Continuous analyte measuring instrument with easy-to-insert electrochemical sensor

Abstract

The present invention may provide a continuous analyzer measuring device comprising: an electrochemical sensor that penetrates into the skin; a main substrate to which a battery is connected and a housing in which the main substrate is housed, wherein the housing is attached to the skin and the main substrate is a transmitter that controls the measured signal of the electrochemical sensor; a needle that penetrates the electrochemical sensor into the skin; and an inserter that moves the transmitter and the needle from a first position to a second position so that the needle penetrates the skin, wherein a part of the electrochemical sensor penetrates into the skin while inserted into the needle, and the electrochemical sensor includes a lateral extension extending in a different direction from the part of the electrochemical sensor, wherein an incision is formed in the lateral extension, and a first lateral extension is provided above the incision and a second lateral extension is provided below the incision.

Description

Technology Field

[0001] The present invention relates to a continuous analyte measuring device equipped with an electrochemical sensor that is easy to insert. Background Technology

[0003] When the inserter is used as the reference position, the end portion of the electrochemical sensor connected to the main board is located close to the inserter and can be called the proximal portion, and the other end of the electrochemical sensor inserted into the body is located far from the inserter and can be called the distal portion.

[0004] The proximal portion of the electrochemical sensor may be electrically connected to the main board of the transmitter, and at least a portion of the distal portion of the electrochemical sensor may be inserted into the body. The proximal and distal portions may be located at opposite ends. The proximal portion of the electrochemical sensor may be electrically connected to the main board of the transmitter, which includes an electrical circuit necessary for measuring analytes including glucose.

[0005] The transmitter can be located inside the inserter along with the electrochemical sensor before being attached to the skin. A type in which the transmitter and the electrochemical sensor are pre-combined can be called an all-in-one type transmitter.

[0006] The transmitter communicates with the sensor via signal, and the sensor is configured to detect and measure the patient's glucose level over a predetermined time period, and is configured to transmit data corresponding to or related to the glucose level measured over the predetermined period for further analysis.

[0007] The proximal end of the electrochemical sensor may be located at the opposite end of the distal end of the electrochemical sensor, where at least a portion is inserted into the body. The proximal end of the electrochemical sensor may be electrically connected to the main board of a transmitter containing an electrical circuit necessary for glucose measurement.

[0008] The transmitter may be provided with a needle for penetrating an electrochemical sensor into the skin of the body, and the needle, once passed into the skin, may be separated from the skin while maintaining only the electrochemical sensor penetrating the skin.

[0009] To attach the transmitter to the skin of the body, it needs to be moved securely inside the inserter.

[0010] In addition, when the needle is guided to penetrate the distal end of the electrochemical sensor into the skin, care must be taken to ensure that the distal end of the electrochemical sensor does not detach from the needle.

[0011] If the distal end of the electrochemical sensor does not adhere tightly to the needle and a gap is formed, it may not be securely inserted into the skin and may be deformed or damaged.

[0012] Furthermore, when the needle is inserted into the skin and then withdrawn, the electrochemical sensor must reliably maintain its position within the skin. Prior art literature

[65535] Publication Number (Date): 1020240107624(2024-07-09) The problem to be solved

[0014] The present invention provides a continuous analyzer equipped with an easy-to-insert electrochemical sensor, wherein the electrochemical sensor is assembled to be in close contact with the inner surface of a needle, and when used and penetrates the skin, the electrochemical sensor is inserted into the skin while maintaining a state of close contact without a gap inside the needle. means of solving the problem

[0016] The present invention may provide a continuous analyzer measuring device comprising: an electrochemical sensor that penetrates into the skin; a main substrate to which a battery is connected and a housing in which the main substrate is housed, wherein the housing is attached to the skin and the main substrate is a transmitter that controls the measured signal of the electrochemical sensor; a needle that penetrates the electrochemical sensor into the skin; and an inserter that moves the transmitter and the needle from a first position to a second position so that the needle penetrates the skin, wherein a part of the electrochemical sensor penetrates into the skin while inserted into the needle, and the electrochemical sensor includes a lateral extension extending in a different direction from the part of the electrochemical sensor, wherein an incision is formed in the lateral extension, and a first lateral extension is provided above the incision and a second lateral extension is provided below the incision. Effects of the invention

[0018] Thus, the present invention provides a side extension on an electrochemical sensor formed by double bending and provided in a transmitter provided inside an inserter, and forms an incision hole in the side extension, wherein the upper part of the incision hole is referred to as the first side extension and the lower part of the incision hole is referred to as the second side extension, and thereby the distal part can be inserted while adhering more closely to the needle by varying due to the repulsive force received by the first side extension when inserted into the body.

[0019] Therefore, since the present invention is inserted in a tightly fitted state inside a needle that guides the electrochemical sensor when it is inserted into the body, it is possible to prevent the electrochemical sensor from being securely inserted into the body or from undergoing deformation due to the occurrence of a gap. Brief explanation of the drawing

[0021] FIG. 1 is a front view of an insertion device included in a continuous analyzer measuring device according to one embodiment of the present invention. FIG. 2 is a perspective view of a transmitter included in a continuous analyzer measuring device according to one embodiment of the present invention. Fig. 3 is a front view of Fig. 2. FIG. 4 is a plan view showing the interior of a transmitter according to one embodiment of the present invention. Figure 5 is an enlarged view of section A of Figure 4. FIG. 6 is an enlarged perspective view of the installation state of a needle and an electrochemical sensor provided in a transmitter according to one embodiment of the present invention. Figure 7 is a plan view of Figure 6. FIG. 8 is a perspective view of a needle and an electrochemical sensor according to one embodiment of the present invention. FIG. 9 is a partial enlarged view from the front of a needle and an electrochemical sensor according to one embodiment of the present invention. Figure 10 is a plan view of Figure 8. FIG. 11 is a perspective view of an electrochemical sensor according to one embodiment of the present invention. FIG. 12 is an enlarged view of a side extension of an electrochemical sensor according to one embodiment of the present invention. Specific details for implementing the invention

[0022] Hereinafter, an example of how the electrochemical sensor of the present invention is used in a Continuous Glucose Monitoring System (CGMS) for measuring interstitial fluid or blood glucose concentration is described. However, the continuous glucose device of the present invention is not limited to measuring glucose concentration in the body and can be extended to a continuous analyte measuring device for measuring other biomarkers.

[0023] FIG. 1 is a front view of an inserter included in a continuous analyzer measuring device according to one embodiment of the present invention, FIG. 2 is a perspective view of a transmitter included in a continuous analyzer measuring device according to one embodiment of the present invention, and FIG. 3 is a front view of FIG. 2.

[0024] Referring to FIGS. 1 to 3, an electrochemical sensor (400) according to one embodiment of the present invention may be attached to the skin (C) together with a transmitter (200). The transmitter (200) may control a signal measured by the electrochemical sensor (400) and continuously transmit the measured blood glucose levels to an external terminal including a mobile phone.

[0025] An external terminal is provided separately from a transmitter (200) attached to the skin and can continuously receive measurement data of an electrochemical sensor (400) wirelessly from the transmitter (200). The user can continuously monitor and diagnose measurement data of the electrochemical sensor (400) for biomarkers including glucose, lactate, etc.

[0026] The electrochemical sensor (400) and transmitter (200) may be provided to the user with the inserter (100) loaded before attachment to the skin. Upon the user's attachment action, the electrochemical sensor (400) and transmitter (200) may detach from the inserter (100) and be attached to the skin.

[0027] The inserter (100) illustrated in FIG. 1 is an example and is not limited thereto, and may include inserters (100) of various structures.

[0028] One end of the electrochemical sensor (400) connected to the electrical component of the transmitter (200) including the main board may be called the proximal part (402), and the other end of the electrochemical sensor (400) into which at least a portion is invaded into the body may be called the distal part (406), and the proximal part (402) and the distal part (406) are interconnected and the part that is flexibly bent and is positioned between the proximal part (402) and the distal part (406) may be called the folding part (405).

[0029] Invasiveness may mean inserting at least a portion of the distal part (406) of the electrochemical sensor (400) into the body.

[0030] The transmitter (200) and the electrochemical sensor (400) can be provided to the user already connected to each other before being attached to the skin.

[0031] The transmitter (200) is positioned in a first position while loaded into the inserter (100), and the transmitter (200) moves from the first position to a second position by user action, and at the second position, the transmitter (200) can be attached to the skin. The insertion direction of the transmitter (200) and the electrochemical sensor (400) may be a direction toward the first position to the second position.

[0032] The needle (300) has a portion exposed in the longitudinal direction, and a portion of the electrochemical sensor (400) may be placed inside the needle (300). The needle (300) may incise the skin so that at least a portion of the distal portion (406) may be penetrated into the human body along the insertion direction, and guide the electrochemical sensor (400).

[0033] The inserter (100) may include a driving unit that moves the transmitter (200) and the electrochemical sensor (400) from a first position to a second position or returns the needle (300) from a second position to a third position.

[0034] The driving unit can advance the needle (300) or transmitter (200) from a first position to a second position so that the needle (300) or distal part (406) is inserted into the skin.

[0035] The driving unit can detach the needle (300) from the transmitter (200) and the electrochemical sensor (400) by retracting the needle (300) from the second position to the third position after the transmitter (200) and the electrochemical sensor (400) are attached to the skin at the second position.

[0036] The drive unit can be connected to a needle handle (310) to which the needle (300) is fixed. The needle handle (310) can be attached to and detached from the drive unit.

[0037] An internal space may be provided between the first housing (210) and the second housing (220), which correspond to the lower lid and upper lid of the transmitter (200). A main board may be installed in the internal space of the transmitter (200).

[0038] As illustrated in FIGS. 2 and FIGS. 4, the transmitter (200) may include a push button (230) that enables power initiation and a battery (240) for power supply.

[0039] One side of the first housing (210) and the second housing (220) may include a recess (202) which is an open surface that is not a closed surface but is partially open. The closed surface may be in the form of a hole (or hole), and thus, due to this open surface rather than a closed surface, the transmitter (200) may have a shape in which there is no hole through which the needle (300) passes, regardless of which side (side, top, bottom) is viewed.

[0040] The recess (202) may be formed in the radial direction of the first housing (210) and the second housing (220), and an opening (204) may be formed in a part of the recess (202).

[0041] The recess (202) may include an inner opening (206) formed at an inner position corresponding to the opposite side of the opening (204), and the distal portion (406) of the needle (300) and the electrochemical sensor (400) may pass through the inner opening (206).

[0042] The inner opening (206) can allow the inclined surface (409) formed on the side extension (408) of the electrochemical sensor (400) to be exposed to the outside, and can allow the side extension (408) to be variable due to the repulsive force acting on the distal part (406) when inserted into the body.

[0043] The opening length of the opening (205) may preferably be narrow enough so that the needle handle (310) does not pass through.

[0044] The needle handle (310) may have multiple contact support points on the recess, and when the needle and transmitter descend and the needle is inserted into the skin, the recess regulates the shaking of the needle handle, so that the hole pierced in the skin may match the diameter of the needle and pain may be relieved. The contact support points of the needle handle (310) may be located around the narrow opening (205).

[0045] The needle (300) can only move in the vertical direction due to contact support of the recess (202), and an opening (204) of such narrow width can be formed that it cannot move away by passing through the opening (204) along the horizontal direction. Accordingly, the width of the center wall (302) of the needle (300) can be formed to be larger than the opening width of the opening (204).

[0046] In this way, when the opening width of the opening (204) is formed to be smaller than the needle handle (310), even if the needle handle (310) provided on the upper part of the needle (300) moves when the needle (300) moves, the side part of the recess (202) and the opening (205) act as guides to enable a stable operation.

[0047] On the main board, at least one of a power supply unit, such as a battery, required for measuring the glucose concentration of the distal portion (406), a control unit including an electrical circuit, a wireless communication unit for controlling data measured by an electrochemical sensor (400) and transmitting it wirelessly to the outside, and an operational amplifier may be installed.

[0048] The power supply unit can supply a bias voltage capable of causing an electrochemical reaction of the working electrode.

[0049] The signal of the analyte measured at the distal portion (406) can be amplified by an operational amplifier.

[0050] One side of the electrochemical sensor (400) may face the main substrate, and the other side of the electrochemical sensor (400) may be exposed from the internal space of the transmitter (200).

[0051] The electrochemical sensor (400) can be flexible so that at least a portion of it penetrates into the skin, thereby relieving pain during penetration and reducing the foreign body sensation when worn.

[0052] The distal end (406) of the electrochemical sensor (400) may be positioned in the exposed portion along the longitudinal direction of the needle (300). The end of the needle (300) is positioned at a location that protrudes further than the end of the distal end (406). After the skin is incised by the needle (300), the distal end (406) of the electrochemical sensor (400) may be inserted into the body.

[0053] Reduction of pain and foreign body sensation is a key performance feature of the continuous analyte measuring device from the user's perspective. To this end, the electrochemical sensor (400) has enough flexibility to prevent it from penetrating the skin alone, and the electrochemical sensor (400) can be thin and flexible enough that it can be inserted into the body only after the needle (300) cuts the skin.

[0054] When the inserter (100) moves and the lower part of the inserter (100) comes into contact with the user's skin, this may be the point at which the transmitter (200) is attached to the skin. When the inserter (100) is moved away from the skin, the point at which the lower part of the inserter (100) is separated from the skin may be the point at which the power of the transmitter (200) is started. However, this is not limited to this, and various types of power start points can be implemented.

[0055] The needle (300) can be manufactured, for example, by bending a steel plate, and the needle (300) may include a central wall portion (302) primarily intended to guide the penetration of the electrochemical sensor (400), and a side wall portion (304) that prevents the electrochemical sensor (400) from detaching from the needle (300) during penetration.

[0056] The central wall portion (302) can prevent the distal portion (406) or the fold portion (405) of the electrochemical sensor (400) from protruding in the first axial direction. The first axial direction may be the direction in which the inside of the needle (300) is opened to the outside. If the distal portion (406) or the fold portion (405) protrudes in the first axial direction, the protruding portion may catch on the skin, causing the electrochemical sensor (400) to buckle, and when the needle (300) is inserted into the user's skin, only the needle (300) is inserted into the skin and the electrochemical sensor (400) may be ejected from the skin.

[0057] The side wall portion (304) can prevent a part of the distal portion (406) or a part of the fold portion (405) from deviating in the second axis direction. The second axis direction may be perpendicular to the first axis direction. The first axis direction, the second axis direction, and the insertion direction may each correspond to an orthogonal coordinate system.

[0058] An opening may be formed in the needle (300) that exposes the interior of the needle (300) to the outside and extends along the longitudinal direction of the needle (300). The opening may be formed between the side walls (304) that are bent and formed on both sides of the central wall (302).

[0059] Accordingly, the internal space of the needle (300) surrounded by the central wall (302) and the side wall (304) can be communicated with the outside through the opening.

[0060] Here, an important point is that when the sensor (400) is inserted into the space between the side walls (304) of the needle (300), it is easily inserted and at the same time, it is not ejected from the outside of the needle (300) after insertion.

[0061] In other words, the distal portion (406) of the electrochemical sensor (400) needs to be provided so as to be in close contact with the inner surface of the central wall portion (302) of the needle (300) without a gap.

[0062] If the needle (300) and the distal part (406) are inserted into the body with a gap, there is a high possibility that the distal part (406) of the electrochemical sensor (400) will not be inserted into the body due to the gap, and there is a possibility that deformation such as bending may occur.

[0063] Therefore, since the needle (300) and the electrochemical sensor (400) are inserted into the body and only the needle (300) is removed from the body, the distal portion (406) of the electrochemical sensor (400) must be accurately inserted into the body during this process and must maintain the inserted state when the needle (300) is removed after insertion. Therefore, it may be desirable for the distal portion (406) of the electrochemical sensor (400) to be in close contact with the inner surface of the central wall portion (302) of the needle (300) and not to interfere with the side wall portion (304) of the needle (300).

[0064] An electrochemical sensor (400) according to one embodiment of the present invention may be twisted or directionally bent. In order for the intermediate portion (404) to extend to the proximal portion (402) without interfering with the side wall portion (304) of the needle (300), the intermediate portion (404) may be twisted or directionally bent multiple times.

[0065] Referring to FIG. 8, a side extension (408) may be formed to reduce the number of twists of the intermediate part (404) until it reaches the main board provided in the transmitter (200), and so that the side wall part (304) of the rising needle (300) does not get caught on the intermediate part (404) or proximal part (402) of the electrochemical sensor (400).

[0066] The intermediate portion (404) between the distal portion (406) and the proximal portion (402) may be extended in the first direction to form a lateral extension portion (408). The intermediate portion (404) adjacent to the distal portion (406) is in the same plane as the distal portion (406), and the intermediate portion (404) in the same plane as the distal portion (406) is extended in the first direction, which is the exposure direction of the needle (300) to form a lateral extension portion (408).

[0067] A folded portion (405) can be formed by bending from the side extension portion (408) toward the middle portion (404) in the second direction.

[0068] A cut hole (410) may be formed in the side extension (408), and the upper part of the cut hole (410) may be provided as a first side extension (408a), and the lower part of the cut hole (410) may be provided as a second side extension (408b).

[0069] It may be preferable for the incision hole (410) to be formed as a rounded ellipse without any sharp edges. This is because if the structure has sharp edges, for example, if it is formed as a rectangle, the sharp edges may actually cause cracks to occur.

[0070] As the incision hole (410) is formed, the width of the first side extension (408a) provided above the incision hole (410) is significantly reduced compared to a structure without the incision hole (410), so that the electrochemical sensor (400) can be extended like a spring by the force acting when inserted into the body.

[0071] Basically, the electrochemical sensor (400) is made of a flexible material, but if the width (longitudinal length) of the side extension (408) is large, it may be difficult to shorten the length in the transverse direction by the displacement required for the distal part (406) to be in close contact with the needle (300). The present invention is characterized by the provision of a first side extension (408a) that is formed by creating an incision (410) to facilitate shortening of the length so as to accommodate the displacement of the distal part (406), taking this into account. Accordingly, it may be preferable for the first side extension (408a) to have a small first length (d1) described later so that the length of the first side extension (408a) can be easily varied (the transverse length can be varied in a bent form).

[0072] The second side extension (408b) provided at the lower part of the incision hole (410) receives a force that is applied in the lateral direction by the repulsive force acting when the distal part (406) is inserted into the body, so that the first side extension (408a) contracts to a variable length, but the second side extension (408a) can maintain the shape of the side extension (408).

[0073] If displacement occurs towards the needle (300) due to a force to adhere to the needle (300) of the distal portion (406) and then returns to its original position, the length of the first side extension (408a) that has contracted can be restored to its original length.

[0074] A stopper (411) may be formed on one side of the side extension (408). When the electrochemical sensor (400) is assembled inside the transmitter (200), it can be assembled in the correct position by being caught by the stopper (411), thereby improving the assembly of the product.

[0075] Referring to FIG. 12, when the longitudinal length of the first side extension (408a) in the drawing is called the first length (d1) and the longitudinal length of the second side extension (408a) is called the second length (d2), the first length (d1) can be formed to be smaller than the second length (d2).

[0076] Meanwhile, referring to FIG. 10, the distal portion (406) can be inserted into the inside between the sidewall portions (304) of the needle (300) in the thickness direction, and in this case, the distal portion (406) can be provided at a distance (s) from the sidewall portions (304). Thus, when the needle (300) and the electrochemical sensor (400) are inserted into the body and only the needle (300) is removed, the sidewall portions (304) of the needle (300) and the distal portion (406) of the electrochemical sensor (400) do not interfere with each other, so the needle (300) can be easily separated from the body without affecting the electrochemical sensor (400) inserted into the body.

[0077] Additionally, referring to FIG. 12, when the length of the side extension (408) in the drawing is denoted as the first extension length (L1) in the transverse direction and the length in the longitudinal direction as the second extension length (L2), it may be preferable for the first extension length (L1) to be formed longer than the second extension length (L2). When the electrochemical sensor (400) is inserted into the skin (C), if the distal part (406) receives a force in the upward direction, the upper part of the distal part (406) applies force toward the side extension (408) that is extended in the transverse direction, and accordingly, the first side extension (408a) of the side extension (408) is pressed and its length can be varied (contracted). At this time, since the first extension length (L1) is formed to be longer than the second extension length (L2), the length of the first side extension (408a) can be easily varied.

[0078] If the first extension length (L1) and the second extension length (L2) are the same, or if the first extension length (L1) is shorter than the second extension length (L2), the length becomes shorter when receiving a force applied laterally by the distal part (406), so the first side extension part (408a) may be difficult to vary.

[0079] Referring to FIG. 9, the distal portion (406) (shown as a dotted line in the drawing) of the electrochemical sensor (400) according to one embodiment of the present invention may be provided at an angle so as to face the central wall portion (302) of the needle (300) before being inserted into the body. By doing so, the distal portion (406) may be provided with tension with respect to the central wall portion (302).

[0080] If the distal portion (406) of the electrochemical sensor (400) is not properly inserted into the side wall portion (304) of the needle (300) and a gap occurs during insertion, the needle (300) is inserted normally into the body, but the electrochemical sensor (400) is not inserted securely or cannot be inserted at all.

[0081] In this way, the electrochemical sensor (400) according to the present invention, while being provided inside the needle (300), can be inserted into the body, and the distal portion (406) can be brought closer to the central wall portion (302) of the needle (300), so that it can be inserted securely without being separated from the needle (300) during the insertion process.

[0082] Furthermore, when the electrochemical sensor (400) according to one embodiment of the present invention is inserted into the body by means of a first side extension (408a) which is variably provided by forming an incision (410) in the side extension (408), the length of the first side extension (408a) is varied so that the distal portion (406) can be closely attached to the inner surface of the center wall (302) of the needle (300), and accordingly, when inserted into the body, the distal portion (406) can be reliably inserted without a gap from the needle (300) while receiving guidance from the needle (300). Explanation of the symbols

[0084] 100... Inserter 110... Main body 120... Sealing cap 200... Transmitter 202... Recess 204... Opening 206... Inner opening 210... First housing 220... Second housing 230... Push button 240... Battery 300... Needle 302... Center wall 304... Side wall 310... Needle handle 400... Electrochemical sensor 402... Proximal part 404... Intermediate part 405... Fold 406... Distal part 408... Lateral extension 408a... First lateral extension 408b... Second lateral extension 410... Incision 411... Catching tab C... Skin d1... First length d2... Second length L1... First extension length L2 : Second extension length s... Spacing

Claims

Claim 1 An electrochemical sensor comprising a distal portion that penetrates into the skin; a main substrate to which a battery is connected and a housing in which the main substrate is housed, wherein the housing is attached to the skin and the main substrate is a transmitter that controls the measured signal of the electrochemical sensor; a needle that penetrates the electrochemical sensor into the skin; and an inserter that moves the transmitter and the needle from a first position to a second position so that the needle penetrates the skin. A continuous analyzer comprising: a portion of the electrochemical sensor that is inserted into the skin while inserted into the needle; the electrochemical sensor includes a proximal portion connected to the transmitter and a lateral extension portion extending in a different direction between the proximal portion and the distal portion; an incision is formed in the lateral extension portion; a first lateral extension portion is provided above the incision portion by the incision portion, and a second lateral extension portion is provided below the incision portion; a first length, which is the longitudinal length of the first lateral extension portion, is formed to be smaller than a second length, which is the longitudinal length of the second lateral extension portion; and the first lateral extension portion elastically contracts in the longitudinal direction due to a repulsive force acting when the distal portion is inserted into the skin, so that the distal portion adheres to the inner surface of the needle. Claim 2 delete Claim 3 A continuous analyzer according to claim 1, wherein the needle comprises a central wall portion, side wall portions formed on both sides of the central wall portion, and an opening formed between the side wall portions, and the distal portion inserted into the needle faces the central wall portion, and the side extension portion protrudes from inside the needle to the outside. Claim 4 In claim 3, the distal portion is inserted at an angle so as to face the central wall portion inside the needle. Claim 5 In claim 3, the distal portion is a continuous analyzer provided in the thickness direction with a gap from the sidewall portion. Claim 6 In claim 1, the transmitter comprises a first housing corresponding to the upper portion and a second housing corresponding to the lower portion, and the second housing comprises an opening through which the distal portion passes, forming a continuous analyzer. Claim 7 delete Claim 8 In claim 1, the continuous analyzer measuring device wherein the incision hole is formed as a rounded elliptical shape without any angled parts. Claim 9 A continuous analyzer measuring device according to claim 1, wherein the transverse length of the side extension is called the first extension length and the longitudinal length is called the second extension length, and the first extension length is formed to be longer than the second extension length.

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