Medical puncture needle

Abstract

The medical puncture needle (10) includes: a needle unit (14); and a needle protection member (16) which protects the needle (18) (catheter (28)) of the needle unit (14) by covering the outer periphery of the needle (18) and can be removed when using the needle (18). The needle protection member (16) includes a cylindrical cover (72) having a receiving space (721) for receiving the needle (18) inside and extending axially to cover the outer periphery of the needle (18). When viewed from the axial direction of the needle (18), the opening (722) provided at the base end of the cover (72) is larger than the needle (18), and the cover (72) and the needle (18) do not contact each other when the needle (18) is received in the cover (72).

Description

Technical Field

[0001] This invention relates to medical puncture needles. Background Technology

[0002] International Publication No. 2023 / 188851 discloses a drug delivery device equipped with a needle. The needle of the drug delivery device is a multi-needle consisting of an outer needle (catheter) and an inner needle capable of penetrating the skin of a living organism and remaining in place. In the initial state before use, the needle is covered by a needle protection member. During the assembly process of the drug delivery device, a tubular needle protection member is installed relative to the outer periphery of the needle.

[0003] Patent Document 1: International Publication No. 2023 / 188851

[0004] During the assembly process of the drug delivery device, sometimes the needle protection component may come into contact with the tip of the needle and damage the tip. Summary of the Invention

[0005] The purpose of this invention is to solve the above-mentioned problems.

[0006] (1) The present invention provides a medical puncture needle, comprising: a needle unit having a needle with an inner cavity; and a needle protection member that protects the needle by covering the outer periphery of the needle and can be removed from the needle unit when using the needle, the needle unit comprising: a needle component having the needle; a retainer that retains the base end of the needle component; and an adhesive having a first surface that is adhered to the surface of the organism to which the needle is punctured, and a second surface opposite to the first surface, and at least a portion of the second surface being connected to the retainer, the needle protection member comprising: a cylindrical cover having a receiving space for receiving the needle internally and extending axially to cover the outer periphery of the needle; and an opening disposed at the base end of the cover and connected to the receiving space, the opening being larger than the needle when viewed from the axial direction of the needle, and the cover and the needle not contacting each other when the needle is received in the cover.

[0007] According to this medical puncture needle, when the needle protection component is installed onto the needle unit during the assembly process, the tip of the needle can be prevented from contacting the opening of the cover, thus suppressing damage to the tip of the needle caused by contact with the base of the cover. Furthermore, when the needle is housed in the needle protection component, the needle protection component does not contact the needle, thus suppressing damage to the tip of the needle caused by contact with the cover.

[0008] (2) In the medical puncture needle described in (1) above, the needle may be a flexible catheter, and the medical puncture needle may have an inner needle inserted into the catheter.

[0009] This structure effectively protects the flexible tip of the catheter.

[0010] (3) In the medical puncture needle described in (1) or (2) above, the needle protection component may also be supported on the retainer.

[0011] With this structure, the needle protection component is supported by a retainer, thereby enabling the needle protection component to be supported with a simple structure.

[0012] (4) In the medical puncture needle described in (1) above, the needle component may be an outer needle component, and the needle unit may have an inner needle component, which has an inner needle inserted into the inner cavity of the needle and a needle holding portion for holding the base end of the inner needle, and the inner needle component is installed in a manner that allows it to be detached from the outer needle component.

[0013] With this structure, damage to the tip of the needle constituting the outer side of the double needle can be suppressed during the assembly process of a medical puncture needle having a needle unit with double needles.

[0014] (5) In the medical puncture needle described in (4) above, the needle protection component may also be supported on the retainer or the needle retainer.

[0015] This structure allows for the simple support of the needle protection component while the needle is contained.

[0016] (6) In any of the medical puncture needles described in (1) to (5) above, the needle protection component may also have an adhesive receiving portion that receives at least a portion of the adhesive.

[0017] This structure protects the needle with a needle protection component and houses the adhesive in an adhesive receiving part, thereby effectively preventing deformation and damage to the adhesive before use.

[0018] (7) In the medical puncture needle described in (6) above, the needle protection component may also keep the front end of the needle and the adhesive body in a state of separation.

[0019] This structure prevents the tip of the needle from contacting the adhesive through a needle protection component, thus keeping the tip of the needle clean.

[0020] (8) In the medical puncture needle described in (6) above, the adhesive receiving part may also be a slit part, which is provided in the cover part of the needle protection component and intersects with the inner wall of the cover part.

[0021] This structure allows for the simultaneous containment of the needle-to-shelter portion and the adhesive portion based on the slit portion within the needle protection component.

[0022] (9) In the medical puncture needle described in (8) above, the cover may have: a first portion including the front end of the cover and a second portion including at least a portion of the base end of the cover and separated from the first portion by means of the slit portion, and the needle protection member has a connecting portion at the outer surface of the cover to connect the first portion and the second portion.

[0023] This structure allows for a larger containment area for the adhesive through the slit, and also ensures that the adhesive is the right size.

[0024] (10) In the medical puncture needle described in (9) above, the slit portion may extend from the opening portion to the connecting portion.

[0025] This structure expands the slit area, thereby ensuring a larger area for accommodating the adhesive and accommodating larger adhesives.

[0026] According to the present invention, a medical puncture needle includes a needle protection component that protects the needle by covering its outer periphery and can be removed from the needle unit during needle use. The needle protection component has a cylindrical cover portion that covers the outer periphery of the needle. When the needle is housed in the cover portion, the cover portion and the needle are disposed without contact. Therefore, when the needle protection component is installed into the needle unit during the assembly process of the medical puncture needle, the tip of the needle can be prevented from contacting the opening of the cover portion. Thus, damage to the tip of the needle due to contact with the base of the cover portion can be suppressed. Furthermore, when the needle is housed in the needle protection component, the needle protection component and the needle are not in contact, thus suppressing damage to the tip of the needle due to contact with the cover portion. Attached Figure Description

[0027] Figure 1 This is an overall top view of a drug delivery device for a medical puncture needle according to the first embodiment of the present invention.

[0028] Figure 2 yes Figure 1 The overall cross-sectional view of the drug delivery device shown.

[0029] Figure 3 This is an enlarged cross-sectional view showing the vicinity of the medical puncture needle in the drug delivery device.

[0030] Figure 4 It is along Figure 1 A cross-sectional view along line IV-IV.

[0031] Figure 5 It means in Figure 1 The diagram illustrates the state of the drug delivery device with the main body of the device installed.

[0032] Figure 6 It means from Figure 2 The diagram illustrates the state of the drug delivery device after the needle protection component has been removed.

[0033] Figure 7 This is a 3D view of the needle protection component.

[0034] Figure 8 This is an illustrative diagram showing the medical puncture needle from the basal direction.

[0035] Figure 9 This is an anatomical view showing the state after the needle protection component has been removed from the needle unit.

[0036] Figure 10 This is a three-dimensional sectional view showing the front end of the drug delivery device.

[0037] Figure 11 This is an explanatory diagram showing the needle of the puncture drug delivery device.

[0038] Figure 12 This is a top view of a drug delivery device for a medical puncture needle with a modified version.

[0039] Figure 13 It means Figure 12 A three-dimensional sectional view of the front end of the drug delivery device.

[0040] Figure 14 This is an overall top view of a drug delivery device for a medical puncture needle according to the second embodiment of the present invention.

[0041] Figure 15 It is along Figure 14 A cross-sectional view of the XV-XV line.

[0042] Figure 16 It is along Figure 15 A cross-sectional view along the XVI-XVI line. Detailed Implementation

[0043] like Figure 1 As shown, the medical puncture needle 10 of this embodiment is used in the drug delivery device 12.

[0044] The drug delivery device 12 is configured to be placed on the body surface P1, such as the abdomen of the user P (organism) (see reference). Figure 11 ), and automatically deliver the drug solution S into the body (within the organism) (refer to Figure 5For example, the drug delivery device 12 is used to administer drug S to user P at a predetermined time after medical treatment, or to administer drug S gradually over a period of time. The drug S administered by the drug delivery device 12 is not particularly limited. Examples of liquid pharmaceuticals that can be used as drug S include antibody drugs, anticancer agents, chemotherapy agents, anesthetics, antibiotics, insulin, blood products, and nutritional supplements.

[0045] like Figure 2 As shown, the drug delivery device 12 has a medical puncture needle 10. The medical puncture needle 10 has a needle unit 14 and a needle protection member 16 that covers the outer periphery of the needle 18 of the needle unit 14 and can be removed from the needle unit 14.

[0046] The needle unit 14 includes: a needle component 20 having a needle 18; a retainer 22 retaining the base end of the needle component 20; and an adhesive body 24 connected to the retainer 22.

[0047] like Figure 3 As shown, needle component 20 is outer needle component 201. Outer needle component 201 includes a needle 18 and a catheter sleeve 26 that retains the base of the needle 18. Needle 18 is a flexible catheter 28 having an inner lumen 181. Catheter 28 is inserted into the user P (see reference). Figure 11 The skin is placed inside the body (subcutaneous).

[0048] The catheter 28 is a tube with an internal lumen 181 that allows the drug solution S to flow through. The lumen 181 of the catheter 28 communicates with the opening at the front end of the catheter 28. The front end of the catheter 28 protrudes obliquely downward from the lower surface of the catheter sleeve 26 (opposite to the body surface P1) toward the front end (in the direction of arrow B) (see reference). Figure 11 ).

[0049] The catheter sheath 26 is a needle sheath 261. The needle sheath 261 includes: a sheath body 262 supporting the base end of the catheter 28; and a side port 263 protruding from the side of the sheath body 262 and connected to the front end of the tube 30. The sheath body 262 extends linearly from the front end toward the base end, and has a space 32 inside. The space 32 communicates with the inner lumen 181 of the catheter 28 and the tube 30 connected to the side port 263. Figure 2 As shown, a needle retaining part 38 with a holding member 34 attached is detachably mounted on the base end of the sleeve body 262. The base end of the guide tube 28 is fixed to the needle sleeve 261 by riveting with a rivet pin (not shown).

[0050] The needle holder 38 has a pressing part 381 at its front end. The pressing part 381 is provided on the outer peripheral surface of the needle holder 38, and a set of them is provided in the width direction orthogonal to the axial direction of the needle holder 38. When the needle holder 38 is pulled out relative to the catheter sleeve 26 towards its base, the user P presses the base end of the pressing part 381 inward in the width direction. By pressing the base end of the pressing part 381, the front end of the pressing part 381 tilts outward in the width direction, thereby releasing the engagement of the needle holder 38 with the catheter sleeve 26.

[0051] like Figure 3 As shown, the needle unit 14 also includes an inner needle component 40, which has an inner needle 36 inserted into the cavity 181 of the needle 18 (conduit 28) and a needle holding portion 38 for holding the base end of the inner needle 36. The inner needle 36 is made of a metallic material. A portion of the inner needle 36 penetrates the interior of the conduit 28. The front end of the inner needle 36 is inserted into the cavity 181 of the conduit 28. The base end of the inner needle 36 is inserted into the interior of the needle sheath 261. The inner needle 36 is inserted into the conduit 28, thereby forming a double needle 42 that overlaps radially. The conduit 28 is inserted from the body surface P1 of the user P (see reference). Figure 11 The inner needle 42, consisting of the catheter 28 and the inner needle 36, is inserted into the body and left in place, thus forming the inlet of the drug solution S. After the user P punctures the body with the double needle 42 consisting of the catheter 28 and the inner needle 36, the inner needle 36 is pulled out from the catheter 28 while the catheter is punctured, thereby leaving the catheter 28 in the body of the user P. That is, the inner needle component 40 is installed in a manner that allows it to detach from the outer needle component 201 in the base direction.

[0052] like Figure 1 As shown, the retainer 22 has: a base portion 221, which is formed in the shape of a flat plate and has an adhesive body 24 fixed thereon; and a sleeve retaining portion 222 and a port retaining portion 223, which are disposed on the upper part of the base portion 221 and retain the needle sleeve 261.

[0053] The base portion 221 is roughly circular in shape when viewed from above. A sleeve retaining portion 222 and a port retaining portion 223 are provided on the surface of the base portion 221.

[0054] like Figure 3 As shown, the sleeve retaining portion 222 holds the sleeve body 262 of the needle sleeve 261. The sleeve retaining portion 222 is formed in a cylindrical shape and is disposed in the center of the base portion 221. The sleeve retaining portion 222 extends along the extending direction of the guide tube 28. The front end of the sleeve retaining portion 222 is inclined toward the base portion 221 (see reference). Figure 4 ).like Figure 5 As shown, a hole 224 is provided at the connection between the sleeve retaining part 222 and the port retaining part 223. Figure 4As shown, when the needle protection component 16 is installed to cover the outer periphery of the catheter 28, the base end of the second portion 802 of the needle protection component 16 covers the front end of the sleeve retainer 222.

[0055] like Figure 2 As shown, the adhesive body 24 has: a first adhesive portion 241 through which the conduit 28 is inserted; and a second adhesive portion 242 disposed at the base end of the first adhesive portion 241 and fixed with a retainer 22. Figure 4 As shown, the adhesive 24 has an adhesive surface P1 that adheres to the body surface of the organism (see reference). Figure 11 The adhesive body 24 has a first surface 441 and a second surface 442 opposite to the first surface 441. The first and second surfaces 441 and 442 are formed covering the first and second adhesive portions 241 and 242, respectively. At least a portion of the second surface 442 of the adhesive body 24 is fixed to the back side of the base portion 221 of the retainer 22. The second surface 442 is covered by a release tab 46. The release tab 46 has: a first portion 461 that covers the first surface 441 of the first adhesive portion 241; and a second portion 462 that covers the first surface 441 of the second adhesive portion 242.

[0056] In addition, the drug delivery device 12 includes: a tube 30, which is held in the needle sheath 261 and is capable of supplying drug solution S (see reference). Figure 5 ) Flow; and connector 48, which is disposed at the base end of tube 30.

[0057] The tube 30 is formed of a flexible tube that allows the drug solution S to flow inside, and the front end of the tube 30 is fixed to the connection port 50 of the needle sheath 261. Thus, the tube 30 communicates with the space portion 32 of the needle sheath 261 through the connection port 50.

[0058] Connector 48 can selectively connect a pre-fill solution delivery device (not shown) capable of dispensing pre-fill solution (physiological saline) filled inside from the front end, and a device body 54 capable of dispensing medication S filled inside (see reference). Figure 5 ).

[0059] Connector 48 has: a first connection portion 58, which is capable of engaging with the pre-filled syringe 56 of the device body 54 (see reference). Figure 5 The first connection 58 includes: a second connection 60, which can be connected to a prefill delivery device (not shown) that can deliver prefill liquid; and a tube holder 62, which holds the base end of the tube 30 and is mounted on the first connection 58.

[0060] The first connecting portion 58 has a first connecting member 66 connected to the base end of the pipe 30 via a pipe retainer 62. The communication state between the interior of the first connecting member 66 and the pipe 30 is switched by a valve body (not shown).

[0061] like Figure 1As shown, the second connecting portion 60 has a second connecting member 68 that is detachably mounted to the base end of the first connecting member 66. The second connecting member 68 can be connected to the front end of a pre-filled liquid dispensing device (not shown).

[0062] The tube holder 62 is a bottomed cylindrical part with an open front end. The tube holder 62 is fitted and fixed by inserting into the holder hole (not shown) of the first connecting member 66. The base end of the tube 30 is inserted and fixed inside the tube holder 62.

[0063] like Figure 2 As shown, when the second connecting part 68 is connected to the first connecting part 66, the interior of the first connecting part 66 is connected and communicated with the interior of the second connecting part 68 through the hollow pin 64.

[0064] like Figure 3 As shown, the needle protection component 16 is detachably configured to cover the outer periphery of the catheter 28. In the initial state before use, before puncture with the inner needle 36 and the catheter 28 (double needle 42), the needle protection component 16 is installed to cover the outer periphery of the catheter 28. By covering the outer periphery and tip of the double needle 42, including the catheter 28, the needle protection component 16 prevents accidental puncture of the inner needle 36 before use. When puncturing with the double needle 42, the needle protection component 16 is removed from the needle unit 14 (see reference). Figure 5 and Figure 6 ).

[0065] like Figure 7 As shown, the needle protection component 16 has: a cover portion 72, an adhesive receiving portion 74, and a connecting portion 76.

[0066] The cover 72 is a cylindrical portion having an internal receiving space 721 and extending axially. When the needle protection member 16 is configured to cover the outer periphery of the guide tube 28, the outer periphery of the guide tube 28 is covered by the cover 72. Figure 4 As shown, the base of the cover 72 has an opening 722. The opening 722 is connected to and communicates with the receiving space 721. Figure 8 As shown, when the conduit 28 is housed inside the cover 72, viewed axially from the conduit 28, the inner diameter of the opening 722 is larger than the outer diameter of the conduit 28. The outer circumferential surface of the conduit 28 is radially separated from the opening 722. The outer circumferential surface of the conduit 28 is radially separated from the inner circumferential surface of the cover 72. With the conduit 28 housed within the housing space 721 of the cover 72, the cover 72 and the conduit 28 do not contact each other. Figure 3 As shown, the front end of the cover 72 has a front opening 723. The diameter of the front opening 723 is smaller than the diameter of the opening 722. The front opening 723 communicates with the receiving space 721.

[0067] like Figure 4As shown, when the conduit 28 is housed in the cover portion 72, at least a portion of the adhesive 24 is housed in the adhesive receiving portion 74. Figure 7 As shown, the adhesive receiving portion 74 has a pair of slits 78 disposed on the cover portion 72 and intersecting the axial direction of the cover portion 72. The pair of slits 78 are opposite to each other with the axis of the cover portion 72 as the center. Figure 9 As shown, the slit 78 intersects the peripheral wall 724 of the cover 72. The slit 78 is inclined relative to the axial direction of the cover 72 and penetrates a portion of the peripheral wall 724 of the cover 72. Figure 4 As shown, with the needle protection member 16 installed on the needle unit 14, the slit portion 78 extends upward from below the cover portion 72. The slit portion 78 is inclined upward and towards the front end. The inclination angle of the slit portion 78 relative to the axial direction of the cover portion 72 is, for example, about 30°. However, the inclination angle of the slit portion 78 is not limited to 30°. For example, the inclination angle of the slit portion 78 can be in the range of 5° to 45°.

[0068] like Figure 9 As shown, the slit portion 78 includes an open end 781 and a closed end 782 located on the opposite side of the open end 781. The open end 781 opens to the outside of the cover portion 72. The open end 781 is located at one end of the slit portion 78 and extends to the opening 722 of the cover portion 72. The open end 781 is an insertion portion when the adhesive 24 is received in the adhesive receiving portion 74. The closed end 782 is located at the other end (front end) of the slit portion 78. The closed end 782 is positioned relative to the open end 781 in the front end direction of the cover portion 72. The closed end 782 is located at the connecting portion 76. The slit portion 78 extends upward from the open end 781 toward the closed end 782. Furthermore, the open end 781 of the slit portion 78 is not limited to being located at the opening 722 of the cover portion 72. For example, the open end 781 of the slit portion 78 may also be positioned in the front direction (arrow B direction) of the opening 722 of the cover portion 72.

[0069] like Figure 10 As shown, in the adhesive receiving portion 74, the adhesive 24 is received from the first adhesive portion 241 of the adhesive 24 through the open end 781. In the adhesive receiving portion 74, the front end portion of the adhesive 24 is opposite to the closed end 782. The middle portion between the front end portion and the base end portion of the adhesive 24 is disposed at the open end 781.

[0070] like Figure 4As shown, when the needle protection component 16 is installed to cover the outer periphery of the guide tube 28, the first adhesive portion 241 of the adhesive body 24 is inserted into the adhesive body receiving portion 74 of the needle protection component 16 in an inclined state relative to the second adhesive portion 242. When the needle protection component 16 is installed on the needle unit 14, the adhesive body 24 received in the adhesive body receiving portion 74 is held separately from the front end of the guide tube 28. The adhesive body 24 does not contact the front end of the guide tube 28. The adhesive body 24 protrudes to the outside of the cover portion 72 through a pair of slits 78. In the width direction of the adhesive body 24, which is orthogonal to the axial direction of the needle protection component 16 and is the extending direction of the adhesive body 24, the adhesive body 24 protrudes to both sides in the width direction relative to the peripheral wall 724 of the cover portion 72 (see reference). Figure 1 The adhesive 24 is centrally housed in the receiving space 721 of the needle protection component 16 along its width.

[0071] Furthermore, the adhesive receiving portion 74 is not limited to being provided on the cover portion 72. For example, an adhesive receiving portion 74 that protrudes outward in the width direction from the peripheral wall 724 of the cover portion 72 and is capable of receiving the adhesive 24 may also be provided.

[0072] like Figure 9 As shown, the cover 72 further includes: a first portion 801, and a second portion 802 separated from the first portion 801 by means of a slit portion 78. The first portion 801 includes the front end of the cover 72. The first portion 801 is the portion between the slit portion 78 and the front end of the cover 72. The second portion 802 includes at least a portion of the base end of the cover 72. The second portion 802 is the portion between the slit portion 78 and the base end of the cover 72. The base end of the second portion 802 includes an extension 82 protruding in the base end direction, and an engaging portion 84 protruding radially inward from the extension 82. The extension 82 is a portion protruding from a portion of the base end of the second portion 802. Figure 4 As shown, the engaging portion 84 protrudes from the inner circumferential surface of the peripheral wall 724 of the cover portion 72. When the needle protection member 16 is installed on the needle unit 14, the front end of the sleeve holding portion 222 of the needle sheath 261 is inserted into the opening 722 of the cover portion 72. At this time, the protruding portion 82 faces the upper surface of the sleeve holding portion 222, and the engaging portion 84 is inserted into the hole 224 of the sleeve holding portion 222. The engaging portion 84 engages with the hole 224, thereby restricting the movement of the needle protection member 16 relative to the retainer 22 in the forward direction (arrow B direction) in the initial state before use of the drug delivery device 12.

[0073] The connecting portion 76 connects the upper part of the first portion 801 and the upper part of the second portion 802 on the outer surface of the cover portion 72. The connecting portion 76 is provided on the outer periphery of the cover portion 72. The connecting portion 76 is arranged parallel to the cover portion 72 along the outer peripheral surface of the cover portion 72.

[0074] like Figure 8As shown, the connecting portion 76 has a first wall portion 761 protruding from the outer peripheral surface of the cover portion 72, and a second wall portion 762 disposed at the end of the first wall portion 761. When the needle protection member 16 is viewed axially, the connecting portion 76 is formed into a T-shape by the first wall portion 761 and the second wall portion 762. The first wall portion 761 protrudes radially outward from the outer peripheral surface of the cover portion 72. Figure 9 As shown, the first wall portion 761 connects the outer peripheral surface of the first portion 801 and the outer peripheral surface of the second portion 802. A portion of the slit portion 78 is provided in the first wall portion 761. The second wall portion 762 intersects the first wall portion 761. The closed end 782 of the slit portion 78 is provided in the first wall portion 761 of the connecting portion 76. In addition, the connecting portion 76 is not limited to a T-shape having the first wall portion 761 and the second wall portion 762.

[0075] like Figure 5 As shown, the main body 54 of the device includes a housing 86, which has the function of storing liquid medicine S and discharging liquid medicine S from the front end at the appropriate time, and has a receiving space (not shown) inside to accommodate various structures.

[0076] Inside the housing 86 are: a pre-filled syringe 56 for storing liquid S, a moving mechanism 90 for moving a first washer 88 inside the pre-filled syringe 56, a control unit 92 for driving control of the moving mechanism 90, and a power supply unit (not shown) for supplying power to each component.

[0077] The pre-filled syringe 56 is formed into a cylindrical shape along the axial direction (arrows A and B) and is filled with a drug solution S inside. The front end of the pre-filled syringe 56 protrudes a predetermined length from the front end of the housing 86 in the axial direction (arrow B) and protrudes to the outside.

[0078] The pre-filled syringe 56 has a delivery nozzle 94 at its front end. The drug solution S is held inside the pre-filled syringe 56 by means of a liner (not shown) disposed on the delivery nozzle 94.

[0079] Next, the assembly process of installing the needle protection component 16 into the needle unit 14 of the drug delivery device 12 will be described.

[0080] For example, in making Figure 9 With the needle tip of the needle unit 14 facing the opening 722 of the needle protection member 16, the guide tube 28 is inserted from the needle tip into the opening 722 of the needle protection member 16, causing the needle protection member 16 to move toward the needle unit 14. Thus, as shown... Figure 4As shown, the conduit 28 is received in the receiving space 721 of the needle protection member 16 from its tip toward its base. At this time, the first adhesive part 241 is inserted from the open end 781 of the slit 78 of the adhesive receiving part 74. The conduit 28 is received in the receiving space 721 of the cover 72, while a portion of the adhesive 24 is received in the adhesive receiving part 74 along the slit 78. In the adhesive receiving part 74, the first adhesive part 241 is received near the closed end 782, and a portion of the second adhesive part 242 is received near the open end 781.

[0081] The engaging portion 84 of the needle protector 16 is inserted into and engaged with the hole 224 of the sleeve retaining portion 222 in the needle sheath 261, thereby supporting the needle protector 16 on the retainer 22 with the base end of the cover 72 covering the front end of the sleeve retaining portion 222. Before use of the drug delivery device 12, i.e., in the initial state, movement of the needle protector 16 relative to the catheter 28 in the forward direction (arrow B direction) is restricted. In the receiving space 721, the catheter 28 is received inside the cover 72 with sufficient clearance between the outer peripheral surface of the catheter 28 and the inner peripheral surface of the cover 72. That is, the catheter 28 is received in the receiving space 721 of the needle protector 16 without contact with it. The front end of the catheter 28 is axially separated from the front end of the cover 72.

[0082] Thus, the assembly process of installing the needle protection component 16 onto the medical puncture needle 10 of the needle unit 14 is completed while the catheter 28 is protected by covering its outer periphery with the needle protection component 16.

[0083] Next, the method of administering medication S to user P using the medication delivery device 12 will be described. When using the medication delivery device 12, the catheter 28 is placed on the surface P1 of user P's body, a pre-filled fluid delivery device (not shown) is connected, the inside of the catheter 28 is filled with pre-filled fluid, and then the device body 54 is connected to automatically administer medication S to user P.

[0084] First, the inside of the conduit 28 and tube 30 is filled with pre-filling fluid for the first pre-filling.

[0085] Compared to Figure 2 The connector 48 of the drug delivery device 12 shown connects the pre-filled solution delivery device to the base of the second connecting member 68. Pre-filled solution flows into the interior of the second connecting member 68. The pre-filled solution flows through the connector 48 to the tube 30. The pre-filled solution flows from the tube 30 through the side port 263 into the space 32 of the needle sheath 261. Thus, the tube 30, the space 32, and the interior of the catheter 28 are filled with pre-filled solution, completing the first pre-filling. If the supply of pre-filled solution based on the pre-filled solution delivery device is stopped, the communication between the first connecting member 66 and the tube 30 is cut off by a valve body (not shown).

[0086] Next, the catheter 28 is left in the body of the user P. After the user P holds the catheter 28 and positions it at the desired location on the body surface P1, the needle protection component 16 is removed from the catheter 28 towards the tip.

[0087] After the user P disengages the locking portion 84 of the needle protection component 16 from the hole 224 of the retainer 22, thus releasing the locking state, as follows: Figure 9 As shown, the needle protection member 16 is moved axially toward the front end relative to the needle unit 14 (arrow B direction). When the base end of the cover 72 reaches the front end of the inner needle 36, the needle protection member 16 is pulled off from the guide tube 28 and the inner needle 36.

[0088] like Figure 11 As shown, after the user P inserts the tip of the catheter 28, which consists of the catheter 28 and the inner needle 36, into the body, the user P peels off the first piece 461 from the first adhesive part 241 and uses the first adhesive part 241 to attach a portion of the adhesive body 24 along the body surface P1 of the user P. Thus, the tip of the catheter 28 is fixed to the body surface P1 in the state of being punctured by the user P.

[0089] Next, the needle holding part 38 and the holding part 34 are pulled out relative to the catheter 28 in the base direction (arrow A direction), thereby removing the inner needle 36 held in the needle holding part 38 from the needle sheath 261. At this time, the catheter 28 is fixed to the body surface P1, so the inner needle 36 is removed from the inside of the catheter 28, leaving only the catheter 28 in the body.

[0090] After catheter 28 is placed, a second pre-filling is performed to refill the interior of catheter 28 and tube 30 with pre-filling fluid.

[0091] The second pre-charge is performed using the pre-charge fluid delivery device remaining from the first pre-charge. After the second pre-charge is completed, the pre-charge fluid delivery device and the second connecting part 68 are removed together. The second pre-charge is performed after the second piece 462 is peeled from the second adhesive part 242 of the adhesive body 24 and the second adhesive part 242 is attached along the surface P1 of the user P's body.

[0092] After disconnecting the second connecting part 68 from the first connecting part 66, user P pulls the pre-filled liquid delivery device and the second connecting part 68 together toward the base end (arrow A direction) to remove the pre-filled liquid delivery device.

[0093] Next, as Figure 5 As shown, the main body 54 of the device is installed on the connector 48 and the drug solution S is applied.

[0094] The front end of the pre-filled syringe 56 of the device body 54 is inserted into the interior of the base end of the first connecting member 66 in the connector 48. The hollow needle 64 punctures the axial center of a liner (not shown). The front end of the device body 54 is connected to the base end of the connector 48.

[0095] After user P turns on the power switch 96 located on housing 86 to start the device body 54, the control unit 92 measures the timing of the start of drug delivery based on the drug delivery device 12. When the start timing is reached, the moving mechanism 90 is driven according to the control signal from the control unit 92, the first washer 88 moves towards the front end, and the drug solution S in the pre-filled syringe 56 is pushed out towards the delivery nozzle 94. The drug solution S flows through the hollow needle 64 into the interior of the first connecting member 66. The valve body (not shown) elastically deforms towards the front end due to the pressure of the drug solution S, and the drug solution S flows from the tube 30 into the space 32 of the needle sheath 261, and is then delivered into the body of user P through the inner cavity 181 of the conduit 28.

[0096] The drug solution S is administered from the main body 54 into the body, and the flow of drug solution S stops, causing the valve body to return to its original shape due to its elasticity. Thus, the drug solution S is administered into the body of the user P.

[0097] The first implementation method has the following effects.

[0098] like Figure 3 As shown, the medical puncture needle 10 includes: a needle unit 14 having a catheter 28 (needle 18); and a needle protection member 16, which protects the catheter 28 by covering its outer periphery and can be removed from the needle unit 14 when using the catheter 28. The needle protection member 16 has a cylindrical cover 72 having a receiving space 721 that internally accommodates the catheter 28 and extends axially to cover the outer periphery of the catheter 28. When the catheter 28 is accommodated in the cover 72, the cover 72 and the catheter 28 are disposed without contacting each other. Therefore, when the needle protection member 16 is installed to the needle unit 14 during the assembly process of the medical puncture needle 10, the tip of the catheter 28 can be prevented from contacting the opening 722 of the cover 72. Thus, damage to the tip of the catheter 28 caused by contact with the base of the cover 72 can be suppressed. In addition, in the initial state of the drug delivery device 12 in which the catheter 28 is housed in the receiving space 721 of the needle protection member 16, the needle protection member 16 does not contact the catheter 28, thus suppressing damage to the tip of the catheter 28 caused by contact with the cover 72.

[0099] The catheter 28 is a flexible catheter, and the medical puncture needle 10 has an inner needle 36 inserted into the catheter 28. Thus, the tip of the flexible catheter 28 can be effectively protected during the assembly of the medical puncture needle 10. The needle protection member 16 is supported by the retainer 22, thereby allowing the needle protection member 16 to be supported with a simple structure.

[0100] The needle component 20 is the outer needle component 201, and the needle unit 14 includes an inner needle component 40. The inner needle component 40 has an inner needle 36 that is inserted into the lumen 181 of the catheter 28, and a needle holding portion 38 that holds the base end of the inner needle 36. The inner needle component 40 is installed in a manner that allows it to be detached from the outer needle component 201. Therefore, during the assembly process of the medical puncture needle 10 equipped with the needle unit 14 having double needles 42, damage to the tip of the catheter 28 constituting the outer side of the double needles 42 can be effectively suppressed.

[0101] like Figure 4 As shown, the needle protection member 16 has an adhesive receiving portion 74 that accommodates at least a portion of the adhesive 24. Thus, by protecting the catheter 28 with the needle protection member 16 and accommodating the adhesive 24 in the adhesive receiving portion 74, deformation and damage to the adhesive 24 before use can be effectively suppressed.

[0102] The needle protection component 16 keeps the tip of the catheter 28 and the adhesive 24 separated from each other. Thus, the needle protection component 16 prevents the tip of the catheter 28 from contacting the adhesive 24, thereby keeping the tip of the catheter 28 clean.

[0103] The adhesive receiving portion 74 is a slit portion 78 provided on the cover portion 72 of the needle protection member 16 and intersecting the inner wall of the cover portion 72. Thus, in the needle protection member 16, the catheter 28 can be received into the receiving space 721 of the cover portion 72, and the adhesive 24 based on the slit portion 78 can be received into the adhesive receiving portion 74 simultaneously.

[0104] The cover portion 72 has a connecting portion 76 on its outer surface that connects the first portion 801 and the second portion 802. As a result, the slit portion 78 can ensure a larger accommodating range for the adhesive 24 and ensure that the adhesive 24 is of a suitable size.

[0105] The slit portion 78 extends from the opening portion 722 to the connecting portion 76. Thus, by expanding the range of the slit portion 78, a larger adhesive body 24 can be accommodated by ensuring a larger accommodating area.

[0106] The engaging portion 84 of the needle protection component 16 engages with the hole 224 of the sleeve retaining portion 222 of the retainer 22, thereby effectively preventing the needle protection component 16 from being pulled out in the front direction while the needle protection component 16 is installed in the needle unit 14.

[0107] Figure 12 The modified medical puncture needle 10A shown has a needle protection member 16A supported by a retainer 22. For example... Figure 13 As shown, the cover portion 72A of the needle protection member 16A has a first portion 801, a second portion 802, and an adhesive receiving portion 74. When the needle protection member 16A is installed in the needle unit 14, the base end of the second portion 802 covers a portion of the sleeve retaining portion 222 and the port retaining portion 223 of the retainer 22. The base end of the second portion 802 has a locking portion 84A that protrudes radially inward from the inner circumferential surface of the base end. When the needle protection member 16A is installed in the needle unit 14, the locking portion 84A engages with the base end 222A of the sleeve retaining portion 222. The base end 222A of the sleeve retaining portion 222 is an end orthogonal to the axial direction of the needle sleeve 261. The locking portion 84A engages with the base end 222A of the sleeve retaining portion 222, thereby preventing the needle protection member 16A from moving towards the front end relative to the retainer 22.

[0108] When the needle protection component 16A is removed from the needle unit 14, the engaging portion 84A of the needle protection component 16A is disengaged from the base end 222A of the sleeve retaining portion 222, thereby releasing the engaging state. Then, the needle protection component 16A is moved axially toward the front end relative to the needle unit 14. When the base end of the cover portion 72A reaches the front end of the inner needle 36, the needle protection component 16A is pulled off from the guide tube 28 and the inner needle 36.

[0109] The modified example achieves the following effect.

[0110] like Figure 13 As shown, the needle protection member 16A is supported on the retainer 22, thus enabling the needle protection member 16A to be supported with a simple structure. By engaging the engagement portion 84A of the needle protection member 16A with the base end 222A of the sleeve retaining portion 222 of the retainer 22, it is possible to effectively prevent the needle protection member 16A from being pulled out in the forward direction while it is installed in the needle unit 14.

[0111] Figure 14 The medical puncture needle 10B of the second embodiment shown has a needle protection member 16B supported on the needle holding portion 38. For example... Figure 15 As shown, the cover portion 72B of the needle protection member 16B has a first portion 801, a second portion 802, and an adhesive receiving portion 74. When the needle protection member 16B is installed in the needle unit 14, the base end of the second portion 802 covers the front end of the needle holding portion 38. The base end of the second portion 802 has an engaging portion 84B on its inner surface opposite to the needle holding portion 38. Figure 16As shown, the engaging portion 84B has a set of recesses 100 provided in the width direction orthogonal to the axial direction of the needle holding portion 38. The set of recesses 100 are recessed outward in the width direction on the inner surface of the cover portion 72B.

[0112] The needle holder 38 has a protrusion 102 that protrudes upward from the pressing part 381. The protrusion 102 is housed inside the cover 72B. With the needle protector 16B installed in the needle unit 14, a portion of the protrusion 102 engages with the recess 100. The engaging part 84B engages with the recess 100 of the cover 72B, thereby restricting the movement of the needle protector 16B relative to the holder 22 in the forward direction before use of the drug delivery device 12, i.e., in the initial state.

[0113] When removing the needle protection component 16B from the needle unit 14, the needle protection component 16B is pulled towards the front end relative to the needle unit 14, thereby disengaging the recess 100 from the protrusion 102 and releasing the engaging state of the engaging portion 84B. When the base end of the cover portion 72B reaches the front end of the inner needle 36, the needle protection component 16B is pulled off from the guide tube 28 and the inner needle 36.

[0114] The second implementation method has the following effects.

[0115] like Figure 16 As shown, the needle protection member 16B is supported on the protrusion 102 of the needle holding part 38, thus enabling the needle protection member 16B to be supported in a simple structure while the catheter 28 is being housed. The engaging portion 84B (recess 100) of the needle protection member 16B engages with the protrusion 102 provided at the base end of the needle holding part 38, thereby effectively preventing the needle protection member 16B from being pulled out towards the tip when the needle protection member 16B is installed in the needle unit 14 before use of the drug delivery device 12, i.e., in the initial state.

[0116] Furthermore, the present invention is not limited to the above disclosure, and various structures may be adopted without departing from the spirit of the present invention.

Claims

1. A medical puncture needle, characterized in that, have: A needle unit having a needle with an inner cavity; and A needle protection component protects the needle by covering its outer periphery and can be removed from the needle unit when the needle is in use. The needle unit includes: A needle component having the needle; A retainer that holds the base end of the needle component; and An adhesive having a first surface that adheres to the surface of the organism being punctured by the needle, and a second surface opposite to the first surface, wherein at least a portion of the second surface is connected to the retainer. The needle protection component includes: A cylindrical cover having an internal receiving space for accommodating the needle and extending axially to cover the outer periphery of the needle; and An opening is provided at the base end of the cover and connected to the receiving space. When viewed from the axial direction of the needle, the opening is larger than the needle itself. When the cover contains the needle, the cover and the needle do not come into contact with each other.

2. The medical puncture needle according to claim 1, characterized in that, The needle is a flexible catheter. The medical puncture needle has an inner needle inserted into the catheter.

3. The medical puncture needle according to claim 1, characterized in that, The needle protection component is supported by the retainer.

4. The medical puncture needle according to claim 1, characterized in that, The needle component is an external needle component. The needle unit includes an inner needle component, which has an inner needle inserted into the inner cavity of the needle, and a needle holding portion for holding the base end of the inner needle. The inner needle component is installed in a manner that allows it to be detached from the outer needle component.

5. The medical puncture needle according to claim 4, characterized in that, The needle protection component is supported by the retainer or the needle retainer.

6. The medical puncture needle according to any one of claims 1 to 5, characterized in that, The needle protection component has an adhesive receiving portion that accommodates at least a portion of the adhesive.

7. The medical puncture needle according to claim 6, characterized in that, The needle protection component keeps the tip of the needle and the adhesive body separated from each other.

8. The medical puncture needle according to claim 6, characterized in that, The adhesive receiving portion is a slit portion, which is disposed in the cover portion of the needle protection component and intersects with the inner wall of the cover portion.

9. The medical puncture needle according to claim 8, characterized in that, The cover has: a first portion including a front end portion of the cover, and a second portion including at least a portion of a base end portion and separated from the first portion by means of the slit portion. The needle protection component has a connecting portion on the outer surface of the cover that connects the first portion and the second portion.

10. The medical puncture needle according to claim 9, characterized in that, The slit extends from the opening to the connection.

Images