JPH09124511A - Embrocation for injection needle, injection needle coated with the same and packing container for the same injection needle - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain the subject embrocation for injection needle capable of alleviating a sick ache feeling followed by injection, making a local anesthetic directly on a needle wound, by applying the embrocation on an injection needle, consisting essentially of the local anesthetic. SOLUTION: This embrocation for injection needle comprises mainly a local anesthetic (preferably an amide type local anesthetic such as lidocaine hydrochloride or dibucaine hydrochloride). The objective embrocation can be generally prepared by dissolving the local anesthetic as a main solute in distilled water for injection. The concentration of the embrocation obtained as the embrocation is preferably 2-4%. When the embrocation is used together with a vasoconstrictor such as epinephrine, a blood vessel around a needle is immediately constricted, preferably the local anesthetic is prevented from being diffused into tissue and diluted with blood. When the embrocation is used with a humectant, vaporization of water, etc., from the embrocation can be preferably prevented. When oils and fats are used as a solvent for the embrocation, preferably injection with less pain can be actualized by lubricating action.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an injection needle coating agent to be used by applying it to an injection needle, an injection needle obtained by applying the coating agent, and the injection needle in order to relieve pain during injection. The present invention relates to a packaging container for storage and distribution.

[0002]

2. Description of the Related Art As a technique for alleviating the pain of injection, a technique of coating an injection needle with a silicone resin is known. This technique increases the smoothness by coating the microscopic level irregularities on the metal surface forming the injection needle with silicone resin, and reduces the friction between the needle and the skin or muscle, thereby reducing the occurrence of pain. It tries to minimize it.

[0003]

The effects of silicone resins on the living body, especially on the human body, have been harmless for many years, but due to the changes in criteria, judgment techniques, and social consciousness regarding the judgment of harmlessness, today , Its safety is being questioned.

In order to deal with such a situation, in the industry related to the injection needle, a study has been made on a coating material to replace the silicone resin, or a technique for making the surface of the injection needle smooth without using the coating material has been sought. The current situation is that no clues for alternative materials or alternative technologies have been obtained.

This invention attempts to realize so-called injection without pain from a completely different viewpoint from the prior art. Specifically, it is a coating agent for an injection needle that utilizes the anesthetic action of an anesthetic. Another object of the present invention is to provide an injection needle using the coating agent and a packaging container for actually using the injection needle.

[0006]

SUMMARY OF THE INVENTION The construction of a coating agent for an injection needle corresponding to this purpose is characterized by using a local anesthetic as a main component.

The coating agent for injection needles contains a local anesthetic as a main component, and a vasoconstrictor can be used in combination therewith.

The coating agent for the injection needle may also contain a water retaining material.

The coating agent for the injection needle may use fats and oils as a solvent.

The gist of the injection needle is to apply a coating agent for the injection needle on the surface of the needle.

The packaging container for the injection needle comprises a main body for accommodating the injection needle and a cap lid which is hermetically engaged with the main body. The main body is provided with a liquid storage portion which is thinly formed corresponding to the needle of the injection needle. The point is to provide.

[0012]

The coating agent for the injection needle is used by applying it to the surface of the needle of the injection needle. The applied coating agent wets the surface of the metal forming the injection needle, and adheres in a state of entering the unevenness of the metal surface.

Most of the coating agent adhered to the surface of the needle will remain on the surface of the skin while surrounding the needle when the needle penetrates the skin during injection. Due to the unevenness, a part of the coating agent remains on the surface of the needle and penetrates into the skin tissue together with the needle. Therefore, the local anesthetic, which is the main component of the ointment, acts directly on the nerve cells around the needle simultaneously with the injection. In addition, the coating agent remaining on the skin surface can enter the inside of the tissue via the needle wound when the needle is pulled out, and can act after the injection.

The vasoconstrictor used in combination with the local anesthetic, which is the main component, causes the blood vessels around the needle to contract immediately after injection, and the local anesthetic diffuses into the tissue via blood, or Prevents it from being diluted by blood.

When the coating agent for the injection needle contains a water retaining material, an aqueous solution containing a local anesthetic is held by the water retaining material to obtain a composition of the composition, and the water retaining material can be used according to the degree of water retaining performance. Further, it is possible to prevent vaporization of water from the coating agent and other vaporized components.

When the coating composition for the injection needle uses oil and fat as a solvent, an oil film can be formed on the surface of the needle when the coating composition is applied to the needle, so that the skin tissue and the needle are not separated from each other. In addition to being able to reduce friction between the oils and fats, the oils and fats have a poor vaporization property, and thus serve to prevent changes in the component ratio of the coating agent with time.

An injection needle formed by applying a coating agent for an injection needle on the surface of the needle does not require the number of steps for applying the coating agent at the time of use and can be used in the same manner as a normal injection needle.

In the packaging container for the injection needle, the amount of air that may come into contact with the coating agent can be minimized by forming a thin portion corresponding to the needle to which the coating agent is applied. Capillary action can be generated between the periphery of the needle and the main body forming the liquid reservoir to retain the coating agent. Further, the cap lid is airtightly engaged with the main body, and can block the inside and the outside of the packaging container from being impermeable.

[0019]

[Example-1] A coating agent for an injection needle can basically be easily prepared by using distilled water for injection as a solvent and a solute containing a local anesthetic as a main component.

At this time, the requirement is to adjust the concentration of the solution obtained as a coating agent to be about 2% to 4% (weight ratio, the same applies hereinafter). The local anesthetic used is preferably an amide type local anesthetic rather than an ester type local anesthetic, and examples of the amide type local anesthetic include lidocaine hydrochloride, dibucaine hydrochloride and bupivacaine hydrochloride.

The numerical value indicating the concentration of the solution as the coating agent is taken into consideration whether or not the local anesthetic as the main component can effectively exert an anesthetic action, and consideration of the side effect of the local anesthetic. It is a numerical value that is comprehensively determined from the viewpoint that it is a use mode in which it is applied to an injection needle, and does not have a property of critical significance.

That is, the concentration of 2%, which is the lower limit of the concentration of the solution as the coating agent, is a general concentration when this kind of local anesthetic is used for injection and is a concentration confirmed to be safe. On the other hand, the concentration of 4%, which is the upper limit of the solution concentration, is
It is said that the concentration is not necessarily free from side effects when used for injection, but as long as it is used for application to an injection needle, there is no problem as a common sense in the medical field.

The injection needle coating agent adjusted to satisfy the required items is used by being applied to the needle portion of the injection needle attached to the injection cylinder through the connecting tube. However, applying means, for example, the action of attaching the coating agent to the surface of the needle by wiping it with absorbent cotton or gauze containing the coating agent, or immersing the needle in the coating agent placed in a suitable container. In addition to the act of applying a coating agent to the needle, it is meant to include any act of applying a coating agent to the needle.

The procedure for injecting a specific drug solution into a blood vessel and the action of the coating agent during the injection will be described below.

Inhalation of the drug solution into the syringe may be carried out by a commonly used method. After inhaling the drug solution, the needle is wiped with absorbent cotton or the like to remove the drug solution adhering to the surface of the needle. Next, the coating agent for the injection needle is applied. Usually, the coating agent is prepared in an appropriate subdivision container,
It may be applied by immersing the tip side of the needle in the coating agent.

At this time, when the needle does not get wet with the coating agent and the coating agent is not sufficiently adhered, the adhesion can be enhanced by thoroughly wiping the needle with rubbing alcohol. Also,
When the needle does not get wet with the coating agent, a method of using a spray container and spraying the coating agent onto the needle can be used as a method for sufficiently attaching the coating agent to the needle. The sprayed coating agent adheres to the needle while maintaining the state of fine water droplets.

The coating agent attached to the needle can enter the inside of the tissue in association with the surface of the needle inserted into the skin tissue or the like, and directly act on the nerve cells around the needle. That is, the local anesthetic, which is the main component of the coating agent, reversibly blocks the transmission of the stimulus from the nerve cells to the brain at the same time as the injection, so that the pain sensation upon injection is almost instantly eliminated.

On the other hand, the coating agent remaining on the surface of the skin penetrates inside the tissue through the needle wound after the needle is withdrawn and quantitatively supplements the local anesthetic, so that the duration of the anesthetic action is increased. Can prolong and eliminate persistent pain after injection.

The coating agent dispensed in the subdivision containers is
Since it is a method of immersing the needle before use, even in the case of sequentially injecting to a large number of people, there is no risk of infectious disease through the application agent and it can be repeatedly used. However, even if the needle is clean enough,
Return of the coating agent remaining in the subdivision container to the original container after use should be avoided because it may pick up bacteria in the air during use. Further, when a spray container is used, there is no concern that germs and the like will enter the interior of the container, so it can be reused by keeping the spray port closed and refrigerating.

As the solvent for the local anesthetic, instead of distilled water for injection, sodium chondroitin sulfate 2
% Aqueous solution may be used, and in this case as well, it can be used by the same usage method, and the same effects can be contained.

[0031]

Example-2 A coating agent for an injection needle can contain a vasoconstrictor. Here, epinephrine and naphazoline nitrate can be mentioned as examples of the vasoconstrictor that can be used. When epinephrine is used, it is approximately 1.25 times that of the coating agent, assuming that no other vasoconstrictor is used together
% So that it is mixed and used so that
When naphazoline nitrate is used, it should be used in a proportion of about 0.05% of the coating agent.

The effect of the combined use of a vasoconstrictor with a local anesthetic is generally known and, except for some of them, is also applicable as it is to a coating agent for an injection needle. That is,
During injection, the vasoconstrictor contracts the blood vessels around the needle to suppress the absorption and diffusion of the local anesthetic and acts to hold the local anesthetic in place, thereby maintaining the duration of the anesthetic action. Can be lengthened.

[0033]

Example-3 A coating material for an injection needle may contain a water retention material. Here, the water-retaining material is a substance containing water, which is a liquid or a semi-solid when it contains water, has low irritation to the living body, and is diffusely absorbed in the living body over time. It must be a substance that meets the conditions. Further, the water retaining material is more preferably a substance that exhibits an appropriate flow viscosity when containing water.

Agar and starch can be mentioned as the water-retaining material satisfying such conditions. First, the case of using agar will be described.

As the agar, those commercially available as food can be used. Agar is cut into appropriate pieces, and water is added to this to dissolve it by heating. The amount of agar to be used with respect to water is such that the amount of agar aqueous solution attached to foreign matter in the molten state is about twice the amount of foreign matter attached to water. In other words, for example, a wire is inserted into an agar solution for a certain length, and the amount of agar solution adhering to the wire is the same when the same wire is inserted into water. This means that the amount of agar is adjusted so that the amount of water adhering to is about twice.

The molten agar aqueous solution is sterilized by filtration and then added as a solvent to a local anesthetic, or a local anesthetic and a vasoconstrictor, and thoroughly mixed to obtain an application for an injection needle. The agent can be obtained. The ratio of the local anesthetic to the agar aqueous solution is the same as the ratio when water is used as the solvent.

The coating agent for an injection needle thus obtained may solidify into a semi-solid state at room temperature, but it is usually warmed to an appropriate temperature and returned to a molten state before use. Since this coating agent has good adhesion to the needle of the injection needle, the required amount can be easily applied even to a needle that is difficult to get wet with water. In the use mode in which a needle is applied and injection is performed, the amount of agar that may remain in the living tissue on the injection side is extremely small, and the agar remaining in the living body is It is diffusely absorbed without causing any damage. It should be noted that the semi-solidified coating agent cannot be used, and its usage will be described later.

Production method when starch is used as a water retention material,
Usage and action are the same as when agar is used. As for the starch that can be used, the type of plant that provided the raw material for the starch and the method for producing the starch are not critical as long as they are obtained as pure starch. Further, as the water retaining material, it is also possible to use animal fibrin such as collagen in addition to the plant material.

[0039]

Example-4 A coating agent for an injection needle can be prepared by using fats and oils as a solvent. The conditions required for oils and fats that can be used are the same as those required for the above-mentioned water-retaining material, as long as they do not violate the properties as oils and fats in the sense that they will remain in the living tissue after injection. As long as the oil and fat satisfy these conditions, the oil or fat may be animal or vegetable, and may be liquid, sherbet, cream or semi-solid. can do. The same ratio can be applied to the ratio of the local anesthetic to the oil or fat as the solvent. In order to mix the local anesthetic and the like with the semi-solid fats and oils, generally, the fats and oils may be heated to be in a liquid state. Examples of suitable fats and oils include olive oil, rapeseed oil, sunflower oil and the like.

The coating agent for injection needles using oil and fat as a solvent,
Hard to rot and has a long service life. Oils and fats are generally non-volatile, and the composition ratio as a whole does not change much. The lubricating action of oils and fats allows for less painful injections. Due to the viscosity of fats and oils, it has high adhesion to needles. Depending on the type of fats and oils, the coating agent finished as a semi-solid one can be easily used by rubbing a needle on the surface of the coating agent. It has features such as long-term storage at room temperature.

[0041]

[Embodiment 5] An example of an injection needle in which a coating material for an injection needle is applied to the surface of the needle will be described with reference to the drawings.

The injection needle 10 comprises a hollow pipe-shaped needle 11 made of metal, a connecting pipe 12 for connecting to an injection cylinder (not shown), and a coating agent R applied on the surface of the needle 11 (FIG. 1). .

The connecting pipe 12 is made of a plastic material and is formed into a stepped cylindrical shape as a whole.
Connect the needle 1 to the connecting tube 12 from the end on the side connected to the syringe.
Flange 1 in order toward the end on the side where 1 is attached
2a, a large diameter portion 12b, an intermediate portion 12c, and a small diameter portion 12
d and are formed. Further, ribs 12e, 12e are formed around the small diameter portion 12d.

However, the inside of the connecting pipe 12 is not formed stepwise, and the large diameter portion 12b to the intermediate portion 12c are not formed.
Further, a taper hole having a taper rate that matches the taper rate of the connection nipple projectingly provided on the distal end of the injection cylinder is formed, and the inside of the small diameter portion 12d matches the outside diameter of the needle 11. An attachment hole is formed in the inner diameter that communicates with the tapered hole.

The needle 11 is made of a metal thin tube having high rust resistance, one end on the base needle portion 11b side is cut in the radial direction, and one end on the tip portion 11a side is cut obliquely. The tip surface of the needle 11 cut obliquely includes a polishing surface S ₁ for polishing along the cutting angle and a polishing surface S ₂ , S ₂ for polishing from both sides by changing the polishing angle to finish the tip more sharply. It is formed by three surfaces (Fig. 2). The needle 11 is a base needle portion 11
One end on the b side is inserted into a mounting hole formed in the small diameter portion 12d of the connecting pipe 12 and then bonded by an adhesive that also serves as a sealing agent (FIG. 1).

On the surface of the needle 11, except for a part on the side of the base needle portion 11b, a coating agent R for injection needle is applied (FIG. 2).
Here, the coating agent R used is one in which agar is used as the water retaining material, and the coating of the coating agent R on the needle 11 is
In the final step of the manufacturing line of the injection needle 10, after drying the washed injection needle 10 with hot air, immerse the portion of the needle 11 in the coating agent R of which the viscosity has been reduced under heating conditions, and naturally cool it. The thin layer of the semi-solid coating material R is formed on the surface of the needle 11. At this time, the coating material R is not only the outer peripheral portion of the needle 11, but also the polishing surfaces S ₁ , S ₂ , S _{2 of} the needle tips,
Although it is attached to a part of the peripheral needle hole 11h, the needle hole 11 is caused by the surface tension of the coating agent R in the hot water state.
The coating agent R does not adhere to the inside of h. It should be noted that these series of coating operations must be performed in a sterile atmosphere.

In such an injection needle 10, the coating material R has the needle 1
Since it adheres to the surface of No. 1 in the form of a semi-solid, the application agent R does not flow out even if the needle 11 is dipped in the liquid medicine for injection for a short time. Therefore, an injection needle 10 for blood collection or the like which is not intended to inject a specific drug solution
As a matter of course, the injection needle 10 for injecting a drug solution can be easily used. In addition, the water retaining function of the agar can prevent the coating agent from drying during preparation for use.

[0048]

[Embodiment 6] A packaging container 20 of an injection needle 10 formed by applying a coating agent for an injection needle is a body 21 made of a resin material that can be appropriately elastically deformed, and the body 21 is hermetically sealed. It is a closed container including a cap lid 22 that engages with it (FIGS. 3 and 4).

The main body 21 is a bottomed cylindrical body that is narrowed down in two stages so that the diameter gradually decreases from the opening side to the tip side, and the large diameter portion 21b and the intermediate portion 21 are sequentially arranged from the opening side.
c and a liquid storage portion 21d are formed. At this time, the inner diameter of the large-diameter portion 21b of the main body 21 is equal to the connecting pipe 12 of the injection needle 10.
The large diameter portion 12b can be received in a loosely fitted state, the inner diameter of the intermediate portion 21c of the main body 21 can tightly receive the intermediate portion 12c of the connecting pipe 12, and the inner diameter of the liquid storage portion 21d is The size is set to be about 3 to 5 times the outer diameter of the needle 11. The outer peripheral portion of the opening side of the large diameter portion 21b of the body 21, an annular flange 21a is formed, the flange 21a, the groove C ₁ to go around the flange 21a is engraved.

On the other hand, the cap lid 22 has an upper bottom surface 22c.
And a peripheral portion 22b having a flange 22a on the opening side, which is a cap-like body, and can be airtightly integrated with the main body 21 via the flange 22a. That is, the inner diameter of the flange 22a is the outer diameter of the main body 21 side of the flange 21a, approximately equal to the inner surface of the flange 22a, the annular ridge C ₂ corresponding to the groove C ₁ is formed. Further, the inner diameter of the peripheral portion 22b is equal to the flange 21a on the main body 21 side.
The size is set to be slightly smaller than the outer diameter.

The main body 21 and the cap lid 22 have their flanges 21a and 22a overlapping each other in the longitudinal direction of the main body 21, and the end surface of the flange 21a on the main body 21 side and the end surface of the peripheral portion 22b on the cap 22 side. Are overlapped with each other, and the ridge C ₂ is fitted in the groove C ₁ so that they can be detachably integrated.

Such a packaging container 20 can basically be used in two ways (FIG. 5). Essentially, the needle 11 accommodates the injection needle 10 in which any kind of coating agent is applied. The intermediate portion 12c of the connecting pipe 12 is fitted into the intermediate portion 21c of the main body 21 by dropping the injection needle 10 into the main body 21 of the packaging container 20 with the needle 11 facing downward and urging it downward. Can be crowded. At this time, the vertical position of the injection needle 10 is determined by the fact that the large diameter portion 12b of the connecting pipe 12 cannot advance into the intermediate portion 21c of the main body 21. After accommodating the injection needle 10 in the main body 21, by closing the opening of the main body 21 using the cap lid 22, the injection needle 10 is isolated from the outside air as a hermetically-sealed packaging container 20 and the injection needle 10 is protected from various germs. It is possible to prevent the adhesion of fine dust and prevent the coating liquid from being dried and deteriorated by oxidation.

As another usage of the packaging container 20, in addition to allowing the injection needle 10 to be hermetically sealed and placed in the storage and distribution process, at the same time, used as a container for applying a coating agent to the needle. You can

In this case, in the liquid storage portion 21d of the main body 21,
For example, the coating agent is injected until reaching the level L ₁ , and then the injection needle 10 is housed and used. At this time, the level L ₁ at which the coating agent should be injected is such that the liquid level of the coating agent rises to about the level L ₂ when the injection needle 10 is stored, and the type of coating agent and the thickness of the needle 11. Determined in consideration of

That is, in the relationship between the coating agent and the needle 11, when the needle 11 is not wet with the coating agent, the coating agent does not enter the inside of the needle 11 and the coating agent removed by the needle 11 When the needle 11 is easily wetted by the coating agent although the amount is large and the liquid level of the coating agent changes greatly, the coating agent is repelled by the needle 11 when the coating agent enters the inside of the needle 11. Therefore, the change of the liquid surface level becomes small.

In any case, the liquid storage section 2 formed thinly
The coating agent injected into 1d entered a long space having a small cross-sectional area formed between the needle 11 located at the center of the liquid storage portion 21d and the peripheral wall of the main body 21 forming the liquid storage portion 21d. Since it is in a state, it is constrained in the liquid storage portion 21d by a capillary phenomenon caused by the relationship between the void and the coating agent as a liquid. Therefore, the coating agent does not flow out from the inside of the liquid storage portion 21d to other space portions even if the entire packaging container 20 is turned over. The inner diameter of the liquid storage portion 21d is 3 that of the outer diameter of the needle 11.
About 5 times to 5 times is a range in which the needle 11 can be easily housed and is a convenient size setting for causing a capillary phenomenon. The size setting must be based on the outer diameter of the needle 11. It is not something that must be done. Further, it is preferable that the size of the liquid storage portion 21d is set so that the capillary phenomenon occurs in a state where the injection needle 10 is not stored.

By using the packaging container 20 in this way, when the injection needle 10 is taken out from the packaging container 20, a state in which the coating agent is applied to the needle 11 is realized.
The step of applying the coating agent to the needle 11 can be omitted. However, when the coating agent is used by such a method and the coating agent has penetrated into the inside of the needle 11, after attaching the injection needle 10 to the syringe barrel, the piston of the syringe barrel is advanced to move the needle 11 It is desirable to discharge the coating material inside.

[0058]

The effects of each invention resulting from the above explanation are as described below.

The coating composition for injection contains a local anesthetic as its main component, and by applying it to an injection needle, the local anesthetic is directly acted on the needle wound, So-called painless injection can be easily achieved.

A coating agent for an injection needle in which a vasoconstrictor is used in combination with a local anesthetic as a main component has a synergistic effect between the local anesthetic and the vasoconstrictor, that is, the vasoconstrictor causes the blood vessels around the needle wound to contract. As a result, the local anesthetic can be retained in place and the effect duration of the local anesthetic can be lengthened.

When the coating agent for the injection needle contains a water-retaining material, the water-retaining material can hold an aqueous solution containing an active ingredient such as a local anesthetic, so that the coating agent can be dried during storage or preparation for use. Can be prevented,
It is possible to improve the practicality in various medical fields that must deal with various actual situations.

In the coating agent for injection needles using oil and fat as a solvent, in addition to the pharmacological pain-relieving effect of a local anesthetic,
Since the friction between the injection needle and the biological tissue can be reduced by the anti-friction action of the oil and fat, the physical pain reducing effect can be exerted together and the injection with less pain can be realized.

An injection needle obtained by applying a coating agent for an injection needle on the surface of a needle is a ready-made product such as a ready-to-use needle in a medical field without the need to apply the coating agent. Similarly, it can be used easily.

In the packaging container for the injection needle, a portion corresponding to the needle of the injection needle to be stored is formed as a thin reservoir, so that when the injection needle coated with the coating agent is stored, the air around the coating agent is stored. Since it is possible to suppress the amount of the coating agent to a minimum, it is possible to prevent the coating agent from being dried and deteriorated over a long period of time and to realize a stable storage state of the injection needle. In addition, the packaging container can hold the coating agent in the liquid storage part by utilizing the capillary phenomenon, so store and store the injection needle that does not apply the coating agent in the packaging container filled with the coating agent. With this, when the needle is taken out of the packaging container during use, the condition after applying the coating agent to the needle is obtained, so that the needle can be stably distributed and stored, and the needle can be applied to the needle. The step of applying the agent can be omitted.

[Brief description of the drawings]

FIG. 1 is an overall perspective view of an injection needle

FIG. 2 is a front view of the main part of the injection needle.

FIG. 3 is an overall perspective view of a packaging container

FIG. 4 is a vertical sectional view of the packaging container.

FIG. 5 is an explanatory view of the usage state of the packaging container.

[Explanation of symbols]

 R ... Coating agent 10 ... Injection needle 11 ... Needle 20 ... Packaging container 21 ... Main body 21d ... Liquid storage part 22 ... Cap lid

Claims (6)

[Claims] 1. A coating agent for an injection needle, which comprises a local anesthetic as a main component. 2. The coating composition for an injection needle according to claim 1, which contains a vasoconstrictor. 3. The method according to claim 1, which contains a water retention material.
The coating agent for the injection needle described. 4. The coating agent for an injection needle according to claim 1 or 2, wherein oil or fat is used as a solvent. 5. An injection needle obtained by applying the coating composition for an injection needle according to any one of claims 1 to 4 on the surface of the needle. 6. A main body for accommodating an injection needle, and a cap lid which is airtightly engaged with the main body, wherein the main body is provided with a liquid storage part which is thinly formed corresponding to the needle of the injection needle. The packaging container for the injection needle according to claim 5.