JP3976635B2 - Syringe for kit preparation, intermediate sliding valve for syringe-type kit preparation, syringe-type kit preparation, and X-ray contrast agent kit preparation - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention has an internal sliding valve slidable inside, and another sliding valve (plunger sliding valve or other intermediate sliding valve) in a syringe barrel on the plunger operating side of the intermediate sliding valve. ) Syringe-type kit formulation having a pre-filled drug solution in the space formed together with the kit formulation syringe that enables such a kit formulation, an intermediate sliding valve for the syringe-type kit formulation, and a kit formulation for an X-ray contrast agent About.
[0002]
[Prior art]
Syringe-type kit preparations are pre-filled with the necessary drug solution in the syringe, so it is not only possible to operate quickly, but it is also necessary to aspirate the drug solution from an ampoule or vial into the syringe barrel as with conventional injections. Therefore, there is no risk of contamination such as glass powder and rubber pieces, and it is an excellent technology having many advantages such as prevention of medical accidents such as infection in advance.
[0003]
Here, for example, two or more kinds of drugs having different physical, chemical or pharmacological properties are required for treatment, but these drugs cannot be used as a mixed solution due to problems such as ensuring stability. (For example, a combination of an acidic drug and an alkaline drug), or in order to give severe pain to the administration site at the time of injection of a therapeutic drug (second drug solution), the second drug solution is administered for the purpose of pain relief. A device in which a local anesthetic is administered as a first drug solution in advance is known.
[0004]
Among these, as the latter example, the first drug solution such as knee osteoarthritis and shoulder periarthritis is a local anesthetic such as lidocaine hydrochloride, the influence of the thickness of the injection needle, the pH and osmotic pressure ratio are the body fluid It is very different, and treatments such as sodium hyaluronate that may cause severe pain to the affected part of the patient due to doctors' inferior techniques, etc. A typical example is a combination with a known induction anesthetic (propofol).
[0005]
As such a syringe-type kit preparation, a syringe-type kit using a serial sequential dispensing type syringe that can be sequentially injected without mixing two or more kinds of drugs in one injection operation by the present inventors. The preparation will be described.
[0006]
Fig.1 (a) is a model figure which shows the example of the syringe type kit formulation using the serial sequential dispensing type syringe which can inject two types of chemical | medical agents by one operation.
[0007]
The syringe of the kit preparation shown here has one intermediate slide valve 3 and one syringe valve 1 in the syringe barrel 1 having an injection needle connecting portion 1a at one end and an opening at the other end of the plunger operation side. The plunger sliding valve 2 is accommodated, and the inside of the syringe barrel 1 is partitioned watertight before and after the sliding valves 2 and 3. Further, the syringe needle mounting portion 1a of the syringe barrel 1 is sealed with a cap 4 made of an elastomeric material, and the first drug solution 5 is placed in the syringe barrel needle side space of the intermediate slide valve 3 in the intermediate slide valve 3. And the plunger slide valve 2 are filled with the second chemical 6 respectively. In this example, a detachable plunger operating portion 2 a is attached to the plunger sliding valve 2.
[0008]
In the vicinity of the syringe needle side end on the side surface of the syringe barrel 1 of this syringe, a communication passage 1c is provided in which a part of the side wall protrudes in the radial direction with respect to the syringe barrel axis.
[0009]
The intermediate sliding valve 3 ′ is substantially cylindrical as shown in FIG. 2 (a) as viewed from the front side in the traveling direction and as viewed from the rear side in the traveling direction in FIG. 2 (b). One annular lip 3a 'that goes around in the circumferential direction is provided on the side (rear side in the advancing direction). This annular lip 3a' abuts against the inner wall of the syringe barrel 1, and the space before and after the syringe barrel is partitioned in a watertight manner. is doing. On the other hand, the side of the intermediate slide valve 3 ′ is in contact with the inner wall of the syringe barrel 1 on the side of the syringe barrel (traveling direction side), and the axis is injected even when the substantially cylindrical intermediate slide valve 3 ′ slides. A holding portion 3 b ′ is provided so as to coincide with the axis of the cylinder 1. Unlike the annular lip 3a ′, the holding portion 3b ′ does not go around the side surface of the intermediate sliding valve 3 ′, but between the annular lip 3a ′ on the side surface of the intermediate sliding valve 3 ′ and the holding portion 3b ′. This space communicates with and is integrated with the space on the syringe needle side of the intermediate slide valve 3 ′, so that the first space is the same as the space between the syringe needle side space, the intermediate slide valve, and the plunger slide valve. The chemical solution 5 is filled.
[0010]
Here, when an intermediate sliding valve having two or more annular lips is used instead of the intermediate sliding valve having such a shape, a sealed space formed by the intermediate sliding valve and the inner wall of the syringe barrel 1 is formed. Although air may be trapped and injected into the subject's body by an injection operation, such an inconvenience can be avoided by an intermediate sliding valve having only one annular lip. Further, a convex portion 3c ′ is provided on the bottom surface of the intermediate sliding valve 3 ′ in the traveling direction.
FIG.1 (b) is sectional drawing (model figure) in LL of Fig.1 (a).
[0011]
Prior to use of such a kit preparation, the injection needle 7 is attached to the injection needle connecting portion 1a of the injection cylinder 1 as shown in FIG.
[0012]
At this time, when air bubbles are generated in the first drug solution 5 by an injection needle mounting operation or the like, the air bubbles can be removed by operating the plunger operation portion 2a with the injection needle side up. In addition, when especially reducing the injection amount of the 1st chemical | medical solution 5, the amount of the 1st chemical | medical solution 5 is reduced by operating the plunger operation part 2a at this stage.
[0013]
Next, the injection needle 7 is stabbed into the injection site, and then the plunger operation section 2a is moved to the syringe barrel 1 needle mounting side to inject the first drug solution 5 (see FIG. 3A).
[0014]
Thereafter, when the operation of the plunger operation unit 2a is further continued, the second drug solution 6 is injected into the injection required site. At this time, the intermediate sliding valve 3 ′ moves toward the syringe barrel needle and reaches the tip of the syringe barrel. However, since the convex portion 3c ′ provided on the intermediate slide valve 3 ′ contacts the syringe barrel bottom 1b, Since the intermediate slide valve 3 'does not adhere to the syringe barrel bottom 1b and the communication passage 1c is bypassed, even if these slide valves move toward the syringe barrel bottom 1b, A supply passage to the injection needle 7 is secured.
[0015]
FIG. 3B shows a state (injection completion state) in which the operation of the plunger operation unit 2a is finished and the injection of the second chemical liquid 6 is finished. Normally, the injection needle is removed from the injection site in this state. However, when the injection amount of the second drug solution 6 is reduced, the injection needle is inserted with the second drug solution 6 remaining in the syringe barrel 1. You can unplug it.
[0016]
In such a serial sequential dispensing syringe type kit formulation, when the first drug solution is a local anesthetic and the second drug solution is a therapeutic drug, the second drug solution is injected at the site where the first drug solution 5 is injected. Therefore, even if the second drug solution 6 is greatly different in pH, osmotic pressure, temperature, and the like as compared with the body fluid, the injection can be performed without pain or with less pain.
[0017]
However, such serial sequential dispensing syringes also have drawbacks.
That is, the space between the side surface of the intermediate sliding valve and the inner surface of the syringe barrel becomes a dead volume, and the drug solution existing in this space does not contribute to the injection. Here, some injections are expensive such as several thousand yen to several tens of thousands of yen per ml, and the price may not be negligible. This is particularly noticeable when a large-bore syringe is used when the injection volume per injection is as large as 100 ml as in the case of an X-ray contrast medium.
[0018]
However, if the holding portion 3b ′ is increased in order to reduce the dead volume, the contact area with the inner wall of the syringe barrel increases, and as a result, the sliding resistance of the intermediate sliding valve increases and the operability is significantly deteriorated. Alternatively, in order to reduce the dead volume without enlarging the holding part 3b ', if the thickness of the space formed between the side surface of the intermediate sliding valve and the inner surface of the syringe barrel is reduced, the drug solution filling at the time of manufacturing the kit preparation Sometimes the atmosphere gas, such as air, is trapped as bubbles in the space and cannot be easily removed, and the gas may be injected at the time of injection, resulting in frequent defective products and increased productivity. Not only is it reduced, but the reliability as a pharmaceutical kit preparation is also significantly reduced.
[0019]
Here, the syringe itself is a conventional one (one having no communication passage), provided that a hollow portion is provided in the intermediate slide valve, and the intermediate is made by the pressure of the rear liquid when the front liquid injection operation is completed. Techniques have been proposed in which a part of the sliding valve is deformed to form a fluid passage between the side surface and the inner wall of the syringe barrel (Japanese Patent Laid-Open Nos. 10-57486 and 10-80485). Issue gazette).
[0020]
However, since the formation condition of the fluid passage due to the deformation of the intermediate slide valve depends on the dynamic pressure applied to the intermediate slide valve and the flexibility of the material forming the intermediate slide valve, the formation of the fluid passage is extremely hot. Depending on conditions such as how to apply the operator's force, the viscosity and temperature of the drug, and the thickness of the injection needle to be used, it is always accompanied by the risk of malfunction and its reliability. The performance is extremely low, and it has not been able to sufficiently meet the required performance of reliably sequentially injecting a plurality of drugs in one injection operation.
[0021]
[Problems to be solved by the invention]
The present invention improves the above-mentioned conventional problems, that is, it is possible to inject a plurality of medicines sequentially and reliably with a single injection operation, good operability, and possible mixing of bubbles when filling with a chemical solution An object of the present invention is to provide a syringe for kit preparation that has a low dead volume that causes a chemical solution that does not contribute to injection and has a very small dead volume, and an intermediate sliding valve that enables such a syringe for kit preparation.
[0022]
[Means for Solving the Problems]
In order to solve the above-mentioned problem, the syringe for kit preparation of the present invention has a substantially cylindrical shape as defined in claim 1 and is partitioned watertight together with the inner wall of the syringe barrel when inserted into the syringe barrel on the side surface thereof. An intermediate sliding valve having a concave portion that forms a space, the intermediate sliding valve plunger operating side formed when the intermediate sliding valve is inserted into the syringe barrel independently of the concave portion A passage for the backward medicinal solution from the inner space of the syringe barrel to the front side further than the most concave portion on the front side of the intermediate slide valve in the advancing direction of the intermediate slide valve, on the surface of the side surface of the intermediate slide valve in contact with the inner wall of the syringe barrel An intermediate slide valve is slidable inside the syringe barrel, and
Near the injection needle side end of the inner wall of the syringe barrel, when the intermediate slide valve reaches the most needle side in the syringe barrel, it is connected to the rear drug solution passage of the intermediate slide valve, and the rear drug solution Kit formulation having a communication passage capable of bypassing the intermediate sliding valve and supplying the liquid medicine on the plunger operating side of the intermediate sliding valve to the in-cylinder injection needle side of the intermediate sliding valve when connected to the use passage It is a syringe.
[0023]
With such a configuration, while the sliding resistance is reduced by the recess formed on the side surface of the intermediate sliding valve, the water-tight space formed by the recess and the inner wall of the syringe barrel is not filled with the chemical solution, which is wasteful. In addition, since the rear chemical liquid passage is provided independently of the concave portion, there is no possibility that air or the like enters the passage.
[0024]
In addition, since the tip of the rear drug solution passage is provided on a surface of the side surface of the intermediate slide valve that contacts the inner wall of the syringe barrel, the slide valve itself slides in the syringe barrel and reaches the vicinity of the syringe needle side end. Unless the rear chemical liquid passage is connected to the communication passage provided near the injection needle side end of the inner wall of the syringe barrel, the chemical liquid behind the intermediate sliding valve is supplied in the forward direction of the intermediate sliding valve. Nevertheless, it is extremely reliable. Furthermore, since the rear chemical solution passage is further to the top side of the concave portion than the most concave portion in the traveling direction of the intermediate slide valve, the communication passage and the rear chemical solution in a state where the communication passage and the concave portion are not connected to each other. It is possible to ensure the connection with the passage. At that time, the gas existing in the space between the recess and the inner wall of the syringe barrel does not connect with the communication passage. Yes.
[0025]
DETAILED DESCRIPTION OF THE INVENTION
The intermediate sliding valve in the present invention is not a sliding valve that is directly driven by a plunger, but a sliding valve that is indirectly driven by a chemical solution on the rear side in the traveling direction. An intermediate slide valve having a recess that forms a watertight compartment with the inner wall of the syringe barrel when inserted into the syringe barrel, the intermediate slide valve being independent of the recess From the space inside the syringe barrel on the side of the operation of the intermediate slide valve plunger, which is formed when inserted into the inside, into the surface of the intermediate slide valve that is in contact with the inner wall of the syringe barrel in the recess in the direction of travel of the intermediate slide valve It is necessary to provide a passage for the backward chemical solution that extends further to the top side than the most concave portion on the top side.
[0026]
An example α of the intermediate sliding valve according to the present invention is shown in FIGS. 4 (a) to 4 (c).
4A is a side view, FIG. 4B is a perspective view from the rear in the sliding valve traveling direction, and FIG. 4C is a perspective view from the front in the sliding valve traveling direction. The intermediate sliding valve α is used as a rear chemical liquid passage, and a rear chemical liquid inlet α1 that opens into a syringe operating space on the plunger operation side that is formed when the intermediate sliding valve α is inserted into the syringe. Of the recesses on the side of the valve operating side that is in contact with the inner wall of the syringe barrel, the foremost side of the recesses α4 (there is only one in this example, but there may be a plurality of them) The rear chemical solution outlet α2 that opens at a location, and the communication hole α3 that is formed in the sliding valve α itself that connects the rear chemical solution inlet α1 and the rear chemical solution outlet α2 are formed. The rear chemical liquid passage is provided independently of the concave portion α4 provided for the purpose of improving the slidability of the intermediate sliding valve. In this example, three rear chemical liquid passages are provided so as to be equiangular (120 °) with respect to the substantially cylindrical intermediate sliding valve α. The cross-sectional area of the rear drug solution passage is usually sufficient if it is equal to or larger than the cross-sectional area of the inner diameter of the injection needle to be used, and the smaller the amount, the smaller the amount of remaining drug solution.
[0027]
4 (d) to 4 (f) show an example β of another intermediate sliding valve according to the present invention.
4D is a side view, FIG. 4E is a perspective view from the rear in the sliding valve traveling direction, and FIG. 4F is a perspective view from the front in the sliding valve traveling direction.
[0028]
In this intermediate slide valve β, the rear chemical liquid passage β1 is provided in a groove shape on the side surface of the intermediate slide valve β, and a recess β2 provided for the purpose of improving the slidability of the intermediate slide valve and Are provided independently, and the tip of the rear chemical liquid passage β1 in the direction of travel of the sliding valve β is located further to the front side than the concave portion β2. Also in this example, three rear chemical liquid passages are provided so as to be equiangular (120 °) with respect to the substantially cylindrical intermediate sliding valve β. The cross-sectional area of the rear drug solution passage is usually sufficient if it is equal to or larger than the cross-sectional area of the inner diameter of the injection needle to be used, and the smaller the amount, the smaller the amount of remaining drug solution.
[0029]
4 (g) to 4 (i) show a normal plunger sliding valve (sliding valve directly driven by the plunger) γ.
4 (g) is a side view, FIG. 4 (h) is a perspective view from the rear in the sliding valve traveling direction, and FIG. 4 (i) is a perspective view from the front in the sliding valve traveling direction.
[0030]
The plunger slide valve is provided with a recess γ1 for reducing the sliding resistance like the slide valves α and β, but is not provided with a rear chemical liquid passage. In addition, γ2 is a fitting hole that fits into the fitting portion at the distal end of the injection needle side of the plunger operation portion (not shown).
[0031]
The intermediate sliding valve according to the present invention as described above is slidably accommodated in the syringe barrel 1 as shown in a sectional view in FIG. 5A and in a perspective view in FIG. .
The syringe barrel 1 has an injection needle connection portion 1a at the center of the bottom surface on the injection needle side at one end, and an opening at the plunger operation side end at the other end.
[0032]
Near the injection needle side end of the inner wall of the syringe barrel 1, the intermediate slide valve according to the present invention is connected to the rear drug solution passage of the intermediate slide valve when reaching the most injection needle side in the syringe barrel, and A communication passage that bypasses the intermediate sliding valve and can supply the liquid medicine on the plunger operating side of the intermediate sliding valve to the syringe needle side of the intermediate sliding valve when connected to the rear chemical solution passage 1c is provided. In this example, the communication passage 1c is provided so as to make a round in the circumferential direction of the inner wall of the syringe barrel 1, but the rear drug solution passage 1d has a substantially cylindrical shape like the slide valve α or β according to the present invention described above. When three are provided so as to be equiangular (120 °) with respect to the intermediate sliding valve, it is sufficient if the circumferential sliding valve is provided to be more than 120 ° (for example, 130 to 140 °). is there.
[0033]
Further, when the intermediate slide valve is located closest to the injection needle on the bottom of the syringe barrel 1, the intermediate slide valve is connected to the in-cylinder injection needle side (intermediate slide valve) by the communication passage 1c connected to the rear drug solution passage. Groove-shaped injection needle side surface liquid for supplying the liquid medicine on the plunger operating side (backward in the intermediate sliding valve advance direction) of the intermediate sliding valve supplied to the forward direction (forward direction) to the liquid introduction hole 1a1 to the injection needle. Four passages 1d are provided at the same angle (90 °) with respect to the substantially cylindrical syringe barrel 1 on the bottom surface of the syringe barrel 1 on the injection needle side. However, it is usually sufficient to provide one injection needle side liquid passage 1d, and the cross-sectional area of the passage is equal to or greater than the cross-sectional area of the inner diameter of the injection needle to be used (preferably 1.5 times to 2 times) is usually sufficient, and the smaller the amount, the smaller the amount of remaining chemical solution.
[0034]
FIGS. 6A to 6C show Example 2 of the plunger sliding valve used together.
6A is a side view, FIG. 6B is a perspective view from the rear in the sliding valve traveling direction, and FIG. 6C is a perspective view from the front in the sliding valve traveling direction.
[0035]
By adapting the front surface of the plunger sliding valve in the traveling direction to the shape of the rear surface in the traveling direction of the intermediate sliding valve to be used, the amount of the chemical remaining between these sliding valves can be reduced. In addition, a fitting hole (shown as a model) that fits in the fitting portion at the distal end of the plunger operating portion (not shown) of the plunger operating portion (not shown) is visible at the center of the rear surface in the traveling direction of the intermediate sliding valve in FIG. It is.
[0036]
FIG. 7A shows an example of a syringe-type kit preparation using the serial sequential dispensing syringe according to the present invention produced using the intermediate sliding valve α, the syringe cylinder 1 and the plunger sliding valve 2 as described above. Shown in model cross section.
[0037]
The kit preparation shown in FIG. 7 has one intermediate sliding valve α and one plunger in a syringe barrel 1 having an injection needle connecting portion 1a at one end and an opening at the other end of the plunger operation side. The sliding valve 2 is slidably housed, and the inside of the injection cylinder 1 is partitioned watertight before and after the sliding valves α and 2. Further, the syringe needle mounting portion 1a of the syringe barrel 1 is sealed with a cap 4 made of an elastomeric material, and the first drug solution 5 is placed in the space on the syringe barrel needle side of the intermediate slide valve α. And the plunger slide valve 2 are filled with the second chemical 6 respectively.
[0038]
Prior to the use of such a kit preparation, the injection needle 7 is attached to the injection needle connecting portion 1a of the injection cylinder 1 as shown in FIG. 7 (b) (in addition to the injection needle 7, a tube, a stopcock, etc.) Accessories may be connected). A plunger operating portion 2 a is attached to the plunger sliding valve 2.
[0039]
At this time, when air bubbles are generated in the portion of the first drug solution 5 by an injection needle mounting operation or the like, the air bubbles can be removed by operating the plunger operation portion 2a with the injection needle side up. In addition, when especially reducing the injection amount of the 1st chemical | medical solution 5, the amount of the 1st chemical | medical solution 5 is reduced by operating the plunger operation part 2a at this stage.
[0040]
Next, the injection needle 7 is stabbed into the injection site, and then the plunger operation section 2a is moved to the injection cylinder 1 injection needle side to inject the first drug solution 5 (see FIG. 7 (c)).
[0041]
Thereafter, when the operation of the plunger operation unit 2a is further continued, the second drug solution 6 is injected into the injection required site. At this time, the intermediate slide valve α moves to the syringe barrel injection needle side and reaches the tip of the syringe barrel (most side of the syringe needle) (see FIG. 8A).
[0042]
At this time, the rear chemical solution outlet α2 of the rear chemical solution passage of the intermediate slide valve α is connected to the communication passage 1c provided near the injection needle side end of the inner wall of the syringe barrel 1, and the communication passage 1c is further connected to the syringe barrel 1. Since it is connected to the injection needle side surface fluid passage 1d provided on the bottom surface of the injection needle, the rear chemical solution 6 in the plunger operation side space of the intermediate slide valve α is connected to the communication hole α3 from the rear chemical solution inlet α1 of the rear chemical solution passage. It is introduced into the injection needle through the rear drug solution outlet α2, the communication passage 1c, and the injection needle side surface liquid passage 1d. Note that when the intermediate slide valve α does not reach the tip of the syringe barrel 1, the rear chemical solution outlet α2 is sealed by the inner surface of the syringe barrel 1, so that the middle of the rear chemical solution 6 in the plunger operation side space of the intermediate slide valve α is provided. The sliding valve does not move toward the injection needle in the syringe barrel.
[0043]
FIG. 9 shows a state (injection completion state) in which the operation of the plunger operation unit 2a is completed and the injection of the second drug solution 6 is completed. Usually, the injection needle is removed from the injection site in this state, but when the injection amount of the second drug solution 6 is reduced, the injection needle is inserted in the state where the second drug solution 6 remains in the syringe barrel 1. You can unplug it.
[0044]
In such a serial sequential dispensing syringe type kit formulation, when the first drug solution is a local anesthetic and the second drug solution is a therapeutic drug, the second drug solution is injected at the site where the first drug solution 5 is injected. Therefore, even if the second drug solution 6 is greatly different in pH, osmotic pressure, temperature, and the like as compared with the body fluid, the injection can be performed without pain or with less pain.
[0045]
Although the example using the intermediate sliding valve α according to the present invention has been described above, the operation is the same even when the intermediate sliding valve β according to the present invention is used, except that FIG. ) In the plunger operation side space of the intermediate sliding valve α is from the rear chemical solution inlet α1 to the communication hole α3 and the rear chemical solution outlet α2, the communication channel 1c, and the injection needle side surface liquid. As shown in FIG. 8 (b), the introduction into the injection needle through the passage 1d is a groove-shaped rear drug solution passage β1, communication passage 1c, injection needle side surface liquid provided on the side surface of the intermediate slide valve β. It is introduced into the injection needle through the passage 1d.
[0046]
Further, in the intermediate sliding valve β according to the present invention, an example of the introduction of the rear fluid of the intermediate sliding valve through the communication hole that has opened the intermediate sliding valve itself as the rear chemical liquid passage by the intermediate sliding valve α according to the present invention. Examples of the introduction of the rear liquid of the intermediate sliding valve by the groove provided on the side surface of the intermediate sliding valve as the rear chemical liquid passage are shown, for example, as shown in FIGS. 10 (a) and 10 (b), The rear liquid of the intermediate sliding valve may be introduced as a rear chemical liquid passage by using a groove and a communication hole together (the order of the groove and the communication hole may be reversed). include.
[0047]
In the present invention, the movement of the intermediate slide valve in the syringe barrel is caused by the pressure applied via the rear drug solution, but the rear drug solution passage is connected to a communication passage provided near the injection needle side end of the syringe barrel inner wall. Since the pressure suddenly drops at the moment, the movement of the intermediate sliding valve is not performed before the cross-sectional area of the connecting portion between the rear drug solution passage and the communication passage does not become larger than the inner cross-sectional area of the used injection needle. It may stop, and a very large force may be required for the subsequent operation of the plunger.
[0048]
In order to eliminate such an inconvenience, it is desirable to provide an enlarged portion that enlarges the rear chemical liquid passage in the circumferential direction of the sliding valve side surface at the foremost side of the rear chemical liquid passage in the intermediate sliding valve traveling direction.
[0049]
Examples of such an intermediate sliding valve are shown in FIGS.
FIG. 11 (a) to FIG. 11 (c) show α ′ provided with an enlarged portion α5 ′ that enlarges the rear chemical liquid passage in the circumferential direction of the side surface of the sliding valve in an example α of the intermediate sliding valve according to the present invention. 11 (d) to 11 (f) show β ′ provided with an enlarged portion β3 ′ that expands the rear chemical liquid passage in the circumferential direction of the side surface of the sliding valve in an example β of the intermediate sliding valve according to the present invention. The reference numerals in these figures correspond to the reference numerals in FIGS. 4A to 4F without “′”.
[0050]
The syringe cylinder 1 used above has a groove-shaped injection needle side liquid passage 1d on the injection needle side bottom surface, but the groove-shaped injection needle side liquid passage is formed on the injection needle side bottom surface of the injection cylinder. For example, a groove-like injection needle side liquid passage may be provided on the front side surface in the traveling direction of the intermediate sliding valve. Examples of such an intermediate sliding valve are shown in FIGS. .
[0051]
12 (a) to 12 (c) show an example of an intermediate sliding valve α according to the present invention with α ″ provided with a groove-like injection needle side liquid passage α6 ″ on the front side surface in the traveling direction of the intermediate sliding valve. 12 (d) to FIG. 12 (f), an example of the intermediate sliding valve according to the present invention β is provided with a groove-like injection needle side liquid passage β4 ″ on the front side surface in the traveling direction of the intermediate sliding valve. Indicates. The reference numerals in these figures correspond to the reference numerals in FIG. 4A to FIG.
[0052]
By means of a groove-shaped injection needle side liquid passage provided on the front side surface in the direction of travel of these intermediate slide valves, the intermediate slide valve reaches the most injection needle side in the injection cylinder, and the injection needle side surface is the injection cylinder injection needle. The liquid flow between the communication passage provided near the injection needle side end of the inner wall of the syringe barrel and the liquid introduction hole to the injection needle provided on the syringe barrel injection needle side bottom surface also when closely attached to the side bottom surface Is secured. The cross-sectional area of the injection needle side surface fluid passage is preferably equal to or larger than the inner diameter cross-sectional area of the used injection needle. In the above example, there are three injection needle side liquid passages, but one is usually sufficient.
[0053]
Further, instead of the groove-shaped injection needle side surface fluid passage, even when the intermediate sliding valve moves to the most injection needle side, it does not adhere to the injection needle side bottom surface of the syringe barrel, and from the communication passage to the injection needle. A convex portion may be provided on the front side surface in the traveling direction of the intermediate sliding valve so as to ensure the liquid flow, and such an example is shown in FIGS. The intermediate sliding valve β ″ ′ has the above-described intermediate anti-protrusion β5 ″ ′ that prevents the intermediate sliding valve from contacting the bottom surface of the syringe syringe needle even when the intermediate slide valve reaches the most syringe needle in the syringe barrel. The sliding valve β is provided on the front side surface in the traveling direction of the intermediate sliding valve. However, securing the liquid passage by the adhesion prevention convex portion tends to increase the dead volume more than the other examples described above, and the amount of the chemical solution that is wasted at that time increases.
[0054]
Here, as an application example of the syringe for a kit preparation as described above, there is a kit preparation for an X-ray contrast medium.
That is, two or more spaces that are watertightly partitioned by an intermediate sliding valve or a plunger sliding valve inserted into the syringe barrel are filled with a chemical solution in advance, and the chemical solutions are sequentially mixed without being mixed by the operation of the plunger. In a kit preparation using a serial sequential dispensing syringe to be discharged, one drug solution is a drug solution having an X-ray contrast agent, and a drug solution having no X-ray contrast agent after discharge of the drug solution having the X-ray contrast agent Is an X-ray contrast medium kit preparation.
[0055]
At this time, the medicinal solution having no X-ray contrast agent is various effects because it is one or a mixture of two or more selected from physiological saline, blood substitutes other than physiological saline, vitamins, and distilled water. can get.
[0056]
For example, in the kit preparation shown in FIG. 7, 70 mL of an X-ray contrast agent is filled as the first drug solution 5, and physiological saline, blood substitutes other than saline, vitamins, distilled water are used as the second drug solution The mixture is filled with 30 mL of one kind or a mixture of two or more kinds. Here, as a blood substitute, for example, physiological saline, sodium chloride injection, dextran injection, ammonium chloride injection, potassium chloride injection, hydroxyethyl starch injection, dipotassium phosphate injection, starting solution (salt chloride) Sodium / glucose, etc.), glucose / dextran, maintenance liquid (sodium lactate / inorganic salts / sugar), postoperative recovery liquid, dehydration replenisher, Ringer's acetate, Ringer's solution, mannitol combination, and the like. That is, the second drug need not have a large medicinal / physiological effect, and has the following three main purposes.
[0057]
1. An X-ray contrast medium is often introduced into a subject's body via an extension tube or a catheter. The internal volume of the tube and catheter becomes a dead volume, and the chemical solution remains. Therefore, in the case of a kit preparation, it is necessary to fill the necessary amount to be introduced into the body plus the dead volume. However, the X-ray contrast medium is very expensive at about 20,000 yen per 100 ml, and it is not economical to fill it in excess. Here, as an X-ray contrast agent for the first drug solution, only the necessary amount to be introduced into the subject's body is filled, and even if it is introduced into the body (or blood vessel) as the second drug solution, there is no problem in pharmacological / physiological aspects. It is possible to select an object and “push out” the entire required amount including the first liquid remaining in the tube into the subject's body.
[0058]
Note that the plunger operation for introducing the X-ray contrast agent is performed in the X-ray imaging room, and thus is performed by automatic / remote control by an automatic injector. For example, serial sequential dispensing as described above is performed. By using the type injector, the operation by the conventional automatic injector is possible, and it is not necessary to purchase a new automatic injector.
[0059]
Furthermore, since it is a kit preparation as described above, it is not necessary to open the drug container, suction into the syringe, etc., and there is no concern about foreign matter contamination, bacterial / viral contamination, etc. Because there is no need to use both, it is possible to prevent bacterial and virus contamination from the stopcocks and operational errors in advance.
[0060]
2. The contrast agent remaining in the vein or venous valve after the introduction of the X-ray contrast agent may coagulate, and may cause thrombophlebitis. By introducing this, the residual of these contrast agents is prevented.
[0061]
3. It is possible to quickly extrude (flash) the contrast medium into the body, improve the contrast effect of the main blood vessels, and reduce the appearance of artifacts around the vein (virtual image). The amount of the contrast agent can be reduced, which is advantageous in terms of cost and can reduce the burden on the subject's body.
[0062]
【The invention's effect】
The syringe for a kit preparation of the present invention can reliably and sequentially inject a plurality of drugs in one injection operation, has good operability, has a low possibility of mixing bubbles when filled with a drug solution, and is injected. It is an excellent syringe for kit preparation that has a very small dead volume that causes a chemical solution that does not contribute to the drug.
[Brief description of the drawings]
BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is a model diagram showing a conventional example of a syringe-type kit preparation using a serial sequential dispensing syringe capable of injecting two kinds of drugs in one operation.
(B) It is sectional drawing (model figure) in LL of Fig.1 (a).
(C) It is a figure which shows the state with which the injection needle was mounted | worn.
FIG. 2 is a view showing an intermediate sliding valve 3 ′ according to the prior art.
(A) Perspective view seen from the front side in the direction of travel
(B) Perspective view seen from the back in the direction of travel
FIG. 3 (a) is a diagram showing a state in which the injection of the first drug solution 5 is completed.
(B) It is a figure which shows the state (injection completion state) which operation of the plunger operation part 2a was complete | finished and injection of the 2nd chemical | medical solution 6 was complete | finished.
FIG. 4 is a view showing intermediate sliding valves α and β according to the present invention and a plunger sliding valve γ according to the prior art.
(A) Side view of intermediate sliding valve α
(B) Perspective view of intermediate sliding valve α as seen from the rear side in the direction of travel
(C) Perspective view of intermediate slide valve α as seen from the front side in the direction of travel
(D) Side view of intermediate sliding valve β
(E) Perspective view of intermediate slide valve β viewed from the rear side in the direction of travel
(F) Perspective view of intermediate slide valve β viewed from the front side in the direction of travel
(G) Side view of plunger slide valve γ
(H) Perspective view of plunger sliding valve γ as viewed from the rear side in the direction of travel
(I) Perspective view of plunger sliding valve γ as seen from the front side in the direction of travel
FIG. 5 is a diagram showing an example of a syringe barrel used in the syringe for kit preparation of the present invention.
(A) Sectional view
(B) Partial perspective view seen from the injection needle mounting side
FIG. 6 is a view showing an example of a plunger sliding valve used in the syringe for kit preparation of the present invention. (A) Side view
(B) Perspective view seen from the back in the direction of travel
(C) Perspective view seen from the front side in the direction of travel
FIG. 7 (a) is a model diagram showing a syringe-type kit preparation using a serial sequential dispensing syringe according to the present invention, which can inject two kinds of drugs in one operation.
(B) It is a figure which shows the state with which the injection needle 7 and the plunger operation part 2a were mounted | worn.
(C) It is a figure which shows the state which injection of the 1st chemical | medical solution 5 was complete | finished.
FIG. 8 (a) is a partially enlarged sectional view showing a flow of the second chemical liquid when the intermediate sliding valve α according to the present invention is used.
(B) It is a partial expanded sectional view which shows the mode of the flow of the 2nd chemical | medical solution when using the intermediate | middle sliding valve (beta) which concerns on this invention.
9A is a diagram showing a state (injection completion state) in which the operation of the plunger operation unit 2a has been completed and the injection of the second drug solution 6 has been completed. FIG.
FIG. 10 is a view showing another sliding valve according to the present invention.
(A) Side view
(B) Perspective view seen from the back in the direction of travel
FIG. 11 shows an intermediate sliding valve α ′ according to the present invention having an enlarged portion for enlarging the rear chemical liquid passage in the circumferential direction of the side surface of the sliding valve at the foremost side of the rear chemical liquid passage in the traveling direction of the intermediate sliding valve; It is a figure which shows (beta) '.
(A) Side view of intermediate sliding valve α ′
(B) Perspective view of intermediate sliding valve α ′ viewed from the rear side in the direction of travel
(C) Perspective view of the intermediate sliding valve α ′ viewed from the front side in the traveling direction
(D) Side view of intermediate sliding valve β ′
(E) Perspective view of intermediate slide valve β ′ viewed from the rear side in the traveling direction
(F) Perspective view of intermediate slide valve β ′ viewed from the front side in the direction of travel
FIG. 12 is a view showing intermediate sliding valves α ″ and β ″ in which a groove-shaped injection needle side liquid passage is provided on the front side surface in the traveling direction of the intermediate sliding valve.
(A) Side view of intermediate sliding valve α ″
(B) Perspective view of intermediate sliding valve α ″ viewed from the rear side in the direction of travel
(C) Perspective view of intermediate sliding valve α ″ viewed from the front side in the direction of travel
(D) Side view of intermediate sliding valve β ″
(E) Perspective view of intermediate sliding valve β ″ viewed from the rear side in the direction of travel
(F) Perspective view of intermediate sliding valve β ″ viewed from the front side in the direction of travel
FIG. 13 is a view showing an intermediate sliding valve β ″ ′ having an adhesion preventing convex portion for preventing adhesion to the bottom surface of the syringe barrel injection needle even when it reaches the most side of the injection needle in the syringe barrel.
(A) Side view
(B) Perspective view seen from the back in the direction of travel
(C) Perspective view seen from the front side in the direction of travel
[Explanation of symbols]
1 syringe
1a Injection needle connection
1c Communication passage
2 Plunger sliding valve
2a Plunger operation part
α, β Intermediate sliding valve according to the present invention
4 Cap
5 First chemical
6 Second chemical
7 Injection needle

Claims (10)

An intermediate sliding valve having a substantially cylindrical shape and having a recess that forms a watertight compartment with the inner wall of the syringe barrel when inserted into the syringe barrel on a side surface thereof, independently of the recess The concave portion of the surface of the intermediate sliding valve that is formed when the intermediate sliding valve is inserted into the syringe barrel from the space inside the syringe barrel on the plunger operating side and that is in contact with the inner wall of the syringe barrel on the side surface of the intermediate slide valve An intermediate sliding valve provided with a rear drug solution passage further leading to the leading side than the most leading concave portion in the middle sliding valve traveling direction is slidable inside the syringe barrel, and
Near the injection needle side end of the inner wall of the syringe barrel, when the intermediate slide valve reaches the most needle side in the syringe barrel, it is connected to the rear drug solution passage of the intermediate slide valve, and the rear drug solution Having a communication passage that bypasses the intermediate sliding valve and can supply the liquid medicine on the plunger operating side of the intermediate sliding valve to the syringe needle side of the intermediate sliding valve when connected to the use passage. A syringe for a kit preparation.   2. The kit according to claim 1, further comprising an adhesion prevention convex portion that prevents adhesion to the bottom surface of the syringe barrel injection needle even when the intermediate slide valve reaches the most injection needle side in the syringe barrel. Formulation syringe.   The intermediate slide valve is provided near the injection needle side end of the inner wall of the syringe cylinder even when the intermediate slide valve reaches the most injection needle side in the syringe cylinder and the side surface of the injection needle is in close contact with the bottom surface of the syringe cylinder injection needle side. The intermediate sliding valve is provided with an injection needle side liquid passage that secures a liquid flow between the communication passage and the liquid introduction hole to the injection needle provided on the bottom surface of the syringe barrel injection needle. Item 2. The syringe for kit preparation according to Item 1.   In the intermediate slide valve for a syringe-type kit preparation, which has a substantially cylindrical shape and has a recess that forms a water-tightly partitioned space together with the inner wall of the syringe barrel when inserted into the syringe barrel on its side surface, Independently, from the space in the syringe barrel on the operation side of the intermediate slide valve plunger formed when the intermediate slide valve is inserted into the syringe barrel, An intermediate slide valve for a syringe-type kit preparation, comprising a backward medicinal solution passage extending further to the leading side than the most leading concave portion in the traveling direction of the intermediate sliding valve.   5. The syringe-type kit according to claim 4, further comprising an enlarged portion for enlarging the rear chemical liquid passage in the circumferential direction of the side surface of the sliding valve on the foremost side of the rear chemical liquid passage in the traveling direction of the intermediate slide valve. Intermediate sliding valve for pharmaceutical products.   The rear drug solution passage is formed by a rear drug solution inlet that opens into a space in the syringe barrel on the plunger operation side formed when the intermediate slide valve for syringe-type kit preparation is inserted into the syringe barrel. The rear chemical solution outlet that opens to the top side of the concave portion on the surface in contact with the inner wall of the syringe barrel that is further forward than the most front concave portion in the advancing direction of the intermediate sliding valve, and the rear chemical solution inlet and the rear chemical solution outlet communicate with each other. The intermediate slide valve for a syringe-type kit preparation according to any one of claims 4 and 5, wherein the intermediate slide valve is formed by a communication hole bored in the intermediate slide valve for a syringe-type kit preparation.   6. The syringe-type kit formulation according to claim 4, wherein the rear drug solution passage is provided in a groove shape on a side surface of the syringe-type kit formulation intermediate sliding valve. Intermediate sliding valve. An intermediate sliding valve having a substantially cylindrical shape and having a recess that forms a watertight compartment with the inner wall of the syringe barrel when inserted into the syringe barrel on a side surface thereof, independently of the recess The concave portion of the surface of the intermediate sliding valve that is formed when the intermediate sliding valve is inserted into the syringe barrel from the space inside the syringe barrel on the plunger operating side and that is in contact with the inner wall of the syringe barrel on the side surface of the intermediate slide valve An intermediate sliding valve provided with a rear drug solution passage further leading to the leading side than the most leading concave portion in the middle sliding valve traveling direction is slidable inside the syringe barrel, and
Near the injection needle side end of the inner wall of the syringe barrel, when the intermediate slide valve reaches the most needle side in the syringe barrel, it is connected to the rear drug solution passage of the intermediate slide valve, and the rear drug solution Kit having a communication passage capable of bypassing the intermediate sliding valve and supplying the liquid medicine on the plunger operating side of the intermediate sliding valve to the syringe needle side of the intermediate sliding valve when connected to the passage A syringe-type kit preparation, wherein a drug solution is filled in at least a plunger operation side space of an intermediate sliding valve of a syringe barrel of the preparation syringe. A series of two medicinal solutions filled in advance in watertight by an intermediate sliding valve or plunger sliding valve inserted into the syringe barrel, respectively, and sequentially discharged without being mixed by the operation of the plunger. In a kit preparation using a sequential injection syringe, one chemical solution is a chemical solution having an X-ray contrast agent, and a chemical solution not having an X-ray contrast agent is discharged after discharging the chemical solution having the X-ray contrast agent The syringe-type kit preparation according to claim 8, wherein 10. The chemical solution having no X-ray contrast agent is one or a mixture of two or more selected from physiological saline, blood substitutes other than physiological saline, vitamins, and distilled water. The syringe-type kit preparation described in 1.

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