Needle assembly and puncture device

Abstract

A puncture needle according to the present disclosure comprises a puncture section provided with a blade surface on the distal end surface, and a to-be-held section joined to the base end side of the puncture section and configured to be holdable in a hub, wherein: the puncture section comprises a slit that extends to the distal end surface; and the to-be-held section comprises a pipe section that has an approximately constant outer diameter larger than the maximum outer diameter of the puncture section, and a tapered section which is positioned between the puncture section and the pipe section and of which the outer diameter decreases from the pipe section side toward the puncture section side. A profile line of the lower sides of the puncture section, the pipe section, and the tapered section extends in a straight line shape as seen from a side upwardly facing the slit.

Description

[Technical Field]

[0001] The present disclosure relates to puncture needles and needle assemblies. [Background technology]

[0002] In some cases, a medical device such as a sensor is implanted in the living body of a subject, such as a patient. For example, a sensor is implanted in the living body of the subject to monitor analytes (e.g., glucose, pH, cholesterol, protein, etc.) in the subject's blood or body fluids. In this case, a puncturing device is used to penetrate the subject's skin and quickly and easily implant the sensor in the living body. Patent Documents 1 and 2 disclose this type of puncturing device. With the puncturing device disclosed in Patent Document 1, the sensor is inserted into the living body together with the puncturing needle, the sensor is left subcutaneously, and only the puncturing needle is removed from the living body.

[0003] In the puncture devices described in Patent Documents 1 and 2, placement of a sensor in a living body and placement of an electronic device, such as a transmitter, connected to the sensor on the living body surface are performed in conjunction with the insertion and removal of the puncture needle. In such cases, a puncture device configured to remove the puncture needle while avoiding the contact point between the sensor and the electronic device is required. Therefore, the puncture devices described in Patent Documents 1 and 2 use a U-shaped or V-shaped puncture needle with a slit formed therein. Patent Document 1 also discloses an example in which the base end of such a puncture needle is long enough to penetrate a hub that holds the puncture needle. Furthermore, Patent Document 2 discloses a configuration in which a pair of wing-shaped portions is provided on the puncture needle. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] US Patent Application Publication No. 2017 / 265791 [Patent Document 2] International Publication No. 2013 / 035455 Summary of the Invention [Problem to be solved by the invention]

[0005] The puncture needles described in Patent Documents 1 and 2 are preferably thin to reduce pain to the subject. Furthermore, the puncture needles with slits described in Patent Documents 1 and 2 may require a smaller attachment area to the hub and a smaller amount of adhesive to adhere to the hub than tubular needles. This can result in a problem with the strength of the puncture needle's attachment to the hub. In Patent Document 1, the base end of the slit needle serving as the puncture needle is elongated so as to penetrate the hub, thereby increasing the attachment area of ​​the puncture needle to the hub and ensuring the strength of the attachment to the hub. Furthermore, in Patent Document 2, a pair of wing-shaped portions provided on the slit needle serving as the puncture needle are attached to the head serving as the hub, ensuring the strength of the attachment to the head.

[0006] However, the puncture needles described in Patent Documents 1 and 2 still have room for improvement in terms of simplifying the configuration to ensure the strength of the connection to the hub.

[0007] The present disclosure aims to provide a puncture needle and a needle assembly that, with a simple configuration, reduces pain to the subject and improves the joining strength to the hub. [Means for solving the problem]

[0008] A puncture needle according to a first aspect of the present disclosure comprises a puncturing portion having a blade surface at its tip end, and a holdable portion connected to the base end of the puncturing portion and configured to be holdable by a hub, the puncturing portion having a slit extending to the tip end, the holdable portion having a tubular portion having a substantially constant outer diameter larger than the maximum outer diameter of the puncturing portion, and a tapered portion located between the puncturing portion and the tubular portion and having an outer diameter that gradually decreases from the tubular portion side toward the puncturing portion side, and in a side view with the slit facing upward, the lower contours of the puncturing portion, the tubular portion, and the tapered portion are connected in a straight line.

[0009] In one embodiment of the present disclosure, the slit extends from the tip surface of the puncturing portion to the tapered portion of the held portion.

[0010] In one embodiment of the present disclosure, the slit terminates in the tapered portion.

[0011] In one embodiment of the present disclosure, the width of the slit gradually decreases toward the base end at the tapered portion.

[0012] In one embodiment of the present disclosure, the outer diameter of the puncture portion is approximately constant from the distal end surface to the proximal end side.

[0013] A needle assembly according to a second aspect of the present disclosure includes the puncture needle described above and a hub that holds the held portion of the puncture needle. [Effects of the Invention]

[0014] According to the present disclosure, it is possible to provide a puncture needle and a needle assembly that, with a simple configuration, reduces pain to the subject and improves the joining strength to the hub. [Brief explanation of the drawings]

[0015] [Figure 1] 1 is a perspective view of a puncture needle according to an embodiment of the present disclosure. FIG. [Figure 2] 2 is a perspective view of the puncture needle shown in FIG. 1, seen from a different viewpoint than that of FIG. 1. FIG. [Figure 3] FIG. 2 is a top view of the puncture needle shown in FIG. [Figure 4] FIG. 2 is a bottom view of the puncture needle shown in FIG. [Figure 5] FIG. 2 is a left side view of the puncture needle shown in FIG. [Figure 6] FIG. 2 is a right side view of the puncture needle shown in FIG. [Figure 7] FIG. 2 is a diagram showing the tip end surface of the puncture needle shown in FIG. 1, as viewed from the tip end surface side. [Figure 8] 2 is a proximal end view of the puncture needle shown in FIG. 1, as viewed from the proximal end side. FIG. [Figure 9] FIG. 4 is an enlarged top view of a part of FIG. 3. [Figure 10] FIG. 6 is an enlarged left side view of a part of FIG. 5. [Figure 11] FIG. 11 is a cross-sectional view taken along line II in FIGS. 9 and 10. [Figure 12] FIG. 11 is a cross-sectional view taken along line II-II in FIGS. 9 and 10. [Figure 13] FIG. 11 is a cross-sectional view taken along line III-III in FIGS. 9 and 10. [Figure 14] 9 is a cross-sectional view of a needle assembly according to one embodiment of the present disclosure, including the puncture needle shown in FIG. 1, taken along line IV-IV in FIG. [Figure 15] 15 is a cross-sectional view showing a cross section of the puncture needle at the position of line VV in FIG. 10 for the needle assembly shown in FIG. 14. [Figure 16] 15 is a diagram showing a puncture device including the needle assembly shown in FIG. 14, with the puncture needle in a standby position. FIG. [Figure 17] 17 is a diagram showing a state in which the puncture needle of the puncture device shown in FIG. 16 is in the middle of moving from a standby position to an insertion position. FIG. [Figure 18] 17 is a diagram showing a state in which the puncture needle of the puncture device shown in FIG. 16 is at an insertion position. FIG. [Figure 19] 17 is a diagram showing a state in which the puncture needle of the puncture tool shown in FIG. 16 has been removed from the insertion position to outside the living body. FIG. [Figure 20] 1A to 1C are diagrams showing a manufacturing flow of the puncture needle of the present disclosure. [Figure 21] FIG. 21 is a diagram showing a first step of the press molding process shown in FIG. 20. [Figure 22] FIG. 21 is a diagram showing a second step of the press molding step shown in FIG. 20. [Figure 23] FIG. 21 is a diagram showing an example of the separation step shown in FIG. 20. DETAILED DESCRIPTION OF THE INVENTION

[0016] Hereinafter, embodiments of a puncture needle and a needle assembly according to the present disclosure will be described with reference to the drawings. The same reference numerals are used to designate common components in the various drawings.

[0017] [Puncture needle] FIG. 1 is a perspective view of a puncture needle 1 as one embodiment of the puncture needle according to the present disclosure. FIG. 2 is a perspective view of the puncture needle 1 viewed from a different perspective than that of FIG. 1. Hereinafter, in this specification, the distal end of the puncture needle 1 in the longitudinal direction A that is inserted into a living body will be referred to as the "tip." Furthermore, the proximal end of the puncture needle 1 opposite the distal end in the longitudinal direction A will be referred to as the "base end." Furthermore, the direction from the base end of the puncture needle 1 toward the tip in the longitudinal direction A will sometimes be referred to as the "insertion direction A1." Furthermore, the direction from the tip of the puncture needle 1 toward the base end in the longitudinal direction A will sometimes be referred to as the "removal direction A2."

[0018] As shown in Figures 1 and 2, the puncture needle 1 comprises a puncturing part 2 and a held part 3. As shown in Figure 1, the puncturing part 2 comprises a blade surface 2a on its tip surface. As shown in Figure 1, the puncturing part 2 comprises a slit 2b extending in the longitudinal direction A. The slit 2b extends to the tip surface. The held part 3 is continuous with the base end side of the puncturing part 2. The held part 3 is configured to be able to be held by a hub (see, for example, "hub 50" shown in Figures 14 to 19).

[0019] For ease of explanation, the side surface of the puncture needle 1 on which the slit 2b is formed will be referred to as the "top surface of the puncture needle 1." The side surface of the puncture needle 1 opposite to the side surface on which the slit 2b is formed will be referred to as the "bottom surface of the puncture needle 1." Furthermore, when the puncture needle 1 is viewed from the base end toward the tip end in the longitudinal direction A, the side surface located to the right of the slit 2b will be referred to as the "right side surface of the puncture needle 1," and the side surface located to the left of the slit 2b will be referred to as the "left side surface of the puncture needle 1." Therefore, the perspective view of the puncture needle 1 shown in FIG. 1 is a perspective view showing the top surface, tip surface, and right side surface of the puncture needle 1. The perspective view of the puncture needle 1 shown in FIG. 2 is a perspective view showing the bottom surface, base end surface, and left side surface of the puncture needle 1.

[0020] 3 is a top view of the puncture needle 1. FIG. 4 is a bottom view of the puncture needle 1. FIG. 5 is a left side view of the puncture needle 1. FIG. 6 is a right side view of the puncture needle 1. FIG. 7 is a distal end view of the puncture needle 1 as viewed from the distal end side. FIG. 8 is a proximal end view of the puncture needle 1 as viewed from the proximal end side. FIG. 9 is an enlarged top view of a portion of the top view of the puncture needle 1 shown in FIG. 3. FIG. 10 is an enlarged left side view of a portion of the left side view of the puncture needle 1 shown in FIG. 5. FIG. 11 is a cross-sectional view of the puncture needle 1 taken along line II in FIGS. 9 and 10. FIG. 12 is a cross-sectional view of the puncture needle 1 taken along line II-II in FIGS. 9 and 10. FIG. 13 is a cross-sectional view of the puncture needle 1 taken along line III-III in FIGS. 9 and 10.

[0021] As shown in FIGS. 1 to 10, the held portion 3 includes a tubular portion 11 and a tapered portion 12. The tubular portion 11 has a substantially constant outer diameter T2 (see FIG. 13). The outer diameter T2 of the tubular portion 11 is larger than the outer diameter T1 of the puncturing portion 2 (see FIG. 11). More specifically, the outer diameter T2 of the tubular portion 11 is larger than the maximum outer diameter T1max of the puncturing portion 2. As shown in FIG. 11, the outer diameter T1 of the puncturing portion 2 refers to the maximum cross-sectional length of the cross section of the puncturing portion 2 perpendicular to the longitudinal direction A. The maximum outer diameter T1max of the puncturing portion 2 refers to the maximum value when comparing the outer diameter T1 at a position in the longitudinal direction A. Furthermore, as shown in FIG. 13, the outer diameter T2 of the tubular portion 11 refers to the maximum cross-sectional length of the cross section of the tubular portion 11 perpendicular to the longitudinal direction A. As shown in FIG. 13, when the outer shape of the cross section of the pipe portion 11 perpendicular to the longitudinal direction A is circular, the outer diameter T2 of the pipe portion 11 described above is the diameter of the outer peripheral surface of the pipe portion 11.

[0022] Tapered portion 12 is located between puncture portion 2 and tubular portion 11. The outer diameter T3 of tapered portion 12 gradually decreases from the tubular portion 11 side toward the puncture portion 2 side. As shown in Figure 12, the outer diameter T3 of tapered portion 12 means the maximum cross-sectional length of the cross section of tapered portion 12 perpendicular to the longitudinal direction A.

[0023] In this way, the holdable portion 3 configured to be holdable by a hub (see, for example, "hub 50" shown in Figures 14 to 19) has the tapered portion 12 described above. This makes it easier for the outer surface of the tapered portion 12, which is inclined with respect to the longitudinal direction A, to be fixed to the hub directly or indirectly via an adhesive or the like. As a result, the puncture needle 1 is less likely to come off the hub in the insertion direction A1. The holdable portion 3 of the puncture needle 1 has a tubular portion 11. This improves the bonding strength of the puncture needle 1 to the hub compared to a puncture needle configured with a slit along its entire length and no tubular holdable portion. By providing the puncture needle 1 with the tapered portion 12, the outer surface shape of the tapered portion 12 improves the bonding strength to the hub. The puncture needle 1 can achieve a higher bonding strength to the hub compared to a puncture needle whose holdable portion is only a tubular portion. This allows the length of the puncture needle 1 to be shortened, thereby enabling the puncture device to be made more compact.

[0024] Furthermore, by providing the tapered portion 12, it is not necessary to increase the diameter of the puncturing portion 2 located at the tip side of the held portion 3 in order to increase the joining strength of the puncturing needle 1 to the hub. Furthermore, as described above, providing the tapered portion 12 makes it easier to fix the puncturing needle 1 to the hub. By providing the tubular portion 11 adjacent to the tapered portion 12, the outer diameter T2 of the tubular portion 11 can be set to 110 to 210% of the outer diameter T1max of the puncturing portion 2. In other words, by providing the tubular portion 11 and the tapered portion 12, the joining strength of the puncturing needle 1 to the hub can be further increased while maintaining the minimum cross-sectional length of the puncturing portion 2 required for inserting the sensor. This reduces the puncturing resistance when the puncturing portion 2 punctures the living body. Furthermore, it also reduces the pain experienced by the subject.

[0025] Thus, with the puncture needle 1, the simple configuration of providing the tapered portion 12 on the held portion 3 can reduce pain for the subject and improve the joining strength to the hub.

[0026] Furthermore, by providing the held part 3 with the tubular part 11, the assembly work of the puncture needle 1 to the hub (see, for example, "hub 50" shown in Figures 14 to 19) becomes easier. Specifically, for example, the position of the central axis O of the tubular part 11 of the held part 3 can be used to relatively position the puncture needle 1 and the hub in a plane perpendicular to the longitudinal direction A. In this way, by using the tubular part 11, the assembly work of the puncture needle 1 to the hub can be made easier.

[0027] Furthermore, as shown in FIGS. 5, 6, and 10, in a side view with the slit 2b of the puncture portion 2 facing upward, the lower contour lines of the puncture portion 2, tubular portion 11, and tapered portion 12 are connected in a straight line. That is, in the side views of FIGS. 5, 6, and 10, the lower contour line CL1 of the puncture portion 2, the lower contour line CL2 of the tubular portion 11, and the lower contour line CL3 of the tapered portion 12 are connected in a straight line. This configuration allows for a puncture needle 1 that is suitable for mass production. Specifically, by integrally supporting the puncture portion 2, tubular portion 11, and tapered portion 12 of the puncture needle 1 on the side of the linearly connected contour lines CL1, CL2, and CL3, the blade surface forming step of forming a blade surface on the distal end surface of the puncture portion 2 can be easily performed. More specifically, the linearly connected contour lines CL1, CL2, and CL3 allow the puncture needle 1 to be accurately supported on a jig or the like. This allows the center of the blade surface to be accurately cut out while maintaining mass productivity. It also makes it easy to perform any processing on the blade surface. A puncture needle 1 with a precisely formed blade surface not only reduces puncture resistance, but also reduces pain to the subject.

[0028] The material of the puncture needle 1 can be, for example, a metal material such as stainless steel, aluminum, aluminum alloy, titanium, titanium alloy, or magnesium alloy. The material selected for the puncture needle 1 is one that can be manufactured by plastic processing. Examples of plastic processing include cutting a drawn tube having a predetermined inner diameter, and manufacturing a metal plate by pressing. Preferably, the material selected for the puncture needle 1 is one that can be subjected to press processing.

[0029] The puncture needle 1 of this embodiment will be described in further detail below with reference to FIGS.

[0030] <Puncture part 2> As shown in Figures 1 to 6, the puncture part 2 of this embodiment extends linearly in the longitudinal direction A. As shown in Figure 1, the tip surface of the puncture part 2 is formed with a blade surface 2a that is an inclined surface that is inclined with respect to the longitudinal direction A. The needlepoint 4 of the puncture needle 1 is formed with the tip, which is the distal end of the blade surface 2a of the puncture part 2. In other words, the tip surface of the puncture needle 1 is formed with the tip surface of the puncture part 2 on which the blade surface 2a is formed.

[0031] In this embodiment, the blade surface 2a is configured with a single plane inclined with respect to the longitudinal direction A, but the blade surface 2a is not limited to this configuration. For example, the blade surface 2a may be configured with multiple planes inclined at different angles with respect to the longitudinal direction A. Furthermore, the blade surface 2a may be configured to include a curved surface inclined with respect to the longitudinal direction A.

[0032] As shown in FIG. 1 and other figures, the puncturing portion 2 has a slit 2b extending in the longitudinal direction A. In this embodiment, the slit 2b extends from the tapered portion 12 of the held portion 3 to the distal end surface of the puncturing portion 2. By configuring the slit 2b in this manner, it is possible to ensure a sufficient length of the slit 2b in the longitudinal direction A. In this embodiment, the slit 2b can be arranged over the entire area in the longitudinal direction A in the distal end portion of the puncturing needle 1 that protrudes from the held portion 3 held by a hub (see, for example, "hub 50" shown in FIGS. 14 to 19) and is exposed to the outside of the hub. This prevents the sensor 300 (see FIGS. 16 to 19) and the contact portion 90 of the detector 106 (see FIGS. 16 to 19), which will be described later, from getting caught on the proximal end of the slit 2b and being damaged or broken.

[0033] Furthermore, as shown in Figures 1, 3, 9, etc., the slit 2b of this embodiment terminates at the tapered portion 12. In other words, the base end side of the slit 2b of this embodiment terminates at the position of the tapered portion 12. In other words, the base end side of the slit 2b of this embodiment terminates further toward the tip side than the tubular portion 11. This ensures an endless tubular portion 11 with a substantially constant outer diameter T2, maintaining ease of assembly to the hub of the puncture needle 1 (see, for example, "hub 50" shown in Figures 14 to 19). Furthermore, since the held portion 3 has the tubular portion 11, the tubular portion 11 can ensure adhesive strength equivalent to that of a so-called tubular needle. Furthermore, processing conventionally used for tubular needles can be performed.

[0034] Furthermore, as shown in FIGS. 3 and 9, the width W of the slit 2b in this embodiment gradually decreases toward the base end in the tapered portion 12. The width W of the slit 2b refers to the length of the slit 2b in a direction perpendicular to the extension direction of the slit 2b (in this embodiment, the longitudinal direction A) in a top view of the puncture needle 1 seen from the slit 2b side (see FIGS. 3 and 9). As shown in FIG. 3, the width W of the slit 2b in this embodiment is constant regardless of the position in the longitudinal direction A in the puncture portion 2. In contrast, the width W of the slit 2b in this embodiment gradually decreases toward the base end in the tapered portion 12. As described above, the slit 2b in this embodiment terminates at the tapered portion 12. When the maximum slit width of the puncture portion 2 is taken as 100%, the width W of the slit 2b closes toward the base end at a pitch of 3 to 100% per 1 mm of the axial length of the puncture needle 1.

[0035] As shown in Fig. 11, the puncture unit 2 of this embodiment is a U-shaped needle part having a substantially U-shaped outer shape in a cross section perpendicular to the longitudinal direction A. The puncture unit 2 of this embodiment has a substantially U-shaped outer shape in a cross section perpendicular to the longitudinal direction A at any position in the longitudinal direction A. In other words, as shown in Fig. 11, the puncture unit 2 of this embodiment has opposing side walls 13a, 13b and a bottom 13c continuous with these side walls 13a, 13b. The bottom 13c is located on the underside of the puncture needle 1.

[0036] As shown in FIG. 11 , side wall portions 13a and 13b of this embodiment are configured as flat plate portions extending in a substantially linear shape in a cross section perpendicular to the longitudinal direction A, but are not limited to this configuration. Side wall portions 13a and 13b may also be configured as curved plate portions extending in an arc shape smoothly connected to bottom portion 13c of this embodiment in a cross section perpendicular to the longitudinal direction A. In other words, puncturing portion 2 of this embodiment may be a C-shaped needle portion having a substantially C-shaped outer shape in a cross section perpendicular to the longitudinal direction A. Alternatively, puncturing portion 2 of this embodiment may be a V-shaped needle portion having a substantially V-shaped outer shape in a cross section perpendicular to the longitudinal direction A, which is configured only by side wall portions 13a and 13b.

[0037] Furthermore, although the thickness of side walls 13a, 13b and bottom 13c of puncturing part 2 in this embodiment is generally uniform, this is not limitative. Side walls 13a, 13b and bottom 13c may have different thicknesses.

[0038] Furthermore, the outer diameter T1 (see FIG. 11) of the puncture portion 2 of this embodiment is substantially constant from the distal end surface on which the blade surface 2a is formed to the proximal end side. That is, the puncture portion 2 of this embodiment is configured with a substantially uniform thickness in the longitudinal direction A, except for the distal end surface on which the blade surface 2a is formed. However, the outer diameter T1 of the puncture portion 2 may, for example, gradually decrease from the proximal end side to the distal end side in the longitudinal direction A.

[0039] <Holded part 3> As shown in Figure 1 and other figures, the held portion 3 of this embodiment is composed of the above-mentioned tubular portion 11 and tapered portion 12. That is, as shown in Figures 9 and 10 and other figures, the tip of the tapered portion 12 of this embodiment is continuous with the base end of the puncture portion 2. Furthermore, the base end of the tapered portion 12 of this embodiment is continuous with the tip of the tubular portion 11. Furthermore, the base end surface of the puncture needle 1 of this embodiment is composed of the base end surface of the tubular portion 11. The base end surface of the tubular portion 11 of this embodiment is composed of a plane perpendicular to the longitudinal direction A.

[0040] As described above, the outer diameter T2 of the pipe portion 11 is approximately constant along the longitudinal direction A. Furthermore, the inner diameter of the pipe portion 11 of this embodiment is approximately constant along the longitudinal direction A. Furthermore, as shown in FIG. 13 , the pipe portion 11 of this embodiment has a approximately uniform wall thickness throughout the entire area in the circumferential direction B around the central axis O. However, the wall thickness of the pipe portion 11 may vary depending on the position in the circumferential direction B.

[0041] As described above, the outer diameter T3 of the tapered portion 12 gradually decreases from the base end side toward the tip end side in the longitudinal direction A. Furthermore, the inner diameter of the tapered portion 12 of this embodiment also gradually decreases from the base end side toward the tip end side in the longitudinal direction A. Furthermore, as shown in FIG. 12 , the tapered portion 12 of this embodiment has a substantially uniform thickness regardless of the position in the circumferential direction B. However, the thickness of the tapered portion 12 may vary depending on the position in the circumferential direction B.

[0042] As described above, the width W of the slit 2b in this embodiment gradually decreases toward the base end in the tapered portion 12. More specifically, as shown in FIG. 9 and other figures, the width W of the slit 2b in this embodiment starts to decrease from the tip end of the tapered portion 12 and terminates at the base end of the tapered portion 12. However, the position where the width W of the slit 2b starts to decrease is not limited to the tip end of the tapered portion 12. The slit 2b may start to decrease on the base end side of the tip end of the tapered portion 12. Furthermore, the position where the slit 2b terminates is not limited to the base end of the tapered portion 12. The slit 2b may terminate on the tip end side of the base end of the tapered portion 12.

[0043] <Shapes of the contour lines of the puncture part 2 and the held part 3> Next, the shapes of the contours of the puncture part 2 and the held part 3 when the puncture needle 1 of this embodiment is viewed from a predetermined viewpoint will be described.

[0044] As described above, in a side view with the slit 2b of the puncturing portion 2 facing upward (see FIGS. 5, 6, and 10), the lower contour line CL1 of the puncturing portion 2, the lower contour line CL2 of the tubular portion 11, and the lower contour line CL3 of the tapered portion 12 are connected in a straight line. In addition, in this embodiment, in a side view with the slit 2b of the puncturing portion 2 facing upward (see FIGS. 5, 6, and 10), the lower contour lines of the puncturing portion 2, the tubular portion 11, and the tapered portion 12 that are connected in a straight line extend parallel to the longitudinal direction A (or the central axis O). The distal end side of this linearly connected contour line terminates at the position of the needle tip 4. Furthermore, the proximal end side of this linearly connected contour line terminates at the position of the proximal end of the tubular portion 11.

[0045] In contrast, in this embodiment, when viewed from the side with the slit 2b of the puncture portion 2 facing upward (see Figures 5, 6, and 10), the upper contour line CL4 of the puncture portion 2, the upper contour line CL5 of the tubular portion 11, and the upper contour line CL6 of the tapered portion 12 are not connected in a straight line.

[0046] Specifically, in a side view with the slit 2b of the puncturing portion 2 facing upward (see FIGS. 5, 6, and 10), the upper contour line CL4 of the puncturing portion 2 and the upper contour line CL6 of the tapered portion 12 are connected at an angle. More specifically, in a side view with the slit 2b of the puncturing portion 2 facing upward (see FIGS. 5, 6, and 10), the upper contour line CL4 of the puncturing portion 2 is a straight line extending parallel to the longitudinal direction A. In contrast, in a side view with the slit 2b of the puncturing portion 2 facing upward (see FIGS. 5, 6, and 10), the upper contour line CL6 of the tapered portion 12 is a straight line extending at an angle with respect to the longitudinal direction A so as to approach the lower contour line CL3 from the base end toward the tip end.

[0047] Furthermore, in a side view with the slit 2b of the puncture portion 2 facing upward (see FIGS. 5, 6, and 10), the upper contour line CL5 of the tubular portion 11 and the upper contour line CL6 of the tapered portion 12 are connected at an angle. More specifically, in a side view with the slit 2b of the puncture portion 2 facing upward (see FIGS. 5, 6, and 10), the upper contour line CL5 of the tubular portion 11 is a straight line extending parallel to the longitudinal direction A. In contrast, in a side view with the slit 2b of the puncture portion 2 facing upward (see FIGS. 5, 6, and 10), the upper contour line CL6 of the tapered portion 12 is a straight line extending at an angle with respect to the longitudinal direction A so as to approach the lower contour line CL3 as it moves from the base end to the tip end, as described above. In a side view of the puncture needle 1, the contour line CL6 of the tapered portion 12 is inclined with respect to the central axis O of the tubular portion 11.

[0048] Furthermore, in a side view with slit 2b of puncturing portion 2 facing upward (see FIGS. 5, 6, and 10), the upper contour line CL4 of puncturing portion 2 and the upper contour line CL5 of tubular portion 11 are both straight lines parallel to the longitudinal direction A, but their upper and lower positions are different in the side view, and they are not located on the same straight line. More specifically, in a side view with slit 2b of puncturing portion 2 facing upward (see FIGS. 5, 6, and 10), the upper contour line CL5 of tubular portion 11 is located above the upper contour line CL4 of puncturing portion 2.

[0049] 10, in a side view with the slit 2b of the puncturing unit 2 facing upward, the heightwise distance H1 between the lower contour line CL1 and the upper contour line CL4 of the puncturing unit 2 is shorter than the heightwise distance H2 between the lower contour line CL2 and the upper contour line CL5 of the tubular portion 11. In this embodiment, the above-mentioned distance H1 is longer than ½ of the above-mentioned distance H2.

[0050] Thus, in the puncture needle 1 of this embodiment, when viewed from the side with the slit 2b of the puncture portion 2 facing upward (see Figures 5, 6, and 10), the lower contour lines of the puncture portion 2, tubular portion 11, and tapered portion 12 are connected in a straight line, whereas the upper contour lines of the puncture portion 2, tubular portion 11, and tapered portion 12 are not connected in a straight line.

[0051] Next, we will explain the outlines of the puncturing part 2 and the held part 3 when viewed from above (see Figs. 3 and 9) as the puncturing needle 1 is viewed from the slit 2b side. The shapes of the outlines of the puncturing part 2 and the held part 3 when viewed from below (see Fig. 4) as the puncturing needle 1 is viewed from the opposite side to the slit 2b are the same as when viewed from above (see Figs. 3 and 9), so we will not explain them here.

[0052] In top view (see FIGS. 3 and 9), the centers of the puncture section 2, tubular section 11, and tapered section 12 in the width direction C, which is perpendicular to the longitudinal direction A, are aligned. That is, in top view (see FIGS. 3 and 9), the center line passing through the center position of the puncture section 2 in the width direction C, the center line passing through the center position of the tubular section 11 in the width direction C, and the center line passing through the center position of the tapered section 12 in the width direction C are common. In the present embodiment, for ease of explanation, the common center line will be referred to as a "common center line M." In this embodiment, the common center line M extends parallel to the longitudinal direction A.

[0053] In addition, in this embodiment, when viewed from above (see Figures 3 and 9), the contour lines of the puncture section 2, tubular section 11 and tapered section 12 located on both sides of the width direction C are arranged symmetrically with respect to the above-mentioned common center line M.

[0054] Furthermore, in this embodiment, when viewed from above (see FIGS. 3 and 9), the contour line CL7 on one side in the width direction C of the puncture portion 2, the contour line CL8 on one side in the width direction C of the tubular portion 11, and the contour line CL9 on one side in the width direction C of the tapered portion 12 are not connected in a straight line. Also, when viewed from above (see FIGS. 3 and 9), the contour line CL10 on the other side in the width direction C of the puncture portion 2, the contour line CL11 on the other side in the width direction C of the tubular portion 11, and the contour line CL12 on the other side in the width direction C of the tapered portion 12 are not connected in a straight line.

[0055] Specifically, in top view (see FIGS. 3 and 9), a contour line CL7 on one side in the width direction C of the puncture portion 2 and a contour line CL9 on one side in the width direction C of the tapered portion 12 are connected at an angle. More specifically, in top view (see FIGS. 3 and 9), the contour line CL7 on one side in the width direction C of the puncture portion 2 is a straight line extending parallel to the longitudinal direction A. In contrast, in top view (see FIGS. 3 and 9), the contour line CL9 on one side in the width direction C of the tapered portion 12 is a straight line extending at an angle with respect to the longitudinal direction A so as to approach the common center line M from the base end side toward the tip end side.

[0056] In addition, in top view (see FIGS. 3 and 9), a contour line CL8 on one side of the tubular portion 11 in the width direction C and a contour line CL9 on one side of the tapered portion 12 in the width direction C are connected at an angle. More specifically, in top view (see FIGS. 3 and 9), the contour line CL8 on one side of the tubular portion 11 in the width direction C is a straight line extending parallel to the longitudinal direction A. In contrast, in top view (see FIGS. 3 and 9), the contour line CL9 on one side of the tapered portion 12 in the width direction C is a straight line extending at an angle with respect to the longitudinal direction A so as to approach the common center line M from the base end side toward the tip end side, as described above.

[0057] Furthermore, in a top view (see FIGS. 3 and 9), a contour line CL7 on one side in the width direction C of the puncturing portion 2 and a contour line CL8 on one side in the width direction C of the tubular portion 11 are both straight lines parallel to the longitudinal direction A, but the contour lines extend at different positions in the top view and are not located on the same straight line. More specifically, in a top view (see FIGS. 3 and 9), the contour line CL8 on one side in the width direction C of the tubular portion 11 is located farther from the common center line M in the width direction C than the contour line CL7 on one side in the width direction C of the puncturing portion 2. In other words, as shown in FIG. 9, in a top view, a distance H3 in the width direction C between the contour lines CL7 and CL10 on both sides of the puncturing portion 2 is shorter than a distance H4 in the width direction C between the contour lines CL8 and CL11 on both sides of the tubular portion 11. In this embodiment, the distance H3 is longer than half the distance H4.

[0058] When viewed from above (see Figures 3 and 9), the relationship between the contour line CL10 on the other side of the width direction C of the puncture portion 2, the contour line CL11 on the other side of the width direction C of the tubular portion 11, and the contour line CL12 on the other side of the width direction C of the tapered portion 12 is similar to the relationship between the contour line CL7 on one side of the width direction C of the puncture portion 2, the contour line CL8 on one side of the width direction C of the tubular portion 11, and the contour line CL9 on one side of the width direction C of the tapered portion 12, as described above, and therefore will not be explained here.

[0059] Here, the inclination angle of the contour line CL6 on the upper side of the tapered portion 12 with respect to the longitudinal direction A shown in FIG. 10 is defined as θ1. θ1 is preferably 0.5° or more and 60° or less, more preferably 3° or more and 10° or less. By setting θ1 within this range, attachment to the hub and the amount of adhesive to be applied, which will be described later, can be ensured sufficiently, and the puncture needle can be prevented from coming off the hub. The inclination angle of the contour lines CL9 and CL12 on one side and the other side of the width direction C of the tapered portion 12 with respect to the longitudinal direction A shown in FIG. 9 is defined as θ2. In this embodiment, θ1 is greater than θ2.

[0060] [Manufacturing method of puncture needle] As shown in Figure 20, the method of manufacturing the puncture needle 1 includes a receiving step S1 in which a band-shaped metal plate material is received in a press molding machine, a press molding step S2 in which the plate material is continuously press-molded using this press molding machine to obtain a plurality of rod-shaped members 150 (see Figure 23) some of which are connected to the plate material, a separation step S3 in which the rod-shaped members 150 are separated from the plate material, a blade surface forming step S4 in which a blade surface is formed on one end of the rod-shaped members 150 to form the blade surface, and a cleaning step S5 in which the rod-shaped members 150 are cleaned.

[0061] <Receiving process S1> A band-shaped metal plate is received in a press molding machine (not shown). In this case, a movement mechanism moves the plate along its longitudinal direction relative to the press molding machine, and the forming portion of the plate is positioned at the forming position of the press molding machine. First, the portion of the plate from which a predetermined unfolded shape will be punched is positioned at the punching section of the press molding machine (described later), which punches out the unfolded shape.

[0062] <Press forming process S2> The press molding step S2 is a step of obtaining a rod-shaped member 150 (see FIG. 23) from a plate material 160 using a press molding machine. Here, the rod-shaped member 150 is substantially equivalent to the puncture needle 1 without the blade surface 2a, and is formed with a slit 2b (see FIG. 1), a tapered portion 12 (see FIG. 1), and a tubular portion 11 (see FIG. 1). The press molding step S2 includes a first step (see FIG. 21) of punching out an unfolded body of the rod-shaped member 150 while a portion of the body is connected to the plate material, and a second step (see FIG. 22) of bending this unfolded body at least once using a convex mold and a concave mold in the press molding machine to form it into a tubular shape, thereby obtaining a rod-shaped member 150 while a portion of the body is connected to the plate material. In the second step, a continuous press molding machine is used to continuously press-molde the unfolded body 170 with a plurality of concave dies (metal molds) 180 and convex dies (metal molds) 190 to form the rod-shaped member 150 corresponding to the puncture needle 1 except for the blade surface 2a. If surface processing such as knurling is to be performed on the outer surface of the rod-shaped member 150, this is done during the press molding step.

[0063] <Separation process S3> In the separation step S3, the rod-shaped members 150 are sequentially separated from the plate material 160 on the frame. In this case, the rod-shaped members 150 are separated at the boundary between the rod-shaped members 150 and the pair of connection portions 270. The method for separating the rod-shaped members 150 from the plate material 160 is not particularly limited, and may be, for example, mechanical cutting or separation using a laser or the like. In addition, in the separation step S3, the rod-shaped members 150 are temporarily fixed to maintain the relative positions of the rod-shaped members 150 approximately simultaneously with or after the separation of the rod-shaped members 150. In this embodiment, this temporary fixing is performed by attaching both ends of the rod-shaped members 150 to a pair of adhesive tapes (temporary fixing members) 290 (see FIG. 23), or by attaching at least one location of the rod-shaped members 150 excluding the center portion in the longitudinal direction to the adhesive tape 290.

[0064] <Blade surface formation process S4> In the blade surface forming step, the blade surface 2a is formed on at least one end of each temporarily fixed rod-shaped member 150a, thereby forming the puncture needle 1. The rod-shaped member 150 has linearly connected contour lines CL1, CL2, and CL3 (see FIG. 5, etc.), which allows the puncture needle 1 to be accurately supported on the temporary fixing jig. This allows the blade surface 2a to be formed while accurately defining the position of the blade surface 2a relative to the slit 2b.

[0065] In the present disclosure, the slit 2b is formed in advance in the press-molding step S2. However, it is also possible to form a normal closed tube in the press-molding step S2 and then form the blade surface and slit in the blade surface forming step S4. However, because the area to be ground for the slit 2b is significantly larger than that of the blade surface 2a, forming the blade surface and slit 2b in the blade surface forming step S4 would significantly reduce mass productivity. For this reason, the present disclosure employs a manufacturing process in which the slit 2b is formed in the press-molding step S2 and then the blade surface 2a is formed in the blade surface forming step S4. In order to form the blade surface 2a at a fixed position relative to the slit 2b in the blade surface forming step S4, linear contour lines CL1, CL2, and CL3 (see FIG. 5, etc.) are provided on the rod-shaped member 150 (puncture needle 1).

[0066] <Cleaning process S5> In the cleaning step S5, metal pieces and the like that have adhered to the puncture needle 1 in the blade surface forming step S4 etc. can be removed. Any known cleaning method can be used.

[0067] The manufacturing process of the puncture needle 1 may include a correction process, a polishing process, a joining process, etc., as needed.

[0068] [Needle assembly] Next, a needle assembly 20 as one embodiment of a needle assembly according to the present disclosure will be illustrated with reference to Figures 14 and 15. The needle assembly 20 includes the above-described puncture needle 1 and a hub 50 that holds the held portion 3 of the puncture needle 1. Figures 14 and 15 are views of the needle assembly 20. Specifically, Figures 14 and 15 are cross-sectional views of the needle assembly 20, showing the held portion 3 of the puncture needle 1 held by the hub 50. Figure 14 shows a cross-section of the puncture needle 1 taken along line IV-IV in Figure 9. Figure 15 shows a cross-section of the puncture needle 1 taken along line VV in Figure 10.

[0069] 14 and 15, the hub 50 has an enclosure wall 51 that defines an accommodation space 50a capable of accommodating the held portion 3 of the puncture needle 1. As shown in Figures 14 and 15, the puncture needle 1 is held by the hub 50 with the held portion 3 housed in the accommodation space 50a within the enclosure wall 51 and the puncture portion 2 protruding from an opening 51a1 on one side of the enclosure wall 51 (the lower side in Figures 14 and 15).

[0070] More specifically, the needle assembly 20 of this embodiment includes an adhesive member 200 that bonds the outer surface of the tapered portion 12 of the holdable portion 3 of the puncture needle 1 to the inner surface of the surrounding wall portion 51. The adhesive member 200 may be, for example, an adhesive that is filled into the surrounding wall portion 51 and solidified. The adhesive as the adhesive member 200 is filled so as to contact the outer surface of the tapered portion 12, which is inclined with respect to the longitudinal direction A, and solidifies in that state. This allows the tapered portion 12 to be caught by the adhesive as the adhesive member 200, preventing the holdable portion 3 of the puncture needle 1 from falling off the hub 50 in the insertion direction A1. In other words, providing the tapered portion 12 on the holdable portion 3 of the puncture needle 1 improves the bonding strength of the puncture needle 1 to the hub 50. As long as the adhesive member 200 is applied at least to the tapered portion 12, the puncture needle 1 and the hub 50 can be reliably bonded together.

[0071] 14 and 15, the hub 50 of the needle assembly 20 shown in this embodiment includes a surrounding wall portion 51 and a wall end surface 52. The opening 51a1 is defined by the inner edge of the wall end surface 52. The opening 51a1 in this embodiment is a circular opening, but the shape thereof is not particularly limited.

[0072] 14 and 15, the minimum diameter R of the opening 51a1 in this embodiment is approximately the same as or slightly larger than the outer diameter T2 of the tubular portion 11 of the puncture needle 1. Therefore, in this embodiment, the adhesive as the adhesive member 200 is filled at least around the tapered portion 12 of the held portion 3, thereby preventing the held portion 3 from falling off the hub 50 through the opening 51a1. In this way, filling the tapered portion 12 with the adhesive member 200 improves the retention of the adhesive member 200 in the storage space 50a. However, the minimum diameter R of the opening 51a1 may be smaller than the outer diameter T2 of the tubular portion 11. By providing the wall end surface 52 with such an opening 51a1, the puncture needle 1 can be prevented from falling off the hub 50.

[0073] The shape of the hub 50 shown in this embodiment is just an example, and there are no particular limitations on its shape as long as it is configured to hold the held portion 3 of the puncture needle 1. Therefore, the hub 50 may have a shape like that shown in Figures 16 to 19, which will be referred to later.

[0074] Examples of materials for the hub 50 include resin materials. Examples of resin materials include thermoplastic resins used in injection molding, such as ABS resin, AS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethylene methacrylate, polyoxyethylene, fluororesin, polycarbonate, polyamide, acetal resin, acrylic resin, and polyethylene terephthalate, as well as thermosetting resins, such as phenolic resin, epoxy resin, silicone resin, and unsaturated polyester. Furthermore, any adhesive, such as a UV-curable resin, can be used as the adhesive member 200.

[0075] [Puncture tool 100] 16 to 19, which show a puncture device 100 including a needle assembly 20 having a puncture needle 1 and a hub 50. The shape of the hub 50 shown in Figs. 16 to 19 differs from the shape of the hub 50 shown in Figs. 14 and 15 described above, but may be similar. The shape of the hub 50 may be designed as appropriate depending on the configuration of the puncture device 100 to which the needle assembly 20 is applied.

[0076] 16 to 19 are diagrams showing the puncture tool 100. Each of Figs. 16 to 19 shows an overview of the operation of the puncture tool 100 when the puncture tool 100 is used to insert and place a sensor 300 inside a living body. Specifically, Fig. 16 shows a state in which the puncture needle 1 is in the standby position. Fig. 17 shows a state in which the puncture needle 1 is in the middle of moving from the standby position to the insertion position. Fig. 18 shows a state in which the puncture needle 1 is in the insertion position. Fig. 19 shows a state in which the puncture needle 1 has been removed from the insertion position to outside the living body.

[0077] 16 to 19, the puncture device 100 includes a needle assembly 20, a moving member 103, a housing 104, a biasing member 105, a detector 106, and a sensor 300. As shown in FIGS. 16 to 19, the needle assembly 20 of this embodiment includes a puncture needle 1 and a hub 50.

[0078] First, with reference to FIGS. 16 to 19, a method of using the puncture device 100 of this embodiment will be described. As described above, the puncture device 100 of this embodiment can be used to insert and place the sensor 300 inside a living body. The puncture device 100 is placed on the living body surface BS in the state shown in FIG. 16. That is, FIG. 16 shows the state before the puncture needle 1 and the sensor 300 of the needle assembly 20 are inserted into the living body. Thereafter, an operator such as a patient operates the puncture device 100, thereby inserting the puncture needle 1 and the sensor 300 of the needle assembly 20 into the living body (see FIGS. 17 and 18). FIG. 17 shows the state in the middle of inserting the puncture needle 1 and the sensor 300 into the living body by the puncture device 100. FIG. 18 shows the state in which the puncture needle 1 and the sensor 300 have reached the deepest position inside the living body that the puncture device 100 can insert. Next, as shown in Figure 19, the puncture needle 1 of the needle assembly 20 is removed from the living body, leaving the sensor 300 in the living body. In this manner, the sensor 300 can be inserted and placed in the living body using the puncture device 100. For ease of explanation, the position of the puncture needle 1 in Figure 16 where the puncture needle 1 is housed in the housing 104 will be referred to as the "standby position of the puncture needle 1." Also, for ease of explanation, the position of the puncture needle 1 in Figure 18 where the puncture needle 1 protrudes most from the housing 104 will be referred to as the "insertion position of the puncture needle 1."

[0079] The sensor 300 placed in a living body detects a substance to be measured (analyte) and transmits information on the detection results to the detector 106. The detector 106 is connected to the sensor 300 by wire and placed on the living body surface BS together with the sensor 300. The detector 106 is composed of a processor as a control unit, a memory as a storage unit, a battery as a power supply unit, and the like. The sensor 300 of this embodiment shown in FIGS. 16 to 19 transmits information including the detection results to the detector 106. By using the sensor 300 together with the detector 106, a signal corresponding to the concentration of the substance to be measured can be detected. The detection signal is processed by the detector 106 and transmitted to the subject's smartphone or dedicated terminal. The subject or user can check the measurement results of the substance to be measured displayed on the screen of the smartphone or dedicated terminal over time. The period for which the sensor 300 is attached to the subject, such as for several hours, several days, one week, or one month, is determined appropriately by the doctor or other appropriate person. The substance to be measured is not particularly limited, but by selecting the sensing unit of the sensor 300, it is possible to measure glucose, oxygen, pH, lactate, etc. in blood or interstitial fluid. The detector 106 is connected to a separately provided transmitter (not shown) after the sensor 300 is inserted. In this case, the transmitter, rather than the detector 106, may have a memory, a battery, etc. Furthermore, the detector 106 placed together with the sensor 300 may be a transmitter including a transmitter capable of transmitting information to an external device. In other words, the transmitter may include a processor, memory, a battery, etc. The transmitter may be configured to be used for a longer period than the sensor 300. The detector 106 may also be connected to the sensor 300 via a contact portion after the sensor 300 is placed by the puncture device 100. In such a case, only the contact portion is placed on the biological surface BS together with the sensor 300 by the puncture device 100, and then the detector 106 is connected to the contact portion.

[0080] The puncture needle 1 of the needle assembly 20 has the same configuration as described above, and therefore will not be described here.

[0081] The hub 50 of the needle assembly 20 includes a main body 55 and a locking claw 56. The main body 55 includes a surrounding wall 51. The surrounding wall 51 defines a storage space 50a that penetrates in the longitudinal direction A. The held portion 3 of the puncture needle 1 is inserted into the storage space 50a and fixed to the surrounding wall 51 of the main body 55 via an adhesive that serves as an adhesive member 200. A wall end surface 52 is continuous with the end of the surrounding wall 51 on the insertion direction A1 side. The main body 55 of this embodiment also includes an outer flange 57 that is continuous with the end of the surrounding wall 51 on the removal direction A2 side. The locking claw 56 protrudes from the outer flange 57 of the main body 55 in the removal direction A2. Furthermore, in the needle assembly 20 of this embodiment, a plurality of locking claws 56 are provided around the puncture needle 1 in a direction perpendicular to the longitudinal direction A of the puncture needle 1, so as to surround the periphery of the puncture needle 1. The locking claws 56 include an extension 58 protruding from the main body 55, and an engaging protrusion 59 provided at the end of the extension 58 in the removal direction A2. The extension 58 is elastically deformable in a direction perpendicular to the longitudinal direction A, with a position continuous with the main body 55 as a fulcrum. The engaging protrusion 59 protrudes from the end of the extension 58 in a direction perpendicular to the longitudinal direction A.

[0082] The movable member 103 of this embodiment is attached within the housing 104 so as to be movable in the longitudinal direction A. The upper surface of the movable member 103 of this embodiment, which faces the removal direction A2, is exposed to the outside from the housing 104. Therefore, the operator of the puncture device 100 can move the movable member 103 in the insertion direction A1 by pressing the movable member 103 exposed from the housing 104 in the insertion direction A1. As a result, the needle assembly 20 is pressed in the insertion direction A1 by the movable member 103 and moves.

[0083] The movable member 103 includes an engaging portion 61 that presses the locking claw portion 56 of the hub 50 of the needle assembly 20 outward in the radial direction D of the puncture needle 1. The radial direction D of the puncture needle 1 refers to the radial direction of a circle around the central axis O of the tubular portion 11. The movable member 103 also defines an engaging recess 62, in which the engaging protrusion 59 of the locking claw portion 56 can be fitted, at a position adjacent to the removal direction A2 of the engaging portion 61. The engaging recess 62 is recessed inward in the radial direction D from the engaging portion 61. As shown in FIGS. 16 to 19, the engaging portion 61 is, for example, formed of a disk portion. As shown in FIGS. 16 to 19, the engaging recess 62 is, for example, formed of an annular groove that is adjacent to the removal direction A2 of the disk portion serving as the engaging portion 61 and recessed inward in the radial direction D from the outer edge of the disk portion. However, the configurations of the engaging portion 61 and the engaging recess 62 are not limited to the shapes and positions shown in this embodiment.

[0084] 16 to 18, the puncture tool 100 of this embodiment can insert the puncture needle 1 and the sensor 300 into a living body by pushing the movable member 103 in the insertion direction A1. At this time, the engaging portion 61 of the movable member 103 engages with the inclined surface 59a of the engaging protrusion 59 of the locking claw portion 56, which is positioned in the removal direction A2, and presses the engaging protrusion 59 outward in the radial direction D. As a result, as shown in FIG. 17, the extending portion 58 of the locking claw portion 56 elastically deforms outward in the radial direction D. In other words, the multiple locking claws 56 positioned around the outer periphery of the puncture needle 1 in the radial direction D elastically deform so as to move away from each other outward in the radial direction D. Therefore, as shown in FIG. 18, the engaging portion 61 of the movable member 103 can slide over the inclined surface 59a of the engaging protrusion 59 and move over the engaging protrusion 59 in the insertion direction A1.

[0085] 18, when the engaging portion 61 of the movable member 103 rides over the engaging protrusion 59 of the hub 50 of the needle assembly 20, the engaging protrusion 59 fits into the engaging recess 62 of the movable member 103. This causes interference between the movable member 103 and the hub 50 of the needle assembly 20 in the longitudinal direction A. In other words, the needle assembly 20 and the movable member 103 can move together in the longitudinal direction A. This allows the needle assembly 20 and the movable member 103 to be integrated and both to move together in the removal direction A2.

[0086] Resin materials can be used as the material for the moving member 103. Examples of resin materials include thermoplastic resins used in injection molding, such as ABS resin, AS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethylene methacrylate, polyoxyethylene, fluororesin, polycarbonate, polyamide, acetal resin, acrylic resin, and polyethylene terephthalate, as well as thermosetting resins, such as phenol resin, epoxy resin, silicone resin, and unsaturated polyester.

[0087] The housing 104 is an exterior member that covers the needle assembly 20, the movable member 103, the biasing member 105, the detector 106, and the sensor 300, which will be described later. As shown in Figures 16 to 19, the housing 104 of this embodiment includes a cylindrical member 71 that covers the periphery of the needle assembly 20, the movable member 103, the biasing member 105, the detector 106, and the sensor 300, which will be described later, in the radial direction D when the puncture needle 1 is in the standby position (see Figure 16), and a base plate 72 that covers the end face of the cylindrical member 71 in the insertion direction A1.

[0088] The surface of the base plate 72 on the insertion direction A1 side forms a contact surface 72a that comes into contact with the biological surface BS when the puncture needle 1 and sensor 300 are inserted into the living body. A through-hole 74 that penetrates the base plate 72 in the longitudinal direction A is formed. When the puncture needle 1 is moved from the standby position (see FIG. 16) to the insertion position (see FIG. 18), the puncture needle 1 protrudes from the contact surface 72a in the insertion direction A1 through the through-hole 74. The contact surface 72a is provided with an attachment portion for placement on the biological surface BS.

[0089] Furthermore, although the housing 104 of this embodiment has a configuration in which the cylindrical member 71 and the base plate 72 are detachable, the present invention is not limited to this configuration. The cylindrical member 71 and the base plate 72 may both be formed as a single unit. However, by making both detachable, the size of the portion placed on the biological surface BS can be easily reduced, thereby reducing the burden on the subject.

[0090] Examples of materials that can be used for the housing 104 include resin materials, such as thermoplastic resins used in injection molding, such as ABS resin, AS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethylene methacrylate, polyoxyethylene, fluororesin, polycarbonate, polyamide, acetal resin, acrylic resin, and polyethylene terephthalate, as well as thermosetting resins such as phenol resin, epoxy resin, silicone resin, and unsaturated polyester.

[0091] The biasing member 105 of this embodiment is elastically deformable in the longitudinal direction A. The biasing member 105 of this embodiment is a coil spring that elastically deforms in the longitudinal direction A. The coil spring serving as the biasing member 105 is disposed between the hub 50 of the needle assembly 20 and the base plate 72 of the housing 104. Therefore, the coil spring serving as the biasing member 105 of this embodiment is compressed and deformed when the puncture needle 1 moves from the standby position (see FIG. 16) to the insertion position (see FIG. 18). Furthermore, by releasing the restoring force of the coil spring serving as the biasing member 105 while the puncture needle 1 is in the insertion position (see FIG. 18), the puncture needle 1 can be moved from the insertion position (see FIG. 18) in the removal direction A2.

[0092] Therefore, in the puncture device 100 of this embodiment, when the puncture needle 1 and the sensor 300 are inserted into a living body, the needle assembly 20 and the moving member 103 are moved in the insertion direction A1 against the restoring force of the coil spring serving as the biasing member 105. As a result, as shown in FIGS. 17 and 18 , the needle assembly 20 and the moving member 103 move in the insertion direction A1, and the puncture needle 1 and the sensor 300 are inserted into the living body. Then, after the puncture needle 1 and the sensor 300 have been inserted into the living body, the pressing force applied to the needle assembly 20 and the moving member 103 in the insertion direction A1 is released, and the restoring force of the coil spring serving as the biasing member 105 moves the needle assembly 20 and the moving member 103 in the removal direction A2. This allows the puncture needle 1 to be removed from the living body, leaving the sensor 300 inside the living body. In this embodiment, the restoring force of the coil spring serving as the biasing member 105 causes the puncture needle 1 to return from the inserted position (see FIG. 18) to a position where it is housed again in the housing 104 (for example, the standby position the same as in FIG. 16) (see FIG. 19).

[0093] The detector 106 is operably connected to the sensor 300. Specifically, the detector 106 is connected to the sensor 300 via a contact portion 90 including, for example, a conductive plate, an electrical signal line, etc. The contact portion 90 connects the detector 106 and the sensor 300 through the slit 2b of the puncture needle 1. Therefore, the detector 106 can receive detection information from the sensor 300 placed in the living body. As described above, the detector 106 analyzes the detection signal received from the sensor 300 and transmits the analysis results to an external device such as a display device as necessary. The detector 106 is composed of a processor, memory, battery, etc. As described above, the detector 106 may be provided on a separate transmitter that can be combined with the base plate 72, rather than on the base plate 72. In this case, instead of the detector 106, only the contact portion with the transmitter is first placed on the base plate 72 by the puncture device 100.

[0094] As shown in FIGS. 16 to 19 , the detector 106 of this embodiment moves in the insertion direction A1 together with the puncture needle 1 and the sensor 300 when the puncture needle 1 and the sensor 300 are inserted into a living body. More specifically, the detector 106 of this embodiment is held by the hub 50 when the puncture needle 1 is in the standby position (see FIG. 16 ). When the puncture needle 1 moves from the standby position (see FIG. 16 ) to the insertion position (see FIG. 18 ), the detector 106 moves in the insertion direction A1 together with the needle assembly 20. When the puncture needle 1 reaches the insertion position (see FIG. 18 ), the detector 106 engages with the base plate 72 of the housing 104, and is released from being held by the needle assembly 20. Any means, such as adhesive or mechanical engagement, can be used to engage the detector 106 with the base plate 72. As a result, the detector 106 is held on the base plate 72. Therefore, when the puncture needle 1 is removed from the living body, that is, when the puncture needle 1 returns from the insertion position to the standby position, the needle assembly 20 moves in the removal direction A2, but the detector 106 does not move in the removal direction A2 and is left on the base plate 72 of the housing 104.

[0095] The sensor 300 of this embodiment is a thin wire-like member housed inside the puncture needle 1. A member that detects an electrical signal corresponding to the amount or concentration of the substance to be measured can be used as the sensor 300. The sensor 300 extends inside the puncture needle 1 along the longitudinal direction A of the puncture needle 1.

[0096] The sensor 300 may be, for example, a wire electrode with a circular cross section. The wire electrode is housed within the puncture needle 1. The outer diameter of the wire electrode may be, for example, 0.02 mm to 0.2 mm. The puncture needle 1 may house, for example, two wire electrodes: a working electrode and a reference electrode. The working electrode may be constructed based on a core material having a conductive surface, and may include a sensing unit configured to detect the substance to be measured on the outer wall of the core material, and a protective unit coated on the outer wall of the core material with an insulating material. The sensing unit can detect changes in electrical characteristics in response to the substance to be measured. The sensing unit is formed on the surface of the core material using a thin film formation method such as dipping, electropolymerization, or sputtering. A reagent that specifically reacts with the substance to be measured is applied to the surface of the working electrode. When the substance to be measured is glucose, a reagent containing glucose oxidase or a phenylboronic acid compound is used. The reference electrode is used as a reference electrode for the above-mentioned working electrode. A reference electrode or a counter electrode may be wound around the working electrode in a coil shape to form a single wire electrode. Alternatively, the puncture needle 1 itself may be used as the reference electrode or the counter electrode. Information on the substance to be measured detected by the sensing portion of the working electrode is transmitted to the detector 106.

[0097] The puncture needle and needle assembly according to the present disclosure are not limited to the specific configurations shown in the above-described embodiments, and various modifications, alterations, and combinations are possible without departing from the scope of the claims.

[0098] The aspects of the puncture needle and needle assembly according to the present disclosure are as follows. 1. A puncture needle comprising: a puncture portion having a blade surface at a tip end surface and a slit extending to the tip end surface; and a retained portion connected to a base end of the puncture portion and configured to be retained by a hub, the retained portion including: a tubular portion having a substantially constant outer diameter larger than a maximum outer diameter of the puncture portion, and a tapered portion located between the puncture portion and the tubular portion, an outer diameter of the tapered portion gradually decreasing from a side of the tubular portion to a side of the puncture portion, wherein in a lateral view with the slit facing upward, lower contour lines of the puncture portion, the tubular portion, and the tapered portion are collinear. 2. The puncture needle according to claim 1, wherein the slit extends from the tip end surface of the puncture portion to the tapered portion of the retained portion. 3. The puncture needle according to claim 2, wherein the slit terminates at the tapered portion. 4. The puncture needle according to any one of claim 2 or 3, therefore in the tapered portion, a width of the slit gradually decreases to a side of a base end. 5. The puncture needle according to any one of claims 1 to 4, however an outer diameter of the puncture portion is substantially constant on a side of the base end relative to the tip end surface. 6.A needle assembly comprising: the puncture needle according to any one of claims 1 to 5; and a hub for retaining the retained portion of the puncture needle. [Industrial Applicability]

[0099] The present disclosure relates to puncture needles and needle assemblies. [Explanation of symbols]

[0100] 1: Puncture needle 2: Puncture part 2a: Blade surface 2b: Slit 3:Holded part 4: Needle tip 11: Pipe part 12: Tapered section 13a, 13b: Side wall part 13c: Bottom 20: Needle assembly 50: Hub 50a: Containment space 51: Enclosure wall 51a1:Aperture 52: Wall end surface 55: Main body 56: Locking claw part 57: Outer flange 58: Extension part 59: Engagement convex part 59a: Inclined surface 61: Engagement part 62: Engagement recess 71: Cylindrical member 72: Base plate 72a: Contact surface 74:Through hole 90: Contact point 100: Puncture device 103: Moving member 104: Housing 105: biasing member 106:Electronic equipment 200: Adhesive material 300: Sensor A: Longitudinal direction of the puncture needle A1: Insertion direction A2: Removal direction B: Circumferential direction of the needle C: Width direction of the puncture needle D: Radial direction of the puncture needle H1: Distance between the contour lines of the puncture part when viewed from the side with the slit of the puncture part facing upward H2: Distance between the contour lines of the tube when viewed from the side with the slit of the puncture part facing upward H3: Distance between contour lines of the puncture site in top view H4: Distance between the contour lines of the pipes when viewed from above M: Common center line R: Minimum diameter of the hub opening T1: Outer diameter of the puncture part T2: Outer diameter of the pipe T3: Outer diameter of tapered part W: Slit width BS: Biological surface CL1, CL4, CL7, CL10: contour of the puncture site CL2, CL5, CL8, CL11: Pipe outline CL3, CL6, CL9, CL12: Contour line of tapered section θ1: Inclination angle of the upper contour line of the tapered portion relative to the longitudinal direction in side view θ2: Inclination angle of the contour lines on both sides of the tapered portion in the width direction relative to the longitudinal direction when viewed from above

Claims

1. a puncture needle including a puncture part having a blade surface on its distal end surface and a held part connected to a base end side of the puncture part; a hub for holding the held portion of the puncture needle, the puncture portion has a slit extending to the distal end surface, The held portion is a tubular portion having a substantially constant outer diameter larger than the maximum outer diameter of the puncture portion; a tapered portion located between the puncture portion and the tubular portion, the tapered portion having an outer diameter gradually decreasing from the tubular portion side toward the puncture portion side, In a side view of the puncture needle with the slit facing upward, the contour lines of the lower sides of the puncture portion, the tubular portion, and the tapered portion are continuous in a straight line, the slit extends from the distal end surface of the puncturing portion to the tapered portion of the held portion, a needle assembly, wherein the slit is formed over the entire longitudinal area of ​​the portion of the puncture needle that protrudes from the hub and is exposed to the outside of the hub.

2. The needle assembly of claim 1 , wherein the slit terminates in the tapered portion.

3. 3. The needle assembly according to claim 1, wherein the width of the slit gradually decreases toward the base end in the tapered portion.

4. The needle assembly according to claim 1 , wherein the outer diameter of the puncture portion is substantially constant from the distal end surface to the proximal end.

5. A needle assembly described in any one of claims 1 to 4, wherein, when viewed from the top of the puncture needle from the slit side, the contour lines of both sides of the puncture portion, the tubular portion and the tapered portion are not connected in a straight line.

6. A needle assembly according to any one of claims 1 to 5; a sensor held inside the puncture unit; a contact portion that extends from the inside to the outside of the puncture portion through the slit and is capable of connecting the sensor to a detector or transmitter.

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