Drug solution administration device

Abstract

A drug solution administration device (10), wherein an attachment body (22), which has an attachment surface (22a) to be affixed to a body surface (12a) of a user (12), is fused to the back surface of a holder (20) holding a catheter hub (16). The attachment surface (22a) of the attachment body (22) is provided with a release sheet (72) that is peeled off when the holder (20) is fixed to the body surface (12a). The holder (20) and the attachment body (22) are joined by a fused portion (82). The fused portion (82) is provided with peeling assisting portions (86a, 86b) having a smaller bonding force than a general fused portion (84).

Description

Medical solution administration device

[0001] The present invention relates to a drug solution administration device in which a device main body is attached to the body surface of a living body and a catheter is placed inside the living body.

[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 time (see International Publication No. 2018 / 173962). The drug solution administration device is connected to a patch-type needle-equipped tube. The needle-equipped tube includes a connector connectable to a tip of a cylindrical body, a patch section connected to the connector via a liquid supply tube and attachable to the patient's skin, and a puncture needle protruding from the patch section and capable of puncturing the skin.

[0003] When adhering a patch unit of a drug solution administration device to the skin, for example, a sheet fused to the adhesive surface of the patch unit is peeled off to expose the adhesive surface, and then the patch unit is attached to the body surface. In this case, it is desirable that the sheet can be easily peeled off from the patch unit.

[0004] An aspect of the present invention comprises a catheter to be placed in a living body, a catheter hub that holds the base end of the catheter, a holder that holds the catheter hub, an adhesive patch that has an adhesive surface to be attached to the body surface of the living body and is fused to the back surface of the holder, a release sheet that is overlaid on the adhesive surface to cover the patch and is peeled off from the adhesive surface when the holder is fixed to the body surface, and a fused portion that extends along the outer periphery of the holder between the holder and the patch and joins the holder and the patch, wherein the fused portion has a general fused portion and a peel assist portion whose joining strength is weaker than that of the general fused portion.

[0005] According to the present invention, by providing a fusion part that joins the holder that holds the catheter hub and the patch that is to be attached to the body surface of a living body, and by providing the fusion part with a peeling aid that has a bonding strength weaker than that of a general fusion part, it is possible to suitably prevent the peeling resistance of the release sheet from becoming too large when peeling it from the attachment surface of the patch, thereby making it possible to easily peel the release sheet from the patch and attach the patch from which the release sheet has been peeled to the body surface.

[0006] FIG. 1 is an overall plan view of a drug solution administration device according to a first embodiment. FIG. 2 is an overall cross-sectional view of the drug solution administration device shown in FIG. 1. FIG. 3 is an overall plan view showing a state in which a device main body is attached to a connector of the drug solution administration device shown in FIG. 1. FIG. 4 is an overall cross-sectional view showing a state in which a priming solution delivery tool is attached to a connector of the drug solution administration device shown in FIG. 2. FIG. 5 is an enlarged cross-sectional view showing the vicinity of a needle portion in the drug solution administration device of FIG. 2. FIG. 6 is an enlarged plan view showing the vicinity of the tip of the drug solution administration device of FIG. 1. FIG. 7 is an enlarged plan view showing the vicinity of the tip of a drug solution administration device having a holder according to a modified example. FIG. 8 is an enlarged plan view of the vicinity of the tip of FIG. 6 as seen from the back. FIG. 9A is a cross-sectional view taken along line IXA-IXA of FIG. 1, and FIG. 9B is an enlarged cross-sectional view of a catheter holding portion in FIG. 9A. FIG. 10 is an enlarged side view of the vicinity of the needle portion of FIG. 6 as seen from the side. FIG. 11 is a plan view of the holder as seen from the base side. FIG. 12 is an enlarged cross-sectional view of the vicinity of the connector in the drug solution administration device of FIG. 2. Fig. 13 is an enlarged cross-sectional view of the vicinity of the valve body in the drug solution administration device of Fig. 12. Fig. 14 is a front view of the valve body shown in Fig. 13 as viewed from the distal end direction. Fig. 15 is an enlarged cross-sectional view showing the vicinity of the connection portion with the pre-filled syringe in the drug solution administration device of Fig. 2. Fig. 16 is an enlarged cross-sectional view showing the vicinity of the connector in a drug solution administration device of a second embodiment. Fig. 17 is an enlarged cross-sectional view showing a state in which a priming solution delivery tool is connected to the connector of Fig. 16. Fig. 18 is an enlarged cross-sectional view showing a state in which the device main body is connected to the connector of Fig. 16.

[0007] The medicinal solution administration device 10 according to the first embodiment is configured to be placed on a body surface 12a, such as the abdomen, of a user (living body) 12, and to automatically administer a medicinal solution S1 into the body (inside the living body). For example, the medicinal solution administration device 10 is used when administering the medicinal solution S1 to the user 12 a predetermined time after a medical procedure has been performed on the user 12, or when administering the medicinal solution S1 gradually over time. The medicinal solution S1 administered by the medicinal solution administration device 10 is not particularly limited. Examples of the medicinal solution S1 include liquid pharmaceuticals such as antibody drugs, anticancer drugs, chemotherapy drugs, anesthetics, antibiotics, insulin, blood products, and nutrients.

[0008] 1 and 2, the drug solution administration device 10 includes a needle portion 14, a catheter hub 16 that holds the needle portion 14, a tube 18 whose tip is held by the catheter hub 16 and connected to a catheter 30, through which the drug solution S1 can flow, a holder 20 that holds the catheter hub 16, an adhesive 22 that is fixed to the back surface of the holder 20 and attached along the body surface 12a of the user 12, and a connector 24 that is provided at the base end of the tube 18. As shown in Figures 3 and 4, the connector 24 can be selectively connected to a priming solution delivery device 26 that can deliver priming solution S2 (physiological saline) filled therein from the tip, or a device main body 28 that can deliver the drug solution S1 filled therein.

[0009] 5, the needle portion 14 includes a catheter 30 that is placed inside the body (subcutaneously) of the user 12, and an inner needle 32 that penetrates the inside of the catheter 30. The needle portion 14 forms an introduction portion for the medicinal solution S1 by inserting and placing the catheter 30 inside the body from the body surface 12a of the user 12.

[0010] The catheter 30 is a flexible tubular body having an internal lumen (not shown) through which the medicinal solution S1 can flow. The internal lumen of the catheter 30 communicates with the distal end opening of the catheter 30 and also communicates with a space 42 within the catheter hub 16 at the proximal end side (direction of arrow A) of the catheter 30. The distal end of the catheter 30 protrudes obliquely downward from the lower surface of the catheter hub 16 (the surface facing the body surface 12a) toward the distal end (direction of arrow B) (see FIG. 9A ). The proximal end of the catheter 30 is fixed to the catheter hub 16 by crimping a crimping pin (not shown).

[0011] A portion of the inner needle 32 penetrates into the catheter 30. The tip side of the inner needle 32 is inserted into the lumen of the catheter 30. The base end of the inner needle 32 is inserted into the catheter hub 16 and is held at the tip of a needle hub 46, which will be described later. By inserting the inner needle 32 into the catheter 30, a multi-needle 34 is formed in which the catheter 30 and the inner needle 32 are overlapped in the radial direction. A protector 36 is attached to the multi-needle 34. The protector 36 is tubular and is attached so as to cover the outer periphery of the catheter 30.

[0012] The user 12 inserts the multi-needle 34 consisting of the catheter 30 and the inner needle 32 into the body, and then pulls out the inner needle 32 from the catheter 30 while it is still inserted (detaching the needle hub 46 from the needle portion 14 toward the base end (in the direction of arrow A)), thereby leaving the catheter 30 in the body of the user 12.

[0013] 2, the catheter hub 16 includes a hub body 38 that supports the proximal end of the catheter 30, and a side port 40 that protrudes from the side of the hub body 38 and to which the distal end of the tube 18 is connected. The hub body 38 extends linearly from the distal end to the proximal end, and has a space 42 inside the hub body 38. The space 42 communicates with the lumen of the catheter 30 and a flow passage 50 of the tube 18 that is connected to the side port 40. A needle hub 46 with a gripping member 44 adhered thereto is detachably attached to the proximal end of the hub body 38.

[0014] The side port 40 branches out and protrudes obliquely from near the distal end of the hub body 38 toward the proximal end. The proximal end of the side port 40 has a connection port 48 into which the distal end of the tube 18 is inserted.

[0015] The tube 18 is formed from a flexible tube having a flow path 50 therein through which the medicinal solution S1 can flow. Tubular extension tubes 52a, 52b are attached to the outer peripheries of the distal and proximal ends of the tube 18, respectively. The distal end of the tube 18 together with the extension tube 52a is fixed to the connection port 48 of the catheter hub 16 by an appropriate fixing method such as adhesive bonding, welding, or crimping. As a result, the flow path 50 of the tube 18 communicates with the space 42 of the catheter hub 16 through the connection port 48.

[0016] The base end of the tube 18 together with the extension pipe 52b is inserted into a tube holder 96 of the connector 24, which will be described later, and fixed by an appropriate fixing method such as adhesive, welding, or crimping (see FIG. 4).

[0017] As shown in Figure 6, the holder 20 has a base portion 54 formed in a flat plate shape to which the patch 22 is fixed, and a catheter holding portion 56 and a port holding portion 58 that are provided on the upper part of the base portion 54 and hold the catheter hub 16.

[0018] The base 54 is formed in a substantially circular shape when viewed from above. A catheter holding portion 56 and a port holding portion 58 are provided on the front surface of the base 54. The patch 22 is fixed to the back surface of the base 54. The base 54 has a notch 60a provided at the tip and an opening 60b provided in approximately the center. The notch 60a and the opening 60b each penetrate to the back surface of the base 54 (see FIGS. 8 to 9B).

[0019] As shown in Figures 6 and 9A, the catheter holding section 56 holds the hub body 38 of the catheter hub 16. The catheter holding section 56 is formed in a cylindrical shape and is disposed in the center of the base section 54. The catheter holding section 56 extends in the extension direction of the catheter 30. The tip of the catheter holding section 56 is disposed at an angle facing the base section 54 (see Figures 9A and 9B). In other words, the catheter holding section 56 is inclined upward from the tip toward the base end (direction of arrow B). An introduction hole 61 opens at the top of the catheter holding section 56. The introduction hole 61 communicates with a first receiving hole 62, which will be described later.

[0020] A first accommodating hole 62 is formed inside the catheter holding part 56 shown in Figures 5 and 9A. The first accommodating hole 62 opens at the distal and proximal ends of the catheter holding part 56. The first accommodating hole 62 communicates with the notch 60a and opening 60b in the base part 54 (see Figure 9B). The hub body 38 of the catheter hub 16 is inserted into and held in the first accommodating hole 62 from the proximal end of the catheter holding part 56. At this time, the lower part of the distal end of the hub body 38 is positioned within the notch 60a. In other words, when the holder 20 is fixed to the body surface 12a together with the adhesive body 22, the distal end of the hub body 38 is positioned close to the body surface 12a through the notch 60a (see Figure 9A).

[0021] A portion of the lower part of the hub body 38 is inserted into and held in the opening 60b. When the hub body 38 of the catheter hub 16 is inserted into the first receiving hole 62 of the catheter holding part 56, adhesive D is injected into the inside of the first receiving hole 62 through the introduction hole 61. The hub body 38 is fixed to the catheter holding part 56 by the adhesive D. Note that the method for fixing the hub body 38 is not particularly limited, and for example, the catheter holding part 56 and the hub body 38 may be fitted together.

[0022] 5 and 10 , the port holding portion 58 holds the side port 40 of the catheter hub 16. The port holding portion 58 protrudes obliquely from the side of the catheter holding portion 56 toward the proximal end. The port holding portion 58 is formed in a cylindrical shape and is placed on the surface of the base portion 54. A second receiving hole 64 is formed inside the port holding portion 58. The side port 40 of the catheter hub 16 is inserted into and held in the second receiving hole 64.

[0023] The port holding portion 58 is open on the catheter holding portion 56 side. The port holding portion 58 has a U-shaped cross section when viewed in the direction in which the port holding portion 58 extends. The port holding portion 58 has an upper wall 66a that covers the side port 40 from above. The upper wall 66a abuts against the upper surface of the side port 40 to hold it. Note that, as shown in FIG. 7 , the port holding portion 58 may not have an upper wall 66a in the holder 20a. In that case, the hub body 38 is fixed to the holder 20a with an adhesive or the like.

[0024] The port holding portion 58 has a side wall 66b that intersects the top wall 66a and constitutes a side portion of the port holding portion 58. The side wall 66b covers the side of the port holding portion 58 opposite the catheter holding portion 56. The port holding portion 58 has an opening 66c that opens toward the catheter holding portion 56. The catheter holding portion 56 side of the port holding portion 58 is open through the opening 66c. When the side port 40 is assembled to the port holding portion 58, the side port 40 is accommodated in the second accommodation hole 64 of the port holding portion 58 through the opening 66c.

[0025] As shown in Figures 6 and 8, the patch 22 is flexible and formed in a sheet shape that is wider in the planar direction than the base portion 54 of the holder 20. The patch 22 has an elliptical shape that extends distally (in the direction of arrow B) from the tip of the base portion 54. The patch 22 has a first patch portion 68 through which the catheter 30 is inserted, and a second patch portion 70 that is disposed at the proximal end of the first patch portion 68 and is fixed to the holder 20. The first patch portion 68 is disposed distally (in the direction of arrow B) from the center of the patch 22. The second patch portion 70 is disposed proximally (in the direction of arrow B) from the center of the patch 22. The first patch portion 68 and the second patch portion 70 are divided approximately at the center of the patch 22. When viewed from above, the first and second patch portions 68, 70 are each approximately semicircular.

[0026] The back surface of the adhesive body 22 is an adhesive surface 22a that is to be attached to the body surface 12a of the user 12, and the adhesive surface 22a has adhesiveness. A release sheet 72 is attached to the adhesive surface 22a so as to cover the adhesive surface 22a.

[0027] The release sheet 72 is formed in a thin sheet shape and is fused to the attachment surface 22 a by heat welding or the like so as to be superimposed on the attachment surface 22 a. The release sheet 72 has a first sheet 74 fused to the first attachment portion 68 and a second sheet 76 fused to the second attachment portion 70.

[0028] The first and second sheets 74, 76 have first and second gripping pieces 78, 80, respectively, that protrude outward from the outer edge of the patch 22 and can be gripped by the user 12. The first and second gripping pieces 78, 80 protrude in the width direction (the direction of arrow C in Figures 6 and 8 ) that is perpendicular to the longitudinal direction along the distal and proximal ends of the patch 22. When the holder 20 and patch 22 are fixed to the body surface 12a of the user 12, the release sheets 72 are peeled off from the patch 22 in the order of the first sheet 74 and the second sheet 76. As a result, the release sheet 72 is peeled off from the adhesive surface 22a of the patch 22, exposing the adhesive surface 22a.

[0029] At this time, the user 12 grasps the first and second gripping pieces 78, 80 and peels the first and second sheets 74, 76 in the width direction (direction of arrow C) relative to the adhesive body 22. The second gripping piece 80 is grasped to peel the second sheet 76 from the second adhesive part 70. The peeling direction of the release sheet 72 is the width direction (direction of arrow C) perpendicular to the longitudinal direction of the adhesive body 22, and the peeling direction may be either one width direction or the other width direction.

[0030] The surface of the release sheet 72 that is attached to the attachment surface 22a of the adhesive body 22 is coated to facilitate peeling from the attachment surface 22a.

[0031] The adhesive body 22 is fixed by being fused to the back surface of the base portion 54 of the holder 20. A fused portion 82 that joins the holder 20 and the adhesive body 22 is provided between the back surface of the base portion 54 and the second adhesive portion 70 of the adhesive body 22 (see FIGS. 6 and 11).

[0032] 11 , the fused portion 82 is disposed inward from the outer edge of the holder 20 and extends in a generally annular shape along the outer periphery of the holder 20. The fused portion 82 has a general fused portion 84 and peeling aids 86a, 86b that have a smaller bonding strength than the general fused portion 84. The general fused portion 84 is formed by thermally welding the back surface of the holder 20 and the adhesive body 22. The general fused portion 84 firmly fixes the base portion 54 of the holder 20 and the adhesive body 22 together.

[0033] When the base part 54 of the holder 20 and the adhesive body 22 are fused together, the release sheet 72 is already fused to the adhesive surface 22a of the adhesive body 22. Therefore, in a plan view, the release sheet 72 and the adhesive body 22 are fused together at a position corresponding to the fused portion 82. The bonding strength between the release sheet 72 and the adhesive body 22 at the position corresponding to the fused portion 82 is greater than the bonding strength between the release sheet 72 and the adhesive body 22 at positions other than the fused portion 82.

[0034] The peeling aids 86a, 86b are a pair of non-fused portions 88 formed by cutting out a portion of the general fused portion 84, and are arranged on the inner circumferential side of the general fused portion 84. The peeling aids 86a, 86b are cut out in a substantially rectangular shape from the inner circumferential portion of the general fused portion 84 toward the outside in the radial direction. The shape of the peeling aids 86a, 86b is not limited to a rectangular shape. The peeling aids 86a, 86b may not be a pair of non-fused portions, but may be a pair of weakly fused portions, or a combination of a non-fused portion and a weakly fused portion.

[0035] The peeling assisting portions 86a, 86b are arranged at positions where the maximum load is applied when peeling the second sheet 76 from the second attachment portion 70 of the adhesive body 22 in the width direction (peeling direction). Because the second sheet 76 is peeled in the width direction from the second attachment portion 70, the position that is the outer edge of the fused portion 82 in the width direction (general fused portion 84) is the position where the second sheet 76 first starts to peel in the fused portion 82. Therefore, this position becomes the maximum load at which the load (peeling resistance) when peeling the release sheet 72 is greatest.

[0036] The peeling direction of the second sheet 76 may be either one width direction or the other width direction, so peeling aids 86a, 86b are arranged at two locations that correspond to the outer widthwise ends of the fused portion 82 (general fused portion 84) to correspond to the two peeling directions. In the peeling direction of the second sheet 76, the fused range (fused area) of the fused portion 82 is smaller than the fused range of the general fused portion 84 due to the peeling aids 86a, 86b.

[0037] The peeling assistant portions 86a, 86b are arranged at positions spaced apart from the port holding portion 58 of the holder 20 in the circumferential direction of the fused portion 82 (general fused portion 84). The peeling assistant portion 86b is spaced apart from the port holding portion 58 in the distal direction.

[0038] The peeling assisting portions 86a, 86b are not limited to being non-fused portions 88 formed by cutting out a part of the general fused portion 84 and not fused to the base portion 54 of the holder 20 and the adhesive body 22. For example, a fused portion (second fused portion) fused with a bonding strength weaker than that of the general fused portion 84 may be provided in a part of the general fused portion 84. When the holder 20 and the adhesive body 22 are fused by thermal welding, it is possible to provide a fused portion 82 with a bonding strength weaker than that of the general fused portion 84 in a part of the fused portion 82 by lowering the welding temperature in a part of the fused portion.

[0039] As shown in Figures 1 and 12, the connector 24 has a first connection part 92 that can be connected to a prefilled syringe 90 of the device main body 28 described later, a second connection part 94 that can be connected to a priming solution delivery device 26 that can deliver priming solution S2, a tube holder 96 that holds the base end of the tube 18 and is attached to the first connection part 92, and a hollow needle 98 that is held by the first connection part 92 and protrudes toward the base end.

[0040] The first connecting portion 92 has a first connecting member 100 that is connected to the proximal end of the tube 18 via the tube holder 96 .

[0041] The first connecting member 100 comprises a tip connecting portion 102 formed at the tip and which holds the base end of the tube 18 together with the tube holder 96, a base end connecting portion 104 formed at the base end to which the device main body 28 or the second connecting portion 94 is selectively connected, and an intermediate portion 105 arranged between the tip connecting portion 102 and the base end connecting portion 104.

[0042] 13 , the tip connecting part 102 is formed in a cylindrical shape that opens toward the tip. Inside the tip connecting part 102 are a holder hole 106 into which the tube holder 96 is inserted and held, and a valve hole 110 that is disposed at the base end of the holder hole 106 and that houses a valve body 108. The diameter of the holder hole 106 gradually decreases from the tip toward the base end (direction of arrow A) to hold the tube holder 96 inside.

[0043] The valve hole 110 has a circular cross section with a reduced diameter relative to the holder hole 106. The base end surface 110a of the valve hole 110 shown in Figure 13 is a flat surface perpendicular to the axial direction of the first connecting member 100. The valve body 108 abuts against the base end surface 110a, and a communication passage 122, which will be described later, opens in the center. This makes it possible to keep the dead volume in the first connecting member 100 small.

[0044] 13 and 14, the valve element 108 is formed in a disk shape from an elastic material such as silicone rubber, etc. The valve element 108 is formed with a constant thickness such that the axial dimension (thickness dimension) is smaller than the radial dimension.

[0045] A slit-shaped opening / closing hole 112 is formed in the center of the valve body 108. When viewed in the axial direction of the valve body 108 shown in Figure 14, the opening / closing hole 112 has a straight line shape. The opening / closing hole 112 extends in a straight line from the center of the valve body 108 radially outward and penetrates through it in the thickness direction. The shape of the opening / closing hole 112 is not limited to a straight line (slit-shaped) and may be, for example, a cross shape.

[0046] The proximal end surface of the valve body 108 is subjected to the pressure of the priming solution S2 or the drug solution S1 supplied from the hollow needle 98 (described later) to the communicating passage 122. When pressure is applied, the periphery of the openable hole 112 is pushed toward the distal end, causing the openable hole 112 to elastically deform toward the distal end (see the two-dot chain line in FIG. 13 ). This opens the openable hole 112, and the communicating passage 122 of the first connecting member 100 in the connector 24 communicates with the tube 18 held by the tube holder 96 through the openable hole 112. The opening pressure applied to the valve body 108 by the drug solution S1 when the openable hole 112 is opened is lower than the pressure applied to the valve body 108 by the driving force when the device main body 28 is driven. This allows the opening and closing hole 112 of the valve body 108 to open at low pressure, preventing the first gasket 162 (see Figure 15) from deforming and increasing the dead volume due to back pressure from the valve body 108 when administration of the medicinal solution S1 is completed.

[0047] When no pressure is applied to the base end surface of the valve body 108 , the open / close hole 112 is closed, and the communication between the communication passage 122 of the first connecting member 100 and the tube 18 is blocked by the valve body 108 .

[0048] As shown in Figure 12, the base end connecting portion 104 is provided at the base end of the intermediate portion 105 and has a cylindrical shape that opens toward the base end (direction of arrow A). The base end connecting portion 104 has a larger diameter than the tip connecting portion 102 and the intermediate portion 105. The outer peripheral wall of the base end connecting portion 104 is provided with a pair of rectangular engaging holes 114 that penetrate the outer peripheral wall in the radial direction. The pair of engaging holes 114 face each other with the axis of the base end connecting portion 104 as the center. When the second connecting portion 94 is connected to the base end connecting portion 104, arms 142 of the second connecting portion 94, which will be described later, engage with the engaging holes 114.

[0049] The outer peripheral wall of the base-end connecting portion 104 is provided with a pair of connector claws 116 that protrude radially inward from the inner peripheral surface. As shown in Figure 15, when the tip end of the pre-filled syringe 90 of the device body 28 is connected to the first connecting member 100, the connector claws 116 engage with an engaging recess 174 formed in the tip end. This connects the device body 28 to the base end of the first connecting member 100 via the base-end connecting portion 104.

[0050] The intermediate portion 105 is formed in a cylindrical shape and has a separation wall 118 formed at the tip, a support portion 120 protruding from the center of the separation wall 118 toward the base end (the direction of arrow A), and a communication passage 122 formed inside the separation wall 118. The communication passage 122 passes through the center of the separation wall 118 and communicates with the valve hole 110.

[0051] The support part 120 extends in the axial direction from the separation wall 118 to the tip of the proximal end connecting part 104, and has a needle fitting hole 124 formed therein. The tip of the needle fitting hole 124 communicates with the communication passage 122. The hollow needle 98 is fitted into and held in the needle fitting hole 124. The hollow needle 98 may also be held in place by adhesive or by insert molding.

[0052] The second connecting portion 94 has a second connecting member 126 that is detachably attached to the base end of the first connecting member 100. The second connecting member 126 has a first cylindrical body 128 to which the tip end of the priming solution delivery tool 26 is connected, a second cylindrical body 130 that covers the outside of the first cylindrical body 128 and is engaged with the first connecting member 100, and a cap 132 that is held on the tips of the first and second cylindrical bodies 128, 130.

[0053] The first cylinder 128 is formed in a cylindrical shape and is press-fitted into the interior of the second cylinder 130 to be held together. The first cylinder 128 has a holding end 134 provided at the tip and capable of holding the cap 132, and an intermediate wall 136 disposed at the base end of the holding end 134.

[0054] The holding end 134 opens toward the tip, and holds the cap 132 by inserting the base end of the cap 132 into the holding end 134. The outer circumferential surface of the holding end 134 engages with the inner circumferential surface of the second cylindrical body 130, thereby holding the cap 132 integrally. The intermediate wall 136 is formed perpendicular to the axial direction of the first cylindrical body 128, and has an insertion hole 138 formed in the center of the intermediate wall 136. The insertion hole 138 passes through the intermediate wall 136 in the axial direction.

[0055] The base end of the first cylindrical body 128 has a fitting hole 140 that opens toward the base end (the direction of arrow A), and the fitting hole 140 is tapered from the base end to the tip. A tip nozzle portion 176a of a barrel 176 of the priming solution delivery device 26 is inserted into the fitting hole 140, and the tip end of the barrel 176 is connected to the base end of the first cylindrical body 128. At this time, the tip nozzle portion 176a of the barrel 176 is tapered toward the tip end, and is therefore fitted into the fitting hole 140 in a tapered manner.

[0056] The second cylindrical body 130 is formed in a cylindrical shape with a larger diameter than the first cylindrical body 128. The tip of the second cylindrical body 130 is formed in a tapered shape toward the tip. The tip of the second cylindrical body 130 can be inserted into the inside of the proximal end connecting portion 104 of the first connecting member 100. A pair of arms 142 is provided on the outer periphery of the second cylindrical body 130.

[0057] The arm 142 is elastically deformable. The arm 142 is arranged at a position symmetrical with respect to the axial center of the second cylindrical body 130. The arm 142 is arranged parallel to the outer peripheral surface of the second cylindrical body 130 in the radial direction outward, and an approximate center portion along the extension direction is supported against the outer peripheral surface. The arm 142 is tiltable around the approximate center portion. The tip of the arm 142 has an engaging portion 144 that protrudes radially inward. The engaging portion 144 is claw-shaped and tapers radially inward.

[0058] The arm 142 tilts, so that the engaging portion 144 can move closer to or away from the first connecting member 100 .

[0059] When the second connecting member 126 is connected to the proximal end connecting portion 104 of the first connecting member 100, the engaging portion 144 of the arm 142 is elastically engaged with the engaging hole 114 of the proximal end connecting portion 104. This connects the second connecting member 126 to the proximal end of the first connecting member 100. The first connecting member 100 and the second connecting member 126 are connected in a state where relative movement in the axial direction (directions of arrows A and B) and rotational direction is prevented.

[0060] The cap 132 is formed of an elastic material such as rubber and has a circular cross section when viewed in the axial direction. A needle insertion hole 146, through which the hollow needle 98 is inserted, passes through the axial center of the cap 132. The cap 132 is held between the tip of the first cylindrical body 128 and the tip of the second cylindrical body 130.

[0061] 12 and 13, the tube holder 96 is cylindrical with a bottom and an open tip. The outer circumferential surface of the tube holder 96 is tapered from the tip toward the base end, and the tube holder 96 is fitted and fixed by being inserted into the holder hole 106 of the first connecting member 100.

[0062] A tube hole 148 that opens toward the distal end is formed inside the tube holder 96 (see FIG. 12). The proximal end of the tube 18 to which the extension pipe 52b is attached is inserted into the tube hole 148 and fixed by an appropriate fixing method such as adhesive, welding, or crimping.

[0063] The base end of the tube holder 96 has a through hole 150 formed in the center, which passes through in the axial direction and communicates with the flow passage 50 of the tube 18, and an annular valve seat 152 arranged radially outward of the through hole 150.

[0064] As shown in Figure 13 , the valve seat 152 protrudes from the proximal end of the tube holder 96 in the proximal direction (the direction of arrow A). The distal end surface of the valve element 108 abuts against the proximal end of the valve seat 152. The valve element 108 is sandwiched between the valve seat 152 of the tube holder 96 and the distal end surface of the separation wall 118 of the first connecting member 100. The valve seat 152 is positioned radially outward of the opening / closing hole 112 of the valve element 108 and abuts against the valve element 108 (see Figures 13 and 14 ). At this time, as shown in Figure 13 , the proximal end of the valve seat 152 abuts against the distal end surface of the valve element 108 and slightly bites into it in the proximal direction (the direction of arrow A), thereby crimping and holding the valve element 108 between the proximal end surface 110 a of the valve hole 110 and the valve seat 152 (see Figure 13 ).

[0065] As shown in Figures 12 and 15, the hollow needle 98 is a needle body made of metal and having a needle hole 154 therein, and connects the device main body 28 or the second connecting member 126 to the communication passage 122 of the first connecting member 100. The hollow needle 98 is held at the axial center of the first connecting member 100 by fitting the hollow needle 98 into the needle fitting hole 124 of the support portion 120 of the first connecting member 100. Note that the hollow needle 98 may be held in place by adhesive or insert molding instead of fitting. The hollow needle 98 may also be integrally molded from plastic. The tip of the hollow needle 98 communicates with the communication passage 122 via the needle hole 154.

[0066] The base end of the hollow needle 98 is formed in a sharp shape, and a base end opening 156 that communicates with the needle hole 154 is formed at the base end. A predetermined length of the base end of the hollow needle 98 is exposed in the base end direction (direction of arrow A) from the base end of the support part 120. The base end of the hollow needle 98 is housed inside the base end connecting part 104 and does not protrude in the base end direction (direction of arrow A) from the base end of the base end connecting part 104. The outer periphery of the hollow needle 98 is surrounded by the base end connecting part 104 (see FIG. 12 ).

[0067] 12 , when the second connecting member 126 is connected to the first connecting member 100, the base end of the hollow needle 98 exposed inside the base end connecting portion 104 is inserted into the insertion hole 138 of the first cylindrical body 128 through the needle insertion hole 146 of the cap 132. As a result, the base end of the hollow needle 98 protrudes toward the base end of the cap 132, and the cap 132 seals the gap between the hollow needle 98 and the first cylindrical body 128. The base end opening 156 of the hollow needle 98 is disposed inside the first cylindrical body 128 and communicates with the interior of the first cylindrical body 128, thereby connecting and communicating the communication passage 122 of the first connecting member 100 and the interior of the first cylindrical body 128 via the hollow needle 98.

[0068] As shown in FIG. 3, the device body 28 has the function of storing the medicinal solution S1 and discharging the medicinal solution S1 from the tip end at an appropriate timing, and includes a case 158 having an internal storage space (not shown) for storing each component.

[0069] Inside the case 158, there is provided a pre-filled syringe 90 that stores the medicinal solution S1, a moving mechanism 164 that moves the first gasket 162 inside the pre-filled syringe 90, a control unit 166 that controls the driving of the moving mechanism 164, and a power supply unit (not shown) that can supply power to each component.

[0070] 15, the prefilled syringe 90 is formed in a cylindrical shape along the axial direction (the direction of arrows A and B), and is filled with the medicinal solution S1. The tip of the prefilled syringe 90 protrudes a predetermined length in the axial direction (the direction of arrow B) from the tip of the case 158 and is exposed to the outside (see FIG. 3).

[0071] The tip of the prefilled syringe 90 is provided with a delivery nozzle portion 170 that is reduced in diameter and sealed with a packing 168. The packing 168 is sandwiched between the tip of the delivery nozzle portion 170 and the tip of a cylindrical cover member 172 that is provided to cover the outer periphery of the delivery nozzle portion 170. This allows the drug solution S1 to be held sealed inside the prefilled syringe 90 by the packing 168. An engagement recess 174 that is recessed radially inward is formed on the outer periphery of the cover member 172. The connector claw portion 116 of the second connecting member 126 can engage with the engagement recess 174.

[0072] As shown in FIG. 4 , the priming solution delivery device 26 includes a cylindrical barrel 176, a second gasket 178 movably provided inside the barrel 176, and a rod 180 connected to the second gasket 178. The base end of the rod 180 protrudes from the base end of the barrel 176 toward the base end. The tip nozzle portion 176a of the barrel 176 has a smaller diameter than the barrel 176 and is tapered toward the tip. Inside the barrel 176, the priming solution S2 is filled between the tip nozzle portion 176a and the second gasket 178. The tip nozzle portion 176a of the barrel 176 is tapered and fitted into the fitting hole 140 of the first cylindrical body 128 of the connector 24. This provides a liquid-tight connection between the tip nozzle portion 176a of the barrel 176 and the fitting hole 140 of the first cylindrical body 128.

[0073] The second gasket 178 is connected to the tip of the rod 180, and when the user 12 pushes the rod 180 in the tip direction, the second gasket 178 moves in the tip direction (direction of arrow B) along the barrel 176. As a result, the priming solution S2 inside the barrel 176 is pushed in the tip direction by the second gasket 178 and is delivered from the opening at the tip portion (tip nozzle portion 176a) of the barrel 176.

[0074] Next, a description will be given of the administration of medicinal solution S1 to the user 12 using the medicinal solution administration device 10. When using the medicinal solution administration device 10, the needle portion 14 is placed on the body surface 12a of the user 12, the priming solution delivery device 26 is connected, and the inside of the catheter 30 is filled with priming solution S2. Then, the device main body 28 is connected, and the medicinal solution S1 is automatically administered to the user 12.

[0075] First, a first priming is performed to fill the needle portion 14 and the inside of the tube 18 with the priming solution S2.

[0076] The priming solution delivery device 26 is connected to the proximal end of the second connecting member 126 of the connector 24 of the drug solution administration device 10 shown in Figures 1 and 2 (see Figure 4). The distal nozzle portion 176a of the barrel 176 of the priming solution delivery device 26 is inserted from the proximal end of the first cylindrical body 128 of the connector 24 into the fitting hole 140. The distal nozzle portion 176a of the barrel 176 is fitted into the fitting hole 140 of the first cylindrical body 128 and maintained liquid-tight. This places the interior of the barrel 176 in communication with the interior of the first cylindrical body 128. The priming solution S2 in the barrel 176 flows from the distal nozzle portion 176a of the barrel 176 into the fitting hole 140.

[0077] When the user 12 pushes the rod 180 of the priming liquid delivery device 26 toward the tip (in the direction of arrow B), the second gasket 178 moves toward the tip along the barrel 176, and as a result, the priming liquid S2 in the barrel 176 is delivered from the tip nozzle portion 176a of the barrel 176 to the mating hole 140 of the first cylinder 128.

[0078] The priming solution S2 in the first cylindrical body 128 flows toward the distal end through the proximal end opening 156 and the needle hole 154 of the hollow needle 98 and is introduced into the communication passage 122.

[0079] The priming solution S2 supplied into the communication passage 122 presses the base end surface of the valve element 108 toward the distal end (direction of arrow B). The central portion of the valve element 108 elastically deforms around the open / close hole 112 so as to curve toward the distal end, thereby opening the open / close hole 112. The priming solution S2 flows from the communication passage 122 through the open / close hole 110 and into the flow passage 50 of the tube 18.

[0080] The priming solution S2 flows from the flow passage 50 of the tube 18 through the side port 40 into the space 42 of the catheter 30, and then the priming solution S2 flows into the space 42 of the catheter 30. As a result, the inside of the tube 18, the space 42, and the catheter 30 are filled with the priming solution S2, and the first priming is completed.

[0081] When the supply of priming solution S2 by the priming solution delivery device 26 is stopped, pressure is no longer applied to the base end surface of the valve body 108, and the open opening / closing hole 112 returns to its original shape due to the elasticity of the valve body 108, and the opening / closing hole 112 is closed.

[0082] Next, the needle portion 14 is placed inside the body of the user 12. The user 12 grasps the needle portion 14 (multiple needle 34) and positions it at a desired position on the body surface 12a, and then removes the protector 36 from the multiple needle 34 toward the tip.

[0083] After the tips of the multiple needles 34 have been inserted into the body, the first gripping pieces 78 of the first sheet 74 (release sheet 72) are grasped and the first sheet 74 is peeled off in the width direction from the patch 22. By peeling the first sheet 74 off the back surface of the patch 22, the adhesive surface 22a of the first adhesive portion 68 is exposed. The adhesive surface 22a of the first adhesive portion 68 is attached along the body surface 12a of the user 12 by adhesive force. This causes the tips of the needle portions 14 to be fixed to the body surface 12a while puncturing the user 12. In other words, only the tip side (first adhesive portion 68) of the patch 22 where the needle portions 14 are held is fixed to the body surface 12a.

[0084] Next, by pulling the needle hub 46 and the gripping member 44 outward from the needle portion 14 in the proximal direction (direction of arrow A), the needle hub 46 is disengaged from the catheter hub 16, and the inner needle 32 held by the needle hub 46 is pulled out from the catheter hub 16. At this time, because the catheter 30 of the needle portion 14 is fixed to the body surface 12a, the inner needle 32 is pulled out from inside the catheter 30, and only the catheter 30 is left in the body.

[0085] After placement of the catheter 30 is complete, the user 12 grasps the second gripping piece 80 of the second sheet 76 and peels it off in the width direction from the patch body 22. The second sheet 76 is peeled off from the adhesive surface 22a from one width direction of the patch body 22 to the other width direction. At this time, the bonding force between the release sheet 72 and the patch body 22 is strong at the position corresponding to the fused portion 82, but because peeling aids 86a, 86b are provided at the outer width direction ends of the fused portion 82 and the fused area at the outer width direction ends is smaller than the general fused portion 84, the load required for peeling (peeling resistance) is small.

[0086] Therefore, even if the adhesive strength of the release sheet 72 at the position corresponding to the fused portion 82 increases due to the fusion between the holder 20 and the adhesive body 22, the second sheet 76 can be easily peeled off from the adhesive body 22.

[0087] By peeling the second sheet 76 from the back surface of the adhesive body 22, the adhesive surface 22a of the second adhesive part 70 is exposed. The adhesive surface 22a of the second adhesive part 70 is attached along the body surface 12a of the user 12 by adhesive force. In addition to the first adhesive part 68 of the adhesive body 22, the second adhesive part 70 is fixed to the body surface 12a. That is, the entire adhesive surface 22a of the adhesive body 22 is attached and fixed to the body surface 12a. As a result, the holder 20 that holds the catheter hub 16 is fixed to the body surface 12a of the user 12 together with the adhesive body 22.

[0088] Next, a second priming is performed to fill the needle portion 14 and the inside of the tube 18 with the priming solution S2 again.

[0089] The second priming is performed using the priming solution S2 remaining in the barrel 176 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.

[0090] By performing the second priming described above, the priming solution S2 filled in the tube 18 and the catheter 30 effectively prevents backflow of blood, cells, etc. from the body surface 12a punctured by the catheter 30. This prevents clogging of the catheter 30 and the tube 18 due to coagulation of blood, etc.

[0091] After the second priming is completed, the priming fluid delivery tool 26 is removed together with the second connecting member 126 .

[0092] The user 12 pushes the base end of the arm 142 of the second connecting member 126 radially inward. The base end of the arm 142 elastically deforms radially inward, and the tip of the arm 142 moves radially outward, causing the engaging portion 144 to disengage from the engaging hole 114. This releases the connection of the second connecting member 126 to the first connecting member 100.

[0093] By pulling out the priming fluid delivery tool 26 together with the second connecting member 126 in the proximal direction (direction of arrow A), the second connecting member 126 and the priming fluid delivery tool 26 are removed from the proximal connecting portion 104 of the first connecting member 100.

[0094] Next, as shown in FIG. 3, the device main body 28 is attached to the connector 24 and the medicinal liquid S1 is administered.

[0095] 15 , the tip of the prefilled syringe 90 in the device body 28 is inserted into the proximal connecting portion 104 of the first connecting member 100 in the connector 24. This causes the proximal end of the hollow needle 98 to pierce the axial center of the packing 168. The proximal end of the hollow needle 98 is inserted into the delivery nozzle portion 170, and the connector claw portion 116 is engaged with the engaging recess 174 of the cover member 172. This connects the tip of the device body 28 to the proximal connecting portion 104 of the connector 24.

[0096] After the user 12 turns on the power switch 182 provided on the case 158 to start the device main body 28, the control unit 166 determines the timing for the start of drug solution administration by the drug solution administration device 10. When the administration start timing arrives, the control unit 166 sends a control signal to drive the movement mechanism 164, which moves the first gasket 162 toward the distal end. As the first gasket 162 moves, the drug solution S1 in the prefilled syringe 90 is pushed toward the distal end, and the drug solution S1 flows through the proximal end opening 156 and the needle hole 154 of the hollow needle 98 disposed in the delivery nozzle portion 170 into the communication passage 122 of the first connecting member 100.

[0097] The drug solution S1 supplied into the communication passage 122 presses the base end surface of the valve element 108 toward the distal end, causing the central portion of the valve element 108 to elastically deform toward the distal end around the opening / closing hole 112. This opens the opening / closing hole 112 of the valve element 108. At this time, the opening pressure that opens the opening / closing hole 112 is in a range lower than the pressure applied from the drug solution S1 to the base end surface of the valve element 108 by the driving force of the device body 28.

[0098] The medicinal solution S1 flows from the open / close hole 112 through the valve hole 110 and the flow passage 50 of the tube 18 to the space 42 of the catheter hub 16. The medicinal solution S1 is administered from the space 42 through the lumen of the catheter 30 into the body of the user 12.

[0099] When the administration of the medicinal liquid S1 from the device main body 28 into the body is completed and the flow of the medicinal liquid S1 stops, the valve body 108 returns to its original shape due to its elasticity, and the opening / closing hole 112 is closed. This completes the administration of the medicinal liquid S1 into the body of the user 12.

[0100] As described above, the first embodiment comprises the catheter hub 16 that holds the base end of the catheter 30, and the connector 24 that is provided at the base end of the tube 18 and to which the device main body 28 is attached, and the flow path through which the medicinal solution S1 flows between the catheter hub 16 and the base end of the connector 24 comprises a disk-shaped valve body 108 having a slit-shaped opening / closing hole 112 that opens when the medicinal solution S1 is delivered.

[0101] As a result, when the catheter 30 is not indwelled in the body of the user 12, the valve body 108 reliably prevents leakage of the medicinal solution S1 from the device body 28 to the catheter 30, which would be caused by pressure toward the distal end that occurs when the device body 28 is connected to the connector 24. Furthermore, when the catheter 30 is indwelled in the body, the valve body 108 reliably prevents leakage of the medicinal solution S1 before administration. When the catheter 30 is indwelled in the body and the medicinal solution S1 is to be delivered from the device body 28, the moving mechanism 164 of the device body 28 can be driven with a small driving force to easily open the open / close hole 112 formed in a slit shape with a small force, thereby enabling the medicinal solution S1 to be delivered.

[0102] By placing the valve body 108 between the base end of the tube 18 and the connector 24, the delivery state of the medicinal solution S1 to the catheter 30 can be switched by the valve body 108 between the device main body 28 connected to the connector 24 and the tube 18 connected to the catheter 30.

[0103] A priming solution delivery device 26 capable of delivering priming solution S2 is selectively connected to the connector 24, an annular valve seat 152 arranged on the connector 24 abuts against the valve element 108 radially outward of the opening / closing hole 112, and the valve element 108 is sandwiched between the base end surface 110a (see FIG. 13 ) of the valve hole 110 of the first connecting member 100 and the valve seat 152. As a result, when the priming solution delivery device 26 is removed from the connector 24 with the catheter 30 remaining in the body, back pressure applied to the tip surface of the valve element 108 prevents bodily fluids (blood) from infiltrating into the connector 24 through the base end surface 110a of the valve hole 110 and between the valve seat 152 and the valve element 108.

[0104] When the medicinal solution S1 is administered from the device main body 28, the opening pressure of the valve body 108 is set to a range lower than the pressure applied to the valve body 108 by the driving force when the device main body 28 is driven, so that the opening / closing hole 112 can be reliably opened when the catheter 30 is placed in the body and the medicinal solution S1 is delivered, and by keeping the opening / closing hole 112 of the valve body 108 closed when the connector 24 and the prefilled syringe 90 are connected when the catheter 30 is not placed, or when the catheter 30 is placed, leakage of the medicinal solution S1 due to changes in the internal pressure of the medicinal solution S1 caused by changes in air pressure, temperature, etc. can be reliably prevented.

[0105] The device has a connector 24 that is placed at the base end of the tube 18, and has a hollow needle 98 inside the connector 24 that protrudes toward the base end.The connector 24 also has a first connection part 92 that can be connected to a prefilled syringe 90, and a second connection part 94 that is provided at a location different from the first connection part 92 and can be connected to the priming liquid delivery device 26.

[0106] This allows the base end of the hollow needle 98 to be housed inside the connector 24, preventing the user 12 from accidentally puncturing the hollow needle 98 when connecting the priming solution delivery device 26 to the second connection part 94, performing priming, and then removing the priming solution delivery device 26 and the second connection part 94. When the prefilled syringe 90 is connected to the first connection part 92 of the connector 24, no pressure is applied by the prefilled syringe 90 toward the distal end, preventing the medicinal solution S1 from leaking toward the distal end.

[0107] Since the connector 24 can be connected to the priming liquid delivery device 26 via the second connection part 94, priming can be performed using the medicinal liquid administration device 10 before connecting the prefilled syringe 90 to the device main body 28.

[0108] The first connecting part 92 is provided on a first connecting member 100 that is connected to the base end of the tube 18, and the second connecting part 94 is provided on a second connecting member 126 that is detachably attached to the base end of the first connecting member 100. As a result, after the priming solution delivery tool 26 has completed delivery of the priming solution S2, the priming solution delivery tool 26 can be removed from the first connecting member 100 together with the second connecting member 126, and the prefilled syringe 90 can be connected to the first connecting part 92 of the first connecting member 100 to administer the medicinal solution S1.

[0109] The second connecting member 126 includes a cylindrical first cylinder 128 connected to the tip end of the priming solution delivery tool 26, and a second cylinder 130 that covers the outside of the first cylinder 128 and engages with the first connecting member 100. This allows the tip nozzle portion 176a of the barrel 176 to be liquid-tightly connected to the fitting hole 140 of the first cylinder 128, and also allows the second cylinder 130 to be detachably connected to the first connecting member 100.

[0110] The second cylindrical body 130 of the second connecting member 126 has an arm 142 that can tilt in a direction toward or away from the first connecting member 100, and an engaging portion 144 provided at the tip of the arm 142 is engaged with an engaging hole 114 formed on the outer circumferential surface of the first connecting member 100. This allows the priming solution delivery tool 26 to be connected to the first connecting portion 92 of the first connecting member 100 via the second connecting member 126, and by tilting the arm 142 to remove the engaging portion 144 from the engaging hole 114, the connection of the second connecting member 126 to the connector 24 (first connecting member 100) can be easily released.

[0111] The first connecting part 92 has a tapered fitting hole 140 that faces the tip of the hollow needle 98 and into which the tip nozzle part 176a of the priming solution delivery device 26 can be inserted and fitted. As a result, when the tip nozzle part 176a of the barrel 176 is fitted into the fitting hole 140, the tip nozzle part 176a of the barrel 176 and the fitting hole 140 are fitted together liquid-tightly, thereby enabling a good connection between the priming solution delivery device 26 and the connector 24.

[0112] By providing a cap 132 that is held at the tip of the first cylindrical body 128 and the second cylindrical body 130 and is punctured by a hollow needle 98, the tip of the first cylindrical body 128 and the tip of the second cylindrical body 130 can be liquid-tightly connected, and therefore the cap 132 prevents leakage of the priming liquid S2.

[0113] The catheter hub 16 includes a catheter hub 16 that holds the base end of the catheter 30, a holder 20 that holds the catheter hub 16, and a sheet-like adhesive sheet 22 that is fixed to the back surface of the holder 20 and adhered along the body surface 12a of the user 12. As a result, when the catheter 30 is placed inside the body of the user 12, the catheter hub 16 is securely fixed to the adhesive sheet 22 by the holder 20, preventing the catheter hub 16 from moving relative to the catheter 30 due to bodily movements of the user 12, etc. This prevents deformation of the catheter 30 due to bodily movements of the user 12, and also prevents the catheter 30 from becoming dislodged from the body.

[0114] The holder 20 includes a flat base 54 to which the patch 22 is fixed, and a cylindrical catheter holding portion 56 connected to the base 54 and into which the tip of the catheter hub 16 is inserted and held, so that the holder 20 can be securely fixed to the patch 22 by the flat base 54. By inserting the tip of the catheter 30 (hub body 38) into the catheter holding portion 56, the tip of the hub body 38 can be held so as to point toward the body surface 12a of the user 12.

[0115] The holder 20 has a port holding portion 58 that holds the side port 40 of the catheter hub 16, and the port holding portion 58 has an upper wall 66 that covers the side port 40 from above. Therefore, when the tube 18 connected to the side port 40 is pulled in a direction away from the body surface 12a (base portion 54), the port holding portion 58 can prevent the side port 40 from floating up from the base portion 54. Therefore, even if the tube 18 is pulled, the catheter hub 16 can be prevented from coming off the holder 20.

[0116] The base portion 54 has a notch 60a that penetrates the base portion 54, and the lower part of the tip of the catheter hub 16 is positioned within the notch 60a, making it possible to position the tip of the catheter 30 held by the catheter hub 16 even closer to the body surface 12a, effectively preventing the catheter 30 from slipping out of the body.

[0117] The device comprises a holder 20 for holding a catheter hub 16, an adhesive patch 22 fused to the back surface of the holder 20 and attached to the body surface 12a of the user 12, and a release sheet 72 that is overlaid on the attachment surface 22a of the adhesive patch 22 and peeled off when fixing the adhesive patch 22 to the body surface 12a, the holder 20 and the adhesive patch 22 being joined to each other by a fused portion 82, the fused portion 82 having a general fused portion 84 and release assisting portions 86a, 86b having a bonding strength smaller than that of the general fused portion 84. As a result, when the user 12 peels the release sheet 72 from the attachment surface 22a of the adhesive patch 22, the release assisting portions 86a, 86b prevent the release sheet 72 from facing excessively high peel resistance. This allows the release sheet 72 to be easily peeled off from the adhesive patch 22. The catheter 30 already indwelling in the body is prevented from becoming dislodged when the release sheet 72 is peeled off.

[0118] By arranging the peeling assistance parts 86a and 86b at the position in the fused portion 82 where the maximum load (maximum peeling resistance) occurs when peeling off the release sheet 72, it is possible to effectively assist the peeling operation of the release sheet 72.

[0119] The peeling assisting portions 86a and 86b can be easily realized by forming the non-fused portions 88 by cutting out a part of the general fused portion 84.

[0120] Because the peeling aids 86a, 86b are disposed on the inner periphery of the fused portion 82, an appropriate bonding force is obtained on the outer periphery of the fused portion 82, and the adhesive body 22 can be fixed to the holder 20 with the desired bonding force. When the release sheet 72 is peeled off from the adhesive body 22, a sudden increase in the peel resistance of the release sheet 72 can be prevented.

[0121] The peeling auxiliary portions 86a and 86b can be easily realized by forming the peeling auxiliary portions 86a and 86b as fused portions that are fused with a bonding force smaller than the bonding force of the general fused portion 84.

[0122] The patch body 22 has a first patch part 68 through which the catheter 30 is inserted, and a second patch part 70 that is disposed at the base end of the first patch part 68 and to which the holder 20 is fixed, and peeling aids 86a, 86b are provided between the holder 20 and the second patch part 70. By fusing the holder 20 and the patch body 22 together, the release sheet 72 becomes difficult to peel from the second patch part 70, but by providing the peeling aids 86a, 86b between the holder 20 and the second patch part 70, it becomes possible to effectively improve the ease of peeling from the second patch part 70.

[0123] The holder 20 has a port holding portion 58 that holds the side port 40 of the catheter hub 16, and the peeling aids 86a, 86b are arranged at a position spaced apart from the port holding portion 58 in the circumferential direction of the fused portion 82. As a result, when a load is applied in the tensile direction to the tube 18 connected to the side port 40 and the side port 40 is pulled together with the tube 18, the bonding state between the patch 22 and the holder 20 is not weakened by the peeling aids 86a, 86b.

[0124] Next, a chemical solution administration device 200 according to a second embodiment is shown in Figures 16 to 18. Note that the same components as those in the chemical solution administration device 10 according to the first embodiment described above are given the same reference numerals, and detailed description thereof will be omitted.

[0125] 16, the connector 202 of the drug solution administration device 200 according to the second embodiment includes a single connecting member 208 having a first connecting portion 204 connectable to the prefilled syringe 90 (see FIG. 18) of the device main body 28 and a second connecting portion 206 connectable to the priming solution delivery tool 26 (see FIG. 17) capable of delivering the priming solution S2. The first connecting portion 204 includes the connector claw portion 116 and the hollow needle 216, and is the portion to which the delivery nozzle portion 170 of the prefilled syringe 90 is connected. The second connecting portion 206 has a fitting hole 218, and is the portion to which the tip nozzle portion 176a of the priming solution delivery tool 26 is connected.

[0126] The connecting member 208 is formed by molding from a resin material, and has a tip connecting portion 210 formed at the tip and holding the base end of the tube 18, a base end connecting portion 212 formed at the base end and connected to the device main body 28, and an intermediate portion 214 arranged between the tip connecting portion 210 and the base end connecting portion 212 and to which the priming liquid delivery device 26 is connected.

[0127] In the single connecting member 208 , the first connecting portion 204 and the second connecting portion 206 are different portions, with the proximal connecting portion 212 being the first connecting portion 204 and the intermediate portion 214 being the second connecting portion 206 .

[0128] The separation wall 118 of the intermediate portion 214 has a hollow needle 216 that protrudes toward the base end (the direction of arrow A). The hollow needle 216 is formed integrally with the connecting member 208.

[0129] The middle portion 214 has a fitting hole 218 into which the tip nozzle portion 176a of the barrel 176 is inserted. The fitting hole 218 faces the tip of the hollow needle 216 and is tapered toward the tip.

[0130] 17 is connected to the barrel 176 of the priming solution delivery device 26, the base end of the hollow needle 216 is inserted into the distal nozzle portion 176a of the barrel 176, and the distal nozzle portion 176a is tapered and fitted into the fitting hole 218. As a result, the priming solution S2 inside the barrel 176 is supplied in the distal direction through the needle hole 154 of the hollow needle 216, and the distal nozzle portion 176a of the barrel 176 and the fitting hole 218 of the connecting member 208 are liquid-tightly connected.

[0131] 18 is connected to the prefilled syringe 90 of the device main body 28, the base end of the hollow needle 216 is pierced through the axial center of the packing 168, and the base end is inserted into the delivery nozzle portion 170 of the prefilled syringe 90. This allows the medicinal solution S1 of the prefilled syringe 90 to be supplied toward the tip through the needle hole 154 of the hollow needle 216.

[0132] In this second embodiment of the medicinal solution administration device 200, by providing a first connection part 204 that can be connected to a prefilled syringe 90 and a second connection part 206 that can be connected to a priming solution delivery device 26 on the same connection member 208, the number of parts and assembly labor can be reduced, thereby reducing manufacturing costs, and the connector 202 can be made smaller in the axial direction.

[0133] By integrally molding the hollow needle 216 with the connecting member 208, the number of parts and assembly steps of the drug solution administration device 200 can be reduced.

[0134] The above embodiment can be summarized as follows.

[0135] The above embodiment comprises a catheter (30) to be placed in a living body (12), a catheter hub (16) that holds the base end of the catheter, a holder (20) that holds the catheter hub, an adhesive patch (22) that has an attachment surface (22a) that is adhered to the body surface (12a) of the living body and is fused to the back surface of the holder, a release sheet (72) that is overlaid on the attachment surface so as to cover the patch and is peeled off from the attachment surface when the holder is fixed to the body surface, and a fusion portion (82) that extends along the outer periphery of the holder between the holder and the patch and joins the holder and the patch, and the fusion portion has a general fusion portion (84) and peeling auxiliary portions (86a, 86b) that have a bonding strength smaller than that of the general fusion portion.

[0136] The peeling aid is disposed at a position where the maximum load is applied when peeling off the release sheet, or at a position where the load becomes large.

[0137] The peeling aid portion is a non-fused portion (88) or a weakly fused portion provided by cutting out a part of the generally fused portion.

[0138] The peeling aid is disposed on the inner circumferential side of the fused portion.

[0139] The peeling auxiliary portion is a second fused portion fused with a bonding strength smaller than that of the general fused portion.

[0140] The adhesive body has a first adhesive part (68) through which the catheter is inserted, and a second adhesive part (70) that is disposed at the base end of the first adhesive part and to which the holder is fixed, and the peeling assist part is provided between the holder and the second adhesive part.

[0141] The catheter hub has a hub body (38) that supports the catheter and a side port (40) that protrudes from the hub body, the tip of a tube (18) is connected to the side port, the holder has a port holding portion (58) that holds the side port, and the peeling aid portion is positioned at a position spaced from the port holding portion in the circumferential direction of the fused portion.

[0142] The present invention is not limited to the above disclosure, and various configurations can be adopted without departing from the gist of the present invention.

Claims

1. A catheter that is placed in a living body; a catheter hub for holding a proximal end of the catheter; a holder for holding the catheter hub; an adhesive body having an adhesive surface to be attached to the body surface of the living body and fused to the back surface of the holder; a release sheet that is placed on the adhesive surface so as to cover the adhesive body and is peeled off from the adhesive surface when the holder is fixed to the body surface; a fusion portion extending along an outer periphery of the holder between the holder and the adhesive body and joining the holder and the adhesive body; Equipped with The fusion portion of the drug solution administration device has a general fusion portion and a peeling auxiliary portion having a bonding strength smaller than that of the general fusion portion.

2. 2. The drug solution administration device according to claim 1, The peeling assistant part is arranged at a position where a maximum load is applied when peeling off the release sheet, or at a position where the load is large.

3. 3. The drug solution administration device according to claim 1, A drug solution administration device, wherein the peeling auxiliary portion is a non-fused portion or a weakly fused portion provided by cutting out a portion of the generally fused portion.

4. 4. The drug solution administration device according to claim 3, The peeling auxiliary portion is disposed on the inner circumferential side of the fused portion, the drug solution administration device.

5. 3. The drug solution administration device according to claim 1, A drug solution administration device, wherein the peeling auxiliary portion is a second fused portion fused with a bonding strength smaller than the bonding strength of the general fused portion.

6. 2. The drug solution administration device according to claim 1, The patch has a first patch part through which the catheter is inserted; a second attachment portion disposed at a base end of the first attachment portion and fixed to the holder; having The peeling assistant part is provided between the holder and the second attachment part.

7. 2. The drug solution administration device according to claim 1, The catheter hub includes a hub body that supports the catheter; a side port protruding from the hub body; having A tip of a tube is connected to the side port, the holder has a port holding portion that holds the side port, A drug solution administration device, wherein the peeling auxiliary portion is arranged at a position spaced apart from the port holding portion in the circumferential direction of the fused portion.