JP5875617B2 - Medical device connector and drug administration device - Google Patents

Description

  The present invention relates to a medical device connector for connecting a medical liquid injection device (for example, a prefilled syringe) and a drug container, a prefilled syringe, a drug container, and a drug administration device using the medical device connector.

  As a prefilled syringe, it is provided in the state with which medical liquids, such as a chemical | medical solution and a chemical | medical agent solution, were filled. The drug solution-filled prefilled syringe is used when administering a powder preparation that needs to be dissolved at the time of use, such as a freeze-dried preparation. A prefilled syringe filled with a drug solution is connected to a drug container (vial) containing a powder formulation, the solution in the syringe is injected into the drug container, and the powder formulation in the container is dissolved in the solution, then the syringe It becomes possible to administer by aspirating the inside. Generally, a metal needle is used to connect a pre-filled syringe filled with a drug solution to a drug container containing a powder formulation. Recently, a product using a dedicated connector has also been proposed. In addition, the administration preparation work may be performed not only by medical personnel but also by the patient himself who needs self-injection. In particular, patient preparations are often performed in environments where contamination is a concern and in unstable locations.

Japanese Unexamined Patent Publication No. 7-213585 (Patent Document 1) discloses the following.
In the mixed injection adapter of Patent Document 1, a hollow puncture needle 12 and a tubular tip mounting portion 13 are provided on the opposite sides of the disk-shaped hub 11 on the same axis, and the puncture needle is provided on the outer edge of the hub 11. A cylindrical vial mounting part 14 that extends concentrically beyond the tip of 12 and a cylindrical syringe mounting part 15 that extends concentrically beyond the tip of the chip mounting part 13 are provided. The puncture needle 12 opens to the chemical solution passage 122 communicating with the tip mounting portion 13 and opening to the blade edge 121, and the vent 16 with the sterilization filter 17 provided in the vial mounting portion 14 adjacent to the hub 11. In addition, it has a gas passage 123 that opens to the cutting edge 121 of the puncture needle 12.

Japanese Patent Laid-Open No. 7-213585

In Patent Document 1, when the co-injection adapter is connected to a drug container (vial) whose inside is decompressed, outside air flows into the drug container from both the drug solution passage and the gas passage. Since the gas flowing in from the gas passage passes through the filter, there is no possibility of containing bacteria in the outside air. However, since such a filter is not provided in the chemical solution passage, the bacteria in the outside air are removed from the drug container. There is a high possibility of sucking in.
The object of the present invention is that the connecting operation to the drug container is easy, and even when connected to the drug container in a reduced pressure state, the bacteria in the outside air are not sucked into the drug container, and the drug is safe. The present invention provides a medical device connector capable of administration and a drug administration device including the medical device connector.

What achieves the above object is as follows.
(1) The opening sealed by the sealing member of a medicine container comprising a container body having an opening, a sealing member for sealing the opening of the container body, and a medicine stored in the container body. One end of the adapter is connectable and the other end is connectable to a medical liquid injection device, and a housing member that houses the adapter and accommodates the one end of the adapter. a medical device connector, the adapter is provided on one end side of the adapter, and the drug container mounting portion connectable to the opening that is sealed by the sealing member, provided on said one end, said A hollow needle-like portion having a cutting edge portion capable of penetrating the seal member of the drug container, and an internal flow path provided on the other end side of the adapter and communicating with the internal flow path of the hollow needle-shaped portion And an infusion device connecting portion to which the medical liquid infusion device can be connected, wherein the medical device connector is located in the storage member, and the infusion device connecting portion of the adapter is provided. At least the other end side that is encapsulated and provided with a bacteria-impermeable filter, and the internal flow path of the injection device connecting portion of the adapter communicates with the inside of the housing member only through the bacteria-impermeable filter. And the storage member stores and holds the adapter, and the medical device connector is attached to the drug container and hollow when the adapter is stored in the storage member. are possible penetrating the sealing member with a needle-like portion, the piercing of the seal member by the hollow needle portion, and the interior of the internal and the receiving member of the drug container, said adapter Has become one that communicates only through the bacteria-impermeable filter of the internal flow path and the filter portion of the hollow needle portion and the injection device connecting portion of the terpolymer, further wherein the medical device connector is A separation restricting portion for restricting separation of the filter portion from the storage member, and the separation restriction portion is in contact with the rib, or a plurality of non-continuous ribs provided on the storage member; And it is comprised by the peripheral part of the said filter part of the part accommodated in the upper part inside the said storage member from the said rib, and when the said storage part is made to detach | leave from the said adapter, the said filter part is with the said storage member A medical device connector that detaches from the adapter side .

(2) The medical device connector according to (1), wherein the adapter is held by the storage member via the filter portion .
(3) The medical device connector is housed in the housing member, and includes a cylindrical protective member that holds the adapter and encloses the adapter, and the filter portion is an opening of the protective member. The medical device connector according to (1) or (2), wherein the medical device connector is attached to a part.
(4) The medical device connector according to any one of (1) to (3), wherein the medical device connector includes a seal member that seals the opening of the storage member.
(5) The medical device connector according to any one of (1) to (4), wherein the inside of the drug container is decompressed.

Moreover, what achieves the said objective is as follows.
(6) housed in the above (1) to (5) any of the medical device connector of the sealing member and the container body to seal the opening of the container body and the container body having an opening consists of a drug, and the drug container connectable to said drug container mounting portion of the adapter of the medical device connector, and the outer cylinder body portion, the tip provided at the distal end portion of the outer cylinder main body opening, and An outer cylinder having a nozzle portion connectable to the injection device connection portion of the adapter of the medical device connector, a sealing member for sealing the nozzle portion, and slidably housed in the outer cylinder. gasket and a push rod capable attached or mounted to the rear end of the gasket, drug administration device comprising a prefilled syringe and a medical liquid filled in the outer tube.

The medical device connector according to the present invention includes an adapter that can be connected at one end to the opening sealed by the seal member of the drug container and can be connected to the medical liquid injection device at the other end, and the adapter. And a storage member having an opening for storing one end of the adapter. The medical device connector is provided on one end side of the adapter and can be connected to a drug container, and a hollow needle-like portion provided on one end side and having a cutting edge that can penetrate the seal member of the drug container; , Provided on the other end side of the adapter, communicated with the inside of the hollow needle-like portion, and provided with an injection device connecting portion to which a medical liquid injection device can be connected. Further, the medical device connector is located in the storage member, encapsulates at least the other end side where the adapter injection device connection portion is provided, and includes a bacteria-impermeable filter, and the adapter injection device connection portion The internal passage is provided with a filter portion that communicates with the inside of the storage member only through the bacteria-impermeable filter, and the storage member stores and holds the adapter. The medical device connector can be attached to the medicine container and pierced by the seal member with the hollow needle-like portion in a state where the adapter is housed in the storage member. Thus, the inside of the drug container and the inside of the storage member are communicated only via the hollow needle-shaped portion of the adapter, the internal flow path of the injection device connecting portion, and the bacteria-impermeable filter of the filter portion. Yes.
For this reason, when the adapter is connected to a drug container whose inside is in a reduced pressure state, only the outside air that has passed through the bacteria-impermeable filter is sucked into the drug container, so that bacteria may flow into the drug container. Absent.

FIG. 1 is a front view of an embodiment of the medical device connector of the present invention. 2 is a cross-sectional view taken along line AA in FIG. 3 is a cross-sectional view taken along line BB in FIG. FIG. 4 is an explanatory diagram for explaining members constituting the medical device connector of the present invention shown in FIG. 1. FIG. 5 is an explanatory diagram for explaining components used in the medical device connector of the present invention shown in FIG. FIG. 6 is an explanatory view for explaining members constituting the adapter of the medical device connector of the present invention shown in FIG. 1. FIG. 7 is a front view of the drug container connector used in the medical device connector of the present invention shown in FIG. FIG. 8 is a plan view of the drug container connector shown in FIG. 9 is a cross-sectional view taken along the line CC of FIG. 10 is a cross-sectional view taken along the line DD of FIG. FIG. 11 is a perspective view of the drug container connector shown in FIG. FIG. 12 is a front view of an infusion device connector used in the medical device connector of the present invention shown in FIG. FIG. 13 is a plan view of the connector for an injection device shown in FIG. 14 is a cross-sectional view taken along line EE in FIG. FIG. 15 is a front view of a cylindrical protective body of a protective member used in the medical device connector of the present invention shown in FIG. 16 is a longitudinal sectional view of the cylindrical protector shown in FIG. FIG. 17 is a plan view of the cylindrical protector shown in FIG. FIG. 18 is a front view of the filter portion of the protective member used in the medical device connector of the present invention shown in FIG. FIG. 19 is a plan view of the filter section shown in FIG. FIG. 20 is a longitudinal sectional view of a storage member used in another embodiment of the medical device connector of the present invention. FIG. 21 is a longitudinal sectional view for explaining another embodiment of the medical device connector of the present invention. FIG. 22 is a front view of an example of a prefilled syringe used in the drug administration device of the present invention. 23 is a longitudinal sectional view of the prefilled syringe shown in FIG. 24 is a perspective view of a pusher used in the prefilled syringe shown in FIG. FIG. 25 is an explanatory diagram for explaining the operation of the prefilled syringe shown in FIG. FIG. 26 is a front view of another example of a prefilled syringe used in the drug administration device of the present invention. FIG. 27 is a plan view of the prefilled syringe shown in FIG. FIG. 28 is a longitudinal sectional view of the prefilled syringe shown in FIG. FIG. 29 is a perspective view of a pusher used in the prefilled syringe shown in FIG. FIG. 30 is an explanatory diagram for explaining the operation of the prefilled syringe shown in FIG. FIG. 31 is an explanatory diagram for explaining the operation of the medical device connector and the drug administration device of the present invention. FIG. 32 is an explanatory diagram for explaining the operation of the medical device connector and the drug administration device of the present invention.

The medical device connector and drug administration device of the present invention will be described with reference to the embodiments shown in the drawings.
The medical device connector 1 of the present invention includes a container main body 86 having an opening, a seal member 87 that seals the opening of the container main body 86, and a medicine container 80 that is contained in the container main body 86. One end of the adapter 87 can be connected to the opening sealed by the member 87, and the other end can be connected to the medical liquid injection device 20. And a storage member 8 having a portion to be opened.
The adapter 2 is provided on one end side of the adapter 2 and connected to the opening sealed by the seal member 87, and the adapter 2 is provided on one end side. A hollow needle-like part 33 having a penetrating blade tip part, an internal flow path 42a provided on the other end side of the adapter 2 and communicating with the internal flow path 33a of the hollow needle-like part 33, and a medical fluid An injection device connecting portion 43 to which the injection device 20 can be connected, and between the internal flow path 42a of the injection device connection portion 43 and the internal flow path 33a of the hollow needle-shaped portion 33 or in the internal flow path 42a of the injection device connection portion 43 or hollow. And a liquid-permeable filter 12 for removing foreign substances disposed in the internal flow path 33a of the needle-like portion 33.
The medical device connector 1 is located in the storage member 8 and includes at least the other end of the adapter 2 where the injection device connector 43 of the adapter 2 is provided, and includes the bacteria-impermeable filter 11. The filter portion 9 is provided that communicates the internal flow path 42 a of the injection device connection portion 43 of the adapter 2 only with the inside of the storage member 8 through the bacteria-impermeable filter 11.
The storage member 8 stores and holds the adapter 2, and the medical device connector 1 is attached to the medicine container 80 and the hollow needle-like portion 33 in a state where the adapter 2 is stored in the storage member 8. The sealing member 87 can be pierced, and the piercing of the sealing member 87 by the hollow needle-shaped portion 33 causes the inside of the drug container 80 and the inside of the storage member 8 to be connected to the hollow needle-shaped portion 33 and the injection device of the adapter 2. It communicates only through the internal flow paths 33a, 42a of the connection part 43 and the bacteria-impermeable filter 11 of the filter part 9.
Then, a medical liquid injection device (for example, a prefilled syringe) is attached to the adapter, a medical liquid (for example, a drug solution) is injected into the drug container, and then the drug solution is again injected into the medical liquid injection device. In the medical liquid injection device, since the drug solution that has passed through the liquid-permeable filter for removing foreign substances is stored in the medical liquid injection device, insoluble components exist in the drug stored in the drug container. Even if it is, it is not sucked into the medical liquid injection device, and it is possible to administer a medicine that does not contain foreign substances.

As shown in FIGS. 1 to 4, the medical device connector 1 of the present invention includes an adapter 2 and a storage body 6 that stores the adapter 2. In the medical device connector 1 of this embodiment, the storage body 6 includes a storage member 8 that stores the adapter 2 and a seal member 15 that seals the opening. A filter portion (filter member) 9 is disposed in the storage body 6 (specifically, in the storage member 8). The adapter 2 includes a cylindrical protector 7. For this reason, it can be said that the protection part is formed by the filter part 9 and the cylindrical protection body 7.
In the medical device connector 1 of this embodiment, as shown in FIGS. 1 to 5, the adapter 2 includes a drug container connector 3, an injection device connector 4 having an injection device connection portion 43, and a liquid passage therethrough. And a connecting member 5 having a property filter 12.
As shown in FIGS. 6 to 11, the drug container connector 3 includes a drug container mounting portion 31, a hollow needle-shaped portion 33, and an injection device connector mounting portion 32 for mounting the injection device connector 4. Have.
The medicine container mounting portion 31 is a short cylindrical portion having a relatively large diameter, and can accommodate an opening portion of the medicine container 80 sealed by the seal member 87 therein. Further, the end portion of the medicine container mounting portion 31 is provided with claw portions 34 a and 34 b that project inward and engage with a lower portion of the opening of the medicine container 80 (a lower portion of the neck portion of the medicine container). In addition, slits 38 are provided on the side portions of the claw portions 34a and 34b of the medicine container mounting portion 31 for imparting easy deformability to the mounting portion 31 (claw portion forming portion). In this embodiment, the claw portion 34a and the claw portion 34b are provided so as to face each other. Two sets of slits 38 are also provided so as to face each other. Specifically, four slits 38 are provided, and the slits 38 reach the upper surface of the drug container mounting portion 31 and further extend a predetermined length in the facing slit direction.

The upper surface of the medicine container mounting portion 31 is a partition surface, and a hollow needle-like portion 33 is provided so as to extend from the center portion toward the opening end of the mounting portion 31. The hollow needle-like portion 33 has an acute-angled blade edge at the tip, and can be pierced through the seal member 87 of the drug container 80. Further, the tip of the blade edge portion does not protrude from the opening end of the medicine container mounting portion 31. And the side hole 33b is provided in the front-end | tip part of a hollow needle-like part, specifically, the side surface of a blade-tip part, and the flow path 33a in the hollow needle-like part 33 and the exterior communicate. .
An injection device connector mounting portion 32 is provided on the upper portion of the drug container mounting portion 31. The injection device connector mounting portion 32 is a short cylindrical portion extending upward from the closing surface of the upper surface of the drug container mounting portion 31, and has a smaller diameter than the drug container mounting portion 31. And the opening formed by the edge part of the flow path 33a in the hollow needle-shaped part 33 is provided in the obstruction | occlusion surface of the upper surface of the chemical | medical agent container mounting part 31. FIG. The injection device connector mounting portion 32 can accommodate one end side portion of the injection device connector 4 described later. The injection instrument connector mounting portion 32 includes windows 36a and 36b that house lower portions of the side protrusions 44a and 44b of the injection instrument connector 4. And the upper part of window part 36a, 36b is equipped with the engaging parts 35a and 35b which approach into the recessed parts 45a and 45b provided in the side part protrusion parts 44a and 44b of the connector 4 for injection devices, and engage. Yes. Moreover, the part which has window part 36a, 36b is side part bulging part 37a, 37b for accommodating the side part protrusion part 44a, 44b of the connector 4 for injection devices.

As shown in FIGS. 6, 12 to 14, the injection device connector 4 is a cylindrical injection device connection portion to which a nozzle portion 23 of a medical liquid injection device (specifically, prefilled syringe) 20 can be connected. 43, the injection device connecting portion 43, the connecting member mounting tubular portion 42 extending downward from the injection device connecting portion 43, the outer tube portion 41 enclosing the injection device connecting portion 43, and the outer tube portion 41 Two side protrusions 44a and 44b are provided so as to face the side surfaces. And the connector 4 for injection devices is equipped with the internal flow path 42a inside. The internal flow path 42 a extends from the injection device connection portion 43 to the connecting member mounting tubular portion 42. The injection device connecting portion 43 has a storage portion 43a for storing the nozzle portion 23 of the medical liquid injection device 20 therein, and a collar portion of the medical liquid injection device 20 is provided on the outer surface of the injection device connection portion 43. The connector side screwing part screwed with the injection device side screwing part formed in the inner surface of 24 is provided. Further, a collar portion storage portion 48 for storing the collar portion 24 of the medical liquid injection device 20 formed between the injection device connecting portion 43 and the outer cylinder portion 41 is provided.
The lower portions of the side protrusions 44a and 44b of the injection device connector 4 enter the windows 36a and 36b as described above, and the engagement portions 35a and 35b provided on the injection device connector mounting portion 32 are The injection instrument connector 4 has entered the recesses 45a and 45b, thereby restricting the injection instrument connector mounting portion 4 from being detached from the injection instrument connector mounting portion 32. Further, bulging portions 46a and 46b are provided at the upper ends of the side protrusions 44a and 44b of the injection device connector 4 so that the injection device connector 4 can be rotated in the injection device connector mounting portion 32. Is restricted.

A connecting member 5 having a liquid-permeable filter 12 for removing foreign substances is mounted inside the connecting member mounting tubular portion 42 of the connector 4 for injection device. As shown in FIGS. 2 and 3, the connecting member 5 is a cylindrical member having an annular rib protruding inward at the lower end, and a liquid-permeable filter 12 is disposed on the upper portion of the annular rib. The liquid filter 12 is sandwiched between the annular rib of the connecting member 5 and the tip of the connecting member mounting tubular portion 42 of the injection instrument connector 4. The connection member 5 is preferably formed of an elastic material. Further, the lower end portion of the connecting member 5 is arranged so that the opening at the lower end portion is on the opening formed on the partition surface of the connector 3 for drug container. Further, the lower end portion having the opening of the connecting member 5 is pressed between the distal end surface of the connecting member mounting tubular portion 42 of the infusion device connector 4 and the partition surface of the drug container connector 3, so that the infusion device connector 4 The distal end portion of the connecting member mounting tubular portion 42 and the rear end portion of the hollow needle-like portion 33 of the drug container connector 3 are liquid-tightly connected. Note that the pressure between the distal end surface of the connecting member mounting tubular portion 42 of the lower end portion of the injection device connector 4 having the opening of the connection member 5 and the partition surface of the drug container connector 3 is the injection device connector mounting portion 32. Is maintained by contact between the engaging portions 35a and 35b provided on the side and the lower portions of the side protrusions 44a and 44b provided on the connector 4 for injection device.
As the liquid-permeable filter 12 for removing foreign substances, a filter capable of removing foreign substances such as drug solids that could not be dissolved or dispersed in the drug container is used. Specifically, those capable of removing solids of about 50 μm or more are preferable. As the filter, a membrane filter, a mesh, a woven fabric, a non-woven fabric, and the like, which are hydrophilic, are preferable.
For example, polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin can be used as a material for forming the adapter 2 (pharmaceutical container connector 3, injection device connector 4). Polyesters such as acrylonitrile-butadiene-styrene copolymer and polyethylene terephthalate can be preferably used.

As shown in FIGS. 1 to 5, the medical device connector 1 of the present invention has a filter unit (filter member) 9 stored in the upper portion of the storage body 6, specifically, the storage member 8. In addition, the filter unit 9 is held inside the storage member 8.
Furthermore, in the medical device connector 1 of this embodiment, the adapter 2 is equipped with a cylindrical protector 7 that encapsulates at least the other end of the adapter 2 where the injection device connection portion 43 of the adapter 2 is provided. In this embodiment, the filter portion 9 is airtightly attached to the distal end opening of the cylindrical protector 7 that encloses the outer surface of the adapter. In addition, it is good also as what encloses the other end side in which the injection instrument connection part 43 of the adapter 2 is provided, without providing the cylindrical protective body 7, and the filter part 9 is the adapter 2 further. May be held.
The upper end of the cylindrical protective body 7 is an opening 75, and the cylindrical protective body 7 includes an adapter accommodating lumen that communicates from the upper end to the lower end. The cylindrical protector 7 includes a portion that encapsulates and holds the other end of the adapter 2 where the injection device connecting portion of the adapter 2 is provided. In particular, in this embodiment, the cylindrical protector 7 encapsulates the entire adapter 2. Further, as shown in FIGS. 2, 3, 15 and 16, the tubular protector 7 encapsulates and holds the upper end portion of the injection device connector 4 at the upper end portion thereof. 74. A storage portion 72 for storing the injection device connector mounting portion 32 of the drug container connector 3 is provided below the injection device connector holding portion 74, and protrudes from a side portion of the storage portion 72. 3 is provided with storage portions 73a and 73b for storing the side bulge portions 37a and 37b. Furthermore, a storage part 71 for storing the medicine container mounting part 31 of the medicine container connector 3 is provided below the storage part 72. The storage portion 72 and the storage portion 73 are not in close contact with the adapter 2 (specifically, the drug container connector 3).

And the filter part 9 is attached to the upper-end opening 75 of the cylindrical protection body 7 so that attachment or detachment is possible airtightly. In this embodiment, as shown in FIGS. 2, 3, 18, and 19, the filter unit 9 includes a cylindrical member 67, a lid member 61, and a bacteria-impermeable filter 11. As shown in FIGS. 2 and 3, the cylindrical member 67 includes an annular rib 69 provided at a position slightly lower than the upper end, and the bacteria-impermeable filter 11 is placed on the annular rib 69. I rim portion is located are urchin arranged. The lid member 61 includes an annular protrusion 64 on the lower surface. The lid member 61 and the tubular member 67 are fixed and are sandwiched between the annular rib 69 of the tubular member 67 and the annular protrusion 64 of the lid member 61. Further, as shown in FIGS. 2, 3 and 19, the lid member 61 is provided with an opening 62. Further, in this embodiment, as shown in FIG. A plurality of notches 63 are provided for ensuring air circulation. And the filter part 9 is enabling the distribution | circulation of the gas between the upper direction of the filter part 9, and the cylindrical member 67 by providing the opening 62 and the filter 11 which were mentioned above. In the medical device connector 1 of the present invention, the adapter 2 housed in the housing member 8 communicates with the upper space in the housing body only through the bacteria-impermeable filter 11 of the filter portion 9. ing.
And although this filter part 9 encloses the upper-end opening part of the cylindrical protection body 7 and connects the side part between both airtightly, it is not fixed, but the cylindrical protection body 7 It is possible to leave more. For this reason, when the storage member 8 is detached from the adapter 2, the filter portion 9 is detached from the adapter (cylindrical protector) together with the storage member 8, and the adapter 2 is encapsulated only by the cylindrical protector 7. It becomes a state.
The tubular member 67 of the filter portion is preferably formed of an elastic material. The bacteria-impermeable filter 11 may be any filter as long as it has air permeability and can prevent the bacteria from permeating. For example, a membrane filter, a mesh, a woven fabric, a nonwoven fabric, or the like can be used.

As shown in FIGS. 1 to 5 (particularly, FIG. 5), the medical device connector 1 of the present invention is a storage member for storing the adapter 2 encapsulated by the cylindrical protective body 7. 8, a seal member 15 that seals the opening, and the above-described filter portion 9 housed in the housing member 8.
The storage member 8 is a container body having an open lower end as shown in FIGS. 1 to 5, and includes a storage portion for storing a cylindrical protective body 7 enclosing the adapter 2 therein. The storage member 8 has a closed upper end and an open lower end, and stores the adapter 2 so that the drug container mounting portion 31 side of the drug container connector 3 is on the lower end side that opens. . Therefore, the medical device connector 1 can mount the drug container mounting portion 31 of the drug container connector 3 on the drug container 80 in a state where the adapter 2 is stored in the storage member 8. In other words, in the state where the adapter 2 is housed in the housing member 8, the medical device connector 1 is moved to the seal member 87 of the medicine container 80 by the hollow needle-like portion 33 of the medicine container mounting portion 31 of the medicine container connector 3. Piercing is possible.

In this embodiment, the storage member 8 has a detachment restricting portion that restricts the detachment of the filter portion 9 from the storage member 8. For this reason, even if the later-described seal member 15 is peeled off from the storage member, the adapter 2 is maintained in the state of being stored and held in the storage member 8. Specifically, the storage member 8 includes an annular rib 83 formed on the inner surface of a portion slightly lower than the upper end, and the lid member 61 of the filter unit 9 is provided at a portion above the annular rib 83. The peripheral edge of the lid member 61 is in contact with the annular rib 83 of the storage member 8, so that detachment is restricted. The rib of the storage member 8 is not limited to the annular rib, and may be a plurality of discontinuous ribs 83a such as the storage member 8a shown in FIG. In this embodiment, as shown in FIGS. 1 to 5, the storage member 8 includes a storage member main body 81 and a flange portion 82 provided at the lower end thereof. Part bulge parts 84a and 84b are provided. And the accommodating member 8 is accommodated so that the lower end of the cylindrical protector 7 may not be exposed, as shown in FIGS. In the medical device connector 1 of this embodiment, the adapter is held by the storage member 8 via the filter unit 9, but the storage member 8 can hold the adapter in a detachable manner, Any thing is acceptable. For example, a protrusion that holds the side portion of the adapter may be provided on the inner surface of the storage member, and the adapter may be detachably held by the protrusion. And in this medical device connector 1, the sealing member 15 is fixed to the lower end opening of the storage member 8 in a peelable manner. Specifically, the seal member 15 is detachably sealed to the lower end surface of the flange of the storage member 8. Further, the seal member 15 includes a peeling start portion 15a that extends.
The material of the storage member 8 preferably has a certain degree of strength and hardness. For example, polyolefin such as polypropylene and polyethylene, vinyl chloride resin, polyester resin, polystyrene, and polypropylene resin can be suitably used.
As the sealing member 15, adhesiveness (thermal fusion) between the base material layer and the surface (upper surface) of the base material layer with the container forming material (specifically, the material forming the lower surface of the flange 82 of the storage member 8) And an adhesive resin layer having an adhesive property or adhesive property). Furthermore, the sealing member 15 may have a surface protective layer on the surface (lower surface) of the base material layer.

Moreover, in the medical device connector 1 described above, the adapter 2 is composed of the drug container connector 3, the injection device connector 4, and the connection member 5 as separate members. is not. For example, the medical device connector 10 of the embodiment shown in FIG. 21 may be used.
The difference between the medical device connector 10 of this embodiment and the above-described medical device connector 1 is the configuration of the adapter and the configuration of the filter unit. In this embodiment, the adapter 2a is formed by integrating a connector for a medicine container and a connector for an injection device. For this reason, the adapter 2a includes a drug container mounting portion 31 that is a short cylindrical portion having a relatively large diameter on the lower side, and the drug container mounting portion 31 is sealed inside by a seal member 87. The opening of the medicine container 80 can be stored. Further, the end portion of the medicine container mounting portion 31 is provided with claw portions 34 a and 34 b that project inward and engage with a lower portion of the opening of the medicine container 80 (a lower portion of the neck portion of the medicine container). In addition, slits 38 are provided on the side portions of the claw portions 34a and 34b of the medicine container mounting portion 31 for imparting easy deformability to the mounting portion 31 (claw portion forming portion). In this embodiment, the claw portion 34a and the claw portion 34b are provided so as to face each other. Two sets of slits 38 are also provided so as to face each other. Specifically, four slits 38 are provided, and the slits 38 reach the upper surface of the drug container mounting portion 31 and further extend a predetermined length in the facing slit direction.
The upper surface of the medicine container mounting portion 31 is a partition surface, and a hollow needle-like portion 33 is provided so as to extend from the center portion toward the opening end of the mounting portion 31. The hollow needle-like portion 33 has an acute-angled blade edge at the tip, and can be pierced through the seal member 87 of the drug container 80. Further, the tip of the blade edge portion does not protrude from the opening end of the medicine container mounting portion 31. And the side hole 33b is provided in the front-end | tip part of a hollow needle-like part, specifically, the side surface of a blade-tip part, and the flow path 33a in the hollow needle-like part 33 and the exterior communicate. .

  The upper part of the medicine container mounting part 31 is connectable with the nozzle part 23 of the medical liquid injection device (specifically, prefilled syringe) 20 and communicates with the internal space (flow path) 33a of the hollow needle-like part 33. And a cylindrical injection device connection portion 43 to be provided, and an outer cylinder portion 41 that encloses the injection device connection portion 43. The injection device connecting portion 43 has a storage portion 43 a for storing the nozzle portion 23 of the medical liquid injection device 20 inside, and the outer surface of the injection device connection portion 43 has the collar portion 24 of the medical liquid injection device 20. The connector side screwing part screwed with the injection device side screwing part formed in the inner surface is provided. Further, a collar portion storage portion 48 for storing the collar portion 24 of the medical liquid injection device 20 formed between the injection device connecting portion 43 and the outer cylinder portion 41 is provided. Furthermore, a liquid-permeable filter 12 for removing foreign substances is disposed on the bottom surface of the injection device connecting portion 43, and this filter 12 is fixed to the adapter 2 a by a ring-shaped fixing member 16. Therefore, the filter 12 separates the upper end of the internal space (flow path) 33a of the hollow needle-like portion 33 and the lower end of the injection device connection portion 43 from the liquid flowing between them. ) Is removed. As the liquid-permeable filter 12 for removing foreign substances, a filter capable of removing foreign substances such as drug solids that could not be dissolved or dispersed in the drug container is used. Therefore, in this embodiment, the liquid-permeable filter 12 is arranged in the injection device connecting portion. In addition, the liquid-permeable filter 12 may be accommodated in the hollow needle-like part. As the liquid-permeable filter 12, those described above are used.

As shown in FIG. 21, the filter portion 9a holds the adapter 2a and encloses the portion where the injection device connecting portion 43 of the adapter 2a is formed (the upper side portion of the adapter 2a). For this reason, it does not have the cylindrical protective body which encloses the whole adapter like the Example mentioned above. The filter portion 9a includes a cylindrical member 17 that encloses the outer surface of the upper part of the adapter 2a, a lid member 61 that is airtightly attached to the upper end portion thereof, and a bacteria-impermeable filter 11 that is disposed therebetween. Is provided. The upper end of the cylindrical member 17 includes a top plate portion 18 having an opening, and the bacteria-impermeable filter 11 is placed on the top surface of the top plate portion 18. The cylindrical member 17 encapsulates and holds the upper side of the adapter 2a where the injection device connecting portion is provided. In particular, the cylindrical member 17 has a plurality of annular ribs 19 provided on the inner surface, and the annular ribs 19 are in airtight contact with the outer peripheral surface of the adapter 2a and hold the adapter 2a. The lid member 61 includes an annular protrusion on the lower surface. The lid member 61 and the cylindrical member 17 are fixed, and the filter 11 is sandwiched between the peripheral edge portion of the top plate portion 18 of the cylindrical member 17 and the annular protruding portion of the lid member 61. Further, as shown in FIG. 21, the lid member 61 is provided with an opening 62. Further, in this embodiment, a plurality of air passages for ensuring the air flow to the opening 62 in the peripheral portion are provided. A notch 63 is provided. The lid member 61 includes the opening 62 and the filter 11 described above, thereby enabling gas to flow between the upper side of the lid member 61 and the inside of the cylindrical member 17. And also in the medical instrument connector 10 of this embodiment, the adapter 2a accommodated in the accommodating member 8b communicates with the upper space in the accommodating body only through the bacteria-impermeable filter 11 of the filter portion 9a. It has become.

Next, the drug administration device of the present invention will be described.
The drug administration device of the present invention includes a medical device connector 1, a container main body 86 having an opening, a seal member 87 that seals the opening of the container main body 86, and a drug 88 stored in the container main body 86. And the medicine container 80 connectable to the medicine container mounting part 31 of the adapter 2 of the medical device connector 1, the outer cylinder main body part 22, the front end part of the outer cylinder main body part 22 provided at the front end, and The outer cylinder 21 including the nozzle portion 23 that can be connected to the injection device connection portion 43 of the adapter 2 of the medical device connector 1, the sealing member 28 that seals the nozzle portion 23, and the slide inside the outer cylinder 21. And a prefilled syringe 20 including a pusher 50 attached to or attachable to the rear end of the gasket 90, and a medical liquid 29 filled in the outer cylinder 21. .

As the medical device connector, those of all the above-described embodiments can be suitably used.
The drug container 80 has an opening, can store the drug 88 therein, and can be connected to the drug container mounting part 31 of the adapter 2 of the medical device connector 1 used. Anything is acceptable. For example, a rigid or semi-rigid synthetic resin container, a glass container, or the like is used. As the sealing member 87 for sealing the opening, any member may be used as long as it can be punctured (pierced) by the hollow needle-like portion 33. Examples of the sealing member include elastic rubber (for example, butyl rubber, latex rubber, silicone rubber, styrene butadiene rubber), synthetic resin (for example, styrene elastomer such as SBS elastomer and SEBS elastomer, ethylene-α olefin copolymer). It is preferable to use an olefin elastomer such as a polymer elastomer).
Any drug, such as a powdered drug, a lyophilized drug, a solid drug, or a liquid drug, can be used as long as it can be dissolved in a medical liquid (specifically, a solution) filled in the prefilled syringe. However, the present invention is particularly effective when a drug that is difficult to be liquefied is used. Examples of drugs include protein preparations, antitumor agents, vitamins (general vitamins), various amino acids, antithrombotic agents such as heparin, insulin, antibiotics, antitumor agents, analgesics, cardiotonics, intravenous anesthetics Antiparkinsonian agent, ulcer treatment agent, corticosteroid agent, arrhythmia agent and the like.

Moreover, as for the chemical | medical agent container 80, it is preferable that the inside is pressure-reduced.
As shown in FIGS. 22 to 25, the prefilled syringe 20 is provided at the outer cylinder main body 22 and the distal end of the outer cylinder main body 22, the distal end is open, and the injection device for the adapter 2 of the medical device connector 1. An outer cylinder 21 having a nozzle part 23 that can be connected to the connection part 43, a sealing member 28 that seals the nozzle part 23, a gasket 90 that is slidably accommodated in the outer cylinder 21, and a gasket 90 It consists of a pusher 50 attached to or attachable to the rear end and a medical liquid 29 filled in the outer cylinder 21.
The outer cylinder 21 is a cylindrical body made of a transparent or translucent material and, if necessary, a material having little oxygen permeability and water vapor permeability. The outer cylinder 21 includes an outer cylinder main body portion 22, a nozzle portion 23 provided at the distal end portion of the outer cylinder main body portion 22, and a flange 26 provided at the rear end portion of the outer cylinder main body portion 22.

The outer cylinder main body portion 22 is a substantially cylindrical portion that accommodates the gasket 90 in a liquid-tight and slidable manner, and the nozzle portion 23 is a cylindrical portion having a smaller diameter than the outer cylinder main body portion 22. The flange 26 is an elliptical donut-shaped disc part formed so as to protrude in the vertical direction from the entire rear end circumference of the outer cylinder main body part 22. The flange includes two gripping portions that are wide and face each other, and a plurality of ribs are formed on the tip surface side of the gripping portion. The nozzle portion 23 is configured to be connectable to a medical device having a connection portion to the nozzle portion conforming to the ISO standard. In addition, the syringe includes a collar portion 24 that encapsulates the nozzle portion 23. The collar portion 24 is provided with a collar portion side screwing portion 25 that can be screwed with the connector side screwing portion formed on the outer surface of the injection device connecting portion 43 described above on the inner surface.
Examples of the material for forming the outer cylinder 21 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate. Various resins such as polyesters such as tarates and cyclic polyolefins can be mentioned. Among them, resins such as polypropylene and cyclic polyolefins are preferable because they are easy to mold and have heat resistance.

The gasket 90 has a main body portion extending with substantially the same outer diameter, and a plurality of annular ribs provided in the main body portion (in this embodiment, two or two or more satisfy liquid tightness and slidability) If possible, the number may be set as appropriate), and these ribs are in liquid-tight contact with the inner surface of the outer cylinder 21. Further, the front end surface of the gasket 90 has a shape corresponding to the shape of the inner surface of the front end of the outer cylinder 21 so as not to form a gap as much as possible when contacting the inner surface of the front end of the outer cylinder 21.
The material for forming the gasket 90 includes elastic rubber (for example, butyl rubber, latex rubber, silicone rubber, styrene butadiene rubber), synthetic resin (for example, styrene elastomer such as SBS elastomer and SEBS elastomer, ethylene-α olefin). It is preferable to use an olefin-based elastomer such as a copolymer elastomer).
In the prefilled syringe 20 of this embodiment, a pusher mounting member 92 is housed in the gasket 90.
The pusher 50 has a distal end portion 52 that can be attached to a pusher mounting member 92 housed in a gasket 90 at the distal end portion, and the distal end of the distal end portion 52 engages with the pusher mounting member 92. An engagement portion 59 is provided. The pusher 50 includes a main body 51 extending in the axial direction having a cross-shaped cross section, a pressing disk 53 provided at the rear end, and a rib provided in the middle of the main body.
The medical liquid 29 filled in the prefilled syringe 20 contains a drug solution such as distilled water for injection and physiological saline, and further contains a drug (for example, vitamins and minerals). It may also be a chemical solution capable of dissolving the powder formulation.

And the prefilled syringe 20 in this embodiment pushes the pusher 50 attached to the gasket 90, engages when the gasket 90 reaches the distal end portion of the outer cylinder 21, and engages means for restricting the retreat of the pusher. I have.
Specifically, the pusher 50 includes a protrusion 54 that protrudes outwardly from the rear end of the main body 51 and is provided at a position on the front end side of a predetermined length. Two protrusions 54 are provided so as to face each other at least. Two or more (for example, four) protrusions 54 may be provided. And the outer cylinder 21 is provided with the rib 27 provided in the inner surface of the site | part which becomes a front end side a little from proximal end opening. The rib 27 and the protrusion 54 constitute an engaging means for restricting the backward movement of the pusher. The rib 27 of the outer cylinder 21 is preferably an annular rib, and the rear end surface of the annular rib is preferably an inclined surface for guiding the protrusion. Similarly, the tip surface of the protrusion 54 of the pusher 50 is preferably an inclined surface. The engagement between the rib 27 and the protrusion 54 is released by pulling the pusher 50. That is, the engagement means for restricting the backward movement of the pusher can be deregulated.

In addition, as a prefilled syringe, what is shown to FIG. 26 thru | or FIG. 30 may be used. The difference between the prefilled syringe 20a and the prefilled syringe 20 described above is only the presence / absence of the release means of the engagement means that regulates the retraction of the presser provided in the presser 50a. In this embodiment, the release mechanism is formed by an operation unit having a function of pushing down the vicinity of the protrusion 54 of the pusher 50a . Specifically, the pusher 50 a includes engagement release means provided at a portion slightly on the tip side from the disk portion 53. The disengagement means is provided at the slit 57 extending beyond the formation part of the protrusion 54 from the base end part of the main body part 51, the rod-like part 56 extending to the base end side from the projection 54, and the end part of the rod-like part 56. The operation unit 55 is provided. Therefore, as shown in FIG. 30, in a state where the projections 54 are engaged in the ribs 27 and impactor 50 a of the outer tube 21 by pressing the operation portion 55, it pushed down around the projection 54 of the push rod 50a, Both engagements are released.

Next, operations of the medical device connector and the drug administration device of the present invention will be described with reference to FIGS. 1 to 3, 31, and 32.
First, the seal member 15 is peeled off from the medical device connector 1. In this state, the adapter 2 is stored and held in the storage member 8. And the medicine container 80 is connected to the medicine container mounting part 31 of the adapter 2 in that state. As a result, the hollow needle-like portion 33 of the adapter 2 punctures the seal member 87 that seals the opening of the drug container 80. When the inside of the medicine container 80 is depressurized, outside air passes through the inner peripheral edge of the storage member 8, and opens from the upper part of the storage member 8 to the opening of the filter unit 9, the bacteria-impermeable filter 11, and the adapter 2. The hollow needle-shaped portion 33 flows into the drug container 80 through the internal flow channel 33 a and the injection device connection portion 43. Therefore, the inflow of bacteria into the medicine container is prevented during the mounting operation of the adapter 2 to the medicine container 80. Then, the storage member 8 is detached from the adapter 2 to which the medicine container 80 is attached. By the removal of the storage member 8, the filter part 9 is detached from the cylindrical protector 7 encapsulating the adapter 2, and the adapter 2 is encapsulated on the outer surface only by the cylindrical protector 7, and the injection device connecting part 43 is exposed. Then, as shown in FIG. 32, the prefilled syringe 20 is connected to the injection device connecting portion 43 of the adapter 2 and pushed in to inject the medical liquid 29 in the syringe into the drug container 80. At this time, as shown in FIG. 32, the rib 27 of the outer cylinder 21 and the projection 54 of the pusher 50 engage with each other, so that the pushback of the pusher is restricted. By shaking the container 80, the drug 88 and the medical liquid 29 are mixed to prepare a drug solution. Then, by pulling the pusher 50, the drug solution prepared in the drug container 80 is sucked into the syringe, whereby the administration preparation is completed. At the time of aspiration, chemical prepared, after passing through the liquid permeability filter over 12, since it is sucked into the syringe, is not to suck the foreign matter drug insolubles etc. into the syringe.

DESCRIPTION OF SYMBOLS 1 Medical device connector 2 Adapter 3 Drug container connector 4 Injection device connector 5 Connection member 6 Storage body 7 Cylindrical protector 8 Storage member 9 Filter part 10 Medical device connector 11 Bacteria impermeable filter 12 Liquid-permeable filter 20 Prefilled syringe 21 Outer cylinder 50 Pusher 80 Drug container

Claims (6)

One end of the opening sealed by the sealing member of a medicine container comprising a container main body having an opening, a sealing member for sealing the opening of the container main body, and a medicine stored in the container main body Can be connected, and the other end can be connected to a medical liquid injection device, and a medical device connection comprising a housing member for housing the adapter and opening a portion for housing the one end side of the adapter Tools,
The adapter is provided at one end of the adapter, and the drug container mounting portion connectable to the opening that is sealed by the sealing member, provided on said one end, through the seal member of the drug container A hollow needle-like part having a possible blade edge part, an internal flow path provided on the other end side of the adapter and communicating with an internal flow path of the hollow needle-like part, and the medical liquid injection device A connectable infusion device connection,
The medical device connector is located in the housing member and encapsulates at least the other end side of the adapter where the injection device connector is provided, and includes a bacteria-impermeable filter, the adapter The internal flow path of the injection device connecting portion of the injection device includes a filter portion that communicates with the inside of the storage member only through the bacteria-impermeable filter, and the storage member stores and holds the adapter, medical devices connecting device, in a state in which the adapter is received in the receiving member is capable penetrating the sealing member by mounting and the hollow needle-like portion to the medicament container, by the hollow needle portion By the piercing of the seal member, the inside of the drug container and the inside of the storage member are connected to the internal flow path of the hollow needle-like portion of the adapter and the connecting portion of the injection device. Has become one that communicates only through the bacteria-impermeable filter of the filter unit, further,
The medical device connector has a detachment restricting portion that restricts detachment of the filter portion from the storage member, and the detachment restricting portion includes an annular rib provided on the storage member or a plurality of discontinuous ribs. The filter portion is configured by a peripheral portion of the filter portion that is in contact with the rib and is housed in an upper portion of the housing member from the rib, and the filter portion disengages the housing member from the adapter. The medical device connector is released from the adapter side together with the storage member . The medical device connector according to claim 1, wherein the adapter is held by the storage member via the filter portion. The medical device connector is housed in the housing member and includes a cylindrical protective member that holds the adapter and encloses the adapter, and the filter portion is attached to the opening of the protective member The medical device connector according to claim 1, wherein the medical device connector is provided. The medical device connector according to any one of claims 1 to 3, wherein the medical device connector includes a seal member that seals the opening of the storage member. The medical device connector according to any one of claims 1 to 4, wherein the inside of the drug container is decompressed. Claims 1 consists of a one of the medical device connecting device 5, and the drug which is housed a seal member for sealing to the container body to the opening of the container main body said container body having an opening, said a drug container connectable to said drug container mounting portion of the adapter of the medical device connector, and the outer cylinder body portion, the tip provided at the distal end portion of the outer cylinder main body is opened, and the medical device connector wherein an outer cylinder to the injection device connecting unit comprises a nozzle unit can be connected, and a sealing member for sealing the nozzle portion, a gasket which is slidably received in the outer tube, the gasket of the adapter A drug administration device comprising a pusher attached to or attachable to a rear end of the medical device, and a prefilled syringe including a medical liquid filled in the outer cylinder.

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