Continuous analyte sensor system

Abstract

A continuous analyte sensor system (110) is disclosed, comprising: − an analyte sensor (114) comprising an insertable portion (116) adapted for being at least partially inserted into a body tissue of a user, wherein the analyte sensor (114) is configured for detecting an analyte in the body tissue of the user; − an electronics unit (118) configured for being electrically connected to the analyte sensor (114); and − an insertion device (122) configured for inserting the insertable portion (116) of the analyte sensor (114) into the body tissue of the user, wherein the insertion device (122) comprises a housing (124), a protective cap (126) and a sterile compartment (112), wherein the sterile compartment (112) encloses at least the analyte sensor (114) and a removable insertion component (128), wherein the insertable portion (116) of the analyte sensor (114) is at least partially placed inside the removable insertion component (128), wherein the sterile compartment (112) comprises a sealed opening (130) and at least one opening mechanism (132) configured for releasing the sealed opening (130), wherein the opening mechanism (132) is configured for interacting with the insertion device (122) such that a use of the insertion device (122) releases the sealed opening (130) of the sterile compartment (112), wherein the released sealed opening (130) is configured for enabling electrically connecting the analyte sensor (114) to the electronics unit (118) upon insertion of the insertable portion (116) of the analyte sensor (114) into the body tissue of the user.

Description

[0001] July 27, 2025

[0002] P39296-WO-1

[0003] Continuous analyte sensor system

[0004] Technical Field

[0005] The invention relates to a continuous analyte sensor system, to a method of manufacturing a continuous analyte sensor system and to a method of using a continuous analyte sensor system. The devices and methods according to the present invention may 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.

[0006] Background art

[0007] 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.

[0008] 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.

[0009] 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, contin- uous measurements are increasingly becoming established. Thus, in the recent past, continuous measuring of glucose in the interstitial tissue (also referred to as continuous glucose monitoring, CGM) for example has been established as another important method for managing, monitoring and controlling a diabetes state.

[0010] 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.

[0011] 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 a human or animal body. In the process, the sensor may be 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.

[0012] 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 acts as a protection against humidity and other detrimental substances and, as an example, may comprise one or more cover layers such as resists.

[0013] Examples of continuous glucose monitoring devices are described e.g. in US 2023 / 0115793 Al, which discloses a system for managing a patient's glucose level including a glucose sensor to generate raw data signals for measurements of the patient's glucose level. The system further includes sensor electronics operatively coupled to the glucose sensor. The sensor electronics have a memory storing one or more predetermined characteristics associated with the sensor electronics. The sensor electronics are in electronic communication with the glucose sensor. The system further includes a receiving device and external devices, wherein the external devices include a first disposable device and a second disposable device. Each external device is configured for wireless communication with both the receiving device and the sensor electronics. The system enables the transfer of sensor context information from the first disposable device to the second disposable device. US 2023 / 301556 Al describes a one piece continuous glucose monitoring (CGM) device (device or sensor) and a fully disposable, one piece, mounting unit for mounting the CGM device. The device and the mounting unit, in some embodiments, are pre-assembled in the factory to a one piece, disposable, mounting assembly. The mounting assembly, can be comprised of sealed compartment that includes a portion of the sensor and a non-sealed compartment that includes another portion of the sensor. The mounting assembly can be fully automatic, at a button press, the sensor is adhered to the skin, and the sensor probe is inserted into the subcutaneous tissue.

[0014] US 9,788,771 B2 discloses an automatic sensor inserter for placing a transcutaneous sensor into the skin of a living body. The sensor insertion speed may be varied by a user. In some embodiments, insertion speed may be varied by changing an amount of drive spring compression. The amount of spring compression may be selected from a continuous range of settings and / or it may be selected from a finite number of discrete settings.

[0015] Despite the advantages achieved by known methods and devices, several technical challenges remain. Current CGM systems using a two-step insertion of the analyte sensor into the body tissue of the user may require a separate packaging for the sterile unit comprising the analyte sensor and an insertion component, and an insertion device. Specifically, a first step may comprise unpacking the CGM system with the insertion device followed by a second step of unpacking a separately packed sterile unit, which comprises the analyte sensor and the insertion component. The sterile unit and the CGM system with the insertion device can be assembled by the user by contacting the analyte sensor to a contact on a lower side of the CGM system. The CGM system may be ready for user only after this assembly by the user.

[0016] US 2015 / 080684 Al discloses a sensor insertion assembly comprising a sensor cartridge having 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.

[0017] KR 2023 0003689 discloses a sensor unit, wherein a sensor inserted into the skin of a user along with a needle can be kept stably inserted into the skin without being affected by the movement of the needle in the process of the needle being separated from the skin of the user. The sensor unit is attached to the skin of a user to measure the biometric information of the user and comprises: a sensor including a sensor body and an insertion part connected to the sensor body so as to be placed on a different plane from the sensor body and capable of being inserted into the skin of the user; a housing base including a housing base hole through which the insertion part passes, and supporting the sensor body; a housing cap coupled to the housing base and covering the sensor body; and a retention protrusion protruding from the housing cap to be able to be in contact with the sensor in order to prevent the insertion part from moving backward toward the housing cap.

[0018] Other current CGM systems are known having preassembled and integrated sterile units. However, in these systems, the entire assembled module must be sterilized to ensure appropriate hygienic standards. The sterilization of these systems must be aware of sensitive electronic parts of the CGM system.

[0019] Problem to be solved

[0020] It is therefore desirable to provide methods and device which at least partially address above- mentioned technical challenges. Specifically, a continuous analyte sensor system, a method of manufacturing a continuous analyte sensor system and a method of using a continuous analyte sensor system shall be proposed which provide a fully integrated system to the user and enable easy sterilization of the system.

[0021] Summary

[0022] This problem is addressed by a continuous analyte sensor system, a method of manufacturing a continuous analyte sensor system and a method of using a continuous analyte sensor 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.

[0023] As used in the following, the terms “have”, “comprise” or “include” or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms may both refer to a situation in which, besides the feature introduced by these terms, no further features are present in the entity described in this context and to a situation in which one or more further features are present. As an example, the expressions “A has B”, “A comprises B” and “A includes B” may both refer to a situation in which, besides B, no other element is present in A (i.e. a situation in which A solely and exclusively consists of B) and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D or even further elements. Further, it shall be noted that the terms “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.

[0024] 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.

[0025] In a first aspect of the present invention, a continuous analyte sensor system is disclosed. The term “continuous analyte sensor 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 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 sensor 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.

[0026] The continuous analyte sensor 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 a body tissue and / or of contributing to the detection of the analyte in the body tissue. The continuous analyte sensor 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 sensor system generally may also be referred to as wearable analyte sensor system.

[0027] The continuous analyte sensor system specifically may be configured for monitoring or detecting a presence of the analyte in the body tissue and / or in a 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 sensor 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 acquired data elements or signals per time unit may vary over time. Specifically, the continuous analyte sensor 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 sensor system may be configured for outputting warning signals under certain circumstances.

[0028] The continuous analyte sensor system may specifically be a continuous glucose sensor system, also referred to as continuous glucose monitoring (CGM) 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 comprise a time-dependent concentration, e.g. a concentration varying or changing 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 different 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.

[0029] The continuous analyte sensor system may be configured to be mounted on a skin site of a body part of a user selected from the group consisting of: an arm, exemplarily an upper arm; a stomach; a shoulder; a back; hip; a leg. Specifically, the body part may be the upper arm. However, also other applications may be feasible.

[0030] The continuous analyte sensor 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 an electronic housing comprising an electronics compartment with an electronics unit received therein. Further, the analyte sensor, comprises, as will be outlined in further detail below, an insertable portion. The insertable portion may be configured for being inserted into the body tissue of the user.

[0031] The continuous analyte sensor system may specifically be a one-piece continuous analyte sensor system. Thus, the continuous analyte sensor system may be provided to the user in a single piece. The user may not need to pre-assemble the continuous analyte sensor system prior to insertion of the analyte sensor into the body tissue. The continuous analyte sensor system may specifically be an all-in-one continuous analyte sensor system. The continuous analyte sensor system may be a compact system provided to the user.

[0032] The continuous analyte sensor system comprises:

[0033] - an analyte sensor comprising an insertable portion adapted for being at least partially inserted into a body tissue of a user, wherein the analyte sensor is configured for detecting an analyte in the body tissue of the user;

[0034] - an electronics unit configured for being electrically connected to the analyte sensor; and

[0035] - an insertion device configured for inserting the insertable portion of the analyte sensor into the body tissue of the user, wherein the insertion device comprises a housing, a protective cap and a sterile compartment, wherein the sterile compartment encloses at least the analyte sensor and a removable insertion component, wherein the insertable portion of the analyte sensor is at least partially placed inside the removable insertion component, wherein the sterile compartment comprises a sealed opening and at least one opening mechanism configured for releasing the sealed opening, wherein the opening mechanism is configured for interacting with the insertion device such that a use of the insertion device releases the sealed opening of the sterile compartment, wherein the released sealed opening is configured for enabling electrically connecting the analyte sensor to the electronics unit upon insertion of the insertable portion of the analyte sensor into the body tissue of the user.

[0036] 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 specifically may refer, without limitation, 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 sensor system. 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 handling the continuous analyte sensor system may be different from the user.

[0037] The term “body tissue” 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 any bodily tissue of a user or patient. Specifically, the body tissue may comprise a bodily tissue of a user or patient in which at least one bodily fluid is present. For example, the body tissue may be interstitial tissue. The bodily fluid present in the interstitial tissue may comprise at least one of interstitial fluid and blood. Alternatively or additionally, the body tissue may comprise a bodily tissue of a skin of a user or patient. Specifically, the body tissue may be subcutaneous tissue. Other examples are also feasible.

[0038] 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 may refer, without limitation, to an arbitrary element, component or compound which may be present in a body tissue 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. The analyte may specifically be glucose. In the following, the continuous analyte sensor system may specifically be described with respect to glucose monitoring. The detection of the analyte specifically may be an analyte-specific detection.

[0039] 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 may refer, without limitation, 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.

[0040] 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 may refer, without limitation, to a sensor which is capable of qualitatively or quantitatively detecting a presence and / or a concentration of an analyte.

[0041] 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 render the analyte sensor 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.

[0042] 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 also feasible.

[0043] 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 present in a body tissue of a user. The term “electrochemical measurement” may refer to a detection of an electrochemically detectable property of the analyte, such as 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.

[0044] 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 be connectable to the electronics unit, such as via an electrode contact which connects with a corresponding contact of an electronic component of the electronics unit.

[0045] The at least two electrodes may comprise 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-elec- trode 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 coun- ter / 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 tissue. 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 a body fluid in the body tissue, 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 analyte 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.

[0046] 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 tissue, 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.

[0047] 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 a reference electrode. The reference electrode may have a stable and well-known electrode potential. The electrode potential may preferably be highly stable. The counter electrode and the reference electrode may be 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.

[0048] The electrodes, particularly the working electrode, the counter electrode and / or the reference electrode, may have an identical dimension. The term “dimension” may refer to one or more of a width, a length, a surface area, a shape of the working electrode, the counter electrode and / or the reference electrode. A shape of the electrodes may be determined by a manufacturing process, such as a cutting and / or a printing process. The shape may be rectangular or round. Still, other embodiments are feasible, such as embodiments in which the dimensions of the working electrode and the counter / reference electrodes differ and / or embodiments in which a non-circular shape or a non-rectangular shape is used. The electrodes may be made of a non-corrosive and non-passivating material. With regard to possible electrode materials, reference may be made to the prior art documents cited above.

[0049] 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.

[0050] The carrier, specifically the substrate, specifically may have an elongated shape, such as a strip-shape and / or a bar-shape. The substrate, as an example, may comprise a shaft, specifically a shaft having an elongate shape. For example, the shaft may have a shape selected from the group consisting of a strip, a needle, a tape. Other shapes may also be feasible.

[0051] 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.

[0052] 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.

[0053] The analyte sensor may specifically comprise an in vivo proximal portion and an ex vivo distal portion. The in vivo proximal portion may correspond to the insertable portion. Prior to insertion of the insertable portion of the analyte sensor into the body tissue of the user, the in vivo proximal portion and the ex vivo distal portion may be enclosed in the sterile compartment. Further, the insertion device may be configured for electrically connecting the ex vivo distal portion to the electronics unit upon inserting the insertable portion of the analyte sensor into the body tissue of the user. The ex vivo distal portion of the analyte sensor may be enclosed in a liquid-tight and / or gas-tight enclosure, wherein the insertable portion of the analyte sensor may protrude through the enclosure.

[0054] As outlined above, the continuous analyte sensor system comprises the electronics unit configured for being electrically connect to the analyte sensor. 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 may refer, without limitation, 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 long-term monitoring one or more analytes, such as from one or more of the above-mentioned prior art documents.

[0055] 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 be fully or partially made of one or more flexible plastic materials, such as one or more plastic foils or laminate, such as polyimides.

[0056] 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). 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. Thus, for example, the electronics unit may comprise a printed circuit board. 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 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 may be 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 partially surrounds the electronic component. The electronic housing may comprise at least one housing recess enabling electrical connection to the encapsulated electronic component. For example, the electronics unit may comprise one or more electrical sensor contacts at the housing recess to electrically contact the analyte sensor to the electronics unit, specifically to the electronic component of the electronics unit. 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.

[0057] 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.

[0058] The electronics unit may specifically be an on-body electronics unit comprising at least one sensor patch for attaching the on-body electronics unit to a skin of the user. The on-body electronics unit may be configured for being attached to the skin of the user. For example, the on-body electronics unit may comprise at least one adhesive, such as at least one adhesive plaster, for attaching the on-body electronics unit to the skin of the user.

[0059] The electronics unit may comprise at least one electrical sensor contact for electrically connecting the analyte sensor to the electronics unit. Further, the analyte sensor may comprise a counterpart to the electrical sensor contacts of the electronics unit, wherein the counterpart may be configured for mechanically connecting to the electrical sensor contacts thereby establishing an electrical connection between the analyte sensor and the electronics unit.

[0060] The term “electrically connected” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a state in which an electrical connection between two or more elements or components is established. The term “configured for being electrically connected” 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 enabling an electrical connection between two or more elements or components. In other words, the situation that the electronics unit is configured for being electrically connected to the analyte sensor may refer to a property or suitability of the electronics unit of enabling an electrical connection with the analyte sensor, specifically in case the analyte sensor is contacted to the electronics unit via one or more electrical sensor contacts.

[0061] As outlined above, the continuous analyte sensor system comprises the insertion device configured for inserting the insertable portion of the analyte sensor into the body tissue of the user. 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 may refer, without limitation, 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 insertable portion of the analyte sensor into the body tissue. The insertion device may be configured for driving insertion of the insertable portion of the analyte sensor into the body tissue of the user, e.g. when activated or released by an action of the user, such via a triggering mechanism, as will be outlined in further detail below. 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 movements and / or generates a desired set of output forces and movements when initiated. Specifically, the insertion mechanism may be configured such that the user may apply a force and / or may initiate the insertion thereby causing the insertion mechanism to the desired set of output forces and movements driving the insertion of the insertable portion of the analyte sensor into the body tissue of the user. The insertion device may be configured to facilitate a handling of the continuous analyte sensor system by the user and / or to reduce application errors. The insertion mechanism may at least partially be coupled to the housing and / or to the electronics unit. For example, the insertion mechanism may at least partially be enclosed by the housing. The insertion device may further partially enclose the electronics unit and may be configured for holding the electronics unit in place, specifically applied to a skin site of the user, when driving insertion of the insertable portion of the analyte sensor into the body tissue.

[0062] The term “inserting” 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 putting or introducing at least a part of an element or device into a body of another element. Specifically, the inserting of the insertable portion of the analyte sensor into the body tissue of the user may comprise putting or introducing at least a part of the insertable portion of the analyte sensor into the body tissue of the user. The inserting may specifically comprise an introduction of the insertable portion of the analyte sensor into the body tissue of the user to a depth at which the analyte sensor can detect the analyte in the body tissue of the user.

[0063] The insertion device may be configured for electrically connecting the analyte sensor to the electronics unit upon inserting the insertable portion of the analyte sensor into the body tissue of the user.

[0064] The electronics unit may be arranged at a proximal end of the insertion device. Thus, specifically, the insertion device may be configured for directly applying the electronics unit to a skin site of the user during insertion of the insertable portion of the analyte sensor into the body tissue of the user. The direct application of the electronics unit onto the skin of the user may avoid a tilted system during insertion and may pretension the skin of the user which facilitates correct insertion of the analyte sensor into the body tissue of the user. As outlined above, the insertion device comprises the housing, the protective cap and the sterile compartment. 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 may refer, without limitation, 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 provide one or more interior spaces for receiving one or more of the sterile compartment and the electronics unit, specifically separately from each other. The housing may specifically be a sealed housing, such as a sealed housing configured to provide environmental protection for the received sterile compartment and / or the electronics unit.

[0065] The housing may comprise a triggering mechanism connected to the insertion device. The triggering mechanism may be configured for releasing insertion of the insertable portion of the analyte sensor into the body tissue of the user. For example, the triggering mechanism may be activated by the user or any other person to cause the insertion device to insert the insertable portion of the analyte sensor into the body tissue of the user.

[0066] The term “protective 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 arbitrary element configured for fully or partially closing an object. Specifically, the protective cap may provide a closure of the insertion device. The protective cap may be or may comprise a shell, particularly a half-shell, removable connected the housing. The protective cap may be a removable protective cap. The electronics unit may be at least partially enclosed by the protective cap of the insertion device, specifically prior to removal of the protective cap. The protective cap may be configured such that a removal of the protective cap reveals the elements received in the housing, specifically the electronics unit.

[0067] The housing and the protective cap 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 housing and the protective cap may form an encapsulation for the electronics unit and 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.

[0068] 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 relates to an arbitrary subpart of a superior element creating a sterile enclosed space configured for containing and / or storing one or more other elements or objects. The subpart may specifically be completely closed such that an interior of the sterile compartment is isolated from a surrounding environment. For example, the sterile compartment may provide an interior space separated from other parts of the superior element by one or more walls, capsules or sleeves. Thus, within the continuous analyte sensor system, two or more compartments may be comprised which may fully be separated from one another by one or more walls, capsule or sleeves, wherein one compartment form the sterile compartment, wherein the at least one other compartment is formed by the remainder. Each compartment may comprise a continuous space or lumen configured for receiving one or more objects. The sterile compartment may specifically be modular sterile compartment. Thus, the modular sterile compartment may be handled independently from the insertion device and / or the electronics unit during manufacturing of the continuous analyte sensor system. For example, during manufacturing of the continuous analyte sensor system, the modular sterile compartment may be assembled and sterilized independently from the other part of the continuous analyte sensor system. Thus, the analyte sensor and the removable insertion component can be sterilized independent from the electronics unit thereby facilitating the manufacturing process.

[0069] As outlined above, the sterile compartment encloses at least the analyte sensor and the removable insertion component. The term “removable 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 may refer, without limitation, to an arbitrary element which may be insertable at least partially into the body tissue, particularly in order to deliver or to transfer a further element. The removable insertion component may be configured for supporting the insertion of the analyte sensor or the insertion of a part of the analyte sensor. The removable insertion component may be configured for being removed after insertion of the insertable portion of the analyte sensor into the body tissue of the user leaving the inserted insertable portion of the analyte sensor in the body tissue of the user. The removable insertion component may specifically be configured for transferring the insertable portion of the analyte sensor into the body tissue of the user and for being retracted after insertion.

[0070] The removable insertion component may comprise, specifically may be, an 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.

[0071] As outlined above, the sterile compartment comprises the sealed opening and the at least one opening mechanism configured for releasing the sealed opening. The term “sealed 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 may refer, without limitation, to any structural arrangement at a compartment having at least two states, wherein a first state may prevent access to the compartment, wherein a second state allows access to the compartment. Specifically, the sealed opening may have at least two states, wherein a first state of the sealed opening may prevent access to the sterile compartment, wherein a second state of the sealed opening may allow access to the sterile compartment. Thus, in particular, in the first state, the sealed opening may be configured to seal to the sterile compartment from an outside environment. In the first state, the sealed opening may specifically be configured for isolating an interior of the sterile compartment 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. Further, the first state of the sealed opening may permit or prevent a pass or drive through of elements in the sterile compartment. Similarly, the second state of the sealed opening may allow passing or driving through of elements in the sterile compartment, specifically of the removable insertion component with insertable portion of the analyte sensor. In the preassembled and / or manufactured sate of the continuous analyte sensor system, the sealed opening may be in the first state to isolate the interior of the sterile compartment from the surroundings. In the use state of the continuous analyte sensor system, specifically prior to insertion of the insertable portion of the analyte sensor into the body tissue, the sealed opening may be in the second state allowing the removable insertion component and the insertable portion of the analyte sensor to pass or drive through the sealed opening. The state of the sealed opening may be changed by the opening mechanism.

[0072] The term “opening mechanism” 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 any mechanical, physical and / or electrical arrangement configured for causing a change of state of at least one further element or device. Specifically, the opening mechanism may be configured for changing a state of the sealed opening. The opening mechanism may specifically be configured for changing the first sate of the sealed opening into the second state. The change of state of the sealed opening may also be referred to as “releasing”. Consequently, the term “released”, as used herein, may refer, without limitation, to a state of being released. Specifically, the released sealed opening may be in the second state and, thus, may allow the removable insertion component and the insertable portion of the analyte sensor to pass or drive through the released sealed opening. The change of state may be irreversible. Thus, a change of a state of the sealed opening from the second state to the first may not be possible. The opening mechanism may therefore be configured for ensuring a single use of the continuous analyte sensor system.

[0073] As an example, the sealed opening may comprises at least one screw closure. A removal of the protective cap may open the screw closure of the sealed opening, as will be outlined in further detail below.

[0074] As outlined above, the opening mechanism is configured for interacting with the insertion device such that a use of the insertion device releases the sealed opening of the sterile compartment, wherein the released sealed opening is configured for enabling electrically connecting the analyte sensor to the electronics unit upon insertion of the insertable portion of the analyte sensor into the body tissue of the user. The use of the insertion may comprise at least one action selected from the group consisting of: a removal of the protective cap; an insertion of the insertable portion of the analyte sensor into the body tissue of the user. The term “interacting” 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 conditional action. Specifically, two or more interacting components may be configured such that a first action or movement of a first component causes the second interacting component to perform a second action or movement. For example, the opening mechanism may be configured for interacting with the protective cap of the insertion device such that the removal of the protective cap causes the opening mechanism to release the sealed opening.

[0075] The term “removal” 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 removing and / or unplugging an element or device from another element or device. Specifically, the removal of the protective cap may comprise removing and / or unplugging the protective cap from the continuous analyte sensor system, more specifically from the insertion device of the continuous analyte sensor system. The removal of the protective cap may be performed prior to insertion of the insertable portion of the analyte sensor into the body tissue for preparing the continuous analyte sensor system for use. The removal of the protective cap may be performed by the user or by another person using the continuous analyte sensor system. The removal of the protective cap may comprise a rotational movement of the protective cap, specifically relative to the housing to unscrew the protective cap from the housing. The removal of the protective cap may reveal the electronics unit, specifically a sensor patch of the electronics unit for attaching the electronics unit to a skin of the user. Additionally, the removal of the protective cap may cause the opening mechanism to release the sealed opening, such as to enable electrically connecting the analyte sensor to the electronics unit.

[0076] The term “enabling electrically connecting” 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 providing of means or a suitability of means to establish an electrical connection. Specifically, the enabling of electrically connecting the analyte sensor to the electronics unit may comprise a providing of specific means at the electronics or a suitability of the electronics unit itself to establish an electrical connection with the analyte sensor. Thus, in particular, the term “enabling electrically connecting” may not refer to a situation in which the analyte sensor is already electrically connected to the electronics unit but rather to a situation in which the analyte sensor can be electrically connecting to the electronics unit upon insertion of the insertable portion of the analyte sensor into the body tissue of the user. Prior to insertion of the insertable portion of the analyte sensor into the body tissue of the user, the analyte sensor and the removable insertion component may be separated in the sterile compartment from the electronics unit. Additionally or alternatively, prior to insertion of the insertable portion of the analyte sensor into the body tissue of the user, the analyte sensor may be disconnected from the electronics unit. Thus, in particular, the continuous analyte sensor system may be provided in a fully assembled state in which the analyte sensor is accommodated in the sterile compartment, wherein the electronics unit may be accommodated outside the sterile compartment. The analyte sensor may not be electrically connected to the electronics unit the preassembled state. The electrical connection between the analyte sensor and the electronics unit may be established during insertion of the insertable portion of the analyte sensor into the body tissue of the user.

[0077] The sterile compartment may further comprise

[0078] - an outer capsule fixedly attached to the protective cap;

[0079] - an inner capsule fixedly attached to the housing; and

[0080] - an insertion component holder arranged inside the inner capsule, wherein the removable insertion component is fixedly attached to the insertion component holder.

[0081] The term “capsule” 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 encapsulation of one or more elements. The capsule may specifically provide a full or partial encapsulation of one or more elements or components received in the capsule. The capsule may be or may comprise a sleeve or cylindrically shaped container. However, other forms of the capsule are also feasible.

[0082] The term “outer capsule” may refer, without limitation, to a capsule being arranged more distanced to an axis of extension of the sterile compartment compared to the inner capsule. Similarly, the term “inner capsule” may refer, without limitation, a capsule being arranged less distanced to an axis of extension of the sterile compartment compared to the outer capsule. Both the outer capsule and the inner capsule may be housed inside the continuous analyte sensor system, specifically inside the insertion device, more specifically inside the housing of the insertion device. Thus, both the outer capsule and the inner capsule may not form a boundary of the continuous analyte sensor system to user. The outer capsule and the inner capsule may be movable with respect to each other. Specifically, the outer capsule and the inner capsule may be movable with respect to each along the axis of extension of the sterile compartment. The axis of extension of the sterile compartment may be essentially identical to a direction of insertion of the insertable portion of the analyte sensor into the body tissue of the user.

[0083] The insertion device may further comprise at least one insertion drive element configured for driving an insertion of the insertable portion of the analyte sensor into the body tissue of the user via the insertion component holder. The insertion drive element may be or may comprise at least one spring, specifically a preloaded spring, for driving the insertion of the insertable portion of the analyte sensor into the body tissue of the user via the insertion component holder. The insertion drive element may be arranged inside the inner capsule, specifically at a distal end of the insertion component holder. The distal end of the insertion component holder may face away from the skin site of the user.

[0084] The insertion device may further at least one retraction drive element configured for driving a retraction of the removable insertion component after insertion of the insertable portion of the analyte sensor into the body tissue of the user via the insertion component holder. The insertion drive element may be or may comprise at least one spring, specifically a preloaded spring, for driving the driving the retraction of the removable insertion component via the insertion component holder. The retraction drive element may be arranged inside the inner capsule, specifically at a proximal end of the insertion component holder. The proximal end of the insertion component holder may face towards from the skin site of the user.

[0085] A proximal end of the outer capsule may comprise at least one first opening and a proximal end of the inner capsule may comprise at least one second opening. The term “proximal end” 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 end of a device or element facing towards a skin site of the user. Specifically, the proximal end may refer to an end of a device or element facing towards a skin site of the user when using the continuous analyte sensor system in orientation intended for use. The proximal end may comprise an end of a device or element being in close proximity or even in direct contact to the skin site of the user.

[0086] Prior to insertion of the insertable portion of the analyte sensor into the body tissue of the user, the first opening of the outer capsule may be incongruent with the second opening of the inner capsule. The term “incongruent” 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 any offset, shifted and / or screwed arrangement of two or more elements or objects. The incongruent arrangement of the first opening to the second opening may comprise any offset, shifted and / or screwed arrangement of the first opening with respect to the second opening. As an example, the first opening of the outer capsule may be rotated with regard to the second opening of the inner capsule, e.g. by an angle of 90° with respect to each other.

[0087] The sterile compartment may further comprise at least one sealing contour between the first opening of the outer capsule and the second opening of the inner capsule to form the sealed opening. The sealing contour may be made from at least one rubber-like material, e.g. silicone. Thus, prior to insertion of the insertable portion of the analyte sensor into the body tissue of the user, the sealing contour may be configured for sealing the sterile compartment.

[0088] Further, the opening mechanism may be configured for aligning the first opening of the outer capsule with the second opening of the inner capsule. Specifically, the opening mechanism may be configured for aligning the first opening of the outer capsule with the second opening of the inner capsule upon the removal of the protective cap. As an example, the opening mechanism may comprise at least one fixed connection between the protective cap and the outer capsule such that a rotational movement of the protective cap causes a rotational movement of the outer capsule relative to the inner capsule. Thus, via the opening mechanism, the removal of the protective cap may cause the outer capsule to rotate relative to the inner capsule thereby aligning the first opening with the second opening. In this example, the use of the insertion device may comprise a removal of the protective cap, e.g. by the user of the continuous analyte sensor system.

[0089] Further, the insertion component holder may be attached to the outer capsule via at least one bayonet mount and may comprise at least one sealing contour between the inner capsule and the outer capsule. The bayonet mount may secure the insertion component holder to the outer capsule preventing any insertion and / or retraction movement. The bayonet mount may be opened by the removal of the protective cap and the resulting rotational movement of the outer capsule relative to the inner capsule. Thus, the removal of the protective cap may cause the releasing of the sealed opening and the opening of the bayonet mount. The opened bayonet mount may be configured for allowing an insertion movement and a retraction movement of the insertion component holder driven by the insertion drive element and the retraction drive element, respectively.

[0090] Alternatively or additionally, the sealed opening may comprise at least one membrane. The membrane may specifically be pierceable by the removable insertion component upon insertion of the insertable portion of the analyte sensor into the body tissue of the user. In this example, the use of the insertion device may comprise an insertion of the insertable portion of the analyte sensor into the body tissue of the user. Upon insertion of the insertion portion of the analyte sensor into the body tissue of the user, the removable insertion component may pierce the membrane thereby opening the sealed opening and enabling contacting the analyte sensor via the electrical sensor contact to the electronics unit. Specifically, the removable insertion component may pierce the membrane such that the counterpart of the analyte sensor can penetrate through the membrane to connect to the electrical sensor contacts of the electronics unit. The pierced membrane may allow the analyte sensor, specifically the insertable portion of the analyte sensor and the ex vivo distal portion of the analyte sensor, to penetrate fully through the membrane. For example, the removable insertion component may rupture the membrane enabling a full penetration of the analyte sensor through the membrane. Thus, as an example, the ex vivo distal portion of the analyte sensor in the liquid-tight enclosure carrying the counterparts of the electrical sensor contacts may be able to contact to the electrical sensor contacts of the electronics unit upon insertion of the insertable portion of the analyte sensor.

[0091] The continuous analyte sensor system may further comprise a sensor controller comprised by the electronics unit. The sensor controller may be coupled to the analyte sensor. The sensor controller may be configured to receive analyte sensor data from the analyte sensor. Further, the continuous analyte sensor system may comprise a remote control which is configured for receiving sensor data from the sensor controller and to process and / or display sensor data.

[0092] 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.

[0093] 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.

[0094] The continuous analyte sensor system may specifically 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.

[0095] In a further aspect of the present invention, a method of manufacturing a continuous analyte sensor system is disclosed. The continuous analyte sensor system is a continuous analyte sensor system according to the present invention, such as according to any one of the embodiments disclosed above and / or according to any one of the embodiments disclosed in further details below.

[0096] The method comprise the following method steps. 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.

[0097] The method comprises: a) providing the sterile compartment; b) providing the electronics unit and the insertion device; and c) assembling the continuous analyte sensor system by mounting the sterile compartment and the electronics unit to the insertion device.

[0098] The method may specifically comprise sterilizing the sterile compartment before conducting step b).

[0099] In a further aspect of the present invention, a method of using a continuous analyte sensor system is disclosed. The continuous analyte sensor system is a continuous analyte sensor system according to the present invention, such as according to any one of the embodiments disclosed above and / or according to any one of the embodiments disclosed in further details below.

[0100] The method comprise the following method steps. 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.

[0101] The method comprises: i) providing the continuous analyte sensor system; ii) using the insertion device, e.g. by removing the protective cap, to release the sealed opening of the sterile compartment; iii) inserting the analyte sensor into a body tissue of the user; and iv) removing the removable insertion component.

[0102] The method may specifically be an in vivo method. Further, the method may comprise steps in addition to those explicitly mentioned above. For example, further steps may relate, e.g., to disinfecting the skin site before insertion. As is understood by the skilled person, the method does not require specific medical skills and does not impose a significant health risk on a subject and, thus, is usually performed by the subject receiving said medical device itself. Thus, the method may be a method of self-administration.

[0103] The present invention provides a large number of advantages over known methods and devices. Specifically, the continuous analyte sensor system may provide an improved all-in- one sensor-inserter system with a sterile compartment comprising the at least partially insertable analyte sensor and the insertion component, specifically the insertion needle, separated from the electronics unit. The insertion may be a two-step insertion process comprising opening the sterile compartment, driving the analyte sensor and the insertion component out of the capsule and coupling the analyte sensor with the electronics unit. The sterile compartment may optionally comprise at least part of an insertion and retraction mechanism. The sterile compartment may provide a sealed insertion opening at a lower end that may be opened by a rotation of an inner capsule part relative to an outer capsule part when removing the protective cap.

[0104] The continuous analyte sensor system may have the analyte sensor and the insertion component arranged separately from the electronics units in the insertion device. Thus, it may be possible to arrange the electronics unit at a lower end of the insertion device. By applying the insertion device to the skin site of the user, the electronics unit can be applied to the user prior to insertion of the analyte sensor into the body tissue of the user. The sealing contour at the sterile compartment may provide a complete sterile protection for the components received in the sterile compartment. The removal of the protective cap, e.g. by unscrewing the protective cap, may release the sealed opening of the sterile compartment. In a next step, the insertable portion of the analyte sensor may be inserted into the body tissue of the user thereby connecting the analyte sensor to the electronics unit, e.g. via one or more electrical sensor contacts.

[0105] The continuous analyte sensor system may enable an easy sterilization of the analyte sensor and the insertion component in the sterile compartment independent of the electronics unit without the drawback of any extra steps or multiple packages. Specifically, the continuous analyte sensor system may provide a compact and separate sterile compartment which can be handled and sterilized independently from the electronics unit in a large number during the manufacturing process. Thus, the sterilization of the analyte sensor and the insertion component may be chosen freely without damaging sensitive part of the electronics unit.

[0106] Further, the linking of the rotational opening mechanism of the sterile compartment with the rotational movement of the protective cap when removed as well as the linking of the insertion mechanism inside the sterile compartment via the trigger mechanism on the outside of the insertion device may ensure a simple insertion process for the user. Specifically, the application of the electronics unit at a skin site of the user prior to insertion of the analyte sensor may ensure a precise and correct insertion by avoiding a tilted system. The application of the electronics unit may further pretension the skin of the user which facilitates the insertion of the analyte sensor. Further, the triggering mechanism may facilitate the insertion of the analyte sensor into the body tissue of the user by providing a constant insertion force without the need for the user to move parts of the insertion device, in particular without the need that a hand of the user drives the insertion.

[0107] The continuous analyte sensor system may have the sterile compartment arranged in the insertion device and, thus, may provide a compact system, specifically an all-in-one system.

[0108] Summarizing and without excluding further possible embodiments, the following embodiments may be envisaged:

[0109] Embodiment 1 : A continuous analyte sensor system comprising:

[0110] - an analyte sensor comprising an insertable portion adapted for being at least partially inserted into a body tissue of a user, wherein the analyte sensor is configured for detecting an analyte in the body tissue of the user;

[0111] - an electronics unit configured for being electrically connected to the analyte sensor; and

[0112] - an insertion device configured for inserting the insertable portion of the analyte sensor into the body tissue of the user, wherein the insertion device comprises a housing, a protective cap and a sterile compartment, wherein the sterile compartment encloses at least the analyte sensor and a removable insertion component, wherein the insertable portion of the analyte sensor is at least partially placed inside the removable insertion component, wherein the sterile compartment comprises a sealed opening and at least one opening mechanism configured for releasing the sealed opening, wherein the opening mechanism is configured for interacting with the insertion device such that a use of the insertion device releases the sealed opening of the sterile compartment, wherein the released sealed opening is configured for enabling electrically connecting the analyte sensor to the electronics unit upon insertion of the insertable portion of the analyte sensor into the body tissue of the user.

[0113] Embodiment 2: The continuous analyte sensor system according to the preceding embodiment, wherein, prior to insertion of the insertable portion of the analyte sensor into the body tissue of the user, the analyte sensor and the removable insertion component are separated in the sterile compartment from the electronics unit.

[0114] Embodiment 3 : The continuous analyte sensor system according to any one of the preceding embodiments, wherein, prior to insertion of the insertable portion of the analyte sensor into the body tissue of the user, the analyte sensor is disconnected from the electronics unit.

[0115] Embodiment 4: The continuous analyte sensor system according to any one of the preceding embodiments, wherein the use of the insertion comprises at least one action selected from the group consisting of: a removal of the protective cap; an insertion of the insertable portion of the analyte sensor into the body tissue of the user.

[0116] Embodiment 5: The continuous analyte sensor system according to any one of the preceding embodiments, wherein the sealed opening comprises at least one screw closure, wherein a removal of the protective cap opens the screw closure of the sealed opening.

[0117] Embodiment 6: The continuous analyte sensor system according to any one of the preceding embodiments, wherein the sterile compartment further comprises

[0118] - an outer capsule fixedly attached to the protective cap;

[0119] - an inner capsule fixedly attached to the housing; and

[0120] - an insertion component holder arranged inside the inner capsule, wherein the removable insertion component is fixedly attached to the insertion component holder. Embodiment 7: The continuous analyte sensor system according to the preceding embodiment, wherein the insertion device further comprises at least one insertion drive element configured for driving an insertion of the insertable portion of the analyte sensor into the body tissue of the user via the insertion component holder.

[0121] Embodiment 8: The continuous analyte sensor system according to the preceding embodiment, wherein the insertion drive element is arranged inside the inner capsule, specifically at a distal end of the insertion component holder.

[0122] Embodiment 9: The continuous analyte sensor system according to any one of the three preceding embodiments, wherein the insertion device further at least one retraction drive element configured for driving a retraction of the removable insertion component after insertion of the insertable portion of the analyte sensor into the body tissue of the user via the insertion component holder.

[0123] Embodiment 10: The continuous analyte sensor system according to the preceding embodiment, wherein the retraction drive element is arranged inside the inner capsule, specifically at a proximal end of the insertion component holder.

[0124] Embodiment 11 : The continuous analyte sensor system according to any one of the five preceding embodiments, wherein a proximal end of the outer capsule comprises at least one first opening, wherein a proximal end of the inner capsule comprises at least one second opening, wherein, prior to insertion of the insertable portion of the analyte sensor into the body tissue of the user, the first opening of the outer capsule is incongruent with the second opening of the inner capsule.

[0125] Embodiment 12: The continuous analyte sensor system according to the preceding embodiment, wherein the sterile compartment further comprises at least one sealing contour between the first opening of the outer capsule and the second opening of the inner capsule to form the sealed opening.

[0126] Embodiment 13 : The continuous analyte sensor system according to any one of the two preceding embodiments, wherein the first opening of the outer capsule is rotated with regard to the second opening of the inner capsule.

[0127] Embodiment 14: The continuous analyte sensor system according to any one of the three preceding embodiments, wherein the opening mechanism is configured for aligning the first opening of the outer capsule with the second opening of the inner capsule. Embodiment 15: The continuous analyte sensor system according to the preceding embodiment, wherein the opening mechanism comprises at least one fixed connection between the protective cap and the outer capsule such that a rotational movement of the protective cap causes a rotational movement of the outer capsule relative to the inner capsule.

[0128] Embodiment 16: The continuous analyte sensor system according to any one of the ten preceding embodiments, wherein the insertion component holder is attached to the outer capsule via at least one bayonet mount and comprises at least one sealing contour between the inner capsule and the outer capsule.

[0129] Embodiment 17: The continuous analyte sensor system according to any one of the preceding embodiments, wherein the sealed opening comprises at least one membrane, wherein the membrane comprises at least one electrical sensor contact for electrically connecting the analyte sensor to the electronics unit.

[0130] Embodiment 18: The continuous analyte sensor system according to any one of the preceding embodiments, wherein the sterile compartment is a modular sterile compartment.

[0131] Embodiment 19: The continuous analyte sensor system according to any one of the preceding embodiments, wherein the housing comprises a triggering mechanism connected to the insertion device, wherein the triggering mechanism is configured for releasing insertion of the insertable portion of the analyte sensor into the body tissue of the user.

[0132] Embodiment 20: The continuous analyte sensor system according to any one of the preceding embodiments, wherein the removable insertion component comprises, specifically is, an insertion cannula.

[0133] Embodiment 21 : The continuous analyte sensor system according to any one of the preceding embodiments, wherein the electronics unit is an on-body electronics unit comprising at least one sensor patch for attaching the on-body electronics unit to a skin of the user.

[0134] Embodiment 22: The continuous analyte sensor system according to the preceding embodiment, wherein the on-body electronics unit is configured for being attached to the skin of the user. Embodiment 23 : The continuous analyte sensor system according to any one of the preceding embodiments, wherein the insertion device is configured for electrically connecting the analyte sensor to the electronics unit upon inserting the insertable portion of the analyte sensor into the body tissue of the user.

[0135] Embodiment 24: The continuous analyte sensor system according to the preceding embodiment, wherein the electronics unit comprises at least one electrical sensor contact for electrically connecting the analyte sensor to the electronics unit.

[0136] Embodiment 25: The continuous analyte sensor system according to any one of the preceding embodiments, wherein the electronics unit is arranged at a proximal end of the insertion device.

[0137] Embodiment 26: The continuous analyte sensor system according to any one of the preceding embodiments, wherein the electronics unit is at least partially enclosed by the protective cap of the insertion device, specifically prior to removal of the protective cap.

[0138] Embodiment 27: The continuous analyte sensor system according to any one of the preceding embodiments, wherein the electronics unit comprises a printed circuit board.

[0139] Embodiment 28: The continuous analyte sensor system according to any one of the preceding embodiments, wherein the continuous analyte sensor system is a continuous glucose monitoring (CGM) system.

[0140] Embodiment 29: The continuous analyte sensor system according to any one of the preceding embodiments, wherein the continuous analyte sensor system is a one-piece continuous analyte sensor system.

[0141] Embodiment 30: The continuous analyte sensor system according to any one of the preceding embodiments, wherein the analyte sensor comprises an in vivo proximal portion and an ex vivo distal portion.

[0142] Embodiment 31 : The continuous analyte sensor system according to the preceding embodiment, wherein the in vivo proximal portion corresponds to the insertable portion.

[0143] Embodiment 32: The continuous analyte sensor system according to any one of the two preceding embodiments, wherein, prior to insertion of the insertable portion of the analyte sensor into the body tissue of the user, the in vivo proximal portion and the ex vivo distal portion are enclosed in the sterile compartment.

[0144] Embodiment 33: The continuous analyte sensor system according to any one of the three preceding embodiments, wherein the insertion device is configured for electrically connecting the ex vivo distal portion to the electronics unit upon inserting the insertable portion of the analyte sensor into the body tissue of the user.

[0145] Embodiment 34: A method of manufacturing a continuous analyte sensor system according to any one of the preceding embodiments, wherein the method comprises: a) providing the sterile compartment; b) providing the electronics unit and the insertion device; and c) assembling the continuous analyte sensor system by mounting the sterile compartment and the electronics unit to the insertion device.

[0146] Embodiment 35: The method according to the preceding embodiment, wherein the method comprises sterilizing the sterile compartment before conducting step b).

[0147] Embodiment 36: A method of using a continuous analyte sensor system according to any one of the preceding embodiments referring to a continuous analyte sensor system, wherein the method comprises: i) providing the continuous analyte sensor system; ii) using the insertion device to release the sealed opening of the sterile compartment; iii) inserting the analyte sensor into a body tissue of the user; and iv) removing the removable insertion component.

[0148] Short description of the Figures

[0149] Further optional features and embodiments will be disclosed in more detail in the subsequent description of embodiments, preferably in conjunction with the dependent claims. Therein, the respective optional features may be realized in an isolated fashion as well as in any arbitrary feasible combination, as the skilled person will realize. The scope of the invention is not restricted by the preferred embodiments. The embodiments are schematically depicted in the Figures. Therein, identical reference numbers in these Figures refer to identical or functionally comparable elements. In the Figures:

[0150] Figures 1 A to IF show an embodiment of a continuous analyte sensor system in different views at different stages of insertion;

[0151] Figure 2 shows a flow chart of a method of manufacturing a continuous analyte sensor system; and

[0152] Figure 3 shows a flow chart of a method of using a continuous analyte sensor system.

[0153] Detailed description of the embodiments

[0154] Figures 1 A to IF show an exemplary embodiment of a continuous analyte sensor system 110 in different views at different stages of insertion. Specifically, Figures 1A to 1C show the continuous analyte sensor system 110 in a preassembled state as provided to a user of the continuous analyte sensor system 110. Figures ID to IF show a sterile compartment 112 of the continuous analyte sensor system 110 during insertion of an analyte sensor 114 into the body tissue of the user.

[0155] The continuous analyte sensor system 110 comprises the analyte sensor 114 comprising an insertable portion 116 adapted for being at least partially inserted into a body tissue of a user. The analyte sensor 114 is configured for detecting an analyte in the body tissue of the user. The analyte sensor 114 may specifically be an electrochemical analyte sensor. The analyte sensor may 11 further be a transcutaneous sensor, such as an analyte sensor 114 being adapted to be fully or at least partly arranged within the body tissue of the user. For details on possible embodiments of the analyte sensor 114, reference is made e.g. to WO 2007 / 071562 Al.

[0156] The continuous analyte sensor system 110 further comprises an electronics unit 118 configured for being electrically connected to the analyte sensor 114. The electronics unit 118 may specifically be an on-body electronics unit comprising at least one sensor patch 120 for attaching the on-body electronics unit to a skin of the user. The on-body electronics unit may be configured for being attached to the skin of the user. For example, the on-body electronics unit may comprise at least one adhesive, such as at least one adhesive plaster, for attaching the on-body electronics unit to the skin of the user.

[0157] The continuous analyte sensor system 110 further comprises an insertion device 122 configured for inserting the insertable portion 116 of the analyte sensor 114 into the body tissue of the user. The insertion device 122 comprises a housing 124, a protective cap 126 and the sterile compartment 112. The sterile compartment 112 encloses at least the analyte sensor 114 and a removable insertion component 128. The insertable portion 116 of the analyte sensor 114 is at least partially placed inside the removable insertion component 128. The sterile compartment 112 is shown in Figure IB in more detail and comprises a sealed opening 130 and at least one opening mechanism 132 configured for releasing the sealed opening 130. The opening mechanism 132 is configured for interacting with the insertion device 122 such that a use of the insertion device 122 releases the sealed opening 130 of the sterile compartment 112. In this example, the opening mechanism 132 may be configured for interacting with the protective cap 126 such that a removal of the protective cap 126 releases the sealed opening 130 of the sterile compartment 112. The released sealed opening 130 is configured for enabling electrically connecting the analyte sensor 114 to the electronics unit 118 upon insertion of the insertable portion 116 of the analyte sensor 114 into the body tissue of the user.

[0158] As can be seen in Figure 1 A, the electronics unit 118 may be arranged at a proximal end 134 of the insertion device 122. Thus, specifically, the insertion device 122 may be configured for directly applying the electronics unit 118 to a skin site of the user during insertion of the insertable portion 116 of the analyte sensor 114 into the body tissue of the user. The direct application of the electronics unit 118 onto the skin of the user may avoid a tilted system during insertion and may pretension the skin of the user which facilitates correct insertion of the analyte sensor 114 into the body tissue of the user.

[0159] Further, prior to insertion of the insertable portion 116 of the analyte sensor 114 into the body tissue of the user, the analyte sensor 114 and the removable insertion component 128 may be separated in the sterile compartment 112 from the electronics unit 118. Additionally or alternatively, prior to insertion of the insertable portion 116 of the analyte sensor 114 into the body tissue of the user, the analyte sensor 114 may be disconnected from the electronics unit 118. Thus, in particular, the continuous analyte sensor system 110 may be provided in a fully assembled state, as shown e.g. in Figure 1A, in which the analyte sensor 114 is accommodated in the sterile compartment 112, wherein the electronics unit 118 may be accommodated outside the sterile compartment 112. The analyte sensor 114 may not be electrically connected to the electronics unit 118 the preassembled state. The electrical connection between the analyte sensor 114 and the electronics unit 118 may be established during insertion of the insertable portion 116 of the analyte sensor 114 into the body tissue of the user, as will be outlined in further detail below. Further, in this exemplary embodiment and as can be seen best in Figure IB, the sterile compartment 112 may further comprise an outer capsule 136 fixedly attached to the protective cap 126, an inner capsule 138 fixedly attached to the housing 124, and an insertion component holder 140 arranged inside the inner capsule 138, wherein the removable insertion component 128 is fixedly attached to the insertion component holder 140.

[0160] The insertion device 122 may further comprise at least one insertion drive element 142 configured for driving an insertion of the insertable portion 116 of the analyte sensor 114 into the body tissue of the user via the insertion component holder 140. The insertion drive element 142 may be or may comprise at least one spring, specifically a preloaded spring, for driving the insertion of the insertable portion 116 of the analyte sensor 114 into the body tissue of the user via the insertion component holder 140. The insertion drive element 142 may be arranged inside the inner capsule 138, specifically at a distal end 144 of the insertion component holder 140. The distal end 144 of the insertion component holder 140 may face away from the skin site of the user.

[0161] The insertion device 122 may further at least one retraction drive element 146 configured for driving a retraction of the removable insertion component 128 after insertion of the insertable portion 116 of the analyte sensor 114 into the body tissue of the user via the insertion component holder 140. The insertion drive element 142 may be or may comprise at least one spring, specifically a preloaded spring, for driving the driving the retraction of the removable insertion component 128 via the insertion component holder 140. The retraction drive element 146 may be arranged inside the inner capsule 138, specifically at a proximal end 148 of the insertion component holder 140. The proximal end 148 of the insertion component holder 140 may face towards from the skin site of the user.

[0162] As shown in Figure IB, a proximal end of the outer capsule 136 may comprise at least one first opening 150 and a proximal end of the inner capsule 138 may comprise at least one second opening 152. Prior to insertion of the insertable portion 116 of the analyte sensor 114 into the body tissue of the user, the first opening 150 of the outer capsule 136 may be incongruent with the second opening 152 of the inner capsule 138. For example, the first opening 150 of the outer capsule 136 may be rotated with regard to the second opening 152 of the inner capsule 138, e.g. by an angle of 90° with respect to each other.

[0163] The sterile compartment 112 may further comprise at least one sealing contour 154 between the first opening 150 of the outer capsule 136 and the second opening 152 of the inner capsule 138 to form the sealed opening 130. Thus, prior to insertion of the insertable portion 116 of the analyte sensor 114 into the body tissue of the user, the sealing contour 154 may be configured for sealing the sterile compartment 112. The insertion component holder 140 may be attached to the outer capsule 136 via at least one bayonet mount 156 and may comprise at least one sealing contour between the inner capsule 138 and the outer capsule 136. The bayonet mount 156 may secure the insertion component holder 140 to the outer capsule 136 preventing any insertion and / or retraction movement.

[0164] Thus, in this exemplary embodiment, the sterile compartment 112 comprises, specifically consists of, the outer capsule 136, the inner capsule 138, the insertion component holder 140 with the bayonet mount 156 providing an upper sterile closure of the sterile compartment 112, the analyte sensor 114, the removable insertion component 128 and the sealed opening 130, specifically the screw closure providing a lower sterile closure of the sterile compartment 112. The sterile compartment 112 may therefore be sealed completely. The insertion component holder 140 may be secured in this position by the bayonet mount 156 to the outer capsule 136 having a smooth contour acting as the sealing contour 158 to provide the upper sterile closure of the sterile compartment 112. The lower part of the sterile compartment 112 may be sealed by the screw closure, specifically by the first opening 150, the second opening 152 and the sealing contour 154 in between, and the bottom part of the outer capsule 136. The screw closure may be formed by the interaction of the outer capsule 136 and the inner capsule 138, specifically by the first opening 150 being rotated with respect to the second opening 152, e.g. an angle of 90°. In the position as shown in Figure IB, the first opening 150 and the second opening 152 may be covered. When the protective cap 126 is removed and the outer capsule 136 is rotated with respect to the inner capsule 138, the first opening 150 and the second opening 152 may overlap with each other to release the sealed opening 130, specifically opening the sterile compartment 112. Similarly, the rotation of the outer capsule 136 rotated with respect to the inner capsule 138 may open the bayonet mount 156.

[0165] Further, as can be seen in Figure IB, the sterile compartment 112 may specifically be modular sterile compartment. Thus, the modular sterile compartment may be handled independently from the insertion device 122 and / or the electronics unit 118 during manufacturing of the continuous analyte sensor system 110. The modular sterile compartment 112 may be configured for being inserted into the insertion device 122. The inner capsule 138 may be attached to the housing 124 of the insertion device 122. The outer capsule 136 may be attached to the protective cap 126, e.g. via at least one fixed connection 158 of the protective cap 126 to outer capsule 136. The fixed connection may be an inner structure of the protective cap 126 for connecting the outer capsule 136 to the protective cap 126. Thus, both capsules 136, 138 may be attached separately to the insertion device 122 thereby enabling that the removal of the protective cap 126 releases the sealed opening 130 to open the sterile compartment 112. Inner structure of the insertion device 122 may allow a single opening of sterile compartment 112 only to ensure the sterile closure of the sterile compartment 112.

[0166] Figure 1C shows the continuous analyte sensor system 110 in a perspective view. As can be seen in Figure 1C, the housing 124 may comprise a triggering mechanism 160 connected to the insertion device 122. The triggering mechanism 160 may be configured for releasing insertion of the insertable portion 116 of the analyte sensor 114 into the body tissue of the user. For example, the triggering mechanism 160 may be activated by the user or any other person to cause the insertion device 122 to insert the insertable portion 116 of the analyte sensor 114 into the body tissue of the user.

[0167] For example, the user or any person using the continuous analyte sensor system 110 may hold the housing 124 of the insertion device 122 (denoted by reference number 162), remove the protective cap 126 (denoted by reference number 164) and activate the triggering mechanism 160, e.g. by pushing a button (denoted by reference number 166), to cause the insertion device 122 to insert the insertable portion 116 of the analyte sensor 114 into the body tissue of the user.

[0168] Further, Figures ID to IF show the insertion of an analyte sensor 114 into the body tissue of the user and, specifically, show the functioning of the opening mechanism 132. Figure ID show the sterile compartment 112 before insertion of the insertable portion 116 of the analyte sensor 114 into the body tissue of the user. In this example, the opening mechanism 123 may be configured for aligning the first opening 150 of the outer capsule 136 with the second opening 152 of the inner capsule 138. Specifically, the opening mechanism 132 may be configured for aligning the first opening 150 of the outer capsule 136 with the second opening 152 of the inner capsule 138 upon the removal of the protective cap 126. As an example, the opening mechanism 132 may comprise the at least one fixed connection 158 between the protective cap 126 and the outer capsule 136 such that a rotational movement of the protective cap 126 causes a rotational movement of the outer capsule 136 relative to the inner capsule 138. Thus, via the opening mechanism 132, the removal of the protective cap 126 may cause the outer capsule 136 to rotate relative to the inner capsule 138 thereby aligning the first opening 150 with the second opening 152. This situation is shown in Figures IE and IF.

[0169] Figures IE and IF show the released sealed opening 130 during (Figure IE) and after insertion of the insertable portion 116 of the analyte sensor 114 into the body tissue of the user (Figure IF). As outlined above, the bayonet mount 156 may be opened by the removal of the protective cap 126 and the resulting rotational movement of the outer capsule 136 relative to the inner capsule 138. Thus, the removal of the protective cap 126 may cause the releasing of the sealed opening 130 and the opening of the bayonet mount 156. The opened bayonet mount 156 may be configured for allowing an insertion movement and a retraction movement of the insertion component holder 140 driven by the insertion drive element 142 and the retraction drive element 146, respectively.

[0170] Thus, for example, the triggering mechanism 160 may be configured for starting the insertion of the insertable portion 116 of the analyte sensor 114 into the body tissue of the user. The triggering mechanism 160 may be released only after removal of the protective cap 126 and the corresponding rotation of the outer capsule 136 relative to the inner capsule 138. The triggering mechanism 160 may specifically be configured for releasing the insertion drive element 142 in order to move the insertion component holder 140 to the bottom of the sterile compartment 112. The removable insertion component 128 and the analyte sensor 114 may be moved together with the insertion component holder 140 through the released sealed opening 130 and towards the skin of the user. The insertion movement may also contact the analyte sensor 114 to the electronics unit 118.

[0171] As can be seen in Figure IF, the retraction drive element 146 may be configured for driving the retraction of the removable insertion component 128 after insertion of the insertable portion 116 of the analyte sensor 114 into the body tissue of the user via the insertion component holder 140. For example, the retraction drive element 146 may comprise a spring having a lower spring constant compared to the spring of the insertion drive element 142. Thus, if the insertion movement is completed, the retraction drive element 146 may be loaded to drive the retraction movement of the removable insertion component 128 via the insertion component holder 140.

[0172] Figure 2 shows a flow chart of a method of manufacturing a continuous analyte sensor system 110. The continuous analyte sensor system 110 is a continuous analyte sensor system 110 according to the present invention, such as according to the exemplary embodiment shown in Figures 1 A to IF and / or according to any other embodiment disclosed herein.

[0173] The method comprise the following method steps. 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.

[0174] The method comprises: a) (denoted by reference number 168) providing the sterile compartment 112; b) (denoted by reference number 170) providing the electronics unit 118 and the insertion device 122; and c) (denoted by reference number 172) assembling the continuous analyte sensor system 110 by mounting the sterile compartment 112 and the electronics unit 118 to the insertion device 122.

[0175] The method may specifically comprise sterilizing the sterile compartment 112 before conducting step b).

[0176] Figure 3 shows a flow chart of a method of using a continuous analyte sensor system 110. The continuous analyte sensor system 110 is a continuous analyte sensor system 110 according to the present invention, such as according to the exemplary embodiment shown in Figures 1 A to IF and / or according to any one other embodiment disclosed herein.

[0177] The method comprise the following method steps. 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.

[0178] The method comprises: i) (denoted by reference number 174) providing the continuous analyte sensor system 110; ii) (denoted by reference number 176) using the insertion device , e.g. by removing the protective cap 126, to release the sealed opening 130 of the sterile compartment 112; iii) (denoted by reference number 178) inserting the analyte sensor 114 into a body tissue of the user; and iv) (denoted by reference number 180) removing the removable insertion component 128.

[0179] List of reference numbers continuous analyte sensor system sterile compartment analyte sensor insertable portion electronics unit sensor patch insertion device housing protective cap removable insertion component sealed opening opening mechanism proximal end outer capsule inner capsule insertion component holder insertion drive element distal end retraction drive element proximal end first opening second opening sealing contour bayonet mount inner structure triggering mechanism hold the housing remove the protective cap activate the triggering mechanism providing the sterile compartment providing the electronics unit and the insertion device assembling the continuous analyte sensor system providing the continuous analyte sensor system using the insertion device inserting the analyte sensor removing the removable insertion component

Claims

- 43 -P39296-WO-1 July 27, 2025Claims1. A continuous analyte sensor system (110) comprising:- an analyte sensor (114) comprising an insertable portion (116) adapted for being at least partially inserted into a body tissue of a user, wherein the analyte sensor (114) is configured for detecting an analyte in the body tissue of the user;- an electronics unit (118) configured for being electrically connected to the analyte sensor (114); and- an insertion device (122) configured for inserting the insertable portion (116) of the analyte sensor (114) into the body tissue of the user, wherein the insertion device (122) comprises a housing (124), a protective cap (126) and a sterile compartment (112), wherein the sterile compartment (112) encloses at least the analyte sensor (114) and a removable insertion component (128), wherein the insertable portion (116) of the analyte sensor (114) is at least partially placed inside the removable insertion component (128), wherein the sterile compartment (112) comprises a sealed opening (130) and at least one opening mechanism (132) configured for releasing the sealed opening (130), wherein the opening mechanism (132) is configured for interacting with the insertion device (122) such that a use of the insertion device (122) releases the sealed opening (130) of the sterile compartment (112), wherein the released sealed opening (130) is configured for enabling electrically connecting the analyte sensor (114) to the electronics unit (118) upon insertion of the insertable portion (116) of the analyte sensor (114) into the body tissue of the user- wherein the opening mechanism is configured for interacting with the protective cap of the insertion device such that the removal of the protective cap causes the opening mechanism to release the sealed opening.

2. The continuous analyte sensor system (110) according to the preceding claim, wherein, prior to insertion of the insertable portion (116) of the analyte sensor (114) into the body tissue of the user, the analyte sensor (114) and the removable insertion component (128) are separated in the sterile compartment (112) from the electronics unit (H8).- 44 -3. The continuous analyte sensor system (110) according to any one of the preceding claims, wherein, prior to insertion of the insertable portion (116) of the analyte sensor (114) into the body tissue of the user, the analyte sensor (114) is disconnected from the electronics unit (118).

4. The continuous analyte sensor system (110) according to any one of the preceding claims, wherein the sterile compartment (112) further comprises- an outer capsule (136) fixedly attached to the protective cap (126);- an inner capsule (138) fixedly attached to the housing (124); and- an insertion component holder (140) arranged inside the inner capsule (138), wherein the removable insertion component (128) is fixedly attached to the insertion component holder (140).

5. The continuous analyte sensor system (110) according to the preceding claim, wherein the insertion device (122) further comprises at least one insertion drive element (142) configured for driving an insertion of the insertable portion (116) of the analyte sensor (114) into the body tissue of the user via the insertion component holder (140), wherein the insertion drive element (142) is arranged inside the inner capsule (138).

6. The continuous analyte sensor system (110) according to any one of the two preceding claims, wherein the insertion device (122) further at least one retraction drive element (146) configured for driving a retraction of the removable insertion component (128) after insertion of the insertable portion (116) of the analyte sensor (114) into the body tissue of the user via the insertion component holder (140), wherein the retraction drive element (146) is arranged inside the inner capsule (138).

7. The continuous analyte sensor system (110) according to any one of the three preceding claims, wherein a proximal end of the outer capsule (136) comprises at least one first opening (150), wherein a proximal end of the inner capsule (138) comprises at least one second opening (152), wherein, prior to insertion of the insertable portion (116) of the analyte sensor (114) into the body tissue of the user, the first opening (150) of the outer capsule (136) is incongruent with the second opening (152) of the inner capsule (138), wherein the sterile compartment (112) further comprises at least one sealing contour (154) between the first opening (150) of the outer capsule (136) and the second opening (152) of the inner capsule (138) to form the sealed opening (130), wherein the opening mechanism (132) is configured for aligning the first opening (150) of the outer capsule (136) with the second opening (152) of the inner capsule (138).- 45 -8. The continuous analyte sensor system (110) according to any one of the four preceding claims, wherein the insertion component holder (140) is attached to the outer capsule (136) via at least one bayonet mount (156) and comprises at least one sealing contour between the inner capsule (138) and the outer capsule (136).

9. The continuous analyte sensor system (110) according to any one of the preceding claims, wherein the sealed opening (130) comprises at least one membrane, wherein the membrane comprises at least one electrical sensor contact for electrically connecting the analyte sensor (114) to the electronics unit (118).

10. The continuous analyte sensor system (110) according to any one of the preceding claims, wherein the housing (124) comprises a triggering mechanism (160) connected to the insertion device (122), wherein the triggering mechanism (160) is configured for releasing insertion of the insertable portion (116) of the analyte sensor (114) into the body tissue of the user.

11. The continuous analyte sensor system (110) according to any one of the preceding claims, wherein the electronics unit (118) is an on-body electronics unit comprising at least one sensor patch (120) for attaching the on-body electronics unit to a skin of the user.

12. The continuous analyte sensor system (110) according to any one of the preceding claims, wherein the insertion device (122) is configured for electrically connecting the analyte sensor (114) to the electronics unit (118) upon inserting the insertable portion (116) of the analyte sensor (114) into the body tissue of the user, wherein the electronics unit (118) comprises at least one electrical sensor contact for electrically connecting the analyte sensor (114) to the electronics unit (118).

13. The continuous analyte sensor system (110) according to any one of the preceding claims, wherein the electronics unit (118) is arranged at a proximal end (134) of the insertion device (122).

14. A method of manufacturing a continuous analyte sensor system (110) according to any one of the preceding claims, wherein the method comprises: a) providing the sterile compartment (112); b) providing the electronics unit (118) and the insertion device (122); andc) assembling the continuous analyte sensor system (110) by mounting the sterile compartment (112) and the electronics unit (118) to the insertion device (122).

15. A method of using a continuous analyte sensor system (110) according to any one of the preceding claims referring to a continuous analyte sensor system (110), wherein the method comprises: i) providing the continuous analyte sensor system (110); ii) using the insertion device (122) to release the sealed opening (130) of the sterile compartment (112); iii) inserting the analyte sensor (114) into a body tissue of the user; and iv) removing the removable insertion component (128).

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