DE202016009188U1 - Medical device for detecting at least one analyte in a body fluid - Google Patents

Abstract

Medical device (110) for detecting at least one analyte in a body fluid, the medical device (110) comprising the following:
• at least one analyte sensor (122) with an insertable part (134) which is designed to be at least partially inserted into a user's body tissue (200),
• at least one introducer cannula (144), wherein the analyte sensor (122) is at least partially placed in the introducer cannula (144);
• at least one electronics unit (118), the analyte sensor (122) being operatively connected to the electronics unit (118);
• at least one housing (114), wherein the housing (114) comprises at least one electronics chamber (116), which is designed to at least partially accommodate the electronics unit (118), and at least one sensor chamber (120), which is designed to accommodate the analyte sensor ( 122) at least partially, the sensor chamber (120) forming a sealed chamber (162) which receives at least the insertable part of the analyte sensor (122), the sealed chamber (162) having at least one removable top cap (164) and at least one removable lower cap (166), the removable lower cap (166) being adapted to be removed prior to insertion to thereby open the insertable part (162) for insertion, the insertion cannula (144) being attached to the removable upper cap (164 ), wherein the removable top cap (164) is adapted to be removed after insertion, thereby removing the introducer cannula (144), the sensor chamber (120) comprising at least one intermediate component (168), the removable top cap (164 ) and the removable lower cap (166) are removably connected to the intermediate component (168), the electronics chamber (116) surrounding the sensor chamber (120).

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 applied both in the field of home care and in the field of professional care, such as in hospitals. Other applications are possible.

Related technology

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 excluding further possible applications, the invention is described below using blood sugar monitoring. Additionally or alternatively, however, the invention can also be applied to other types of analytes.

In addition to using optical measurements, blood sugar monitoring can be carried out in particular using electrochemical biosensors. Examples of electrochemical biosensors for measuring glucose, particularly in blood or other body fluids, are out 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 punctual measurements, in which a sample of body fluid is specifically taken from a user and examined for analyte concentration, continuous measurements are increasingly becoming established. For example, in the recent past, continuous measurement of glucose in the interstitial tissue (also referred to as continuous monitoring, CM) has emerged as another important method for setting, monitoring and controlling a diabetic condition.

The active sensor area is applied directly to the measuring point, which is generally located in the interstitial tissue, and converts, for example, glucose into an electrical charge using an enzyme (e.g. glucose oxidase, GOD), the charge corresponding to the glucose concentration relationship 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.

Therefore, current continuous monitoring systems are typically transcutaneous systems or subcutaneous systems, both terms being used interchangeably hereinafter. This means that the actual sensor or at least a measuring section of the sensor is arranged 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. During the process, the sensor is generally applied using a piercing instrument, also exemplified in US 6,360,888 B1 is described. Other types of piercing instruments are also known.

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

As stated above, transcutaneous systems typically require a control part that can be located outside of the body tissue and that must be in communication with the sensor. Typically, this connection is made 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 contacting a triangular arrangement of contact pads are, for example: Am DE 954712 B shown. Other techniques or providing electrical contacts, such as through suitable spring contacts, are generally known and may be used.

To avoid adverse effects of the aggressive environment on the conductive properties of the electrical contact, the electrical contact area is typically encapsulated and protected from moisture. In general, encapsulations of electrical locks and contacts are possible using suitable seals, e.g. B. out DE 200 20 566 U1 known. Especially with transcutaneous or subcutaneous sensors, where the area of electrical contact between the sensor and the control part is close to the human skin, effective protection against moisture, dirt, sweat and cleaning agents, such as cleaning products used for personal care, is crucial.

US 2012/0197222 A1 discloses piercing devices for medical devices and methods for piercing and using medical devices. A method is disclosed which includes removing a substantially cylindrical cap from a piercing device to expose a substantially cylindrical sleeve; removing a cover from a substantially cylindrical container containing sensor components; and fitting the sensor components into the piercing device. A member of the patent family of US 2012/0197222 A1 , namely WO 2011/119896 A1 , describes a device for piercing a medical device into the skin of a patient and methods for piercing medical devices. The device includes a sheath, a device carrier movable between proximal and distal positions, a needle carrier movable between proximal and distal positions, a handle movable between proximal and distal positions, and a drive.

WO 2010/091028 A1 discloses a one-piece analyte monitoring device assembly. The one-piece analyte monitoring device assembly includes an analyte sensor for transcutaneous positioning through a skin layer and maintained in fluid contact with an interstitial fluid under 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 coupled to the proximal portion of the analyte sensor to maintain a continuous electrical connection. 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 configured 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 request signal received from the remote location.

WO 2014/018928 A1 discloses on-body analyte monitoring devices configured for uncompressed and compressed configurations and methods of using the analyte monitoring devices. The devices include a foldable housing, wherein upon desired placement and application of force by the user on the housing, the analyte monitoring device converts from a non-compressed configuration to a low-profile compressed state while an analyte sensor is passed through the skin and into contact with body fluid to measure analyte levels in it and. Systems and kits are also provided.

The European patent application no. 14 180 045.8 , filed August 6, 2014, 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 that is suitable for being at least partially implanted into a user's body tissue. 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 configured to receive the implantable portion. The housing is configured to provide sterile packaging so that the implantable portion is sealed from an environment. The housing includes at least a first part and at least a second part. The first part and the second part are detachably connectable 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 region. The implantable device has a connection section that connects the implantable section and the contact section. The connecting section is guided through the sealing area.

US 2010/0049014 A1 describes sensor piercing device arrangements. In particular, an analyte monitor includes a sensor, a sensor control unit and a display unit. The sensor control unit typically includes a housing that is adapted to be placed on the skin and to house a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and connected to the Pairing with two or more contact pads are configured on the sensor. A transmitter is disposed within the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit includes a receiver for receiving data transmitted from the transmitter of the sensor control unit, and a display coupled to the receiver for displaying a report of the level of an analyte, such as blood sugar. A piercing device with a retractable introducer for subcutaneously implanting the sensor in a predictable and reliable manner is described.

US 2006/0020186 A1 describes a transcutaneous analyte sensor. In particular, it relates to systems and methods for measuring an analyte in a host. In particular, systems and methods for transcutaneously measuring glucose in a host are described.

Despite the advantages and advances achieved with the above developments, particularly in the area of continuous monitoring technology, some significant technical challenges remain. Thus, known techniques for protection and electrical contact between a sensor and a control part are generally quite complex. In general, an assembly of multiple components is required, which typically involves a complex and expensive manufacturing process. Furthermore, known techniques generally require bulky components, which is a problem, particularly 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 required to protect electrical contacts, increases in cost and sensor volume typically need to be considered. Furthermore, cleaning complex protective covers, such as guards that include O-rings or other seals, proves difficult.

Problem to be solved

An object of the present invention is therefore 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 easy manufacturing and simple handling processes by a user.

Summary of the invention

This task is solved by a medical device for detecting at least one analyte in a body fluid, which has the features of the independent claim. Preferred embodiments according to the invention, which can be implemented alone or in any combination, are disclosed in the subclaims.

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

Furthermore, it should be noted that the terms “at least one,” “one or more,” or similar expressions indicating that a feature or element may be present one or more times are typically used only once when that feature or element is introduced becomes. Hereinafter, in most cases, when referring to the relevant feature or element, 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 herein, the terms “preferably,” “more preferably,” “particularly,” “in particular,” “special,” “more specifically,” or similar terms are used in connection with optional features without limiting alternative possibilities. Thus, features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. The invention may be embodied using alternative features, as will be apparent to those skilled in the art. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without limitation as to alternative embodiments of the invention, without limitation as to the scope of the invention, and without limitation restriction on the possibility of combining the features introduced in this way with other optional or non-optional features according to 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 placed in the insertion cannula. Furthermore, the medical device comprises at least one electronic unit. The analyte sensor is operatively connected to the electronic unit. The medical device further comprises at least one housing. The housing includes at least one electronics chamber, which is designed to at least partially accommodate the electronics unit. The housing further comprises at least one sensor chamber, which is designed to at least partially accommodate the analyte sensor. 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 designed to be removed after insertion, thereby removing the introducer cannula. The electronics chamber at least partially surrounds the sensor chamber.

As generally used within the scope of the present invention, the term “medical device” may refer to any device configured to perform 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. In the following, the present invention will be described, without limiting further embodiments, primarily with reference to a medical device which is designed to fulfill at least one diagnostic purpose, and in particular a medical device which comprises at least one analyte sensor for carrying out at least one analysis. The medical device may in particular comprise an arrangement of two or more components capable of interacting with each other, such as to fulfill one or more diagnostic and/or therapeutic purposes, such as 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 a 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. One or more materials can therefore be particularly cost-effective 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 to be designed for single use. Thus, after detecting the at least one analyte in the body fluid, the user can remove the electronic units from the body tissue, dispose of the electronic unit and use a further, new medical device comprising a further, new electronic unit for another detection of the analyte in the body fluid .

As generally used within the scope of the present invention, the terms "patient" and "user" may refer to a human or an animal, regardless of whether the human or animal is in a healthy condition or suffering from a disease or suffers from several illnesses. The patient or user may be, for example, a human or an animal suffering from diabetes. However, the invention may additionally or alternatively 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 body tissue. The body fluid can therefore, for example, be selected from the group consisting of blood and interstitial fluid. Additionally or alternatively, however, one or more other types of body fluids are used, such as saliva, tears, urine or other body fluids. When the at least one analyte is detected, the body fluid can be present in the body or body tissue. Thus, in particular, as explained in more detail below, the sensor can be set up 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 the presence and/or concentration of which is significant to the user, patient or healthcare professional, like 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 the patient, such as at least one metabolite. The at least one analyte can, for example, 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 process of determining the presence and/or amount and/or concentration of the at least one analyte. Thus, the detection can be or include a qualitative detection, with which the presence of the at least one analyte or the absence of the at least one analyte is determined, and / or a quantitative detection, with which the amount and / or the concentration of the at least one analyte is determined. As a result of the detection, at least one signal can be produced that characterizes a result of the detection, such as at least one measurement signal. The at least one signal can in particular be or comprise at least one electronic signal such as at least one voltage and/or at least one current. The at least one signal can be or include at least one analog signal and/or can be or include at least one digital signal. As further used herein, the term “determining a concentration” may generally refer to a process 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 that is configured to perform the aforementioned detection process and/or that is configured to be used in the aforementioned detection process. The sensor can therefore in particular be set up 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 the 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. For example, the electrochemical detection reaction can be detected by comparing one or more electrode potentials. The electrochemical sensor can in particular be set up or usable to generate 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. Still other embodiments are possible.

The analyte sensor can in particular be a transcutaneous sensor. As used herein, the term “transcutaneous sensor” generally refers to any sensor that is adapted to be located entirely or at least partially within the body tissue of the patient or user. For this purpose, the analyte sensor includes an insertable part. The term “insertable part” may generally refer to a part or component of an element that is adapted to be insertable into any body tissue. In order to make the analyte sensor further usable as a transcutaneous sensor, the analyte sensor can provide, in whole or in part, a biocompatible surface, ie a surface that has no adverse effects on the user, the patient or the body tissue, at least during the period 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 suitable for the at least one analyte and/or the at least one Body fluid is permeable and, on the other hand, retains sensor substances such as one or more test chemicals within the sensor and prevents these substances from migrating into the body tissue. Other parts or components of the analyte sensor may remain outside the body tissue. The other parts can be connectable to an evaluation device, such as the electronic units, as described below.

The transcutaneous sensor may generally be sized to permit transcutaneous insertion, such as by providing a width in a direction perpendicular to an insertion direction of not more than 5 mm, preferably not more than 2 mm, more preferably not more than 1.5mm. 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 may be insertable into the user's body tissue, in particular to deliver or transfer 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. have at least one cross section selected from the group consisting of: round, elliptical, U-shaped, V-shaped. Still other embodiments are possible. In particular, the insertion cannula can be a slotted cannula. Alternatively, the insertion cannula can be a non-slit 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 used generally herein, the term “septum” may generally refer to any sealing element configured to seal a volume or space that provides environmental protection from moisture and/or ambient atmosphere or the like. The septum may be, for example, or include at least one pierceable film, a pierceable disk, a pierceable plate, a pierceable plug or a pierceable plate, which may be made of a material that can be pierced by the introducer cannula and which is a can seal the piercing hole created by the insertion cannula after it 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 may be penetrable by a small diameter elongated object, such as the introducer cannula. After penetration by the elongated object, an opening of the septum caused by the elongated object may seal itself and the septum may further be configured to provide a tight seal of the volume or space from the environment. In particular, the septum can be designed to seal a remainder of the sensor chamber after the removable top cap has been removed. 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 indented so that the portion can be applied to hold another object. Furthermore, the barbed hook may be shaped in a particular manner such that the other object can only pass through the barbed hook in one direction, with movement in the opposite direction being completely suppressed or at least largely reduced. In particular, this property can be realized by accommodating small, additional hooks in such a way that ends of the hooks can 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 inserting 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 before the retraction mechanism is applied. 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 incorporated into the removable top cap.

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

The electronic unit can comprise at least one connection device, preferably a printed circuit board, more preferably a flexible printed circuit board. As described above, the analyte sensor is “effectively connected” to the electronic unit. The term “interconnected” can particularly refer to a state in which two or more objects are connected to one another so that they can interact. 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 can be electrically connected to the connection device, preferably via at least one of a soldered connection, a welded connection, a potential equalization, a conductive adhesive material or a plug connection. The connecting device can be positioned in a stationary manner within the electronics chamber of the housing.

As used generally herein, the term "housing" may generally refer to any element configured to completely or partially surround and/or contain one or more elements to provide one or more of a mechanical protection, a mechanical To provide stability, environmental protection against moisture and/or ambient atmosphere, shielding against electromagnetic influences or the like. Thus, the housing can easily provide a base for attaching and/or holding one or more additional 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 produced by injection molding. However, other embodiments are possible. For example, the electronics unit may be sealed or encapsulated, as described in detail below.

As used herein, the term “chamber” may generally refer to any subpart of a parent element that creates a partially or fully 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 an environment. For example, the chamber may be separated from other parts of the parent element by one or more walls. Thus, two or more chambers may be contained within the housing, which may be completely or partially separated from each other by one or more walls of the housing. Each chamber may include a continuous space or lumen configured to receive one or more objects.

As described above, the sensor chamber forms a sealed chamber. The term “sealed chamber” may refer to a property of a chamber to be isolated from an environment such that transfer of gas, liquids and/or solid elements is completely or at least substantially 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” may generally refer to a property of any object to be at least substantially free of all life forms and/or other biological agents, such as prions, viruses, fungi, bacteria or spore forms. Thus, the sterile object may be treated by 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 specified region or area of the object, such as an area of the object.

The electronics chamber and the sensor chamber can be formed in one piece. The term “one-piece” can refer to a condition where two or more components are space-saving or arranged compactly. At least one of the two or more components can be permanently installed in at least one other of the two or more components. Additionally, the two or more components may be designed to be complementary such that the components are capable of interacting with one another. The electronics chamber and the sensor chamber can, for example, form a single part. The electronics chamber and the sensor chamber can be at least partially formed by a single housing element. The electronics chamber and the sensor chamber can share a common wall of the housing. The common wall can be at least partially designed as a cylindrical ring that surrounds the insertion cannula.

The sensor chamber can include at least one intermediate component. The term “intermediate component” may refer to any component or 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 located in the sensor chamber and sealed from the electronics chamber. The intermediate component can be or comprise an intermediate chamber or, for example, a sealing ring or an annular element. Other embodiments are possible. The electronics chamber can be connected to the intermediate component. In particular, the electronics chamber can at least partially surround the intermediate component. The electronics chamber and the intermediate component can share at least one common wall. The intermediate component can form a wall of the electronics chamber. In addition, the intermediate component can also be part of the sensor chamber. The intermediate component can be at least partially designed as a cylindrical ring that surrounds the insertion cannula. The removable top cap and the removable lower cap may be separated by the intermediate component and may both be releasably connected to the intermediate component.

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 as descriptive without specifying any order and without excluding the possibility that multiple types of top cap and bottom cap may be used. The term “removable” can refer to a property of an element to be removable from any object. This can break a close connection or contact between the element and the object. In general, the element may be removable in a reversible manner, in which the element may be attachable and removable from the object, or in an irreversible manner, in which the element may not be attachable to the object after removal. In particular, as explained in more detail below, the removable upper cap and the removable lower cap can be connected to the intermediate component via at least one predetermined breaking point, for example via at least one predetermined breaking point with a weakening of the wall of the housing, in order to enable simple and precisely defined removal of the To allow capping by hand, such as at least a predetermined breaking point comprising one or more grooves, notches or slots in the wall.

For example, the removable top cap and/or the removable bottom 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 that allow a user to remove the respective 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 opposite sides of the intermediate component. 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 stated above, the removable top cap may be removably connected to the intermediate component at at least one upper predetermined breaking point. 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 under mechanical stress while leaving other parts of the element 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 breaking point and the lower predetermined breaking point can in particular be annular predetermined breaking points. The terms “upper predetermined breaking point” and “lower predetermined breaking point” can be viewed as a description without specifying an order and without that To exclude the possibility that several types of upper breaking points and lower breaking points can be used.

The electronics chamber and the sensor chamber can be connected to one another via at least one sealed opening. The term "sealed" can generally refer to a property of any element of being completely or at least largely isolated from an environment. The sealed opening may include at least one sealing element. The term “sealing element” may generally refer to any element designed to cover one or more elements for sealing against environmental influences such as moisture. The sealing element can seal the sensor chamber from the electronics 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, when the sealing element is pressed onto another surface thereon, the first part of the sealing element is in contact with the other surface. The profile itself can be shaped symmetrically or asymmetrically, with an asymmetrical profile being preferred. 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 electronics chamber and partially in the sensor chamber. In particular, the insertable part can be at least partially accommodated in the sensor chamber.

The electronics chamber can comprise at least two housing sections. The at least two housing sections can include at least one lower housing section and at least one upper housing section. The terms “lower housing section” and “upper housing section” can be considered as a description without specifying any order and without excluding the possibility that multiple types of lower housing sections and upper housing sections may be used.

For example, the upper housing portion may include one or more covers made of an adhesive sealing material, more preferably at least one elastic material, particularly an elastic polymer material. The upper housing section and the lower housing section can be connected via one or more of a positive connection, a non-positive connection or a material connection, in particular by a connection using at least one adhesive and/or at least one bonding. The upper housing section can form an encapsulation for the electronic components of the electronic unit.

The lower housing portion may include at least one lower surface configured to be placed on a user's skin. In particular, the medical device can comprise at least one adhesive surface for attachment to the user's skin. The term “adhesive surface” can refer to a property of any surface to be able to bind to an object and resist separation. For example, the adhesive surface can comprise at least one plaster or an adhesive strip. The patch or adhesive strip can comprise at least one adhesive material. The adhesive surface can be attached directly or indirectly to the housing. The adhesive surface can be a lower surface of the electronics chamber. The insertable portion of the analyte sensor and the removable bottom cap may extend from a lower surface of the electronics chamber. The term “lower surface” may particularly refer to a surface of the electronics chamber that faces the skin of the skin user. The adhesive surface can, for example, have the shape of a circular ring surrounding the analyte sensor.

The removable top cap and/or the removable top 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 lower cap may include the handle configured to allow the user to remove the removable lower 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 further used herein, the term "inserter" may refer to any technical structure designed to insert one object into another object. Therefore, the insertion aid can include 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 has a force in one Insertion direction can exert on the insertion cannula. Therefore, the insertion aid can be set up to make it easier for the user to handle the medical device 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 further used herein, the term “cover” may refer to any element that completely or at least substantially occupies an object. In particular, the cover can be or comprise a shell surrounding the medical device, in particular a half-shell. 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 one or both of the introducer cannula 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 considered as a description without specifying any order and without excluding the 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” may refer to any element that may be arranged to support other components of a physical structure. The frame can be displaceable on the user's skin and which at least partially surrounds the housing and the upper cover which is displaceable relative to the frame.

In another 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 as follows. 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 mindestens einen Teil der Elektronikkammer und der Sensorkammer mit der abnehmbaren oberen Kappe und der abnehmbaren unteren Kappe umfasst;
2. b) Platzieren des Analytsensors zumindest teilweise in die 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) Platzieren mindestens einer Elektronikeinheit in den in Schritt a) bereitgestellten mindestens einen Teil der Elektronikkammer.

The procedure for assembling the medical device includes:

1. a) providing at least a portion of the housing, the at least one portion of the housing including at least a portion of the electronics chamber and 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) placing at least one electronics unit in the at least part of the electronics chamber provided in step a).

The housing can be manufactured by injection molding. During 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 group consisting of: an insertion cannula, a sealing element, in particular a septum. The method can further include the operative connection, in particular the electronic connection, of the analyte sensor to the electronic unit. The method may further include attaching at least one further portion of the electronics chamber to the at least one portion of the electronics chamber that receives the electronics unit, thereby forming the electronics chamber with the electronics unit received therein. In particular, after carrying out step d), the electronics chamber can be sealed by at least one cover.

Step c) can be carried out by at least one sterilization process based on radiation, in particular electron 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 so that step c) is carried out before carrying out step d) in order to avoid exposing the electronic unit to radiation. Similarly, the sterilization of the electronics unit may be performed after placing the electronics unit into the electronics chamber or at least a part thereof in a state in which the sensor chamber is sealed, such as by the removable top cap and the removable lower cap. Consequently, gas sterilization can be used to sterilize the electronic unit, for example using ethylene oxide. Since the sensor chamber is sealed by the top cap and the bottom cap, it can be prevented from causing gas sterilization tion of the electronic unit, gas used penetrates into the sensor chamber and thus adversely affects the analyte sensor or at least the insertable part of the analyte sensor arranged therein.

This two-stage sterilization allows the specific requirements and sensitivities of the various components to be taken into account. Thus, the electronic unit is generally sensitive to high-energy radiation, such as gamma rays or electron beams, and can be damaged by them. The radiation sterilization can thus 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, the analyte sensor or typical sensor chemicals used therein are in most cases sensitive to sterilizing gases such as ethylene oxide and can be damaged as a result. Consequently, the sterilization of the electronic unit connected to the analyte sensor can be carried out so that the sterilizing gas such as ethylene oxide is prevented from interacting with the insertable part of the analyte sensor. Consequently, the sterilization processes can be optimized independently without the risk of destruction of the electronic unit by radiation and without the risk of destruction of the analyte sensor by sterilization gas.

In a further aspect, a method of using a medical device according to any embodiment as described above or as further described below is disclosed. The procedures include the process steps listed as follows. 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. Abnehmen der abnehmbaren unteren Kappe;
3. III. Einführen des Analytsensors in das Körpergewebe; und
4. IV. Abnehmen der abnehmbaren oberen Kappe, wodurch die Einführkanüle von der medizinischen Vorrichtung entfernt wird.

The method of 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 Anwenden eines Einführmechanismus über 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. The method for using a medical device can further include the following:

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

The housing can comprise the at least one adhesive surface which is covered with at least one protective film, the protective film being removed during step i. Will get 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 driver, and the spring driver may be prior to performing step i. be tensioned, whereby parts of the insertion mechanism are secured, the insertion cannula being retracted by at least one spring after carrying out step II.

The proposed medical packaging, method of assembling a medical device, and method of using a medical device offer numerous advantages over known devices and methods.

Common medical devices can typically initially comprise two components. The two components can form a final product after application of the medical device to the user's body tissue. The analyte sensor may usually have to be connected to the electronic unit via the user. In particular, this can lead to errors in application and thus to serious consequences such as measurement errors. Therefore, complex designs generally have to be implemented in common medical devices in order to avoid sources of error. The complex constructions can include, for example, seals, electrical contacts or locking forces.

Particularly in the case of analyte sensors, which are electrochemical sensors, electronic components are generally not treatable by radiation sterilization. However, electrochemical sensors themselves can generally only be treated via radiation sterilization, so that 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, including the analyte sensor, and the electronic unit, which may in particular be a disposable electronic unit. The sterile chamber can be integrated into the electronics unit.

The user can obtain a complete medical device without having to assemble the medical device. The medical device can also be robust and inexpensive. Application of 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 predetermined 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. In addition, compact and small construction and easy assembly can be possible.

The housing, in particular the lower housing section, can be manufactured by injection molding. Furthermore, the housing can include at least two predetermined breaking points. To assemble the medical device, the insertion cannula, the septum and/or the analyte sensor can be inserted into the housing. The opening that connects the electronics chamber and the sensor chamber can then be sealed. The handles can be attached to the removable top cap or to the removable bottom cap. The handles can optionally include the at least one desiccant or activated carbon. This arrangement can be sterilized. The connecting device can be placed on the lower housing section and can be attached to the lower housing section, for example by heat caulking. The analyte sensor can be operatively connected to the connecting device, in particular by a conductive adhesive material. The upper housing section and the adhesive surface can be attached. The adhesive surface can be attached to the lower housing section. The upper housing section can be firmly attached to the lower housing section, for example by laser welding or gluing. The medical device can be packaged primary and, if necessary, secondary, with no major requirements being placed on the packaging.

While using the medical device, the packaging can be opened by the user. The protective film on 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 single 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 electronics chamber may be a closed chamber or may be an encapsulated mass. In particular, the electronics chamber can be encapsulated with an elastomeric material. This allows a flexible system to be attached to the user's body tissue. This can lead to increased wearing comfort. The electronics unit can in particular comprise a flexible printed circuit board. Optionally, the lower housing portion may include rigid structures for attaching the adhesive surface.

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 may include the retraction mechanism configured 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. When opening the removable bottom cover, the removable bottom cap can be opened at the same time and the adhesive surface can be exposed. The yardarm men can protect the insertion cannula, especially before using the medical device. The user can hold the medical device against the body tissue. The frame may require an initial force to allow the user to build up force and quickly insert it when manually inserting the introducer cannula. The frame can trigger a mechanism so that the introducer cannula can be automatically retracted when the frame is compressed. In particular, the mechanism can be a spring-loaded mechanism. The insertion aid can provide the user with easy handling.

The removable bottom cover may include a base that is securely connected to a lower portion of the removable bottom cap, for example via a snap connection, an adhesive, and/or a longitudinal guide or power transmission. 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 an extended durability of the adhesive surface. Removing the removable bottom cover allows the removable bottom cap to be opened, exposing the introducer cannula and analyte sensor while simultaneously exposing the adhesive surface.

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 electronic unit is pressed into the insertion aid. The insertion cannula 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 within the insertion aid is at least largely suppressed. For example, the electronics unit may have a non-round shape, guide rails may be present in an outer shape of the electronics unit and/or special constructions such as nuts may be present within the electronics unit.

The insertion aid can be triggered using a release button. The medical device can be shot 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. Optionally, the user can remove the removable top cap containing the introducer cannula by hand. The user can optionally tilt the introducer to remove the removable top cap.

The medical device can be clamped using a rotary movement. This allows the housing to be rotated and held up from below. This can be achieved, for example, through appropriately shaped primary packaging. This allows the primary packaging to be coupled with the removable bottom cap. For example, the insertion aid can be set up to carry out the rotational movement for removing the removable lower cap itself. 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 relate to rotational movement as described above. The electronic unit can be fixed at a top dead center within the insertion aid. As soon as the electronic unit is fixed, a rotational movement in the opposite direction can occur.

Alternatively, other mechanisms for removing the removable top cap from the electronics chamber may be used, such as a coupled mechanism that is easily removable, cutting a break point with a knife, or twisting off 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 removal of the removable top cap by the user, the coupling mechanism may be employed. For example, a tube-in-tube system can be used that includes a seal with an elastic mass such as rubber, thermoplastic polymers or silicone.

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

• • 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 platziert ist;
• • mindestens eine Elektronikeinheit, wobei der Analytsensor mit der Elektronikeinheit wirkverbunden ist;
• • mindestens ein Gehäuse, wobei das Gehäuse mindestens eine Elektronikkammer, welche eingerichtet ist, die Elektronikeinheit zumindest teilweise aufzunehmen, und mindestens eine Sensorkammer umfasst, welche eingerichtet ist, den Analytsensor zumindest teilweise aufzunehmen, wobei die Sensorkammer eine abgedichtete Kammer bildet, die zumindest den einführbaren Teil des Analytsensors aufnimmt, wobei die abgedichtete Kammer mindestens eine abnehmbare obere Kappe und mindestens eine abnehmbare untere Kappe umfasst, 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, wodurch die Einführkanüle entfernt wird, wobei die Elektronikkammer die Sensorkammer zumindest teilweise umgibt.

Embodiment 1: 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 introducer cannula, wherein the analyte sensor is at least partially placed in the introducer cannula;
• • at least one electronic unit, wherein the analyte sensor is operatively connected to the electronic unit;
• • at least one housing, wherein the housing comprises at least one electronics chamber, which is designed to at least partially accommodate the electronics unit, and at least one sensor chamber, which is configured to at least partially accommodate the analyte sensor, the sensor chamber forming a sealed chamber which contains at least the insertable Part of the analyte sensor, wherein the sealed chamber comprises at least one removable upper cap and at least one removable lower cap, the removable lower cap being adapted to be removed before insertion, thereby allowing the insertable part to be inserted, the insertion cannula being attached to the removable top cap is attached, the removable top cap being adapted to be removed after insertion, thereby removing the insertion cannula, the electronics chamber at least partially surrounding the sensor chamber.

Embodiment 2: The medical device according to the previous embodiment, wherein the electronics chamber and the sensor chamber are formed in one piece.

Embodiment 3: The medical device according to the previous embodiment, wherein the electronics chamber and the sensor chamber form a single part.

Embodiment 4: The medical device according to one of the preceding embodiments, wherein the electronics chamber and the sensor chamber share a common wall of the housing.

Embodiment 5: The medical device according to the previous embodiment, wherein the common wall is at least partially formed as a cylindrical ring surrounding the insertion cannula.

Embodiment 6: The medical device according to any one of the preceding embodiments, wherein the sensor chamber comprises at least one intermediate component, the removable top cap and the removable lower cap being removably connected to the intermediate component.

Embodiment 7: The medical device according to the foregoing embodiment, wherein the removable upper cap and the removable lower cap are removably connected to the intermediate component on opposite sides of the intermediate component.

Embodiment 8: The medical device according to one of the two preceding embodiments, wherein the intermediate component is at least partially formed as a cylindrical ring that surrounds the insertion cannula.

Embodiment 9: The medical device according to any one of the preceding embodiments, wherein the removable upper cap is removably connected to the intermediate component at at least one upper predetermined breaking point, wherein the removable lower cap is removably connected to the intermediate component at at least one lower predetermined breaking point.

Embodiment 10: The medical device according to the foregoing embodiment, wherein the upper predetermined breaking point and the lower predetermined breaking point are annular predetermined breaking points.

Embodiment 11: The medical device according to any one of the five preceding embodiments, wherein the electronics chamber is connected to the intermediate component.

Embodiment 12: The medical device according to the preceding embodiment, wherein the electronics chamber at least partially surrounds the intermediate component.

Embodiment 13: The medical device according to one of the two previous embodiments, wherein the electronics chamber and the intermediate component share a common wall.

Embodiment 14: The medical device according to the preceding embodiment, wherein the intermediate component forms a wall of the electronics chamber.

Embodiment 15: The medical device according to any one of the preceding embodiments, wherein the medical device comprises at least one adhesive surface for attachment to the user's skin.

Embodiment 16: The medical device according to the preceding embodiment, wherein the adhesive surface is attached directly or indirectly to the housing.

Embodiment 17: The medical device according to one of the two previous embodiments leadership forms, wherein the adhesive surface is a lower surface of the electronics chamber.

Embodiment 18: The medical device according to the preceding embodiment, wherein the insertable portion of the analyte sensor and the removable bottom cap extend from a lower surface of the electronics chamber.

Embodiment 19: The medical device according to one of the four previous embodiments, wherein the adhesive surface has the shape of a circular ring surrounding the analyte sensor.

Embodiment 20: The medical device according to one of the five previous embodiments, wherein the adhesive surface comprises at least one plaster or an adhesive strip.

Embodiment 21: The medical device according to any one of the preceding embodiments, wherein the medical device is a disposable medical device.

Embodiment 22: The medical device according to any one of the preceding embodiments, wherein the electronic unit is a disposable electronic unit.

Embodiment 23: The medical device according to one of the preceding embodiments, wherein the sensor chamber is arranged to provide a sterile packaging for the insertable part of the analyte sensor.

Embodiment 24: The medical device according to any one of the preceding embodiments, wherein the removable lower cap is 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.

Embodiment 25: The medical device according to any one of the preceding embodiments, wherein the removable top cap at least partially surrounds the introducer cannula.

Embodiment 26: The medical device according to any one of the preceding embodiments, wherein the introducer cannula is securely connected to the removable top cap.

Embodiment 27: The medical device according to one of the preceding embodiments, wherein the removable upper cap and/or the removable lower cap comprise at least one predetermined breaking point which is adapted to remove the removable upper cap and/or the removable lower cap by mechanical force to enable.

Embodiment 28: The medical device according to any one of the preceding embodiments, wherein the electronics chamber and the sensor chamber are connected to one another via at least one sealed opening, the analyte sensor passing through the sealed opening.

Embodiment 29: The medical device according to the preceding embodiment, wherein the analyte sensor is partially accommodated in the electronics chamber and partially in the sensor chamber, wherein the insertable part is at least partially accommodated in the sensor chamber.

Embodiment 30: The medical device according to one of the two preceding embodiments, wherein the sealed opening comprises at least one sealing element, the sealing element sealing the sensor chamber from the electronics chamber.

Embodiment 31: The medical device according to the preceding embodiment, wherein the sealing element comprises at least one sealing lip.

Embodiment 32: The medical device according to one of the two preceding embodiments, wherein the sealing element comprises at least one sealing material, preferably a deformable sealing material, more preferably an adhesive material.

Embodiment 33: The medical device according to any one of the preceding embodiments, wherein the introducer cannula comprises at least one barbed hook configured to prevent further movement of the introducer cannula after use.

Embodiment 34: 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 introducer cannula extending through the septum.

Embodiment 35: The medical device according to the preceding embodiment, wherein the introducer cannula is adapted to be pulled through the septum when the removable top cap is removed from the housing.

Embodiment 36: The medical device according to one of the two previous embodiments guide forms, wherein the septum is arranged to seal a remainder of the sensor chamber after removal of the removable top cap.

Embodiment 37: The medical device according to one of the three previous embodiments, wherein the septum is manufactured by injection molding, in particular by two-component injection molding.

Embodiment 38: The medical device according to any one of the preceding embodiments, wherein the removable top cap and/or the removable top cap include at least one handle.

Embodiment 39: The medical device according to the preceding embodiment, wherein the handle comprises at least one hygroscopic material, preferably at least one desiccant, more preferably activated carbon.

Embodiment 40: The medical device according to one of the preceding embodiments, wherein the electronics chamber and the sensor chamber are at least partially formed by a single housing element.

Embodiment 41: The medical device according to any one of the preceding embodiments, wherein the housing is manufactured by injection molding.

Embodiment 42: The medical device according to one of the preceding embodiments, wherein the electronic unit comprises at least one connection device, preferably a circuit board, more preferably a flexible circuit board.

Embodiment 43: The medical device according to the preceding embodiment, wherein the analyte sensor is electrically connected to the connection device, preferably via at least one of a solder connection or a plug connection.

Embodiment 44: The medical device according to one of the two previous embodiments, wherein the connecting device is positioned in a stationary manner within the electronics chamber of the housing.

Embodiment 45: The medical device according to one of the preceding embodiments, wherein the electronics chamber comprises at least two housing sections. Embodiment 46: The medical device according to the preceding embodiment, wherein the at least two housing sections include at least a lower housing section and at least an upper housing section.

Embodiment 47: The medical device according to the preceding embodiment, wherein the lower housing portion includes at least one lower surface adapted to be placed on a user's skin.

Embodiment 48: The medical device according to one of the two preceding embodiments, wherein the upper housing portion comprises one or more covers made of an adhesive sealing material, more preferably an elastic material, in particular an elastic polymer material.

Embodiment 49: The medical device according to one of the three previous embodiments, wherein the upper housing section and the lower housing section are connected via one or more of a positive connection, a non-positive connection or a material connection, in particular by a connection using at least one adhesive and/or at least one bonding.

Embodiment 50: The medical device according to any one of the four preceding embodiments, wherein the upper housing portion forms an encapsulation for the electronic components of the electronic unit.

Embodiment 51: The medical device according to any one of the preceding embodiments, wherein the medical device further comprises at least one retraction mechanism for retracting the introducer cannula after inserting the insertable portion of the analyte sensor into the body tissue.

Embodiment 52: The medical device according to the preceding embodiment, wherein the retraction mechanism is at least partially contained in the removable top cap.

Embodiment 53: The medical device according to one of the two preceding embodiments, wherein the retraction mechanism comprises at least one retraction spring element, more preferably at least one retraction spring element, arranged between the housing and the introducer cannula and biased to retract the introducer cannula from the body tissue.

Embodiment 54: The medical device according to one of the preceding embodiments forms, wherein the medical device further comprises at least one insertion aid configured to enable a user to drive the insertion cannula into the body tissue and to insert the insertable part of the analyte sensor.

Embodiment 55: The medical device according to the previous embodiment, wherein the insertion aid at least partially surrounds the housing.

Embodiment 56: The medical device according to one of the two previous embodiments, wherein the insertion aid is at least partially coupled to the housing.

Embodiment 57: The medical device according to any one of the three preceding embodiments, wherein the introducer includes a removable bottom cover mechanically coupled to the removable bottom cap, the removable bottom cover being configured such that removal of the removable bottom cover affects the removable bottom cap removed.

Embodiment 58: The medical device according to one of the four previous embodiments, wherein the insertion aid comprises at least one frame and at least one upper cover which is displaceable relative to the frame, wherein the frame is displaceable on the skin of the user and which at least partially surrounds the housing, wherein the top cover is coupled directly or indirectly to one or both of the introducer cannula or the removable top cap such that displacement of the top cover against the frame drives the introducer cannula.

1. a) Bereitstellen mindestens eines Teils des Gehäuses, wobei der mindestens eine Teil des Gehäuses mindestens einen Teil der Elektronikkammer und der Sensorkammer mit der abnehmbaren oberen Kappe und der abnehmbaren unteren Kappe umfasst;
2. b) Platzieren des Analytsensors zumindest teilweise in die 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) Platzieren mindestens einer Elektronikeinheit in den in Schritt a) bereitgestellten mindestens einen Teil der Elektronikkammer.

Embodiment 59: 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 including at least a portion of the electronics chamber and 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) placing at least one electronics unit in the at least part of the electronics chamber provided in step a).

Embodiment 60: The method according to the previous embodiment, wherein the method further comprises an active connection, in particular an electronic connection, of the analyte sensor to the electronic unit.

Embodiment 61: The method according to one of the two preceding embodiments, wherein the method further comprises attaching at least one further part of the electronics chamber to the at least one part of the electronics chamber that receives the electronics unit, thereby forming the electronics chamber with the electronics unit received therein. Embodiment 62: The method according to one of the three preceding embodiments, wherein the housing is manufactured by injection molding.

Embodiment 63: The method according to one of the preceding embodiments, which relate to a method for assembling a medical device, wherein during step b) at least one further element is at least partially placed in the sensor chamber, the at least one further element being selected from the Group consisting of: an introducer cannula; a sealing element, in particular a septum.

Embodiment 64: The method according to one of the preceding embodiments, which relate to a method for assembling a medical device, wherein step c) is carried out by at least one sterilization process based on radiation, in particular electron beam sterilization.

Embodiment 65: The method according to one of the preceding embodiments, which relate to a method for assembling a medical device, the method further comprising at least one step of sterilizing the electronic unit, in particular by gas sterilization.

Embodiment 66: The method Device according to one of the preceding embodiments, which relate to a method for assembling a medical device, wherein after carrying out step d), the electronics chamber is sealed by at least one cover.

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

Embodiment 67: Method for using the medical device according to one of the preceding claims, which relates to a obtain 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.

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

Embodiment 68: A method of using the medical device according to the preceding embodiment, wherein the medical device further comprises at least one introducer, the introducer comprising at least one top cover connected to the removable top cap and comprising at least one removable bottom cover connected to the removable lower cap, the method of using the medical device further comprising:

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

Embodiment 69: Method of using the medical device according to the preceding embodiment, wherein the housing comprises at least one adhesive surface covered with at least one protective film, the protective film being removed during step i. Will get removed.

Embodiment 70: A method of using the medical device according to either of the preceding two embodiments, wherein the removable bottom cover is removed by a rotational movement.

Embodiment 71: Method of using the medical device according to one of the three preceding embodiments, wherein the top cover comprises at least one spring drive, the spring drive being activated before performing step i. is tensioned, thereby securing parts of the insertion mechanism, with the insertion cannula after carrying out step ii. is retracted by at least one spring.

Short description of the characters

Further details of the invention can be derived from the following disclosure of 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 symbols in the figures refer to identical elements or functionally identical elements or elements corresponding to one another in terms of their functions.

• 1A bis 1D eine beispielhafte Ausführungsform eines Verfahrens zum Zusammenbau einer medizinischen Vorrichtung;
• 2A bis 2C eine beispielhafte Ausführungsform eines Verfahrens zur Benutzung einer medizinischen Vorrichtung;
• 3 eine beispielhafte Ausführungsform einer abnehmbaren oberen Kappe in einer Querschnittsansicht;
• 4A bis 4C eine beispielhafte Ausführungsform einer Elektronikeinheit in verschiedenen perspektivischen Ansichten (4A und 4B) und eines Gehäuses in einer perspektivischen Ansicht (4C);
• 5A bis 5B eine beispielhafte Ausführungsform einer medizinischen Vorrichtung (5A) und einer beispielhaften oberen Abdeckung (5B) in Querschnittsansicht; und
• 6A bis 6B eine beispielhafte Ausführungsform einer medizinischen Vorrichtung in einer Querschnittsansicht (6A) und in einer Rückansicht (6B).

Show in the figures:

• 1A until 1D an exemplary embodiment of a method for assembling a medical device;
• 2A until 2C an exemplary embodiment of a method for using a medical device;
• 3 an exemplary embodiment of a removable top cap in a cross-sectional view;
• 4A until 4C an exemplary embodiment of an electronics unit in various perspective views ( 4A and 4B) and a housing in a perspective view ( 4C );
• 5A until 5B an exemplary embodiment of a medical device ( 5A) and an example top cover ( 5B) in cross-sectional view; and
• 6A until 6B an exemplary embodiment of a medical device in a cross-sectional view ( 6A) and in a rear view ( 6B) .

Detailed description of the embodiments

In 1A until 1D An exemplary embodiment of a method for assembling a medical device 110 is shown. Show it 1A until 1C Semi-finished products 111 of the medical device 110, while the medical device 110 in 1D is shown. However, other embodiments of the medical device 110 are possible.

In a first step, as in 1A shown, at least a part 112 of a housing 114 is provided. The part 112 can in particular be a lower housing section 113 of the housing 114. The housing 114 can be manufactured in particular by injection molding. The housing 114 may include at least a portion 115 of an electronics chamber 116 configured to at least partially accommodate an electronics unit 118, as described in detail below. Furthermore, the housing 114 includes at least one sensor chamber 120, which is designed to at least partially accommodate an analyte sensor 122 increase, as described in detail below.

The electronics chamber 116 and the sensor chamber 120 can be formed in one piece. Thus, the electronics chamber 116 and the sensor chamber 120 can form a single part. In particular, the electronics chamber 116 and the sensor chamber 120 can share a common wall 124 of the housing 114. The common wall 124 can be at least partially formed as a cylindrical ring 126. The electronics chamber 116 and the sensor chamber 120 can be connected to one another via at least one opening 128. Furthermore, the housing 114 may include predetermined breaking points 130, which are described in detail below.

In a second step, as in 1B shown, the analyte sensor 122 is at least partially placed in the sensor chamber 120. The analyte sensor 122 can in particular be a transcutaneous sensor 132. The transcutaneous sensor 132 may be configured to be placed completely or at least partially in a body tissue of a patient or a user. For this purpose, the analyte sensor 122 includes an insertable part 134. The insertable part 134 can be configured to be insertable into the body tissue. In addition, the analyte sensor 122 may include at least one further section 136, which may be configured to remain outside of the body tissue and which may be connectable to the electronics unit 118. Thus, the further section 136 may include one or more electrodes 138 that are designed to be connectable to the electronics unit 118. The analyte sensor 122 can pass through the opening 128. In particular, the analyte sensor 122 is at least partially included in the electronics chamber 116 and at least partially included in the sensor chamber 120. The insertable part 134 can be at least partially accommodated in the sensor chamber 120. The opening 128 may be sealed and thus form a sealed opening 140. The sealed opening 140 may include at least one sealing element 142. The sealing element 142 can seal the sensor chamber 120 from the electronics chamber 116. The sealing element 142 may comprise at least one sealing material, in particular a deformable sealing material, more preferably an adhesive material.

Furthermore, at least one insertion cannula 144 and at least one septum 146 can be placed at least partially in the sensor chamber 120. The analyte sensor 122 is at least partially placed in the insertion cannula 144. For example, the introducer cannula 144 may be a hollow tube and may have a round cross section. Still other embodiments are possible. In particular, the insertion cannula 144 can be a slotted cannula 148. The introducer cannula 144 may be configured to be inserted vertically to the user's body tissue.

The septum 146 may be made of a resilient material such as an elastomer and may be injection molded. The septum 146 can be penetrated by the insertion cannula 144. Furthermore, the septum 146 can be set up to seal the sensor chamber 120 from an environment. Furthermore, at least two handles 150 can be attached. A first handle 152 may be located at a lower end 154 of the sensor chamber 120 and a second handle 156 may be located at an upper end 158 of the sensor chamber 120. The first handle 152 and/or the second handle 156 may optionally comprise at least one hygroscopic material.

The sensor chamber 120 forms a sealed chamber 162. The sealed chamber 162 receives the insertable portion 134 of the analyte sensor 122. Further, the sealed chamber 162 includes at least one removable top cap 164 and at least one removable bottom cap 166. The removable bottom cap 166 is adapted to be removed prior to insertion, thereby opening the insertable portion 134 for insertion. The introducer cannula 144 is attached to the removable top cap 164 and the removable top cap 164 is adapted to be removed after insertion, thereby removing the introducer cannula 144. Thus, the removable top cap 164 may partially surround the introducer cannula 144. The introducer cannula 144 may be securely attached to the removable top cap 164.

The sensor chamber 120 may include at least one intermediate component 168. The electronics chamber 116 may at least partially surround the intermediate component 168. In particular, the electronics chamber 116 and the intermediate component 168 may have at least one common wall 176.

The removable top cap 164 and the removable bottom cap 166 may be removably connected to the intermediate component 168. In particular, the removable top cap 164 and the removable lower cap 166 may be removably connected to the intermediate component 168 on opposite sides of the intermediate component 168. The removable top cap 164 may be releasably connected to the intermediate component 168 at at least one upper predetermined breaking point 170, and the removable lower cap 166 may be detachable from at least one lower predetermined breaking point 172 bar be connected to the intermediate component 168. The upper predetermined breaking point 170 and/or the lower predetermined breaking point 172 can be annular predetermined breaking points 174.

The analyte sensor 122 and the at least one part 112 of the housing 114 form an intermediate product 178. The intermediate product 178 is sterilized. In particular, at least one sterilization process based on radiation, in particular electron beam sterilization, can be used. Thus, the removable lower cap 166 may be a sterile cap 179 configured to provide a sterile packaging 181 for the insertable portion 134 of the analyte sensor 122.

In a further step, as in 1C illustrated, the at least one electronics unit 116 is placed in the at least one part 115 of the electronics chamber 116. The electronics unit 118 can include at least one connection device 180, preferably a connection for a circuit board 182. The analyte sensor 122 is operatively connected to the electronics unit 118. In particular, the analyte sensor 122 can be electrically connected to the connection device 180, preferably via at least one of a conductive adhesive material or a plug connection. The connecting device 180 can be positioned in a stationary manner within the electronics chamber 116 of the housing 114.

The electronics chamber 116 may include at least two housing sections 184. In particular, the electronics chamber 116 may include at least one lower housing section 186 and at least one upper housing section 188. In a further step, as in 1D shown, the upper housing section 188 can be attached to the lower housing section 186. The upper housing portion 188 may include a cover 190. The cover 190 can be connected to the lower housing section 186 via one or more of a positive connection, a non-positive connection or a material connection, in particular by a connection using at least one adhesive and/or at least one bonding.

The lower housing portion 186 may include at least one lower surface 192 configured to be placed on a user's skin. Therefore, at least one adhesive surface 194 may be attached to the lower surface 192 of the lower housing portion 186. The adhesive surface 194 can be adapted to be attached to the user's skin. Therefore, the adhesive surface 194 may include at least one of a patch 196 or an adhesive strip 198. The adhesive surface 194 may have the shape of a circular ring that surrounds the analyte sensor 122. The insertable portion 134 of the analyte sensor 122 and the removable bottom cap 166 may extend from the bottom surface 192 of the electronics chamber 116.

2A until 2C show an exemplary embodiment of a method for using a medical device 110. In a first step, the medical device 110 is as in 1D illustrated provided. Thus, the above description of 1D be referred to. In 2A until 2C Various intermediate stages 199 of the medical device 110 are shown.

In a first step, as in 2A shown, the removable bottom cap 164 removed. Thus, the introducer cannula 144, which includes the insertable portion 134 of the analyte sensor 122, can be exposed. Furthermore, a protective film that covers the adhesive surface 194 can be used in 2A is not illustrated, can be removed and the adhesive surface 194 can be exposed.

In a further step, as in 2 B illustrates, the analyte sensor 122 is inserted into a body tissue 200 of the user. The insertion cannula 144 can then be retracted so that the insertion cannula 144 can be moved in a direction 202 opposite to an insertion direction 160. This allows the introducer cannula 144 to be located completely within the detectable top cap 164.

In a further step, as in 2C shown, the removable top cap 164, as in 2A and 2 B illustrated, removed, thereby removing the introducer cannula 144 from the medical device 110. The sensor chamber 120 may be sealed by the septum 146.

3 shows an exemplary embodiment of a removable top cap 164 in a cross-sectional view. The removable top cap 164 corresponds at least in large part to the removable top cap 164 as shown in 1A until 2C illustrated. Thus, the above description of 1A until 2C be referred to.

The removable top cap 164 may include the septum 146. The septum 146 may be located at one end 204 of the removable top cap 164 opposite the electronics chamber 116. Furthermore, the insertion cannula 144 may include at least one barbed hook 206. The barbed hook 206 can be set up another To prevent movement of the introducer cannula 144 after use. The barbed hook 206 may surround the introducer cannula 144 and may be located between the introducer cannula 144 and the removable top cap 164.

4A and 4B show an exemplary embodiment of an electronics unit 118 in different perspective views and 4C shows a corresponding housing 114 in a perspective view. The electronics unit 118 and the housing 114 are at least largely similar to the electronics unit 118 and the housing 114, as shown in 1A until 2C described. Thus, the above description of 1A until 2C be referred to.

The upper housing portion 188 of the housing 114 may form an encapsulation 208 for electronic components of the electronics unit 118. Therefore, the encapsulation 208 may be made of at least one elastomeric material. The encapsulation 208 can in particular be an encapsulated mass 210. Consequently, a flexible system may be attachable to the user's body tissue 210. This can lead to increased wearing comfort. The housing 114, in particular the lower housing section 186, can provide at least one rigid region 212. The rigid area 212 may be configured to secure the adhesive surface 194, as shown in 1A until 2C shown.

5A until 5B show an exemplary embodiment of a medical device 110 ( 5A) and an exemplary top cover 220 ( 5B) in cross-sectional view. The medical device 110 corresponds at least in large parts to the medical device 110, as in 1A until 2C described. Thus, the above description of 1A until 2C be referred to.

The medical device 110 further includes at least one insertion aid 214 configured to allow a user to drive the insertion cannula 144 into the body tissue 200 and to insert the insertable portion 134 of the analyte sensor 122. The insertion aid 214 can at least partially surround the housing 114. Furthermore, the insertion aid 214 can be at least partially coupled to the housing 114. In particular, the insertion aid 214 includes a removable bottom cover 216 that is mechanically coupled to the removable bottom cap 166. The removable bottom cover 216 may be configured such that removal of the removable bottom cover 216 removes the removable bottom cap 166.

Furthermore, the insertion aid 214 can include at least one frame 218 that can be moved on the user's skin. The frame 218 can at least partially surround the housing 114. Furthermore, the insertion aid 214 can include at least one top cover 220. The top cover 220 may be coupled directly or indirectly to one or both of the introducer cannula 144 or the removable top cap 164 such that displacement of the top cover 220 against the frame 218 can propel the introducer cannula 144. Therefore, the top cover 220 may be slidable against the frame 218. The frame 218 may require an initial force so that the user can build up force and quickly insert it when manually inserting the introducer cannula 144. The frame 218 may be configured to trigger a retraction mechanism 222 so that the introducer cannula 144 can be automatically retracted once the frame 218 is compressed. In particular, the retraction mechanism 222 may include a spring-biased mechanism 224. Further details can be found below 5B be described.

The top cover 220 of the insertion aid 214, as in 5B illustrated may include a spring drive 228. The spring drive 228 can be set up to trigger the insertion of the insertion cannula 144. While the electronic unit 118 is being pressed into the puncture aid 214, the spring drive 228 can be tensioned. The insertion cannula 144 can snap into an element 230, which can be designed to trigger a retraction of the insertion cannula 144 after insertion. The insertion aid 214 can be triggered via a release button 232. Furthermore, the insertion aid 214 can include at least one spring 234. In particular, the insertion aid 214 can be set up in such a way that the spring 234 can be triggered at a bottom dead center to retract the insertion cannula 144.

6A and 6B show an exemplary embodiment of a medical device 110 in a cross-sectional view ( 6A) and in a rear view ( 6B) . The medical device 110 corresponds at least in large parts to the medical device 110, as in 1A until 2C described. Thus, the above description of 1A until 2C be referred to.

Furthermore, an exemplary embodiment of an insertion aid 214 is shown. The insertion aid 214 may include the removable bottom cover 216. The removable bottom cover 216 may include a base 236 connected to the removable bottom cap 166, for example via a snap fit 238. The base 236 may include handles 240 for removing the removable bottom cover 216, particularly via a rotational movement schematically illustrated with an arrow 242. The base 236 can also be a cover 244 for the adhesive surface 194. By removing the removable bottom cover 216, the removable bottom cap 166 can be opened, the introducer cannula 144 and the analyte sensor 122 exposed, and at the same time the adhesive surface 192 can be exposed.

List of reference symbols

110

Medical device

111

Semi-finished product

112

Part

113

lower housing section

114

Housing

115

Part

116

Electronics chamber

118

Electronics unit

120

Sensor chamber

122

Analyte sensor

124

common wall

126

cylindrical ring

128

opening

130

Predetermined breaking point

132

transcutaneous sensor

134

insertable part

136

further section

138

Electrodes

140

sealed opening

142

Sealing element

144

introducer cannula

146

Septum

148

slotted cannula

150

Handle

152

first grip

154

lower end

156

second handle

158

top end

160

Insertion direction

162

sealed chamber

164

removable top cap

166

removable bottom cap

168

Intermediate component

170

upper predetermined breaking point

172

lower predetermined breaking point

174

ring-shaped predetermined breaking point

176

common wall

178

intermediate product

179

sterile cap

180

Connection device

181

sterile packaging

182

Circuit board

184

Housing section

186

lower housing section

188

upper housing section

190

cover

192

lower surface

194

adhesive surface

196

Pavement

198

Adhesive strips

199

Intermediate stage

200

body tissue

202

Direction

204

End

206

barbed hook

208

Encapsulation

210

encapsulated mass

212

stiff area

214

lancing aid

216

removable bottom cover

218

Frame

220

top cover

222

Retraction mechanism

224

spring-loaded mechanism

226

Spring drive

228

Spring drive

230

element

232

Release button

234

Feather

236

Base

238

Snap connection

240

Handle

242

Arrow

244

cover

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

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• US 5762770 A [0003]
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• US 6129823 A [0003]
• US 20050013731 A1 [0003]
• US 6360888 B1 [0005, 0006]
• US 20080242962 A1 [0005]
• DE 954712 B [0008]
• DE 20020566 U1 [0009]
• US 20120197222 A1 [0010]
• WO 2011119896 A1 [0010]
• WO 2010091028 A1 [0011]
• WO 2014018928 A1 [0012]
• EP 14180045 [0013]
• US 20100049014 A1 [0014]
• US 20060020186 A1 [0015]

Claims (40)

Medical device (110) for detecting at least one analyte in a body fluid, the medical device (110) comprising the following: • at least one analyte sensor (122) with an insertable part (134) which is designed to be at least partially inserted into a user's body tissue (200), • at least one introducer cannula (144), wherein the analyte sensor (122) is at least partially placed in the introducer cannula (144); • at least one electronics unit (118), the analyte sensor (122) being operatively connected to the electronics unit (118); • at least one housing (114), wherein the housing (114) comprises at least one electronics chamber (116), which is designed to at least partially accommodate the electronics unit (118), and at least one sensor chamber (120), which is designed to accommodate the analyte sensor ( 122) at least partially, the sensor chamber (120) forming a sealed chamber (162) which receives at least the insertable part of the analyte sensor (122), the sealed chamber (162) having at least one removable top cap (164) and at least one removable lower cap (166), the removable lower cap (166) being adapted to be removed prior to insertion to thereby open the insertable part (162) for insertion, the insertion cannula (144) being attached to the removable upper cap (164 ), wherein the removable top cap (164) is adapted to be removed after insertion, thereby removing the introducer cannula (144), the sensor chamber (120) comprising at least one intermediate component (168), the removable top cap (164 ) and the removable lower cap (166) are removably connected to the intermediate component (168), the electronics chamber (116) surrounding the sensor chamber (120). Medical device (110) for detecting at least one analyte in a body fluid, the medical device (110) comprising the following: • at least one analyte sensor (122) with an insertable part (134) which is designed to be at least partially inserted into a user's body tissue (200), • at least one introducer cannula (144), wherein the analyte sensor (122) is at least partially placed in the introducer cannula (144); • at least one electronics unit (118), the analyte sensor (122) being operatively connected to the electronics unit (118); • at least one housing (114), wherein the housing (114) comprises at least one electronics chamber (116), which is designed to at least partially accommodate the electronics unit (118), and at least one sensor chamber (120), which is designed to accommodate the analyte sensor ( 122) at least partially, the sensor chamber (120) forming a sealed chamber (162) which receives at least the insertable part of the analyte sensor (122), the sealed chamber (162) having at least one removable top cap (164) and at least one removable lower cap (166), the removable lower cap (166) being adapted to be removed prior to insertion to thereby open the insertable part (162) for insertion, the insertion cannula (144) being attached to the removable upper cap (164 ) is attached, the removable top cap (164) being adapted to be removed after insertion, thereby removing the introducer cannula (144), the electronics chamber (116) surrounding the sensor chamber (120); and • at least one insertion aid (214) which is designed to enable the user to drive the insertion cannula (144) into the body tissue (200) and to insert the insertable part (134) of the analyte sensor (122), the insertion aid ( 214) at least partially surrounds the housing (114), the insertion aid (214) comprising a removable lower cover (216) which is mechanically coupled to the removable lower cap (166), the removable lower cover (216) being configured in this way that a removal of the removable lower cover (216) removes the removable lower cap (166), the insertion aid (214) comprising at least one frame (218) and at least one upper cover (220) displaceable relative to the frame, the frame ( 218) is displaceable on a user's skin and at least partially surrounds the housing (114), wherein the top cover (220) is coupled directly or indirectly to one or both of the insertion cannula (144) or the removable top cap (164), so that a displacement of the top cover (220) against the frame (218) drives the insertion cannula (144). Medical device (110) for detecting at least one analyte in a body fluid, the medical device (110) comprising the following: • at least one analyte sensor (122) with an insertable part (134) which is designed to be at least partially inserted into a body tissue ( 200) to be inserted by a user, • at least one insertion cannula (144), wherein the analyte sensor (122) is at least partially placed in the insertion cannula (144); • at least one electronics unit (118), the analyte sensor (122) being operatively connected to the electronics unit (118); • at least one housing (114), whereby the Housing (114) comprises at least one electronics chamber (116), which is designed to at least partially accommodate the electronics unit (118), and at least one sensor chamber (120), which is configured to at least partially accommodate the analyte sensor (122), wherein the sensor chamber ( 120) forms a sealed chamber (162) that receives at least the insertable portion of the analyte sensor (122), the sealed chamber (162) comprising at least one removable top cap (164) and at least one removable lower cap (166), the a removable lower cap (166) is adapted to be removed prior to insertion to thereby open insertion of the insertable part (162), the insertion cannula (144) being attached to the removable upper cap (164), the removable upper cap ( 164) is set up for removal after insertion, whereby the insertion cannula (144) is removed, the electronics chamber (116) surrounding the sensor chamber (120), the electronics chamber (116) and the sensor chamber (120) sharing a common wall (124 ) of the housing (114), the electronics chamber (116) and the sensor chamber (120) being connected to one another via at least one sealed opening (140), the analyte sensor (122) passing through the sealed opening (140). The medical device (110) according to Claim 1 , after Claim 2 , or after Claim 3 , wherein the electronic unit (118) comprises at least one connection device (180), preferably a circuit board, more preferably a flexible circuit board. The medical device (110) according to Claim 4 , wherein the connecting device (180) is a circuit board. The medical device (110) according to one of the Claims 4 and 5 , wherein the connecting device (180) is a flexible circuit board. The medical device (110) according to one of the Claims 4 until 6 , wherein the analyte sensor (122) is electrically connected to the connection device (180). The medical device (110) according to one of the Claims 1 and 4 until 7 , according to one of the Claims 2 and 4 until 7 , or after one of the Claims 3 until 7 , wherein the sensor chamber (120) is designed to provide sterile packaging for the insertable part (134) of the analyte sensor (122). The medical device (110) according to one of the Claims 1 and 4 until 8th , according to one of the Claims 2 and 4 until 8th , or after one of the Claims 3 until 8th , wherein the removable lower cap (166) is a sterile cap configured to provide sterile packaging for the insertable portion (134) of the analyte sensor (122) such that the insertable portion (134) is sealed from an environment. The medical device (110) according to one of the Claims 1 and 4 until 9 , according to one of the Claims 2 and 4 until 9 , or after one of the Claims 3 until 9 , wherein the insertion cannula (144) 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 4 until 10 , according to one of the Claims 2 and 4 until 10 , or after one of the Claims 3 until 10 , 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 1 and 4 until 11 , according to one of the Claims 2 and 4 until 11 , or after one of the Claims 3 until 11 , wherein the analyte sensor (122) is an electrochemical sensor. The medical device (110) according to one of the Claims 1 and 4 until 12 , according to one of the Claims 2 and 4 until 12 , or after one of the Claims 3 until 12 , wherein the insertion cannula (144) is adapted to be inserted vertically to the body tissue (200) of the user. The medical device (110) according to one of the Claims 1 and 4 until 13 , according to one of the Claims 2 and 4 until 13 , or after one of the Claims 3 until 13 , wherein the medical device (110) further comprises at least one retraction mechanism (222) for retracting the insertion cannula (144) after inserting the insertable part (134) of the analyte sensor (122) into the body tissue (200). The medical device (110) according to Claim 14 , wherein the retraction mechanism (222) comprises at least one retraction spring element. The medical device (110) according to one of the Claims 1 and 4 until 15 , according to one of the Claims 2 and 4 until 15 , or after one of the Claims 3 until 15 , wherein the electronic unit (118) comprises at least one transmitter for transmitting data. The medical device (110) according to one of the Claims 1 and 4 until 16 , after one the Claims 2 and 4 until 16 , or after one of the Claims 3 until 16 , wherein the introducer cannula (144) is attached to the removable top cap (164). The medical device (110) according to Claim 17 , wherein the introducer cannula (144) is securely attached to the removable top cap (164). The medical device (110) according to one of the Claims 1 and 4 until 18 , according to one of the Claims 2 and 4 until 18 , or after one of the Claims 3 until 18 , wherein the electronics chamber (116) comprises at least two housing sections (184), the at least two housing sections (184) comprising at least one lower housing section (186) and at least one upper housing section (188). The medical device (110) according to Claim 19 , wherein the lower housing portion (186) includes at least one lower surface (192) adapted to be placed on a user's skin. The medical device (110) according to one of the Claims 2 and 4 until 20 , or after one of the Claims 3 until 20 , wherein the sensor chamber (120) comprises at least one intermediate component (168), the removable top cap (164) and the removable lower cap (166) being removably connected to the intermediate component (168). The medical device (110) according to Claim 1 and 4 until 20 or after Claim 21 , wherein the removable top cap (164) and the removable lower cap (166) are removably connected to the intermediate component (168) on opposite sides of the intermediate component (168). The medical device (110) according to one of the Claims 1 , 4 until 20 and 22 , or after one of the Claims 21 until 22 , wherein the intermediate component (168) is at least partially designed as a cylindrical ring that surrounds the insertion cannula (144). The medical device (110) according to one of the Claims 1 , 4 until 20 and 22 until 23 , or after one of the Claims 21 until 23 , wherein the removable lower cap (166) is removably connected to the intermediate component (168) at at least one lower predetermined breaking point (172). The medical device (110) according to one of the Claims 1 , 4 until 20 and 22 until 24 , or after one of the Claims 21 until 24 , wherein the electronics chamber (116) at least partially surrounds the intermediate component (168). The medical device (110) according to one of the Claims 1 , 4 until 20 and 22 until 25 , or after one of the Claims 21 until 25 , wherein the electronics chamber (116) and the intermediate component (168) share a common wall (176). The medical device (110) according to one of the Claims 1 , 4 until 20 and 22 until 26 , or after one of the Claims 21 until 26 , wherein the intermediate component (168) forms a wall of the electronics chamber (116), wherein the intermediate component (168) is at the same time part of the sensor chamber (120). The medical device (110) according to one of the Claims 1 , 4 until 20 and 22 until 27 , or after one of the Claims 21 until 27 , wherein the removable top cap (164) and the removable lower cap (166) are separated by the intermediate component (168) and are both releasably connected to the intermediate component (168). The medical device (110) according to one of the Claims 1 , 4 until 20 and 22 until 28 , or after one of the Claims 21 until 28 , wherein the intermediate component (168) comprises at least one sealing ring. The medical device (110) according to one of the Claims 1 , 4 until 20 and 22 until 29 or after one of the Claims 3 until 29 , wherein the medical device (110) further comprises at least one insertion aid (214) adapted to enable the user to drive the insertion cannula (144) into the body tissue (200) and the insertable part (134) of the analyte sensor (122), wherein the insertion aid (214) at least partially surrounds the housing (114), the insertion aid (214) comprising a removable lower cover (216) which is mechanically coupled to the removable lower cap (166), the removable lower cover (216) is set up such that removal of the removable lower cover (216) removes the removable lower cap (166), the insertion aid (214) having at least one frame (218) and at least one upper cover displaceable relative to the frame (220), wherein the frame (218) is displaceable on the user's skin and at least partially surrounds the housing (114). The medical device (110) according to Claim 30 , with the top cover (220) directly or indirectly coupled to one or both of the introducer cannula (144) or the removable top cap (164) such that displacement of the top cover (220) against the frame (218) drives the introducer cannula (144). The medical device (110) according to one of the Claims 2 and 4 until 29 , or after one of the Claims 30 until 31 , wherein the removable bottom cover (216) includes a base (236) connected to a lower portion of the removable bottom cap (166). The medical device (110) according to one of the Claims 2 , 4 until 29 and 32 , or after Claim 32 , wherein the base (236) is connected to a lower part of the removable lower cap (166) via a snap connection, an adhesive and/or a longitudinal guide or force transmission. The medical device (110) according to one of the Claims 2 , 4 until 29 and 32 until 33 , or after one of the Claims 30 until 33 , wherein the insertion aid (214) comprises at least one insertion mechanism, the insertion mechanism being set up such that a force can be exerted by the user in an insertion direction on the insertion cannula (144). The medical device (110) according to one of the Claims 2 , 4 until 29 and 32 until 34 , or after one of the Claims 30 until 34 , wherein the frame (218) is arranged to trigger a mechanism so that the insertion cannula (144) is automatically retracted as soon as the frame (218) is compressed. The medical device (110) according to one of the Claims 2 , 4 until 29 and 32 until 34 , or after one of the Claims 30 until 35 , wherein the upper cover (220) comprises guide elements so that circulation of the electronic unit (118) within the insertion aid (214) is at least largely suppressed. The medical device (110) according to one of the Claims 1 , 4 until 20 and 22 until 36 , or after one of the Claims 2 , 4 until 29 and 32 until 36 , wherein the electronics chamber (116) and the sensor chamber (120) are connected to one another via at least one sealed opening (140), the analyte sensor (122) passing through the sealed opening (140). The medical device (110) according to one of the Claims 3 until 36 , or after Claim 37 , wherein the analyte sensor (122) is partially accommodated in the electronics chamber (116) and partially in the sensor chamber (120), wherein the insertable part (134) is accommodated in the sensor chamber (120). The medical device (110) according to one of the Claims 1 , 4 until 20 and 22 until 38 , or after one of the Claims 2 , 4 until 29 and 32 until 38 , wherein the electronics chamber (116) and the sensor chamber (120) share a common wall (124) of the housing (114). The medical device (110) according to one of the Claims 3 until 36 and 38 , or after Claim 39 , wherein the common wall (124) is at least partially designed as a cylindrical ring (126) which surrounds the insertion cannula (144).

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