JP2568289B2 - Continuous drug infusion device with balloon - Google Patents

Description

Description: TECHNICAL FIELD The present invention relates to a continuous drug injector with a balloon used for injecting a drug solution into a balloon and injecting a predetermined amount of the drug solution into a human body within a predetermined time. .

[Background technology]

Conventionally, as a method of injecting a drug solution into a human body for a relatively long time, a syringe containing the drug solution is connected to an injection needle or a catheter, and the injector is operated manually, by a spring, or electrically to let the drug solution flow out, or by infusion. The drug solution was put in a bottle or easily, and the drug solution was flown out by natural dropping or electric operation.

When injecting a drug solution into the human body over a period of several minutes to several hours, a syringe or an infusion bottle as a drug solution source must be connected to the injection needle or the catheter only for that time, which is a problem for many patients and practitioners. It was inconvenient.

For example, in the case of manual continuous infusion, the patient and practitioner are restrained and fixed on the human body for a certain period of time, which causes great physical and psychological pain. Actually, 1-2
Minutes are said to be the limit. Even if electric power or a spring is used, it is necessary to secure a power source, install a syringe, etc., which limits the behavior of the patient.

In the case of continuous infusion of the drug solution by drip, a large amount of replenisher solution is put in as compared with the drug solution, and unnecessary liquid is put in even a patient who does not need the replenisher solution. The drip bottle or container must be installed higher than the patient, and the complicated and long conduit connecting the injection needle or the catheter and the drip bottle is required, so that the patient's body movement is restricted and The practitioner also had to properly inspect.

As a flow rate adjusting device for injecting a liquid medicine into a human body, there is one disclosed in Japanese Patent Publication No. 55-45799. This device adjusts the flow rate by inserting a spirally grooved core into a sleeve and sandwiching the sleeve with a ring from the outside. However, this device cannot continuously inject the liquid medicine for a long time.

In addition, as a continuous infusion device for medical liquids, US Pat.
Some are disclosed in No. 0. In this injector, a balloon containing a drug solution is inserted into a cylinder, and the contraction force of the balloon causes the drug solution to flow out of the balloon,
The inside of the cylinder shrinks in the axial direction. However, this injector has a drawback that the drug solution cannot be completely discharged from the balloon.

Therefore, in order to obtain a continuous drug injector having a simple structure and a high safety when the medical solution is continuously injected into the human body for a relatively long time, the applicant has previously described " Continuous drug infusion device with balloon "(Japanese Patent No. 138428
No. 90) was proposed.

The continuous drug infusion device with a balloon of this patent is provided with a tubular body having a drug solution flow channel formed along the longitudinal axis, and a drug solution injecting portion having a check valve is provided at one end of the tubular body, A chemical liquid outflow portion is provided at the other end of the main body, a member for blocking the chemical liquid flow path is provided in the middle of the tubular main body, and an inflow hole on the chemical liquid injection portion side is provided near the cutoff member and to the chemical liquid outflow portion side. Outflow holes or outflow holes with a fine porous film attached are formed through the tube wall of the tubular body, respectively.
The inflow hole and the outflow hole are surrounded by a balloon made of an elastic material, and the periphery of the balloon is fixed to the outer periphery of the tubular body in an airtight manner.

Further, the present applicant has previously disclosed a "medical solution continuous injector with a blood vessel balloon" (Japanese Patent Laid-Open No. 62-11465) in which an intravascular indwelling device is connected to the drug solution outflow portion of the injector of the above patent.

Furthermore, the Applicant has proposed a “continuous infusion catheter for medical fluid for urinary bladder” which has a simple structure, is easy to handle, and is highly safe when injecting the medical fluid into the human body for a relatively long period of time (Japanese Patent Application Laid-Open No. Sho 60-96).
No. 62-11464) was previously disclosed.

For this catheter, a conventional general catheter for bladder is used, a recess is provided in a part of the outer circumference of the proximal end side of the catheter, the recess is surrounded by a balloon made of an elastic material, and the peripheral edge of the balloon is Airtightly fixed to the outer circumference of the catheter, a thin tube is provided on the tube wall of the catheter along the longitudinal axis, and the proximal end side of the thin tube is opened to form a drug solution outlet. Is communicated with the recess, the chemical injection part is airtightly fixed to the central part of the balloon, a central passage is provided in the central part of the chemical injection part, and a valve is provided on the inlet side of the central passage and the outlet side. Is connected to the recess.

The above-mentioned injector or catheter is provided with pores or capillaries for controlling the outflow time of the drug solution. However, it is very difficult to actually form these pores or capillaries, and they may be easily clogged with fine dust or the like.

Therefore, the applicant has made it possible to relatively easily form a thin tube for controlling the outflow time of the chemical solution, and
A chemical liquid continuous infusion device with a balloon having a structure capable of preventing clogging of a thin tube was previously disclosed (PCT-JP-88-01055).

This chemical liquid continuous injector is provided with a tubular body having a chemical liquid flow path formed along the longitudinal axis, a chemical liquid injection part having a check valve at one end of the tubular body, and the other end of the tubular body. Is provided with a chemical solution outflow portion, and the other end of the tubular body is filled with a predetermined amount of a room temperature or thermosetting type fluid resin that does not have an adhesive ability to a particular material, and the fluid resin contains a predetermined material made of the particular material. A fine wire having a diameter is embedded in a linear shape, a spiral shape, or a meandering shape, one end of the fine wire material is penetrated into the tubular body, and the other end of the fine wire material is guided to the outside through the chemical solution outflow portion, A hole is formed through the tube wall of the tubular body, the hole is surrounded by a balloon made of an elastic material, and the peripheral edge of the balloon is fixed to the outer periphery of the tubular body in an airtight manner.

The thin wire may be pulled out of the tubular body to form pores in the fluid resin, and a human body indwelling device can be attached to the drug solution outflow portion.

However, in this continuous liquid injector, it is difficult to form stable pores because fine burrs are generated on the inner surface of the pores after the thin wire is pulled out.

[Disclosure of Invention]

Therefore, an object of the present invention is to provide a balloon-equipped drug solution continuous injector capable of variously changing the drug solution outflow time as necessary and having stable drug solution outflow pores.

The continuous drug injector according to the present invention is provided with a tubular body having a drug channel formed along the longitudinal axis, and a drug injector having a check valve or a one-way cock at one end of the tubular body, A chemical liquid outflow portion is provided at the other end of the tubular body, a chemical liquid outflow control portion is provided at the other end adjacent to the chemical liquid outflow portion, and a plurality of holes are formed through the tube wall of the tubular body to form an elastic material. The hole is surrounded by a balloon consisting of, and the peripheral edge of the balloon is fixed to the outer periphery of the tubular body in an airtight manner.

The chemical liquid outflow control unit has a structure in which a thin tube such as a resin tube having pores, a metal tube, or a ceramic tube is embedded in a synthetic resin, or a structure filled with a porous or permeation-diffusible material. .

The tube is preferably embedded in a synthetic resin in a linear shape, a meandering shape, or a spiral shape.

The chemical liquid outflow control unit is configured such that a fine wire is freely inserted into and removed from a fine tube such as a resin tube having a fine hole, a metal tube, or a ceramics tube, and these are embedded in a synthetic resin, or the fine hole is formed. The structure may be such that a thin tube such as a resin tube, a metal tube, or a ceramics tube that is included is inserted up to an intermediate portion of a small diameter tube and these are embedded in a synthetic resin.

[Brief description of drawings]

FIG. 1 is a vertical sectional view of a continuous drug injecting device of the present invention. FIG. 2 is a transverse sectional view taken along the line II-II in FIG. FIG. 3 is a cross-sectional view taken along the line III-III in FIG. FIG. 4 is a side view showing an example of a human body indwelling device connected to the liquid medicine continuous infusion device of the present invention. FIG. 5 is a partially enlarged vertical cross-sectional view showing various modifications of the chemical liquid outflow control unit of the chemical liquid continuous injector of the present invention. 6 and 7 are operation explanatory views of the continuous drug injecting device of the present invention. FIG. 8 is an explanatory view showing various usage examples of the continuous drug infusion device of the present invention.

[Best mode for carrying out the invention]

The basic structure of the continuous drug injector according to the present invention will be described with reference to FIGS. 1 to 3. The continuous drug infusion device of the present invention comprises a tubular body 1 and a balloon 2.

The tubular body 1 has a chemical liquid flow path 11 formed along the longitudinal axis. A chemical liquid injecting portion 12 is provided at one end (right end in the illustrated example) of the tubular body 1, and a chemical liquid outflow portion 13 is provided at the other end (left end in the illustrated example). The chemical liquid injection part 12 and the chemical liquid outflow part 13 may be integrally formed with the tubular body 1, but it is preferable to connect separate parts as shown in the figure in consideration of convenience of manufacturing and handling. The chemical injection part 12 is provided with a conventional check valve or one-way cock 121. The check valve or one-way cock 121 may have a function of allowing the injection of the chemical solution in the direction of the arrow 122 but not of the reverse flow thereof, or a function of opening / closing the flow path of the chemical solution.

In the middle of the tubular body 1, the drug solution flow passage is formed by penetrating the tube wall.
A plurality of holes 111 communicating with 11 are provided. Balloon 2 has hole 1
A peripheral edge 21 of the balloon 2 is fixed to the outer circumference of the tubular main body 1 in an airtight manner by surrounding 11. It is preferable that the balloon 2 is made of a material having a high elasticity and a wear resistance and a high toughness that are not easily damaged by an external action. In particular, a transparent or translucent material is preferable. As such a material, for example, commercially available silicone rubber or latex rubber is most suitable.

As shown in FIG. 1, the balloon 2 is in close contact with the outer periphery of the tubular body 1 in the normal state before injecting the drug solution, and at the peripheral edge as shown in FIG. 6 in the operation after injecting the drug solution. The remaining portion, apart from 21, expands away from the outer circumference of the tubular body 1.

The chemical liquid outflow control unit 3 is provided in the chemical liquid passage 11 inside the chemical liquid outflow unit 13. Various modifications of the chemical liquid outflow control unit 3 are shown in FIG. FIGS. 5 (A) to 5 (E) show a chemical liquid outflow control unit 3 in which a thin tube 31 such as a resin tube having pores, a metal tube, or a ceramic tube is embedded in a synthetic resin 32. Tube 31
May be embedded in the synthetic resin 32 in a linear shape (A), a meandering shape (B), or a spiral shape (C). Instead of the straight thin tube 31, the synthetic resin 32 may be perforated by a laser or the like.

(D) shows a structure in which a thin wire 34 is inserted in and out of the tube 31, and (E) shows a structure in which a tube 35 having a smaller diameter is inserted in the tube 31.

The figure (F) shows what constituted the chemical | medical solution outflow control part 3 which filled up the porous material 33 in the chemical | medical solution flow path 11. Activated carbon, pumice stone, resin particles, silicone gel, urethane gel or the like can be used as the porous or permeation diffusive material.

The pore length of the tube 31 or the porous or permeation-diffusible material 33 makes the pore volume an important factor that determines the outflow time of the drug solution.

Next, with reference to FIG. 6 and FIG. 7, an operation example of the chemical liquid continuous infusion device of the present invention will be described.

A predetermined amount of the liquid medicine is injected from the liquid medicine injection section 12 of the continuous liquid medicine injector. The drug solution flows into the balloon 2 through the drug solution flow passage 11 and the hole 111 of the tubular main body 1 and fills the balloon 2 while inflating the balloon 2. The drug solution filled in the balloon 2 does not flow back by the check valve or the one-way cock 121.

When it is necessary to prevent air from entering the balloon 2 or the drug solution flow path 11, the same kind of drug solution or physiological saline is injected into the flow path 11 in advance, or the drug solution injection part 12
When the balloon 2 is placed upright, the bubbles in the balloon 2 enter the liquid medicine flow path 11 through the plurality of holes 111 and the flow path 1
The bubbles in 1 will naturally gather near the injection part 12 as they are. Air can be easily exhausted by inserting an air vent tube (not shown) into the injection part 12.

After a predetermined amount of the drug solution has been injected, the cap 131 attached to the tip of the outflow portion 13 is removed, and a separately prepared human body indwelling device such as the injection needle 6 is attached (FIG. 7).

The chemical liquid filled in the balloon 2 is compressed by the contraction force of the balloon itself, so that the hole 111, the chemical liquid flow 11, the thin tube 31 having fine pores,
It flows into the injection needle 6 through the drug solution outlet 13.

Finally, if necessary, normal air bleeding is performed. In order to confirm bleeding, each element is preferably transparent or translucent.

The time for injecting the drug solution is determined by the injection amount and viscosity of the drug solution, the contraction characteristics of the balloon 2, the cross-sectional area and length of the pores, the internal pressure of the injection site, and the like. Actually, it suffices to actually measure whether or not each standard continuous drug injecting device is a standard drug solution.

FIG. 4 shows a typical example of a human body indwelling device connected to the liquid medicine outflow portion 13 of the liquid medicine continuous injector of the present invention. (A) is a normal injection needle, (B) is an injection needle having a flexible conduit,
(C) shows a normal catheter, respectively.

The balloon 2 is basically spherical, but can be formed into any shape according to the shape of the place where the human body is used. For example, it may have a flat ellipsoidal shape.

A transparent cover 7 (FIG. 8 (A)) that covers the outside of the balloon may be detachably attached to the tubular body 1 so that the balloon does not burst due to contact with a sharp object outside. At this time, it is preferable to provide the belt 71 to facilitate the attachment to the human body.

FIG. 8 (B) shows a urinary or digestive catheter 61.
An example is shown in which the liquid medicine continuous injecting device 100 of the present invention is connected to the liquid medicine injecting section 611.

FIG. 8 (C) shows the drug solution injecting portion 62 of the vein catheter 62.
1 shows an example in which the injector 100 of the present invention is connected.

FIG. 8 (D) shows an example in which the injector 100 of the present invention is connected to the drug solution injector 631 of the gynecological catheter 63.

FIG. 8 (E) is a drug solution injection part of the brain surgery catheter 64.
641 shows an example in which the injector 100 of the present invention is connected.

Since the continuous drug injector according to the present invention integrally functions as a container for the drug solution and as a device for injecting the drug solution, it has a simple structure and is easy to handle. Therefore, the behavior and body movement of the patient are not limited, and the practitioner's labor and restraint time are reduced. Further, once the air is deflated, the air is not mixed in until the balloon is completely deflated.

Furthermore, the continuous drug infusion device of the present invention can very easily form pores that greatly affect the injection time, and
Since the formation of the pores is performed immediately before use, the problem of pore clogging does not occur.

[Industrial availability]

 Widely used as a human or animal medical device.

Claims (8)

(57) [Claims] 1. A liquid medicine injection having a tubular body (1) having a liquid medicine flow path (11) formed along a longitudinal axis and having a check valve or one-way cock (121) at one end of the tubular body. A part (12) is provided, and a chemical liquid outflow part (1
3) is provided, a chemical solution outflow control section (3) is provided in the chemical solution flow path at the other end adjacent to the chemical solution outflow section, and a plurality of holes (111) are formed through the management of the tubular body. A continuous solution injector with a balloon, wherein the hole is surrounded by a balloon (2) made of an elastic material, and a peripheral edge (21) of the balloon is airtightly fixed to the outer periphery of the tubular body. 2. The chemical liquid continuation according to claim 1, wherein the chemical liquid outflow control section (3) has a structure in which a thin tube (31) having pores is embedded in a synthetic resin (32). Injector. 3. The continuous chemical injector according to claim 2, wherein the thin tube (31) is linearly embedded in the synthetic resin (32). 4. The continuous chemical injector according to claim 2, wherein the thin tube (31) is embedded in a synthetic resin (32) in a meandering shape. 5. The continuous drug injector according to claim 2, wherein the thin tube (31) is embedded in a synthetic resin (32) in a spiral shape. 6. The continuous liquid injector according to claim 1, wherein the liquid chemical outflow control unit (3) has a structure filled with a porous or permeative diffusive material (33). 7. The chemical liquid outflow control section (3) has a structure in which a thin wire (34) is freely inserted into and removed from a thin tube (31) having pores and these are embedded in a synthetic resin (32). The continuous drug infusion device according to claim 1, wherein 8. The chemical liquid outflow control part (3) is inserted up to an intermediate part of a narrow tube (31) having a pore and a small diameter tube (35),
2. The continuous liquid injector according to claim 1, which has a structure in which these are embedded in a synthetic resin (32).