Medical system and method of manufacturing thereof

Abstract

The present invention discloses a medical system (110). The medical system (110) includes: a. a housing (112); b. a pre-assembled functional module (118) housed in the housing (112), the pre-assembled functional module (118) including b1. an analytical sensor (120) for detecting at least one analyte in a user's bodily fluids; b2. an electronic unit (126) electrically connected to the analytical sensor (120); and b3. an insertion part (130) for inserting the analytical sensor (120) into the user's body tissue; c. at least one removable protective cap (134) connected to the housing (112) to cover the pre-assembled functional module (118).

Description

[0001] This application is a divisional application of the invention patent application filed on December 20, 2018, with application number 201880082537.3 and title "Medical System and Manufacturing Method Thereof". Technical Field

[0002] This invention relates to medical systems and methods of manufacturing medical systems. The medical system is particularly useful for detecting at least one analyte in bodily fluids, such as those contained in body tissues. Specifically, the medical system can be used to insert an analyte sensor included in the system into a user's body tissue. The medical system can be applied in home care and professional care fields, such as for use in hospitals. Other applications are possible. Background Technology

[0003] Monitoring certain bodily functions, and more particularly monitoring the concentration of one or more analytes, such as at least one metabolite, in bodily fluids, plays an important role in the prevention and treatment of various diseases. Such analytes may include, but are not exclusive to, blood glucose, lactate, cholesterol, or other types of analytes and metabolites. Without limiting further possible applications, the invention will be described below with reference to blood glucose monitoring. However, alternatively or otherwise, the invention may also be applied to other types of analytes, such as those mentioned above.

[0004] To monitor these bodily functions, particularly the concentration of at least one analyte over a period of time, electrochemical sensors are used, specifically those that are percutaneously inserted into the user's body tissue. The sensors typically comprise an elongated, flexible substrate, multiple electrodes, including one or more working electrodes and one or more additional electrodes, such as one or more counter electrodes and / or one or more reference electrodes, applied to the flexible substrate.

[0005] As an example, US2010 / 0200538A1 discloses a method for manufacturing analyte sensor components using IC- or MEM-based manufacturing techniques and sensors thus fabricated. The fabrication of the analyte sensor components includes providing an inorganic substrate on which a release layer is deposited, a first flexible dielectric layer and a second flexible dielectric layer insulating between electrodes, contact pads, and traces connecting the electrodes and multiple sensors. An opening is provided in one of the dielectric layers above one or more electrodes to accommodate an analyte sensing membrane for detecting a target analyte and electrically connecting to external electronics. Multiple fabricated sensor components are then lifted from the inorganic substrate.

[0006] As another example, EP 2348964 B1 discloses an electrode system for measuring analyte concentration under in vivo conditions. This electrode system includes a counter electrode having an electrical conductor, a working electrode having an electrical conductor, an enzyme layer comprising immobilized enzyme molecules for the catalytic conversion of the analyte disposed on the working electrode, and a diffusion barrier that slows the diffusion of the analyte from the body fluid surrounding the electrode system to cause the enzyme molecules to descend. The present invention provides an enzyme layer in the form of multiple fields arranged at intervals between each other on the conductor of the working electrode.

[0007] Several challenges must be addressed in the field of continuous monitoring systems. First, there is the challenge of finding suitable devices for inserting analyte sensors into body tissue. A further challenge lies in the fact that in many systems, the analyte sensors must be electrically connected to electronic units positioned on the user's skin. A further challenge is the overall handling of the medical system, which in many cases must be performed by untrained users (including children and the elderly), often requiring easy-to-operate procedures with as few steps as possible.

[0008] WO 2016 / 012482 A1 discloses an insertion device for inserting an analyte sensor into body tissue, the device having an insertion needle hub and a drive mechanism for linearly driving the insertion needle hub in a longitudinal direction. The drive mechanism includes at least one actuator for actuating the drive mechanism. The actuator includes at least one actuator arm pivotable about at least one axis to actuate the drive mechanism. The insertion device further includes at least one protective device to prevent reuse, comprising at least one locking mechanism. Once the actuator arm has pivoted by at least one threshold angle, the locking mechanism is adapted to at least partially prevent rearward pivoting of the actuator arm in a direction opposite to the actuation direction.

[0009] Similarly, WO 2016 / 012497 A1 discloses an insertion device for inserting an analyte sensor into body tissue. The insertion device includes an insertion needle hub and a drive mechanism for driving the insertion needle hub in a longitudinal direction. The drive mechanism includes at least one actuator for actuating the drive mechanism. The drive mechanism includes a rotor adapted to convert the actuating motion of the actuator into motion of the insertion needle hub in the longitudinal direction. The insertion device further includes at least one safety lock. In a locked position, the safety lock is adapted to at least partially prevent rotation of the rotor. In an unlocked position, the safety lock is adapted to allow rotation of the rotor.

[0010] Furthermore, disposable systems for long-term monitoring of analytes and corresponding insertion devices for analyte sensors are known. WO 2017 / 037191 A1 discloses a kit for determining the concentration of at least one analyte in a user's bodily fluids, comprising: a) a sensor module including i. at least one sensor element adapted to determine the concentration of the analyte, wherein the sensor element is at least partially implantable in the user's body tissue; ii. at least one control device connected to the sensor element, wherein the control device includes at least one data collection device adapted to collect measurement data acquired by using the sensor element, wherein the control device further includes at least one wireless near-field communication device adapted to transmit the measurement data, wherein the sensor module includes a sensor module mechanical interface; b) at least one data reader module adapted to receive measurement data transmitted by the sensor module via wireless near-field communication, wherein the data reader module includes at least one data storage device and is adapted to store the measurement data; c) at least one data transmission module adapted to receive measurement data transmitted by the sensor module via wireless near-field communication, wherein the data transmission module includes at least one wireless far-field communication device adapted to transmit at least a portion of the measurement data to an external device via wireless far-field communication. The data reader module and the data transmission module each include a mechanical interface adapted to reversibly engage the sensor module's mechanical interface, thereby alternatively creating a fixed spatial relationship between the sensor module and the data reader module or between the sensor module and the data transmission module.

[0011] Furthermore, EP 2991552A1 describes systems, apparatuses, and methods for altering the power state of a sensor control device in an in vivo analyte monitoring system in various ways, such as by using external stimuli (light, magnetism) and radio frequency transmission.

[0012] WO 2011 / 119896A1 describes a device for inserting a medical device into the skin of a subject and a method for inserting the medical device. The device includes a sheath, a device support movable between proximal and distal positions, a pointed support movable between proximal and distal positions, a handle movable between proximal and distal positions, and an actuator.

[0013] US 2010 / 286714A1 describes an inserter device for inserting a medical device into a subcutaneous or intramuscular region of a patient. More specifically, an inserter device is described, which includes means for providing controlled and defined acceleration and deceleration of the penetrating member. The inserter device according to the invention includes a housing (enclosing the penetrating member), a rotating member, and a drive mechanism for rotating the rotating member about a rotation axis. The rotating member includes a conversion mechanism that converts the rotational motion into longitudinal motion of the penetrating member in the insertion direction, and the conversion mechanism includes a control mechanism that provides controlled variation of the velocity of the penetrating member in the insertion direction.

[0014] US 2007 / 202488A1 describes a method for determining the relative benefit of a product that affects the epithelial tissue of an animal. A method is also provided for assessing quantitative changes in one or more affected surfaces of the epithelial tissue of a subject caused by a test product.

[0015] US 2016 / 331284A1 describes a compact medical device inserter, a system incorporating the inserter, and related methods of use. The inserter may include a housing, a tip support, a tip body, and a shield, and can be used to apply sensor control to a recipient via sensor implantation into the recipient's body. The shield may extend from the sensor control in a position covering or protecting the sensor and tip, and may be retracted by applying pressure to the inserter against the recipient's body to allow the tip and sensor to penetrate the body; thereafter, the tip may automatically retract using a biasing element.

[0016] Despite the advantages of the aforementioned devices, several technical challenges remain. In particular, reliably connecting the analyte sensor to the electronic unit remains a challenge. Furthermore, the trend towards miniaturization often encourages the use of disposable electronics, including batteries. However, these devices should generally be turned off during storage and transportation, and should be turned on after the analyte sensor is inserted into body tissue. However, switching usually requires additional steps performed by the user. Moreover, protecting the analyte sensor and electronics during storage, transportation, and use, especially against moisture and mechanical shock, remains an issue.

[0017] The problem to be solved

[0018] Therefore, it is desirable to provide apparatus and methods for addressing the aforementioned technical challenges. In particular, it is desirable to provide a medical system that allows for easy and user-friendly insertion of analyte sensors into body tissues, involves few processing steps, and provides high protection against harmful mechanical and environmental influences. Summary of the Invention

[0019] The medical system and its manufacturing method, which have the features of the independent claims, solve this problem. Advantageous embodiments that can be implemented in isolated manner or in any combination are listed in the dependent claims.

[0020] As described below, the terms “have,” “contain,” or “include,” or any grammatical variations thereof, are used in a non-exclusive manner. Therefore, these terms can refer to the absence of any other features in the entity described in the context besides those introduced by these terms, or the presence of one or more other features. For example, the expressions “A has B,” “A contains B,” and “A includes B” can refer to the absence of any other element in A besides B (i.e., A is uniquely and exclusively composed of B), and the presence of one or more other elements in entity A besides B, such as element C, elements C and D, or even other elements.

[0021] Furthermore, it should be noted that the terms "at least one," "one or more," or similar expressions indicating that a feature or element may exist once or more are generally used only once when the corresponding feature or element is introduced. In the following text, in most cases, the expression "at least one" or "one or more" will not be repeated when referring to the corresponding feature or element, without implying the fact that the corresponding feature or element may exist once or more.

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

[0023] In a first aspect of the invention, a medical system is disclosed. This system can be specifically configured for qualitative and / or quantitative detection of at least one analyte in bodily fluids, such as one or more analytes listed above.

[0024] The medical system includes:

[0025] a. shell;

[0026] b. A pre-assembled functional module housed in the housing, the pre-assembled functional module comprising:

[0027] b1. An analytical sensor for detecting at least one analyte in a user's bodily fluids;

[0028] b2. An electronic unit, electrically connected to the analytical sensor; and

[0029] b3. An insertion component for inserting analytical sensors into a user's body tissue;

[0030] c. At least one removable protective cap, which is attached to the housing and covers the pre-assembled functional module.

[0031] Components a., b., and c., as specifically listed above, can be pre-assembled, such as to form pre-assembled modules, pre-assembled individual units, or modules assembled in a single factory. In particular, the pre-assembled module or unit can be packaged, as will be outlined in more detail below, for example, in blister packs.

[0032] As used herein, the term "medical system" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customized meaning. In particular, the term can refer to, but is not limited to, a system configured to perform at least one medical function. Specifically, as described above, a medical system can be configured for qualitative and / or quantitative detection of at least one analyte in bodily fluids, such as those contained in a user's body tissue. Specifically, a medical system can be configured to perform at least two actions: inserting an analytical sensor into body tissue and detecting the analyte in the bodily fluid using the analytical sensor. Specifically, the medical system, in its basic state before use, can be a single system that can be processed as a single unit. After use, i.e., after the analyte sensor is inserted into the body tissue, the medical system can be disassembled into a disposable processing component including an inserter in use, and an analyte sensor unit having a main body base and an analyte sensor, wherein the main body base can be attached to the user's skin, and wherein the analyte sensor can protrude from the analyte sensor unit into the body tissue.

[0033] As used further herein, the term "shell" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or custom meaning. In particular, the term can refer to, but is not limited to, substantially any element configured to completely or partially enclose one or more components and provide protection to those components, such as against mechanical influence and / or moisture. Specifically, the shell can be or may include a rigid shell, such as a rigid shell made of one or more of plastic, metallic, or cardboard materials. The shell may have a front surface configured to be disposed on the user's skin, such as a substantially flat front surface. As an example, the front surface may have an edge with an opening surrounded by the edge, wherein, as an example, the edge is configured to tighten the skin to apply an analyte sensor. As will be explained in further detail below, the shell may include, may contain, or may enclose one or more other components, such as insertion actuators.

[0034] As used further herein, the term "functional module" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or customized meaning. In particular, the term can refer to, but is not limited to, a module, such as a single module made of one or more components, particularly of multiple interconnected components, configured to interact to perform at least one function, particularly at least one medical function. In the present context, a functional module can particularly be a medical functional module configured to perform at least one medical function, such as for the qualitative and / or quantitative detection of at least one analyte in bodily fluids.

[0035] As used further herein, the term "pre-assembled" generally refers to the fact that an assembly process has already been performed. Therefore, as claimed, a medical system includes functional modules as defined above in a pre-assembled state, meaning that the components of the functional module have been assembled, such as by mechanical and / or electrical interconnections, to prepare them for use in at least one function, such as at least one medical function, for example, at least one analytical function. In particular, pre-assembly can be performed in a factory, thus making the pre-assembled functional module a factory-assembled functional module. Specifically, the medical system can be configured such that at least one pre-assembled functional module is completely covered by a combination of a housing and a protective cap, such that a user may not see or manipulate the pre-assembled functional module without opening the medical device, for example, without removing the protective cap.

[0036] As used further herein, the term "enclosed in a housing" generally refers to the fact that the pre-assembled functional module is completely or partially surrounded by the housing. Specifically, as described above, the housing may include at least one receiving portion for housing the pre-assembled functional module. As an example, the receiving portion may be located at the front of the housing, wherein the receiving portion may be completely or partially surrounded, for example, by a frame formed by the housing. The receiving portion may be covered by a protective cap such that the functional module is accessible and can be placed on the user's skin when the protective cap is removed from the housing.

[0037] As used herein, the term "sensor" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or custom meaning. Specifically, the term can refer to, but is not limited to, any element or device configured to detect at least one condition or to measure at least one measurement variable. Specifically, a sensor can be or can include an analyte sensor for at least partial implantation in a user's body tissue, and more particularly, an analyte sensor for continuous monitoring of an analyte. Specifically, a sensor can be a monolithic sensor element.

[0038] Therefore, and as further used herein, the term "analytical sensor" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or customized meaning. In particular, the term may refer to, but is not limited to, a sensor configured for analytical purposes according to the definition given above. Specifically, an analytical sensor may be configured for the qualitative and / or quantitative detection of at least one analyte in a user's bodily fluids, such as one or more analytes listed above, more specifically glucose. As an example, the bodily fluids may be or may contain one or more of blood or tissue fluid.

[0039] Analytical sensors can be specifically configured for long-term monitoring of analytes. As an example, an analytical sensor can be configured to be placed in body tissue and retained therein for at least one week to provide measurement data during use. In particular, the analytical sensor can be or may include an electrochemical analytical sensor, as will be described in further detail below.

[0040] As used herein, the term "electronic unit" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or custom meaning. Specifically, the term may refer to, but is not limited to, a unit configured to perform at least one electronic function, such as a unit that can be processed as a single piece. In particular, the electronic unit may have at least one interface for connection to an analytical sensor, wherein the electronic unit can provide at least one electronic function that interacts with the analytical sensor, such as at least one measurement function. As will be further detailed below, the electronic unit may in particular be configured to measure at least one voltage and / or to measure at least one current, thereby interacting with the analytical sensor, particularly an electrochemical analytical sensor. In particular, the electronic unit may include at least one electronic unit housing, wherein the analytical sensor, such as an analytical sensor having a proximal end, may protrude into the housing and be electrically connected to at least one electronic component within the housing. As an example, the proximal end and / or at least one contact portion of an electrochemical sensor may protrude into the housing, and wherein it may be electrically connected to at least one electronic component, such as electrically connected to at least one printed circuit board and / or at least one contact portion of the electronic unit, for example, via one or more of soldering connections, bonding connections, plugs, clamping connections, etc. As will be further detailed below, the electronic unit can in particular be used as a transmitter for transmitting measurement data to at least one external device, such as to at least one receiver, for example wirelessly.

[0041] The electronic unit is electrically connected to the analytical sensor. Therefore, an electrical connection exists between the analytical sensor and the electronic unit. Through this electrical connection, the electronic unit can interact with the analytical sensor to perform at least one electrochemical measurement. Specifically, as described above, the electrical connection can be established through at least one connection portion of the analytical sensor protruding into the housing of the electronic unit. The functional module can be pre-assembled in such a sense that the electronic unit is already electrically connected to the analytical sensor when the functional module is housed in the housing and the protective cap is attached to the housing. Specifically, the electronic unit can be irreversibly electrically connected to the analytical sensor. Therefore, in particular, it is not necessary to assemble the electronic unit and the analytical sensor, because in the pre-assembled functional module, the electronic unit and the analytical sensor are already electrically connected and optionally also mechanically connected.

[0042] As used herein, the term "insertion component" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or custom meaning. Specifically, the term can refer to, but is not limited to, an element or combination of elements configured for inserting (e.g., percutaneously or subcutaneously) at least one component into a user's body tissue. Thus, in particular, at least one insertion component can be or may include at least one cannula having a tip or point configured to pierce the user's skin, and optionally, further having at least one slot configured to receive at least a portion of an analytical sensor. The insertion component may include other elements, such as at least one support for manipulating or holding the insertion component, such as a cannula.

[0043] The electronic unit may have an opening through which an insertion component can protrude. Thus, as an example, the electronic unit may have an upper and a lower side, with the lower side facing the user's skin and the upper side facing the housing, such as toward an insertion actuator. The insertion actuator can drive the insertion component, such as a cannula, through the opening, such as through a through-hole in the housing of the electronic unit.

[0044] As used herein, the term "protective cap" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or custom meaning. Specifically, the term can refer to, but is not limited to, an element configured to partially cover at least one other device, component, or element, thereby providing at least partial protection against mechanical and / or environmental influences. Specifically, the protective cap can be made wholly or partially of at least one rigid material, such as at least one plastic material and / or at least one metal. The protective cap can particularly have an opening configured to point towards the housing of the medical system. Specifically, the protective cap can be made substantially rotationally symmetrical, for example, by having axial rotational symmetry about an axis, such as a cylindrical axis. As an example, the protective cap can be designed as a cylinder, hemisphere, or dome.

[0045] As an example, the protective cap can be connected to the housing via at least one of form-fit or force-fit connections. Specifically, the edge of the protective cap can be pushed against the edge of the housing, or vice versa. Thus, as an example, the protective cap can have round, elliptical, or polygonal edges that fit snugly against the edge of the housing with the corresponding shape, or vice versa. In the connected state, there may be overlapping areas where the protective cap overlaps with the housing, or vice versa.

[0046] As described above, the housing may specifically include at least one receiving portion for accommodating the electronic unit, the receiving portion being open toward one end of the housing covered by the protective cap. As an example, the receiving portion may include at least one open space facing the front of the housing, within which the electronic unit is housed. The electronic unit can be held in the receiving portion by at least one retaining device, such as by at least one hook, which can release the electronic unit once it is applied to the user's skin, for example, by inserting an analytical sensor into body tissue.

[0047] As described above, the electronic unit may specifically include at least one electronic component. Specifically, the electronic unit may include at least one of the following: a measuring device for providing electrochemical measurements, particularly at least one of a current measuring device or a potentiostatic measuring device; a transmitter for transmitting the measurements to at least one external receiver; an integrated data storage device; or an integrated battery. These electronic components are generally known in the field of long-term monitoring of one or more analytes, such as those described in the aforementioned prior art literature.

[0048] As described above, specifically in the assembled state of the analysis system and before the protective cap is removed, the analytical sensor is fixedly electrically connected to the electronic unit. Therefore, unlike systems where the analytical sensor is connected to the electronic unit during insertion, in the current case, in particular, the analytical sensor can be electrically connected to the electronic unit before insertion. Thus, the analytical sensor and the electronic unit can form part of a disposable unit.

[0049] Specifically, the analytical sensor can be an electrochemical analytical sensor. Therefore, an electrochemical analytical sensor can specifically have at least one working electrode and at least one additional electrode selected from the group consisting of a counter electrode and a reference electrode. As an example, the at least one working electrode may comprise at least one chemical reagent for detecting at least one analyte, such as at least one chemical reagent containing at least one enzyme. The at least one working electrode and the at least one additional electrode can specifically be connected to an electronic unit via at least two electrical wires.

[0050] The pre-assembled functional module may further include at least one sterile cap that at least partially surrounds the insertion component.

[0051] As used herein, the term "sterile cap" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or custom meaning. The term may specifically refer to, but is not limited to, elements such as caps configured to maintain a sterile atmosphere within a space wholly or partially enclosed by the element. As an example, a sterile cap may be a rigid sterile cap, for example, made of rigid plastic materials and / or metal. As an example, a sterile cap may have rotational symmetry about an axis, which may, for example, be the same as the rotational symmetry axis of a protective cap and / or the rotational symmetry axis of a shell. As an example, a sterile cap may have an elongated shape, with a length exceeding its diameter or equivalent diameter by at least 2 times, more preferably at least 5 times. As an example, the length of a sterile cap may be from 5 to 20 mm, for example, from 10 to 15 mm.

[0052] As described above, the insertion component may specifically include at least one cannula. The cannula may be wholly or partially contained within a sterile cap. As an example, the sterile cap may have an elongated shape with a closed end and an open end, the cannula protruding from the open end into the sterile cap with its tip facing the closed end. The analytical sensor may be partially contained within the cannula, such as within a slot in the cannula. The insertion component may further include at least one support for the cannula, wherein the support, the cannula, and the sterile cap form components of a sterile container for the analytical sensor. As an example, the support may include a rigid member connected to the proximal end of the cannula, i.e., connected to the end of the cannula opposite the tip. As an example, the cannula may be attached to the support by gluing and / or by injection molding and / or, for example, by other material bonding devices. As an example, the support may have a cylindrical shape.

[0053] Specifically, the protective cap can be removed from the housing by pulling it off. Therefore, as described above, the protective cap can overlap with the housing during the attachment phase, or vice versa. Specifically, the protective cap can be adhered tightly to the housing. The housing may specifically include at least one guide surface, particularly a circumferential guide surface, for guiding the protective cap during its removal. Therefore, the guide surface can be an outer surface of the housing, such as an outer surface having a circular cross-section, an elliptical cross-section, or a polygonal cross-section. In the attached state, the protective cap can overlap with the housing within the guide surface. When pulled off the housing, the protective cap, such as its inner surface, can slide on the guide surface.

[0054] The sterile cap can be securely attached to the protective cap. Therefore, the sterile cap can be configured to be pulled off the insert when the protective cap is pulled off the housing. However, the sterile cap may differ from the protective cap. Therefore, even if the sterile cap can be housed within the protective cap, the walls of the sterile cap should be different from the walls of the protective cap. However, the sterile cap can be attached to the protective cap at its distal end, for example, by one or more of a form-fit connection, a force-fit connection, or a connection by material bonding (such as gluing) or injection molding. The protective cap and the sterile cap can, in particular, be made of different materials.

[0055] The option of linking the action of removing the protective cap from the housing with the action of pulling the sterile cap off the insert component provides several other options and advantages. Thus, as an example, a pre-assembled functional module may include at least one guide surface for guiding the sterile cap during the pulling-off of the sterile cap from the insert component. The length of the guide surface of the housing may exceed the length of the guide surface of the sterile cap, particularly at least twice, more particularly at least five times, or at least ten times. Additionally or alternatively, the length of the guide surface of the housing may exceed the length of the sterile cap, particularly such that when the protective cap is pulled off the housing, the sterile cap is completely pulled off the insert component before the guidance by the guide surface of the housing ends. Therefore, in other words, by combining the action of removing the protective cap from the housing (e.g., by pulling the protective cap off the housing) and the action of removing the sterile cap from the insert component (e.g., from the cannula), the option of guiding the sterile cap via the housing through the guide protective cap is provided, such that the sterile cap performs a well-defined movement until the insert component, such as the cannula, is fully released, and until the sterile cap is completely removed from the insert component. Therefore, the risk of mechanical damage to the insertion component, such as the cannula, during the removal of the sterile cap can be significantly reduced because the movement of the sterile cap is well-defined and can be precisely oriented along the longitudinal axis of the insertion component, such as the cannula, especially along the entire length of the cannula.

[0056] The guide surface of the housing can specifically provide for at least one movement selected from the group consisting of: translational movement of the protective cap and sterile cap when the protective cap is pulled off the housing; rotational movement of the protective cap and sterile cap when the protective cap is pulled off the housing; and both translational and rotational movement of the protective cap and sterile cap when the protective cap is pulled off the housing. Thus, several movements are possible, and even combinations thereof. As an example, when the protective cap is pulled off, the protective cap can only perform translational movement, e.g., along the longitudinal axis of the medical system. However, rotational movement can be additionally or alternatively introduced. As an example, at least one guide surface can be provided for one or more helical guide elements or guide surfaces to introduce rotational movement. Rotational movement can also be used, in particular, to prevent or unlock actions. Thus, as an example, when the protective cap is pulled off the housing, the guide surface of the housing can provide at least a rotational component. The sterile cap can be connected to a pre-assembled functional module via at least one bayonet connection, wherein the bayonet connection can be disengaged and the sterile cap can be removed from the pre-assembled functional module by the rotational component.

[0057] The medical system may further include at least one indicator seal connected to the protective cap and the housing. As used herein, the term "indicator seal" can specifically refer to a user-visible element that indicates whether the medical system has been previously used, particularly whether the protective cap has been previously removed from the housing. Therefore, the indicator seal can also be referred to as a creative seal. The medical system may include one or more tamper-evident closure devices, and the indicator seal may be part of such tamper-evident closure device. As an example, the indicator seal may be configured to break when the protective cap is removed from the housing. The indicator seal may specifically include one of a sealing foil and a sealing strip. The indicator seal may be exemplary of a creative closure.

[0058] The indicator seal can provide further functionality for the medical system. Therefore, the indicator seal can also provide sealing properties, such as preventing moisture from entering the housing and / or the protective cap. Additionally or alternatively, the indicator seal can be opaque. This is particularly useful in relation to the option of activating the electronics via a light switch, which will be described in further detail below.

[0059] Therefore, medical systems can typically be configured such that the electronic unit is switched on when the protective cap is removed from the housing. Specifically, the electronic unit can be switched on by at least one switching mechanism selected from the group consisting of: a mechanical switch connected to the cap, wherein the mechanical switch is switched on when the protective cap is removed from the housing; a photosensitive switch, wherein the photosensitive switch is switched on by ambient light when the protective cap is removed from the housing; and a liner covering the battery of the electronic unit, wherein the liner is pulled down when the protective cap is removed from the housing. Thus, as an example, the protective cap may include a pin or strap connected to the electronic unit. By removing the protective cap, for example by pulling down the protective cap, the pin or strap can release a switch within the electronic unit, thereby switching on the electronic unit. Additionally or alternatively, the electronic unit may include a photodiode, phototransistor, or other photosensitive element configured to detect the removal of the protective cap and ambient light illuminating the electronic unit, the electronic unit being configured to be switched on by detecting light. Additionally or alternatively, the photosensitive element may generate a photocurrent or photovoltage sufficient to switch on the electronic unit.

[0060] The medical system may further include at least one adhesive plaster for attaching an electronic unit to the user's skin surface. The adhesive plaster may be attached directly or indirectly to the electronic unit or to a portion connected to the electronic unit, for example, during the insertion of an analytical sensor. The adhesive plaster may be or may include an adhesive surface, such as the adhesive surface of a rigid component or a flexible bandage. In the initial state of the medical system, with the protective cap attached to the housing, the adhesive plaster may be covered by at least one removable liner. The liner may be attached to the protective cap, for example by directly attaching the liner or a portion thereof (such as a strap or latch on the liner) to the protective cap, or indirectly, for example by connecting the protective cap and the liner using a strap, a protrusion on the protective cap, etc. Thus, by these or other means, the liner may be configured to be pulled off the adhesive plaster when the protective cap is removed from the housing.

[0061] The medical system may further include at least one insertion actuator. As used herein, the term "insertion actuator" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or custom meaning. The term may specifically refer to, but is not limited to, any device configured to insert at least one insertable element directly or indirectly into body tissue. The insertion actuator may include at least one mechanical device configured to drive the insertable element or insertion component, such as a cannula, forward into the body tissue. As an example, the insertion actuator may include at least one slider or a support for the insertion component connected to it, and configured to perform a forward linear movement in the insertion direction and optionally a backward linear movement in the opposite direction. As an example, the slider may be driven by at least one spring element that may be pre-tensioned or biased in the forward or backward direction. Additionally or alternatively, the slider may be connected to at least one actuation button that can be pressed by a user to drive the slider in the forward direction. Therefore, the insertion actuator can be configured to drive the insertion component into body tissue, and optionally, to drive it backward again after the insertion of the insertable analytical sensor. As an example, the backward movement for withdrawing the insertion component, such as a cannula, from body tissue can be driven by a return spring or a motion inverter. Insertion actuation of the insertion actuator can also initiate or provide other actions, such as the assembly of components of the main body base, the assembly of components providing a housing for the electronics unit, and / or the attachment of the main body base to the user's skin. Insertion actuators configured to drive insertion movement, as known to those skilled in the art, can also be used in the context of this invention. As an example, reference can be made to actuators disclosed in the aforementioned documents WO2016 / 012482A1, WO2016 / 012497 A1, or WO 2017 / 037191 A1 and the prior art referenced therein. These insertion actuators can also be used directly or, depending on the specific circumstances, in the context of this invention. Typically, the insertion actuator can be configured to advance the insertion component after the protective cap has been removed from the housing and to insert the analytical sensor into the body tissue.

[0062] As described above, the medical system may include a main body base. As used herein, the term "main body base" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or custom meaning. The term may specifically refer to, but is not limited to, an analytical component that interacts with an analytical sensor configured for insertion onto a user's skin. The main body base may include an adhesive bandage and a bracket attached to the bandage and configured to house an electronic unit, and to house all or part of the electronic unit. Alternatively, the main body base may include an upper shell covering the electronic unit, wherein, as an example, the upper shell may be attached to the bracket to form a shell that completely or partially encloses the electronic unit. In an inserted state, attached to the skin via the main body base, the analytical sensor may protrude from the underside of the electronic unit into the body tissue through openings in the bracket and the adhesive bandage.

[0063] In its initial state, the main body base can be housed within the housing before the protective cap is removed from the housing. The main body base can be housed in either an assembled or disassembled state within the housing, wherein, in the latter case, assembly can be performed during or after insertion of the analytical sensor into the body tissue. Therefore, typically, the main body base may include at least one bracket for attachment to the user's skin and at least one upper shell, in which the electronic unit is housed. The bracket and upper shell can be disassembled before the insertion actuator is actuated. The medical system, particularly the bracket and upper shell, can be configured to be assembled when the insertion actuator is actuated. Thus, as an example, when the insertion actuator moves forward toward the user's skin, the adhesive bandage and / or bracket can reach the skin and thus prevent forward movement of these components, to which the electronic unit with the analytical sensor is attached, can be prevented, and optionally, the upper shell can still move forward toward the skin. Thus, firstly, the electronic unit can be inserted into the bracket. Secondly, the upper shell can then be placed on top and locked to the electronic unit and / or bracket, thereby forming a housing or shell for the electronic unit. Simultaneously, during forward movement, the insertion component can be driven into the body tissue, thereby inserting the analytical sensor into the body tissue. Afterwards, the insertion component can be withdrawn from the body tissue, while the analytical sensor remains within the body tissue.

[0064] As described above, the insertion actuator may in particular include at least one button. As an example, the button may include a linearly sliding button that can be actuated in a linear direction (such as perpendicular to the user's skin). The insertion actuator, particularly the button, may be included in a housing, may be attached to a housing, or may be integrated into a housing. As further outlined above, the insertion actuator may be further configured to retract the insertion component from body tissue after the insertion analysis sensor has been inserted.

[0065] As a complement to or alternative to one or more of the aforementioned functions, the protective cap may provide other functions. Thus, as an example, the protective cap may also provide the function of maintaining a low level of humidity within a closed medical system before the protective cap is removed. Therefore, in particular, the protective cap may include multiple chambers at least partially filled with a desiccant such as silica gel. As an example, on one or more inner surfaces facing the housing, the protective cap may include one or more partition walls protruding from at least one of these surfaces into the interior of the protective cap, thereby forming chambers that may, for example, open towards the housing. These chambers may be wholly or partially filled with at least one desiccant.

[0066] As an additional or alternative measure to prevent the analytical sensors and / or electronic units in a medical system from being affected by moisture, the medical system may further include at least one moisture seal housed between a protective cap and a housing. Thus, as described above, the protective cap may overlap with the housing in an overlapping area, which may also provide at least one guide surface. In this overlapping area, at least one moisture seal may be provided, such as by providing an O-ring and / or by providing an adhesive line, such as a circumferential line. The moisture seal may break when the protective cap is removed from the housing.

[0067] The medical system may further include at least one package. This package may be, in particular, an airtight and / or moisture-tight package, such as a blister pack. The remaining components of the medical system may be enclosed in a sealed package, especially a blister pack. Thus, the housing, the pre-assembled functional modules, and the removable protective cap attached to the housing can form a single enclosed unit of the medical system. The pre-assembled functional modules, which are pre-assembled, for example, in a factory assembly, are enclosed in the housing by the protective cap attached to them. Therefore, once the user opens the sealed package and removes the unit, the unit is ready for use.

[0068] In another aspect of the invention, a method for manufacturing a medical system is provided, particularly a method for manufacturing a medical system disclosed above or in more detail below. The method includes the steps disclosed below. Specifically, the steps can be performed in a given order. However, different orders are possible. The method may include additional steps not mentioned. One or more method steps may also be repeated. Furthermore, two or more method steps may be performed in an overlapping manner or simultaneously.

[0069] The methods for manufacturing medical systems include the following steps:

[0070] i. Provide a housing;

[0071] ii. Pre-assembled functional modules, which include:

[0072] - An analytical sensor used to detect at least one analyte in a user's bodily fluids;

[0073] - An electronic unit, which is electrically connected to the analytical sensor; and

[0074] - An insertion component used to insert analytical sensors into body tissues;

[0075] iii. The pre-assembled functional modules are housed within the casing;

[0076] iv. Attach at least one removable protective cap to the housing to cover the pre-assembled functional module.

[0077] As described above, this method can be used specifically to manufacture the medical systems proposed therein, such as those disclosed above and / or those disclosed in further detail below.

[0078] A method for using a medical system according to the invention is further proposed, such as a method using a medical system according to any embodiment disclosed above or any embodiment disclosed in further detail below. The method may include the steps, preferably in a given order. However, a different order is also possible. Furthermore, one, more, or even all of the method steps may be performed repeatedly. Additionally, two or more method steps may be performed entirely or partially simultaneously. The method may include other steps.

[0079] The method includes:

[0080] I. Provide a medical system,

[0081] II. Remove the protective cap from the casing.

[0082] III. Place the casing against the user's skin, and

[0083] IV. Insert the analytical sensor into the user's body tissue.

[0084] Method step I may also include removing a unit of a medical system, including a housing, protective cap, and pre-assembled functional modules, from a sealed package, such as a blister pack.

[0085] Method step II may include multiple sub-steps that can be activated by removing a protective cap from the housing. It may include one or more sub-steps disclosed below. Thus, as described above, the step may include activating the electronic unit. Additionally or alternatively, the step may include removing the sterile cap from the insertion part. Additionally or alternatively, the step may also include destroying the indicator seal. Additionally or alternatively, the step may also include removing the liner from the adhesive tape.

[0086] Method step III may include applying adhesive tape to the skin, and further optionally, placing the bracket on the skin and adhering the bracket to the skin with adhesive tape.

[0087] Similarly, method step IV. may include one or more of the following sub-steps. Thus, as an example, this method step may include the following steps: initiating insertion by activating an insertion actuator, such as by pushing a button. This step may also include assembling the main body base, for example by assembling the adhesive pad, bracket, and electronic unit, along with an optional ground housing, to form a single unit.

[0088] Compared with known methods and apparatuses, the medical system and method according to the present invention offer many advantages. Therefore, in particular, the aforementioned technical challenges of known insertion devices are addressed, especially insertion devices for continuous monitoring sensors.

[0089] Specifically, this medical system can provide a completely disposable continuous monitoring system, such as a completely disposable continuous glucose monitoring system. Functional modules can be pre-assembled, with the main body, electronics, and analytical sensors already assembled. Functional modules combined with a housing and a removable protective cap can also form pre-assembled modules, which can be delivered to the customer in this pre-assembled manner. Therefore, users typically do not need to perform further assembly steps. Pre-assembled modules can include a housing, functional modules, and a protective cap. The protective cap can incorporate different functions in a single element. Such functions can include one or more of the following: ensuring a sterile and safe environment, providing simple user operation to remove the protective cap, providing a sterile barrier for the analytical sensor compartment, initializing the medical system, providing a tamper-evident sealing device such as an indicator seal, or other functions. In particular, the protective cap can ensure high robustness and easy system initialization and easy handling procedures in a simple and cost-effective manner within a single system element. This medical system can provide a sensor system for monitoring analyte concentrations, comprising components of an analytical sensor, inserter, and electronics. The analytical sensor, inserter, and electronics can be pre-assembled before application of the analytical sensor. Specifically, this pre-assembly can be factory pre-assembly before the user opens the system packaging. The component may further include a protective cap that holds the inserter, analytical sensor, and electronics in place and, upon removal of the cap, allows insertion of the analytical sensor into subcutaneous tissue. As mentioned above, the protective cap can be part of the medical system initialization concept, for example, via the electronics, which includes at least one photosensitive element that, once the cap is removed, detects ambient light to activate the electronics associated with the analytical sensor. Additionally or alternatively, the protective cap may include a guiding device to facilitate user operation during cap removal, for example, via a screw that can also serve as a seal. Additionally or alternatively, the protective cap may include a tamper-evident closure that can also act as a barrier against liquids or moisture.

[0090] Therefore, protective caps can offer a variety of functions and solutions to address technical challenges. Thus, as mentioned above, by providing protection against moisture, protective caps can protect sensitive components of analytical sensors, such as substrates and enzymes. This can increase shelf life. Typically, there is no need to include additional desiccant in the outer packaging, which requires extra space. The desiccant can be placed inside the protective cap, for example, by placing the desiccant directly into the cap and / or by implementing one or more packets of desiccant into the cap, for example, by joining with materials such as adhesives and / or by form-fitting connections. The amount of desiccant can be tailored to the expected shelf life of the medical system.

[0091] As described above, the protective cap can be further used as a switch for activating electrical units such as transmitters. Therefore, several functions and / or switching concepts can be implemented as described above. As an example, an optical switch, such as one or more phototransistors, can be used, where ambient light can activate the electronic unit when the protective cap is removed from the housing. The protective cap can typically be designed using opaque materials to prevent unintentional activation of the electronic unit, and to provide a light barrier that is immediately broken before the user uses the medical system. An appropriate geometry for the protective cap can be selected.

[0092] Protective caps can provide further mechanical protection. Therefore, additional mechanical protection is provided for the entire medical system. Thus, through appropriate and / or flexible design of the protective cap or its components, the protective cap, alone or in conjunction with the shell, can absorb or reduce mechanical impacts and shocks. Therefore, as an example, without a protective cap, the medical system might fall onto the sterile cap covering insertion parts, such as cannulas, and thereby cause damage to the insertion parts. Without a protective cap, other constructive protective measures would be required.

[0093] Furthermore, as mentioned above, the sterile cap and its removal present further technical challenges to typical medical systems. Due to the length of the insert (such as the length of a cannula), pulling down the sterile cap typically requires a minimum guide length, such as 10 mm, to safely remove the cap from the insert and to avoid damage to the insert during removal. The guidance of the sterile cap during removal can be increased and improved by attaching a protective cap to it. Thus, as an example, when removing the protective cap from the housing, the protective cap can be guided by the housing, where the guide length or guide distance increases the length of the insert and / or the protective cap. Therefore, as an example, with this increased guidance, lateral movement is only possible after the sterile cap has safely cleared the insert, such as a cannula.

[0094] The protective cap can be further used to prepare the main body base for attachment to the user's skin. Therefore, as mentioned above, removing the protective cap from the shell can also be used to remove the lining from the adhesive tape.

[0095] The protective cap can be further combined with an indicator seal (such as a creative closure) and / or a moisture barrier. Thus, an indicator seal can be provided between the protective cap and the housing, for example by providing visible tape that clearly indicates whether the medical system has been opened and / or damaged. The indicator seal can also provide an additional moisture barrier, thus allowing for the disposal of additional packaging. Alternatively or additionally, a moisture barrier can be provided between the protective cap and the housing or the actuator button.

[0096] Furthermore, as mentioned above, various movements are possible when removing the protective cap from the housing. Therefore, pure translational movements and combinations thereof are feasible. Moreover, the movement of the protective cap can be translated into appropriate movement of the sterile cap. Thus, even if the protective cap performs a pure translational movement, this translational movement can be converted into a rotational component of the sterile cap, or vice versa. To translate the movement of the protective cap into the desired movement of the sterile cap, the sterile cap can be connected to the protective cap via one or more guiding elements (such as one or more cam controls). Thus, the sterile cap can be unlocked from one or more of the insertion component, electronic unit, support, or pre-assembled functional module, for example, via a bayonet lock. Typically, by using one or more of these options, the geometry of the medical system (such as the geometry of the insertion actuator) can be separated from the geometry of other components of the medical system and is generally freely selectable. The insertion actuator does not necessarily have to have a circular cross-section, and the electronic unit can be optimized to a smaller area. Typically, the geometry can be selected independently of the function of components such as the transmitter.

[0097] In summary, and without excluding other possible embodiments, the following embodiments are conceivable:

[0098] Example 1: A medical system comprising:

[0099] a. shell;

[0100] b. A pre-assembled functional module housed in the housing, the pre-assembled functional module comprising:

[0101] b1. An analytical sensor for detecting at least one analyte in a user's bodily fluids;

[0102] b2. An electronic unit electrically connected to the analytical sensor; and

[0103] b3. An insertion component for inserting the analytical sensor into the user's body tissue;

[0104] c. At least one removable protective cap, which is attached to the housing and covers the pre-assembled functional module.

[0105] Example 2: The medical system according to the foregoing embodiments, wherein the housing includes at least one receiving portion for accommodating the electronic unit, the receiving portion being open toward one end of the housing covered by the protective cap.

[0106] Example 3: A medical system according to any one of the foregoing embodiments, wherein the electronic unit includes at least one of the following: a measuring device for providing electrochemical measurements, particularly at least one of a current measuring device or a potentiostatic measuring device; a transmitter for transmitting the measurements to at least one external receiver; an integrated data storage device; and an integrated battery.

[0107] Example 4: A medical system according to any one of the foregoing embodiments, wherein the analytical sensor is fixedly electrically connected to the analytical sensor.

[0108] Example 5: A medical system according to any one of the preceding claims, wherein the analytical sensor is an electrochemical analytical sensor having at least one working electrode and at least one additional electrode selected from the group consisting of a counter electrode and a reference electrode, wherein the at least one working electrode and the at least one additional electrode are connected to the electronic unit via at least two electrical wires.

[0109] Example 6: A medical system according to any one of the foregoing embodiments, wherein the pre-assembled functional module further includes at least one sterile cap, the at least one sterile cap at least partially surrounding the insertion component.

[0110] Example 7: A medical system according to the foregoing embodiments, wherein the insertion component includes at least one cannula in which the analytical sensor is partially housed.

[0111] Example 8: The medical system according to the foregoing embodiments, wherein the insertion component further includes at least one support for the cannula, wherein the support, the cannula, and the sterile cap form a component for a sterile container for the analytical sensor.

[0112] Example 9: A medical system according to any one of the preceding three embodiments, wherein the protective cap can be removed from the housing by pulling it off, wherein the housing includes at least one guide surface, particularly a circumferential guide surface, for guiding the protective cap when it is pulled off.

[0113] Example 10: A medical system according to the foregoing embodiments, wherein the sterile cap is connected to the protective cap, wherein the sterile cap is configured to be pulled off from the insertion member when the protective cap is pulled off from the housing.

[0114] Example 11: The medical system according to the foregoing embodiments, wherein the pre-assembled functional module includes at least one guide surface for guiding the sterile cap during the process of pulling the sterile cap off the insert component.

[0115] Example 12: The medical system according to the foregoing embodiments, wherein the length of the guide surface of the housing exceeds the length of the guide surface of the sterile cap, particularly at least twice, more particularly at least five times or at least ten times.

[0116] Example 13: A medical system according to any one of the foregoing three embodiments, wherein the length of the guide surface of the housing exceeds the length of the sterile cap, in particular, such that when the protective cap is pulled off the housing, the sterile cap is completely pulled off the insertion member before the guidance through the guide surface of the housing ends.

[0117] Example 14: A medical system according to any one of the foregoing four embodiments, wherein the guide surface of the housing provides at least one movement selected from the group consisting of: translational movement of the protective cap and the sterile cap when the protective cap is pulled off the housing; rotational movement of the protective cap and the sterile cap when the protective cap is pulled off the housing; and translational and rotational movement of the protective cap and the sterile cap when the protective cap is pulled off the housing.

[0118] Example 15: The medical system according to the foregoing embodiments, wherein when the protective cap is pulled off the housing, the guide surface of the housing provides at least a rotational component, wherein the sterile cap is connected to the pre-assembled functional module via at least one bayonet connection, wherein the bayonet connection is disengaged by the rotational component, and the sterile cap can be removed from the pre-assembled functional module.

[0119] Example 16: The medical system according to any one of the foregoing embodiments further includes at least one indicator seal connected to the protective cap and the housing, wherein the indicator seal is configured to break when the protective cap is removed from the housing.

[0120] Example 17: The medical system according to the foregoing embodiments, wherein the indicator seal includes one of a sealing foil and a sealing strip.

[0121] Example 18: A medical system according to any one of the foregoing two embodiments, wherein the indicator seal is opaque.

[0122] Example 19: A medical system according to any one of the foregoing embodiments, wherein the medical system is configured such that the electronic unit is turned on when the protective cap is removed from the housing.

[0123] Example 20: A medical system according to the foregoing embodiments, wherein the electronic unit is switched on by at least one switching mechanism selected from the group consisting of: a mechanical switch connected to the cap, wherein the mechanical switch is switched on when the protective cap is removed from the housing; a photosensitive switch, wherein the photosensitive switch is switched on by ambient light when the protective cap is removed from the housing; and a liner covering the battery of the electronic unit, wherein the liner is pulled down when the protective cap is removed from the housing.

[0124] Example 21: A medical system according to any one of the foregoing embodiments, wherein the medical system further includes at least one adhesive plaster for attaching the electronic unit to the surface of a user's skin, wherein the adhesive plaster is covered by a liner connected to the protective cap, wherein the liner is configured to be pulled off the adhesive plaster when the protective cap is removed from the housing.

[0125] Example 22: A medical system according to any one of the foregoing embodiments, wherein the medical system further includes at least one insertion actuator, wherein the insertion actuator is configured to advance the insertion member and insert the analytical sensor into body tissue after the protective cap is removed from the housing.

[0126] Example 23: The medical system according to the foregoing embodiments, wherein the medical system further includes a main body base housed in the housing, wherein the electronic unit is at least partially included in the main body base.

[0127] Example 24: The medical system according to the foregoing embodiments, wherein the main body base includes at least one bracket for attachment to the user's skin and at least one upper shell, wherein the electronic unit is housed in the upper shell, wherein the bracket and the upper shell are disassembled before actuation of the insertion actuator, and wherein the bracket and the upper shell are configured to be assembled when the insertion actuator is actuated.

[0128] Example 25: A medical system according to any one of the preceding three embodiments, wherein the insertion actuator includes at least one button.

[0129] Example 26: A medical system according to any one of the foregoing four embodiments, wherein the insertion actuator is configured to withdraw the insertion component from the body tissue after the insertion of the analytical sensor.

[0130] Example 27: A medical system according to any one of the preceding embodiments, wherein the protective cap includes a plurality of chambers at least partially filled with a desiccant.

[0131] Example 28: A medical system according to any one of the foregoing embodiments, wherein the medical system further includes at least one moisture seal, the moisture seal being accommodated between the protective cap and the housing.

[0132] Example 29: A medical system according to any one of the foregoing embodiments, wherein the medical system is contained in a closed package, particularly in a blister pack.

[0133] Example 30: A method for manufacturing a medical system, comprising:

[0134] i. Provide a housing;

[0135] ii. Pre-assembled functional modules, the pre-assembled functional modules including:

[0136] - An analytical sensor used to detect at least one analyte in a user's bodily fluids;

[0137] - An electronic unit electrically connected to the analytical sensor; and

[0138] - An insertion component for inserting the analytical sensor into body tissue;

[0139] iii. The pre-assembled functional module is housed within the housing;

[0140] iv. Attach at least one removable protective cap to the housing to cover the pre-assembled functional module.

[0141] Example 31: The method according to the foregoing embodiments, wherein the medical system is a medical system according to any one of the foregoing embodiments involving a medical system. Attached Figure Description

[0142] Further optional features and embodiments will be disclosed in more detail in the following description of the embodiments, preferably in conjunction with the dependent claims. As those skilled in the art will recognize, the various optional features may be implemented in an isolated manner and in any feasible combination. The scope of the invention is not limited to the preferred embodiments. Embodiments are schematically depicted in the drawings. The same reference numerals in the drawings denote the same or functionally equivalent elements.

[0143] In the attached diagram:

[0144] Figure 1 A cross-sectional view of an embodiment of a medical system is shown. Detailed Implementation

[0145] exist Figure 1The image shows a cross-sectional view of an embodiment of a medical system 110. The medical system includes a housing 112, which, by way of example, may be made of a plastic material. The housing 112 may include one or more components.

[0146] In this exemplary embodiment, an insertion actuator 114 is included within the housing 112, which, for example, may include a button 116. Examples of potential details regarding the insertion actuator can be found in the aforementioned prior art documents, such as WO 2017 / 037191 A1 and the prior art referenced therein. However, it should be noted that other insertion mechanisms are also feasible.

[0147] The pre-assembled functional module 118 is also housed within the housing 112. Therefore, as an example, the housing 112 may include a receiving portion 122 in which the pre-assembled functional module 118 is housed. The pre-assembled functional module 118 includes an analytical sensor 120, which is not visible in this figure and is housed within a sterile cap 124. The pre-assembled functional module 118 further includes at least one electronic unit 126, such as at least one transmitter 128. Furthermore, the pre-assembled functional module 118 includes at least one insertion member 130, which is also not visible in this figure. As an example, the insertion member 130 may include at least one cannula 132, for example, the cannula 132 having a slot in which the analytical sensor 120 is housed.

[0148] The medical system 110 further includes at least one protective cap 134. In such cases... Figure 1 In the closed state shown, the protective cap 134 is connected to the housing 112, the state prior to the use of the medical system 110. Therefore, as an example, the protective cap 134 can overlap with the housing 112 in the overlap region 136. Thus, the circumferential edge 138 of the protective cap 134 can fit tightly onto the circumferential guide surface 140 on the upper outer side of the housing 112. The protective cap 134 can be pulled off the housing 112 for disconnection, wherein the guide surface 140 can have a length L in the direction of pulling down the protective cap 134.

[0149] When the protective cap 134 is pulled off the housing 112, various functions can be activated. Therefore, as an example, the sterile cap 124 can be connected to the protective cap 134 via connection 142. Thus, when the protective cap 134 is pulled off the housing 112, the sterile cap 124 can be pulled off the insertion member 130. The length L of the sterile cap 124 can be less than the guide length L, such that the sterile cap 124 completely clears the insertion member 130 before the guide surface 140 terminates the guidance of the protective cap 134. This avoids misalignment of the sterile cap 124 relative to the insertion member 130, which could potentially damage the insertion member 130. Therefore, the connection between the sterile cap 124 and the protective cap 134 allows the sterile cap 124 to be safely removed from the insertion member 130.

[0150] The sterile cap 124, the insertion part 130, and the support 144 for the insertion part 130 can form a small sterile container 146 for the analytical sensor 120. The sterile container 146 can be disassembled by removing the sterile cap 124 when the protective cap 134 is removed from the housing 112.

[0151] The medical system 110 may further include a main body base 148. The main body base 148, also housed in the receiving portion 122, may include a bracket 150 that can be placed against the user's skin once the protective cap 134 is removed. The main body base 148 may further include an adhesive bandage 152 on top of the bracket 150 for adhering the bracket 150 to the skin. The adhesive bandage 152 may be protected by a liner 154, which may be attached to the protective cap 134, for example, via one or more protrusions 156 of the protective cap 134. Thus, when the protective cap 134 is removed from the housing 112, the liner 154 can also be removed from the adhesive bandage 152.

[0152] The bracket 150 can be configured to house the electronic unit 126. Therefore, the electronic unit 126 can also be wholly or partially part of the main body base 148. In this exemplary embodiment, the electronic unit 126 can be housed in an upper shell 158, which can also form part of the main body base 148 and can interact with the bracket 150 to provide a cover for the electronic unit 126.

[0153] The medical system 110 may further include at least one desiccant 160. The desiccant 160 may be contained in a protective cap 134, and particularly in a plurality of chambers 162 provided by the protective cap 134.

[0154] The medical system 110 may further include at least one indicator seal 164, such as at least one clearly visible band, at the transition between the protective cap 134 and the housing 112. Firstly, the indicator seal 164 clearly indicates whether the medical system 110 has been used, and can be destroyed when the protective cap 134 is removed from the housing 112. The indicator seal 164 may provide further functionality, such as by providing a moisture barrier and by preventing or reducing moisture from entering the protective cap 134 and / or the housing 112. Furthermore, the indicator seal 164 may provide a light barrier and may be made opaque. This is particularly useful when combined with a light-switching mechanism.

[0155] Therefore, electronic unit 126 may include an optical switch, such as an optical switch having a photodiode or phototransistor. Protective cap 134 may be opaque. When protective cap 134 is first removed from housing 112, the photosensitive element of electronic unit 126 can record ambient light and can turn on electronic unit 126. Other switches connected to the movement and removal of protective cap 134 are feasible, such as mechanical switches. Therefore, electronic unit 126 may typically be configured to be turned on when protective cap 134 is removed from housing 112.

[0156] To provide further moisture protection, at least one moisture seal 166 may be provided between the protective cap 134 and the housing. Therefore, as an example, one or more rows of adhesive may be provided on the guide surface 140.

[0157] In order to use according to Figure 1 The medical system 110 allows the protective cap 134 to be removed from the housing 112. As described above, this allows the sterile cap 124 to be removed from the insertion part 130. The removal of the sterile cap 124 can be performed by a purely translational movement, such as in… Figure 1 In the axial direction. Additionally or alternatively, the removal of the sterile cap 124 may also imply rotational motion, for example by converting the translational motion of the protective cap 134 into the rotational motion of the sterile cap 124. Thus, as an example, the connection between the protective cap 134 and the sterile cap 124 can provide suitable motion conversion, for example, by providing one or more cams.

[0158] Furthermore, as described above, by removing the protective cap 134, the liner 154 can be removed, and the electronic unit 126 can be switched on. After removing the protective cap 134, the housing 112 can be placed on the desired skin side. Thus, the bracket 150 is adhered to the skin using adhesive tape 152.

[0159] Subsequently, by pressing button 116, the insertion component 130, such as cannula 132, is driven into the body tissue, thereby placing the analytical sensor 120 into the body tissue. Once insertion has been made, the insertion component 130 is withdrawn from the body tissue and returned to the housing 112, remaining there and protected from damage. Furthermore, during the insertion movement initiated by the insertion actuator 114, the main body base 148 is assembled. Therefore, the upper housing 158 is connected to the bracket 150, thereby securely placing the electronic unit 126 between them. However, it should be noted that since the functional module 118 is pre-assembled, such as... Figure 1 As shown, the analytical sensor 120 is already electrically connected to the electronic unit 126 in an unused state. Therefore, during insertion, an electrical connection between the analytical sensor 120 and the electronic unit 126 is not required, reducing the complexity of the insertion movement and lowering the risk of electrical failure during connection. Thus, the electronic unit 126, with the analytical sensor 120 (which is fixedly connected to the electronic unit 126), can be designed as a completely disposable unit without any reusable components. By providing a battery and by providing a switching mechanism, triggered, for example, by removing the protective cap 134, the number of operating steps can be significantly reduced, resulting in simplified operation that can be managed even by the elderly and children.

[0160] After the analytical sensor 120 is inserted into the body tissue and the main body base 148 is placed on the skin, the rest of the medical system 110, particularly the housing 112 and the insertion actuator 114, can be removed and disposed of. No further processing steps are required from the user; for example, there are no further processing steps such as connecting electronic components to the analytical sensor 120 and / or the main body base 148 or the electronic unit 126. Therefore, after performing the above steps, the analytical sensor 120 and the electronic unit 126 can provide measurement values ​​without any further steps. As an example, the measurement values ​​can be wirelessly transmitted to a receiver such as a medical data management system.

[0161] List of reference numerals

[0162] 110 Medical System

[0163] 112 housing

[0164] 114 Insertion Actuator

[0165] 116 buttons

[0166] 118 pre-assembled functional modules

[0167] 120 Analysis Sensor

[0168] 122 containment section

[0169] 124 Sterile Cap

[0170] 126 electronic units

[0171] 128 transmitter

[0172] 130 Insert Parts

[0173] 132 intubation

[0174] 134 Protective Cap

[0175] 136 overlapping regions

[0176] 138 edge

[0177] 140 guide surface

[0178] 142 connections

[0179] 144 brackets

[0180] 146 Aseptic Containers

[0181] 148 main body base

[0182] 150 bracket

[0183] 152 adhesive plaster

[0184] 154 Lining

[0185] 156 protrusions

[0186] 158 top shell

[0187] 160 desiccant

[0188] 162 chambers

[0189] 164 indicator seal

[0190] 166 Moisture Seal

Claims

1. A medical system (110), comprising: a. Shell (112); b. A pre-assembled functional module (118) housed in the housing (112), the pre-assembled functional module (118) comprising: b1. An analytical sensor (120) for detecting at least one analyte in a user's bodily fluids; b2. An electronic unit (126) electrically connected to the analytical sensor (120); and b3. An insertion part (130) for inserting the analytical sensor (120) into the user's body tissue; b4. At least one sterile cap (124) that at least partially surrounds the insertion member (130). c. At least one removable protective cap (134) is attached to the housing (112) and covers the pre-assembled functional module (118). The protective cap (134) can be removed from the housing (112) by pulling it down, wherein the housing (112) includes at least one guide surface (140) for guiding the protective cap (134) during the pulling down of the protective cap (134). The insertion component (130) includes at least one cannula (132) in which the analysis sensor (120) is partially housed. The insertion component (130) further includes a support (144) for inserting a cannula (132). The support (144), cannula (132), and sterile cap (124) form components for a sterile container of the analytical sensor (120). The sterile cap (124) is configured to be pulled off from the insertion member (130) when the protective cap (134) is pulled off from the housing (112). The sterile cap (124) is connected to the protective cap (134) at its distal end via one or more of the following methods: form-fit connection, force-fit connection, material bonding connection, or injection molding connection. The sterile cap is distinct from the protective cap. The medical system (110) is configured such that, after the protective cap (134) is removed from the housing (112) and the medical system (110) is attached to the user's skin, the insertion member (130) is inserted into the user's body tissue by advancing the insertion member (130) relative to the housing (112). The insertion component is configured to be withdrawn from the body tissue and back into the housing after the analytical sensor (120) has been inserted into the user's body tissue.

2. The medical system (110) of claim 1, wherein, The sterile cap (124) is contained within a protective cap (134), wherein the wall of the sterile cap (124) is different from the wall of the protective cap (134).

3. The medical system (110) according to claim 1 or 2, wherein, The protective cap (134) and the sterile cap (124) are made of different materials.

4. The medical system (110) according to claim 1 or 2, wherein, The protective cap (134) can be removed from the housing (112) by pulling the protective cap (134) off the housing (112), wherein the housing (112) includes at least one guide surface (140) for guiding the protective cap (134) during the pulling off of the protective cap (134).

5. The medical system (110) according to claim 4, wherein, The pre-assembled functional module (118) includes at least one guide surface for guiding the sterile cap (124) during the pulling of the sterile cap (124) from the insertion part (130).

6. The medical system (110) according to claim 5, wherein, The length of the guide surface (140) of the housing (112) exceeds the length of the guide surface used for the sterile cap (124).

7. The medical system (110) according to claim 1 or 2, wherein, The length of the guide surface (140) of the housing (112) exceeds the length of the sterile cap (124), such that when the protective cap (134) is pulled off from the housing (112), the sterile cap (124) is completely pulled off from the insertion part (130) before the guidance by the guide surface (140) of the housing (112) ends.

8. The medical system (110) according to claim 4, wherein, The guide surface (140) of the housing (112) provides at least one movement selected from the group consisting of: translational movement of the protective cap (134) and the sterile cap (124) when the protective cap (134) is pulled off the housing (112); rotational movement of the protective cap (134) and the sterile cap (124) when the protective cap (134) is pulled off the housing (112); and both translational and rotational movement of the protective cap (134) and the sterile cap (124) when the protective cap (134) is pulled off the housing (112).

9. The medical system (110) according to claim 8, wherein, When the protective cap (134) is pulled off the housing (112), the guide surface (140) of the housing (112) provides at least a rotational component, wherein the sterile cap (124) is connected to the pre-assembled functional module (118) by at least one connection, wherein the connection is released by the rotational component, and the sterile cap (124) can be removed from the pre-assembled functional module (118).

10. The medical system (110) according to claim 1 or 2, wherein, The electronic unit (126) includes at least one of the following: a measuring device for providing electrochemical measurements; a transmitter (128) for transmitting the measurements to at least one external receiver; an integrated data storage device; and an integrated battery.

11. The medical system (110) according to claim 1 or 2, wherein, The electronic unit (126) includes at least one electronic unit housing, wherein the analytical sensor (120) protrudes into the electronic unit housing and is electrically connected to at least one electronic component within the electronic unit housing.

12. The medical system (110) according to claim 1 or 2, wherein, The medical system (110) is configured such that the electronic unit (126) is turned on by a switching mechanism.

13. The medical system (110) according to claim 1 or 2, wherein, The medical system (110) is configured such that the electronic unit (126) is turned on after the protective cap (134) is removed from the housing (112).

14. The medical system (110) according to claim 1 or 2, wherein, The protective cap (134) is connected to the housing (112) by at least one of a form fit or a force fit connection.

15. The medical system (110) according to claim 1 or 2, wherein, The housing (112) includes at least one receiving portion (122) for accommodating a pre-assembled functional module (118), wherein the receiving portion (122) is located at the front of the housing (112), and wherein the receiving portion (122) is completely or partially surrounded by a frame formed by the housing (112).

16. The medical system (110) according to claim 15, wherein, The receiving portion (122) is covered by a protective cap (134) such that when the protective cap (134) is removed from the housing (112), the pre-assembled functional module (118) is accessible and can be placed on the user's skin.

17. The medical system (110) according to claim 1 or 2, further comprising at least one indicator seal (164) connected to the protective cap (134) and the housing (112), wherein, The indicator seal (164) is configured to break when the protective cap (134) is removed from the housing (112).

18. The medical system (110) according to claim 1 or 2, wherein, The medical system (110) further includes at least one insertion actuator (114), wherein the insertion actuator (114) includes at least one mechanical device configured to drive the insertion part (130) forward into body tissue.

19. The medical system (110) according to claim 18, wherein, The electronic unit (126) has an opening therethrough, through which an insertion member (130) protrudes, wherein an insertion actuator (114) drives the insertion member (130) through the opening.

20. The medical system (110) according to claim 18, wherein, The insertion actuator is further configured to drive the insertion member (130) backward again after the insertion of the insertable analytical sensor (120), wherein the backward movement for withdrawing the insertion member (130) from the body tissue is driven by a return spring.

21. The medical system (110) according to claim 1 or 2, wherein, The housing (112), the pre-assembled functional modules (118), and the removable protective cap (134) form a pre-assembled single unit.

22. The medical system (110) according to claim 1 or 2, wherein, The sterile cap (124) is securely attached to the protective cap (134).

23. The medical system (110) according to claim 1 or 2, wherein, The analytical sensor (120) is an electrochemical analytical sensor.

24. The medical system (110) according to claim 1 or 2, wherein, The medical system (110) further includes at least one moisture seal (166) which is housed between the protective cap (134) and the housing (112).

25. The medical system (110) according to claim 1 or 2, wherein, The desiccant (160) is placed in the protective cap (134).

26. The medical system (110) according to claim 25, wherein the sterile cap (124) is connected to the protective cap (134) via one or more guiding elements for converting the movement of the protective cap (134) into the desired movement of the sterile cap (124), wherein, The sterile cap (124) can be unlocked from the bracket (144) via a bayonet lock.

27. The medical system (110) according to claim 25, wherein, The stent (144) includes a rigid component connected to the proximal end of the cannula (132).

28. The medical system (110) according to claim 1 or 2, wherein, When the functional modules are housed in the housing, the electronic unit is electrically connected to the analytical sensor, while the protective cap is connected to the housing.

29. The medical system (110) according to claim 1 or 2, wherein, The housing has a front side configured to be placed on the user's skin, wherein the front side has an edge configured to tighten the skin to apply analytical sensors.

30. The medical system (110) according to claim 10, wherein, The measuring device for providing electrochemical measurements is at least one of a current measuring device or a potentiostatic measuring device.

31. A method for manufacturing a medical system (110), wherein, The medical system is the medical system according to any one of claims 1-30, wherein the method includes: i. Provide housing (112); ii. A pre-assembled functional module (118), the pre-assembled functional module (118) comprising: - An analytical sensor (120) for detecting at least one analyte in a user's bodily fluids; - Electronic unit (126), which is electrically connected to the analytical sensor (120); and - Insertion component (130) for inserting the analytical sensor (120) into body tissue; iii. The pre-assembled functional module (118) is housed in the housing (112); iv. Attach at least one removable protective cap (134) to the housing (112) to cover the pre-assembled functional module (118).

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