JPH0467873A - Balloon infuser - Google Patents

Abstract

PURPOSE:To extremely reduce clearance between an inner shaft and an outer shaft only considering the slidability of both shafts and to remarkably reduce a residual flow rate in a balloon by providing a drug solution in/outflow port on the foot port of the inner shaft, injecting and bleeding drug solution from the drug solution in/ outflow port from the drug solution in/outflow port. CONSTITUTION:The injection of the drug is performed by inserting the injection needle of a syringe, etc., to a drug solution input/output part 13, and piercing the injection needle through a cock 14 for drug injection. The balloon 3 is swollen in not only a radial direction but an axial direction as packaging the drug solution. At this time, inside air remaining in the balloon 3 is discharged to the outside passing through a hydraulic pressure-tight filter 8. Also, the outer shaft outer-packaged closely on the inner shaft 1 is slided in a longitudinal direction simultaneously with the expansion of the balloon 3, and is moved along the inside plane of a housing. When the packaging of prescribed quantity of drug solution is completed, the injection needle is extracted from the cock 41 for drug injection. When the packaging of the drug solution is completed, a shade member 15 is closely aligned with the inner plane of the terminal part of the housing B, and bending when the balloon 3 is swollen and burst due to vibration can be prevented from the occurring.

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, epidural, subcutaneous, bladder, etc. little by little. More specifically, the present invention relates to a balloon infuser that can minimize the amount of liquid remaining in the balloon and effectively utilize the chemical liquid without wasting it.

[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. Balloon infusers are used to continuously inject medicinal solutions into blood vessels over a relatively long period of time. and,
The present applicant has proposed a balloon infuser that has been improved and improved from the viewpoint of preventing the leakage of the chemical liquid and also preventing the contamination of bacteria etc. Publication No.).

The balloon inflator described in the publication is the fourth
~ As shown in Figure 5, the flow rate system is equipped with a balloon part (ω), an I\Using <b) that accommodates the balloon part (a), a chemical injection needle (■), and a vibrator (31) having micro holes. It consists of a control section (c).

Specifically, as shown in FIG. 5, the balloon portion (a) includes a cylindrical outer shaft (32), an inner shaft (33) slidably housed within the nuclear outer shaft (32), A balloon (34) made of an elastic material is provided on the outside of both shafts to cover both shafts, one end of which is closely fixed to the outer ring, and the other end of which is tightly fixed to the inner shaft; and one end of the outer shaft. It consists of a drug solution injection stopper (35) mounted inside the end opposite to the side where the inner shaft is installed.

When using the syringe, first insert the needle of the syringe into the drug solution injection stopper (35) and inject the drug into the balloon (34), and when the predetermined amount of drug solution is filled, insert the syringe needle into the drug solution injection stopper (35). Remove it from the stopper (35). Next, insert the chemical liquid injection needle ■ of the flow rate control unit (c) into the chemical liquid injection stopper (35).
The drug is inserted into the patient's body, and after predetermined operations such as air bleeding are performed, the medicinal solution is injected into the patient's body.

[Problems to be Solved by the Invention] According to the balloon infuser described in the above-mentioned publication, the use of a sealed housing prevents the leakage of chemical liquid even if the balloon is damaged. Although it can produce excellent effects, the chemical solution is made to flow out from one end of the outer shaft, and the inside of the outer shaft serves as a movement space for the inner shaft and also serves as a flow path for the chemical solution, so the inner surface of the outer ring and the outer surface of the inner shaft A certain amount of clearance is required between the balloon and the outer shaft, so even if the balloon is completely deflated, a certain amount of the chemical solution inevitably remains inside the outer shaft. If the drug solution is expensive, such as morphine hydrochloride or an anticancer drug, this large amount of residual solution is a big economic problem. Therefore, it has been desired to reduce the amount of liquid remaining in the balloon as much as possible.

SUMMARY OF THE INVENTION In view of the above circumstances, it is an object of the present invention to provide a balloon infuser that eliminates the drawbacks of the prior art. That is, an object of the present invention is to provide a balloon infuser that can significantly reduce the amount of liquid remaining in the balloon.

[Means for Solving the Problems] The balloon infuser of the present invention comprises: (a) a rod-shaped inner shaft, a cylindrical outer shaft slidably mounted on the inner shaft, and one end of the inner shaft; An inner bearing is formed integrally with the inner shaft at the end opposite to the side where the outer shaft is sheathed, and an inner bearing is provided on the outside of both the shafts so as to cover the inner shaft and the outer shaft, and the lower end thereof is connected to the inner ring. a balloon made of an elastic material, the other end of which is tightly fixed to the outer shaft;
) a substantially cylindrical housing that accommodates the balloon part and has a chemical solution inlet/outlet at one end; (c) a drug solution outlet connected to the drug solution inlet/outlet and having a flow rate control part for controlling the amount of the drug solution; and at least one on the inner bearing.
It is characterized in that a chemical solution inlet is formed, and the drug solution inlet and the drug solution inlet/outlet are in communication with each other.

[Example] Hereinafter, the balloon infuser of the present invention will be described in detail based on the accompanying drawings.

FIG. 1 is an explanatory diagram of one embodiment of the balloon infuser of the present invention, showing a state in which the drug solution injection needle is not actually used as the drug solution injection stopper, and FIG. 2 is an illustration of the balloon infuser shown in FIG. 1. FIG. 3 is an enlarged sectional view showing the balloon portion of the infuser when it is filled with a medical solution, and FIG. 3 is a perspective view of the inner shaft and inner bearing of the balloon infuser shown in FIG. 1.

In FIG. 1, (I) is a balloon infuser according to an embodiment of the present invention, which is composed of a balloon part (5), a housing (Bl), and a chemical liquid outflow part (c). , 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,
A rod-shaped inner shaft (1), a cylindrical outer shaft (2) slidably mounted on the inner shaft (1), a balloon (3) provided on the outside of both of these shafts, and an inner ring (1). ) and an integrally formed inner bearing (4). An umbrella-shaped member (5) is fixed to one end of the outer shaft (2), which is opposite to the side covered by the inner shaft (1). This umbrella-shaped member (
5) can also be formed integrally with the outer shaft (2).

The inside of the outer shaft (2) is a portion on which the inner shaft (1) slides, but it does not need to function as a flow path for the chemical solution as in the conventional example described above. Therefore, the clearance between the inner shaft (1) and the outer shaft (2) should be as small as possible, for example 0.05 to 0.
．． It is preferable to set it to about 51. The inner shaft (1) and the outer shaft (2) are made of synthetic resin such as polycarbonate, polyethylene, or polypropylene. Also balloons (
3) can be made of elastic materials such as silicone rubber, butyl rubber, nitrile butadiene rubber, poly-1,4-butadiene, polyisoprene, polyurethane, butadiene-styrene copolymer, but the applicant has (Japanese Patent Application No. 2-103510), a multilayer structure based on a tubular body made of natural rubber and having the inner surface of the hollow part of the tubular body covered with a silicone resin film layer may be adopted.

The balloon (3) has a cylindrical shape and is provided outside the inner shaft (1) and outer shaft (2) so as to cover both shafts, and one end thereof is attached to the inner shaft (1) and The other end is the outer shaft (
2) is airtightly and tightly fixed by a sealing means (6) such as an O-ring. The balloon (3) can be of various sizes and 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.

The balloon (3) has a structure that can be expanded not only in the radial direction but also in the longitudinal direction (in the axial direction of the inner shaft (1) or the outer shaft (2)) by filling it with a medical solution. The outer shaft (2) moves in the axial direction along with the movement of the balloon (3) using the inner shaft (1) as a guide, and the relationship between its position and the amount of drug solution remaining in the balloon (3) is constant. Therefore, by providing a scale on the inner shaft (1) or the housing (B), it is also possible to check the amount of outflow of the chemical solution.

A water pressure filter (8) is provided at one end of the outer shaft (2), which is opposite to the side covered by the inner shaft (1). This water pressure filter (8) is a member that plays the role of expelling air remaining in the balloon (3) to the outside when a chemical solution is injected, and can be made of polyester, fluororesin, or a laminate of these. can.

The water pressure filter (8) preferably has a structure that allows ethylene oxide gas to pass therethrough in order to sterilize the inside of the balloon (3). Furthermore, when the filling of the chemical liquid is completed, the internal pressure of the balloon rises to about 600 to 1000m100O, so the water pressure resistance of the water pressure filter (8) is at least 1.
Must be 5kg4.

An inner bearing (4) is formed integrally with the inner shaft (1) at one end of the inner shaft (1) opposite to the side where the outer shaft is sheathed (Fig. 3). reference). The inner bearing (4) is a short cylindrical member, and a chemical solution inlet 1 (9) is formed at its end on the inner shaft (1) side. In the present invention, the shape and number of the chemical liquid (first-stream inlet/outlet) (9) are not particularly limited, and are determined depending on the flowability of the chemical liquid and the inner bearing (9).
It may be selected appropriately taking into consideration the strength of 4). The chemical liquid inlet/outlet (9) communicates with a chemical liquid inlet/outlet of a housing (Bl, which will be described later), through the inside of the inner bearing (4).

The housing +8) prevents the balloon (3) from being damaged by contact with sharp objects on the outside, and also prevents chemical liquid from leaking to the outside in the event that liquid leaks from the balloon due to a defect such as a pinhole in the balloon itself. This part functions to seal the chemical solution to prevent it from scattering. Housing [Bl
is preferably made of a synthetic resin such as polyvinyl chloride, polypropylene, polycarbonate, or 8BS.

In the present invention, the shape of the housing (Bl) is not particularly limited and may be any suitable shape such as a cylindrical shape or a square pipe shape. However, as in this embodiment, the end opposite to the chemical solution inlet/outlet is attached to the outer shaft ('2J umbrella-shaped member (5)).
) If the diameter is reduced so that the taper has approximately the same angle as the taper of the balloon, the umbrella-shaped member (5) and the inner surface of the nozzing will fit tightly together when the drug solution is filled, preventing the balloon from bending when inflated. This has the effect of preventing bursts caused by vibration. It is preferable that the housing (Bl) is made of a transparent material so that the injection status of the chemical solution can be visually observed from the outside.The dimensions of the housing (B) are the same as the dimensions of the balloon (3) when it is inflated. are selected accordingly.

The housing (Bl) seals between the balloon parts to prevent the chemical from leaking outside even if the balloon (3) is damaged, but if the inside is completely airtight, the balloon (3) As the chemical solution is injected into the housing B), the air inside is compressed and the pressure increases, causing the inconvenience that the chemical solution cannot be injected beyond a certain point.For this reason, air vent openings are provided at appropriate locations in the housing B). It is preferable that a hydrophobic filter is provided in the opening to allow air to pass through but not to allow the chemical solution to pass through. 1st to 2nd
In the embodiment shown in the figure, an opening ℃ is formed in one end surface of the housing (B), and this opening ℃)
A hydrophobic filter (Ill) is provided to cover the housing (B).The material of the hydrophobic filter (old hydrophobic filter) is such that even if the balloon (3) is damaged, the chemical solution inside the balloon (3) will leak out of the housing (B). Polyester, Teflon, etc. are used in consideration of the fact that the air inside the housing B) will be expelled as the balloon (3) expands when the chemical solution is injected into the balloon (3). is preferred.

One end surface of the housing [B] is closed by a cap 0z, and the central part of the cap 02) is used for injecting a medical solution into a balloon (3) or injecting a medical solution from the balloon (3) into a predetermined location. It is formed at the medicinal solution inlet/output part which becomes the medicinal solution flow path.

The inside of the liquid inlet/outlet part n is made of a rubber-like elastic material such as silicone rubber, and has puncture resistance (remains liquid-tight even if the liquid injection needle is pierced many times, and prevents the internal liquid from leaking). A chemical solution injection stopper 04) having excellent properties (characteristics) is inserted airtightly and liquid-tightly. The drug solution injection stopper (14) in the embodiment shown in FIGS. 1 and 2 has a head, and is fixed by engaging with the protrusion aθ formed on the cap a'2J. It looks like this. The drug solution injection stopper 04) may be fixed using an adhesive.

07) is a short cylindrical plug fixing cap. A threaded portion Oa is formed on the outer periphery of the end of the stopper fixing cap O'7) for connecting a chemical liquid outflow portion to be described later.

The drug solution outflow part (c) is the part that sends the drug solution poured out from the balloon (3) to devices such as the PSv set and balloon catheter, and is connected to the tube 09 and the flow control part ■, and if necessary, the connector of the mini clamp. It is composed of n, etc.

In this embodiment, a drug solution injection needle is attached to one end of the drug solution outlet part (c1), and by inserting this drug solution injection needle n into the drug solution injection stopper 04, the balloon (3)
The chemical solution that has been filled in advance is guided to the flow rate control section (■).

The housing (Bl) and the drug solution outlet (c) can be connected by simply inserting the drug solution injection needle into the drug solution injection stopper (14). It is preferable to screw the connector and the stopper fixing cap 07'I together using a connector with a section formed therein, from the viewpoint of ensuring a reliable connection. It is also possible to use other connection methods such as.

The flow rate control unit (■) is a part that controls the flow rate of the chemical liquid, and the present applicant previously proposed it in Japanese Patent Application Laid-Open No. 1-135356 (Japanese Patent Application No. 1983-1989).
294809), 1) a pipe whose downstream end is closed and has at least one microscopic hole, 2) a pipe with holes such as a porous glass vibrator, etc. can be used.

A liquid chemical injection tube a9 made of a soft synthetic resin such as soft polyvinyl chloride, polypropylene, or polyester is connected to the human body side of the flow control unit. The inner diameter, wall thickness, and length of the tube 09 may be appropriately selected in consideration of the amount of the chemical solution and the mode of use.

Providing a mini-clamp in the middle of the tube 09 has the advantage that injection of the drug solution can be easily stopped and restarted.

A luer tapered connector (24) is provided at the tip of the drug solution injection tube Og, and an intravenous needle, PS set, etc. is connected through the connector (24).
24 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.

Injection of the drug solution is performed by inserting a needle (not shown) of a syringe into the drug solution inlet and sticking the needle into the drug solution injection stopper 04). As the balloon (3) is filled with the medical solution, it expands in both the radial and axial directions. At this time, the internal air remaining in the balloon (3) is expelled to the outside through the water pressure filter (8). Additionally, as the balloon (3) expands, the outer shaft (2), which is tightly fitted to the inner shaft (1), slides in the longitudinal direction.
Proceed along the inner surface of the housing. When a predetermined amount of the drug solution is filled, the injection needle is removed from the drug solution injection stopper (14). When the filling of the chemical liquid is completed, the umbrella-shaped member (5) and the inner surface of the end of the housing fB) fit snugly, preventing the balloon (3) from bending when inflated and from bursting due to vibration.

Next, the drug solution injection needle of the drug solution outlet part fc) is inserted into the drug solution injection stopper (14). At this time, it is necessary to keep the mini clamp (211) in a stopped state so that the chemical solution does not flow out toward the tube η.

After that, connect to the PSv set, balloon catheter, etc. via the connector (24) depending on the actual drug injection location.
After performing predetermined operations such as air bleeding, the medicinal solution is injected into the patient's body.

[Effects of the Invention] As explained above, in the balloon infuser of the present invention, a chemical liquid inlet is provided at the root portion of the inner shaft, and the chemical liquid is injected and flows out from the medical liquid inlet. The clearance between the outer shaft and the outer shaft can be made extremely small by considering only the slidability of these two shafts. As a result, it is possible to achieve the effect that the amount of liquid remaining in the balloon can be significantly reduced compared to the conventional balloon inflator.

[Brief explanation of drawings]

FIG. 1 is an explanatory view of one embodiment of the balloon infuser of the present invention, showing a state in which a drug solution injection needle is not actually used as a drug solution injection plug, and FIG. 2 is an explanatory diagram of an embodiment of the balloon infuser of the present invention. An enlarged sectional view showing the balloon part of the fuser when it is filled with a chemical solution, Figure 3 is a perspective view of the inner shaft and inner bearing of the balloon infuser shown in Figure 1, and Figure 4 is a conventional view. FIG. 5 is an explanatory diagram of the balloon infuser shown in FIG. 4, and shows a state in which the drug solution injection needle is not actually used in the drug solution injection stopper. FIG. 5 is an explanatory diagram of the balloon infuser shown in FIG. FIG. 3 is an enlarged cross-sectional view showing the state when filled with . (Main symbols in the drawing) (I): Balloon inflator user (A): Balloon part B): Housing (c): Chemical solution outlet (1): Inner shaft (2): Outer shaft (3): Balloon (4) : Inner bearing [5): Umbrella-shaped member (8): Water-resistant filter (9): Chemical solution inlet al): Hydrophobic filter 02): To the cap: Chemical solution inlet/outlet part 04): Chemical solution injection stopper r): Stopper fixing cap U: Tube (2G dual flow control unit (2V: mini clamp n: drug injection needle (23: connector (2J, connection tool)

Claims (1)

[Scope of Claims] 1 (a) A rod-shaped inner shaft, a cylindrical outer shaft slidably sheathed on the inner shaft, and one end of the inner shaft opposite to the side on which the outer shaft is sheathed. an inner bearing formed integrally with the inner shaft at the end thereof, and an inner bearing provided outside the inner and outer shafts so as to cover the inner shaft and the outer shaft, one end of which is closely fixed to the inner shaft, and the other end of which is fixed to the outer shaft. (b) a substantially cylindrical housing that accommodates the balloon part and has a medical fluid inlet/outlet at one end; (c) a housing connected to the chemical fluid inlet/outlet; and a chemical solution outflow section having a flow rate control section for controlling the amount of the chemical solution, at least one drug solution outflow port is formed in the inner bearing, and the drug solution outflow port and the drug solution inlet/output section communicate with each other. A balloon infuser that is characterized by: 2. The balloon according to claim 1, wherein a drug solution injection stopper is provided in the drug solution inlet/outlet portion, and a drug solution injection needle is provided at one end of the drug solution outlet portion to be inserted into the drug solution injection stopper. Infuser. 3. The balloon infuser according to claim 1 or 2, wherein a water pressure filter is provided at one end of the outer shaft, which is opposite to the side covered by the inner shaft. 4. One end of the housing, the end opposite to the chemical solution inlet/outlet part, is tapered in diameter, and one end of the outer shaft, opposite to the side to be sheathed on the inner shaft. 4. The balloon infuser according to claim 1, wherein an umbrella-shaped member having a taper having substantially the same angle as the taper of the housing is formed on the housing. 5 Clearance between the inner surface of the outer shaft and the outer surface of the inner shaft is 0.05~
A balloon infuser according to claim 1, 2, 3 or 4, having a diameter in the range of 0.5 mm.