Medical device for detecting analyte in bodily fluid

Abstract

A medical device (146) for detecting an analyte in a bodily fluid is disclosed. The medical device (146) comprises:-an analyte sensor (110) having an insertable portion (115) adapted to be at least partially inserted into a body tissue of a user, where the analyte sensor (110) is configured to detect the analyte in the body fluid, wherein the analyte sensor (110) comprises at least two conductor paths (136) configured to activate a sensor circuit, and wherein the analyte sensor further comprises at least two electrodes (124), each electrode comprising an electrode conductor path (125) configured to transmit a sensor current to detect the analyte; -an insertion member (147) comprising an insertion sleeve (148) wherein the analyte sensor (110) is at least partially placed inside the insertion sleeve (148); -an electronic unit, said electronic unit comprising said sensor circuit; -a housing (154) having an electronics compartment (156) in which the electronics unit is at least partially housed, where the housing (154) further comprises an open channel (170) at least partially surrounding the analyte sensor (110) and the insert member (147); and-a connector element (200) wherein the insertion part (147) is configured for retraction from the open channel (170), thereby triggering electrical contact of the connector element (200) with the at least two conductor paths (136) of the analyte sensor (110) such that the sensor circuit is activated.

Description

Technical Field

[0001] This invention relates to a medical device for detecting analytes in bodily fluids, a method of using the medical device, and a medical device system. The device and method according to the invention can be primarily used for long-term monitoring of analyte concentrations in bodily fluids, such as for long-term monitoring of blood glucose levels or the concentration of one or more other types of analytes in bodily fluids. The invention is applicable to both home care and professional care fields such as hospitals. Other applications are possible. Background Technology

[0002] Monitoring certain bodily functions, and more specifically, monitoring the concentration of one or more analytes, plays an important role in the prevention and treatment of various diseases. Without limiting further possible applications, the invention will be described below with reference to blood glucose monitoring. However, additionally or alternatively, the invention can also be applied to other types of analytes.

[0003] In addition to optical measurements, blood glucose monitoring can also be performed specifically using electrochemical biosensors. Examples of electrochemical biosensors for measuring glucose (specifically in blood or other bodily fluids) are known from US 5,413,690 A, US 5,762,770 A, US 5,798,031 A, US 6,129,823 A, or US 2005 / 0013731A1.

[0004] In addition to so-called single-point measurements that involve obtaining bodily fluid samples from users in a targeted manner and checking the sample for analyte concentration, continuous measurements are becoming increasingly established. Therefore, recently, for example, continuous measurement of glucose in interstitial tissues (also known as continuous monitoring, CM) has been established as another important method for managing, monitoring, and controlling diabetes status.

[0005] In this process, the active sensor region is applied directly to the measurement site, which is typically located in the interstitial tissue, and glucose is converted into a charge, for example, by using an enzyme (e.g., glucose oxidase, GOD), which is related to the glucose concentration and can be used as a measurement variable. Examples of such transdermal measurement systems are described in US 6,360,888 B1 or US 2008 / 0242962 A1.

[0006] Therefore, current continuous monitoring systems are typically percutaneous or subcutaneous systems, both of which will be used equivalently below. This means that the actual sensor, or at least the measuring portion of the sensor, can be placed under the user's skin. However, the evaluation and control portion of the system (also known as a patch) can typically be located outside the user's body, either in a human or animal body. In this process, the sensor is typically applied using an insertion instrument, which is also described exemplarily in US 6,360,888 B1. Other types of insertion instruments are also known.

[0007] Sensors typically include a substrate, such as a flat substrate, onto which conductive patterns of electrodes, conductive traces, and contact pads can be applied. In use, the conductive traces are typically isolated using one or more electrically insulating materials. These electrically insulating materials often further serve to protect against moisture and other harmful substances, and, as an example, may include one or more coatings such as a resist.

[0008] WO 2019 / 122095 A1 discloses a medical system. The medical system includes: a housing and a pre-assembled functional module housed within the housing. The pre-assembled functional module includes an analytical sensor for detecting at least one analyte in a user's bodily fluids; an electronic unit electrically connected to the analytical sensor; and an insertion part for inserting the analytical sensor into the user's body tissue. Further, the medical system includes at least one removable protective cover connected to the housing and covering the pre-assembled functional module.

[0009] EP 2 393 417 A1 describes methods and apparatus for monitoring analytes in bodily fluids. Examples include the automatic, or on-demand, continuous or discrete acquisition of analyte-related data from a transdermal analyte sensor. A family member of EP 2 393 417 A1 is CN 102307518 B.

[0010] US 11,246,519 B2 describes an apparatus for inserting a medical device into the skin of a subject and a method for inserting the medical device. Embodiments include removing a generally cylindrical cap from an inserter to expose a generally cylindrical sleeve, removing the cover from a generally cylindrical container holding sensor components, and assembling the sensor components into the inserter.

[0011] EP 3 641 636 B1 describes embodiments of applicators generally relating to skin-touch sensor assemblies for measuring analytes in a host, as well as methods of using and manufacturing them. In some aspects, an applicator for applying a skin-touch sensor assembly to the skin of a host is described. The applicator includes an applicator housing; a needle carrier assembly including an insertion element configured to insert a sensor of the skin-touch sensor assembly into the skin of the host; a retainer releasably coupled to the needle carrier assembly and configured to guide the skin-touch sensor assembly upon coupling to the needle carrier assembly; and a drive assembly configured to drive the insertion element from a proximal starting position to a distal insertion position and from the distal insertion position to a proximal retraction position.

[0012] Miniaturization of continuous glucose monitoring devices can benefit from the ability to use small batteries. This can be further achieved if power consumption can be minimized during the time between manufacturing and activation of the continuous monitoring device. In existing integrated continuous glucose monitoring devices, the electronics typically switch between a wake-up mode and a low-power mode, also known as a sleep mode and wake-up mode. During wake-up mode, the electronics of the continuous glucose monitoring device can assess whether the sensor has been tampered with and / or turned on, in which case the electronics typically transition to an active state, in which case the device can begin detecting analyte concentrations and / or establishing wired or wireless communication with a remote monitoring device. If no activation is detected, the electronics can switch back to low-power mode. This mechanism may have drawbacks, such as the need to select battery capacity and therefore battery size, such that the battery capacity supports power consumption not only during the shelf life of the continuous monitoring device, for example, 1-12 months, but also during typical 1-2 weeks of wear. Therefore, it is desirable to provide a continuous monitoring device in which the battery is completely turned off during storage until the user uses the continuous monitoring device, thus requiring a much smaller power capacity. This, in turn, will allow for the design of smaller, more compact continuous monitoring devices than currently used systems. Furthermore, these devices are therefore less expensive to manufacture and more user-friendly, especially since the smaller sensors are less visible and less likely to be detected when, for example, a bump or touch occurs on a body part wearing the sensor.

[0013] Current continuous glucose monitoring devices may have a housing with an electronic compartment (in which the electronic unit is housed) and a sterile sensor compartment for an analyte sensor, formed by an insert cannula, its retainer, and a sterile cap together with a sealed cylindrical opening in the housing. The insertable portion of the analyte sensor can be sealed and isolated from the space within the electronic compartment and the sterile cap. Therefore, sealing and isolating the electronic connection portion of the analyte sensor, which may penetrate the housing, specifically the electronic compartment, may present additional challenges. Furthermore, the sterile cap may limit the possibility of introducing a switching mechanism into the continuous glucose monitoring device. The concept outlined above may require that the insert cannula and analyte sensor be pre-installed within the housing and connected to the electronic unit at the time of manufacture.

[0014] In alternative continuous glucose monitoring device concepts, the analyte sensor and insertion cannula are not connected to the electronics unit at the time of manufacture. These concepts typically require two parts: one including the sensor and / or cannula, and the other including the electronics unit, which the user connects before or after inserting the sensor into the skin. Given that the industry is moving away from these concepts, they may have lost their relevance to the new continuous glucose monitoring device market.

[0015] The concept of using electronic units to switch between sleep and wake modes can consume significant amounts of energy, potentially necessitating the use of large batteries to ensure sufficient power to support the continuous glucose monitoring device throughout its shelf life and during use after the analyte sensor is inserted into the user's body tissue. Meanwhile, currently available activation mechanisms inevitably suffer from the aforementioned drawbacks. Therefore, it may be necessary to provide a medical device that overcomes these drawbacks by reducing power consumption until the device is activated, while providing a continuous glucose monitoring device that is easily and reliably activated and / or inserted when the analyte sensor is activated. Furthermore, any further disruption to the sealed interior of the housing should be avoided.

[0016] Problems to be solved

[0017] Therefore, it is desirable to provide a medical device for detecting analytes in bodily fluids, a method for using the medical device, and a medical device system that solves at least one of the aforementioned problems. In particular, it is desirable to provide a medical device for detecting analytes in bodily fluids, a method for using the medical device, and a medical device system that allows for reduced power consumption before activating the medical device while providing reliable activation. Summary of the Invention

[0018] At least one of the aforementioned problems is solved by a medical device for detecting at least one analyte in bodily fluids, a method of using the medical device, and a medical device system having the features of the independent claims. Advantageous embodiments that can be implemented individually or in any combination are set forth in the dependent claims and throughout the specification.

[0019] As used below, the terms “have,” “contain,” or “include,” or any grammatical variations thereof, are used in a non-exclusive manner. Thus, these terms can refer either to a situation where no other features exist in the entity described in this context besides those introduced by these terms, or to a situation where one or more other features exist. For example, the statements “A has B,” “A includes B,” and “A contains B” can refer to a situation where no other elements exist in A besides B (i.e., where A is solely and uniquely composed of B); or to a situation where one or more other elements (such as element C, element D, or even other elements) exist in entity A besides B.

[0020] Furthermore, it should be noted that the terms "an element" and "the element" may indicate that there may be multiple elements in a particular embodiment, such as at least two elements.

[0021] Furthermore, it should be noted that the terms "at least one," "one or more," or similar expressions indicating that a feature or element may exist once or more are generally used only once when introducing the corresponding feature or element. In the following text, in most cases, when referring to the corresponding feature or element, the expressions "at least one" or "one or more" will not be used repeatedly, even though the corresponding feature or element may exist only once or more.

[0022] Furthermore, as used below, the terms “preferredly,” “more preferably,” “particularly,” “more particularly,” “specifically,” “more specifically,” or similar terms are used in combination with optional features without limiting the possibility of alternatives. Therefore, features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. As those skilled in the art will recognize, the invention can be practiced by using alternative features. Similarly, features introduced by “in one embodiment of the invention” or similar expressions are intended to be optional features without limiting alternative embodiments of the invention, without limiting the scope of the invention, and without limiting the possibility of combining features introduced in this way with other optional or non-optional features of the invention.

[0023] In a first aspect of the invention, a medical device for detecting an analyte in bodily fluids is disclosed. The medical device includes:

[0024] ● Analyte sensor having an insertable portion adapted to be at least partially inserted into a user’s body tissue, wherein the analyte sensor is configured to detect an analyte in a body fluid, wherein the analyte sensor includes at least two conductor paths configured to activate sensor circuitry, wherein the analyte sensor further includes at least two electrodes, each electrode including an electrode conductor path configured to transmit sensor current to detect the analyte.

[0025] ● Insertion component, including an insertion sleeve, wherein the analyte sensor is at least partially placed within the insertion sleeve;

[0026] ● Electronic unit, which includes sensor circuitry;

[0027] ● A housing having an electronic compartment in which an electronic unit is at least partially housed, wherein the housing further includes an open channel at least partially surrounding the analyte sensor and the insertion component; and

[0028] ● Connector element, wherein the insertion part is configured to retract from the open channel, thereby triggering electrical contact between the connector element and at least two conductor paths of the analyte sensor, thereby activating the sensor circuitry.

[0029] As used herein, the term "user" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term exemplarily refers to a person who wants to monitor analyte values ​​(such as glucose levels) in a person's body tissues. In embodiments, the term may specifically refer to (but is not limited to) a person using a medical device. For example, a user may be a patient with a condition such as diabetes. A user may also be referred to as a subject or patient. However, in another embodiment, the person using the medical device differs from a user.

[0030] As used herein, the term "medical device" is a broad term and will be given its common and conventional meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term may refer to (but is not limited to) any element or article configured for use in the field of medical technology, exemplarily for use in the field of medical analysis or medical diagnosis. A medical device may be configured to perform a medical function and / or be used in a medical procedure, such as one or more of a treatment procedure, diagnostic procedure, or other medical procedure.

[0031] Medical devices may specifically include components of two or more parts capable of interacting with each other, such as for one or more diagnostic and / or therapeutic purposes, such as for medical analysis. Specifically, the two or more parts may be capable of detecting analytes in bodily fluids and / or facilitating the detection of analytes in bodily fluids. Medical devices may also be commonly referred to as sensor assemblies, sensor systems, sensor kits, or sensor devices. Further, medical devices may also be commonly referred to as wearable analyte sensor systems.

[0032] The medical device can be configured to be mounted on a skin site on a body part selected from the group consisting of: the arm, for example the upper arm; the abdomen; the shoulder; the back; the hip; and the leg. Specifically, the body part may be the upper arm. However, other applications may also be possible.

[0033] Medical devices may include components that can be configured to remain outside of body tissue. Specifically, a component configured to remain outside of body tissue may be a housing having an electronic compartment housing an electronic unit. Further, a medical device, specifically an analytical sensor, may include an insertable portion as outlined above. The insertable portion may be configured for insertion into a user's body tissue.

[0034] The medical device may be a single-use medical device. The term "single-use medical device" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any specific or customary meaning. Specifically, the term may refer to (but is not limited to) any medical device configured for disposal after use. Thus, one or more materials may specifically be inexpensive and / or easily recyclable. Specifically, the electronic unit may be a single-use electronic unit. The term "single-use" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any specific or customary meaning. Specifically, the term may refer to (but is not limited to) the property of any element being configured for application only once. Thus, after detecting an analyte in bodily fluids, the user can remove the electronic unit from body tissue, dispose of the electronic unit, and can utilize another new medical device including a new electronic unit for a further detection of the analyte in the bodily fluids.

[0035] Specifically, the analyte sensor, insertion cannula, electronic unit, housing, and connector elements can form a pre-assembled single unit. As used herein, the term "pre-assembled" is a broad term and will be given a meaning common and customary to those skilled in the art, and is not limited to a specific or customary meaning. The term can specifically refer to (but is not limited to) the fact that an assembly process has already occurred. Thus, components of a medical device may have already been assembled, such as by being mechanically interconnected, thereby preparing them for function, such as medical functions, for example, for analytical functions. Pre-assembly can specifically be performed in a factory, thereby making the medical device a functional module assembled in the factory. Specifically, the medical device can be configured such that the user cannot see or manipulate the medical device, preferably before putting the medical device into use or before applying it to the body.

[0036] The term "body fluid" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term refers to fluids that are generally present in the body or body tissues of a user or patient and / or can be generated by the body of a user or patient. As an example of body tissue, interstitial tissue may be mentioned. Thus, by way of example, body fluids may be selected from the group consisting of blood and interstitial fluid. However, additionally or alternatively, one or more other types of body fluids, such as saliva, tears, urine, or other body fluids, may be used. During the detection of an analyte, body fluids may be present in the body or body tissues. Therefore, specifically, as will be further detailed below, an analyte sensor may be configured to detect analytes in body tissues.

[0037] As used herein, the term "analyte" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term refers to any element, component, or compound that may be present in bodily fluids, and whose presence and / or concentration may be of interest to a user, patient, or medical professional (such as a physician). In particular, an analyte can be or may include any chemical substance or chemical compound that may participate in the metabolism of a user or patient, such as metabolites. As an example, an analyte may be selected from the group consisting of glucose, cholesterol, triglycerides, and lactate. However, additionally or alternatively, other types of analytes and / or any combination that can identify an analyte may be used. Specifically, however, an analyte may be glucose. In the following, a medical device may be specifically described in relation to glucose monitoring. The detection of an analyte may specifically be an analyte-specific detection.

[0038] The term "detection" as used herein is a broad term and should be given its common and conventional meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term relates to the process of determining the presence and / or quantity and / or concentration of an analyte. Therefore, detection may be or may include qualitative detection, simply determining the presence or absence of an analyte, and / or may be or may include quantitative detection, determining the quantity and / or concentration of an analyte. As a result of detection, signals characterizing the detection result may be generated, such as at least one measurement signal. Measurement signals may specifically be or may include electronic signals, such as voltage and / or current. Measurement signals may be or may include analog signals and / or may be or may include digital signals.

[0039] As used herein, the term "analyte sensor" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to (but is not limited to) a sensor capable of qualitatively or quantitatively detecting the presence and / or concentration of an analyte.

[0040] The analyte sensor may in particular be a transdermal sensor. The term "transdermal sensor" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term may refer to (but is not limited to) any sensor adapted to be disposed wholly or at least partially within the body tissue of a patient or user. For this purpose, the analyte sensor includes an insertable portion. The term "insertable portion" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term may refer to (but is not limited to) a portion or component of an element configured to be insertable into any body tissue. To further enable the analyte sensor to be used as a transdermal sensor, the analyte sensor may provide, wholly or partially, a biocompatible surface, i.e., a surface that does not have any harmful effect on the user, patient, or body tissue during at least the duration of use. Specifically, the insertable portion of the analyte sensor may have a biocompatible surface. As an example, a transdermal sensor, specifically an insertable portion, may be completely or partially covered by a biocompatible membrane (such as a polymer membrane or gel membrane) that is permeable to the analyte and / or body fluids, and on the other hand, retains sensor material (such as one or more analyte detection agents) within the sensor and prevents these substances from migrating into body tissues. Other parts or components of the analyte sensor may remain outside the body tissues. These other parts may be connected to an evaluation device, such as to an electronics unit, as will be further described below.

[0041] The dimensions of a percutaneous sensor can typically be designed to make percutaneous insertion feasible, such as by providing a width of no more than 5 mm, preferably no more than 2 mm, and more preferably no more than 1.5 mm in the direction perpendicular to the insertion direction. The sensor can have a length of less than 50 mm, such as 30 mm or less, for example, a length from 5 mm to 30 mm. The term "length" as used herein can refer to the direction parallel to the insertion direction. However, it should be noted that other dimensions are feasible.

[0042] The analyte sensor may specifically be an electrochemical analyte sensor. The term "electrochemical sensor" as used herein is a broad term and should be given its common and conventional meaning to those skilled in the art, and is not limited to any particular or custom meaning. The term may specifically refer to (but is not limited to) a sensor configured to perform electrochemical measurements, specifically for detecting analytes in a user's bodily fluids. The term "electrochemical measurement" may refer to the detection of the electrochemically detectable properties of an analyte, such as an electrochemical detection reaction. Thus, for example, an electrochemical detection reaction can be detected by comparing one or more electrode potentials. The electrochemical sensor may specifically be adapted to and / or can be used to generate an electrical sensor signal, such as current and / or voltage, that directly or indirectly indicates the presence and / or extent of an electrochemical detection reaction. Detection may be analyte-specific. Measurement may be qualitative and / or quantitative. Other embodiments are also possible.

[0043] As used herein, the term "electrode" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. Specifically, the term may refer to (but is not limited to) any element configured or usable for the electrochemical or electrochemical detection of an analyte. Specifically, each electrode may include a conductive pad or conductive element, such as a metal pad and / or a metal element and / or a pad or element made of conductive inorganic or organic materials, such as carbon and / or conductive polymers. The conductive pad or conductive element may be uncovered and / or may be covered by an additional material, such as sensor chemicals. At least two electrodes of an analyte sensor may be configured such that an electrochemical reaction can occur at one or more electrodes, such as one or more working electrodes. Thus, electrodes may be configured such that oxidation and / or reduction reactions can occur at one or more electrodes. An electrochemical detection reaction can be detected by comparing the potentials of one or more electrodes (such as the electrostatic potential of a working electrode) with the electrostatic potentials of one or more other electrodes (such as a counter electrode or reference electrode). Typically, two or more electrodes may be used for one or more of current measurement, current galvanometry, potential measurement, or potentialometry. These types of measurements are generally known to those skilled in the art of analyte detection, such as from WO 2007 / 071562 A1 and / or prior art documents disclosed therein. Reference can be made to this document for potential configurations of electrodes, electrode materials, or measurement setups. However, it should be noted that other configurations, electrode materials, or measurement setups may be used within the scope of this invention. Electrodes typically include electrode conductor paths configured to transmit sensor current for detecting analytes. In turn, the electrode conductor paths may be connected to sensor electronics in certain embodiments, such as electrode contacts connected to corresponding contacts of electronic components of the sensor electronics. As summarized above, the analyte sensor includes at least two conductor paths configured to activate sensor circuitry, and additionally, the analyte sensor includes at least two electrodes. The at least two conductor paths may differ from the at least two electrodes comprising the electrode conductor paths.

[0044] Exemplarily, an analyte sensor may include a two-electrode sensor. A two-electrode sensor may precisely include two electrodes, such as a working electrode and an additional electrode, such as a counter electrode, for example, a working electrode and a combined counter / reference electrode. The term "working electrode" as used herein is a broad term and should be given its common and conventional meaning to those skilled in the art, and is not limited to any particular or custom meaning. The term may specifically refer to (but is not limited to) an electrode adapted to or usable for performing an electrochemical detection reaction for detecting an analyte in bodily fluids. The working electrode may have an analyte detector sensitive to the analyte to be detected. The working electrode may further include a conductive working electrode pad. The conductive working electrode pad may be in contact with the analyte detector. Therefore, the analyte detector may be coated onto the conductive working electrode pad. The analyte detector may form an analyte detector surface that can contact the bodily fluid. As an example, the analyte detector surface may be an open analyte detector surface or may be covered by the aforementioned membrane, which is permeable to the analyte to be detected and / or to the bodily fluid or a portion thereof, allowing the analyte to interact with the analyte detector. Furthermore, for potential analyte detectors and / or materials used for conductive working electrode pads, reference can be made to WO 2007 / 071562 A1 and / or the prior art documents disclosed therein. However, other embodiments are also possible. One or more “working electrode pads” can specifically be formed by dots, lines, or grids, each of which can form a coherent area of ​​electrode material. If more than one dot, line, or grid of electrode material is superimposed, the sensor can provide more than one electrode pad. All electrode pads together can constitute a working electrode. The sensor may include a working electrode having an amount ranging from 1 to 50, preferably 2 to 30, and preferably 5 to 20 electrode pads.

[0045] The term "analyte detector" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or custom meaning. Specifically, the term may refer to (but is not limited to) any material or composition of materials adapted to alter a detectable property in the presence of an analyte. This property may be an electrochemically detectable property. Specifically, an analyte detector may be a highly selective analyte detector that alters the property only in the presence of the analyte in bodily fluids, and does not change it in the absence of the analyte. The extent or change of the property depends on the concentration of the analyte in the bodily fluids to allow for the quantitative detection of the analyte. As an example, an analyte detector may include enzymes such as glucose oxidase and / or glucose dehydrogenase.

[0046] At least two electrodes may further include a counter electrode. The term "counter electrode" as used herein is a broad term and should be given its common and conventional meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term may refer to (but is not limited to) an electrode adjusted to be suitable for carrying out an electrochemical pair reaction and adjusted to be suitable for balancing the current required for the detection reaction at the working electrode. Additionally or alternatively, at least two electrodes may further include a reference electrode. The reference electrode may have a stable and well-known electrode potential. The electrode potential may preferably be highly stable. The counter electrode and the reference electrode may be a common electrode or one of two separate electrodes. Again, for potential materials that may be used for the counter electrode and / or the reference electrode, reference may be made to WO 2007 / 071562 A1 and / or the prior art documents disclosed therein. However, other embodiments are also possible.

[0047] Electrodes, particularly working electrodes, counter electrodes, and / or reference electrodes, may have the same dimensions. The term "dimensionality" may refer to one or more of the width, length, surface area, and shape of the working electrode, counter electrode, and / or reference electrode. The shape of the electrode may be determined by a manufacturing process (such as a cutting and / or printing process). The shape may be rectangular or circular. Furthermore, other embodiments are feasible, such as embodiments in which the dimensions of the working electrode and the counter / reference electrode differ and / or embodiments using non-circular or non-rectangular shapes. Electrodes may be made of non-corrosive and non-passivating materials. Reference can be made to the prior art literature cited above regarding possible electrode materials.

[0048] Analyte sensors may include a carrier, specifically a substrate. The term "carrier" as used herein is a broad term and should be given its common and conventional meaning to those skilled in the art, and is not limited to any particular or customary meaning. The term may specifically refer to (but is not limited to) any element suitable for carrying one or more other elements disposed thereon or in it. The term "substrate" as used herein is a broad term and is given its common and conventional meaning to those skilled in the art, and is not limited to any particular or customary meaning. The term may specifically refer to (but is not limited to) any flat element having a lateral extension of at least 2, 5, 10, or even 20 or more times its thickness.

[0049] The carrier, specifically a substrate, may have an elongated shape, such as a strip shape and / or a rod shape. As an example, the substrate may include a shaft, specifically a shaft with an elongated shape. For example, the shaft may have a shape selected from the group consisting of strips, needles, and bands. Other shapes may also be feasible.

[0050] The carrier, specifically the substrate, can be a flexible carrier or substrate, i.e., a carrier or substrate that can be bent or deformed by forces (such as 10 N or less) typically occurring during wear and insertion into body tissue. Specifically, the carrier or substrate can be made of or may include deformable materials, such as plastics or stretchable and / or elastic materials. As an example, the carrier or substrate can be or may include foil, such as foil made of one or more of paper, cardboard, plastic, metallic, ceramic, or glass materials. As an example, the carrier or substrate may include polyimide foil. The carrier or substrate may specifically include electrically insulating materials, such as electrically insulating plastic foil.

[0051] Specifically, the analyte sensor can be a needle-shaped or strip-shaped analyte sensor having a flexible substrate and electrodes disposed thereon. As an example, the analyte sensor can have an overall length of 5 mm to 50 mm, for example, 7 mm to 30 mm. In the context of this invention, the term "overall length" refers to the total length of the analyte sensor, meaning both the portion of the analyte sensor that is inserted and the portion that may remain outside body tissue. The portion of the analyte sensor that is inserted can also be referred to as the in vivo portion, and the portion that may remain outside body tissue can also be referred to as the in vitro portion. For example, the in vivo portion can have a length in the range of 3 mm to 12 mm. The analyte sensor may further include a biocompatible covering, such as a biocompatible membrane that completely or partially covers the analyte sensor and prevents the analyte detector from migrating into body tissue and allows bodily fluids and / or analytes to diffuse to the electrodes.

[0052] As summarized above, the analyte sensor includes at least two conductive paths. Specifically, the analyte sensor may include two conductive paths. The term "conductor path" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or custom meaning. The term specifically refers to any conductive element suitable for or configured to establish an electrical connection with another element. The conductor path may specifically have a shape that is at least two-dimensional. The conductor path may specifically have an elongated shape, such as a length along a substrate exceeding the width in the plane of the substrate by at least 5 times, such as at least 10 times, or even at least 100 times. For example, the conductor path may include wires or traces. Furthermore, the conductor path may include a conductive material. Exemplarily, the conductive material may include a metallic material. Thus, as an example, the conductor path may include gold. Additionally or alternatively, other types of metallic materials may be applied, such as at least one of the following: Cu, Ni, Ag, Au, Pd, Pt. Furthermore, or alternatively, the conductor paths may be made wholly or partially of a non-metallic conductive material, such as at least one of the following: conductive carbon materials, such as graphite, graphene, carbon nanotubes, glassy carbon; conductive organic materials, such as conductive polymers. Alternatively, other types of conductive materials may also be used. Specifically, at least two conductor paths may be arranged at a distance from each other. Therefore, at least two conductor paths may not be in contact with each other. At least two conductor paths may be arranged to be substantially parallel to each other or may extend substantially parallel to each other. Thus, the term "substantially parallel" may refer to the property that at least two conductor paths are parallel to each other. Exemplarily, at least two conductor paths may be precisely parallel to each other. However, small deviations may be feasible. Specifically, at least two conductor paths may be arranged at an angle of + / - 20°, preferably + / - 10°, more preferably + / - 5° to each other. Further, at least two conductor paths may have the same dimensions. For further details regarding the expression "dimensions," refer to the description above.

[0053] At least two conductor paths can be disposed on a carrier or substrate, respectively. Specifically, the at least two conductor paths can be disposed as layers on a carrier, such as on the surface of the carrier. The at least two conductor paths can be at least partially covered by a protective layer. The protective layer can be configured to protect the at least two conductor paths from environmental influences. The protective layer can specifically be made of an electrically insulating material.

[0054] Specifically, each of at least two conductor paths may include a contact area. The term "contact area" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or custom meaning. The term specifically refers to any region of a conductor path having an open or electrically contactable surface. The contact area may be positioned parallel to the surface of the carrier or substrate, specifically the size or orientation of the supporting surface. The contact area may have any shape, such as rectangular, polygonal, or circular. Other shapes are possible. The contact areas may be arranged at a distance from each other, specifically opposite each other. Thus, a first contact area of ​​a first conductor path may be arranged at a distance from a second contact area of ​​a second conductor path, for example, to prevent contact from being established without a contact connector. Therefore, the first and second contact areas may not be in contact with each other.

[0055] Specifically, the contact area may be located on or disposed on the surface of the analyte sensor, specifically on the surface of the carrier, and more specifically on the surface of the substrate of the carrier. Specifically, the contact area of ​​each of at least two conductor paths may be at least partially located on and / or near the surface of the carrier. As summarized above, at least two conductor paths may be at least partially covered by a protective area. The contact area may be exposed. Specifically, the contact area may be exposed by laser ablation. In the contact area, the protective layer may have grooves or cutouts.

[0056] Additionally or alternatively, the contact area may be raised relative to the surrounding surface of the analyte sensor, specifically relative to the surrounding surface of the carrier. This arrangement can improve the contact of the connector element with at least two conductor paths. Specifically, the contact area may be or may include a conductive material layer, which may be deposited directly or indirectly onto the at least two conductor paths and can provide an electrically contactable surface. Specifically, the contact area may each include a soldering area. Thus, specifically, the pathways for electrically connecting the connector element can be increased for at least two conductor paths. Specifically, a more defined contact surface can be provided by mounting and / or soldering conductive material to the contact area.

[0057] The analyte sensor may be partially housed inside the electronic compartment, while another portion of the analyte sensor may be partially housed outside the electronic compartment, such as within an open channel. At least two conductor paths may be at least partially housed outside the electronic compartment. Specifically, at least two conductor paths may be partially housed inside the electronic compartment and partially housed outside the electronic compartment. Specifically, contact areas of the at least two conductor paths may be arranged outside the electronic compartment. More specifically, the contact area of ​​each of the at least two conductor paths may be arranged within an open channel of the housing. The contact area may specifically be arranged inside an insertion sleeve. Further, each of the at least two conductor paths may have a contact pad for connection to one or more electronic components of the electronic unit. Specifically, the at least two conductor paths may be configured for connection to one or more of an energy storage device (such as a battery), sensor electronics, or a switch (such as a relay). The contact pad may differ from the contact area of ​​each of the at least two conductor paths. Thus, each of the at least two conductor paths may include a contact pad and a contact area. The contact pad may be arranged separately inside the electronic compartment. However, there may also be one or more components that are different from the contact pads used to electrically connect at least two conductor paths to one or more electronic components of an electronic unit, such as solder joints, joint joints, plugs, clamping joints, etc.

[0058] As used herein, the term "insertion component" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term can specifically refer to (but is not limited to) any element that can be at least partially inserted into body tissue, particularly for the delivery or transfer of additional elements. An insertion cannula can be configured to support the insertion of an analyte sensor or a portion thereof. As summarized above, the insertion component includes an insertion cannula. The insertion component may further include a retainer for the insertion cannula. The insertion cannula may be attached to the retainer. Specifically, the insertion cannula may be fixedly attached to the retainer. The retainer may at least partially surround the insertion cannula. Specifically, the insertion cannula may have a first end and an opposing second end. The first end may have a tip or point for at least partially inserting the analyte sensor into body tissue. The second end may be attached to the retainer.

[0059] The term "insertion cannula" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or custom meaning. Specifically, the term may refer to (but is not limited to) a hollow needle that may be at least partially or completely slotted. An analyte sensor may be housed within the insertion cannula, such as within the lumen of the insertion cannula. The insertion cannula may include a tip or point for at least partially inserting the analyte sensor into body tissue. The insertion cannula may, for example, include at least one cross-section selected from the group consisting of: circular, elliptical, U-shaped, and V-shaped. Other embodiments are also possible. Specifically, the insertion cannula may be a slotted cannula. Alternatively, the insertion cannula may be a slotless cannula. The insertion cannula may be configured for vertical insertion or insertion at an angle of 90° to 30° relative to the user's body tissue.

[0060] As used herein, the term "electronic unit" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term refers to any device configured to perform electronic functions. Specifically, an electronic unit may have electronic components. Specifically, an electronic unit may include electronic components for performing one or more of the following: performing measurements using an analyte sensor, performing voltage measurements, performing current measurements, recording sensor signals, storing measurement signals or measurement data, and transmitting sensor signals or measurement data to another device. An electronic unit may specifically be embodied as a transmitter or may include a transmitter for transmitting data. Other embodiments of the electronic components are also possible. These electronic components are generally known in the art of long-term monitoring of one or more analytes, such as those known from one or more of the aforementioned prior art documents.

[0061] The electronic unit may include at least one circuit carrier, preferably a printed circuit board, more preferably a flexible printed circuit board. The term "circuit carrier" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or custom meaning. Specifically, the term refers to an element or combination of elements capable of carrying one or more electronic components and capable of interconnecting these one or more electronic components, such as electrically or electronically interconnecting one or more electronic components with each other and / or interconnecting with one or more contact pads. As an example, the circuit carrier may include a substrate and one or more electrical traces and / or one or more electrical contact pads disposed thereon and / or therein. As an example, the substrate may be a flat element having a lateral extension at least 10 times, more preferably at least 100 times, or even 1000 times its width. Other embodiments are possible. The rigid material that can be used for the substrate may be a fiber-reinforced plastic material, such as a fiber-reinforced epoxy material, such as a glass fiber-reinforced epoxy material, such as FR-4. Other materials may be used. Specifically, the substrate may be a flexible substrate, such that the circuit carrier can be wholly or partially embodied as a flexible printed circuit board. In this context, as an example, the flexible substrate may be made wholly or partially from one or more flexible plastic materials, such as one or more plastic foils or laminates, such as polyimide.

[0062] Electronic components can be attached to a circuit carrier. The term "electronic component" can generally refer to any element or combination of elements that serves an electrical or electronic purpose. Specifically, an electronic component can be or may include at least one component selected from the group consisting of integrated circuits, amplifiers, resistors, transistors, capacitors, diodes, or any combination thereof. Specifically, an electronic component can be or may include a device capable of controlling an analyte sensor to perform analytical measurements using the analyte sensor. Specifically, the device may include voltage measuring devices and / or current measuring devices. Other arrangements or embodiments are possible. An example of an electronic component may be an application-specific integrated circuit (ASIC).

[0063] In this embodiment, electronic components can be attached directly or indirectly to a circuit carrier. The circuit carrier can be a printed circuit board, particularly a flexible printed circuit board. As an example, electronic components can be directly attached to the circuit carrier using one or more of soldering, bonding, or conductive adhesives. Therefore, the circuit carrier can include one or more contact pads, wherein corresponding contacts of the electronic components are electrically connected to one or more contact pads. However, additionally or alternatively, electronic components can be indirectly attached to the circuit carrier, such as via an electronic housing. Therefore, an electronic housing can be attached to the circuit carrier. Furthermore, electrical contacts can be formed between the electronic components and the circuit carrier, such as via contacts passing through the electronic housing. The electronic housing can completely or partially surround the electronic components. As an example, the electronic housing can include a lower electronic housing component attached to the circuit carrier, wherein the electronic device is inserted into the lower electronic housing component on the side opposite the circuit carrier. The electronic housing can further include additional electronic housing components, such as an upper electronic housing component, which, when combined with the lower electronic housing component, can form an encapsulation that completely or partially surrounds the electronic components. However, additionally or alternatively, other types of encapsulation of the electronic components can be used, such as encapsulation using one or more casting and / or potting compounds. Therefore, as an example, a lower electronic housing component can be used to house electronic components, wherein the upper shell or protection above the electronic components is formed by casting and / or potting, such as by using one or more of epoxy resin, thermoplastic polymer, silicone resin, and epoxy resin. Alternatively or additionally, an electronic housing component may not be used at all, such as by placing the electronic components directly onto the circuit carrier.

[0064] As summarized above, the electronic unit includes sensor circuitry. The term "sensor circuitry" as used herein is a broad term and should be given its common and conventional meaning to those skilled in the art, and is not limited to any particular or custom meaning. Specifically, the term refers to any electrical network having a closed loop or a loopable circuit that provides a current return path. The electrical network can be or may include interconnections of electrical components. Sensor circuitry may be specifically configured to operate a medical device. Different components of the sensor circuitry are described in more detail below. Specifically, the electronic unit may include a printed circuit board on which the sensor circuitry is disposed. Sensor circuitry may include the electronic components described above.

[0065] Specifically, the sensor circuit may include an energy storage device, specifically a battery. The term "battery" as used herein is a broad term and should be given its common and conventional meaning to those skilled in the art, and is not limited to any particular or custom meaning. The term specifically refers to any power source comprising one or more electrochemical cell units with external connections for powering an electrical device. When powered, the positive terminal of the battery may be referred to as the cathode, and the negative terminal as the anode. The battery may specifically be a primary battery. A primary battery may be configured for single use. A primary battery may also be referred to as a single-use or disposable battery. Connector elements may be configured to establish electrical contact between the energy storage device and the electronic components of the sensor circuitry via at least two conductor paths of the analyte sensor.

[0066] As summarized above, when the insert is retracted from the open channel, the sensor circuit is activated, thereby triggering electrical contact between the connector element and at least two conductor paths of the analyte sensor; thus, the sensor circuit is activated. Specifically, activation can be triggered by removing the insert sleeve from the open channel. Therefore, when the insert sleeve is removed from the open channel, the connector element can electrically contact the contact area of ​​each of the at least two conductor paths, and the sensor circuit can close. Thus, the electronic components of the sensor circuit can be powered by a power storage device. Further, the electronic unit, specifically the electronic components of the electronic unit, can be electrically connected to the analyte sensor, specifically to at least two electrodes of the analyte sensor. Through this electrical connection, the electronic unit can interact with the analyte sensor to perform electrochemical measurements. This embodiment can be specifically associated with the advantage over systems known to date, namely, that it eliminates the need for the medical device to switch back and forth between wake-up mode and low-power mode. Instead, activation caused by the removal of the insert can, for the first time, establish an electrical connection between the power source (specifically the power storage device) and the sensor circuit system (specifically the sensor circuit). This allows for the provision of miniaturized medical devices equipped with energy sources that are smaller in capacity and size compared to currently known systems. Furthermore, the medical devices of this invention are therefore less expensive to manufacture and more user-friendly, especially because the smaller devices are less visible and less likely to be felt when, for example, bumped or touched, the body part wearing the device is touched.

[0067] Connector elements can be configured to establish transient or permanent electrical contact between at least two conductor paths of an analyte sensor. In a permanent configuration, an electrical connection can be established between a power storage device and an energized sensor circuit via at least two conductor paths, which are contacted via the connector element. In another embodiment, the electrical contact can be transient, in which case an electrical connection is established between a power storage device and a switch, such as a relay switch, via at least two conductor paths, which are contacted via the connector element. As a result of the electrical signal, the switch (such as a relay switch) can establish a circuit between the power storage device and the sensor circuit, which is maintained even after the electrical connection between the at least two conductor paths via the connector element is interrupted (e.g., when the insert is removed from the open channel).

[0068] As used herein, the term "housing" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term refers to any element adapted to completely or partially surround and / or house one or more components to provide one or more of the following: mechanical protection, mechanical stability, environmental protection against moisture and / or ambient atmosphere, shielding against electromagnetic influences, etc. Thus, a housing may simply provide a base for attaching and / or retaining one or more additional parts or components. Additionally or alternatively, a housing may provide one or more internal spaces for housing one or more additional parts or components. The housing may specifically be manufactured by injection molding. However, other embodiments are feasible. Exemplarily, the electronic unit may be sealed or potted, as will be further described below.

[0069] The housing may include a top side and a bottom side. The terms "top side" and "bottom side" may refer to two opposite sides of the housing. The terms "top side" and "bottom side" may be considered as descriptions without a specified order and do not exclude the possibility of applying several possibilities for top side and bottom side.

[0070] Specifically, "upper side" can refer to the distal side of the housing. The term "distal side" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or custom meaning. The term can specifically refer to (but is not limited to) an indication of the position of the side of the housing relative to the user, the position furthest from the user's skin. For example, the housing may be in contact with the user's skin for inserting an analyte sensor. "Distal side" can refer to the side that is at a distance from the user's skin.

[0071] Specifically, "below" can refer to the proximal side of the housing. The term "proximal" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or custom meaning. The term can specifically refer to (but is not limited to) an indication of the position of the side of the housing relative to the user, the position closest to the user's skin. For example, the housing may be in contact with the user's skin for inserting an analyte sensor. "Proximal" can refer to the side very close to or even in direct contact with the user's skin.

[0072] As used herein, the term "compartment" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. Specifically, the term refers to any sub-section of a higher-level element that can be used to accommodate and / or store objects, either partially or completely enclosed. The sub-section can specifically be completely or at least substantially enclosed, such that the interior of the compartment is isolated from the surrounding environment. Exemplarily, a compartment can be separated from other parts of the higher-level element by one or more walls. Thus, within a housing, two or more compartments can be included, which can be completely or partially separated from each other by one or more walls of the housing. Each compartment can include a continuous space or cavity configured to receive one or more objects.

[0073] As summarized above, the housing includes an electronic compartment. The term "electronic compartment" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or custom meaning. Specifically, the term refers to any compartment configured to house elements or combinations of elements for achieving electrical or electronic purposes. Specifically, electronic components may be configured to house circuit carriers as summarized above. The circuit carriers may be fixedly positioned inside the electronic compartment of the housing. Insertable portions of the analyte sensor and a removable lower cover may extend downward beyond the lower surface of the electronic compartment in an open channel.

[0074] An electronic compartment may include at least two housing portions. The at least two housing portions may include a lower housing portion and an upper housing portion. The terms "lower housing portion" and "upper housing portion" are to be considered as an unspecified order and do not preclude the possibility of applying several lower and upper housing portions. The upper and lower housing portions may be connected via one or more of form-fit connectors, press-fit connectors, or material-bonded connectors, more specifically through the use of adhesives and / or bonding. The upper and lower housing portions may form an encapsulation of electronic components for an electronic unit.

[0075] The lower housing portion may include a lower surface configured for placement on a user's skin. Specifically, the medical device may include an adhesive surface for attachment to the user's skin. The term "adhesive surface" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or custom meaning. The term specifically refers to a surface capable of bonding to an object and resisting separation. Exemplarily, the adhesive surface may include an ointment or adhesive tape. The ointment or adhesive tape may include an adhesive material. The adhesive surface may be attached directly or indirectly to the housing. The adhesive surface may be or may be located at the lower surface of the electronic compartment or at the lower side of the housing. The term "lower surface" may specifically refer to the surface of the electronic compartment facing the user's skin. The adhesive surface may exemplary have a ring shape surrounding an analyte sensor.

[0076] As summarized above, the housing includes an open channel. As used herein, the term "channel" is a broad term and should be given its common and customary meaning to those skilled in the art, and should not be limited to a specific or customary meaning. Specifically, the term refers to any element that may have an elongated shape and may provide a free volume or cavity allowing other elements to pass through it. Specifically, the channel may be a substantially straight channel. As further used herein, the term "straight" may refer to a continuous extension of the channel in one direction, substantially without bends, angles, or curves. The channel may extend along the insertion direction of the analyte sensor. Further, the channel may extend laterally, specifically substantially perpendicular to the extension direction of the housing. The open channel may specifically have an upper opening and an opposing lower opening. The upper opening may be located on the upper side of the housing facing away from the skin, and the lower opening may be located on the lower side of the housing facing the skin. The open channel may connect the upper and lower sides. The insertable portion of the analyte sensor may extend downwards within the open channel beyond the lower side of the housing.

[0077] The open channel can form a compartment, specifically a compartment for at least partially housing the analyte sensor and the insertion sleeve. As summarized above, the open channel at least partially surrounds the analyte sensor and the insertion sleeve, specifically circumferentially. The open channel can be formed by an open channel wall. The electronic compartment can also be at least partially formed by the open channel wall. Therefore, the open channel wall can have a first side facing the interior space of the electronic compartment and an opposing second side facing the interior space of the open channel. The open channel wall can be at least partially designed as a cylindrical ring.

[0078] The open channel wall may include an opening through which an analyte sensor passes. The analyte sensor may be partially housed inside the electronic compartment and may be partially located outside the electronic compartment, such as within the open channel. An insertable portion of the analyte sensor may be located outside the electronic compartment. The opening may specifically be a sealed opening. The term "sealed" can generally refer to the property of any element being completely or at least substantially isolated from the surrounding environment. A sealed opening may include a sealing element. The term "sealing element" can generally refer to any element configured to cover one or more elements to be sealed against environmental influences such as liquids, dust, germs, and moisture. The sealing element can seal the electronic compartment from the external environment. Exemplarily, the sealing element may include a sealing lip. As used herein, the term "sealing lip" may refer to the maximum value in the cross-sectional profile of the sealing element, which is the first portion of the sealing element in contact with the other surface when the sealing element thereon is pressed against another surface. The shape of the profile itself may be symmetrical or asymmetrical, with an asymmetrical profile possibly being advantageous. The sealing element may include a sealing material, particularly a deformable sealing material, and more preferably an adhesive material. The analyte sensor can pass through a sealed opening.

[0079] The medical device may include a removable upper cover. Further, the medical device may include a removable lower cover. The removable upper cover may be configured to be removed after the insertable portion of the analyte sensor has been inserted into body tissue. The removable lower cover may be configured to be removed before the insertable portion of the analyte sensor has been inserted into body tissue. At least one of the removable lower cover and the removable upper cover may include a moisture-absorbing material, preferably a desiccant, more preferably activated carbon. The removable upper cover may seal with an upper opening of the open channel, and the removable lower cover may seal with a lower opening of the open channel.

[0080] As used herein, the term "lid" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term specifically refers to any element configured to close or seal a volume. Specifically, a lid can close or seal the opening of any container. The terms "upper lid" and "lower lid" can be considered as descriptions without specifying an order and without excluding the possibility that several upper and lower lids may be applied. A removable lower lid and a removable upper lid can be arranged or positioned on opposite sides of a housing, specifically on opposite sides of an open passage. Specifically, a removable lower lid can be arranged on the underside of the housing. A removable lower lid can be removably connected, specifically attached to at least one of the underside of the housing and a removable upper lid. Specifically, a removable upper lid can be arranged on the upper side of the housing. A removable upper lid can be removably connected, specifically attached to at least one of the upper side of the housing and a removable lower lid. The removable upper lid and / or the removable lower lid can, by way of example, have an elongated shape and can provide an internal volume.

[0081] As used herein, the term "removable" is a broad term and will be given the common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. Specifically, the term refers to the property that a component can be removed from any object. Thus, the tight attachment, contact, or connection between the component and the object can be broken. Generally, a component can be removable in a reversible manner, where the component can be attached to an object and detached from it, or irreversibly removed, where the component can be unattached to the object after detachment. Further details are given below.

[0082] The removable top cover may specifically be or may include a retainer for inserting a cannula. The removable bottom cover may specifically be a sterile cap. The sterile cap may be configured to provide sterile packaging for the insertable portion of an analyte sensor, such that the insertable portion is sealed relative to the surrounding environment, such as relative to liquids, moisture, dust, and pathogens. As used herein, the term "sterile cap" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. The term may specifically refer to (but is not limited to) elements such as covers configured to maintain a sterile atmosphere in a space completely or partially surrounded by the element. As an example, the sterile cap may be a rigid sterile cap, for example, made of rigid plastic materials and / or metal. As an example, the sterile cap may have rotational symmetry about an axis, which may be the same as the axis of rotational symmetry of the protective cap and / or the axis of rotational symmetry of the housing. As an example, the sterile cap may have an elongated shape, the length of which exceeds its diameter or equivalent diameter by at least 2 times, more preferably at least 5 times. As an example, sterile caps can have a length of 5 mm to 20 mm, such as 10 mm to 15 mm.

[0083] Embodiments of medical analytical sensor devices, including analytical sensors, cannulas, lower and upper caps, lower and upper covers, sterile caps, sterile compartments, and insertion aids, are disclosed in EP3202324A1, EP3727130A1, EP3988014A1, and EP3202323A1, which are hereby incorporated by reference.

[0084] A removable top cover and / or a removable bottom cover may be reversibly or irreversibly connected to the housing and / or to each other. The removable bottom cover, the removable top cover, and the open channel may form a sensor compartment for at least partially housing an analyte sensor. The analyte sensor may be partially housed in an electronics compartment and partially housed in the sensor compartment. Specifically, an insertable portion may be at least partially housed in the sensor compartment. The sensor compartment may be a sealed compartment, specifically a sterile compartment. The sensor compartment may be configured to provide sterile packaging for the insertable portion of the analyte sensor. The sensor compartment and the electronics compartment may share a common wall. The common wall may be an open channel wall. The term "sealed compartment" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to (but is not limited to) a compartment isolated from the surrounding environment, such that the transfer of gaseous, fluid, and / or solid elements is completely or at least substantially reduced. Specifically, the sensor compartment can be configured to provide a sterile package for an insertable portion of the analyte sensor. The term "sterile" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or customary meaning. The term can specifically refer to (but is not limited to) the property of any object being at least substantially free from all forms of life and / or other biological agents (such as prions, viruses, fungi, bacteria, or spores) and free from the intrusion of liquids, moisture, and dust. Therefore, sterile objects can be handled by a sterilization process that eliminates and / or deactivates various forms of life and / or other biological agents. The sterilization process can include one or more of the following techniques: heating, chemical treatment, irradiation, autoclaving, filtration. However, other techniques are also feasible. The sterilization process can be performed within a specific area or area of ​​the object (such as the surface of the object).

[0085] The sensor compartment may include an intermediate component. The intermediate component may be formed by an open channel wall. Therefore, an intermediate component may refer to a compartment formed by an open channel. The term "intermediate component" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or custom meaning. The term may specifically refer to (but is not limited to) any component or compartment between at least two other compartments and / or located within another compartment. Therefore, the intermediate component may be located within the sensor compartment and may be hermetically separated from the electronics compartment. The intermediate component may be or may include an intermediate compartment and / or (as an example) a sealing ring or annular element. Specifically, the electronics compartment may at least partially surround the intermediate component. The intermediate component may be at least partially designed as a cylindrical ring surrounding an insertion sleeve. A removable upper cover and a removable lower cover may be separated from the intermediate component and both may be removably connected to the intermediate component.

[0086] The removable top cover and / or removable bottom cover can be reversibly or irreversibly connected to the housing and / or connected to each other. The removable top cover can be at least partially located on the upper side of the housing and / or at least partially located within the open channel. Further, the removable top cover can be configured to close and / or seal the upper opening of the open channel. Optionally, the removable top cover can extend through the lower opening of the open channel, specifically to establish a connection with the removable bottom cover.

[0087] The removable top cover can be removably connected to the housing via at least one of a connector, specifically via a threaded connector, or via a bayonet connector, specifically connected to the surface of the housing. The removable bottom cover can be removably connected to the housing via at least one of a connector, specifically via a threaded connector, or via a bayonet connector, specifically connected to the surface of the housing. Specifically, the removable top cover can be reversibly or irreversibly connected to the upper surface of the housing and / or connected to the removable bottom cover. Specifically, the removable bottom cover can be reversibly or irreversibly connected to the lower surface of the housing and / or connected to the removable top cover.

[0088] Specifically, the removable lower cover can be pulled down from the housing and / or from the removable upper cover. Further, specifically, the removable upper cover can be pulled down from the housing and / or from the removable lower cover. Therefore, the removable lower cover and / or the removable upper cover can overlap with the housing during the attachment phase, and vice versa. Additionally or alternatively, the removable lower cover can overlap with the removable upper cover, and vice versa. The housing may specifically include guide surfaces for guiding the removable lower cover or the removable upper cover during the pulling down of the removable lower cover or the removable upper cover. Additionally or alternatively, the removable lower cover may include guide surfaces for guiding the removable upper cover during the pulling down of the removable upper cover from the removable lower cover, and vice versa. Therefore, the removable upper cover may include guide surfaces for guiding the removable lower cover during the pulling down of the removable lower cover from the removable upper cover.

[0089] Furthermore, specifically, a removable upper cover may be removably attached to the housing at an upper predetermined break point, and / or a removable lower cover may be removably attached to the housing at a lower predetermined break point. As further used herein, the term "predetermined break point" may refer to any portion of the element configured to break during mechanical loading while other portions of the element remain undamaged. Specifically, a predetermined break point may include a notch, wherein the thickness of the element may be smaller compared to other portions of the element. The upper and / or lower predetermined break points may specifically be annular break points. The terms "upper break point" and "lower break point" may be considered as descriptions without a specified order and do not preclude the possibility that several upper and lower break points may be applied.

[0090] As summarized above, medical devices include connector elements. The term "connector element" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or custom meaning. Specifically, the term refers to any conductive element configured for electrical contact with additional conductive elements. Specifically, a conductive element may be configured for electrical contact with at least two additional conductive elements, thereby establishing an electrical connection between the at least two additional conductive elements. A connector element may be configured for electrical contact with the contact area of ​​each of at least two conductor paths. Thus, an electrical connection can be established between at least two conductor paths, and a sensor circuit can be closed. Further, an electrical connection can be established between an energy storage device and the electronic components of the sensor circuit. Further, the electronic components of the sensor circuit may be electrically connected to an analyte sensor, specifically to the electrodes of the analyte sensor. The electronic units may interact with the analyte sensor for electrochemical measurements. This process may refer to the activation of the sensor circuit. Therefore, the sensor circuit can be in an active state. Conversely, when the connector element is arranged at a distance from the contact area of ​​each of the at least two conductor paths, specifically when there is no electrical connection between the connector element and the contact area of ​​each of the at least two conductor paths, the sensor circuit can be inactive. Therefore, the sensor circuit can be open or disconnected. Specifically, the electrical connection between the energy storage device and the electronic components of the sensor circuit can be interrupted or disconnected. Furthermore, there may be no interaction between the electronic unit and the analyte sensor for performing electrochemical measurements. Specifically, the medical device can be inactive as long as it is stored. Specifically, the medical device can be inactive as long as it is not activated during insertion onto the user's skin, specifically until the insert is not removed from the open channel.

[0091] As summarized above, the insert component, specifically the insert sleeve and / or the retainer of the insert sleeve, is configured to retract from the open channel, thereby triggering electrical contact between the connector element and at least two conductor paths of the analyte sensor, thus activating the sensor circuitry. The term "trigger" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or custom meaning. The term specifically relates to a process that initiates another process. Therefore, the retraction process (e.g., removing the insert component, specifically the insert sleeve and / or the retainer of the insert sleeve from the open channel) can cause electrical contact between the connector element and at least two conductor paths of the analyte sensor, thus activating the sensor circuitry. Specifically, by retracting or removing the insert component from the open channel, the connector element can electrically contact at least two conductor paths of the analyte sensor. Thus, the sensor circuitry can be activated.

[0092] The sensor circuitry may be inactive before the insertable portion of the analyte sensor is inserted into the body tissue. After the insertable portion of the analyte sensor is inserted into the body tissue, the sensor circuitry may be active. Furthermore, the sensor circuitry may be inactive before the inserting component, specifically the insert cannula, and / or the retainer of the insert cannula, is retracted or removed from the open channel, and may be active during and / or after the removal or retraction of the inserting component, specifically the insert cannula, and / or the retainer of the insert cannula from the open channel.

[0093] Connector elements can be configured to electrically contact at least two conductor paths of an analyte sensor via movement, displacement, relaxation, or expansion of the connector element or a component of the connector element. Before retraction or removal of the insert component, specifically the insert sleeve and / or the retainer of the insert sleeve from the open channel, the connector element can be arranged at a distance from the contact area of ​​each of the at least two conductor paths. During and / or after removal or retraction of the insert component, specifically the insert sleeve and / or the retainer of the insert sleeve from the open channel, the connector element can electrically contact at least two conductor paths, specifically via movement, displacement, relaxation, or expansion of the connector element. Specifically, the connector element can directly contact at least two conductor paths, specifically via movement, displacement, relaxation, or expansion of the connector element. Different embodiments of the connector element can be included in medical devices. Preferred embodiments will be described in more detail below.

[0094] Specifically, the connector element can be attached to the surface of the open channel wall. Specifically, the connector element can be fixedly attached to the surface of the open channel wall. As an example, the connector element can have a first end and an opposing second end. The connector element can be attached to the surface of the open channel wall via the first end. The opposing second end and / or the intermediate section of the connector element can be configured for electrical contact with the contact area of ​​each of at least two conductor paths. Specifically, the connector element can be attached to the surface of the open channel wall facing the internal space surrounded by the open channel. The connector element can be disposed inside the open channel. Further, the connector element can be disposed wholly or at least partially outside the electronic compartment. Before the insertion component, specifically the insertion sleeve and / or the retainer of the insertion sleeve, is removed or retracted from the open channel, the insertion sleeve and / or the retainer can be configured as a spacer between the connector element and at least two conductor paths, specifically a non-conductive spacer. The contact area of ​​each of the at least two conductor paths can be located inside the insertion sleeve. The connector element can be placed outside the insertion sleeve. Specifically, the contact areas of each of at least two conductor paths can be arranged opposite to the connector element, specifically opposite to the contact areas of each of the connector elements. Specifically, the connector element can be compressed or tensioned by the outer surface of the insert sleeve before the insert member, specifically the insert sleeve, and / or the retainer of the insert sleeve are removed or retracted from the open channel. Therefore, before the insert member, specifically the insert sleeve, and / or the retainer of the insert sleeve are removed or retracted from the open channel, the connector element can be in direct contact with the outer surface of the insert sleeve and / or the retainer, specifically via the second end and / or intermediate section of the connector element. By retracting or removing the insert member, specifically the insert sleeve, and / or the retainer of the insert sleeve, the connector element can move, displace, relax, or expand, thereby establishing an electrical connection between the contact areas of each of the at least two conductor paths and the connector element.

[0095] The connector element may specifically be selected from the group consisting of: contact spring elements, specifically curved contact spring elements, specifically sheet-like contact spring elements; conductive elastomer elements. Before the insert member, specifically the insert sleeve, and / or the retainer of the insert sleeve are retracted or removed from the open channel, the connector element may be in direct contact with the surface of the insert member, specifically the insert sleeve, and / or the retainer of the insert sleeve. During and / or after the insert member, specifically the insert sleeve, and / or the retainer of the insert sleeve are removed or retracted from the open channel, the connector element may electrically contact at least two conductor paths. Specifically, the connector element may be pressed against the contact area of ​​each of the at least two conductor paths.

[0096] The term "contact spring element" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term refers to any contact element whereby the function of a closed circuit is achieved by the detection of an element supported by a spring. A contact spring element may have a contact surface configured to contact another element. A contact spring element, or at least a portion thereof, may be configured to store mechanical energy through elastic deformation, and thereby maintain contact with another element. As summarized above, a contact spring element may specifically be a curved contact spring element. The term "curved contact spring element" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term refers to any contact element where the shape of the curved contact spring element differs from the substantially straight shape of a contact spring element. Specifically, the contact spring element may extend along at least one of a circular segment, an oval segment, an elliptical segment, or a hyperelliptical segment. A curved contact spring element may have a first end and an opposing second end. A curved contact spring element may be attached to the wall of the open channel via a first end, and a second end may protrude into the interior space of the open channel. Specifically, before the insertion member, specifically the insertion sleeve, and / or the retainer of the insertion sleeve are retracted or removed from the open channel, the second end of the curved contact spring element and / or the middle section of the curved contact spring element may be in direct contact with the insertion member, specifically the insertion sleeve, and / or the retainer of the insertion sleeve. Before the insertion member, specifically the insertion sleeve, and / or the retainer of the insertion sleeve are removed or retracted from the open channel, the contact spring element may be in a tensioned state, and the contact spring element may be in direct contact with the surface of the insertion member, specifically the insertion sleeve, and / or the retainer of the insertion sleeve. Specifically, the contact spring element may be pressed against the surface of the insertion member, specifically the insertion sleeve, and / or the retainer of the insertion sleeve. During and / or after the removal or retraction of the insert, specifically the insert sleeve and / or the retainer of the insert sleeve from the open channel, the contact spring element may be in a further tensioned or relaxed state, and the contact spring element may be in electrical contact with at least two conductor paths, specifically the contact area of ​​each of the at least two conductor paths. Thus, the contact spring element can be pressed against the contact area of ​​each of the at least two conductor paths. The contact spring element may be made of a conductive material. The contact spring element may be made of any suitable material, such as plastic, thermoplastic polymer, or metal. Other materials may also be feasible.

[0097] The term "conductive elastomer element" as used herein is a broad term and should be given its common and conventional meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term refers to any elastomer element having conductive properties. The conductive elastomer element may have an elongated shape. Specifically, the conductive elastomer element may have a substantially straight shape. The conductive elastomer element may have a first end and an opposing second end. The conductive elastomer element may be attached to the wall of the open channel via the first end, and the second end may protrude into the interior space of the open channel, specifically transverse to, and more specifically substantially perpendicular to, the longitudinal axis of the insert member, specifically the insert sleeve. Before the insert member, specifically the insert sleeve, and / or the retainer of the insert sleeve are removed from or retracted from the open channel, the conductive elastomer element may be in a compressed state, and the conductive elastomer element may be in direct contact with the surface of the insert member, specifically the insert sleeve, and / or the retainer of the insert sleeve. During and / or after the removal or retraction of the insert, specifically the insert sleeve and / or the retainer of the insert sleeve from the open channel, the conductive elastomer element may be in a further compressed or expanded state, and the conductive elastomer element electrically contacts at least two conductor paths, specifically the contact area of ​​each of the at least two conductor paths. Thus, the conductive elastomer element can be pressed against the contact area of ​​each of the at least two conductor paths. Exemplarily, the conductive elastomer element may be made of a carbon-filled elastomer such as carbon-filled silicone resin. However, other materials may also be feasible.

[0098] Specifically, the connector element can be movably attached to the surface of the analyte sensor, specifically to the surface of the carrier of the analyte sensor. Exemplarily, the connector element can be movably attached to the surface of the analyte sensor via an adhesive. However, other types of attachment may also be feasible. The connector element can be arranged inside the open channel. The connector element can be arranged outside the electronic compartment. The connector element can be arranged below at least two conductor paths before the insertion member, specifically the insertion sleeve and / or the retainer of the insertion sleeve, is removed or retracted. The insertion member, specifically the insertion sleeve and / or the retainer of the insertion sleeve, can be configured to move or displace the connector element such that the connector element electrically contacts at least two conductor paths, specifically the contact area of ​​each of the at least two conductor paths, specifically when the insertion member, specifically the insertion sleeve and / or the retainer of the insertion sleeve, is removed or retracted from the open channel. Before retracting or removing the insertion member, specifically the insertion sleeve and / or the retainer of the insertion sleeve from the open channel, the connector element can be arranged at a distance from at least two conductor paths. During and / or after the insertion component, specifically the insertion sleeve and / or the retainer of the insertion sleeve, are removed or retracted from the open channel, the connector element may electrically contact at least two conductor paths. Specifically, during and / or after the insertion component, specifically the insertion sleeve and / or the retainer of the insertion sleeve, are removed or retracted from the open channel, the connector element may at least partially cover the contact area of ​​each of the at least two conductor paths. The insertion component, specifically the insertion sleeve and / or the retainer of the insertion sleeve, may include a protrusion configured to move the connector element in the retraction direction of the insertion sleeve such that the connector element electrically contacts at least two conductor paths after the insertable portion of the analyte sensor is inserted into body tissue. In another embodiment, the connector element may electrically contact at least two conductor paths during the removal or retraction of the insertion component, specifically the insertion sleeve and / or the retainer of the insertion sleeve from the open channel, but may no longer electrically contact the conductor paths once the removal or retraction movement has been completed; that is, the connector element may only momentarily contact at least two conductor paths.

[0099] The medical device may further include an insertion aid configured to enable a user to drive an insertion cannula into body tissue and insert an insertable portion of an analyte sensor. The term "insertion aid" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or custom meaning. Specifically, the term may refer to (but is not limited to) any technical construction configured to insert an object into another object. Thus, the insertion aid may include an insertion mechanism. As further used herein, the term "mechanism" may refer to any mechanism designed to convert input forces and motions into a desired set of output forces and motions. Specifically, the insertion mechanism may be configured to enable a user to apply force to the insertion cannula in the insertion direction. Therefore, the insertion aid may be configured to facilitate user handling of the medical device and / or reduce application errors. The insertion aid may at least partially surround the housing, the analyte sensor, the insertion cannula, and / or connector elements. Further, the insertion aid may at least partially couple to the housing and / or to at least one of a removable upper cover and a removable lower cover.

[0100] The insertion aid may include a removable lower cover mechanically coupled to a removable lower cover. As used further herein, the term "cover" may refer to any element that completely or at least substantially encloses an object. Specifically, the cover may be or may include a shell surrounding the medical device, particularly a half-shell. The removable lower cover may be configured such that removal of the removable lower cover removes the removable lower cover. The insertion aid may further include a frame. The term "frame" may refer to any element that may be configured to support other components of the physical structure. The frame may be displaceable on the user's skin and may at least partially surround the shell, analyzer sensor, insertion cannula, removable lower cover, and / or connector element. The insertion aid may further include an upper cover. The upper cover may be directly or indirectly coupled to one or both of the insertion component or the removable upper cover, such that movement of the upper cover against the frame drives the insertion cannula. The terms "lower cover" and "upper cover" may be considered as descriptions without a specified order and do not exclude the possibility of applying several lower and upper covers.

[0101] The removable lower cover may include a base, which is exemplarily attached to the lower portion of the removable lower cover via a snap-fit ​​connection, adhesive bonding, and / or longitudinal guidance or force transmission. The base may include a gripping surface for removing the removable lower cover. The base may also serve as a cover for the adhesive surface. This can result in an extended shelf life of the adhesive surface. By removing the removable lower cover, the removable lower cover can be opened, exposing the insertion components and analyte sensor, and simultaneously exposing the adhesive surface.

[0102] The medical device may further include a retraction mechanism for retracting the insert cannula after the insertable portion of the analyte sensor has been inserted into body tissue. The term "retraction mechanism" can generally refer to any configuration configured to move an object in a direction opposite to the direction in which the object might have been moved before the application of the retraction mechanism. Therefore, the retraction mechanism may include a retraction contact spring element. The retraction contact spring element may be biased to retract the insert cannula from the body tissue. The retraction mechanism may be at least partially included within a removable top cover and / or an upper covering.

[0103] In a further aspect, a medical device system is disclosed. The medical device system includes medical devices as described above or as will be described in further detail below.

[0104] Furthermore, the medical device system includes a sensor controller coupled to an analyte sensor. The sensor controller is configured to receive analyte sensor data from the analyte sensor. Specifically, the sensor controller may include at least one data processing unit, such as a processor. Further, the sensor controller may include at least one volatile or non-volatile data memory. The sensor controller may include at least one interface configured for inputting commands and / or outputting information. The at least one interface may include a wired interface and / or a wireless interface for one-way or two-way exchange of data or commands, specifically between the sensor controller and at least one additional device.

[0105] Furthermore, the medical device system includes a remote controller configured to receive sensor data from a sensor controller and process and / or display the sensor data. The sensor controller may be configured to transmit analyte sensor data to the remote controller. The term "communication" as used herein is a broad term and should be given its common and conventional meaning to those skilled in the art, and is not limited to any particular or customary meaning. The term may specifically refer to (but is not limited to) the process of transmitting information. In particular, information from a computing device may be transmitted, such as by sending or outputting information, for example, to another device. Specifically, a communication interface may be provided. The communication interface may specifically provide a means for transmitting or exchanging information. In particular, the communication interface may provide data transmission connectivity, such as Bluetooth, NFC, inductive coupling, etc.

[0106] Specifically, a medical device system may include a user interface. As used herein, the term "user interface" is a broad term and should be given its common and conventional meaning to those skilled in the art, and should not be limited to a particular or customary meaning. The term may refer to, but is not limited to, elements or devices configured to interact with their environment, such as for the purpose of exchanging information in one or two directions, such as for exchanging one or more data or commands. For example, a user interface may be configured to share information with and receive information from a user. A user interface may have features for visual interaction with a user, such as a display, or features for acoustic interaction with a user. As examples, a user interface may include one or more of the following: a graphical user interface; a data interface, such as a wireless and / or wired data interface.

[0107] In a further aspect, an additional medical device is disclosed. This additional medical device includes an analyte sensor having an insertable portion adjusted for at least partial insertion into a user's body tissue. The analyte sensor is configured to detect an analyte in bodily fluids. Further, the additional medical device includes an insertion member comprising an insertion cannula. The analyte sensor is at least partially disposed within the insertion cannula. Further, the additional medical device includes an electronic unit comprising sensor circuitry. Further, the additional medical device includes a housing having an electronic compartment in which the electronic unit is at least partially housed. The housing further includes an open channel at least partially surrounding the analyte sensor and the insertion member. Reference is made to the description above regarding the analyte sensor, insertion member, electronic unit, and housing.

[0108] Furthermore, an additional medical device includes a push-button switch. The insertion component is configured to retract from the open channel, thereby triggering the push-button switch to open, thus activating the sensor circuitry.

[0109] The term "push-button switch" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and is not limited to any particular or custom meaning. Specifically, the term may refer to (but is not limited to) any operating element configured to close and disconnect a circuit by means of a button. This controls whether current flows in the circuit. Specifically, a push-button switch can be deactivated by pressing a movable element such as a button and can be activated by releasing it. When released, the push-button switch can establish an electrical connection. When pressed, the push-button switch can disconnect the electrical connection. To enable the push-button switch to function, a spring may be applied, which occupies the released position after the movable element is pressed. For a push-button switch, the released position (also referred to as the open state) can be either the normal position or the open state. The circuit can only be interrupted by pressing a movable element (such as a button). The circuit can remain interrupted only while the movable element remains pressed. If the movable element is released, the circuit closes.

[0110] The push-button switch may include a push-button switch housing and a movable element. The movable element may be configured to move laterally, specifically perpendicular to the insertion direction of the analyte sensor and / or the longitudinal axis of the insertion component, specifically the insertion sleeve. The movable element may protrude into an internal space surrounded by an open channel. The push-button switch may be disposed within the open channel. Specifically, the push-button switch may be attached to the wall of the open channel, specifically fixedly attached, specifically attached to the wall of the open channel facing the internal space of the open channel.

[0111] Before the insertion sleeve is inserted, for example before the insertion component, specifically the insertion sleeve, and / or the retainer of the insertion sleeve are retracted or removed from the open channel, the insertion component, specifically the insertion sleeve, and / or the retainer of the insertion sleeve can compress the movable element into the push-button switch housing, thereby interrupting the sensor circuit. By retracting or removing the insertion component, specifically the insertion sleeve, and / or the retainer of the insertion sleeve from the open channel, the movable element can be released. Specifically, the movable element can be moved out of the push-button switch housing, which causes the sensor circuit to close. In turn, the electronic unit can be turned on upon receiving power from the battery.

[0112] In a further aspect of the invention, a method of using a medical device according to any embodiment as described above or further described below is disclosed. These methods include method steps as given in the independent claims and listed below. These method steps may be performed in a given order. However, other orders of these method steps are also possible. Additionally, one or more of these method steps may be performed in parallel and / or in a time-overlapping manner. Additionally, one or more of these method steps may be performed repeatedly. Furthermore, additional method steps not listed may be present.

[0113] The method includes the following steps:

[0114] a) Provide medical devices;

[0115] b) Inserting the analyte sensor into body tissue; and

[0116] c) Remove the insert sleeve from the open channel, thereby triggering electrical contact between the connector element and at least two conductor paths of the analyte sensor, thus activating the sensor circuitry.

[0117] The proposed medical device and method of using the medical device offer many advantages over known devices and methods.

[0118] A medical device may be disclosed, specifically a wearable, specifically integrated analyte sensor system, comprising an analyte sensor having an insertable portion adjusted for at least partial insertion into a user's body tissue, the analyte sensor being configured to detect an analyte in a patient's bodily fluids. The analyte sensor may include a carrier (specifically a carrier material), a working electrode configured for detecting the analyte, a counter electrode and / or a reference electrode, and at least two conductive paths configured to establish electrical contact between a battery and electronic components of an electronic unit when connected to each other via elements (such as mechanical switching elements). The medical device further includes an insertion cannula in which the analyte sensor is at least partially disposed. The medical device further includes a housing that may include upper and lower sides, and an open channel that can connect the upper and lower sides. The open channel may be hermetically separated from an electronic chamber formed by the upper and lower sides and by the open channel walls. The electronic chamber may include an electronic unit configured to connect to the analyte sensor. Furthermore, the medical device may include a sterile capsule surrounding a portion of an insertion cannula and an analyte sensor, wherein the sterile capsule may be formed of a removable upper cover including the insertion cannula, a wall having an open channel, and a removable lower cover. The removable lower cover may be configured for removal prior to insertion. The insertion cannula may be attached to the removable upper cover. The removable upper cover may be configured for removal after insertion, thereby removing the insertion cannula. The insertion cannula and / or the removable upper cover may be configured to move a connector element, the connector element being configured to electrically connect at least two conductor paths.

[0119] The sensor circuitry can be activated by an insertion sleeve. Retraction of the insertion sleeve triggers a connector element to electrically connect at least two conductor paths. Specifically, the sensor circuitry can be activated by retracting the insertion sleeve via triggering the connector element to electrically connect at least two conductor paths.

[0120] Advantageously, at least two conductor paths can be part of the analyte sensor itself. This allows for a simple construction setup. Furthermore, specifically, by using a simple switching mechanism that can be triggered by the retraction movement of the insertion sleeve and / or removable top cover, and by the at least two conductor paths of the analyte sensor, the electronic components of the electronic unit (specifically, the sensor electronics) can be kept in an off state throughout their entire storage life, without consuming power until the analyte sensor is finally inserted. Simultaneously, the switching mechanism, apart from the analyte sensor itself, does not require the introduction of an additional opening penetrating the electronic chamber for the analyte sensor. In this way, compared to known devices to date, in which the electronic unit switches back and forth between a low-power sleep mode and a high-power test mode, the size of the battery and the overall size of the medical device can be significantly reduced. Furthermore, the risk of incomplete sealing of the electronic chamber and the sterile capsule can be reduced. Finally, manufacturing costs can be reduced.

[0121] In summary, and without excluding other possible embodiments, the following embodiments are conceivable:

[0122] Example 1: A medical device for detecting an analyte in bodily fluids, the medical device comprising:

[0123] ● Analyte sensor having an insertable portion adapted to be at least partially inserted into a user’s body tissue, wherein the analyte sensor is configured to detect an analyte in a body fluid, wherein the analyte sensor includes at least two conductor paths configured to activate sensor circuitry, wherein the analyte sensor further includes at least two electrodes, each electrode including an electrode conductor path configured to transmit sensor current to detect the analyte.

[0124] ● Insertion component, including an insertion sleeve, wherein the analyte sensor is at least partially placed within the insertion sleeve;

[0125] ● Electronic unit, which includes sensor circuitry;

[0126] ● A housing having an electronic compartment in which the electronic unit is at least partially housed, wherein the housing further includes an open channel at least partially surrounding the analyte sensor and the insertion member; and

[0127] ● Connector element, wherein the insertion part is configured to retract from the open channel, thereby triggering electrical contact of the connector element with the conductor path of the analyte sensor, thereby activating the sensor circuit.

[0128] Example 2: The medical device according to the preceding claims, wherein the sensor circuit includes a power storage device, specifically a battery, wherein the connector element is configured to establish an electrical connection between the power storage device and the electronic components of the sensor circuit by electrically contacting the at least two conductor paths of the analyte sensor.

[0129] Example 3: A medical device according to any one of the preceding claims, wherein the electronic unit includes a printed circuit board and the sensor circuit is disposed on the printed circuit board.

[0130] Example 4: A medical device according to any one of the preceding claims, wherein the sensor circuit is inactive before the insertable portion of the analyte sensor is inserted into the body tissue, and wherein the sensor circuit is active after the insertable portion of the analyte sensor is inserted into the body tissue.

[0131] Example 5: A medical device according to any one of the preceding claims, wherein the sensor circuit is inactive before the insert cannula is retracted or removed from the open channel, and wherein the sensor circuit is active during and / or after the insert cannula is retracted or removed from the open channel.

[0132] Example 6: A medical device according to any one of the preceding claims, wherein the connector element is configured to electrically contact the at least two conductor paths of the analyte sensor by movement, displacement, relaxation, or expansion of the connector element or a component of the connector element.

[0133] Example 7: A medical device according to any one of the preceding claims, wherein the housing includes an upper side and a lower side, wherein the open channel connects the upper side and the lower side.

[0134] Example 8: The medical device according to the preceding claims, wherein the insertable portion of the analyte sensor extends downward beyond the lower side of the housing in the open channel.

[0135] Example 9: A medical device according to any one of the preceding claims, wherein the at least two conductor paths are arranged parallel to each other.

[0136] Example 10: A medical device according to any one of the preceding claims, wherein the at least two conductor paths are arranged to be a distance apart from each other.

[0137] Example 11: A medical device according to any one of the preceding claims, wherein each of the at least two conductor paths includes a contact area, wherein the connector element is configured to electrically contact the contact area of ​​each of the at least two conductor paths.

[0138] Example 12: The medical device according to the preceding claims, wherein the contact areas are arranged opposite to each other.

[0139] Example 13: A medical device according to any one of the preceding two claims, wherein the contact area is exposed by laser ablation.

[0140] Example 14: A medical device according to any one of the preceding three claims, wherein the contact area is located on or disposed on the surface of the analyte sensor.

[0141] Example 15: The medical device according to the preceding claims, wherein the contact area is raised relative to the surrounding surface of the analyte sensor.

[0142] Example 16: A medical device according to any one of the preceding five claims, wherein the contact area includes a welding area.

[0143] Example 17: A medical device according to any one of the preceding six claims, wherein the contact area of ​​each of the at least two conductor paths is arranged opposite to the connector element.

[0144] Example 18: A medical device according to any one of the preceding seven claims, wherein the contact area of ​​each of the at least two conductor paths is arranged opposite to the contact area of ​​the connector element.

[0145] Example 19: A medical device according to any one of the preceding eight claims, wherein the contact area of ​​each of the at least two conductor paths is arranged outside the electronic compartment.

[0146] Example 20: A medical device according to any one of the preceding claims, wherein the connector element is selected from the group consisting of: a contact spring element, specifically a bent contact spring element, specifically a sheet-like contact spring element; a conductive elastomer element.

[0147] Example 21: The medical device according to the preceding claims, wherein the connector element is in direct contact with the surface of the insertion member before the insertion sleeve is retracted or removed from the open channel, wherein the connector element is in electrical contact with the at least two conductor paths during and / or after the insertion sleeve is retracted or removed from the open channel.

[0148] Example 22: A medical device according to any one of the preceding two claims, wherein the connector element is the contact spring element, wherein the contact spring element is in a tensioned state before the insert sleeve is retracted or removed from the open channel, and the contact spring element is in direct contact with the surface of the insert sleeve, wherein the contact spring element is in a further tensioned state or in a relaxed state during and / or after the insert sleeve is removed from the open channel, and the contact spring element is in electrical contact with the at least two conductor paths.

[0149] Example 23: A medical device according to any one of the preceding three claims, wherein the connector element is the conductive elastomer element, wherein the conductive elastomer element is in a compressed state before the insertion sleeve is retracted or removed from the open channel, and the conductive elastomer element is in direct contact with the surface of the insertion sleeve, wherein during and / or after the insertion sleeve is retracted or removed from the open channel, the conductive elastomer element is in a further compressed state or in an expanded state, and the conductive elastomer element is in electrical contact with the at least two conductor paths.

[0150] Example 24: A medical device according to any one of the preceding claims, wherein the connector element is movably attached to the surface of the analyte sensor.

[0151] Example 25: In the medical device according to the preceding claims, the insertion cannula is configured to move the connector element such that the connector element electrically contacts the at least two conductor paths.

[0152] Example 26: A medical device according to any one of the preceding two claims, wherein the connector element is arranged at a distance from the at least two conductor paths before the insert cannula is retracted or removed from the open channel, wherein the connector element is in electrical contact with the at least two conductor paths during and / or after the insert cannula is retracted or removed from the open channel.

[0153] Example 27: A medical device according to any one of the preceding three claims, wherein the insert cannula includes a protrusion configured to move the connector element in the retraction direction of the insert cannula such that the connector element electrically contacts the at least two conductor paths after the insertable portion of the analyte sensor is inserted into the body tissue.

[0154] Example 28: A medical device according to any one of the preceding four claims, wherein the connector element is movably attached to the surface of the analyte sensor via an adhesive.

[0155] Example 29: A medical device according to any one of the preceding five claims, wherein the connector element is disposed below the at least two conductor paths.

[0156] Example 30: A medical device according to any one of the preceding claims, wherein the open channel is formed by an open channel wall.

[0157] Example 31: The medical device according to the preceding claims, wherein the electronic compartment is at least partially formed by the open passage wall.

[0158] Example 32: A medical device according to any one of the preceding two claims, wherein the open channel wall includes an opening through which the analyte sensor passes.

[0159] Example 33: The medical device according to the preceding claims, wherein the opening is a sealed opening.

[0160] Example 34: A medical device according to any one of the preceding four claims, wherein the connector element is attached to the surface of the open channel wall, wherein, specifically, the connector element is fixedly attached to the surface of the open channel wall.

[0161] Example 35: The medical device according to the preceding claims, wherein the connector element is attached to the surface of the open channel wall facing the interior space surrounded by the open channel.

[0162] Example 36: A medical device according to any one of the preceding two claims, wherein the insert cannula is configured as a non-conductive spacer between the connector element and the at least two conductor paths before the insert cannula is retracted or removed from the open channel.

[0163] Example 37: A medical device according to any one of the preceding three claims, wherein the connector element is compressed or tensioned by the outer surface of the insert sleeve before the insert sleeve is retracted or removed from the open channel.

[0164] Example 38: A medical device according to any one of the preceding claims, wherein the analyte sensor is partially housed in the electronic compartment and partially located outside the electronic compartment, wherein the insertable portion of the analyte sensor is located outside the electronic compartment.

[0165] Example 39: A medical device according to any one of the preceding claims, wherein the medical device further includes a removable top cover, wherein the insertion cannula is attached to the removable top cover, specifically wherein the insertion cannula is fixedly attached to the removable top cover.

[0166] Example 40: The medical device according to the preceding claims, wherein the removable top cover is configured to be removed after the insertable portion of the analyte sensor has been inserted into the body tissue.

[0167] Example 41: The medical device according to the preceding claims, wherein the removable top cover at least partially surrounds the insertion cannula.

[0168] Example 42: A medical device according to any one of the preceding three claims, wherein the removable top cover is removably connected to the housing via at least one of a connection, specifically via a threaded connection, or a bayonet connection.

[0169] Example 43: A medical device according to any one of the preceding claims, wherein the medical device further includes a removable lower cover, wherein the removable lower cover is configured to be removed before the insertable portion of the analyte sensor is inserted into the body tissue.

[0170] Example 44: The medical device according to the preceding claims, wherein the removable lower cover is a sterile cap configured to provide a sterile package for the insertable portion of the analyte sensor, such that the insertable portion forms a seal relative to the surrounding environment.

[0171] Example 45: A medical device according to any of the preceding claims, wherein the open channel at least partially surrounds the analyte sensor and the insertion cannula.

[0172] Example 46: A medical device according to any one of the preceding claims, wherein the medical device further includes a retraction mechanism for retracting the insertion cannula after the insertable portion of the analyte sensor has been inserted into the body tissue.

[0173] Example 47: A medical device according to any one of the preceding two claims, wherein the retraction mechanism includes a retraction contact spring element, more preferably disposed between the housing and the insertion cannula and biased to retract the insertion cannula from the body tissue.

[0174] Example 48: A medical device according to any one of the preceding claims, wherein the analyte sensor includes a carrier, specifically a substrate, wherein the at least two conductor paths are disposed on the carrier.

[0175] Example 49: A medical device according to any one of the preceding claims, wherein the at least two electrodes are a working electrode and another electrode configured for detecting the analyte, wherein the other electrode is selected from the group consisting of: a counter electrode and a reference electrode.

[0176] Example 50: A medical device according to any one of the preceding claims, wherein the medical device includes an adhesive surface for attachment to a user's skin.

[0177] Example 51: The medical device according to the preceding claims, wherein the adhesive surface is directly or indirectly attached to the housing.

[0178] Example 52: A medical device according to any one of the preceding two claims, wherein the adhesive surface has an annular shape surrounding the analyte sensor.

[0179] Example 53: A medical device according to any one of the preceding three claims, wherein the adhesive surface comprises at least one of an ointment or an adhesive tape.

[0180] Example 54: A medical device according to any one of the preceding claims, wherein the medical device is a disposable medical device.

[0181] Example 55: A medical device according to any one of the preceding claims, wherein the electronic unit is a single-use electronic unit.

[0182] Example 56: A medical device according to any of the preceding claims, wherein the analyte sensor, the insertion cannula, the electronic unit, the housing, and the connector element form a pre-assembled single unit.

[0183] Example 57: A medical device according to any one of the preceding claims, wherein the housing comprises at least two housing portions, specifically an underground housing portion and an upper housing portion.

[0184] Example 58: The medical device according to the preceding claims, wherein the upper housing portion and the lower housing portion are connected via one or more of a form-fit connection, a press-fit connection, or a material bonding connection, more specifically by using an adhesive and / or a bonding connection.

[0185] Example 59: A medical device according to any one of the preceding two claims, wherein the upper housing portion and the lower housing portion form an encapsulation of electronic components for the electronic unit.

[0186] Example 60: A method of using a medical device according to any one of the preceding claims, the method comprising:

[0187] a) Provide medical devices;

[0188] b) Inserting the analyte sensor into body tissue; and

[0189] c) Remove the insert sleeve from the open channel, thereby triggering electrical contact between the connector element and at least two conductor paths of the analyte sensor, thus activating the sensor circuitry.

[0190] Example 61: A medical device system comprising:

[0191] ●A medical device according to any one of the foregoing embodiments relating to a medical device;

[0192] ● A sensor controller coupled to the analyte sensor, wherein the sensor controller is configured to receive analyte sensor data from the analyte sensor; and

[0193] ● Remote control, configured to receive sensor data from the sensor controller and process and / or display the sensor data. Attached Figure Description

[0194] Other optional features and embodiments will be disclosed in more detail in the following description of embodiments, in conjunction with the dependent claims. As those skilled in the art will recognize, each optional feature can be implemented individually and in any feasible combination. The scope of the invention is not limited to the preferred embodiments. Embodiments are schematically depicted in the accompanying drawings. In these drawings, the same reference numerals refer to the same or functionally equivalent elements.

[0195] In the attached diagram:

[0196] Figures 1A to 1C show top views (Figure 1A) and cross-sectional views of the analyte sensor (Figures 1B and 1C). Figure 1C This illustrates an exemplary embodiment of the analyte sensor according to the present invention;

[0197] Figures 2A and 2B illustrate exemplary embodiments of the medical device according to the invention after insertion of the analyte sensor (Figure 2A) and after insertion of the analyte sensor and during removal of the insertion cannula (Figure 2B);

[0198] Figures 3A and 3B illustrate further exemplary embodiments of the medical device according to the invention after insertion of the analyte sensor (Figure 3A) and after insertion of the analyte sensor and during removal of the insertion cannula (Figure 3B);

[0199] Figures 4A to 4C illustrate exemplary embodiments of the medical device according to the invention after insertion of the analyte sensor (Figure 4A), during removal of the insertion cannula (Figure 4B), and after removal of the insertion cannula (Figure 4C).

[0200] Figures 5A and 5B illustrate further exemplary embodiments of the medical device after insertion of the analyte sensor (Figure 5A) and after insertion of the analyte sensor and during removal of the insertion cannula (Figure 5B);

[0201] Figure 6 illustrates a schematic embodiment of a medical device system according to the present invention. Detailed Implementation

[0202] Figure 1A shows an exemplary embodiment of the analyte sensor 110 according to the present invention in top view. The analyte sensor 110 may be an electrochemical sensor 112. The analyte sensor 110 may have an elongated shape. Specifically, the analyte sensor 110 may be straight, curved, or bent. Specifically, the analyte sensor 110 may have an in vivo proximal portion 114 and an external distal portion 116. The in vivo proximal portion 114 may be referred to as an insertable portion 115. The in vivo proximal portion 114 may be configured for insertion into a user's body tissue. The external distal portion 116 may be configured to remain outside the user's body tissue. The external distal portion 116 and the in vivo proximal portion 114 may be arranged laterally to each other, specifically substantially perpendicular to each other. The in vivo proximal portion 114 may extend along an insertion direction as indicated by arrow 118. The insertion direction may be laterally to, specifically substantially perpendicular to, the user's skin site.

[0203] The analyte sensor 110 may include a carrier 120, which may specifically be or may include a substrate 122. In the embodiment according to FIG. 1A, the analyte sensor 110 includes two electrodes 124, each electrode including an electrode conductor path 125. A first electrode 126 may be a working electrode 128. A second electrode 130 may be a counter electrode or a reference electrode 132. Electrodes 124 may be attached to the carrier 120 or may be disposed within the carrier 120. Electrodes 124 may extend along the carrier 120. Specifically, electrodes 124 may be formed as lines. Electrodes 124 may be arranged parallel to each other and spaced apart. The first electrode 126 and the second electrode 130 may each include a contact pad 134 for electrical connection with one or more electronic components of an electronic unit.

[0204] Furthermore, the analyte sensor 110 may include at least two conductive paths 136. The at least two conductive paths 136 may be attached to or disposed on the carrier 120. Specifically, the at least two conductive paths 136 may be arranged on the external distal portion 116 of the analyte sensor 110. After insertion of the analyte sensor 110 (specifically, the internal proximal portion 114 of the analyte sensor 110), the at least two conductive paths 136 may remain outside the body tissue. The at least two conductive paths 136 may each be formed as lines. The at least two conductive paths 136 may be arranged parallel to each other and spaced apart to prevent unintentional contact. Each of the at least two conductive paths 136 may include a contact pad 138 for connection to one or more electronic components of the electronic unit or to an energy source such as a battery. Furthermore, the at least two conductive paths 136 may each include a contact area 140. Further details regarding the contact area 140 are provided in Figures 1B and 1C.

[0205] Figures 1B and 1C show cross-sectional views (section AA, see Figure 1A) of the analyte sensor 110 according to Figure 1A. Figures 1B and 1C illustrate different embodiments. As shown in Figures 1B and 1C, the contact areas 140 of at least two conductor paths 136 may be at least partially located on and / or near the surface 142 of the analyte sensor 110, specifically the carrier 120. As shown in Figure 1B, the contact areas 140 may be exposed by laser ablation, as exemplarily shown. To increase the pathways of at least two conductor paths 136 for contact by connector elements, the contact areas 140 may be raised relative to the surface 142, such as by adding soldered contact elements 144 to the exposed contact areas 140 of the at least two conductor paths 136, as shown in Figure 1C. It is also contemplated that a more defined contact surface can be provided by mounting and / or soldering contact elements 144 to the contact areas 140.

[0206] Figures 2A and 2B show the situation after the analyte sensor 110 is inserted and the insert cannula 148 is inserted ( Figure 2A The medical device 146 according to the invention is described in FIG2B, after insertion of the analyte sensor 110 and during removal of the insertion cannula 148. The medical device 146 includes the analyte sensor 110 as shown in FIG1A to FIG1C. Therefore, reference is made to the description above in FIG1A to FIG1C.

[0207] The medical device 146 further includes an insertion member 147, which includes an insertion cannula 148. An analyte sensor 110 is at least partially disposed within the insertion cannula 148. The insertion cannula 148 may include a tip 150 for at least partially inserting the analyte sensor 110 into body tissue. Specifically, the insertion cannula 148 may be a slotted needle 152. The insertion cannula 140 may be configured for perpendicular insertion relative to the user's body tissue.

[0208] The medical device 146 further includes a housing 154 having an electronic compartment 156, in which an electronic unit (not shown in Figures 2A and 2B) is at least partially housed. The housing 154 may include an upper side 158 and a lower side 160. Specifically, the upper side 158 may refer to the distal side 162 of the housing 154. Specifically, the lower side 160 may refer to the proximal side 164 of the housing 154. The lower side 160 may include a surface 166 for placement on a user's skin. Specifically, the medical device 146 may include an adhesive surface 168 for attachment to the user's skin.

[0209] The housing 154 further includes an open channel 170 that at least partially surrounds the analyte sensor 110 and the insertion cannula 148. Specifically, the open channel 170 may be a substantially straight channel. The open channel 170 may extend along the insertion direction of the analyte sensor 110, as indicated by arrow 118. Specifically, the open channel 170 may have an upper opening 172 and an opposing lower opening 174. The upper opening 172 may be located on an upper side 158 of the housing 154 facing away from body tissue, and the lower opening 174 may be located on a lower side 160 of the housing 154 facing towards body tissue. The open channel 170 may connect the upper side 158 and the lower side 160. An insertable portion 115 of the analyte sensor 110 may extend downwards in the open channel beyond the lower side 160 of the housing 154.

[0210] The open passage 170 may be formed by the open passage wall 176. The electronic compartment 156 may be formed at least partially by the open passage wall 176. Therefore, the open passage wall 176 may have a first side 178 facing the internal space 180 of the electronic compartment 156 and an opposing second side 182 facing the internal space 184 of the open passage 170.

[0211] The open channel wall 176 may include an opening (not shown in Figures 2A and 2B) through which the analyte sensor 110 passes; this opening may be a sealed opening. The analyte sensor 110 may be partially housed inside the electronics chamber 156, while another portion of the analyte sensor 110 may be partially housed outside the electronics chamber 156, such as within the open channel 170. An insertable portion 115 of the analyte sensor 110 may be located outside the electronics chamber 156. Specifically, the opening may be a sealed opening.

[0212] The medical device 146 may include a removable cap 186. The removable cap 186 may be configured to be removed after the insertable portion 115 of the analyte sensor 110 has been inserted into body tissue. Specifically, the removable cap 186 may be or may include a retainer 188 for inserting a cannula 148. The insert cannula 148 may be connected to the retainer 188, specifically, in a fixed connection.

[0213] Furthermore, the medical device 146 may include a removable lower cover (not shown). The removable lower cover may be configured to be removed before the insertable portion 115 of the analyte sensor 110 is inserted into body tissue. Specifically, the removable lower cover may be a sterile cap. The sterile cap may be configured to provide sterile packaging for the insertable portion 115 of the analyte sensor 110, such that the insertable portion 115 forms a seal relative to the surrounding environment.

[0214] A removable lower cover and a removable upper cover 186 may be disposed or located on opposite sides of the housing 154, specifically on opposite sides of the open channel 170. Specifically, the removable lower cover may be disposed on the lower side 160 of the housing 154. The removable lower cover may be removably connected, specifically attached to the lower side 160 of the housing 154. The removable upper cover 186 may be disposed on the upper side 158 of the housing 154. The removable upper cover 186 may be removably connected, specifically attached to the upper side 158 of the housing 154.

[0215] A removable top cover 186 and a removable bottom cover can be reversibly or irreversibly connected to the housing 154. The removable bottom cover, the removable top cover 186, and the open channel 170 can form a sensor compartment 194 for at least partially housing the analyte sensor 110. The analyte sensor 110 can be partially housed in the electronic compartment 156 and partially housed in the sensor compartment 194. The sensor compartment 194 can be a sealed compartment, specifically a sterile compartment, before the removable bottom cover is removed from the housing 154.

[0216] The electronic unit may include a circuit carrier, preferably a printed circuit board. Similarly, an optional energy storage device (such as a battery) may be attached directly or indirectly to the printed circuit board. Sensor circuitry may be disposed on the printed circuit board. These features are not shown in Figures 2A and 2B.

[0217] The medical device 146 further includes a connector element 200 disposed within an open channel 170 of the housing 154. The connector element 200 can be configured for electrical contact with at least two conductor paths 136 of the analyte sensor 110.

[0218] In the embodiment according to Figures 2A and 2B, connector element 200 is contact spring element 202, specifically a bent contact spring element 204, and more specifically a sheet-like contact spring element 206. Contact spring element 202 can be fixedly attached to surface 208 of open channel wall 176.

[0219] Before the insertion sleeve 148 is retracted or removed from the open channel 170, as shown in FIG. 2A, the contact spring element 202 can be in direct contact with the surface 210 of the insertion sleeve 148. Thus, the contact spring element 202 can be in a tensioned state, and the contact spring element 202 can be arranged at a distance from at least two conductor paths 136 of the analyte sensor 110. The sensor circuit can be in an inactive state.

[0220] During the retraction or removal of the insertion sleeve 148 from the open channel 170, as shown in FIG. 2B, the contact spring element 202 electrically contacts at least two conductor paths 136. The contact spring element 202 can be in a further tensioned or relaxed state, and the contact spring element 202 can electrically contact at least two conductor paths 136. Therefore, the sensor circuit can be closed and can be in an active state.

[0221] Figures 3A and 3B illustrate exemplary embodiments of a further medical device 146 according to the invention after insertion of the analyte sensor 110 (Figure 3A), and after insertion of the analyte sensor 110 and during removal of the insertion cannula 148 (Figure 3B). The medical device 146 includes the analyte sensor 110 as shown in Figures 1A to 1C. Therefore, reference is made to the description above of Figures 1A to 1C. Furthermore, the medical device 146 according to Figures 3A and 3B corresponds at least partially to the medical device 146 according to Figures 2A and 2B. Therefore, reference is made to the description above of Figures 2A and 2B.

[0222] In the embodiment according to Figures 3A and 3B, connector element 200 is conductive elastomer element 210. Conductive elastomer element 210 can be fixedly attached to surface 208 of open channel wall 176.

[0223] Before the insertion sleeve 148 is retracted or removed from the open channel 170, as shown in FIG. 3A, the conductive elastomer element 210 can be in direct contact with the surface 210 of the insertion sleeve 148. Thus, the conductive elastomer element 210 can be in a compressed state, and the conductive elastomer element 210 can be arranged at a distance from at least two conductor paths 136 of the analyte sensor 110. The sensor circuitry can be in an inactive state.

[0224] During the retraction or removal of the insertion sleeve 148 from the open channel 170, as shown in FIG. 3B, the conductive elastomer element 210 electrically contacts at least two conductor paths 136. The conductive elastomer element 210 may be in a further compressed or relaxed state, and the conductive elastomer element 210 may electrically contact at least two conductor paths 136. Therefore, the sensor circuit can be closed and can be in an active state.

[0225] Figures 4A to 4C show the sequence after insertion of the analyte sensor 110 and the insertion cannula 148. Figure 4A Exemplary embodiments of the further medical device 146 according to the invention, after insertion of the analytical sensor 110, during removal of the insertion cannula 148, and after removal of the insertion cannula 148 (FIG. 4C). In FIG. 4A to... Figure 4C In the figures, medical device 146 is shown in a top view (top) and a cross-sectional view (bottom). Medical device 146 includes an analyte sensor 110 as shown in Figures 1A to 1C. Therefore, reference is made to the description above for Figures 1A to 1C. Furthermore, medical device 146 according to Figures 4A to 4C corresponds at least partially to medical device 146 according to Figures 2A and 2B. Therefore, reference is made to the description above for Figures 2A and 2B.

[0226] In the embodiment according to Figures 4A-4C, connector element 200 is movably attached (e.g., via adhesive) to surface 212 of analyte sensor 110. Insertion sleeve 148 can be configured to move connector element 200 such that connector element 200 electrically contacts at least two conductor paths 136 of analyte sensor 110. For this purpose, insertion sleeve 148 may include protrusion 214. Protrusion 214 can be configured to move connector element 200 in a retraction direction of insertion sleeve 148, as indicated by arrow 214.

[0227] Before the insertion sleeve 148 is retracted or removed from the open channel 170, as shown in FIG. 4A, the connector element 200 may be arranged at a distance from at least two conductor paths 136. The connector element 200 may be arranged below at least two conductor paths 136. Furthermore, the connector element 200 may be arranged above the protrusion 214.

[0228] During and after the insertion sleeve 148 is retracted or removed from the open channel 170, as shown in Figures 4B and 4C, the connector element 200 makes electrical contact with at least two conductor paths 136. Specifically, the connector element 200 may be at least partially disposed on both of the at least two conductor paths 136.

[0229] Figures 5A and 5B show the situation after the analyte sensor 110 is inserted and the insert cannula 148 is inserted ( Figure 5A An exemplary embodiment of a further medical device 146 is shown in Figures 5A and 5B, after the insertion of the analytical sensor 110 and during the removal of the insertion cannula 148. In Figures 5A and 5B, the medical device 146 is shown in cross-sectional views, respectively.

[0230] Medical device 146 may include an analyte sensor 110, which at least partially corresponds to the analyte sensor 110 shown in Figures 1A to 1C. Therefore, referring to the description above in Figures 1A to 1C, the analyte sensor 110 shown in Figures 5A and 5B does not include at least two conductor paths 136, compared to the analyte sensor 110 shown in Figures 1A to 1C.

[0231] Furthermore, the medical device 146 according to Figures 5A and 5B corresponds at least partially to the medical device 146 according to Figures 2A and 2B. Therefore, refer to the description of Figures 2A and 2B above.

[0232] In the embodiment according to Figures 5A and 5B, connector element 200 may be a push-button switch 216. Push-button switch 216 may be disposed within open channel 170. Specifically, push-button switch 216 may be fixedly attached to open channel wall 176. Push-button switch 216 may include push-button switch housing 218 and movable element 220. Movable element 220 may be configured to move laterally, specifically perpendicularly, to the insertion direction of analyte sensor 110, as indicated by arrow 118. Before insertion of insertion sleeve 148, for example before insertion sleeve 148 is retracted or removed from open channel 170, as shown in Figure 5A, insertion sleeve 148 may compress movable element 220 into push-button switch housing 218, thereby interrupting sensor circuitry. This state may also indicate a factory state. By retracting the insert sleeve 148 from the open channel 170, the movable element 220 can be removed from the push-button switch housing 218, which causes the sensor circuit to close, and in turn, the electronic unit is turned on upon receiving power from the battery.

[0233] Figure 6 illustrates an exemplary embodiment of the medical device system 222 according to the present invention.

[0234] Medical device system 222 includes medical device 146. The medical device may correspond to, for example, those shown in Figure 2A and... Figure 2B The embodiments shown in Figures 3A and 3B, or in Figures 4A to 4C, are described above. Therefore, please refer to the description of these figures above.

[0235] The medical device system 222 further includes a sensor controller 224 coupled to the analyte sensor 110 of the medical device 146. The sensor controller is configured to receive analyte sensor data from the analyte sensor 110, such as that indicated by arrow 226.

[0236] The medical device system 222 further includes a remote controller 228 configured to receive sensor data (such as indicated by arrow 230) from a sensor controller 224, and to process and / or display the sensor data, such as via a user interface 232. The sensor controller 224 may be configured to communicate sensor data to the remote controller 228.

[0237] List of reference numerals

[0238]

Claims

1. A medical device (146) for detecting an analyte in bodily fluids, said medical device (146) comprising: ● An analyte sensor (110) having an insertable portion (115) adapted to be at least partially inserted into a user's body tissue, wherein the analyte sensor (110) is configured to detect the analyte in the body fluid, wherein the analyte sensor (110) includes at least two conductor paths (136) configured to activate sensor circuitry, and wherein the analyte sensor (110) further includes at least two electrodes (124), each electrode including an electrode conductor path (125) configured to transmit sensor current to detect the analyte; ● Insertion component (147), the insertion component including an insertion sleeve (148), wherein the analyte sensor (110) is at least partially disposed inside the insertion sleeve (148); ● Electronic unit, the electronic unit including the sensor circuit; ● A housing (154) having an electronic compartment (156) in which the electronic unit is at least partially housed, wherein the housing (154) further includes an open channel (170) at least partially surrounding the analyte sensor (110) and the insertion member (147); and ● Connector element (200), wherein the insertion part (147) is configured to retract from the open channel (170), thereby triggering electrical contact of the connector element (200) with the at least two conductor paths (136) of the analyte sensor (110), thereby activating the sensor circuit.

2. The medical device (146) according to the preceding claim, wherein the sensor circuit includes a power storage device, wherein the connector element (200) is configured to establish an electrical connection between the power storage device and the electronic components of the sensor circuit by electrically contacting the at least two conductor paths (136) of the analyte sensor (110).

3. The medical device (146) according to any one of the preceding claims, wherein, The sensor circuit is inactive before the insertion sleeve (148) retracts from the open channel (170), and the sensor circuit is active during and / or after the retraction of the insertion sleeve (148) from the open channel (170).

4. The medical device (146) according to any of the preceding claims, wherein the connector element (200) is configured to electrically contact the at least two conductor paths (136) of the analyte sensor (110) by means of movement, displacement, relaxation or expansion of the connector element (200) or a component of the connector element (200).

5. The medical device (146) according to any one of the preceding claims, wherein the connector element (200) is configured to establish a transient or permanent electrical contact between the at least two conductor paths (136) of the analyte sensor (110).

6. The medical device (146) according to any one of the preceding claims, wherein the housing (154) includes an upper side (158) and a lower side (160), wherein an open channel (170) connects the upper side (158) and the lower side (160), wherein the insertable portion (115) of the analyte sensor (110) extends downward in the open channel (170) beyond the lower side (160) of the housing (154).

7. The medical device (146) according to any one of the preceding claims, wherein each of the at least two conductor paths (136) includes a contact area (140), wherein the connector element (200) is configured to electrically contact the contact area (140) of each of the at least two conductor paths (136).

8. The medical device (146) according to the preceding claim, wherein the contact area (140) is located on or disposed on the surface of the analyte sensor (110), wherein the contact area (140) is raised relative to the surrounding surface of the analyte sensor (110).

9. The medical device (146) according to any one of the preceding claims, wherein the connector element (200) is selected from the group consisting of: contact spring element (202) and conductive elastomer element (210).

10. The medical device (146) according to the preceding claim, wherein, Before the insertion sleeve (148) retracts from the open channel (170), the connector element (200) is in direct contact with the surface of the insertion sleeve (148), wherein, during and / or after the insertion sleeve (148) retracts from the open channel (170), the connector element (200) is in electrical contact with the at least two conductor paths (136).

11. The medical device (146) according to any one of the preceding claims, wherein the connector element (200) is movably attached to the surface (142) of the analyte sensor (110), wherein the insertion sleeve (148) is configured to move the connector element (200) such that the connector element (200) electrically contacts the at least two conductor paths (136).

12. The medical device (146) according to any one of the preceding claims, wherein the open channel (170) is formed by an open channel wall (176), wherein the connector element (200) is attached to a surface (208) of the open channel wall (176) facing the interior space surrounded by the open channel (170).

13. The medical device (146) according to the preceding claim, wherein, Before the insertion sleeve (148) retracts from the open channel (170), the insertion sleeve (148) is configured as a non-conductive spacer between the connector element (200) and the at least two conductor paths (136).

14. The medical device (146) according to any one of the preceding claims, wherein the medical device (146) further comprises a removable top cover (186), wherein the insertion cannula (148) is attached to the removable top cover (186), wherein the removable top cover (186) is configured to be removed after the insertable portion (115) of the analyte sensor (110) is inserted into the body tissue, wherein the medical device (146) further comprises a removable bottom cover, wherein the removable bottom cover is configured to be removed before the insertable portion (115) of the analyte sensor (110) is inserted into the body tissue, wherein the removable bottom cover, the removable top cover (186) and the open channel (170) form a sensor chamber (194) for at least partially receiving the analyte sensor (110), wherein the sensor chamber (194) is a sealed chamber.

15. The medical device (146) according to the preceding claim, wherein at least one of the removable upper cover (186) and the removable lower cover is removably connected to the housing (154) via a connector, and / or wherein the removable upper cover (186) and the removable lower cover are removably connected to each other.

16. The medical device (146) according to the preceding claim, wherein the removable upper cover (186) forms a seal with the upper opening (172) of the open channel (170), and wherein the removable lower cover forms a seal with the lower opening (174) of the open channel (170).

17. A medical device system (222) comprising: -A medical device (146) according to any one of the preceding claims; - Sensor controller (224), the sensor controller being coupled to the analyte sensor (110), wherein the sensor controller (224) is configured to receive analyte sensor data from the analyte sensor (110); as well as - Remote controller (228), which is configured to receive sensor data from the sensor controller (224) and process and / or display the sensor data.

18. A method of using the medical device (146) according to any one of the preceding claims, the method comprising: a) Provide the medical device (146); b) Insert the analyte sensor (110) into the body tissue; as well as c) The insertion sleeve (148) is retracted from the open channel (170), wherein the electrical contact of the connector element (200) with the at least two conductor paths (136) of the analyte sensor (110) is triggered, thereby activating the sensor circuit.

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