Puncture needle and needle assembly

Abstract

The puncture needle of the present disclosure is provided with: a puncture portion provided with a blade surface at a front end surface; and a held portion connected to a base end side of the puncture portion and configured to be able to be held to a bushing, the puncture portion is provided with a slit extending to the front end surface, the held portion is provided with: a tube 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 tube portion and having an outer diameter gradually decreasing from the tube portion side toward the puncture portion side, in a side view in which the slit is directed upward, a contour line of the puncture portion, the tube portion, and a lower side of the tapered portion is connected in a straight line shape.

Description

Technical Field

[0001] This disclosure relates to puncture needles and needle assemblies. Background Technology

[0002] Sometimes, medical devices such as sensors are implanted into the body of a patient or other subject being tested. For example, a sensor is implanted into the body of a subject to monitor analytes (e.g., glucose, pH, cholesterol, proteins, etc.) in the subject's blood or bodily fluids. In this case, a puncture tool is used to quickly and easily implant the sensor into the body by penetrating the subject's skin. Such puncture tools are disclosed in Patent Documents 1 and 2. In the puncture tool described in Patent Document 1, the sensor and a puncture needle are inserted into the body, leaving the sensor subcutaneously, and only the puncture needle is withdrawn from the body.

[0003] In the puncture tools described in Patent Documents 1 and 2, the placement of a sensor into the body and the placement of an electronic device such as a transmitter connected to the sensor onto the surface of the body are performed in conjunction with the insertion and withdrawal of the puncture needle. In this case, a puncture tool with a structure that allows the puncture needle to be withdrawn without obstructing the contact points between the sensor and the electronic device is required. Therefore, in the puncture tools described in Patent Documents 1 and 2, a U-shaped or V-shaped puncture needle with a slit is used. Furthermore, Patent Document 1 discloses an example where the base of such a puncture needle is designed to penetrate and maintain the length of the puncture needle bushing. Additionally, Patent Document 2 discloses a structure in which a pair of wing-like portions are provided on the puncture needle.

[0004] Patent Document 1: U.S. Patent Application Publication No. 2017 / 265791

[0005] Patent Document 2: International Publication No. 2013 / 035455

[0006] The puncture needles described in Patent Documents 1 and 2 are preferably thinner to reduce pain for the patient. However, compared to tubular needles, the puncture needles with slits described in Patent Documents 1 and 2 have a smaller mounting area to the bushing and a smaller amount of adhesive used for bonding to the bushing. Therefore, the bonding strength between the puncture needle and the bushing becomes problematic. In Patent Document 1, by extending the base end of the slit needle (which serves as the puncture needle) to penetrate the bushing, the mounting area of ​​the puncture needle to the bushing is increased, ensuring the strength of the bonding to the bushing. Furthermore, in Patent Document 2, by attaching a pair of wing-like portions provided on the slit needle (which serves as the puncture needle) to the head (which serves as the bushing), the strength of the bonding to the head is ensured.

[0007] However, in the puncture needles described in Patent Documents 1 and 2, there is still room for improvement from the viewpoint of simplifying the structure used to ensure the strength of the connection to the bushing. Summary of the Invention

[0008] The purpose of this disclosure is to provide a puncture needle and needle assembly that achieves reduced pain for the test subject and increased strength of engagement with the bushing through a simple structure.

[0009] The puncture needle of the first embodiment disclosed herein comprises: a puncture portion having a cutting edge on its front end face; and a retaining portion connected to the base end side of the puncture portion and configured to be retained in a bushing, the puncture portion having a slit extending to the front end face, and the retaining portion comprising: a tube having a substantially constant outer diameter larger than the maximum outer diameter of the puncture portion; and a tapered portion located between the puncture portion and the tube, the outer diameter of which gradually decreases from the tube side toward the puncture portion side, and in a side view with the slit facing upward, the outlines of the puncture portion, the tube, and the lower side of the tapered portion are connected in a straight line.

[0010] As one embodiment of this disclosure, the slit extends from the front end face of the puncture portion to the tapered portion of the retained portion.

[0011] In one embodiment of this disclosure, the slit forms an end in the tapered portion.

[0012] As one embodiment of this disclosure, the width of the slit gradually decreases toward the base end in the tapered portion.

[0013] As one embodiment of this disclosure, the outer diameter of the puncture portion is approximately constant at a position closer to the base end than the front end face.

[0014] As a second embodiment of the needle assembly disclosed herein, it includes the aforementioned puncture needle and a bushing that holds the held portion of the puncture needle.

[0015] According to this disclosure, a puncture needle and needle assembly can be provided that achieves reduced pain for the subject and increased bonding strength with the bushing through a simple structure. Attached Figure Description

[0016] Figure 1 This is a perspective view of a puncture needle as one embodiment of the present disclosure.

[0017] Figure 2 From and Figure 1 Observing from different perspectives Figure 1 A three-dimensional view of the puncture needle shown.

[0018] Figure 3 yes Figure 1 The top view of the puncture needle shown.

[0019] Figure 4 yes Figure 1 The image shows a bottom view of the puncture needle.

[0020] Figure 5 yes Figure 1 The left-side view of the puncture needle shown.

[0021] Figure 6 yes Figure 1 The right-side view of the puncture needle shown.

[0022] Figure 7 Viewed from the front side Figure 1 The diagram shows the front end of the puncture needle.

[0023] Figure 8 Viewed from the base side Figure 1 The diagram shows the base of the puncture needle.

[0024] Figure 9 It is Figure 3 A magnified top view of a portion of the image.

[0025] Figure 10 It is Figure 5 A magnified left-side view of a portion of the image.

[0026] Figure 11 yes Figure 9 , Figure 10 A cross-sectional view at the location of line II.

[0027] Figure 12 yes Figure 9 , Figure 10 A cross-sectional view at the location of line II-II.

[0028] Figure 13 yes Figure 9 , Figure 10 A cross-sectional view at the location of line III-III.

[0029] Figure 14 It has Figure 1 The diagram shows a cross-sectional view of a needle assembly according to one embodiment of this disclosure, and is intended to illustrate the puncture needle. Figure 9 A cross-sectional view of the puncture needle at the location of the IV-IV line.

[0030] Figure 15 It is about Figure 14 The needle assembly shown is a representation of the needle assembly. Figure 10 A cross-sectional view of the puncture needle at the location of the VV line.

[0031] Figure 16 It means possessing Figure 14 The diagram shown is of the puncture tool of the needle assembly, indicating that the puncture needle is in the standby position.

[0032] Figure 17 It means Figure 16 The diagram shows the state of the puncture needle of the puncture tool as it moves from the standby position to the insertion position.

[0033] Figure 18 It means Figure 16 The diagram shows the puncture needle of the puncture tool in the insertion position.

[0034] Figure 19 It means Figure 16 The diagram shows the state of the puncture needle of the puncture tool being withdrawn from the insertion position outside the organism.

[0035] Figure 20 This is a diagram illustrating the manufacturing process of the puncture needle disclosed herein.

[0036] Figure 21 It means Figure 20 The diagram shows the first step of the stamping process.

[0037] Figure 22 It means Figure 20 The diagram shows the second step of the stamping process.

[0038] Figure 23 It means Figure 20 A diagram illustrating an example of a separation process. Detailed Implementation

[0039] Hereinafter, embodiments of the puncture needle and needle assembly of the present disclosure will be described by way of example with reference to the accompanying drawings. Common structures in all figures are labeled with the same reference numerals.

[0040] [Puncture needle]

[0041] Figure 1 This is a perspective view of a puncture needle 1, which is one embodiment of the puncture needle disclosed herein. Figure 2 From and Figure 1 A three-dimensional view of the puncture needle 1 from different perspectives. In this specification, the distal end of the puncture needle 1 in the longitudinal direction A, where it is inserted into the body, is referred to as the "proximal end." The proximal end of the puncture needle 1 on the opposite side of the distal end in the longitudinal direction A is referred to as the "base end." Furthermore, in the longitudinal direction A, the direction from the base end of the puncture needle 1 towards the proximal end is sometimes referred to as the "insertion direction A1." Additionally, in the longitudinal direction A, the direction from the proximal end of the puncture needle 1 towards the base end is sometimes referred to as the "withdrawal direction A2."

[0042] like Figure 1 , Figure 2 As shown, the puncture needle 1 has a puncture portion 2 and a holding portion 3. Figure 1 As shown, the puncture section 2 has a cutting edge 2a on its front end face. Figure 1 As shown, the puncture portion 2 has a slit 2b extending along the length direction A. The slit 2b extends to the front end face. The retaining portion 3 is connected to the base end side of the puncture portion 2. The retaining portion 3 is configured to be retained in the bushing (for example, see reference). Figures 14-19 (as shown in "Bushing 50").

[0043] For ease of explanation, the side of the puncture needle 1 where the slit 2b is formed will be referred to as the "upper surface of the puncture needle 1". The side of the puncture needle 1 opposite to the side where the slit 2b is formed will be referred to as the "lower surface of the puncture needle 1". Furthermore, when viewing the puncture needle 1 from the base side towards the front side in the longitudinal direction A, the side 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 located to the left of the slit 2b will be referred to as the "left side surface of the puncture needle 1". Therefore, Figure 1 The three-dimensional view of the puncture needle 1 shown is a three-dimensional view of the upper surface, the front end surface and the right side surface of the puncture needle 1. Figure 2 The three-dimensional view of the puncture needle 1 shown is a three-dimensional view of the lower surface, base surface and left side of the puncture needle 1.

[0044] in addition, Figure 3 This is a top view of puncture needle 1. Figure 4 This is a bottom view of puncture needle 1. Figure 5 This is a left-side view of puncture needle 1. Figure 6 This is a right-side view of puncture needle 1. Figure 7 This is a view of the front end of the puncture needle 1 from the front side. Figure 8 This is a view of the base of the puncture needle 1 from the base side. Figure 9 It is Figure 3 The enlarged top view of a portion of the puncture needle 1 shown. Additionally, Figure 10 It is Figure 5 The enlarged left-side view of a portion of the left-side view of the puncture needle 1 shown. Figure 11 yes Figure 9 , Figure 10 A cross-sectional view of the puncture needle 1 at the location of line II. Figure 12 yes Figure 9 , Figure 10 A cross-sectional view of the puncture needle 1 at the location of line II-II. Figure 13 yes Figure 9 , Figure 10 A cross-sectional view of the puncture needle 1 at the location of line III-III.

[0045] like Figures 1-10 As shown, the holding part 3 includes a tube portion 11 and a tapered portion 12. The tube portion 11 has a substantially constant outer diameter T2 (see reference). Figure 13 The outer diameter T2 of the tube 11 is greater than the outer diameter T1 of the puncture section 2 (refer to...). Figure 11 More specifically, the outer diameter T2 of the tube 11 is larger than the maximum outer diameter T1max of the puncture section 2. For example... Figure 11 As shown, the outer diameter T1 of the puncture section 2 refers to the maximum cross-sectional length of the puncture section 2 in a section orthogonal to the length direction A. Furthermore, the maximum outer diameter T1max of the puncture section 2 refers to the maximum value when comparing the aforementioned outer diameter T1 at a position in the length direction A. Additionally, as... Figure 13 As shown, the outer diameter T2 of the tube 11 refers to the maximum cross-sectional length of the tube 11 in the section orthogonal to the length direction A. For example... Figure 13 As shown, when the cross-section of the tube 11 orthogonal to the length direction A is circular, the outer diameter T2 of the tube 11 becomes the diameter of the outer circumferential surface of the tube 11.

[0046] The tapered portion 12 is located between the puncture portion 2 and the tube portion 11. The outer diameter T3 of the tapered portion 12 gradually decreases from the tube portion 11 side towards the puncture portion 2 side. Figure 12 As shown, the outer diameter T3 of the tapered portion 12 refers to the maximum cross-sectional length of the tapered portion 12 in the section orthogonal to the length direction A.

[0047] Thus, it is configured to remain in the bushing (e.g., refer to...) Figures 14-19 The retaining portion 3 of the "shelter 50" shown has the aforementioned tapered portion 12. Therefore, the outer surface of the tapered portion 12, which is inclined relative to the length direction A, can be easily fixed to the bushing directly or indirectly via adhesive or the like. As a result, the puncture needle 1 is difficult to detach from the bushing in the insertion direction A1. The retaining portion 3 of the puncture needle 1 has a tubular portion 11. Therefore, compared to puncture needles with a structure having slits throughout their entire length and lacking a tubular retaining portion, the bonding strength between the puncture needle 1 and the bushing can be improved. The puncture needle 1 has a tapered portion 12, thereby improving the bonding strength with the bushing through the shape of the outer surface of the tapered portion 12. Compared to puncture needles where the retaining portion is only a tubular portion, the puncture needle 1 can achieve high bonding strength with the bushing. Therefore, the length of the puncture needle 1 can be shortened, thus enabling miniaturization of the puncture tool.

[0048] Furthermore, if the tapered portion 12 is provided, it is not necessary to increase the diameter of the puncture portion 2 located at the front end of the holding portion 3 in order to improve the strength of the engagement between the puncture needle 1 and the bushing. Additionally, by providing the tapered portion 12, as described above, it is easier to fix it to the bushing. By providing the tube portion 11 adjacent to the tapered portion 12, the outer diameter T2 of the tube portion 11 can be 110% to 210% relative to the outer diameter T1max of the puncture portion 2. That is, by providing both the tube portion 11 and the tapered portion 12, the minimum cross-sectional length required for the insertion of the puncture portion 2 into the sensor can be maintained, further improving the strength of the engagement between the puncture needle 1 and the bushing. Therefore, the puncture resistance during biological puncture of the puncture portion 2 can be reduced. Furthermore, the pain of the subject can be reduced.

[0049] Thus, by providing a simple structure with a tapered portion 12 in the retaining portion 3, it is possible to reduce the pain of the subject and increase the strength of the engagement with the bushing, based on the puncture needle 1.

[0050] Additionally, the holding part 3 has a tube 11, through which the puncture needle 1 is inserted into the bushing (for example, see reference). Figures 14-19 The assembly of the "shoulder 50" shown becomes easier. Specifically, for example, the position of the central axis O of the tube 11 of the holding part 3 can be used for relative positioning of the puncture needle 1 and the bushing in a plane orthogonal to the length direction A. In this way, by utilizing the tube 11, the assembly of the puncture needle 1 to the bushing can be easily performed.

[0051] In addition, such as Figure 5 , Figure 6 , Figure 10 As shown, in a side view with the slit 2b of the puncture section 2 facing upwards, the outlines of the puncture section 2, the tube section 11, and the lower side of the conical section 12 are connected by a straight line. That is, in Figure 5 , Figure 6 , Figure 10 In the side view, the lower contour line CL1 of the puncture portion 2, the lower contour line CL2 of the tube portion 11, and the lower contour line CL3 of the tapered portion 12 are connected in a straight line. This structure enables the production of a puncture needle 1 with excellent mass production capabilities. Specifically, by integrally supporting the puncture portion 2, tube portion 11, and tapered portion 12 of the puncture needle 1 along the straight contour lines CL1, CL2, and CL3, the blade-forming process of forming a cutting edge on the front end face of the puncture portion 2 is easily performed. More specifically, by having the straight contour lines CL1, CL2, and CL3, the puncture needle 1 can be accurately supported on a clamp or similar fixture. This maintains mass production capabilities and allows for accurate cutting of the center of the cutting edge. Furthermore, arbitrary machining of the cutting edge is easily applied. The puncture needle 1 with its precisely formed cutting edge not only reduces puncture resistance but also alleviates pain for the patient.

[0052] For example, stainless steel, aluminum, aluminum alloy, titanium, titanium alloy, magnesium alloy, and other metallic materials can be used as the material for the puncture needle 1. The material chosen for the puncture needle 1 is one that can be manufactured through plastic forming. Examples of plastic forming include machining a drawn tube with a specified inner diameter by cutting, or stamping a metal plate. Preferably, a material suitable for stamping is chosen as the material for the puncture needle 1.

[0053] The following is for reference Figures 1 to 13 Further details of the puncture needle 1 in this embodiment will be described.

[0054] <Puncture Section 2>

[0055] like Figures 1-6 As shown, in this embodiment, the puncture portion 2 extends linearly along the length direction A. Figure 1 As shown, a cutting edge 2a, which is formed by an inclined surface that is inclined relative to the length direction A, is formed on the front end face of the puncture part 2. The needle tip 4 of the puncture needle 1 is formed from the distal end, i.e., the front end, of the cutting edge 2a of the puncture part 2. That is, the front end face of the puncture needle 1 is formed from the front end face of the puncture part 2 on which the cutting edge 2a is formed.

[0056] In this embodiment, the cutting surface 2a is formed by a plane inclined relative to the length direction A, but the cutting surface 2a is not limited to this structure. For example, the cutting surface 2a may also be a structure formed by multiple planes inclined at different angles relative to the length direction A. Alternatively, the cutting surface 2a may also be a structure that includes a curved surface inclined relative to the length direction A.

[0057] like Figure 1 As shown, the puncture portion 2 has a slit 2b extending along the length direction A. In this embodiment, the slit 2b extends from the tapered portion 12 of the holding portion 3 to the front end face of the puncture portion 2. By forming such a slit 2b, the length of the slit 2b in the length direction A can be sufficiently ensured. In this embodiment, from the holding portion 3 (for example, see the bushing)... Figures 14-19 The portion of the puncture needle 1 on the front end side, where the retaining part 3 of the "shelter 50" (shown) protrudes and protrudes outside the bushing, allows for the arrangement of a slit 2b across the entire length direction A. Therefore, it is possible to suppress the sensor 300 (described later) Figures 16-19 ) and detector 106 (reference) Figures 16-19 The contact portion 90 is stuck at the base of the slit 2b, and is damaged or broken.

[0058] In addition, such as Figure 1 , Figure 3 , Figure 9As shown, in this embodiment, the slit 2b terminates at the tapered portion 12. That is, the base end of the slit 2b in this embodiment terminates at the position of the tapered portion 12. In other words, the base end of the slit 2b in this embodiment terminates at a position closer to the front end of the tube portion 11. Therefore, it is possible to ensure that the annular tube portion 11, having a substantially constant outer diameter T2, can maintain the puncture needle 1 towards the bushing (for example, see reference 1). Figures 14-19 The ease of assembly of the "shield 50" shown is enhanced. Furthermore, since the retaining part 3 has a tube portion 11, the same level of bonding strength as that of a so-called tubular needle can be ensured in the tube portion 11. Additionally, the machining processes conventionally used in tubular needles can be performed.

[0059] In addition, such as Figure 3 , Figure 9 As shown, in this embodiment, the width W of the slit 2b gradually decreases towards the base end in the tapered portion 12. The width W of the slit 2b refers to the width in the top view of the puncture needle 1 viewed from the slit 2b side (see reference 1). Figure 3 , Figure 9 The length of slit 2b in a direction orthogonal to the extension direction of slit 2b (length direction A in this embodiment). Figure 3 As shown, in this embodiment, the width W of the slit 2b is constant within the puncture section 2 and is independent of its position in the length direction A. In contrast, the width W of the slit 2b in this embodiment gradually decreases towards the base end within the tapered section 12. Furthermore, as described above, the slit 2b in this embodiment terminates at the tapered section 12. When the maximum slit width of the puncture section 2 is 100%, the width W of the slit 2b closes towards the base end at intervals of 3 to 100% of the axial length of the puncture needle 1 per 1 mm.

[0060] like Figure 11 As shown, the puncture portion 2 of this embodiment is a U-shaped needle portion having a generally U-shaped shape in a cross-sectional view orthogonal to the length direction A. The puncture portion 2 of this embodiment has a generally U-shaped shape in a cross-sectional view orthogonal to the length direction A at any position along the length direction A. In other words, as... Figure 11 As shown, the puncture section 2 of this embodiment includes opposing sidewall portions 13a and 13b and a bottom portion 13c connected to these sidewall portions 13a and 13b. The bottom portion 13c is located on the lower surface side of the puncture needle 1.

[0061] like Figure 11As shown, the sidewall portions 13a and 13b of this embodiment are composed of flat plate portions extending in a generally straight line in a cross-sectional view orthogonal to the length direction A, but are not limited to this structure. The sidewall portions 13a and 13b may also be composed of curved plate portions extending in an arc shape, smoothly connected to the bottom 13c of this embodiment in a cross-sectional view orthogonal to the length direction A. In other words, the puncture portion 2 of this embodiment may also be a C-shaped needle portion having a generally C-shaped shape in a cross-sectional view orthogonal to the length direction A. Alternatively, the puncture portion 2 of this embodiment may also be a V-shaped needle portion having a generally V-shaped shape in a cross-sectional view orthogonal to the length direction A, composed only of the sidewall portions 13a and 13b.

[0062] Furthermore, the sidewall portions 13a, 13b and bottom portion 13c of the puncture portion 2 in this embodiment have approximately the same wall thickness, but the structure is not limited to this. The wall thicknesses of the sidewall portions 13a, 13b and bottom portion 13c may also be different.

[0063] In addition, the outer diameter T1 of the puncture section 2 in this embodiment (refer to...) Figure 11 The outer diameter T1 of the puncture portion 2 is approximately constant towards the base end compared to the front end surface where the blade surface 2a is formed. That is, in this embodiment, the puncture portion 2, except for the front end surface where the blade surface 2a is formed, is composed of approximately the same thickness in the length direction A. However, the outer diameter T1 of the puncture portion 2 may, for example, gradually decrease from the base end side toward the front end side in the length direction A.

[0064] <Part 3 of the Preservation Section>

[0065] like Figure 1 As shown, the holding part 3 in this embodiment is composed of the aforementioned tube part 11 and tapered part 12. That is, as... Figure 9 , Figure 10 As shown, in this embodiment, the front end of the tapered portion 12 is connected to the base end of the puncture portion 2. Furthermore, the base end of the tapered portion 12 in this embodiment is connected to the front end of the tube portion 11. Additionally, the base end face of the puncture needle 1 in this embodiment is formed by the base end face of the tube portion 11. The base end face of the tube portion 11 in this embodiment is formed by a plane orthogonal to the length direction A.

[0066] As described above, the outer diameter T2 of the tube 11 is approximately constant along the length direction A. Furthermore, the inner diameter of the tube 11 in this embodiment is also approximately constant along the length direction A. Additionally, as... Figure 13 As shown, the tube 11 of this embodiment has approximately the same wall thickness throughout the circumferential region B surrounding the central axis O. However, the wall thickness of the tube 11 may vary depending on the position of the circumferential region B.

[0067] As described above, the outer diameter T3 of the tapered portion 12 gradually decreases from the base end side towards the front end side in the length direction A. Furthermore, the inner diameter of the tapered portion 12 in this embodiment also gradually decreases from the base end side towards the front end side in the length direction A. Additionally, as... Figure 12 As shown, the tapered portion 12 in this embodiment has approximately the same wall thickness, regardless of the position of the circumferential direction B. However, the wall thickness of the tapered portion 12 can also vary depending on the position of the circumferential direction B.

[0068] As described above, in this embodiment, the width W of the slit 2b gradually decreases towards the base end side in the tapered portion 12. More specifically, as... Figure 9 As shown, in this embodiment, the width W of the slit 2b gradually decreases from the front 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 begins to gradually decrease is not limited to the front end of the tapered portion 12. The slit 2b may also begin to gradually decrease closer to the base end than the front 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 also terminate closer to the front end than the base end of the tapered portion 12.

[0069] <Shape of the outline of the puncture part 2 and the retaining part 3>

[0070] Next, the shapes of the outlines of the puncture portion 2 and the held portion 3 when viewed from a prescribed perspective will be described.

[0071] As described above, in the side view with the slit 2b of the puncture section 2 facing upward (refer to...) Figure 5 , Figure 6 , Figure 10 The lower contour line CL1 of the puncture section 2, the lower contour line CL2 of the tube section 11, and the lower contour line CL3 of the conical section 12 are connected in a straight line. Furthermore, in this embodiment, in a side view with the slit 2b of the puncture section 2 facing upwards (refer to...), Figure 5 , Figure 6 , Figure 10 The lower sides of the puncture section 2, the tube section 11, and the conical section 12 are connected by a straight outline that extends parallel to the length direction A (or the central axis O). The front end of this straight outline forms a terminal at the needle tip 4. Furthermore, the base end of this straight outline forms a terminal at the base end of the tube section 11.

[0072] In contrast, in this embodiment, in a side view with the slit 2b of the puncture section 2 facing upwards (refer to...), Figure 5 , Figure 6 , Figure 10The outlines of the upper side of the puncture section 2 (CL4), the upper side of the tube section 11 (CL5), and the upper side of the cone section 12 (CL6) are not connected in a straight line.

[0073] Specifically, in the side view with the slit 2b of the puncture section 2 facing upwards (see reference) Figure 5 , Figure 6 , Figure 10 The upper contour line CL4 of the puncture section 2 is connected at an angle to the upper contour line CL6 of the conical section 12. More specifically, in a side view with the slit 2b of the puncture section 2 facing upwards (see reference...), Figure 5 , Figure 6 , Figure 10 The outline CL4 on the upper side of the puncture section 2 is a straight line extending parallel to the length direction A. In contrast, in a side view with the slit 2b of the puncture section 2 facing upwards (see reference...), Figure 5 , Figure 6 , Figure 10 The upper contour line CL6 of the tapered portion 12 is a straight line that extends obliquely relative to the length direction A as it approaches the lower contour line CL3 from the base end side toward the front end side.

[0074] Additionally, in the side view with the slit 2b of the puncture section 2 facing upwards (see reference...) Figure 5 , Figure 6 , Figure 10 The upper contour line CL5 of the tube 11 is connected at an angle to the upper contour line CL6 of the tapered portion 12. More specifically, in a side view with the slit 2b of the puncture portion 2 facing upwards (see reference...), Figure 5 , Figure 6 , Figure 10 The outline CL5 on the upper side of the tube 11 is a straight line extending parallel to the length direction A. In contrast, as described above, in the side view with the slit 2b of the puncture section 2 facing upwards (see reference...), Figure 5 , Figure 6 , Figure 10 The upper contour line CL6 of the tapered portion 12 is a straight line that extends obliquely relative to the length direction A, approaching the lower contour line CL3 from the base side towards the front side. In the side view of the puncture needle 1, the contour line CL6 of the tapered portion 12 is oblique relative to the central axis O of the tube portion 11.

[0075] Additionally, in the side view with the slit 2b of the puncture section 2 facing upwards (see reference...) Figure 5 , Figure 6 , Figure 10The upper contour line CL4 of the puncture section 2 and the upper contour line CL5 of the tube section 11 are both straight lines parallel to the length direction A, but their positions are different in the side view, and they are not on the same straight line. More specifically, in the side view with the slit 2b of the puncture section 2 facing upwards (see reference...), Figure 5 , Figure 6 , Figure 10 The upper contour line CL5 of the tube 11 is located above the upper contour line CL4 of the puncture section 2.

[0076] In other words, such as Figure 10 As shown, in a side view with the slit 2b of the puncture section 2 facing upwards, the distance H1 in the height direction between the lower contour line CL1 and the upper contour line CL4 of the puncture section 2 is shorter than the distance H2 in the height direction between the lower contour line CL2 and the upper contour line CL5 of the tube section 11. In this embodiment, the distance H1 is longer than half of the distance H2.

[0077] Thus, in the puncture needle 1 of this embodiment, in the side view with the slit 2b of the puncture portion 2 facing upward (refer to...), Figure 5 , Figure 6 , Figure 10 The lower contour lines of the puncture section 2, the tube section 11, and the conical section 12 are connected in a straight line, while the upper contour lines of the puncture section 2, the tube section 11, and the conical section 12 are not connected in a straight line.

[0078] Next, in the top view of the puncture needle 1 viewed from the slit 2b side (refer to...) Figure 3 , Figure 9 The outlines of the puncture portion 2 and the retaining portion 3 of the needle 1 will be explained. A bottom view of the puncture needle 1 viewed from the side opposite to the slit 2b (refer to...) Figure 4 The shape and top view of the outline of the puncture part 2 and the held part 3 (refer to) Figure 3 , Figure 9 Since they are the same, the explanation is omitted here.

[0079] In the top view (refer to) Figure 3 , Figure 9 The centers of the puncture section 2, the tube section 11, and the tapered section 12 are aligned in the width direction C, which is orthogonal to the length direction A. That is, in the top view (refer to...) Figure 3 , Figure 9The common center line is shared by the center line at the center of the width direction C of the puncture portion 2, the center line at the center of the width direction C of the tube portion 11, and the center line at the center of the width direction C of the tapered portion 12. In this embodiment, for ease of explanation, the common center line will be referred to as "common center line M". The common center line M in this embodiment extends parallel to the length direction A.

[0080] Additionally, in this embodiment, in the top view (refer to...) Figure 3 , Figure 9 The outlines of the puncture portion 2, the tube portion 11, and the tapered portion 12, located on both sides of the width direction C, are symmetrically arranged with respect to the aforementioned common center line M.

[0081] Additionally, in this embodiment, in the top view (refer to...) Figure 3 , Figure 9 The outlines CL7 on one side of the width direction C of the puncture section 2, CL8 on one side of the width direction C of the tube section 11, and CL9 on one side of the width direction C of the tapered section 12 are not connected in a straight line. Furthermore, in the top view (refer to...) Figure 3 , Figure 9 The outlines CL10 on the other side of the width direction C of the puncture section 2, CL11 on the other side of the width direction C of the tube section 11, and CL12 on the other side of the width direction C of the tapered section 12 are not connected in a straight line.

[0082] Specifically, in the top view (refer to...) Figure 3 , Figure 9 The outline CL7 of the puncture portion 2 along the width direction C is connected at an angle to the outline CL9 of the tapered portion 12 along the width direction C. More specifically, in the top view (refer to...) Figure 3 , Figure 9 The outline CL7 of the puncture section 2 on one side of the width direction C is a straight line extending parallel to the length direction A. In contrast, in the top view (refer to...) Figure 3 , Figure 9 The outline CL9 of the tapered portion 12 on one side of the width direction C is a straight line that extends obliquely relative to the length direction A in a manner that approaches the common center line M from the base end side toward the front end side.

[0083] Additionally, in the top view (refer to...) Figure 3 , Figure 9 The outline CL8 of the tube 11 along the width direction C is connected at an angle to the outline CL9 of the tapered portion 12 along the width direction C. More specifically, in the top view (refer to...) Figure 3 , Figure 9The outline CL8 on one side of the width direction C of the tube 11 is a straight line extending parallel to the length direction A. In contrast, as described above, in the top view (refer to...) Figure 3 , Figure 9 The outline CL9 of the tapered portion 12 on one side of the width direction C is a straight line that extends obliquely relative to the length direction A in a manner that approaches the common center line M from the base end side toward the front end side.

[0084] Additionally, in the top view (refer to...) Figure 3 , Figure 9 The outline CL7 on one side of the width direction C of the puncture section 2 and the outline CL8 on one side of the width direction C of the tube section 11 are both straight lines parallel to the length direction A, but in this top view, the positions where the outlines extend are different and they are not located on the same straight line. More specifically, in the top view (refer to...) Figure 3 , Figure 9 The outline CL8 of the tube portion 11 in the width direction C is located further away from the common center line M in the width direction C than the outline CL7 of the puncture portion 2 in the width direction C. In other words, as... Figure 9 As shown in the top view, the distance H3 in the width direction between the outlines CL7 and CL10 on both sides of the puncture section 2 is shorter than the distance H4 in the width direction between the outlines CL8 and CL11 on both sides of the tube section 11. In this embodiment, the distance H3 is longer than half of the distance H4.

[0085] In the top view (refer to) Figure 3 , Figure 9 The relationship between the outline CL10 on the other side of the width direction C of the puncture part 2, the outline CL11 on the other side of the width direction C of the tube part 11, and the outline CL12 on the other side of the width direction C of the conical part 12 is the same as the relationship between the outline CL7 on one side of the width direction C of the puncture part 2, the outline CL8 on one side of the width direction C of the tube part 11, and the outline CL9 on one side of the width direction C of the conical part 12, so the explanation is omitted here.

[0086] Here, will Figure 10 The contour line CL6 of the upper side of the tapered portion 12 shown is inclined at an angle θ1 relative to the length direction A. θ1 is preferably 0.5° to 60°, more preferably 3° to 10°. By setting it within this range, sufficient assurance can be made for the installation of the bushing and the amount of adhesive applied (described later), and detachment of the puncture needle from the bushing can be prevented. Figure 9 The contour lines CL9 and CL12 of the tapered portion 12 shown on one side and the other side in the width direction C are inclined at an angle of θ2 relative to the length direction A. In this embodiment, θ1 is greater than θ2.

[0087] [Manufacturing method of puncture needle]

[0088] like Figure 20 As shown, the manufacturing method of the puncture needle 1 includes: a receiving step S1, in which a stamping machine receives a strip of metal sheet; and a stamping step S2, in which the stamping machine continuously stamps the sheet to obtain a plurality of rod-shaped parts 150 (see reference) connected to the sheet. Figure 23 The process includes: separation step S3, separating the rod-shaped component 150 from the sheet metal; blade forming step S4, forming a blade at one end of the rod-shaped component 150; and cleaning step S5, cleaning the rod-shaped component 150.

[0089] <Acceptance Process S1>

[0090] A stamping machine (not shown) accepts a strip of metal sheet. In this case, a moving mechanism is used to move the sheet relative to the stamping machine along its length, positioning the forming portion of the sheet at the forming position of the stamping machine. First, the portion of the sheet to be punched into a predetermined unfolded shape is positioned in the punching section of the stamping machine, which performs the punching of the unfolded shape (described later).

[0091] <Stamping process S2>

[0092] Stamping process S2 uses a stamping machine to obtain a rod-shaped part 150 from sheet metal 160 (see reference). Figure 23 The process involves a rod-shaped component 150 that is substantially the same as the puncture needle 1 without a cutting edge 2a, forming a slit 2b (see reference). Figure 1 ), conical part 12 (refer to) Figure 1 ), pipe part 11 (refer to Figure 1 The stamping process S2 includes: a first process (refer to...) Figure 21 The first process involves punching out an unfolded shape, where a portion of the rod-shaped component 150 is connected to the sheet metal; and the second process (refer to...). Figure 22 In the first step, using a stamping machine, the unfolded shape 170 is bent at least once using a punch and a die to form a tubular shape, resulting in a rod-shaped component 150 partially connected to the sheet metal. In the second step, using a continuous stamping machine, multiple dies (molds) 180 and punches (molds) 190 are used to continuously stamp the unfolded shape 170, forming the rod-shaped component 150, which corresponds to the piercing needle 1 other than the cutting edge 2a. Furthermore, surface finishing processes such as knurling are performed on the outer surface of the rod-shaped component 150 during the stamping process.

[0093] <Separation Process S3>

[0094] In separation step S3, the rod-shaped components 150 are sequentially separated from the plate 160 on the frame. In this case, the rod-shaped components 150 are separated at the boundary between the rod-shaped component 150 and the pair of connecting portions 270. The method of separating the rod-shaped components 150 from the plate 160 is not particularly limited; for example, mechanical cutting or laser cutting can be used. In addition, in separation step S3, each rod-shaped component 150 is temporarily fixed approximately simultaneously with or after the separation of the rod-shaped components 150, maintaining the positional relationship between the rod-shaped components 150. In this embodiment, this temporary fixing is achieved by attaching both ends of the rod-shaped components 150 to a pair of adhesive tapes (temporary fixing components) 290 (see reference). Figure 23 Alternatively, at least one portion of the rod-shaped component 150, excluding the central portion in the longitudinal direction, can be adhered to the adhesive tape 290.

[0095] <S4 process for forming the cutting edge>

[0096] In the blade-forming process, a puncture needle 1 is formed by forming a blade 2a at the end of at least one of the temporarily fixed rod-shaped components 150a. The rod-shaped components 150 have outlines CL1, CL2, and CL3 connected in a straight line (see reference). Figure 5 (etc.), thereby enabling the puncture needle 1 to be accurately supported in the temporary fixing clamp. Thus, the cutting edge 2a can be formed while accurately defining the position of the cutting edge 2a relative to the slit 2b.

[0097] In this disclosure, the slit 2b is pre-formed in the stamping process S2, but a normally closed tube can also be formed in the stamping process S2, and the cutting edge and slit are formed in the cutting edge forming process S4. However, since the area to be ground of the slit 2b is significantly larger than that of the cutting edge 2a, mass production is significantly reduced when the cutting edge and slit 2b are formed in the cutting edge forming process S4. Therefore, in this disclosure, a manufacturing process is adopted in which the slit 2b is formed in the stamping process S2, and the cutting edge 2a is formed in the cutting edge forming process S4. Moreover, in the cutting edge forming process S4, in order to form the cutting edge 2a at a certain position relative to the slit 2b, contour lines CL1, CL2, and CL3 (see reference) connected in a straight line are provided on the rod-shaped member 150 (puncture needle 1). Figure 5 wait).

[0098] <Cleaning Process S5>

[0099] In the cleaning process S5, the metal sheet or the like that attached to the puncture needle 1 during the blade forming process S4 is removed. A known cleaning method can be used.

[0100] Furthermore, in the manufacturing process of the puncture needle 1, a straightening process, a grinding process, a bonding process, etc., can be incorporated as needed.

[0101] [Needle Assembly]

[0102] Next, refer to Figure 14 , Figure 15 The needle assembly 20, which is one embodiment of the needle assembly disclosed herein, will be described by way of example. The needle assembly 20 includes the puncture needle 1 described above and a bushing 50 that holds the puncture needle 1 in a holding portion 3. Figure 14 , Figure 15 This is a diagram showing the needle assembly 20. Specifically, Figure 14 , Figure 15 This is a cross-sectional view of the needle assembly 20, showing the needle 1 being held in place by the retaining part 3 within the bushing 50. Figure 14 In, it means Figure 9 The cross-section of the puncture needle 1 at the location of the IV-IV line. Additionally, in Figure 15 In, it means Figure 10 The cross-section of the puncture needle 1 at the location of the VV line.

[0103] like Figure 14 , Figure 15 As shown, the bushing 50 has a surrounding wall portion 51 that divides into a receiving space 50a capable of accommodating the holding portion 3 of the puncture needle 1. Figure 14 , Figure 15 As shown, the puncture needle 1 is housed in the receiving space 50a within the enclosure 51 by the holding part 3, and the puncture part 2 extends from one side of the enclosure 51 (in... Figure 14 , Figure 15 The opening 51a1 (located on the lower side) protrudes from the bushing 50.

[0104] 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 holding 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 cured. The adhesive, serving as the adhesive member 200, is filled in such a way that it contacts the outer surface of the tapered portion 12, which is inclined relative to the length direction A, and is cured in this state. Thus, the tapered portion 12 hooks onto the adhesive, which serves as the adhesive member 200, preventing the holding portion 3 of the puncture needle 1 from detaching from the bushing 50 in the insertion direction A1. That is, by providing the tapered portion 12 to the holding portion 3 of the puncture needle 1, the bonding strength between the puncture needle 1 and the bushing 50 can be improved. As long as the adhesive member 200 is applied at least to the tapered portion 12, the bushing 50 and the puncture needle 1 can be reliably bonded.

[0105] like Figure 14 , 15As shown, the bushing 50 of the needle assembly 20 in this embodiment includes a surrounding wall portion 51 and a wall end face 52. Furthermore, the opening 51a1 is divided by the inner edge of the wall end face 52. The opening 51a1 in this embodiment is a circular opening, but its shape is not particularly limited.

[0106] In addition, such as Figure 14 , Figure 15 As shown, in this embodiment, the minimum diameter R of the opening 51a1 is approximately the same as, or slightly larger than, the outer diameter T2 of the tube portion 11 of the puncture needle 1. Therefore, in this embodiment, by filling at least the area around the tapered portion 12 of the retained portion 3 with the adhesive as the adhesive member 200, the retained portion 3 is prevented from detaching from the bushing 50 through the opening 51a1. In this way, by filling the area around the tapered portion 12 with the adhesive member 200, the retention of the adhesive member 200 in the receiving space 50a can be improved. However, the minimum diameter R of the opening 51a1 can also be smaller than the outer diameter T2 of the tube portion 11. By providing a wall end face 52 having such an opening 51a1, the puncture needle 1 can be prevented from detaching from the bushing 50.

[0107] The shape of the bushing 50 shown in this embodiment is an example; its shape is not particularly limited as long as it holds the puncture needle 1's holding portion 3. Therefore, it can also be the shape referred to later. Figures 16-19 The bushing 50 shown has the same shape.

[0108] For example, resin materials can be used as the material for bushing 50. Examples of such resin materials include ABS resin, AS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene ether, thermoplastic polyurethane, polymethyl methacrylate, polyoxyethylene, fluoropolymers, polycarbonate, polyamide, acetal resin, acrylic resin, polyethylene terephthalate, and other thermoplastic resins used in injection molding, as well as phenolic resins, epoxy resins, silicone resins, and thermosetting resins such as unsaturated polyesters. Furthermore, any adhesive, such as a UV-curable resin, can be used as the bonding component 200.

[0109] [Piercing tools 100]

[0110] Next, refer to Figures 16-19 This is a diagram showing a puncture tool 100 including a needle assembly 20 having a puncture needle 1 and a bushing 50. Figures 16-19 The shape of the bushing 50 shown is the same as described above. Figure 14 , Figure 15 The shape of the bushing 50 shown may vary, but it may also be the same. The shape of the bushing 50 may also be appropriately designed according to the structure of the puncture tool 100 of the application needle assembly 20.

[0111] Figures 16-19 This is a diagram representing puncture tool 100. Figures 16-19 This section outlines the actions of the puncture tool 100 when inserting and retaining the sensor 300 within a living organism. Specifically, Figure 16 This indicates that the puncture needle 1 is in the standby position. Figure 17 This indicates the state of the puncture needle 1 during its movement from the standby position to the insertion position. Figure 18 This indicates that the puncture needle 1 is in the insertion position. Figure 19 This indicates that the puncture needle 1 has been withdrawn from the insertion position and is outside the body.

[0112] like Figures 16-19 As shown, the puncture tool 100 includes a needle assembly 20, a moving part 103, a housing 104, a force-applying part 105, a detector 106, and a sensor 300. Figures 16-19 As shown, the needle assembly 20 of this embodiment includes a puncture needle 1 and a bushing 50.

[0113] First, refer to Figures 16-19 The method of using the puncture tool 100 of this embodiment will be described. As described above, the puncture tool 100 of this embodiment can be used to insert and leave the sensor 300 inside a living organism. The puncture tool 100... Figure 16 The configuration shown is applied to the surface BS of a living organism. That is, Figure 16 This represents the state of the needle assembly 20, including the puncture needle 1 and sensor 300, before they are inserted into the body. Then, an operator, such as a patient, operates the puncture tool 100, thereby inserting the needle assembly 20, including the puncture needle 1 and sensor 300, into the body (see reference). Figure 17 , Figure 18 ). Figure 17 This diagram shows the intermediate state of inserting the puncture needle 1 and sensor 300 into a living organism using the puncture tool 100. Figure 18 This diagram shows the state where the puncture needle 1 and sensor 300 have reached the deepest point within the organism into which the puncture tool 100 can be inserted. Next, as... Figure 19 As shown, with the sensor 300 remaining inside the organism, the puncture needle 1 of the needle assembly 20 is pulled out of the organism. Therefore, the sensor 300 can be inserted into and left inside the organism using the puncture tool 100. Hereinafter, for ease of explanation, the puncture needle 1 will be housed within the housing 104. Figure 16 The position of the puncture needle 1 is described as "standby position of puncture needle 1". Furthermore, for ease of explanation, the puncture needle 1 is positioned from the most protruding part of the housing 104. Figure 18 The position of the puncture needle 1 is recorded as "the insertion position of the puncture needle 1".

[0114] The sensor 300, placed inside the organism, detects the analyte and sends the detection result to the detector 106. The detector 106 is wired to the sensor 300 and is placed on the surface BS of the organism along with the sensor 300. The detector 106 consists of a processor as a control unit, a memory as a storage unit, and a battery as a power source. Figures 16-19 The sensor 300 of this embodiment shown sends information containing the detection result to the detector 106. By using the sensor 300 and the detector 106 together, a signal corresponding to the concentration of the measured substance can be detected. The detection signal is processed by the detector 106 and sent to the subject's smartphone or dedicated terminal. The subject or user can check the measurement result of the measured substance displayed on the screen of the smartphone or dedicated terminal over time. The period during which the sensor 300 is installed on the subject can be appropriately determined, for example, for several hours, several days, a week, a month, etc., depending on the judgment of a doctor or other person. There is no particular limitation on the measured substance, but glucose, oxygen, pH, lactic acid, etc. in blood or interstitial fluid can be measured by selecting the sensing part of the sensor 300. In addition, after the sensor 300 is inserted, the detector 106 is connected to a transmitter (not shown) which is set as a separate unit. In this case, it is also possible to form a structure in which the transmitter, rather than the detector 106, has a memory, battery, etc. In addition, the detector 106, which is left with the sensor 300, can also be a transmitter that includes a transmitter capable of sending information to an external device. That is, the transmitter can also include a processor, memory, battery, etc. The transmitter can be a structure that lasts longer than the sensor 300. In addition, the detector 106 can also be connected to the sensor 300 via a contact portion after the sensor 300 has been placed using the puncture tool 100. In this case, only the contact portion and the sensor 300 are first placed on the surface BS of the organism by the puncture tool 100, and then the detector 106 is connected to the contact portion.

[0115] The puncture needle 1 of the needle assembly 20 has the same structure as described above, so its description is omitted here.

[0116] The bushing 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. A receiving space 50a extending through the surrounding wall 51 in the length direction A is defined. The holding part 3 of the puncture needle 1 is inserted into the receiving space 50a and fixed to the surrounding wall 51 of the main body 55 by an adhesive that serves as an adhesive member 200. The end face 52 of the wall is connected to the end of the surrounding wall 51 on the insertion direction A1 side. In addition, the main body 55 of this embodiment includes an outer flange 57 connected to the end of the surrounding wall 51 on the withdrawal direction A2 side. The locking claw 56 protrudes from the outer flange 57 of the main body 55 toward the withdrawal 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 orthogonal to the length direction A of the puncture needle 1 in a manner that surrounds the puncture needle 1. The locking claw portion 56 includes an extension portion 58 protruding from the main body portion 55 and an engaging protrusion 59 located at the end of the extension portion 58 in the pull-out direction A2. The extension portion 58 is elastically deformable in a direction orthogonal to the length direction A, with a fulcrum at a position continuous with the main body portion 55. The engaging protrusion 59 protrudes from the end of the extension portion 58 in a direction orthogonal to the length direction A.

[0117] In this embodiment, the movable member 103 is movably mounted within the housing 104 along the length direction A. The upper surface of the movable member 103 in the withdrawal direction A2 protrudes from the housing 104. Therefore, the operator of the puncture tool 100 can move the movable member 103 in the insertion direction A1 by pressing the movable member 103 protruding from the housing 104 towards the insertion direction A1. Consequently, the needle assembly 20 is moved by the pressing of the movable member 103 towards the insertion direction A1.

[0118] The moving member 103 includes a locking portion 61 that presses the locking claw portion 56 of the bushing 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 surrounding the central axis O of the tube portion 11. Furthermore, the moving member 103 has a locking recess 62 at a position adjacent to the pull-out direction A2 of the locking portion 61, which allows the locking protrusion 59 of the locking claw portion 56 to engage. The locking recess 62 is recessed radially inward than the locking portion 61. Figures 16-19 As shown, the engaging portion 61 is, for example, composed of a disc portion. Additionally, as... Figures 16-19 As shown, the engaging recess 62 is adjacent to the pull-out direction A2 of the disc portion, which serves as the engaging portion 61, and is formed by an annular groove that is recessed inward toward the radial direction D from the outer edge of the disc portion. However, the structure of the engaging portion 61 and the engaging recess 62 is not limited to the shape and position shown in this embodiment.

[0119] like Figures 16-18As shown, the puncture tool 100 of this embodiment can insert the puncture needle 1 and sensor 300 into a biological body by pressing the moving member 103 in the insertion direction A1. At this time, the engaging portion 61 of the moving member 103 engages with the inclined surface 59a of the engaging protrusion 59 of the locking claw portion 56 in the withdrawal direction A2, pressing the engaging protrusion 59 outward in the radial direction D. Thus, as Figure 17 As shown, the extension 58 of the locking claw portion 56 elastically deforms outward in the radial direction D. That is, the plurality of locking claw portions 56 located around the radial direction D of the puncture needle 1 elastically deform in a manner that separates outward in the radial direction D. Therefore, as Figure 18 As shown, the engaging portion 61 of the moving member 103 can slide against the inclined surface 59a of the engaging protrusion 59 while passing over the engaging protrusion 59 in the insertion direction A1.

[0120] like Figure 18 As shown, when the engaging portion 61 of the moving member 103 passes the engaging protrusion 59 of the bushing 50 of the needle assembly 20, the engaging protrusion 59 engages with the engaging recess 62 of the moving member 103. Therefore, the moving member 103 and the bushing 50 of the needle assembly 20 interfere in the longitudinal direction A. That is, the needle assembly 20 and the moving member 103 can move as a single unit in the longitudinal direction A. Thus, the needle assembly 20 and the moving member 103 can be integrated, allowing both to move together in the pull-out direction A2.

[0121] Examples of resin materials that can be used as materials for the moving part 103 include ABS resin, AS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene ether, thermoplastic polyurethane, polymethyl methacrylate, polyoxyethylene, fluoropolymers, polycarbonate, polyamide, acetal resin, acrylic resin, polyethylene terephthalate, and other thermoplastic resins used in injection molding, as well as phenolic resins, epoxy resins, silicone resins, and thermosetting resins such as unsaturated polyesters.

[0122] The housing 104 is an external component covering the needle assembly 20, the moving part 103, the force-applying part 105, the detector 106, and the sensor 300 (described later). For example... Figures 16-19 As shown, the housing 104 of this embodiment includes: a cylindrical member 71, which is used when the puncture needle 1 is in the standby position (see reference). Figure 16 In the state of ), the cover needle assembly 20, the moving part 103, the force-applying part 105, the detector 106 and the sensor 300 described later are around the radial direction D; and the base plate 72 covers the end face of the cylindrical part 71 in the insertion direction A1.

[0123] The surface of the base plate 72 on the insertion direction A1 side forms an abutment surface 72a that abuts against the surface BS of the organism when the puncture needle 1 and sensor 300 are inserted into the organism. A through hole 74 extending along the length direction A is formed in the base plate 72. In the standby position (refer to...) Figure 16 The insertion position of the puncture needle 1 (refer to) Figure 18 During movement, the puncture needle 1 protrudes from the contact surface 72a in the insertion direction A1 through the through hole 74. The contact surface 72a has an adhesive portion for placement on the surface BS of the organism.

[0124] Furthermore, the housing 104 in this embodiment has a detachable structure for the cylindrical component 71 and the base plate 72, but is not limited to this structure. The cylindrical component 71 and the base plate 72 can also be formed integrally. However, by making them detachable, the size of the portion left on the surface of the organism BS can be easily reduced, thus reducing the burden on the subject.

[0125] Examples of resin materials that can be used as the material for the housing 104 include ABS resin, AS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene ether, thermoplastic polyurethane, polymethyl methacrylate, polyoxyethylene, fluoropolymers, polycarbonate, polyamide, acetal resin, acrylic resin, polyethylene terephthalate, and other thermoplastic resins used in injection molding, as well as phenolic resins, epoxy resins, silicone resins, unsaturated polyesters, and other thermosetting resins.

[0126] The force-applying component 105 of this embodiment is capable of elastic deformation in the longitudinal direction A. The force-applying component 105 of this embodiment is a helical spring that elastically deforms in the longitudinal direction A. The helical spring, serving as the force-applying component 105, is disposed between the bushing 50 of the needle assembly 20 and the base plate 72 of the housing 104. Therefore, the helical spring, serving as the force-applying component 105 of this embodiment, is activated by the puncture needle 1 from the standby position (see reference 105). Figure 16 ) to the insertion position (reference) Figure 18 The needle moves and compresses. Additionally, by placing the puncture needle 1 in the insertion position (see reference...) Figure 18 When the puncture needle 1 is in the state of being released, the restoring force of the coil spring, which is the force-applying component 105, is released, which allows the puncture needle 1 to move from the insertion position (refer to the reference position). Figure 18 Move in the direction of pulling out, A2.

[0127] Therefore, in the puncture tool 100 of this embodiment, when the puncture needle 1 and sensor 300 are inserted into a biological body, the needle assembly 20 and the moving part 103 overcome the restoring force of the helical spring, which is the force-applying part 105, and move in the insertion direction A1. Thus, as... Figure 17 , Figure 18As shown, the needle assembly 20 and the moving member 103 move in the insertion direction A1, inserting the puncture needle 1 and the sensor 300 into the biological body. Then, after inserting the puncture needle 1 and the sensor 300 into the biological body, the pressure applied to the needle assembly 20 and the moving member 103 in the insertion direction A1 is released, thereby moving the needle assembly 20 and the moving member 103 in the withdrawal direction A2 by means of the restoring force of the coil spring, which is the force-applying member 105. Thus, the puncture needle 1 can be withdrawn from the biological body while the sensor 300 remains inside the biological body. In this embodiment, the puncture needle 1 is withdrawn from the insertion position (see reference 105) by means of the restoring force of the coil spring, which is the force-applying member 105. Figure 18 ) and return to the position contained within the housing 104 (e.g., with Figure 16 Same standby position (refer to) Figure 19 ).

[0128] The detector 106 is operatively connected to the sensor 300. Specifically, the detector 106 is connected to the sensor 300, for example, via a contact portion 90 including a conductive plate, electrical signal lines, 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 inside the organism. In addition, as described above, the detector 106 analyzes the detection signal received from the sensor 300 and sends the analysis result to an external device such as a display device as needed. The detector 106 is composed of a processor, memory, battery, etc. Furthermore, as described above, the detector 106 may not be mounted on the base plate 72, but may be mounted on a separate transmitter side that can be combined with 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 tool 100.

[0129] like Figures 16-19 As shown, in this embodiment, the detector 106 moves together with the puncture needle 1 and sensor 300 in the insertion direction A1 when the puncture needle 1 and sensor 300 are inserted into the organism. More specifically, in this embodiment, the detector 106 moves in the standby position when the puncture needle 1 is in the standby position (see reference). Figure 16 The needle 1 is held in the bushing 50 in the standby position. Figure 16 ) to the insertion position (reference) Figure 18 During movement, the detector 106 moves together with the needle assembly 20 in the insertion direction A1. When the puncture needle 1 reaches the insertion position (refer to...), Figure 18When the needle 1 is withdrawn from the body, the detector 106 engages with the base plate 72 of the housing 104, and the state in which it is held on the needle assembly 20 is released. The engagement of the detector 106 with the base plate 72 can be achieved by any means such as adhesive or mechanical engagement. Thus, the detector 106 is held on the base plate 72. Therefore, when the puncture needle 1 is withdrawn from the body, that is, when the puncture needle 1 returns from the insertion position to the standby position, the needle assembly 20 moves in the withdrawal direction A2, but the detector 106 does not move in the withdrawal direction A2 and remains on the base plate 72 of the housing 104.

[0130] The sensor 300 in this embodiment is a thin-diameter wire-like component housed within the puncture needle 1. As the sensor 300, a component capable of detecting an electrical signal corresponding to the amount or concentration of the analyte can be used. The sensor 300 extends within the puncture needle 1 along the length direction A of the puncture needle 1.

[0131] The sensor 300 may be, for example, a wire electrode with a circular cross-sectional shape. 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 also house both an active electrode and a reference electrode. The active electrode may be configured based on a core material with a conductive surface, and have a sensing portion and a protective portion on the outer wall of the core material. The sensing portion is configured to detect the analyte, and the protective portion is formed by coating the outer wall of the core material with an insulating material. The sensing portion can detect changes in the electrical properties of the analyte. The sensing portion is formed on the surface of the core material using thin film forming methods such as impregnation, electrolytic polymerization, or sputtering. A reagent that specifically reacts with the analyte is coated on the surface of the active electrode. In the case of glucose, a reagent containing glucose oxidase and a phenylboronic acid compound is used. The reference electrode serves as a reference electrode relative to the active electrode. Alternatively, the reference electrode and counter electrode may be spirally wound around the active electrode as a single wire electrode. Furthermore, the puncture needle 1 itself may also be used as the reference electrode or counter electrode. Information about the analyte detected by the sensing part of the working electrode is sent to the detector 106.

[0132] The puncture needle and needle assembly disclosed herein are not limited to the specific structures shown in the above embodiments. Various modifications, alterations, and combinations can be made without departing from the description in the claims.

[0133] The puncture needle and needle assembly disclosed herein are as follows.

[0134] 1. A puncture needle, characterized in that it comprises:

[0135] The puncture portion has a cutting edge on its front end face and a slit extending to the front end face; and

[0136] The retaining portion, which is connected to the base end side of the puncture portion, is configured to be retained in the bushing.

[0137] The retained part includes:

[0138] The tube portion has a substantially constant outer diameter larger than the maximum outer diameter of the puncture portion; and

[0139] A tapered portion, located between the puncture portion and the tubular portion, has an outer diameter that gradually decreases from the tubular portion side toward the puncture portion side.

[0140] In a side view with the slit facing upwards, the outlines of the puncture portion, the tube portion, and the lower side of the conical portion are connected in a straight line.

[0141] 2. The puncture needle according to technical solution 1, characterized in that,

[0142] The slit extends from the front end face of the puncture portion to the tapered portion of the retained portion.

[0143] 3. The puncture needle according to technical solution 2, characterized in that,

[0144] The slit terminates at the tapered portion.

[0145] 4. The puncture needle according to technical solution 2 or 3, characterized in that,

[0146] The width of the slit gradually decreases towards the base end in the tapered portion.

[0147] 5. The puncture needle according to any one of technical solutions 1 to 4, characterized in that,

[0148] The outer diameter of the puncture site is approximately constant at a position closer to the base end than the front end face.

[0149] 6. A needle assembly, characterized in that it comprises:

[0150] The puncture needle described in any one of technical solutions 1 to 5; and

[0151] A bushing that holds the portion of the puncture needle in place.

[0152] Industrial applicability

[0153] This disclosure relates to puncture needles and needle assemblies.

[0154] Explanation of reference numerals in the attached figures

[0155] 1...puncture needle; 2...puncture section; 2a...blade; 2b...slit; 3...holding section; 4...needle tip; 11...tube section; 12...conical section; 13a, 13b...sidewall sections; 13c...bottom; 20...needle assembly; 50...shroud; 50a...reception space; 51...enclosing wall section; 51a1...opening; 52...wall end face; 55...main body section; 56...locking claw section; 57...outer flange section; 58...extension section; 59... 59a... Engaging protrusion; 61... Engaging part; 62... Engaging recess; 71... Cylindrical component; 72... Base plate; 72a... Abutting surface; 74... Through hole; 90... Contact point; 100... Puncture tool; 103... Moving component; 104... Housing; 105... Force-applying component; 106... Electronic device; 200... Adhesive component; 300... Sensor; A... Length direction of puncture needle; A1... Insertion direction; A2... Withdrawal direction; B ...circumferential direction of the puncture needle; C...width direction of the puncture needle; D...radial direction of the puncture needle; H1...distance between the outlines of the puncture section in the side view with the slit facing upward; H2...distance between the outlines of the tube section in the side view with the slit facing upward; H3...distance between the outlines of the puncture section in the top view; H4...distance between the outlines of the tube section in the top view; M...common center line; R...minimum diameter of the bushing opening; T1...outer diameter of the puncture section; T2... . Outer diameter of the tube; T3... Outer diameter of the conical section; W... Width of the slit; BS... Surface of the organism; CL1, CL4, CL7, CL10... Outline of the puncture site; CL2, CL5, CL8, CL11... Outline of the tube; CL3, CL6, CL9, CL12... Outline of the conical section; θ1... Angle of inclination of the upper outline of the conical section relative to the length direction in the side view; θ2... Angle of inclination of the outlines on both sides of the width direction of the conical section relative to the length direction in the top view.

Claims

1. A needle assembly, characterized in that, have: A puncture needle comprising: a puncture portion having a cutting edge on its front end face; and a holding portion connected to the base end side of the puncture portion; and A bushing that holds the portion of the puncture needle in place. The puncture portion has a slit extending to the front end face. The retained part includes: The tube portion has a substantially constant outer diameter larger than the maximum outer diameter of the puncture portion; and A tapered portion, located between the puncture portion and the tubular portion, has an outer diameter that gradually decreases from the tubular portion side toward the puncture portion side. In a side view of the puncture needle with the slit facing upwards, the outlines of the puncture portion, the tube portion, and the lower side of the conical portion are connected by a straight line. The slit extends from the front end face of the puncture portion to the tapered portion of the retained portion. The slit is configured along the entire length of the portion of the puncture needle that protrudes from the bushing and protrudes outside the bushing.

2. The needle assembly according to claim 1, characterized in that, The slit terminates at the tapered portion.

3. The needle assembly according to claim 1 or 2, characterized in that, The width of the slit gradually decreases towards the base end in the tapered portion.

4. The needle assembly according to claim 1 or 2, characterized in that, The outer diameter of the puncture site is approximately constant at a position closer to the base end than the front end face.

5. The needle assembly according to claim 1 or 2, characterized in that, In a top view of the puncture needle viewed from the slit side, the outlines of the puncture portion, the tube portion, and the tapered portion on both sides are not connected in a straight line.

6. A puncture tool, characterized in that, have: The needle assembly according to any one of claims 1 to 5; The sensor is held inside the puncture site; and The contact portion 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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