JP2880237B2 - 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 in a long place. Secondly, the administration of the drug solution to the tumor requires a long period of time. Although it is necessary to repeat the procedure, the catheter must be inserted and removed every time the treatment is performed in order to prevent the above-mentioned infection.

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 a main body, an internal space formed in the main body, a drug solution inlet and a channel for drug solution flowing out of the space, and a rubber plug attached to the drug solution inlet. (Septum) and a catheter formed with a lumen for injecting a drug solution, 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 port of the drug solution injection port is recognized by palpation from above the skin, and then a metal needle tube whose base end is connected to a syringe containing the drug solution via a tube. The tip of (for example, an L-shaped needle) pierces and penetrates the septum of the drug solution inlet, and then operates the syringe,
The drug solution is injected into the target site through the needle tube, the drug solution injection port and the lumen of the cartel communicating therewith.

The needle tube used for the injection of the drug solution is a so-called Huber needle. The tip surface of the needle tube is set so as to be substantially parallel to the axis of the needle tube, whereby the core when the needle tube is pierced into the septum. Prevents rings (perforation of septum and occurrence of nicks).

Conventionally, the main body of the liquid injection port is made of a metal such as stainless steel. However, in order to cope with tomography by nuclear magnetic resonance imaging (magnetic resonance imaging), the main body of the liquid injection port is made of, for example, polyether. Those made of a hard resin such as sulfone have been developed.

However, in such a hard resin main body, when the needle tip comes into contact with the bottom of the internal space serving as a needle stopper when the needle tube is punctured (particularly when the needle tip is displaced in the lateral direction in the contact state). ), There is a problem in that the bottom surface (bottom surface) is scratched or distorted, and kerfs are generated.

Such kezurikas migrates into the human body with the injection of the drug solution, and has an adverse effect. In addition, kezurikasu is clogged in the lumen for the drug solution outflow channel and catheter,
These may be obstructed and hinder the injection of the drug solution.

<Problem to be Solved by the Invention> It is an object of the present invention to provide a chemical liquid injection port capable of preventing the above-mentioned adverse effects due to nicks generated by contact of a needle tip.

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

(1) a main body made of a non-metallic hard material, an internal space formed in the main body, a chemical liquid inlet communicating with the internal space, an elastic body sealing the chemical liquid inlet, A chemical liquid injection port having a flow path for chemical liquid outflow communicating with an internal space, wherein a coating member made of a soft material is provided at a bottom of the internal space.

(2) The chemical injection port according to (1), wherein the thickness of the covering member is smaller than the length of the blade surface of the needle tube for puncturing the elastic body.

(3) The chemical injection port according to (1) or (2), wherein the covering member is made of silicone rubber.

<Operation> According to the liquid injection port having such a configuration, the covering member made of a soft material is provided at the bottom of the internal space, so that the tip of the needle tube abuts and the bottom surface is scratched, and even if nicks occur. However, the scabs remain between the covering member and the bottom surface, and do not migrate to the internal space, the flow path for drug solution flowing out therethrough and the lumen of the catheter.

<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, and FIG. 2 is a cross-sectional side view of the drug solution injection port shown in FIG.

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

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

As a constituent material of the main body 2, a hard material other than metal, which is preferably inert to a living body and has chemical resistance to a chemical solution to be injected, is used. Specifically, various resins such as polypropylene, polyethylene (particularly high-density PE), polyethylene terephthalate, polyvinyl chloride, polycarbonate, polyacetal, polysulfone, polyethersulfone, acrylic resin, ABS resin, PTFF, polyurethane, polyimide, and the like Examples of such resins include those obtained by blending fibers such as glass fibers, nylon fibers, and tetron fibers or inorganic fine powders into the above resins, and various ceramics such as alumina, silica, and apatite.

A chemical liquid inlet 4 for injecting a chemical liquid is formed in the upper part of the internal space 3 in FIG. 2, and an elastic body (septum) for sealing the chemical liquid inlet 4 in an airtight manner 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).

Various rubbers such as silicone rubber, isoprene rubber and natural rubber, polyurethane,
Examples thereof include various resins such as polyamide ester tester, polybutadiene, and soft vinyl chloride, or a combination of two or more of these. Among them, silicones that are particularly inactive in living bodies and have relatively little change in physical properties Rubber is preferred.

In the upper part of the main body 2 in FIG. 2, 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 liquid 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.

As shown in FIG. 2, a tube 9 extends through the side of the main body 2 so that a lumen 10 thereof communicates with the internal space 3.
Is fixedly installed. The lumen of this tube 9
10 is a channel for outflow of the chemical solution.

The distal end of the tube 9 has a lumen 12 for injecting a chemical solution.
The proximal end of the catheter 11 in which is formed is connected, whereby the lumen 10 of the tube 9 and the lumen 12 of the catheter 11 communicate.

As a constituent material of the tube body 9, the same material as that of the main body 2 can be used.

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.

A film-like covering member 14 made of a soft material is provided on the bottom of the internal space 3, that is, on the bottom surface 31.

As a constituent material of the covering member 14, a material capable of self-closing after puncturing, that is, a material capable of self-closing after piercing and removing a needle tube is preferable, for example, silicone rubber,
Various rubbers such as isoprene rubber and natural rubber, various resins such as polyurethane, polyamide elastomer, polybutadiene, soft vinyl chloride and ethylene-vinyl acetate copolymer, or those obtained by laminating two or more of these resins are exemplified. Among them, various rubbers are preferable, and particularly, silicone rubber which is inert to a living body and has relatively little change in physical properties is preferable.

The thickness of the covering member 14 is preferably smaller than the length of the blade surface of the needle tube to be punctured, and specifically, the thickness, 0.
It is preferably about 1 to 3.0 mm, particularly about 0.3 to 1.5 mm.

If the thickness of the covering member 14 exceeds 3.0 mm, the thickness may be larger than the length of the blade surface of the needle tube, and the entire blade surface is buried in the covering member 14 and the chemical solution flows from the tip of the needle tube. Also, if the thickness is less than 0.1 mm, the strength of the covering member 14 is reduced, the durability is deteriorated, and the covering member 14 may be broken to block the flow path.

Note that the covering member 14 is preferably provided over the entire area of the bottom surface 31, but a range in which the probability that the distal end of the needle tube comes into contact is high,
That is, for example, near the center of the circular bottom 31, for example, the bottom 31
A coating member having a diameter of about 50 to 99% of the diameter of the coating may be provided.

By providing such a covering member 14, even if the distal end of the needle tube abuts against the bottom surface 31 and the bottom surface 31 is scratched, and the scuffing occurs, the scuffing residue is held between the covering member 14 and the bottom surface 31, and the covering is performed. Since it does not move into the internal space 3 beyond the member 14, it is possible to prevent kerchis from entering the liquid medicine to be injected and from clogging the lumen 10 of the tube 9 and the lumen 12 of the catheter 11. Is done.

The installation of the covering member 14 can be performed, for example, by the following method.

The covering member 14 in a completed state is bonded to the bottom surface 31 using, for example, an adhesive or fused to the bottom surface 31 by heat fusion, ultrasonic fusion, high frequency fusion, or the like (when the main body 2 is made of resin). In this method, the bonding or fusion portion between the bottom surface 31 and the covering member 14 may be the whole or a part of the joint portion between them, but it is preferable to adhere or fuse the entire region.

A method of fitting the completed covering member 14 to the bottom surface 31 A precursor of a constituent material of the covering member 14 or a liquid containing the precursor is applied to the bottom surface 31, and this is cured to cover the covering member 14.
Examples of precursors include UV curable resin, one-pack, two-pack RTV
(Room temperature curing type), LTV (low temperature curing type) rubber, etc.
An example is a substance which is cured by moisture or the like. In addition, a film may be formed by curing a monomer or oligomer and a crosslinking agent by a chemical reaction.

A method of applying a solution containing the constituent material of the covering member 14 to the bottom surface 31 and evaporating the solvent from the solution to form the covering member 14. As described above, the chemical solution injection port of the present invention is configured as shown in FIGS. 1 and 2. Although described based on examples, it goes without saying that the present invention is not limited to these.

<Effects of the Invention> As described above, according to the drug solution injection port of the present invention, even if the tip of the needle tube comes into contact with the bottom surface of the main body to generate a dent, the dent is formed between the covering member and the bottom surface. And does not move into the internal space.

Therefore, Kezurikas may be mixed into the drug solution to be injected,
In addition, it is possible to prevent an accident of clogging the flow path for drug solution or the lumen of the catheter and closing them.

[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 side view of the chemical injection port shown in FIG. DESCRIPTION OF SYMBOLS 1 ... Chemical liquid injection port 2 ... Main body 3 ... Internal space 31 ... Bottom surface 4 ... Chemical liquid injection port 5 ... Elastic body 6 ... Rib part 7 ... Flange part 8 ... Through hole 9 ... … Tube 10… lumen 11… catheter 12… lumen 14… coating material

Continuation of the front page (56) References JP-A-61-234870 (JP, A) JP-A-2-79955 (JP, U) (58) Fields investigated (Int. Cl. ⁶ , DB name) A61M 37 / 00

Claims (3)

(57) [Claims] 1. A main body made of a nonmetallic hard material, an internal space formed in the main body, a chemical liquid inlet communicating with the internal space, and an elastic body sealing the chemical liquid inlet. A chemical liquid injection port having a flow path for chemical liquid outflow communicating with the internal space, wherein a coating member made of a soft material is provided at a bottom of the internal space. 2. The liquid injection port according to claim 1, wherein the thickness of the covering member is smaller than the length of the blade surface of the needle tube for puncturing the elastic body. 3. The chemical injection port according to claim 1, wherein the covering member is made of silicone rubber.