JPH0687898B2 - Balloon infusor - Google Patents

Description

TECHNICAL FIELD The present invention relates to a balloon infusor used for continuously injecting a predetermined amount of drug solution little by little into a blood vessel, a bladder or the like. More specifically, the present invention relates to a balloon infusor capable of accurately adjusting the flow rate of a drug solution over a wide range and reducing the amount of the drug solution remaining in the balloon portion.

[Conventional technology]

Conventionally, as a means for injecting a minute amount of a drug solution such as an antibiotic or an anti-cancer agent into a blood vessel, bladder, etc., a drug solution is injected into a balloon made of an elastic material, and the contraction force of the balloon is used to provide a relatively long drug solution. A continuous drug injector with a balloon that continuously injects into a blood vessel or the like over time has been proposed (for example, JP-A-62-11465). The continuous drug infusion device with a balloon described in this publication has a structure as shown in FIG. 8, and a liquid drug injected from a liquid medicine injection part (152) provided with a check valve (151). Fills the balloon (156) through the inflow hole (154) formed in the tubular body (153). In this case, the end of the intravascular indwelling device (157) should be manually closed or the flow control valve (1
58) is narrowed down to the maximum. The drug solution filled in the balloon (156) in a predetermined amount is introduced into the blood vessel by the contraction force of the balloon (156) through the outflow hole (159), the drug solution outlet (160) and the intravascular indwelling device (157). Injected. It is described that such a continuous drug infusion device with a balloon has a simpler structure and is easier to handle than an infusion pump or the like used before the device.

[Problems to be Solved by the Invention]

However, this is due to the cross-sectional area of the outflow hole (159),
Since the flow rate of the drug solution is adjusted by the throttling ratio of the flow rate control valve (158) and the conduit resistance of the blood vessel catheter to be connected, it is difficult to finely adjust the flow rate. is there. Furthermore, since the balloon (156) is deformed only in the radial direction of the tubular body (153) (the direction indicated by (Y) in FIG. 8), the inside of the tubular body (153) remains without being injected with a considerable amount of drug solution. There is a problem that it will remain in.

The present invention has been made in view of the above circumstances, and an object thereof is to provide a balloon infusor in which the drawbacks of the conventional example are eliminated. That is, an object of the present invention is to provide a balloon infusor capable of finely adjusting the flow rate of a chemical solution and reducing the amount of the residual chemical solution.

[Means for Solving the Problems]

The balloon infusor of the present invention is provided with a cylindrical outer shaft, an inner shaft slidably mounted inside the outer shaft, and an outer shaft of the both shafts so as to cover these shafts. A balloon made of an elastic material, which is tightly fixed to the outer shaft and the other end is tightly fixed to the inner shaft, and a chemical solution which is one end of the outer shaft and is connected to the end opposite to the side where the inner shaft is installed. A balloon part comprising an inflow part and a drug solution outflow part, a housing in which the balloon part is accommodated, and the drug solution inflow part and the drug solution outflow part are fixed to one end surface thereof, an inner diameter of 10 to 500 microns, and a length of It is characterized by a flow control unit consisting of a pipe of 1 to 3000 mm.

〔Example〕

Next, the balloon infusor of the present invention will be described with reference to the drawings.

FIG. 1 is a plan view of an embodiment of the balloon infusor of the present invention, and FIG. 2 is an enlarged cross-sectional view showing the balloon portion of the balloon infusor shown in FIG. FIG. 3, FIG. 4 and FIG. 6 are plan views of other embodiments of the balloon infusor of the present invention.

In FIGS. 1 and 2, (I) is a balloon infusor according to an embodiment of the present invention, which includes a balloon part (A), a housing, a branch passage, a drug solution outflow tube, a flow rate control part and a connector. It consists of and. Hereinafter, each part will be described in detail.

The balloon portion (A) is a portion that is filled with the liquid medicine and is a drive portion that moves the liquid medicine to the injection site of the human body, and is slidable in the cylindrical outer shaft (1) and the outer shaft (1). An inner shaft (2) internally mounted, a balloon (3) provided outside both of these shafts, and one end of the outer shaft (1) on which the inner shaft (2) is mounted. It is composed of a chemical solution inflow section and a chemical solution outflow section which are connected to opposite ends. The outer shaft (1) and the inner shaft (2) are made of polycarbonate,
The balloon (3) is made of synthetic resin such as polyethylene and polypropylene, and the balloon (3) is an elastic material such as silicone rubber, butyl rubber, nitrile butadiene rubber, poly-1,4-butadiene, polyisoprene, polyurethane and butadiene styrene copolymer. It is made in. The balloon (3) has a cylindrical shape, and is provided outside of both the outer shaft (1) and the inner shaft (2) so as to cover the outer shaft (1) and the outer shaft (1), and one end of the balloon (3) The other end is airtightly fixed to the inner shaft by a sealing means such as an O-ring (5) or a metal spiral stopper. The O-ring (5)
Are fitted in annular grooves (4) formed in the outer shaft (1) and the inner shaft (2). The inside of the outer shaft (1) is a portion where the inner shaft (2) slides as described above, and also serves as a flow path when the drug solution filled in the balloon (3) gradually flows out to a flow rate control unit described later. That is the part. Therefore, it is preferable to provide a clearance of about 0.5 mm to 3 mm between the inner surface of the outer shaft (1) and the outer surface of the inner shaft (2). The balloon (3) may have various sizes and wall thicknesses depending on the amount of drug solution to be injected into the patient, the time of injection, etc., and is not particularly limited in the present invention, but shows a general value. Then, the outer diameter is 2 to 30 mm, the wall thickness is 0.1 to 2.0 mm, and the length is 3 to 30 cm. The balloon (3) has a structure capable of expanding in the radial direction as well as in the longitudinal direction (axial direction of the outer shaft (1) or the inner shaft (2)) by being filled with the liquid medicine. Inner shaft (2)
Moves in and out of the outer shaft (1) along with the movement of the balloon (3), and the relationship between the position and the amount of the drug solution remaining in the balloon (3) is constant, so the inner shaft ( It is also possible to confirm the outflow amount of the chemical liquid by providing a scale in 2).

The housing (6) prevents the balloon (3) from being damaged by touching an external sharp object, and when the balloon leaks due to a defect such as a pinhole of the balloon itself, the chemical liquid is exposed to the outside. This is the part that functions to seal the drug solution so that the water does not scatter. Housing (6)
Is preferably made of a synthetic resin such as polyvinyl chloride, polypropylene or polycarbonate. The shape of the housing (6) is not particularly limited in the present invention, and an appropriate shape such as a cylindrical shape or a square pipe shape may be adopted, as long as it is a shape that can be stored so as to cover the balloon (3) after inflation. Good. The housing (6) is preferably made of a transparent material so that the injection situation of the drug solution can be visually observed from the outside. The size of the housing (6) is selected according to the size of the balloon (3) when inflated. In the example shown in FIG. 2, there is a clearance between the inner surface of the housing (6) and the balloon (3), but this is not particularly necessary and rather the balloon (3) is smaller in terms of downsizing. It is better to select the inner diameter of the housing (6) so that it contacts the inner surface of the housing (6).

The housing (6) covers the balloon portion (A) in a sealed state so that the chemical liquid does not leak to the outside even if the balloon (3) is damaged, but when the inside is completely airtight,
As the liquid medicine is injected into the balloon (3), the internal air is compressed and the pressure becomes high, and the liquid medicine cannot be injected to a certain extent or more. Therefore, it is preferable to form an air vent opening at an appropriate location of the housing (6) and to provide a hydrophobic filter that allows air to pass therethrough but does not allow the chemical solution to pass therethrough. First
In the embodiment shown in FIGS. 2 to 2, the housing (6)
An opening (7) is formed on one end face of the, and a hydrophobic filter (8) is provided so as to cover the opening (7). As the material of the hydrophobic filter (8), even if the balloon (3) is damaged, the drug solution in the balloon (3) does not leak out of the housing (6), and the drug solution is injected into the balloon (3). It is preferable to use polyester, Teflon, or the like in consideration of the fact that the air in the housing (6) is expelled as the balloon (3) expands during the process.

A chemical liquid inflow part and a chemical liquid outflow part (hereinafter referred to as a connection part) (10) are connected to one end of the outer shaft (1), which is opposite to the side where the inner shaft (2) is installed. There is. The connection part (10) is a part that serves as a passage for inflow of the drug solution into the balloon or outflow of the drug solution from the balloon. Connection part (1
At the end of the housing (6) opposite to the housing (6), the branch passage (1
2) is connected. In the present embodiment, the branch passage (12) is composed of a Y-shaped tube, and one end of the branch passage (12) is covered and fixed to the connecting portion (12).
May be constituted by a V-shaped tube, and its end may be fixed to the connecting part (10). The branching device (12) comprises a chemical solution inflow route (13) and a chemical solution outflow route (14), and may be made of, for example, polyolefin, polyvinyl chloride, polycarbonate or the like.

At the tip of the drug solution inflow route (13), there is provided a drug solution injection plug (15) capable of injecting the drug solution into the balloon (3) using a syringe or the like (not shown).

The injection-side end surface of the stopper body (15) has a stopper body (15) after the chemical solution is injected.
It is preferable to form a concave shape as shown in FIG. 2 so that the chemical solution adhering to the surface does not come into contact with a hand or the like. The chemical solution injection plug (15) may be made of a rubber-like elastic body such as silicon rubber, and by doing so, puncture resistance (liquid tightness is maintained even when the chemical solution injection needle is pierced many times,
It is possible to obtain a plug excellent in the property that the internal chemical liquid does not leak). In the present embodiment, the chemical solution injection plug (15) is fixed to the chemical solution inflow route (13) with an adhesive, but the chemical solution injection plug (15) and the chemical solution inflow route (1
3) and may be fixed by another method of integrally molding.

On the other hand, a drug solution outflow tube (11) is connected to the tip of the drug solution outflow route (14), and this tube (11) can stop the flow of the drug solution at any position of the tube (11) at any time. It has a clamp (17) and a flow rate control unit (18) described later.

The flow rate control section (18) is a section for controlling the flow rate of the chemical liquid,
In this embodiment, the pipe is made of a linear ultrafine pipe. The pipe may be made of metal such as stainless steel, ceramics, or synthetic resin such as polyolefin, polyvinyl chloride, polyester, and the like, and the inner diameter is 10 to 500 microns and the length is 1 to 3000 mm. If the inner diameter of the pipe is less than 10 microns, the flow of the chemical solution tends to stop due to the inclusion of air in the chemical solution, while if it exceeds 500 microns, it tends to be difficult to control the flow rate of the chemical solution.

Further, if the length of the pipe is less than 1 mm, it tends to be difficult to control the amount of the chemical liquid, and if it exceeds 3000 mm, the device tends to be too large.

Considering the above, it is particularly preferable that the inner diameter of the pipe is 50 to 200 μm and the length of the pipe is 10 to 500 mm.

(11) is a chemical solution outflow tube made of a soft synthetic resin such as soft polyvinyl chloride, polypropylene, polyester, etc. The inside diameter, wall thickness and length of this tube (11) are appropriately determined in consideration of the quantity of the chemical solution and the usage mode. You can select it.

A luer taper connector (19) is provided at the tip of the chemical liquid outflow tube (11), and the connector (19) is provided.
A venous needle or PSV set is connected via. The connector (19) may be equipped with a check valve (not shown) to prevent the drug solution from flowing back due to venous pressure or the like.

FIG. 3 is a plan view of another embodiment of the balloon infusor of the present invention. In the embodiment shown in the drawing, a clamp (17) is provided at an arbitrary position of a tube (21). (29) is a connector for connecting an injection needle or the like. Note that, in FIGS. 3 to 6, the same reference numerals as those in FIGS. 1 and 2 represent the same elements.

FIG. 4 shows still another embodiment of the balloon infusor of the present invention, in which the balloon portion is omitted. The portion shown in FIG. 4 is used in combination with the balloon portion whose cross section is shown in FIG. 5, and in use, the injection needle (23) is fixed to the housing, and the chemical liquid injection stopper (25) is used. To pierce. Reference numeral (22) is an injection needle side end portion that can be fitted or screwed into the connection portion (20) formed in the housing (6). (31) is a chemical solution outflow tube,
(17) shows a clamp that can stop the flow of the drug solution, and (29) shows a connector such as an injection needle for injecting the drug solution into the human body.

FIG. 6 shows an embodiment of a balloon infusor which employs an elastic pipe having a crimped structure in place of the ultrafine pipe extending in the longitudinal direction. The crimped structure is
As shown in FIG. 6, it means a spring-like or spiral-like shape, which is capable of expanding and contracting to some extent in the axial direction. By housing the pipe (40) having such a structure in the casing (41), the flow rate control unit can be downsized.

Although the balloon infusor of the present invention has been described above based on various embodiments, the balloon infusor of the present invention may have various embodiments other than the above-described embodiments. For example, without using a stopper for injecting a drug solution, a connection part formed in a housing is connected to a three-way cock to which a drug solution outflow tube having a flow rate control part and a clamp is connected, and a syringe is connected from one of the cocks. It is also possible to inject the drug solution into the balloon using such as, and switch the cock after injection to inject the drug solution to the human body side, or to prevent clogging of the pipe upstream of the ultrafine pipe. The filter may be provided.

Next, a method of using the balloon infusor of the present invention will be described based on the embodiment shown in FIG.

The liquid medicine is injected, for example, by inserting an injection needle (not shown) of a syringe into the liquid medicine injection plug (15). At that time, it is necessary to keep the clamp (17) in a stopped state so that the drug solution does not flow out to the human body side. As the drug solution is filled, the balloon (3) expands not only in the radial direction but also in the axial direction. When the prescribed amount of the drug solution is filled, the injection needle is pulled out from the drug solution injection plug (6).

After that, PS via the connection tool depending on the actual chemical solution injection point
It is connected to a V-set, a balloon catheter, etc., and after performing a predetermined operation such as air bleeding, the drug solution is injected into the patient's body.

FIG. 7 is a diagram showing the flow rate characteristic of the balloon infusor shown in FIG. 1, in which 50 ml of physiological saline (concentration: 0.9%
The results of measuring the relationship between the injection time and the injection amount by filling the balloon with NaCl) are shown. In FIG. 7, the circles represent the flow characteristics of the balloon infusor that uses an ultra-fine stainless pipe (outer diameter: 0.3 mm, inner diameter: 0.1 mm, length: 230 mm).

From FIG. 7, it can be seen that the balloon infusor of the present invention has a stable drug solution dispensing pace, that is, a linearity in which the drug solution dispensing amount is good.

Since the balloon infusor of the present invention is lightweight and easy to handle, it is possible for a patient to put a housing in a pocket and walk while injecting a drug solution depending on the drug solution injecting position, and the patient can move freely. Is improved.

〔The invention's effect〕

As described above, according to the balloon infusor of the present invention, the following effects can be obtained.

Since the chemical liquid is poured out through an extremely fine pipe, the flow rate accuracy can be remarkably improved.

The outer shaft and the inner shaft slidably inserted into the outer shaft are closely fixed to the balloons so that the balloons can be expanded not only in the radial direction but also in the axial direction.
The inner shaft is guided by the outer shaft when the balloon is deflated,
Since the balloon returns to the original state completely, the residual amount of the drug solution can be extremely reduced.

When injecting a drug solution through the drug solution injection stopper,
There is no leakage of the chemical solution, and even if the chemical solution adheres to the surface of the stopper body after injection of the chemical solution, by placing the piercing surface of the stopper body in a recessed position that does not appear directly outside. , It is possible to prevent the chemical solution from touching the hands.

[Brief description of drawings]

FIG. 1 is a plan view of an embodiment of the balloon infusor of the present invention, and FIG. 2 is an enlarged cross-sectional view showing the balloon portion of the balloon infusor shown in FIG. 3, 4, and 6 are plan views of another embodiment of the balloon infusor of the present invention, and FIG. 5 is a sectional view of the balloon portion used in combination with the embodiment shown in FIG. FIG. 7 is a diagram showing a flow rate characteristic of the balloon infusor shown in FIG. 1, and FIG. 8 is a longitudinal sectional view of a conventional balloon infusor. (Main symbols in the drawing) (I): Balloon infusor (A): Balloon part (1): Outer shaft (2): Inner shaft (3): Balloon (6): Housing (12): Branch path (15) : Plug for injection of chemical liquid (17): Clamp (18): Flow controller

Claims (2)

[Claims] 1. A cylindrical outer shaft, an inner shaft slidably mounted in the outer shaft, and an outer shaft provided so as to cover both of these shafts, one end of which is the outer shaft. A balloon made of an elastic material, which is tightly fixed and the other end of which is tightly fixed to the inner shaft, and a chemical liquid inflow portion connected to one end of the outer shaft, the end being opposite to the side where the inner shaft is installed, and A balloon part consisting of a chemical solution outflow part, a housing in which the balloon part is accommodated, and the chemical solution inflow part and the chemical solution outflow part are fixed to one end surface thereof, an inner diameter of 10 to 500 microns, and a length of 1 to 3000 mm A balloon infusor, comprising: 2. The balloon infusor according to claim 1, wherein the pipe of the flow rate control unit has a crimped structure.