Sensor-inserting needle and analyte monitoring device comprising same

Abstract

The present invention provides a sensor-inserting needle of an analyte monitoring device, and an analyte monitoring device comprising same, the needle comprising: a needle body positioned to surround at least a portion of the sensor; a needle tip formed to be inclined at a proximal side of the needle; a first inclined part located at a proximal end of the needle tip; and a second inclined part located between the first inclined part and the needle body at a proximal side of the needle.

Description

Needle for sensor insertion and an analyte monitoring device including the same

[0001] The present invention relates to a needle for inserting a sensor into the skin to measure components in blood, and an analyte monitoring device including the same.

[0002]

[0003] Recently, devices that measure and monitor blood components (analytes) in real time are being used as devices for measuring blood components, such as blood glucose.

[0004] In this way, the real-time analyte monitoring device inserts an electrochemical sensor with a fine thickness into the user's skin and transmits the signal measured by the sensor in real time according to the analyte to enable monitoring.

[0005] The sensor of the analyte monitoring device is very thin, making it difficult to penetrate the skin directly.

[0006] Accordingly, most analyte monitoring devices are commercially available assembled with an insertion device that inserts a needle into the skin along with a sensor and withdraws the needle.

[0007] The needle for inserting the sensor penetrates the analyte monitoring device and is positioned together with the sensor; however, there are cases where the needle tilts or rotates inside the analyte monitoring device.

[0008] If a firing motion is performed in this state to attempt to insert the needle and sensor into the user's skin, the needle may become separated from the sensor or be inserted into an unintended position, thereby compromising the stability of the sensor.

[0009] In addition, depending on the shape of the needle, skin penetration power may be reduced or severe pain may be caused during insertion, which leads to a problem where users avoid using the analyte monitoring device.

[0010]

[0011] (Patent Document) US 2021-0361197 A1

[0012]

[0013] Accordingly, the present invention has been devised to solve the problems of the prior art by focusing on the issues of the prior art. It aims to provide a sensor insertion needle and an analyte monitoring device including the same, which prevents tilting or rotation when the needle is assembled in an analyte monitoring device, and also improves the shape of the needle to increase penetration power and alleviate pain when the needle is inserted into the skin.

[0014]

[0015] To achieve the above objective, the present invention provides a needle for inserting a sensor of an analyte monitoring device, comprising: a needle body positioned to surround at least a portion of the sensor; a needle tip formed at an angle on the proximal side of the needle; a first angled portion located at the proximal end of the needle tip; and a second angled portion located between the first angled portion and the needle body on the proximal side of the needle.

[0016] It is preferable that the above-mentioned second slope form a concave curve.

[0017] It is preferable that the second inclined portion is inclined at a different angle from the first inclined portion.

[0018] It is preferable that the angle formed by the first inclined part and the needle body is 10 degrees or more and 30 degrees or less.

[0019] It is preferable that the horizontal cross-section of the above needle body be U-shaped.

[0020] It is preferable to further include a coupling portion that protrudes to a predetermined height from one side of the above needle body.

[0021] It is preferable that the above-mentioned coupling portion be located on both sides of the opening where the needle body does not surround the sensor.

[0022] At least a portion of the above-mentioned coupling part is located at the bottom of the analysis monitoring device and is preferably fitted into a lower through hole formed in a shape corresponding to the horizontal cross-section of the coupling part.

[0023] It is preferable to further include a needle head located at the distal end of the above-mentioned needle body and connected to a connecting plate during the manufacture of the above-mentioned needle.

[0024] It is preferable to further include alignment holes formed in the above needle head.

[0025] It is preferable that the length of the needle tip be 4% or more and 31% or less of the total length of the needle.

[0026] In addition, an analyte monitoring device including the above needle is provided.

[0027] The present invention provides an analyte monitoring device in which the needle is installed through, comprising: an upper through hole located at the upper part of the analyte monitoring device; and a lower through hole located vertically parallel to the upper through hole at the lower part of the analyte monitoring device and formed in a shape corresponding to the horizontal cross-section of the coupling part, wherein when the needle penetrates the upper through hole and the lower through hole and is coupled to the analyte monitoring device, at least a portion of the coupling part is inserted into the lower through hole.

[0028]

[0029] According to the sensor insertion needle and the analyte monitoring device including the same according to the present invention, the following effects can be obtained.

[0030] 1) By forming multiple bevels on the needle tip and forming some of the bevels into curves, the skin penetration rate can be improved while reducing pain.

[0031] 2) By optimally setting the length of the needle tip and the angle of the bevel, the skin penetration rate and pain reduction effect can be maximized.

[0032] 3) A large number of needles can be easily manufactured.

[0033] 4) The needle coupling portion, having a cross-sectional shape corresponding to the shape of the through hole of the analyte monitoring device, is positioned to pass through the through hole, thereby preventing tilting and rotation of the needle.

[0034]

[0035] FIG. 1 is an overall perspective view of an insertion device assembly according to one embodiment of the present invention.

[0036] FIG. 2 is an exploded perspective view of an insertion device assembly according to one embodiment of the present invention.

[0037] FIG. 3 is an exploded perspective view of an analyte monitoring device assembly according to one embodiment of the present invention.

[0038] FIG. 4 is a plan view and a partial enlarged view of an analyte monitoring device according to one embodiment of the present invention.

[0039] FIG. 5 is an overall perspective view of a needle for inserting a sensor according to one embodiment of the present invention.

[0040] FIG. 6 is a front view of a needle for inserting a sensor according to one embodiment of the present invention.

[0041] FIG. 7 is a perspective view of the needle tip portion of a needle for inserting a sensor according to one embodiment of the present invention.

[0042] FIG. 8 is a side view of the needle tip portion of a sensor insertion needle according to one embodiment of the present invention.

[0043] FIG. 9 is a perspective view of a needle tip portion according to another embodiment of the present invention.

[0044] FIG. 10 is a side view of a needle tip portion according to another embodiment of the present invention.

[0045] FIG. 11 is a diagram showing part of the manufacturing process of a sensor insertion needle according to the present invention.

[0046] FIG. 12 is an overall perspective view showing a needle hub coupled to a needle according to one embodiment of the present invention.

[0047] FIG. 13 is an exploded perspective view (a) in which a needle hub and a sealing member are separated according to one embodiment of the present invention, and an overall perspective view (b) of a needle hub according to another embodiment.

[0048] FIG. 14 is a cross-sectional view of an analyte monitoring device assembly according to one embodiment of the present invention, showing a state (a) in which a needle and a needle hub are separated from the analyte monitoring device and a state (b) in which they are combined.

[0049] FIG. 15 is an overall perspective view of the lower housing of an insertion device according to one embodiment of the present invention.

[0050] FIG. 16 is a plan view of the lower housing of an insertion device according to one embodiment of the present invention.

[0051] FIG. 17 is a bottom view of the lower housing of an insertion device according to one embodiment of the present invention.

[0052] FIG. 18 is a top-view perspective view of a state in which an analyte monitoring device assembly is coupled to the lower part of a holder according to one embodiment of the present invention.

[0053] FIG. 19 is a perspective view taken from below, showing a state in which an analyte monitoring device is coupled to the lower part of a holder according to one embodiment of the present invention.

[0054] FIG. 20 is a plan view showing a state in which a holder combined with an analyte monitoring device according to one embodiment of the present invention is inserted into the upper part of a lower housing.

[0055] Figure 21 is a cross-sectional view along line A of Figure 20, showing the appearance before the firing operation.

[0056] FIG. 22 is a cross-sectional view along line A of FIG. 20, showing the appearance after the firing operation.

[0057] Figure 23 is a cross-sectional view along line B of Figure 20, showing the state before firing.

[0058] Figure 24 is a cross-sectional view along line B of Figure 20, showing the appearance after the firing operation.

[0059] Figure 25 is a cross-sectional view along line C of Figure 20, showing the appearance before the firing operation.

[0060] Figure 26 is a cross-sectional view along line C of Figure 20, showing the appearance after the firing operation.

[0061] FIG. 27 is a cross-sectional view along line C of FIG. 20, showing the dehumidifying part coupled to the cap after firing operation coupled to the lower housing.

[0062]

[0063] Some embodiments of the present disclosure are described in detail below with reference to the exemplary drawings. It should be noted that in assigning reference numerals to the components of each drawing, the same components are given the same reference numeral whenever possible, even if they are shown in different drawings. Furthermore, in describing the present disclosure, if it is determined that a detailed description of related known components or functions could obscure the essence of the present disclosure, such detailed description is omitted.

[0064] In describing the components of the embodiments according to the present disclosure, terms such as "first," "second," etc., may be used. These terms are intended merely to distinguish the component from other components, and the nature, order, or sequence of the component is not limited by the symbols thereof. When a part in the specification is described as "comprising" or "having" a component, this means that, unless explicitly stated otherwise, it does not exclude other components but may include additional components.

[0065]

[0066] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the attached drawings.

[0067] The present invention relates to an analyte monitoring device (100) for analyzing components in a user's blood and an insertion device for attaching the device to the user's skin.

[0068] Therefore, in the following explanation, "distal position" refers to a location relatively further from the skin than "proximal position," and conversely, "proximal position" refers to a location relatively closer to the skin than "distal position."

[0069] Meanwhile, distal and proximal are concepts regarding relative positions, and can be understood as an element being proximal to another element while simultaneously being distal.

[0070] In addition, upper, superior, and upper side can be understood as the distal part, distal direction, and distal side, respectively, while lower, inferior, and lower side can be understood as the proximal side.

[0071] Additionally, in the following description, "fire" refers to the user's action of operating the drive unit (230) of the insertion device to insert the needle (250) into the user's skin.

[0072] Additionally, in the following description, "return" refers to the process in which the needle (250) returns to its original position by the driving unit (230) after being inserted through the user's skin.

[0073] Additionally, in the following description, "horizontal" may refer to the surface of the user's skin that comes into contact when the device of the present invention is used. Alternatively, it may refer to a surface that intersects the direction connecting the distal and proximal regions. Curvature of the skin surface is not considered, and the description assumes that the user's skin surface is flat.

[0074]

[0075] As shown in FIGS. 1 and 2, an insertion device assembly (1000) according to one embodiment of the present invention is assembled with an insertion device and an analyte monitoring device (100), and the insertion device assembly (1000) includes an insertion device and an analyte monitoring device (1000) installed inside it.

[0076] The analyte monitoring device (100) includes electronic components such as a transmitter for transmitting a signal of a blood component measured by a sensor (101).

[0077] The insertion device is a device for inserting a sensor (101) of an analysis monitoring device (100) into a user's skin through a sensor insertion needle (250) (hereinafter simply referred to as 'needle (250)'), and includes an upper housing (210) forming the exterior of the insertion device, a lower housing (260) located below the upper housing (210), and a cap (270) that can be attached to the lower housing (260).

[0078] Additionally, a needle hub (240), a needle carrier (233), a driving unit (230), a holder (220), and a dehumidifying unit (280) are arranged inside the insertion device.

[0079] The needle hub (240) is coupled to the upper part of the needle (250) of the analyte monitoring device (100), and the needle carrier (233) is coupled to the upper part of the needle hub (240).

[0080] Hereinafter, the configuration in which the analyte monitoring device (100), needle (250), and needle hub (240) are assembled is referred to as the ‘analyte monitoring device assembly’.

[0081] The driving unit (230) is configured to move the analyte monitoring device assembly in a straight line along the up and down direction of the insertion device.

[0082] The drive unit (230) includes a spring (231), a wheel (232), and a locking member (234).

[0083] And, a button (211) is installed in the upper housing (210). The button (211) is installed on one side of the upper housing (210) and is configured to be pressed into the inside of the insertion device by external pressure.

[0084] The spring (231) is a power source that provides power to the needle carrier (233) so that the needle carrier (233) can move in a straight line, and the spring (231) is composed of a wound reel spring.

[0085] The spring (231) is compressed and assembled in an initial state. Meanwhile, as the compression of the spring (231) is released by the pressure of the button (211), the spring (231) is tensioned to return to its original state, and one end of the spring (231) rotates.

[0086] One side of the wheel (232) is connected to one end of the spring (231) and configured to rotate together by the rotation of the spring (231).

[0087] A groove for coupling with a locking member (234) may be formed on the outer surface of the wheel (232).

[0088] One end of the locking member (234) is connected to the button (211), and the other end is configured to be connected to the wheel (232).

[0089] At this time, a groove is formed at the other end of the locking member (234) so ​​that it can engage with the groove of the wheel (232). As a result, the wheel (232) is fixed and rotation is prevented, and furthermore, tension of the spring (231) is prevented.

[0090] When the button (211) is pressed toward the inside of the insertion device by the user's firing action, the locking member (234) also moves in conjunction with this, thereby releasing the fixation of the wheel (232) and releasing the compression of the spring (231), and as the wheel (232) rotates due to the elasticity of the spring (231), the needle carrier (233) and the needle hub (240) move downward and then return upward.

[0091] When the needle hub (240) moves downward by the firing action, the analyte monitoring device assembly moves proximal together with the holder (220), and the needle (250) and sensor (101) are inserted together into the user's skin.

[0092] Afterwards, as the needle hub (240) moves upward due to the return motion, only the needle (250) moves to the distal side.

[0093] The portion of the analysis monitoring device (100), excluding the needle (250), remains attached to the user's skin, and the proximal side of the sensor (101) is located within the skin.

[0094] As shown in FIG. 3, the analyte monitoring device assembly includes a needle (250), a needle hub (240), and an analyte monitoring device (100).

[0095] Hereinafter, with further reference to FIG. 4, an analysis monitoring device assembly according to one embodiment of the present invention will be described in detail.

[0096] As shown in FIG. 4, the analyte monitoring device (100) includes a sensor (101) and a case.

[0097] The case forms the exterior of the analysis monitoring device (100) and consists of a lower case (140) located at the bottom and an upper case (120) located at the top of the lower case (140).

[0098] A printed circuit board (not shown) is housed in the upper part of the lower case (140), and electronic components (not shown), such as a sensor (101), battery, and transmitter, are electrically connected to the PCB.

[0099] A catch portion (142) is formed on the perimeter of the bottom surface of the lower case (140). The catch portion (142) is formed with an inclined surface that slopes downward toward the inside from the perimeter of the outer bottom surface of the lower housing (260). Additionally, an adhesive tape (143) for attaching to the user's skin is attached to the bottom surface of the lower case (140) (see FIG. 19).

[0100] The upper case (120) may include a sensor case (121) covering the upper part of the sensor (101) and an electronic case (122) covering the upper part of an electronic component connected to the sensor (101), but the sensor case (121) and the electronic case (122) may be formed as a single unit.

[0101] The upper case (120) and the lower case (140) each have an upper through hole (123) and a lower through hole (141).

[0102] The upper through hole (123) is formed through the upper case (120), and the lower through hole (141) is formed through the lower case (140).

[0103] As shown in FIG. 4, the upper through hole (123) and the lower through hole (141) are positioned vertically side by side, and a part of the sensor (101) is positioned between the upper through hole (123) and the lower through hole (141).

[0104] One side of the sensor (101) extends proximal through a lower through hole (141), and the other side of the sensor (101) is placed on a lower case (140) (see FIG. 14).

[0105] A needle (250) is positioned to penetrate the case vertically through an upper through hole (123) and a lower through hole (141) located side by side.

[0106] In this state, the needle (250) surrounds a portion of the circumference of the sensor (101) on the proximal side, which extends to the lower side of the lower case (140) through the lower through hole (141).

[0107] Additionally, a sensor placement hole (124) is connected to the lower part of the upper through hole (123), and the sensor placement hole (124) is formed with a stepped shape smaller than the upper through hole (123). Preferably, the shape of the sensor placement hole (124) may not be a perfect circle.

[0108] Meanwhile, the shape of the lower through hole (141) is formed in a shape corresponding to the horizontal cross-section of the connecting part (256) of the needle (250) described later, and preferably, it may not be a perfect circle.

[0109] Additionally, the analyte monitoring device (100) may further include a rotation-preventing projection (144). The rotation-preventing projection (144) is formed to protrude from the periphery of the analyte monitoring device (100).

[0110] Next, a needle (250) according to an embodiment of the present invention will be described in detail with reference to FIGS. 5 to 8.

[0111] As shown in FIG. 5, the needle (250) includes a needle body (251), a needle tip (252), a connecting part (256), and a needle head (257).

[0112] The needle body (251) is formed in an elongated shape and is positioned to pass through the upper through hole (123) and the lower through hole (141) of the analysis monitoring device (100), so as to extend to the lower part of the analysis monitoring device (100) and surround a portion of the periphery of the exposed sensor (101).

[0113] As shown in FIG. 6, an opening (259) is formed in the needle (250) with one side open along the distal to proximal direction. That is, the horizontal cross-section forms an approximate 'U' shape.

[0114] Therefore, when manufacturing the needle (250), a flat plate-shaped material can be easily manufactured by bending it.

[0115] A sensor (101) is placed inside a needle (250) of this shape, and one side of the sensor (101) is exposed through the opening (259) without being surrounded by the needle body (251).

[0116] The connecting portion (256) is formed to protrude from one side of the needle body (251). The connecting portion (256) is formed to protrude horizontally to a predetermined height along the vertical direction of the needle body (251).

[0117] The connecting portion (256) is formed such that both sides of the opening (259) of the needle body (251) protrude. Thus, when manufacturing the needle (250) as described above, the connecting portion (256) is not formed separately, but can be easily manufactured by forming the connecting portion (256) together with the needle in a flat plate shape and bending it.

[0118] When the needle (250) is positioned penetrating the case of the analysis monitoring device (100), it is inserted into the lower through hole (141) of the lower case (140), which is formed in a shape corresponding to the horizontal cross-section of the coupling part (256).

[0119] Thus, tilting and rotation of the needle (250) while it is coupled to the analyte monitoring device (100) are prevented.

[0120] The needle tip (252) is located on the proximal side of the needle body (251). The needle tip (252) is sharply formed on the proximal side of the needle body (251) and is inserted into the user's skin upon firing, at which time the proximal side of the sensor (101) located within the needle (250) extending outside the analysis monitoring device (100) is inserted into the skin together with the needle (250).

[0121] As shown in FIGS. 7 and 8, the needle tip (252) includes a first inclined portion (253) and a second inclined portion (254).

[0122] The first inclined portion (253) is located at the proximal end of the needle tip (252). That is, the needle tip (252) forms the proximal end of the needle (250) and becomes the part that first contacts and penetrates the user's skin upon firing.

[0123] The angle formed by the first inclined portion (253) and one side of the needle body (251), that is, the needle body (251) on the side where the first inclined portion (253) is not formed, is 10 degrees or more and 30 degrees or less.

[0124] The second inclined section (254) extends from the distal side of the first inclined section (253) and connects to the needle body (251).

[0125] That is, the second inclined section (254) is located between the first inclined section (253) and the needle body (251) on the proximal side of the needle (250).

[0126] The second inclined portion (254) may be formed at an angle different from the angle that the first inclined portion (253) forms with the needle body (251), and the second inclined portion (254) may also be formed to form a concave curve.

[0127] Next, another embodiment of the needle tip (252') is described with reference to FIGS. 9 and FIGS. 10.

[0128] As shown in FIGS. 9 and 10, a needle tip (252') according to another embodiment includes a first inclined portion (253), a second inclined portion (254), and a third inclined portion (255).

[0129] In the present embodiment, the needle tip (252') has a third inclined portion (255) further formed between the second inclined portion (254) and the needle body (251).

[0130] That is, the first inclined section (253), the second inclined section (254), and the third inclined section (255) are sequentially formed and positioned from the end of the needle tip (252').

[0131] Likewise, the third slope (255) can be formed at a different angle from the first slope (253) and the second slope (254).

[0132] In addition, in each of the above embodiments, the needle tip (252, 252') is formed to be 4% or more and 31% or less of the total length of the needle (250) for sensor insertion.

[0133] Due to the structure of the needle tip (252, 252') as in each of the above embodiments, the skin penetration rate during firing is improved compared to conventional needle tips, while the user's pain can be reduced.

[0134] The needle head (257) is located at the distal end of the needle body (251). An alignment hole (258) is formed in the needle head (257) that penetrates the needle head (257).

[0135] As shown in FIG. 11, a plurality of needles (250) are manufactured by connecting them to a connecting plate (1) by a needle head (257) and separated one by one.

[0136] Additionally, the needles (250), separated one by one, are joined by insert injection with the needle hub (240), and at this time, the precise position can be aligned by the alignment hole (258).

[0137] Each preferred embodiment of the needle hub (240) is described with reference to FIGS. 12 and 13.

[0138] As shown in FIG. 12, the needle hub (240) is connected to the upper part of the needle body (251). As described above, the needle hub (240) can be connected to the upper part of the needle (250) by insert injection.

[0139] The needle hub (240) includes an insertion part (242), a cover part (245), and a sealing member (244). A coupling projection (241) is formed on the upper part of the needle hub (240).

[0140] The lower part of the needle carrier (233) is coupled to the coupling projection (241), and the needle hub (240) moves up and down between the distal and proximal sides together with the needle (250) according to the operation of the needle carrier (233).

[0141] The insertion part (242) is located at the lower part of the needle hub (240), that is, at the proximal side of the needle hub (240).

[0142] The insertion part (242) is formed such that its cross-section corresponds to the shape of the sensor placement hole (124) formed in the upper case (120) of the analysis sensor (101).

[0143] Accordingly, when the needle (250) is coupled to the analyte monitoring device (100), the insertion part (242) is inserted into the sensor placement hole (124).

[0144] Additionally, a seating groove (247) is formed on one side of the insertion part (242), and a portion of the upper side of the coupling part (256) of the needle (250) coupled to the needle hub (240) is positioned within the seating groove.

[0145] The cover portion (245) is located on the upper part of the insert portion (242). The cover portion (245) is formed to be larger than the diameter of the upper case (120) of the analyte monitoring device (100), so that when the needle (250) is coupled to the analyte monitoring device (100), the cover portion (245) is not inserted into the upper through hole (123) but covers the upper part of the upper through hole (123).

[0146] Additionally, a fixing groove (246) is formed on the circumferential side of the needle hub (240). A fixing projection (222) of the holder (220), which will be described later, is fitted into the fixing groove (246).

[0147] The sealing member (244) is located between the insertion part (242) and the cover part (245). As shown in FIG. 13(a), the sealing member (244) is formed in the shape of an elastic ring and is fitted into an installation groove (243) located on the upper part of the insertion part (242).

[0148] FIG. 13(b) shows a needle hub (240') according to another embodiment.

[0149] In another embodiment of the needle hub (240'), the needle hub (240') itself is made of an elastic material, and the sealing member (244') is not separately configured and coupled to the installation groove (243), but is integrally formed between the insertion part (242) and the cover part (245).

[0150] Therefore, it is easy to manufacture as there is no need to form an installation groove (243) and attach a separate sealing member thereto.

[0151] The sealing member (244, 244') of each of the above embodiments is positioned between the inner surface of the upper through hole (123) of the analyte monitoring device (100) and the outer surface of the needle hub (240') when the needle (250) is coupled to the analyte monitoring device (100), thereby sealing the inner and outer surfaces of the upper part of the analyte monitoring device (100).

[0152] Referring to the following Fig. 14, the structure in which the analyte monitoring device assembly is combined is described.

[0153] As shown in FIG. 14(a), the needle (250) is inserted from the top of the analyte monitoring device (100) and positioned to penetrate the analyte monitoring device (100).

[0154] Specifically, the proximal end of the needle (250) is positioned by passing through the upper through hole (123) of the analyte monitoring device (100) and through the lower through hole (141) of the lower case (140).

[0155] As shown in FIG. 14(b), when the needle (250) is coupled to the analyte monitoring device (100), the lower part of the coupling portion (256) of the needle (250) is inserted into and fixed in the lower through hole (141) of the lower case (140), thereby preventing tilting or rotation of the needle (250).

[0156] The proximal side of the needle (250) is exposed outside the lower case (140), and the part of the sensor (101) that extends outside the lower case (140) is located inside the needle (250).

[0157] Additionally, a portion of the sensor (101) that is not exposed outside the lower case (140) is placed inside the coupling part (256).

[0158] The insertion part (242) of the needle hub (240) is fitted into and fixed in the sensor placement hole (124), thereby preventing rotation of the needle hub (240).

[0159] The sealing member (244) is positioned between the needle hub (240) and the inner surface of the upper through hole (123) at the upper part of the insertion part (242) to seal the upper part of the analysis monitoring device (100), and the cover part (245) is positioned to cover the upper part of the upper through hole (123) at the upper part of the sealing member (244).

[0160] Thus, foreign substances, etc. are prevented from entering the interior of the analysis monitoring device (100) from the upper part of the analysis monitoring device (100).

[0161] Next, with further reference to FIGS. 2 and FIGS. 15 to 19, the configuration and coupling relationship of the lower housing (260), holder (220), and cap (270) of the insertion device will be described in detail.

[0162] As shown in FIG. 2, the lower housing (260) is coupled to the lower side of the upper housing (210). The lower housing (260) includes a moving hole (261).

[0163] As shown in FIGS. 15 to 17, the moving hole (261) is formed to penetrate in the vertical direction inside the lower housing (260), and a holder (220) is inserted into the moving hole (261) to enable movement between the distal side and the proximal side.

[0164] A support member (262), an upward stopper (263), a guide rail (265), and a rotation prevention groove (269) are located on the inner surface of the moving hole (261).

[0165] The support member (262) is positioned protruding toward the center side from the inner circumference of the moving hole (261).

[0166] The upper stopper (263) is formed in a stepped shape on the inner surface of the moving hole (261) and is positioned thereon, and an inclined surface (264) is positioned on the upper side where the upper stopper (263) is located.

[0167] The guide rail (265) is positioned in a shape where the inner surface of the moving hole (261) is cut in the vertical direction. A downward stopper (266) is located at the bottom of the guide rail (265) where the cut portion is closed off.

[0168] The anti-rotation groove (269) is located on the inner surface of the moving hole (261). The anti-rotation groove (261) is configured to accommodate the anti-rotation projection (144) formed in the analyte monitoring device (100). When the analyte monitoring device (100) is positioned in the moving hole (261), the anti-rotation projection (144) is positioned to protrude from the inner surface of the moving hole (261) toward the outer surface of the analyte monitoring device (100) so that it can be fitted.

[0169] Before the firing operation, when the analysis monitoring device (100) is positioned on the upper part of the moving hole (261), the anti-rotation projection (144) on the circumference side of the analysis monitoring device (100) is fitted into the anti-rotation groove (269) and fixed, thereby preventing the analysis monitoring device (100) from rotating in the moving hole (261) before firing.

[0170] Preferably, the support member (262), upward stopper (263), guide rail (265), and anti-rotation groove (269) may each be positioned in multiple numbers along the circumferential direction of the inner circumference of the moving hole (261), and although the number is not limited, preferably two or more may be positioned, and each component may be positioned so as not to be adjacent to each other. However, this is not limited thereto, and it is also possible for each component to be positioned adjacent to each other.

[0171] The bottom surface of the lower housing (260) is a part that comes into contact with the skin before firing after removing the cap (270) when using the insertion device.

[0172] An adhesive tape (267) may be attached to the bottom surface of the lower housing (260). However, the adhesive tape (267) is not an essential component and can be omitted.

[0173] The adhesive tape (267) is attached and secured so that the bottom surface of the lower housing (260) is in contact with the skin.

[0174] A bottom groove (268) is located on the bottom surface of the lower housing (260). The bottom groove (268) is formed to be connected from one side of the lower housing (260) to the other side by passing through a moving hole (261).

[0175] When the cap (270) is coupled to the lower housing (260), the rib (275) located at the bottom of the cap (270) is positioned within the bottom groove (268).

[0176] Additionally, the bottom groove (268) is formed such that its width is smaller than the diameter of the moving hole (261) and larger than the width of the rib (275), thereby providing a structure in which the rib (275) can be joined when the cap (270) is joined to the lower housing (260), while also maximizing the area of ​​the part that the skin contacts on the bottom surface of the lower housing (260).

[0177] Next, the configuration of a holder (220) according to one embodiment of the present invention is described with reference to FIG. 2, FIG. 18 and FIG. 19.

[0178] The holder (220) is coupled to the upper part of the analyte monitoring device (100). The holder (220) has a needle hub through hole (221), a guide projection (223), a hook (224), and a return prevention part (226).

[0179] The needle hub through hole (221) is formed to penetrate the upper and lower directions of the holder (220) at approximately the center inside the holder (220).

[0180] In addition, a fixing projection (222) is formed to protrude toward the center on the inner surface of the needle hub through hole (221) (see FIG. 20).

[0181] When the analysis monitoring device assembly is mounted on the lower part of the holder (220), the needle hub (240) is positioned inside the needle hub through hole (221).

[0182] At this time, the fixing projection (222) located on the inner circumference of the needle hub through hole (221) is inserted into the fixing groove (246) located on the side of the needle hub (240), thereby fixing the needle hub (240).

[0183] And, the upper part of the needle hub (240) and the lower part of the needle carrier (233) are joined inside the needle hub through hole (221).

[0184] The guide projection (223) is formed protruding from the upper outer surface of the holder (220).

[0185] When the holder (220) equipped with the analysis monitoring device assembly is fitted into the moving hole (261) of the lower housing (260), the guide projection (223) is inserted into the guide rail (265) of the lower housing (260).

[0186] Accordingly, rotation of the holder (220) is prevented inside the moving hole (261) of the lower housing (260), and the vertical movement of the holder (220) is guided.

[0187] The hook (224) is formed to protrude horizontally from the lower outer surface of the holder (220) toward the inside, that is, toward the center of the holder (220).

[0188] Specifically, the first connecting bar (225) is formed protruding from the end of the holder (220) which is located on the outer surface of the holder (220) and extends downward to have elasticity, and the hook (224) also forms an inclined surface inclined from top to bottom.

[0189] When the analysis monitoring device assembly is mounted on the lower part of the holder (220), the hook (224) of the holder (220) is fixed in a state where it is hooked onto the catch (142) located on the lower case (140) of the analysis monitoring device (100).

[0190] However, since the first connecting bar (225) of the hook (224) has elasticity, when the analyte monitoring device (100) is pulled with a predetermined force in this state, the first connecting bar (225) bends and the hook (224) spreads outward, allowing the analyte monitoring device (100) to be separated from the holder (220).

[0191] However, when the analysis monitoring device assembly is inserted into the upper part of the moving hole (261) of the lower housing (260) while mounted on the lower part of the holder (220), the support part (262) of the lower housing (260) comes into contact with and supports the outer side of the first connecting bar (225) of the hook (224), so that the hook (224) cannot spread outward.

[0192] Therefore, in this state, the analysis monitoring device (100) is not separated from the holder (220) even if a predetermined force is applied.

[0193] The return prevention part (226) is formed to protrude outward from the upper outer surface of the holder (220), that is, toward the horizontal outer side of the holder (220).

[0194] Specifically, it is formed protruding from the end of the second connecting bar (227), which has elasticity and extends upward from the outer surface of the holder (220), and also forms an inclined surface inclined from top to bottom.

[0195] When the holder (220) equipped with the analysis monitoring device assembly is inserted into the moving hole (261) of the lower housing (260), the return prevention part (226) is positioned to contact the inclined surface (264) located on the upper part of the upper stopper (263) of the lower housing (260).

[0196] Additionally, a cut portion (228) is located in the second connecting bar (227) connecting the holder (220) and the return prevention portion (226), so that when a predetermined force is applied from the bottom while the upper part of the holder (220) is fixed, the second connecting bar (227) can be broken or bent.

[0197] The cap (270) is coupled to the outside of the lower housing (260) and configured to cover the lower side of the lower housing (260) and at least a portion of the outside thereof.

[0198] Referring again to FIG. 2, the bottom surface of the cap (270) has an opening (271) that is partially open, and a sealing member (272) can be attached to the opening (271).

[0199] The cap (270) includes a needle receiving portion (273), a packing member (274), and a rib (275).

[0200] The needle receiving portion (273) forms a tube shape positioned in the up-and-down direction on the inner side of the cap (270).

[0201] The packing member (274) is located at the upper part of the needle receiving portion (273) and can be formed at the upper part of the needle receiving portion (273) by a double injection method together with the cap (270).

[0202] The rib (275) extends from both sides of the outer surface of the needle receiving portion (273) and is connected to the inner surface of the cap (270), so that the needle receiving portion (273) is fixed to the cap (270).

[0203] The rib (275) is inserted from the bottom of the bottom groove (268) of the lower housing (260) and placed within the bottom groove (268) of the lower housing (260) when it is coupled to the lower housing (260) during the assembly process of the cap (270).

[0204] Before use of the insertion device, when the cap (270) is coupled to the lower housing (260) and covers the lower housing (260), the needle receiving portion (273) is positioned within the moving hole (261) of the lower housing (260), and accordingly, the sensor (101) and the needle (250) of the analysis monitoring device assembly are received within the needle receiving portion (273).

[0205] Additionally, the packing member (274) at the top of the needle receiving portion (273) is positioned to be in contact with the lower through hole (141) at the bottom of the analysis monitoring device (100), thereby preventing the inflow of foreign substances through the lower through hole (141).

[0206] As shown in FIG. 2, the dehumidification unit (280) is placed inside the cap (270). The dehumidification unit (280) includes an insertion hole (281) and an upper groove (282).

[0207] The insertion hole (281) is formed by penetrating the dehumidification unit (280) in the vertical direction, and the upper groove (282) is formed to communicate from one side of the dehumidification unit (280) to the other side by passing through the insertion hole (281).

[0208] Additionally, the upper groove (282) is formed such that its width is smaller than the diameter of the needle receiving portion (273) and larger than the width of the rib (275).

[0209] Accordingly, the dehumidifying part (280) is inserted into the interior of the cap (270) from the lower part of the opening (271) of the cap (270), and accordingly, the rib (275) is inserted into the upper groove (282), and the needle receiving part (273) is inserted into the insertion hole (281) and surrounded by the dehumidifying part (280). In this state, as the cap (270) is coupled to the lower housing (260), the dehumidifying part (280) is inserted into the moving hole (261) of the holder (220).

[0210] Next, with reference to FIGS. 20 to 27, the firing and return operations of the insertion device will be explained.

[0211] However, for the sake of understanding the invention, the needle carrier (233) and the driving unit (230) connected to the needle hub (240) are not shown in the drawings related to the description below, and it should be understood that the needle carrier (233) moves from the upper side (distal) to the lower side (proximal) by the operation of the driving unit (230) by the aforementioned firing operation, and then moves from the lower side (proximal) to the upper side (distal) by a subsequent return operation.

[0212] FIG. 20 is a plan view showing a state in which a holder (220) coupled with an analyte monitoring device (100) according to one embodiment of the present invention is inserted into the upper part of a lower housing (260).

[0213] First, with reference to FIGS. 21 and 22, the operation of the hook (224) of the lower housing (260) and the locking part (142) of the analysis monitoring device (100) according to the firing and return operation of the insertion device will be explained in detail.

[0214] As shown in FIG. 21, after the cap (270) is removed from the lower housing (260), the analysis monitoring device assembly is coupled to the lower part of the holder (220) and inserted into the upper part of the lower housing (260) before the firing operation.

[0215] At this time, the outer side of the hook (224), that is, the outer side of the first connecting bar (225) connected to the hook (224), is supported by the support portion (262) of the lower housing (260), so that the hook (224) and the catch portion (142) of the lower part of the analysis monitoring device (100) are maintained in contact.

[0216] When firing occurs here, the holder (220) and the analysis monitoring device (100) move to the lower part of the moving hole (261), and the analysis monitoring device (100) approaches the user's skin with the support on the outside of the hook (224) by the support member (262) released.

[0217] Accordingly, as shown in FIG. 22, the needle (250) and the sensor (101) are inserted into the user's skin, and the bottom surface of the analyte housing comes into contact with the user's skin. Then, by a return operation, the needle (250) is separated from the analyte monitoring device (100) and returns to the distal side of the insertion device.

[0218] Afterwards, the user removes the insertion device from the skin.

[0219] At this time, the analysis monitoring device (100) is attached to the skin by an adhesive tape (143) located on its bottom surface, and the support on the outside of the hook (224) by the support member (262) is released.

[0220] Accordingly, due to the adhesive force of the adhesive tape (143), the analyte monitoring device (100) is separated from the holder (220) and remains on the skin, and only the insertion device is removed from the skin.

[0221] Next, with reference to FIGS. 23 and 24, the operation of the guide rail (265) of the lower housing (260) and the guide projection (223) of the holder (220) according to the firing and return operation of the insertion device will be explained in detail.

[0222] As shown in FIG. 23, prior to firing, the analysis monitoring device assembly is coupled to the lower part of the holder (220) and inserted into the upper part of the lower housing (260).

[0223] At this time, the guide projection (223) of the holder (220) is inserted into the upper part of the guide rail (265) of the lower housing (260).

[0224] Here, when firing occurs, as the holder (220) and the analysis monitoring device (100) move to the lower part of the moving hole (261), the guide projection (223) moves downward along the guide rail (265).

[0225] At this time, as shown in FIG. 24, when the holder (220) moves downward a predetermined distance, the guide projection (223) catches on the downward stopper (266) located on the lower side of the guide rail (265), so that the holder (220) does not move downward beyond a predetermined distance.

[0226] The position of the lower stopper (266) is located in a part where the bottom surface of the analysis monitoring device (100) and the bottom surface of the lower housing (260) are positioned approximately horizontally side by side.

[0227] As the holder (220) and the analysis monitoring device assembly move downward a predetermined distance, they approach the user's skin, and the needle (250) and sensor (101) are inserted into the user's skin, and the bottom surface of the analysis housing comes into contact with and attaches to the user's skin.

[0228] Afterward, the needle (250) is separated from the analyte monitoring device (100) by a return motion and returns to the distal side of the insertion device, and the user removes the insertion device from the skin.

[0229] Next, with reference to FIGS. 25 to 27, the operation of the return prevention part (226) of the holder (220) and the upper stopper (263) of the lower housing (260) according to the firing and return operation of the insertion device will be explained in detail.

[0230] As shown in FIG. 25, prior to firing, the analysis monitoring device assembly is coupled to the lower part of the holder (220) and inserted into the upper part of the lower housing (260).

[0231] At this time, the inclined surface of the return prevention part (226) is in contact with and overlaps the inclined surface (264) located on the upper part of the lower housing (260).

[0232] Here, when firing occurs, the holder (220) and the analysis monitoring device assembly move to the lower part of the moving hole (261) as shown in FIG. 26.

[0233] At this time, due to the elasticity of the second connecting bar (227), the return prevention part (226) bends along the inclined surface (264) of the lower housing (260) toward the center of the holder (220), and the holder (220) and the analysis monitoring device assembly continue to move toward the lower part of the moving hole (261).

[0234] As the holder (220) and the analysis monitoring device assembly move downward a predetermined distance, they approach the user's skin, and the needle (250) and sensor (101) are inserted into the user's skin, and the bottom surface of the analysis housing comes into contact with and attaches to the user's skin.

[0235] At this time, the return prevention part (226) comes down to the part where the upper stopper (263) is placed, and moves toward the inner surface of the lower housing (260) by the elasticity of the second connecting bar (227) and gets caught on the stepped part of the upper stopper (263).

[0236] Afterwards, the needle (250) moves upward by a return operation, but since the holder (220) cannot move upward due to the return prevention part (226) caught on the upper stopper (263), only the needle (250) is separated from the analysis monitoring device (100) and moves to the upper part of the insertion device to be removed, thereby completing the use of the insertion device.

[0237] Then, after using the insertion device, the user discards the insertion device by reattaching the cap (270), which was removed before use, to the lower housing (260). However, at this time, the holder (220) cannot move upward due to the return prevention part (226) caught on the upper stopper (263), so the cap (270) cannot be attached to the lower housing (260).

[0238] However, in the present invention, a cut portion (228) is formed in the second connecting bar (227) connecting the return prevention portion (226) and the holder (220).

[0239] Accordingly, as shown in FIG. 27, when the cap (270) is joined by applying a predetermined force from the bottom of the lower housing (260), the second connecting bar (227) is bent or broken by the cut portion (228), allowing the holder (220) to move back up, thereby joining the cap (270) to the lower housing (260) and disposing of the insertion device.

[0240]

[0241] According to the sensor insertion needle and the analyte monitoring device including the same according to the present invention, the following effects can be obtained.

[0242] 1) By forming multiple bevels on the needle tip and forming some of the bevels into curves, the skin penetration rate can be improved while reducing pain.

[0243] 2) By optimally setting the length of the needle tip and the angle of the bevel, the skin penetration rate and pain reduction effect can be maximized.

[0244] 3) A large number of needles can be easily manufactured.

[0245] 4) The needle coupling portion, having a cross-sectional shape corresponding to the shape of the through hole of the analyte monitoring device, is positioned to pass through the through hole, thereby preventing tilting and rotation of the needle.

[0246]

[0247] The above description is merely an illustrative explanation of the technical concept of the present embodiment, and a person skilled in the art to which the present embodiment belongs would be able to make various modifications and variations within the scope of the essential characteristics of the present embodiment. Accordingly, the present embodiments are intended to explain, not limit, the technical concept of the present embodiment, and the scope of the technical concept of the present embodiment is not limited by these embodiments. The scope of protection of the present embodiment shall be interpreted by the claims below, and all technical concepts within an equivalent scope shall be interpreted as being included within the scope of rights of the present embodiment.

[0248]

[0249] (Explanation of symbols)

[0250] 100: Analyst monitoring device

[0251] 101: Sensor

[0252] 120: Upper case

[0253] 121: Sensor case

[0254] 122: Electronic case

[0255] 123: Upper penetration hole

[0256] 124: Sensor placement hole

[0257] 140: Lower case

[0258] 141: Lower penetration hole

[0259] 142: Hinder

[0260] 143: Adhesive tape

[0261] 144: Anti-rotation protrusion

[0262] 210: Upper housing

[0263] 211: Button

[0264] 220: Holder

[0265] 221: Needle hub through hole

[0266] 222: Fixed protrusion

[0267] 223: Guide protrusion

[0268] 224: Hook

[0269] 225: 1st connecting bar

[0270] 226: Return Prevention Unit

[0271] 227: Second connecting bar

[0272] 228: Incision

[0273] 230: Drive unit

[0274] 231: Wheel

[0275] 232: Spring

[0276] 233: Needle Carrier

[0277] 240. 240': Needle Hub

[0278] 241: Connecting protrusion

[0279] 242: Insert

[0280] 243: Installation Home

[0281] 244, 244': Sealing member

[0282] 245: Cover

[0283] 246: Fixed groove

[0284] 247: Settlement Home

[0285] 250: Needles

[0286] 251: Needle main body

[0287] 252, 252': Needle Tip

[0288] 253: First Slope

[0289] 254: Second slope

[0290] 255: Third Slope

[0291] 256: Joint

[0292] 257: Needle Head

[0293] 258: Alignment Worker

[0294] 259: Frog

[0295] 260: Lower housing

[0296] 261: Moving hole

[0297] 262: Jijibu

[0298] 263: Upward Stopper

[0299] 264: Slope

[0300] 265: Guide Rail

[0301] 266: Downward Stopper

[0302] 267: Adhesive tape

[0303] 268: Bottom groove

[0304] 269: Anti-rotation groove

[0305] 270: Cap

[0306] 271: Open section

[0307] 272: Sealing member

[0308] 273: Your Reception Unit

[0309] 274: Packing member

[0310] 275: Liv

[0311] 280: Dehumidification unit

[0312] 281: Insertion hole

[0313] 282: Top surface groove

[0314] 1: Connecting plate

Claims

1. As a needle for inserting a sensor of an analyte monitoring device, A needle body positioned to surround at least a portion of the above sensor; A needle tip formed at an angle on the proximal side of the above needle; A first inclined portion located at the proximal end of the above needle tip; and A second inclined portion located between the first inclined portion and the needle body on the proximal side of the needle; comprising You guys.

2. In Paragraph 1, The above-mentioned second slope forms a concave curve, You guys.

3. In Paragraph 1, The second inclined portion is inclined at a different angle from the first inclined portion, You guys.

4. In Paragraph 1, The angle formed by the first inclined portion and the needle body is 10 degrees or more and 30 degrees or less, You guys.

5. In Paragraph 1, The horizontal cross-section of the above needle body is U-shaped, You guys.

6. In Paragraph 1, A coupling portion further comprising a portion protruding at a predetermined height from one side of the above needle body, You guys.

7. In Paragraph 6, The above coupling portion is located on both sides of an opening where the needle body does not surround the sensor, You guys.

8. In Paragraph 6 or 7, At least a portion of the above-mentioned coupling part is located at the bottom of the analysis monitoring device and is fitted into a lower through hole formed in a shape corresponding to the horizontal cross-section of the coupling part, You guys.

9. In Paragraph 1, A needle head further comprising a needle head located at the distal end of the above-mentioned needle body and connected to a connecting plate during the manufacture of the above-mentioned needle. You guys.

10. In Paragraph 9, Further including alignment holes formed in the needle head, You guys.

11. In Paragraph 1, The length of the needle tip is 4% or more and 31% or less of the total length of the needle, You guys.

12. A needle comprising any one of claims 1 to 11, Analytical monitoring device.

13. An analyzer monitoring device in which the needle of Claim 6 or 7 is installed through, An upper through hole located at the top of the above-mentioned analyte monitoring device; and A lower through hole located vertically parallel to the upper through hole at the bottom of the above-mentioned analysis monitoring device and formed in a shape corresponding to the horizontal cross-section of the coupling part; When the above needle penetrates the upper through hole and the lower through hole and is coupled to the analysis monitoring device, at least a portion of the coupling part is inserted into the lower through hole. Analytical monitoring device.

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