Drug administration device

Abstract

A connector unit (18) in a liquid medicine administration device (10) is provided with: a hollow needle (76) that communicates with a tube (16) and projects on the side of a device main body (14) or a syringe (80) so as to allow the device main body (14) or the syringe (80) to communicate with the tube (16); and a valve (88) that is arranged on the tip side of the hollow needle (76) and is opened upon the delivery of a liquid medicine (S1) in the device main body (14) or a priming solution (S2) in the syringe (80) so as to allow the device main body (14) or the syringe (80) to communicate with the tube (16). The valve (88) is formed in a disk-like shape having a slit hole (94) at the center part thereof, and a plurality of projecting parts (92) are formed on a base end surface (90a) of a valve hole (90) with which the valve (88) contacts.

Description

[Technical Field]

[0001] The present invention relates to a drug solution administration device in which the device body is attached and left on the body surface of a living body. [Background technology]

[0002] The present applicant has proposed a drug solution administration device for administering a desired dose of drug solution to a living body at an appropriate timing (see International Publication No. 2018 / 173962).

[0003] This drug solution administration device is connected to, for example, a patch-type needle-equipped tube, which includes a connector connectable to the tip of a cylindrical body, a flexible liquid supply tube connected to the connector, a patch unit connected to the other end of the liquid supply tube and attachable to the patient's skin, and a puncture needle protruding from the patch unit, which punctures the skin approximately perpendicularly.The drug solution discharged from the cylindrical body is then injected into the patient's body through the needle-equipped tube. Summary of the Invention

[0004] A general object of the present invention is to provide a medicinal liquid administration device that can reliably prevent leakage of medicinal liquid before administration and can reliably open and close the valve body by preventing displacement of the valve body relative to the connector.

[0005] An aspect of the present invention is a drug solution administration device comprising: a needle portion that is inserted into and left in a living body; a device main body that is provided separately from the needle portion and that is capable of delivering a drug solution filled inside from a tip portion; a tube that is connected to the needle portion at the tip and through which the drug solution can flow; and a connector to which either a priming solution delivery means (attached via an adapter member) that is provided at the base end of the tube and that is capable of delivering a priming solution filled inside from the tip portion or the device main body is attached, The connector has a hollow needle whose hole is formed inside and communicates with the tube, and which protrudes toward the device body or the priming liquid delivery means so as to be freely communicated with the inside of the device; a valve body that is disposed on the distal end side of the hollow needle and that opens when the drug solution or priming solution is delivered, thereby connecting the tube with the device main body side or the priming solution delivery means side; Equipped with The connector has an uneven portion formed unevenly in the axial direction on the surface that contacts the valve body.

[0006] According to the present invention, a connector is provided at the base end of a tube connected to a needle portion inserted and left in a living body, and this connector is selectively equipped with either an apparatus main body capable of delivering a drug solution or a priming solution delivery means (attached via an adapter member) capable of delivering a priming solution, and the connector is equipped with a hollow needle having an internal needle hole that communicates with the tube and protrudes toward the apparatus main body or the priming solution delivery means to communicate with the interior, and a valve body disposed at the distal end of the hollow needle that opens when the drug solution or priming solution is delivered, thereby connecting the apparatus main body or the priming solution delivery means to the tube, and the connector is equipped with an uneven portion formed unevenly in the axial direction on the surface that abuts the valve body.

[0007] Therefore, when connecting the device body to the connector, the hollow needle is inserted into the device body, thereby establishing communication between the inside of the device body and the tube via the hollow needle. Therefore, when connecting the device body to the connector in the drug solution administration device, the connection can be made without increasing the pressure of the drug solution inside the device body. As a result, it is possible to reliably prevent the drug solution from leaking from the valve due to a pressure increase when connecting the device body to the connector.

[0008] Furthermore, even if the pressure of the medicinal solution or priming solution is suddenly applied to the valve body when administering the medicinal solution through the needle portion to a living body or when priming, the frictional resistance of the valve body can be increased under contact with the uneven portion to prevent the valve body from moving relative to the connector, and by holding the valve body in a predetermined position, the opening and closing hole can be opened and closed reliably and stably. [Brief explanation of the drawings]

[0009] [Figure 1] 1 is an overall plan view of a chemical solution administration device according to an embodiment of the present invention. [Figure 2] FIG. 2 is an overall cross-sectional view of the drug solution administration device shown in FIG. [Figure 3] 2 is an overall plan view showing a state in which the device body is attached to a connector portion in the drug solution administration device of FIG. 1. FIG. [Figure 4] 3 is an enlarged cross-sectional view of the vicinity of a needle in the drug solution administration device of FIG. 2. FIG. [Figure 5] 4 is an enlarged cross-sectional view showing the vicinity of a connection portion of the device body in the drug solution administration device of FIG. 3. FIG. [Figure 6] 3 is an enlarged cross-sectional view showing the vicinity of a connector portion in the drug solution administration device of FIG. 2. FIG. [Figure 7] FIG. 7 is an enlarged cross-sectional view showing the vicinity of the valve body in FIG. 6. [Figure 8] FIG. 8 is a further enlarged cross-sectional view of the vicinity of the valve body in FIG. 7. [Figure 9] 1 is a plan view of a connector body that constitutes a connector portion, viewed from the tip side along the axial direction. FIG. [Figure 10] FIG. 10 is a cross-sectional view taken along line XX in FIG. 9. [Figure 11] 3 is an overall cross-sectional view showing a state in which a syringe is attached to a connector portion in the drug solution administration device of FIG. 2. FIG. [Figure 12] 12 is an enlarged cross-sectional view showing the vicinity of a connector portion and a syringe in the drug solution administration device of FIG. 11. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0010] This medicinal solution administration device 10 is configured to be placed on the body surface of a patient (living body), such as the abdomen, and to automatically administer medicinal solution S1 (see FIG. 5) into the body. For example, the medicinal solution administration device 10 is used when administering medicinal solution S1 to a patient a predetermined time after a medical procedure has been performed on the patient, or when administering medicinal solution S1 gradually over time. The medicinal solution S1 administered by the medicinal solution administration device 10 is not particularly limited, and examples thereof include liquid pharmaceuticals such as antibody drugs, anticancer drugs, chemotherapy drugs, anesthetics, antibiotics, insulin, blood products, and nutrients.

[0011] 1 to 3, this drug solution administration device 10 includes a needle portion 12, a device main body 14 (see FIG. 3) capable of supplying drug solution S1, a tube 16 capable of circulating drug solution S1 between the needle portion 12 and the device main body 14, and a connector portion (connector) 18 provided at the base end of the tube 16 and capable of selectively connecting the device main body 14, etc. In other words, the drug solution administration device 10 connects the device main body 14 and the needle portion 12 via the tube 16 in a separated state.

[0012] As shown in Figures 1 to 4, the needle portion 12 forms an introduction portion for the medicinal solution S1 by inserting and leaving a catheter 20 inside the body (subcutaneously) from the body surface, and includes the catheter (outer needle) 20, an inner needle 22 that penetrates the inside of the catheter 20, a hub 24 that holds the base end of the catheter 20 and to which the tube 16 is connected, a seal body 26 that attaches the hub 24 to the body surface, a needle hub 28 that is connected to the base end of the hub 24 and holds the base end of the inner needle 22, and a gripping part 30 that is attached to the base end of the needle hub 28.

[0013] The catheter 20 is a flexible tubular body having an internal lumen (not shown) through which the medicinal solution S1 can flow, and protrudes downward from the lower surface (the surface facing the body surface) of the hub 24. This lumen communicates with a distal end opening of the catheter 20 and also communicates with a space 32 within the hub 24 on the proximal end side (direction of arrow A) of the catheter 20 (see FIGS. 2 and 4). The proximal end of the catheter 20 is fixed to the hub 24 by, for example, crimping a crimping pin (not shown).

[0014] The distal end of the inner needle 22 is inserted into the lumen of the catheter 20, and the proximal end is inserted into the inside of the hub 24 and held at the distal end of the needle hub 28. The multiple needle 46, in which the catheter 20 and the inner needle 22 overlap, is covered on the outer periphery with a tubular protector 29.

[0015] The hub 24 is formed, for example, from a resin material, and is bifurcated at a location midway between its distal and proximal ends. The hub body 34 extends linearly from the distal end to the proximal end and has an internal space 32 that connects the lumen of the catheter 20 to a flow passage 38 of the tube 16. Meanwhile, the needle hub 28, to which the gripping part 30 is adhered, is detachably connected to the proximal end of the hub body 34.

[0016] In addition, the hub 24 has a hub branch portion 36 that branches at a predetermined angle from its intermediate portion toward the base end (in the direction of arrow A), and the tip of the tube 16 is connected to the base end via an open inlet port 70, thereby connecting the flow passage 38 of the tube 16 to the space portion 32 through the inlet port 70.

[0017] Furthermore, a flat hub substrate 40 is formed below hub 24, and seal body 26 is affixed to the underside of this hub substrate 40. This seal body 26 is formed in the shape of a flexible sheet that is wider in the planar direction than hub substrate 40. The underside of seal body 26 is provided with an adhesive surface (not shown) that can be attached to the body surface, and before needle portion 12 is used, a sheet-like mount 42 is affixed to this adhesive surface.

[0018] The backing 42 has tabs 44 that protrude from the sticker 26 and can be grasped by the user, and the adhesive surface is exposed by grasping the tabs 44 and peeling the sticker 26 away from the backing 42. The top surface of the backing 42, to which the sticker 26 is attached, is provided with a coating that makes the adhesive surface easier to peel off.

[0019] The user of the drug solution administration device 10 then inserts the multiple needle 46, in which the catheter 20 and the inner needle 22 overlap, into the body, and then pulls out the inner needle 22 from the catheter 20 while it is still inserted (detaching the needle hub 28 from the needle portion 12 toward the base end (in the direction of arrow A)), thereby leaving the catheter 20 in the patient's body.

[0020] 3 and 5, the device main body 14 has a function of storing the chemical solution S1 and discharging the chemical solution S1 from the tip at an appropriate timing, and includes a case 48 having an internal storage space (not shown) for storing each component. Inside the case 48, there are provided a container 50 for storing the chemical solution S1, a movement mechanism 54 for moving a first gasket 52 inside the container 50, a control unit 56 for controlling the operation of the movement mechanism 54, and a power supply unit (not shown) capable of supplying power to each component.

[0021] The container 50 is formed in a cylindrical shape along the axial direction (direction of arrows A and B), is filled with the chemical solution S1, and its tip protrudes a predetermined length in the axial direction (direction of arrow B) from the tip of the case 48 and is exposed to the outside.

[0022] The container 50 has at its tip an outlet port 60 which is narrowed to open and sealed with a packing 58, and the packing 58 is sandwiched between the tip of the container 50 and a cylindrical main body connector 62 which is provided so as to cover the outer periphery of the outlet port 60. This allows the medicinal solution S1 to be held sealed inside the container 50.

[0023] The main body side connector 62 is formed in a cap shape and has a hole 64 at the center of its tip through which a hollow needle 76 (described later) can be inserted, and an engaging recess 66 on the outer circumferential surface that is recessed radially inward and engages with a connector main body 72 of the connector part 18 (described later). When the connector main body 72 engages with the engaging recess 66 of the main body side connector 62, the device main body 14 is connected to the base end side of the connector main body 72 (in the direction of arrow A) via the main body side connector 62.

[0024] 1 to 4 and 6, tube 16 is formed from a flexible tube having a predetermined length and having therein a flow path 38 through which medicinal solution S1 can flow, and one end of tube 16 is fixed to inlet port 70 of hub branch portion 36 of hub 24 by appropriate fixing means such as adhesive, welding, or crimping via a tubular joint tube 68a attached to the outer periphery of tube 16. As a result, flow path 38 of tube 16 communicates with space 32 of hub 24 through inlet port 70.

[0025] The other end of the tube 16, with a tubular extension pipe 68b attached to its outer periphery, is inserted into the tube holder 74 in the connector portion 18 described later, and fixed by an appropriate fixing means such as adhesive, welding, or crimping.

[0026] As shown in Figures 1 to 3 and 5 to 11, the connector portion 18 has a connector body 72, a tube holder 74 housed at the tip side (in the direction of arrow B) of the connector body 72, and a hollow needle 76 held along the axial center within the connector body 72.

[0027] The connector body 72 is formed, for example, from a resin material, and includes a fixed portion 78 formed on the tip side (direction of arrow B) to which the tube 16 is fixed together with the tube holder 74, a connected portion 82 formed on the base end side (direction of arrow A) to which either the device body 14 or the syringe 80 is selectively connected, and an intermediate portion 84 connecting the fixed portion 78 and the connected portion 82.

[0028] The fixed part 78 is formed in a cylindrical shape that opens toward the tip side (direction of arrow B), and has a holder hole 86 inside, into which the tube holder 74 is inserted and fixed, and a valve hole 90 formed on the base end side (direction of arrow A) of the holder hole 86 and into which the valve body 88 is housed. The holder hole 86 opens on the tip side of the fixed part 78 and is formed in a tapered shape so that its diameter gradually decreases toward the base end side (direction of arrow A).

[0029] 7 to 10, the valve hole 90 is formed with a circular cross section that is smaller in diameter than the holder hole 86, and is formed with a predetermined length in the axial direction (direction of arrows A and B). The base end surface (face) 90a of the valve hole 90 is formed with a circular shape when viewed from the axial direction of the connector main body 72, and is formed so as to be perpendicular to the axial direction, with a communication chamber 104 (described later) opening into its center. The base end surface 90a of the valve hole 90 also has a plurality of protrusions (uneven portions) 92 formed in a convex shape toward the tip side (direction of arrow B) that is the valve body 88 side, radially outward of the opening of the communication chamber 104.

[0030] The protrusions 92 are formed, for example, in a triangular cross section that gradually tapers toward the tip when viewed in a direction perpendicular to the axial direction of the connector main body 72, and are formed in a straight line along the perpendicular direction, with multiple protrusions 92 provided parallel to each other and equally spaced apart. In other words, as shown in Fig. 8, the space between two adjacent protrusions 92 is formed like a groove recessed with a rectangular cross section toward the base end (direction of arrow A). The multiple protrusions 92 are provided so as to be able to abut against the upper surface of the valve body 88 accommodated in the valve hole 90.

[0031] The valve element 88 is formed in a disk shape of a constant thickness from an elastic material such as silicone rubber, and has a straight slit hole (opening / closing hole) 94 formed in a central position when viewed in the thickness direction as shown in Fig. 9. The valve element 88 is formed in a thin plate shape whose axial dimension (thickness dimension) is smaller than its radial dimension. The slit hole 94 extends in a straight line from the center of the valve element 88 radially outward and penetrates through in the thickness direction (directions of arrows A and B in Fig. 8). The slit hole 94 is not limited to being formed in a straight line (slit shape) and may be formed in a cross shape, for example.

[0032] The valve body 88 is accommodated in the valve hole 90 and is positioned so that the slit hole 94 is approximately parallel to the multiple protrusions 92 (see Figure 9), and is also positioned so that the tips of the protrusions 92 abut against and slightly dig into the upper surface of the valve body 88 (see Figure 8).

[0033] As shown in Figures 7 and 8, when pressure is applied to the upper surface of the valve body 88 toward the tip (direction of arrow B), a pair of opposing slit pieces 96a, 96b facing the slit hole 94 elastically deform so as to bend toward the tip, causing one slit piece 96a and the other slit piece 96b to separate radially, creating a gap and entering an open state (see the dashed-dotted line shape in Figures 7 and 8).

[0034] On the other hand, when the pressure toward the tip side on the upper surface of the valve body 88 is deactivated, the pair of slit pieces 96a, 96b do not elastically deform, so one slit piece 96a and the other slit piece 96b face each other and abut, resulting in a closed state with no gap between them.

[0035] 5 and 6, the connected part 82 is formed in a cylindrical shape that opens toward the base end side (in the direction of arrow A), and its outer peripheral wall is formed with a pair of rectangularly opening engagement holes 98. The pair of engagement holes 98 engage with the device main body 14, which is connected to the connected part 82 from the base end side (in the direction of arrow A), or with connection arms 136 of an adapter member 100 for attaching a syringe (priming liquid delivery means) 80.

[0036] In addition, the connected portion 82 is formed with a pair of connector claws 102 that protrude radially inward from the inner surface that is the base end side (direction of arrow A) of the engagement hole 98, and as shown in Figure 5, when the main body side connector 62 of the device main body 14 is connected to the connector main body 72, the connector claws 102 engage with the engagement recess 66, so that the device main body 14 is connected to the base end side (direction of arrow A) of the connector main body 72 via the main body side connector 62 in a state where relative movement in the axial direction (direction of arrows A and B) with respect to the connector portion 18 is restricted.

[0037] As shown in Figures 6 to 10, the intermediate portion 84 has a communication chamber 104 formed at the axial center, opening toward the tip side (in the direction of arrow B) on the fixed portion 78 side and communicating with the valve hole 90, and a needle fitting hole 106 penetrating from the base end of the communication chamber 104 to the inside of the connected portion 82, and the communication chamber 104 is formed with a constant diameter along the axial direction, extends from approximately the center along the axial direction of the intermediate portion 84 to the tip side, and opens at the base end face 90a of the valve hole 90 so as to face the valve body 88.

[0038] 5 to 7, the needle fitting hole 106 is formed with a smaller diameter than the communicating chamber 104 and is configured to be able to hold a hollow needle 76 fitted therein. The hollow needle 76 is provided to connect the device main body 14 or the adapter member 100 connected to the connector portion 18 to the communicating chamber 104 of the connector main body 72, and has a needle hole 108 therein. One sharp end side is held through the needle fitting hole 106 so as to be exposed to the axial center by a predetermined length inside the connected part 82, and the other end side is held through the needle fitting hole 106 so as to be exposed to the axial center by a predetermined length inside the communicating chamber 104. That is, the axial center of the hollow needle 76 is held by the intermediate part 84 in the connector main body 72, and one end side and the other end side protrude into the connected part 82 and the communicating chamber 104, respectively.

[0039] Further, the hollow needle 76 has a tip opening (first opening) 110 communicating with the needle hole 108 near one end thereof, and a side hole (middle opening) 112 communicating with the needle hole 108 near the other end housed in the communication chamber 104, and the base end opening 110 is disposed inside and communicates with the connected part 82. The base end opening 110 and the side hole 112 each open on the outer circumferential surface so as to be perpendicular to the axial direction of the hollow needle 76 (directions of arrows A and B).

[0040] On the other hand, a base end opening (second opening) 114 that opens in the axial direction (arrow B direction) and communicates with the needle hole 108 is formed at the other end of the hollow needle 76. This tip opening 114 is spaced a predetermined distance toward the base end (arrow A direction) from the valve body 88 and is disposed inside the communication chamber 104 so as to face the slit hole 94. In other words, in the hollow needle 76, a side hole 112 is formed at a position midway between the base end opening 110 and the tip opening 114.

[0041] 2 and 5 to 8, the tube holder 74 is formed in a cylindrical shape with a bottom and an open tip, and its outer circumferential surface is formed in a tapered shape that gradually reduces in diameter from the tip to the base end side (direction of arrow A). Then, by inserting it into the holder hole 86 of the connector main body 72, it is fitted and fixed coaxially.

[0042] Inside the tube holder 74, a tube hole 116 is formed that opens to the tip side (in the direction of arrow B) and extends in the axial direction, and the other end of the tube 16 to which the extension pipe 68b is attached is inserted into the tube hole 116 and fixed by an appropriate fixing means such as adhesive, welding, crimping, etc. The flow passage 38 of the tube 16 is open to the base end side (in the direction of arrow A) inside the holder hole 86.

[0043] Furthermore, the bottom wall 118, which forms the base end of the tube holder 74, is formed in a circular shape extending in a direction perpendicular to the axial direction (the direction of arrows A and B), and a through hole 120 is formed in the center thereof, penetrating in the axial direction and communicating with the flow passage 38 of the tube 16, and a ring-shaped valve seat 122 is formed radially outward of the through hole 120 and protruding from the base end of the bottom wall 118.

[0044] 7, 8, and 10, the valve seat 122 protrudes a predetermined height from the bottom wall 118, and its outer circumferential surface 124 is formed perpendicular to the bottom wall 118, while its inner circumferential surface 126 is formed in a tapered shape that is inclined radially outward in a direction (toward the base end) away from the bottom wall 118. In other words, the valve seat 122 is formed in an inward tapered shape, with the radially inner side tapered.

[0045] Furthermore, the valve seat 122 is provided with a valve seat surface 128 formed substantially parallel to the bottom wall 118 on the base end side (in the direction of arrow A) of the outer peripheral surface 124 and the inner peripheral surface 126, against which the lower surface of the valve element 88 can abut, and this valve seat surface 128 is formed flat along the radial direction. In other words, the inner peripheral surface 126 is formed so as to be inclined radially inward in the direction away from the valve seat surface 128, i.e., toward the tip end side (in the direction of arrow B).

[0046] 10, the valve seat 122 is disposed so as to be located radially outward of the slit 94 when the valve element 88 abuts against the valve seat surface 128. In other words, the valve seat 122 is disposed at a position where it does not overlap with the slit 94.

[0047] As shown in Figures 8 and 10, the underside of the valve body 88 abuts against the valve seat 122 at a position on the outer periphery of the slit hole 94 and bites slightly toward the base end, so that the valve body 88 is held between the base end surface 90a of the valve hole 90 and the valve seat 122 in a state where it is crimped in the axial direction (direction of arrows A and B).

[0048] As shown in Figures 1, 2, 6, 11 and 12, the adapter member 100 is attached when attaching the syringe 80 for priming the priming liquid S2 (physiological saline) to the connector portion 18, and includes a cylindrically formed adapter main body 130, a syringe connector 132 inserted into the adapter main body 130, and a sealing member 134 housed inside the adapter main body 130 on the tip side of the syringe connector 132.

[0049] The adapter body 130 has a tapered tip that gradually reduces in diameter toward the tip side (in the direction of arrow B), and is formed so that it can be inserted into the connected part 82 of the connector body 72. Also, a pair of connecting arms 136 extending toward the tip side are provided on the outer periphery of the central axial part.

[0050] The connecting arm 136 is positioned symmetrically about the axial center of the adapter body 130, with its central portion along the axial direction being parallel to and spaced radially outward from the outer surface of the adapter body 130 via a leg portion, and its tip having a claw portion 138 that protrudes toward the adapter body 130.

[0051] When the adapter member 100 is connected to the connector body 72, the claw portion 138 of the connecting arm 136 engages with the engagement hole 98 of the connected part 82, thereby restricting relative movement in the axial direction (direction of arrows A and B) and rotational direction, and the adapter member 100 is connected and fixed to the connected part 82 at the base end side (direction of arrow A).

[0052] Syringe connector 132 is formed in a cylindrical shape with a smaller diameter than adapter body 130, and is fixed integrally, for example, by being pressed into the interior of adapter body 130, and at its tip side (direction of arrow B) is formed a partition portion 142 having an insertion hole 140 in the center perpendicular to the axial direction (see Figure 6).

[0053] Furthermore, syringe connector 132 is formed with a holding end 144 capable of holding sealing member 134 at a position more distal than partition wall portion 142, and this holding end 144 is formed to open toward the distal end side (direction of arrow B), and is held by inserting the base end side of sealing member 134 into it, and is held integrally with adapter body 130 by engaging its outer peripheral surface with the inner peripheral surface of adapter body 130.

[0054] 11 and 12, the proximal end of the syringe connector 132 is connected to the distal end of a cylindrical body 146 that constitutes the syringe 80 and is filled with a priming liquid S2.

[0055] Seal member 134 is made of an elastic material such as rubber and has a circular cross section when viewed in the axial direction, with a needle insertion hole 148, through which hollow needle 76 is inserted, penetrating axially at its axial center. As shown in Fig. 6 , when adapter member 100 is connected to connector main body 72, one end of hollow needle 76 exposed inside connected portion 82 is inserted into insertion hole 140 through needle insertion hole 148, causing hollow needle 76 to protrude toward the base end side (direction of arrow A) of seal member 134 through through hole 120 inside syringe connector 132, and seal member 134 forms a seal between hollow needle 76 and syringe connector 132.

[0056] Furthermore, hollow needle 76 has its base end opening 110 disposed inside and communicating with syringe connector 132, and its side hole 112 and tip end opening 114 disposed inside and communicating with communicating chamber 104 of connector main body 72. In other words, communicating chamber 104 of connector main body 72 and the interior of syringe connector 132 are connected and communicated with by hollow needle 76.

[0057] The chemical solution administration device 10 according to the embodiment of the present invention is basically configured as described above, and its operation, function and effect will now be described.

[0058] When using this drug solution administration device 10, the needle portion 12 and tube 16 are placed on the surface of the patient's body, a syringe 80 is connected to fill the inside of the catheter 20 with priming solution S2, and then the device main body 14 is connected and drug solution S1 is automatically administered to the patient under the control of the control unit 56.

[0059] 11 and 12, the user first connects a syringe 80 filled with a priming solution S2 to the connector portion 18 of the medical solution administration device 10. Specifically, by inserting the tip of the syringe 80 from the base end side into the syringe connector 132 of the connector portion 18, the inside of the cylindrical body 146 of the syringe 80 and the inside of the syringe connector 132 are brought into communication with each other.

[0060] Then, a first priming is performed to fill the inside of the tube 16 and the needle portion 12 of the drug solution administration device 10 with the priming liquid S2.

[0061] First, the user grasps the rod 150 of the syringe 80 and urges it toward the tip (in the direction of arrow B), causing the second gasket 152 attached to the tip of the rod 150 to move toward the tip along the cylindrical body 146, and as a result, the priming liquid S2 filled inside the cylindrical body 146 is ejected from the outlet 154 opening at the tip of the cylindrical body 146 into the inside of the syringe connector 132.

[0062] As shown in Figure 7, the priming liquid S2 flows into the needle hole 108 through the base end opening 110 of the hollow needle 76 opened inside the syringe connector 132, flows in the axial direction (direction of arrow B), and is introduced into the communicating chamber 104 of the connector body 72 from the tip end opening 114, and a portion of it is discharged from the needle hole 108 through the side hole 112 into the communicating chamber 104.

[0063] That is, a portion of the priming solution S2 is discharged from the tip opening 114 to the communicating chamber 104 in the axial direction toward the tip side (direction of arrow B), while the remainder is discharged from the side holes 112 radially outward, and then flows in the axial direction (direction of arrow B) along the inner circumferential surface of the communicating chamber 104. In other words, the priming solution S2 is discharged in two directions from the tip opening 114 and the side holes 112, which have different opening directions relative to the communicating chamber 104.

[0064] The priming liquid S2 supplied into this communicating chamber 104 presses the upper surface of the valve body 88 toward the tip side (in the direction of arrow B), causing the pair of slit pieces 96a, 96b to elastically deform so as to bend toward the tip side, thereby opening the slit hole 94 radially, and the priming liquid S2 flows through the slit hole 94 toward the tube holder 74 side (in the direction of arrow B) and then flows through the through hole 120 into the flow passage 38 of the tube 16.

[0065] At this time, the pressure applied from the priming solution S2 to the upper surface of the valve element 88 is suitably distributed between that which is discharged from the tip opening 114 and applied to the vicinity of the center of the valve element 88, and that which is discharged from the side hole 112, flows along the inner circumferential surface of the communication chamber 104, and is applied to the vicinity of the outer edge of the valve element 88. Therefore, compared to when the priming solution S2 is discharged only from the tip opening 114 of the hollow needle 76 and pressure is applied only to the vicinity of the center of the valve element 88, the pressure applied to the vicinity of the center of the valve element 88, which has the slit hole 94, is reduced.

[0066] As a result, even when the pressure of the priming fluid S2 is suddenly applied to the valve element 88, the load on the slit 94 is reduced, preventing the area around the slit 94 from being plastically deformed and remaining in an open state, and the slit 94 can be elastically restored to its original shape and reliably closed when pressure from the priming fluid S2 is no longer being applied. In other words, when the flow of the priming fluid S2 is completed, the slit 94 can be reliably closed, blocking communication between the communication chamber 104 and the tube 16.

[0067] In other words, by providing the hollow needle 76 with a side hole 112 from which the priming liquid S2 is discharged in addition to the tip opening 114 from which the priming liquid S2 is discharged, a pressure loss occurs when the priming liquid S2 flows, and by suitably dispersing the internal pressure of the priming liquid S2 within the communicating chamber 104, it becomes possible to radially disperse the pressure applied to the upper surface of the valve body 88.

[0068] Furthermore, when the priming solution S2 flows into the communication chamber 104 and opens the slit hole 94, a force is applied to the valve element 88 in a direction that separates the slit pieces 96a, 96b on both sides of the slit hole 94 from each other, i.e., a force that pushes the valve element 88 radially outward. However, the upper surface of the valve element 88 abuts slightly against the multiple protrusions 92 extending in a direction perpendicular to the radial force, thereby suppressing radial movement of the valve element 88. Therefore, the valve element 88 is maintained at a predetermined position within the valve hole 90 so as to be on the axis of the connector main body 72. In other words, by abutting the valve element 88 against the multiple protrusions 92, the frictional resistance of the valve element 88 with respect to the connector main body 72 is increased, making it possible to suppress radial movement.

[0069] Furthermore, when the slit hole 94 is opened and the slit pieces 96a, 96b elastically deform toward the tip side, the inner surface 126 of the valve seat 122 is formed in a tapered shape, so that stress concentration at the portion of the valve seat surface 128 that contacts the upper end of the inner surface 126 can be alleviated compared to when the inner surface 126 is a perpendicular surface that is perpendicular to the bottom wall 118, and as a result, the slit pieces 96a, 96b can be elastically deformed toward the tip side (in the direction of arrow A) by a substantially constant amount of deformation.

[0070] As a result, it is possible to stabilize the amount of deformation of the slit pieces 96a, 96b in the valve body 88 when the slit hole 94 is in an open state, and the priming liquid S2 can be supplied at a stable flow rate to the connector main body 72 through the slit hole 94 regardless of the amount of pressure applied from the priming liquid S2 to the valve body 88.

[0071] Furthermore, when the valve disc 88 is urged toward the distal end (in the direction of arrow B) by the pressure of the priming solution S2, stress is generated at the boundaries between the outer circumferential surface 124 and the inner circumferential surface 126 on the underside of the valve disc 88 that abuts against the valve seat surface 128 of the valve seat 122. However, since the inner circumferential surface 126 is inclined radially inward relative to the direction of pressure application (in the axial direction toward the distal end) while the outer circumferential surface 124 stands upright in the direction of pressure application (in the direction of arrow B), i.e., toward the distal end, the stress generated on the inner circumferential surface 126 side can be kept smaller than that on the outer circumferential surface 124 side. As a result, when the valve disc 88 is pressed toward the distal end (in the direction of arrow B) under the supply of priming solution S2, the amount of deformation on the inner circumferential side of the valve seat 122 can be kept smaller than the amount of deformation on the outer circumferential side.

[0072] As a result, when the priming solution S2 is caused to flow through the slit hole 94 of the valve body 88, the opening degree of the slit hole 94 provided on the inner peripheral side of the valve seat 122 can be maintained substantially constant, so that the slit hole 94 can be stably opened by a predetermined pressure applied to the valve body 88, and the priming solution S2 can be supplied at a stable flow rate toward the needle portion 12. In other words, the opening pressure of the priming solution S2 for opening the slit hole 94 does not fluctuate, and the slit hole 94 can be reliably opened at a substantially constant pressure at all times.

[0073] The priming solution S2 flowing from the connector main body 72 to the flow passage 38 of the tube 16 flows through the inflow port 70 into the space 32 of the hub 24 and into the inside of the catheter 20, thereby filling the tube 16, the space 32 of the hub 24, and the inside of the catheter 20 with the priming solution S2, completing the first priming. Furthermore, when the flow of the priming solution S2 through the slit 94 of the valve body 88 stops and pressure on the valve body 88 is released, the elastically deformed slit pieces 96a, 96b return to their original shape and close the slit 94. This blocks communication between the communication chamber 104 of the connector main body 72 and the tube 16.

[0074] Next, the user grasps needle portion 12 and positions it at a desired location on the body surface, and then removes protector 29 toward the tip side (in the direction of arrow B) of multi-needle 46. Then, multi-needle 46 protruding from the underside of hub 24 is inserted into the body, tab 44 is grasped from seal body 26 fixed to needle portion 12 to peel off backing 42, and the adhesive surface (not shown) of seal body 26 is attached to the body surface, thereby fixing needle portion 12 to the body surface.

[0075] After this puncture, the user pulls the needle hub 28 and the gripping part 30 relative to the needle portion 12 toward the proximal end (in the direction of arrow A), as shown in Figure 3, thereby releasing the engagement of the needle hub 28 with the hub 24 and removing the inner needle 22 held by the needle hub 28 from the catheter 20. At this time, the needle portion 12 affixed to the seal body 26 remains fixed to the body surface. The removal of the inner needle 22 from the needle portion 12 completes the placement of the needle portion 12.

[0076] Next, a second priming is performed to fill the inside of the tube 16 and the needle portion 12 of the drug solution administration device 10 with priming solution S2. This second priming is performed using the priming solution S2 remaining in the syringe 80 used in the first priming. Note that the second priming is the same as the first priming, and therefore a detailed description thereof will be omitted.

[0077] By performing the second priming described above, the priming liquid S2 filled in the tube 16 and the catheter 20 effectively prevents backflow of blood, cells, etc. from the body surface punctured by the catheter 20, and prevents clogging of the catheter 20 and the tube 16 due to coagulation of the blood, etc.

[0078] After the second priming is completed, the syringe 80 is removed from the connector portion 18 together with the adapter member 100, and the device main body 14 is attached. Specifically, the claw portion 138 of the connecting arm 136 of the adapter main body 130 is disengaged outward from the engagement hole 98 of the connector main body 72, and then the syringe 80 is pulled out together with the adapter main body 130 toward the base end side (in the direction of arrow A), thereby removing the adapter member 100 and the syringe 80 from the connector portion 18.

[0079] When attaching the device main body 14 to the connector portion 18 described above, first, as shown in FIG. 5, the main body side connector 62 of the device main body 14 is inserted into the inside of the connector main body 72 (connected portion 82) of the connector portion 18, and one end of the hollow needle 76 is pierced through the axial center of the packing 58 and inserted into the inside of the outflow port 60 filled with the medicinal solution S1, and the connector claw portion 102 is engaged with the engagement recess 66, and as shown in FIG. 3, the device main body 14 is connected to the connector portion 18 in a state where relative movement in the axial direction (direction of arrows A and B) is restricted.

[0080] Then, after the user turns on the power switch 156 provided on the case 48 to start the device, it is placed in a state where it is attached to the body surface by a seal (not shown) provided on the underside, and under the control of the control unit 56, the timing to start administration is determined after the drug solution administration device 10 is placed on the body surface, and at the timing to start administration, the first gasket 52 is moved by the moving mechanism 54 toward the tip side of the container 50 (in the direction of arrow B in Figure 5), and the drug solution S1 in the container 50 is automatically administered to the patient.

[0081] As described above, when the drug solution administration device 10 has been left on the body surface for a predetermined time and it is time to start administering the drug solution S1, in the device main body 14, the moving mechanism 54 is driven by a control signal from the control unit 56, and the first gasket 52 is pressed toward the tip side (in the direction of arrow B) within the container 50, causing the drug solution S1 to be pressed toward the tip side by the first gasket 52.As a result, the drug solution S1 flows into the needle hole 108 through the base end opening 110 of the hollow needle 76 arranged in the outflow port 60 and flows along the needle hole 108 toward the connector main body 72 side (in the direction of arrow B).

[0082] 7, the medicinal solution S1 is introduced into the communication chamber 104 of the connector main body 72 from the needle hole 108 of the hollow needle 76 through the tip opening 114 and the side hole 112. At this time, the medicinal solution S1 is discharged from the tip opening 114 toward the tip side (the direction of arrow B) in the axial direction into the communication chamber 104, and at the same time, is discharged radially outward from the side hole 112. In other words, the medicinal solution S1 is discharged from the hollow needle 76 into the communication chamber 104 from two different directions.

[0083] When the upper surface of the valve element 88 is urged toward the tip side (in the direction of arrow B) by the chemical solution S1 supplied into this communication chamber 104, stress is generated at the boundaries between the outer circumferential surface 124 and the inner circumferential surface 126 on the lower surface of the valve element 88 that abuts against the valve seat 122. However, because the inner circumferential surface 126 is inclined radially inward, it is possible to keep the stress generated on the inner circumferential surface 126 side smaller than on the outer circumferential surface 124 side. Therefore, when the valve element 88 is pressed toward the tip side (in the direction of arrow B) under the supply of the chemical solution S1, the slit hole 94 elastically deforms to open radially outward and opens in a state in which the amount of deformation on the inner circumferential side is suitably suppressed compared to the amount of deformation on the tip side of the outer circumferential side of the valve seat 122.

[0084] As a result, when the chemical solution S1 is caused to flow through the slit hole 94 of the valve body 88, the opening degree of the slit hole 94 provided on the inner peripheral side of the valve seat 122 can be maintained substantially constant, so that the slit hole 94 can be stably opened by a predetermined pressure applied to the valve body 88, and the chemical solution S1 can be caused to flow toward the tube holder 74 side and from the through-hole 120 to the flow passage 38 of the tube 16. In other words, the opening pressure of the chemical solution S1 for opening the slit hole 94 does not fluctuate, and the slit hole 94 can be reliably opened at a substantially constant pressure at all times.

[0085] The medicinal liquid S1 that has flowed along this tube 16 passes through the inflow port 70 of the hub 24 and into the interior of the catheter 20 from the space 32, and is then administered to the body that has been punctured by the catheter 20. When the administration of the medicinal liquid S1 into the body is completed and the flow of the medicinal liquid S1 through the slit hole 94 of the valve body 88 stops, the pressure applied to the valve body 88 by the medicinal liquid S1 is relieved, and the elastically deformed slit pieces 96a, 96b return to their original shape by their elasticity, thereby closing the slit hole 94.

[0086] Furthermore, when the above-described medicinal solution administration device 10 is shipped as a product, sterilization is performed by circulating a sterilization gas (e.g., ethylene oxide gas) inside the device. For example, with the adapter member 100 attached to the connector portion 18 shown in FIG. 1 , this sterilization gas is supplied into the syringe connector 132 of the connector portion 18, which is the proximal end side. As a result, the sterilization gas flows from the syringe connector 132 through the proximal end opening 110 of the hollow needle 76 to the needle hole 108, and then flows from the distal end opening 114 and the side hole 112 into the communication chamber 104 of the connector main body 72 and into the valve hole 90.

[0087] At this time, because the multiple protrusions 92 formed on the valve hole 90 are formed to extend in the same direction, the sterilization gas flows radially outward along the grooves between adjacent protrusions 92, wraps around the outer periphery of the valve body 88, and flows toward the tube holder 74. As a result, even when multiple protrusions 92 are provided on the base end surface 90a of the valve hole 90, the sterilization gas can be circulated through the valve body 88, the valve hole 90 in which the valve body 88 is housed, and the tube holder 74, ensuring reliable sterilization.

[0088] As described above, in this embodiment, in the drug solution administration device 10, the base end of the tube 16 connected to the needle portion 12 inserted into and left in place in the patient is provided with a connector portion 18 to which either the device main body 14 capable of delivering the drug solution S1 or the syringe 80 (attached via the adapter member 100) capable of delivering the priming solution S2 is selectively attached, and this connector portion 18 is provided with a hollow needle 76 having a needle hole 108 therein that communicates with the tube 16 and protrudes toward the device main body 14 side or the syringe 80 side, and is capable of communicating with the inside of the container 50 filled with the drug solution S1 and the cylindrical body 146 filled with the priming solution S2, and a valve body 88 that is arranged facing the tip opening 114 of the hollow needle 76 and opens when the drug solution S1 or the priming solution S2 is delivered, thereby connecting the device main body 14 side or the syringe 80 side with the tube 16.

[0089] The valve body 88 is formed in a disk shape from an elastic material and has a slit hole 94 in the center, while the valve hole 90 of the connector body 72 has a plurality of protrusions 92 that protrude toward the tip side (in the direction of arrow B) on the base end surface 90a with which the upper surface of the valve body 88 abuts.

[0090] Therefore, when either the device main body 14 or the syringe 80 is selected and connected to the connector portion 18 (the syringe 80 is connected via the adapter member 100), the hollow needle 76 provided on the connector portion 18 and protruding toward the base end is pierced into the inside of the container 50 via the main body side connector 62 of the device main body 14, and by connecting the syringe 80 to the adapter member 100, the inside of the device main body 14 or the syringe 80 can be connected to the tube 16 via the hollow needle 76.

[0091] Therefore, when connecting the device main body 14 to the connector portion 18 in the drug solution administration device 10, even if the main body-side connector 62 is inserted into the inside of the connector portion 18, only one end of the hollow needle 76 is inserted into the inside of the container 50 filled with the drug solution S1, so connection can be made without increasing the pressure inside the container 50. As a result, when connecting the device main body 14 to the connector portion 18, leakage of the drug solution S1 from the valve body 88 due to an increase in the internal pressure of the container 50 can be prevented.

[0092] Furthermore, even if the pressure of the medicinal solution S1 or the priming solution S2 is suddenly applied to the valve body 88 when administering the medicinal solution S1 or performing priming, the frictional resistance is increased under contact with the multiple protrusions 92, thereby preventing the valve body 88 from moving radially (in a direction perpendicular to the axial direction), and the valve body 88 can be held in a predetermined position in the valve hole 90.

[0093] As a result, by maintaining the valve body 88 in a predetermined position on the axis of the connector body 72 within the valve hole 90 of the connector part 18, the slit hole 94 can be stably opened when the medicinal solution S1 and the priming solution S2 are flowing, and can be reliably closed when they are not flowing.

[0094] Furthermore, the hollow needle 76 is provided with a base end opening 110 that opens on its base end side (in the direction of arrow A) and is inserted into and communicates with the container 50 of the device body 14, a tip end opening 114 that opens on its tip end side (in the direction of arrow B) and communicates with the communication chamber 104 of the connector body 72 to which the tube 16 is connected, and a side hole 112 that opens between the base end opening 110 and the tip end opening 114 and communicates with the communication chamber 104. Therefore, for example, when the medicinal solution S1 from the device body 14 or the priming solution S2 from the syringe 80 is supplied to the communication chamber 104 through the hollow needle 76, the medicinal solution S1 or the priming solution S2 can be dispersed from the tip end opening 114 and the side hole 112 and introduced into the communication chamber 104.

[0095] As a result, the pressure applied to the upper surface of the valve body 88 from the drug solution S1 or the priming solution S2 can be dispersed into pressure that is derived from the tip opening 114 and applied near the center, and pressure that is derived from the side holes 112 and applied near the outer edge of the valve body 88. Compared to when pressure is applied only from the tip opening 114 to only near the center of the valve body 88, the pressure applied near the center of the valve body 88, which has a slit hole 94, is reduced, and the load near the slit hole 94 is reduced.

[0096] This prevents the pair of slit pieces 96a, 96b from being plastically deformed in an open state due to concentrated pressure being applied to approximately the center of the valve body 88, and allows the slit hole 94 to return to its original shape by elasticity and be securely closed when no pressure is being applied from the medicinal solution S1 and the priming solution S2.For example, by securely closing the slit hole 94 before priming is completed and the medicinal solution S1 is administered, leakage through the slit hole 94 can be prevented until administration of the medicinal solution S1 begins.

[0097] Furthermore, when the chemical solution S1 or the priming solution S2 is introduced into the communication chamber 104 and the slit hole 94 of the valve element 88 is forced radially outward to open, the upper surface of the valve element 88 is prevented from moving radially by the plurality of protrusions 92 that extend perpendicular to the radial force that forces the slit hole 94 to open. Therefore, the valve element 88 can be maintained at a predetermined position within the valve hole 90 so as to be on the axis of the connector main body 72.

[0098] Furthermore, since the multiple protrusions 92 formed in the valve hole 90 are formed to extend in the same direction, for example, when the drug solution administration device 10 is sterilized before being shipped, the sterilization gas supplied to the connector portion 18 and flowing into the communicating chamber 104 through the hollow needle 76 can be circulated radially outward along between two adjacent protrusions 92, thereby making it possible to circulate the sterilization gas around the outer periphery of the valve body 88 and reliably sterilize up to the tube holder 74 side.

[0099] The drug solution administration device according to the present invention is not limited to the above-described embodiment, and it goes without saying that various configurations can be adopted without departing from the gist of the present invention.

Claims

1. A drug solution administration device comprising: a needle portion that is inserted into and left in a living body; a device main body that is provided separately from the needle portion and that is capable of delivering a drug solution filled inside from a tip portion; a tube that is connected to the needle portion at a tip portion and through which the drug solution can flow; and a connector to which either a priming solution delivery means that is provided at a base end of the tube and that is capable of delivering a priming solution filled inside from the tip portion or the device main body is attached, The connector has a hollow needle having a needle hole formed therein that communicates with the tube and protruding toward the device body or the priming solution delivery means so as to be freely communicable with the interior thereof; a valve body that is disposed on the distal end side of the hollow needle and that opens when the drug solution or the priming solution is delivered, thereby allowing the tube to communicate with the device body side or the priming solution delivery means side; Equipped with The connector has a concave-convex portion formed in an axial direction as a concave-convex shape on a surface that contacts the valve body, The hollow needle has a first opening formed on a base end side thereof and communicating with the inside of the device body; a second opening formed on the distal end side and communicating with the tube; an intermediate opening between the first opening and the second opening and communicating with the tube; Equipped with The valve body has a slit-shaped opening and closing hole, The second opening is spaced from the valve body toward the base end and is positioned opposite the opening / closing hole.

2. 2. The drug solution administration device according to claim 1, The valve body is formed from an elastic material into a circular disk shape whose axial dimension along the axial direction of the hollow needle is smaller than its radial dimension, and has the opening and closing hole in the center, and the uneven portion has a protrusion that protrudes toward the valve body side, in this drug solution administration device.

3. 3. The drug solution administration device according to claim 2, The protrusion is formed so as to have a cross section tapering toward the valve body side, and a plurality of protrusions are provided so as to be approximately parallel to each other.

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