JPH067867B2 - Implantable chemical injection port - Google Patents

Description

Description: TECHNICAL FIELD The present invention relates to a subcutaneous implantable drug solution injection port used when repeatedly injecting drug solutions for a long period of time in medical treatment for diseases of blood vessels or organs. .

(Prior Art) In order to continuously treat various diseases of organs and blood vessels with long-term injection of drug solution, a pump mechanism is also available in the method of continuously administering a minute amount of insulin, heparin or urokinase from a drug solution pool buried under the skin. Infusaid-400 (Infusa
id company, USA) and Infusaid-A-Port (Infusaid company, USA), which does not have a pump mechanism and intermittently repeatedly fills the chemical liquid reservoir, P
ort-A-Cath (Pharmacia, Sweden), Vascular-Ac
cess-Port (Norfolk Medical Products, USA) and arterial infusion reservoir (Create Medic, Japan) are used. These applications have been used for intermittent or continuous administration of anti-cancer agents because it is easy to secure blood vessels in elderly patients.In addition, compared with the conventional method of introducing a catheter out of the body, it is possible to infect the skin penetration site. Since there is no need to worry about the problem and the restrictions on daily life such as bathing for patients can be lifted, it is also used for central parenteral nutrition supplementation, and home parenteral nutrition, which is a prerequisite for home and social rehabilitation, is becoming possible.

In the treatment of intermittent or continuous administration of anti-cancer drug to the affected area of cancer or tumor, the above-mentioned ports and reservoirs that do not have a pump function performed well, but intra-arterial therapy that actively promotes the retention of anti-cancer drug in the lesion area. Then, it is injected as cloudy or adsorbed in a sticky gel embolic material such as oily contrast agent or gelatin having high viscosity like Lipiovador. In this case, the slow intravascular injection causes sticking or clogging due to retention in the drug solution reservoir or drug solution passage to cause no function, and also causes an obstacle to the operation. As described above, it is common to inject a drug solution having a low fluidity or an anticancer agent containing an adhesive substance by applying pressure, and the drug solution is pushed all at once, and the drug solution pool becomes an obstacle in this case. For this reason, a mixed injection valve body or a catheter cap in which only a puncture portion of an elastic body is incorporated is used in place of the above-mentioned implantable drug solution reservoir. These use, because there is no reservoir or retention part of the drug solution, the injection of the anti-cancer drug containing a drug solution or an adhesive substance with a small fluidity that is press-fitted from a syringe or the like enters the blood vessel through the catheter from the injection port all at once. It is recognized that there is no sticking or residue in the liquid passages such as valve bodies, caps, and catheters with narrow flow passages, and they are reliably injected, and there is no hindrance to the operation. However, since the flow path inside the valve body and cap is thin, the piercable part of the elastic body is extremely small, and even if the puncture operation outside the body is guaranteed, implantation under the skin will affect thick subcutaneous fat etc. There is a technical difficulty in successfully applying the needle to the small puncture area. In addition, since the body of these valve bodies and caps is usually made of synthetic resin, it is inconvenient that the puncture needle may be stuck in an unnecessary portion and caught or may be forced to bend the needle. Carefulness is required. Also, since the flow of the drug solution is straight in these valve bodies and caps, they will be placed sideways when they are embedded in the skin, and the puncture part that punctures the needle will be sideways, making operation difficult.

The injection solution injection port proposed by Arvidson Karin (Published Japanese Patent Publication No. 63-501405) has a structure in which the puncture part of the injection needle is exposed on the surface of the skin and the outflow of the drug solution is embedded under the skin. This structure seems to be ideal with no problems with puncture or drug flow, but internal and external conduction due to this type of skin penetration is afraid of infection from the penetration part, and great care should be taken in daily infection prevention. Not only the patient himself but also the person who is engaged in nursing, it is not preferable because his daily life including bathing is limited.

(Problems to be Solved by the Invention) An object of the present invention is to provide an easy-to-operate solution that does not cause chemical solution retention.

(Means for Solving the Problem) In order to achieve the object of the present invention, the following configuration is provided. That is, the present invention relates to a chemical liquid injection port in which a chemical liquid introduction port (5) sealed with a pierceable self-contractile elastic body and a chemical liquid discharge port (8) of a press-fitted chemical liquid communicate with each other through a chemical liquid flow path. The present invention relates to an implantable chemical liquid injection port, which has no chemical liquid reservoir in the flow path, and the chemical liquid introduction passage (6) and the chemical liquid passage (7) form an angle of 90 ° to 150 °.

The chemical injection port of the present invention will be described with reference to the drawings.

FIG. 1 is an overall view (a) of the implantable chemical liquid inlet of the present invention and a sectional view (b) showing a basic chemical liquid flow path system. FIG. 2 is a sectional view of a structure in which the diameter of the chemical liquid inlet is wider than that of the chemical liquid passage, and the diameter is gradually expanded in a funnel shape toward the chemical liquid inlet where a part of the chemical liquid passage is sealed with an elastic body. FIG. 3 shows an example in which the pipe-shaped chemical solution outlet connected to the chemical solution passage is taken out from the lower side of the base having wings, and FIG. 4 shows the chemical solution inlet and the chemical solution passage which are sealed with an elastic body as a base horizontal surface. A cross-sectional view is shown for each application example in which the insertion of the injection needle or the like is inclined at a certain angle and the bending of the drug solution passage is moderated.

In FIG. 1, a housing (1) having a substantially semispherical shape as a whole has a substantially cylindrical cavity inside, and a generally circular opening is opened upward as a chemical solution inlet (5). A disk-shaped elastic body (2) whose diameter is larger than the diameter of the opening is closed from below the inside of the housing (1) to the chemical solution inlet (5). Since the insert (3) presses the disc-shaped elastic body (2) against the opening from below, the elastic body (2) may be deformed by its pressure.

The insert (3) is perforated in the center, the inlet side faces the opening with the elastic body (2) sandwiched, and the outlet side faces the chemical liquid introduction passage (6), the chemical liquid passage (7), and the chemical liquid outlet (8). ) To.

When the diameter of the opening of the housing (1) is larger than the inner diameter of the chemical liquid outlet (8), the chemical liquid passage (7) has a chemical liquid introduction passage (6) and a chemical liquid as shown in FIG. A part or the whole length of the passage (7) is gradually expanded in the shape of a funnel toward the elastic body (2) so as to match the enlarged opening of the housing (1) facing the elastic body (2). However, it is also possible to provide a step to face each other.

The chemical liquid passage (7) is 90 ° to 1 with respect to the chemical liquid introduction passage (6).
It must be curved or bent to form an angle of 50 °, preferably 90 ° to 135 °.

Further, the other end of the drug solution passage (7) is preferably designed so that a tube such as a catheter is connected to it.

It is also preferable to provide a wing having a structure in which a fixing thread is hooked under the skin on the outer periphery of the main body. For example insert (3)
Is supported by a base (4) from below, and this base (4) is attached with a circular or rectangular wing (9) around which holes for suture thread are provided, and is screwed to the housing (1). They are fixed by adhesion, welding or welding or hermetic method.

When a part of the cavity in the housing (1) that is not filled with the insert (3) or the like occurs, the void is filled with silicon resin or the like and used.

The drug solution inlet of the present invention has a smooth surface which is almost a hemisphere, and the lower part is a smooth and flat surface of the base (4), which is shown in FIG. As described above, the bend of the chemical liquid passage (7) is not sufficiently curved, and the structure is such that it bends out from below the base (4), and if the portion is further covered, the whole fly with wings (9). It looks like a disc. Further, as shown in FIG. 4, the liquid medicine passage (7) is tilted with respect to the horizontal plane of the base (4), and the liquid medicine passage (7) has a gentle angle so that the housing is parallel to the base (4) having the wings (9). The semi-spherical sphere has a slanted shape when the structure goes out from the side wall of (1).

Next, each component of the implantable chemical injection port of the present invention will be described.

The parts of the housing (1) and the insert (3) that come into contact with the injection needle and the like are made of metal, and a metal such as stainless steel or titanium, an alloy, an alloy such as Vitalis, or a hard and scratch-resistant material such as ceramics is preferable. However, even if a part or the whole is made of synthetic resin, it does not interfere with the use and the manufacturing cost is reduced. The use of synthetic resin for the base (4), the pipe-shaped chemical liquid introduction passage (6), and the chemical liquid passage (7) is preferable for making the chemical liquid injection port of the present invention lightly, but the whole is small and durable. The above metals, alloys, and ceramics are particularly preferable in terms of durability. It is preferable that each surface is subjected to mechanical polishing, and the portion in contact with the internal tissue is subjected to electrolytic polishing or the like.

The elastic body (2) is usually made of natural rubber, silicone, or a combination of both, but polyurethane is a preferred material to be subjected to various chemical treatments. Normally, a disk-shaped sheet is used as the elastic body (2), but a molded product according to the structure of the tip of the housing (1) or the insert (3) is preferable because it can be used without undue deformation. The silicone resin that fills the extra voids in the housing (1) is preferably a viscous liquid, which is a medical silicone resin that cures at a temperature of 100 ° C. or lower.

The chemical solution inlet of the present invention has a structure in which the chemical solution inlet, the chemical solution flow path and the chemical solution outlet have substantially the same inner diameter as shown in FIG. 1 or the inner diameter of the chemical solution inlet as shown in FIG. It is preferable to use a funnel-shaped structure in which a part or the entire length of the chemical liquid flow passage is larger than that on the chemical liquid outlet side and expands toward the chemical liquid inlet side sealed with an elastic body. Particularly, a funnel-shaped structure in which a part or the entire length of the chemical liquid flow path is expanded toward the chemical liquid inlet side, which is sealed with an elastic body, is preferable.

The diameter of the drug solution inlet (5) is 1 to 10 mm through which the puncture needle passes.
Is used, and 1.5-6 mm is preferably used. The elastic body (2) has a thickness of 1 to 7 mm and is changed according to the diameter of the opening. When the diameter of the opening is large, the elastic body (2) is thin and thin to be adjusted to a thickness that does not respond to the vibration of the blood vessel, and the diameter is set to 5)
Larger than the diameter is used. The inner diameter of the drug solution passage (7) is slightly larger than that of the puncture needle and is 0.5 to 3 mm, and the outer diameter of the drug solution outlet (8) is adjusted to the inner diameter of tubes such as a catheter. The shape of the drug solution outlet (8) is a preferable shape because the shape of inserting tubes such as catheters as shown in the figure is small and light, but a luer lock is also preferably used as a structure for easily and securely fixing operation. To be In addition, interposing a tube made of a flexible synthetic resin or the like between the liquid medicine passage (7) and the liquid medicine outlet (8) is a preferable mechanism that allows free movement according to the movement of the patient.

(Example) Next, an example is given and demonstrated.

Example 1 A base with a housing, inserts and wings was made of stainless steel and had a blood inlet diameter of 1.5.
mm, the diameter of the drug solution passage is 1 mm, and the elastic body is made of natural rubber having a thickness of 2 mm. The drug solution injection port having the shape shown in FIG. Even after repeated punctures, no leakage occurred at a water pressure of 5 kg / cm ² .

Example 2 The implantable drug solution injection port of Example 1 was sterilized with ethylene oxide gas, placed under the skin, and a mixture of lipiodol and a 1 mm square gelatin sponge was injected about every 2 weeks for 6 times conveniently. However, neither gelatin sponge nor Lipiodol remained in the drug solution flow channel.

Further, the retention time is about 2 weeks, and the retention time of DSM (hydrolyzed potato starch) granules of about 80 μ, which is said to be capable of sustaining a long retention time, is about 20 minutes. A high retention effect in the blood vessel was obtained by using the inlet.

Example 3 Silicon having a thickness of 2 mm is provided on the upper side, and the upper side is 1 mmφ on the lower side.
A 2mm-thick natural rubber molded in a spindle shape with a base of 6mmφ and a height of 1.6mm is layered with the top side facing downwards.
Using a disc-shaped elastic body having a two-layer structure, a liquid injection port made by dropping it into the funnel portion of the insert (3) of the liquid injection port shown in FIG. 2 was used, and puncturing was repeated 100 times with a 21G needle. Did not leak at a water pressure of 5 kg / cm ² .

(Effects of the Invention) The implantable drug solution injection port of the present invention is easier to handle than conventional ones, and when used clinically, clogging due to adhesive residue can be prevented.
A certain degree of gelatin sponge can be injected, and the therapeutic effect can be improved for a long time.

[Brief description of drawings]

FIG. 1 is an overall view (a) and a sectional view (b) of the implantable chemical liquid injection port of the present invention. FIG. 2 is a sectional view of a structure in which the diameter of the chemical liquid inlet is wider than that of the chemical liquid passage, and the diameter is gradually expanded in a funnel shape toward the chemical liquid inlet where a part of the chemical liquid passage is sealed with an elastic body. Fig. 3 shows an example in which a pipe-shaped chemical liquid outlet connected to the chemical liquid passage is taken out from below the base having wings, and Fig. 4 shows the chemical liquid inlet and the chemical liquid passage sealed with an elastic body on the horizontal surface of the base. A cross-sectional view is shown for each application example in which the insertion of the injection needle or the like is tilted to some angle and the bending of the drug solution passage is moderated. 1. Housing 2. Elastic body 3. Insert 4. Base 5. Chemical solution inlet 6. Chemical introduction route 7. Chemical passage 8. Chemical solution outlet 9. Wings

Claims (1)

[Claims] 1. A drug solution inlet port (5) sealed with a pierceable self-contractile elastic body and a drug solution outlet port (8) for press-fitting the drug solution.
At the chemical solution inlet communicating with the chemical solution flow path, there is no chemical solution reservoir in the chemical solution flow path, and the chemical solution introduction path (6) and the chemical solution path (7) form an angle of 90 ° to 150 °. The featured implantable chemical injection port.