JPH0532128Y2 - - Google Patents

Description

[Detailed description of the invention] Industrial field of application This invention relates to a device for continuously injecting small amounts of medical solutions such as chemotherapeutic agents, analgesics, anticancer drugs, etc. into blood vessels.

Prior Art As a continuous infusion device for injecting a drug solution as described above,
In recent years, simple devices that do not use roller pumps or electricity have been developed.

An example of this is the continuous infusion device shown in Fig. 2, in which 1 is an outer cylinder, 2 is a balloon housed in the outer cylinder 1, and 3 is a stopper attached to one end of the outer cylinder 1. It has a chemical solution spout 5 that communicates with 2. Reference numeral 6 denotes a drug solution administration tube, one end of which is connected to the spout 5 of the stopper 3 via a filter 7. A luer lock 10 into which a flow rate control tube 8 is inserted is provided at the other end of the tube 6, and a luer cap (not shown) can be attached to the luer lock 10. When using it, remove this lure cap and use the lure lock 10.
Attach a connector (not shown) provided at one end of the drug solution injection tube 12 to be inserted into the blood vessel. In addition, a capacity indicator 14 having a drug solution filling port 13 is located on the opposite side of the balloon 2 from the stopper 3 of the outer cylinder 1.
The balloon 2 is attached so as to be movable in accordance with the deflation of the balloon 2. 15 is a check valve, 16 is an end cap detachably attached to the other end of the outer cylinder 1, and 17 is a hydrophobic filter provided on the end cap 16.

In the case of the continuous infusion device as described above, a syringe (not shown) is inserted from the other end of the outer cylinder 1 from which the end cap 16 has been removed, and the Lure tip of the syringe is attached to the drug solution filling port 13 of the volume indicator 14. Then, the balloon 2 is filled with the drug solution in the syringe barrel. By filling with this chemical solution, the balloon 2 slowly inflates. When a predetermined amount of filling is completed, the syringe barrel is removed and the end cap 16 is attached, the balloon 2 is filled with the drug solution as shown in the figure.

On the other hand, in order to inject the drug solution in the balloon 2 into the patient's blood vessel from the above state, remove the luer cap attached to the luer lock 10, attach the connector of the drug solution injection tube 12 to the luer lock 10, and After the end is inserted into the blood vessel and fixed, an opening/closing clamp (not shown) attached to the tube 12 is operated to open the medicinal solution flow path within the tube 12. As a result, since the internal pressure of the balloon 2 is higher than the blood pressure, the balloon 2 gradually deflates, and this contraction force causes the filled drug solution to be transferred to the administration tube 6 and the infusion tube 1.
After step 2, it is continuously injected into the blood vessels in small amounts.
This injection rate is, for example, about 0.5 to 5 ml/hr when the maximum filling volume of the balloon is 65 ml.

The continuous infusion device described above is driven by the contraction force of the balloon 2, instead of the conventional continuous infusion device that drives a roller pump with a battery and injects a drug solution into a blood vessel, so it can be made smaller and lighter. Moreover, the flow control tube (with different inner diameter)8 eliminates the troublesome flow adjustment.
The advantage is that it can be easily done by selecting the type of .

Problems to be Solved by the Invention By the way, the balloon 2 used in the continuous infusion device described above serves as a reservoir (storage tank) from which the filled drug solution flows out by the contraction force of the balloon itself. Therefore, the desired properties for the material of this balloon 2 are high elongation, low hysteresis and permanent deformation, and physical properties such that the contraction force continues until the state before inflation, low permeability to liquids and gases, and suitable for medical use. It is preferable to use a material that passes the Japanese Pharmacopoeia's plastic container test for infusion fluids.

However, the conventional balloon 2 described above is made of polyisoprene latex that contains substances harmful to the human body, such as vulcanizing agents, reinforcing fillers, stabilizers, and anti-aging agents.
There is a possibility that the above-mentioned substances harmful to the human body used in the manufacture of balloons may leach into the drug solution from the balloon itself, and there is also a risk that the drug solution may be denatured and injected into the blood vessels. be.

Therefore, this invention solves the above-mentioned conventional problems, and has a continuous injection for drug solution injection that has a safe balloon that does not melt the substances harmful to the human body even if it comes into contact with the drug solution for a long time, and does not denature the drug solution. The purpose is to provide equipment.

Means for Solving the Problems In order to achieve the above object, this invention, as shown in FIG. and an inner layer made of silicone rubber that prevents substances harmful to the human body from being dissolved by chemical solutions.

Function As mentioned above, the balloon of this invention has the property that the outer layer has low permeability to liquids and gases, and the inner layer contains vulcanizing agents, reinforcing fillers, stabilizers, anti-aging agents, etc. that are harmful to the human body. Since the substance does not dissolve in the chemical solution and does not denature the drug solution, it compensates for conventional problems such as substances harmful to the human body leaching into the drug solution from the balloon itself even if it comes into contact with the drug solution for a long time. This allows for safer continuous infusion.

Example Figure 1 shows a balloon 2 showing an example of this invention.
0, and as is clear from the figure, the balloon 20 has a large elongation, low hysteresis and permanent deformation, a large modulus, and an outer layer 21 made of rubber with low permeability to liquids and gases. The outer layer 21 has a two-layer structure with an inner layer 22 made of rubber that prevents substances harmful to the human body from being dissolved by chemical solutions and that is difficult to denature.

The outer layer 21 has a thickness of about 0.1 mm, and the inner layer 22 has a thickness of about 0.5 mm.
The thickness is about mm. The inner layer 22 is made of silicone rubber, which prevents substances harmful to the human body from being dissolved by chemical solutions.

The outer layer 21 is made of a synthetic rubber such as butyl rubber that has low permeability to liquids and gases, a thermoplastic elastomer, or the like.

The balloon 20 of this embodiment is manufactured, for example, as follows.

A tube with an inner diameter of 7.0 mmφ, a length of 11 cm, and a thickness of 0.5 mm is made using a press using silicone rubber that has high elongation and low hysteresis and permanent deformation. After coating the outer surface of this silicone rubber tube with a thin layer of high-stretch RTV silicone rubber adhesive dissolved in a solvent, apply a thin solution of butyl rubber, which had been prepared by dissolving it in a solvent, in the same manner as above. Apply. Thereafter, by sufficiently air drying, the balloon 20 as described above is formed, in which a thin film of butyl rubber (outer layer 21) is adhered to the outer surface of the silicone tube (inner layer 22).

Effects of the device Since this device has the above-mentioned configuration, it goes without saying that the stored drug solution can permeate through the balloon.
Even if the balloon comes into contact with a medical solution for a long period of time, substances harmful to the human body can be completely prevented from leaching into the medical solution from the balloon itself, making it possible to continuously inject the medical solution in an extremely safe manner.

[Brief explanation of drawings]

FIG. 1 is an enlarged sectional view of a balloon showing an embodiment of this invention, and FIG. 2 is a schematic diagram showing an example of a conventionally known continuous infusion device for injecting a drug solution. 1... Outer tube, 2... Balloon, 3... Stopper, 5
...Medical solution spout, 6...Medical solution administration tube, 12
...Medical solution injection tube, 13...Medical solution filling port, 1
4... Capacity indicator, 16... End cap, 2
0...Balloon, 21...Outer layer, 22...Inner layer.

Claims (1)

[Utility Model Claims] A continuous infusion device for injecting a medical solution comprising a balloon which causes the filled medical solution to flow out of an outlet by the force of its contraction, a medical solution injection tube attached to the outlet of the balloon, and an opening/closing clamp attached to the tube for opening and closing the medical solution flow path within the tube, wherein when the medical solution flow path within the tube is opened by the opening/closing clamp, the balloon contracts, and the medical solution filled within the balloon can be continuously injected into a blood vessel in small amounts through the tube by the force of the balloon's contraction, wherein the balloon has a two-layer structure consisting of an outer layer made of synthetic rubber or thermoplastic elastomer such as butyl rubber which has low permeability to liquids and gases, and an inner layer made of silicone rubber which does not dissolve substances harmful to the human body in the medical solution.