JP2908503B2 - Chemical injection port - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION <Industrial Application Field> The present invention relates to a drug solution injection port which is a device for injecting a drug solution, and more particularly to a drug solution injection port constituting a subcutaneous implantable catheter assembly.

<Conventional technology> For unresectable malignant tumors, chemotherapy by administration of anticancer drugs is performed, but systemic administration causes side effects, so the dose, administration period, etc. are significantly restricted, Therefore, it is difficult to obtain an effective drug concentration in tumor tissue.

Therefore, intraarterial infusion therapy (arterial infusion therapy) of an anticancer drug has been performed as a method of compensating for such a drawback of the anticancer drug chemotherapy and allowing a high concentration of the drug to act on the tumor as much as possible.

As such an arterial infusion therapy, for example, a catheter for injecting a drug solution is intubated from the femoral artery using an introducer, and the position of the catheter is checked under X-ray fluoroscopy, and the tip of the catheter is moved to the target site (to the tumor site). (Upstream of the artery leading to the artery), and then inject the anticancer drug into the target site through the lumen in the catheter.

According to this method, the medicinal solution is directly administered to the periphery of the artery leading to the local part of the tumor in the tumor-bearing organ, so that there is an advantage that the therapeutic effect is large.

However, in this method, firstly, since the catheter is inserted percutaneously, the risk of infection is increased if the catheter is left for a long time, and secondly, the administration of the drug solution to the tumor requires a long time. Although it is necessary to repeat the treatment over a period, a catheter must be inserted and removed every time the treatment is performed in order to prevent the above-mentioned infection, and there is a disadvantage that the burden on the patient is large.

Therefore, a subcutaneous implantable catheter assembly that can be used while being left in the body for a long time has been developed. The catheter assembly includes an inner space having a substantially circular cross section, a drug solution inlet and a channel for drug solution flowing out of the space, and a rubber stopper (septum) attached to the drug solution inlet. And a catheter in which a lumen for injecting a chemical solution is formed, and the catheter is connected so that the lumen communicates with the flow path.

This subcutaneously implantable catheter assembly is placed in a state where a catheter is inserted into a nutritional artery blood vessel of a tumor-bearing organ to a target site, and a drug solution injection port is fixed to a subcutaneous tissue. Then, when injecting the drug solution, the drug solution inlet of the drug solution injection port is recognized by palpation from above the skin, and then a needle tube (for example, L-tube) whose base end is connected to a syringe containing the drug solution via a tube. Pierce and penetrate the septum of the drug solution inlet, and then operate the syringe to remove the needle tube,
The drug solution is injected into the target site through the drug solution injection port and the lumen of the catheter communicating therewith.

By the way, a drug solution used for such an intraarterial injection therapy, particularly an anticancer drug, has a high viscosity and is easily crystallized, so that it tends to adhere to and remain in the internal space of the drug solution injection port. When such an anticancer agent remains, there is a possibility that the flow path and the like may be blocked. Therefore, after injecting the anticancer agent, a cleaning solution such as a physiological saline solution containing heparin is circulated to wash the internal space of the drug solution injection port. Has been done.

However, as shown in FIGS. 4 and 5, in the conventional chemical liquid injection port 20, the lumen 24 of the tube 23, which is a flow path for chemical liquid outflow, has its axial center extension line 25 connected to the main body 21. It is arranged so as to pass through the center of the circle of the formed internal space 22,
And the inner surface 24a of the lumen 24 is the inner peripheral surface 2 that regulates the inner space 22.
2a and the bottom surface 22b are not continuous.
And 22b are substantially perpendicular to each other, and in particular, stagnation occurs on both sides (edge portions) 26 and 26 of the portion where the pipe 23 and the internal space 22 communicate, and the anticancer agent adheres to this portion and tends to crystallize. was there.

In this case, even if the cleaning liquid was allowed to flow through the internal space of the liquid injection port, the anticancer agent attached to and crystallized on both sides 26 of the communication port was difficult to remove.

<Problem to be solved by the invention> The purpose of the present invention is to attach a chemical solution or its crystal to the internal space,
It is to provide a liquid injection port that does not remain.

<Means for Solving the Problems> Such an object is achieved by the present invention described in the following (1) to (3).

(1) A chemical liquid having an internal space for storing a chemical liquid, a chemical liquid inlet communicating with the internal space, an elastic body sealing the chemical liquid inlet, and a flow path for discharging the chemical liquid communicating with the internal space. In the injection port, in the vicinity of a connection portion between the internal space and the flow path, a wall surface that regulates the internal space and an inner surface of the flow path form a continuous surface having substantially no steps. A liquid injection port.

(2) The internal space has a substantially circular cross section, the upper end portion of the internal space is provided with the chemical solution inlet and the elastic body, and the flow path is formed on the inner peripheral surface of the internal space. The drug solution injection port according to the above (1), which is open.

(3) The chemical liquid injection port according to the above (1) or (2), wherein a space near a connection portion between the internal space and the flow path has a funnel shape.

(4) Any one of the above (1) to (3), wherein at least one of an inner wall surface for regulating the internal space and an inner surface of the flow path is subjected to a coating or a surface smoothing treatment to which a chemical solution is hardly attached. Chemical injection port described in the above.

(5) The chemical injection according to any one of (1) to (3), wherein at least one of an inner wall surface that regulates the internal space and an inner surface of the flow path is coated with a fluororesin or silicone. port.

<Function> According to the liquid injection port having such a configuration, the internal space of the liquid injection port and the flow path for the liquid outflow form a substantially flat continuous surface such as a funnel shape, for example. Accordingly, when a high-viscosity drug is injected, a smooth flow is formed from the internal space to the flow path, whereby the drug is prevented from stagnation, and is less likely to adhere and remain.

Further, even when the drug adheres and remains, when the cleaning liquid is injected, the same smooth flow is formed, so that the cleaning effect is enhanced, and the adhesion and remaining of the drug can be prevented.

<Embodiment> Hereinafter, a chemical injection port of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.

FIG. 1 is a perspective view showing a configuration example of a drug solution injection port of the present invention, FIG. 2 is a cross-sectional view of the drug solution injection port shown in FIG. 1, and FIG. 3 is III-III in FIG. It is sectional drawing in a line.

As shown in these drawings, the chemical liquid injection port 1 has a main body 2 made of a rigid material, and an internal space 3 as a space for storing a chemical liquid is formed inside the main body 2. The internal space 3 preferably has a substantially circular or elliptical cross section (a circular shape in the illustrated example).

Here, “substantially circular” means not only a perfect circle, but also a regular polygon having eight or more angles, a spiral trace, a part of the circle or the polygon, or the like. Or, a shape that is similar to a circle and has the same function as a circle, such as a deformed one or a smooth continuous line, is meant.

 The same applies to “substantially elliptical”.

The diameter of the circular internal space 3 is preferably about 5 to 40 mm, particularly preferably about 6 to 20 mm.

A chemical liquid inlet 4 for injecting a chemical liquid is formed in the upper part of the internal space 3 in FIG. 3, and an elastic body (septum) that hermetically seals the chemical liquid inlet 4 is formed in the chemical liquid inlet 4. ) 5 is inserted.

This elastic body 5 is capable of self-closing after puncturing, that is,
After piercing and removing the needle tube, the needle tube is closed by itself to maintain airtightness (liquid tightness).

Examples of the constituent material of the elastic body 5 include various rubbers such as silicone, isoprene, and natural rubber, various resins such as polyurethane, polyamide elastomer, polybutadiene, and soft vinyl chloride, or a combination of two or more of these. However, among them, silicone rubber which is inert to a living body and has relatively little change in physical properties is particularly preferable.

In the upper part of the main body 2 in FIG. 3, a rib portion 6 protruding along the outer periphery of the chemical solution inlet 4 is formed. This rib 6
Is provided, when the position of the drug solution inlet 4 is confirmed by palpation from above the skin, it can be easily and reliably recognized.

A disk-shaped flange portion 7 for fixing the drug solution injection port 1 to the subcutaneous tissue is provided on the outer periphery of the lower portion of the main body 2 in FIG.
The flange portion 7 has a plurality of through holes 8 formed therein. The liquid injection port 1 is fixed, for example, by passing a thread through each through hole 7 and tying the thread to a subcutaneous tissue such as a muscle.

The constituent material of the main body 2 may be any material as long as it is inert to a living body. For example, polypropylene, polyethylene (particularly high-density PE), polyethylene terephthalate, polyvinyl chloride, polycarbonate, polyacetal, polysulfone, polyether Various resins such as sulfone, acrylic resin, ABS resin, fluorine resin, silicone, polyurethane, or a mixture of fibers such as glass fiber, nylon fiber, tetron fiber or inorganic fine powder in these resins, alumina, silica, Examples include various ceramics such as apatite, and various metals such as stainless steel, titanium, metal plated with metal for obtaining biocompatibility such as cinnamate or chrome plating, and the like.

As shown in FIGS. 2 and 3, a tube 9 is provided in the main body 2 so as to penetrate a side portion of the main body 2 so that a lumen 10 thereof communicates with the internal space 3. The lumen 10 of the tube 9 serves as a flow path for outflow of the drug solution.

In the illustrated example, the tube 9 is installed such that the lumen 10 of the tube 9 opens on the inner peripheral surface 3a that regulates the internal space. As a result, the height of the liquid injection port 1 can be set low, which contributes to making the liquid injection port thinner.

In addition, one end of the tube 9 is connected to a proximal end of a catheter 11 in which a lumen 12 for injecting a drug solution is formed, so that the lumen 10 of the tube 9 and the lumen 12 of the catheter 11 communicate with each other.

The present invention is characterized by the structure near the connecting portion 13 between the lumen 10 of the tube 9 and the internal space 3. That is, this connection portion 13
In the vicinity, the inner peripheral surface 3a and / or the bottom surface 3b of the internal space 3 and the inner surface 10a of the lumen 10 form a smooth continuous surface having substantially no step, and particularly as shown in the configuration example shown in the drawing. Preferably, the space (flow path) near the connection portion 13 has a so-called funnel shape.

Here, the funnel shape refers to a shape whose diameter is continuously reduced, and in addition to a conical tapered tube, all or a part of a profile in a vertical cross section thereof is, for example, convex or inward. It also includes a curved shape such as a concavely curved shape or an S-shaped shape.

The cross-sectional shape of the funnel shape is not particularly limited to a circular shape, but is preferably substantially circular or elliptical as described above.

With such a configuration, the elastic body 5 is punctured,
Since the liquid medicine injected into the internal space 3 from the tip of the penetrated needle tube flows from the internal space 3 to the lumen 10 of the tube 9 via the connection portion 13, a smooth flow is formed.
In particular, no stagnation occurs in the edge portion 26 (see FIG. 5). Therefore, even when a highly viscous chemical such as an anticancer drug is injected, the chemical is prevented from adhering to and remaining on the inner wall surfaces and corners regulating the internal space 3 and crystallizing.

Further, even when a high-viscosity chemical liquid adheres to the internal space 3, if the cleaning liquid is injected in the same manner as the chemical liquid, a similar smooth flow is formed, whereby the adhered chemical liquid is reliably removed.

In addition, the same material as the main body 2 can be used as a constituent material of the tube 9, and among them, various metals such as stainless steel and titanium are particularly preferable.

The inner diameter of the tube 9 is about 0.1 to 5.0 mm, particularly 0.2 to 5.0 mm.
It is preferred to be about 2.0 mm.

In the present invention, as it becomes difficult to adhere a high viscosity chemical solution,
The inner wall surface (inner peripheral surface 3a, bottom surface 3b) that regulates the internal space 3 and the inner surface 10a of the lumen 10 are subjected to a surface treatment such as a surface smoothing treatment such as coating or polishing with a fluororesin or silicone. You can also.

By combining such a surface treatment with the arrangement of the tube 9, a more excellent effect of preventing and removing a chemical solution can be obtained.

In the illustrated example, the tubular body 9 is disposed so that the axial extension of the lumen 10 passes through the center of the circle of the internal space 3.
The present invention is not limited to this, and the tubular body 9 may be arranged so that the extension of the axial center of the lumen 10 does not pass through the center of the circle of the internal space 3.

As mentioned above, although the chemical | medical solution injection port of this invention was demonstrated based on the example of a structure shown to FIG. 1-FIG. 3, it cannot be overemphasized that this invention is not limited to these.

<Effects of the Invention> As described above, according to the drug solution injection port of the present invention, a drug solution, particularly a high-viscosity drug solution such as an anticancer drug and its crystals hardly adhere to and remain in the internal space, and even if it adheres. Can be easily removed by injecting a cleaning solution.

[Brief description of the drawings]

FIG. 1 is a perspective view showing a configuration example of a drug solution injection port of the present invention. FIG. 2 is a cross-sectional view of the chemical liquid injection port shown in FIG. FIG. 3 is a sectional view taken along the line III-III in FIG. FIG. 4 is a cross-sectional view of a conventional chemical injection port. FIG. 5 is a cross-sectional view taken along line VV in FIG. DESCRIPTION OF SYMBOLS 1 ... Chemical liquid injection port 2 ... Main body 3 ... Internal space 3a ... Inner peripheral surface 3b ... Bottom surface 4 ... Chemical liquid injection port 5 ... Elastic body 6 ... Rib part 7 ... Flange part 8 … Through-hole 9… tube 10… lumen 10 a… inner surface 11… catheter 12… lumen 13… connection part 20… conventional liquid injection port 21… body 22… inner space 22 a… … Inner peripheral surface 23… Tube 24… Lumen 24 a… Inner surface 25… Extension of axial center 26… Side (edge)

Claims (5)

(57) [Claims] An internal space for storing a chemical solution, a chemical liquid inlet communicating with the internal space, an elastic body sealing the chemical liquid inlet, and a flow path for chemical liquid outflow communicating with the internal space. In the vicinity of a connection portion between the internal space and the flow path, the wall surface that regulates the internal space and the internal surface of the flow path form a continuous surface having substantially no step. A liquid injection port. 2. The internal space has a substantially circular cross section. The upper end of the internal space is provided with the chemical liquid inlet and the elastic body. 2. The chemical injection port according to claim 1, wherein the passage is open. 3. The chemical liquid injection port according to claim 1, wherein a space near a connecting portion between the internal space and the flow path has a funnel shape. 4. The coating according to claim 1, wherein at least one of an inner wall surface for regulating said internal space and an inner surface of said flow path is subjected to a coating or a surface smoothing treatment to which a chemical solution hardly adheres. The described drug solution injection port. 5. The chemical liquid injection port according to claim 1, wherein at least one of an inner wall surface for regulating the internal space and an inner surface of the flow passage is coated with a fluororesin or silicone. .