JPH03286776A - Liquid drug injecting implement - Google Patents

Abstract

PURPOSE:To prevent the back flow of blood into a catheter by providing a pressure regulating means which operates to increase the pressure in the internal cavity of a needle tube when this pressure drops. CONSTITUTION:An opening 15 communicating with the internal cavity 3 of a tubular body 2 is provided in this tubular body and an expanding body 16 is provided to cover this opening. A syringe contg. liquid drugs is connected to an aperture 51 at the base end. The liquid drugs are injected into an internal space 32 and are dosed to the desired section within a blood vein from the aperture at the front end of a catheter 35 when the needle tube plunging part 10 of a needle tube 7 is plunged into the elastic body 31 of a liquid drug injecting port 30 and the plunger of a syringe is pressed. A positive pressure is attained in a flow passage 14 at this time and the expanding body 16 is thereby expanded. The elastic body 31 is deformed from a dotted line to a solid line when the needle tube 7 is removed after the end of the injection of the liquid drug. Since the pressure in the internal space 32 drops, the pressure in the flow passage 14 drops simultaneously and the expanding body 16 contracts. The liquid drugs in the expanding body 16 flow into the flow passage 14 and the liquid drug of nearly the same amt. as the amt. thereof flows into the internal space 32.

Description

DETAILED DESCRIPTION OF THE INVENTION <Industrial Application Field> The present invention relates to a device for injecting a drug solution, and particularly to a drug solution injection device for injecting a drug solution into a subcutaneously implantable catheter assembly.

<Prior art> Chemotherapy by administering anticancer drugs is performed for unresectable malignant tumors, but systemic administration causes side effects, and there are significant restrictions on the dosage and duration of administration.
Therefore, it is difficult to obtain effective drug concentrations in tumor tissue.

Therefore, intra-arterial injection therapy (kinetic therapy) of anti-cancer drugs is being used as a method to compensate for these drawbacks of anti-cancer drug chemotherapy and to allow the drug to act at a high concentration locally on the tumor as much as possible.

In such dynamic therapy, for example, a catheter for drug injection is inserted into the femoral artery using an introducer, and the tip of the catheter is guided to the target site (tumor region) while confirming the position of the catheter under X-ray fluoroscopy. The anti-cancer drug is then injected into the target site through the lumen within the catheter.

According to this method, the drug solution is directly administered to the periphery of the artery leading to the tumor locality of the tumor-bearing organ, so there is an advantage that the therapeutic effect is large.

However, with this method, firstly, because the catheter is inserted percutaneously, there is a high risk of infection if the catheter is left in place for a long time.Secondly, the administration of drug solution to the tumor requires a long period of time. Although it is necessary to repeat the treatment over a period of time, the catheter must be inserted and removed every time the treatment is performed in order to prevent the above-mentioned infection, which has the drawback of placing a heavy burden on the patient.

Therefore, subcutaneously implantable catheter assemblies have been developed that can be used while being left in the body for a long period of time. This catheter assembly includes a main body, an internal space formed in the main body, a drug solution inlet and a flow path for drug solution outflow communicating with this space, and a rubber stopper attached to the drug solution inlet. The device includes a drug solution injection boat having a septum and a catheter in which a lumen for drug solution injection is formed, and the catheter is connected so that the lumen communicates with the flow path.

This subcutaneously implantable catheter assembly is indwelled with the tip of the catheter inserted into the feeding artery of the tumor-bearing organ to the target site, and the drug solution injection boat fixed to the subcutaneous tissue.

Injection of the drug solution is performed using a drug solution injection device having a configuration in which a needle tube (for example, an L-shaped needle) and a hub are connected to both ends of a tube for feeding the solution.

That is, the drug solution injection port of the drug solution injection boat is recognized by palpation from above the skin, and then the syringe containing the drug solution is connected to the proximal end of the hub, and the tip of the needle tube is punctured and penetrated into the septum of the drug solution injection port. Thereafter, the syringe is operated to inject the drug solution to the target site through the hub, tube, needle tube, drug solution injection boat, and the lumen of the catheter communicating therewith.

When the injection of the drug solution is finished, the needle tube is pulled out from the septum.

However, since the septum is an elastic body, when the needle tube is pulled out, the septum deforms and the volume of the internal space of the drug injection boat expands, creating negative pressure in the internal space, causing blood to flow into the lumen from the opening at the tip of the catheter. A phenomenon occurs in which the water flows backwards.

If such backflow of blood occurs, a thrombus may form within the lumen of the catheter, reducing the flow of the drug solution, and there is also a risk that the lumen may become clogged and occluded.

Therefore, in order to prevent such backflow of blood, when withdrawing the needle tube from the septum, the plunger of the syringe is pressed to create a positive pressure in the channel inside the drug injection device and the internal space of the drug injection boat. It was necessary to maintain it.

However, there is a drawback that it is complicated to press the plunger at the same time as the needle tube is pulled out.

Moreover, if such positive pressure is maintained, the moment the needle is removed, the drug solution leaks from the tip of the needle tube and adheres to the skin surface, but if the drug solution is an anticancer drug, ulcers may occur at the site of adhesion. There is.

<Problems to be Solved by the Invention> An object of the present invention is to provide a drug solution injection device that does not require complicated operations and can prevent blood from flowing back into the catheter without causing drug solution leakage. It is in.

Means for Solving the Problems> These objects are achieved by the following inventions (1) to (7).

(1) A pipe body, a hub connected to the proximal end side of the pipe body,
The drug solution injection device includes a needle tube connected to a distal end side of the tube body, and a flow path through which a drug solution flows is formed by the inner lumen of the hub, the inner lumen of the tube body, and the inner lumen of the needle tube. A liquid drug injection device characterized in that a pressure adjusting means is provided that operates to increase the pressure when the pressure in the inner cavity of the needle tube decreases.

(2) The drug solution injection device according to (1) above, wherein the pressure adjusting means is an expandable body that can be expanded and contracted and whose interior communicates with the flow path.

(3) The liquid drug injection device according to (1) above, wherein the pressure adjusting means is an opening communicating with the flow path and a gas permeable membrane installed to shield this opening.

(4) The drug solution injection device according to (1) above, wherein the pressure adjustment means is an opening communicating with the flow path and an elastic membrane installed to shield the opening.

(5) The drug solution injection device according to (1) above, wherein the pressure regulating means is a branch channel branched from the channel and a check valve installed in the branch channel.

(6) The liquid drug injection device according to any one of (1) to (5) above, wherein the needle tube is an L-shaped needle bent into an L-shape.

(7) The liquid drug injection device according to (6) above, which has a pair of wings that can be opened and closed at the proximal end of the needle tube.

<Operation> According to the chemical injection device having such a configuration, when the needle tube is pulled out from the elastic body (septum) of the chemical liquid injection boat, the elastic body deforms and the inside of the internal space and the needle tube communicating therewith are deformed. Although the pressure in the cavity decreases, the pressure is instantly increased by the pressure regulating means, and in particular, it is instantly returned to the original pressure, thereby preventing blood from flowing back into the lumen of the catheter placed in the blood vessel. be done.

Moreover, since the pressure within the flow path of the liquid medicine injection device does not exceed atmospheric pressure, the liquid medicine remaining in the flow path when the needle tube is pulled out will not leak out from the tip of the needle tube.

<Example> Hereinafter, the liquid drug injection device of the present invention will be described in detail based on a preferred example shown in the accompanying drawings.

FIGS. 1 to 4 are cross-sectional side views each showing an example of the structure of the liquid drug injection device of the present invention.

Hereinafter, the liquid drug injection devices 1a to 1d shown in these figures will be explained in order, but the explanation of common parts among the liquid drug injection devices 1a to 1d shown in each figure will be omitted.

As shown in FIG. 1, the drug solution injection device 1a includes a tube 2 for feeding a drug solution, and a hub 4 connected to the proximal end of the tube 2.
and a needle tube 7 connected to the distal end side of the tube body 2.

The tubular body 2 is preferably made of a flexible tube, and the diameter of the inner lumen 3 is about 3 to 10 mm, particularly about 0.
．． It is preferable to set it as about 5-5 mm.

The constituent materials of the tube body 2 include polyvinyl chloride, polyurethane, polyethylene, polypropylene, polyamide (nylon), ethylene-vinyl acetate copolymer (EVA),
Examples include various resins such as fluororesins, and various rubbers such as silicone rubber, butadiene rubber, and natural rubber.

A distal end portion of a hub 4 is fixed to the base end portion (right side in FIG. 1) of the tubular body 2.

This hub 4 is mainly used as a connector for attaching a syringe containing a medicinal solution and injecting the medicinal solution into the inner cavity 3 of the tube body 2. In order to easily and reliably attach the syringe, The inner cavity 5 on the proximal end side of the hub 4 has a Taber tube shape whose diameter increases toward the proximal end.

Further, a cap 6 is attached to the base end frontage 51 of the hub 40 to airtightly seal the frontage 51. This cap 6 is removed when injecting the drug solution.

The constituent materials of the hub 4 and cap 6 include polyvinyl chloride, polyethylene, polypropylene, polycarbonate, polyurethane, acrylic, ABS, EVA, and PT.
Examples include various resins such as FE and polyamide (nylon), and various rubbers such as silicone rubber, butadiene rubber, natural rubber, and inbrene rubber.

The needle tube 7 is preferably an L-shaped needle bent in an L-shape.

The needle tube 7 is composed of a bent portion 9, a needle tube base portion 8 on the proximal end side of the needle tube bordering the bent portion 9, and a needle tube puncture portion 10 on the needle tube distal end side bordering on the bent portion 9.

In the illustrated configuration example, the angle between the needle tube base 8 and the needle tube puncture section 10 is approximately 90 degrees.

In addition, the tip of the needle tube puncture section 10 is slightly bent toward the needle tube proximal end (right side in FIG. 1), so that the angle formed between the blade surface 11 at the tip of the needle tube puncture section and the needle tube base 8 is 90'. below,
In particular, it is set at about 80 to 90 degrees.

With such a configuration, the chemical liquid injection boat 30
Core ring (for puncturing the elastic body (septum) 31 of
This prevents septum perforation and scar formation.

In addition, as a constituent material of the needle tube 7, metals, such as stainless steel and titanium, are mentioned.

The needle tube base 8 has a covering part 1 that covers the outer periphery of the needle tube base 8.
2 is formed.

Further, a pair of wings 13 extending in the radial direction of the needle tube base 8 are integrally formed on the covering portion 12, preferably by integral molding.

This 1i13 and the covering part 12 are made of, for example, polyvinyl chloride, polyethylene, polypropylene, polyurethane,
Constructed of flexible material such as EVA, both wings 1
3 rotates to open and close. In FIG. 1, the blade 13 is shown in a closed state.

This wing 13 can be opened by pinching the wing 13 with your fingers in the closed state.
It is used to push the needle tube puncture section 10 downward in the figure to puncture the skin and the septum 31 of the subcutaneous drug injection boat. It is also used to fix the needle tube 7 by opening the wings 13 after puncturing and fixing the wings 13 to the skin with tape or the like.

When removing the needle tube puncture section 5 from the septum 31, 6. In the same way as described above, close the wings 13, pinch them with your fingers, and pull them upward in the figure.

In addition, in the present invention, the needle tube 7 is provided with a covering portion 12 and wings 13.
It may not be installed. Moreover, the usable needle tube is not limited to an L-shaped needle, but may be a straight tube shape.

The distal end portion of the tubular body 2 is fitted into the proximal end of the covering portion 12 that covers the needle tube base portion 8, and this fitting portion is preferably adhered with an adhesive.

As a result, the lumen 5 of the hub 4, the lumen 3 of the tubular body 2, and the lumen of the needle tube 7 communicate with each other, and the proximal end opening 51 of the hub 4 communicates with the lumen of the needle tube 7.
A flow path 14 for drug solution distribution is formed up to the opening at the tip.

Now, when the pressure in the inner cavity of the needle tube 7 (the pressure in the flow path 14) decreases, the chemical liquid injection device of the present invention is operated to increase this pressure and preferably return it to the original pressure. Pressure regulating means are provided. The configuration and operation of this pressure regulating means will be explained below.

As shown in FIG.
An opening 15 communicating with (the flow path 14) is formed.
Further, an expansion body 16 is airtightly installed around the outer periphery of the tube body 2 so as to cover the opening 15. Thereby, the inside of the expansion body 16 communicates with the inner cavity 3 of the tube body 2 via the opening 15.

The expansion body 16 expands and contracts in response to changes in its internal pressure. That is, when not in use, it is in a contracted state as shown by the dotted line in FIG. 1, and when in use (during drug injection), it is in an expanded state as shown by a solid line in the same figure.

Preferably, such an expansion body 16 is made of a rubber material such as silicone rubber or latex rubber, or a membrane such as polyurethane, soft polyvinyl chloride, or EVA.

The thickness of the membrane of the expansion body 16 is approximately 0.01 to 1 mm, particularly 0.03 to 0.0 mm, although it depends on its constituent material.
It is preferable to set it to about 8 mm.

A plurality of such expansion bodies 16 may be installed along the longitudinal direction of the tube body 2.

The difference in the internal volume of the expansion body 16 when it is inflated and when it is deflated is 0.0.
It is preferably about 5 to 2+aj, particularly about 0.1 to 1 mj.

The expansion body 16 can be attached by bonding a separate member (an annular or bag-shaped membrane member, etc.) with adhesive or by tightening it with thread, or by integrally molding it with the tube body 2 or by attaching it with two colors. Any method of maintaining the airtightness of the expansion body 16, such as molding, is possible.

To inject a medical solution using such a chemical injection device 1a, first remove the cap 6 from the hub 4, connect a syringe (not shown) containing a medical solution to the base end opening 51, and then 13, and puncture and penetrate the needle canal puncture part 10 of the needle tube 7 into the elastic body (septum) 31 of the drug solution injection boat 30 implanted subcutaneously, thereby inserting the inner lumen of the needle tube 7 and the inside of the drug solution injection boat 30. It communicates with the space 32. Note that the needle tube 7 is pushed in until its tip abuts against the bottom surface 32a.

In this state, when the plunger of the syringe is pressed, the drug solution in the syringe passes through the flow path 14 of the drug solution injection device 1a and flows from the tip of the needle tube 7 to the internal space 32 of the drug solution injection boat 30.
Furthermore, this chemical solution is injected into the chemical solution injection boat 3.
The lumen 34 of the liquid feeding tube 33 provided on the side of the liquid feeding tube 33 and the lumen 3 of the catheter 35 connected to this liquid feeding tube 33.
6, and is administered to the target site within the blood vessel through the tip opening (not shown) of the catheter 35 (see FIG. 5).

When the medicinal solution is injected in this way, the inside of the channel 14 of the medicinal solution injection device 1a is under positive pressure, so the medicinal solution also enters the inside of the expansion body 16, and the expansion body 16 is expanded. .

To remove the needle tube 7 from the elastic body 31 after injection of the drug solution, first remove the syringe from the hub 4 and attach the cap 6 to the proximal opening 51, or remove the needle tube with the syringe attached. 7 upward in the figure as shown in FIG.

At this time, the elastic body 3, which had the shape shown by the dotted line in FIG.
1 deforms into the shape shown by the solid line in the figure as the needle tube 7 is pulled out. Due to this deformation of the elastic body 31, the volume of the internal space 32 increases, and the pressure in the internal space 32 decreases.

Due to this pressure drop, the pressure in the flow path 14 that communicates with the internal space 32 through the opening at the tip of the needle tube 7 also drops at the same time, and the expansion body 16 contracts in response to this pressure drop, causing the medicinal solution in the expansion body 16 to decrease. It flows into the channel 14 through the opening 15 . Approximately the same amount of the chemical liquid that has flowed into the flow path 14 flows into the internal space 32 from the opening at the tip of the needle tube 7, and the pressure in the internal space 32 returns to its original pressure.

In this way, even if the pressure in the internal space 32 decreases due to the withdrawal of the needle tube 7, the expansion body 16 contracts in response to this, and the medicinal solution flows into the internal space 32, returning the original pressure. However, because of its excellent responsiveness, catheter 35
Blood is prevented from flowing back into the lumen 36 through the opening at the tip.

Furthermore, when the tip of the needle tube 7 is pulled out from the elastic body 31, the pressure inside the flow path 14 is about atmospheric pressure or lower, so that the chemical solution remaining in the flow path 14 is removed from the needle tube 7.
It does not leak from the tip opening and cause liquid blurring on the skin surface.

The drug solution injection device 1b shown in FIG. 2 has a different configuration of pressure adjustment means.

That is, an opening 17 communicating with the inner cavity 3 is formed in the outer circumferential portion of the tube body 3, and a gas permeable membrane 18 is further installed so as to cover this opening 17.

The gas permeable membrane 18 preferably has a property that allows gas to pass through but does not substantially allow liquid to pass through. , trade name: Fluorobor), hydrophobic porous membranes such as polypropylene nonwoven fabric, and the like.

The opening area of the opening 17 is set to a level that can obtain a sufficient amount of ventilation, and is approximately 0.1 to ioam, particularly 0.5 to ioam.
It is preferable to set it to about 3 am'.

Note that such openings 17 and gas permeable membrane 18,
It is not limited to the case where it is provided on the tube body 2, but may be provided at a position as shown in FIG. 3, that is, on the hub 4.

Further, the openings 17 and the gas permeable membrane 18 may be provided at multiple locations.

According to the chemical liquid injection device 1b, when the pressure in the internal space 32 of the chemical liquid injection boat 30 decreases as the needle tube 7 is withdrawn, the pressure in the channel 14 also decreases, and the pressure in the liquid chemical injection boat 30 decreases through the gas permeable membrane 18. outside air is introduced into the flow path 14, and approximately the same amount of chemical liquid as the introduced amount flows into the internal space 32 from the tip opening of the needle tube 7.
The internal space 32 returns to its original pressure.

Therefore, blood is prevented from flowing back into the lumen 36 from the opening at the distal end of the catheter 35.

Further, as described above, there is no leakage of liquid from the opening at the tip of the needle tube 7 when the needle tube 7 is pulled out.

Further, since the gas permeable membrane 18 is liquid-impermeable, the medicinal liquid in the channel 14 does not permeate the gas permeable membrane 18 and leak out during injection of the medicinal liquid or the like.

The drug solution injection device IC shown in FIG. 3 is further different in the configuration of the pressure adjustment means. That is, an opening 19 communicating with the inner cavity 5 is formed in the side of the hub 4, and further,
An elastic membrane 20 is installed to cover this frontage 19.

As a result, the elastic membrane 20
deforms into a concave or convex shape and operates to keep the pressure in the flow path 14 constant.

The opening area of the opening 19 is set to such an extent that a sufficient change in volume of the flow path 14 can be obtained, and is preferably about 0.05 to 20 cm, particularly about 0.1 to 1 cm.

Note that the opening 19 and the elastic membrane 20 are not limited to being provided on the hub 4, but may be provided on the tubular body 2 as shown in FIG.

Furthermore, the openings 19 and the elastic membrane 20 may be provided at multiple locations.

According to such a chemical injection device IC, when the pressure in the internal space 32 of the chemical liquid injection boat 30 decreases as the needle tube 7 is withdrawn, the pressure in the channel 14 also decreases, and the elastic membrane 20
is curved and deformed in a convex shape toward the inside of the hub 4, and the medicinal solution in the inner cavity 5 of the hub 4 flows out to the distal end side of the tube body 2, and approximately the same amount of medicinal solution flows from the distal opening of the needle tube 7 into the internal space. 32, and the internal space 32 returns to its original pressure.

Therefore, blood is prevented from flowing back into the lumen 36 from the opening at the distal end of the catheter 35.

Furthermore, when the needle tube 7 is removed, the elastic membrane 20 returns to its original shape, the inside of the flow path 14 becomes negative pressure, and outside air flows into the flow path 14 from the opening at the tip of the needle tube 7, so that Similarly, no liquid leakage occurs.

The chemical liquid injection device 1d shown in FIG. 4 is further different in the configuration of the pressure adjustment means. That is, the liquid drug injection device 1d
In this case, the proximal end of the tube body 2 and the distal end of the hub 4 are connected to the branch connector 2.
1.

This branch connector 21 has a branch flow path 22 branched from the flow path 14, and a check valve 23 that allows fluid to pass only in the direction of the arrow in FIG. 4 is installed in this branch flow path 22. There is.

Note that, unlike the illustration, the hub 4 itself may have a check valve that can introduce outside air into the inner cavity 5 thereof. In this case, a branch flow path similar to that described above is formed in the hub 4, and a check valve is provided in this branch flow path, or a check valve is provided in the inner cavity 5 of the hub 4 having a structure as shown in FIG. It is possible to use a valve equipped with a valve.

According to the chemical liquid injection device 1d, when the pressure in the internal space 32 of the chemical liquid injection boat 30 decreases as the needle tube 7 is withdrawn, the pressure in the flow path 14 also decreases, and the check valve 23 is brought into the open state. As a result, outside air is introduced into the flow path 14 from the branch flow path 22, and approximately the same amount of chemical liquid as the introduced amount flows into the internal space 32 from the tip opening of the needle tube 7, and the internal space 32 returns to its original pressure. Return.

Therefore, blood is prevented from flowing back into the lumen 36 from the opening at the distal end of the catheter 35.

Further, as described above, there is no leakage of liquid from the opening at the tip of the needle tube 7 when the needle tube 7 is pulled out.

Further, due to the action of the check valve 23, the chemical liquid in the flow path 14 does not leak out to the outside via the branch flow path 22 during injection of the chemical liquid.

Although the drug solution injection device of the present invention has been described above with reference to several configuration examples, the present invention is not limited thereto. However, a simple configuration in which the tube body 2 itself expands and contracts in response to pressure fluctuations within the flow path 14 may be used.

<Effects of the Invention> As described above, according to the drug solution injection device of the present invention, when the needle tube is pulled out from the elastic body of the drug solution injection boat, backflow of blood into the lumen of the catheter placed in the body is prevented. Moreover, in this case, there is no need for complicated operations such as pressing the plunger of a syringe to maintain positive pressure in the flow path as in the past.

Further, in the present invention, when the needle tube is removed, the medicinal solution does not leak out from the opening at the tip of the needle tube.

[Brief explanation of the drawing]

FIG. 1, FIG. 2, FIG. 3, and FIG. 4 are cross-sectional side views each showing a configuration example of the liquid drug injection device of the present invention. FIG. 5 is an enlarged cross-sectional side view showing the state when the needle tube of the drug solution injection device is pulled out from the septum of the drug solution injection boat. Explanation of symbols la, lb, lc, 1 d...Medicine injection device 2...
- Tube body 3...Inner lumen 4...Hub 5...Inner lumen 51...Proximal opening 6...Cap 7...Needle tube 8...Needle tube base 9...Bent part 10 ... Needle tube puncture section 1 ... Blade surface 2 ... Covering section 3 ... Wings 4 ... Channel 5 ... Opening 6 ... Expansion body 7 ... Opening 8 ... Gas Permeable membrane 9...Opening 0...Elastic body membrane L...Branch connector 2...Branch channel 3...Check valve O...Medical solution injection board...Elastic body (septum) 2 ...Internal space 2a...Bottom surface 3...Liquid pipe 4...Inner lumen 5...Catheter 36...Runotil

Claims (7)

[Claims] (1) A pipe body, a hub connected to the proximal end side of the pipe body,
The drug solution injection device includes a needle tube connected to a distal end side of the tube body, and a flow path through which a drug solution flows is formed by the inner lumen of the hub, the inner lumen of the tube body, and the inner lumen of the needle tube. A liquid drug injection device characterized in that a pressure adjusting means is provided that operates to increase the pressure when the pressure in the inner cavity of the needle tube decreases. (2) The drug solution injection device according to claim 1, wherein the pressure adjustment means is an expandable body that is expandable and contractible and whose interior communicates with the flow path. (3) The drug solution injection device according to claim 1, wherein the pressure adjustment means is an opening communicating with the flow path and a gas-permeable membrane installed to shield the opening. (4) The drug solution injection device according to claim 1, wherein the pressure adjustment means is an opening communicating with the flow path and an elastic membrane installed to cover the opening. (5) The drug solution injection device according to claim 1, wherein the pressure adjusting means is a branch channel branching from the channel and a check valve installed in the branch channel. (6) The liquid drug injection device according to any one of claims 1 to 5, wherein the needle tube is an L-shaped needle bent in an L-shape. (7) The liquid drug injection device according to claim 6, wherein the needle tube has a pair of wings that can be freely opened and closed at the proximal end thereof.