TW202537585A - Continuous analyte monitoring device - Google Patents

Abstract

A continuous analyte monitoring device (110) is disclosed comprising:• an analyte sensor (112) comprising an insertable portion (116) adapted for at least partially being inserted into a body tissue of a user, wherein the analyte sensor (112) is configured for detecting an analyte in a body fluid of the user;• an insertion component (122) comprising an insertion cannula (124) and an insertion cannula holder (126), wherein the insertion cannula (124) is attached to the insertion cannula holder (126), wherein the analyte sensor (112) is at least partially placed inside the insertion cannula (124);• a removable sterility cap (136), wherein the removable sterility cap (136) at least partially surrounds the insertable portion (116) of the analyte sensor (112);• a housing (111), wherein the housing (111) comprises an open channel (146) which at least partially surrounds the analyte sensor (112) and the insertion component (122), wherein the housing (111) further comprises an electronics compartment (154) with an electronic unit (156) received therein; wherein the housing (111) is at least partially formed by a lower housing portion (160) and by an upper housing portion (162), wherein the housing (111) comprises a sealing channel (234) comprising an input filling port (136) and an output filling port (138), wherein the sealing channel (234) is at least partially filled with a sealing material (240) being configured for sealing an interior space (242) enclosed by the upper housing portion (162) and the lower housing portion (160);wherein the removable sterility cap (136), the open channel (146) of the housing (111) and the insertion cannula holder (126) from a sterile compartment (166) for the insertion cannula (124) and at least the insertable portion (116) of the analyte sensor (112).

Description

Continuous Analyte Monitoring Device

This invention relates to a continuous analyte monitoring device, a continuous analyte monitoring system, a method for assembling the continuous analyte monitoring device, and a method for using the continuous analyte monitoring device. The device and method of this invention can be primarily used for long-term monitoring of analyte concentrations in body fluids, such as for long-term monitoring of blood glucose levels or the concentrations of one or more other types of analytes. This invention can be applied in both home care and professional nursing fields, such as in hospitals. Other applications are also possible.

Monitoring certain bodily functions, and more specifically, monitoring one or more concentrations of certain 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, alternatively or otherwise, the invention can also be applied to other types of analytes.

In addition to optical measurements, blood glucose monitoring can also be performed using electrochemical biosensors. Examples of electrochemical sensors 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 2005/0013731 A1.

In addition to so-called spot measurements, which involve obtaining samples of bodily fluids from users in a targeted manner and checking the concentration of the analyte in those samples, continuous measurements have been increasingly established. Therefore, recently, continuous measurements of glucose in interstitial tissues (also known as continuous monitoring or CM) have been established as another important method for managing, monitoring, and controlling diabetes.

In this process, the active sensing region is applied directly to measurement sites typically located in the interstitial tissue, and glucose is converted into an electrical charge, for example, 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 transcutaneous measurement systems are described in US 6,360,888 B1 or US 2008/0242962 A1.

Therefore, current continuous monitoring systems are typically transdermal or subcutaneous systems, both of which will be used interchangeably 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 can typically be applied using an insertion device, as illustratively described in US 6,360,888 B1. Other types of insertion devices are also known.

Sensors typically include a substrate, such as a planar substrate, on which conductive patterns of electrodes, conductive traces, and contact pads can be applied. In use, the conductive traces are usually separated by using one or more electrical insulating materials. The electrical insulating materials usually also serve to prevent moisture and other harmful substances, and may include, for example, one or more covering layers, such as corrosion inhibitors.

Modern continuous glucose monitoring devices can have a connector with a vertical opening that is part of a sterile unit that houses the portion of the sensor to be inserted into the skin and the insertion cannula. A retainer for the insertion cannula seals the upper side of the connector, while a sterile cap seals the lower side. The sensor can pass horizontally through the connector to connect to the electronic unit, and it is important for maintaining sterility that the horizontal passage surrounding the sensor in the connector is tightly sealed during the journey from the sensor to the electronic unit. Sealing the sensor as it passes through the connector is a technical challenge. Furthermore, typically, after the sensor has been mounted on the lower sensor patch, the sensor patch connector and other sealing elements need to be installed, which complicates the device.

Furthermore, in current continuous glucose monitoring devices, the connection between the shell parts is typically achieved using an adhesive filled within grooves. When the adhesive is applied, air bubbles may form within it. The shell parts can be mounted from above, and air can be displaced and must escape through ventilation holes. If the shell parts are not precisely mounted vertically when in contact with the adhesive, air bubbles may form at the contact point. The disadvantage of air bubbles in the adhesive may be that they represent a weakness in watertight bonding.

EP3727130B1 describes a medical system. The medical system includes: a. a housing; b. a pre-assembled functional module housed within the housing, the pre-assembled functional module including: b1. an analytical sensor for detecting at least one analyte in a user's bodily fluids; b2. an electronic unit electrically connected to the analytical sensor; and b3. an insertion component for inserting the analytical sensor into the user's body tissue; c. at least one removable protective cover connected to the housing and covering the pre-assembled functional module.

EP3202324A1 describes a medical device for detecting at least one analyte in bodily fluids, a method of assembling the medical device, and a method of using the medical device. The medical device includes: at least one analyte sensor having an insertable portion adapted for at least partial insertion into a user's body tissue; at least one insertion cannula, wherein the analyte sensor is at least partially housed within the insertion cannula; at least one electronic unit, wherein the analyte sensor is operatively connected to an electronic device; and at least one housing, wherein the housing includes at least one electronics compartment configured to at least partially house the electronic unit and at least one sensor compartment configured to at least partially house the analyte sensor. The sensor compartment forms a sealed compartment housing at least the insertable portion of the analyte sensor. The sealed compartment includes at least one removable upper cover and at least one removable lower cover. The removable lower cover is configured to be removed before insertion, thereby opening the insertable portion for insertion. An insertion cannula is attached to the removable upper cover. The removable upper cover is configured to be removed after insertion, thereby removing the insertion cannula. The electronic compartment at least partially surrounds the sensor compartment.

EP3202323A1 describes a medical device for detecting at least one analyte in bodily fluids. The medical device includes: at least one analyte sensor having an insertable portion adapted for at least partial insertion into a user's body tissue; at least one insertion cannula, wherein the analyte sensor is at least partially housed within the insertion cannula; and at least one housing having at least one sensor compartment forming a sealed compartment housing at least the insertable portion of the analyte sensor, wherein the sealed compartment includes at least one removable upper cover and at least one removable lower cover. A cover, wherein the removable lower cover is configured to be removed before insertion, thereby opening the insertable portion for insertion, wherein an insertion cannula is attached to a removable upper cover, wherein the removable upper cover is configured to be removed after insertion, thereby removing the insertion cannula; and at least one electronic unit, wherein the analyte sensor is operatively connected to the electronic unit, wherein the electronic unit includes at least one electronic component attached thereto to at least one interconnection device, wherein the interconnection device completely or partially surrounds the housing.

US20220079475A1 describes a system, apparatus, or device including an analyte sensor for monitoring analyte content. The system, apparatus, or device may include a printed circuit board configured to monitor analyte content and a battery connected to and configured to power the printed circuit board. The system, apparatus, or device may also include: a connector connected to and configured to establish an electrical connection between the analyte sensor and the printed circuit board; and a processor connected to and configured to process data related to the monitored analyte content. Furthermore, the system, apparatus, or device may include antennas for transmitting the monitored analyte content, mounted on a plurality of risers. The risers may extend a fixed distance from the surface of the printed circuit board.

CN218451759U describes a sterilization module comprising a monitoring and treatment probe, a medical device, and a graft. The medical device mainly includes a sterilization module, which further includes a sterilization shell. At least a portion of the sterilization shell forms a sterilization cavity. At least one end of the sterilization cavity has an opening, and the living internal portion of the monitoring and treatment probe and a portion of the guide graft are placed within the sterilization cavity. The guide graft can be fixed and cover the opening of the sterilization cavity, forming a seal between the sterilization shell and the guide graft. The sterilization module disclosed in this utility model is smaller in size and easier to sterilize, and increases the number of sterilization modules of the same size, thus reducing sterilization costs. After sterilization, the sterilization module is matched with other modules to form a medical device. When the user uses the medical device, the entire medical device is directly formed and is mounted on the implanter without the need for additional assembly by the user. The implanter is designed for low cost and has an anti-accidental contact function. Users can use the product safely, conveniently and inexpensively.

The problem to be solved

Therefore, it is desirable to provide a continuous analyte monitoring device, a continuous analyte monitoring system, a method for assembling the continuous analyte monitoring device, and a method for using the continuous analyte monitoring device, which solves at least one of the aforementioned problems. Specifically, it is desirable to provide a reliable seal for the continuous analyte monitoring device.

At least one of the problems mentioned above is solved by a continuous analyte monitoring device, a continuous analyte monitoring system, a method for assembling a continuous analyte monitoring system, and a method for using a continuous analyte monitoring device having the features of the independent claim. Advantageous embodiments that can be implemented individually or in any arbitrary combination are listed in the appendix and throughout the specification.

As used below, the terms "have," "comprise," or "include," or any of their arbitrary grammatical variations, are used in a non-exclusive manner. Therefore, these terms can refer to a situation where no further features exist in the entity described herein besides the features introduced by these terms, or they can refer to a situation where one or more further features exist. As an example, the statements "A has B," "A contains B," and "A includes B" can refer to a situation where no other element exists in A besides B (i.e., where A is composed solely and exclusively of B) and can also refer to a situation where one or more further elements (e.g., elements C, C, and D, or even further elements) besides B exist in entity A.

In addition, it should be noted that the terms "an element" and "the element" can indicate that multiple elements may exist in a particular embodiment, such as at least two elements.

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 an individual feature or element. In the following text, in most cases, the expressions "at least one" or "one or more" will not be repeated when referring to individual features or elements, even if there is a fact that an individual feature or element may exist once or more.

Furthermore, as used below, the terms "preferably," "more preferably," "particularly," "more particularly," "specifically," "more specifically," or similar terms are used in combination with features chosen as appropriate, without limiting the possibility of alternatives. Therefore, features introduced by these terms are features as appropriate and are not intended to limit the scope of the patent application in any way. As will be appreciated by those skilled in the art, the invention can be accomplished by using alternative features. Similarly, features introduced by the phrase "in an embodiment of the invention" or similar wording are intended to be features as appropriate, 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 manner with other features of the invention, whether appropriate or not.

Furthermore, the term "essentially parallel" may include a slight deviation from a parallel arrangement (such as an arrangement that deviates from a parallel arrangement by no more than 10 degrees, preferably no more than 5 degrees). The term "essentially perpendicular" may include a slight deviation from a perpendicular arrangement (such as an arrangement that deviates from a perpendicular arrangement by no more than 10 degrees, preferably no more than 5 degrees).

In a first embodiment of the present invention, a continuous analyte monitoring device is disclosed, comprising: • an analyte sensor including 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 the user's bodily fluids; • an insertion assembly including an insertion cannula and an insertion cannula holder, wherein the insertion cannula is attached to the insertion cannula holder, and the analyte sensor is at least partially placed within the insertion cannula; • a removable sterile cap, wherein the removable sterile cap at least partially surrounds the insertable portion of the analyte sensor; A housing, wherein the housing includes an open channel at least partially surrounding the analyte sensor and the insertion assembly, wherein the housing further includes an electronic compartment housing an electronic unit; wherein the housing is at least partially formed by a lower housing portion and an upper housing portion, wherein the housing includes a sealing channel including an inlet filling port and an outlet filling port, wherein the sealing channel is at least partially filled with a sealing material configured to seal the internal space surrounded by the upper housing portion and the lower housing portion; wherein the removable sterile cap, the open channel of the housing, and the insertion cannula retainer originate from the sterile compartment of at least the insertable portion for the insertion cannula and the analyte sensor.

Specifically, this invention can be associated with at least one of the following advantages: the subject matter of this invention can reduce the complexity of product design, which in turn can reduce production costs compared to known continuous analyte monitoring devices. Specifically, this invention can improve the design of continuous analyte monitoring devices employing sterile compartments, wherein one portion of the analyte sensor forms part of the sterile compartment, while another portion of the analyte sensor leaves the sterile compartment to enter an electronic compartment containing electronic units, while maintaining the integrity of the sterile compartment and sealing it separately to the electronic compartment and/or the environment. This, in turn, simplifies the sterilization, sealing, and assembly of embodiments of this invention.

As used herein, the term "user" is a broad term and should be given its common and conventional meaning by those familiar with the technology, not limited to a specific or customized meaning. The term illustratively refers to a person who wants to monitor the values of analytes (such as glucose levels) in a person's body tissues. In one embodiment, the term may specifically refer to, but is not limited to, an individual using a continuous analyte monitoring device, as will be described in further detail below. For example, a user may be a patient with a disease, such as diabetes. A user may also be referred to as an individual or a patient. However, in another embodiment, the individual using the continuous analyte monitoring device is different from a user.

As used herein, the term "continuous analyte monitoring device" is a broad term and should be given its common and conventional meaning by those skilled in the art, without limitation to any specific or customized meaning. Specifically, the term refers to a medical device configured for use in the field of medical technology, exemplarily in the fields of medical analysis or medical diagnosis. A continuous analyte monitoring device can be configured for medical functions and/or for use in medical procedures, such as treatment, diagnosis, or one or more other medical procedures.

A continuous analyte monitoring device may specifically comprise an assembly of two or more components 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 components may be capable of detecting analytes in bodily fluids and/or facilitate the detection of analytes in bodily fluids. A continuous analyte monitoring device may also be commonly referred to as a sensor assembly, sensor system, sensor kit, sensor device, or medical device.

A continuous analyte monitoring device can specifically be configured to monitor or detect the presence of analytes in body tissues and/or body fluids and/or to monitor or detect the concentration of analytes in body tissues and/or body fluids, specifically monitoring or detecting over time or in a time-dependent manner. Specifically, the continuous analyte monitoring device can be configured to acquire and evaluate a data stream of time-dependent concentrations of the analyte. The data stream can be a continuous data stream. However, the data stream may include or have one or more gaps, during which no data is acquired. Furthermore, the number of data elements or signals acquired per time unit can vary over time. Specifically, the continuous analyte monitoring device can be configured to compare the concentration value of the analyte with one or more thresholds. Furthermore, the continuous analyte monitoring device can be configured to output warning signals under certain conditions.

Specifically, a continuous analyte monitoring device can be a continuous glucose monitoring device. The concentration of glucose in a user's or patient's blood or body fluids can depend on events that increase or decrease glucose concentration, such as food intake or physical activity. Therefore, the concentration of glucose in blood or body fluids can be described as a time-dependent concentration, for example, the concentration may change or modify over time. Thus, when assessing the concentration at a first time point, the concentration may have a first value, and when assessing the concentration at a second time point, the concentration may have a second value that may differ from the first value. The second value may be higher or lower than the first value. However, in some scenarios, the first value may be equivalent to the second value.

The continuous analyte monitoring device can be configured to be installed on the skin of a body part (specifically, a user's) selected from the following groups: arm, for example, the upper arm; abdomen; shoulder; back; hip; and leg. Specifically, the body part can be the upper arm. However, other applications may also be possible.

The continuous analyte monitoring device may include components that can be configured to remain outside of body tissue. Specifically, the components that can be configured to remain outside of body tissue may be a housing containing an electronic compartment housing electronic units. Furthermore, as outlined above, the analyte sensor includes an insertable portion. The insertable portion can be configured for insertion into a user's body tissue.

Continuous analyte monitoring devices can originate from pre-assembled single units. As used herein, the term "preassembled" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation to any specific or customized meaning. The term can specifically refer to, but is not limited to, the fact that an assembly process has already occurred. Therefore, components of the continuous analyte monitoring device may have already been assembled, for example by mechanical and/or electrical interconnection, thus preparing it for functional purposes (such as medical functions), such as analytical functions. Specifically, preassembly can be performed in a factory, thereby making the continuous analyte monitoring device a factory-assembled functional module.

As used herein, the term "body fluid" is a broad term and should be given its common and conventional meaning for those familiar with this technique, without being limited to a specific or customized meaning. The term specifically refers to fluids that are generally present in the body or body tissues of the user or patient and/or can be produced by the user or patient's body. Body tissues, for example, may be named interstitial tissue. Therefore, body fluids can be selected, for example, from groups composed of blood and interstitial fluid. However, alternatively, one or more types of body fluids, such as saliva, tears, urine, or other body fluids, may be used. Body fluids may be present in the body or body tissues during the detection of the analyte. Therefore, specifically, as will be further detailed below, analyte sensors can be configured to detect analytes in body tissues.

As used herein, the term "analyte" 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 specific or customized 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 concern to the user, patient, or healthcare professional (e.g., a physician). Specifically, an analyte may be or may contain any chemical substance or chemical compound that participates in the user's or patient's metabolism, such as metabolites. As an example, an analyte may be selected from the group consisting of glucose, cholesterol, triglycerides, and lactates. However, other types of analytes and/or combinations of analytes that can determine any analyte may also be used. However, specifically, the analyte can be glucose. Below, a continuous analyte monitoring device will be specifically described for glucose monitoring. The detection of the analyte can specifically be the detection of analyte specificity.

As used herein, the term "detection" is a broad term and should be given its common and conventional meaning to those of ordinary knowledge in the relevant technical field, and should not be limited to a specific or customized meaning. The term specifically 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, which determines the quantity and/or concentration of the analyte. As a result of detection, a signal characterizing the detection result may be generated, such as at least one measurement signal. The measurement signal may specifically be or may include electrical signals, such as voltage and/or current. The measurement signal may be or may include analog signals and/or may be or may include digital signals.

The term "analyte sensor" as used in this article is a broad term and should be given its common and conventional meaning to those familiar with this technology, rather than being limited to a specific or customized meaning. Specifically, the term refers to a sensor capable of qualitatively or quantitatively detecting the presence and/or concentration of an analyte.

An analyte sensor may specifically be a transcutaneous sensor. The term "transcutaneous sensor" as used herein is a broad term and should be given its common and customary meaning to those skilled in the art, and not limited to a specific or customized meaning. The term specifically refers to, but is not limited to, any sensor adapted for placement wholly or at least partially within the body tissues of a patient or user. For this purpose, an analyte sensor includes an insertable portion. As used herein, the term "insertable portion" is a broad term and should be given its common and customary meaning to those skilled in the art, and not limited to a specific or customized meaning. The term specifically refers to, but is not limited to, a part or component 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 a biocompatible surface, either wholly or partially, i.e., a surface that has no harmful effects on the user, patient, or body tissue, at least during the duration of use. Specifically, the insertable portion of the analyte sensor may have a biocompatible surface. As an example, in a transdermal sensor, the insertable portion may be wholly or partially covered with a biocompatible membrane, such as a polymer membrane or gel membrane, which is permeable to analytes and/or body fluids and (on the other hand) retains sensor substances, such as one or more analyte detection reagents, 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. Other parts can be connected to the evaluation device, such as to the electronic unit, as will be described further below.

The dimensions of a percutaneous sensor are typically designed to facilitate percutaneous insertion, for example, by providing a width in a direction perpendicular to the insertion direction, which does not exceed 5 mm, preferably not more than 2 mm, and more preferably not more than 1.5 mm. The sensor can have a length less than 50 mm, such as 30 mm or less, for example, a length from 5 mm to 30 mm. As used herein, the term "length" can refer to the direction parallel to the insertion direction. However, it should be noted that other dimensions are feasible.

An analyte sensor can specifically be an electrochemical analyte sensor. As used herein, the term "electrochemical sensor" 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 specific or customized meaning. The term can 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" can 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 can be specifically adapted to generate an inductive signal, such as current and/or voltage, that directly or indirectly indicates the presence and/or extent of an electrochemical detection reaction. Detection can be analyte-specific. Measurement can be quantitative and/or qualitative. Other embodiments are also possible.

An analyte sensor may include at least two electrodes. The term "electrode" as used herein is a broad term and should be given its common and conventional meaning by those skilled in the art, without limitation to any specific or customized meaning. Specifically, the term may refer to, but is not limited to, any element configured or usable for the electrical or electrochemical detection of analytes. 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 with additional materials, such as sensor chemicals. The at least two electrodes of the analyte sensor can be configured such that an electrochemical reaction can occur at one or more electrodes (such as one or more working electrodes). Therefore, these electrodes can be configured to allow oxidation and/or reduction reactions to occur at one or more electrodes. The electrochemical detection reaction can be performed by comparing the electrostatic 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 relative electrode or a reference electrode). Generally, the two or more electrodes can be used for one or more of the following: current measurement, constant current measurement, potential measurement, or constant potential measurement. These types of measurements are generally known to those skilled in the art in the detection of the analyte, such as from WO 2007/071562 A1 and/or the prior art disclosed therein. Reference can be made to this document for potential arrangements of electrodes, electrode materials, or measuring devices. However, it should be noted that other arrangements, electrode materials, or measuring devices may be used within the present invention. Electrodes typically include electrode conductor paths configured to transmit sensor current for detecting analytes. In certain embodiments, the electrode conductor paths may be connected to the sensor electronics, for example, via electrode contacts connected to corresponding contacts of electronic components of the sensor electronics.

At least two electrodes can be configured as a working electrode for detecting the analyte, along with other electrodes. These other electrodes can be selected from the following groups: relative electrodes, reference electrodes, and combined relative-reference electrodes. Illustratively, the analyte sensor can comprise a dual-electrode sensor. A dual-electrode sensor can precisely comprise two electrodes, such as a working electrode and other electrodes, such as a relative electrode, for example, a working electrode and a combined relative/reference electrode. As used herein, the term "working electrode" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation to any specific or customized meaning. The term specifically refers to, but is not limited to, an electrode suitable for or usable for performing electrochemical detection reactions to detect analytes in body 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 can contact the analyte detector. Therefore, the analyte detector can be coated onto the conductive working electrode pad. The analyte detector can form an analyte detector surface that can contact the body fluid. As an example, the analyte detector surface can be an open analyte detector surface or can be covered by the aforementioned membrane, which is permeable to the analyte to be detected and/or the body fluid or a portion thereof, allowing the analyte to interact with the analyte detector. For potential analyte detectors and/or materials used in conductive working electrode pads, reference can also be made to WO 2007/071562 A1 and/or the prior art disclosed therein. However, other embodiments are also possible. The one or more "working electrode pads" can specifically be formed by dots, lines, or grids, each dot, line, or grid forming a continuous 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 can include a working electrode having a number of electrode pads ranging from 1 to 50, preferably 2 to 30, or more preferably 5 to 20.

As used herein, the term "analyte assay" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation its specific or customized meaning. Specifically, the term may refer to, but is not limited to, any material or composition of materials adapted to alter detectability in the presence of an analyte. This property may be an electrochemically detectable property. Specifically, an analyte assay may be a highly selective analyte assay 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 degree or change of this property depends on the concentration of the analyte in the bodily fluids to allow for quantitative detection of the analyte. As an example, the analyte assay may contain enzymes, such as glucose oxidase and/or glucose dehydrogenase.

The at least two electrodes may further include a relative electrode. As used herein, the term "relative electrode" is a broad term and should be given its common and customary meaning to those skilled in the art, without limitation any specific or customized meaning. The term may specifically refer to, but is not limited to, an electrode suitable for performing electrochemical relative reactions and for balancing the current required by the detection reaction at the working electrode. Alternatively, the 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 relative electrode and the reference electrode may be a common electrode or one of two separate electrodes. Similarly, for potential materials that can be used as relative electrodes and/or reference electrodes, reference can be made to WO 2007/071562 A1 and/or the prior art documents disclosed therein. However, other embodiments are also possible.

Electrodes, specifically the working electrode, the opposing electrode, and/or the reference electrode, 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, the opposing electrode, and/or the reference electrode. The shape of the electrode may be determined by the manufacturing process (such as cutting and/or printing processes). The shape may be rectangular or circular. Additionally, other embodiments are possible, such as embodiments with different dimensions for the working electrode and the opposing/reference electrode, and/or embodiments using non-circular or non-rectangular shapes. The electrodes may be made of non-corrosive and non-passivating materials. For possible electrode materials, refer to the prior art cited above.

An analyte sensor may include a carrier, specifically a substrate. It may have at least two electrodes, specifically at least two electrode conductor paths, disposed on the carrier. As used herein, the term "carrier" is a broad term and should be given its common and customary meaning to those skilled in the art, and not limited to a specific or customized meaning. The term may specifically refer to, but is not limited to, any element suitable for supporting or disposed thereon or on one or more other elements. As used herein, the term "substrate" is a broad term and should be given its common and customary meaning to those skilled in the art, and not limited to a specific or customized meaning. The term may specifically refer to, but is not limited to, any flat element having a lateral extension that is at least 2, 5, 10, or even 20 or more times its thickness.

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

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 generated during wear and insertion into body tissue. Specifically, the carrier or substrate can be made of or may contain deformable materials, such as plastics or malleable and/or elastic materials. As an example, the carrier or substrate can be or may contain 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 contain polyimide foil. Specifically, the carrier or substrate may contain electrically insulating materials, such as electrically insulating plastic foil.

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 overall length of the analyte sensor, meaning both the portion of the analyte sensor inserted and the portion of the analyte sensor that may remain outside the body tissue. The portion of the analyte sensor inserted may also be referred to as the in vivo portion, and the portion of the analyte sensor that may remain outside the body tissue may also be referred to as the ex vivo portion. For example, the in vivo portion may 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, which completely or partially covers the analyte sensor and prevents the analyte detector from migrating into body tissues, while allowing body fluids and/or analytes to diffuse to the electrode.

As used herein, the term "insertion component" is a broad term and should be given its common and conventional meaning by those familiar with the technology, without being limited to a specific or customized meaning. Specifically, the term refers to any element that can be at least partially inserted into body tissues, specifically for the delivery or transfer of other elements. Insertion components can be configured to support the insertion of an analyte sensor or a portion thereof.

As outlined above, the insertion component includes an insertion cannula. As used herein, the term "insertion cannula" is a broad term and should be given its common and conventional meaning by those skilled in the art, without limitation its specific or customized meaning. The term may specifically 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 still possible. Specifically, the insertion cannula may be a slotted cannula. Alternatively, the insertion cannula may be a slotless cannula. The cannula can be configured for vertical insertion or insertion at an angle of 90° to 30° relative to the user's body tissues.

As further outlined above, the insertion assembly further includes an insertion cannula holder for inserting the cannula. As used herein, the term "insertion cannula holder" is a broad term and should be given its common and customary meaning to those skilled in the art, without limitation to any specific or customized meaning. Specifically, the term refers to any element that can be configured to hold an insertion cannula. The insertion cannula can be attached to the insertion cannula holder. Specifically, the insertion cannula can be securely attached to the insertion cannula holder. The insertion cannula holder can at least partially surround the insertion cannula. Specifically, the insertion cannula can have a first end and an opposing second end. The first end can have a tip or point for at least partially inserting an analyte sensor into body tissue. The second end can be attached to the insertion cannula holder. Further details regarding the insertion of the cannula retainer are provided below.

As outlined above, the continuous analyte monitoring device further includes a removable sterile cap.

The term "cap" as used herein is a broad term and should be given its common and conventional meaning by those familiar with this technology, without being limited to a specific or customized meaning. Specifically, the term refers to any component configured to close or seal its volume. Specifically, a cap can close or seal the opening of any container. A "cap" can take the form of a semi-shell, hemisphere, open container, lid, or covering. Other forms may also be feasible.

As used herein, the term "removable" is a broad term and should be given its common and conventional meaning to those skilled in the art, not limited to a specific or customized meaning. Specifically, this term refers to the property of a component that can be removed from any object. Consequently, the tight connection, contact, or link between the component and the object may be broken. Generally, the component can be removable in a reversible manner, whereby it can be reversibly attached to and detached from an object, or irreversibly removed, whereby it cannot be attached to an object after detachment. Further details are given below.

As used herein, the term "sterile cap" is a broad term and should be given its common and conventional meaning by those familiar with the technology, without being limited to a specific or customized meaning. The term can specifically refer to, but is not limited to, a component configured to maintain a sterile atmosphere in a space completely or partially surrounded by the component, such as a cover. For example, a sterile cap can be a rigid sterile cap, for example, made of rigid plastic materials and/or metal. As an example, a sterile cap can have rotational symmetry about an axis, which, as an example, can be the same as the rotational symmetry axis of the protective cap and/or the rotational symmetry axis of the housing. For example, a 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, a sterile cap may have a length of 5 to 20 mm, such as 10 to 15 mm.

As outlined above, a removable sterile cap at least partially surrounds the insertable portion of the analyte sensor. Therefore, the insertable portion can be at least partially housed within the removable sterile cap. The removable sterile cap can be configured for removal before the insertable portion of the analyte sensor is inserted into body tissue.

As outlined above, continuous analyte monitoring devices further include a housing. As used herein, the term "housing" is a broad term and should be given its common and conventional meaning by those skilled in the art, without limitation to any specific or customized meaning. Specifically, the term refers to any element adapted to wholly 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. Therefore, a housing may simply provide a basis for attaching and/or holding one or more additional components or elements. Alternatively, the housing may provide one or more internal spaces for accommodating one or more additional parts or components. The housing may specifically be manufactured by injection molding. However, other embodiments are also possible.

The shell may include a top side and a bottom side. The terms "top side" and "bottom side" can refer to two opposite sides of the shell. The terms "top side" and "bottom side" can be considered as descriptions without specifying an order and without excluding the possibility of using several possibilities for top and bottom sides.

Specifically, "distal side" can refer to the distal side of the casing. As used herein, the term "distal side" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation any specific or customized meaning. The term can specifically refer to, but is not limited to, the location of the side of the casing relative to the user's skin furthest away from the user's skin. For example, the casing may be in contact with the user's skin for inserting an analyte sensor. "Distal side" can refer to the side furthest from the user's skin.

Specifically, "below" can refer to the proximal side of the casing. As used herein, the term "proximal side" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation to any specific or customized meaning. The term can specifically refer to, but is not limited to, the location of the side of the casing relative to the user's skin closest to the user. For example, to insert an analyte sensor, the casing may be in contact with the user's skin. "Proximal side" can refer to the side very close to or even directly in contact with the user's skin.

As outlined above, the shell includes an open channel. Specifically, the shell may include an upper side and a lower side. The open channel may connect the upper side and the lower side. Specifically, the shell may be at least partially formed as a cylindrical ring surrounding the open channel.

As used herein, the term "channel" is a broad term and should be given its common and conventional meaning to those of ordinary knowledge in the relevant technical field, without being limited to a specific or customized meaning. Specifically, the term refers to any element that can have an elongated shape and provide free volume or cavity through which other elements can pass. Specifically, a channel can be substantially straight, curved, or circular. As further used herein, the term "straight" can refer to a continuous extension of the channel in one direction, substantially without bends, angles, or curves.

The open channel can extend along the insertion direction of the analyte sensor; specifically, the open channel is a straight channel. The insertion direction can be transverse to the user's skin, specifically substantially perpendicular to the user's skin. The insertion direction can be transverse relative to the lower and upper sides of the housing, specifically substantially vertical. Furthermore, the open channel can extend transversely, specifically substantially perpendicular to the extension direction of the housing. The open channel can extend transversely, specifically substantially vertically, relative to the lower and upper sides of the housing. The insertion direction can correspond to the extension direction of the open channel. Specifically, the open channel can have an upper opening and an opposite lower opening. The upper opening can be located on the upper side of the shell away from the skin, and the lower opening can be located on the lower side of the shell facing the skin.

As outlined above, the open channel at least partially surrounds the analyte sensor and the insertion assembly. Specifically, the open channel may at least partially circumferentially surround the analyte sensor and the insertion assembly, specifically at least the insertion cannula of the insertion assembly, and, if appropriate, a portion of the insertion cannula retainer of the insertion assembly. The open channel may form a compartment, specifically a compartment for at least partially housing the analyte sensor and the insertion assembly. The housing may at least partially be formed as a cylindrical ring that at least partially surrounds the analyte sensor and the insertion assembly, specifically at least the insertion cannula of the insertion assembly and/or a portion of the insertion cannula retainer of the insertion assembly.

Specifically, the insertion component and analyte sensor can be at least partially housed within the open channel. The insertable portion of the analyte sensor can extend downwards beyond the lower side of the housing within the open channel. Furthermore, the insertable portion of the insertion cannula can extend downwards beyond the lower side of the housing within the open channel. The insertion cannula retainer can, as appropriate, at least partially surround the open channel. Therefore, the insertion cannula retainer can, as appropriate, at least partially protrude into the open channel, specifically from the upper side of the connector unit. The insertion cannula retainer can be at least partially housed within the open channel. Depending on the situation, the insertion cannula retainer can extend downwards beyond the lower side of the housing within the open channel, specifically when the insertion cannula retainer is connected to a removable sterile cap. Further details are given below.

An insertion cannula retainer may be at least partially disposed on the upper side of the housing. The insertion cannula retainer may be configured to seal the upper opening of the open channel. A removable sterile cap may be at least partially disposed on the lower side of the housing. The removable sterile cap may be configured to seal the lower opening of the open channel. The insertion cannula retainer can seal the upper opening of the open channel, and the removable sterile cap can seal the lower opening of the open channel.

As outlined above, the casing further includes an electronic compartment that houses the electronic units.

As used herein, the term "compartment" is a broad term and should be given its common and conventional meaning by those skilled in the art, without limitation to a specific or customized meaning. Specifically, the term refers to any sub-section of a higher-level component that creates a partially or completely enclosed space for accommodating and/or storing objects. Specifically, the sub-section may be completely or at least substantially enclosed, such that the interior of the compartment is isolated from the surrounding environment. Exemplarily, the compartment may be separated from other parts of the higher-level component by one or more walls. Thus, a continuous analyte monitoring device may include two or more compartments that are completely or partially separated from each other by one or more walls of the continuous analyte monitoring device. Each compartment may contain a continuous space or cavity configured to accommodate one or more objects.

As used herein, the term "electronics compartment" is a broad term and should be given its common and conventional meaning to those skilled in the art, without being limited to a specific or customized meaning. Specifically, the term refers to any compartment configured to house components or combinations of components for implementing electrical or electronic purposes. Electronic units can be positioned, specifically fixedly positioned, within the electronic compartment of a housing.

As used herein, the term "electronics unit" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation to any particular or customized meaning. Specifically, the term refers to any device configured to perform at least one electronic function. Specifically, an electronic unit may have at least one electronic component. Specifically, an electronic unit may include at least one electronic component for performing one or more of the following: measuring using an analyte sensor, measuring voltage, measuring current, recording sensor signals, storing measurement signals or measurement data, or transmitting sensor signals or measurement data to another device. An electronic unit may specifically be embodied as or may include a transmitter for transmitting data. Other embodiments of the electronic components are also possible. Such electronic components are generally known in the art of long-term monitoring of one or more analytes, as can be found in one or more of the aforementioned prior art documents.

An electronic unit may include at least one circuit carrier, preferably a printed circuit board, and more preferably a flexible printed circuit board. As used herein, the term "circuit carrier" is a broad term and should be given its common and customary meaning to those skilled in the art, without limitation to any specific or customized meaning. Specifically, the term refers to an element or combination of elements capable of carrying one or more electronic components and interconnecting such one or more electronic components, such as electrically or electronically interconnecting the one or more electronic components with each other and/or interconnecting with one or more contact pads. As an example, a circuit carrier may include a substrate and one or more traces and/or one or more electrical contact pads disposed thereon and/or therein. As an example, the substrate can be a flat element that extends laterally to at least 10 times, more preferably at least 100 times, or even 1000 times its width. Other embodiments are also possible. The rigid material that can be used for the substrate can 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 can be used. Specifically, the substrate can be a flexible substrate, such that the circuit carrier can be wholly or partially embodied as a flexible printed circuit board. In this case, as an example, the flexible substrate can be wholly or partially made of one or more flexible plastic materials (such as one or more plastic foils or laminates, such as polyimide).

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 may 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 may 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. As an example, an electronic component may include a dedicated integrated circuit (ASIC).

The electronic component can be directly or indirectly attached to the circuit carrier. The circuit carrier can be a printed circuit board, specifically a flexible printed circuit board. As an example, the electronic component 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, to which corresponding contacts of the electronic component are electrically connected. However, alternatively, the electronic component can be indirectly attached to the circuit carrier, such as via an electronic housing. Thus, the electronic housing can be attached to the circuit carrier. However, an electrical contact can be formed between the electronic component and the circuit carrier, such as through a contact that passes through the electronic housing. The electronic housing can completely or partially enclose the electronic component. As an example, the electronic casing may include a lower electronic casing component attached to a circuit carrier, wherein an electronic device is inserted into the lower electronic casing component on the side opposite the circuit carrier. The electronic casing may further include another electronic casing component, such as an upper electronic casing component, which, when combined with the lower electronic casing component, can form a package that completely or partially surrounds the electronic component. However, alternatively, other types of packaging for the electronic component may be used, such as packaging using one or more casting and/or potting compounds. Therefore, as an example, a lower electronic enclosure component can be used to house electronic components, wherein the upper enclosure or protection above the electronic components is formed by casting and/or potting, such as by using one or more of epoxy resins, thermoplastic polymers, and more precisely, silicone resins and epoxy resins. Alternatively, an electronic enclosure component may not be used at all, such as by placing the electronic components directly onto the circuit carrier.

Specifically, an electronic unit may include an energy storage device, specifically a battery. As used herein, the term "battery" is a broad term and should be given its common and conventional meaning by those familiar with the technology, without being limited to a specific or customized meaning. The term specifically refers to any power source comprising one or more electrochemical battery cells, having external connections for supplying power to electrical devices. When the battery supplies power, its positive terminal may be called the cathode, and its negative terminal may be called the anode. A battery may specifically be a primary battery. A primary battery can be configured for single use. A primary battery may also be referred to as a single-use or disposable battery.

As outlined above, the casing is formed at least partially by a lower casing portion and an upper casing portion. The terms "lower casing portion" and "upper casing portion" can be considered as descriptions without specifying an order and without excluding the possibility of using several lower casing portions and upper casing portions. The upper casing portion and the lower casing portion can form a package for an electronic component used in an electronic unit. The upper casing portion and the lower casing portion can be connected to each other via at least one type of connection. More details are given below.

Specifically, the outer shell portion can refer to the distal housing portion of the shell. As used herein, the term "distal housing portion" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation to any specific or customized meaning. The term can specifically refer to, but is not limited to, the location of a portion of the shell furthest from and/or away from the user's skin. For example, the shell may be in contact with the user's skin for insertion of an analyte sensor. The distal housing portion can refer to the portion of the shell that is furthest from the user's skin.

Specifically, the lower housing portion can refer to the proximal housing portion of the housing. As used herein, the term "proximal housing portion" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation to any specific or customized meaning. The term can specifically refer to, but is not limited to, the location of the housing portion of the housing relative to and/or facing the user's skin. For example, the housing may be in contact with the user's skin for inserting an analyte sensor. The proximal housing portion can refer to the housing portion that is very close to or even directly in contact with the user's skin.

The housing may further include a connector unit that includes an open channel within the housing. As used herein, the term "connector unit" is a broad term and should be given its common and customary meaning to those skilled in the art, without limitation to any particular or customized meaning. Specifically, the term refers to any device configured to connect one object to another. Specifically, the connector unit may be configured to connect a sterile compartment to an electronic compartment. Specifically, the connector unit may have a channel through which an analyte sensor can pass. The channel may also be referred to as an opening. The analyte sensor may be partially housed within the sterile compartment, specifically within the open channel, and partially housed within the electronic compartment. More specifically, the analyte sensor can be partially housed in a sterile compartment, specifically within an open channel, partially within a connector unit channel, and partially within an electronic compartment. The channel can specifically be a sealed channel. The term "sealed" generally refers to the property of any component being completely or at least largely isolated from its surrounding environment. Specifically, the channel can be sealed with a sealing material. Further details are given below.

The open channel can be isolated and sealed from the electronic compartment by its walls. The walls of the open channel can be formed by connector units. Specifically, the connector unit can have connector unit walls, extending either in the insertion direction of the analyte sensor or laterally, specifically perpendicular to the longitudinal side of the housing. The connector unit walls can have a first side and an opposing second side. The first side can form the wall of the open channel. The first side can face the interior space of the open channel. Furthermore, the second side can face the interior space of the electronic compartment. The connector unit walls can be manufactured as a single piece, or they can be made from two or more components that can be arranged adjacent to each other and/or overlap each other. Two or more components can be assembled and, as appropriate, bonded together, for example, with sealing materials and/or with another bonding material such as glue.

A connector unit may have an upper connector unit side and a lower connector unit side. An open channel allows connection between the upper and lower connector unit sides. The terms "upper connector unit side" and "lower connector unit side" are considered to be descriptions without specifying an order and do not preclude the possibility of using several upper and lower connector unit sides. The upper and lower connector unit sides of the connector unit may each have substantially flat surfaces.

Specifically, "distal connector unit side" can refer to the distal connector unit side of the connector unit. As used herein, the term "distal connector unit side" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation to any specific or customized meaning. The term can specifically refer to, but is not limited to, the location of the connector unit side relative to the user's skin furthest away from the user's skin. For example, to insert an analyte sensor, the connector unit may be in contact with the user's skin. The distal connector unit side can refer to the side furthest from the user's skin.

Specifically, the "proximal connector unit side" can refer to the proximal side of the connector unit. As used herein, the term "proximal connector unit side" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation to any specific or customized meaning. Specifically, the term can refer to, but is not limited to, the location of the connector unit relative to the user's skin. For example, to insert an analyte sensor, the connector unit may be in contact with the user's skin. The proximal connector unit side can refer to the side that is very close to or even directly in contact with the user's skin.

Open channels and channels can be arranged horizontally to each other, or more specifically, substantially perpendicularly to each other. Channels can be formed by holes or cutouts within the connector unit, specifically within the wall of the connector unit. The channel itself can be implemented as a substantially straight channel. For definitions of the terms "channel" and "straight," please refer to the description above.

The analyte sensor may include a proximal intravitreal portion and a distal ex vivo portion. The proximal intravitreal portion may correspond to the insertable portion of the analyte sensor as described above. The proximal intravitreal portion may be configured for insertion into the user's body tissue. The distal ex vivo portion may be configured to remain outside the user's body tissue. The distal ex vivo portion and the proximal intravitreal portion may be arranged laterally to each other, specifically substantially perpendicular to each other. The proximal intravitreal portion may extend along the insertion direction. The distal ex vivo portion may include a first section housed in a channel and a second section housed in an electronic compartment. An electronic unit may be electrically connected to the analyte sensor. Therefore, specifically, the second segment of the detached distal portion can be electrically connected to the electronic components of the electronic unit.

Specifically, the first and second segments of the distal portion can be arranged substantially along a straight line. Alternatively, the distal portions of the first and second segments can be arranged at angles of 5° to 90°, specifically 20° to 80°, and more specifically 40° to 70° relative to each other. Specifically, the first and second segments of the distal portion can include a bend at angles of 5° to 90°, specifically 20° to 80°, and more specifically 40° to 70° relative to each other. Specifically, the bend can be arranged in a plane parallel to the side of the base plate that can be attached to the skin. This improves the positioning and stability of the analyte sensor within the connector unit and/or in the electronic compartment.

The connector unit can specifically form an intermediate component. As used herein, the term "intermediate component" is a broad term and should be given its common and customary meaning to those skilled in the art, without limitation any specific or customized meaning. The term can specifically refer to, but is not limited to, any component or compartment between at least two other compartments and/or any component or compartment located within another compartment. Thus, the intermediate component can form part of the sensor compartment and can be sealed to the electronic compartment. The intermediate component can be or may include an intermediate compartment and/or (as an example) a sealing ring or annular element. Specifically, the electronic compartment can at least partially surround the intermediate component. The intermediate component may be designed at least partially as a cylindrical ring that at least partially surrounds the analyte sensor and/or the insertion component. The removable sterile cap and the insertion cannula retainer may be separated by the intermediate component, and both may be removably connected to the intermediate component.

A connector unit may specifically comprise a lower part and an upper part. The lower part and the upper part may be combined to form the connector unit. For example, one or both of the lower part and the upper part may be or may include a sealing ring or annular element. The terms "upper part" and "lower part" may be considered as descriptions that do not specify an order and do not exclude the possibility of applying several upper and lower parts.

Specifically, the upper part can refer to the distal portion of the connector unit. As used herein, the term "distal part" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation to any specific or customized meaning. The term can specifically refer to, but is not limited to, the location of a portion of the connector unit relative to the user's skin furthest away from the user's skin. For example, to insert an analyte sensor, the connector unit may be in contact with the user's skin. The distal part can refer to a portion of the skin that is distant from the user's skin or away from the skin.

Specifically, the lower part can refer to the proximal portion of the connector unit. As used herein, the term "proximal part" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation any specific or customized meaning. The term can specifically refer to, but is not limited to, the location of the portion closest to the user's skin. For example, this portion may be in contact with the user's skin for inserting an analyzer sensor. The proximal part can refer to the portion very close to or even directly in contact with the user's skin or facing the skin.

The upper section of the open channel can be formed by the upper part of the connector unit, and the lower section of the open channel can be formed by the lower part of the connector unit. In addition, the wall of the open channel can be formed at least partially by the lower part of the connector unit and by the upper part of the connector unit.

The housing may include a base plate configured for attachment to a user's skin, specifically via at least one adhesive. Additionally, the housing may include a top plate. The base plate and top plate are configured to form at least portions of the longitudinal side of an electronic compartment. Specifically, the base plate may include a lower surface configured for placement on the user's skin. The lower surface may, exemplarily, have a ring shape surrounding an analyte sensor. Specifically, the base plate may include an adhesive surface for attachment to the user's skin. As used herein, the term "adhesive surface" is a broad term and should be given its common and customary meaning to those skilled in the art, without limitation to any specific or customized meaning. This term specifically refers to a surface capable of bonding to an object and resisting separation. In illustrative terms, an adhesive surface may comprise an adhesive paste or tape. The paste or tape may contain an adhesive material. The adhesive surface may be directly or indirectly attached to a housing.

The lower portion of the connector unit and the base plate can be formed as a single unit. The lower portion of the connector unit and the base plate can be permanently built into each other or can be manufactured as a single unit. Therefore, specifically, the lower portion of the connector unit can be formed by a wall, specifically by at least a portion of a circumferential wall protruding from the base plate.

The upper portion and the upper plate of the connector unit can be formed as a single unit. The upper portion and the upper plate of the connector unit can be permanently built into each other or can be manufactured as a single unit. Therefore, specifically, the upper portion of the connector unit can be formed by a wall, specifically by at least a portion of a circumferential wall protruding from the upper plate.

However, other embodiments are also possible. Therefore, specifically, the lower portion and base plate of the connector unit can be a single unit, and the upper plate and upper portion of the connector unit can be separate components. Alternatively, the upper portion and upper plate of the connector unit can be a single unit, and the base plate and upper portion of the connector unit can be separate components. Alternatively, the upper portion, lower portion, upper plate, and base plate of the connector unit can each be separate components.

As outlined above, the base plate and top plate can be configured to form at least a portion of the longitudinal side of the electronic compartment. Specifically, the base plate and top plate can be combined to form a package for the electronic unit. Specifically, the electronic compartment can be formed by the base plate, top plate, and connector unit. The longitudinal side of the electronic compartment can be formed by the base plate and top plate, and may also be formed by the longitudinal side of the connector unit, specifically the longitudinal side of the upper and/or lower portion of the connector unit. The lower side of the housing can be formed by the base plate, and may also be formed by the lower connector unit side of the connector unit. The adhesive surface can specifically be the surface of the base plate, and may also be the surface of the connector unit. The upper side of the housing can be formed by the upper plate, and depending on the situation, it can also be formed by the upper connector unit side of the connector unit.

Specifically, the lower connector unit side of the connector unit can be substantially flush with the lower side of the base plate. Therefore, the lower side of the base plate and the lower connector unit side of the connector unit can form a substantially flat surface. Depending on the situation, the upper connector unit side of the connector unit can be substantially flush with the upper side of the upper plate. Therefore, the upper connector unit side of the connector unit and the upper side of the upper plate can form a substantially flat surface.

Furthermore, the shorter side of the electronic compartment facing the external environment of the continuous analyte monitoring device may be formed at least partially by a base plate and/or a top plate.

As outlined above, a removable sterile cap, an open channel, and an insertion cannula retainer form a sterile compartment for inserting at least the insertable portion of the cannula and analyte sensor. Therefore, at least the insertable portion of the cannula and analyte sensor can be housed within the sterile compartment. The sterile compartment may also be referred to as a sensor compartment.

A sterile compartment can be a sealed compartment. As used herein, the term "sealed compartment" is a broad term and should be given its common and customary meaning to those skilled in the art, without limitation to a specific or customized meaning. Specifically, the term can refer to, but is not limited to, a compartment that is isolated from its surrounding environment, thereby completely or at least substantially reducing the transfer of gases, fluids, and/or solid elements. As used herein, the term "sterile compartment" is a broad term and should be given its common and customary meaning to those skilled in the art, without limitation to a specific or customized meaning. Specifically, the term can refer to, but is not limited to, any compartment configured to provide sterile packaging for objects contained within it. As used herein, the term "sterile" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation to any specific or tailored meaning. Specifically, the term may refer to, but is not limited to, any object that is at least substantially free of all forms of living and/or other biological agents (such as prions, viruses, fungi, bacteria, or spores) and is largely immune to the intrusion of liquids, moisture, and dust. Therefore, sterile objects can be treated by aseptic processes that eliminate and/or inactivate various forms of living and/or other biological agents. Sterilization processes may include one or more of the following techniques: heating, chemical treatment (including treatment by gas), irradiation, high pressure, and filtration. However, other techniques may also be feasible. Aseptic processes can be performed within specific areas or regions of an object (such as the surface of the object). Specifically, sterilization can be performed using known gases such as ethylene oxide (EtO) or vaporized hydrogen peroxide.

Embodiments of medical analytical substance sensor devices comprising an analyte sensor, a cannula, a cannula retainer, a sterile cap in a sterile compartment, and an insertion aid are disclosed in EP3202324A1, EP3727130A1, EP3988014A1, and EP3202323A1, which are incorporated herein by reference.

The removable sterile cap and/or insertion cannula retainer can be reversibly or irreversibly connected to the housing (specifically, to the connector unit) and/or to each other.

As outlined above, the housing may include an upper and a lower side, and the opening channel may connect the upper and lower sides. A removable sterile cap may be at least partially positioned on the lower side of the housing, specifically the connector unit, and at least a portion of the insertion cannula retainer may extend from the upper side of the housing, specifically the connector unit. The insertion cannula retainer and the removable sterile cap may be removably connected to the housing, specifically the connector unit, and more specifically, on opposite sides of the housing, specifically the connector unit, and more specifically, the opening channel. The insertion cannula retainer may seal the upper opening of the opening channel, and the removable sterile cap may seal the lower opening of the opening channel.

Specifically, a removable sterile cap may be at least partially disposed on the underside of the connector unit of the housing. The removable sterile cap may be removably connected to, and specifically attached to, the underside of the connector unit of the housing. Furthermore, additionally or alternatively, the removable sterile cap and the insertion cannula retainer may be reversibly or irreversibly connected to each other. The removable sterile cap may be configured for removal before the insertable portion of the analyte sensor is inserted into body tissue.

An insertion cannula retainer may be at least partially disposed on the upper side of the housing, specifically the connector unit, and may additionally be at least partially positioned within the open channel. The insertion cannula retainer may be removably connected to, specifically attached to, the upper side of the housing, specifically the connector unit. Furthermore, the insertion cannula retainer may be configured to close and/or seal the upper opening of the open channel. Optionally, the insertion cannula retainer may extend through the lower opening of the open channel, specifically to establish a connection with a removable sterile cap. Specifically, the insertion cannula retainer may be at least partially housed within the open channel. The insertion cannula retainer may be configured for removal after the insertable portion of the analyte sensor has been inserted into body tissue.

Specifically, the insertion cannula retainer can form a removable cover, specifically a removable top cover. The insertion cannula retainer can be configured for use on the end of the opening of the housing, specifically the connector unit, specifically the upper opening of the opening.

Therefore, a removable sterile cap can also be called a removable lower cap, and an insertion cannula retainer can also be called a removable upper cap. The terms "upper cap" and "lower cap" can be considered as descriptions without specifying an order and without excluding the possibility of applying several different names for upper and lower caps. The removable lower cap and removable upper cap can be arranged at least partially on or at least partially located on the opposite side of the connector unit's, specifically the open channel.

The insertion cannula retainer can be removably connected to the housing, specifically to the connector unit, specifically to the surface of the housing and the connector unit, and/or to a removable sterile cap via a connection (specifically, at least one of a screw connection and a bayonet connection). The removable sterile cap can be removably connected to the housing, specifically to the connector unit, specifically to the surface of the housing and the connector unit, and/or to the insertion cannula retainer via a connection (specifically, at least one of a press-fit connection, a form-fit connection, a screw connection, a magnetic connection, or a bayonet connection). Specifically, the insertion cannula retainer can be reversibly or irreversibly connected to the upper surface of the housing and the connector unit, and/or to the removable sterile cap. Specifically, the removable sterile cap can be reversibly or irreversibly connected to the underside surface of the housing, specifically the connector unit, and/or to the insertion cannula retainer.

Specifically, the removable sterile cap can be configured to be pulled off from the housing, specifically from the connector unit, and/or from the insertion cannula retainer. Furthermore, specifically, the insertion cannula retainer can be configured to be pulled off from the housing, specifically from the connector unit, and/or from the removable sterile cap. Therefore, the removable sterile cap and/or insertion cannula retainer can overlap with the housing, specifically with the connector unit, or vice versa during connection with the housing, specifically with the connector unit. Additionally or alternatively, the removable sterile cap can overlap with the insertion cannula retainer, or vice versa. The housing, specifically the connector unit, may include a guide surface for guiding the removable sterile cap or inserting the cannula retainer during the pulling down of the removable sterile cap or the insertion of the cannula retainer. Additionally or alternatively, the removable sterile cap may include a guide surface for guiding the insertion of the cannula retainer during the pulling down of the removable sterile cap, or vice versa. Therefore, the insertion cannula retainer may include a guide surface for guiding the removable sterile cap during the pulling down of the removable sterile cap from the insertion cannula retainer.

Furthermore, specifically, the insertion cannula retainer can be removably connected to the housing, and specifically to the connector unit, at an upper predetermined break point, and/or the removable sterile cap can be removably connected to the housing, and specifically to the connector unit, at a lower predetermined break point. As used further herein, the term "predetermined breaking point" can refer to any portion of the element configured to break under mechanical load while the rest of the element remains undamaged. Specifically, the predetermined break point can include a notch, wherein the thickness of the element can be smaller compared to the rest of the element. The upper predetermined break point and/or the lower predetermined break point can specifically be annular break points. The terms "upper fracture point" and "lower fracture point" can be considered as descriptions that do not specify an order and do not exclude the possibility that several upper fracture points and lower fracture points may be applied.

At least one of the removable sterile cap and the insertion cannula retainer may contain a moisture-absorbing material, preferably a desiccant, and more preferably activated carbon.

As outlined above, the housing includes a sealed channel that includes an inlet fill port and an outlet fill port.

As used herein, the term "sealed channel" is a broad term and should be given its common and conventional meaning to those of ordinary skill in the art, without being limited to a specific or customized meaning. Specifically, the term refers to any element that may have an elongated shape and can be configured for filling with a sealing material into a free volume or cavity.

The sealing channel may be partially formed by the lower housing portion and partially formed by the upper housing portion. Exemplarily, the sealing channel may be partially formed by a groove within the lower housing portion (specifically, within the surface of the lower housing portion) and/or by a groove within the upper housing portion (specifically, within the surface of the upper housing portion). The groove within the lower housing portion and/or the groove within the upper housing portion may specifically have a shape selected from the group consisting of: a semi-circular shape; a semi-oval shape; a polygonal shape; a trapezoidal shape; and specifically a rectangular shape. However, other shapes are also possible. Exemplarily, the sealing channel may be partially formed by a groove within the lower housing portion and by a groove within the upper housing portion. Furthermore, exemplarily, the sealing channel may be partially formed by a groove within the lower housing portion and by a flat surface of the upper housing portion. Furthermore, by way of example, the sealing channel may be formed in part by a groove within the upper housing portion and by a flat surface of the lower housing portion. Other embodiments may also be possible.

The grooves within the lower housing portion and/or within the upper housing portion may each form at least one open channel. As used herein, the term "open channel" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation to any specific or customized meaning. Specifically, the term refers to a groove or channel that cuts into the surface of a solid material, and more specifically, into a smooth surface of a solid material. The upper housing portion may form a cover for the grooves within the lower housing portion, and vice versa. Therefore, the lower housing portion may form a cover for the grooves within the upper housing portion. As used herein, the term "cover" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation to any particular or customized meaning. Specifically, the term refers to any element having a surface configured to be attachable to another element. Thus, the shape of the cover surface and the shape of another surface of the element can be at least partially complementary to each other. Exemplarily, the cover surface and the other surface of the element can be at least partially implemented as flat surfaces, such that a tight connection can be formed between the two surfaces. The lower and upper shell portions, specifically the grooves within the lower and upper shell portions, or the grooves within the lower shell portion and the covering of the upper shell portion, or the grooves within the upper shell portion and the covering of the lower shell portion, can overlap at an angle. Therefore, when the lower and upper shell portions are assembled, specifically pressed together, tolerance gaps can be compensated.

A sealing channel can specifically be a sealing channel that is at least partially circumferential. Specifically, a sealing channel can be a circumferential sealing channel. As used herein, the term "circumferential channel" is a broad term and should be given its common and customary meaning to those skilled in the art, without limitation to a specific or customized meaning. The term specifically refers to any channel that can surround an object or a portion of an object in at least two dimensions. A sealing channel can specifically be implemented as a closed channel, for example, as a channel without ends. Sealing material can be filled into the sealing channel through an inlet filling port. Further details are given below. A sealing channel can be at least partially formed as a torus. Specifically, in a top view of a sealing channel, a sealing channel can be formed as a ring. In a top view of the grooves within the upper housing portion and/or the lower housing portion, the grooves may have an annular, specifically circular, shape. Exemplarily, the sealing channel (specifically, the cross-sectional area of the sealing channel, and more specifically, the cross-sectional area of the sealing channel in the direction of its extension) may have an average diameter or width of 0.1 mm to 5 mm, specifically 0.2 mm to 2 mm, and more specifically 0.4 mm to 1.6 mm. However, other dimensions may also be possible.

At least one of the following may be constant along the sealing channel: the width of the cavity of the sealing channel; the shape of the sealing channel, specifically the shape of its cross-section; and the size of the sealing channel, specifically the size of its cross-section. Alternatively, at least one of the following may vary along the sealing channel: the width of the cavity of the sealing channel; the shape of the sealing channel, specifically the shape of its cross-section; and the size of the sealing channel, specifically the size of its cross-section. A change in the width of the cavity of the sealing channel may specifically refer to a change in the cross-sectional area of the sealing channel in the direction of its extension. For example, the cross-sectional area of the sealing channel in the direction of extension of the sealing channel may have an elliptical basic shape, and at least one of the dimensions of the main shaft and the secondary shaft may vary along the sealing channel.

At least one of the following may be larger in the region near the sealing channel intersecting with the channel than in the region away from the sealing channel intersecting with the channel: the width of the inner cavity of the sealing channel; the dimensions of the sealing channel, specifically the dimensions of its cross-section; the cross-sectional area of the sealing channel, specifically the cross-sectional area of the sealing channel in the direction of its extension. Specifically, at least one of the following may decrease as the cross-section of the sealing channel is further from the channel, specifically continuously decreasing: the width of the inner cavity of the sealing channel; the dimensions of the sealing channel, specifically the dimensions of its cross-section; the cross-sectional area of the sealing channel, specifically the cross-sectional area of the sealing channel in the direction of its extension.

Specifically, the sealing channel can be divided into a first arm and a second arm by means of an input filling port and an output filling port. The first arm may intersect with the channel. At least one of the following may be larger in the first arm than in the second arm: the width of the cavity of the sealing channel; the size of the sealing channel, specifically the cross-sectional size of the sealing channel; the cross-sectional area of the sealing channel, specifically the cross-sectional area of the sealing channel in the direction of extension of the sealing channel. More specifically, at least one of the following may be larger in the first arm than in the second arm: the average width of the cavity of the sealing channel; the average size of the sealing channel, specifically the average cross-sectional size of the sealing channel; the average cross-sectional area of the sealing channel, specifically the average cross-sectional area of the sealing channel in the direction of extension of the sealing channel.

At the intersection of the channel and the sealed channel, the analyte sensor may impose increased mechanical resistance on the flow of the sealing material, specifically when the sealing material fills the sealed channel and/or passage. To prevent the sealing material from flowing only along the arm of the sealed channel in areas away from it, the cavity of the sealed channel can be enlarged to balance the difference in flow resistance. Thus, the invention can be accompanied by the remarkable advantage of improved filling of the sealed channel and/or passage with sealing material. This, in turn, improves the seal on the analyte sensor as it passes from the sterile compartment through the open channel into the electronic compartment.

As outlined above, a sealed channel includes an inlet fill port and an outlet fill port. As used herein, the term "port" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation to any specific or customized meaning. Specifically, the term refers to any unit that can be configured to connect two or more elements to each other, allowing the transfer of a fluid or solid medium from one element to another. Specifically, a port can be part of a channel or can form a channel including at least one opening that allows a fluid or solid medium to enter or leave the element and/or allows a fluid connection to be established between two elements. Specifically, a port can be a sealed port configured to at least substantially prevent leakage of a solid or fluid medium.

The input fill port can be configured to fill the sealing channel with sealing material. The output fill port can be configured to allow leakage of sealing material, specifically, to allow excess sealing material to leak from the sealing channel. The leakage of sealing material from the sealing channel through the output fill port can be considered a desired leakage. Optionally, the housing can further include a cavity disposed between the sealing channel and the output fill port. Specifically, the cavity can be fluidly disposed between the sealing channel and the output fill port. The cavity can have free volume. The cavity can be configured to collect sealing material, specifically excess sealing material from the sealing channel. Specifically, by using cavities, and depending on the shape of the sealing channels, the flow front velocity can be synchronized for different distances, allowing air to completely or at least largely exit the sealed channels (and, depending on the channels). Specifically, by using cavities, and depending on the shape of the sealing channels, the flow front velocity can be synchronized, causing the sealing material in all sealed channels to simultaneously converge into the cavity, preventing one flow front from intruding into another sealed channel and eliminating the possibility of air stagnation within the channels. The flow front can push the air in front of it, specifically preventing the formation of bubbles in and/or within the sealed channels.

The input and/or output filling ports can be configured as channels for fluid connection to a sealed channel. The input and/or output filling ports can be arranged laterally, specifically perpendicular to the sealed channel, specifically in a top view of the sealed channel. The input and/or output filling ports and sealed channel can extend along a plane along the extension direction of the housing. Alternatively, the input and/or output filling ports can extend laterally, specifically perpendicular to the plane along which the sealed channel extends. The input and/or output filling ports can enter from the external environment of the continuous analyte monitoring device or from the external environment of the connector unit.

The input and output fill ports can be arranged a distance apart from each other. The input fill ports can be different from the output fill ports. Specifically, the input and output fill ports can be arranged opposite to each other, specifically in the top view of the sealed channel. Specifically, the sealed channel can be divided into a first half and a second half by the input and output fill ports. The first half and the second half can be substantially equivalent.

Specifically, the sealing channel can be configured to be filled with sealing material in the assembled state of the lower and upper shell portions. In the assembled state of the lower and upper shell portions, the sealing channel can be formed by grooves in the lower shell portion and/or by grooves in the upper shell portion. Further details in this regard are given above. In the assembled state of the lower and upper shell portions, sealing material can be filled into the sealing channel through the filling inlet port. The attachment of the lower and upper shell portions to each other can be achieved by filling the sealing channel with sealing material. Conversely, in current continuous glucose monitoring devices, the connection between shell portions is typically achieved using adhesive filled in grooves. When the adhesive is applied, air bubbles may form in the adhesive, and/or when the upper shell portion is not precisely placed vertically on the lower shell portion. The shell portion may be mounted from above, and air may be displaced and must escape through vents.

Filling a sealing channel with a sealing material can be accomplished using known methods and tools, such as an electric pump coupled to a tubing or syringe that injects the sealing material into the inlet filling port of the sealing channel. In another embodiment, the sealing material is injected into the inlet filling port of the sealing channel while a negative pressure is applied to the outlet filling port, for example, by a pump with a tubing syringe, wherein the negative pressure causes the sealing material to flow through the sealing channel.

The shell can be at least partially formed as a ring, specifically a cylindrical ring. The electronic compartment can be sealed to the external environment by encapsulation of the upper and lower shell portions. The upper and lower shell portions can be connected to each other at at least two different locations. Specifically, the electronic compartment can be sealed to the external environment at at least two different locations. Specifically, the first location corresponds to the seal between the electronic compartment and the sterile compartment, specifically with the open passage. Furthermore, specifically, the second location corresponds to the seal between the electronic compartment and the external environment of the continuous analyte monitoring device.

Specifically, the sealing channel can be a circumferentially sealed channel, which can isolate and seal the electronic compartment from the sterile compartment. The sealing channel can be an open channel surrounding, specifically circumferentially, the enclosure. The sealing channel can be located within the wall separating the electronic compartment from the sterile compartment. The sealing channel can be arranged between the sterile compartment (specifically the open channel) and the electronic compartment.

Furthermore, the sealing channel can be a circumferentially sealed channel, and the sealing channel can seal the electronic compartment from the external environment of the continuous analyte monitoring device. The sealing channel can surround, specifically circumferentially surround, the electronic unit housed in the housing. The sealing channel can be located in a wall separating the electronic compartment from the external environment of the continuous analyte monitoring device.

Specifically, the housing may include two sealing channels. The two sealing channels may include an inner circumferential sealing channel and an outer circumferential sealing channel. The inner circumferential sealing channel may have a smaller diameter than the outer circumferential sealing channel.

The inner circumferential sealing channel can isolate and seal the electronic compartment from the sterile compartment. The inner circumferential sealing channel can be an open channel surrounding, specifically, the entire casing. The inner circumferential sealing channel can be located within the wall separating the electronic compartment from the sterile compartment. The inner circumferential sealing channel can be arranged between the sterile compartment (specifically, the open channel) and the electronic compartment.

The outer circumferential sealing channel seals the electronic compartment from the external environment of the continuous analyte monitoring device. Specifically, the outer circumferential sealing channel can surround, or more precisely, circumferentially surround, the electronic unit housed within the housing. The outer circumferential sealing channel can be located within a wall separating the electronic compartment from the external environment of the continuous analyte monitoring device.

Specifically, the outer circumferential sealing channel and the inner circumferential sealing channel can be implemented independently of each other. Specifically, each of the inner circumferential sealing channel and the outer circumferential sealing channel can respectively include an input filling port and an output filling port.

Furthermore, specifically, the inner circumferential sealing channel and the outer circumferential sealing channel, as well as the inner circumferential sealing channel, can be connected to each other, specifically via a connecting channel. The connecting channel can be configured to connect the fluids of the inner and outer circumferential sealing channels. Sealing material can be transferred from one of the inner and outer circumferential sealing channels to the other, and vice versa, via the connecting channel. The connecting channel can be implemented as a substantially straight channel. Specifically, the connecting channel can be formed within the lower housing portion, specifically within the base plate. Specifically, the connecting channel can be formed as a groove within the lower housing portion. The groove can be located on the side of the lower housing portion facing the electronic compartment. The groove can be covered with a covering material to form the connecting channel. Specifically, in the case of connection channels, the housing can have one input filling port and two output filling ports. Specifically, the input filling port can be located at the outer circumferential sealing channel. The input filling port can be fluidly connected to the outer circumferential sealing channel. Furthermore, specifically, one of the two output filling ports can be located at the outer circumferential sealing channel, and the other of the two output filling ports can be located at the inner circumferential sealing channel. Specifically, one of the two output filling ports can be fluidly connected to the outer circumferential sealing channel, and the other of the two output filling ports can be fluidly connected to the inner circumferential sealing channel. As summarized above, in current continuous glucose monitoring devices, the connection between housing parts is typically achieved using an adhesive filled within grooves. When adhesive is applied, bubbles may form within it, and/or may form if the upper shell portion is not precisely placed vertically onto the lower shell portion. In current continuous glucose monitoring devices, adhesive is typically applied in both the inner and outer circumferential sealing channels. By establishing a connection between one inlet filling port and two outlet filling ports, the entire injection process can be completed through the inlet filling port. Therefore, the current adhesive handling can be reduced by adding an additional step of applying adhesive in the inner circumferential sealing channel. The established connection can reduce processing costs and processing time.

As outlined above, the housing may include a connector unit that includes an open channel within the housing. The connector unit may be formed by a lower portion and an upper portion of the connector unit. Specifically, the lower housing portion may be the lower portion of the connector unit, and the upper housing portion may be the upper portion of the connector unit. Specifically, the sealing channel may be a circumferential sealing channel, and the sealing channel may isolate and seal the electronic compartment from the sterile compartment. The sealing channel may be partially formed by the lower portion of the connector unit and may be partially formed by the upper portion of the connector unit. Exemplarily, the sealing channel may be partially formed by a groove within the lower portion (specifically within the surface of the lower portion) and/or by a groove within the upper portion (specifically within the surface of the upper portion). The sealing channel may be located between the lower portion and the upper portion of the connector unit. The sealed channel can be an open channel that surrounds, specifically, circumferentially surrounds, the housing. The sealed channel can be located in the wall separating the electronic compartment from the sterile compartment. The sealed channel can be arranged between the sterile compartment (specifically the open channel) and the electronic compartment.

Furthermore, as outlined above, the connector unit may have a channel through which the analyte sensor can pass. Specifically, the analyte sensor may be partially housed in a sterile compartment, partially housed within the channel of the connector unit, and partially housed in an electronic compartment. The channel may have a first end and an opposing second end. The channel may connect the sterile compartment and the electronic compartment via the first and second ends. The channel may be formed as a recess within a lower portion and/or an upper portion. The sealing channel and the channel may extend along the same plane. Specifically, in a top view of the sealing channel, the channel may be arranged laterally within the sealing channel.

Specifically, the channel can intersect with a sealed channel. The channel can be connected to the sealed channel via fluid at the intersection of the channels. Specifically, the channel can intersect with the sealed channel between the first end and the second end of the channel. The sealed channel can be arranged between the first end and the second end of the channel. Specifically, the channel can be configured to be filled with sealing material in the assembled state of the lower and upper parts. Therefore, the channel can also be sealed with sealing material by filling the sealed channel through the input filling port. Specifically, in the assembled and manufactured states of the continuous analyte monitoring device, the channel is at least partially filled, and preferably completely filled, with sealing material.

Furthermore, specifically, the lower housing portion can be a base plate, while the upper housing portion can be a top plate. The sealing channel can seal the electronic compartment from the sterile compartment, or the sealing channel can isolate and seal the electronic compartment from the external environment of the continuous analyte monitoring device.

As outlined above, the sealing material is configured to seal the internal space enclosed by the upper and lower shell portions. Furthermore, the sealing material can be configured to securely attach the lower and upper shell portions to each other. Therefore, on one hand, the sealing material can be configured to attach the upper shell portion to the lower shell portion via material bonding, and vice versa. Specifically, the sealing material can be an adhesive used to attach the upper shell portion to the lower shell portion, and vice versa. Furthermore, on the other hand, the sealing material can form or facilitate the sealing of the internal space enclosed by the upper and lower shell portions. Therefore, due to the sealing material, the internal space enclosed by the upper and lower shell portions can be at least largely isolated from the surrounding environment, specifically reducing the transfer of gaseous, fluid, and/or solid elements completely or at least largely.

The sealing material can be a liquid material, whose viscosity increases or hardens after it has been introduced into the selected channel. Specifically, the sealing material can be selected from the following groups: silicone resins, adhesives, and binders. The binder can specifically be selected from the following groups: acrylic adhesives, epoxy adhesives, polyurethane adhesives, cyanoacrylate adhesives, and solvent-based adhesives. The acrylic adhesive can specifically be a UV adhesive, such as ^Vitralit® . However, other types of sealing materials are also possible.

In another embodiment of the present invention, a continuous analyte monitoring system is disclosed. The continuous analyte monitoring system includes a continuous analyte monitoring device as described above or as will be described in further detail below.

In addition, the continuous analyte monitoring system includes an insertion device that at least partially covers the continuous analyte monitoring device. The insertion device is configured to allow a user to drive an insertion cannula into body tissue and insert the insertable portion of the analyte sensor.

The term "insertion device" as used herein is a broad term and should be given its common and conventional meaning by those familiar with the technology, without being limited to a specific or customized meaning. Specifically, the term refers to any technical construct configured to insert an object into another object. An insertion device may also be called an insertion aid. An insertion device may include an insertion mechanism. As used further herein, the term "mechanism" can refer to any mechanism designed to convert input force and movement into a desired set of output force and movement. Specifically, the insertion mechanism can be configured to allow the user to apply force to the insertion cannula in the insertion direction. Therefore, the insertion device can be configured to facilitate user operation of the continuous analyzer monitoring device and/or reduce application errors. The insertion device may at least partially surround the continuous analyte monitoring device. In addition, the insertion device may at least partially couple to the continuous analyte monitoring device, specifically to at least one of the insertion cannula retainer and the removable sterile cap.

The insertion device may include a removable undercover that is mechanically coupled to a removable sterile cap. As used further herein, the term "cover" can refer to any element that completely or at least substantially closes an object. Specifically, the cover may be or may include an outer shell, particularly a semi-shell, surrounding the housing and/or continuous analyte monitoring device. The removable undercover may be configured such that removal of the removable undercover removes the removable sterile cap. The insertion device may further include a frame. The term "frame" can refer to any element that can be configured to support other components of the physical structure. The frame may be displaceable over the user's skin and may at least partially surround the housing, analyte sensor, insertion cannula, removable sterile cap, insertion cannula retainer, and/or connector unit. The insertion device may further include a cover. The cover may be directly or indirectly coupled to one or both of the insertion cannula or the insertion cannula retainer, such that movement of the cover against the frame actuates the insertion cannula. The terms "lower cover" and "upper cover" may be considered as descriptions without specifying an order and without excluding the possibility of using several lower and upper covers.

The removable undercover may include a base, which is exemplarily connected to the lower portion of the removable sterile cap via a snap-fit connection, adhesive bonding, and/or longitudinal guiding or transfer force. The base may include a gripping surface for removing the removable sterile cap. The base may also be a cover for the adhesive surface. This can result in an extended shelf life of the adhesive surface. By removing the undercover, the removable sterile cap can be opened, exposing the insertion cannula and analyte sensor, and simultaneously exposing the adhesive surface.

The continuous analyte monitoring 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 construct configured to move an object in a direction opposite to the direction in which the object may have been moved before the retraction mechanism was applied. Therefore, the retraction mechanism may include a retraction contact spring element. The retraction contact spring element can be biased to retract the insert cannula from the body tissue. The retraction mechanism may be at least partially contained within an insert cannula holder and/or within an overlay.

The continuous analyte monitoring system may further include: • a sensor controller coupled to the analyte sensor, wherein the sensor controller is configured to receive analyte sensor data from the analyte sensor; and • a remote control configured to receive sensor data from the sensor controller and process and/or display the sensor data.

The sensor controller may specifically include at least one data processing unit, such as a processor. Additionally, 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. This 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 other device).

Sensor controllers can be configured to transmit analyte sensor data to remote controls. As used herein, the term "communication" is a broad term and should be given its common and conventional meaning to those skilled in the art, without limitation to any specific or customized meaning. The term can specifically refer to, but is not limited to, the process of transmitting information. Specifically, information from a computing device can be transmitted, for example, to another device, by sending or outputting information. Specifically, a communication interface can be provided. A communication interface can specifically provide components for transmitting or exchanging information. Specifically, a communication interface can provide data transmission connections, such as Bluetooth, NFC, inductive coupling, etc.

Specifically, a continuous analyzer monitoring device may include a user interface. The term "user interface" as used herein is a broad term and should be given its common and conventional meaning by those familiar with the technology, without being limited to a specific or customized meaning. This term may refer to, but is not limited to, components or devices configured to interact with their environment, such as for the purpose of one-way or two-way information exchange, 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 the user. A user interface may be a feature that interacts with the user's vision, such as a display, or a feature that interacts with the user's hearing. As an example, 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 connection data interface.

In another embodiment of the present invention, a method for assembling a continuous analyte monitoring device as described above or as will be further described in more detail below is disclosed.

The method comprises the method steps as given in the separate request and as listed below. These method steps can be executed in a predetermined order. However, other orders of the method steps are possible. Additionally, one or more method steps can be executed in parallel and/or in overlapping time. Furthermore, one or more method steps can be executed repeatedly. Additionally, other method steps not listed may exist.

The method includes: a) providing a lower housing portion; b) mounting an analyte sensor onto the lower housing portion; c) placing an upper housing portion onto the lower housing portion; d) injecting a sealing material into a sealing channel, specifically under pressure, through an inlet filling port, such that the lower housing portion and the upper housing portion are fixedly attached to each other, and the internal space enclosed by the upper housing portion and the lower housing portion is sealed.

As outlined above, the housing may include a connector unit comprising a lower portion and an upper portion. In the case where the lower housing portion is the lower portion of the connector unit and the upper housing portion is the upper portion of the connector unit, the continuous analyte monitoring device can be manufactured, exemplarily, as follows: the lower portion of the connector unit may, where appropriate, be provided with a base plate of the housing. The analyte sensor may be housed within a channel or within a portion of the channel formed by the lower portion of the connector unit. Subsequently, the upper portion of the connector unit may be positioned on top of the lower portion of the connector unit. In the assembled state of the upper and lower portions of the connector unit, the sealed channels, and, where appropriate, channels where channels intersect, may be filled with sealing material. Furthermore, a removable sterile cap and insert assembly can be installed. Thus, a sterile unit can be formed. The sterile unit may include a connector unit, a removable sterile cap, an insert assembly, and an analyte sensor. The sterile unit can be sterilized. Subsequently, with a base plate housing the lower part of the connector unit, the electronic unit can be mounted on the base plate, and the upper plate can be mounted on the base plate. Optionally, the upper plate can be sealed to the base plate via a separate sealing channel filled with sealing material. Thus, the separate sealing channel can be different from the sealing channel. This separate sealing channel can be fluidly separated from the sealing channel. This separate sealing channel can have a separate inlet filling port and a separate outlet filling port. Alternatively, the upper plate and the base plate can be connected via one or more of a form-fit connection, a press-fit connection, or a combination thereof. Other types of connections are also possible.

Alternatively, if the lower housing portion can be the lower part of the connector unit and the upper housing portion can be the upper part of the connector unit, the continuous analyte monitoring device can be manufactured exemplarily as follows: The lower part of the connector unit can be provided with a base plate of the housing. The analyte sensor can be housed within a channel or within a portion of the channel formed by the lower part of the connector unit. Then, the upper part of the connector unit can be placed on top of the lower part of the connector unit. An electronic unit can be mounted on the base plate and connected to the analyte sensor. The upper plate of the housing can be placed on top of the base plate of the housing. The continuous analyte monitoring device can include an inner circumferentially sealed channel and an outer circumferentially sealed channel. In the assembled state of the upper and lower parts of the connector unit, and the bottom and upper plates of the housing, the inner and outer circumferential sealing channels can be filled with sealing material. Additionally, a removable sterile cap and insert assembly can be installed.

With the lower housing portion being a base plate and the upper housing portion being a top plate, the continuous analyte monitoring device can be manufactured, exemplarily, as follows: The lower portion of the connector unit may be provided with a base plate containing the housing. The analyte sensor may be housed within a channel or within a portion of the channel formed by the lower portion of the connector unit. Subsequently, the upper portion of the connector unit can be mounted on top of the lower portion of the connector unit. The channel can be sealed. Furthermore, a removable sterile cap and an insertion assembly can be installed. Thus, a sterile unit can be formed. The sterile unit may include a connector unit, a removable sterile cap, an insertion assembly, and an analyte sensor. The sterile unit can be sterilized. Subsequently, with a base plate housing the lower part of the connector unit, the electronic unit can be mounted on the base plate, and the upper plate can be placed on the base plate. In the assembled state of the base plate and the upper plate, the sealing channel can be filled with sealing material.

The method may further include placing a continuous analyte monitoring device within the cavity of the insertion device, specifically to form a continuous analyte monitoring system. For more details regarding the insertion device, refer to the description above. The continuous analyte monitoring system may correspond to the continuous analyte monitoring system described above or as will be described in further detail below.

During step d), the assembly of the lower and upper shell portions can be tilted. Depending on the situation, the shell may further include a cavity disposed between the sealing channel and the outlet filling port. For more details on the cavity, refer to the description above. Specifically, during step d), the assembly of the lower and upper shell portions can be continuously tilted such that the cavity continuously presents the highest point at one end of the flow front of the sealing material through the sealing channel. Therefore, air can escape from the sealing channel, specifically via the outlet filling port. By reducing the possibility of air entering or remaining in the sealing channel, the tightness of the bonded joint between the lower and upper shell portions can be more reliable, and production waste can be reduced.

In another aspect of the present invention, a method is disclosed for using a continuous analyte monitoring device as described above or which will be further described in more detail below.

The method comprises the method steps as given in the separate request and as listed below. These method steps can be executed in a predetermined order. However, other orders of the method steps are possible. Additionally, one or more method steps can be executed in parallel and/or in overlapping time. Furthermore, one or more method steps can be executed repeatedly. In addition, there may be additional method steps not listed.

The method includes: I. providing a continuous analyte monitoring device; II. removing a removable sterile cap; III. inserting an analyte sensor into the user's body tissue; and IV. removing the insertion cannula retainer, thereby removing the insertion cannula from the continuous analyte monitoring device.

The proposed apparatus and method offer many advantages over known apparatus and methods.

With this invention, instead of applying glue first and then assembling the upper and lower shell parts, the upper and lower shell parts can be assembled first and then glued. This is achieved by filling ports and corresponding channels. This simplifies assembly and provides more reliable and reproducible fixation of the parts. Furthermore, bubble-free bonding can be achieved, specifically through the addition of vent ports.

When assembling the housing, a sealed channel system can be created. The sealed channel and/or half of the channel can be designed such that when the housing is pressed together by angled overlap during assembly, these half-sections can compensate for tolerance gaps. The sealed channel system allows for injection of sealing material at a single location, specifically eliminating the need for a dispensing robot to move along adhesive gaps. This reduces costs (specifically manufacturing costs) and processing time. Simultaneously, the channel system can be designed such that the flow front pushes the air in front of it, preventing bubble formation within the channel system. The flow front velocity can be synchronized for different distances, allowing air to completely or at least largely exit. Specifically, this can be achieved by selecting the transverse end face of the channel system and using cavities (specifically, voids) at the points where the flow fronts meet. By tilting the shell so that the cavity (specifically, void) always represents the highest point at the end of the flow front, air can be collected in the cavity and can escape from the output fill port. By reducing the possibility of air entering the channel system, the tightness of the glued joints is ensured, reducing waste.

The following summary illustrates, but does not exclude, more possible embodiments. The following embodiments are conceivable: Embodiment 1: A continuous analyte monitoring device comprising: an analyte sensor including 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 the user's bodily fluids; an insertion assembly including an insertion cannula and an insertion cannula retainer, wherein the insertion cannula is attached to the insertion cannula retainer, and the analyte sensor is at least partially placed within the insertion cannula; a removable sterile cap, wherein the removable sterile cap at least partially surrounds the insertable portion of the analyte sensor; and a housing, wherein the housing includes at least partially surrounding the analyte sensor. The housing includes an open channel for the insertion assembly, wherein the housing further includes an electronic compartment housing an electronic unit; wherein the housing is at least partially formed by a lower housing portion and an upper housing portion, wherein the housing includes a sealing channel including an inlet filling port and an outlet filling port, wherein the sealing channel is at least partially filled with a sealing material configured to seal the internal space enclosed by the upper housing portion and the lower housing portion; wherein the removable sterile cap, the open channel of the housing, and the insertion cannula retainer originate from the sterile compartment of at least the insertable portion for the insertion cannula and the analyte sensor. Example 2: In the continuous analyte monitoring device of the preceding embodiments, the sealed channel is configured to be filled with the sealing material in the assembled state of the lower housing portion and the upper housing portion. Example 3: In the continuous analyte monitoring device of any of the preceding embodiments, the electronic unit is electrically connected to the analyte sensor. Example 4: In the continuous analyte monitoring device of any of the preceding embodiments, the analyte sensor is partially housed in the sterile compartment, specifically within the open channel, and partially housed in the electronic compartment. Example 5: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the sealing channel is formed at least partially by a groove in the lower shell portion and/or by a groove in the upper shell portion. Example 6: A continuous analyte monitoring device as described in the preceding embodiments, wherein the groove in the lower shell portion and/or the groove in the upper shell portion has a shape selected from the group consisting of: semi-circular; semi-oval; polygonal; trapezoidal; and specifically rectangular. Example 7: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the sealing channel is a circumferential sealing channel. Example 8: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the open channel is isolated and sealed from the electronic compartment by the wall of the open channel. Example 9: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the input filling port and the output filling port are arranged opposite to each other. Example 10: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the input filling port and/or the output filling port are arranged laterally, and specifically substantially perpendicular to the sealing channel and/or the extension direction of the housing. Example 11: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the housing further includes at least one cavity disposed between the sealed channel and the output filling port, wherein the cavity is configured to collect the sealing material from the sealed channel, specifically excess sealing material, specifically when the sealing material fills the sealed channel. Example 12: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the housing is at least partially formed as a cylindrical ring, wherein the sealed channel is a circumferentially sealed channel, wherein the sealed channel seals the electronic compartment and the sterile compartment, or wherein the circumferentially sealed channel isolates and seals the electronic compartment from the external environment of the continuous analyte monitoring device. Example 13: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the housing includes two sealing channels among the sealed channels, wherein the two sealing channels include an inner circumferential sealing channel and an outer circumferential sealing channel, wherein the inner circumferential sealing channel has a smaller diameter than the outer circumferential sealing channel. Example 14: A continuous analyte monitoring device as described in the preceding embodiments, wherein the inner circumferential sealing channel and the outer circumferential sealing channel each include an input filling port and an output filling port. Example 15: A continuous analyte monitoring device as described in any of the preceding two embodiments, wherein the inner circumferential sealing channel and the outer circumferential sealing channel are connected to each other via a connecting channel. Example 16: The continuous analyte monitoring device of the foregoing embodiments, wherein the housing includes an input filling port and two output filling ports, wherein the input filling port is disposed at the outer circumferential sealing channel, and wherein one of the output filling ports is disposed at the outer circumferential sealing channel, and the other of the output filling ports is disposed at the inner circumferential sealing channel. Example 17: The continuous analyte monitoring device of any of the foregoing four embodiments, wherein the housing is at least partially formed as a cylindrical ring, wherein the inner circumferential sealing channel seals the electronic compartment and the sterile compartment, and wherein the outer circumferential sealing channel isolates and seals the electronic compartment from the external environment of the continuous analyte monitoring device. Example 18: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the housing comprises: a base plate configured for attachment to a user's skin, specifically via at least one adhesive; and an upper plate, wherein the base plate and the upper plate are configured to form at least a portion of the longitudinal side of the electronic compartment. Example 19: A continuous analyte monitoring device as described in the preceding embodiments, wherein the lower housing portion is the base plate, and wherein the upper housing portion is the upper plate. Example 20: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the housing further includes a connector unit that includes the open channel of the housing, wherein the connector unit has a channel through which the analyte sensor passes. Example 21: A continuous analyte monitoring device as described in the preceding embodiments, wherein the open channel and the channel are arranged laterally and, more specifically, substantially perpendicularly to each other. Example 22: A continuous analyte monitoring device as described in any of the preceding two embodiments, wherein the channel is a sealed channel. Example 23: A continuous analyte monitoring device as described in any of the preceding three embodiments, wherein the channel connects the sterile compartment to the electronic compartment. Example 24: A continuous analyte monitoring device as described in any of the four preceding embodiments, wherein the analyte sensor includes a proximal portion within the living body and a distal portion outside the body, wherein the distal portion outside the body includes a first segment housed in the channel and a second segment housed in the electronic compartment. Example 25: A continuous analyte monitoring device as described in the preceding embodiments, wherein the first segment and the second segment are arranged substantially along a straight line. Example 26: A continuous analyte monitoring device as described in any of the preceding two embodiments, wherein the first segment and the second segment are arranged at an angle of 5° to 90° to each other, specifically 20° to 80°, and more specifically 40° to 70°. Example 27: A continuous analyte monitoring device as described in any of the preceding seven embodiments, wherein the lower housing portion is the lower portion of the connector unit, and wherein the upper housing portion is the upper portion of the connector unit. Example 28: A continuous analyte monitoring device as described in the preceding embodiments, wherein the channel intersects with the sealing channel. Example 29: A continuous analyte monitoring device as described in the preceding embodiments, wherein the channel and the sealing channel are at least partially filled with the sealing material, the sealing material being configured to seal the channel, including the through-passage analyte sensor, specifically such that the sterile compartment is isolated and sealed from the electronic compartment. Example 30: A continuous analyte monitoring device as described in the preceding embodiments, wherein the channel is at least partially filled with the sealing material. Example 31: A continuous analyte monitoring device as described in the preceding embodiments, wherein the channel is configured to be filled with the sealing material in the assembled state of the lower and upper portions. Example 32: A continuous analyte monitoring device as described in any of the preceding five embodiments, wherein the upper section of the open channel is formed by the upper portion of the connector unit, and the lower section of the open channel is formed by the lower portion of the connector unit. Example 33: A continuous analyte monitoring device as described in any of the preceding six embodiments, wherein the wall of the open channel is at least partially formed by the lower portion of the connector unit and the upper portion of the connector unit. Example 34: A continuous analyte monitoring device as described in any of the six embodiments above, wherein at least one of the following changes along the sealed channel: the width of the inner cavity of the sealed channel; the shape of the sealed channel, specifically the shape of the cross section of the sealed channel; the size of the sealed channel, specifically the size of the cross section of the sealed channel. Example 35: In the continuous analyte monitoring apparatus of the foregoing embodiments, at least one of the following may decrease as the cross-section of the sealed channel is further from the channel, specifically decreasing continuously: the width of the inner cavity of the sealed channel; the size of the sealed channel, specifically the size of the cross-section of the sealed channel; the cross-sectional area of the sealed channel, specifically the cross-sectional area of the sealed channel in the direction of extension of the sealed channel. Example 36: A continuous analyte monitoring device as described in either of the two embodiments above, wherein the sealed channel is divided into a first arm and a second arm by means of the input filling port and the output filling port, wherein the first arm intersects the channel, and wherein at least one of the following may be larger in the first arm than in the second arm: the width of the cavity of the sealed channel; the average width of the cavity of the sealed channel; the sealed channel The dimension, specifically, is the dimension of the cross-section of the sealed channel; the average dimension of the sealed channel, specifically, is the average dimension of the cross-section of the sealed channel; the cross-sectional area of the sealed channel, specifically, is the cross-sectional area of the sealed channel in the direction of extension of the sealed channel; the average cross-sectional area of the sealed channel, specifically, is the average cross-sectional area of the sealed channel in the direction of extension of the sealed channel. Embodiment 37: A continuous analyte monitoring device as described in any of the foregoing embodiments, wherein the housing includes an upper side and a lower side, wherein the open channel connects the upper side and the lower side. Example 38: A continuous analyte monitoring device as described in the preceding embodiments, wherein the removable sterile cap is located on the lower side of the housing, and wherein at least a portion of the insertion cannula retainer extends from the upper side of the housing. Example 39: A continuous analyte monitoring device as described in either of the preceding two embodiments, wherein the insertable portion of the analyte sensor extends downward beyond the lower side within the open channel. Example 40: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the insertion cannula retainer and the removable sterile cap are removably connected to the housing, specifically on opposite sides of the housing, specifically on the open channel. Example 41: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the open channel at least partially circumferentially surrounds the analyte sensor and the insertion cannula. Example 42: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the analyte sensor includes at least two electrodes, each electrode including an electrode conductor path configured to transmit a sensor current for detecting the analyte. Example 43: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the analyte sensor includes a carrier, specifically a substrate, wherein at least two electrode conductor paths are disposed on the carrier. Example 44: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the at least two electrodes are configured as working electrodes for detecting the analyte, and an additional electrode, wherein the additional electrode is selected from the group consisting of: a relative electrode, a reference electrode, and a combined relative-reference electrode. Example 45: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the electronic unit includes a printed circuit board. Example 46: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the insertion cannula is fixedly attached to the insertion cannula holder. Example 47: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the insertion cannula retainer is configured to be removed after the insertable portion of the analyte sensor has been inserted into the body tissue. Example 48: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the insertion cannula retainer at least partially surrounds the insertion cannula. Example 49: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the insertion cannula retainer forms a removable cover, specifically a removable top cover, which is configured to seal the end of the open channel of the housing. Example 50: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the insertion cannula retainer is at least partially housed within the open channel. Example 51: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the insertion cannula retainer is removably connected to the housing and/or the removable sterile cap via at least one of a connection, specifically a press-fit connection, a shaped-fit connection, a screw connection, a magnetic connection, or a bayonet connection. Example 52: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the removable sterile cap is removably connected to the housing and/or the insertion cannula retainer via at least one of a connection, specifically a press-fit connection, a form-fit connection, a screw connection, a magnetic connection, or a bayonet connection. Example 53: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the removable sterile cap is configured to be removed before the insertable portion of the analyte sensor is inserted into the body tissue. Example 54: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the continuous analyte monitoring device further includes an insertion device. Example 55: A continuous analyte monitoring device as described in the preceding embodiments, wherein the insertion device includes an insertion mechanism. Example 56: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the continuous analyte monitoring device is a disposable medical device. Example 57: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the electronic unit is a single-use electronic unit. Example 58: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the continuous analyte monitoring device forms a pre-assembled single unit. Example 59: A continuous analyte monitoring device as described in any of the preceding embodiments, wherein the sealing material is configured to securely attach the lower housing portion and the upper housing portion to each other. Example 60: A continuous analyte monitoring system comprising: a continuous analyte monitoring device as described in any of the preceding embodiments; an insertion device that at least partially covers the continuous analyte monitoring device, wherein the insertion device is configured to allow a user to drive the insertion cannula into the body tissue and insert it into the insertable portion of the analyte sensor. Example 61: The continuous analyte monitoring system of the foregoing embodiments, wherein the continuous analyte monitoring system further includes a sensor controller coupled to the analyte sensor, wherein the sensor controller is configured to receive analyte sensor data from the analyte sensor; and a remote control configured to receive sensor data from the sensor controller and process and/or display the sensor data. Example 62: A method of assembling an analyte monitoring device as described in any of the embodiments of the continuous analyte monitoring device mentioned above, wherein the method comprises: a) providing a lower housing portion; b) mounting an analyte sensor onto the lower housing portion; c) placing an upper housing portion onto the lower housing portion; d) injecting a sealing material into a sealing channel, specifically under pressure, through an inlet filling port, such that the lower housing portion and the upper housing portion are fixedly attached to each other, and the internal space enclosed by the upper housing portion and the lower housing portion is sealed. Example 63: A method of using a continuous analyte monitoring device as described in any of the embodiments relating to a continuous analyte monitoring device, the method comprising: I. providing the continuous analyte monitoring device; II. removing a removable sterile cap; III. inserting an analyte sensor into a user's body tissue; and IV. removing an insertion cannula retainer, thereby removing the insertion cannula from the continuous analyte monitoring device.

Figures 1A and 1B show exemplary embodiments of the continuous analyte monitoring device 110 as described in the present invention in different cross-sectional views. Figure 1B shows a cross-sectional view along a plane extending parallel to the extending direction of the housing 111 of the continuous analyte monitoring device 110. Figure 1A shows a cross-sectional view (section A-A, see Figure 1B) of the continuous analyte monitoring device 110 as shown in Figure 1B.

The continuous analyte monitoring device 110 includes an analyte sensor 112. The analyte sensor 112 is configured to detect analytes in a user's bodily fluids.

The analyte sensor 112 may include a carrier 114, specifically a substrate 116. At least two electrodes may be disposed on the carrier 114. The carrier 114, specifically the substrate 116, may have an elongated shape, such as a strip shape and/or a rod shape.

The analyzer sensor 112 has an insertable portion 116 adapted to be at least partially inserted into the body tissue of use. The insertable portion 116 may be referred to as the intravitreal proximal portion 198. A portion of the analyzer sensor 112 that can remain outside the body tissue may also be referred to as the ex vivo distal portion 200. The ex vivo distal portion 200 and the intravitreal proximal portion 198 may be arranged laterally, and specifically substantially perpendicular, to each other. The intravitreal proximal portion 198 may extend along an insertion direction 121. The insertion direction 121 may be laterally, and specifically substantially perpendicular, to the user's skin area.

In addition, the continuous analyte monitoring device 110 includes an insertion assembly 122, which includes an insertion cannula 124 and an insertion cannula retainer 126.

The analyte sensor 112 is at least partially housed within the insertion cannula 124. The insertion cannula 124 may include a tip or pointed end 128 for at least partially inserting the analyte sensor 112 into body tissue. Specifically, the insertion cannula 124 may be a slotted cannula 130. The insertion cannula 124 may be configured for substantially vertical insertion relative to the user's body tissue. The insertion cannula retainer 126 may be configured for removal after the insertable portion 116 of the analyte sensor 112 has been inserted into the body tissue.

The insertion cannula 124 is attached to the insertion cannula retainer 126. Specifically, the insertion cannula 124 may be fixedly attached to the insertion cannula retainer 126. The insertion cannula retainer 126 may at least partially surround the insertion cannula 124. Specifically, the insertion cannula 124 may have a first end 132 and an opposite second end 134. The first end 132 may be a pointed tip 128 for at least partially inserting the analyte sensor 112 into body tissue. The second end 134 may be attached to the insertion cannula retainer 126.

In addition, the continuous analyte monitoring device 110 includes a removable sterile cap 136. The removable sterile cap 136 at least partially surrounds the insertable portion 116 of the analyte sensor 112.

A removable sterile cap 136 at least partially surrounds the insertable portion 116 of the analyte sensor 112. Therefore, the insertable portion 116 can be at least partially housed within the removable sterile cap 136. The removable sterile cap 136 can be configured to be removed before the insertable portion 116 of the analyte sensor 112 is inserted into body tissue.

In addition, the continuous analyte monitoring device 110 includes a housing 111.

The housing 111 may include an upper side 138 and a lower side 140. Specifically, the upper side 138 may refer to the distal side 142 of the housing 111. Specifically, the lower side 140 may refer to the proximal side 144 of the housing 111. The housing 111 includes an opening channel 146 that at least partially surrounds the analyte sensor 112 and the insertion component 122. The opening channel 146 may extend laterally, and specifically substantially vertically, relative to the lower side 140 and the upper side 138 of the housing 111.

The opening channel 146 can connect the upper side 138 and the lower side 140. Specifically, the opening channel 146 can be a substantially straight channel. Furthermore, the opening channel 146 can extend laterally, specifically substantially perpendicular to the extending direction 148 of the shell 111. The opening channel 146 can specifically have an upper opening 150 and an opposite lower opening 152. The upper opening 150 can be located on the upper side 138 of the shell 111 away from the skin, and the lower opening 152 can be located on the lower side 140 of the shell 111 facing the skin.

Specifically, the open channel 146 may at least partially circumferentially surround the analyte sensor 112 and the insertion assembly 122 (specifically, at least the insertion cannula 124 of the insertion assembly 122). The housing 111 may be at least partially formed as a cylindrical ring that at least partially surrounds the analyte sensor 112 and the insertion assembly 122 (specifically, at least the insertion cannula 124 of the insertion assembly 122). The insertable portion 116 of the analyte sensor 112 may extend downward within the open channel 146 beyond the lower side 140 of the housing 111.

The housing 111 further includes an electronic compartment 154 therein housing the electronic unit 156. The electronic compartment 154 may be a sealed compartment 158. The electronic unit 156 may be fixedly positioned within the electronic compartment 154 of the housing 111.

The shell 111 is formed at least in part by a lower shell portion 160 and an upper shell portion 162.

The housing 111 may further include a connector unit 164, which includes an open channel 146 of the housing 111. Specifically, the connector unit 164 may be configured to connect the sterile compartment 166 to the electronic compartment 154. Specifically, the connector unit 164 may have a channel 192 through which the analyte sensor 112 may pass. The channel 192 may also be referred to as an opening 168. The analyte sensor 112 may be partially housed in the sterile compartment 166, specifically within the open channel 146, and partially housed in the electronic compartment 154. More specifically, the analyte sensor 112 may be partially housed in the sterile compartment 166, specifically within the open passage 146, partially housed in the passage 192 of the connector unit 164, and partially housed in the electronic compartment 154.

The open channel 146 can be isolated and sealed from the electronic compartment 154 by its wall 170. The wall 170 of the open channel 146 can be formed by a connector unit 164. Specifically, the connector unit 164 can have a connector unit wall 172 that extends specifically in the insertion direction 121 of the analyte sensor 112 or laterally, specifically perpendicular to the longitudinal side 174 of the housing 111. The connector unit wall 172 can have a first side 176 and an opposing second side 178. The first side 176 can face the interior space 180 of the open channel 146. In addition, the second side 178 can face the interior space 182 of the electronic compartment 154.

Connector unit 164 may have an upper connector unit side 184 and a lower connector unit side 186. Open channel 146 allows connection between the upper connector unit side 184 and the lower connector unit side 186. Specifically, the upper connector unit side 184 may refer to the distal connector unit side 188 of connector unit 164. Specifically, the lower connector unit side 186 may refer to the proximal connector unit side 190 of connector unit 164.

Open channels 146 and 192 can be arranged laterally, and more specifically, substantially perpendicularly, to each other. Channel 192 can be formed by a hole or cutout in the wall 170 of connector unit 164, specifically connector unit 164. Channel 192 itself can be implemented as a substantially straight channel. Channel 192 can have a first end 194 and an opposing second end 196. Channel 192 can connect sterile compartment 166 and electronic compartment 154 via the first end 194 and the second end 196.

The distal analyte portion 200 and the proximal analyte portion 198 of the analyte sensor 112 can be arranged laterally, and specifically substantially perpendicularly, to each other. The proximal analyte portion 198 can extend along the insertion direction 121. The distal analyte portion 200 can include a first segment 202 housed in the channel 192 and a second segment 204 housed in the electronic compartment 154. The electronic unit 156 can be electrically connected to the analyte sensor 112. Therefore, specifically, the second segment 204 of the distal analyte portion 200 can be electrically connected to the electronic components 206 of the electronic unit 156.

Connector unit 164 may specifically include a lower portion 208 and an upper portion 210. The lower portion 208 and the upper portion 210 may be combined to form connector unit 164. Specifically, the upper portion 210 may refer to the distal portion 212 of connector unit 164. Specifically, the lower portion 208 may refer to the proximal portion 214 of connector unit 164. The upper section 216 of open channel 146 may be formed by the upper portion 210 of connector unit 164, and the lower section 218 of open channel 146 may be formed by the lower portion 208 of connector unit 164. Furthermore, the wall 170 of the open channel 146 may be formed at least partially by the lower portion 208 of the connector unit 164 and by the upper portion 210 of the connector unit 164.

The housing 111 may include a base plate 220 configured to attach to a user's skin, specifically via at least one adhesive. Additionally, the housing 111 may include a top plate 222. The base plate 220 and top plate 222 are configured to form at least portions of the longitudinal side 224 of the electronic compartment 154. Specifically, the base plate 220 may include a lower surface 226 configured to rest on the user's skin. The lower surface 226 may, exemplarily, have an annular shape surrounding the analyte sensor 112. Specifically, the lower surface 226 may be, or may include, an adhesive surface 228 for attachment to the user's skin. Specifically, the base plate 220 and the top plate 222 can be combined to form a package for the electronic unit 156. Specifically, the electronic compartment 154 can be formed by the base plate 220, the top plate 222, and the connector unit 164. The longitudinal side 224 of the electronic compartment 154 can be formed by the base plate 220 and the top plate 222, and may also be formed by the longitudinal side 230 of the connector unit 164, depending on the situation. The lower side 140 of the housing 111 can be formed by the base plate 220 and the lower connector unit side 186 of the connector unit 164. The upper side 138 of the housing 111 may be formed by the upper plate 222 and the upper connector unit side 184 of the connector unit 164.

The removable sterile cap 136, the opening channel 146 of the shell 111, and the insertion cannula retainer originate from the sterile compartment 166 of at least the insertable portion 116 for inserting the cannula 124 and the analyte sensor 112. Therefore, the cannula 124 and at least the insertable portion 116 of the analyte sensor 112 can be housed within the sterile compartment 166. The sterile compartment 166 may also be referred to as the sensor compartment 232.

As outlined above, the housing 111 may include an upper side 138 and a lower side 140, and the opening channel 146 may connect the upper side 138 and the lower side 140. A removable sterile cap 136 may be at least partially located on the lower side 140 of the housing 111, specifically on the connector unit 164, and at least a portion of the insertion cannula retainer 126 may extend from the upper side 138 of the housing 111, specifically on the connector unit 164. The insertion cannula retainer 126 and the removable sterile cap 136 are removably connected to the housing 111, and more specifically to the connector unit 164, respectively, on opposite sides of the housing 111, the connector unit 164, and the opening channel 146. The insertion cannula retainer 126 can seal the upper opening 150 of the opening channel 146, and the removable sterile cap 136 can seal the lower opening 152 of the opening channel 146.

The housing 111 includes a sealing channel 234, which includes an inlet filling port 236 and an outlet filling port 238. The sealing channel 234 is at least partially filled with a sealing material 240 configured to securely attach the lower housing portion 160 and the upper housing portion 162 to each other and to seal the internal space 242 enclosed by the upper housing portion 162 and the lower housing portion 160.

In the embodiments shown in Figures 1A and 1B, the lower housing portion 160 can be the lower portion 208 of the connector unit 164, and the upper housing portion 162 can be the upper portion 210 of the connector unit 164. Specifically, the sealing channel 234 can be a circumferential sealing channel 244, and the sealing channel 234 can isolate and seal the electronic compartment 154 from the sterile compartment 166. The sealing channel 234 can be partially formed by the lower portion 208 of the connector unit 164, and can be partially formed by the upper portion 210 of the connector unit 164. The sealing channel 234 may be located between the lower portion 208 and the upper portion 210 of the connector unit 164. The sealing channel 234 may surround, specifically circumferentially surround, the open channel 146 of the housing 111.

Specifically, channel 192 may intersect with sealing channel 234. Channel 192 may be fluidly connected to sealing channel 234 through the intersection of channels 192. Specifically, channel 192 may intersect with sealing channel 234 between a first end 194 and a second end 196 of channel 192. Sealing channel 234 may be arranged between the first end 194 and the second end 196 of channel 192. Channel 192 may be at least partially filled with sealing material 240.

Specifically, sealing channels 234 and 192 are configured to be filled with sealing material in the assembled state of lower portion 208 and upper portion 210. Therefore, by filling sealing channel 234 through input filling port 236, channel 192 can also be sealed with sealing material 240. Specifically, in the assembled and manufactured state of the continuous analyte monitoring device 110, channel 192 is at least partially filled, and preferably completely filled, with sealing material 240.

Figures 2A to 2E illustrate exemplary embodiments of the components of the continuous analyte monitoring device 110 of the present invention in different cross-sectional views. The cross-sectional view of Figure 2A corresponds to the cross-sectional view of Figure 1B. However, the electronic compartment 154, in which the electronic unit 156 is housed, is not shown. Therefore, please refer to the description of Figures 1A and 1B above.

Figure 2B shows a cross-sectional view (section A-A, see Figure 2A) of the components of the continuous analyte monitoring device 110 as shown in Figure 2A. Thus, the upper portion 210 and the lower portion 208 of the connector unit 164 are shown in a disassembled state (top view) and an assembled state (bottom view).

As can be seen in Figure 2B, the sealing channel 234 can be partially formed by a groove 246 within the lower portion 208 of the connector unit 164 (specifically within the surface 248 of the lower portion 208 of the connector unit 164). The upper portion 210 of the connector unit 164 can form a cover 250 for the groove 246 within the lower portion 208 of the connector unit 164. Therefore, the sealing channel 234 can be partially formed by the groove 246 within the lower portion 208 of the connector unit 164 and by the flat surface 252 of the upper portion 210 of the connector unit 164.

Specifically, the sealing channel 234 can be configured to be filled with sealing material 240 in the assembled state of the lower portion 208 and the upper portion 210. Therefore, before assembling the lower portion 208 and the upper portion 210 as shown in the upper figure of Figure 2B, the sealing channel 234 may not have sealing material 240. In the assembled state of the lower portion 208 and the upper portion 210 as shown in the lower figure of Figure 2B, the sealing material 240 can be filled into the sealing channel 234 through the filling input port 236.

The sealing channel 234 can sealably connect the lower portion 208 and the upper portion 210 of the connector unit 164, allowing the sterile compartment 166 to be sealed away from the electronic compartment 154. Furthermore, the sealing channel 234 can seal the analyte sensor 112 passing through the channel 192. To achieve this seal, it is conceivable that the analyte sensor 112 is mounted on the lower portion 208 of the connector unit 164, followed by the upper portion 210 of the connector unit 164. In this state, the channel 192 and the sealing channel 234 are not yet sealed. By injecting sealing material 240 into the inlet filling port 236 under pressure, the sealing material 240 can fill the channel 192 and seal the channel 234, and seal the analyte sensor 112 within the channel 192. This achieves an effective seal.

Figure 2C shows a cross-sectional view (section B-B, see Figure 2A) of the components of the continuous analyte monitoring device 110 as shown in Figure 2A. Thus, the upper portion 210 and the lower portion 208 of the connector unit 164 are shown in the assembled state.

As can be seen in Figure 2C, the cross-section of the sealing channel 234 can vary along the sealing channel 234. Therefore, as shown in Figure 2C, in some areas, the sealing channel 234 can be formed by a groove 246 in the lower portion 208 of the connector unit 164 (specifically, in the surface 248 of the lower portion 208 of the connector unit 164) and a groove 254 in the upper portion 210 of the connector unit 164 (specifically, in the surface 256 of the upper portion 210 of the connector unit 164).

Figure 2D shows a cross-sectional view (section C-C, see Figure 2A) of the components of the continuous analyte monitoring device 110 as shown in Figure 2A. Thus, the upper portion 210 and the lower portion 208 of the connector unit 164 are shown in an assembled state. Figure 2E shows a cross-sectional view (section D-D, see Figure 2A) of the components of the continuous analyte monitoring device 110 as shown in Figure 2A. Thus, the upper portion 210 and the lower portion 208 of the connector unit 164 are shown in an assembled state. Furthermore, in Figure 2E, the analyte sensor 112 passing through channel 192 is shown.

As shown in Figures 2D and 2E, the analyte sensor 112, passing through channel 192, may intersect with the sealed channel 234. Channel 192 may be at least partially filled with sealing material 240. Sealing material 240 may circumferentially surround the analyte sensor 112, specifically the section of the analyte sensor 112 passing through channel 192.

Figures 3A to 3C show exemplary embodiments of the components of the continuous analyte monitoring device 110 of the present invention in different cross-sectional views. The cross-sectional view of Figure 3A corresponds at least partially to the cross-sectional view of Figure 2A. Therefore, refer to the description of Figures 2A and 2E above.

Figure 3B shows a cross-sectional view (section B-B, see Figure 3A) of the components of the continuous analyte monitoring device 110 as shown in Figure 3A. Thus, the upper portion 210 and the lower portion 208 of the connector unit 164 are shown in an assembled state. Furthermore, Figure 3C shows a cross-sectional view (section E-E, see Figure 3A) of the components of the continuous analyte monitoring device 110 as shown in Figure 3A. Thus, the upper portion 210 and the lower portion 208 of the connector unit 164 are shown in an assembled state.

As can be seen in Figures 3B and 3C, the width of the cavity 258 of the sealing channel 234 can be larger in the region near the sealing channel 234 intersecting with the channel 192 (as shown in Figure 3C) than in the region away from the sealing channel 234 intersecting with the channel 192 (as shown in Figure 3B). Furthermore, the cross-sectional area of the sealing channel 234 can be larger in the region near the sealing channel 234 intersecting with the channel 192 than in the region away from the sealing channel 234 intersecting with the channel 192. Specifically, the sealing channel 234 can be divided into a first arm 257 and a second arm 259 by means of the input filling port 236 and the output filling port 238. The first arm 257 can intersect with the channel 192. The width of the cavity 258 of the sealing channel 234, specifically the average width of the cavity 258 of the sealing channel 234, can be larger in the first arm 257 than in the second arm 259.

At the intersection of channel 192 and sealing channel 234, the analyzer sensor 112 can impose increased mechanical resistance on the flow of sealing material 240. To prevent sealing material 240 from flowing only along the arm of the sealing channel in the region away from the sealing channel 234, the cavity 258 of the sealing channel 234 can be enlarged to balance the difference in flow resistance.

Figure 4 shows an exemplary embodiment of the continuous analyte monitoring device 110 as described in the present invention in cross-sectional view. The cross-sectional view of Figure 2A corresponds at least partially to the cross-sectional view of Figure 1B. Therefore, refer to the description of Figures 1A and 1B above.

In contrast to embodiments such as Figures 1A and 1B (where the first segment 202 and the second segment 204 of the distal portion 200 can be arranged substantially along a straight line), the first segment 202 and the second segment 204 of the distal portion 200 can be arranged at an angle of 40° to 70°, specifically 55° to 65°, to each other, as shown in Figure 4. This improves the positioning and stability of the analyzer sensor 112 within the connector unit 164.

Figures 5A and 5B illustrate exemplary embodiments of the components of the continuous analyte monitoring device 110 as described in the present invention. Figure 5A shows an exemplary embodiment of the housing 111 of the continuous analyte monitoring device 110 in perspective view. Figure 5B shows a top view of the base plate 220 of the housing 111 of the continuous analyte monitoring device 110. The housing 111 of the continuous analyte monitoring device 110 shown in Figures 5A and 5B may at least partially correspond to the continuous analyte monitoring device 110 shown in Figures 1A and 1B. Therefore, reference is made to the description of Figures 1A and 1B above.

In the embodiments shown in Figures 5A and 5B, the lower portion 208 and the base plate 220 of the connector unit 164 can be formed as a single piece. The lower housing portion 160 can be the base plate 220, and the upper housing portion 162 can be the upper plate 222, specifically combined with the upper portion 210.

Specifically, the housing 111 may include two sealing channels in the sealing channel 234. The two sealing channels 234 may include an inner circumferential sealing channel 264 and an outer circumferential sealing channel 266. The inner circumferential sealing channel 264 may have a smaller diameter than the outer circumferential sealing channel 266.

The inner circumferential sealing channel 264 can isolate and seal the electronic compartment 154 from the sterile compartment 166. The inner circumferential sealing channel 264 can surround, specifically, the open channel 146 of the housing 111. The inner circumferential sealing channel 264 can be arranged between the sterile compartment 166 (specifically the open channel 146) and the electronic compartment 154.

The outer circumferential sealing channel 266 can seal the electronic compartment 154 from the external environment 268 of the continuous analyte monitoring device 110. The outer circumferential sealing channel 266 can surround, specifically, circumferentially surround, the electronic unit 156 housed in the housing 111. The outer circumferential sealing channel 266 can be located in the wall 270 that separates the electronic compartment 154 from the external environment 268 of the continuous analyte monitoring device 110.

Furthermore, specifically, the inner circumferential sealing channel 264 and the outer circumferential sealing channel 266 can be connected to each other, specifically via a connecting channel 272. The connecting channel 272 can be configured to connect the fluids of the inner circumferential sealing channel 264 and the outer circumferential sealing channel 266. Sealing material 240 can be transferred from one of the inner circumferential sealing channels 264 and the outer circumferential sealing channel 266 to the other of the connecting channel 272. The connecting channel 272 can be implemented as a substantially straight channel. Specifically, the connecting channel 272 can be formed within the lower housing portion 160, specifically within the base plate 220. Specifically, the connection channel 272 can be formed as a recess 274 within the lower housing portion 160. The recess 274 can be located on one side of the lower housing portion 160 facing the electronic compartment 154. The recess 274 can be covered by a cover 276, specifically to form the connection channel 274 (see Figure 6).

The housing 111 may include one input fill port 236 and two output fill ports 238. Specifically, the input fill port 236 and the output fill ports 238 may extend laterally, specifically perpendicularly to the sealed channel 234 along its extended plane. The input fill port 236 and the output fill ports 238 may enter from the external environment 268 of the continuous analyte monitoring device 110.

Specifically, the input filling port 236 can be located at the outer circumferential sealing channel 266. The input filling port 236 can be fluidly connected to the outer circumferential sealing channel 266. Furthermore, specifically, one of the two output filling ports 238 can be located at the outer circumferential sealing channel 266, and the other of the two output filling ports 238 can be located at the inner circumferential sealing channel 264. Specifically, one of the two output filling ports 238 can be fluidly connected to the outer circumferential sealing channel 266, and the other of the two output filling ports 238 can be fluidly connected to the inner circumferential sealing channel 264.

Furthermore, the housing 111 may further include a cavity 278 disposed between the sealing channel 234 and the output filling port 238. Specifically, the cavity 278 may be fluidly disposed between the sealing channel 234 and the output filling port 238. The cavity 278 may have free volume. The cavity 278 may be configured to collect sealing material 240.

Figure 6 shows a cross-sectional view of an exemplary embodiment of the components of the continuous analyte monitoring device 110 as described in the present invention. The components of the continuous analyte monitoring device 110 shown in Figure 6 may at least partially correspond to the components of the continuous analyte monitoring device 110 shown in Figures 5A and 5B. Therefore, refer to the description of Figures 5A and 5B above.

During the injection of sealing material 240 into sealing channel 234 via inlet filling port 236, the assembly of lower housing portion 160 and upper housing portion 162 can be tilted. Housing 111 may include a cavity 278 disposed between sealing channel 234 and outlet filling port 238. Specifically, the assembly of lower housing portion 160 and upper housing portion 162 can be continuously tilted such that cavity 278 continuously presents the highest point at one end of the flow front of sealing material 240 through sealing channel 234. Therefore, air can escape from sealing channel 234, specifically via outlet filling port 238. By reducing the possibility of air entering or remaining in the sealed channel 234, the tightness of the bonded joint between the lower shell portion 160 and the upper shell portion 162 can be more reliable and production waste can be reduced.

Figure 7 shows a cross-sectional view of an exemplary embodiment of the components of the continuous analyte monitoring device 110 as described in the present invention. The components of the continuous analyte monitoring device 110 shown in Figure 7 can at least partially correspond to the components of the continuous analyte monitoring device 110 shown in Figures 5A and 5B. Therefore, referring to the description of Figures 5A and 5B above, it can be specifically seen in the detailed view of Figure 7 that the sealed channel can be realized by means of receiving portions and protrusions of geometric shapes such as those in the lower housing portion 160 and the upper housing portion 162.

Figure 8 schematically illustrates an exemplary embodiment of the continuous analyte monitoring system 280 of the present invention.

The continuous analyte monitoring system 280 includes a continuous analyte monitoring device 110. The continuous analyte monitoring device 110 may correspond to embodiments shown in Figures 1A and 1B. Therefore, refer to the description of these figures above.

The continuous analyte monitoring system 280 further includes an insertion device 282 that at least partially covers the continuous analyte monitoring device 110, wherein the insertion device 282 is configured to allow a user to drive the insertion cannula 124 into body tissue and insert the insertable portion 116 of the analyte sensor 112.

The continuous analyte monitoring system 280 may further include a sensor controller 284 coupled to the analyte sensor 112 of the continuous analyte monitoring device 110. The sensor controller 284 may be configured to receive analyte sensor data from the analyte sensor 110, as indicated by arrow 286.

The continuous analyzer monitoring system 280 may further include a remote control 288 configured to receive sensor data (as indicated by arrow 290) from the sensor controller 284, and to process and/or display the sensor data, such as via a user interface 292. The sensor controller 284 may be configured to transmit sensor data to the remote control 288.

110: Continuous Analyte Monitoring Device 111: Shell 112: Analyte Sensor 114: Carrier 115: Substrate 116: Insertable Part 121: Insertion Direction 122: Insertion Component 124: Insertion Cannula 126: Insertion Cannula Holder 128: Sharp End 130: Slotted Cannula 132: First End 134: Second End 136: Removable Sterile Cap 138: Upper Side 140: Lower Side 142: Distal Side 144: Proximal Side 146: Opening Channel 148: Extension Direction 150: Upper Opening 152: Lower Opening 154: Electronic compartment 156: Electronic unit 158: Sealed compartment 160: Lower housing 162: Upper housing 164: Connector unit 166: Sterile compartment 168: Opening 170: Wall 172: Connector unit wall 174: Longitudinal side 176: First side 178: Second side 180: Internal space 182: Internal space 184: Upper connector unit side 186: Lower connector unit side 188: Distal connector unit side 190: Proximal connector unit side 192: Channel 194: First end 196: Second end 198: 200: In vivo proximal portion; 202: Ex vivo distal portion; 204: First segment; 206: Second segment; 208: Electronic component; 210: Lower portion; 212: Upper portion; 214: Distal portion; 216: Proximal portion; 218: Upper segment; 220: Lower segment; 222: Base plate; 224: Upper plate; 226: Longitudinal side; 228: Lower surface; 230: Adhesive surface; 232: Longitudinal side; 234: Sensor compartment; 236: Sealing channel; 238: Input filling port; 240: Output filling port; 242: Sealing material; 244: Internal space; Circular Circumferential sealing channel 246: Groove 248: Surface 250: Cover 252: Flat plane 254: Groove 256: Surface 257: First arm 258: Inner cavity 259: Second arm 264: Inner circumferential sealing channel 266: Outer circumferential sealing channel 268: External environment 270: Wall 272: Connection channel 274: Groove 276: Cover 278: Cavity 280: Continuous analyte monitoring system 282: Insertion device 284: Sensor controller 286: Arrow 288: Remote control 290: Arrow 292: User interface

Further features and embodiments will be revealed in the detailed information of the following embodiments, preferably in conjunction with the appendix. Individual features may be implemented individually or in any feasible combination, as will be implemented by those skilled in the art. The scope of the invention is not limited to the preferred embodiments. The embodiments are illustrated graphically. Reference numerals in these figures refer to identical or functionally similar elements.

In these figures: Figures 1A and 1B illustrate exemplary embodiments of the continuous analyte monitoring device as described in the present invention in different cross-sectional views; Figures 2A to 2E illustrate exemplary embodiments of the components of the continuous analyte monitoring device as described in the present invention in different cross-sectional views; Figures 3A to 3C illustrate exemplary embodiments of the components of the continuous analyte monitoring device as described in the present invention in different cross-sectional views; Figure 4 illustrates an exemplary embodiment of the continuous analyte monitoring device as described in the present invention in cross-sectional view; Figures 5A to 5B illustrate exemplary embodiments of the components of the continuous analyte monitoring device as described in the present invention in perspective and top view; Figure 6 Figure 7 shows an exemplary embodiment of the components of the continuous analyte monitoring device as described in the present invention in a cross-sectional view; and Figure 8 shows an exemplary embodiment of the continuous analyte monitoring system as described in the present invention in a schematic diagram.

110: Continuous Analyte Monitoring Device

111: Shell

112: Analytical Material Sensor

114: Carrier

115:Substrate

116: Insertable portion

121: Insertion Direction

122: Insert Components

124: Insertion of a cannula

126: Insertion of the cannula retainer

128: Sharp end

130: Slotted insertion tube

132: First End

134: Second End

136: Removable sterile cap

138: Upper side

140: Lower side

142: Far side

144: Proximal

146: Open Access

148: Direction of Extension

150: Upper side opening

152: Lower side opening

154: Electronic Compartment

156: Electronic Unit

158: Sealed compartment

160: Lower shell section

162: Upper shell section

164: Connector Unit

166: Sterile compartments

168: Opening

170:Wall

172: Connector Unit Wall

174: Longitudinal lateral

176: First side

178: Second side

180: Interior Space

182: Interior Space

184: Upper connector unit side

186: Lower connector unit side

188: Remote connector unit side

190: Proximal connector unit side

192: Passage

194: First End

196: Second End

198: Proximal portion within the living organism

200: Distal portion outside the body

202: Section 1

204: Second Section

206: Electronic Components

208: Part Two

210: Upper Part

212: Distant portion

214: Proximal portion

216: Upper Section

218: Lower Section

220: Base Plate

222:On the board

224: Longitudinal lateral

226: Lower surface

228: Adhesive Surface

230: Longitudinal side

232: Sensor Compartment

234: Sealed Channel

240: Sealing material

242: Interior Space

244: Circumferential Sealing Channel

268: External Environment

Claims (18)

A continuous analyte monitoring device (110) includes: an analyte sensor (112) having an insertable portion (116) adapted to be at least partially inserted into a user's body tissue, wherein the analyte sensor (112) is configured to detect an analyte in the user's bodily fluids; an insertion assembly (122) including an insertion cannula (124) and an insertion cannula retainer (126), wherein the insertion cannula (124) is attached to the insertion cannula retainer (126), and wherein the analyte sensor (112) is at least partially placed within the insertion cannula (124); and a removable sterile cap (136), wherein the removable sterile cap (136) at least partially surrounds the insertable portion of the analyte sensor (112). (116); a housing (111), wherein the housing (111) includes an open channel (146) at least partially surrounding the analyte sensor (112) and the insertion assembly (122), wherein the housing (111) further includes an electronics compartment (154) therein housing an electronic unit (156); wherein the housing (111) is at least partially formed by a lower housing portion (160) and an upper housing portion (162), wherein the housing (111) includes a sealing channel (234) including an inlet filling port (136) and an outlet filling port (138), wherein the sealing channel (234) is at least partially filled with a sealing material. (240) The sealing material is configured to seal the internal space (242) enclosed by the upper shell portion (162) and the lower shell portion (160); wherein the removable sterile cap (136), the open channel (146) of the shell (111) and the insertion cannula retainer (126) are derived from the sterile compartment (166) of at least the insertable portion (116) of the insertion cannula (124) and the analyte sensor (112). The continuous analyte monitoring device (110) of claim 1, wherein the sealing channel (234) is configured to be filled with the sealing material (240) in the assembled state of the lower shell portion (160) and the upper shell portion (162). The continuous analyte monitoring device (110) of any one of claims 1 to 2, wherein the sealing material (240) is configured to securely attach the lower housing portion (160) and the upper housing portion (162) to each other. The continuous analyte monitoring device (110) of any one of claims 1 to 3, wherein the sealed channel (234) is formed at least in part by at least one of a groove (246) in the lower shell portion (160) and a groove (154) in the upper shell portion (162). The continuous analyte monitoring device (110) of any of claims 1 to 4, wherein the housing (111) further includes at least one cavity (278) disposed between the sealing channel (234) and the output filling port (238), wherein the cavity (278) is configured to collect excess sealing material (240) from the sealing channel (234). The continuous analyte monitoring device (110) of any of claims 1 to 5, wherein the housing (111) is at least partially formed as a cylindrical ring, wherein the sealing channel (234) is a circumferential sealing channel (244), wherein the sealing channel (234) isolates and seals the electronic compartment (154) from the sterile compartment (166), or wherein the circumferential sealing channel (244) isolates and seals the electronic compartment (154) from the outer environment (268) of the continuous analyte monitoring device (110). The continuous analyte monitoring device (110) of any of claims 1 to 6, wherein the housing (111) further includes a connector unit (164) having an open channel (146) of the housing (111), wherein the connector unit (164) has a channel (192) through which the analyte sensor (112) passes, wherein the channel (192) connects the sterile compartment (166) to the electronic compartment (154). The continuous analyte monitoring device (110) of claim 7, wherein the channel (192) intersects with the sealed channel (234). The continuous analyte monitoring device (110) of claim 8, wherein the channel (192) and the sealed channel (234) are at least partially filled with the sealing material (240), which is configured to seal the channel (192) including the through analyte sensor (112), so that the sterile compartment (166) is isolated and sealed from the electronic compartment (154). The continuous analyte monitoring device (110) of any of claims 7 to 9, wherein the analyte sensor (112) includes a proximal portion (198) in vivo and a distal portion (200) ex vivo, wherein the distal portion (200) includes a first segment (202) housed in the channel (192) and a second segment (204) housed in the electronic compartment (154), wherein the first segment (202) and the second segment (204) are arranged substantially in a straight line, or wherein the first segment (202) and the second segment (204) are arranged at an angle of 20° to 80° to each other. The continuous analyte monitoring device (110) of any of claims 7 to 10, wherein the lower housing portion (160) is the lower portion (208) of the connector unit (164), and wherein the upper housing portion (162) is the upper portion (210) of the connector unit (164). The continuous analyte monitoring device (110) of any of claims 7 to 11, wherein the sealed channel (234) is divided into a first arm (257) and a second arm (259) by means of the input filling port (236) and the output filling port (238), wherein the first arm (257) intersects the channel (192), wherein at least one of the following may be larger in the first arm (257) than in the second arm (259): the width of the cavity (258) of the sealed channel (234); the average width of the cavity (258) of the sealed channel (234); the dimensions of the sealed channel (234), specifically the dimensions of the cross-section of the sealed channel (234); the sealed channel (234) The average size, specifically the average size of the cross section of the sealing channel (234); the cross section area of the sealing channel (234); the average cross section area of the sealing channel (234). The continuous analyte monitoring device (110) of any one of claims 1 to 12, wherein the housing (111) includes two of the sealing channels (234), wherein the two sealing channels (234) include an inner circumferential sealing channel (264) and an outer circumferential sealing channel (266), wherein the inner circumferential sealing channel (264) has a smaller diameter than the outer circumferential sealing channel (266), wherein the inner circumferential sealing channel (264) and the outer circumferential sealing channel (266) are connected to each other via a connecting channel (272). The continuous analyte monitoring device (110) of claim 13, wherein the housing (111) is at least partially formed as a cylindrical ring, wherein the inner circumferential sealing channel (264) isolates and seals the electronic compartment (154) from the sterile compartment (166), and wherein the outer circumferential sealing channel (266) isolates and seals the electronic compartment (154) from the external environment (168) of the continuous analyte monitoring device (110). The continuous analyte monitoring device (110) of any of claims 1 to 14, wherein the housing (111) includes a base plate (220) and an upper plate (222) configured for attachment to a user’s skin, wherein the base plate (220) and the upper plate (222) are configured to form at least a portion of the longitudinal side (224) of the electronic compartment (154), wherein the lower housing portion (160) is the base plate (220), and wherein the upper housing portion (162) is the upper plate (222). A continuous analyte monitoring system (280) comprising: a continuous analyte monitoring device (110) as described in any of claims 1 to 15; an insertion device (282) at least partially covering the continuous analyte monitoring device (110), wherein the insertion device (282) is configured to allow a user to drive an insertion cannula (124) into the body tissue and insert it into the insertable portion (116) of the analyte sensor (112); a sensor controller (284) coupled to the analyte sensor (112), wherein the sensor controller (284) is configured to receive analyte sensor data from the analyte sensor (112); and a remote control. (288) is configured to receive sensor data from the sensor controller (284) and to process and/or display the sensor data. A method of assembling a continuous analyte monitoring device (110) as described in any of claims 1 to 15, wherein the method comprises: a) providing the lower housing portion (160); b) mounting the analyte sensor (112) onto the lower housing portion (160); c) placing the upper housing portion (162) onto the lower housing portion (160); d) injecting a sealing material (240) into the sealing channel (234) via the inlet filling port (136) such that the lower housing portion (160) and the upper housing portion (162) are fixedly attached to each other, and such that the internal space enclosed by the upper housing portion (162) and the lower housing portion (160) is... (242) It is sealed. A method of using a continuous analyte monitoring device (110) as described in any of claims 1 to 15, the method comprising: I. providing the continuous analyte monitoring device (110); II. removing the removable sterile cap (136); III. inserting the analyte sensor (112) into the user's body tissue; and IV. removing the insertion cannula retainer (126), thereby removing the insertion cannula (124) from the continuous analyte monitoring device (110).