Continuous analyte monitoring unit

Abstract

A continuous analyte monitoring unit (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 analyte sensor (112) is at least partially placed inside the insertion cannula (124); • a connector unit (136), wherein the connector unit (136) comprises an open channel (138) which at least partially surrounds one or both of the analyte sensor (112) and the removable insertion component (122), wherein the connector unit (136) further comprises at least two electrical connector unit contacts (158) in electrically conductive connection with the analyte sensor (112), wherein the at least two electrical connector unit contacts (158) are configured for electrically connecting to at least two electrical housing contacts (214) of a housing (188); • a removable sterility cap (168), wherein the removable sterility cap (168) at least partially surrounds the insertable portion (116) of the analyte sensor (112); wherein the removable sterility cap (168), the connector unit (136) and the insertion cannula holder (126) form a sterile compartment (170) for the insertion cannula (124) and at least the insertable portion (116) of the analyte sensor (112).

Description

[0001] Continuous analyte monitoring unit

[0002] Technical Field

[0003] The invention relates to a continuous analyte monitoring unit, to a housing, to a continuous analyte monitoring system, to a method of manufacturing a continuous analyte monitoring system and to a method of using a continuous analyte monitoring system. The devices and methods 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 a 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.

[0004] Background art

[0005] 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.

[0006] 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.

[0007] 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.

[0008] 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.

[0009] 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.

[0010] Current continuous glucose monitoring devices may have 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 lower side of the connector. The sensor may penetrate the connector horizontally to connect to an electronics unit and it is 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.

[0011] Sealing the sensor while passing through the connector is 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 commonly needs to be mounted which renders the device complex. Moreover, a sterilization unit comprising the sensor and the insertion cannula shall be sterilized separately before assembling an integrated inserter - sensor device. The sterilization unit may include a flat out-bulging the sensor patch base plate which comes with a significant diameter and irregular form factor. Thus, the sterilization unit may take up a significant space in a sterilization line and does not lend itself well to sterilization, e.g. by e-beam tunnel sterilization.

[0012] EP4106617A1 describes a sensor control device and methods of making them. The sensor control device includes an electronics housing and a plug assembly. The electronics housing includes an upper shell matable to a lower mount having a skin-facing surface. The plug assembly is coupled to the electronics housing and includes a sensor module that has a sensor and a sharp module having a sharp. The plug assembly includes a base having a skin-facing surface and a plug portion comprising a lumen therethrough. At least a portion of a surface of the electronics housing or the plug assembly comprises an antimicrobial agent. The antimicrobial agent may be a metal and / or a metal oxide.

[0013] WO2013178501 Al describes a sensor insertion assembly comprising a sensor cartridge comprising an insertion needle and a sensor within a sterile capsule. The sensor insertion assembly further comprises an inserter comprising a chamber for receiving the sensor cartridge, wherein the inserter further comprises an insertion mechanism operable for actuating the insertion needle for inserting the sensor into a subject. The sensor cartridge is removable from the chamber. The sensor cartridge is operable for shielding the insertion needle upon removal of the sensor cartridge from the chamber. A family member of WO2013178501 Al is EP2854639B1.

[0014] WO2013178499A1 describes a sensor cartridge comprising a sterile capsule. The sensor cartridge further comprises a sensor within the sterile capsule. The sensor cartridge further comprises a sensor connector connected to the sensor in an initial position. The sensor cartridge further comprises an insertion needle for inserting the sensor into a subject. The insertion needle is within the sterile capsule. The sensor cartridge further comprises a sensor mounting unit for receiving the sensor connector at a mounted position. The sensor mounting unit comprises an adhesive surface for attaching to an exterior surface of the subject. The sensor cartridge further comprises an insertion mechanism operable for actuating the insertion needle and moving the sensor connector from the initial position to the mounted position. A family member of WO2013178499A1 is EP2854638B1.

[0015] 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.

[0016] Problem to be solved

[0017] It is therefore desirable to provide a continuous analyte monitoring unit, a housing, a continuous analyte monitoring system, a method of manufacturing a continuous analyte monitoring system and a method of using a continuous analyte monitoring system, which solve at least one of the problems mentioned above. In particular, it is desirable to provide a reliable sealing of the analyte sensor.

[0018] Summary

[0019] At least one of the above-mentioned problems is addressed by a continuous analyte monitoring unit, a housing, a continuous analyte monitoring system, a method of manufacturing a continuous analyte monitoring system and a method of using a continuous analyte monitoring system 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.

[0020] 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.

[0021] 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 embodi-ments.

[0022] 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.

[0023] 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.

[0024] Thereby, the term “essentially parallel” may comprise slight deviations from a parallel arrangement such as arrangements which deviate from a parallel arrangement by no more than 10 degrees, preferably by no more than 5 degrees. 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.

[0025] In a first aspect of the present invention, a continuous analyte monitoring unit is disclosed. The continuous analyte monitoring unit comprises:

[0026] • 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;

[0027] • 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 analyte sensor is at least partially placed inside the insertion cannula;

[0028] • a connector unit, wherein the connector unit comprises an open channel which at least partially surrounds one or both of the analyte sensor and the removable insertion component, wherein the connector unit further comprises at least two electrical connector unit contacts in electrically conductive connection with the analyte sensor, wherein the at least two electrical connector unit contacts are configured for electrically connecting to at least two electrical housing contacts of a housing, specifically, the at least two electrical connector unit contacts may be configured for mechanically coupling with the at least two electrical housing contacts of the housing; and

[0029] • a removable sterility cap, wherein the removable sterility cap at least partially surrounds the insertable portion of the analyte sensor; wherein the removable sterility cap, 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.

[0030] The embodiments of the present invention may specifically show the advantages that, specifically in view of the form factor advantage, the continuous analyte monitoring unit can be easily coupled mechanically and can be easily connected electrically with the housing. This simplification in design, in turn, may be associated with reduced production costs and: in hitherto known systems such as in Abbott’s Freestyle Libre 3 continuous glucose monitoring system, a part of the analyte sensor that connects with the electronics unit passes into the electronics compartment of the housing and directly couples mechanically and connects electrically with the electronics unit. This may create challenges in design of the sterile compartment which may house the analyte sensor and the insertion cannula, specifically since a passage of a connecting part of the analyte sensor from the sterile compartment into the electronics compartment needs to be sealed. This may complicate a sterilization process of the analyte sensor and the insertion cannula and may further complicate a complexity in sealing and assembling of the continuous analyte monitoring unit of the prior art with the electronics unit. In contrast, in the present invention, the analyte sensor may not directly mechanically couple and electrically connect with the electronics unit in the housing. Instead, the connecting part of the analyte sensor establishing an electrical contact with the electronics unit may be encapsulated in the connector unit of the continuous analyte monitoring unit and may establish an electrical connection with the electronics unit only via the electrical connector unit contacts which in turn are configured for electrically connecting to at least two electrical housing contacts of a housing. In light of the disclosure herein, it will be readily understood that this design may greatly simplify sterilization, sealing and assembly of the embodiments of the invention and may reduce manufacturing costs.

[0031] 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 unit or a continuous analyte monitoring system 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 unit or the continuous analyte monitoring system is different from the user.

[0032] The term “continuous analyte monitoring system” 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 system 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.

[0033] The continuous analyte monitoring system 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 system generally may also be referred to as a sensor assembly, a sensor system, a sensor kit or a sensor device. Further, the continuous analyte monitoring system generally may also be referred to as wearable analyte sensor system.

[0034] The continuous analyte monitoring system 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 system 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 system 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 system may be configured for outputting warning signals under certain circumstances.

[0035] Specifically, the continuous analyte monitoring system may be a continuous glucose monitoring system. A concentration of glucose in a 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 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 be 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.

[0036] The continuous analyte monitoring system may be configured to be mounted on a skin site of a body part 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.

[0037] The continuous analyte monitoring system 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 a housing comprising an electronics compartment with an 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.

[0038] Further details on the continuous analyte monitoring system are given below.

[0039] The term “continuous analyte monitoring 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 a part or a component of a continuous analyte monitoring system which may specifically, together with one or more further parts of the continuous analyte monitoring system, form the continuous analyte monitoring system. Specifically, an assembly of the continuous analyte monitoring unit and a housing with an electronics compartment for receiving an electronics unit may form a continuous analyte monitoring system. Specifically, the continuous analyte monitoring unit may be distinct from the housing. Specifically, the continuous analyte monitoring unit and the housing may be manufactured separately. Further, specifically, the continuous analyte monitoring unit and the housing may be sealed and / or sterilized independently from each other. The continuous analyte monitoring system may further comprise additional parts or components such as an insertion device. Further details will be provided below.

[0040] The continuous analyte monitoring unit may from a pre-assembled 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 unit 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 unit a factory-assembled functional module, preferably before assembling the continuous analyte monitoring unit with the housing with the electronics compartment for receiving the electronics unit. Thus, a sealing and / or a sterilization of the continuous analyte monitoring unit may be conducted before assembling the continuous analyte monitoring unit with the housing comprising the electronics compartment with the electronics unit received therein. Thus, the continuous analyte monitoring unit may also be referred to as sterilization unit.

[0041] 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. Thus, specifically, as will be outlined in further detail below, the analyte sensor may be configured for detecting the analyte in the body tissue.

[0042] 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 unit and the continuous analyte monitoring system may specifically be described with respect to glucose monitoring. The detection of the analyte specifically may be an analyte-specific detection.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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. Each conductor path may be connected to an electrical connector unit contact. 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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-cir- cular 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.

[0053] The analyte sensor may comprise a carrier, specifically a substrate. The at least two electrodes, specifically the at least two electrode conductor paths 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.

[0054] The carrier, specifically the substrate, specifically may have an elongated shape, such as a stripshape 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.

[0055] 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.

[0056] Specifically, the analyte sensor may be a needle-shaped or a strip-shaped analyte sensor comprising 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 portion of the analyte sensor which is inserted may also be called the in-vivo portion, the portion of the analyte sensor which may stay outside of the body tissue may also be called the ex vivo portion. For example, the in vivo 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.

[0057] 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 insertion cannula may be configured for supporting the insertion of the analyte sensor or the insertion of a part of the analyte sensor.

[0058] 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.

[0059] As further outlined above, the removable insertion component further comprise 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 have 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. Further details on the insertion cannula holder are given below.

[0060] 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 mechanically and / or electrically. Specifically, the connector unit may be configured for mechanically coupling the continuous analyte monitoring unit with the housing of the continuous analyte monitoring system. Further, specifically, the connector unit may be configured electrically coupling the analyte sensor with the electronics unit. The electronics unit may be configured for interacting with the analyte sensor for performing the electrochemical measurement. Further, details on the connector unit are given below.

[0061] As outlined above, the connector unit comprises the open channel. The connector unit may specifically comprise an upper side and a lower side. The open channel may connect the upper side and the lower side. The upper side and the lower side may specifically extend essentially parallel to each other. 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.

[0062] The upper side and the lower side may specifically extend transversely, specifically essentially perpendicularly, to a direction of insertion of the analyte sensor. The direction of insertion may be transverse, specifically essentially perpendicular, to a skin site of the user. The upper side and the lower side may specifically extend essentially parallel to the skin site of the user. The open channel may extend transversely, specifically essentially perpendicularly, relative to the lower side and to the upper side of the connector unit. The direction of insertion may correspond to a direction of extension of the open channel.

[0063] Specifically, the upper side may refer to a distal side of the connector unit. 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 connector unit in relation to a user which is furthermost away from a skin site of the user. Exemplarily, for inserting the analyte sensor, the connector unit 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 and / or refer to the side facing away from the skin.

[0064] Specifically, the lower side may refer to a proximal side of the connector unit. 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 connector unit in relation to a user which is closest to a skin site of the user. Exemplarily, for inserting the analyte sensor, the connector unit 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 and / or refer to the side facing the skin.

[0065] The upper side and the lower side of the connector unit may respectively have essentially flat surfaces. The upper side of the connector unit may comprise a supporting surface or a contact surface for the insertion cannula holder. The upper side of the connector unit may be configured for attachment of the insertion cannula holder. The lower side of the connector unit may comprise a supporting surface or a contact surface for the removable sterility cap. The lower side of the connector unit may be configured for attachment of the removable sterility cap. The removable sterility cap may be configured to seal with the lower side of the connector unit and the removable insertion cannula holder may be configured to seal with the upper side of the connector unit. Further details in this regard are be given below.

[0066] 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 channel may extend along the direction of insertion of the analyte sensor, specifically when the channel is a straight channel. Further, the channel may extend transversely, specifically essentially perpendicularly, to a direction of extension of the connector unit. Further, the channel may extend transversely, specifically essentially perpendicularly, to the upper side and to the lower side of the connector unit. The open channel may specifically have 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 the connector unit facing the skin site.

[0067] As outlined above, the open channel at least partially surrounds the analyte sensor and / or the removable insertion component. Specifically, the open channel may at least partially circumferentially surround the analyte sensor and / or the removable insertion component, specifically at least the insertion cannula of the removable insertion component and, optionally also a part of the insertion cannula holder of the removable insertion component. The open channel may form 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 the analyte sensor and / or the removable insertion component specifically at least the insertion cannula of the removable insertion component and, optionally also a part of the insertion cannula holder of the removable insertion component.

[0068] Specifically, the insertion cannula and the analyte sensor may be at least partially received within the open channel. The insertable portion of the analyte sensor may extend downwardly inside the open channel beyond the lower side of the connector unit. Further, an 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 inside 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. Specifically, the insertion cannula holder may extend downwardly inside the open channel beyond the lower side of the connector unit, specifically for establishing a coupling with the removable sterility cap. Further details in this regard are given below.

[0069] The insertion cannula holder may be 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 may be arranged on the lower side of the connector unit. 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.

[0070] Specifically, the analyte sensor may comprise an in vivo proximal portion and an ex vivo distal portion. A part of the insertable portion may be the in vivo proximal portion. The in vivo proximal portion may be configured for being inserted into the body tissue of the user. The ex vivo distal portion may be configured for staying out-side 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 the direction of insertion. The in vivo proximal portion may extend along the direction of extension of the open channel.

[0071] The analyte sensor may be coupled to the connector unit, specifically mechanically. Specifically, the analyte sensor may be fixedly mechanically coupled to the connector unit. Specifically, the ex vivo distal portion of the analyte sensor may be attached to the connector unit, specifically fixedly. The connector unit may comprise a receptacle for receiving the ex vivo distal portion of the analyte sensor. Specifically, the receptacle may be formed by a groove or by a compartment within the connector unit.

[0072] The open channel may be formed by an open channel wall. Thus, a side of the open channel wall may face an interior space of the open channel. The open channel wall may at least partially be designed as a cylindrical ring. The open channel wall may comprise or may have the receptacle. The receptacle may specifically be accessible from the upper side of the connector unit. Further, the receptacle may specifically be accessible from the open channel. The receptacle may specifically be a recess or a cutout within the open channel wall. The analyte sensor may be partially received within the receptacle and may be partially located outside the receptacle such as within the open channel. The insertable portion of the analyte sensor may be located outside of the receptacle. The receptacle may specifically be sealed by a sealing material, specifically by a glue, an elastomer, and / or silicone. 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 from environmental influences such as liquid, dust, germs, and moisture.

[0073] As outlined above, the connector unit comprises the at least two electrical connector unit contacts. The term “electrical connector unit contact” as used herein refers to an electrical contact of the connector unit.

[0074] The term “electrical contact” 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 pass an electrical current. Specifically, the electrical contact may be configured for establishing an electrical connection between electrical components, between or within electrical circuits and / or within electrical components. The electrical contact may be an electrically conductive element which is configured for electrically contacting a further electrically conductive element. Specifically, the electrical contact may provide a contact area. The term “contact area” 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 electrically contactable surface. The contact area may be provided in a dimension or direction parallel to a surface, specifically to a supporting surface, of a carrier or a substrate. The contact area may have an arbitrary shape such as a rectangular shape, a polygonal shape or a round shape. Other shapes are possible.

[0075] The at least two electrical connector unit contacts may be located on a side of the connector unit which extends transversely, specifically essentially perpendicularly, relative to the upper side and the lower side of the connector unit. The at least two electrical connector unit contacts may be located on an outer wall of the connector unit. Specifically, the at least two electrical connector unit contacts may face an outer environment of the connector unit. The outer wall may extend transversely, specifically essentially perpendicularly, relative to the upper side and the lower side of the connector unit. As outlined above, the open channel may comprise the open channel wall. The outer wall of the connector unit may extend essentially parallel to the open channel wall of the open channel. The outer wall on which the least two electrical connector unit contacts may be located may be distinct from the open channel wall.

[0076] The at least two electrical connector unit contacts may specifically be made of at least one material selected from the group consisting of: a metal and a conductive elastomer material. Exemplarily, the conductive elastomer material may be a carbon filled elastomer such as a carbon filled silicone. However, also other materials may be possible.

[0077] The connector unit may specifically comprise two of the electrical connector unit contacts. Further, the connector unit may specifically comprise three of the electrical connector unit contacts. However, also a different number of electrical connector unit contacts is feasible. The at least two electrical connector unit contacts may be arranged in a distance to each other. Thus, a first electrical connector unit contact may be arranged in a distance to a second electrical connector unit contact. The first electrical connector unit contact and the second electrical connector unit contact may not touch each other. The at least two electrical connector unit contacts may be arranged along a straight virtual line which may extend along the direction of extension of the insertion cannula. However, also other embodiments are feasible. Thus, the at least two electrical connector unit contacts may be arranged in an offset.

[0078] As outlined above, the at least two electrical connector unit contacts are in electrically conductive connection with the analyte sensor. Specifically, the at least two electrical connector unit contacts may respectively be in a permanent electrical contact with an electrode or a conductor path of the analyte sensor. Specifically, the at least two electrical connector unit contacts may respectively be electrically connected to the electrode or conductor path of the analyte sensor. Further, as outlined above, the at least two electrical connector unit contacts are configured for electrically connecting to the at least two electrical housing contacts of the electronics unit. Further details are given below.

[0079] As outlined above, the continuous analyte monitoring unit further comprises the removable sterility cap.

[0080] 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. 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 coupling between the element and the object may be decoupled or uncoupled. Generally, the element may be removable in a reversible manner wherein the element may be attachable and detachable from the object or in an irreversible manner wherein the element may not be attachable to the object after detachment.

[0081] 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.

[0082] 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. Specifically as the analyte sensor, specifically at least the insertable portion of the analyte sensor, is at least partially placed inside the insertion cannula, the removable sterility cap may further at least partially surround the insertion cannula. Optionally, specifically in cases wherein the insertion cannula holder may extend downwardly inside the open channel beyond the lower side, the removable sterility cap may further at least partially surround the insertion cannula holder. The removable sterility cap may be configured for removal before insertion of the insertable portion of the analyte sensor into the body tissue.

[0083] As outlined above, the removable sterility cap, 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. Further, a part of the insertion cannula holder may be received in the sterile compartment. The sterile compartment may also be referred to as sensor compartment.

[0084] 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 unit, 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 unit. Each compartment may comprise a continuous space or lumen configured for receiving one or more objects.

[0085] 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.

[0086] Embodiments of a medical analyte sensor device comprising an analyte sensor, a cannula, a lower and upper cap, a lower and upper cover, 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.

[0087] The removable sterility cap and / or the insertion cannula holder may be reversibly or irreversibly coupled to the connector unit and / or to each other. The removable sterility cap may be removably coupled, specifically attached, to at least one of the lower side of the connector unit and the insertion cannula holder. The insertion cannula holder may be removably coupled, specifically attached, to at least one of the upper side of the connector unit and the removable sterility cap.

[0088] As outlined above, the connector unit may comprise the upper side and the lower side and the open channel may connect the upper side and the lower side. At least a part of the removable sterility cap may be located on the lower side of the connector unit or may extend beyond the lower side of the connector unit and at least a part of the insertion cannula holder may be located on the upper side of the connector unit or may extend from the upper side of the connector unit inside the open channel and / or may couple with the upper side of the connector unit. The insertion cannula holder and the removable sterility cap may respectively be removably coupled to the connector unit, specifically on opposing sides of the connector unit, specifically on opposing sides 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.

[0089] At least a part of the insertion cannula holder may extend fromthe upper side of the connector unit and / or may be at least partially located within the open channel. 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 coupling to the removable sterility cap. Specifically, the insertion cannula holder may form a removable cap, specifically a removable upper cap. The insertion cannula holder may be configured for sealing an end of the open chan- nel of the connector unit, specifically of the upper side opening of the open channel. The insertion cannula holder may be configured for removal, specifically from the connector unit, after insertion of the insertable portion of the analyte sensor into the body tissue.

[0090] Thus, 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.

[0091] The insertion cannula holder may be removably coupled to the connector unit, specifically to a surface of the connector unit, via a coupling, specifically via at least one of a form-fit coupling, a force fit coupling, a screwing coupling, a magnetic coupling or a bayonet coupling. The removable sterility cap may be removably coupled to the connector unit, specifically to the surface of the connector unit, via a coupling, specifically via at least one of a form-fit coupling, a force fit coupling, a screwing coupling, a magnetic coupling or a bayonet coupling. Specifically, the insertion cannula holder may be reversibly or irreversibly coupled to a surface of the upper side of the connector unit and / or to the removable sterility cap. Specifically, the removable sterility cap may be reversibly or irreversible coupled to a surface of the lower side of the connector unit and / or to insertion cannula holder.

[0092] Specifically, the removable sterility cap may be pulled off from the connector unit and / or from the insertion cannula holder. Further, specifically, the insertion cannula holder may be pulled off 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 coupled to the connector unit, overlap with the connector unit or vice a versa. Additionally or alternatively, the removable sterility cap may overlap with the insertion cannula holder or vice a versa. 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 coupled to the connector unit at an upper predetermined breaking point and / or the removable sterility cap may be removably coupled 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.

[0093] 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.

[0094] In a further aspect of the present invention, a housing is disclosed. The housing comprises a passage opening configured for receiving a continuous analyte monitoring unit as described above or as will further be described below in more detail. The housing further comprises an electronics compartment with an electronics unit received therein. The housing further comprises at least two electrical housing contacts in electrically conductive connection with the electronics unit. The at least two electrical housing contacts are configured for electrically connecting to the at least two electrical connector unit contacts of the connector unit of the continuous analyte monitoring unit when the continuous analyte monitoring unit is attached to the housing. Optionally, at least two electrical housing contacts may be configured for mechanically coupling with the at least two electrical connector unit contacts of the connector unit of the continuous analyte monitoring unit when the continuous analyte monitoring unit is attached to the housing.

[0095] 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. Exemplarily, the electronics unit may be sealed or potted as will further be described below. The housing may specifically be a sealed housing. The electronics compartment may specifically be a sealed compartment.

[0096] The housing may comprise at least two housing portions. The at least two housing portions may comprise a lower housing portion and an upper housing portion. 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. The upper housing portion and the lower housing portion may be coupled via one or more of a form-fit coupling, a force-fit coupling or a coupling by material engagement, more specifically by a coupling using an adhesive and / or a bonding. The upper housing portion and the lower housing portion may form an encapsulation for electronic components of the electronics unit.

[0097] The lower housing portion may comprise a lower surface configured for being placed on a user’s skin. Specifically, the housing may comprise an adhesive surface for attachment to the user’s skin. 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 comprise 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. The adhesive surface may be or may be located at a lower surface of the housing or at the lower side of the housing. The term “lower surface” may specifically refer to a surface of the housing facing the skin user’s skin. The adhesive surface may exemplarily have a shape of a circular ring surrounding the analyte sensor. Optionally, additionally, a surface of the connector unit may be or may from an adhesive surface.

[0098] As outlined above, the housing comprises the electronics compartment. 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. 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, and 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 longterm monitoring one or more analytes, such as in from one or more of the above-mentioned prior art documents.

[0099] 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.

[0100] An 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 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 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 electronic component, as an example, may comprise an application-specific integrated circuit (ASIC).

[0101] Therein, the 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 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 electronic component are electrically connected to the one or more contact pads. Additionally or alternatively, however, the 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 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 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 electronic component. Additionally or alternatively, however, other types of encapsulation of the 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 electronic component, wherein the upper shell or protection above the 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.

[0102] 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.

[0103] The housing may comprise an upper housing side and a lower housing side. The upper housing side may be formed by the upper housing portion. The lower housing side may be formed by the lower housing portion. The upper housing side and the lower housing side may respectively extend along a direction of extension of the skin side of the user. The upper housing side and the lower housing side may extend essentially parallel to each other. The passage opening may connect the upper housing side and the lower housing side. The terms “upper housing side” and “lower housing side” may refer to two opposing sides of the housing. The terms “upper housing side” and “lower housing side” may be considered as description without specifying an order and without excluding a possibility that several kinds of upper housing sides and lower housing sides may be applied. The upper housing side and the lower housing side of the housing may respectively have essentially flat surfaces.

[0104] Specifically, the upper housing side may refer to a distal housing side of the housing. The term “distal housing 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 the user which is furthermost away from the 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 side may refer to a side being distanced to the skin site of the user.

[0105] Specifically, the lower housing side may refer to a proximal side of the housing. The term “proximal housing 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 and / or which faces the skin. Exemplarily, for inserting the analyte sensor, the housing may be brought into contact with the skin site of the user. The proximal housing side may refer to a side being in close proximity to or even in direct contact with to the skin site of the user.

[0106] As outlined above, the housing comprises a passage opening. The term “passage opening” 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 opening with an elongate shape and which may provide a free volume or lumen and which enables other elements to pass there through. The passage opening may specifically be an essentially straight opening, i.e. the passage opening may specifically extend continuously in one direction essentially without a bend, angle or curve. The passage opening may extend along the direction of insertion of the analyte sensor. Further, the passage opening may extend transversely, specifically essentially perpendicularly, to the direction of extension of the housing. The passage opening may specifically have an upper side housing opening and an opposing lower side housing opening. The upper side housing opening may be located on the upper housing side of the housing facing away from the skin site and the lower side housing opening may be located on the lower housing side of the housing facing the skin site. The passage opening may also be referred to as through hole, through opening or through going opening. The passage opening of the housing may have a diameter which is larger than a diameter of the open channel of the connector unit of the continuous analyte monitoring unit. The diameter of the passage opening of the housing may be essentially equivalent to a diameter of the connector unit of the of the continuous analyte monitoring unit.

[0107] As outlined above, the housing comprises the at least two electrical housing contacts. The term “electrical housing contact” as used herein refers to an electrical contact of the housing. With regard to a definition of the term “electrical contact”, reference is made to the description above.

[0108] The at least two electrical housing contacts may be located on a side of the housing which extends transversely, specifically essentially perpendicularly, relative to the upper housing side and to the lower housing side of the housing. The at least two electrical housing contacts may be located on an outer wall of the housing. Specifically in a disassembled state of the housing and the continuous analyte monitoring unit, the at least two electrical housing contacts may face an outer environment of the housing. Specifically in an assembled state of the housing and the continuous analyte monitoring unit, the at least two electrical housing contacts may face the outer wall of the continuous analyte monitoring unit, specifically of the connector unit. Specifically, the passage opening may comprise a passage opening wall. The at least two electrical housing contacts may be located on the passage opening wall and may specifically face an interior space of the passage opening. The outer wall of the housing on which the at least two electrical housing contacts may be located may correspond to the passage opening wall. The passage opening wall may have a first side facing an interior space of the electronics unit and an opposing second side facing interior space of the passage opening. The at least two electrical housing contacts may be located on the second side.

[0109] The at least two electrical housing contacts may specifically be made of at least one material selected from the group consisting of: a metal and a conductive elastomer material. Exemplarily, the conductive elastomer material may be a carbon filled elastomer such as a carbon filled silicone. However, also other materials may be possible.

[0110] The housing may specifically comprise two of the electrical housing contacts. Further, the housing may specifically comprise three of the electrical housing contacts. However, also a different number of electrical housing contacts is feasible. A number of the electrical housing contacts may specifically be equivalent to a number of the electrical connector unit contacts. Specifically, the number of the electrical housing contacts may be equivalent to the number of the electrical connector unit contacts which in turn may be equivalent to a number of analyte sensor electrodes. The at least two electrical housing contacts may be arranged in a distance to each other. The at least two electrical housing contacts may not touch each other. Thus, a first electrical housing contact may be arranged in a distance to a second electrical housing contact. Thus, the first electrical housing contact and the second housing unit contact may not touch each other. The at least two electrical housing contacts may be arranged along a straight virtual line which may extend along a direction of extension of the insertion cannula. However, also other embodiments are feasible. Thus, the at least two housing unit contacts may be arranged in an offset.

[0111] As outlined above, the at least two electrical housing contacts are in electrically conductive connection with the electronics unit. Specifically, the at least two electrical housing contacts may be in electrically conductive connection with an electronic component of the electronics unit. Specifically, the at least two electrical housing contacts may respectively be permanently electrically connected to the electronic component of the electronics unit.

[0112] In a further aspect of the present invention, a continuous analyte monitoring system is disclosed comprising:

[0113] • a continuous analyte monitoring unit as described above or as will further be described below in more detail; and • a housing according as described above or as will further be described below in more detail; wherein the continuous analyte monitoring unit is mechanically coupled with the housing; and wherein the at least two electrical housing contacts are electrically connected to the at least two electrical connector unit contacts of the connector unit of the continuous analyte monitoring unit.

[0114] Optionally, the at least two electrical housing contacts may be mechanically coupled with the at least two electrical connector unit contacts of the connector unit of the continuous analyte monitoring unit.

[0115] With regard to a definition of the term “continuous analyte monitoring system” reference is made to the description above.

[0116] The continuous analyte monitoring system may be a disposable medical device. The term “disposable continuous analyte monitoring system” 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 continuous analyte monitoring system configured to be disposed of after use. Thus, one or more materials may specifically be low priced and / or easily recyclable. Specifically, the housing comprising the electronics compartment with the electronics unit received therein may be a single-use housing. 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 system with the electronics units from the body tissue, dispose the continuous analyte monitoring system with the electronics unit and may utilize a further, new continuous analyte monitoring system comprising a further, new electronics unit for another detection of the analyte in the body fluid.

[0117] Further, the continuous analyte monitoring unit and the housing may form a pre-assembled single unit. Thus, the components of the continuous analyte monitoring system may already be assembled, such as by being mechanically and / or electrically interconnected, thereby being ready for use for the function, such as the medical function, e.g. for the analytical function. The pre-assembling, specifically of the continuous analyte monitoring unit and the housing, specifically may take place in a factory, thereby rendering the continuous analyte monitoring system a factory-assembled functional module. Specifically, the continuous analyte monitoring system may be configured such that the user may not see or manipulate the medical device system, preferably before putting the continuous analyte monitoring system to use or before applying it to the body. Specifically, the sterile compartment of the continuous analyte monitoring unit and / or the continuous analyte monitoring unit may be sterilized before the continuous analyte monitoring unit is assembled with the housing to form the pre-assembled single unit. The sterile compartment of the continuous analyte monitoring unit and / or the housing may be sterilized separately before being assembled to form the pre-assembled single unit.

[0118] As outlined above, the passage opening is configured for receiving the continuous analyte monitoring unit. The passage opening may at least partially surround the continuous analyte monitoring unit, specifically the connector unit. Specifically, the passage opening may at least partially circumferentially surround continuous analyte monitoring unit, specifically the connector unit, circumferentially. The passage opening may from a compartment, specifically an open compartment, specifically for at least partially receiving the continuous analyte monitoring unit, specifically the connector unit. The housing may be at least partially formed as a cylindrical ring at least partially surrounding the continuous analyte monitoring unit, specifically the connector unit.

[0119] In an assembled state of the housing and the continuous analyte monitoring unit, the connector unit may be received within the passage opening of the housing.

[0120] Specifically in a coupled state of the at least two electrical housing contacts and the at least two electrical connector unit contacts which may specifically also refer to the assembled state of the housing and the continuous analyte monitoring unit, the connector unit may be received within the passage opening of the housing. The removable sterility cap may be at least partially located on the lower housing side and at least a part of the insertion cannula holder may extend from the upper housing side inside the open channel. Further, specifically in the coupled state of the at least two electrical housing contacts and the at least two electrical connector unit contacts, the insertable portion of the analyte sensor may extend downwardly inside the open channel beyond the lower housing side. The removable sterility cap may protrude from the lower housing side of the housing and from the lower side of the connector unit. The insertion cannula holder may protrude from the upper housing side of the housing and from the upper side of the connector unit. Specifically, a thickness of the connector unit may correspond, specifically be essentially equivalent, to a thickness of the housing. Specifically, a length of the open channel of the connector unit may correspond, specifically be essentially equivalent, to a length of the passage opening of the housing. In an assembled state of the housing and the continuous analyte monitoring unit the connector unit, the lower side of the connector unit may be essentially flush with the lower housing side of the housing. Thus, the lower side of the connector unit and the lower housing side of the housing may form an essentially flat surface. Optionally, in an assembled state of the housing and the continuous analyte monitoring unit the connector unit, the upper side of the connector unit may be essentially flush with the upper housing side of the housing. Thus, the upper side of the connector unit and the upper housing side of the housing may form an essentially flat surface.

[0121] As outlined above, the at least two electrical housing contacts are configured for electrically connecting to the at least two electrical connector unit contacts of the continuous analyte monitoring unit. A mechanical and electrical coupling of the at least two electrical housing contacts of the housing with the at least two electrical connector unit contacts of the connector unit may specifically be a reversible or an irreversible coupling.

[0122] The term “mechanical coupling” as used herein may refer to an arrangement of the at least two electrical connector unit contacts and the at least two electrical housing contacts such that the at least two electrical connector unit contacts and the at least two electrical housing contacts are positioned juxtaposed. Specifically, the one of the at least two electrical connector unit contacts may be in direct contact with the one of the at least two electrical housing contacts. Specifically, the first electrical connector unit contact and the first electrical housing contact may be positioned juxtaposed in the coupled state of the housing and the continuous analyte monitoring unit. Specifically, the second electrical connector unit contact and the second electrical housing contact may be positioned juxtaposed in the coupled state of the housing and the continuous analyte monitoring unit. Further, specifically, in the coupled state of the housing and the continuous analyte monitoring unit the first electrical connector unit contact may be in direct contact with the first electrical housing contact and the second electrical connector unit contact may be in direct contact with the second electrical housing contact. A mechanical coupling of the continuous analyte monitoring unit with the housing may specifically be selected from the group consisting of a form-it coupling, a force-fit coupling, optionally a threading coupling, a magnetic coupling, an adhesion coupling a coupling via a hook, and a coupling via a lock. However, also other kinds of mechanical coupling may be feasible. The term “electrical coupling” as used herein may refer to an arrangement of the at least two electrical connector unit contacts and the at least two electrical housing contacts such that an electrical contact between the at least two electrical connector unit contacts and the at least two electrical housing contacts is established. Specifically due to the arrangement of the at least two electrical connector unit contacts and the at least two electrical housing contacts relative to each other as described above, in the coupled state of the housing and the continuous analyte monitoring unit, the first electrical connector unit contact may be electrically connected to the first electrical housing contact and the second electrical connector unit contact may be electrically connected to the second electrical housing contact. As outlined above, the at least two electrical housing contacts are in electrically conductive connection with the electronics unit and the at least two electrical connector unit contacts are in electrically conductive connection with the analyte sensor. Thus, in a coupled state of the housing and the continuous analyte monitoring unit, specifically the connector unit, the analyte sensor is electrically connected to the electronics unit.

[0123] The continuous analyte monitoring system may further comprise an insertion device. The insertion device may be configured for inserting the insertable part of the removable insertion component and the insertable part of the analyte sensor into the skin of the user. Further, the insertion device may specifically be configured to withdraw the insertable part of the removable insertion component from the skin while leaving the insertable part 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. Specifically, the insertion device may be configured for enabling a user to drive the insertion cannula into the body tissue and to insert the insertable portion of the analyte sensor. 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 system by the user and / or to reduce application errors. The insertion device may at least partially surround the housing and the continuous analyte monitoring unit. Further, the insertion device may be at least partially coupled to the housing and / or to the continuous analyte monitoring unit, 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 unit. 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.

[0124] The removable lower cover may comprise a basis which is coupled 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 of the removable 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.

[0125] The continuous analyte monitoring system 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:

[0126] • a sensor controller comprised by the electronics unit, wherein the sensor controller is coupled to the analyte sensor, wherein the sensor controller is configured to receive analyte sensor data from the analyte sensor; and

[0127] • a remote control which is configured to receive sensor data from the sensor controller and to process and / or display sensor data.

[0128] Optionally, the continuous analyte monitoring system may further comprise a drug infusion device such as an insulin pump, which may specifically be controlled by the remote control.

[0129] 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.

[0130] 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.

[0131] Specifically, the continuous analyte monitoring system 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.

[0132] In a further aspect of the present invention, a method of manufacturing the continuous analyte monitoring system as described above or as will further be described below in more detail is disclosed.

[0133] The methods comprise 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.

[0134] The method comprises: a) providing the continuous analyte monitoring unit; b) providing the housing; and c) assembling the continuous analyte monitoring unit and the housing by placing the continuous analyte monitoring unit into the passage opening of the housing, whereby the at least two electrical housing contacts are electrically connected to the at least two electrical connector unit contacts of the connector unit of the continuous analyte monitoring unit.

[0135] In step c), the at least two electrical housing contacts may be mechanically coupled with the at least two electrical connector unit contacts of the connector unit of the continuous analyte monitoring unit.

[0136] Before conducting step c), the continuous analyte monitoring unit may be sterilized.

[0137] The continuous analyte monitoring system may further comprise an insertion device, and the method may further comprises mounting the continuous analyte monitoring unit within the insertion device, specifically within a cavity of the insertion device. For further details in the insertion device, reference is made to the description above.

[0138] In a further aspect of the present invention, a method of using the continuous analyte monitoring unit as described above or as will further be described below in more detail is disclosed. The methods comprise 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

[0139] The method comprises:

[0140] I. providing the continuous analyte monitoring system;

[0141] II. removing the removable sterility cap;

[0142] III. inserting the analyte sensor into a body tissue of the user; and

[0143] IV. removing the insertion cannula holder, thereby removing the insertion cannula from the continuous analyte monitoring system, specifically from the continuous analyte monitoring unit.

[0144] The proposed devices and methods provide many advantages over known devices and methods.

[0145] It is referred to an improved all-in-one continuous analyte monitoring system. The analyte sensor and the insertion cannula may be encapsulated in a sterile compartment formed by the insertion cannula holder, the removable sterility cap and the connector unit to establish electrically conductive connection between the analyte sensor inside the sterile compartment and external contact areas.

[0146] The continuous analyte monitoring unit with external contact areas enables to sterilize the analyte sensor and the insertion cannula independent of the on-body housing comprising the electronics unit. At the same time, it is possible to assemble the continuous analyte monitoring unit comprising the analyte sensor and the on-body housing comprising the electronics unit long before the insertion, in particular, at different stages during manufacturing. Therewith, it is possible to use many different sterilization methods, in particular methods such as e-beam sterilization, which are not applicable for electronics components and without the necessity to supply the end-user with two different units or the necessity to assemble continuous analyte monitoring unit comprising the analyte sensor and the housing comprising the on-body sensor electronics unit, themselves.

[0147] The continuous analyte monitoring unit comprising the analyte sensor may be easily couplable mechanically and connectable electrically with the housing, specifically in view of a slender form. Further, electrical contacts may establish a contact between the electronics unit and the analyte sensor without necessitating that the analyte sensor penetrates the wall of the electronics compartment which would otherwise require additional sealing of a penetration site.

[0148] Summarizing and without excluding further possible embodiments, the following embodiments may be envisaged:

[0149] Embodiment 1 : A continuous analyte monitoring unit comprising:

[0150] • 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;

[0151] • 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 analyte sensor is at least partially placed inside the insertion cannula;

[0152] • a connector unit, wherein the connector unit comprises an open channel which at least partially surrounds one or both of the analyte sensor and the removable insertion component, wherein the connector unit further comprises at least two electrical connector unit contacts in electrically conductive connection with the analyte sensor, wherein the at least two electrical connector unit contacts are configured for electrically connecting to at least two electrical housing contacts of a housing;

[0153] • a removable sterility cap, wherein the removable sterility cap at least partially surrounds the insertable portion of the analyte sensor; wherein the removable sterility cap, 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.

[0154] Embodiment 2: The continuous analyte monitoring unit 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.

[0155] Embodiment 3 : The continuous analyte monitoring unit according to the preceding embodiment, wherein at least a part of the removable sterility cap is located on the lower side of the connector unit and or extends beyond the lower side of the connector unit and wherein at least a part of the cannula holder is located on the upper side of the connector unit or extends from the upper side of the connector unit inside the open channel and / or couples with the upper side of the connector unit.

[0156] Embodiment 4: The continuous analyte monitoring unit according to the preceding embodiment, wherein the removable sterility cap is configured to seal with the lower side of the connector unit and wherein the removable insertion cannula holder is configured to seal with the upper side of the connector unit.

[0157] Embodiment 5: The continuous analyte monitoring unit according to any one of the three preceding embodiments, wherein the at least two electrical connector unit contacts are located on a side of the connector unit which extends transversely, specifically essentially perpendicularly, relative to the upper side and the lower side.

[0158] Embodiment 6: The continuous analyte monitoring unit according to any one of the preceding embodiments, wherein the insertable portion of the analyte sensor extends downwardly inside the open channel beyond the lower side.

[0159] Embodiment 7: The continuous analyte monitoring unit according to any one of the preceding embodiments, wherein the open channel at least partially circumferentially surrounds the analyte sensor and / or the removable insertion component, specifically the insertion cannula.

[0160] Embodiment 8: The continuous analyte monitoring unit 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 the analyte sensor and / or the removable insertion component, specifically the insertion cannula.

[0161] Embodiment 9: The continuous analyte monitoring unit according to any one of the preceding embodiments, wherein the at least two electrical connector unit contacts are made of at least one material selected from the group consisting of: a metal and a conductive elastomer material.

[0162] Embodiment 10: The continuous analyte monitoring unit according to any one of the preceding embodiments, wherein the at least two electrical connector unit contacts are arranged in a distance to each other. Embodiment 11 : The continuous analyte monitoring unit according to any one of the preceding embodiments, wherein the at least two electrical connector unit contacts are located on an outer wall of the connector unit and face an outer environment of the connector unit.

[0163] Embodiment 12: The continuous analyte monitoring unit according to any one of the preceding embodiments, wherein the insertion cannula holder and the removable sterility cap are respectively removably coupled to the connector unit, specifically on opposing sides of the connector unit, specifically on opposing sides of the open channel.

[0164] Embodiment 13: The continuous analyte monitoring unit according to any one of the preceding embodiments, wherein an ex vivo distal portion of the analyte sensor is attached to the connector unit, specifically fixedly.

[0165] Embodiment 14: The continuous analyte monitoring unit according to the preceding embodiment, wherein the connector unit further comprises a receptacle for receiving the ex vivo distal portion of the analyte sensor.

[0166] Embodiment 15: The continuous analyte monitoring unit according to the preceding embodiment, wherein the receptacle is formed by a groove or by a compartment within the connector unit.

[0167] Embodiment 16: The continuous analyte monitoring unit according to any one of the two preceding embodiments, wherein the receptacle is sealed by a sealing material, specifically by a glue, an elastomer, and / or silicone.

[0168] Embodiment 17: The continuous analyte monitoring unit according to any one of the preceding embodiments, wherein the analyte sensor comprises at least two electrodes each comprising an electrode conductor path configured for transmitting a sensor current for detecting the analyte, wherein each conductor path is connected to an electrical connector unit contact.

[0169] Embodiment 18: The continuous analyte monitoring unit according to the preceding embodiment, wherein the analyte sensor comprises a carrier, specifically a substrate, wherein the at least two electrode conductor paths are disposed on the carrier.

[0170] Embodiment 19: The continuous analyte monitoring unit 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.

[0171] Embodiment 20: The continuous analyte monitoring unit according to any one of the preceding embodiments, wherein the insertion cannula is fixedly attached to the insertion cannula holder.

[0172] Embodiment 21 : The continuous analyte monitoring unit 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.

[0173] Embodiment 22: The continuous analyte monitoring unit according to any one of the preceding embodiments, wherein the insertion cannula holder at least partially surrounds the insertion cannula.

[0174] Embodiment 23 : The continuous analyte monitoring unit according to any one of the preceding embodiments, wherein the insertion cannula holder forms a removable cap, specifically a removable upper cap, configured for sealing an end of the open channel of the connector unit.

[0175] Embodiment 24: The continuous analyte monitoring unit according to any one of the preceding embodiments, wherein the insertion cannula holder is at least partially received inside the open channel.

[0176] Embodiment 25: The continuous analyte monitoring unit according to the preceding embodiment, wherein the removable sterility cap is configured to couple with the insertion cannula holder via a coupling, wherein the coupling is preferably a mechanical coupling selected from a form-fit coupling, a force fit coupling, a screwing coupling, a magnetic coupling, or a bayonet coupling.

[0177] Embodiment 26: The continuous analyte monitoring unit according to any one of the preceding embodiments, wherein the insertion cannula holder is configured to removably couple to the connector unit via a coupling, specifically via at least one of a form-fit coupling, a force fit coupling, a screwing coupling, a magnetic coupling or a bayonet coupling.

[0178] Embodiment 27: The continuous analyte monitoring unit according to any one of the preceding embodiments, wherein the removable sterility cap is configured to removably couple to the connector unit via a coupling, specifically via at least one of a form-fit coupling, a force fit coupling, a screwing coupling, a magnetic coupling, or a bayonet coupling. .

[0179] Embodiment 28: The continuous analyte monitoring unit 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.

[0180] Embodiment 29: A housing, wherein the housing comprises a passage opening configured for receiving a continuous analyte monitoring unit according to any one of the preceding embodiments, wherein the housing further comprises an electronics compartment with an electronics unit received therein, wherein the housing further comprises at least two electrical housing contacts in electrically conductive connection with the electronics unit, wherein the at least two electrical housing contacts are configured for electrically connecting to the at least two electrical connector unit contacts of the connector unit of the continuous analyte monitoring unit when the continuous analyte monitoring unit is attached to the housing.

[0181] Embodiment 30: The housing according to any one of the preceding embodiments referring to a housing, wherein the at least two electrical housing contacts are made of at least one material selected from the group consisting of: a metal and a conductive elastomer material.

[0182] Embodiment 31 : The housing according to any one of the preceding embodiments referring to a housing, wherein the housing comprises at least two housing portions, specifically a lower housing portion and an upper housing portion.

[0183] Embodiment 32: The housing according to the preceding embodiment, wherein the upper housing portion and the lower housing portion are coupled via one or more of a form-fit connection, a force-fit connection or a connection by material engagement, more specifically by a connection using an adhesive and / or a bonding.

[0184] Embodiment 33 : The housing according to any one of the two preceding embodiments, wherein the upper housing portion and the lower housing portion form an encapsulation for electronic components of the electronics unit.

[0185] Embodiment 34: The housing according to any one of the preceding embodiments referring to a housing, wherein the housing comprises an upper housing side and a lower housing side, wherein the passage opening connects the upper housing side and the lower housing side. Embodiment 35: The housing according to the preceding embodiment, wherein the at least two electrical housing contacts are located on a side of the housing which extends transversely, specifically essentially perpendicularly, relative to the upper housing side and the lower housing side.

[0186] Embodiment 36: The housing according to any one of the preceding embodiments referring to a housing, wherein the passage opening comprises a passage opening wall, wherein the at least two electrical housing contacts are located on the passage opening wall and face an interior space of the passage opening.

[0187] Embodiment 37: The housing according to any one of the preceding embodiments referring to a housing, wherein the at least two electrical housing contacts are arranged in a distance to each other.

[0188] Embodiment 38: The housing according to any one of the preceding embodiments referring to a housing, wherein the at least two electrical housing contacts are located on an outer wall of the housing and face an outer environment of the housing.

[0189] Embodiment 39: The housing according to any one of the preceding embodiments referring to a housing, wherein the housing is a single-use housing.

[0190] Embodiment 40: A continuous analyte monitoring system comprising:

[0191] • a continuous analyte monitoring unit according to any one of the preceding embodiments referring to a continuous analyte monitoring unit; and

[0192] • a housing according to any one of the preceding embodiments referring to a housing; wherein the continuous analyte monitoring unit is mechanically coupled with the housing; and wherein the at least two electrical housing contacts are electrically connected to the at least two electrical connector unit contacts of the connector unit of the continuous analyte monitoring unit.

[0193] Embodiment 41 : The continuous analyte monitoring system according to the preceding embodiment, wherein the analyte sensor is electrically connected to the electronics unit. Embodiment 42: The continuous analyte monitoring system according to any one of the preceding embodiments referring to a continuous analyte monitoring system, wherein a mechanical and electrical coupling of the at least two electrical housing contacts of the housing with the at least two electrical connector unit contacts of the connector unit is a reversible or an irreversible coupling.

[0194] Embodiment 43 : The continuous analyte monitoring system according to any one of the preceding embodiments referring to a continuous analyte monitoring system, wherein a mechanical coupling of the continuous analyte monitoring unit with the housing is selected from the group consisting of: a form-it coupling, a force-fit coupling, optionally a threading coupling, a magnetic coupling, an adhesion coupling, a coupling via a hook, and a coupling via a lock.

[0195] Embodiment 44: The continuous analyte monitoring system according to any one of the preceding embodiments referring to a continuous analyte monitoring system, wherein the at least two electrical housing contacts of the housing and the at least two electrical connector unit contacts of the housing are positioned juxtaposed such that an electrical contact is established.

[0196] Embodiment 45: The continuous analyte monitoring system according to any one of the preceding embodiments referring to a continuous analyte monitoring system, wherein the continuous analyte monitoring system further comprises an insertion device.

[0197] Embodiment 46: The continuous analyte monitoring system according to the preceding embodiment, wherein the insertion device is configured for inserting the insertable part of the removable insertion component and the insertable part of the analyte sensor into the skin of the user and is specifically further configured to withdraw the insertable part of the removable insertion component from the skin while leaving the insertable part of the analyte sensor inserted in the skin.

[0198] Embodiment 47: The continuous analyte monitoring system according to the preceding embodiment, wherein the insertion device comprises an insertion mechanism.

[0199] Embodiment 48: The continuous analyte monitoring system according to any one of the preceding embodiments referring to a continuous analyte monitoring system, wherein the continuous analyte monitoring system comprises an adhesive surface for attachment to a user’s skin, wherein the adhesive surface is a surface of the housing and, optionally, also a surface of the connector unit, optionally the surface or surfaces facing the skin. Embodiment 49: The continuous analyte monitoring system according to any one of the preceding embodiments referring to a continuous analyte monitoring system, wherein the continuous analyte monitoring system is a disposable medical device.

[0200] Embodiment 50: The continuous analyte monitoring system according to any one of the preceding embodiments referring to a continuous analyte monitoring system, wherein the continuous analyte monitoring unit and the housing form a pre-assembled single unit.

[0201] Embodiment 51 : The continuous analyte monitoring system according to any one of the preceding embodiments referring to a continuous analyte monitoring system, wherein the passage opening at least partially circumferentially surrounds the connector unit.

[0202] Embodiment 50: The continuous analyte monitoring system according to any one of the preceding embodiments referring to a continuous analyte monitoring system, wherein the sterile compartment of the continuous analyte monitoring unit and / or the continuous analyte monitoring unit is sterilized before the continuous analyte monitoring unit is assembled with the housing to form a pre-assembled single unit.

[0203] Embodiment 52: The continuous analyte monitoring system according to any one of the preceding embodiments referring to a continuous analyte monitoring system, wherein the sterile compartment of the continuous analyte monitoring unit and / or the housing are sterilized separately before being assembled to form a pre-assembled single unit.

[0204] Embodiment 53: The continuous analyte monitoring system according to any one of the preceding embodiments referring to a continuous analyte monitoring system, wherein the continuous analyte monitoring system further comprises:

[0205] • a sensor controller comprised by the electronics unit, wherein the sensor controller is coupled to the analyte sensor, wherein the sensor controller is configured to receive analyte sensor data from the analyte sensor; and

[0206] • a remote control which is configured to receive sensor data from the sensor controller and to process and / or display sensor data.

[0207] Embodiment 54: The continuous analyte monitoring system according to the preceding embodiment, wherein the continuous analyte monitoring system further comprises a drug infusion device such as an insulin pump which is specifically controlled by the remote control. Embodiment 55: The continuous analyte monitoring system according to any one of the preceding embodiments referring to a continuous analyte monitoring system, wherein the housing is at least partially formed as a cylindrical ring at least partially surrounding the continuous analyte monitoring unit, specifically the connector unit of the continuous analyte monitoring unit.

[0208] Embodiment 56: A method of manufacturing a continuous analyte monitoring system according to any one of the preceding embodiments referring to a continuous analyte monitoring system, wherein the method comprises: a) providing the continuous analyte monitoring unit; b) providing the housing; and c) assembling the continuous analyte monitoring unit and the housing by placing the continuous analyte monitoring unit into the passage opening of the housing, whereby the at least two electrical housing contacts are electrically connected to the at least two electrical connector unit contacts of the connector unit of the continuous analyte monitoring unit.

[0209] Embodiment 57: The method according to the preceding embodiment, wherein the continuous analyte monitoring system further comprises an insertion device, wherein the method further comprises mounting the continuous analyte monitoring unit within a cavity of the insertion device, specifically after conducting step c).

[0210] Embodiment 58: The method according to any one of the two preceding embodiments, wherein the method comprises sterilizing the analyte monitoring unit before conducting step c).

[0211] Embodiment 59: Method of using a continuous analyte monitoring system according to any one of the preceding embodiments referring to a continuous analyte monitoring system, the method comprising:

[0212] I. providing the continuous analyte monitoring system;

[0213] II. removing the removable sterility cap;

[0214] III. inserting the analyte sensor into a body tissue of the user; and

[0215] IV. removing the insertion cannula holder, thereby removing the insertion cannula from the continuous analyte monitoring system, specifically from the continuous analyte monitoring unit. Short description of the Figures

[0216] 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.

[0217] In the Figures:

[0218] Figure 1 shows an exemplary embodiment of a continuous analyte monitoring unit according to the present invention in a cross-sectional view;

[0219] Figures 2A to 2C show an exemplary embodiment of a manufacturing of a continuous analyte monitoring unit according to the present invention in various detailed views;

[0220] Figures 3A to 3C show an exemplary embodiment of a housing according to the present invention in a cross-sectional view (Figure 3A) and in different side views (Figures 3B and 3C);

[0221] Figure 4 shows an exemplary embodiment of a continuous analyte monitoring system according to the present invention in a cross-sectional view; and

[0222] Figures 5 A and 5B show an exemplary embodiment of a continuous analyte monitoring system according to the present invention after insertion of an analyte sensor into a skin site of a user in a cross-sectional view.

[0223] Detailed description of the embodiments

[0224] Figure 1 shows an exemplary embodiment of a continuous analyte monitoring unit 110 according to the present invention in a cross-sectional view. The continuous analyte monitoring unit 110 comprises an analyte sensor 112. The analyte sensor 112 is configured for detecting an analyte in a body fluid of the 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.

[0225] The analyte sensor 112 comprises an insertable portion 116 adapted for at least partially being inserted into a body tissue of a user. A part of the insertable portion 116 which may be inserted into the body tissue of a user may be called in-vivo proximal portion 118. A portion of the analyte sensor 112 which may stay outside of the body tissue may also be called the ex vivo distal portion 120. The ex vivo distal portion 120 and the in vivo proximal portion 118 may be arranged transversely, specifically essentially perpendicularly, to each other. The in vivo proximal portion 118 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.

[0226] Further, the continuous analyte monitoring unit 110 comprises a removable insertion component 122 comprising an insertion cannula 124 and an insertion cannula holder 126. The analyte sensor 112 is at least partially placed inside the insertion cannula 124. 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.

[0227] 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 have 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.

[0228] Further, the continuous analyte monitoring unit 110 comprises a connector unit 136. The connector unit 136 comprises an open channel 138 which at least partially surrounds the analyte sensor 112 and the removable insertion component 122. The connector unit 136 may specifically comprise an upper side 140 and a lower side 142. The open channel 138 may connect the upper side 140 and the lower side 142. Specifically, the upper side 140 may refer to a distal side 144 of the connector unit 136. Specifically, the lower side 142 may refer to a proximal side 146 of the connector unit 136.

[0229] The open channel 138 may specifically be an essentially straight channel. The open channel 138 may extend along the direction of insertion 121 of the analyte sensor 112. Further, the open channel 138 may extend transversely, specifically essentially perpendicularly, to a direction of extension 147 of the connector unit 136. The open channel 138 may specifically have an upper side opening 148 and an opposing lower side opening 150. The upper side opening 148 may be located on the upper side 140 of the connector unit 136 facing away from the skin site and the lower side opening 150 may be located on the lower side 142 of the connector unit 136 facing the skin site.

[0230] Specifically, the open channel 138 may at least partially circumferentially surround the analyte sensor 112 and the removable insertion component 122, specifically at least the insertion cannula 124 of the removable insertion component 122. The open channel 138 may form a compartment 156, specifically for at least partially receiving the analyte sensor 112 and the insertion cannula 124. The connector unit 136 may be at least partially formed as a cylindrical ring at least partially surrounding the analyte sensor 112 and the removable insertion component 122, specifically the insertion cannula 124 of the removable insertion component 122.

[0231] Specifically, the insertion cannula 124 and the analyte sensor 112 may be at least partially received within the open channel 138. The insertable portion 116 of the analyte sensor 112 may extend downwardly inside the open channel 138 beyond the lower side 142 of the connector unit 136. Further, the insertable portion 116 of the insertion cannula 124 may extend downwardly inside the open channel 138 beyond the lower side 142 of the connector unit 136.

[0232] The connector unit 136 further comprises at least two electrical connector unit contacts 158 in electrically conductive connection with the analyte sensor 112. The at least two electrical connector unit contacts 158 are configured for electrically connecting to at least two electrical housing contacts of an external housing (not shown in Figure 1).

[0233] The at least two electrical connector unit contacts 158 may be located on a side 160 of the connector unit 136 which extends transversely, specifically essentially perpendicularly, relative to the upper side 140 and the lower side 142 of the connector unit 136. The at least two electrical connector unit contacts 158 may be located on an outer wall 162 of the connector unit 136. Specifically, the at least two electrical connector unit contacts 158 may face an outer environment of the connector unit 136. The outer wall 162 may extend transversely, specifically essentially perpendicularly, relative to the upper side 140 and the lower side 142 of the connector unit 136. The outer wall 162 of the connector unit 136 may extend essentially parallel to an open channel wall 164 of the open channel 138. The outer wall 162 on which the least two electrical connector unit contacts 158 may be located may be distinct from the open channel wall 164.

[0234] As outlined above, the at least two electrical connector unit contacts 158 are in electrically conductive connection with the analyte sensor 112. Specifically, the at least two electrical connector unit contacts 158 may respectively be permanently electrically connected to a conductor path 166 of the analyte sensor 112.

[0235] Further, the continuous analyte monitoring unit 110 comprises a removable sterility cap 168. The removable sterility cap 168 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 168. The removable sterility cap 168 may be configured for removal before insertion of the insertable portion 116 of the analyte sensor 112 into the body tissue.

[0236] The removable sterility cap 168, the connector unit 136 and the insertion cannula holder 126 form a sterile compartment 170 for the insertion cannula 124 and at least the insertable portion 116 of the analyte sensor 112. The sterile compartment 170 may be a sealed compartment 172.

[0237] The removable sterility cap 168 and / or the insertion cannula holder 126 may be reversibly or irreversibly coupled to the connector unit 136. The upper side 140 and the lower side 142 of the connector unit 136 may respectively have essentially flat surfaces. The upper side 140 of the connector unit 136 may comprise a supporting surface 152 for the insertion cannula holder 126. The upper side 140 of the connector unit 136 may be configured for attachment of the insertion cannula holder 126. The lower side 142 of the connector unit 136 may comprise a contact surface 154 for the removable sterility cap 168. The lower side 142 of the connector unit 136 may be configured for attachment of the removable sterility cap 168. The insertion cannula holder 126 and the removable sterility cap 168 may be respectively removably coupled to the connector unit 136, specifically on opposing sides of the connector unit 136, specifically of the open channel 138. The insertion cannula holder 126 may seal with the upper side opening 148 of the open channel 138 and the removable sterility cap 168 may seal with the lower side opening 150 of the open channel 138. Figures 2A to 2C show an exemplary embodiment of a manufacturing of a continuous analyte monitoring unit 110 according to the present invention in various detailed views. Figure 2 A shows a cross-sectional view of components of the continuous analyte monitoring unit 110. Figure 2B shows a side view on the outer wall 162 of the continuous analyte monitoring unit 110 as illustrated with arrow 163 in Figure 2 A. Figure 2C shows a top view on the continuous analyte monitoring unit 110 as illustrated with arrow 165 in Figure 2A.

[0238] The continuous analyte monitoring unit 110 according to Figures 2A to 2C corresponds at least partially to the continuous analyte monitoring unit 110 according to Figure 1. Thus, reference is made to the description of Figure 1 above.

[0239] As illustrated in Figure 2A, the analyte sensor 112 may be coupled to the connector unit 136, specifically mechanically. Specifically, the analyte sensor 112 may be fixedly mechanically coupled to the connector unit 136. Specifically, the ex vivo distal portion 120 of the analyte sensor 112 may be attached to the connector unit 136, specifically fixedly.

[0240] The connector unit 136 may comprise a receptacle 174 for receiving the ex vivo distal portion 120 of the analyte sensor 112. Specifically, the receptacle 174 may be formed by a groove 176 within the connector unit 136. The open channel 138 may be formed by the open channel wall 164. Thus, the open channel wall 164 may face an interior space of the open channel 138. The open channel wall 164 may at least partially be designed as a cylindrical ring. The open channel wall 164 may comprise or may have the receptacle 174. The receptacle 174 may specifically be accessible from the upper side 140 of the connector unit 136 such as illustrated in Figures 2A and 2C. The receptacle 174 may specifically be a cutout 178 within the open channel wall 164. The analyte sensor 112 may be partially received within the receptacle 174 and may be partially located outside the receptacle 174 such as within the open channel 138.

[0241] As further illustrated in Figure 2A, the analyte sensor 112, specifically the ex vivo distal portion 120 of the analyte sensor 112, may comprise a protrusion 180 or a hook 182. The protrusion 180 or the hook 182 may be configured for mechanically coupling with the connector unit 136 such as via a recess 184 within the receptacle 174 of the connector unit 136.

[0242] In Figure 2C, an assembly of the analyte sensor 112 and the connector unit 136 is illustrated. As illustrated in the upper picture of Figure 2C, the receptacle 174 may specifically be accessible from the upper side 140 of the connector unit 136. The ex vivo distal portion 120 may be received within the receptacle 174, specifically from the upper side 140 of the connector unit 136. As illustrated in the lower picture of Figure 2C, the receptacle 174 may be sealed by a sealing material 186, specifically by a glue, an elastomer and / or silicone.

[0243] As illustrated in Figure 2B, the connector unit 136 may exemplarily comprise three of the electrical connector unit contacts 158. The three electrical connector unit contacts 158 may be arranged in a distance to each other. The three electrical connector unit contacts 158 may be arranged in an offset.

[0244] Figures 3 A to 3C show an exemplary embodiment of a housing 188 according to the present invention. Figure 3A shows a cross-sectional view. Figure 3B shows a side view on an outer wall 190 of the housing 188 as illustrated with arrow in Figure 2A. Figure 3C shows a top view on the housing 188 as illustrated with arrow 195 in Figure 3 A.

[0245] As illustrated in Figures 3A and 3C, the housing 188 comprises a passage opening 191 configured for receiving the continuous analyte monitoring unit 110. The housing 188 may comprise an upper housing side 192 and a lower housing side 194. The passage opening 191 may connect the upper housing side 192 and the lower housing side 194. Specifically, the upper housing side 192 may refer to a distal side 196 of the housing 188. Specifically, the lower housing side may refer to a proximal side 198 of the housing 188. The passage opening 191 may specifically be an essentially straight opening. The passage opening 191 may extend along the direction of insertion 121 of the analyte sensor 112. Further, the passage opening 191 may extend transversely, specifically essentially perpendicularly, to a direction of extension 200 of the housing 188. The passage opening 191 may specifically have an upper side housing opening 202 and an opposing lower side housing opening 204. The upper side housing opening 202 may be located on the upper housing side 192 of the housing 188 facing away from the skin site and the lower side housing opening 204 may be located on the lower housing side 194 of the housing 188 facing the skin site.

[0246] The passage opening 191 may from a compartment 206, specifically an open compartment 208, specifically for at least partially receiving the continuous analyte monitoring unit 110, specifically the connector unit 136. The housing 188 may be at least partially formed as a cylindrical ring at least partially surrounding the continuous analyte monitoring unit 110, specifically the connector unit 136. As specifically illustrated in Figure 3 A, the housing 188 comprises an electronics compartment 210 with an electronics unit 212 received therein. Further, as specifically illustrated in Figures 3A and 3B, the housing 188 further comprises at least two electrical housing contacts 214 in electrically conductive connection with the electronics unit 212 such as via wires 216.

[0247] The at least two electrical housing contacts 214 may be located on a side of the housing 188 which extends transversely, specifically essentially perpendicularly, relative to the upper housing side 192 and to the lower housing side 194 of the housing 188. The at least two electrical housing contacts 214 may be located on the outer wall 190 of the housing 188. Specifically, the passage opening 191 may comprise a passage opening wall 220 which may specifically face an interior space of the passage opening 191. The at least two electrical housing contacts 214 may be located on the passage opening wall 220. The outer wall 190 of the housing 188 on which the at least two electrical housing contacts 214 may be located may correspond to the passage opening wall 220. The housing 188 may specifically comprise three of the electrical housing contacts 214. The three electrical housing contacts 214 may be arranged in a distance to each other. The three electrical housing unit contacts 214 may be arranged in an offset.

[0248] Figure 4 shows an exemplary embodiment of a continuous analyte monitoring system 222 according to the present invention in a cross-sectional view. The continuous analyte monitoring system comprises 222 the continuous analyte monitoring unit 110. The continuous analyte monitoring unit 110 as illustrated in Figure 4 corresponds to the continuous analyte monitoring unit 110 as illustrated in Figure 1. The housing 188 as illustrated in Figure 4 corresponds to the housing 188 as illustrated in Figures 3 A to 3C. Thus, reference is made to the description of Figures 1 and 3A to 3C above.

[0249] Figure 4 shows the continuous analyte monitoring unit 110 and the housing 188 in an assembled state. Specifically, Figure 4 shows a state of the continuous analyte monitoring unit 110 and the housing 188 wherein the at least two electrical housing contacts 214 are electrically connected to the at least two electrical connector unit contacts 158 of the connector unit 136 of the continuous analyte monitoring unit 110.

[0250] As illustrated in Figure 4, the passage opening 191 may receive the continuous analyte monitoring unit 110, specifically the connector unit 136. The passage opening 191 may at least partially surround the continuous analyte monitoring unit 110, specifically the connector unit 136. Specifically, the passage opening 191 may at least partially circumferentially surround continuous analyte monitoring unit 110, specifically the connector unit 136. The removable sterility cap 168 may be located on the lower housing side 194 and at least a part of the insertion cannula holder 126 may extend from the upper housing side 192 inside the open channel 138. Further, in the coupled state of the at least two electrical housing contacts 214 and the at least two electrical connector unit contacts 158, the insertable portion 116 of the analyte sensor 112 may extend downwardly inside the open channel 138 beyond the lower housing side 194. The removable sterility cap 168 may protrude from the lower housing side 194 of the housing 188 and from the lower side 142 of the connector unit 136. The insertion cannula holder 126 may protrude from the upper housing side 192 of the housing 188 and from the upper side 140 of the connector unit 136.

[0251] Specifically, a thickness tcof the connector unit 136 may correspond, specifically be essentially equivalent, to a thickness th of the housing 188. Specifically, a length lcof the open channel 138 of the connector unit 136 may correspond, specifically be essentially equivalent, to a length loof the passage opening 191 of the housing 188. In an assembled state of the housing 188 and the continuous analyte monitoring unit 110, the connector unit 136, the lower side 142 of the connector unit 136 may be essentially flush with the lower housing side 194 of the housing 188. Thus, the lower side 142 of the connector unit 136 and the lower housing side 194 of the housing 188 may form an essentially flat surface 224. Further, in an assembled state of the housing 188 and the continuous analyte monitoring unit 110, the connector unit 136, the upper side 140 of the connector unit 136 may be essentially flush with the upper housing side 192 of the housing 188. Thus, the upper side 140 of the connector unit 136 and the upper housing side 192 of the housing 188 may form an essentially flat surface 226.

[0252] The at least two electrical connector unit contacts 158 and the at least two electrical housing contacts 214 may be positioned juxtaposed. Thus, a first electrical connector unit contact 228 and a first electrical housing contact 230 may be positioned juxtaposed. A second electrical connector unit contact 232 and a second electrical housing contact 234 may be positioned juxtaposed. A third electrical connector unit contact 236 and a third electrical housing contact 238 may be positioned juxtaposed. The first electrical connector unit contact 228 may be in direct contact with the first electrical housing contact 230. The second electrical connector unit 232 contact may be in direct contact with the second electrical housing contact 234. The third electrical connector unit contact 236 may be in direct contact with the third electrical housing contact 238. The first electrical connector unit contact 228 may be electrically connected with the first electrical housing contact 230. The second electrical connector unit contact 232 may be electrically connected with the second electrical housing contact 234. The third electrical connector unit contact 236 may be electrically connected with the third electrical housing contact 238. Thus, in a coupled state of the housing 188 and the connector unit 136, the analyte sensor 112 may be electrically connected to the electronics unit 212.

[0253] As illustrated in Figure 4, a mechanical coupling of the at least two electrical housing contacts 214 of the housing 188 with the at least two electrical connector unit contacts 158 of the connector unit 136 may specifically be realized via hooks 240. The hooks 240 may be arranged on the outer wall 162 of the connector unit 136 may be received in corresponding receptacles 242 of the housing 188 which may specifically be located on the passage opening wall 220 of the housing 188.

[0254] Figures 5 A and 5B show an exemplary embodiment of a continuous analyte monitoring system 222 according to the present invention after insertion of an analyte sensor 112 into a skin site 244 of a user in a cross-sectional view (Figure 5A) and in a top view (Figure 5B).

[0255] The continuous analyte monitoring system 222 as illustrated in Figures 5 A and 5B corresponds to the continuous analyte monitoring system 222 as illustrated in Figure 4. Thus, reference is made to the description of Figure 4 above.

[0256] The continuous analyte monitoring system 222 is in Figures 5A and 5B shown without the removable sterility cap 168 and without the removable insertion component 122. The removable sterility cap 168 is configured for being removed from the connector unit 136 before insertion of the insertion cannula 124 into the body tissue. The removable insertion component 122 including the insertion cannula 124 and the insertion cannula holder 126 is configured for being removed after insertion of the insertion cannula 124 into the body tissue. As illustrated in Figure 5 A, the insertable portion 116 of the analyte sensor 112 is inserted into the body tissue. The analyte sensor 112 is electrically connected to the electronics unit 212 via the electrical connector unit contacts 158 and the electrical housing contacts 214. List of reference numbers continuous analyte monitoring unit analyte sensor carrier substrate insertable portion in-vivo proximal portion ex vivo distal portion direction of insertion removable insertion component insertion cannula insertion cannula holder sharp end slotted cannula first end second end connector unit open channel upper side lower side distal side proximal side direction of extension upper side opening lower side opening supporting surface contact surface compartment electrical connector unit contact side outer wall arrow open channel wall arrow conductor path removable sterility cap sterile compartment sealed compartment receptacle groove cutout protrusion hook recess sealing material housing outer wall passage opening upper housing side arrow lower housing side arrow distal side proximal side direction of extension upper side housing opening lower side housing opening compartment open compartment electronics compartment electronics unit electrical housing contact wire passage opening wall continuous analyte monitoring system essentially flat surface essentially flat surface first electrical connector unit contact first electrical housing contact second electrical connector unit contact second electrical housing contact third electrical connector unit contact third electrical housing contact hook receptacle skin site

Claims

Claims1. A continuous analyte monitoring unit (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 analyte sensor (112) is at least partially placed inside the insertion cannula (124);• a connector unit (136), wherein the connector unit (136) comprises an open channel (138) which at least partially surrounds one or both of the analyte sensor (112) and the removable insertion component (122), wherein the connector unit (136) further comprises at least two electrical connector unit contacts (158) in electrically conductive connection with the analyte sensor (112), wherein the at least two electrical connector unit contacts (158) are configured for electrically connecting to at least two electrical housing contacts (214) of a housing (188);• a removable sterility cap (168), wherein the removable sterility cap (168) at least partially surrounds the insertable portion (116) of the analyte sensor (112); wherein the removable sterility cap (168), the connector unit (136) and the insertion cannula holder (126) form a sterile compartment (170) for the insertion cannula (124) and at least the insertable portion (116) of the analyte sensor (112).

2. The continuous analyte monitoring unit (110) according to claim 1, wherein the connector unit (136) comprises an upper side (140) and a lower side (142), wherein the open channel (138) connects the upper side (140) and the lower side (142), wherein at least a part of the removable sterility cap (168) is located on the lower side (142) of the connector unit (136) or extends beyond the lower side (142) of the connector unit (136) and wherein at least part of the insertion cannula holder (126) is located on the upper side (140) of the connector unit (136) or extends from the upper side (140) of the connector unit (136) inside the open channel (138) and / or couples with the upper side (140) of the connector unit (136).

3. The continuous analyte monitoring unit (110) according to claim 2, wherein the at least two electrical connector unit contacts (158) are located on a side of the connector unit(136) which extends transversely relative to the upper side (140) and to the lower side (142).

4. The continuous analyte monitoring unit (110) according to any one of claims 1 to 3, wherein the at least two electrical connector unit contacts (158) are located on an outer wall (162) of the connector unit (136) and face an outer environment of the connector unit (136).

5. The continuous analyte monitoring unit (110) according to any one of claims 1 to 4, wherein an ex vivo distal portion (120) of the analyte sensor (112) is attached to the connector unit (136), wherein the connector unit (136) further comprises a receptacle (174) for receiving the ex vivo distal portion (120) of the analyte sensor (112).

6. A housing (188), wherein the housing (188) comprises a passage opening (191) configured for receiving a continuous analyte monitoring unit (110) according to any one of claims 1 to 5, wherein the housing (188) further comprises an electronics compartment (210) with an electronics unit (212) received therein, wherein the housing (188) further comprises at least two electrical housing contacts (214) in electrically conductive connection with the electronics unit (212), wherein the at least two electrical housing contacts (214) are configured for mechanically coupling and electrically connecting with the at least two electrical connector unit contacts (158) of the connector unit (136) of the continuous analyte monitoring unit (110) when the continuous analyte monitoring unit (110) is attached to the housing (188).

7. The housing (188) according to claim 6, wherein the passage opening (191) comprises a passage opening wall (220), wherein the at least two electrical housing contacts (214) are located on the passage opening wall (220) and face an interior space of the passage opening (191).

8. The housing (188) according to any one of claims 6 to 7, wherein the at least two electrical housing contacts (214) are located on an outer wall (190) of the housing (188) and face an outer environment of the housing (188).

9. A continuous analyte monitoring system (222) comprising:• a continuous analyte monitoring unit (110) according to any one of claims 1 to 5; and• a housing (188) according to any one of claims 6 to 8; wherein the continuous analyte monitoring unit (110) is mechanically coupling with the housing; and wherein the at least two electrical housing contacts (214) are electrically connected to the at least two electrical connector unit contacts (158) of the connector unit (136) of the continuous analyte monitoring unit (110).

10. The continuous analyte monitoring system (222) according to claim 9, wherein the analyte sensor (112) is electrically connected to the electronics unit (212)11. The continuous analyte monitoring system (222) according to any one of claims 9 to 10, wherein a mechanical coupling of the continuous analyte monitoring unit (110) with the housing (188) is selected from the group consisting of: a form-it coupling, a force-fit coupling, optionally a threading coupling, a magnetic coupling, an adhesion coupling, a coupling via a hook, and a coupling via a lock.

12. The continuous analyte monitoring system (222) according to any one of claims 9 to 11, wherein the at least two electrical housing contacts (214) of the housing (188) and the at least two electrical connector unit contacts (158) of the housing (188) are positioned juxtaposed such that an electrical contact is established.

13. The continuous analyte monitoring system (222) according to any one of claims 9 to 12, wherein the housing (188) is at least partially formed as a cylindrical ring at least partially surrounding the continuous analyte monitoring unit (110).

14. A method of manufacturing a continuous analyte monitoring system (222) according to any one of claims 9 to 13, wherein the method comprises: a) providing the continuous analyte monitoring unit (110); b) providing the housing (188); and c) assembling the continuous analyte monitoring unit (110) and the housing (188) by placing the continuous analyte monitoring unit (110) into the passage opening (191) of the housing (188), whereby the at least two electrical housing contacts (214) are electrically connected to the at least two electrical connector unit contacts (158) of the connector unit (136) of the continuous analyte monitoring unit (110).

15. Method of using a continuous analyte monitoring system (222) according to any one claims 9 to 13, the method comprising:I. providing the continuous analyte monitoring system (222);II. removing the removable sterility cap (168); III. inserting the analyte sensor (112) into a body tissue of the user; andIV. removing the insertion cannula holder (126), thereby removing the insertion cannula (124) from the continuous analyte monitoring system (222).

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