WO2025162779A1

WO2025162779A1 - Continuous analyte monitoring device

Info

Publication number: WO2025162779A1
Application number: PCT/EP2025/051462
Authority: WO
Inventors: Harald VON CAMPENHAUSEN
Original assignee: Roche Diabetes Care GmbH
Current assignee: Roche Diabetes Care GmbH
Priority date: 2024-01-31
Filing date: 2025-01-22
Publication date: 2025-08-07
Anticipated expiration: 2026-07-31

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; • a removable 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 insertion cannula holder (126) comprises a sealing ring (188), 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 (H2); • an electronics unit (156), wherein the analyte sensor (112) is electrically connected to the electronics unit (156); • a housing (111) comprising: - a base plate (160) being configured for attachment to a skin site of the user and an upper plate (162), wherein the base plate (160) and the upper plate (162) form an electronics compartment (154), wherein the electronics unit (156) is received in the electronics compartment (154); - a connector unit (164), wherein the connector unit (164) is integral to the base plate (160), wherein the connector unit (164) comprises an open channel (146) which at least partially surrounds at least one of the analyte sensor (112) and the removable insertion component (122), wherein the connector unit (164) further comprises a sealed channel (168) connecting the open channel (146) with the electronics compartment (154), wherein the analyte sensor (112) passes through the sealed channel (168); wherein the removable sterility cap (136), the open channel (146) of the connector unit (164) and the insertion cannula holder (126) form a sterile compartment (210) for the insertion cannula (124) and at least the insertable portion (116) of the analyte sensor (112), wherein the sealing ring (188) of the insertion cannula holder (126) is configured for sealing the sterile compartment (210).

Description

Continuous analyte monitoring device

Technical Field

The invention relates to a continuous analyte monitoring device, to a continuous analyte monitoring system and to a method of using a continuous analyte monitoring device. The devices and method according to the present invention may mainly be used for long-term monitoring of an analyte concertation in a body fluid, such as for long-term monitoring of a blood glucose level or of the analyte concentration of one or more other types of analytes in the body fluid. The invention may both be applied in the field of home care as well as in the field of professional care, such as in hospitals. Other applications are feasible.

Background art

Monitoring certain body functions, more particularly monitoring one or more concentrations of certain analytes, plays an important role in the prevention and treatment of various diseases. Without restricting further possible applications, the invention will be described in the following text with reference to blood-glucose monitoring. However, additionally or alternatively, the invention can also be applied to other types of analytes.

Blood glucose monitoring, besides by using optical measurements, specifically may be performed by using electrochemical biosensors. Examples of electrochemical biosensors for measuring glucose, specifically in blood or other body 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 Al.

In addition to so-called spot measurements, in which a sample of a bodily fluid is taken from a user in a targeted fashion and examined with respect to the analyte concentration, continuous measurements are increasingly becoming established. Thus, in the recent past, continuous measuring of glucose in the interstitial tissue (also referred to as continuous monitoring, CM) for example has been established as another important method for managing, monitoring and controlling a diabetes state. In the process, an active sensor region is applied directly to a measurement site, which is generally arranged in the interstitial tissue, and, for example, converts glucose into electrical charge by using an enzyme (e.g. glucose oxidase, GOD), which charge 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 Bl or in US 2008/0242962 Al.

Hence, current continuous monitoring systems typically are transcutaneous systems or subcutaneous systems, wherein both expressions, in the following, will be used equivalently. This means that an actual sensor or at least a measuring portion of the sensor may be arranged under a skin of the user. However, an evaluation and control part of the system (also referred to as a patch) may be generally situated outside of the body of the user, outside of an human or animal body. In the process, the sensor maybe generally applied using an insertion instrument, which is likewise described in US 6,360,888 Bl in an exemplary fashion. Other types of insertion instruments are also known.

The sensor typically comprises a substrate, such as a flat substrate, onto which an electrically conductive pattern of electrodes, conductive traces and contact pads may be applied. In use, the conductive traces typically are isolated by using one or more electrically insulating materials. The electrically insulating material typically further also acts as a protection against humidity and other detrimental substances and, as an example, may comprise one or more cover layers such as resists.

Current continuous glucose monitoring devices such as the Abbott Freestyle Libre 3 device may comprise a connector which comprises a vertical opening that is part of a sterility unit which houses a part of the sensor to be inserted into the skin and an insertion cannula. A holder of the insertion cannula may seal an upper side of the connector whereas a sterility cap may seal a continuous analyte monitoring system of the connector. The sensor may penetrate the connector horizontally to connect to an electronics unit and it is commonly important for a preservation of a sterile state that a horizontal channel of the connector which envelops the sensor on its way to the electronics unit is tightly sealed. Sealing the sensor while passing through the connector is commonly a technical challenge. Moreover, commonly, after the sensor has been mounted on a lower sensor patch plate, a sensor patch connector and on top of that a sealing element needs to be mounted. This may render the continuous glucose monitoring device and its assembly complex.

EP3727130B1 describes a medical system. The medical system comprises: a. a housing; b. a preassembled functional module received in the housing, the pre- assembled functional module comprising bl. an analytical sensor for detecting at least one analyte in a body fluid of a user; b2. an electronics unit electrically connected to the analytical sensor; and b3. an insertion component for inserting the analytical sensor into a body tissue of the user; c. at least one removable protective cap connected to the housing, covering the preassembled functional module.

EP3202324A1 describes a medical device for detecting at least one analyte in a body fluid, a method for assembling the medical device and a method of using the medical device. The medical device comprises at least one analyte sensor having an insertable portion adapted for at least partially being inserted into a body tissue of a user; at least one insertion cannula, wherein the analyte sensor at least partially is placed inside the insertion cannula; at least one electronics unit, wherein the analyte sensor is operably connected to the electronics; at least one housing, wherein the housing comprises at least one electronics compartment configured to at least partially receive the electronics unit and at least one sensor compartment configured to at least partially receive the analyte sensor. The sensor compartment forms a sealed compartment receiving at least the insertable portion of the analyte sensor. The sealed compartment comprises at least one detachable upper cap and at least one detachable lower cap. The detachable lower cap is configured for detachment before insertion, thereby opening the insertable portion for insertion. The insertion cannula is attached to the detachable upper cap. The detachable upper cap is configured for detachment after insertion, thereby removing the insertion cannula. The electronics compartment at least partially surrounds the sensor compartment.

EP3202323 Al describes a medical device for detecting at least one analyte in a body fluid. The medical device comprises: at least one analyte sensor having an insertable portion adapted for at least partially being inserted into a body tissue of a user; at least one insertion cannula, wherein the analyte sensor at least partially is placed inside the insertion cannula; at least one housing, wherein the housing comprises at least one sensor compartment, wherein the sensor compartment forms a sealed compartment receiving at least the insertable portion of the analyte sensor, wherein the sealed compartment comprises at least one detachable upper cap and at least one detachable lower cap, wherein the detachable lower cap is configured for detachment before insertion, thereby opening the insertable portion for insertion, wherein the insertion cannula is attached to the detachable upper cap, wherein the detachable upper cap is configured for detachment after insertion, thereby removing the insertion cannula; and at least one electronics unit , wherein the analyte sensor is operably connected to the electronics unit, wherein the electronics unit comprises at least one interconnect device with at least one electronic component attached thereto, wherein the interconnect device fully or partially surrounds the housing.

US 11642055B2 and US11412966B2 respectively describe systems for applying a transcutaneous monitor to a person which can include a telescoping assembly, a sensor, and a base with adhesive to couple the sensor to skin. The sensor can be located within the telescoping assembly while the base protrudes from a distal end of the system. The system can be configured to couple the sensor to the base by compressing the telescoping assembly.

US11547357B2 describes embodiments which relate to an insertion device that includes a plunger coupled with a lock collar. The insertion device houses contents including: a striker including self-locking striker snap arm(s) where the striker is kept from firing by a striker spring captured between the plunger and the striker when the insertion device is in a cocked position; a sensor assembly; and a needle carrier that holds a piercing member, the needle carrier captured between the striker and a needle carrier spring where a self-releasing snap(s) keeps the needle carrier cocked, where the plunger prevents the self-releasing snap(s) from repositioning and releasing the needle carrier. The striker fires the needle carrier such that the self-locking striker snap arm(s) are positioned to allow the striker to snap down. The needle carrier is then retracted when the user releases the plunger and the piercing member is encapsulated within the insertion device.

US11484228B2 describes various analyte sensing apparatuses and associated housings. Some apparatuses comprise one or more caps. Some apparatuses comprise a two-part adhesive patch. Some apparatuses comprise one or more sensor bends configured to locate and/or hold a sensor in place during mounting. Some apparatuses utilize one or more dams and/or wells to retain epoxy for securing a sensor. Some apparatuses utilize a pocket and one or more adjacent areas and various transitions for preventing epoxy from wi eking to undesired areas of the apparatus. Some apparatuses include heat-sealable thermoplastic elastomers for welding a cap to the apparatus. Related methods of fabricating such apparatuses and/or housings are also described.

Problem to be solved

It is therefore desirable to provide a continuous analyte monitoring device, a continuous analyte monitoring system and a method of using a continuous analyte monitoring device, which solve at least one of the problems mentioned above. In particular, it is desirable to provide a simplified mounting of an analyte sensor in an analyte sensor patch including an easy positioning of the analyte sensor, an efficient sealing and a reliable contacting of the analyte sensor with the electronics unit.

Summary

At least one of the above-mentioned problems is addressed by a continuous analyte monitoring device, by a continuous analyte monitoring system and by a method of using a continuous analyte monitoring device with the features of the independent claims. Advantageous embodiments which might be realized in an isolated fashion or in any arbitrary combinations are listed in the dependent claims as well as throughout the specification.

As used in the following, the terms “have”, “comprise” or “include” or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms may both refer to a situation in which, besides the feature introduced by these terms, no further features are present in the entity described in this context and to a situation in which one or more further features are present. As an example, the expressions “A has B”, “A comprises B” and “A includes B” may both refer to a situation in which, besides B, no other element is present in A (i.e. a situation in which A solely and exclusively consists of B) and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D or even further elements.

Further, it shall be noted that the terms “an element” and “the element” may indicate that several elements such as at least two of the elements may be present in particular embodiments.

Further, it shall be noted that the terms “at least one”, “one or more” or similar expressions indicating that a feature or element may be present once or more than once typically will be used only once when introducing the respective feature or element. In the following, in most cases, when referring to the respective feature or element, the expressions “at least one” or “one or more” will not be repeated, non-withstanding the fact that the respective feature or element may be present once or more than once.

Further, as used in the following, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features, without restricting alternative possibilities. Thus, features introduced by these terms are optional features and are not intended to restrict the scope of the claims in any way. The invention may, as the skilled person will recognize, be performed by using alternative features. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without any restriction regarding alternative embodiments of the invention, without any restrictions regarding the scope of the invention and without any restriction regarding the possibility of combining the features introduced in such way with other optional or non-optional features of the invention.

The term “essentially perpendicular” may comprise slight deviations from a perpendicular arrangement such as arrangements which deviate from a perpendicular arrangement by no more than 10 degrees, preferably by no more than 5 degrees.

In a first aspect of the present invention, a continuous analyte monitoring device is disclosed comprising:

• an analyte sensor comprising an insertable portion adapted for at least partially being inserted into a body tissue of a user, wherein the analyte sensor is configured for detecting an analyte in a body fluid of the user;

• a removable insertion component comprising an insertion cannula and an insertion cannula holder, wherein the insertion cannula is attached to the insertion cannula holder, wherein the insertion cannula holder comprises a sealing ring, wherein the analyte sensor is at least partially placed inside the insertion cannula;

• a removable sterility cap, wherein the removable sterility cap at least partially surrounds the insertable portion of the analyte sensor;

• an electronics unit, wherein the analyte sensor is electrically connected to the electronics unit;

• a housing comprising: o a base plate being configured for attachment to a skin site of the user, and an upper plate, wherein the base plate and the upper plate form an electronics compartment, wherein the electronics unit is received in the electronics compartment; o a connector unit, wherein the connector unit is integral to the base plate, wherein the connector unit comprises an open channel which at least partially surrounds at least one of the analyte sensor and the removable insertion component, wherein the connector unit further comprises a sealed channel connecting the open channel with the electronics compartment, wherein the analyte sensor passes through the sealed channel; wherein the removable sterility cap, the open channel of the connector unit and the insertion cannula holder form a sterile compartment for the insertion cannula and at least the insertable portion of the analyte sensor, wherein the sealing ring of the insertion cannula holder is configured for sealing the sterile compartment.

The term “user” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term exemplarily relates to a person intending to monitor an analyte value, such as a glucose value, in a person’s body tissue. In an embodiment, the term specifically may refer, without limitation, to a person using the continuous analyte monitoring device which will further be described below in more detail. For example, the user may be a patient suffering from a disease, such as diabetes. The user may also be referred to as subject or as patient. However, in another embodiment, the person using the continuous analyte monitoring device is different from the user.

The term “continuous analyte monitoring device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to a medical device which is configured for use in the field of medical technology, exemplarily in the field of medical analytics or medical diagnostics. The continuous analyte monitoring device may be configured for performing a medical function and/or for being used in a medical process, such as in one or more of a therapeutic process, a diagnostic process or another medical process.

The continuous analyte monitoring device specifically may comprise an assembly of two or more components capable of interacting with each other, such as in order to perform one or more diagnostic and/or therapeutic purposes, such as in order to perform a medical analysis. Specifically, the two or more components may be capable of performing a detection of the analyte in the body fluid and/or of contributing to the detection of the analyte in the body fluid. The continuous analyte monitoring device generally may also be referred to as a sensor assembly, a sensor system, a sensor kit, a sensor device or a medical device.

The continuous analyte monitoring device specifically may be configured for monitoring or detecting a presence of the analyte in the body tissue and/or in the body fluid and/or may be configured for monitoring or detecting a concentration of the analyte in the body tissue and/or in the body fluid, specifically over time or in a time-dependent manner. Specifically, the continuous analyte monitoring device may be configured for acquiring and evaluating a data stream of time-dependent concentrations of the analyte. The data stream may be a continuous data stream. However, the data stream may comprise or may have one or more gaps wherein, during the gaps, no data may be acquired. Further, a number of data elements or signals per time unit which are acquired may vary over time. Specifically, the continuous analyte monitoring device may be configured for comparing a value of a concentration of the analyte with one or more threshold values. Further, specifically, the continuous analyte monitoring device may be configured for outputting warning signals under certain circumstances.

Specifically, the continuous analyte monitoring device may be a continuous glucose monitoring device. A concentration of glucose in blood or body fluid of the user or the patient may be dependent on events which increase or decrease a concentration of glucose such as an intake of food or physical activity. Thus, the concentration of glucose in the blood or body fluid may be describable as time-dependent concentration, e.g. the concentration may vary or change over time. Thus, when evaluating the concentration at a first point in time, the concentration may have a first value and when evaluating the concentration at a second point in time, the concentration may have a second value which may specifically differ from the first value. The second value may be higher or lower than the first value. However, in certain scenarios, the first value may be equivalent to the second value.

The continuous analyte monitoring device may be configured to be mounted on a skin site of a body part, specifically of the user, selected from the group consisting of: an arm, exemplarily an upper arm; a stomach; a shoulder; a back; hip; a leg. Specifically, the body part may be the upper arm. However, also other applications may be feasible.

The continuous analyte monitoring device may comprise a component which may be configured to stay outside of the body tissue. The component which may be configured to stay outside of the body tissue may specifically be the housing comprising the electronics compartment with the electronics unit received therein. Further, the analyte sensor, comprises, as outlined above, the insertable portion. The insertable portion may be configured for being inserted into the body tissue of the user.

The continuous analyte monitoring device may from a preassembled single unit. The term “preassembled” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to the fact that an assembly process has already taken place. Thus, the components of the continuous analyte monitoring device may already be assembled, such as by being mechanically interconnected, thereby being ready for use for the function, such as the medical function, e.g. for the analytical function. The pre-assembling specifically may take place in a factory, thereby rendering the continuous analyte monitoring device a factory-assembled functional module.

The continuous analyte monitoring device may be a disposable medical device. The term “disposable medical device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary medical device configured to be disposed of after use. Thus, one or more materials may specifically be low priced and/or easily recyclable. Specifically, the electronics unit may be a single-use electronics unit. The term “single-use” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a property of an arbitrary element of being configured to be applied only for one time. Thus, after detecting the analyte in the body fluid, the user may remove the continuous analyte monitoring device with the electronics units from the body tissue, dispose the continuous analyte monitoring device with the electronics unit and may utilize a further, new continuous analyte monitoring device comprising a further, new electronics unit for another detection of the analyte in the body fluid.

The term “body fluid” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to a fluid which typically is present in a body or body tissue of a user or a patient and/or which may be produced by the body of the user or the patient. As an example for body tissue, interstitial tissue may be named. Thus, as an example, the body fluid may be selected from the group consisting of blood and interstitial fluid. However, additionally or alternatively, one or more other types of body fluids may be used, such as saliva, tear fluid, urine or other body fluids. During detection of the analyte, the body fluid may be present within the body or body tissue.

The term “analyte” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary element, component or compound which may be present in a body fluid and a presence and/or a concentration of which may be of interest for a user, a patient or medical staff such as for a medical doctor. Particularly, the analyte may be or may comprise an arbitrary chemical substance or chemical compound which may take part in a metabolism of the user or the patient, such as a metabolite. As an example, the analyte may be selected from the group consisting of glucose, cholesterol, triglycerides, lactate. Additionally or alternatively, however, other types of analytes may be used and/or any combination of analytes may be determined. However, specifically, the analyte may be glucose. In the following, the continuous analyte monitoring device may specifically be described with respect to glucose monitoring. The detection of the analyte specifically may be an analyte-specific detection.

The term “detecting” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to a process of determining a presence and/or a quantity and/or a concentration of an analyte. Thus, the detection may be or may comprise a qualitative detection, simply determining the presence of the analyte or the absence of the analyte, and/or may be or may comprise a quantitative detection, which determines the quantity and/or the concentration of the analyte. As a result of the detection, a signal may be produced which characterizes an outcome of the detection, such as at least one measurement signal. The measurement signal specifically may be or may comprise an electronic signal such as a voltage and/or a current. The measurement signal may be or may comprise an analogue signal and/or may be or may comprise a digital signal.

The term “analyte sensor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to a sensor which is capable of qualitatively or quantitatively detecting a presence and/or a concentration of an analyte.

The analyte sensor may particularly be a transcutaneous sensor. The term “transcutaneous sensor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary sensor which is adapted to be fully or at least partly arranged within a body tissue of a patient or a user. For this purpose, the analyte sensor comprises the insertable portion. The term “insertable portion” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a part or component of an element configured to be insertable into an arbitrary body tissue. In order to further render the analyte sensor to be usable as a transcutaneous sensor, the analyte sensor may fully or partially provide a biocompatible surface, i.e. a surface which, at least during durations of use, do not have any detrimental effects on the user, the patient or the body tissue. Specifically, the insertable portion of the analyte sensor may comprise a biocompatible surface. As an example, the transcutaneous sensor, specifically the insertable portion, may fully or partially be covered with a biocompatible membrane, such as a polymer membrane or gel membrane which is permeable for the analyte and/or the body fluid and which, on the other hand, retains sensor substances such as one or more analyte detection agents within the sensor and prevents a migration of these substances into the body tissue. Other parts or components of the analyte sensor may stay outside of the body tissue. The other parts may be connectable to an evaluation device such as to the electronics units as will further be described below.

The transcutaneous sensor generally may be dimensioned such that a transcutaneous insertion is feasible, such as by providing a width in a direction perpendicular to an insertion direction of no more than 5 mm, preferably of no more than 2 mm, more preferably of no more than 1.5 mm. The sensor may have a length of less than 50 mm, such as a length of 30 mm or less, e.g. a length of 5 mm to 30 mm. As used herein, the term “length” may refer to a direction parallel to an insertion direction. It shall be noted, however, that other dimensions are feasible.

The analyte sensor may specifically be an electrochemical analyte sensor. The term “electrochemical sensor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a sensor which is configured to conduct an electrochemical measurement, specifically in order to detect an analyte in a body fluid of a user. The term “electrochemical measurement” may refer to a detection of an electrochemically detectable property of the analyte, such as to an electrochemical detection reaction. Thus, for example, the electrochemical detection reaction may be detected by comparing one or more electrode potentials. The electrochemical sensor specifically may be adapted to and/or may be usable to generate an electrical sensor signal which directly or indirectly indicates the presence and/or the extent of the electrochemical detection reaction, such as a current and/or a voltage. The detection may be analyte-specific. The measurement may be a qualitative and/or a quantitative measurement. Still, other embodiments are feasible.

The analyte sensor may comprise at least two electrodes. The term “electrode” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary element which is configured to or which is usable to electrically or electrochemically detect an analyte. Specifically, each electrode may comprise a conductive pad or conductive element, such as a metal pad and/or a metal element and/or a pad or element made of a conductive inorganic or organic material such as carbon and/or a conductive polymer. The conductive pad or conductive element may be uncovered and/or may be covered with an additional material, such as a sensor chemical. The at least two electrodes of the analyte sensor may be embodied such that an electrochemical reaction may take place at one or more of the electrodes, such as one or more working electrodes. Thus, the electrodes may be embodied such that an oxidation reaction and/or reduction reaction may take place at one or more of the electrodes. The electrochemical detection reaction may be detected by comparing one or more electrode potentials, such as an electrostatic potential of a working electrode with an electrostatic potential of one or more further electrodes such as a counter electrode or a reference electrode. Generally, the two or more electrodes may be used for one or more of an amperometric, an amperostatic, a potentiometric or a potentiostatic measurement. These types of measurements generally are known to the skilled person in the art of analyte detection, such as from WO 2007/071562 Al and/or the prior art documents disclosed therein. For potential setups of the electrodes, electrode materials or measurement setups, reference may be made to this document. It shall be noted, however, that other setups, electrode materials or measurement setups may be used within the present invention. The electrodes generally comprise an electrode conductor path configured for transmitting a sensor current for detecting the analyte. The electrode conductor path in turn may in particular embodiments be connected to the sensor electronics, such as via an electrode contact which connects with a corresponding contact of an electronic component of the sensor electronics.

The at least two electrodes may be a working electrode configured for detecting the analyte and a further electrode. The further electrode may be selected from the group consisting of a counter electrode, a reference electrode, and a combined counter-reference electrode. Exemplarily, the analyte sensor may comprise a two-electrode sensor. The two-electrode sensor may comprise precisely two electrodes, such as a working electrode and a further electrode such as a counter electrode, e.g. a working electrode and a combined counter/reference electrode. The term “working electrode” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an electrode being adapted for or being usable for performing an electrochemical detection reaction for detecting an analyte in a body fluid. The working electrode may comprise an analyte detection agent being sensitive to the analyte to be detected. The working electrode may further comprise a conductive working electrode pad. The conductive working electrode pad may be in contact with the analyte detection agent. Thus, the analyte detection agent may be coated onto the conductive working electrode pad. The analyte detection agent may form an analyte detection agent surface which may be in contact with the body fluid. As an example, the analyte detection agent surface may be an open analyte detection agent surface or may be covered by the above-mentioned membrane which is permeable to the analyte to be detected and/or to the body fluid or a part thereof, such that the analyte may interact with the analyte detection agent. For potential analyte detection agents and/or materials for the conductive working electrode pad, again, reference may be made to WO 2007/071562 Al and/or the prior art documents disclosed therein. Other embodiments, however, are feasible. The one or more “working electrode pads” specifically may be formed by a dot, line or grid which each can form a coherent area of an electrode material. If more than one dot, line or grid of the electrode material is superimposed, the sensor may provide more than one electrode pad. All electrode pads together may build the working electrode. The sensor may comprise the working electrode with a number of electrode pads in a range from 1 to 50, preferably from 2 to 30, preferably from 5 to 20 electrode pads.

The term “analyte detection agent” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary material or a composition of materials adapted to change a detectable property in a presence of an analyte. This property may be an electrochemically detectable property. Specifically, the analyte detection agent may be a highly selective analyte detection agent, which only changes the property if the analyte is present in the body fluid whereas no change occurs if the analyte is not present. The degree or change of the property is dependent on the concentration of the analyte in the body fluid, in order to allow a quantitative detection of the analyte. As an example, the analyte detection agent may comprise an enzyme, such as glucose oxidase and/ or glucose dehydrogenase.

The at least two electrodes may further comprise the counter electrode. The term “counter electrode” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an electrode adapted for performing an electrochemical counter reaction and adapted for balancing a current flow required by a detection reaction at a working electrode. Additionally or alternatively the at least two electrodes may further comprise reference electrode. The reference electrode may have a stable and well-known electrode potential. The electrode potential may preferably be highly stable. The counter electrode and the reference electrode may be one of a common electrode or two separate electrodes. Again, for potential materials usable for the counter electrode and/or the reference electrode, reference may be made to WO 2007/071562 Al and/or the prior art documents disclosed therein. Other embodiments, however, are feasible.

The electrodes, particularly the working electrode, the counter electrode and/or the reference electrode, may have an identical dimension. The term “dimension” may refer to one or more of a width, a length, a surface area, a shape of the working electrode, the counter electrode and/or the reference electrode. A shape of the electrodes may be determined by a manufacturing process, such as a cutting and/or a printing process. The shape may be rectangular or round. Still, other embodiments are feasible, such as embodiments in which the dimensions of the working electrode and the counter/reference electrodes differ and/or embodiments in which a non-circular shape or a non-rectangular shape is used. The electrodes may be made of a non-corrosive and non-passivating material. With regard to possible electrode materials, reference may be made to the prior art documents cited above.

The analyte sensor may comprise a carrier, specifically a substrate. The at least two electrodes may be disposed on the carrier. The term “carrier” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary element which is suitable to carry one or more other elements disposed thereon or therein. The term “substrate” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary flat element which has a lateral extension exceeding its thickness by at least a factor of 2, at least a factor of 5, at least a factor of 10, or even at least a factor of 20 or more.

The carrier, specifically the substrate, specifically may have an elongated shape, such as a strip-shape and/or a bar-shape. The substrate, as an example, may comprise a shaft, specifically a shaft having an elongate shape. For example the shaft may have a shape selected from the group consisting of a strip, a needle, a tape. Also other shapes may be feasible.

The carrier, specifically the substrate, may be a flexible carrier or substrate, i.e. a carrier or substrate which may be bent or deformed by forces which usually occur during wearing and insertion into the body tissue, such as forces of 10 N or less. Specifically the carrier or the substrate may be made of or may comprise a deformable material, such as a plastic or malleable material and/or an elastic material. As an example, the carrier or the substrate may be or may comprise a foil, such as a foil made of one or more of a paper material, a cardboard material, a plastic material, a metal material, a ceramic material or a glass material. As an example, the carrier or the substrate may comprise a polyimide foil. The carrier or the substrate specifically may comprise an electrically insulating material, such as an electrically insulating plastic foil.

Specifically, the analyte sensor may be a needle-shaped or a strip-shaped analyte sensor with a flexible substrate and the electrodes disposed thereon. As an example, the analyte sensor may have a total length of 5 mm to 50 mm, e.g. a total length of 7 mm to 30 mm. The term “total length” within the context of the present invention relates to the overall length of the analyte sensor which means a portion of the analyte sensor which is inserted and the portion of the analyte sensor which may stay outside of the body tissue.

The analyte sensor may comprise an in vivo proximal portion and an ex vivo distal portion. The in vivo proximal portion may correspond to the insertable portion of the analyte sensor as described above. The in vivo proximal portion may be configured for being inserted into the body tissue of the user. The in vivo proximal portion may be received in the sterile compartment. The ex vivo distal portion may be configured for staying outside of the body tissue of the user. The ex vivo distal portion and the in vivo proximal portion may be arranged transversely, specifically essentially perpendicularly, to each other. The in vivo proximal portion may extend along a direction of insertion. For example, the in vivo proximal portion may have a length in the range from 3 mm to 12 mm. The analyte sensor may further comprise a biocompatible cover, such as a biocompatible membrane which fully or partially covers the analyte sensor and which prevents the analyte detection agent from migrating into the body tissue and which allows for a diffusion of the body fluid and/or the analyte to the electrodes.

The term “insertion component” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary element which may be insertable at least partially into the body tissue, particularly in order to deliver or to transfer a further element. The removable insertion component may be configured for supporting the insertion of the analyte sensor or the insertion of a part of the analyte sensor. The term “removable” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to a property of an element of being removable from an arbitrary object. Thereby, a close bonding or contact or a connection between the element and the object may be disconnected. Generally, the element may be removable in a reversible manner wherein the element may be attachable and detachable from the object in a reversible manner or in an irreversible manner wherein the element may not be attachable to the object after detachment. Further details are given below.

As outlined above, the removable insertion component comprises the insertion cannula. The term “insertion cannula” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a hollow needle which may be at least partially or completely slotted. The analyte sensor may be received within the insertion cannula, such as within a lumen of the insertion cannula. The insertion cannula may comprise a tip or a sharp end for inserting the analyte sensor at least partially into the body tissue. The insertion cannula e.g. may comprise at least one cross-section selected from the group consisting of: round, elliptical, U shaped, V shaped. Still, other embodiments are feasible. Specifically, the insertion cannula may be a slotted cannula. Alternatively, the insertion cannula may be a non-slotted cannula. The insertion cannula may be configured to be inserted vertically or at an angle of 90° to 30° relative to the body tissue of the user.

As further outlined above, the removable insertion component further comprises the insertion cannula holder for the insertion cannula. The term “insertion cannula holder” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary element which may be configured for holding an insertion cannula. The insertion cannula may be attached to the insertion cannula holder. Specifically, the insertion cannula may be fixedly attached to the insertion cannula holder. The insertion cannula holder may at least partially surround the insertion cannula. Specifically, the insertion cannula may comprise a first end and an opposing second end. The first end may comprise a tip or a sharp end for inserting the analyte sensor at least partially into the body tissue. The second end may be attached to the insertion cannula holder. The insertion cannula holder may be configured for removal, specifically from the housing of the continuous analyte monitoring device, after insertion of the insertable portion of the analyte sensor into the body tissue. As outlined above, the insertion cannula holder comprises the sealing ring and the sealing ring of the insertion cannula holder is configured for sealing the sterile compartment. The term “sealing ring” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary element which is configured to surround one or more elements or one or more compartments to be sealed off from environmental influences such as moisture or dirt. Specifically, the sealing ring may be configured to surround the at least one element or the at least one compartment to be sealed off from the environmental influences in at least two dimensions. The sealing ring may specifically be a ring-shaped element. The ring-shaped element may have the shape of a circular ring, a polygonal ring, an oval ring or any other closed shape. The sealing ring specifically may be made of at least one compressible material. The sealing ring may exemplarily be may made of at least one thermoplastic elastomer. However, also other materials may be possible.

The sealing ring of the insertion cannula holder may be attached to the insertion cannula holder, specifically fixedly. Further, the sealing ring and residual components of the insertion cannula holder may be or may form a two component injection molded element. Exemplarily, the insertion cannula holder may comprise a side, specifically a lower side, facing the housing. Specifically, the sealing ring of the insertion cannula holder may be located at the side, specifically at the lower side. The sealing ring may be arranged on a lower part of the insertion cannula holder which may specifically face an upper side of the connector unit. Specifically, the sealing ring of the insertion cannula holder may face the housing, specifically the upper side of the connector unit. Specifically in an assembled state of the continuous analyte monitoring device, the sealing ring of the insertion cannula holder may be in direct contact with the upper side of the connector unit. Further, specifically in an assembled state of the continuous analyte monitoring device, the sealing ring of the insertion cannula holder may be in direct contact with an upper surface of the sealed channel. Specifically in an assembled state of the continuous analyte monitoring device, the sealing ring of the insertion cannula holder may be configured for sealing with the upper surface of the sealed channel. More specifically, the sealing ring of the insertion cannula holder may be configured for sealing with the upper surface of the sealed channel and with the upper side of the connector unit.

Further, specifically in an assembled state of the continuous analyte monitoring device, the sealing ring may be arranged between a part of the insertion cannula holder and the housing, specifically the connector unit of the housing. The availability of the sealing ring at the insertion cannula holder may obviate the need to provide a corresponding sealing ring on the upper side of the connector unit which may reduce the complexity in design of the device and its assembly compared to hitherto know systems.

As outlined above, the continuous analyte monitoring device further comprises the removable sterility cap.

The term “cap” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary element which is configured to close or to seal a volume. Specifically, the cap may close or seal an opening of an arbitrary container. The “cap” may have the form of a half-shell, a hemisphere, an open container, a lid or a cover. With regard to a definition of the term “removable”, reference is made to the description above.

The term “sterility cap” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an element such as a cover which is configured for maintaining a sterile atmosphere in a space fully or partially surrounded by the element. The sterility cap, as an example, may be a rigid sterility cap, e.g. made of a rigid plastic material and/or a metal. The sterility cap, as an example, may have a rotational symmetry about an axis which, as an example, may be identical to a rotational symmetry axis of the protective cap and/or of a rotational symmetry axis of the housing. The sterility cap, as an example, may have an elongated shape, with a length exceeding its diameter or equivalent diameter by at least a factor of 2, more preferably by at least a factor of five. The sterility cap, as an example, may have a length of 5 to 20 mm, e.g. a length of 10 to 15 mm.

As outlined above, the removable sterility cap at least partially surrounds the insertable portion of the analyte sensor. Thus, the insertable portion of the analyte sensor may be at least partially received in the removable sterility cap. Further, the removable sterility cap may at least partially surround the insertion cannula. Optionally, the removable sterility cap may at least partially surround the insertion cannula holder. The removable sterility cap may be configured for removal, specifically from the housing of the continuous analyte monitoring device, before insertion of the insertable portion of the analyte sensor and of the insertion cannula into the body tissue. The term “electronics unit” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary device which is configured for performing at least one electronic function. Specifically, the electronics unit may comprise at least one electronic component. Specifically, the electronics unit may comprise at least one electronic component for one or more of performing a measurement with the analyte sensor, performing a voltage measurement, performing a current measurement, recording sensor signals, storing measurement signals or measurement data, transmitting sensor signals or measurement data to another device. The electronics unit may specifically be embodied as a transmitter or may comprise a transmitter, for transmitting data. Other embodiments of the electronic components are feasible. These electronic components generally are known in the art of long-term monitoring one or more analytes, such as in from one or more of the above-mentioned prior art documents.

The electronics unit may comprise at least one circuit carrier, preferably a printed circuit board, more preferably a flexible printed circuit board. The term “circuit carrier” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an element or a combination of elements which are capable of carrying one or more electronic components and of interconnecting these one or more electronics components, such as interconnecting the one or more electronics components electrically or electronically with each other and/or with one or more contact pads. As an example, the circuit carrier may comprise a base and one or more electrical traces and/or one or more electrical contact pads disposed thereon and/or therein. The base, as an example, may be a flat element with a lateral extension which exceeds its width by at least a factor of 10, more preferably by at least a factor of 100 or even a factor of 1000. Other embodiments are feasible. Rigid materials which may be used for the base may be fiber-enforced plastic materials such as fiber-enforced epoxy materials like glass-fiber-enforced epoxy materials such as FR- 4. Other materials may be used. Specifically, the base may be a flexible base, such that the circuit carrier may fully or partially be embodied as a flexible printed circuit board. In this case, as an example, the flexible base may fully or partially be made of one or more flexible plastic materials such as one or more plastic foils or laminate, such as polyimides.

At least one electronic component may be attached to the circuit carrier. The term “electronic component” may generally refer to an arbitrary element or combination of elements which fulfill an electrical or electronic purpose. Specifically, the at least one electronic component may be or may comprise at least one component selected from the group consisting of an integrated circuit, an amplifier, a resistor, a transistor, a capacitor, a diode or an arbitrary combination thereof. The at least one electronic component specifically may be or may comprise a device capable of controlling the analyte sensor, in order to perform an analytical measurement with the analyte sensor. Specifically, the device may comprise a voltage measurement device and/or a current measurement device. Other setups or embodiments are feasible. The at least one electronic component, as an example, may comprise an applicationspecific integrated circuit (ASIC).

Therein, the at least one electronic component may directly or indirectly be attached to the circuit carrier. The circuit carrier may be a printed circuit board, particularly a flexible printed circuit board. As an example, the at least one electronic component may directly be attached to the circuit carrier by using one or more of soldering, bonding or electrically conductive adhesive. Thus, the circuit carrier may comprise one or more contact pads, wherein corresponding contacts of the at least one electronic component are electrically connected to the one or more contact pads. Additionally or alternatively, however, the at least one electronic component may indirectly be attached to the circuit carrier, such as via an electronic housing. Thus, the electronic housing may be attached to the circuit carrier. Still, an electrical contact between the at least one electronic component and the circuit carrier may be made, such as via a contact passing through the electronic housing. The electronic housing may fully or partially surround the at least one electronic component. As an example, the electronic housing may comprise a lower electronic housing component attached to the circuit carrier, wherein the electronic devices inserted into the lower electronic housing component on a side opposing the circuit carrier. The electronic housing may further comprise a further electronic housing component, such as an upper electronic housing component, which, in conjunction with the lower electronic housing component, may form an encapsulation which fully or partially surrounds the at least one electronic component. Additionally or alternatively, however, other types of encapsulation of the at least one electronic component may be used, such as encapsulation by using one or more casting and/or potting compounds. Thus, as an example, the lower electronic housing component may be used for receiving the at least one electronic component, wherein the upper shell or protection above the at least one electronic component is created by using a casting and/or potting, such as by using one or more of an epoxy, a thermoplastic polymer, a rather, a silicone, and epoxies or the like. Additionally or alternatively, no electronic housing component may be used at all, such as by directly placing the electronic component onto the circuit carrier. Specifically, the electronics unit may comprise an electrical energy reservoir, specifically a battery. The term “battery” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary source of electric power comprising one or more electrochemical cells with external connections for powering an electrical device. When a battery supplies power, its positive terminal may be referred to as cathode and its negative terminal may be referred to as anode. The battery may specifically be a primary battery. The primary battery may be configured for being used once. The primary battery may also be referred to as single-use or disposable battery.

As outlined above, the continuous analyte monitoring device further comprises the housing. The term “housing” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary element which is adapted to fully or partially surround and/or receive one or more elements in order to provide one or more of a mechanical protection, a mechanical stability, an environmental protection against moisture and/or ambient atmosphere, a shielding against electromagnetic influences or the like. Thus, the housing may simply provide a basis for attachment and/or holding one or more further components or elements. Additionally or alternatively, the housing may provide one or more interior spaces for receiving one or more further components or elements. The housing may specifically be manufactured by injection molding. However, other embodiments are feasible.

The housing may comprise a lower side and an upper side. The terms “upper side” and “lower side” may refer to two opposing sides of the housing. The terms “upper side” and “lower side” may be considered as description without specifying an order and without excluding a possibility that several kinds of upper sides and lower sides may be applied. Specifically, the upper side may refer to a distal side of the housing. Specifically, the lower side may refer to a proximal side of the housing.

The term “distal side” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an indication of a position of the side of the housing in relation to a user which is furthermost away from a skin site of the user. Exemplarily, for inserting the analyte sensor, the housing may be brought into contact with the skin site of the user. The distal side may refer to a side being distanced to the skin site of the user. The term “proximal side” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an indication of a position of the side of the housing in relation to a user which is closest to a skin site of the user. Exemplarily, for inserting the analyte sensor, the housing may be brought into contact with the skin site of the user. The proximal side may refer to a side being in close proximity to or even in direct contact with to the skin site of the user.

The base plate may refer to a lower housing portion of the housing and the upper plate may refer to an upper housing portion of the housing. The terms “lower housing portion” and “upper housing portion” may be considered as description without specifying an order and without excluding a possibility that several kinds of lower housing portions and upper housing portions may be applied.

Specifically, the upper plate may refer to a distal housing portion of the housing. The term “distal housing portion” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an indication of a position of the portion of the housing in relation to a user which is furthermost away from a skin site of the user and/or which faces away from the skin site. Exemplarily, for inserting the analyte sensor, the housing may be brought into contact with the skin site of the user. The distal housing portion may refer to a housing portion being distanced to the skin site of the user and/or refer to a housing portion facing away from the skin site.

Specifically, the base plate may refer to a proximal housing portion of the housing. The term “proximal housing portion” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an indication of a position of the housing portion of the housing in relation to a user which is closest to a skin site of the user and/or which faces the skin site. Exemplarily, for inserting the analyte sensor, the housing may be brought into contact with the skin site of the user. The proximal housing portion may refer to a housing portion being in close proximity to or even in direct contact with to the skin site of the user and/or refer to a housing portion facing the skin site. As outlined above, the base plate is configured for attachment to the skin site of the user, specifically via at least one adhesive. Specifically, the base plate may comprise a lower surface configured for being placed on a user’s skin. The lower surface may exemplarily have a shape of a circular ring surrounding the analyte sensor. More specifically, the base plate may comprise an adhesive surface for attachment to the user’s skin. The lower surface may be or may comprise the adhesive surface. The term “adhesive surface” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to a surface being capable to bind to an object and to resist separation. Exemplarily, the adhesive surface may be provided by a plaster or an adhesive strip. The plaster or the adhesive strip may comprise an adhesive material. The adhesive surface may be directly or indirectly attached to the housing.

As outlined above, the base plate and the upper plate form the electronics compartment with the electronics unit received therein. The base plate and upper plate may form an encapsulation for the at least one electronic component of the electronics unit. The base plate and the upper plate may be connected to each other via at least one connection, specifically such as by at least one of a form-fit connection, a force-fit connection and a connection by material engagement. Specifically, the base plate and the upper plate may be configured to be connected by a sealing connection. The sealing connection may be selected from the group consisting of a force-fit connection, a form-fit connection, a connection established by gluing or ultrasound welding.

The term “compartment” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary subpart of a superior element creating a partially or fully enclosed space that may be usable to contain and/or store objects. The subpart may specifically be completely or at least to a large extent closed such that an interior of the compartment may be isolated from a surrounding environment. Exemplarily, the compartment may be separated from other parts of the superior element by one or more walls. Thus, within the continuous analyte monitoring device, two or more compartments may be comprised which may fully or partially be separated from one another by one or more walls of the continuous analyte monitoring device. Each compartment may comprise a continuous space or lumen configured for receiving one or more objects.

The term “electronics compartment” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary compartment which is configured for receiving an element or a combination of elements which fulfill an electrical or electronic purpose. The electronics unit may be positioned within the electronics compartment of the housing, specifically fixedly positioned.

Further, as outlined above, the housing comprises the connector unit. The term “connector unit” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary device which is configured for connecting one object with another object. Specifically, the connector unit may be configured for connecting the sterile compartment with the electronics compartment.

As outlined above, the connector unit comprises the open channel. The connector unit may comprise an upper side and a lower side. The open channel may connect the upper side of the connector unit and the lower side of the connector unit. Further, the open channel may connect the upper side of the housing and the lower side of the housing. The terms “upper side” and “lower side” may refer to two opposing sides of the connector unit. The terms “upper side” and “lower side” may be considered as description without specifying an order and without excluding a possibility that several kinds of upper sides and lower sides may be applied. Specifically, the upper side may refer to a distal side of the connector unit. Specifically, the lower side may refer to a proximal side of the connector unit. With regard to definitions of the terms “distal side” and “proximal side”, reference is made to the description above.

The term “channel” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary element which may have an elongate shape and which may provide a free volume or lumen and which enables other elements to pass there through. The channel may specifically be an essentially straight, curved or circular shaped channel. As further used herein, the term “straight” may refer to a continuous extension of the channel in one direction essentially without a bend, angle or curve.

The open channel may extend along the direction of insertion of the analyte sensor and the open channel may specifically be a straight channel. The direction of insertion may be transverse, specifically essentially perpendicular, to the skin site of the user. The direction of insertion may be transverse, specifically essentially perpendicular, relative to the upper side and to the lower side of the connector unit. Further, the open channel may extend transversely, specifically essentially perpendicularly, to a direction of extension of the housing. The open channel may extend transversely, specifically essentially perpendicularly, relative to the upper side and to the lower side of the connector unit. The direction of insertion may correspond to a direction of extension of the open channel. The open channel may specifically comprise an upper side opening and an opposing lower side opening. The upper side opening may be located on the upper side of the connector unit facing away from the skin site and the lower side opening may be located on the lower side of connector unit facing the skin site.

As outlined above, the open channel at least partially surrounds at least one of the analyte sensor and the removable insertion component. Specifically, the open channel may at least partially circumferentially surround at least one of the analyte sensor and the removable insertion component, specifically at least the insertion cannula of the removable insertion component and/or a part of the insertion cannula holder of the removable insertion component. The open channel may from a compartment, specifically a compartment for at least partially receiving the analyte sensor and/or the removable insertion component. The connector unit may be at least partially formed as a cylindrical ring at least partially surrounding at least one of the analyte sensor and the removable insertion component, specifically at least the insertion cannula of the removable insertion component and/or a part of the insertion cannula holder of the removable insertion component.

The analyte sensor, specifically the insertable portion of the analyte sensor, may extend downwardly inside the open channel beyond the lower side of the connector unit. Further, the insertable portion of the insertion cannula may extend downwardly inside the open channel beyond the lower side of the connector unit. The insertion cannula holder may optionally be at least partially surrounded by the open channel. Thus, the insertion cannula holder may, optionally, at least partially protrude into the open channel, specifically from the upper side of the connector unit. The insertion cannula holder may be at least partially received inside the open channel. Optionally, the insertion cannula holder may extend downwardly inside the open channel beyond the lower side of the connector unit, specifically in case the insertion cannula holder is connected to the removable sterility cap. Further details are given below.

The insertion cannula holder may be at least partially arranged on the upper side of the connector unit. The insertion cannula holder may be configured for sealing the upper side opening of the open channel. The removable sterility cap may be at least partially arranged on the lower side of the housing. The removable sterility cap may be configured for sealing the lower side opening of the open channel. The insertion cannula holder may seal with the upper side opening of the open channel and the removable sterility cap may seal with the lower side opening of the open channel.

The open channel may be sealed off from the electronics compartment by a wall of the open channel. In particular, this way, a risk that the sealed compartment, which is in particular a sterile compartment, may not be contaminated by anything in the electronics compartment may be reduced and the sealed compartment may remain sterile. The wall of the open channel may be formed by the connector unit. Specifically, the connector unit may comprise a connector unit wall, specifically extending in the direction of insertion of the analyte sensor or extending transversely, specifically essentially perpendicularly, to longitudinal sides of the housing. The connector unit wall may comprise a first side and an opposing second side. The first side may face an interior space of the open channel. Further, second side may face an interior space of the electronics compartment. The electronics compartment and/or the electronics unit may at least partially surround, specifically at least partially circumferentially surround, the sterile compartment, specifically the open channel.

The connector unit may specifically form an intermediate component. The term “intermediate component” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary component or compartment between at least two other compartments or components and/or which may be located in another compartment. Thus, the intermediate component may form part of the sterile compartment and may be sealed from the electronics compartment. The intermediate component may be or may comprise an intermediate compartment and/or, as an example, a sealing ring or a ring-shaped element. Specifically, the electronics compartment may at least partially surround the intermediate component. The intermediate component may be at least partially designed as a cylindrical ring at least partially surrounding the analyte sensor and/or the removable insertion component.

As outlined above, the connector unit is integral to the base plate. The term “integral” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a state wherein two or more components are arranged in a space-saving or compact manner. At least one of the two or more components may be permanently built into at least another one of the two or more components. The connector unit and the base plate may specifically form a single piece. The connector unit and the base plate may be permanently built into each other or may be manufactured in one single piece. The connector unit may be or may be formed as a wall protruding transversely, specifically essentially perpendicularly, from the base plate. The wall of the connector unit may be permanently built onto the base plate or the wall of the connector unit and the base plate may be manufactured in one single piece. The upper plate may be distinct from a unit formed by the connector unit and the base plate. The upper plate may be mounted or mountable onto the base plate. Thus, the upper plate and the unit formed by the connector unit and the base plate may be provided as separate pieces.

The base plate and the upper plate may be configured for forming at least parts of the longitudinal sides of the housing, specifically of the electronics compartment. Specifically, the base plate, in conjunction with the connector unit, and the upper plate, may form an encapsulation for the electronics unit. Specifically, the electronics compartment may be formed by the base plate, by the upper plate and by the connector unit. The longitudinal sides of the electronics compartment may be formed by the base plate and the upper plate and, optionally, also by sides of the connector unit. The adhesive surface may specifically be a surface of the base plate and, optionally, also a surface of the connector unit. Further, shorter sides of the electronics compartment facing the outer environment of the continuous analyte monitoring device may be formed at least partially by the base plate and/or by the upper plate.

As outlined above, the connector unit further comprises the sealed channel connecting the open channel with the electronics compartment, wherein the analyte sensor passes through the sealed channel. Specifically, the connector unit and the electronics compartment may share a common wall. Specifically, the sealed channel may pass through the common wall. With regard to a definition of the term “channel”, reference is made to the description above. The sealed channel may also be referred to as sealed opening, sealed through opening or sealed through going opening. The sealed channel may specifically be an essentially straight channel, i.e. the channel may specifically extend continuously in one direction essentially without a bend, angle or curve. The sealed channel may extend transversely, specifically essentially perpendicularly, to the direction of insertion of the analyte sensor. The sealed channel may be distinct from the open channel. The open channel and the sealed channel may be arranged transversely, specifically essentially perpendicularly, to each other. The sealed channel may specifically be radially oriented. Specifically, the sealed channel may be radially oriented relative to the lower side of the housing and/or to the lower side of the connector unit. Specifically, the sealed channel may extend radially from a center of the open channel. Further, specifically, the sealed channel may extend in a direction of a radius of the connector unit. The term “sealed” may generally refer to a property of an arbitrary element of being completely or at least to a large extent isolated from a surrounding environment. Specifically, the sealed channel may be sealed with the sealing material. Further details are given below.

The sealed channel may connect the sterile compartment, specifically an interior space enclosed by the open channel, with the electronics compartment. Specifically, the sealed channel may comprise a first end and an opposing second end. The first end may lead to the sterile compartment, specifically to the interior space enclosed by the open channel, and the second end may lead to the electronics compartment. The analyte sensor may be partially received in the sterile compartment, specifically inside the open channel, and partially received in the electronics compartment. More specifically, the analyte sensor may be partially received in the sterile compartment, specifically inside the open channel, partially received within the sealed channel of the connector unit and partially received in the electronics compartment. The ex vivo distal portion of the analyte sensor may comprise a first section being received in the sealed channel and a second section being received in the electronics compartment. Specifically, the second section may be electrically connected to the electronics unit. As outlined above, the electronics unit is electrically connected to the analyte sensor. Thus, specifically, the second section of the ex vivo distal portion may be electrically connected to an electronics component of the electronics unit. More specifically, electrical contacts of the analyte sensor may be electrically connected to electrical contacts of the electronics unit.

The sealed channel may be at least partially formed by a groove, by a hole or by a cutout within the connector unit, specifically within a wall of the connector unit and/or of an open channel wall. The groove may specifically be a recess or a cutout within the open channel wall, specifically from the upper side of the connector unit. Further, the sealed channel may be at least partially formed by a compartment of the connector unit, specifically by an open compartment of the connector unit. The groove or the compartment may specifically be accessible from the upper side of the connector unit. Further, the groove or the compartment may specifically be accessible from the open channel and from the electronics compartment. The groove or the compartment may protrude from the upper side of the connector unit towards the lower side of the connector unit. The analyte sensor may be partially received within the groove or the compartment and may be partially located outside the groove or the compartment such as within the open channel and within the electronics compartment. The insertable portion of the analyte sensor may be located outside of the groove or of the compartment.

The groove or the compartment may have an essentially rectangular shape. However, also other kind of shapes may be possible. Thus, exemplarily, the groove or the compartment may be at least partially funnel-shaped. Thereby, a diameter of the groove may decrease, specifically continuously, from the upper side of the connector unit towards the lower side of the connector unit. Due to the funnel-shaped groove or compartment, at least one of a self-positioning, a self-aligning of the analyte sensor within the groove may be facilitated or improved.

The analyte sensor may be fixedly positioned in the sealed channel. Specifically, the analyte sensor may be sealingly embedded by a sealing material in the sealed channel. The sealing material may specifically be glue and/or silicone. However, also other kind of materials may be possible. The sealed channel may be configured to be filled with the sealing material a) in an assembled state of the analyte sensor and the base plate or b) before the analyte sensor is introduced into the base plate. In cases a) and b), the sealed channel may specifically be configured to be filled with the sealing material before the insertion cannula and the insertion cannula holder are mounted onto the connector unit. Specifically, the sealed channel may be configured to be filled with the sealing material before or after the analyte sensor is received in the sealed channel. Thus, firstly, the analyte sensor may be mounted onto the base plate and, secondly, a channel may be filled with the sealing material, specifically such that the sealed channel is formed. Thereafter, the removable sterility cap and the removable insertion component may be mounted onto the connector unit and a sealed sensor compartment may be formed. A unit comprising the base plate with the connector unit, the analyte sensor, the removable sterility cap and the removable insertion component may from a sterile unit. The sterile unit may be sterilized. Thereafter, the electronics unit may be placed into the base plate and the upper plate may be mounted on the base plate.

Specifically, the continuous analyte monitoring device may further comprise at least two locking arms being at least partially received within the sealed channel. The at least two locking arms may be configured for positioning and/or for fixing the analyte sensor within the sealed channel.

The term “locking arm” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary element whereby a function of fixing an object in a desired position is achieved by probing by at least one spring- supported element. The locking arm may comprise at least one contact surface configured for contacting a surface of the object. The locking arm or at least a portion of the locking arm may be configured for storing mechanical energy through elastic deformation and for, thus, maintaining a contact with the object.

The at least two locking arms may respectively comprise a contact surface for contacting the analyte sensor. The term “contact surface” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary surface which is configured for establishing a direct contact to a surface of another element. Specifically, the contact surface may be configured for fixing the other element in a desired position.

Exemplarily, the analyte sensor, specifically the section of the analyte sensor being received in the sealed channel, may comprise a first side and an opposing second side. One of the at least two locking arms may be configured for contacting the analyte sensor on the first side and another one of the at least two locking arms may be configured for contacting the analyte sensor on the second side. Thus, the at least two locking arms may be configured for providing force onto the analyte sensor from two contrary directions. Alternatively, exemplarily, the at least two locking arms may be configured for contacting the analyte sensor on a same side of the analyte sensor. Specifically, the at least two locking arms may respectively be configured for contacting the analyte sensor on a side opposing a contact side of the analyte sensor which rests on a surface of the sealed channel. Also other embodiments may be possible.

The at least two locking arms may respectively be elongate elements. Specifically, the at least two locking arms may respectively comprise at least one first end and at least one opposing second end. The contact surfaces may respectively be located at the second end. Specifically, the first ends of the at least two locking arms may respectively be attached, specifically fixedly attached, to a sidewall of the sealed channel. The at least two locking arms may respectively protrude from the sidewall of the sealed channel. The second ends of the at least two locking arms may respectively protrude into an interior space of the sealed channel. Specifically, the contact surfaces of the at least two locking arms may respectively face, specifically protrude, into the interior space of the sealed channel. Further, specifically, one or both of the at least two locking arms may comprise at least one protrusion protruding into the interior space of the sealed channel. The protrusions may respectively be configured for contacting the analyte sensor. The protrusions may specifically have a basic shape selected from the group consisting of a cylindrical shape, a cone shape, a truncated cone shape, a pyramidal shape. However, also other kind of shapes may be possible. The protrusions may respectively form the contact surfaces of the at least two locking arms as described above. The protrusions may specifically be fixedly attached such as soldered on a surface of the at least two locking arms.

Specifically, the at least two locking arms may be essentially identical locking arms. Specifically, the contact surfaces of the at least two locking arms may be identical contact surfaces. Specifically, the at least two locking arms may be arranged opposite to each other, specifically on opposing sides of the sealed channel.

Further, the continuous analyte monitoring device may comprise at least one foil. As outlined above, the sealed channel may comprise the first end and the opposing second end. The at least one foil may be attached to at least one of the first end and the second end. The at least one foil may be configured for being at least partially opened and/or destroyed when the analyte sensor is placed into the sealed channel. The at least one foil may be configured for preventing a flow of the sealing material into at least one of the open channel and the electronics compartment. The at least one foil may be configured for preventing a flow of the sealing material into at least one of the open channel and the electronics compartment, specifically during filling of the sealing material into the sealed channel, in particular as long as the sealing material is not hardened.

As outlined above, the removable sterility cap, the open channel of the connector unit and the insertion cannula holder form the sterile compartment for the insertion cannula and at least the insertable portion of the analyte sensor. Thus, the insertion cannula and at least the insertable portion of the analyte sensor may be received in the sterile compartment. The sterile compartment may also be referred to as sensor compartment.

The sterile compartment may be a sealed compartment. The term “sealed compartment” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a compartment being isolated from a surrounding environment such that a transfer of gas, fluids and/or solid elements is completely or at least to a large extent reduced. The term “sterile compartment” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary compartment configured to provide a sterile packaging for object received within the sterile compartment. The term “sterile” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a property of an arbitrary object of being at least to a large extent free from all forms of life and/or other biological agents such as prions, viruses, fungi, bacteria or spore forms and also of ingress of liquid, moisture, and dust. Thus, the sterile object may be treated by a sterilization process that eliminates and/or deactivates the forms of life and/or the other biological agents. The sterilization process may comprise one or more of the following techniques: heating, chemical treatment including treatment by gas, irradiation, high pressure, filtration. However, other techniques are feasible. The sterilization process may be conducted within a specified region or area of the object such as a surface of the object. Specifically the sterilization process can be carried out with gas sterilization using generally known gas such as ethylene oxide (EO) gas or vaporized hydrogen peroxide

Embodiments of a medical analyte sensor device comprising an analyte sensor, a cannula, a cannula holder, a sterility cap in a sterility compartment and an insertion aid are disclosed in EP3202324A1, EP3727130A1, EP3988014A1 and EP3202323A1 which are herewith incorporated by reference.

The removable sterility cap and/or the insertion cannula holder may be reversibly or irreversibly connected to the housing, specifically on opposing sides of the housing, specifically of the open channel. Further, additionally or alternatively, the removable sterility cap and/or the insertion cannula holder may be reversibly or irreversibly connected to each other. The insertion cannula holder may seal with the upper side of the housing and/or of the connector unit, specifically with the upper side opening of the open channel and the removable sterility cap may seal with the lower side of the housing and/or of the connector unit, specifically with the lower side opening of the open channel.

Specifically, the removable sterility cap may at least partially be arranged on the lower side of the housing and/or of the connector unit. The removable sterility cap may be removably connected, specifically attached, to the lower side of the housing and/or of the connector unit, specifically to the base plate. Further, additionally or alternatively, the removable sterility cap and the insertion cannula holder may be reversibly or irreversibly connected to each other. The removable sterility cap may be configured for removal before insertion of the insertable portion of the analyte sensor into the body tissue.

The insertion cannula holder may be at least partially arranged on the upper side of the housing and/or of the connector unit, and may optionally additionally be at least partially located within the open channel. The insertion cannula holder may be removably connected, specifically attached, to the upper side of the housing and/or of the connector unit, specifically to the upper plate. Further, the insertion cannula holder may be configured for closing and/or sealing the upper side opening of the open channel. Optionally, the insertion cannula holder may pass through the lower side opening of the open channel, specifically in order for establishing a connection to the removable sterility cap. The insertion cannula holder may be configured for removal after insertion of the insertable portion of the analyte sensor into the body tissue.

Specifically, the insertion cannula holder may form a removable cap or lid, specifically a removable upper cap or upper lid. The insertion cannula holder may be configured for sealing an end of the open channel of the housing, specifically of the connector unit, specifically of the upper side opening of the open channel. The insertion cannula holder may be configured for sealing the sealed channel, specifically an upper side or the upper side opening of the sealed channel. The sealing ring of the insertion cannula holder, specifically of the upper cap or upper lip, may be configured for sealing an end of the open channel, specifically for sealing the upper side opening of the open channel. Further, specifically, the sealing ring of the insertion cannula holder, specifically of the upper cap or upper lip, may be further configured for sealing the sealed channel, especially the upper side of the sealed channel.

The removable sterility cap may also be referred to as removable lower cap and the insertion cannula holder may also be referred to as removable upper cap. The terms “upper cap” and “lower cap” may be considered as description without specifying an order and without excluding a possibility that several kinds of upper caps and lower caps may be applied. The removable lower cap and the removable upper cap may respectively be at least partially arranged or located on opposing sides of the connector unit, specifically of the open channel.

The insertion cannula holder may be removably connected to the housing, specifically to a surface of the housing, more specifically to a surface of the upper plate and/or to a surface of the connector unit, and/or to the removable sterility cap via a connection, specifically via at least one of a form-fit connection, a force fit connection, particularly via a screwing con- nection, a magnetic connection or a bayonet connection. The connection between the insertion cannula holder and the removable sterility cap may be configured to tighten or draw close the attachment of the insertion cannula holder to the upper side of the housing and/or of the connector unit and the attachment of the removable sterility cap to the lower side of the housing and/or of the connector unit. This way, the sealing of the sensor compartment may be supported.

The removable sterility cap may be removably connected to the housing, specifically to a surface of the housing, more specifically to a surface of the base plate and/or to a surface of the connector unit, and/or to the insertion cannula holder via a connection, specifically via at least one of a form-fit connection, a force fit connection, particularly via a screwing connection, a magnetic connection or a bayonet connection. The removable sterility cap may specifically be reversibly attached to the lower side of the housing and/or of the connector unit, specifically by at least one of a breaking point connection, a screwing connection with the lower side of the housing and/or of the connector unit, a screwing connection with the insertion cannula holder. Specifically, the lower side of the connector unit may comprise a sealing element, specifically a sealing ring, which may configured to seal with an upper end of the removable sterility cap and/or the upper end of the sterility cap may comprise a sealing element, specifically a sealing ring, which may be configured to seal with a lower surface of the lower side of the connector unit.

Specifically, the removable sterility cap may be configured to be pulled off from the housing, specifically from the base plate and/or from the connector unit, and/or from the insertion cannula holder. Further, specifically, the insertion cannula holder may be configured to be pulled off from the housing, specifically from the upper plate and/or from the connector unit, and/or from the removable sterility cap. Thus, the removable sterility cap and/or the insertion cannula holder may, in a stage connected to the housing, specifically to the upper plate, to the base pate and/or to the connector unit, overlap with the housing, or vice a versa. Additionally or alternatively, the removable sterility cap may overlap with the insertion cannula holder or vice a versa. The housing, specifically the upper plate, the base pate and/or the connector unit, specifically may comprise a guiding surface for guiding the removable sterility cap or the insertion cannula holder during pulling off the removable sterility cap or the insertion cannula holder. Additionally or alternatively, the removable sterility cap may comprise a guiding surface for guiding the insertion cannula holder during pulling off the insertion cannula holder from the removable sterility cap or vice a versa. Thus, the insertion cannula holder may comprise a guiding surface for guiding removable sterility cap during pulling off the removable sterility cap from the insertion cannula holder. Further, specifically, the insertion cannula holder may be removably connected to the housing, specifically to the upper plate and/or to the connector unit, at an upper predetermined breaking point and/or the removable sterility cap may be removably connected to the housing, specifically to the base plate and/or to the connector unit, at a lower predetermined breaking point. As further used herein, the term “predetermined breaking point” may refer to an arbitrary part of an element being configured to break during mechanical load while other parts of the element remain undamaged. Specifically, the predetermined breaking point may comprise a notch wherein a thickness of the element may be smaller in comparison to other parts of the element. The upper predetermined breaking point and/or the lower predetermined breaking point may specifically be ring-shaped breaking points. The terms “upper breaking point” and “lower breaking point” may be considered as description without specifying an order and without excluding a possibility that several kinds of upper breaking points and lower breaking points may be applied.

At least one of the removable sterility cap and the insertion cannula holder may comprise a hygroscopic material, preferably a desiccant, more preferably activated carbon.

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

Further, the continuous analyte monitoring system comprises an insertion device at least partially covering the continuous analyte monitoring device. The insertion device is configured for enabling a user to drive the insertion cannula into the body tissue and to insert the insertable portion of the analyte sensor into the body tissue. Specifically, the insertion device may be configured for inserting the insertable portion of the insertion cannula and the insertable portion of the analyte sensor into the skin of the user. Further, the insertion device may be configured to withdraw the insertable portion of the insertion cannula from the skin while leaving the insertable portion of the analyte sensor inserted in the skin. The term “insertion device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary technical construction being configured to insert an object into another object. The insertion device may also be referred to as insertion aid. The insertion device may comprise an insertion mechanism. As further used herein, the term “mechanism” may refer to an arbitrary mechanism designed to transform input forces and movement into a desired set of output forces and movement. Specifically, the insertion mechanism may be configured such that the user may apply a force in a direction of insertion to the insertion cannula. Therefore, the insertion device may be configured to facilitate a handling of the continuous analyte monitoring device by the user and/or to reduce application errors. The insertion device may at least partially surround the continuous analyte monitoring device. Further, the insertion device may be at least partially coupled to the continuous analyte monitoring device, specifically to at least one of the insertion cannula holder and the removable sterility cap.

The insertion device may comprise a removable lower cover mechanically coupled to the removable sterility cap. As further used herein, the term “cover” may refer to an arbitrary element that completely or at least to a large extent closes an object. Specifically, the cover may be or may comprise a shell, particularly a half-shell, surrounding the housing and/or to the continuous analyte monitoring device. The removable lower cover may be configured such that a removal of the removable lower cover removes the removable sterility cap. The insertion device may further comprise a frame. The term “frame” may refer to an arbitrary element which may be configured to support other components of a physical construction. The frame may be displaceable on the skin of the user and may at least partially surround the housing, the analyte sensor, the insertion cannula, the removable sterility cap, the insertion cannula holder and/or the connector unit. The insertion device may further comprise an upper cover. The upper cover may be directly or indirectly coupled to one or both of the insertion cannula or the insertion cannula holder, such that a movement of the upper cover against the frame drives the insertion cannula. The terms “lower cover” and “upper cover” may be considered as description without specifying an order and without excluding a possibility that several kinds of lower covers and upper covers may be applied.

The removable lower cover may comprise a basis which is connected to a lower part of the removable sterility cap, exemplarily via a snap connection, an adhesive bonding and/or a longitudinal guide or transferring force. The basis may comprise gripping surfaces for removing the removable sterility cap. The basis may at the same time be a cover for the adhesive surface. This may lead to an extended shelf-life of the adhesive surface. By removing the lower cover the removable sterility cap may be opened, the insertion cannula and the analyte sensor may be exposed and the adhesive surface may be exposed at the same time.

The continuous analyte monitoring device may further comprise a retraction mechanism for retracting the insertion cannula after insertion of the insertable portion of the analyte sensor into the body tissue. The term “retraction mechanism” may generally refer to an arbitrary construction which is configured to move an object in an opposite direction of a direction in which the object may have been moved before the retraction mechanism is applied. Therefore, the retraction mechanism may comprise a retraction contact spring element. The retraction contact spring element may be biased in order to retract the insertion cannula from the body tissue. The retraction mechanism may at least partially be comprised within the insertion cannula holder and/or within the upper cover.

The continuous analyte monitoring system may further comprise:

• a sensor controller which is coupled to the analyte sensor, wherein the sensor controller is configured to receive analyte sensor data from the analyte sensor; and

• a remote control which is configured to receive sensor data from the sensor controller and to process and/or display sensor data.

Optionally, the continuous analyte monitoring system may further comprise a drug infusion device such as an insulin pump, controlled by the remote control.

The sensor controller may specifically be comprised by the electronics unit. The sensor controller may specifically comprise at least one data processing unit, such as a processor. Further, the sensor controller may comprise at least one volatile or non-volatile data storage. The sensor controller may comprise at least one interface configured for entering commands and/or for outputting information. The at least one interface may comprise a wired interface and/or a wireless interface for unidirectionally or bidirectionally exchanging data or commands, specifically between the sensor controller and at least one further device.

The sensor controller may be configured to communicate the analyte sensor data to the remote control. The term “communication” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a process of transferring information. In particular, information from a computational device may be transferred such as by sending or outputting information, e.g. onto another device. Specifically, a communication interface may be provided. The communication interface may specifically provide means for transferring or exchanging information. In particular, the communication interface may provide a data transfer connection, e.g. Bluetooth, NFC, inductive coupling or the like. Specifi cally, the continuous analyte monitoring device may comprise a user interface. The term "user interface" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to an element or device which is configured for interacting with its environment, such as for the purpose of unidirectionally or bidirectionally exchanging information, such as for exchange of one or more of data or commands. For example, the user interface may be configured to share information with a user and to receive information by the user. The user interface may be a feature to interact visually with a user, such as a display, or a feature to interact acoustically with the user. The user interface, as an example, may comprise one or more of a graphical user interface; a data interface, such as a wireless and/or a wire-bound data interface.

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

The method comprises the method steps as given in the independent claims and as listed as follows. The method steps may be performed in the given order. However, other orders of the method steps are feasible. Further, one or more of the method steps may be performed in parallel and/or on a timely overlapping fashion. Further, one or more of the method steps may be performed repeatedly. Further, additional method steps may be present which are not listed.

The method comprises:

I. providing the continuous analyte monitoring device;

II. removing the removable sterility cap;

III. inserting the analyte sensor into a body tissue of the user; and

IV. removing the insertion cannula holder, thereby removing the insertion cannula from the continuous analyte monitoring device.

The proposed device and method provide many advantages over known devices and methods.

Commonly, for continuous analyte monitoring devices, sealing the analyte sensor while passing through the connector unit during assembling is a technical challenge. In the state of the art, sealing is commonly achieved via gluing of a sealing element on top of a lower sensor patch plate and on a sensor patch connector after the analyte sensor is mounted on the lower sensor patch plate. With the present invention, the analyte sensor may be easily inserted into a patch. An additional step of connecting a separate sensor-patch connector or of a sealing element to the base plate may be saved. As a result, the present invention may reduce the complexity in design and also the production costs.

Moreover, attaching a sealing ring to the lower side of the insertion cannula holder may further simplify a design of the continuous analyte monitoring device and the assembling of the continuous analyte monitoring device. According to the present invention, a ready made insertion cannula holder with an attached sealing ring may just be mounted on top of the analyte sensor.

The base plate as described above may from an integral sensor patch connector which may comprise a radially oriented sealed channel to fixedly position the analyte sensor inside the open channel, followed by subsequent sealing. An easy positioning of the analyte sensor may be improved, an efficient sealing and a reliable contacting of the analyte sensor with the electronics unit may be provided.

An application of the sealing material into the channel such that the sealed channel is formed from a top position may also be very easy. The channel may be prefilled with a sealing material and may enable a firm and tightly sealed fixation of the analyte sensor in the channel resulting in an efficient sealing of the sterile compartment from the electronics compartment.

Summarizing and without excluding further possible embodiments, the following embodiments may be envisaged:

Embodiment 1 : A continuous analyte monitoring device comprising:

• a removable sterility cap, wherein the removable sterility cap at least partially surrounds the insertable portion of the analyte sensor; • an electronics unit, wherein the analyte sensor is electrically connected to the electronics unit;

Embodiment 2: The continuous analyte monitoring device according to the preceding embodiment, wherein the connector unit comprises an upper side and a lower side, wherein the open channel connects the upper side and the lower side.

Embodiment 3 : The continuous analyte monitoring device according to the preceding embodiment, wherein the removable sterility cap is located on the lower side of the connector unit and wherein at least a part of the insertion cannula holder extends from the upper side of the connector unit into the open channel and/or connects with the upper side of the open channel.

Embodiment 4: The continuous analyte monitoring device according to the preceding embodiment, wherein the removable sterility cap seals with the lower side.

Embodiment 5: The continuous analyte monitoring device according to any one of the two preceding embodiments, wherein the removable sterility cap is reversibly attached to the lower side, specifically by at least one of a breaking point connection, a screwing connection, with the lower side and/or with the insertion cannula holder. Embodiment 6: The continuous analyte monitoring device according to any one of the three preceding embodiments, wherein the sealing ring of the insertion cannula holder faces the upper side of the connector unit.

Embodiment 7: The continuous analyte monitoring device according to the preceding embodiment, wherein the sealing ring of the insertion cannula holder is in direct contact with the upper side of the connector unit.

Embodiment 8: The continuous analyte monitoring device according to the preceding embodiment, wherein the sealing ring of the insertion cannula holder is in direct contact with an upper surface of the sealed channel.

Embodiment 9: The continuous analyte monitoring device according to the preceding embodiment, wherein the sealing ring of the insertion cannula holder is configured for sealing with the upper surface of the sealed channel.

Embodiment 10: The continuous analyte monitoring device according to the preceding embodiment, wherein the sealing ring of the insertion cannula holder is configured for sealing with the upper surface of the sealed channel and with the upper side of the connector unit.

Embodiment 11 : The continuous analyte monitoring device according to any one of the nine preceding embodiments, wherein the analyte sensor extends downwardly inside the open channel beyond the lower side.

Embodiment 12: The continuous analyte monitoring device according to the preceding embodiment, wherein the insertable portion of the analyte sensor extends downwardly inside the open channel beyond the lower side.

Embodiment 13: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the open channel at least partially circumferentially surrounds at least one of the analyte sensor and the removable insertion component.

Embodiment 14: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the connector unit is at least partially formed as a cylindrical ring at least partially surrounding at least one of the analyte sensor and the removable insertion component. Embodiment 15: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the insertion cannula holder has a side, specifically a lower side, facing the housing, wherein the sealing ring of the insertion cannula holder is located at the side, specifically at the lower side.

Embodiment 16: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the sealing ring of the insertion cannula holder faces the housing.

Embodiment 17: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the sealing ring is arranged between a part of the insertion cannula holder and the housing.

Embodiment 18: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the open channel and the sealed channel are arranged transversely, specifically essentially perpendicularly, to each other.

Embodiment 19: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the sealed channel is radially oriented, in particular radially oriented relative to a lower side of the housing and/or of the connector unit.

Embodiment 20: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the analyte sensor is fixedly positioned in the sealed channel.

Embodiment 21 : The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the analyte sensor is sealingly embedded by a sealing material in the sealed channel.

Embodiment 22: The continuous analyte monitoring device according to the preceding embodiment, wherein the sealing material is silicone and/or glue.

Embodiment 23 : The continuous analyte monitoring device according to any one of the two preceding embodiments, wherein the sealed channel is configured to be filled with the sealing material a) in an assembled state of the analyte sensor and the base plate or b) before the analyte sensor is introduced into the base plate; in any case before the insertion cannula and the insertion cannula holder are mounted onto the connector unit. Embodiment 24: The continuous analyte monitoring device according to any one of the three preceding embodiments, wherein the sealed channel is configured to be filled with the sealing material before or after the analyte sensor is received in the sealed channel.

Embodiment 25: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the sealed channel connects the sterile compartment with the electronics compartment.

Embodiment 26: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the analyte sensor comprises an in vivo proximal portion and an ex vivo distal portion.

Embodiment 27: The continuous analyte monitoring device according to the preceding embodiment, wherein the in vivo proximal portion corresponds to the insertable portion.

Embodiment 28: The continuous analyte monitoring device according to any one of the two preceding embodiments, wherein the in vivo proximal portion is received in the sterile compartment.

Embodiment 29: The continuous analyte monitoring device according to any one of the three preceding embodiments, wherein the ex vivo distal portion comprises a first section being received in the sealed channel and a second section being received in the electronics compartment, specifically wherein the second section is electrically connected with the electronics unit.

Embodiment 30: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the sealed channel is at least partially formed by a groove or by a compartment within the connector unit.

Embodiment 31 : The continuous analyte monitoring device according to the preceding embodiment, wherein the groove or the compartment has an essentially rectangular shape.

Embodiment 32: The continuous analyte monitoring device according to any one of the two preceding embodiments, wherein the groove or the compartment is at least partially funnel- shaped. Embodiment 33: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the continuous analyte monitoring device further comprises at least two locking arms being at least partially received within the sealed channel, wherein the locking arms are configured or at least one of positioning, fixing the analyte sensor within the sealed channel.

Embodiment 34: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the sealed channel comprises a first end and an opposing second end, wherein at least one foil is attached to at least one of the first end and the second end, wherein the at least one foil is configured for preventing a flow of a sealing material into at least one of the open channel and the electronics compartment.

Embodiment 35: The continuous analyte monitoring device according to the preceding embodiment, wherein the at least one foil is configured for preventing a flow of a sealing material into at least one of the open channel and the electronics compartment during filling of the sealing material into the sealed channel, in particular as long as the sealing material is not hardened.

Embodiment 36: The continuous analyte monitoring device according to the preceding embodiment, wherein the at least one foil is configured for being at least partially opened when the analyte sensor is placed into the sealed channel.

Embodiment 37: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the open channel is sealed off from the electronics compartment by a wall of the open channel.

Embodiment 38: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the base plate and the upper plate are configured for forming at least parts of the longitudinal sides of the electronics compartment.

Embodiment 39: The continuous analyte monitoring device according to the preceding embodiment, wherein the base plate and the upper plate are configured to be connected by a sealing connection.

Embodiment 40: The continuous analyte monitoring device according to the preceding embodiment, wherein the sealing connection is selected from the group consisting of: a force- fit connection, a form-fit connection, a connection established by gluing or ultrasound welding.

Embodiment 41 : The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the insertion cannula holder and the removable sterility cap are respectively removably connected to the housing, specifically on opposing sides of the housing, specifically of the open channel.

Embodiment 42: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the open channel at least partially circumferentially surrounds at least one of the analyte sensor and the removable insertion component.

Embodiment 43 : The continuous analyte monitoring device according to the preceding embodiment, wherein the analyte sensor comprises a carrier, specifically a substrate, wherein at least two electrodes are disposed on the carrier.

Embodiment 44: The continuous analyte monitoring device according to the preceding embodiment, wherein the analyte sensor further comprises contacts connected to the at least two electrodes and which are configured to connect with the electronics unit.

Embodiment 45: The continuous analyte monitoring device according to any one of the two preceding embodiments, wherein the at least two electrodes are a working electrode configured for detecting the analyte and a further electrode, wherein the further electrode is selected from the group consisting of: a counter electrode, a reference electrode, and a combined counter-reference electrode.

Embodiment 46: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the electronics unit comprises a printed circuit board.

Embodiment 47: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the insertion cannula is fixedly attached to the insertion cannula holder.

Embodiment 48: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the insertion cannula holder is configured for removal after insertion of the insertable portion of the analyte sensor into the body tissue. Embodiment 49: The continuous analyte monitoring device according to the preceding embodiment, wherein the removable sterility cap is configured for removal from the housing before insertion of the insertion cannula and the analyte sensor into the body tissue.

Embodiment 50: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the insertion cannula holder at least partially surrounds the insertion cannula.

Embodiment 51 : The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the insertion cannula holder forms a removable cap or lid, specifically a removable upper cap or upper lid, configured for sealing an end of the open channel of the housing.

Embodiment 52: The continuous analyte monitoring device according to the preceding embodiment, wherein the insertion cannula holder is further configured for sealing the sealed channel, specifically an upper side of the sealed channel.

Embodiment 53: The continuous analyte monitoring device according to the preceding embodiment, wherein the sealing ring of the upper cap or upper lip is configured for sealing an end of the open and wherein the sealing ring of the upper cap or upper lip is specifically further configured for sealing the sealed channel, especially the upper side of the sealed channel.

Embodiment 54: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the insertion cannula holder is at least partially received inside the open channel.

Embodiment 55: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the insertion cannula holder is removably connected to the housing and/or to the removable sterility cap via a connection, specifically via at least one of a form-fit connection, a force fit connection, particularly via a screwing connection, a magnetic connection or a bayonet connection.

Embodiment 56: The continuous analyte monitoring device according to the preceding embodiment, wherein the connection between the insertion cannula holder and the removable sterility cap is configured to tighten or draw close the attachment of the insertion cannula holder to an upper side of the connector unit and the attachment of the removable sterility cap to a lower side of the connector unit.

Embodiment 57: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the removable sterility cap is removably connected to the housing and/or to the insertion cannula holder via a connection, specifically via at least one of a form-fit connection, a force fit connection, particularly via a screwing connection, a magnetic connection or a bayonet connection.

Embodiment 58: The continuous analyte monitoring device according to the preceding embodiment, wherein a lower side of the connector unit comprises a sealing element, specifically a sealing ring, which is configured to seal with an upper end of the removable sterility cap and/or the upper end of the sterility cap comprises a sealing element, specifically a sealing ring, which is configured to seal with a lower surface of a lower side of the connector unit.

Embodiment 59: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the removable sterility cap is configured for removal before insertion of the insertable portion of the analyte sensor into the body tissue.

Embodiment 60: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the continuous analyte monitoring device is a disposable medical device.

Embodiment 61 : The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the electronics unit is a single-use electronics unit.

Embodiment 62: The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the continuous analyte monitoring device forms a pre-assembled single unit.

Embodiment 63 : The continuous analyte monitoring device according to any one of the preceding embodiments, wherein the connector unit and the base plate form a single piece.

Embodiment 64: The continuous analyte monitoring device according to the preceding embodiment, wherein the connector unit and the base plate are manufactured in one single piece. Embodiment 65: The continuous analyte monitoring device according to any one of the two preceding embodiments, wherein the connector unit is formed by a wall protruding transversely from the base plate.

Embodiment 66: The continuous analyte monitoring device according to the preceding embodiment, wherein the connector unit and the electronics compartment share a common wall, wherein, in particular, the sealed channel passes through the common wall.

Embodiment 67: A continuous analyte monitoring system, wherein the continuous analyte monitoring system comprises:

• a continuous analyte monitoring device according to any one of the preceding embodiments;

• an insertion device at least partially covering the continuous analyte monitoring device, wherein the insertion device is configured for enabling a user to drive the insertion cannula into the body tissue and to insert the insertable portion of the analyte sensor into the body tissue.

Embodiment 68: The continuous analyte monitoring system according to the preceding embodiment, wherein the insertion device comprises an insertion mechanism.

Embodiment 69: The continuous analyte monitoring system according to any one of the two preceding embodiments, wherein the continuous analyte monitoring system further comprises:

Embodiment 70: Method of using a continuous analyte monitoring device according to any one of the preceding embodiments referring to a continuous analyte monitoring device, the method comprising:

I. providing the continuous analyte monitoring device;

II. removing the removable sterility cap;

III. inserting the analyte sensor into a body tissue of the user; and IV. removing the insertion cannula holder, thereby removing the insertion cannula from the continuous analyte monitoring device.

Short description of the Figures

Further optional features and embodiments will be disclosed in more detail in the subsequent description of embodiments, preferably in conjunction with the dependent claims. Therein, the respective optional features may be realized in an isolated fashion as well as in any arbitrary feasible combination, as the skilled person will realize. The scope of the invention is not restricted by the preferred embodiments. The embodiments are schematically depicted in the Figures. Therein, identical reference numbers in these Figures refer to identical or functionally comparable elements.

In the Figures:

Figures 1 A to IB show an exemplary embodiment of components of a continuous analyte monitoring device according to the present invention in different cross-sectional views;

Figure 2 shows an exemplary embodiment of a removable insertion component of a continuous analyte monitoring device according to the present invention in a cross-sectional side view;

Figures 3 A to 3B show an exemplary embodiment of a continuous analyte monitoring device according to the present invention in different cross-sectional views;

Figures 4A to 4E show an exemplary mounting of an analyte sensor within a channel of a connector unit of a housing of a continuous analyte monitoring device according to the present invention in different cross-sectional views;

Figure 5 shows an exemplary embodiment of an analyte sensor within a sealed channel of a connector unit of a housing of a continuous analyte monitoring device according to the present invention in a cross-sectional view; Figures 6A and 6B show an exemplary assembling of an analyte sensor within a channel of a connector unit of a housing of a continuous analyte monitoring device according to the present invention in different cross-sectional views; and

Figure 7 shows an exemplary embodiment of a continuous analyte monitoring system according to the present invention in a schematic view.

Detailed description of the embodiments

Figures 1 A and IB show an exemplary embodiment of components of a continuous analyte monitoring device 110 according to the present invention in different cross-sectional views. The continuous analyte monitoring device 110 is fully illustrated in Figures 3A and 3B. Specifically, Figures 1 A and IB respectively show an analyte sensor 112, a housing 111 and an electronics unit 156. Figure IB shows a cross-sectional view along a plane extending parallel to a direction of extension of the housing 111 of the continuous analyte monitoring device 110. Figure 1A shows a cross-sectional view of the continuous analyte monitoring device 110 according to Figure IB (section A- A, see Figure IB).

The analyte sensor 112 is configured for detecting an analyte in a body fluid of a user. The analyte sensor 112 may comprise a carrier 114, specifically a substrate 115. At least two electrodes may be disposed on the carrier 114. The carrier 114, specifically the substrate 115, specifically may have an elongated shape, such as a strip-shape and/or a bar-shape.

The analyte sensor 112 comprises an insertable portion 116 adapted for at least partially being inserted into a body tissue of a user. The insertable portion 116 may be called in-vivo proximal portion 198. A portion of the analyte sensor 112 which may stay outside of the body tissue may also be called the ex vivo distal portion 200. The ex vivo distal portion 200 and the in vivo proximal portion 198 may be arranged transversely, specifically essentially perpendicularly, to each other. The in vivo proximal portion 198 may extend along a direction of insertion 121. The direction of insertion 121 may be transverse, specifically essentially perpendicular, to a skin site of the user.

The housing 111 may comprise an upper side 138 and a lower side 140. Specifically, the upper side 138 may refer to a distal side 142 of the housing 111. Specifically, the lower side 140 may refer to a proximal side 144 of the housing 111. The housing 111 comprises a base plate 160 being configured for attachment to a skin site of the user and an upper plate 162. The base plate 160 and the upper plate 162 from an electronics compartment 154 with the electronics unit 156 received therein. The electronics compartment 154 may be a sealed compartment 158. The electronics unit 156 may be fixedly positioned within the electronics compartment 154. The electronics unit 156 and/or the electronics compartment 154 may at least partially surround an open channel 146.

The housing 111 further comprises a connector unit 164 comprising the open channel 146 of the housing 111. The connector unit 164 is integral to the base plate 160. The connector unit 164 comprises the open channel 146 which at least partially surrounds the analyte sensor 112. The open channel 146 may extend transversely, specifically essentially perpendicularly, respectively to the lower side 140 and to the upper side 138 of the housing 111. The open channel 146 may connect the upper side 138 and the lower side 140. The open channel 146 may specifically be an essentially straight channel. Further, the open channel 146 may extend transversely, specifically essentially perpendicularly, to a direction of extension 148 of the housing 111. Further, the open channel 146 may extend transversely, specifically essentially perpendicularly, to the lower side of the base plate 160. The open channel 146 may specifically comprise an upper side opening 150 and an opposing lower side opening 152. The upper side opening 150 may be located on the upper side 138 of the housing 111 facing away from the skin site and the lower side opening 152 may be located on the lower side 140 of housing 111 facing the skin site. The housing 111 may be at least partially formed as a cylindrical ring at least partially surrounding the analyte sensor 112 and the open channel 146. The insertable portion 116 of the analyte sensor 112 may extend downwardly inside the open channel 146 beyond the lower side of 140 the housing 111.

The connector unit 164 comprises a sealed channel 168 connecting the open channel 146 with the electronics compartment 154. The analyte sensor 112 passes through the sealed channel 168. The analyte sensor 112 may be partially received in the open channel 146, and partially received in the electronics compartment 154. More specifically, the analyte sensor 112 may be partially received in the open channel 146, partially received within the channel 168 of the connector unit 164 and partially received in the electronics compartment 154. In the assembled state of the continuous analyte monitoring device 110, the sealed channel 168 may be sealed to sealingly enclose the analyte sensor 112 and to sealingly separate the electronics compartment 154 from the open channel 146.

The ex vivo distal portion 200 and the in vivo proximal portion 198 of the analyte sensor 112 may be arranged transversely, specifically essentially perpendicularly, to each other. The in vivo proximal portion 198 may extend along the direction of insertion 121. The ex vivo distal portion 200 may comprise a first section 202 being received in the sealed channel 168 and a second section 204 being received in the electronics compartment 154. The electronics unit 156 may be electrically connected to the analyte sensor 112. Thus, specifically, the second section 204 of the ex vivo distal portion 200 may be electrically connected to an electronics component 206 of the electronics unit 156. The open channel 146 and the sealed channel 168 may be arranged transversely, specifically essentially perpendicularly, to each other.

The open channel 146 may be sealed off from the electronics compartment 154 by a wall 170 of the open channel 146. The wall 170 of the open channel 146 may be formed by the connector unit 164. Specifically, the connector unit 164 may comprise a connector unit wall 172, specifically extending in the direction of insertion 121 of the analyte sensor 112. The connector unit wall 172 may comprise a first side 176 and an opposing second side 178. The first side 176 may face an interior space 180 of the open channel 146. Further, second side 178 may face an interior space 182 of the electronics compartment 154. The sealed channel 168 may comprise a first end 194 and an opposing second end 196. The sealed channel 168 may connect the open channel 146 with the electronics compartment 154 via the first end 194 and the second end 196.

The sealed channel 168 may be at least partially formed by a groove 166 of the connector unit 164, specifically in the connector unit wall 172. The groove 166 may specifically be a cutout within the connector unit wall 172, specifically from the upper side 138 of the connector unit 164. The groove 166 may specifically be accessible from the upper side 138 of the connector unit 164. Further, the groove 166 may specifically be accessible from the open channel 146 and from the electronics compartment 154. The sealed channel 168, specifically the groove 166, may be filled with a sealing material 192.

The housing 111 may comprise the base plate 160 being configured for attachment to a skin site of a user, specifically via at least one adhesive, and the upper plate 162. The base plate 160 and the upper plate 162 may be configured for forming at least parts of longitudinal sides 174 of the electronics compartment 154. Specifically, the base plate 160 may comprise a lower surface 184 configured for being placed on a user’ s skin. The lower surface 184 may exemplarily have a shape of a circular ring surrounding the analyte sensor 112. More specifically, the lower surface 184 may be or may comprise an adhesive surface 186 for attachment to the user’s skin. Specifically, the base plate 160 and the upper plate 162, in conjunction may form an encapsulation for the electronics unit 156. Specifically, the electronics compartment 154 may be formed by the base plate 160, the upper plate 162 and the connector unit 164.

Figure 2 shows an exemplary embodiment of a removable insertion component 122 of a continuous analyte monitoring device according to the present invention in a cross-sectional side view.

The removable insertion component 122 comprises an insertion cannula 124 and an insertion cannula holder 126.

The insertion cannula 124 may comprise a tip or a sharp end 128 for inserting the analyte sensor 112 at least partially into the body tissue. Specifically, the insertion cannula 124 may be a slotted cannula 130. The insertion cannula 124 may be configured to be inserted essentially vertically relative to the body tissue of the user. The insertion cannula holder 126 may be configured for removal after insertion of the insertable portion 116 of the analyte sensor 112 into the body tissue.

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

Further, the insertion cannula holder 126 comprises a sealing ring 188. The sealing ring 188 may be attached to the insertion cannula holder 126, specifically fixedly. The insertion cannula holder 126 may comprise a side 190, specifically a lower side 208, facing the housing 111 as can be seen in Figure 3 A. Specifically, the sealing ring 188 of the insertion cannula holder 126 may be located at the side 190.

Figures 3 A to 3B show an exemplary embodiment of a continuous analyte monitoring device 110 according to the present invention in different cross-sectional views. Figure 3B shows a cross-sectional view along a plane extending parallel to a direction of extension of the continuous analyte monitoring device 110. Figure 3 A shows a cross-sectional view of the continuous analyte monitoring device 110 according to Figure 3B (section A- A, see Figure 3B).

The analyte sensor 112 of the continuous analyte monitoring device 110, the housing 111 of the continuous analyte monitoring device 110 and the electronics unit 156 of the continuous analyte monitoring device 110 correspond to the analyte sensor 112, the housing 111 and to the electronics unit 156 such as illustrated in Figures 1A and IB. Further, the removable insertion component 122 of the continuous analyte monitoring device 110 corresponds to the removable insertion component 122 such as illustrated in Figure 2. Thus, specifically with regard to these components, reference is made to the description of Figures 1 A, IB and 2 above.

Further, the continuous analyte monitoring device 110 comprises a removable sterility cap 136. The removable sterility cap 136 at least partially surrounds the insertable portion 116 of the analyte sensor 112. Thus, the insertable portion 116 may be at least partially received in the removable sterility cap 136. The analyte sensor 112 is at least partially placed inside the insertion cannula 124. The removable sterility cap 136 may be configured for removal before insertion of the insertable portion 116 of the analyte sensor 112 into the body tissue.

The removable sterility cap 136, the open channel 146 of the housing 111 and the insertion cannula holder from a sterile compartment 210 for the insertion cannula 124 and at least the insertable portion 116 of the analyte sensor 112. Thus, the insertion cannula 124 and at least the insertable portion 116 of the analyte sensor 112 may be received in the sterile compartment 210. The sterile compartment 210 may also be referred to as sensor compartment 212.

As outlined above, the housing 111 may comprise the upper side 138 and the lower side 140 and the open channel 146 may connect the upper side 138 and the lower side 140. The removable sterility cap 136 may be at least partially located on the lower side 140 of the housing 111, specifically of the connector unit 164, and the insertion cannula holder 126 may at least partially be located on the upper side 138 of the housing 111, specifically of the connector unit 164. The insertion cannula holder 126 and the removable sterility cap 136 may be respectively removably connected to the housing 111, specifically to the connector unit 164, specifically on opposing sides of the housing 111, specifically of the connector unit 164, more specifically of the open channel 146. The insertion cannula holder 126 may seal with the upper side opening 150 of the open channel 146 and the removable sterility cap 136 may seal with the lower side opening 152 of the open channel 146. The sealing ring 188 of the insertion cannula holder 126 is configured for sealing the sterile compartment 210. The sealing ring 188 may be arranged on a lower part 214 of the insertion cannula holder 126 which may specifically face the upper side 138 of the connector unit 164. Specifically, the sealing ring 188 of the insertion cannula holder 126 may face the housing 111, specifically the upper side 138 of the connector unit 164. Specifically in an assembled state of the continuous analyte monitoring device 110, the sealing ring 188 of the insertion cannula holder 126 may be in direct contact with the upper side 138 of the connector unit 164. Specifically, the sealing ring 188 may be configured for sealing an end of the open channel 146 of the housing 111 and may be in particular configured also for sealing the sealed channel 168, especially the upper side of the sealed channel 168.

Figures 4 A to 4E show an exemplary assembling of an analyte sensor 112 within a channel 163 of a connector unit 164 of a housing 111 of a continuous analyte monitoring device 110 according to the present invention in different cross-sectional views. Thereby, the cross- sectional view respectively corresponds to a section B-B such as illustrated in Figure IB.

As illustrated in Figures 4A to 4E, the channel 163 may be at least partially formed by the groove 166. The groove 166 may have an essentially rectangular shape.

Specifically, the continuous analyte monitoring device 110 may further comprise at least two locking arms 216 being at least partially received within the channel 163. The at least two locking arms 216 may be configured for positioning and/or for fixing the analyte sensor 112 within the channel 163. More specifically, the at least two locking arms 216 may be configured for positioning and/or for fixing the ex vivo distal portion 200, specifically the first section 202 of the ex vivo distal portion 200, within the channel 163.

The at least two locking arms 216 may respectively comprise a contact surface 218 for contacting the analyte sensor 112. The at least two locking arms 216 may respectively be elongate elements. Specifically, the at least two locking arms 216 may respectively comprise at least one first end 220 and at least one opposing second end 222. The contact surfaces 218 may respectively be located at the second end 222. The second ends 222 of the at least two locking arms 216 may respectively protrude into an interior space 224 of the channel 163. The at least two locking arms 216 may respectively protrude from a sidewall 226 of the channel 163. Specifically, the first ends 220 of the at least two locking arms 216 may respectively be attached to the sidewall 226 of the channel 163. Further, specifically, one or both of the at least two locking arms 216 may comprise at least one protrusion 228 protruding into the interior space 224 of the channel 163. The protrusions 228 may respectively be configured for contacting the analyte sensor 112. The protrusions 228 may specifically have a pyramidal shape. The protrusions 228 may respectively form the contact surfaces 218 of the at least two locking arms 216 as described above.

Specifically, the at least two locking arms 216 may be essentially identical locking arms. Specifically, the contact surfaces 218 of the at least two locking arms 216 may be identical contact surfaces. Specifically, the at least two locking arms 216 may be arranged opposite to each other.

Exemplarily, the at least two locking arms 216 may be configured for contacting the analyte sensor 112 on a same side 230 of the analyte sensor 112. Specifically, the at least two locking arms 216 may respectively be configured for contacting the analyte sensor 112 on a side opposing a contact side 232 of the analyte sensor 112 which rests on a surface 234 of the channel 163. Thus, the at least two locking arms 216 may be configured for providing force onto the analyte sensor 112.

Specifically, the mounting of the analyte sensor 112 within the channel 163 of the connector unit 164 may be conducted as follows:

The analyte sensor 112, specifically the first section 202 of the ex vivo distal portion 200, may be placed into the groove 166 from the upper side 138 of the connector unit 164 such as indicated with arrow 236 as illustrated in Figure 4B. Thereby, the at least two locking arms 216 may spread apart from each other such as indicated with arrows 238 in Figure 4C and the analyte sensor 112 may be placed between the at least two locking arms 216. When the analyte sensor 112 rests on the surface 234 of the channel 163, the at least two locking arms 216 may exert a force on the analyte sensor 122, such as illustrated with arrows 240 in Figures 4 A and 4E. The analyte sensor 122 may stay in position. Thereafter, the groove 166 may be filled with the sealing material 192, as illustrated in Figure 4E, such that the sealed channel 168 is formed.

Figure 5 shows an exemplary embodiment of an analyte sensor 112 within a sealed channel 168 of a connector unit 164 of a housing 111 of a continuous analyte monitoring device 110 according to the present invention in a cross-sectional view. Thereby, the cross-sectional view respectively corresponds to a section B-B such as illustrated in Figure IB. As illustrated in Figure 5, the sealed channel 168 may be at least partially formed by the groove 166. The groove 166 may be at least partially funnel-shaped. Thereby, a diameter of the groove 166 may decrease, specifically continuously, from the upper side 138 of the connector unit 164 towards the lower side 140 of the connector unit 164. Specifically, the sealed channel 168 may comprise a first section 242 and a second section 244. The first section 242 may be funnel-shaped and the second section 244 may have a rectangular shape. The second section 244 may follow on from the first section 242. Due to the funnel-shaped groove 166, at least one of a self-positioning, a self-aligning of the analyte sensor 112 within the groove 166 may be facilitated or improved.

Figures 6 A and 6B show an exemplary assembling of an analyte sensor 112 within a channel 163 of a connector unit 164 of a housing 111 of a continuous analyte monitoring device 110 according to the present invention in different cross-sectional views. Specifically, Figures 6 A and 6B show an exemplary assembling of the analyte sensor 112 within the channel 163 of the connector unit 164. Thereby, the cross-sectional view respectively corresponds to a section C-C such as illustrated in Figure IB.

As illustrated in Figure 6A, the continuous analyte monitoring device 110 may comprise a foil 246. The channel 163 may comprise the first end 194 and the opposing second end 196. In Figure 6A, the first end 194 of the channel 163 is shown. The foil 246 may be attached to the first end 194.

The foil 246 may be configured for being at least partially opened and/or destroyed when the analyte sensor 112 is placed into the channel 163, such as illustrated in Figure 6B. The foil 246 may be configured for preventing a flow of the sealing material 192 into the open channel 146. The sealing material 192 is not shown in Figures 6A or 6B.

Figure 7 shows an exemplary embodiment of a continuous analyte monitoring system 248 according to the present invention in a schematic view.

The continuous analyte monitoring system 248 comprises a continuous analyte monitoring device 110. The continuous analyte monitoring device 110 may correspond to the embodiments such as illustrated in Figures 1A and IB. Thus, reference is made to the description of these figures above.

The continuous analyte monitoring system 280 further comprises an insertion device 250 at least partially covering the continuous analyte monitoring device 110, wherein the insertion device 250 is configured for enabling a user to drive the insertion cannula 124 into the body tissue and to insert the insertable portion 116 of the analyte sensor 112.

The continuous analyte monitoring system 248 may further comprise a sensor controller 252 which may be coupled to the analyte sensor 112 of the continuous analyte monitoring device 110. The sensor controller 252 may be configured to receive analyte sensor data from the analyte sensor 110 such as indicated with arrow 254.

The continuous analyte monitoring system 248 may further comprise a remote control 256 which is configured to receive sensor data from the sensor controller 252, such as indicated with arrow 258, and to process and/or display sensor data such as via a user interface 264. The sensor controller 252 may be configured to communicate the sensor data to the remote control 256.

List of reference numbers continuous analyte monitoring device housing analyte sensor carrier substrate insertable portion direction of insertion removable insertion component insertion cannula insertion cannula holder sharp end slotted cannula first end second end removable sterility cap upper side lower side distal side proximal side open channel direction of extension upper side opening lower side opening electronics compartment electronics unit sealed compartment base plate upper plate channel connector unit groove sealed channel wall connector unit wall longitudinal side first side second side interior space interior space lower surface adhesive surface sealing ring side sealing material first end second end in vivo proximal portion ex vivo distal portion first section second section electronics component lower side sterile compartment sensor compartment lower part locking arm contact surface first end second end interior space sidewall protrusion side contact side surface arrow arrow arrow first section section section foil continuous analyte monitoring system insertion device sensor controller arrow remote control arrow user interface

Claims

1. A continuous analyte monitoring device (110) 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;

• a removable 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 insertion cannula holder (126) comprises a sealing ring (188), 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 (H2);

• an electronics unit (156), wherein the analyte sensor (112) is electrically connected to the electronics unit (156);

• a housing (111) comprising: o a base plate (160) being configured for attachment to a skin site of the user and an upper plate (162), wherein the base plate (160) and the upper plate (162) form an electronics compartment (154), wherein the electronics unit (156) is received in the electronics compartment (154); o a connector unit (164), wherein the connector unit (164) is integral to the base plate (160), wherein the connector unit (164) comprises an open channel (146) which at least partially surrounds at least one of the analyte sensor (112) and the removable insertion component (122), wherein the connector unit (164) further comprises a sealed channel (168) connecting the open channel (146) with the electronics compartment (154), wherein the analyte sensor (112) passes through the sealed channel (168); wherein the removable sterility cap (136), the open channel (146) of the connector unit (164) and the insertion cannula holder (126) form a sterile compartment (210) for the insertion cannula (124) and at least the insertable portion (116) of the analyte sensor (112), wherein the sealing ring (188) of the insertion cannula holder (126) is configured for sealing the sterile compartment (210).

2. The continuous analyte monitoring device (110) according to claim 1, wherein the connector unit (164) comprises an upper side (138) and a lower side (140), wherein the open channel (146) connects the upper side (138) and the lower side (140).

3. The continuous analyte monitoring device (110) according to claim 2, wherein the sealing ring (188) of the insertion cannula holder (126) faces the upper side (138) of the connector unit (164).

4. The continuous analyte monitoring device (110) according to any one of claims 1 to

3, wherein the sealing ring (188) of the insertion cannula holder (126) faces the housing (H I).

5. The continuous analyte monitoring device (110) according to any one of claims 1 to

4, wherein the connector unit (164) and the base plate (160) form a single piece.

6. The continuous analyte monitoring device (110) according to claim 5, wherein the connector unit (164) and the base plate (160) are manufactured in one single piece.

7. The continuous analyte monitoring device (110) according to any one of claims 5 and 6, wherein the connector unit (164) is formed by a wall protruding transversely from the base plate (160).

8. The continuous analyte monitoring device (110) according to any one of claims 1 to 7, wherein the sealed channel (168) comprises a first end (194) and an opposing second end (196), wherein at least one foil (246) is attached to at least one of the first end (194) and the second end (196), wherein the at least one foil (246) is configured for preventing a flow of a sealing material (192) into at least one of the open channel (146) and the electronics compartment (154).

9. The continuous analyte monitoring device (110) according to claim 8, wherein the foil (246) is configured for being at least partially opened when the analyte sensor (112) is placed into the sealed channel (168).

10. The continuous analyte monitoring device (110) according to any one of claims 8 to 9, wherein the sealed channel (168) is configured to be filled with the sealing material (192) in an assembled state of the analyte sensor (112) and the base plate (160).

11. The continuous analyte monitoring device (110) according to any one of claims 1 to 10, wherein the sealed channel (168) is at least partially formed by a groove (166) within the connector unit (164).

12. The continuous analyte monitoring device (110) according to claim 11, wherein the groove (166) within the connector unit (164) has an essentially rectangular shape or wherein the groove (166) within the connector unit (164) is at least partially funnel- shaped.

13. The continuous analyte monitoring device (110) according to any one of claims 1 to 12, wherein the continuous analyte monitoring device (110) further comprises at least two locking arms (216) being at least partially received within the sealed channel (168), wherein the at least two locking arms (216) are configured or at least one of positioning, fixing the analyte sensor (112) within the sealed channel (168).

14. A continuous analyte monitoring system (248) comprising:

• a continuous analyte monitoring device (110) according to any one of claims 1 to 13;

• an insertion device (150) at least partially covering the continuous analyte monitoring device (110), wherein the insertion device (150) is configured for enabling a user to drive the insertion cannula (124) into the body tissue and to insert the insertable portion (116) of the analyte sensor (110) into the body tissue;

• a sensor controller (252) which is coupled to the analyte sensor (112), wherein the sensor controller (252) is configured to receive analyte sensor data from the analyte sensor (112); and

• a remote control (256) which is configured to receive sensor data from the sensor controller (252) and to process and/or display sensor data.

15. A method of using a continuous analyte monitoring device (110) according to any one of claims 1 to 13, the method comprising:

I. providing the continuous analyte monitoring device (110);

II. removing the removable sterility cap (136) ;

III. inserting the analyte sensor (112) into a body tissue of the user; and

IV. removing the insertion cannula holder (126), thereby removing the insertion cannula (124) from the continuous analyte monitoring device (110).