DE202016009189U1 - Medical device for detecting at least one analyte in a body fluid - Google Patents

Abstract

A medical device (110) for detecting at least one analyte in a body fluid, the medical device (110) comprising:
• at least one analyte sensor (112) with an insertable part (114) which is designed to be at least partially inserted into a user's body tissue,
• at least one insertion cannula (116), the analyte sensor (112) being at least partially arranged in the insertion cannula (116);
• at least one housing (118), the housing (118) comprising at least one sensor chamber (120), the sensor chamber (120) forming a sealed chamber (122) which receives at least the insertable part (114) of the analyte sensor (112). , wherein the sealed chamber (122) has at least one removable upper cap (124) and at least one removable lower cap (126), the removable lower cap (126) being adapted to be removed prior to insertion, thereby providing the insertable part (114 ) to open insertion, wherein the introducer cannula (116) is attached to the removable top cap (124), the removable top cap (124) being adapted to be removed after insertion, thereby removing the introducer cannula (116), wherein the sensor chamber (120) comprises at least one intermediate component (128) disposed between the removable upper cap (124) and the removable lower cap (126), the removable upper cap (124) and the removable lower cap (126). the intermediate component (128) is attached and connected to each other in a removable manner; and
• at least one electronics unit (134), wherein the analyte sensor (112) is operatively connected to the electronics unit (134), wherein the electronics unit (134) comprises at least one connecting device (136) with at least one electronic component (142) attached thereto, wherein the connecting device ( 136) completely or partially surrounds the housing (118).

Description

Field of invention

The invention relates to a medical device for detecting at least one analyte in a body fluid. The device according to the present invention can be used primarily for long-term monitoring of an analyte concentration in a body fluid, such as long-term monitoring of a blood sugar level or the concentration of one or more other types of analytes in a body fluid. The invention can be used in the field of home care as well as in the field of professional care, such as in hospitals. Other applications are possible.

Relevant state of the art

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

In addition to the use of optical measurements, blood glucose monitoring can be carried out in particular using electrochemical biosensors. Examples of electrochemical biosensors for glucose measurement, particularly in blood or other body fluids, are lacking US 5,413,690 A , US 5,762,770 A , US 5,798,031 A , US 6,129,823 A or US 2005/0013731 A1 known.

In addition to so-called point measurements, in which a sample of body fluid is specifically taken from a user and examined with regard to the analyte concentration, continuous measurements are becoming increasingly common. Consequently, in the recent past, for example, continuous glucose measurement in interstitial tissue (also referred to as continuous monitoring, CM) has been established as another important method for the management, monitoring and control of a diabetic condition.

In the method, the active sensor region is applied directly to the measurement site, generally located in the interstitial tissue, and it converts, for example, glucose into electrical charge using an enzyme (e.g. glucose oxidase, GOD), the charge being with the Glucose concentration is related and can be used as a measurement variable. Examples of such transcutaneous measurement systems are in US 6,360,888 B1 or in US 2008/0242962 A1 described.

Current continuous monitoring systems are therefore typically transcutaneous systems or subcutaneous systems, both terms being used equivalently in the following text. This means that the actual sensor or at least a measuring portion of the sensor is located under the user's skin. However, an evaluation and control part of the system (also called a patch) is generally located outside the user's body, outside the human or animal body. In the method, the sensor is generally attached using an insertion instrument, also exemplified in US 6,360,888 B1 is described. Other types of import instruments are also known.

The sensor typically includes a substrate, such as a flat substrate, onto which an electrically conductive pattern of electrodes, conductive tracks and contact pads can be attached. In use, the conductive traces are typically insulated using one or more electrically insulating materials. The electrically insulating material typically also serves as a protection against moisture and other harmful substances, and may, for example, include one or more covering layers such as photoresists.

As explained above, transcutaneous systems typically require a control part that can be located outside of the body tissue and must be in communication with the sensor. Typically, this communication is established by providing at least one electrical contact between the sensor and the control part, which may be a permanent electrical contact or a detachable electrical contact. Examples of electrical contacts for contact with a triangular arrangement of contact pads are e.g. Am DE 954712 B shown. Other techniques for providing electrical contacts, such as appropriate spring contacts, are well known and may be used.

To avoid harmful effects of the aggressive environment on the conductive properties of the electrical contact, the area of the electrical contact is typically encapsulated and protected from moisture. In general, encapsulations of electrical locks and contacts can be achieved by using appropriate seals e.g. B. out DE 20020566 U1 known. Especially in Transcutaneous or subcutaneous sensors, in which the area of electrical contact between the sensor and the control part is close to human skin, effective protection against moisture, dirt, sweat and cleaning agents, such as cleaning agents used for personal care, is of crucial importance.

US2012/0197222 A1 discloses insertion instruments for medical devices and methods for insertion and use of medical devices. Disclosed is a method comprising removing a substantially cylindrical cap from an introducer to expose a substantially cylindrical sleeve; removing a cover from a substantially cylindrical container containing sensor components; and the attachment of the sensor components in the insertion instrument.

WO 2010/091028 A1 discloses an integrated analyte monitoring device assembly. The integrated analyte monitoring device assembly includes an analyte sensor for transcutaneous positioning through a skin layer that is maintained in fluid contact with an interstitial fluid beneath the skin layer for a predetermined period of time. The analyte sensor has a proximal section and a distal section. Sensor electronics are coupled to the analyte sensor. The sensor electronics includes a circuit board with a conductive layer and a sensor antenna arranged on the conductive layer. Further, the sensor electronics includes one or more electrical contacts provided on the circuit board and connected to the proximal portion of the analyte sensor to maintain continuous electrical communication. The sensor electronics further comprises: a data processing component which is provided on the circuit board and is in signal connection with the analyte sensor. The data processing component is designed to execute one or more routines to process signals received from the analyte sensor. Further, the data processing component is configured to control the transmission of data associated with the processed signals received from the analyte sensor to a remote location using the sensor antenna in response to a command signal received from the remote location.

WO 2014/018928 A1 discloses body-worn monitoring devices designed for uncompressed and compressed configurations and methods of using the analyte monitoring devices. The devices include a collapsible housing wherein upon desired placement and application of force by the user to the housing, the analyte monitoring device is converted from a non-compressed configuration to a low profile compressed state while an analyte sensor is transmitted through the skin and into contact with body fluid Measurement of an analyte concentration is carried out in it. Systems and kits are also provided.

European patent application number filed on August 6, 2014 14 180 045.8 discloses a medical device and a method for producing a medical device. The medical device includes at least one implantable device having at least one implantable portion designed for at least partial implantation into body tissue of a user. The implantable device further has at least one contact section that is connected to the implantable section. The medical device further comprises at least one housing. The housing is designed to accommodate the implantable section. The housing is designed to provide sterile packaging so that the implantable portion is sealed from a surrounding environment. The housing includes at least a first part and at least a second part. The first part and the second part can be releasably connected to form the sterile packaging. The first part includes at least a first sealing surface and the second part includes at least a second sealing surface. The first sealing surface and the second sealing surface cooperate to form a sealing area. The implantable device has a connection section that connects the implantable section to the contact section. The connecting section is guided through the sealing area.

Despite the advantages and progress achieved with the above-mentioned developments, particularly in the area of continuous monitoring technology, some significant technical challenges remain. Thus, generally known techniques for protecting an electrical contact between a sensor and a control part are generally quite complex. An assembly of multiple components is generally required, which typically means a complex and expensive manufacturing process. Furthermore, known techniques generally require bulky components, which is a problem, especially given that miniaturization of sensor systems is a factor contributing to ease of use. Particularly when complex encapsulation parts manufactured using plastic molding techniques are needed to protect electrical contacts, typi an increase in costs and sensor volume must be taken into account. Furthermore, cleaning complex protective covers, such as protective devices with O-rings or other seals, proves to be difficult.

Problem to be solved

Therefore, an object of the present invention is to provide a medical device for detecting at least one analyte in a body fluid, which at least partially avoids the disadvantages of known devices of this type and at least partially addresses the challenges mentioned above. In particular, a device is disclosed that enables simple manufacturing and simple handling processes by a user.

Summary of the invention

This problem is solved by a medical device for detecting at least one analyte in a body fluid with the features of the independent claim. Preferred embodiments of the invention, which may be implemented in isolation or in any combination, are disclosed in the dependent claims.

As used herein, the terms “have,” “comprise,” or “comprise,” or any grammatical variations thereof, are used in a non-exclusive manner. Consequently, these terms can refer both to a situation in which, in addition to the feature introduced by these terms, there are no other features present in the unit described in this context, or to a situation in which one or more other features are present. For example, the expressions “A has B,” “A includes B,” and “A has B” can both refer to a situation in which there is no other element in A besides B (i.e., a situation in which A alone and exclusively consists of B), as well as a situation in which, in addition to B, one or more other elements are present in the unit A, such as element C, elements C and D or even other elements.

Furthermore, it should be noted that the terms "at least one", "one or more" or similar expressions, which indicate that a feature or element may be present once or more than once, typically only once when the respective feature or element is introduced be used. In most cases, when reference is made to the relevant feature or element hereinafter, the expressions “at least one” or “one or more” will not be repeated, notwithstanding the fact that the relevant feature or element may be present once or more than once.

Furthermore, as used below, the terms “preferred,” “more preferred,” “particular,” “particular,” “specific,” “more specific,” or similar terms are used in connection with optional features without limiting alternative possibilities. Features introduced by these terms are therefore optional features which are not intended to limit the scope of the claims in any way. As those skilled in the art will recognize, the invention may be practiced using alternative features. Similarly, features introduced by "in one embodiment of the invention" or similar expressions are intended to be optional features, without any limitation as to alternative embodiments of the invention, without any limitation as to the scope of the invention, and without any limitation as to the possibility of combining the same introduced features with other optional or non-optional features of the invention.

In a first aspect of the present invention, a medical device for detecting at least one analyte in a body fluid is disclosed. The medical device includes at least one analyte sensor with an insertable part that is configured to be at least partially inserted into a user's body tissue. The medical device further comprises at least one insertion cannula. The analyte sensor is at least partially arranged in the insertion cannula. The medical device further comprises at least one housing. The housing includes at least one sensor chamber. The sensor chamber forms a sealed chamber that accommodates at least the insertable part of the analyte sensor. The sealed chamber includes at least one removable top cap and at least one removable bottom cap. The removable lower cap is adapted to be removed prior to insertion, thereby allowing insertion of the insertable part. The introducer cannula is attached to the removable top cap. The removable top cap is adapted to be removed after insertion to thereby remove the introducer cannula. Furthermore, the medical device comprises at least one electronic unit. The analyte sensor is operatively connected to the electronic unit. The electronic unit comprises at least one connection device with at least one electronic component attached thereto. The connecting device surrounds the housing completely or partially, i.e. H. at least partially.

As generally used in the present invention, the term “medical” may mean: “technical device” refers to any device that is designed to carry out at least one medical analysis and/or at least one medical procedure. The medical device can therefore generally be any device that is designed to fulfill at least one diagnostic purpose and/or at least one therapeutic purpose. Without limiting further embodiments, the present invention is described below with regard to a medical device that is designed to fulfill at least one diagnostic purpose, and in particular a medical device that includes at least one analyte sensor for carrying out at least one analysis. The medical device can in particular comprise an arrangement of two or more components that can work together, for example to fulfill one or more diagnostic and/or therapeutic purposes, for example to carry out the medical analysis and/or the medical procedure. In particular, the two or more components may be capable of performing at least one detection of the at least one analyte in the body fluid and/or contributing to the at least one detection of the at least one analyte in the body fluid. The medical device can generally also be or include at least one sensor arrangement, a sensor system, a sensor kit or a sensor device.

The medical device may be a disposable medical device. The term “disposable medical device” may generally refer to any medical device that is designed to be discarded after use. Consequently, one or more materials can be particularly inexpensive and/or easily recyclable. In particular, the electronics unit can be a disposable electronics unit. The term “disposable” can generally refer to a property of any element that is designed to be used once. Accordingly, upon detection of the at least one analyte in the body fluid, the user may remove the electronics units from the body tissues, discard the electronics unit, and use another new medical device comprising further new electronics for another detection of the analyte in the body fluid.

As generally used in the present invention, the terms "patient" and "user" may refer to a human or an animal, regardless of the fact that the human or animal may or may not be in a healthy state or may have multiple diseases. For example, the human or user may be a human or animal suffering from diabetes. Additionally or alternatively, the invention can also be applied to other types of users or patients or diseases.

As further used herein, the term “body fluid” may generally refer to a fluid that is typically present in a body or body tissue of the user or patient and/or that may be produced by the body of the user or patient. Interstitial tissue can be mentioned as an example of a body tissue. Consequently, the body fluid can be selected, for example, from the group consisting of blood and interstitial fluid. Additionally or alternatively, however, one or more other types of body fluids may be used, such as saliva, tears, urine, or other body fluids. During the detection of the at least one analyte, the body fluid may be present in the body or body tissue. As will be explained in more detail below, the sensor can therefore be set up in particular to detect at least one analyte in a body tissue.

As further used herein, the term “analyte” may refer to any element, component or compound that may be present in the body fluid and its presence and/or concentration to the user, patient or healthcare professional , such as a doctor, may be of interest. In particular, the analyte may be or include any chemical substance or chemical compound that may be involved in the metabolism of the user or patient, such as at least one metabolite. For example, the at least one analyte can be selected from the group consisting of glucose, cholesterol, triglycerides, lactate. Additionally or alternatively, however, other types of analytes may be used and/or any combination of analytes may be determined. The detection of the at least one analyte can in particular be an analyte-specific detection.

As further used herein, the term “detect” generally refers to the method of determining the presence and/or amount and/or concentration of the at least one analyte. The detection can therefore be or include a qualitative detection in which the presence of the at least one analyte or the absence of the at least one analyte is determined, and / or it can be or include a quantitative detection in which the amount and / or the Concentration of the minimum an analyte is determined. As a result of the detection, at least one signal can be generated that characterizes a detection result, such as at least one measurement signal. The at least one signal can in particular be or include at least one electronic signal, such as at least one voltage and/or one current. The at least one signal can be or include at least one analog signal and/or it can be or include at least one digital signal. As further used herein, the term “determination of a concentration” may generally refer to a method for producing at least one representative result or a plurality of representative results indicative of the concentration of the analyte in the body fluid.

As further used herein, the term “analyte sensor” may generally refer to any element adapted to perform the above-mentioned method of detection and/or that is adapted for use in the above-mentioned method of detection. The sensor can therefore be adapted in particular to determine the concentration of the analyte and/or the presence of the analyte.

The analyte sensor can in particular be an electrochemical sensor. As used herein, an “electrochemical sensor” is generally a sensor configured to perform an electrochemical measurement to detect at least one analyte contained in the body fluid. The term “electrochemical measurement” refers to a detection of an electrochemically detectable property of the analyte, such as an electrochemical detection reaction. The electrochemical detection reaction can therefore be detected, for example, by comparing one or more electrode potentials. The electrochemical sensor can in particular be adapted and/or usable for generating at least one electrical sensor signal that directly or indirectly indicates the presence and/or the extent of the electrochemical detection reaction, such as at least one current and/or at least one voltage. The detection can be analyte-specific. The measurement can be a qualitative and/or a quantitative measurement. Other embodiments are also possible.

The analyte sensor can in particular be a transcutaneous sensor. As used herein, the term “transcutaneous sensor” generally refers to any sensor adapted for complete or at least partial placement within the body tissue of the patient or user. For this purpose, the analyte sensor includes the insertable part. The term “insertable part” may generally refer to a part or component of an element adapted to be inserted into any body tissue. In order for the analyte sensor to continue to be usable as a transcutaneous sensor, the analyte sensor can completely or partially provide a biocompatible surface, i.e. H. a surface that does not have any harmful effects on the user, the patient or the body tissue, at least during periods of use. In particular, the insertable part of the analyte sensor can have a biocompatible surface. For example, the transcutaneous sensor, in particular the insertable part, can be completely or partially covered with at least one biocompatible membrane, such as at least one polymer membrane or gel membrane, which is permeable to the at least one analyte and/or the at least one body fluid and which, on the other hand, contains sensor substances, such as one or more test chemicals, is retained in the sensor and prevents these substances from migrating into the body tissue. Other parts or components of the analyte sensor may remain outside of body tissue. The other parts may be connectable to an evaluation device, such as the electronics unit, as will be further described below.

The transcutaneous sensor may generally have a size such that transcutaneous insertion is possible, for example by providing a width in a direction perpendicular to an insertion direction of at most 5 mm, preferably at most 2 mm, more preferably at most 1.5 mm. The sensor may have a length of less than 50 mm, such as a length of 30 mm or less, e.g. B. a length of 5 mm to 30 mm. As used herein, the term “length” may refer to a direction parallel to the insertion direction. However, it should be noted that other dimensions are possible.

The term “introducer cannula” may generally refer to any element that can be inserted into the user's body tissue, particularly for delivery or delivery of another element. Therefore, the insertion cannula can in particular be or comprise a hollow tube or a hollow needle. The insertion cannula can e.g. B. include at least one cross section selected from the group consisting of round, elliptical, U-shaped, V-shaped. Other embodiments are also possible. In particular, the insertion cannula can be a slotted cannula. The insertion cannula may be configured to be inserted vertically or at an angle of 90° to 30° to the user's body tissue.

The medical device may further include at least one septum received in the sensor chamber. As generally used herein, the term “septum” may generally refer to any sealing element designed to seal a volume or space and provide environmental protection from moisture and/or an ambient atmosphere or the like. The septum can, for example, be or comprise at least one pierceable film, disk, shim, plug or plate made of a material that can be pierced by the insertion cannula and that can seal a puncture hole created by the insertion cannula after the insertion cannula has been retracted. In particular, the septum can be made of an elastic material, such as an elastomer. The septum can be manufactured by injection molding, in particular by two-component injection molding. The septum can be penetrated by an elongated object with a small diameter, such as an insertion cannula. After penetration by the elongated object, an opening of the septum caused by the elongated object may be closed by itself and the septum may further be configured to provide a tight seal to the environment of the volume or space. In particular, the septum can be designed to seal a remainder of the sensor chamber after removal of the removable top cap. The introducer cannula may be adapted to be pulled through the septum when the removable top cap is removed from the housing.

Furthermore, the insertion cannula may comprise at least one barbed hook which is designed to prevent further movement of the insertion cannula after use. As further used herein, the term "barbed hook" may refer to any tool that may include a portion that is curved or notched so that the portion can be used to hold another object. Further, the barbed hook provided hooks may be shaped in a special way so that passage of the other object through the barbed hook may only be possible in one direction, with movement in the opposite direction being able to be completely suppressed or at least reduced to a large extent. In particular, this can Property can be realized with small additional hooks, which are arranged so that ends of the hooks point in a direction that is opposite to a direction in which the other object is movable.

The medical device may further include at least one retraction mechanism for retracting the introducer cannula after insertion of the insertable portion of the analyte sensor into the body tissue. The term "retraction mechanism" may generally refer to any structure designed to move an object in a direction opposite to a direction in which the object may have been moved prior to application of the retraction mechanism. Therefore, the retraction mechanism may include at least one retraction spring element, more preferably at least one retraction spring element, disposed between the housing and the introducer cannula and biased to retract the introducer cannula from the body tissue. The retraction mechanism may be at least partially contained in the removable top cap.

As used herein, the term “electronic device” generally refers to any device that includes at least one electronic component. In particular, the electronic unit can have at least one electronic component for one or more of carrying out a measurement with the analyte sensor, carrying out a voltage measurement, carrying out a current measurement, recording sensor signals, storing measurement signals or measurement data, transmitting sensor signals or measurement data to another Include device. The electronic unit can in particular be designed as a transmitter or it can include a transmitter for transmitting data. Other embodiments of the electronic components are possible.

The electronic unit comprises at least one connection device, preferably a printed circuit board, more preferably a flexible printed circuit board. As used herein, a connector device generally refers to an element or combination of elements capable of supporting one or more electronic components and interconnecting one or more electronic components, such as electrically or electronically interconnecting and/or connecting the one or more electronic components or connect multiple contact pads. For example, the connection device may include a base and one or more electrical traces and/or one or more electrical contact pads disposed thereon and/or therein. For example, the connection device may comprise a circuit board, which may either be rigid or may be fully or partially formed as a flexible printed circuit board. The base can, for example, be a flat element with a side extension exceeds its width by at least a factor of 10, more preferably by at least a factor of 100 or even a factor of 1000. Other embodiments are possible. Rigid materials that can be used for the base are fiber-reinforced plastic materials, such as fiber-reinforced epoxy materials, such as glass fiber-reinforced epoxy materials such as FR-4. Other materials can be used. As stated above, the base can in particular be a flexible base, so that the connecting device can be designed completely or partially as a flexible printed circuit board. In this case, the flexible base can, for example, be made entirely or partially from one or more flexible plastic materials, such as one or more plastic films or laminates, such as polyimides.

As listed above, the electronics unit includes at least one electronic component attached to the connection device. The at least one electronic component can be attached directly or indirectly to the connecting device. For example, the electronic component may be attached directly to the connection device by one or more of soldering, bonding, or electrically conductive adhesive. The connecting device can therefore comprise one or more contact pads, with corresponding contacts of the electronic component being electrically connected to the one or more contact pads. Additionally or alternatively, however, the at least one electronic component can be attached indirectly to the connecting device, for example via at least one electronics housing. The at least one electronics housing can therefore be attached to the connecting device. An electrical contact between the at least one electronic component and the connecting device can still be established, for example via at least one contact that runs through the electronics housing. The electronics housing can completely or partially surround the at least one electronic component. The electronics housing can, for example, comprise at least one lower electronics housing component that is attached to the connecting device, wherein the at least one electronics device is inserted into the lower electronics housing component on a side opposite the connecting device. The at least one electronics housing may further comprise at least one further electronics housing component, such as at least one upper electronics housing component, which, in conjunction with the lower electronics housing component, may form an encapsulation that completely or partially surrounds the electronics component. Additionally or alternatively, however, other types of encapsulation of the at least one electronic component can be used, such as encapsulation using one or more potting and/or investment compounds. The lower electronics housing component can therefore be used, for example, to accommodate the at least one electronics component, with the upper shell or protection over the electronics component being created by casting and/or overmolding, for example using one or more of epoxy, a thermoplastic polymer, a rather , a silicone and epoxies or the like. Additionally or alternatively, no electronic housing component at all can be used, for example by placing the at least one electronic component directly on the connection device.

Analogously, the at least one optional energy storage device, such as the at least one battery, can be attached directly or indirectly to the at least one connection device. The at least one energy storage can therefore in turn be completely or partially encapsulated by at least one energy storage housing. In turn, the at least one energy storage housing may include one or more components, such as a lower electronics housing component, which is placed on the connection device and is configured to receive the at least one energy storage device. Either an upper energy storage housing, such as a top cover, or additionally or alternatively potting or remolding can be used as upper protection. In both cases, the energy storage can be electrically connected to the at least one electronic component via the at least one connection device. Consequently, in general, in this embodiment or in other embodiments, the at least one connection device may comprise one or more electrical paths for directly or indirectly electrically connecting the optional energy storage device to the at least one electronic component.

As further used herein, the term “electronic component” generally refers to any element or combination of elements that serves at least one electrical or electronic purpose. In particular, the at least one electronic component may be or include at least one component selected from the group consisting of an integrated circuit, an amplifier, a resistor, a transistor, a capacitor, a diode or any combination thereof. The at least one electronic component can in particular be or include at least one device that can control the analyte sensor in order to carry out at least one analytical measurement with the analyte sensor. In particular, the at least one front Direction include at least one voltage measuring device and / or at least one current measuring device. Other structures or embodiments are possible. The at least one electronic component can, for example, include at least one application-specific integrated circuit (ASIC).

As described above, the analyte sensor is operatively connected to the electronic unit. The term “interconnected” can specifically refer to a state in which two or more objects are connected to each other so that they can work together. In particular, the analyte sensor can be operatively connected to the electronic unit, so that sensor signals from the analyte sensor can be transmitted to the electronic unit. The term “actively connected” can therefore also refer to an electrically conductive connection. The analyte sensor may be electrically connected to the connection device, preferably via at least one of a solder connection, a weld connection, an electrical connection, a conductive adhesive material, or a plug connection. The connection device can be permanently arranged in the electronics chamber of the housing.

As used generally herein, the term "enclosure" may generally refer to any element designed to completely or partially surround and/or contain one or more elements to provide one or more of mechanical protection, mechanical stability, to provide environmental protection from moisture and/or ambient atmosphere, shielding against electromagnetic influences or the like. The housing can therefore easily provide a base for mounting and/or holding one or more further components or elements. Additionally or alternatively, the housing may provide one or more interior spaces for receiving one or more additional components or elements. The housing can in particular be manufactured by injection molding. However, other embodiments are possible.

As used herein, the term “chamber” may generally refer to any subpart of a superior element that creates a partially or completely enclosed space that can be used to contain and/or store objects. The lower part can in particular be completely or at least largely closed, so that an interior of the chamber can be isolated from the environment. For example, the chamber may be separated from other parts of the superior element by one or more walls. Consequently, two or more chambers may be contained within the housing, which may be completely or partially separated from one another by one or more walls of the housing. Each chamber may include a continuous space or lumen configured to accommodate one or more objects. However, the housing may also be formed entirely or partially in a deformable state and/or in a hardened or hardened state by using one or more deformable materials.

As described above, the sensor chamber forms a sealed chamber. The term “sealed chamber” may refer to a characteristic of a chamber that is isolated from an environment so that transfer of gas, liquids and/or solid elements is completely or at least largely reduced. In particular, the sensor chamber can be set up to provide sterile packaging for the insertable part of the analyte sensor. For example, the removable bottom cap may be a sterile cap configured to provide sterile packaging for the insertable portion of the analyte sensor such that the insertable portion is sealed from an environment. The term “sterile” can generally refer to a property of any object that is at least largely free of all life forms and/or other biological agents, such as prions, viruses, fungi, bacteria or spore forms. The sterile object can thus be treated with at least one sterilization process that eliminates and/or deactivates the life forms and/or the other biological agents. The sterilization process may include one or more of the following techniques: heating, chemical treatment, irradiation, high pressure, filtration. However, other techniques are possible. The sterilization process may be performed within a specific region or area of the object, such as a surface of the object.

As will be further explained below, the sensor chamber may include at least one intermediate component. The term “intermediate component” may refer to any chamber between at least two other chambers and/or which may be located in at least one other chamber. The intermediate component can therefore be arranged in the sensor chamber. The top cap and the bottom cap may be attached to the intermediate component and/or they may be connected to each other in a removable manner. The intermediate component may be disposed between the top cap and the bottom cap. As will be explained in more detail below, the Connecting device may be attached to the intermediate component or vice versa.

The term “cap” can refer to any element designed to close or seal a volume. In particular, the cap can close or seal an opening of any container. The terms “top cap” and “bottom cap” may be considered descriptive without specifying any order and without excluding any possibility that multiple types of top caps and bottom caps may be applied. The term “detachable” can refer to a property of an element that is removable from any object. This can break a tight connection or contact between the element and the object. In general, the element may be removable in a reversible manner, in which the element can be attachable to or detachable from the object, or in an irreversible manner, in which the element cannot be attachable to the object once detached. As will be explained in more detail below, the removable upper cap and/or the removable lower cap can in particular be connected to one another and/or to the intermediate component via at least one predetermined breaking point, for example via at least one predetermined breaking point with a weakening in the wall of the housing, to allow easy and well-defined removal of the cap by hand, such as at least one predetermined breaking point comprising one or more grooves, notches or slots in the wall. Alternatively, instead of using a predetermined breaking point, other types of removable connections can be used, such as a screw connection.

For example, the removable top cap and/or the removable under cap may have an elongated shape and provide an internal volume. The removable top cap and/or the removable bottom cap may include one or more handles to allow a user to remove each cap. The removable top cap and the removable lower cap may be removably connected to the intermediate component. In particular, the removable top cap and the removable lower cap may be removably connected to the intermediate component on sides opposite to the intermediate component. Alternatively, the removable top cap and the removable lower cap may be removably connected to each other with the intermediate component therebetween. In particular, the removable top cap can partially surround the insertion cannula. The introducer cannula may be securely attached to the removable top cap.

As noted above, the removable top cap may be removably connected to the intermediate components, for example at at least one upper predetermined breaking point. Additionally or alternatively, the removable lower cap can be removably connected to the intermediate component at at least one lower predetermined breaking point. As further used herein, the term "predetermined breaking point" may refer to any part of an element that is designed to break during mechanical loading while other parts of the element remain undamaged. In particular, the predetermined breaking point can comprise at least one notch, wherein a thickness of the element can be smaller compared to other parts of the element. The upper predetermined predetermined breaking point and the lower predetermined predetermined breaking point can in particular be annular predetermined breaking points. The terms “upper debit point” and “lower debit point” may be considered descriptive without specifying any order and without excluding any possibility that multiple types of upper debit points and lower debit points may be used. Additionally or alternatively, instead of using one or more predetermined breaking points, other types of removable connections may be used, such as one or more screw connections.

The sensor chamber can comprise at least one sealed opening, for example for passing a part of the analyte sensor out of the sensor chamber for functional connection to the electronic unit, for example to the connection device and/or the at least one electronic component attached thereto. The term “sealed” can generally refer to a property of any element that is completely or at least largely isolated from the environment. The sealed opening can include at least one sealing element. The term “sealing element” can generally refer to any element designed to cover one or more elements in order to seal them from environmental influences such as moisture. The sealing element can seal the sensor chamber. For example, the sealing element can comprise at least one sealing lip. As used herein, the term "seal lip" may refer to a maximum in a cross-sectional profile of the sealing element that is the first portion of the sealing element that contacts the other surface when the sealing element is pressed onto another surface thereon. The profile itself can be symmetrical or asymmetrical Have metric shape, with an asymmetrical profile being advantageous. The sealing element can comprise at least one sealing material, in particular a deformable sealing material, more preferably an adhesive material. The analyte sensor can pass through the sealed opening. The analyte sensor can be partially accommodated in the sensor chamber. In particular, the insertable part can be at least partially accommodated in the sensor chamber. The at least one sealed opening can in particular be completely or partially part of the intermediate component or be completely or partially integrated therein. The intermediate component can therefore, for example, be made entirely or partially from a deformable or flexible material, such as at least one elastomeric material.

The connection device can generally have any shape. As stated above, the connecting device can therefore in particular be a flat device with a flat base. The flat base can be attached directly or indirectly to the user's skin. The connecting device can therefore, for example, comprise a top and a bottom, in particular a flat bottom, the bottom comprising at least one adhesive element for attaching the connecting device to the user's skin. Consequently, for example, at least one adhesive can be applied directly or indirectly to the underside. Additionally or alternatively, at least one plaster or adhesive strip can be attached directly or indirectly to the underside, with an adhesive surface facing the user's skin. The underside can in particular be a side from which the analyte sensor protrudes from the medical device.

However, the cross section of the connecting device, such as the cross section of the flat base, can be adapted to the handling steps for the insertion. In particular, the connection device, such as the flexible connection device and in particular the flexible circuit board, can have a non-circular shape with one or more parts. In particular, an asymmetrical shape can be used. For example, the connecting device can have a first part, preferably a first flap, to which the electronic component is attached, and a second part, preferably a second flap, with an electrical energy storage device, preferably a battery, attached thereto. The first part or the second part can, for example, each have a substantially circular shape, wherein the circular shape can, for example, be interrupted only in a region in which the first or second part is connected to a central part of the connecting device, which is connected to the housing can be connected. The connecting device may therefore comprise, for example, a central part connected to the housing and one, two or more than two parts connected to the central part. The middle part can, for example, comprise an opening through which the housing can penetrate the connecting device.

The connecting device can therefore include, for example, in particular one, two or more than two flaps or wings that protrude from the housing. For example, the connecting device may have a shape of the wings of a moth or butterfly, preferably with foldable wings that can be folded up or down. Consequently, for example, the first part and the second part may be foldable, preferably up or down towards an axis of the housing. The folding can be used in particular during insertion in order to be able to grip the medical device more stably when the insertion cannula is pushed into the user's body tissue. Thus, for example, the first and second portions may be folded upward during insertion and subsequently folded back into the flat configuration to lay flat against the user's skin and preferably to be adhered to the user's skin with at least one adhesive .

As explained above, the connecting device can have an opening, wherein the housing of the connecting device can completely or partially penetrate the opening. Consequently, for example, the housing may be partially arranged on an upper side of the connecting device and partially arranged on a lower side of the connecting device, for example by partially protruding upward from the connecting device and partially projecting downward from the connecting device. An upward direction can be a direction that faces away from the user's skin, and a downward direction can be a direction that faces the user's skin. As mentioned above, the introducer cannula can point in the downward direction.

As further mentioned above, the housing may be fully or partially attached to the connecting device. In particular, the housing can be attached to an edge of the opening of the connecting device. For example, the housing may comprise an intermediate component as mentioned above, wherein the connecting device may be fully or partially attached to the intermediate component. The intermediate component can therefore be the one mentioned above Include edge, with the connecting device attached thereto.

The removable upper cap and the removable lower cap can in particular be arranged on opposite sides of the connecting device. As further discussed above, the housing may include at least one intermediate component disposed between the removable top cap and the removable lower cap. The intermediate component can in particular comprise a sealing ring, in particular a sealing ring that seals a connection between the upper cap and the lower cap. The removable top cap and the removable bottom cap may be attached to each other, preferably by a screw mechanism, with the intermediate component disposed between the removable top cap and the removable bottom cap.

As explained above, the analyte sensor can be arranged, for example with the insertable part, within the sensor chamber, and it can be arranged with at least one other part, for example with a connecting part, outside the sensor chamber in order to be operatively connected to the electronic unit, for example with the connection device and/or the at least one electronic component. To guide the analyte sensor out of the sensor chamber in a sealed manner and to avoid ingress of moisture, dirt or microbial contamination, the intermediate component may include at least one sealed opening, with the analyte sensor passing through the sealed opening. The insertable part of the analyte sensor can be at least partially accommodated in the sensor chamber, wherein an opposite end of the analyte sensor, for example a connecting section of the analyte sensor, can be attached to the electronic unit.

The intermediate component can, for example, be made of a rigid material. Alternatively, however, the intermediate component can be made completely or partially from a deformable material, for example from a completely or partially flexible or elastic material. The at least one intermediate component can therefore be made, for example, from an elastomeric material.

The connecting device can, as explained above, be mechanically connected to the intermediate component. For example, the connecting device can completely or partially surround the intermediate component. The intermediate component can comprise a projecting edge, wherein the connecting device can be connected completely or partially, in particular mechanically, to the projecting edge. In general, any type of connecting mechanism can be used to mechanically connect the connecting device to the housing, for example to the intermediate component. In particular, however, the connecting device can be connected to the housing using an adhesive or welded connection. However, other connections are possible, such as positive or non-positive connections.

The insertion cannula can in particular be firmly attached to the removable top cap. The medical device may further include at least one septum received within the sensor chamber, the introducer cannula extending through the septum, the septum adapted to seal a remainder of the sensor chamber upon removal of the removable top cap.

The electronics unit may contain one or more electronic components attached to the connection device. The electronic component can in particular be set up to control a measurement carried out with the analyte sensor. The medical electronic component can in particular contain an application-specific integrated circuit (ASIC). The electronic component can in particular contain at least one measuring device that is set up to carry out an electrochemical measurement with the analyte sensor, for example at least one current measuring device and/or at least one voltage measuring device. Furthermore, one or more of a current source and/or a voltage source may be included.

The removable top cap and/or the removable bottom cap may include at least one handle. As further used herein, the term “handle” may refer to any element that may be part of an object that can be moved or used by hand. In particular, the removable bottom cap may include the handle configured to allow the user to remove the removable bottom cap from the medical device. The handle may comprise at least one hygroscopic material, preferably at least one desiccant, more preferably activated carbon.

The medical device may further include at least one insertion aid configured to allow a user to drive the insertion cannula into the body tissue and insert the insertable portion of the analyte sensor. As used herein, the term “introducer” may refer to any technical term Refer to construction that is designed to insert one object into another object. The insertion aid can therefore comprise at least one insertion mechanism. As further used herein, the term “mechanism” may refer to any mechanism configured to convert input forces and motion into a desired set of output forces and motion. In particular, the insertion mechanism can be set up in such a way that the user can exert a force on the insertion cannula in an insertion direction. Consequently, the insertion aid can be designed to facilitate handling of the medical device by the user and/or to reduce application errors. The insertion aid can at least partially surround the housing. Furthermore, the insertion aid can be at least partially coupled to the housing.

The introducer may include a removable bottom cover mechanically coupled to the removable bottom cap. As used herein, the term "cover" may refer to any element that completely or at least largely occupies an object. In particular, the cover can be or comprise a shell, in particular a half-shell, which surrounds the medical device. The removable bottom cover may be configured such that removal of the removable bottom cover removes the removable bottom cap. The insertion aid can further comprise at least one top cover. The top cover may be coupled directly or indirectly to the introducer cannula and/or the removable top cap such that displacement of the top cover against the frame drives the introducer cannula. The terms “bottom cover” and “top cover” may be viewed as descriptive without specifying any order and without excluding any possibility that multiple types of bottom covers and top covers may be used. The insertion aid can further comprise at least one frame. The term “frame” can refer to any element designed to support other components of a physical structure. The frame can be displaceable on the user's skin and at least partially surround the housing. The top cover can be slidable against the frame.

In a further aspect, a method of assembling a medical device according to any embodiment as described above or as further described below is disclosed. The procedures include the process steps listed below. The process steps can be carried out in the order given. However, other sequences of the process steps are possible. Furthermore, one or more of the method steps can be carried out in parallel and/or overlapping in time. Furthermore, one or more of the process steps can be carried out repeatedly. There may also be additional process steps that are not listed.

1. a) Bereitstellen mindestens eines Teils des Gehäuses, wobei der mindestens eine Teil des Gehäuses die Sensorkammer mit der abnehmbaren oberen Kappe und der abnehmbaren unteren Kappe umfasst;
2. b) Platzieren des Analytsensors zumindest teilweise in der Sensorkammer, wobei der Analytsensor und der in Schritt a) bereitgestellte mindestens eine Teil des Gehäuses ein Zwischenprodukt bilden;
3. c) Sterilisieren des Zwischenprodukts; und
4. d) Verbinden der Elektronikeinheit mit dem Zwischenprodukt.

The method of assembling the medical device includes:

1. a) providing at least a portion of the housing, the at least one portion of the housing comprising the sensor chamber with the removable top cap and the removable bottom cap;
2. b) placing the analyte sensor at least partially in the sensor chamber, the analyte sensor and the at least part of the housing provided in step a) forming an intermediate product;
3. c) sterilizing the intermediate product; and
4. d) Connecting the electronic unit to the intermediate product.

The housing can be manufactured by injection molding. In step b), at least one further element can be placed at least partially in the sensor chamber. The at least one further element can be selected from the following group: an insertion cannula, a sealing element, in particular a septum. The method can further include the functional connection, in particular the electronic connection, of the analyte sensor with the electronic unit.

Step c) can be carried out with at least one sterilization method that is based on radiation, in particular electron beam (e-beam) sterilization. The method can further comprise at least one step of sterilizing the electronic unit, in particular by gas sterilization.

In particular, the method can be carried out in such a way that step c) is carried out before step d) in order to avoid that the electronic unit is exposed to radiation. Analogously, the sterilization of the electronics unit can be carried out after placement of the electronics unit in the electronics chamber or in at least a part thereof in a state in which the sensor chamber is tightly closed, for example by the removable upper cap and the removable lower cap. Gas sterilization can therefore be used to sterilize the electronic unit, for example using ethylene oxide. There the sensor chamber is tightly closed by the upper cap and the lower cap, penetration of the gas used to sterilize the electronic unit into the sensor chamber can be prevented, so that impairment of the analyte sensor or at least the insertable part of the analyte sensor arranged therein can be prevented can.

By using this two-stage sterilization, the specific requirements and sensitivities of the different components can be taken into account. In general, the electronic unit is sensitive to high energy radiation, such as gamma rays or electron beams, and can be damaged as a result. Consequently, the radiation sterilization can be carried out on the intermediate product without the electronic unit being connected to the analyte sensor in order to sterilize the analyte sensor or at least the insertable part of the analyte sensor. In contrast, in most cases, the analyte sensor or typical sensor chemicals used therein is/are sensitive to and can be damaged by sterilizing gases such as ethylene oxide. Consequently, the sterilization of the electronic unit connected to the analyte sensor can be carried out in such a way that interaction of the sterilization gas, such as ethylene oxide, with the insertable part of the analyte sensor is prevented. Consequently, the sterilization procedures can be optimized independently without the risk of the electronics unit being damaged by radiation and without the risk of the analyte sensor being damaged by sterilizing gas.

In another aspect, a method of using the medical device according to any embodiment as described above or as further described below is disclosed. The procedures include the process steps listed below. The process steps can be carried out in the order given. However, other sequences of the process steps are possible. Furthermore, one or more of the method steps can be carried out in parallel and/or overlapping in time. Furthermore, one or more of the process steps can be carried out repeatedly. There may also be additional process steps that are not listed.

1. I. Bereitstellen der medizinischen Vorrichtung;
2. II. Entfernen der abnehmbaren unteren Kappe;
3. III. Einführen des Analytsensors in das Körpergewebe; und
4. IV. Entfernen der abnehmbaren oberen Kappe, wodurch die Einführkanüle aus der medizinischen Vorrichtung entfernt wird.

The procedure for using a medical device includes:

1. I. Providing the medical device;
2. II. Removing the removable bottom cap;
3. III. introducing the analyte sensor into the body tissue; and
4. IV. Remove the removable top cap, thereby removing the introducer cannula from the medical device.

1. i. Entfernen der abnehmbaren unteren Abdeckung, wodurch die abnehmbare untere Kappe entfernt wird;
2. ii. Einführen des Analytsensors in den Körper durch Anlegen eines Einführmechanismus durch die obere Abdeckung.

The medical device may further include the at least one introducer comprising the at least one top cover and the removable bottom cover as described above. Thereby, the method of using a medical device may further include:

1. i. removing the removable bottom cover, thereby removing the removable bottom cap;
2. ii. Inserting the analyte sensor into the body by applying an insertion mechanism through the top cover.

The housing and/or the connecting device can comprise the at least one adhesive surface, for example an adhesive surface, which can optionally be covered with at least one protective film, for example in step i. and/or in step ii., the protective film can be removed. In particular, the removable bottom cover can be removed by a rotational movement. However, other embodiments are possible. The top cover may include at least one spring drive and before performing step i. The spring drive can be tightened, thereby securing parts of the insertion mechanism, after completing step ii. the insertion cannula is retracted by at least one spring.

The proposed medical device, the method of assembling a medical device, and the method of using a medical device provide many advantages over known devices and methods.

Typically, common medical devices may initially include two components. The two components can form a final product after the medical device is applied to the user's body tissue. The analyte sensor usually has to be connected to the electronic unit by the user if necessary. This can lead in particular to errors during use and thus to serious consequences such as measurement errors. In common medical devices, complex constructions may therefore generally have to be implemented in order to avoid sources of error. The complex constructions can include, for example, seals, electrical contacts or blocking forces.

Particularly in the case of analyte sensors, which are electrochemical sensors, electronic components may generally not be treatable using beam sterilization. However, electrochemical sensors themselves may generally only be treatable by beam sterilization, so that the functionality of the electrochemical sensor can be guaranteed.

Therefore, the medical device according to the present invention may comprise a combination of a sterile chamber with the analyte sensor and the electronic unit, which may in particular be a single-use electronic unit. The sterile chamber can be integrated into the electronics unit or attached to it.

The user can obtain a complete medical device without the need to assemble the medical device. The medical device can also be robust and inexpensive. Applying the medical device to the user's body tissue can be carried out in a simple and intuitive manner.

Parts of the medical device may remain on the user's body tissue after use of the medical device. These parts can remain on the body tissue for a given period of use. Sterilization of the analyte sensor and subsequent assembly of the electronics unit during assembly of the medical device can be realized without opening the sealed chamber. Furthermore, a compact and small design as well as easy assembly can be possible.

While using the medical device, the housing can be opened by the user. A protective film of the adhesive element can be removed and the removable bottom cap can be removed. The medical device can be attached to the user's body tissue and the analyte sensor can be inserted into the body tissue. The introducer cannula can be removed from the body tissue. The removable top cap can then be removed from the medical device.

The septum can be a custom component or manufactured by injection molding. The barbed hook can be designed to prevent a second use of the insertion cannula. The barbed hook may be an additional component or integrated as a component. The insertion cannula can be a tube or a stamped and bent part. The introducer cannula can be sealed by the septum. Therefore, the insertion cannula can in particular have a round cross section. However, other embodiments, such as a flat design, are possible.

The insertion aid may include the top cover. The top cover can be part of the primary packaging. Furthermore, the user can use the top cover to use the medical device. The top cover can be firmly connected to the removable top cap. The insertion aid can have the retraction mechanism, which is set up to automatically retract the insertion cannula after the insertion cannula has been inserted into the body tissue. The introducer's removable bottom cover may be part of the primary packaging. Further, the removable bottom cover may be securely connected to the removable bottom cap. During the opening of the removable bottom cover, the removable bottom cap can be simultaneously opened and the adhesive surface can be exposed. The frame can protect the insertion cannula, especially before use of the medical device. The user can hold the medical device on the body tissue. The frame may require initial force so that the user can build up force during manual insertion of the introducer cannula and insert quickly. The frame can trigger a mechanism so that the introducer cannula can be automatically retracted as soon as the frame is compressed. In particular, the mechanism can be a spring-biased mechanism. The insertion aid can provide easy handling for the user.

The removable bottom cover may include a base fixedly connected to a lower portion of the removable bottom cap, for example via a snap connection, an adhesive connection, and/or a longitudinal guide or transfer force. The base may include gripping surfaces for removing the removable bottom cover. The base can also be a cover for the adhesive surface. This can lead to extended durability of the adhesive surface. By removing the removable bottom cover, the removable bottom cap can be opened, the introducer cannula and analyte sensor can be exposed, and the adhesive surface can be exposed at the same time.

The top cover of the insertion aid can include the spring drive. The spring drive can be set up to trigger the insertion of the insertion cannula. The spring drive can be tensioned while the electronics unit is pressed into the insertion sleeve. The insertion sleeve can snap into an element that can trigger the insertion cannula to be retracted after insertion.

The upper cover can include guide elements so that circulation of the electronic unit in the insertion aid is at least largely suppressed. For example, the electronics unit can have a non-round shape, guide rails can be present in an external shape of the electronics unit and/or special structures such as nuts can be present in the electronics unit.

The insertion aid can be triggered by a release button. The medical device can be fired at body tissue. At a bottom dead center, the spring drive can be released to retract the insertion cannula. The insertion aid can be removed from the body tissue. The user can optionally remove the removable top cap containing the introducer cannula by hand. Optionally, the user can tilt the introducer, thereby removing the removable top cap.

Tensioning of the medical device can be achieved by a rotational movement. This allows the housing to be screwed on and held from below. This can be achieved, for example, through appropriately shaped primary packaging. This allows the primary packaging to be connected to the removable bottom cap. For example, the insertion aid itself can be set up to carry out the rotary movement to remove the removable lower cap. This can be realized as follows: Two mechanisms can be tensioned while the medical device is being tensioned. A first mechanism may relate to a spring system for introducing the analyte sensor into the body tissue as described above. A second mechanism may refer to the rotational movement described above. The electronic unit can be attached to a top dead center within the insertion aid. As soon as the electronic unit can be attached, a rotational movement can take place in an opposite direction.

Alternatively, other mechanisms may be used to remove the removable top cap from the electronics chamber, such as a coupled mechanism that may be easily retractable, cutting a break with a knife, or unscrewing the removable top cap. The removable top cap does not need to be firmly attached to the electronics chamber. To facilitate assembly of the medical device and/or to facilitate removal of the removable top cap by the user, the clutch mechanism may be used. For example, a tube-in-tube system may be used that includes a seal with an elastic mass such as rubber, thermoplastic polymers, an epoxy or silicone.

By using a flexible connection device, such as a flexible printed circuit board, the at least one electronic component can be applied to a flexible bendable part and thus be in a less bulky state than the electronic unit, in which the analyte sensor is inserted into the body tissue and the electronic unit is flat lies on the user's skin.

During the insertion procedure, when the entire medical device is pressed against the skin and when the sensor is inserted into the body tissue, the skin at the insertion site may become distorted and bulge inward. Consequently, unless the skin is held in place by a rigid device, such as a body restraint with a plaster, the depth of insertion may vary depending on the curvature of the skin. By deforming the electronic unit during insertion, for example by folding the flaps upwards, a more constant insertion depth can be achieved.

Furthermore, the use of a flexible connection device, such as a flexible printed circuit board, can significantly increase the comfort of wearing the medical device and the analyte sensor inserted into the body tissue. Additionally, a stiff body mount is more likely to lose contact with and separate from the user's skin. In contrast, a flexible system can move with the movement of the skin and provides less surface area for mechanical influences. Consequently, the stability of the device is increased compared to conventional devices.

In step VII of the method for using the medical device, the at least two sections of the connecting device, such as the at least two flaps, can therefore generally be folded or bent upwards. Once inserted, the minimum two sections can be folded back to lie flat against the user's skin. The foldable medical device can generally result in a compact medical device that can be easily manufactured. The user can have a fully manufactured continuous monitoring system without the need for white ter assembly received, compared to e.g. B. to a system that requires the user to make electrical connections, for example using one or more plugs. This greatly reduces the risk of failure during use of the analyte sensor. Furthermore, the medical device can be set up as a compact system for insertion. Furthermore, the robustness can be increased and the cost of the medical device can be reduced due to a reduction in the number of parts required for the medical device.

Furthermore, part of the housing can remain on the user's body after insertion. Thus, as explained above, an intermediate component may remain on the user's skin after removal of the removable bottom and top caps and insertion of the analyte sensor.

The at least one electronic component can be completely or partially encapsulated. As explained above, encapsulation can therefore even be provided in a soft manner, using soft materials for encapsulating the at least one electronic component. The at least one electronics housing can therefore be made completely or partially from at least one flexible or deformable or soft material. For example, rubber, silicone, a thermoplastic polymer, or other soft materials may be used, further increasing the comfort of the medical device.

By using an insertion aid, such as an insertion aid that includes the at least one housing and/or the at least one upper cap and/or the insertion cannula, the electronics unit can be designed to be small during insertion, with the section of the connecting device then being folded down Electronic unit can be attached to the user's skin, e.g. B. without opening a sterile area. Consequently, a compact system and easy assembly and introduction can be realized.

In summary, the following embodiments are potential embodiments of the present invention and the present disclosure. However, other embodiments are possible.

• • mindestens einen Analytsensor mit einem einführbaren Teil, der dazu eingerichtet ist, zumindest teilweise in ein Körpergewebe eines Benutzers eingeführt zu werden,
• • mindestens eine Einführkanüle, wobei der Analytsensor zumindest teilweise in der Einführkanüle angeordnet ist;
• • mindestens ein Gehäuse, wobei das Gehäuse mindestens eine Sensorkammer umfasst, wobei die Sensorkammer eine abgedichtete Kammer bildet, die mindestens den einführbaren Teil des Analytsensors aufnimmt, wobei die abgedichtete Kammer mindestens eine abnehmbare obere Kappe und mindestens eine abnehmbare untere Kappe aufweist, wobei die abnehmbare untere Kappe zur Abnahme vor dem Einführen eingerichtet ist, um dadurch dem einführbaren Teil das Einführen zu eröffnen, wobei die Einführkanüle an der abnehmbaren oberen Kappe angebracht ist, wobei die abnehmbare obere Kappe zur Abnahme nach dem Einführen eingerichtet ist, um dadurch die Einführkanüle zu entfernen; und
• • mindestens eine Elektronikeinheit, wobei der Analytsensor mit der Elektronikeinheit wirkverbunden ist, wobei die Elektronikeinheit mindestens eine Verbindungsvorrichtung mit mindestens einer daran angebrachten Elektronikkomponente umfasst, wobei die Verbindungsvorrichtung das Gehäuse vollständig oder teilweise umgibt.

Embodiment 1: A medical device for detecting at least one analyte in a body fluid, the medical device comprising:

• • at least one analyte sensor with an insertable part that is designed to be at least partially inserted into a user's body tissue,
• • at least one insertion cannula, wherein the analyte sensor is at least partially arranged in the insertion cannula;
• • at least one housing, the housing comprising at least one sensor chamber, the sensor chamber forming a sealed chamber that receives at least the insertable part of the analyte sensor, the sealed chamber having at least one removable upper cap and at least one removable lower cap, the removable lower cap is adapted to be removed before insertion, thereby opening insertion to the insertable part, the insertion cannula being attached to the removable upper cap, wherein the removable upper cap is adapted to be removed after insertion, thereby removing the insertion cannula ; and
• • at least one electronics unit, wherein the analyte sensor is operatively connected to the electronics unit, wherein the electronics unit comprises at least one connecting device with at least one electronic component attached thereto, wherein the connecting device completely or partially surrounds the housing.

Embodiment 2: The medical device according to the foregoing embodiment, wherein the connection device comprises a printed circuit board.

Embodiment 3: The medical device according to any one of the preceding embodiments, wherein the connection device comprises a flexible printed circuit board.

Embodiment 4: The medical device according to the foregoing embodiment, wherein the flexible printed circuit board is made entirely or partially of polyimide.

Embodiment 5: The medical device according to any one of the preceding embodiments, wherein the connecting device comprises an upper side and a lower side, the lower side comprising at least one adhesive member for attaching the connecting device to the user's skin.

Embodiment 6: The medical device according to one of the preceding embodiments, wherein the connecting device comprises a first part, preferably a first flap, to which the electronic component is attached, and a second part, preferably a second flap, with an attached thereto electrical energy storage, preferably a battery.

Embodiment 7: The medical device according to the foregoing embodiment, wherein the first part and the second part each have a substantially circular shape.

Embodiment 8: The medical device according to one of the two preceding embodiments, wherein the connecting device has the shape of wings of a moth or a butterfly.

Embodiment 9: The medical device according to one of the three preceding embodiments, wherein the first part and the second part are foldable, preferably up or down to an axis of the housing.

Embodiment 10: The medical device according to any one of the preceding embodiments, wherein the connecting device has an opening, the housing penetrating the connecting device completely or partially through the opening.

Embodiment 11: The medical device according to the foregoing embodiment, wherein the housing is attached to an edge of the opening of the connecting device.

Embodiment 12: The medical device according to any one of the preceding embodiments, wherein the removable top cap and the removable lower cap are disposed on opposite sides of the connecting device.

Embodiment 13: The medical device according to any one of the preceding embodiments, wherein the sensor chamber includes at least one intermediate component disposed between the removable top cap and the removable lower cap.

Embodiment 14: The medical device according to the preceding embodiment, wherein the intermediate component comprises a sealing ring.

Embodiment 15: The medical device according to one of the two preceding embodiments, wherein the removable upper cap and the removable lower cap are attached to each other, preferably by a screw mechanism, with the intermediate component being arranged between the removable upper cap and the removable lower cap.

Embodiment 16: The medical device according to any one of the three preceding embodiments, wherein the intermediate component comprises at least one sealed opening, the analyte sensor passing through the sealed opening.

Embodiment 17: The medical device according to the preceding embodiment, wherein the insertable part of the analyte sensor is at least partially accommodated in the sensor chamber, with an opposite end of the analyte sensor attached to the electronic unit.

Embodiment 18: The medical device according to one of the four preceding embodiments, wherein the intermediate component is made entirely or partially from a deformable material, preferably from a flexible or an elastic material.

Embodiment 19: The medical device according to any one of the five preceding embodiments, wherein the connecting device is connected to the intermediate component.

Embodiment 20: The medical device according to the preceding embodiment, wherein the connecting device at least partially surrounds the intermediate component.

Embodiment 21: The medical device according to one of the two preceding embodiments, wherein the intermediate component comprises a protruding edge, the connecting device being connected to the protruding edge.

Embodiment 22: The medical device according to any one of the preceding embodiments, wherein the introducer cannula is securely connected to the removable top cap.

Embodiment 23: The medical device according to any one of the preceding embodiments, wherein the medical device further comprises at least one septum received in the sensor chamber, the insertion cannula extending through the septum, the septum for sealing a remainder of the sensor chamber after removal of the removable top cap.

Embodiment 24: The medical device according to one of the preceding embodiments, wherein the electronic unit is a contains an individual electronic component that is attached to the connecting device, the electronic component being set up to control a measurement carried out with the analyte sensor.

Embodiment 25: The medical device according to the preceding embodiment, wherein the electronic component comprises an application-specific integrated circuit.

Embodiment 26: The medical device according to one of the two previous embodiments, wherein the electronic component contains at least one of a measuring device that is set up to carry out an electrochemical measurement with the analyte sensor.

1. a) Bereitstellen mindestens eines Teils des Gehäuses, wobei der mindestens eine Teil des Gehäuses die Sensorkammer mit der abnehmbaren oberen Kappe und der abnehmbaren unteren Kappe umfasst;
2. b) Platzieren des Analytsensors zumindest teilweise in der Sensorkammer, wobei der Analytsensor und der in Schritt a) bereitgestellte mindestens eine Teil des Gehäuses ein Zwischenprodukt bilden;
3. c) Sterilisieren des Zwischenprodukts; und
4. d) Verbinden der Elektronikeinheit mit dem Zwischenprodukt.

Embodiment 27: A method of assembling a medical device according to any one of the preceding embodiments, the method comprising:

1. a) providing at least a portion of the housing, the at least one portion of the housing comprising the sensor chamber with the removable top cap and the removable bottom cap;
2. b) placing the analyte sensor at least partially in the sensor chamber, the analyte sensor and the at least part of the housing provided in step a) forming an intermediate product;
3. c) sterilizing the intermediate product; and
4. d) Connecting the electronic unit to the intermediate product.

Embodiment 28: Method according to the previous embodiment, wherein step c) comprises radiation sterilization.

Embodiment 29: Method according to one of the two previous embodiments, wherein the method further comprises at least one step of sterilizing the electronic unit.

Embodiment 30: Method according to the previous embodiment, wherein the step of sterilizing the electronic unit comprises gas sterilization.

1. I. Bereitstellen der medizinischen Vorrichtung;
2. II. Entfernen der abnehmbaren unteren Kappe;
3. III. Einführen des Analytsensors in das Körpergewebe; und
4. IV. Entfernen der abnehmbaren oberen Kappe, wodurch die Einführkanüle aus der medizinischen Vorrichtung entfernt wird.

Embodiment 31: A method of using the medical device according to any one of the preceding embodiments relating to a medical device, the method comprising:

1. I. Providing the medical device;
2. II. Removing the removable bottom cap;
3. III. introducing the analyte sensor into the body tissue; and
4. IV. Remove the removable top cap, thereby removing the introducer cannula from the medical device.

Short description of the characters

Further details of the invention can be derived from the following disclosure of the preferred embodiments. The features of the embodiments can be implemented in isolation or in any combination. The invention is not limited to the embodiments. The embodiments are shown schematically in the figures. Identical reference numbers in the figures refer to identical elements or functionally identical elements or to elements which correspond to each other in terms of their functions.

• 1 eine Querschnittsansicht einer ersten Ausführungsform einer medizinischen Vorrichtung;
• 2 eine Draufsicht auf eine zweite Ausführungsform einer medizinischen Vorrichtung;
• 3 eine perspektivische Ansicht der zweiten Ausführungsform der medizinischen Vorrichtung, mit einem geöffneten Elektronikgehäuse und einem Energiespeicher;
• 4 den Aufbau von 3 mit entfernter Elektronikkomponenten und entferntem Energiespeicher;
• 5 die Ausführungsform von 2 mit einem ersten Teil und einem zweiten Teil, nach oben gebogen, in einer perspektivischen Ansicht;
• 6 den Aufbau von 5 in einer Seitenansicht, wobei die untere Kappe entfernt ist, mit der Einführkanüle vor der Einführung;
• 7 den Aufbau von 6 während der Einführung; und
• 8 die medizinische Vorrichtung nach der Einführung (ohne Körpergewebe).

Show in the figures:

• 1 a cross-sectional view of a first embodiment of a medical device;
• 2 a top view of a second embodiment of a medical device;
• 3 a perspective view of the second embodiment of the medical device, with an opened electronics housing and an energy storage device;
• 4 the construction of 3 with electronic components and energy storage removed;
• 5 the embodiment of 2 with a first part and a second part, bent upwards, in a perspective view;
• 6 the construction of 5 in a side view, with the bottom cap removed, with the introducer cannula before insertion;
• 7 the construction of 6 during the introduction; and
• 8th the medical device after insertion (excluding body tissue).

Detailed description of the embodiments

In 1 A cross-sectional view of a first embodiment of a medical device 110 for detecting at least one analyte in a body fluid is shown. The medical device 110 includes an analyte sensor 112, which can be designed, for example, as a flexible analyte sensor and which is preferably designed as an electrochemical analyte sensor. The analyte sensor 112 includes an insertable portion 114, which is adapted to be introduced into a user's body tissue.

The medical device 110 further comprises an insertion cannula 116, which can be designed, for example, as a slotted insertion cannula 116. Other types of introducer cannulas are also possible. The insertable part 114 of the analyte sensor 112 is arranged inside the insertion cannula 116.

The medical device 110 further includes a housing 118 that surrounds a sensor chamber 120. The sensor chamber 120 forms a sealed chamber 122 that is sealed from an environment of the medical device 110. The sealed chamber 122 receives the insertable portion 114 of the analyte sensor 112 and can further accommodate the insertion cannula 116.

The housing 118, such as the sealed chamber 122, includes a removable top cap 124 and a removable bottom cap 126. The removable top cap 124 and the removable bottom cap 126 may be connected together, such as by a screw mechanism. Alternatively, however, the removable top and bottom caps 124, 126 may be releasably connected to other components of the housing 118.

The housing 118 may further comprise an intermediate component 128, which may preferably have the shape of a ring and/or which may surround the insertion cannula 116 in a ring shape. The intermediate component 128 may include a sealed opening 130 through which the analyte sensor 112 is guided out of the sealed chamber 122 so that a connecting part 132 of the analyte sensor 112 is arranged outside the sealed chamber 122. For example, the intermediate component 128 may be made entirely or partially of a deformable or flexible material that forms a seal between the top cap 124 and the bottom cap 126. For example, the intermediate component 128 may be made entirely or partially of an elastomeric material, such as rubber and/or a silicone.

The medical device 110 further includes at least one electronics unit 134. The electronics unit 134 includes a connection device 136, which is preferably designed completely or partially as a flexible printed circuit board 138. The connection device 136 may include one or more conductive traces and/or one or more contact points, such as contact pads, not shown in the figures. For example, the connection portion or contact portion 132 of the analyte sensor 112 may be electrically connected to one or more of the electrical traces and/or contact pads of the connection device 136 to electrically contact the analyte sensor 112. For example, the intermediate component 128 may thus include one or more projections 140, which may easily support the connection portion or contact portion 132 of the analyte sensor 112 and/or which, for example. B. can press the connecting section or contact section 132 of the analyte sensor 112 onto the connecting device 136, for example onto one or more contact pads of the connecting device 136 and/or onto one or more conductive tracks. The projection 140 may include an edge 141 that completely or partially surrounds a region in which the analyte sensor 112 is electrically connected to the connection device 136. Furthermore, a solder connection and/or a conductive adhesive can be used for the electrical connection of the analyte sensor 112 to the connection device 136.

The electronics unit 134 further comprises at least one electronic component 142, which can be attached directly or indirectly to the connecting device 136. As described in more detail below, the at least one electronic component 142 may be completely or partially encapsulated, for example by one or more electronic housings 144.

The connecting device 136 may include at least one adhesive surface. Accordingly, the medical device 110 may include at least one adhesive member 148 and/or at least one adhesive surface, such as a plaster, on a side of the connector 136 that faces the user, also referred to as a lower side 146. On the lower side 146, the patch may include at least one removable cover layer that can be removed before adhering to the user's skin.

To produce the medical device 110 as in 1 shown, the housing 118 can first be provided, in which the insertion cannula 116 and the analyte sensor 112 are at least partially arranged. Furthermore, the connection device 136 can be provided and at this stage or in a later stage the analyte sensor 112 can be operatively connected to the connection device 136 and/or to an electronic component 142 arranged thereon. Preferably, the analyte sensor 112 can be sterilized before providing an electronic component of the electronic unit 134, for example by radiation sterilization, e.g. B. by electron beam sterilization. The at least one electronic component 112 can then be attached, for example by attaching the at least one electronic component electronic component 142 on the connection device 136. At this stage, after sealing the housing 118, a further sterilization step can preferably be used to sterilize the electronics unit 134. For this purpose, a sterilization method that is incompatible with the insertable portion 114 of the analyte sensor 112 may be used, such as using gas sterilization. However, due to the sealing properties of the housing 118 and in particular the sealed chamber 122, the sterilization gas cannot reach the insertable part 114 of the analyte sensor 112. Consequently, the at least one electronic component 142 and the insertable part 114 can be independently sterilized without harmful influences.

In the 2 until 8th A second embodiment of the medical device 110 is shown, which is largely similar to that in 1 Embodiment shown is similar, except for minor differences explained in more detail below. Various views and various configurations of the embodiment are shown therein. 2 shows a top view, 3 and 4 show partial perspective views, 5 , 6 and 7 show a folded configuration and 8th shows a configuration in which the upper and lower caps 124, 126 and the introducer cannula 116 are removed and the electronics unit 134 rests on a user's skin (not shown), with the insertable portion 114 of the analyte sensor 112 protruding into a body tissue of the user. The various views and configurations of the second embodiment of the present invention will be explained together below. For most components and reference numbers please refer to the description 1 referenced above.

Consequently, the medical device 110 largely corresponds to that in 1 structure shown. Again, a connection device 136 is provided, which can be designed as a flexible printed circuit board 138. However, in this embodiment, the connecting device 136 includes a first section 150, also referred to as a first flap, and a second section 152, also referred to as a second flap. As is particularly the case in 2 As can be seen, the first and second parts may preferably have a circular shape. However, other shapes are possible. However, the circular shape can increase comfort. The connector 136 may further include a central portion 154 that connects the connector 136 to the housing 118, such as shown in FIG 3 can be seen, with the intermediate component 128 of the housing 118. The middle part 154 of the connecting device 136 may include an opening 156 for receiving the housing 118. The connecting device 136 may be attached directly or indirectly to the intermediate component 128 of the housing 118, such as using a protruding edge of the intermediate component 128 or the like.

In contrast to that in 1 The structure shown in 2 until 8th Embodiment shown is an alternative connection between the analyte sensor 112 and the electronics unit 134. In each embodiment, the analyte sensor 112 can thus be electrically connected to the electronics component 142 of the electronics unit 134, as e.g. Am 3 can be seen, and / or with the connecting device 136, as z. B. in the embodiment of 1 you can see. However, a combination of both embodiments is possible.

The ones in the 2 until 8th The embodiment shown further shows an option in which the electronics unit 134 comprises, in addition to the at least one electronic component 142, at least one electrical energy storage device 158, such as a battery or the like. The at least one electronic component 142 can be arranged directly or indirectly on the first part 150 or the first flap, while the at least one electrical energy storage 158 can be arranged directly or indirectly on the second part 152, for example the second flap. The electrical energy storage 158 can be connected to the electronic component 142 via at least one electrical path on and/or in the connecting device 136, which cannot be seen in the figures.

As explained above, the at least one electronic component 142 and/or the at least one electrical energy storage device 158 can be connected directly or indirectly to the connection device 136. As in the embodiment of the 2 until 8th is shown, the electronic component 142 and/or the electrical energy storage 158 may in particular be completely or partially surrounded by at least one housing and/or encapsulation. In the in the 2 until 8th In the embodiment shown, the electronic component 142 is thus completely or partially encapsulated by an electronics housing 160, which has a lower electronics housing component 162 attached to the connection device 136, with a receptacle 162 therein for receiving the electronic component 142. Within the receptacle 164, one or more Contact pads and/or one or more electrical paths are provided to connect the electronic component 142 to the connection device 136. After placing the electronic component 142 and connecting the analyzer tsensors 112 with the electronic component 142, an upper electronics housing component 166 can be attached to cover the electronic component 142, as is the case when comparing the structure of the 3 and 5 you can see. However, other encapsulation techniques can be used, such as by casting, e.g. B. using a rubber, mold or other seal to encapsulate the electronic component 142.

Analogously, the electrical energy storage 158 can be completely or partially encapsulated. Like it e.g. Am 3 and 4 can be seen, the electronics unit 134 can therefore be an energy storage housing 168 z. B. with a lower energy storage housing component 170 with a receptacle 172 therein that can be attached directly or indirectly to the connection device 136, and optionally an upper energy storage housing component 174. The housings 160, 168 may be made entirely or partially from rigid materials, or they may be made entirely or partially from deformable or soft materials. Consequently, for example, the upper energy storage housing component 174 can also be made entirely or partially from a deformable material, such as a moldable or castable material.

As explained above, the connection device 136 is preferably made entirely or partially of a flexible or deformable material. Consequently, for example, a flexible printed circuit board 138 may be used. This allows for handling where the connector 136 has a different configuration during insertion compared to the later configuration when the analyte sensor 112 is inserted. The foldable flaps 150, 152 can be folded up, for example, as z. Tie 5 until 7 you can see. Accordingly, first the flaps 150, 152 can be bent upward and the bottom cap 126 can be removed as shown in FIG 6 you can see. The introducer cannula 116 can pierce the user's skin 176, as shown in 6 you can see. An adhesive surface 178 on a lower side 146 of the medical device 110 can initially come into contact with the skin 176 in the area of the central part 154, as is the case, for example. Am 7 you can see. Subsequently, the parts 150, 152 can be folded back into a horizontal position after insertion, lying on the skin 176 and adhering to the skin 176. Furthermore, the removable top cap 124 with the introducer cannula 116 can be removed, thereby changing the configuration 7 into the configuration 8th is transformed, with the sensor 112 with its insertable portion 114 inserted into the body tissue and the removable top cap 124 and the cannula 116 removed.

List of reference numbers

110

Medical device

112

Analyte sensor

114

Insertable part

116

introducer cannula

118

Housing

120

Sensor chamber

122

Sealed chamber

124

Removable top cap

126

Removable bottom cap

128

Intermediate component

130

Sealed opening

132

connecting part

134

Electronics unit

136

Connection device

138

Flexible printed circuit board

140

head Start

141

edge

142

Electronic component

144

Electronics housing

146

Bottom side

148

Adhesive element

150

First part

152

Second part

154

Middle part

156

opening

158

Electric energy spoke

160

Electronics housing

162

Lower electronics housing component

164

Recording

166

Upper electronics housing component

168

Energy storage enclosure

170

Lower energy storage enclosure component

172

Recording

174

Upper energy storage enclosure component

176

skin

178

Adhesive surface

QUOTES INCLUDED IN THE DESCRIPTION

This list of documents listed by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• US 5413690 A [0003]
• US 5762770 A [0003]
• US 5798031 A [0003]
• US 6129823 A [0003]
• US 2005/0013731 A1 [0003]
• US 6360888 B1 [0005, 0006]
• US 2008/0242962 A1 [0005]
• DE 954712 B [0008]
• DE 20020566 U1 [0009]
• US 2012/0197222 A1 [0010]
• WO 2010/091028 A1 [0011]
• WO 2014/018928 A1 [0012]
• EP 14180045 [0013]

Claims (44)

A medical device (110) for detecting at least one analyte in a body fluid, the medical device (110) comprising: • at least one analyte sensor (112) with an insertable part (114) which is designed to be at least partially inserted into a user's body tissue, • at least one insertion cannula (116), the analyte sensor (112) being at least partially arranged in the insertion cannula (116); • at least one housing (118), the housing (118) comprising at least one sensor chamber (120), the sensor chamber (120) forming a sealed chamber (122) which receives at least the insertable part (114) of the analyte sensor (112). , wherein the sealed chamber (122) has at least one removable upper cap (124) and at least one removable lower cap (126), the removable lower cap (126) being adapted to be removed prior to insertion, thereby providing the insertable part (114 ) to open insertion, wherein the introducer cannula (116) is attached to the removable top cap (124), the removable top cap (124) being adapted to be removed after insertion, thereby removing the introducer cannula (116), wherein the sensor chamber (120) comprises at least one intermediate component (128) disposed between the removable upper cap (124) and the removable lower cap (126), the removable upper cap (124) and the removable lower cap (126). the intermediate component (128) is attached and connected to each other in a removable manner; and • at least one electronics unit (134), wherein the analyte sensor (112) is operatively connected to the electronics unit (134), wherein the electronics unit (134) comprises at least one connecting device (136) with at least one electronic component (142) attached thereto, wherein the connecting device ( 136) completely or partially surrounds the housing (118). A medical device (110) for detecting at least one analyte in a body fluid, the medical device (110) comprising: • at least one analyte sensor (112) with an insertable part (114) which is designed to be at least partially inserted into a user's body tissue, • at least one insertion cannula (116), the analyte sensor (112) being at least partially arranged in the insertion cannula (116); • at least one housing (118), the housing (118) comprising at least one sensor chamber (120), the sensor chamber (120) forming a sealed chamber (122) which receives at least the insertable part (114) of the analyte sensor (112). , wherein the sealed chamber (122) has at least one removable upper cap (124) and at least one removable lower cap (126), the removable lower cap (126) being adapted to be removed prior to insertion, thereby providing the insertable part (114 ) open the insertion, the introducer cannula (116) being attached to the removable top cap (124), the removable top cap (124) being adapted for removal after insertion, thereby removing the introducer cannula (116); • at least one electronics unit (134), wherein the analyte sensor (112) is operatively connected to the electronics unit (134), wherein the electronics unit (134) comprises at least one connecting device (136) with at least one electronic component (142) attached thereto, wherein the connecting device ( 136) completely or partially surrounds the housing (118); and • at least one insertion aid that is designed to enable a user to drive the insertion cannula (116) into the body tissue and to insert the insertable part (114) of the analyte sensor (112), the insertion aid at least partially surrounding the housing (118). , wherein the introducer includes a removable bottom cover mechanically coupled to the removable bottom cap (126), the removable bottom cover being configured such that removal of the removable bottom cover removes the removable bottom cap (126), wherein the Insertion aid comprises at least one frame and at least one upper cover that is displaceable relative to the frame, the frame being displaceable on the user's skin and at least partially surrounding the housing (118), the upper cover being directly or indirectly connected to the insertion cannula (116) and/or or the removable top cap (124) such that displacement of the top cover against the frame drives the introducer cannula (116). The medical device (110) according to Claim 1 or after Claim 2 , wherein the connection device (136) comprises a printed circuit board (138). The medical device (110) according to one of the Claims 1 and 3 or after one of the Claims 2 until 3 , wherein the connection device (136) comprises a flexible printed circuit board (138). The medical device (110) according to one of the Claims 1 and 3 until 4 or after one of the Claims 2 until 4 , wherein the connecting device (136) comprises an upper side and a lower side (146), the lower side (146) comprising at least one adhesive element (148) for attaching the connecting device (136) to the skin of the user, wherein at least one adhesive directly or indirectly on the lower side (146). The medical device (110) according to one of the Claims 1 and 3 until 5 or after one of the Claims 2 until 5 , wherein the connecting device (136) has an opening (156), wherein the housing (118) completely or partially penetrates the connecting device (136) through the opening (156). The medical device (110) according to one of the Claims 1 and 3 until 6 or after one of the Claims 2 until 6 , wherein the removable top cap (124) and the removable lower cap (126) are arranged on opposite sides of the connection device (136). The medical device (110) according to one of the Claims 1 and 3 until 7 or after one of the Claims 2 until 7 , wherein the analyte sensor (112) is electrically connected to the connection device (136). The medical device (110) according to one of the Claims 1 and 3 until 8th or after one of the Claims 2 until 8th , wherein the analyte sensor (112) is electrically connected to the connection device (136) via at least one of a solder connection, a weld connection, an electrical connection, a conductive adhesive material or a plug connection. The medical device (110) according to one of the Claims 1 and 3 until 9 or after one of the Claims 2 until 9 , wherein the analyte sensor (112) is arranged with the insertable part (114) inside the sensor chamber (120) and with a connecting part is arranged outside the sensor chamber (120) in order to be operatively connected to the electronic unit (134). The medical device (110) according to one of the Claims 1 and 3 until 10 or after one of the Claims 2 until 10 , wherein the removable upper cap (124) and the removable lower cap (126) are connected to each other by means of a screw connection. The medical device (110) according to one of the Claims 1 and 3 until 11 or after one of the Claims 2 until 11 , wherein the sensor chamber (120) is set up to provide sterile packaging for the insertable part (114) of the analyte sensor (112). The medical device (110) according to Claim 12 , wherein the removable lower cap (126) is a sterile cap configured to provide sterile packaging for the insertable portion (114) of the analyte sensor (112) such that the insertable portion (114) is sealed from an environment. The medical device (110) according to one of the Claims 1 and 3 until 13 or after one of the Claims 2 until 13 , wherein the medical device (110) comprises at least one retraction mechanism for retracting the insertion cannula (116) after inserting the insertable part (114) of the analyte sensor (112) into the body tissue. The medical device (110) according to one of the Claims 1 and 3 until 14 or after one of the Claims 2 until 14 , wherein the medical device (110) is a disposable medical device. The medical device (110) according to one of the Claims 1 and 3 until 15 or after one of the Claims 2 until 14 , wherein the electronics unit (134) is a disposable electronics unit. The medical device (110) according to one of the Claims 1 and 3 until 16 or after one of the Claims 2 until 16 , wherein the electronic unit (134) comprises a transmitter for transmitting data. The medical device (110) according to one of the Claims 1 and 3 until 17 or after one of the Claims 2 until 17 , wherein the insertion cannula (116) has at least one cross section selected from the group consisting of: round, elliptical, U-shaped, V-shaped. The medical device (110) according to one of the Claims 1 and 3 until 18 or after one of the Claims 2 until 18 , wherein the insertion cannula (116) is a slotted cannula. The medical device (110) according to one of the Claims 1 and 3 until 19 or after one of the Claims 2 until 19 , wherein the insertion cannula (116) is adapted to be inserted vertically to the user's body tissue. The medical device (110) according to one of the Claims 1 and 3 until 20 or after one of the Claims 2 until 20 , wherein the removable top cap (124) at least partially surrounds the insertion cannula (116). The medical device (110) according to one of the Claims 1 and 3 until 21 or after one of the Claims 2 until 21 , wherein the introducer cannula (116) is firmly connected to the removable top cap (124). The medical device (110) according to one of the Claims 1 and 3 until 22 or after one of the Claims 2 until 22 , wherein the analyte sensor (112) is an electrochemical sensor. The medical device (110) according to one of the Claims 1 and 3 until 23 or after one of the Claims 2 until 23 , wherein the analyte sensor (112) is a transcutaneous sensor. The medical device (110) according to one of the Claims 1 and 3 until 24 or after one of the Claims 2 until 24 , where the at least one analyte is selected from the group consisting of: glucose, cholesterol, triglycerides, lactate. The medical device (110) according to one of the Claims 2 until 25 , wherein the sensor chamber (120) comprises at least one intermediate component (128) disposed between the removable upper cap (124) and the removable lower cap (126), the removable upper cap (124) and the removable lower cap (126 ) are attached to the intermediate component (128) and connected to each other in a removable manner. The medical device (110) according to one of the Claims 1 and 3 until 25 , or after Claim 26 , wherein the removable top cap (124) and the removable lower cap (126) are removably connected to the intermediate component (128) on sides opposite to the intermediate component (128). The medical device (110) according to one of the Claims 1 , 3 until 25 and 27 , or after one of the Claims 26 until 27 , wherein the intermediate component (128) is adapted to remain on the user's skin after insertion of the analyte sensor (112) and after removal of the removable lower cap (126) and the removable upper cap (124). The medical device (110) according to one of the Claims 1 , 3 until 25 and 27 until 28 , or after one of the Claims 26 until 28 , wherein the intermediate component (128) is made of a rigid material or is made entirely or partially of a deformable material. The medical device (110) according to one of the Claims 1 , 3 until 25 and 27 until 29 , or after one of the Claims 26 until 29 , wherein the intermediate component (128) comprises at least one sealed opening (130), wherein the analyte sensor (112) extends through the sealed opening (130). The medical device (110) according to Claim 30 , wherein the insertable part (114) of the analyte sensor (112) is at least partially accommodated in the sensor chamber (120), with an opposite end of the analyte sensor (112) being attached to the electronic unit (134). The medical device (110) according to one of the Claims 30 until 31 , wherein the at least one sealed opening (130) is completely or partially integrated in the intermediate component (128). The medical device (110) according to one of the Claims 1 , 3 until 25 and 27 until 32 , or after one of the Claims 26 until 32 , wherein the connecting device (136) is connected to the intermediate component (128). The medical device (110) according to one of the Claims 1 , 3 until 25 and 27 until 33 , or after one of the Claims 26 until 33 , wherein the connecting device (136) at least partially surrounds the intermediate component (128). The medical device (110) according to one of the Claims 1 , 3 until 25 and 27 until 34 , wherein the medical device (110) further comprises at least one insertion aid which is designed to enable a user to drive the insertion cannula (116) into the body tissue and to insert the insertable part (114) of the analyte sensor (112), wherein the Insertion aid at least partially surrounds the housing (118), the insertion aid comprising a removable bottom cover mechanically coupled to the removable bottom cap (126), the removable bottom cover being configured such that removal of the removable bottom cover causes the removable lower cap (126) removed, the insertion aid comprising at least one frame and at least one upper cover displaceable relative to the frame, the frame being displaceable on the user's skin and at least partially surrounding the housing (118). The medical device (110) according to Claim 35 , wherein the top cover is directly or indirectly coupled to the introducer cannula (116) and/or the removable top cap (124) such that displacement of the top cover against the frame drives the introducer cannula (116). The medical device (110) according to one of the Claims 2 until 34 , or after one of the Claims 35 until 36 , wherein the insertion aid is at least partially coupled to the housing (118). The medical device (110) according to one of the Claims 2 until 34 and 37 , or after one of the Claims 35 until 37 , wherein the removable bottom cover includes a base connected to a lower part of the removable bottom cap via a snap connection, an adhesive connection, and/or a longitudinal guide or transfer force. The medical device (110) according to Claim 38 , wherein the base is at the same time a cover for an adhesive surface (178), wherein by removing the removable lower cover, the removable lower cap (126) can be opened, the insertion cannula (116) and the analyte sensor (112) can be exposed and the adhesive surface (178 ) can be exposed at the same time. The medical device (110) according to one of the Claims 2 until 34 and 37 until 39 , or after one of the Claims 35 until 39 , wherein the frame is designed to protect the insertion cannula (116). The medical device (110) according to one of the Claims 2 until 34 and 37 until 40 , or after one of the Claims 35 until 40 , wherein the frame requires an initial force so that when the insertion cannula (116) is manually inserted by the user, a force can be built up and the insertion cannula (116) can be inserted quickly. The medical device (110) according to one of the Claims 2 until 34 and 37 until 41 , or after one of the Claims 35 until 41 , wherein the frame is designed to trigger a mechanism so that the insertion cannula (116) is automatically retracted as soon as the frame is compressed. The medical device (110) according to one of the Claims 2 until 34 and 37 until 42 , or after one of the Claims 35 until 42 , wherein the insertion aid comprises at least one insertion mechanism, the insertion mechanism being set up in such a way that the user can apply a force in an insertion direction to the insertion cannula (116). The medical device (110) according to one of the Claims 2 until 34 and 37 until 43 , or after one of the Claims 35 until 43 , wherein the upper cover comprises guide elements so that circulation of the electronic unit (134) in the insertion aid is at least largely suppressed.

Images