JPH0211159A - Baloon infuser - Google Patents

Abstract

PURPOSE:To surely prevent the leak of a chemical, a mixture muddiness and the mixture of bacteria, etc., into the chemical by connecting a chemical outflow tube having a cock body for injecting a chemical and a flow rate control part into a branched route to be seal-housed with a housing and to communicate to a chemical inflow part and a chemical outflow part. CONSTITUTION:A cylindrical outer shaft 1, an inner shaft 2 inside the outer shaft 1 and a baloon A provided outside both shafts are covered in a sealed condition with a housing 6. To one edge of the outer shaft 1, a connecting part 40 composed of the liquid inflow part and chemical outflow part and a branched route 42 are connected, the branched route 42 is composed of a chemical inflow route 43 and a chemical outflow route 44, a cock body 45 for injection and a chemical outflow tube 41 are provided, respectively, and a clamp 47 and a flow rate control part 48 are provided to the tube 41. By such a structure, even when the baloon A is broken, the chemical is prevented from leaking outside. Since a flow route switching part is not provided, the muddiness of the chemical and the mixture of the bacteria into the chemical can be prevented. Since the injection is executed through the cock body 45, the leak of the chemical is not executed.

Description

DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to a balloon infuser used to continuously inject a predetermined amount of a medicinal solution into a blood vessel, bladder, etc. little by little. More specifically, it is important to ensure that the chemical solution does not leak outside, not only during normal operation, but also in the unlikely event that the balloon ruptures, and also to ensure that the drug solution does not become cloudy or that bacteria or other substances enter the drug solution. Regarding the balloon infuser that can be used.

[Prior Art] Traditionally, as a means of injecting small amounts of medicinal solutions such as antibiotics and anticancer drugs into blood vessels, bladders, etc., the medicinal solution is injected into a balloon made of an elastic material and the contraction force of the balloon is used. A continuous drug injector with a balloon for continuously injecting a drug into a blood vessel or the like over a relatively long period of time has been proposed (for example, Japanese Patent Laid-Open No. 11465/1983). The continuous drug injector with a balloon described in the publication has a configuration as shown in FIG. is filled into the balloon (15B) through the inlet hole (154) formed in the tubular body (153).

In this case, the end of the intravascular indwelling device (157) may be closed with your hand to prevent the outflow of the drug solution, or the flow control valve (158) may be closed with your hand.
) is maximized. The predetermined amount is in the balloon (
56) The medical liquid filled in the inside is transferred to the outflow hole (159) and the medical liquid spouting part (160) by the contraction force of the balloon (15B).
is injected into the blood vessel via the intravascular indwelling device (157). It is described that such a continuous drug infusion device with a balloon has a simpler structure and is easier to handle than the infusion pumps and the like that were used before this device.

However, this device is configured so that the flow rate of the medicinal solution is adjusted by the cross-sectional area of the outflow hole (159), the throttling rate of the flow control valve (15g), the line resistance of the connected vascular catheter, etc. Therefore, there is a problem in that it is difficult to finely adjust the flow rate. Further, the balloon (15B) is arranged in the radial direction ((Y) in FIG. 9) of the tubular body (153).
Since it deforms only in the direction shown by , there is a problem that a considerable amount of the medicinal liquid remains in the tubular body (153) without being injected into the body.

In order to solve the above problems, the applicant first adopted a pipe with micro holes formed on the side for the flow rate control section, and the pipe is expandable not only in the radial direction but also in the axial direction. proposed a balloon infuser with such a balloon portion (Japanese Patent Application No. 1982-204791). This thing has a cylindrical outer shaft (31) as shown in FIGS.
, an inner shaft (32) slidably housed inside the outer shaft (31), and an inner shaft (32) provided outside the shafts so as to cover both shafts, one end of which is attached to the outer shaft (31). Closely fixed,
a balloon part (a) consisting of a balloon (33) made of an elastic material whose other end is closely fixed to the inner ring (32); and one end of the outer shaft (31) where the inner ring (32) is placed inside. a stopcock part (b) connected to the opposite end of the stopcock part, having a chemical liquid inlet and a chemical liquid outlet, and capable of switching the flow path of the chemical liquid when the chemical liquid flows in or flows out; a flow rate control unit (c) having a closed pipe (51) at a downstream end with at least one microhole (52) formed in the side thereof; A drug injection tube (d) made of soft synthetic resin, and a part of the shunt adapter connected to the tip of the tube (d).
e), characterized in that a synthetic resin filter (50) is provided at an appropriate position between the chemical solution outflow part of the stopcock part and the pipe of the flow rate control part.

According to this balloon infuser, as mentioned above,
By forming micro holes on the side of the pipe and dispensing the chemical liquid through the micro holes, the flow rate accuracy can be significantly improved. A balloon is closely fixed to each of the freely inserted inner rings so that the balloon can expand not only in the radial direction but also in the axial direction, and when the balloon is deflated, the inner shaft is guided by the outer ring, Since the balloon completely returns to its original state, it is possible to significantly reduce the amount of residual drug, which is an effect not found in the prior art.

However, even with the above-mentioned excellent effects of the balloon infuser, there are problems such as the balloon not being stored in a sealed container, which causes the chemical solution to scatter when the balloon bursts, and the three-way stopcock. Since the stopcock is used to inject and dispense the chemical solution into the balloon, there are problems such as a slight leakage of the liquid, the chemical solution becoming cloudy at the stopcock, and the possibility that bacteria may leak from the stopcock. There was a problem that substances such as these could get into the chemical solution.

In view of the above circumstances, it is an object of the present invention to provide a balloon infuser in which the problems of the balloon infuser previously proposed by the present applicant are solved at once. That is, an object of the present invention is to provide a balloon infuser that can reliably prevent leakage, turbidity, and contamination of the medicinal solution with bacteria and the like.

[Means for Solving the Problems] The balloon infuser of the present invention includes a cylindrical outer shaft, an inner shaft slidably housed within the outer shaft, and a shaft that covers both wheels of the shaft. a balloon made of an elastic material provided externally, one end of which is closely fixed to the outer ring, and the other end of which is closely fixed to the inner shaft; and one end of the outer shaft opposite to the side where the inner shaft is installed. A balloon part comprising a chemical liquid inlet and a chemical liquid outlet connected to ends; a housing that houses the balloon part and has the chemical liquid inlet and the chemical liquid outlet fixed to one end surface thereof; and the medical liquid inlet. One route of the branch path is provided with a drug solution injection stopper into which a drug solution injection needle can be pierced, and the other route is connected to the flow of the drug solution. It is characterized in that it is connected to a chemical liquid outflow tube having an IN and m control section for controlling the .

[Example] Next, the balloon infuser of the present invention will be explained based on the drawings.

FIG. 1 is a plan view of an embodiment of the balloon infuser of the present invention, FIG. 2 is an enlarged sectional view showing the balloon portion of the balloon infuser shown in FIG. 1 when filled with a medical solution, and FIG. Figure 3 is an enlarged sectional view of the flow control section of the balloon infuser shown in Figure 1, and Figure 4 is the (
It is a sectional view taken along the line X)-(X).

In FIGS. 1, 2, and 3, (+) indicates a balloon infuser according to an embodiment of the present invention, which includes a balloon portion (A), a housing, a branch path, a chemical solution outflow tube, and a connector. It is made up of. below,
Each part will be explained in detail.

The balloon part (^) is a part filled with a medicinal solution and a driving part that moves the medicinal solution to the injection site of the human body. An inner ring (2) that is lined inside, a balloon (3) provided on the outside of both wheels, and one end of the outer shaft (1) that is opposite to the side that is lined with the inner sleeve (2). It consists of a chemical liquid inlet and a chemical liquid outlet connected to the end of the tube. The outer shaft (1) and the inner shaft (21) are made of synthetic resin such as polycarbonate, polyethylene, polypropylene, etc., and the balloon (3) is made of silicone rubber, butyl rubber, nitrile butadiene rubber, poly-1,4-butadiene, It is made of an elastic material such as polyisoprene, polyurethane, butadiene styrene copolymer, etc. The balloon (3) has a cylindrical shape and has an outer shaft (1) and an inner ring (
'2J is provided on the outside of both shafts, one end of which is attached to the outer shaft (1), and the other end is attached to the inner ring by sealing means such as an O-ring (5) or a metal spiral stopper. It is tightly fixed. The O-ring (5)
is an annular groove (4) formed in the outer ring (1) and the inner shaft (2).
) is included. As mentioned above, the inside of the outer ring (1) is the part on which the inner shaft ('2J) slides, and also serves as a flow path when the medicinal solution filled in the balloon (3) gradually flows out to the flow rate control section to be described later. It is a part.

Therefore, the gap between the inner surface of the outer ring (1) and the outer surface of the inner ring (2) is 0.5 to 3 ff! It is preferable to provide a clearance of about +1. The balloon (3) can be of various sizes and wall thicknesses depending on the amount of drug solution injected into the patient, the injection time, etc., and is not particularly limited in the present invention, but the approximate values are shown below. Then, the outer diameter is 2~301111, and the wall thickness is 0.1~2.0m.
m, and the length is 3 to 30 cm. balloon(
3) has a structure that can expand not only in the radial direction but also in the longitudinal direction (outer shaft (1) or inner ring ('2J axial direction)) by filling it with a chemical solution.
) moves in and out of the outer shaft (1),
Since the relationship between the position and the amount of the chemical solution remaining in the balloon (3) is constant, the amount of the chemical solution flowing out can also be checked by providing a scale on the inner ring (2).

The housing (6) prevents the balloon (3) from being damaged by contact with sharp objects on the outside, and also prevents chemical liquid from leaking from the balloon due to defects such as pinholes in the balloon itself. This part functions to seal the chemical solution to prevent it from scattering. Housing (6)
is preferably made of synthetic resin such as polyvinyl chloride, polypropylene, or polycarbonate. /% The shape of the housing (6) is not particularly limited in the present invention, and any suitable shape such as a cylindrical shape or a square pipe shape may be adopted, and in short, it must have a shape that can be stored so as to cover the balloon (3) after inflation. Good to have. The filling (6) is preferably made of a transparent material so that the injection status of the chemical solution can be visually observed from the outside. Further, the dimensions of the housing (61) are selected in accordance with the dimensions of the balloon [3] when it is inflated. In the example shown in Figure 2, there is a clearance between the inner surface of the housing (6) and the balloon (3), but this is not particularly necessary; rather, from the standpoint of miniaturization, the balloon (3) It is better to select the inner diameter of the housing (6) to such an extent that it contacts the inner surface of the housing (6).

The housing (6) is intended to cover the balloon part (A) in a sealed state so that the chemical solution does not leak outside even if the balloon (3) is damaged, but if the inside is made completely airtight,
As the medicinal solution is injected into the balloon (3), the air inside is compressed and the pressure increases, causing the inconvenience that the medicinal solution cannot be injected beyond a certain level. Therefore, it is preferable to form an air vent opening at an appropriate location in the housing (6) and provide a hydrophobic filter in the opening that allows air to pass through but not the chemical solution. 1st
In the embodiment shown in Figures ~2, the housing (6)
An opening ('7) is formed in one end face of the filter, and a hydrophobic filter (8) is provided to cover this opening (7). The material of the hydrophobic filter (8) is such that even if the balloon (3) is damaged, the chemical solution inside the balloon (3) will not leak out of the housing (6), and the chemical solution will not be injected into the balloon (3). Balloon when going (3)
It is preferable to use polyester, Teflon, etc. in consideration of the fact that the air inside the housing (6) is expelled as the housing (6) expands.

A chemical solution inlet and a chemical solution outlet (hereinafter referred to as the connection section) (40) are connected to one end of the outer shaft (1) opposite to the side where the inner shaft (2) is installed. There is. This connecting portion (40) is a passage for the medical solution to flow into the balloon or for the medical solution to flow out from the balloon. Connection part (
40) is provided with a branch passage (
42) is connected. In the present embodiment, this branching path (42) is formed of a Y-shaped tube, one end of which is fixed to the connecting portion (40) in an overturned manner. It consists of a pipe, and its end is connected to a connecting part (40
) may be fixed. The branch path (42) consists of a chemical liquid inflow route (43) and a chemical liquid outflow route (44), and includes, for example, polyolefin, polyvinyl chloride,
It may be made of polycarbonate or the like.

A drug solution injection stopper (45) is provided at the tip of the drug solution inflow route (43), which allows the drug solution to be injected into the balloon (3) using a syringe or the like (not shown).

The injection side end surface of the stopper (45) is connected to the stopper (45) after the drug solution is injected.
5) It is preferable to form the container in a concave shape as shown in FIG. 2 so that the chemical solution attached to the surface does not come into contact with hands or the like. The drug solution injection stopper (45) may be made of a rubber-like elastic material such as silicone rubber, and by doing so, it has puncture resistance (remains liquid-tight even if the drug solution injection needle is pierced many times, and the internal It is possible to use a stopper with excellent properties to prevent chemical liquid from leaking. In this embodiment, the drug solution injection stopper (45) is fixed to the drug solution inflow route (43) with adhesive, but the drug solution injection stopper (45) and the drug solution inflow route (43) are integrally molded. It may be fixed by other methods.

On the other hand, a chemical liquid outflow tube (41) is connected to the tip of the chemical liquid outflow route (44).
has a clamp (47) that can stop the flow of the chemical solution at any position on the tube (41) and a flow rate control section (48) to be described later.

The flow rate control unit (48) is a part that controls the flow rate of the chemical solution, and the flow rate is controlled by providing a pipe having at least one micropore in the flow path of the chemical solution and making all the chemical solution pass through the micropore. Control takes place.

As the pipe with micropores, a pipe with a closed downstream end, which was adopted in the balloon infuser proposed earlier by the present applicant, may be used, or other perforated pipes such as a porous glass pipe may be used. Good too. In addition, the first
The embodiment shown in the figure employs a porous glass pipe.

First, the case of using a pipe whose downstream end is closed will be described based on FIGS. 7 and 8. The drug solution flows into the drug solution outflow tube through the micropores. The pore diameter of the micropores can be selected appropriately depending on the type and flow rate of the chemical solution.
In the present invention, the thickness is not particularly limited, but is approximately 20 to 100 microns. Depending on the flow rate of the chemical solution, it may be possible to accurately control the flow rate by forming only one micropore, but it is important to consider the need for accurate control of the flow rate, especially when using highly viscous chemical solutions. In this case, it is preferable to form a plurality of holes as small as possible for boat fishing.

When such a pipe is used, it is necessary to provide a filter made of synthetic resin such as nylon on the upstream side of the flow rate control section (48). As the filter, a membrane filter such as a mesh filter, a filter made of woven fabric, a non-woven fabric, etc. can be suitably used, but it is also possible to use a layered filter made of a sintered body such as polypropylene. . The pore size of the filter is determined in consideration of the relationship with the pore size of the micropores formed in the pipe of the flow rate control section (48). That is,
The filter is provided to prevent the micropores formed in the pipe from becoming clogged with foreign matter in the chemical solution, which prevents the prescribed flow rate from flowing or, in the worst case, from stopping the chemical solution from flowing at all. When considering this point of view, the pore size of the filter needs to be smaller than the pore size of the micropores of the pipe. Specifically, when the pore diameter of the micropores of the pipe is 60 microns, the average pore diameter of the filter is preferably 50 microns or less. Note that it is preferable to use stainless steel as the pipe in which the micropores are formed from the viewpoints of chemical resistance, workability, non-toxicity, etc. However, it is preferable to use a pipe made of stainless steel as long as it has the above-mentioned characteristics. A pipe may be used, and synthetic resin such as polycarbonate, polypropylene, ABS resin, etc. may also be used.

Next, as a pipe with micro holes, the pipes shown in Figs. 1 and 3 are
The case where a porous glass pipe is used as shown in the figure will be explained. Porous glass pipe 01) is made by forming borosilicate glass into a pipe using a normal method, for example.
After phase-separating the glass by heat treatment at a temperature of about 600℃,
Manufactured by acid treatment, this pipe is heat resistant and chemical resistant, and has uniform pores, with many pores on the sides with a pore diameter of about 0.1 to 3.0 microns. It's a pipe. The length and inner diameter of the pipe may be appropriately set depending on the intended flow rate and viscosity of the chemical solution, and are not particularly limited in the present invention, but are approximately 2 to 20 mm and 0.5 to 5 fflff, respectively.
l is the standard, 5-15 [11111 and 1-3I
Preferably it is I1m. Also, the thickness of the pipe is 0.5
~5 mm is preferred.

When using such a porous glass vibrator, there is an advantage that the accuracy of flow rate control can be further improved compared to when using a stainless steel pipe having micropores as described above. That is, when drilling microscopic holes in a pipe, the lower limit of the hole diameter that can be drilled is about 15 microns, and therefore there is a limit to the number of holes that can be drilled. Therefore, if the filter is used for a long time, some of the micropores may become clogged with dirt between the filter and the micropores, making the flow rate unstable. On the other hand, when a porous glass pipe is used, since many holes are formed on the side of the pipe, even slight clogging will not cause the flow rate to become unstable.

When using a pipe with microscopic pores such as a porous glass vibrator, if air bubbles are present in the chemical solution, the so-called air block phenomenon (air may be drawn into the microscopic pores due to the surface tension of the chemical solution filling the microscopic pores). In order to prevent this phenomenon, porous glass vibrators etc. are used to prevent this phenomenon. It is preferable to provide an air vent Oz having a hydrophobic filter for air venting upstream of the air vent Oz.

Next, one embodiment of the air vent section 02) will be described based on FIGS. 3 and 4. In the embodiment shown in FIG. 3, the air vent part (121 is constituted by a short cylindrical space, and one side of the short cylinder (the side shown in FIG. 3)
is provided with an air vent filter U made of a hydrophobic filter. However, in order to make the drawings easier to understand, the filter 03 is drawn transparent in FIGS. 3 and 4.

04) is a plate-shaped baffle plate, which is provided in the air vent part 0'2J so as to be in contact with the filter 03) and the bottom surface 4 of the flow rate control part (48) constituting the short cylindrical space.
(See Figure 4). Since the chemical liquid advances in an S-shape as shown by the arrow in Figure 3, the chemical liquid directly hits the porous glass vibrator 0.
1) can be prevented. While the chemical liquid moves in an S-shape, the air bubbles O (see FIG. 4) contained in the chemical liquid are discharged to the outside through the air vent filter. The distance (Ω) between the air vent filter n and the bottom surface of the flow rate control unit is preferably as narrow as possible to ensure that even small air bubbles come into contact with the filter color, specifically 0.05 to 1.0 a+m. is preferable, and particularly preferably from 0.1 to 0.51. Note that the arrangement of the baffle plate 04) may be such that the chemical solution does not easily reach the porous glass vibrator 01).
It is not limited to what is shown in FIG.

Further, the shape of the filter Oa and the shape of the air vent Oa are not limited to those of this embodiment, and may be appropriately selected.

The porous glass vibe (Ill and the chemical solution outflow tube are connected and fixed by a fixing member 07).

In this embodiment, a liquid chemical outflow tube (41) made of a soft synthetic resin such as soft polyvinyl chloride, polypropylene, or polyester is connected to the balloon side and the human body side of the flow rate control section (48). The inner diameter, wall thickness, and length of the tube (41) may be appropriately selected in consideration of the amount of chemical solution and usage mode.

The tip of the chemical solution outflow tube (41) has a luer taper.
A connecting device (3) is provided, and an intravenous needle, a PSv set, etc. are connected through the connection page head. The connector (2) may be equipped with a check valve (not shown) to prevent the medical solution from flowing back due to venous pressure or the like.

Next, a method of using the balloon infuser of the present invention will be explained.

The drug solution is injected by inserting the injection needle (not shown) of the syringe into the drug solution injection stopper (45).

At that time, clamp (4
As the balloon (3) is filled with the chemical solution, which must be kept in a stopped state, the balloon (3) expands in both the radial and axial directions. When a predetermined amount of the drug solution has been filled, the injection needle is removed from the drug solution injection stopper (6).

After that, connect the P
After connecting to an Sv set, a balloon catheter, etc., and performing predetermined operations such as air bleeding, a medicinal solution is injected into the patient's body.

FIG. 5 is a diagram showing the flow rate characteristics of a balloon infuser according to an embodiment of the present invention, and shows the results of filling a balloon with 40 ml of physiological saline and measuring the relationship between injection time and injection amount. ing. In FIG. 5, O mark indicates a balloon infuser according to an embodiment of the present invention (average pore diameter in the flow rate control section is 0.22 microns, outer diameter is 3.0a+α).
, using a porous glass pipe with an inner diameter of 2.0IIIn).
Balloon infuser proposed in No. 240159 (
The flow rate characteristics of a stainless steel pipe with an outer diameter of 0.9 sa+ and an inner diameter of 0.6 mm, in which one fine hole with a diameter of 60 microns was formed in the flow rate control section, are shown. In the measurement example shown in FIG. 5, the flow rate accuracy of the balloon infuser of the present invention is approximately -1.5% (39.5-40.0/40.
OX 100), while that of the previously proposed balloon infuser is approximately -10% (36,0-4
0,0/40. OX 100), and the balloon infuser of the present invention has a stable drug solution dispensing pace.
In other words, it can be seen that the better the amount of liquid medicine dispensed, the higher the quality.

The balloon infuser of the present invention is lightweight and easy to handle, so depending on the location where the drug is injected, the patient can put the housing in his pocket and walk while injecting the drug, giving the patient greater freedom of movement. is improved.

[Effects of the Invention] As explained above, the balloon infuser of the present invention can provide the following effects.

■The housing that covers the balloon is a sealed type, so
Even if the balloon is damaged, the medicinal solution is prevented from leaking to the outside.

■Since there is no flow switching part such as a three-way stopcock, it is possible to prevent the chemical solution from becoming turbid and to prevent bacteria from entering the chemical solution from the flow path switching part.

■Since the drug solution is injected through the drug solution injection stopper, there is no leakage of the drug solution, and even if the drug solution adheres to the surface of the stopper after the drug solution is injected, the stopper will not pierce the stopper. By locating the passageway in a recessed position where it cannot be exposed directly to the outside, it is possible to prevent the chemical solution from coming into contact with hands, etc.

■When using a porous glass pipe for the flow rate control section, there is less possibility of the flow rate becoming unstable due to clogging than when using a pipe with micro holes, which further improves flow rate accuracy. can be done.

[Brief explanation of the drawing]

FIG. 1 is a plan view of an embodiment of the balloon infuser of the present invention, FIG. 2 is an enlarged sectional view showing the balloon portion of the balloon infuser shown in FIG. 1 when filled with a medical solution, and FIG. Figure 3 is an enlarged sectional view of the flow control section of the balloon infuser shown in Figure 1, and Figure 4 is the (
X)-(X) line schematic cross-sectional view, FIG. 5 is a diagram showing the flow rate characteristics of a balloon infuser according to an embodiment of the present invention, and FIG. A plan view of the embodiment, FIG. 7 is an enlarged cross-sectional view of the flow control section of the balloon infuser shown in FIG. 6, and FIG. 8 is an enlarged view of the tip of the pipe of the flow control section of the balloon infuser shown in FIG. 7. , FIG. 9 is a longitudinal sectional view of a conventional balloon infuser. (Main symbols in the drawing) (I): Balloon inflator user (A): Balloon part (1): Outer shaft (2): Inner shaft (3): Balloon (6): Housing (42): Branch path (45) : Chemical liquid injection stopper (47) : Clamp (48) : Flow control department Applicant: Nilasho Co., Ltd. Figure 3

Claims (1)

[Scope of Claims] 1. A cylindrical outer shaft, an inner shaft slidably housed inside the outer shaft, and an inner shaft provided outside the shafts so as to cover both shafts, one end of which is outside the shaft. A balloon made of an elastic material that is tightly fixed to the shaft and whose other end is tightly fixed to the inner shaft; and a chemical liquid inflow connected to one end of the outer shaft that is opposite to the side where the inner shaft is installed. a housing configured to accommodate the balloon part and have the chemical solution inlet and the chemical solution outlet fixed to one end surface thereof, and a housing that is in communication with the chemical solution inlet and the drug solution outlet. One route of the branch path is provided with a drug solution injection stopper into which a drug solution injection needle can be inserted, and the other route has a flow rate control unit for controlling the flow of the drug solution. A balloon infuser characterized by being connected to a chemical liquid outflow tube. 2. The balloon infuser according to claim 1, wherein the flow rate control section comprises a pipe having at least one micropore. 3. The balloon infuser according to claim 2, wherein the pipe is a porous glass pipe. 4. The balloon infuser according to claim 1, 2 or 3, wherein a hydrophobic filter is attached to an appropriate wall surface of the housing. 5. The balloon infuser according to claim 1, 2, 3, or 4, wherein an air vent section having an air vent filter made of a hydrophobic filter is formed upstream of the flow rate control section.