The present disclosure relates to a liquid medicine administration device having a device body that is to be attached to and placed on a body surface of a living body.
The applicant of the present application has proposed a liquid medicine administration device for administering a desired dose of a liquid medicine to a living body at an appropriate time (see WO 2018/173962 A).
The liquid medicine administration device described above is connected with, for example, a patch-type tube with needle. The patch-type tube with needle includes a connector connectable to a nozzle of a barrel, a liquid delivery tube that is flexible and connected to the connector, a patch part connected to the other end of the liquid delivery tube and is adherable to a skin of a patient, and a puncture needle protruding from the patch part. The puncture needle is punctured substantially perpendicularly to the skin. Liquid medicine discharged from the barrel is injected into the body of the patient through the tube with needle.
A general object of certain embodiments of the present disclosure is to provide a liquid medicine administration device capable of reliably avoiding leakage of a liquid medicine before administration and reliably opening and closing a valve body by preventing displacement of the valve body with respect to a connector.
According to one aspect of the present disclosure, a liquid medicine administration device includes: a needle unit inserted into and placed on a living body; a device body provided separately from the needle unit and capable of delivering a liquid medicine filled inside from a distal portion; a tube that allows the liquid medicine to flow, the tube having a distal end connected to the needle unit; and a connector to which either one of a priming solution delivery device (attached via an adapter member) or the device body is attached, the priming solution delivery device being provided at a proximal end of the tube and capable of delivering a priming solution filled inside from a distal portion. The connector includes: a hollow needle having a needle hole that is formed inside the hollow needle and that communicates with the tube, the hollow needle protruding toward the device body or the priming solution delivery device so as to be freely communicable with the inside, and a valve body that is disposed distal to the hollow needle, the valve body being open during delivery of the liquid medicine or the priming solution to allow the device body or the priming solution delivery device to communicate with the tube. The connector includes an uneven portion formed along an axial direction in an uneven shape on a surface that contacts the valve body.
According to certain embodiments of the present disclosure, a connector is provided at the proximal end of a tube connected to a needle unit that is inserted into and placed on a living body. Either one of a priming solution delivery device (attached via an adapter member) capable of delivering a priming solution or a device body capable of delivering a liquid medicine is selectively attached to the connector. The connector includes: a hollow needle having a needle hole formed therein and communicating with the tube, the hollow needle protruding toward the device body or the priming solution delivery device so as to communicate with the inside; and a valve body that is disposed distal to the hollow needle, the valve body being open during delivery of the liquid medicine or the priming solution to allow the device body or the priming solution delivery device to communicate with the tube. The connector includes an uneven portion formed along the axial direction in an uneven shape on a surface that contacts the valve body.
Therefore, when the device body is connected to the connector, the hollow needle punctures the device body, so that the inside of the device body and the tube can communicate with each other via the hollow needle. Thus, the device body can be connected to the connector in the liquid medicine administration device without increasing the pressure of the liquid medicine in the device body during connection between the device body and the connector. As a result, leakage of the liquid medicine from the valve body due to an increase in pressure during connection of the device body to the connector can be reliably prevented.
In addition, even when the pressure of the liquid medicine or the priming solution is rapidly applied to the valve body during administration of the liquid medicine to the living body through the needle unit or during priming, the movement of the valve body with respect to the connector can be prevented due to an increase in frictional resistance by the contact with the uneven portion, whereby the valve body can be held at a predetermined position. Thus, the opening/closing hole can be reliably and stably opened and closed.
A liquid medicine administration device 10 is placed on a body surface of, for example, the abdomen of a patient (living body) and automatically administers a liquid medicine S1 (see
As illustrated in
As illustrated in
The catheter 20 is a flexible tubular body and having a lumen through which the liquid medicine S1 can flow, and protrudes downward from a lower surface (surface facing the body surface) of the hub 24. The lumen communicates with a distal end opening of the catheter 20 and communicates with a space 32 in the hub 24 on the proximal side (direction of arrow A) of the catheter 20 (see
The distal side of the inner needle 22 is inserted into the lumen of the catheter 20, and the proximal end thereof is inserted into the hub 24 and held by the distal end of the needle hub 28. The outer peripheral side of a multi-needle 46 in which the catheter 20 and the inner needle 22 overlap is covered with a tubular protector 29.
The hub 24 is formed of, for example, a resin material, and is bifurcated at an intermediate portion between the distal end and the proximal end thereof. The hub 24 has a hub body 34 that linearly extends from the distal end to the proximal side. The hub body 34 has the space 32 that allows the lumen of the catheter 20 to communicate with a flow path 38 of the tube 16. On the other hand, the needle hub 28 to which the gripping component 30 is joined is detachably connected to the proximal end of the hub body 34.
The hub 24 also has a hub branch part 36 that branches at a predetermined angle from the intermediate portion toward the proximal side (direction of arrow A). The distal end of the tube 16 is connected to the proximal end of the hub branch part 36 via an opened inlet port 70, so that the flow path 38 of the tube 16 and the space 32 communicate with each other through the inlet port 70.
Further, a flat hub substrate 40 is formed below the hub 24, and the sealing body 26 is attached to a lower surface of the hub substrate 40. The sealing body 26 is flexible and formed in a sheet shape wider than the hub substrate 40 in the planar direction. An adhesive surface adherable to the body surface is provided on the entire lower surface of the sealing body 26, and a sheet-like backing sheet 42 is attached to the adhesive surface before the needle unit 12 is used.
The backing sheet 42 has a tab 44 that protrudes from the sealing body 26 and can be picked up by a user, and the adhesive surface is exposed when the user picks up the tab 44 and removes the backing sheet 42 from the sealing body 26. The upper surface of the backing sheet 42 to which the sealing body 26 is attached is coated for facilitating removal of the backing sheet from the adhesive surface.
The user of the liquid medicine administration device 10 punctures the body with the multi-needle 46 in which the catheter 20 and the inner needle 22 overlap, and further pulls out the inner needle 22 from the catheter 20 in a punctured state (disengages the needle hub 28 from the needle unit 12 to the proximal side (direction of arrow A)), thereby placing the catheter 20 into the body of the patient.
As illustrated in
The container 50 is formed in a tubular shape along the axial direction (direction of arrow A, B), and is filled with the liquid medicine S1. A distal portion of the container 50 protrudes in the axial direction (direction of arrow B) by a predetermined length from a distal end of the case 48 and is exposed to the outside.
In addition, the container 50 has an outlet port 60 that is opened at the distal end with a reduced diameter and that is sealed with a packing 58. The packing 58 is sandwiched between a distal end of a cylindrical body-side connector 62 provided to cover the outer peripheral side of the outlet port 60 and the distal end of the container 50. Thus, the liquid medicine S1 is sealed and held in the container 50.
The body-side connector 62 is formed in a cap shape, has a hole 64 through which a hollow needle 76 to be described below can be inserted at the center of the distal end, and has an engagement recess 66 that is recessed radially inward and that is to be engaged with a connector body 72 of the connector unit 18 to be described below on the outer peripheral surface. When the connector body 72 is engaged with the engagement recess 66 of the body-side connector 62, the device body 14 is connected to the proximal side (direction of arrow A) of the connector body 72 via the body-side connector 62.
As illustrated in
In addition, the other end of the tube 16 is inserted into a tube holder 74 of the connector unit 18 to be described below in a state in which a tubular joint tube 68b is attached to the outer peripheral side, and is fixed by appropriate fixing means such as adhesion, welding, or crimping.
As illustrated in
The connector body 72 includes, for example, a fixing portion 78 to which the tube 16 is fixed together with the tube holder 74, the fixing portion 78 being formed from a resin material and formed on the distal side (direction of arrow B), a connected portion 82 to which either one of the device body 14 or the syringe 80 is selectively connected, the connected portion 82 being formed on the proximal side (direction of arrow A), and an intermediate portion 84 that connects the fixing portion 78 and the connected portion 82.
The fixing portion 78 is formed in a cylindrical shape opened toward the distal side (direction of arrow B), and has a holder hole 86 into which the tube holder 74 is inserted and fixed and a valve hole 90 that is located proximal to (direction of arrow A) the holder hole 86 and in which the valve body 88 is accommodated. The holder hole 86 is formed in a tapered shape so as to open toward the distal side of the fixing portion 78 and gradually reduce in diameter toward the proximal side (direction of arrow A).
As illustrated in
For example, when viewed in a direction orthogonal to the axial direction of the connector body 72, the protruding portions 92 have a triangular cross-sectional shape that gradually taper toward the distal side, are arranged in a straight line along the orthogonal direction, and are equally spaced in parallel to each other. In other words, a region between two adjacent protruding portions 92 is formed in a groove shape recessed in a rectangular cross-sectional shape toward the proximal side (direction of arrow A) as illustrated in
The valve body 88 is formed in a disk shape with a constant thickness of an elastic material such as silicone rubber, for example, and is formed with a linear slit hole (opening/closing hole) 94 illustrated in
The valve body 88 is accommodated in the valve hole 90 so that the slit hole 94 is substantially parallel to the plurality of protruding portions 92 (see
In addition, as illustrated in
On the other hand, the pair of slit pieces 96a and 96b is not elastically deformed in a state in which the pressure on the upper surface of the valve body 88 toward the distal side is reduced, and thus, the slit piece 96a and the slit piece 96b face each other in contact with each other, thereby forming a closed state without having a gap therebetween.
As illustrated in
Further, the connected portion 82 is provided with a pair of connector claws 102 protruding inward in the radial direction from the inner peripheral surface on the proximal side (direction of arrow A) of the engagement holes 98. When the body-side connector 62 of the device body 14 is connected to the connector body 72, the connector claws 102 are engaged with the engagement recesses 66, whereby the device body 14 is connected to the proximal side (direction of arrow A) of the connector body 72 with the body-side connector 62 in a state in which the relative movement with respect to the connector unit 18 in the axial direction (direction of arrow A, B) is restricted as illustrated in
As illustrated in
As illustrated in
The hollow needle 76 also has a distal end opening (first opening) 110 communicating with the needle hole 108 in the vicinity of one end thereof and a side hole (intermediate opening) 112 communicating with the needle hole 108 in the vicinity of the other end accommodated in the communication chamber 104. The proximal end opening 110 is located inside and communicates with the connected portion 82. The proximal end opening 110 and the side hole 112 are opened on the outer peripheral surface so as to be orthogonal to the axial direction (direction of arrow A, B) of the hollow needle 76.
On the other hand, a proximal end opening (second opening) 114 that opens in the axial direction (direction of arrow B) and communicates with the needle hole 108 is opened at the other end of the hollow needle 76. The distal end opening 114 is disposed inside the communication chamber 104 so as to be apart from the valve body 88 toward the proximal side (direction of arrow A) by a predetermined distance and face the slit hole 94. That is, the side hole 112 is formed in the hollow needle 76 at a position intermediate between the proximal end opening 110 and the distal end opening 114.
As illustrated in
In addition, the tube holder 74 has a tube hole 116 that is open to the distal side (direction of arrow B) and that extends in the axial direction. The other end of the tube 16 to which the joint tube 68b is attached is inserted into the tube hole 116 and fixed by an appropriate fixing means such as adhesion, welding, or crimping. The flow path 38 of the tube 16 is opened to the proximal side (direction of arrow A) inside the holder hole 86.
Furthermore, a bottom wall 118 serving as the proximal end of the tube holder 74 is formed in a circular shape extending in a direction orthogonal to the axial direction (direction of arrow A, B). The bottom wall 118 has a through hole 120 formed in the central part so as to penetrate in the axial direction and communicate with the flow path 38 of the tube 16, and an annular valve seat 122 protruding from the proximal end of the bottom wall 118 on the outside of the through hole 120 in the radial direction.
As illustrated in
The valve seat 122 has a valve seat surface 128 that is formed substantially parallel to the bottom wall 118 and to which the lower surface of the valve body 88 is contactable on the proximal side (direction of arrow A) of the outer peripheral surface 124 and the inner peripheral surface 126. The valve seat surface 128 is formed to be flat along the radial direction. In other words, the inner peripheral surface 126 is inclined radially inward as it extends in a direction away from the valve seat surface 128, that is, to the distal side (direction of arrow B).
The valve seat 122 described above is provided so as to be located radially outside the slit hole 94 when the valve body 88 contacts the valve seat surface 128 as illustrated in FIG. 10. That is, the valve seat 122 is disposed at a position not overlapping the slit hole 94.
Then, as illustrated in
As illustrated in
The adapter body 130 has a tapered shape such that the distal end thereof gradually decreases in diameter toward the distal side (direction of arrow B) so as to be insertable into the connected portion 82 of the connector body 72. The adapter body 130 also has a pair of connection arms 136 extending to the distal side on the outer peripheral side at the central part in the axial direction.
The connection arms 136 are symmetrical with respect to the center of the axis of the adapter body 130. Each of the connection arms 136 is parallel to the outer peripheral surface of the adapter body 130 and is separated radially outward from the outer peripheral surface of the adapter body 130 via a leg part at the central part along the axial direction. Each of the connection arms 136 has a claw 138 protruding toward the adapter body 130 at the distal end.
When the adapter member 100 is connected to the connector body 72, the claws 138 of the connection arms 136 are engaged with the engagement holes 98 of the connected portion 82, so that the relative movement in the axial direction (direction of arrow A, B) and the rotational direction are restricted, and the adapter member 100 is connected to the proximal side (direction of arrow A) of the connected portion 82 and fixed.
The syringe connector 132 has a cylindrical shape having a diameter smaller than that of the adapter body 130, and is integrally fixed by, for example, being press-fitted into the adapter body 130. The syringe connector 132 has a partition wall 142 formed on the distal side (direction of arrow B) so as to be perpendicular to the axial direction, the partition wall 142 having an insertion hole 140 at the center (see FIG. 6).
The syringe connector 132 also has a holding end 144 capable of holding the seal member 134 at a position distal to the partition wall 142. The holding end 144 is open to the distal side (direction of arrow B). The seal member 134 is integrally held such that the proximal side is inserted into and held by the holding end 144, and the outer peripheral surface is engaged with the inner peripheral surface of the adapter body 130.
As illustrated in
The seal member 134 is formed of, for example, an elastic material such as rubber, has a circular cross section when viewed in the axial direction, and has a needle insertion hole 148 into which the hollow needle 76 is inserted, the needle insertion hole 148 passing through the seal member 134 in the axial direction at the center of the axis. Then, as illustrated in
The proximal end opening 110 of the hollow needle 76 is located in and communicates with the syringe connector 132, and the side hole 112 and the distal end opening 114 of the hollow needle 76 are located in and communicates with the communication chamber 104 of the connector body 72. That is, the communication chamber 104 of the connector body 72 and the inside of the syringe connector 132 are connected and communicates with each other by the hollow needle 76.
The liquid medicine administration device 10 according to the embodiment of the present invention is basically configured as described above, and operation and effects will be described below.
When the liquid medicine administration device 10 is used, the needle unit 12 and the tube 16 are placed on the body surface of the patient, the syringe 80 is connected to fill the inside of the catheter 20 with the priming solution S2, and then the device body 14 is connected to automatically administer the liquid medicine S1 to the patient under the control of the control unit 56.
First, as illustrated in
Then, the first priming for filling the tube 16 and the needle unit 12 of the liquid medicine administration device 10 with the priming solution S2 is performed.
First, when the user grips a rod 150 of the syringe 80 and pushes the rod 150 toward the distal side (direction of arrow B), a second gasket 152 attached to the distal end of the rod 150 moves to the distal side along the barrel 146, and accordingly, the priming solution S2 filled in the barrel 146 is discharged from a discharge port 154 opened at the distal end of the barrel 146 to the inside of the syringe connector 132.
Then, as illustrated in
That is, a portion of the priming solution S2 is guided to the distal side (direction of arrow B) to the communication chamber 104 through the distal end opening 114 along the axial direction, and at the same time, the remaining portion is guided radially outward through the side hole 112, and then, flows in the axial direction (direction of arrow B) along the inner peripheral surface of the communication chamber 104. In other words, the priming solution S2 is guided to the communication chamber 104 in two directions through the distal end opening 114 and the side hole 112 having different opening directions.
The upper surface of the valve body 88 is pressed to the distal side (direction of arrow B) by the priming solution S2 supplied into the communication chamber 104, and the pair of slit pieces 96a and 96b is elastically deformed so as to be bent toward the distal side, whereby the slit hole 94 is opened in the radial direction, and the priming solution S2 flows toward the tube holder 74 (direction of arrow B) through the slit hole 94 and flows to the flow path 38 of the tube 16 through the through hole 120.
At this time, the pressure applied from the priming solution S2 to the upper surface of the valve body 88 is suitably distributed into a pressure applied to the vicinity of the central part of the valve body 88 from the priming solution S2 introduced through the distal end opening 114 and a pressure applied to the vicinity of the outer edge of the valve body 88 from the priming solution S2 introduced through the side hole 112 and then flowing along the inner peripheral surface of the communication chamber 104. Therefore, the application of the pressure to the vicinity of the central part of the valve body 88 having the slit hole 94 is reduced as compared to a configuration in which the pressure due to the priming solution S2 that is introduced only through the distal end opening 114 of the hollow needle 76 is applied only to the vicinity of the central part of the valve body 88.
As a result, even when the pressure of the priming solution S2 is rapidly applied to the valve body 88, the load on the slit hole 94 is reduced, and thus, the situation in which the slit hole 94 remains opened due to the vicinity of the slit hole 94 being plastically deformed can be avoided. In a state in which the pressure from the priming solution S2 is not applied, the slit hole 94 can be reliably closed with the vicinity of the slit hole 94 being restored to the original shape by elasticity. That is, when the flow of the priming solution S2 is completed, it is possible to reliably close the slit hole 94 and block the communication between the communication chamber 104 and the tube 16.
In other words, due to the configuration in which the hollow needle 76 has the side hole 112 through which the priming solution S2 is introduced in addition to the distal end opening 114 through which the priming solution S2 is introduced, a pressure loss is generated when the priming solution S2 flows, and the internal pressure of the priming solution S2 in the communication chamber 104 is suitably distributed. Thus, the pressure applied to the upper surface of the valve body 88 can be distributed in the radial direction.
Further, when the priming solution S2 flows into the communication chamber 104 and the slit hole 94 is opened, a force for separating the slit pieces 96a and 96b defining both sides of the slit hole 94 from each other—that is, a force for pressing the slit pieces 94a and 96b radially outward—is applied to the valve body 88. However, the upper surface of the valve body 88 is in contact with and slightly bites into the plurality of protruding portions 92 extending in the direction orthogonal to the force in the radial direction, whereby the movement of the valve body 88 in the radial direction is restricted. Therefore, the valve body 88 is maintained at a predetermined position in the valve hole 90 so that the valve body 88 is located on the axis of the connector body 72. In other words, the frictional resistance of the valve body 88 with respect to the connector body 72 is increased to restrict the movement in the radial direction by bringing the valve body 88 into contact with the plurality of protruding portions 92.
Furthermore, the inner peripheral surface 126 of the valve seat 122 has a tapered shape. Thus, when the slit hole 94 is opened and the slit pieces 96a and 96b are elastically deformed toward the distal side, stress concentration at a portion where the valve body 88 contacts the upper end of the inner peripheral surface 126 of the valve seat surface 128 can be reduced as compared with a configuration in which the inner peripheral surface 126 is an orthogonal surface upright with respect to the bottom wall 118, and accordingly, the slit pieces 96a and 96b can be elastically deformed by a substantially constant deformation amount toward the distal side (direction of arrow A).
As a result, the valve body 88 enables the deformation amount of the slit pieces 96a and 96b in the opened state of the slit hole 94 to be stabilized, and the priming solution S2 can be supplied toward the connector body 72 at a stable flow rate through the slit hole 94 regardless of how much pressure is applied from the priming solution S2 to the valve body 88.
When the valve body 88 is biased to the distal side (direction of arrow B) by the pressure of the priming solution S2, stress is generated on the lower surface of the valve body 88 in contact with the valve seat surface 128 of the valve seat 122 at a boundary portion between the outer peripheral surface 124 and the inner peripheral surface 126. Although the outer peripheral surface 124 is upright along the application direction (direction of arrow B) in which the pressure is applied, that is, the axial direction toward the distal side, the inner peripheral surface 126 is inclined radially inward with respect to the application direction. Therefore, the stress generated on the inner peripheral surface 126 side can be suppressed relative to the stress generated on the outer peripheral surface 124 side. As a result, when the valve body 88 is pressed toward the distal side (direction of arrow B) under the action of supplying the priming solution S2, the deformation amount on the inner peripheral side of the valve seat 122 can be suppressed relative to the deformation amount on the outer peripheral side of the valve seat 122.
As a result, when the priming solution S2 flows 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 toward the needle unit 12 at a stable flow rate. In other words, the opening pressure due to the priming solution S2 for opening the slit hole 94 does not fluctuate, and the slit hole 94 can be reliably opened with a substantially constant pressure at all times.
Then, the priming solution S2 flowing from the connector body 72 to the flow path 38 of the tube 16 flows into the space 32 of the hub 24 through the inlet port 70 and flows into the catheter 20, whereby the tube 16, the space 32 of the hub 24, and the inside of the catheter 20 are filled with the priming solution S2. Thus, the first priming is completed. In addition, when the flow of the priming solution S2 through the slit hole 94 of the valve body 88 is stopped and the pressure applied to the valve body 88 is reduced, the slit pieces 96a and 96b that have been elastically deformed return to the original shapes, and the slit hole 94 is closed. Accordingly, communication between the communication chamber 104 of the connector body 72 and the tube 16 is blocked.
Next, the user grips and positions the needle unit 12 at a desired position on the body surface, and then removes the protector 29 from the multi-needle 46 to the distal side (direction of arrow B). Then, the user punctures the body with the multi-needle 46 protruding from the lower surface of the hub 24, removes the backing sheet 42 by picking up the tab 44 from the sealing body 26 fixed to the needle unit 12, and attach the adhesive surface of the sealing body 26 to the body surface. Thus, the needle unit 12 is fixed to the body surface.
After the puncture, the user relatively pulls out the needle hub 28 and the gripping component 30 to the proximal side (direction of arrow A) from the needle unit 12 to release the engagement between the needle hub 28 and the hub 24, and pulls out the inner needle 22 held by the needle hub 28 from the catheter 20 as illustrated in
Next, the second priming for filling the tube 16 and the needle unit 12 of the liquid medicine administration device 10 with the priming solution S2 is performed. The second priming is performed using the priming solution S2 remaining in the syringe 80 used in the first priming. Since the second priming is the same as the first priming, the detailed description thereof will be omitted.
By performing the second priming described above, backflow of blood, cells, and the like from the body surface punctured by the catheter 20 is suitably prevented by the priming solution S2 filled in the tube 16 and the catheter 20, by which clogging of the catheter 20 and the tube 16 due to coagulation of the blood and the like is prevented.
After the second priming is completed, the syringe 80 is removed from the connector unit 18 together with the adapter member 100, and the device body 14 is mounted. Specifically, after the claws 138 of the connection arms 136 of the adapter body 130 are detached outward from the engagement holes 98 of the connector body 72, the syringe 80 is pulled out together with the adapter body 130 to the proximal side (direction of arrow A), whereby the adapter member 100 and the syringe 80 are removed from the connector unit 18.
When the device body 14 is attached to the connector unit 18 described above, first, the body-side connector 62 of the device body 14 is inserted into the connector body 72 (connected portion 82) of the connector unit 18, so that one end of the hollow needle 76 is punctured into the packing 58 at the center of the axis and inserted into the outlet port 60 filled with the liquid medicine S1 as illustrated in
Then, after turning on a power switch 156 provided on the case 48 to activate the liquid medicine administration device the user places the liquid medicine administration device on the body surface with the sealing body provided on the lower surface. After placing the liquid medicine administration device 10 on the body surface, the user waits until an administration start time has come, and at the administration start time, the user moves the first gasket 52 to the distal side (direction of arrow B in
As described above, when a predetermined time elapses after the liquid medicine administration device 10 is placed on the body surface and the time to administer the liquid medicine S1 has come, the moving mechanism 54 in the device body 14 is driven by a control signal from the control unit 56, so that the first gasket 52 is pressed to the distal side (direction of arrow B) in the container 50. Thus, the liquid medicine S1 is pushed to the distal side by the first gasket 52, and accordingly, the liquid medicine S1 flows into the needle hole 108 through the proximal end opening 110 of the hollow needle 76 located in the outlet port 60 and flows toward the connector body 72 (direction of arrow B) along the needle hole 108.
Then, as illustrated in
When the upper surface of the valve body 88 is biased to the distal side (direction of arrow B) by the liquid medicine S1 supplied to the communication chamber 104, stress is generated on the lower surface of the valve body 88 in contact with the valve seat 122 at a boundary portion between the outer peripheral surface 124 and the inner peripheral surface 126. The inner peripheral surface 126 is inclined radially inward, and thus, the stress generated on the inner peripheral surface 126 side can be suppressed relative to the stress generated on the outer peripheral surface 124 side. Therefore, when the valve body 88 is pressed to the distal side (direction of arrow B) under the action of supplying the liquid medicine S1, the slit hole 94 is elastically deformed and opened radially outward with the deformation amount on the inner peripheral side being suitably suppressed relative to the deformation amount on the distal side on the outer peripheral side of the valve seat 122.
As a result, when the liquid medicine S1 flows 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 liquid medicine S1 can be supplied to the tube holder 74 side and to the flow path 38 of the tube 16 through the through hole 120. In other words, the opening pressure due to the liquid medicine S1 for opening the slit hole 94 does not fluctuate, and the slit hole 94 can be reliably opened with a substantially constant pressure at all times.
The liquid medicine S1 flowing along the tube 16 flows from the space 32 to the inside of the catheter 20 through the inlet port 70 of the hub 24, and then is administered into the body punctured with the catheter 20. In addition, when the flow of the liquid medicine S1 through the slit hole 94 of the valve body 88 is stopped after the completion of the administration of the liquid medicine S1 into the body and the pressure applied to the valve body 88 by the liquid medicine S1 is reduced, the slit pieces 96a and 96b that have been elastically deformed return to the original shapes by elasticity, and the slit hole 94 is closed.
In addition, when being shipped as a product, the above-described liquid medicine administration device 10 is sterilized by circulating a sterilization gas (for example, ethylene oxide gas) therein. The sterilization gas is supplied into the syringe connector 132 of the connector unit 18 on the proximal side in the state illustrated in
The plurality of protruding portions 92 formed in the valve hole 90 extends along the same direction. Thus, the sterilization gas flows radially outward along a groove between the adjacent protruding portions 92, and flows to the tube holder 74 side around the outer peripheral side of the valve body 88. As a result, even when the plurality of protruding portions 92 is provided on the proximal end face 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 accommodated, and the tube holder 74, and thus, sterilization can be reliably performed.
As described above, in the present embodiment, the liquid medicine administration device 10 has, at the proximal end of the tube 16 connected to the needle unit 12 inserted into and placed on the patient, the connector unit 18 to which either one of the device body 14 capable of delivering the liquid medicine S1 or the syringe 80 (attached via the adapter member 100) capable of delivering the priming solution S2 is selectively attached. The connector unit 18 has the hollow needle 76 that has the needle hole 108 formed therein and that communicates with the tube 16, the hollow needle 76 protruding toward the device body 14 or the syringe 80 to be capable of communicating with the inside of the container 50 filled with the liquid medicine S1 or the inside of the barrel 146 filled with the priming solution S2, and the valve body 88 disposed to face the distal end opening 114 of the hollow needle 76, the valve body 88 being open during delivery of the liquid medicine S1 or the priming solution S2 to allow the tube 16 to communicate with the device body 14 or the syringe 80.
The valve body 88 is formed in a disk shape of an elastic material, and has the slit hole 94 in the central part. On the other hand, the valve hole 90 of the connector body 72 has a plurality of protruding portions 92 protruding toward the distal side (direction of arrow B) on the proximal end face contacted by the upper surface of the valve body 88.
Therefore, when either one of the device body 14 or the syringe 80 is selected and connected to the connector unit 18 (the syringe 80 is connected using the adapter member 100), the hollow needle 76 provided in the connector unit 18 and protruding toward the proximal side punctures into the container 50 via the body-side connector 62 of the device body 14, and when the syringe 80 is connected to the adapter member 100, the tube 16 and the inside of the device body 14 or the inside of the syringe 80 can be communicated with each other via the hollow needle 76.
Therefore, even when the body-side connector 62 is inserted into the connector unit 18 during connection of the device body 14 to the connector unit 18 in the liquid medicine administration device 10, the device body 14 can be connected without increasing the pressure within the container 50 filled with the liquid medicine S1, because one end of the hollow needle 76 is only inserted into the container 50. As a result, when the device body 14 is connected to the connector unit 18, leakage of the liquid medicine S1 from the valve body 88 due to an increase in the internal pressure of the container 50 can be prevented.
In addition, even when the pressure of the liquid medicine S1 or the priming solution S2 is rapidly applied to the valve body 88 during administration of the liquid medicine S1 or during priming, the movement of the valve body 88 in the radial direction (direction orthogonal to the axial direction) can be prevented due to an increase in frictional resistance by the contact with the plurality of protruding portions 92, whereby the valve body 88 can be held at a predetermined position in the valve hole 90.
As a result, the valve body 88 is maintained at a predetermined position on the axis of the connector body 72 in the valve hole 90 of the connector unit 18, whereby the slit hole 94 can be stably opened when the liquid medicine S1 and the priming solution S2 flow, and can be reliably closed when the liquid medicine S1 and the priming solution S2 do not flow.
Further, the hollow needle 76 includes the proximal end opening 110 that opens on the proximal side (direction of arrow A) and is inserted into and communicates with the container 50 of the device body 14, the distal end opening 114 that opens on the distal side (direction of arrow B) and communicates with the communication chamber 104 of the connector body 72 to which the tube 16 is connected, and the side hole 112 that opens between the proximal end opening 110 and the distal end opening 114 and communicates with the communication chamber 104. Therefore, when, for example, the liquid medicine 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 liquid medicine S1 or the priming solution S2 can be distributed and introduced into the communication chamber 104 through the distal end opening 114 and the side hole 112.
As a result, the pressure applied from the liquid medicine S1 or the priming solution S2 to the upper surface of the valve body 88 can be distributed into a pressure applied to the vicinity of the central part from the liquid medicine S1 or the priming solution S2 introduced through the distal end opening 114 and a pressure applied to the vicinity of the outer edge of the valve body 88 from the liquid medicine S1 or the priming solution S2 introduced through the side hole 112. Therefore, the pressure applied to the vicinity of the central part of the valve body 88 having the slit hole 94 can be reduced as compared with the configuration in which the pressure is applied only to the vicinity of the central part of the valve body 88 only through the distal end opening 114, and thus, the load on the vicinity of the slit hole 94 is reduced.
This configuration can avoid a situation in which the pair of slit pieces 96a and 96b is elastically deformed in an open state due to the concentrated application of the pressure to the substantially central part of the valve body 88, and can restore the slit hole 94 to its original shape by elasticity and reliably close the slit hole 94 in a state in which the pressure from the liquid medicine S1 and the priming solution S2 is not applied. For example, leakage through the slit hole 94 before the administration of the liquid medicine S1 is started can be prevented by reliably closing the slit hole 94 during a period from the completion of the priming to the start of the administration of the liquid medicine S1.
Furthermore, when the liquid medicine S1 or the priming solution S2 is introduced into the communication chamber 104 and the slit hole 94 of the valve body 88 is opened radially outward, the movement of the upper surface of the valve body 88 in the radial direction of the valve body 88 is restricted by the plurality of protruding portions 92 extending along the direction orthogonal to the force in the radial direction for pushing and opening the slit hole 94. Therefore, the valve body 88 can be maintained at a predetermined position in the valve hole 90 so that the valve body 88 is located on the axis of the connector body 72.
Furthermore, the plurality of protruding portions 92 formed in the valve hole 90 extends along the same direction, whereby, during, for example, the sterilization treatment before shipment of the liquid medicine administration device 10, the sterilization gas supplied to the connector unit 18 and flowing into the communication chamber 104 through the hollow needle 76 can be sent radially outward along the region between the two adjacent protruding portions 92. Therefore, the sterilization gas can be delivered to the tube holder 74 side around the outer periphery of the valve body 88, and thus, the liquid medicine administration device 10 can be reliably sterilized up to the tube holder 74 side.
It is obvious that the liquid medicine administration device according to the present invention is not limited to the abovementioned embodiment, and can employ various configurations without departing from the scope of the present invention.
Number | Date | Country | Kind |
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2021-050715 | Mar 2021 | JP | national |
This is a bypass continuation of PCT Application No. PCT/JP2022/009797, filed on Mar. 7, 2022, which claims priority to Japanese Application No. 2021-050715, filed on Mar. 24, 2021. The entire contents of these application are incorporated herein by reference.
Number | Date | Country | |
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Parent | PCT/JP2022/009797 | Mar 2022 | US |
Child | 18469892 | US |