JP4487307B2 - Chemical solution discharging method, chemical solution containing sealing body, and puncture type chemical solution discharging device - Google Patents

Description

  This invention contains a plurality of chemical solutions in respective compartments of the chemical solution bag in a separated state, opens a weak seal between the compartments during drip or dialysis, and mixes the chemical solutions for use. The chemical solution discharging method and system, the chemical solution containing sealing body, and the puncture type chemical solution discharging tool.

2. Description of the Related Art There are two or more liquid-mixed multi-liquid mixed type medical sealers for infusion or dialysis. In the multi-liquid mixed type chemical liquid sealed body, the internal cavity of the chemical liquid bag made of a soft film is separated into a plurality of compartments each containing different chemical liquids by a weak seal portion. A chemical solution discharge port as a plastic molded product is provided on the outer periphery of the chemical solution bag, the chemical solution discharge port is formed in a cylindrical shape, and its internal cavity opens to one compartment on one end side, but on the other end Is provided with a rubber stopper. Prior to administration of the drug solution to the patient, the weak seal is opened by pressurizing the drug solution bag from the outside, and the internal cavity of the drug solution bag becomes a single chamber, so the two types of drug solutions are mixed and connected to the tube for infusion The rubber plug is punctured by the puncture needle of the infusion set thus made, and the drug solution can be administered from the drug solution bag. In this type of medical mixed-type liquid medicine sealed body, the work of mixing the two liquids by opening the weak seal part prior to the administration of the chemical liquid is essential, while the weak seal part is opened. If the rubber stopper is punctured at the chemical solution outlet without being present, there is a possibility of an erroneous operation in which only the chemical solution in the compartment on the chemical solution outlet side is administered. As a conventional technique for coping with this problem, in addition to the first weak seal portion that separates the internal cavity of the chemical solution bag into two compartments, a second weak seal portion is provided immediately before the chemical solution outlet, It has been proposed that the second weak seal portion be equal to or higher than the pressure required for opening the weak seal portion so that the discharge is performed after mixing of the chemicals (patent) Reference 1).
JP 2004-661 A

  In the technique of Patent Document 1, in addition to the first weak seal portion that separates the two compartments, a second weak seal portion is provided immediately before the chemical solution discharge port, and these weak seal portions are sequentially opened so that they are not mixed. However, since the two weak seals are provided, the manufacturing process becomes complicated and the cost increases, and the user is forced to open the work by two stages of pressurization. The workability was not always good. In addition, depending on the method of pressurizing the chemical solution bag, the first weak seal portion is not necessarily opened in the order of the second weak seal portion, and the second weak seal portion on the chemical solution outlet side is the first. If it is opened, there is a possibility of shifting to the administration work as it is. In this case, only one solution is administered without mixing.

  The present invention has been made in view of the above problems, and provides a novel structure of a two-component mixed-type drug solution bag that cannot be administered in an unopened state. The object is to more surely eliminate the possibility of an erroneous operation in which only one solution is administered in spite of good workability.

According to the first aspect of the present invention, the internal cavity of the chemical solution bag formed of the soft film-like material is divided into a plurality of compartments by the partition means, and separate chemical solutions are sealed in each compartment, Detection means for detecting that the chemical solution has been mixed by opening the partition means by changing the chemical characteristics of the chemical solution after mixing, and until the detection, the puncture-type chemical solution is discharged into the internal cavity of the chemical solution bag And a medicine discharge prohibiting means for prohibiting the discharge of the chemical solution from the chemical solution bag by preventing the access of the device, and after detecting the mixing of the chemical solution by the detection means , the puncture type chemical solution discharge device into the internal cavity of the chemical solution bag A chemical discharge method is provided in which the chemical discharge prohibiting means is disabled to allow access to the liquid and the chemical liquid can be discharged from the chemical bag.

According to invention of Claim 2 , it is formed with a soft film-like raw material, the internal cavity is divided into a plurality of compartments by the partition means, and separate chemicals are sealed in each compartment. Closed to the chemical solution bag and close to one of the compartments, the internal cavity of the chemical solution bag is normally closed, and the puncture type chemical solution discharge tool is inserted to allow the chemical solution in the chemical solution bag to be discharged. The closure member is responsive to the chemical characteristics of the chemical solution contained in one compartment adjacent to the closure member, and provides access to the puncture-type chemical solution discharge tool to the internal cavity of the chemical solution bag in the separated state of the chemical solution. There is provided a medicinal solution storage / sealing body characterized in that the state changes between a blocking state and a state in which access to the puncture-type medicinal solution discharging tool into the internal cavity of the medicinal solution bag in a mixed state of the medicinal solution is permitted.

According to the third aspect of the present invention, the internal cavity of the chemical solution bag formed of the soft film-like material is divided into a plurality of compartments by the partition means, and separate chemical solutions are accommodated in the respective compartments and closed. A puncture-type drug solution discharging device having a needle-like portion that is punctured into the closure member for discharging the drug solution from a drug solution bag closed by the member, and the drug solution when puncturing the closure member in the puncture-type discharge device An opening / closing means for opening and closing the chemical liquid passage in response to the chemical characteristics of the chemical solution is provided at a site in contact with the chemical solution, and the opening / closing means is configured to keep the chemical solution in the chemical solution bag separated by the partition means of the chemical solution bag. There is provided a puncture-type drug solution discharger that closes the passage and opens the drug solution passage by opening the partition means after the solution is mixed.

  According to the present invention, since the chemical solution is prohibited from being carried out and permitted to be discharged by detecting a change in the chemical properties of the chemical solution such as the hydrogen ion concentration (pH) value, the chemical solution is kept until the partition means is opened. Elimination can be reliably prevented, and the possibility of misadministration of an unmixed drug solution can be completely eliminated.

  In FIG. 1, the chemical solution bag 10 is made of a soft film such as a polypropylene film having a thickness of 200 microns. The outer periphery of the polypropylene film is sealed by a strong seal portion 12 formed by being pressed at a high temperature such as 120 ° C., which is sufficiently higher than its softening temperature, and has a rectangular bag shape when viewed from above. A suspension hole 13 is formed in the strong seal portion 12, and the drug solution bag 10 is suspended and held by the suspension hole 13 on an infusion stand or the like to perform infusion or dialysis.

  The weak seal portion 14 extends over the entire width at an intermediate portion in the length direction of the chemical solution bag 10, and the front and back surfaces of the chemical solution bag 10 are adhered by the weak seal portion 14, and the internal cavity of the chemical solution bag 10 is connected to the first compartment 16. It is partitioned into a second compartment 18. The weak seal portion 14 constitutes the compartment means of the present invention, and the partition means includes a compartment member (a partition jig) such as a flange jiggle pin in addition to the weak seal portion 14. The first compartment 16 is filled with the first chemical solution, and the second compartment 18 is filled with the second chemical solution. The weak seal portion 14 is formed by pressing the front and back surfaces of the polypropylene film forming the chemical solution bag 10 at a relatively low temperature such as 110 ° C., which is slightly higher than the softening temperature. Therefore, the strong seal portion 12 is left as it is by pressurizing the chemical solution in the chemical solution bag 10 from the outside in the compartments 16 and 18 in a state where the respective chemical solutions are accommodated in the first compartment 16 and the second compartment 18. The weak seal portion 14 can be broken and opened, and the first chemical solution and the second chemical solution can be mixed. In the case of a dialysis replenisher, the first chemical is mainly composed of glucose and contains calcium chloride, etc., and is adjusted to an acidity such as pH = 4.0, and the second chemical is mainly adjusted to an alkalinity, such as sodium chloride, and pH = 9.0. . Then, by mixing, a blood pH equivalent value of pH = 7.4 is obtained. However, if a long time elapses after mixing the first chemical solution and the second chemical solution, insoluble foreign matter may be generated, so that the first chemical solution and the second chemical solution should be mixed just before administration, so that it is weak as the previous preliminary work. Administration is performed after the seal portion 14 is opened. In addition, a cautionary note that the opening operation of the weak seal portion 14 is necessary immediately before administration is printed on the surface of the drug solution bag 10. However, there is a risk of erroneous work neglecting to open the weak seal portion 14, and in this case, only the chemical solution in the second compartment 18 may be administered. In the first embodiment of the present invention, the presence or absence of opening of the weak seal portion 14 is detected by detecting a change in the hydrogen ion concentration (pH) due to the mixing of the first chemical liquid and the second chemical liquid, and it is determined that there is mixing. In addition, a device is added to the configuration of the chemical solution discharge unit from the chemical solution bag 10 so that the dialysis and the drip operation can be shifted to the above.

  The chemical solution outlet 20 has a cylindrical shape with one end 20-1 closed, and is made of a molded product of plastic such as polypropylene (need to be made of the same plastic material as the chemical solution bag in order to obtain adhesion to the chemical solution bag 10). The The plastic film forming the front and back surfaces of the chemical solution bag 10 is heated and adhered while sandwiching the chemical solution discharge port 20 from above and below, thereby sealing the compartment 18 on the side close to the chemical solution discharge port 20. An inner lid 22 (chemical liquid discharge prohibiting means of the present invention) as a closing member is provided inside the chemical liquid discharge port 20. The inner lid 22 is provided with a hydrogen ion concentration sensitive elastic member (so-called shape memory element) that responds to the hydrogen ion concentration (pH) of the liquid in contact with the inner lid 22, and normally tightly adheres to the inner peripheral surface of the chemical solution outlet 20. As a result, the internal cavity of the drug solution bag 10 is sealed from the outside and insertion of the puncture needle 50 (puncture type drug solution discharger of the present invention) of the infusion set extending from the drip tube is prevented. It is configured to respond to changes in the hydrogen ion concentration due to the mixing of the chemical solution, eliminate the close contact with the inner peripheral surface of the chemical solution discharge port 20, and allow the insertion of the puncture needle 50. That is, as shown in FIG. 2, the inner lid 22 is a disk-shaped hydrogen ion concentration sensor 24 that expands / contracts in response to the hydrogen ion concentration of the liquid in contact with the inner lid 22 (before mixing the chemical solution). And a disc-like member 26 formed of a hard plastic thin plate sandwiching and holding the hydrogen ion concentration sensor 24 from above and below. , 28. The disk-shaped members 26 and 28 may be made of any material other than hard plastic, and depending on the case, a thin metal plate may be used. The disk-like member 26 on the inner cavity side (upper side in FIG. 2) of the chemical solution bag 10 is configured in a mesh shape having a large number of liquid circulation holes 26A, and the liquid circulation holes 26A allow free circulation of the chemical solution in the chemical solution bag 10. It is set to an inner diameter (about 0.5 to 1.0 mm) that does not hinder. The disk-shaped member 28 on the outer side (the lower side of FIG. 2) of the medical solution bag 10 is a solid hard plastic thin plate, and has a hardness and a thickness that does not break through even when the puncture needle 50 of the infusion set is inserted. Any material can be used. Even if a hard plastic is used as a raw material, it can sufficiently meet this purpose if it has a thickness of about 0.5 to 1.0 mm. As shown in FIG. 2, the disk-shaped members 26 and 28 have an inner diameter somewhat smaller than the inner diameter of the cylindrical portion 20-2 of the chemical solution discharge port 20, and an adhesive or the like is provided on the opposite surface of the hydrogen ion concentration sensor 24. It is firmly attached by appropriate means. The hydrogen ion concentration sensor 24 is a mixture of the chemical solution hydrogen ion concentration (alkaline) of the chemical solution in the second chamber 18 when the weak seal portion 14 of the chemical solution bag 10 is not opened and the mixed chemical solution after the weak seal portion 14 of the chemical solution bag 10 is opened. The expansion / contraction is performed using the hydrogen ion concentration value between the hydrogen ion concentration values (substantially neutral) as a threshold value. That is, when the hydrogen ion concentration sensor 24 is alkaline with a liquid hydrogen ion concentration value that is larger than a threshold value (for example, pH = 8.0), as shown in FIG. The expanded diameter state is in close contact with and fixed to the inner diameter of the cylindrical portion 20-2. However, when the hydrogen ion concentration value of the liquid in contact with the hydrogen ion concentration sensor 24 becomes smaller than a threshold value (for example, pH = 8.0) and becomes a neutral value (pH = 7.4), the hydrogen ion concentration sensor 24 is displayed as shown in FIG. As shown in (b), the outer diameter of the cylindrical portion 20-2 of the chemical solution discharge port 20 is in a reduced diameter state separated from the inner diameter.

  As the hydrogen ion concentration sensor 24, a polymer gel whose volume is changed depending on the hydrogen ion concentration value is known. Examples of the polymer gel include those made of an acrylamide copolymer amphoteric gel. This type of acrylamide copolymer amphoteric gel exhibits a minimum volume in the neutral state near pH = 7.0, and even when immersed in a solution having a hydrogen ion concentration value on the acid side from the neutral state, the alkali side hydrogen ion concentration value The volume increases in any case when immersed in the solution. In other words, in the vicinity of pH = 7.0, it is in a contracted state due to ionic crosslinking between anions and cations, but when the gel is moved to the acid or alkali side, the ionic crosslinking is cut and the gel swells (“New functional rubber / elastomer Development ”, published by Toray Research Center, Inc., pages 69-84, June 1997). In addition, the specification of Japanese Patent No. 2945966 discloses a method for producing microbeads made of an acrylamide copolymer. As the hydrogen ion concentration sensor 24 of the embodiment of the present invention, such microbeads are used in the mold. And can be formed into a disk shape. By adopting the sintered structure, the liquid can be rapidly permeated into the hydrogen ion concentration sensing body 24, and a reliable volume change can be performed when the hydrogen ion concentration value changes from neutral.

  When the weak seal portion 14 is not opened, the alkaline chemical solution in the second chamber 18 is immersed in the hydrogen ion concentration sensor 24 through the liquid flow hole 26A of the hard plastic disk 26, and the hydrogen ion concentration sensor 24 is expanded. As shown in FIG. 2 (a), the outer periphery is closely attached and fixed to the inner diameter of the cylindrical portion 20-2 of the chemical solution discharge port 20. For the drip operation, the medicinal solution bag 10 is suspended and held on an instillation stand or the like by the suspension hole 13, and a puncture needle 50 of an infusion set extending from the drip tube is inserted into the flange portion 20-1 of the rubber medicinal solution discharge port 20. The However, the tip of the puncture needle 50 hits the hard plastic disk 28 on the lower surface of the hydrogen ion concentration sensing body 24 and cannot break through it, and the hydrogen ion concentration sensing body 24 is fixed to the chemical solution outlet 20 (chemical solution discharge). The fixing of the hydrogen ion concentration sensing body 24 to the outlet 20 is ensured by engaging the chemical solution outlet 20 with the protrusion 20-3 on the inner periphery of the cylindrical portion 20-2), and pushing the inner lid 22 open. I can't.

  When the weak seal 14 is opened, the mixed neutral chemical is immersed in the hydrogen ion concentration sensor 24 through the liquid flow hole 26A of the hard plastic disk 26, and the hydrogen ion concentration sensor 24 is shown in FIG. ) And the outer periphery thereof is separated from the inner diameter of the cylindrical portion 20-2 of the chemical solution discharge port 20. Therefore, by engaging the tip of the puncture needle 50 inserted into the flange portion 20-1, the inner lid 22 is pushed up as indicated by the arrow a and pushed out into the drug solution bag 10. Therefore, the mixed chemical solution in the chemical solution bag 10 can be discharged from the infusion set.

  FIG. 3 shows an inner lid 122 of the second embodiment. As in FIG. 2, the inner lid 122 has a hydrogen ion concentration sensor 124 that is sensitive to the pH of the liquid that contacts the inner lid 122 and a hydrogen ion concentration sensor 124. Are formed of disk-like members 126 and 128 formed of a hard plastic thin plate that is sandwiched and held from above and below. The disk-shaped members 126 and 128 are provided with openings 126A and 128A at the centers thereof. The hydrogen ion concentration sensor 124 switches between the state shown in FIG. 3 (a) where the center is closed and the state shown in FIG. 3 (b) where an opening 124A is formed in the center according to the hydrogen ion concentration value of the chemical solution in contact therewith. is there. The material of the hydrogen ion concentration sensor 124 is the same as that of the first embodiment. In this embodiment, the tip of the puncture needle 50 is prevented from reaching the hydrogen ion concentration sensor 124 even if it is inserted deepest into the flange portion (corresponding to the flange portion 20-1 in FIG. 1).

  The operation of the second embodiment shown in FIG. 3 will be described. When the weak seal portion 14 is not opened, the center of the hydrogen ion concentration sensor 124 is completely closed by the alkaline chemical solution in the second chamber 18 (a). Take a state. Therefore, even if the internal cavity of the drug solution bag 10 is closed and the puncture needle 50 of the infusion set is inserted into the flange portion 20-1 of the drug solution discharge port 20, the drug solution cannot be discharged. In contrast, when the weak seal portion 14 is opened, the hydrogen ion concentration sensor 124 forms an opening 124A at the center as shown in FIG. Therefore, the mixed chemical solution in the chemical solution bag 10 can be discharged from the infusion set.

  FIG. 4 shows a third embodiment. In this third embodiment, the chemical solution outlet 220 itself is formed of a hydrogen ion concentration sensing expansion / contraction material (the chemical solution outlet 220 is a detection means in the present invention. It is also a means to prohibit chemical discharge). That is, the chemical solution discharge port 220 includes a tip 220-1 extending toward the internal cavity of the chemical solution bag, and the tip 220-1 of the chemical solution discharge port 220 corresponds to the hydrogen ion concentration value of the chemical solution in contact therewith. It switches between the state shown in FIG. 4 (a) where the length is extended and the state shown in FIG. 4 (b) where the length is contracted.

  The operation of the third embodiment shown in FIG. 4 will be described. When the weak seal portion 14 is not opened, the distal end portion 220-1 of the chemical solution discharge port 220 is expanded by the alkaline chemical solution in the second chamber 18 (A). Take the state. In this extended state, even if the puncture needle 50 of the infusion set is inserted deepest into the chemical solution outlet 220, the tip cannot protrude into the internal cavity of the chemical solution bag, and the chemical solution cannot be discharged. On the other hand, when the weak seal portion 14 is opened, the chemical solution discharge port 220 is in a contracted (b) state as shown in 220-1A. In this contracted state, by inserting the puncture needle 50 of the infusion set into the chemical solution discharge port 220, the tip can be protruded into the internal cavity of the chemical solution bag, and the chemical solution can be discharged.

  FIG. 5 shows a fourth embodiment. In this embodiment, the chemical solution outlet 320 itself is formed of a hydrogen ion concentration sensing expansion / contraction material as in the third embodiment, but depending on the hydrogen ion concentration value. It is characterized by hard and soft changes. That is, when the weak seal portion 14 is not opened, the chemical solution discharge port 320 is cured (solid structure) by the alkaline chemical solution in the second chamber 18, and in this cured state, as shown in FIG. Even if the puncture needle 50 is to be inserted into the drug solution outlet 320, it cannot be inserted and the drug solution cannot be discharged. On the other hand, when the weak seal portion 14 is opened, the neutral chemical liquid comes into contact with the chemical liquid discharge port 320, so that the chemical liquid discharge port 320 is softened (network structure). In this softened state, FIG. As shown, the puncture needle 50 of the infusion set can be inserted into the drug solution outlet 320, and the drug solution can be discharged.

  FIG. 6 shows a fifth embodiment. In this embodiment, the puncture needle 450 of the infusion set (the puncture-type drug solution discharge device of the present invention) and the hydrogen ion concentration sensing opening / closing section 450-1 (the detection means in the present invention). It is also a chemical discharge prohibition means. That is, the hydrogen ion concentration sensing opening / closing part 450-1 is formed of a hydrogen ion concentration sensing expansion / contraction material, and the puncture needle 450 has a hydrogen ion concentration as shown in FIG. The inner diameter of the sensing opening / closing part 450-1 contracts to 0, and the chemical solution cannot be discharged from the chemical solution bag. On the other hand, when the weak seal part 14 is opened, the neutral chemical solution acts on the pH sensing opening / closing part 450-1, so that the hydrogen ion concentration sensing opening / closing part is indicated by 450-1A in FIG. It becomes fully open, and the chemical solution can be discharged from the chemical solution bag.

  In the above embodiment, the weak seal part of the chemical solution bag is opened and closed by sensing the hydrogen ion concentration (pH) of the chemical solution, but in the chemical solution that contacts the shape memory material in the chemical solution instead of the hydrogen ion concentration The opening and closing of the weak seal portion may be detected by detecting specific ions that are included in the liquid but are not included in the mixed chemical (for example, sodium ions that are present in the second chamber 18 but are not present in the mixed chemical). . Moreover, in the case where the temperature changes between the mixed state and the unmixed state of the chemical solution, a material whose form changes depending on the temperature can be used.

  In the above embodiment, the presence or absence of weak seal opening is determined by detecting the alkaline chemical in the second chamber 18 located on the lower side (the puncture needle 50 side of the infusion set) in the suspended state of the chemical bag. However, the acidic first chamber 16 is set to the side (lower side) of the puncture needle 50 of the infusion set, and the presence or absence of the weak seal portion is determined by changing the form between acidic and neutral. May be.

FIG. 1 is a plan view of the medical mixed-type drug solution sealed body (unopened state) of the present invention. 2A and 2B are schematic cross-sectional views of the chemical solution outlet according to the first embodiment of the present invention. FIG. 2A shows a closed state and FIG. 2B shows a discharged state. FIGS. 3A and 3B are schematic cross-sectional views of the chemical solution outlet according to the second embodiment of the present invention. FIG. 3A shows a closed state and FIG. 3B shows a discharged state. FIG. 4 is a schematic cross-sectional view of a chemical solution discharge port according to a third embodiment of the present invention, where (A) shows a closed state and (B) shows a discharged state. FIG. 5 is a schematic cross-sectional view of a chemical solution discharge port according to the fourth embodiment of the present invention, where (A) shows a closed state and (B) shows a discharged state. FIG. 6 is a schematic cross-sectional view of a chemical solution discharge port according to a fifth embodiment of the present invention, where (A) shows a closed state and (B) shows a discharged state.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 ... Chemical solution bag 12 ... Strong seal part 13 ... Suspension hole 14 ... Weak seal part 16 ... 1st compartment 18 ... 2nd compartment
20, 120, 220, 320 ... Chemical solution outlet 22 ... Inner lid 24 ... Hydrogen ion concentration (pH) sensor
26, 28 ... disk-shaped members
50, 450 ... puncture needle

Claims (3)

The internal cavity of the chemical bag formed of a soft film material is divided into a plurality of compartments by partition means, and separate chemical solutions are sealed in each compartment, and the chemical solutions are mixed by opening the partition means. Detection means for detecting the change in the chemical characteristics of the chemical solution before and after mixing, and until the detection, the access from the puncture-type chemical solution discharge tool to the internal cavity of the chemical solution bag is prevented. And a medicine discharge prohibiting means for prohibiting the discharge of the chemical liquid, and after the detection of the mixing of the chemical liquid by the detecting means, the chemical discharge prohibiting means is provided to allow access of the puncture-type chemical liquid discharging tool to the internal cavity of the chemical liquid bag. A chemical solution discharge method that disables the chemical solution from the chemical solution bag.   It is made of a soft film material, and its internal cavity is divided into a plurality of compartments by partition means, and a chemical solution bag configured by enclosing a separate chemical solution in each compartment, and close to one of the compartments A closing member that normally closes the internal cavity of the drug solution bag and allows the drug solution in the drug solution bag to be discharged by insertion of the puncture-type drug solution discharge tool. In response to the chemical characteristics of the chemical solution contained in one adjacent compartment, the state in which the access to the puncture-type chemical solution discharge tool to the internal cavity of the chemical solution bag in the separated state of the chemical solution is blocked, and the chemical solution in the mixed state of the chemical solution A medicinal solution storage sealing body characterized in that the state changes between a state allowing access of a puncture type medicinal solution discharging tool to an internal cavity of a bag. The internal cavity of the chemical solution bag formed of a soft film-like material is partitioned into a plurality of compartments by partition means, and separate chemical solutions are accommodated in the respective compartments and the chemical solution from the chemical solution bag closed by the closing member is contained. A puncture type liquid medicine discharge device having a needle-like portion pierced into the closing member for discharge, wherein the liquid medicine reacts with a chemical property of the liquid medicine at a portion that comes into contact with the liquid medicine when puncturing the closing member in the discharge device An opening / closing means for opening and closing the passage is provided, and the opening / closing means closes the chemical liquid passage while the chemical liquid in the chemical liquid bag is maintained in a separated state by the partition means of the chemical liquid bag, and the partition means is opened. A puncture-type drug solution discharger that opens the drug channel after the drug solution is mixed.

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