Medical puncture needles and needle protection components

Abstract

To suppress removal of a lubricant applied around an outer periphery of a needle, when removing a needle protection member from the needle.SOLUTION: A medical puncture needle 12 includes a needle protection member 10 covering the outer periphery of an outer needle 30, and removable from the outer needle. The needle protection member has a cylindrical body 38 having a housing hole 42 for storing the outer needle of the needle 12a. and multiple swollen parts 40a-40c arranged on the inner peripheral surface 42a of the housing hole. The multiple swollen parts project toward the outer peripheral surface 30a of the outer needle and brought into contact with the outer peripheral surface.SELECTED DRAWING: Figure 7

Description

Technical Field

[0001] The present invention relates to a medical puncture needle and a needle protection member provided with a needle protection member that protects the needle by covering the needle.

Background Art

[0002] Patent Document 1 discloses a chemical solution administration device including a needle and a needle protection member that protects the needle. The needle is a multi-needle composed of a catheter and an inner needle that can be inserted through the skin of a living body. When the living body is not punctured by the needle, a tubular needle protection member is attached to the outer periphery of the needle. The needle protection member is long along the axial direction. By inserting the needle protection member along the outer periphery of the needle, the outer peripheral surface of the needle and the inner peripheral surface of the needle protection member come into contact with each other, and the needle protection member is held. When puncturing the living body with the needle, the user removes the needle protection member along the axial direction of the needle, thereby exposing the needle.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] The needle protection member is often formed of a resin material, and due to manufacturing variations of the needle protection member and the needle, temperature changes, etc., the diameter difference (diameter difference) between the outer diameter of the needle and the inner diameter of the needle protection member may change. At this time, since the contact length along the axial direction between the needle and the needle protection member is long, there is a concern that the needle protection member cannot be attached to or detached from the needle due to manufacturing variations or the like. In addition, it may be impossible to attach the needle protection member to the needle, making it impossible to assemble the medical puncture needle. Furthermore, when a lubricant is applied to the outer peripheral surface of the needle to enhance the puncturability against the living body, when the needle protection member is removed from the needle, the lubricant may be taken out and removed together with the needle protection member.

[0005] The present invention aims to solve the problems described above. [Means for solving the problem]

[0006] (1) A first aspect of the present invention is a medical puncture needle comprising a needle and a needle protection member that covers the outer circumference of the needle to protect the needle and can be removed from the needle when the needle is to be used, wherein the needle protection member comprises a cylindrical body having a housing hole in which the needle is housed, having an annular cross-section and extending along the axial direction with a gap between the outer surface of the needle and the inner surface of the housing hole, and a bulge disposed on the inner surface of the housing hole and projecting toward the outer surface of the needle and contacting the outer surface.

[0007] With this medical puncture needle, the needle protection member covering the needle can hold the needle by a bulge protruding from the inner circumference of the cylindrical body, thereby reducing the contact area between the cylindrical body of the needle protection member and the needle. Compared to a structure in which the outer circumference of the needle and the inner circumference of the needle protection member are in contact around the entire circumference, the effects of manufacturing variations in the needle and needle protection member are suppressed, and the attachment and detachment of the needle protection member to the needle can be made easier. By reducing the contact area between the needle protection member and the outer circumference of the needle with the bulge, the removal of lubricant applied to the outer circumference of the needle is suppressed when the needle protection member is removed from the needle.

[0008] (2) In the medical puncture needle described in (1) above, the bulge may extend along the longitudinal direction of the cylindrical body.

[0009] With this configuration, when the needle is housed in the suction hole of the cylindrical body, the bulging portion can stably and easily hold the outer surface of the needle along its longitudinal direction.

[0010] (3) In the medical puncture needle described in (1) or (2) above, three or more bulging portions may be arranged at equal intervals in the circumferential direction of the housing hole.

[0011] This configuration enhances stability when attaching and detaching the needle protection member to the needle by holding the outer surface of the needle with three or more bulges, allowing for easy and reliable attachment and detachment of the needle protection member to the needle.

[0012] (4) In a medical puncture needle described in any one of (1) to (3) above, in a cross section perpendicular to the longitudinal direction of the cylindrical body, the bulging portion has a top that faces the outer surface of the needle and is convex toward the outer surface, and has a curved surface, and the top may be deformed by contacting the outer surface of the needle.

[0013] This configuration allows the top of the bulge to deform when it contacts the outer surface of the needle, thereby enabling surface contact between the bulge and the outer surface of the needle. This increases the fixing force of the needle to the cylinder via the bulge. When attaching the needle protection member to the needle, the lubricant applied to the outer surface of the needle is prevented from being removed by the cylinder.

[0014] (5) In the medical puncture needle described in (4) above, the difference in diameter between the outer diameter of the outer surface of the needle and the inner diameter of the apex of the bulge that is most radially inward may be 0.20 mm or less.

[0015] This configuration optimizes the contact relationship between the top of the bulge and the outer surface of the needle, making it even easier to attach and detach the needle protection member to the needle.

[0016] (6) In a medical puncture needle described in any one of (1) to (5) above, the needle may have an outer needle and an inner needle inserted inside the outer needle.

[0017] (7) In the medical puncture needle described in (3) above, the inner circumferential surface of the housing hole has an arc-shaped inner circumferential portion arranged between adjacent bulging portions, and when viewed from the axial direction of the cylindrical body, the width of the bulging portion in the circumferential direction of the cylindrical body may be smaller than the width of the inner circumferential portion.

[0018] This configuration allows for an effective balance between the ease of attaching and detaching the needle protection component to the needle.

[0019] (8) A second aspect of the present invention is a needle protection member that protects the needle by covering the outer circumference of the needle and can be removed from the needle when the needle is used, comprising: a cylindrical body having a housing hole in which the needle is housed, having an annular cross-section and extending along the axial direction, with a gap between the outer surface of the needle and the inner surface of the housing hole; and a bulge disposed on the inner surface of the housing hole, projecting toward the outer surface of the needle and contacting the outer surface, It is a needle protection member having [a certain characteristic].

[0020] (9) In the needle protection member described in (8) above, the bulging portion may extend along the longitudinal direction of the cylindrical body.

[0021] (10) In the needle protection member described in (8) or (9) above, three or more bulging portions may be arranged at equal intervals in the circumferential direction of the receiving hole.

[0022] (11) In the needle protection member described in (10) above, the inner circumferential surface of the housing hole has an arc-shaped inner circumferential portion arranged between adjacent bulging portions, and when viewed from the axial direction of the cylindrical body, the width of the bulging portion in the circumferential direction of the cylindrical body may be smaller than the width of the inner circumferential portion. [Effects of the Invention]

[0023] According to the present invention, in a needle protection member that covers a needle, the needle can be held by a bulge that protrudes from the inner circumferential surface of the cylindrical body, thereby reducing the contact area between the cylindrical body of the needle protection member and the needle. Compared to a structure in which the outer circumferential surface of the needle and the inner circumferential surface of the needle protection member are in contact around the entire circumference, the effects of manufacturing variations in the needle and the needle protection member are suppressed, and the attachment and detachment of the needle protection member to the needle can be made easier. By reducing the contact area between the needle protection member and the outer circumferential surface of the needle with the bulge, the removal of lubricant applied to the outer circumferential surface of the needle is suppressed when the needle protection member is removed from the needle. [Brief explanation of the drawing]

[0024] [Figure 1] Figure 1 is an overall plan view of a chemical solution administration device provided with a medical puncture needle according to an embodiment of the present invention. [Figure 2] Figure 2 is an overall cross-sectional view of the chemical solution administration device shown in Figure 1. [Figure 3] Figure 3 is an overall cross-sectional view showing a state in which a priming liquid feeder is attached to a connector of the chemical solution administration device shown in Figure 2. [Figure 4] Figure 13 is an overall plan view showing a state in which the device main body is attached to the connector of the chemical solution administration device of Figure 1. [Figure 5] Figure 5 is an enlarged cross-sectional view showing the vicinity of the medical puncture needle in the chemical solution administration device of Figure 2. [Figure 6] Figure 6 is a cross-sectional view taken along line VI-VI of Figure 1. [Figure 7] Figure 7 is a cross-sectional view taken along line VII-VII of Figure 5. [Figure 8] Figure 8 is an enlarged cross-sectional view showing a state in which the needle protection member is removed from the needle of the chemical solution administration device shown in Figure 5. [Figure 9] Figure 9 is an external perspective view of the needle protection member shown in Figure 8. [Figure 10] Figure 10 is a cross-sectional view taken along line X-X of Figure 8. [Figure 11] Figure 11 is a table showing experimental data obtained based on the relationship between the inner diameter of the needle protection member, the outer diameter of the outer needle, and the diameter difference.

Embodiments for Carrying Out the Invention

[0025] As shown in Figure 1, the medical puncture needle 12 provided with the needle protection member 10 according to the present embodiment is used in the chemical solution administration device 14.

[0026] The drug administration device 14 is placed on the body surface 16a of the user (living body) 16, such as the abdomen, and is configured to automatically administer drug solution S1 (see Figure 4) into the body. For example, the drug administration device 14 is used when administering drug solution S1 to the user 16 at a predetermined time after a medical procedure has been performed on the user 16, or when administering drug solution S1 gradually over time. The drug solution S1 administered by the drug administration device 14 is not particularly limited. Examples of drug solution S1 include liquid pharmaceuticals such as antibody drugs, anticancer drugs, chemotherapy agents, anesthetics, antibiotics, insulin, blood products, and nutritional supplements.

[0027] As shown in Figure 2, the drug administration device 14 comprises a medical puncture needle 12, a needle hub 18 that holds the medical puncture needle 12, a tube 20 held by the needle hub 18 through which the drug solution S1 (see Figure 4) can flow, a holder 22 that holds the needle hub 18, and a connector 24 provided at the base end of the tube 20.

[0028] The connector 24 can be selectively connected to a priming fluid dispenser 26 (see Figure 3) that can dispense priming fluid S2 (physiological saline solution) filled inside from its tip, and a device body 28 (see Figure 4) that can dispense drug solution S1 filled inside.

[0029] As shown in Figure 5, the medical puncture needle 12 comprises a needle 12a and a needle protection member 10 that can be attached to the outer circumference of the needle 12a. The needle 12a comprises an outer needle 30 that is placed inside the body (subcutaneously) of the user 16 (see Figure 6) and an inner needle 32 that penetrates the inside of the outer needle 30. The needle 12a is a multi-needle in which the outer needle 30 and the inner needle 32 overlap radially. The needle 12a constitutes the introduction point for the drug solution S1 by inserting and placing the outer needle 30 into the body from the body surface 16a of the user 16 (see Figure 6).

[0030] The outer needle 30 is a tubular body having a lumen (not shown) through which the drug solution S1 can flow. The lumen of the outer needle 30 communicates with the tip opening of the outer needle 30 and also communicates with the space 34 inside the needle hub 18 at the base end side of the outer needle 30 (direction of arrow A). The tip of the outer needle 30 protrudes diagonally downward from the lower surface of the needle hub 18 (the surface opposite the body surface 16a) toward the tip (direction of arrow B) (see Figure 6). The base end of the outer needle 30 is fixed to the needle hub 18 by crimping a crimping pin (not shown).

[0031] As shown in Figure 7, the outer circumferential surface 30a of the outer needle 30 is formed with an outer diameter D. The outer needle 30 is formed with the same outer diameter D along the axial direction. The outer diameter D of the outer needle 30 is not particularly limited, but the outer diameter D may be, for example, within the range of 2.25 mm or less, 0.5 to 1.2 mm, or 0.65 to 0.95 mm.

[0032] A lubricant 36, such as silicone, is applied to the outer surface 30a of the outer needle 30. The lubricant 36 is applied almost uniformly along the outer surface 30a of the outer needle 30. The lubricant 36 facilitates the smooth insertion of the outer needle 30 into the user 16.

[0033] As shown in Figure 5, a portion of the inner needle 32 penetrates into the interior of the outer needle 30. The tip end of the inner needle 32 is inserted into the lumen of the outer needle 30. The base end of the inner needle 32 is inserted into the interior of the needle hub 18 and held at the tip of the needle hub 54, which will be described later. By inserting the inner needle 32 into the interior of the outer needle 30, a needle 12a is formed in which the outer needle 30 and the inner needle 32 overlap radially.

[0034] After inserting the needle 12a, which consists of an outer needle 30 and an inner needle 32, into the body, the user 16 withdraws the inner needle 32 from the outer needle 30 while the needle is still inserted (detaching the needle hub 54 from the needle 12a towards the proximal end (direction of arrow A)), thereby leaving the outer needle 30 in the user 16's body.

[0035] A needle protection member 10 is detachably positioned around the outer circumference of the needle 12a. In the initial state before use, when puncture is performed with the needle 12a as shown in Figure 5, the needle protection member 10 is attached to the needle 12a. The outer circumference and tip of the needle 12a (outer needle 30) are covered by the needle protection member 10, preventing accidental puncture by the needle 12a before use. When puncture is performed with the needle 12a in the initial state, the needle protection member 10 is removed from the needle 12a (see Figure 8).

[0036] As shown in Figure 9, the needle protection member 10 is a tubular body formed by extruding a resin material along the axial direction (arrows A and B). The tubular molded body is cut to the desired length to become the needle protection member 10.

[0037] As shown in Figure 10, the needle protection member 10 is fitted so as to cover the outer circumference of the outer needle 30. The needle protection member 10 has a cylindrical body 38 and a plurality of bulges 40 arranged inside the cylindrical body 38.

[0038] The cylindrical body 38 has an outer surface with a circular cross-section. The outer diameter of the outer surface of the cylindrical body 38 is constant along the axial direction of the cylindrical body 38. The inside of the cylindrical body 38 has a stimulating hole 42 capable of accommodating the needle 12a (see Figure 7). The stimulating hole 42 extends along the axial direction of the cylindrical body 38 and penetrates from the tip to the base of the cylindrical body 38. The inner surface 42a of the stimulating hole 42 is formed with a first inner diameter d1. The first inner diameter d1 of the stimulating hole 42 (inner surface 42a) is greater than the outer diameter D of the outer needle 30 (d1>D).

[0039] As shown in Figure 7, when the needle 12a is housed in the housing hole 42 of the cylindrical body 38, the inner circumferential surface 42a of the housing hole 42 and the outer circumferential surface 30a of the outer needle 30 face each other. There is a gap 44 of a predetermined radial distance between the inner circumferential surface 42a of the housing hole 42 and the outer circumferential surface 30a of the outer needle 30. In other words, the inner circumferential surface 42a of the housing hole 42 and the outer circumferential surface 30a of the outer needle 30 are not in contact.

[0040] As shown in FIG. 10, the plurality of bulges 40 are arranged on the inner peripheral surface 42a of the accommodation hole 42. Hereinafter, the case of including three bulges 40a to 40c will be described. The number of the bulges 40a to 40c may be two or more, and three or more is optimal. Each of the bulges 40a to 40c protrudes radially inward from the inner peripheral surface 42a of the accommodation hole 42. Each of the bulges 40a to 40c extends along the axial direction of the cylindrical body 38. In a cross section orthogonal to the axial direction of the cylindrical body 38 shown in FIG. 10, the plurality of bulges 40a to 40c are arranged at equal intervals in the circumferential direction of the accommodation hole 42 (cylindrical body 38).

[0041] In a cross section orthogonal to the axial direction of the cylindrical body 38 shown in FIG. 10, the bulges 40a to 40c have a top portion 46 arranged radially inward. The top portion 46 is composed of a curved surface convexly curved radially inward. When a circle inscribed in each top portion 46 of the plurality of bulges 40a to 40c is defined as a virtual circle C and the diameter of the virtual circle C is defined as the second inner diameter d2 of the bulges 40a to 40c, the second inner diameter d2 is smaller than the outer diameter D of the outer needle 30 (d2 < D). The second inner diameter d2 is the diameter most radially inward in the bulges 40a to 40c. In other words, the outer diameter D of the outer needle 30 is larger than the second inner diameter d2 of the bulges 40a to 40c.

[0042] As shown in FIG. 7, when the needle 12a is accommodated in the accommodation hole 42 of the cylindrical body 38, the plurality of bulges 40a to 40c protrude toward the outer peripheral surface 30a of the outer needle 30, and the top portions 46 of the bulges 40a to 40c abut against the outer peripheral surface 30a of the outer needle 30. At this time, since the second inner diameter d2 of the bulges 40a to 40c is smaller than the outer diameter D of the outer needle 30, the top portions 46 of each of the bulges 40a to 40c are pressed by the outer peripheral surface 30a of the outer needle 30 and elastically deformed radially outward. The top portions 46 of each of the bulges 40a to 40c are recessed radially outward. The outer peripheral surface 30a of the outer needle 30 is held in the accommodation hole 42 of the needle protection member 10 at three locations equally spaced in the circumferential direction by the three bulges 40a to 40c.

[0043] The diameter difference H (also called diameter difference) between the outer diameter D of the outer needle 30 and the second inner diameter d2 of the bulging portion 40a to 40c is not particularly limited, but it is optimal if it is 0.20 mm or less (H ≤ 0.20 mm).

[0044] Here, referring to the experimental results by the inventors shown in Figure 11, the relationship between the diameter difference H between the outer diameter D of the outer needle 30 and the second inner diameter d2 of the bulging portions 40a to 40c, and the release force F when removing the needle protection member 10 from the needle 12a will be explained. Note that experimental results 1 to 6 in Figure 11 are for a needle protection member 10 having bulging portions 40a to 40c in the housing hole 42, while experimental result 7 is for a conventional needle protection member that does not have a bulging portion 40 in the housing hole 42.

[0045] As shown in experimental results 1-6 in Figure 11, when the diameter difference H between the second inner diameter d2 of the bulging portions 40a-40c of the needle protection member 10 and the outer diameter D of the outer needle 30 of the needle 12a is set to 0.23 mm or less, it was confirmed that the release force F when removing the needle protection member 10 from the needle 12a is below a predetermined value that allows for removal. It was confirmed that the diameter difference H decreases in the order of experimental results 1-6, and that the release force F decreases as the diameter difference H decreases. Compared to experimental result 1, where the diameter difference H is 0.23 mm, the release force F is even smaller in experimental results 2-6, where the diameter difference H is 0.20 mm or less. Therefore, when the diameter difference H is 0.20 mm or less, it becomes even easier to remove the needle protection member 10 from the outer needle 30 of the needle 12a. Similarly, the insertion force when attaching the needle protection member 10 to the needle 12a is also below a predetermined value, making it possible to attach (assemble) the needle protection member 10. In other words, by making the diameter difference H 0.20 mm or less, it is understood that the attachment and detachment of the needle protection member 10 to the needle 12a is good.

[0046] In contrast, Experimental Result 7 shows that, because it does not have a bulge 40, the inner circumferential surface 42a of the needle protection member 10 (housing hole 42) and the outer circumferential surface 30a of the needle 12a (outer needle 30) are in contact over the entire circumferential direction. Therefore, as can be understood from Experimental Result 7, even if the diameter difference H between the second inner diameter d2 of the bulge 40 in the needle protection member 10 and the outer diameter D of the outer needle 30 of the needle 12a is 0.20 mm or less, the contact resistance between the outer needle 30 and the needle protection member 10, which are in contact over the entire circumferential direction, becomes large, resulting in an excessive release force F when removing the needle protection member 10 from the needle 12a, making removal impossible. In this case, the insertion force when attaching the needle protection member 10 to the needle 12a is also excessive, similar to the release force F, making attachment (assembly) impossible.

[0047] In the experiment shown in Figure 11 above, the outer needle 30 was housed inside the needle protection member 10, and a tensile test was performed on one axial end of the outer needle 30 and the other axial end of the needle protection member 10, which was positioned in the opposite direction to the axial end of the outer needle 30, in a direction away from each other using a tensile strength testing machine (not shown). The tensile speed in this case was 100 mm / min, and the tension was measured until the needle protection member 10 moved relative to the outer needle 30 in the axial direction. The maximum value of the measured tension was defined as the release force F when the needle protection member 10 was removed from the needle 12a.

[0048] The lower limit of the diameter difference H is not particularly limited. Preferably, the diameter difference H is 0.02 mm or more (for example, 0.04 mm or more, 0.06 mm or more, or 0.09 mm or more). The upper limit of the diameter difference H is not particularly limited. From the viewpoint of reducing the release force F when removing the needle protection member 10 from the needle 12a, the upper limit of the diameter difference H is preferably 0.3 mm or less (for example, 0.25 mm or less, or 0.23 mm or less). From the viewpoint of further reducing the release force F, it is optimal for the upper limit of the diameter difference H to be 0.20 mm or less (for example, 0.18 mm or less, 0.14 mm or less, or 0.12 mm or less).

[0049] As shown in Figure 10, the housing hole 42 of the cylindrical body 38 has multiple inner circumferential portions 42b. Each inner circumferential portion 42b is positioned between three bulging portions 40a to 40c. That is, the number of inner circumferential portions 42b is the same as the number of bulging portions 40a to 40c. An inner circumferential portion 42b is positioned between two adjacent bulging portions 40a to 40c. The inner circumferential portion 42b is formed in an arc shape and is part of the inner circumferential surface 42a of the housing hole 42. When viewed from the axial direction of the cylindrical body 38 as shown in Figure 10, the width W1 of each bulging portion 40a to 40c in the circumferential direction of the cylindrical body 38 is smaller than the width W2 of each inner circumferential portion 42b (W1 <W2)。

[0050] The second inner diameter d2 of the bulging portions 40a to 40c of the needle protection member 10 is not particularly limited. From the viewpoint of reducing the detachment force F when removing the needle protection member 10 from the needle 12a, it is preferable to appropriately set the second inner diameter d2 so that the diameter difference H is within the above range based on the outer diameter D of the outer needle 30.

[0051] As shown in Figure 5, the needle hub 18 comprises a hub body 48 that supports the base end of the outer needle 30, and a side port 50 that protrudes from the side of the hub body 48 and to which the tip of the tube 20 is connected. The hub body 48 extends linearly from the tip to the base end, and has a space 34 inside the hub body 48. The space 34 communicates with the lumen of the outer needle 30 and the tube 20 connected to the side port 50. A needle hub 54 to which a gripping member 52 is bonded is detachably attached to the base end of the hub body 48.

[0052] The tube 20 is formed from a flexible tube through which the drug solution S1 can flow, and the tip of the tube 20 is fixed to the connection port 56 of the needle hub 18. This allows the tube 20 to communicate with the space 34 of the needle hub 18 through the connection port 56.

[0053] The holder 22 has a base portion 58 formed in a flat plate shape to which the adhesive body 57 (see Figure 2) is fixed, and a hub holding portion 60 and a port holding portion 62 provided on the upper part of the base portion 58 to hold the needle hub 18. As shown in Figure 1, the adhesive body 57 has a first adhesive portion 57a ​​through which the outer needle 30 is inserted, and a second adhesive portion 57b located at the base end of the first adhesive portion 57a ​​to which the holder 22 is fixed. The adhesive body 57 is covered with a release sheet 59. The release sheet 59 has a first sheet portion 59a that covers the first adhesive portion 57a, and a second sheet portion 59b that covers the second adhesive portion 57b.

[0054] The base portion 58 is formed in a substantially circular shape when viewed from above. A hub holding portion 60 and a port holding portion 62 are provided on the surface of the base portion 58. An adhesive body 57 is fixed to the back surface of the base portion 58.

[0055] The hub holder portion 60 holds the hub body 48 of the needle hub 18. The hub holder portion 60 is formed in a cylindrical shape and is positioned in the center of the base portion 58. The hub holder portion 60 extends along the extending direction of the outer needle 30. The tip of the hub holder portion 60 is positioned at an angle toward the base portion 58 (see Figure 6).

[0056] As shown in Figure 1, the connector 24 has a first connection part 66 that can be connected to a pre-filled syringe 64 (see Figure 4) of the device body 28, a second connection part 68 that can be connected to a priming fluid dispenser 26 (see Figure 3) that can dispense priming fluid S2, a tube holder 70 that holds the base end of the tube 20 and is attached to the first connection part 66, and a hollow needle 72 that is held by the first connection part 66 and protrudes toward the base end.

[0057] As shown in Figure 2, the first connection portion 66 has a first connecting member 74 connected to the base end of the tube 20 via a tube holder 70. The first connecting member 74 includes a valve body 76. When pressure is applied to the valve body 76, the communication passage (not shown) of the first connecting member 74 and the tube 20 are connected through the valve body 76. When no pressure is applied to the valve body 76, the communication between the inside of the first connecting member 74 and the tube 20 is blocked by the valve body 76.

[0058] As shown in Figure 3, the second connecting portion 68 has a second connecting member 78 that is detachably attached to the base end of the first connecting member 74. The tip of the priming fluid dispenser 26 can be connected to the second connecting member 78. The tip nozzle portion 94a of the barrel 94 of the priming fluid dispenser 26 is inserted into the fitting hole 80 of the second connecting member 78, and the tip of the barrel 94 is connected to the base end of the second connecting member 78. At this time, the tip nozzle portion 94a of the barrel 94 and the fitting hole 80 are tapered-fitted.

[0059] The tip of the second connecting member 78 is provided with a cap 82. The cap 82 is made of an elastic material such as rubber. A needle insertion hole (not shown) through which the hollow needle 72 is inserted passes through the axial center of the cap 82.

[0060] The tube holder 70 is a bottomed cylindrical shape with an open tip. The tube holder 70 is fitted and fixed by inserting it into a holder hole (not shown) of the first connecting member 74. The base end of the tube 20 is inserted into and fixed inside the tube holder 70.

[0061] As shown in Figure 3, the hollow needle 72 is a needle body made of metal and having a needle hole (not shown) inside, and connects the device body 28 or the second connecting member 78 to the communication passage (not shown) between the first connecting member 74. The hollow needle 72 is held at the axial center of the first connecting member 74.

[0062] As shown in Figure 2, when the second connecting member 78 is connected to the first connecting member 74, the base end of the hollow needle 72 is inserted into the interior of the second connecting member 78 through the needle insertion hole of the cap 82. As a result, the base end of the hollow needle 72 protrudes toward the base end of the cap 82, and the communication passage (not shown) of the first connecting member 74 and the interior of the second connecting member 78 are connected and communicated by the hollow needle 72.

[0063] As shown in Figure 4, the main body of the device 28 has the function of storing the chemical solution S1 and dispensing the chemical solution S1 from the tip at an appropriate timing, and includes a case 90 in which a storage space (not shown) for housing each component is formed.

[0064] The case 90 contains a pre-filled syringe 64 for storing the drug solution S1, a moving mechanism 86 for moving the first gasket 84 inside the pre-filled syringe 64, a control unit 88 for controlling the drive of the moving mechanism 86, and a power supply unit (not shown) capable of supplying power to each component.

[0065] The pre-filled syringe 64 is formed in a cylindrical shape along the axial direction (arrows A and B), and is filled with the drug solution S1 inside. The tip of the pre-filled syringe 64 protrudes a predetermined length from the tip of the case 90 in the axial direction (arrow B) and is exposed to the outside.

[0066] The tip of the pre-filled syringe 64 is equipped with a dispensing nozzle 92. A packing (not shown) placed on the dispensing nozzle 92 holds the drug solution S1 sealed inside the pre-filled syringe 64.

[0067] As shown in Figure 3, the priming fluid dispenser 26 includes a cylindrical barrel 94, a second gasket 96 movably provided inside the barrel 94, and a rod 98 connected to the second gasket 96. The base end of the rod 98 protrudes from the base end of the barrel 94 toward the base end. Inside the barrel 94, priming fluid S2 is filled between the tip nozzle portion 94a and the second gasket 96. The tip nozzle portion 94a of the barrel 94 and the fitting hole 80 of the connector 24 are tapered-fitted.

[0068] The second gasket 96 is connected to the tip of the rod 98, and when the user 16 pushes the rod 98 toward the tip (direction of arrow B), the second gasket 96 moves toward the tip (direction of arrow B) along the barrel 94. As a result, the priming fluid S2 inside the barrel 94 is pushed toward the tip by the second gasket 96 and discharged from the opening at the tip of the barrel 94 (tip nozzle portion 94a).

[0069] Next, we will describe the case in which drug solution S1 is administered to user 16 using drug solution administration device 14. When using drug solution administration device 14, a needle 12a is placed on the surface 16a of user 16, a priming fluid delivery device 26 is connected to fill the inside of the outer needle 30 with priming fluid S2, and then the device body 28 is connected to automatically administer drug solution S1 to user 16.

[0070] First, the initial priming is performed by filling the inside of needle 12a and tube 20 with priming solution S2.

[0071] A priming fluid dispenser 26 is connected to the base end of the second connecting member 78, which is connected to the connector 24 of the drug administration device 14 shown in Figure 2 (see Figure 3). The tip nozzle portion 94a of the barrel 94 of the priming fluid dispenser 26 is inserted into the base end of the connector 24. The tip nozzle portion 94a of the barrel 94 is fitted into the base end of the second connecting member 78 and held in a liquid-tight manner. This creates communication between the inside of the barrel 94 and the inside of the second connecting member 78. The priming fluid S2 in the barrel 94 flows from the tip nozzle portion 94a of the barrel 94 into the inside of the second connecting member 78.

[0072] In Figure 3, when the user 16 pushes the rod 98 of the priming fluid dispenser 26 toward the tip (direction of arrow B), the second gasket 96 moves toward the tip along the barrel 94, and consequently, the priming fluid S2 in the barrel 94 is dispensed from the tip nozzle portion 94a of the barrel 94 into the interior of the second connecting member 78.

[0073] The priming fluid S2 in the second connecting member 78 is introduced into the communication passage through the hollow needle 72, and the valve body 76 is pressed toward the tip (direction of arrow B) by the priming fluid S2, causing the priming fluid S2 to flow from the communication passage into the tube 20.

[0074] The priming fluid S2 flows from the tube 20 through the side port 50 into the space 34 of the needle hub 18. As a result, the inside of the tube 20, the space 34, and the needle 12a are filled with the priming fluid S2, and the first priming is completed.

[0075] When the supply of priming fluid S2 by the priming fluid delivery device 26 is stopped, the pressure applied to the valve body 76 is eliminated, and consequently, the valve body 76 returns to its original shape elastically, blocking communication between the first connecting member 74 and the tube 20.

[0076] Next, the outer needle 30 is placed inside the user 16's body. After the user 16 grasps the needle 12a and positions it at the desired location on the body surface 16a, the needle protective member 10 is removed from the outer needle 30 of the needle 12a toward the tip.

[0077] The needle protection member 10 is moved axially toward the tip of the outer needle 30, and as shown in Figure 8, when the base end of the needle protection member 10 reaches the tip of the outer needle 30, the needle protection member 10 is removed from the outer needle 30. At this time, the needle protection member 10 moves along the outer needle 30 while the tops 46 of the three bulges 40a to 40c slide against the outer circumferential surface 30a of the outer needle 30. Since only the three bulges 40a to 40c are in contact with the outer circumferential surface 30a of the outer needle 30, the lubricant 36 on the outer circumferential surface 30a facing the inner circumferential portion 42b is adequately maintained (see Figure 7).

[0078] As shown in Figure 6, after the tip of the outer needle 30 is inserted into the body, the first sheet portion 59a is peeled off from the first adhesive portion 57a, and a part of the adhesive body 57 is attached to the user's body surface 16a by the first adhesive portion 57a. This fixes the tip of the outer needle 30 to the body surface 16a while it is inserted into the user's body.

[0079] Next, the needle hub 54 and gripping member 52 are pulled out from the outer needle 30 in the direction of the proximal end (arrow A direction), thereby removing the inner needle 32 held by the needle hub 54 from the needle hub 18. At this time, since the outer needle 30 is fixed to the body surface 16a, the inner needle 32 is removed from inside the outer needle 30, and only the outer needle 30 is left in the body.

[0080] After the placement of the outer needle 30 is complete, a second priming procedure is performed in which the inside of the outer needle 30 and tube 20 are filled again with priming solution S2.

[0081] The second priming is performed using the priming liquid S2 remaining in the barrel 94 used in the first priming. After the second priming is completed, the priming liquid dispenser 26 is removed together with the second connecting member 78. The second priming is performed after peeling the second sheet portion 59b from the second adhesive portion 57b of the adhesive body 57 and attaching the second adhesive portion 57b along the user's body surface 16a.

[0082] After the user 16 disconnects the second connecting member 78 from the first connecting member 74, the user 16 removes the priming fluid dispenser 26 by pulling it out together with the second connecting member 78 towards the base end (direction of arrow A).

[0083] Next, as shown in Figure 4, the device body 28 is attached to the connector 24 and the drug solution S1 is administered.

[0084] The tip of the pre-filled syringe 64 of the device body 28 is inserted into the base end of the first connecting member 74 of the connector 24. A hollow needle 72 is punctured into the axial center of a packing (not shown). The tip of the device body 28 is connected to the base end of the connector 24.

[0085] After the user 16 turns on the power switch 100 located on the case 90 to start the device body 28, the control unit 88 determines the timing for starting drug administration by the drug administration device 14. When the timing for administration is reached, the control signal from the control unit 88 drives the movement mechanism 86, causing the first gasket 84 to move toward the tip and the drug solution S1 in the prefilled syringe 64 to be pushed toward the delivery nozzle 92. The drug solution S1 flows into the first connecting member 74 through the hollow needle 72. The pressure of the drug solution S1 causes the valve body 76 to elastically deform toward the tip, and the drug solution S1 flows from the tube 20 into the space 34 of the needle hub 18, and then is administered into the user 16's body through the lumen of the outer needle 30.

[0086] Once the administration of the drug solution S1 from the device body 28 into the body is complete and the flow of the drug solution S1 stops, the valve body 76 returns to its original shape due to its elasticity. This completes the administration of the drug solution S1 into the user's body 16.

[0087] As described above, in the embodiment of the present invention, in the needle protection member 10 that covers the outer needle 30 of the needle 12a, the outer needle 30 can be held by a plurality of bulges 40 (40a to 40c) protruding from the inner circumferential surface 42a of the cylindrical body 38 (housing hole 42), thereby reducing the contact area between the inner circumferential surface 42a of the needle protection member 10 and the outer circumferential surface 30a of the outer needle 30. Therefore, compared to a structure in which the outer circumferential surface 30a of the needle 12a and the inner circumferential surface 42a of the needle protection member 10 are in contact around the entire circumference, the effects of manufacturing variations and temperature changes of the outer needle 30 and the needle protection member 10 are suppressed, and the needle protection member 10 can be easily attached to and detached from the outer needle 30. By reducing the contact area between the needle protection member 10 and the outer circumferential surface 30a of the outer needle 30 with the bulges 40, the removal of the lubricant 36 applied to the outer circumferential surface 30a of the needle 12a is suppressed when the needle protection member 10 is removed from the outer needle 30.

[0088] In the needle protection member 10, since the bulging portions 40a to 40c extend along the longitudinal direction of the cylindrical body 38, when the outer needle 30 is housed in the housing hole 42 of the cylindrical body 38, the bulging portions 40a to 40c can stably and easily hold the outer circumferential surface 30a of the outer needle 30 along the longitudinal direction.

[0089] Three bulges 40a to 40c are arranged at equal intervals around the circumferential direction of the receiving hole 42, and the outer circumferential surface 30a of the outer needle 30 is held by the three bulges 40a to 40c, thereby increasing stability when attaching and detaching the needle protection member 10 to the outer needle 30, and enabling easy and reliable attachment and detachment of the needle protection member 10 to the needle 12a including the outer needle 30.

[0090] Since the bulging portions 40a to 40c have a curved top portion 46 that faces the outer circumferential surface 30a of the outer needle 30 and is convex toward the outer circumferential surface 30a, when the top portion 46 of the bulging portions 40a to 40c come into contact with the outer circumferential surface 30a of the outer needle 30, the top portion 46 deforms, allowing the bulging portions 40a to 40c to make surface contact with the outer circumferential surface 30a of the outer needle 30. This increases the fixing force of the outer needle 30 to the cylindrical body 38 via the bulging portions 40a to 40c. When the needle protection member 10 is attached to the needle 12a (outer needle 30), the lubricant 36 applied to the outer circumferential surface 30a of the outer needle 30 is prevented from being removed by the cylindrical body 38.

[0091] By making the diameter difference H between the outer diameter D of the outer needle 30 and the second inner diameter d2 of the top portion 46 of the bulging portion 40a to 40c 0.20 mm or less, the contact relationship between the top portion 46 of the bulging portion 40a to 40c and the outer peripheral surface 30a of the outer needle 30 is optimized, making it even easier to attach and detach the needle protection member 10 (tube 38) to the outer needle 30.

[0092] By making the width W1 of the bulging portion 40a to 40c smaller than the width W2 of the inner circumference portion 42b in the circumferential direction of the cylindrical body 38, the ease of attaching and detaching the cylindrical body 38 to the outer needle 30 can be effectively balanced.

[0093] Furthermore, the present invention is not limited to the disclosure described above, and can take various configurations without departing from the spirit of the invention. [Explanation of symbols]

[0094] 10... Needle protection component 12... Medical puncture needle 12a... Needle 14... Drug administration device 30...Outer needle 30a...Outer surface 38...Cylinder body 40, 40a~40c...Bulging part 42...Housing hole 42a...Inner circumferential surface 44... Gap

Claims

1. A needle, A needle protection member that covers the outer circumference of the needle to protect the needle and can be removed from the needle when the needle is in use, In a medical puncture needle equipped with, The aforementioned needle protection member is A cylindrical body having a housing hole in which the needle is housed, having an annular cross-section and extending along the axial direction, with a gap between the outer surface of the needle and the inner surface of the housing hole, A bulge is provided which is positioned on the inner circumferential surface of the receiving hole and protrudes toward the outer circumferential surface of the needle and contacts the outer circumferential surface, It has, In a cross-section of the cylindrical body perpendicular to the axial direction, the bulging portion has a top that faces the outer circumferential surface of the needle and is convex toward the outer circumferential surface, and has a curved surface. When the needle is not housed in the housing hole of the cylindrical body, the diameter of the virtual circle, which is a circle inscribed in the top of the bulge, is formed to be smaller than the outer diameter of the needle. A medical puncture needle, wherein when the needle is housed in the housing hole of the cylindrical body, the top portion of the needle contacts the outer surface of the needle and undergoes elastic deformation.

2. In the medical puncture needle according to claim 1, A medical puncture needle in which the bulge extends along the longitudinal direction of the cylindrical body.

3. In a medical puncture needle according to claim 1 or 2, The bulging portions are arranged in groups of three or more at equal intervals around the circumferential direction of the receiving hole, in a medical puncture needle.

4. In the medical puncture needle according to claim 3, A medical puncture needle in which the difference in diameter between the outer diameter of the outer surface of the needle and the inner diameter at the top of the bulge that is radially inward is 0.20 mm or less.

5. In a medical puncture needle according to claim 1 or 2, A medical puncture needle comprising an outer needle and an inner needle inserted into the outer needle, wherein the needle protection member covers the outer circumference of the outer needle.

6. In the medical puncture needle according to claim 3, The inner circumferential surface of the aforementioned housing hole has an arc-shaped inner circumferential portion positioned between adjacent bulging portions. A medical puncture needle, wherein, when viewed from the axial direction of the cylindrical body, the width of the bulging portion in the circumferential direction of the cylindrical body is smaller than the width of the inner circumference.

7. A needle protection member used in a needle having an outer needle and an inner needle inserted inside the outer needle, which protects the needle by covering the outer circumference of the outer needle and can be removed from the needle when the needle is in use, A cylindrical body having a housing hole in which the needle is housed, having an annular cross-section and extending along the axial direction, with a gap between the outer surface of the needle and the inner surface of the housing hole, A bulge is provided which is positioned on the inner circumferential surface of the housing hole and protrudes toward the outer circumferential surface of the outer needle and contacts the outer circumferential surface, A needle protection member having the following features.

8. In the needle protection member according to claim 7, A needle protection member in which the bulge extends along the longitudinal direction of the cylindrical body.

9. In the needle protection member according to claim 7 or 8, The bulging portions are needle protection members, of which three or more are arranged at equal intervals around the circumferential direction of the receiving hole.

10. In the needle protection member according to claim 9, The inner circumferential surface of the aforementioned housing hole has an arc-shaped inner circumferential portion positioned between adjacent bulging portions. A needle protection member wherein, when viewed from the axial direction of the cylindrical body, the width of the bulging portion in the circumferential direction of the cylindrical body is smaller than the width of the inner circumference.

Images