Medical puncture needle

Abstract

A medical puncture needle (10) comprises: a needle unit (14); and a needle protection member (16) that protects a needle (18) (catheter (28)) of the needle unit (14) by covering the outer periphery of the needle (18), and that can be removed when using the needle (18). The needle protection member (16) includes a cylindrical cover part (72) having a storage space (721) in which the needle (18) is accommodated, extending in the axial direction, and covering the outer periphery of the needle (18). When viewed from the axial direction of the needle (18), an opening (722) provided at the base end of the cover part (72) is larger than the needle (18), and in a state in which the needle (18) is accommodated in the cover part (72), the cover part (72) and the needle (18) are not in contact with each other.

Description

medical puncture needle

[0001] The present invention relates to a medical puncture needle.

[0002] International Publication No. 2023 / 188851 discloses a drug solution administration device equipped with a needle. The needle of the drug solution administration device is a multi-needle consisting of an outer needle (catheter) and an inner needle that can puncture and be placed in the skin of a living body. In an initial state before use, the drug solution administration device has a needle covered by a needle protection member. During the assembly process of the drug solution administration device, a tubular needle protection member is attached to the outer periphery of the needle.

[0003] WO 2023 / 188851

[0004] During the assembly process of the drug solution administration device, the needle protection member may come into contact with the tip of the needle and damage the tip.

[0005] The present invention aims to solve the above-mentioned problems.

[0006] (1) An aspect of the present invention is a medical puncture needle comprising: a needle unit having a needle with an internal cavity; and a needle protection member that covers the outer periphery of the needle to protect the needle and can be removed from the needle unit when the needle is to be used. The needle unit comprises: a needle member having the needle; a holder that holds the base end of the needle member; and an adhesive member that has a first surface that is affixed to the body surface of a living body to be punctured by the needle and a second surface opposite to the first surface, with at least a portion of the second surface connected to the holder. The needle protection member has an accommodation space within which the needle is accommodated, and comprises a tubular cover portion that extends axially and covers the outer periphery of the needle, and an opening provided at the base end of the cover portion that communicates with the accommodation space. When viewed axially of the needle, the opening is larger than the needle, and when the needle is accommodated in the cover portion, the cover portion and the needle are not in contact with each other.

[0007] With this medical puncture needle, when attaching the needle protection member to the needle unit during the assembly process, the tip of the needle can be prevented from coming into contact with the opening of the cover, thereby reducing damage to the tip of the needle due to contact with the base end of the cover. Furthermore, when the needle is housed in the needle protection member, there is no contact between the needle protection member and the needle, reducing damage to the tip of the needle due to 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 configuration effectively protects the tip of the flexible catheter.

[0010] (3) In the medical puncture needle described in (1) or (2) above, the needle protection member may be supported by the holder.

[0011] With this configuration, the needle protection member is supported by the holder, and therefore the needle protection member can be supported with a simple configuration.

[0012] (4) In the medical puncture needle described in (1) above, the needle member is an outer needle member, and the needle unit comprises an inner needle member having an inner needle inserted into the inner cavity of the needle and a needle holding portion that holds the base end of the inner needle, and the inner needle member may be detachably attached to the outer needle member.

[0013] This configuration makes it possible to prevent damage to the tip of the needle that constitutes the outer side of the double needle during the assembly process of a medical puncture needle that includes a needle unit having a double needle.

[0014] (5) In the medical puncture needle described in (4) above, the needle protection member may be supported by the holder or the needle holding portion.

[0015] This configuration makes it possible to support the needle protection member with the needle housed in it with a simple configuration.

[0016] (6) In the medical puncture needle according to any one of (1) to (5) above, the needle protection member may have a patch housing portion that houses at least a part of the patch.

[0017] With this configuration, the needle is protected by the needle protection member, and by storing the patch in the patch storage section, deformation and damage to the patch before use can be effectively suppressed.

[0018] (7) In the medical puncture needle described in (6) above, the needle protection member may hold the tip of the needle and the patch apart from each other.

[0019] With this configuration, the needle protection member prevents the tip of the needle from coming into contact with the patch, so the tip of the needle can be kept clean.

[0020] (8) In the medical puncture needle described in (6) above, the patch accommodating section may be a slit section that is provided in the cover section of the needle protection member and intersects with an inner wall of the cover section.

[0021] With this configuration, in the needle protection member, the needle can be housed in the cover portion and the patch can be housed in the slit portion at the same time.

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

[0023] With this configuration, the slit section can ensure a large storage range for the patch, and a suitable size for the patch can be ensured.

[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] With this configuration, by enlarging the range of the slit portion, a larger accommodation range for the patch can be secured, making it possible to accommodate a larger patch.

[0026] According to the present invention, a medical puncture needle includes a needle protection member that protects the needle by covering its outer periphery and can be removed from the needle unit when the needle is to be used, and the needle protection member includes a tubular cover that covers the outer periphery of the needle. When the needle is housed in the cover, the cover and the needle are provided in a non-contact state. This prevents the tip of the needle from contacting the opening of the cover when the needle protection member is attached to the needle unit during the assembly process of the medical puncture needle. This prevents damage to the tip of the needle due to contact with the base end of the cover. Furthermore, because the needle protection member and the needle are not in contact when the needle is housed in the needle protection member, damage to the tip of the needle due to contact with the cover can be prevented.

[0027] FIG. 1 is an overall plan view of a drug solution administration device equipped with a medical puncture needle according to a first embodiment of the present invention. FIG. 2 is an overall cross-sectional view of the drug solution administration device shown in FIG. 1. FIG. 3 is an enlarged cross-sectional view showing the vicinity of the medical puncture needle in the drug solution administration device. FIG. 4 is a cross-sectional view taken along line IV-IV in FIG. 1. FIG. 5 is an explanatory diagram showing the drug solution administration device of FIG. 1 with the device main body attached. FIG. 6 is an explanatory diagram showing the drug solution administration device of FIG. 2 with the needle protection member removed. FIG. 7 is an external perspective view of the needle protection member. FIG. 8 is an explanatory diagram showing the medical puncture needle as viewed from the proximal end. FIG. 9 is an exploded cross-sectional view showing the needle protection member removed from the needle unit. FIG. 10 is a perspective cross-sectional view showing the distal end of the drug solution administration device. FIG. 11 is an explanatory diagram showing the needle of the drug solution administration device being punctured. FIG. 12 is a plan view of a drug solution administration device equipped with a medical puncture needle according to a modified example. FIG. 13 is a perspective cross-sectional view showing the distal end of the drug solution administration device of FIG. 12. Fig. 14 is an overall plan view of a drug solution administration device equipped with a medical puncture needle according to a second embodiment of the present invention. Fig. 15 is a cross-sectional view taken along line XV-XV in Fig. 14. Fig. 16 is a cross-sectional view taken along line XVI-XVI in Fig. 15.

[0028] As shown in FIG. 1 , a medical puncture needle 10 according to this embodiment is used in a drug solution administration device 12 .

[0029] The medicinal solution administration device 12 is configured to be placed on a body surface P1 (see FIG. 11 ), such as the abdomen, of a user P (living body), and to automatically administer a medicinal solution S (see FIG. 5 ) into the body (inside the living body). For example, the medicinal solution administration device 12 is used when administering the medicinal solution S to the user P a predetermined time after a medical procedure has been performed on the user P, or when administering the medicinal solution S gradually over time. The medicinal solution S administered by the medicinal solution administration device 12 is not particularly limited. Examples of the medicinal solution S include liquid pharmaceuticals such as antibody drugs, anticancer drugs, chemotherapy drugs, anesthetics, antibiotics, insulin, blood products, and nutrients.

[0030] As shown in Figure 2, medical solution administration device 12 has medical puncture needle 10. Medical puncture needle 10 has needle unit 14 and needle protection member 16 that covers the outer periphery of needle 18 of needle unit 14 and is removable from needle unit 14.

[0031] The needle unit 14 includes a needle member 20 having a needle 18 , a holder 22 that holds the base end of the needle member 20 , and an adhesive body 24 that is connected to the holder 22 .

[0032] As shown in Fig. 3, the needle member 20 is an outer needle member 201. The outer needle member 201 includes a needle 18 and a catheter hub 26 that holds the base end of the needle 18. The needle 18 is a flexible catheter 28 having an inner lumen 181. The catheter 28 is inserted into the skin of a user P (see Fig. 11) and placed inside the body (subcutaneously).

[0033] The catheter 28 is a tubular body having an internal lumen 181 through which the medicinal solution S can flow. The internal lumen 181 of the catheter 28 communicates with a distal end opening of the catheter 28. The distal end of the catheter 28 protrudes obliquely downward from the lower surface of the catheter hub 26 (the surface facing the body surface P1) in the distal direction (the direction of arrow B) (see FIG. 11 ).

[0034] The catheter hub 26 is a needle hub 261. The needle hub 261 includes a hub body 262 that supports the proximal end of the catheter 28, and a side port 263 that protrudes from the side of the hub body 262 and to which the distal end of the tube 30 is connected. The hub body 262 extends linearly from the distal end to the proximal end, and has a space 32 inside. The space 32 communicates with the lumen 181 of the catheter 28 and the tube 30 that is connected to the side port 263. As shown in FIG. 2 , a needle holding portion 38 to which a gripping member 34 is bonded is detachably attached to the proximal end of the hub body 262. The proximal end of the catheter 28 is fixed to the needle hub 261 by crimping a crimping pin (not shown).

[0035] The tip of the needle holding part 38 has a pressing part 381. The pressing parts 381 are provided on the outer peripheral surface of the needle holding part 38, and a set of pressing parts 381 are provided in the width direction perpendicular to the axial direction of the needle holding part 38. When pulling the needle holding part 38 in the proximal direction away from the catheter hub 26, 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 tip of the pressing part 381 tilts outward in the width direction, and the engagement of the needle holding part 38 with the catheter hub 26 can be released.

[0036] As shown in FIG. 3 , the needle unit 14 further includes an inner needle member 40 having an inner needle 36 inserted into the lumen 181 of the needle 18 (catheter 28) and a needle holder 38 that holds the proximal end of the inner needle 36. The inner needle 36 is made of a metal material. A portion of the inner needle 36 penetrates the interior of the catheter 28. The distal end of the inner needle 36 is inserted into the lumen 181 of the catheter 28. The proximal end of the inner needle 36 is inserted into the needle hub 261. When the inner needle 36 is inserted into the catheter 28, a radially overlapping double needle 42 is formed. The catheter 28 is inserted into the body from the body surface P1 (see FIG. 11 ) of the user P and left therein, forming an introduction section for the medicinal solution S. After inserting the double needle 42, consisting of the catheter 28 and the inner needle 36, into the body, the user P leaves the catheter 28 in the body by withdrawing the inner needle 36 from the catheter 28 in the punctured state. That is, the inner needle member 40 is attached to the outer needle member 201 so as to be releasable in the proximal direction.

[0037] As shown in FIG. 1, the holder 22 has a base portion 221 formed in a flat plate shape to which the patch 24 is fixed, and a hub holding portion 222 and a port holding portion 223 that are provided on the upper part of the base portion 221 and hold the needle hub 261.

[0038] The base portion 221 is formed in a substantially circular shape when viewed from above. A hub holding portion 222 and a port holding portion 223 are provided on the surface of the base portion 221.

[0039] As shown in FIG. 3 , the hub holding portion 222 holds the hub body 262 of the needle hub 261. The hub holding portion 222 is formed in a cylindrical shape and is disposed at the center of the base portion 221. The hub holding portion 222 extends along the extension direction of the catheter 28. The tip of the hub holding portion 222 is disposed at an angle facing the base portion 221 (see FIG. 4 ). As shown in FIG. 5 , a hole 224 is formed at the connection portion between the hub holding portion 222 and the port holding portion 223. As shown in FIG. 4 , when the needle protecting member 16 is attached so as to cover the outer periphery of the catheter 28, the base end of the second portion 802 of the needle protecting member 16 covers the tip end of the hub holding portion 222.

[0040] As shown in Fig. 2, the patch 24 has a first patch part 241 through which the catheter 28 is inserted, and a second patch part 242 that is disposed at the proximal end of the first patch part 241 and is fixed to the holder 22. As shown in Fig. 4, the patch 24 has a first surface 441 that is attached to the body surface P1 of a living body (see Fig. 11 ), and a second surface 442 that is opposite to the first surface 441. The first and second surfaces 441, 442 are formed across the first and second patch parts 241, 242, respectively. At least a portion of the second surface 442 of the patch 24 is fixed to the back surface of the base part 221 of the holder 22. The second surface 442 is covered with a release sheet 46. The release sheet 46 has a first sheet portion 461 that covers the first surface 441 of the first adhesive portion 241 and a second sheet portion 462 that covers the first surface 441 of the second adhesive portion 242 .

[0041] The drug solution administration device 12 further includes a tube 30 held by the needle hub 261 and through which the drug solution S (see FIG. 5) can flow, and a connector 48 provided at the proximal end of the tube 30 .

[0042] The tube 30 is formed from a flexible tube through which the medicinal solution S can flow, and the tip of the tube 30 is fixed to the connection port 50 of the needle hub 261. This allows the tube 30 to communicate with the space 32 of the needle hub 261 through the connection port 50.

[0043] The connector 48 can selectively connect to a priming fluid delivery device (not shown) that can deliver the priming fluid (physiological saline solution) filled inside from the tip, and to a device main body 54 (see Figure 5) that can deliver the medicinal solution S filled inside.

[0044] The connector 48 has a first connection part 58 that can be connected to a prefilled syringe 56 (see Figure 5) of the device main body 54, a second connection part 60 that can be connected to a priming liquid delivery device (not shown) that can deliver priming liquid, and a tube holder 62 that holds the base end of the tube 30 and is attached to the first connection part 58.

[0045] The first connecting portion 58 has a first connecting member 66 that is connected to the proximal end of the tube 30 via a tube holder 62. A valve body (not shown) switches the communication state between the inside of the first connecting member 66 and the tube 30.

[0046] 1, the second connecting portion 60 has a second connecting member 68 that is detachably attached to the proximal end of the first connecting member 66. The second connecting member 68 can be connected to the distal end of a priming solution delivery tool (not shown).

[0047] The tube holder 62 is cylindrical and has a bottom and an open tip. The tube holder 62 is fitted and fixed by being inserted into a holder hole (not shown) of the first connecting member 66. The proximal end of the tube 30 is inserted into the tube holder 62 and fixed therein.

[0048] As shown in FIG. 2, when the second connecting member 68 is connected to the first connecting member 66, the hollow needle 64 connects the interior of the first connecting member 66 and the interior of the second connecting member 68 to communicate with each other.

[0049] As shown in Figure 3, the needle protection member 16 is removably arranged to cover the outer periphery of the catheter 28. In the initial state before use when puncture is performed with the inner needle 36 and catheter 28 (double needle 42), the needle protection member 16 is attached to cover the outer periphery of the catheter 28. The needle protection member 16 covers the outer periphery and tip of the double needle 42 including the catheter 28, thereby preventing accidental puncture by the inner needle 36 before use. When puncture is performed with the double needle 42, the needle protection member 16 is removed from the needle unit 14 (see Figures 5 and 6).

[0050] As shown in FIG. 7, the needle protection member 16 has a cover portion 72, a patch receiving portion 74, and a connecting portion 76.

[0051] The cover portion 72 has an axially extending cylindrical shape and an internal storage space 721. When the needle protection member 16 is positioned to cover the outer periphery of the catheter 28, the outer periphery of the catheter 28 is covered by the cover portion 72. As shown in FIG. 4 , the base end of the cover portion 72 has an opening 722. The opening 722 is connected to and communicates with the storage space 721. As shown in FIG. 8 , when the catheter 28 is housed inside the cover portion 72, the inner diameter of the opening 722 is larger than the diameter (outer diameter) of the catheter 28 when viewed in the axial direction of the catheter 28. The outer periphery of the catheter 28 and the opening 722 are radially spaced apart. The outer periphery of the catheter 28 and the inner periphery of the cover portion 72 are radially spaced apart. When the catheter 28 is housed in the storage space 721 of the cover portion 72, the cover portion 72 and the catheter 28 are not in contact with each other. As shown in FIG. 3 , the tip of the cover portion 72 has a distal end opening 723. The diameter of the tip opening 723 is smaller than the diameter of the opening 722. The tip opening 723 communicates with the accommodation space 721.

[0052] As shown in FIG. 4 , when the catheter 28 is housed in the cover portion 72, at least a portion of the patch 24 is housed in the patch housing portion 74. As shown in FIG. 7 , the patch housing portion 74 has a pair of slits 78 provided in the cover portion 72 and intersecting the axial direction of the cover portion 72. The pair of slits 78 face each other about the axis of the cover portion 72. As shown in FIG. 9 , the slits 78 intersect with the peripheral wall 724 of the cover portion 72. The slits 78 are inclined with respect to the axial direction of the cover portion 72 and penetrate a portion of the peripheral wall 724 of the cover portion 72. As shown in FIG. 4 , when the needle protection member 16 is attached to the needle unit 14, the slits 78 extend from below to above the cover portion 72. The slits 78 are inclined upward toward the tip. The inclination angle of the slits 78 with respect to the axial direction of the cover portion 72 is, for example, approximately 30°. The inclination angle of the slit portion 78 is not limited to 30°, but may be within the range of 5° to 45°, for example.

[0053] As shown in FIG. 9 , the slit portion 78 has an open end 781 and a closed end 782 provided on the opposite side to the open end 781. The open end 781 opens to the outside of the cover portion 72. The open end 781 is provided 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 for accommodating the patch 24 in the patch accommodating portion 74. The closed end 782 is provided at the other end (tip end) of the slit portion 78. The closed end 782 is disposed in the tip direction of the cover portion 72 relative to the open end 781. The closed end 782 is provided in the connecting portion 76. The slit portion 78 extends upward from the open end 781 toward the closed end 782. It should be noted that the open end 781 of the slit portion 78 is not limited to being provided at the opening 722 of the cover portion 72. For example, the open end 781 of the slit portion 78 may be disposed further distally (in the direction of arrow B) than the opening 722 of the cover portion 72 .

[0054] 10 , the patch accommodating portion 74 accommodates the patch 24 from the first patch portion 241 of the patch 24 through the open end 781. In the patch accommodating portion 74, the tip end of the patch 24 faces the closed end 782. An intermediate portion between the tip end and the base end of the patch 24 is disposed at the open end 781.

[0055] As shown in FIG. 4 , when the needle protection member 16 is attached so as to cover the outer periphery of the catheter 28, the patch 24 is inserted into the patch housing 74 of the needle protection member 16 with the first patch portion 241 of the patch 24 inclined relative to the second patch portion 242. When the needle protection member 16 is attached to the needle unit 14, the patch 24 housed in the patch housing 74 and the tip of the catheter 28 are held apart from each other. The patch 24 and the tip of the catheter 28 are not in contact with each other. The patch 24 is exposed to the outside of the cover portion 72 through a pair of slits 78. In the width direction of the patch 24, which is perpendicular to the axial direction of the needle protection member 16 and corresponds to the extension direction of the patch 24, the patch 24 protrudes on both sides in the width direction from the peripheral wall 724 of the cover portion 72 (see FIG. 1 ). The center of the width direction of the patch 24 is housed in the housing space 721 of the needle protection member 16.

[0056] It should be noted that the patch accommodating section 74 is not limited to being provided in the cover section 72. For example, the patch accommodating section 74 may be provided so as to protrude outward in the width direction from the peripheral wall 724 of the cover section 72 and be capable of accommodating the patch 24.

[0057] As shown in FIG. 9 , the cover portion 72 further includes a first portion 801 and a second portion 802 separated from the first portion 801 by a slit portion 78. The first portion 801 includes a distal end portion of the cover portion 72. The first portion 801 is a portion between the slit portion 78 and the distal end of the cover portion 72. The second portion 802 includes at least a portion of the proximal end portion of the cover portion 72. The second portion 802 is a portion between the slit portion 78 and the proximal end of the cover portion 72. The proximal end of the second portion 802 includes an extension portion 82 that protrudes toward the proximal end and an engagement portion 84 that protrudes radially inward from the extension portion 82. The extension portion 82 is a portion that protrudes from a portion of the proximal end of the second portion 802. As shown in FIG. 4 , the engagement 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 attached to the needle unit 14, the tip of the hub holding portion 222 of the needle hub 261 is inserted into the opening 722 of the cover portion 72. At this time, the extension portion 82 faces the upper surface of the hub holding portion 222, and the engagement portion 84 is inserted into the hole 224 of the hub holding portion 222. By engaging the engagement portion 84 with the hole 224, movement of the needle protection member 16 toward the tip (direction of arrow B) relative to the holder 22 is restricted in the initial state before use of the medicinal solution administration device 12.

[0058] The connecting portion 76 connects the upper portion of the first portion 801 and the upper portion 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 disposed parallel to the cover portion 72 along the outer periphery of the cover portion 72.

[0059] As shown in FIG. 8 , 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 provided at an end of the first wall portion 761. When the needle protection member 16 is viewed in the axial direction, the connecting portion 76 is formed in 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. As shown in FIG. 9 , the first wall portion 761 connects the outer peripheral surfaces of the first portion 801 and 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 with the first wall portion 761. A closed end 782 of the slit portion 78 is provided in the first wall portion 761 of the connecting portion 76. The connecting portion 76 is not limited to a T-shape including the first wall portion 761 and the second wall portion 762 .

[0060] As shown in FIG. 5, the device body 54 has the function of storing the medicinal solution S and discharging the medicinal solution S from the tip end at an appropriate timing, and includes a case 86 having an internal storage space (not shown) for storing each component.

[0061] Inside the case 86, there is a prefilled syringe 56 that stores the medicinal solution S, a moving mechanism 90 that moves the first gasket 88 inside the prefilled syringe 56, a control unit 92 that controls the drive of the moving mechanism 90, and a power supply unit (not shown) that can supply power to each component.

[0062] Prefilled syringe 56 is formed in a cylindrical shape along the axial direction (direction of arrows A and B), and is filled with medicinal solution S. The tip of prefilled syringe 56 protrudes a predetermined length from the tip of case 86 in the axial direction (direction of arrow B) and is exposed to the outside.

[0063] The tip of the prefilled syringe 56 is provided with a delivery nozzle portion 94. A packing (not shown) arranged in the delivery nozzle portion 94 keeps the medicinal solution S sealed inside the prefilled syringe 56.

[0064] Next, an assembly process for attaching the needle protection member 16 to the needle unit 14 of the drug solution administration device 12 will be described.

[0065] For example, with the needle tip of the needle unit 14 and the opening 722 of the needle protection member 16 facing each other as shown in Fig. 9 , the catheter 28 is inserted needle tip-first into the opening 722 of the needle protection member 16, and then the needle protection member 16 is moved toward the needle unit 14. As a result, as shown in Fig. 4 , the catheter 28 is housed in the housing space 721 of the needle protection member 16 from the distal end to the proximal end. At this time, the first adhesive part 241 is inserted from the open end 781 of the slit part 78 of the patch housing part 74. The catheter 28 is housed in the housing space 721 of the cover part 72, and a portion of the patch 24 is housed in the patch housing part 74 along the slit part 78. In the patch housing part 74, the first adhesive part 241 is housed closer to the closed end 782, and a portion of the second adhesive part 242 is housed closer to the open end 781.

[0066] By inserting and engaging the engaging portion 84 of the needle protection member 16 into the hole 224 of the hub holding portion 222 of the needle hub 261, the needle protection member 16 is supported relative to the holder 22 with the base end of the cover portion 72 covering the tip of the hub holding portion 222. In the initial state before use of the drug solution administration device 12, movement of the needle protection member 16 toward the tip (direction of arrow B) relative to the catheter 28 is restricted. In the accommodation space 721, the catheter 28 is accommodated inside the cover portion 72 with a sufficient gap between the outer circumferential surface of the catheter 28 and the inner circumferential surface of the cover portion 72. In other words, the catheter 28 is accommodated in the accommodation space 721 of the needle protection member 16 with the catheter 28 and the needle protection member 16 not in contact with each other. The tip of the catheter 28 and the tip of the cover portion 72 are axially spaced apart.

[0067] This completes the assembly process of the medical puncture needle 10, in which the needle protection member 16 is attached to the needle unit 14 with the catheter 28 protected by being covered with the needle protection member 16.

[0068] Next, a description will be given of the administration of medicinal solution S to user P using medicinal solution administration device 12. When using medicinal solution administration device 12, catheter 28 is placed on body surface P1 of user P, a priming solution delivery device (not shown) is connected to fill the inside of catheter 28 with priming solution, and then device main body 54 is connected to automatically administer medicinal solution S to user P.

[0069] First, a first priming is performed to fill the inside of the catheter 28 and the tube 30 with a priming solution.

[0070] A priming solution delivery tool is connected to the proximal end of the second connecting member 68 of the connector 48 of the drug solution administration device 12 shown in Figure 2. The priming solution flows into the inside of the second connecting member 68. The priming solution flows into the tube 30 through the connector 48. The priming solution flows from the tube 30 through the side port 263 into the space 32 of the needle hub 261. This fills the inside of the tube 30, the space 32, and the catheter 28 with priming solution, completing the first priming. When the supply of priming solution by the priming solution delivery tool is stopped, communication between the first connecting member 66 and the tube 30 is blocked by a valve (not shown).

[0071] Next, the catheter 28 is placed inside the body of the user P. The user P grasps the catheter 28 and positions it at a desired position on the body surface P1, and then removes the needle protection member 16 from the catheter 28 in the distal direction.

[0072] After the user P disengages the engaging portion 84 of the needle protection member 16 from the hole 224 of the holder 22 to release the engagement state, as shown in Figure 9, the user P moves the needle protection member 16 axially toward the tip (direction of arrow B) relative to the needle unit 14. When the base end of the cover portion 72 reaches the tip of the inner needle 36, the needle protection member 16 is removed from the catheter 28 and the inner needle 36.

[0073] 11 , after the user P inserts the tip of the catheter 28, which is made up of the catheter 28 and the inner needle 36, into the body, the user P peels off the first sheet portion 461 from the first adhesive portion 241 and uses the first adhesive portion 241 to attach a part of the adhesive body 24 along the body surface P1 of the user P. As a result, the tip of the catheter 28 is fixed to the body surface P1 while remaining inserted into the user P.

[0074] Next, the needle holding portion 38 and the gripping member 34 are pulled out in the proximal direction (direction of arrow A) relative to the catheter 28, thereby removing the inner needle 36 held by the needle holding portion 38 from the needle hub 261. At this time, because the catheter 28 is fixed to the body surface P1, the inner needle 36 is removed from inside the catheter 28, and only the catheter 28 remains in the body.

[0075] After the placement of the catheter 28 is completed, a second priming is performed to fill the inside of the catheter 28 and the tube 30 with the priming solution again.

[0076] The second priming is performed using the priming solution remaining in the priming solution delivery tool used in the first priming. After the second priming is completed, the priming solution delivery tool is removed together with the second connecting member 68. The second priming is performed after the second sheet portion 462 is peeled off from the second adhesive portion 242 of the adhesive body 24 and the second adhesive portion 242 is attached along the body surface P1 of the user P.

[0077] After the user P disconnects the second connecting member 68 from the first connecting member 66, he or she pulls out the priming liquid delivery tool together with the second connecting member 68 in the proximal direction (direction of arrow A) to remove the priming liquid delivery tool.

[0078] Next, as shown in FIG. 5, the device main body 54 is attached to the connector 48 and the medicinal liquid S is administered.

[0079] The tip of the prefilled syringe 56 of the device body 54 is inserted into the inside of the base end of the first connecting member 66 of the connector 48. The hollow needle 64 is pierced through the axial center of the packing (not shown). The tip of the device body 54 is connected to the base end of the connector 48.

[0080] After the user P turns on the power switch 96 provided on the case 86 to start the device main body 54, the control unit 92 times the timing for the drug solution administration device 12 to start administering the drug solution. When the administration start time arrives, the movement mechanism 90 is driven by a control signal from the control unit 92, the first gasket 88 moves toward the distal end, and the drug solution S in the prefilled syringe 56 is pushed toward the delivery nozzle 94. The drug solution S flows into the inside of the first connecting member 66 through the hollow needle 64. The pressure of the drug solution S elastically deforms the valve body (not shown) toward the distal end, and the drug solution S flows from the tube 30 to the space 32 of the needle hub 261 and is then administered into the body of the user P through the lumen 181 of the catheter 28.

[0081] When the administration of the medicinal liquid S from the device main body 54 into the body is completed and the flow of the medicinal liquid S stops, the valve body returns to its original shape due to its elasticity. This completes the administration of the medicinal liquid S into the body of the user P.

[0082] The first embodiment has the following advantages.

[0083] As shown in FIG. 3 , the medical puncture needle 10 comprises a needle unit 14 having a catheter 28 (needle 18), and a needle protection member 16 that protects the catheter 28 by covering the outer periphery of the catheter 28 and can be removed from the needle unit 14 when the catheter 28 is to be used. The needle protection member 16 has an accommodation space 721 in which the catheter 28 is accommodated, and comprises a tubular cover portion 72 that extends axially and covers the outer periphery of the catheter 28. When the catheter 28 is accommodated in the cover portion 72, the cover portion 72 and the catheter 28 are provided in a non-contact state. This prevents the distal end of the catheter 28 from contacting the opening 722 of the cover portion 72 when the needle protection member 16 is attached to the needle unit 14 during the assembly process of the medical puncture needle 10. This prevents damage to the distal end of the catheter 28 due to contact with the proximal end of the cover portion 72. Furthermore, in the initial state of the drug solution administration device 12 in which the catheter 28 is accommodated in the accommodation space 721 of the needle protection member 16, the needle protection member 16 and the catheter 28 are not in contact with each other, so damage to the tip of the catheter 28 due to contact with the cover portion 72 can be suppressed.

[0084] Catheter 28 is a flexible catheter, and medical puncture needle 10 has an inner needle 36 inserted into catheter 28. This makes it possible to effectively protect the tip of flexible catheter 28 when assembling medical puncture needle 10. Needle protection member 16 is supported by holder 22, so that needle protection member 16 can be supported with a simple configuration.

[0085] The needle member 20 is an outer needle member 201, and the needle unit 14 comprises an inner needle member 40 having an inner needle 36 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, and the inner needle member 40 is detachably attached to the outer needle member 201. This makes it possible to effectively prevent damage to the tip of the catheter 28 that forms the outside of the double needle 42 during the assembly process of the medical puncture needle 10 that is equipped with the needle unit 14 having the double needle 42.

[0086] 4, the needle protection member 16 has a patch housing portion 74 that houses at least a portion of the patch 24. This allows the needle protection member 16 to protect the catheter 28, and by housing the patch 24 in the patch housing portion 74, deformation and damage to the patch 24 before use can be effectively suppressed.

[0087] The needle protection member 16 holds the tip of the catheter 28 and the patch 24 apart from each other. This prevents the tip of the catheter 28 from coming into contact with the patch 24, so the tip of the catheter 28 can be kept clean.

[0088] The patch accommodating portion 74 is a slit portion 78 that is provided in the cover portion 72 of the needle protection member 16 and intersects with the inner wall of the cover portion 72. This allows the needle protection member 16 to simultaneously accommodate the catheter 28 in the accommodation space 721 of the cover portion 72 and the patch 24 in the patch accommodating portion 74 via the slit portion 78.

[0089] The cover part 72 has a connection part 76 that connects the first part 801 and the second part 802 on the outer surface of the cover part 72. This allows the slit part 78 to ensure a large accommodation range for the patch 24, and ensures a suitable size for the patch 24.

[0090] The slit portion 78 extends from the opening 722 to the connecting portion 76. In this way, by expanding the range of the slit portion 78, a larger accommodation range for the patch 24 can be secured, and a larger patch 24 can be accommodated.

[0091] By engaging the engaging portion 84 of the needle protection member 16 with the hole portion 224 of the hub holding portion 222 of the holder 22, the needle protection member 16 can be effectively prevented from coming off toward the tip when the needle protection member 16 is attached to the needle unit 14.

[0092] The medical puncture needle 10A according to the modified example shown in Fig. 12 has a needle protection member 16A supported by a holder 22. As shown in Fig. 13, the cover portion 72A of the needle protection member 16A has a first portion 801, a second portion 802, and a patch housing portion 74. When the needle protection member 16A is attached to the needle unit 14, the base end of the second portion 802 covers a portion of the hub holding portion 222 and the port holding portion 223 of the holder 22. The base end of the second portion 802 has an engaging portion 84A that protrudes radially inward from the inner circumferential surface of the base end. When the needle protection member 16A is attached to the needle unit 14, the engaging portion 84A engages with the base end 222A of the hub holding portion 222. The base end 222A of the hub holding portion 222 is an end that is perpendicular to the axial direction of the needle hub 261. When the engaging portion 84A engages with the proximal end 222A of the hub holding portion 222, the needle protection member 16A is prevented from moving in the distal direction relative to the holder 22.

[0093] When the needle protection member 16A is to be removed from the needle unit 14, the engagement portion 84A of the needle protection member 16A is released from the proximal end 222A of the hub holding portion 222 to release the engagement, and then the needle protection member 16A is moved axially toward the distal end relative to the needle unit 14. When the proximal end of the cover portion 72A reaches the distal end of the inner needle 36, the needle protection member 16A is pulled out from the catheter 28 and the inner needle 36.

[0094] The modified example has the following effects.

[0095] 13 , needle protection member 16A is supported by holder 22, allowing for a simple configuration to support needle protection member 16A. By engaging engagement portion 84A of needle protection member 16A with base end 222A of hub holding portion 222 of holder 22, needle protection member 16A can be effectively prevented from coming off in the distal direction while attached to needle unit 14.

[0096] A medical puncture needle 10B according to the second embodiment shown in Fig. 14 has a needle protection member 16B supported by the needle holding part 38. As shown in Fig. 15, a cover part 72B of the needle protection member 16B has a first part 801, a second part 802, and a patch housing part 74. When the needle protection member 16B is attached to the needle unit 14, the base end of the second part 802 covers the tip end of the needle holding part 38. The base end of the second part 802 has an engaging part 84B on its inner surface facing the needle holding part 38. As shown in Fig. 16, the engaging part 84B has a set of recesses 100 provided in the width direction perpendicular to the axial direction of the needle holding part 38. The set of recesses 100 are recessed outward in the width direction on the inner surface of the cover part 72B.

[0097] Needle holding portion 38 has protrusion 102 that protrudes upward from pressing portion 381. Protrusion 102 is housed inside cover portion 72B. When needle protection member 16B is attached to needle unit 14, a portion of protrusion 102 engages with recess 100. By engaging engagement portion 84B with recess 100 of cover portion 72B, movement of needle protection member 16B toward the distal end relative to holder 22 is restricted in the initial state, i.e., before use of medical solution administration device 12.

[0098] When the needle protection member 16B is to be removed from the needle unit 14, the needle protection member 16B is pulled toward the distal end relative to the needle unit 14, causing the recess 100 to disengage from the protrusion 102 and disengage the engaging portion 84B. When the base end of the cover portion 72B reaches the distal end of the inner needle 36, the needle protection member 16B is removed from the catheter 28 and the inner needle 36.

[0099] The second embodiment has the following advantages.

[0100] 16 , the needle protection member 16B is supported by the protrusion 102 of the needle holding portion 38, and therefore, a simple configuration can be used to support the needle protection member 16B while the catheter 28 is housed. By engaging the engagement portion 84B (recess 100) of the needle protection member 16B with the protrusion 102 provided at the base end of the needle holding portion 38, removal of the needle protection member 16B toward the distal end can be effectively prevented when the needle protection member 16B is attached to the needle unit 14 in the initial state before use of the drug solution administration device 12.

[0101] 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 medical puncture needle comprising: a needle unit having a needle with a lumen; and a needle protection member that covers the outer periphery of the needle to protect the needle and can be removed from the needle unit when the needle is used. The needle unit includes: a needle member having the needle; a holder that holds the proximal end portion of the needle member; and an attachment body having a first surface that is attached to the body surface of a living body to be punctured by the needle and a second surface that is opposite to the first surface, and at least a part of the second surface is connected to the holder. The needle protection member includes: a cylindrical cover portion that has an accommodation space in which the needle is accommodated and extends in the axial direction to cover the outer periphery of the needle; and an opening portion provided at the proximal end of the cover portion and connected to the accommodation space. When viewed from the axial direction of the needle, the opening portion is larger than the needle, and in a state where the needle is accommodated in the cover portion, the cover portion and the needle are not in contact with each other.

2. The medical puncture needle according to claim 1, wherein the needle is a flexible catheter, and the medical puncture needle has an inner needle inserted through the catheter.

3. The medical puncture needle according to claim 1, wherein the needle protection member is supported by the holder.

4. The medical puncture needle according to claim 1, wherein the needle member is an outer needle member, and the needle unit includes an inner needle member having an inner needle inserted into the lumen of the needle and a needle holding portion that holds the proximal end portion of the inner needle, and the inner needle member is detachably attached to the outer needle member.

5. The medical puncture needle according to claim 4, wherein the needle protection member is supported by the holder or the needle holding portion.

6. The medical puncture needle according to any one of claims 1 to 5, wherein the needle protection member has an attachment body accommodation portion that accommodates at least a part of the attachment body.

7. The medical puncture needle according to claim 6, wherein the needle protection member holds the tip of the needle and the attachment body in a state of being separated from each other.

8. The medical puncture needle according to claim 6, wherein the attachment body accommodation portion is a slit portion provided in the cover portion of the needle protection member and intersects the inner wall of the cover portion.

9. In the medical puncture needle according to claim 8, the cover portion has a first portion including the tip portion of the cover portion and a second portion including at least a part of the base end portion of the cover portion and separated from the first portion by the slit portion, and the needle protection member has a connecting portion connecting the first portion and the second portion on the outer surface of the cover portion. Medical puncture needle.

10. In the medical puncture needle according to claim 9, the slit portion extends from the opening portion to the connecting portion. Medical puncture needle.

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