JP2007111181A - Medicament storage/sealing body and adhesive seal - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To more securely prevent the risk of an operational error such as dosing while a medicament bag is unopened, in relation to a medicament discharge preventer for a multi-liquid mixing type medicament bag. <P>SOLUTION: The medicament bag is formed of a soft film-like material, and the internal hollow space of the bag is divided into a plurality of compartments. An outlet is opened in one of the compartments and the medicament discharge preventer is disposed to cover the outlet 12. The medicament discharge preventer is composed of half-divided bodies forming the internal hollow space complemental to the shape of the outlet. The half-divided bodies are integrated with each other with the outlet in-between by an elastic restraining means, and are held to the medicament bag. An adhesive seal 42 with a notch 42-1 is stuck to end faces 32A and 32B of the half-divided bodies, which are integrated in the shape of a circle, along the joint seam 33. The adhesive seal 42 functions as a hinge. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  This invention stores a plurality of medicines in respective compartments of a medicine bag in a separated state, opens a weak weld between the compartments during drip or dialysis, and mixes the medicines for use. The present invention relates to a stationary body and an adhesive seal.

There is a multi-liquid mixed type medical mixed-type liquid seal for medical infusion such as infusion or dialysis. In a multi-liquid mixed type liquid medicine sealed body, the internal cavity of a medicine bag made of a soft (flexible) film is separated into a plurality of compartments that store different liquid medicines by weak welds. A chemical solution discharge port as a synthetic resin molded product is provided on the outer periphery of the drug bag, the chemical solution discharge port is formed in a cylindrical shape, and the internal cavity opens to one compartment on one end side, but the other end Is provided with a rubber stopper. Prior to administration of the drug solution to the patient, the weakly welded part is opened by pressurizing the drug bag from the outside, and since the internal cavity of the drug bag becomes a single chamber, the two 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 bag. In this type of medical mixed-type liquid medicine sealed body, the work of mixing the two liquids by opening the weakly welded part prior to the administration of the chemical liquid is essential, while the weakly welded 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 weld portion that separates the internal cavity of the drug bag into two compartments, a second weak weld portion is provided immediately before the chemical solution outlet, By setting the second second weak weld portion to be equal to or higher than the pressure required for opening the weak weld portion, the first weak weld portion and then the second weak weld portion are opened in this order. Thus, there has been proposed a method in which discharge is performed after mixing of chemicals (see Patent Document 1).
JP 2004-661 A

  In the technique of Patent Document 1, in addition to the first weakly welded part that separates the two compartments, a second weakly welded part is provided immediately before the chemical solution discharge port, and these weakly welded parts are sequentially opened so that they are not mixed. However, since the two weak welds are provided, the manufacturing process becomes complicated and the cost increases, and the user is forced to perform two-stage pressurization work. The workability was not always good. In addition, depending on the method of pressurizing the medicine bag, it is not always opened in the order of the first weakly welded portion → the second weakly welded portion, and the second weakly welded portion on the side of the chemical solution discharge port 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 multi-liquid mixing type drug bag that cannot be administered in an unopened state (not connected), and is low in manufacturing cost. The object is to more reliably eliminate the possibility of an erroneous operation in which administration is performed in an unmixed state even though there is good workability on the user side.

  According to this invention, it is formed of a flexible (soft film) material, the internal cavity is divided into a plurality of compartments by the weak welded portion, and outside the medicine bag in which separate medicines are sealed in each compartment. A medicine discharge prevention tool for preventing discharge of the medicine from the discharge port is attached. The drug discharge prevention device has a cylindrical shape that is substantially closed at the end face when united, and is disposed across the discharge port, and is spread and separated by receiving a drug bag due to internal liquid pressure at the time of weak weld opening. And a restraining means for restraining the pair of halves in a combined state so as to prevent the closed end from discharging the medicine from the medicine bag in a normal state. In a normal state in which a pair of halves constituting the medicine discharge preventing device are combined to form a cylindrical cavity across the discharge port at one end of the medicine bag, an adhesive seal is adhered to the closed end surface of the cylindrical cavity. The adhesive seal basically has a shape that covers a substantially entire surface of the closed end surface formed by the pair of halves when they are combined, but is cut out from the shape along the seam of the halves. .

  By installing a drug discharge prevention tool, infusion can be blocked by the drug discharge prevention tool even if trying to puncture in an unopened state, and it is possible to reliably prevent an erroneous operation of infusion without mixing. In addition, the halved body constituting the drug discharge prevention tool is automatically separated and separated by the opening operation that must be performed before the infusion, so that there is no problem in the smooth transition to the infusion operation.

  The adhesive seal attached to the circular closed end surface formed when the pair of halves constituting the drug bag is combined can function as a hinge for holding the pair of halves. Since the adhesive seal has a shape partially cut out along the joint of the halved body from the shape covering substantially the entire closed end surface, it can be caused by stress at the joint. Since the peeling of the adhesive surface is blocked by the notch and is not propagated to the outside, it is possible to maintain the relatively strong adhesive force of the adhesive seal and to prevent the peeling of the seal.

  1 to 5, the medical mixed chemical liquid sealer is composed of a flat drug bag 10 and a discharge port 12. The drug bag 10 is made of a soft synthetic resin film (flexible material of the present invention) such as a polyethylene film having a thickness of 200 microns. The outer periphery of the polyethylene film is sealed by a strong welded portion 14 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. As is well known, the medicine bag 10 is suspended and held on an infusion stand or the like to perform infusion or dialysis.

  The weakly welded portion 18 extends over the entire width at an intermediate portion in the length direction of the drug bag 10, and the front and back surfaces of the drug bag 10 are adhered to each other by the weakly welded portion 18. It is partitioned into a second compartment 22. The first compartment 20 is filled with the first chemical solution, and the second compartment 22 is filled with the second chemical solution. The weakly welded portion 18 is formed by pressurizing the front and back surfaces of the polyethylene film forming the drug bag 10 at a low temperature such as 110 ° C., which is slightly higher than its softening temperature. Therefore, the strong welded portion 14 is left as it is by pressurizing the drug solution in the drug bag 10 from the outside in the compartments 20 and 22 with the respective drug solutions stored in the first compartment 20 and the second compartment 22. The upper and lower film surfaces in the weakly welded portion 18 can be separated and opened, and the first chemical solution and the second chemical solution can be mixed.

  The discharge port 12 is a synthetic resin such as polyethylene having a thickness and rigidity capable of maintaining its form (similar to and compatible with the drug bag 10 in order to obtain adhesion with the drug bag 10). Need to be molded). As shown in FIG. 2, the discharge port 12 is formed in a cylindrical shape having openings at both upper and lower ends, an intermediate portion forming a tapered portion 12-1, and a lower end having a flange portion 12-2 (FIG. 2). A polyethylene cap 12-3 is abutted and welded to the flange portion 12-2, and a rubber inner lid 12-4 is attached to an end surface opening of the cap 12-3. At the time of instillation, a rubber inner lid 12-4 is punctured by a puncture needle (not shown) of an infusion device, and the inside cavity of the medicine bag 10 is communicated with an infusion tube to perform infusion. The synthetic resin film forming the front and back surfaces of the drug bag 10 is heat-adhered while sandwiching the cylindrical portion of the discharge port 12 from above and below, whereby the drug bag 10 is sealed with respect to the discharge port 12.

  In FIG. 1, reference numeral 28 denotes a medicine discharge prevention tool according to the first embodiment of the present invention. In order to prevent access to the puncture needle of the infusion set. The medicine discharge preventing device 28 is formed of a synthetic resin molded product such as polyethylene and has sufficient hardness and / or thickness to prevent puncture by a puncture needle. As shown in FIG. 2 and FIG. 3, the medicine discharge preventing device 28 is composed of first and second halves 29A and 29B which are completely separated, and the first and second halves 29A and 29B are discharged. When combined with the outlet 12 in between, a bottomed cylindrical body (see FIG. 2) is formed. First and second flaps 30A and 30B extend integrally from one end (the upper end in FIG. 2) of the first and second halves 29A and 29B, respectively. The first and second flaps 30 </ b> A and 30 </ b> B are brought into contact with respective opposing surfaces of the drug bag 10 as shown in FIG. 2 when the drug discharge preventing device 28 is attached to the drug bag 10. As shown in FIG. 3, the peripheral portions (bottom edge portions and side edge portions) of the first and second flaps 30A and 30B are tapered or chamfered. The other ends (lower ends in FIG. 2) of the first and second halves 29A and 29B form half-divided enlarged portions 31A and 31B, respectively, from the lower ends of the half-divided enlarged portions 31A and 31B. The semicircular wall portions 32A and 32B project in the radial direction. In the combined state of the first and second halves 29A and 29B shown in FIG. 2, a cavity 34 having a shape complementary to the shape of the discharge port 12 is formed between the halves 29A and 29B. The outlet 12 is stored in the portion 34. Then, the semicircular wall surface portions 32A, 32B protruding from the lower ends of the half-divided diameter expanded portions 31A, 31B are joined at the seam 33 on the diameter to form a single disk in a pseudo manner, Even when trying to puncture the rubber inner lid 12-4 of the discharge port 12 with the puncture needle of the infusion set, the puncture needle is blocked by the wall surface portions 32A and 32B, and the puncture needle is inserted into the rubber inner lid 12-4. This is not possible and the risk of the drug flowing unmixed into the infusion set is eliminated. As shown in FIG. 3, the half-expanded portions 31A and 31B are formed with circumferential cutouts 35A and 35B. The cutouts 35A and 35B are rubber plugs 12-4 of the discharge port 12 (FIG. 2). This is provided for the escape of the tamper seal attached to the part.

  As described above, the first and second halves 29A and 29B constituting the drug discharge preventing device 28 have a completely separated structure, and the first and second halves 29A and 29B are in a state where the drug discharge blocking device 28 is attached to the drug bag 10. Elastic restraining means for restraining the two halves 29A and 29B in the combined state is provided. The elastic restraint device will be described. A pair of engaging projections 38 (FIG. 3) are integrally extended from the half end face of one cylindrical half body 29A so as to be orthogonal to the half face. A pair of box-shaped receiving portions 40 are provided on the half end face of the cylindrical half body 29B. As shown in FIG. 4 (a), each box-shaped receiving portion 40 forms a hollow portion having a rectangular cross section, and a locking piece 72 having a slightly inclined front surface is integrally formed on the end face of the hollow portion having the rectangular cross section. It is formed. Therefore, when the first and second halves 29A and 29B are merged at their halves, the first and second halves 29A and 29B are moved relative to each other in the direction f in FIG. In this case, the engaging protrusion 38 is accommodated in the opposing box-shaped receiving portion 40, and at this time, the tip protrusion 38-1 of the engaging protrusion 38 pushes down the locking piece 72 somewhat against its elasticity. However, the tip protrusion 38-1 of the engagement protrusion 38 finally reaches the state shown in FIG. In this state, the first and second halves 29A, 29B, in other words, the first and second flaps 30A, are engaged by the engagement between the tip protrusion 38-1 of the engagement protrusion 38 and the locking piece 72. , 30B are held together by a predetermined elastic force.

  As shown in FIG. 3, an adhesive seal 42 is adhered to the wall surface portions 32A and 32B joined so as to form a pseudo circular surface in a normal state (unopened state). The adhesive seal 42 is formed by forming an adhesive layer on one surface of a synthetic resin film having an appropriate thickness, and holds the first and second halves 29A and 29B so as to be rotatable around the joint 33. It is provided to function as a hinge. Moreover, the shape with the notch which prevents peeling as mentioned later is comprised.

  FIG. 2 shows a state in which the weakly welded portion 18 of the drug bag 10 is not opened, and each drug solution is individually stored in each of the compartments 20 and 22, and the drug is stored by the amount of the drug solution stored in the compartments 20 and 22. The bag 10 is swollen. The discharge port 12 provided in the strong welding portion 14 of the drug bag 10 so as to open to the compartment 22 is covered with a drug discharge prevention tool 28. That is, the first flap 30A is applied to one side of the drug bag 10, the second flap 30B is applied to the opposite side of the drug bag 10, and the first and second flaps 30A and 30B are applied to the drug bag 10. It is made to unite on both sides. The discharge port 12 is accommodated in the cavity 34 formed between the halves 29A and 29B and the enlarged diameter portions 31A and 31B connected to the first and second flaps 30A and 30B, and the radial direction extends from the enlarged diameter portions 31A and 31B. Since the puncture needle is blocked by the wall surface portions 32A and 32B which form a pseudo disk portion by extending and joining, the rubber inner lid 12-4 of the discharge port 12 cannot be punctured by the puncture needle . Then, the halves 29A and 29B constituting the medicine discharge preventing tool are held together by the restraining action by the engagement (FIG. 4 (b)) between the engagement protrusion 38 and the box-shaped receiving portion 40.

  In order to open the medicine bag 10, the medicine bag 10 is placed flat on a desk or the like, and the medicine bag 10 is pressurized with a palm from the upper surface. The liquid pressure is applied to the weakly welded portion 18 by the pressurization of the medicine bag 10, and the weakly welded portion 18 is instantaneously opened (or peeled) by a predetermined pressure. The internal pressure of the drug bag 10 is increased by the pressurization, and this increased pressure is released at once by the opening of the weakly welded portion 18, so that a shocking flow of the drug solution is induced in the drug bag 10. In FIG. 5, the flow of the shocking chemical liquid that is induced in the drug bag 10 is schematically indicated by an arrow F. The rapid flow F of the drug solution induced in the drug bag 10 when the weakly welded portion 18 is opened causes the drug bag 10 to expand outward as indicated by an arrow a, and the opposite surface of the spread drug bag 10. The first and second flaps 30A and 30B that are in contact with each other are rotated about the joint 33 as shown in FIG. 5 against the elastic restraint force caused by the engagement between the engagement protrusion 38 and the box-shaped receiving portion 40. At this time, the adhesive seal 42 made of a flexible film adhered to the end faces (wall surface portions 32A, 32B) of the halves 29A, 29B functions like a hinge, and the engaging protrusion 38 is a box-shaped receiving portion. The medicine discharge prevention tool is detached from the discharge port 12 and removed from the discharge port 12 (moved as indicated by an arrow f ′ in FIG. 4A). Therefore, the discharge port 12 is exposed, and the drip operation can be started by inserting the puncture needle of the infusion set into the rubber stopper 12-4.

  The adhesive seal 32 affixed to the wall surface portions 32A and 32B functions as a hinge that holds the completely divided halves 29A and 29B together and rotates around the joint 33. The shape is devised so that peeling of 32 is hard to occur. That is, as the shape of the adhesive seal 42, a circular adhesive seal 42 as shown in FIG. 6 (a) is used so that it can be attached to substantially the entire surface of the halves 29A and 29B that form pseudo disks when they are combined. It is usually assumed that '. However, in this case, the total width (the length of the diameter) along the seam 33 due to the stress applied to the seam 33 (the force that shifts the first and second halves 29A and 29B as indicated by arrows a1 and a2). In this region (the region between the two-dot chain line L ′ on both sides of the joint 33 in FIG. 6A), the adhesive seal 42 ′ peels off and floats. Therefore, the peeling of the adhesive seal 42 'proceeds every time stress is applied to the adhesive seal 42'.

  The adhesive seal of the present invention that solves this problem is shown by 42 in FIG. 6 (b). In this embodiment, the adhesive seal 42 is placed on both sides in the region sandwiching the joint 33 between the halves 29A and 29B. A notch 42-1 is formed, in other words, the adhesive seal 42 is absent on the joint 33 in the notch 42-1. That is, the adhesive seal 42 of the present invention is adhered to the opposing surface of the halved body in a region shorter than the entire length across the seam between a pair of halves, and longer to the opposing surface in the outer region. Has been. That is, by providing the notch 42-1, an edge portion 42A extending along the seam 33 while being separated from the seam 33 is formed. Therefore, in the adhesive seal 42 of the present invention, the portion of the adhesive seal that floats (peels) due to stress is only the portion located on the seam 33 and sandwiched between the two-dot chain lines L in FIG. The outer edge portion 42A is blocked from the floating portion (peeling portion) at the joint 33. That is, the adhesive seal 42 of the present invention does not float over the entire length along the seam 33, and the adhesive seal 42 maintains the adhesive at the notch portion 42-1 (edge portion 42A). The peeling does not propagate any more and can maintain a strong adhesive state.

  8 (a) to 8 (d) show various shapes of the adhesive seal 42 of the present invention. In FIG. 8 (a), rectangular notches are formed from both sides along the joint, and in FIG. In (c), an oval notch is formed in the middle, and in (d), two circular notches are formed along the seam.

  The size of the adhesive seal 42 depends on the size of the surface of the agent discharge prevention tool 28 to which the adhesive seal 42 is attached, that is, the diameter of a pseudo circle formed when the wall surface portions 32A and 32B are combined. In the case of the shape of FIG. 8 (b), good results could be obtained with an adhesive seal diameter of 26 mm, a notch diameter φ of 8 mm, and a distance of 9 mm from the center of the adhesive seal to the center of the notch. .

FIG. 1 is a plan view (viewed in the direction of arrow I in FIG. 2) of a medicine bag provided with the medicine discharge preventing device of the present invention. FIG. 2 is a longitudinal cross-sectional view (a cross-sectional view taken along the line II-II in FIG. 1) of a medicine bag provided with the medicine discharge preventing device of the present invention. FIG. 3 is a perspective view of the medicine discharge preventing device according to the embodiment of the present invention. 4 is a cross-sectional view taken along the line IV-IV in FIG. 1 and shows an enlarged view of the elastic restraining means for holding the halved body in the medicine discharge prevention device. ) Indicates before merging, and (b) indicates after merging. FIG. 5 is a partially enlarged view of FIG. 2 and shows a released state of the medicine discharge prevention tool when the medicine bag is opened. FIG. 6 shows the shape of an adhesive seal that is affixed to the end face of the drug discharge prevention device attached to the drug bag. (A) is an ordinary circular adhesive seal, and (b) is a notch in the present invention. It is an adhesive seal. FIG. 7 is an arrow view seen from the VII direction of FIG. 6 and shows a sticking state of the adhesive seal to the halved body constituting the medicine discharge prevention tool. 8A to 8D are views showing various shapes of the pressure-sensitive adhesive seal of the present invention.

Explanation of symbols

10 ... Drug bag 12 ... Discharge port
12-4 ... rubber plug 14 ... strong weld 18 ... weak weld
20,22 ... compartment 28 ... drug discharge prevention device
29A, 29B ... first and second halves
30A, 30B ... 1st and 2nd flaps
31A, 31B… expanded part
32A, 32B ... Semicircular wall surface 38 ... Engaging protrusion (restraint means)
40 ... Box-shaped receiving part (restraint means)
42 ... Adhesive seal
42-1 ... Notch

Claims (4)

  An internal cavity of a drug bag formed of a flexible material is divided into a plurality of compartments by weak welding portions, and separate medicines are sealed in the respective compartments, and are discharged into one of the plurality of compartments. A medicine storage sealing body provided with an outlet, and further equipped with a medicine discharge prevention device for preventing discharge of the medicine from the discharge port outside the medicine bag, wherein the medicine discharge prevention device has an end face when combined In a normal state, a pair of halves that present a substantially closed cylindrical shape, are disposed across the discharge port, and receive and spread apart a drug bag due to internal liquid pressure at the time of weak weld opening, A medicine comprising restraining means for restraining the pair of halves in a combined state so as to prevent discharge of medicine from a medicine bag at the closed end, and an adhesive seal adhered on the surface of the closed end Storage sealing body.   2. The medicine container sealing body according to claim 1, wherein the adhesive seal has a shape partially cut out along the seam between a pair of halves.   In the invention according to claim 1, the adhesive seal is adhered to the opposing surface of the halved body in a region shorter than the entire length across the seam between a pair of halves, and substantially in the outer region. The medicine storage sealing body which has a shape that is adhered to the opposite surface over its entire length. It is an adhesive seal for holding a pair of halves, and is adhered to the surface facing the halves in a region shorter than the entire length across the seam between the pair of halves, and is substantially in the outer region Adhesive seal that is shaped to adhere to the opposite surface over its entire length.

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