outer layer
A liquid sending test was conducted in the same manner as in Example 1 except that the bag (25 mm wide × 42 mm long) laminated with a laminated film of (thickness 12 μm) was used and the elastic member 7 shown in Table 1 was used. The results are shown in Table 1.

Reference Example 2 A liquid feeding test was conducted in the same manner as in Examples 7 to 9 except that the elastic member 7 and the acrylic plate 8 were not used and the chemical liquid container was composed of only the container body 20. I did. The results are shown in Table 1.

[0066]

[Table 1]

[0067]

The chemical liquid container for a chemical liquid injection device according to the present invention comprises a container body made of a flexible material which is easily deformed as the liquid is fed, and an elastic member which assists in pressing this deformation. The internal pressure that does not cause blocking can be maintained and the flow rate can be stably and accurately delivered. Especially, even if it is a suction pump that generates a very small negative pressure, it is the last regardless of the direction of the chemical solution discharge direction. You can use up the chemical solution without waste. Therefore, the present invention provides a light-weight, compact and inexpensive chemical injection device including such a chemical container and a suction pump. Further, since the chemical injection device of the present invention is operated by the chemical injection instruction directly input to the control device or the chemical injection instruction programmed in advance by the external control device, it is possible to inject the medicine at an arbitrary set amount and set time. realizable. Furthermore, if the container body, pump, and if necessary the injection line are integrated, they can be discarded after only one use, so the power source such as a motor with a short life and heavy weight is eliminated from the control device that is used repeatedly. It is also possible to provide a chemical injection device that is smaller, lighter and cheaper than conventional electric pumps, has few failures, and basically does not require maintenance.

[Brief description of drawings]

FIG. 1 is a partial cross-sectional view showing a schematic configuration example of a chemical injection device of the present invention.

2 (a) and 2 (b) are plan views showing a preferred embodiment of the container body in the present invention.

3 (a) to 3 (c) are explanatory views showing an arrangement example of elastic members in the present invention.

4A and 4B are cross-sectional views showing an example of one embodiment of the chemical liquid container according to the present invention, in which FIG. 4A is a state before starting liquid feeding, and FIG. 4B is a diagram showing a state after liquid feeding is finished.

FIG. 5 is a cross-sectional view showing an example of an opening aspect of a drug solution container according to the present invention.

6 (a) and 6 (b) are cross-sectional views showing a structure and an operating principle of a diaphragm pump used in the chemical liquid injector of the present invention.

FIG. 7 is a block diagram illustrating a mode in which the chemical liquid injector according to the present invention includes an external control device.

FIG. 8 is a schematic explanatory diagram of a circuit used in a liquid delivery test of an example.

FIG. 9 is a graph showing the results of the liquid sending test of Examples 1 and 2 and Reference Example 1.

Claims (8)

[Claims] 1. A container body made of a soft material that is easily deformable,
A liquid medicine container composed of a casing member made of a hard material and spaced apart from the container body, and an elastic member including an air layer compressed and held by the casing member and the container body, and the container body. A pump of a system for generating a negative pressure in the container body, an internal control device connected to the pump for controlling the operation of the pump, and a pump provided downstream of the pump from the pump. A liquid medicine injection device having a liquid supply path for supplying a liquid medicine to be discharged. 2. The chemical liquid injector according to claim 1, wherein the elastic member is made of soft low-resilience urethane foam. 3. The chemical liquid container is integrally formed by housing the container body and the elastic member inside the casing member.
The chemical injection device according to. 4. The drug solution injector according to claim 3, wherein the drug solution container is a prefilled preparation in which a drug solution is filled in the container body. 5. The chemical liquid injector according to claim 1, wherein the casing member constitutes a part of a housing of the chemical liquid injector. 6. The drug solution is insulin or an insulin analog having insulin-like activity.
The drug solution injector according to any one of 1. 7. The chemical liquid injector according to claim 1, wherein the pump is a diaphragm type pump. 8. A container body made of a soft material which is easily deformable,
A casing member made of a hard material arranged apart from the container body, and an elastic member including an air layer,
A drug solution container for a drug solution injector, wherein the elastic member is integrally held by being compressed and held by the casing member and the container body.