HK1261053B - Medical device for detecting at least one analyte in a body fluid - Google Patents

Description

Medical device for detecting at least one analyte in a body fluid

Technical Field

The present invention relates to a medical device for detecting at least one analyte in a body fluid, a method for assembling a medical device and a method for using a medical device. The device and method according to the present invention may be primarily used for long term monitoring of analyte concentrations in body fluids, such as blood glucose levels or the concentration of one or more other types of analytes in body fluids. The invention can be applied both in the field of home care as well as in the field of professional care, such as in hospitals. Other applications are possible.

Background

Monitoring certain bodily functions, more particularly monitoring one or more concentrations of certain analytes, plays an important role in the prevention and treatment of various diseases. Without limiting further possible applications, the invention will be described hereinafter with reference to blood glucose monitoring. However, the invention may additionally or alternatively be applied to other types of analytes.

In addition to by using optical measurements, blood glucose monitoring may be performed in particular by using electrochemical biosensors. Examples of electrochemical biosensors, in particular for measuring glucose in blood or other body fluids, are known from US 5,413,690A, US 5,762,770,762,770 5,762,770A, US 5,798,031,798,031 5,798,031A, US 6,129,823 a or US 2005/0013731 a 1.

Continuous measurements are increasingly being established, except for so-called spot measurements, in which a sample of body fluid is taken from the user in a targeted manner and checked for analyte concentration. Therefore, recently, continuous measurement of glucose in interstitial tissue (also referred to as continuous monitoring, CM), for example, has been established as another important method for managing, monitoring and controlling diabetic conditions.

In this process, an active sensor region (region) is applied directly to a measurement site, which is usually arranged in the interstitial tissue and converts glucose into an electrical charge, which is related to the glucose concentration and can be used as a measurement variable, for example by using an enzyme (e.g. glucose oxidase, GOD). Examples of such transcutaneous measurement systems are described in US 6,360,888B 1 or US 2008/0242962 a 1.

Thus, current continuous monitoring systems are typically transcutaneous or subcutaneous systems, wherein both expressions will be used equally hereinafter. This means that the actual sensor or at least the measuring part of the sensor is arranged under the skin of the user. However, the evaluation and control part of the system (also called patch) is typically located outside the body of the user, outside the human or animal body. In this process, the sensor is usually applied using an insertion instrument, which is also described in an exemplary manner in US 6,360,888B 1. Other types of insertion instruments are also known.

The sensor typically comprises a substrate, such as a flat substrate, onto which an electrically conductive pattern of electrodes, conductive tracks and contact pads can be applied. In use, the conductive traces are typically insulated by the use of one or more electrically insulating materials. The electrically insulating material typically also serves further protection against humidity and other undesirable substances and may include, for example, one or more cover layers (such as a resist).

As outlined above, in a transcutaneous system, a control part is typically required, which may be positioned outside the body tissue and which has to communicate with the sensor. Typically, this communication is established by providing at least one electrical contact between the sensor and the control portion, which may be a permanent electrical contact or a releasable electrical contact. An example of an electrical contact for contacting a triangular component of a contact pad is shown for example in DE 954712B. Other techniques or providing electrical contacts (such as by suitable spring contacts) are generally known and may be applied.

To avoid the adverse effects of the aggressive environment on the conductive properties of the electrical contacts, the regions of the electrical contacts are typically encapsulated and protected from moisture. It is generally known, for example from DE 20020566U 1, to encapsulate electric locks and contacts by using suitable seals. In particular, in transcutaneous or subcutaneous sensors, where the electrical contact area between the sensor and the control part is close to the human skin, effective protection against humidity, dirt, sweat and cleaning agents (such as cleaning agents for body care) is critical.

US2012/0197222 a1 discloses medical device inserts and processes for inserting and using medical devices. A method is disclosed, comprising: removing the substantially cylindrical cap from the insert to expose the substantially cylindrical sleeve; removing the lid from the substantially cylindrical container housing the sensor component; and installing the sensor component into the insert.

WO 2010/091028 a1 discloses an integrated analyte monitoring device assembly. The integrated analyte monitoring device assembly includes an analyte sensor for transcutaneous positioning through a skin layer and maintained in fluid contact with interstitial fluid beneath the skin layer during a predetermined period of time. The analyte sensor has a proximal portion and a distal portion. Sensor electronics are coupled to the analyte sensor. The sensor electronics include a circuit board having a conductive layer and a sensor antenna disposed on the conductive layer. In addition, the sensor electronics include one or more electrical contacts provided on the circuit board and coupled with the proximal portion of the analyte sensor to maintain continuous electrical communication. Further, the sensor electronics includes: a data processing component provided on the circuit board and in signal communication with the analyte sensor. The data processing component is configured to execute one or more routines for processing signals received from the analyte sensor. Further, the data processing component is configured to control transmission of data associated with the processed signal 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 in vivo analyte monitoring devices configured for use in uncompressed and compressed configurations and methods of using the analyte monitoring devices. The device includes a collapsible housing, wherein application of a force by a user to the housing at a desired location converts the analyte monitoring device from an uncompressed configuration to a low-profile compressed state while directing the analyte sensor through the skin and into contact with a bodily fluid to measure an analyte level therein. Systems and kits (kits) are also provided.

European patent application No. 14180045.8 filed on 6/8/2014 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 adapted to be at least partially implanted into a body tissue of a user. The implantable device further has at least one contact portion connected to the implantable portion. The medical device further comprises at least one housing. The housing is configured to receive the implantable portion. The housing is configured to provide a sterile package such that the implantable portion is sealed from the surrounding environment. The housing comprises at least one first portion and at least one second portion. The first portion and the second portion are removably connectable to form a sterile package. The first portion includes at least one first sealing surface and the second portion includes at least one second sealing surface. The first sealing surface and the second sealing surface interact to form a sealing region. The implantable device has an interconnecting portion that connects the implantable portion with the contact portion. The interconnect is led through the sealing area.

Despite the advantages and advances achieved by the above developments, there are still some significant technical challenges, particularly in the area of continuous monitoring technology. Thus, in general, known techniques for protecting and electrically contacting between the sensor and the control portion are often quite complex. It is often necessary to assemble multiple parts, which often implies a complex and expensive manufacturing process. Furthermore, the known techniques generally require a large number of components, which is a problem, especially in view of the fact that miniaturization of the sensor system is a factor contributing to ease of use. Especially in the case of complex package parts which need to be manufactured by plastic molding techniques for protecting the electrical contacts, an increase in cost and an increase in volume of the sensor must generally be considered. Furthermore, cleaning of complex protective caps (such as protectors containing O-rings or other seals) can prove difficult.

Problems to be solved

It is therefore an object of the present invention to provide a medical device for detecting at least one analyte in a body fluid, a method for assembling a medical device and a method for using a medical device, which at least partly avoid the disadvantages of such known devices and methods and which at least partly solve the above-mentioned challenges. In particular, a device and a method should be disclosed which allow easy manufacture and simple handling procedures by the user.

Disclosure of Invention

This problem is solved by a medical device for detecting at least one analyte in a body fluid, a method for assembling a medical device and a method for using a medical device, which medical device and which method have the features of the independent claims. Preferred embodiments of the invention are disclosed in the dependent claims, which can be realized in an independent manner or in any arbitrary combination.

As used hereinafter, the terms "having," "including," "containing," or "including" or any grammatical variations thereof are used in a non-exclusive manner. Thus, these terms may represent the following two scenarios: no other features than those described by these terms are present in the entities described in this context; and one or more other features. For example, the expressions "a has B", "a includes B", and "a includes B" may refer to the following two cases: there are no other elements in a than B (i.e., a includes B individually and exclusively), and there are one or more other elements in entity a than B, such as element C, elements C and D, or even other elements.

Furthermore, it should be noted that the terms "at least one," "one or more," or similar expressions indicating that a feature or element may appear one or more than one time are generally used only once when the corresponding feature or element is introduced. In the following, in most cases, the expression "at least one" or "one or more" will not be repeated when referring to corresponding features or elements, although corresponding features or elements may be present one or more than one time.

Furthermore, as used hereinafter, the terms "preferably," "more preferably," "specifically," "more specifically," "particularly," "more particularly," or similar terms are used in conjunction with optional features, without limiting the possibilities of alternatives. Thus, the features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. As the skilled person will appreciate, the invention may be implemented using alternative features. Similarly, features introduced by "in embodiments of the invention" or similar expressions are intended to be optional features without any limitation of alternative embodiments of the invention, without any limitation of the scope of the invention, and without any limitation of the possibilities of combining features introduced in this way with other optional or non-optional features of the invention.

In a first aspect of the invention, a medical device for detecting at least one analyte in a bodily fluid is disclosed. The medical device comprises at least one analyte sensor having an insertable portion adapted to be at least partially inserted into body tissue of a user. The medical device further comprises at least one insertion cannula. The analyte sensor is at least partially disposed within the insertion cannula. Furthermore, the medical device comprises at least one electronic unit. The analyte sensor is operatively connected to the electronics unit. Furthermore, the medical device comprises at least one housing. The housing includes at least one electronics compartment configured to at least partially receive the electronics unit. The housing also includes at least one sensor compartment configured to at least partially receive an analyte sensor. The sensor compartment forms a sealed compartment that receives at least the insertable portion of the analyte sensor. The sealed compartment includes at least one removable upper cap and at least one removable lower cap. The removable lower cap is configured for removal prior to insertion, thereby leaving the insertable portion open for insertion. The insertion cannula is attached to a removable upper cap. The removable upper cap is configured for detachment after insertion, thereby removing the insertion cannula. The electronics compartment at least partially encloses the sensor compartment.

As generally used within the present disclosure, the term "medical device" may refer to any device configured for performing at least one medical analysis and/or at least one medical procedure. Thus, a medical device may generally be any device configured for performing at least one diagnostic purpose and/or at least one therapeutic purpose. In the following, without limiting further embodiments, the invention will be described mainly in terms of a medical device configured for performing at least one diagnostic purpose, and in particular a medical device comprising at least one analyte sensor for performing at least one analysis. The medical device may particularly comprise an assembly of two or more components capable of interacting with each other, such as for performing one or more diagnostic and/or therapeutic purposes, such as for performing medical analyses and/or medical procedures. In particular, the two or more components may be capable of performing and/or so as to facilitate at least one detection of at least one analyte in a bodily fluid. The medical device may also typically be or include at least one of a sensor assembly, a sensor system, a sensor suite, 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 configured to be disposed of after use. Thus, the one or more materials may in particular be cheap and/or easily recyclable. In particular, the electronic unit may be a single-use electronic unit. The term "single-use" may generally refer to the nature of any element that is configured to be applied only once. Thus, after detecting at least one analyte in the body fluid, the user may remove the electronic unit from the body tissue, set the electronic unit and may utilize a further new medical device comprising a further new electronic unit for detecting the analyte in the body fluid again.

As generally used within the present invention, the terms "patient" and "user" may refer to a human or an animal, regardless of the fact that the human or animal, respectively, may be in a healthy state or may be suffering from one or more diseases. For example, the patient or user may be a human or animal with 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 "bodily fluid" may generally refer to a fluid that is typically present in and/or producible by a body of a user or patient. As an example of body tissue, mention may be made of interstitial tissue. Thus, for example, the bodily fluid may be selected from the group consisting of blood and interstitial fluid. However, additionally or alternatively, one or more other types of bodily fluids may be used, such as saliva, tears, urine, or other bodily fluids. During the detection of the at least one analyte, a body fluid may be present within the body or body tissue. Thus, in particular, as will be outlined in further detail below, the sensor may be configured for detecting 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 a bodily fluid and of which the presence and/or concentration may be of interest to a user, patient, or medical personnel, such as a physician. In particular, the analyte may be or may comprise any chemical substance or chemical compound which may participate in the metabolism, such as at least one metabolism, of the user or patient. For example, the at least one analyte may be selected from the group comprising glucose, cholesterol, triglycerides, lactate. However, other types of analytes may be used in addition or alternatively, and/or any combination of determinable analytes. The detection of the at least one analyte may in particular be an analyte-specific (analyte-specific) detection.

As further used herein, the term "detecting" generally refers to the process of determining the presence and/or amount and/or concentration of at least one analyte. Thus, the detection may be or comprise a qualitative detection, simply determining the presence or absence of the at least one analyte, and/or may be or comprise a quantitative detection, determining the amount and/or concentration of the at least one analyte. As a result of the detection, at least one signal, such as at least one measurement signal, may be generated that characterizes the result of the detection. The at least one signal may particularly be or may comprise at least one electronic signal, such as at least one voltage and/or at least one current. The at least one signal may be or may comprise at least one analog signal and/or may be or may comprise at least one digital signal. As further used herein, the term "determining a concentration" may generally refer to a process that generates at least one representative result or a plurality of representative results indicative of a concentration of an analyte in a bodily fluid.

As further used herein, the term "analyte sensor" may generally refer to any element suitable for performing and/or for use in the detection processes described above. Thus, the sensor may be particularly adapted to determine the concentration of the analyte and/or the presence of the analyte.

The analyte sensor may in particular be an electrochemical sensor. As used herein, an "electrochemical sensor" is generally a sensor configured to perform an electrochemical measurement in order to detect at least one analyte contained in a body fluid. The term "electrochemical measurement" refers to the detection of an electrochemically detectable property of an analyte, such as an electrochemical detection reaction. Thus, for example, an electrochemical detection reaction can be detected by comparing one or more electrode potentials. The electrochemical sensor may particularly be adapted and/or may be capable of being used for generating at least one electrical sensor signal, such as at least one electrical current and/or at least one electrical voltage, directly or indirectly indicative of the presence and/or the range of an electrochemical detection reaction. The detection may be analyte-specific. The measurement may be a qualitative and/or quantitative measurement. However, other embodiments are possible.

The analyte sensor may in particular be a transcutaneous sensor. As used herein, the term "transcutaneous sensor" generally refers to any sensor adapted to be disposed entirely or at least partially within a body tissue of a patient or user. For this purpose, the analyte sensor comprises an insertable portion. The term "insertable portion" may generally refer to a portion or component of an element that is configured to be inserted into any body tissue. To further enable the analyte sensor to be used as a transcutaneous sensor, the analyte sensor may fully or partially provide a biocompatible surface, i.e. a surface which does not have any adverse effect on the user, the patient or body tissue, at least during the duration of use. In particular, the insertable portion of the analyte sensor may have a biocompatible surface. For example, the transcutaneous sensor (in particular, the insertable portion) may be completely or partially covered with at least one biocompatible membrane, such as at least one polymer membrane or gel membrane, which is permeable for the at least one analyte and/or the at least one body fluid and which on the other hand also retains sensor substances, such as the one or more test chemical substances, within the sensor and prevents these substances from being transferred into the body tissue. Other portions or components of the analyte sensor may reside outside of the body tissue. The other part may be connectable to an evaluation device, such as an electronic unit as will be further described below.

The transcutaneous sensor may typically be dimensioned such that transcutaneous insertion is feasible, such as by providing a width in a direction perpendicular to the insertion direction of no more than 5 mm, preferably no more than 2 mm, more preferably no more than 1.5 mm. The sensor may have a length of less than 50 mm, such as a length of 30 mm or less, for example a length of 5 mm to 30 mm. As used herein, the term "length" may refer to a direction parallel to the direction of insertion. However, it should be noted that other dimensions are possible.

The term "insertion cannula" may generally refer to any element that may be capable of being inserted into a body tissue of a user, particularly in order to deliver or deliver additional elements. The insertion cannula may thus in particular be or may comprise a hollow tube or a hollow needle. The insertion cannula may for example comprise at least one cross section selected from the group comprising: circular, oval, U-shaped, V-shaped. However, other embodiments are possible. In particular, the insertion cannula may be a slotted cannula. Alternatively, the insertion sleeve may be a grooveless sleeve. 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 also include at least one septum received in the sensor compartment. As generally used herein, the term "membrane" may generally refer to any sealing element configured to seal a volume or space to provide environmental protection from moisture and/or ambient atmosphere, among other things. For example, the septum may be or include at least one pierceable foil, disc, gasket, plug or plate made of a material that can be pierced by the insertion cannula and reseal the pierced hole created by the insertion cannula after retraction of the insertion cannula. In particular, the septum may be made of an elastic material (such as an elastomer). The septum may be manufactured by injection moulding, in particular by two-part injection moulding. The septum may be capable of being penetrated by an elongated object having a small diameter (such as by an insertion cannula). The septum opening caused by the elongated object may close upon itself after penetration by the elongated object, and the septum may also be configured to provide a tight seal to isolate it from the environment of the volume or space. In particular, the diaphragm may be configured for sealing the remainder of the sensor compartment after removal of the removable upper cap. The insertion cannula may be configured to be drawn through the septum upon removal of the removable upper cap from the housing.

Furthermore, the insertion sleeve may comprise at least one barb (barbed hook) configured to prevent further movement of the insertion sleeve after use. As further used herein, the term "barb" may refer to any tool that may include a curved or serrated portion such that the portion may be applied to hold another object. Furthermore, the shape of the barb may also be arranged in a specific manner, so that another object may only be able to pass through the barb in one direction, wherein movements in the opposite direction may be completely suppressed or at least largely reduced. In particular, this property can be achieved by a thin additional hook positioned such that the end of the hook can point in the opposite direction to the direction in which another object can move.

The medical device may further comprise at least one retraction mechanism for retracting the insertion cannula after insertion of the insertable portion of the analyte sensor into the body tissue. The term "retraction mechanism" may generally refer to any structure configured to move an object in a direction opposite to the direction in which the object may be moved prior to application of the retraction mechanism. Thus, the retraction mechanism may comprise at least one retraction spring element, more preferably at least one retraction spring element arranged between the housing and the insertion sleeve and biased so as to retract the insertion sleeve from the body tissue. The retraction mechanism may be at least partially included within the removable upper cap.

As used herein, the term "electronic unit" generally refers to any device having at least one electronic component. In particular, the electronic unit may comprise at least one electronic component for performing one or more of the following: performing a measurement with an analyte sensor, performing a voltage measurement, performing a current measurement, recording a sensor signal, storing a measurement signal or measurement data, transmitting a sensor signal or measurement data to another device. The electronic unit may particularly be realized as a transmitter, or may comprise a transmitter for transmitting data. Other embodiments of the electronic component are possible.

The electronic unit may comprise at least one interconnect means, preferably a printed circuit board, more preferably a flexible printed circuit board. As described above, the analyte sensor is "operably connected" to the electronics unit. The term "operatively connected" may particularly denote a state in which two or more objects are connected to each other such that they can interact with each other. In particular, the analyte sensor may be operatively connected to the electronics unit such that a sensor signal of the analyte sensor may be transmitted to the electronics unit. Thus, the term "operably connected" may also refer to an electrically conductive connection. The analyte sensor may be electrically connected to the interconnect means, preferably via at least one of a solder connection, a weld connection, an electrical bond, a conductive adhesive material, or a plug connection. The interconnect device may be fixedly positioned within an electronics compartment of the housing.

As generally used herein, the term "housing" may generally refer to any element adapted to completely or partially enclose and/or receive one or more elements so as to provide one or more of the following: mechanical protection, mechanical stability, environmental protection against moisture and/or ambient atmosphere, protection against electromagnetic influences, etc. Thus, the housing may simply provide a basis 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 may in particular be manufactured by injection moulding. However, other embodiments are possible. Illustratively, the electronic unit may be sealed or potted, as will be described further below.

As used herein, the term "compartment" may generally refer to any sub-portion of a superordinate element that creates a partially or fully enclosed space that may be used to contain and/or store objects. The sub-section may in particular be completely or at least largely closed such that the interior of the compartment may be insulated from the surrounding environment. Illustratively, the compartment may be separated from other portions of the superordinate element by one or more walls. Thus, within the housing, two or more compartments may be included, which may be completely or partially separated from each other by one or more walls of the housing. Each compartment may include a continuous space or lumen configured for receiving one or more objects.

As described above, the sensor compartment forms a sealed compartment. The term "sealed compartment" may refer to the property of the compartment that is sealed from the surrounding environment such that the transfer of gaseous, fluid and/or solid elements is completely or at least largely reduced. In particular, the sensor compartment may be configured to provide sterile packaging for the insertable portion of the analyte sensor. Illustratively, the removable lower cap may be a sterile cap configured to provide a sterile package for the insertable portion of the analyte sensor such that the insertable portion is sealed from the surrounding environment. The term "sterile" may generally refer to the property of any element that is at least largely free of all life forms and/or other biological agents (such as prions, viruses, fungi, bacteria, or spores). Thus, sterile objects can be treated by at least one sterilization process that eliminates and/or renders ineffective these life forms and/or other biological agents. The sterilization process may include one or more of the following techniques: heating, chemical treatment, irradiation, high pressure, and filtering. However, other techniques are possible. The sterilization process can be performed within a designated area or region of the object, such as a surface of the object.

The electronics compartment and the sensor compartment may be designed integrally. The term "integrally" may refer to a state in which two or more components are arranged in a space-saving or compact manner. At least one of the two or more components may be permanently built into at least another one of the two or more components. Furthermore, two or more components may be designed in a complementary manner, such that these components may be able to interact with each other. Illustratively, the electronics compartment and the sensor compartment may form a single piece. The electronics compartment and the sensor compartment may be at least partially formed by one single housing element. The electronics compartment and the sensor compartment may share a common wall of the housing. The common wall may be at least partially designed as a cylindrical ring surrounding the insertion sleeve.

The sensor compartment may comprise at least one intermediate component. The term "intermediate component" may refer to any component or compartment between at least two other compartments and/or may be located in at least one other compartment. Thus, the intermediate component may be located in the sensor compartment and may be sealed to isolate it from the electronics compartment. The intermediate component may be or may comprise an intermediate compartment, or a sealing ring or annular element, for example. Other embodiments are possible. The electronics compartment may be connected to the intermediate component. In particular, the electronic device compartment may at least partially enclose the intermediate component. The electronic device compartment and the intermediate member may share at least one common wall. The intermediate member may form a wall of the electronic device compartment. Additionally, the intermediate component may simultaneously be part of the sensor compartment. The intermediate part can be designed at least partially as a cylindrical ring surrounding the insertion sleeve. The removable upper cap and the removable lower cap may be separated by an intermediate component, and both may be removably connected to the intermediate component.

The term "cap" may refer to any element configured to close or seal a space. In particular, the cap may close or seal the opening of any container. The terms "upper cap" and "lower cap" may be considered as descriptions that do not present a specified order and do not exclude the possibility that several upper and lower caps may be applied. The term "detachable" may refer to the property of an element that is capable of being removed from any object. Thereby, the intimate bond or contact between the element and the object can be broken. In general, an element may be removable in a reversible manner (where the element may be attachable and detachable from an object) or an irreversible manner (where the element may not be attachable to an object after detachment). In particular, as will be outlined in further detail below, the upper and lower removable caps may be connected to the intermediate part via at least one predetermined breaking point (such as via at least one predetermined breaking point having a weakening in the wall of the housing) so as to allow simple and unambiguous removal of these caps by hand, such as at least one predetermined breaking point comprising one or more grooves, notches or slots in the wall.

The removable upper cap and/or the removable lower cap may illustratively have an elongated shape and provide an interior volume. The removable upper cap and/or the removable lower cap may have one or more grips that allow a user to remove the respective cap. The removable upper cap and the removable lower cap may be removably connected to the intermediate member. In particular, the removable upper cap and the removable lower cap may be removably connected to the intermediate part on opposite sides of the intermediate part. In particular, the removable upper cap may partially enclose the insertion cannula. The insertion cannula may be fixedly attached to the removable upper cap.

As outlined above, the removable upper cap may be removably connected to the intermediate part at least one upper predetermined breaking point. The removable lower cap may be removably connected to the intermediate part at least one lower predetermined breaking point. As further used herein, the term "predetermined breaking point" may refer to any portion of an element that is configured to break during mechanical loading, while other portions of the element remain intact. In particular, the predetermined breaking point may comprise at least one notch, in which the thickness of the element is small compared to other parts of the element. The upper predetermined breaking point and the lower predetermined breaking point may in particular be annular breaking points. The terms "upper breaking point" and "lower breaking point" can be considered as a description that does not present the indicated order and does not exclude the possibility that several upper and lower breaking points can be applied.

The electronics compartment and the sensor compartment may be connected to each other via at least one sealed opening. The term "sealed" may generally refer to the property of any element to be completely or at least largely sealed from the surrounding environment. The sealing opening may comprise at least one sealing element. The term "sealing element" may generally refer to any element configured to cover one or more elements to be sealed from environmental influences such as moisture. The sealing element may seal the sensor compartment from the electronics compartment. Exemplarily, the sealing element may comprise at least one sealing lip. As used herein, the term "sealing lip" may refer to the highest point of the cross-sectional profile of the sealing element that is the first portion of the sealing element to contact another surface when the sealing element thereon is pressed onto the other surface. The profile itself may be symmetrical or asymmetrical in shape, wherein an asymmetrical profile may be advantageous. The sealing element may comprise at least one sealing material, in particular a deformable sealing material, more preferably an adhesive material. The analyte sensor may pass through the sealed opening. The analyte sensor may be partially received in the electronics compartment and partially received in the sensor compartment. In particular, the insertable portion may be at least partially received in the sensor compartment.

The electronic equipment compartment may comprise at least two housing parts. The at least two housing portions may comprise at least one lower housing portion and at least one upper housing portion. The terms "lower housing part" and "upper housing part" may be considered as descriptions that do not present a specified order and do not exclude the possibility that several lower housing parts and upper housing parts may be applied.

Illustratively, the upper housing portion may comprise one or more of a cover or an adhesive sealing material (more preferably at least one elastomeric material, particularly an elastomeric polymeric material). The upper housing portion and the lower housing portion may be connected via one or more of a form-fit connection, a force-fit connection, or a connection by material joining (more particularly, a connection achieved by using at least one adhesive and/or at least one bonding agent). The upper housing part may form an encapsulation for electronic components of the electronic unit.

The lower housing portion may include at least one lower surface configured for placement on the skin of a user. In particular, the medical device may comprise at least one adhesive surface for attachment to the skin of a user. The term "adhesive surface" may refer to the property of any surface that is capable of bonding to an object and resisting separation. Illustratively, the adhesive surface may comprise at least one patch or adhesive strip. The patch or adhesive strip may comprise at least one adhesive material. The adhesive surface may be attached to the housing directly or indirectly. The adhesive surface may be a lower surface of the electronic device compartment. The insertable portion of the analyte sensor and the removable lower cap may extend from a lower surface of the electronics compartment. The term "lower surface" may particularly denote a surface of the electronic device compartment facing the skin of the user. The binding surface may illustratively have the shape of a circular ring surrounding the analyte sensor.

The removable upper cap and/or the removable upper cap may include at least one grip. As further used herein, the term "grip" may refer to any element that may be part of an object that may be moved or used by hand. In particular, the removable lower cap may comprise a grip configured for enabling a user to remove the removable lower cap from the medical device. The grip may comprise at least one hygroscopic material, preferably at least one hygroscopic material (desiccant), more preferably activated carbon.

The medical device may further comprise at least one insertion aid (insertion aid) configured for enabling a user to drive the insertion cannula into the body tissue and to insert the insertable portion of the analyte sensor. As further used herein, the term "insertion aid" may refer to any technical structure configured to insert one object into another object. Thus, the insertion aid may comprise at least one insertion mechanism. As further used herein, the term "mechanism" may refer to any mechanism designed to translate an input force and movement into a desired set of output forces and movements. In particular, the insertion mechanism may be configured such that a user may apply a force to the insertion cannula in the insertion direction. Accordingly, the insertion aid may be configured to help facilitate manipulation of the medical device by the user and/or reduce application errors. The insertion aid may at least partially surround the housing. Furthermore, the insertion aid may be at least partially coupled to the housing.

The insertion aid may include a removable lower cover mechanically coupled to the removable lower cap. As further used herein, the term "lid" may refer to any element that completely or at least to a large extent closes an object. In particular, the cover may be or may comprise a housing, in particular a half-housing, enclosing the medical device. The removable lower cover may be configured such that removal of the removable lower cover removes the removable lower cap. The insertion aid may further comprise at least one upper cover. The upper cover may be directly or indirectly coupled to one or both of the insertion sleeve or the removable upper cap such that movement of the upper cover against the frame drives the insertion sleeve. The terms "lower cover" and "upper cover" may be considered as a description that does not present a designated order and does not exclude the possibility that several lower covers and upper covers may be applied. The insertion aid may also include at least one frame. The term "frame" may refer to any element that may be configured to support other components of a physical structure. The frame may be displaceable on the skin of the user and at least partially encloses the housing and the upper cover movable against the frame.

In a further aspect of the invention, a method for assembling a medical device according to any embodiment as described above or as further described below is disclosed. The method comprises the method steps as set out in the independent claims and as listed below. The method steps may be performed in a given order. However, other orders of the method steps are possible. Furthermore, one or more of the method steps may be performed in parallel and/or in a time overlapping manner. Furthermore, one or more of the method steps may be performed repeatedly. Furthermore, there may be additional method steps not listed.

A method for assembling a medical device includes:

a) providing at least one portion of a housing comprising at least a portion of a sensor compartment and an electronics compartment having a removable upper cap and a removable lower cap;

b) placing an analyte sensor at least partially into the sensor compartment, wherein the analyte sensor and at least one part of the housing provided in step a) form an intermediate product;

c) sterilizing the intermediate product; and

d) placing at least one electronic unit into at least one portion of the electronic equipment compartment provided in step a).

The housing may be manufactured by injection molding. During step b), at least one further element may be placed at least partially into the sensor compartment. The at least one further element may be selected from the group consisting of: insertion sleeve, sealing element (in particular, septum). The method may further comprise operatively connecting (in particular, electronically connecting) the analyte sensor with an electronics unit. The method may further include attaching at least one additional portion of the electronic equipment compartment to at least one portion of the electronic equipment compartment that receives the electronic unit, thereby forming the electronic equipment compartment having the electronic unit received therein. In particular, after carrying out step d), the electronic device compartment may be sealed by at least one lid.

Step c) may be carried out by at least one sterilization process based on radiation, in particular electron beam sterilization. The method may further comprise at least one step of sterilizing the electronic unit, in particular by gas.

In particular, the method may be performed such that step c) is performed before step d) in order to avoid exposing the electronic unit to radiation. Similarly, sterilization of the electronics unit may be performed after placement of the electronics unit into the electronics compartment or at least a portion thereof in a state in which the sensor compartment is sealed (such as by a removable upper cap and a removable lower cap). Thus, in order to sterilize the electronic unit, gas sterilization may be used, such as by using ethylene oxide. Since the sensor compartment is sealed by the upper and lower caps, gas for sterilizing the electronics unit can be prevented from entering the sensor compartment and thus from affecting the analyte sensor or at least the insertable part of the analyte sensor disposed therein.

By using this two-step sterilization process, the specific requirements and sensitivities of the different components can be addressed. Thus, in general, the electronic unit is sensitive to and can be damaged by high-energy radiation (such as gamma rays or electron beams). Thus, in case the electronics unit is not connected to the analyte sensor, radiation sterilization may be performed on the intermediate product in order to sterilize the analyte sensor or at least the insertable part of the analyte sensor. In contrast, analyte sensors, or in most cases typical sensor chemistries used therein, are sensitive to and can be damaged by sterilizing gases (such as ethylene oxide). Accordingly, sterilization may be performed on the electronics unit connected to the analyte sensor such that a sterilizing gas (such as ethylene oxide) is prevented from interacting with the insertable portion of the analyte sensor. Thus, the sterilization process can be optimized independently without risking damage to the electronics unit due to radiation and without risking damage to the analyte sensor due to the sterilizing gas.

In a further aspect of the invention, a method of using a medical device according to any embodiment as described above or as further described below is disclosed. The method comprises the method steps as set out in the independent claims and as listed below. The method steps may be performed in a given order. However, other orders of the method steps are possible. Furthermore, one or more of the method steps may be performed in parallel and/or in a time overlapping manner. Furthermore, one or more of the method steps may be performed repeatedly. Furthermore, there may be additional method steps not listed.

The method of using a medical device comprises:

I. providing a medical device;

II, removing the detachable lower cap;

inserting an analyte sensor into body tissue; and

removing the removable upper cap, thereby removing the insertion cannula from the medical device.

The medical device may further comprise at least one insertion aid comprising at least one upper cover and a detachable lower cover as described above. Thus, the method of using a medical device may further comprise:

i. removing the removable lower cover, thereby removing the removable lower cap;

inserting the analyte sensor into the body by applying an insertion mechanism through the upper cover.

The housing may comprise at least one adhesive surface covered by at least one protective foil, wherein the protective foil is removed during step i. In particular, the removable lower cover may be removed by a rotational movement. However, other embodiments are possible. The upper cover may comprise at least one spring driver and the spring driver may tension thereby fixing the portions of the insertion mechanism before performing step i.

The proposed medical package, method for assembling a medical device and method for using a medical device provide a number of advantages over known devices and methods.

Generally, a common medical device may initially include two components. The two components may form a final product after application of the medical device to the body tissue of the user. The analyte sensor may typically have to be connected to the electronics unit via a user. This can lead to errors, and thus serious consequences (such as measurement errors), in particular during application. Therefore, in common medical devices, elaborate structures may often have to be implemented to circumvent the source of the error. The delicate structure may illustratively include a seal, an electrical contact, or a locking force.

In particular, where the analyte sensor is an electrochemical sensor, the electronic components may not typically be able to be processed via beam sterilization. However, the electrochemical sensor itself may typically only be able to be processed via beam sterilization, so that the functionality of the electrochemical sensor may be ensured.

Thus, the medical device according to the invention may comprise a combination of sterile compartments comprising the analyte sensor and the electronics unit (which may in particular be a single-use electronics unit). The sterile compartment may be integrated into the electronics unit.

A user may receive an "all-in-one" medical device without assembling the medical device. Medical devices may also be robust and inexpensive. The application of the medical device to the body tissue of the user may be implemented in a simple and intuitive manner.

After the medical device is used, portions of the medical device may remain at the user's body tissue. These portions may stay at the body tissue during the predetermined application period. Sterilization of the analyte sensor and subsequent assembly of the electronics unit may be accomplished during assembly of the medical device without opening the sealed compartment. Furthermore, a compact and small structure and simple assembly may be possible.

The housing (in particular the lower housing part) may be manufactured by injection moulding. Furthermore, the housing may comprise at least two predetermined breaking points. To assemble the medical device, an insertion cannula, septum, and/or analyte sensor may be inserted into the housing. Thereafter, the opening connecting the electronics compartment and the sensor compartment to each other may be sealed. The grips may be attached to the removable upper cap and the removable lower cap, respectively. Optionally, the grip may include at least one absorbent material or activated carbon. The assembly may be sterilized. The interconnect means may be placed on the lower housing part and may be secured to the lower housing part, typically via heat staking. The analyte sensor may be operatively connected to the interconnect means, in particular by a conductive adhesive material. The upper housing portion and the adhesive surface may be mounted. The adhesive surface may be mounted on the lower housing portion. The upper housing portion may be tightly mounted on the lower housing portion, illustratively via laser welding or adhesive bonding. The medical device may be primary packaged and optionally may be secondary packaged, wherein there is no significant need for packaging.

The package may be opened by a user during use of the medical device. The protective foil of the adhesive element can be removed and the removable lower cap can be removed. The medical device may be mounted on a body tissue of a user and the analyte sensor may be inserted into the body tissue. The insertion cannula may be removed from the body tissue. Thereafter, the removable upper cap may be removed from the medical device.

The diaphragm may be a separate component or may be manufactured by injection moulding. The barbs may be configured to prevent secondary use of the insertion cannula. The barb may be an additional component or may be integrated into one component. The insertion sleeve may be a tube or a stamped and bent part. The insertion cannula may be sealed by a septum. The insertion sleeve may thus in particular have a circular cross section. However, other embodiments (such as a flat design) are possible.

The electronics compartment may be a closed compartment or may be a potted block. In particular, the electronics compartment may be potted with an elastomeric material. Thereby, the flexible system is attachable to the body tissue of the user. This may result in improved wearing comfort. The electronic unit may particularly comprise a flexible printed circuit. Alternatively, the lower housing portion may comprise a hard structure for mounting the adhesive surface.

The insertion aid may comprise an upper cover. The cover may be part of the primary package. Further, the user may use the cover in order to use the medical device. The upper cover may be fixedly attached to the removable upper cap. The insertion aid may have a retraction mechanism configured to automatically retract the insertion cannula after the insertion cannula has been inserted into the body tissue. The removable lower lid of the insertion aid may be part of the primary package. Further, the removable lower cover may be fixedly connected to the removable lower cap. During opening of the removable lower cover, the removable lower cap may be opened simultaneously and the adhesive surface may be exposed. The frame may protect the insertion cannula, in particular before use of the medical device. The user may hold the medical device to the body tissue. The frame may require an initial force so that the user can accumulate force during manual insertion of the insertion cannula and can insert quickly. The frame may trigger a mechanism so that the insertion cannula may be automatically withdrawn as soon as the frame is compressed. In particular, the mechanism may be a spring pretensioner mechanism. The insertion aid may provide easy handling for the user.

The removable lower cap may comprise a base (basis) fixedly connected to the lower portion of the removable lower cap, illustratively via a snap connection, an adhesive bond and/or a longitudinal guide or transmission of force. The base may include a gripping surface for removal of the removable lower cover. The base may at the same time be a cover for the adhesive surface. This can lead to an extended shelf life of the adhesive surface. By removing the removable lower cover, the removable lower cap may be opened, the insertion cannula and the analyte sensor may be exposed, and the adhesive surface may be exposed simultaneously.

The upper cover of the insertion aid may comprise a spring driver. The spring driver may be configured to trigger insertion of the insertion cannula. The spring drive can be tensioned during the pressing of the electronic unit into the insertion aid. The insertion cannula may after insertion snap into an element that may trigger withdrawal of the insertion cannula.

The upper cover can comprise guide elements such that a circulation (circulation) of the electronic unit within the insertion aid is at least largely suppressed. Illustratively, the electronic unit may have a non-circular shape, there may be a guide rail in the shape of the exterior of the electronic unit within the electronic unit and/or there may be a special structure (such as a nut).

The insertion aid can be triggered via a release button. The medical device may be fired onto body tissue. At the bottom dead center, the spring driver may be released for withdrawal of the insertion cannula. The insertion aid can be removed from the body tissue. Alternatively, the user may manually remove the removable upper cap with the insertion cannula. Alternatively, the user may tilt the insertion aid, thereby removing the removable upper cap.

Tensioning of the medical device may be achieved via rotational movement. Thereby, the housing can be opened and lifted from the bottom. This may exemplarily be achieved by a suitably formed primary package. Thereby, the primary package can be coupled with the detachable lower cap. For example, the insertion aid may be configured to perform a rotational movement for individually detaching the removable lower cap. This can be achieved as follows: during tensioning of the medical device, both mechanisms may be tensioned. The first mechanism may refer to a spring system for inserting the analyte sensor into body tissue, as described above. The second mechanism may refer to rotational movement as described above. The electronic unit may be fixed at the top dead center in the insertion aid. As soon as the electronics unit is fixed, there is a rotational movement in the opposite direction.

Alternatively, other mechanisms may be applied to remove the removable upper cap from the electronic equipment compartment, such as a coupling mechanism that may be capable of being withdrawn, cut out of the break point with a knife, or close the removable upper cap in a simple manner. The removable upper cap need not be fixedly attached to the electronics compartment. To facilitate assembly of the medical device and/or to facilitate removal of the removable upper cap by a user, a coupling mechanism may be applied. Illustratively, a tube-in-tube system may be employed that includes a seal having a resilient block (such as rubber, thermoplastic polymer, or silicone).

To summarize, the following examples are potential embodiments of the present invention. However, other embodiments are possible.

Example 1: a medical device for detecting at least one analyte in a bodily fluid, the medical device comprising:

at least one analyte sensor having an insertable portion adapted to be at least partially inserted into a body tissue of a user;

at least one insertion cannula, wherein the analyte sensor is at least partially disposed within the insertion cannula;

at least one electronics unit, wherein the analyte sensor is operatively connected to the electronics unit;

at least one housing, wherein the housing comprises at least one electronics compartment configured to at least partially receive the electronics unit and at least one sensor compartment configured to at least partially receive the analyte sensor, wherein the sensor compartment forms a sealed compartment that receives at least the insertable portion of the analyte sensor, wherein the sealed compartment comprises at least one removable upper cap and at least one removable lower cap, wherein the removable overcap is configured for removal prior to insertion, thereby leaving the insertable portion open for insertion, wherein the insertion cannula is attached to the removable upper cap, wherein the removable upper cap is configured for removal after insertion, thereby removing the insertion cannula, wherein the electronics compartment at least partially encloses the sensor compartment.

Example 2: the medical apparatus according to the previous embodiment, wherein the electronics compartment and the sensor compartment are designed integrally.

Example 3: the medical apparatus according to the previous embodiment, wherein the electronics compartment and the sensor compartment form a single piece.

Example 4: the medical apparatus of any one of the preceding embodiments, wherein the electronics compartment and the sensor compartment share a common wall of the housing.

Example 5: the medical device according to the preceding embodiment, wherein the common wall is at least partially designed as a cylindrical ring surrounding the insertion sleeve.

Example 6: the medical device of any one of the preceding embodiments, wherein the sensor compartment comprises at least one intermediate component, wherein the removable upper cap and the removable lower cap are removably connected to the intermediate component.

Example 7: the medical device according to the previous embodiment, wherein the removable upper cap and the removable lower cap are removably connected to the intermediate part on opposite sides of the intermediate part.

Example 8: the medical device according to any one of the two preceding embodiments, wherein the intermediate part is at least partially designed as a cylindrical ring surrounding the insertion sleeve.

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

Example 10: the medical device according to the previous embodiment, wherein the upper and lower predetermined breaking points are annular breaking points.

Example 11: the medical apparatus of any one of the preceding five embodiments, wherein the electronics compartment is connected to the intermediate component.

Example 12: the medical apparatus according to the previous embodiment, wherein the electronics compartment at least partially encloses the intermediate component.

Example 13: the medical apparatus according to any one of the two preceding embodiments, wherein the electronics compartment and the intermediate component share at least one common wall.

Example 14: the medical apparatus according to the previous embodiment, wherein the intermediate part forms a wall of the electronics compartment.

Example 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 skin of a user.

Example 16: the medical device according to the previous embodiment, wherein the adhesive surface is attached to the housing directly or indirectly.

Example 17: the medical apparatus according to any one of the two preceding embodiments, wherein the adhesive surface is a lower surface of the electronics compartment.

Example 18: the medical apparatus according to the previous embodiment, wherein the insertable portion of the analyte sensor and the removable lower cap extend from a lower surface of the electronics compartment.

Example 19: the medical device of any one of the preceding four embodiments, wherein the adhesive surface has the shape of a circular ring surrounding the analyte sensor.

Example 20: the medical device of any one of the preceding five embodiments, wherein the adhesive surface comprises at least one of a plaster or an adhesive strip.

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

Example 22: the medical apparatus according to any one of the preceding embodiments, wherein the electronic unit is a single-use electronic unit.

Example 23: the medical device of any one of the preceding embodiments, wherein the sensor compartment is configured to provide sterile packaging for the insertable portion of the analyte sensor.

Example 24: the medical device of 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 the surrounding environment.

Example 25: the medical device according to any one of the preceding embodiments, wherein the removable upper cap partially surrounds the insertion cannula.

Example 26: the medical device of any one of the preceding embodiments, wherein the insertion cannula is fixedly attached to the removable upper cap.

Example 27: the medical device according to any one of the preceding embodiments, wherein the detachable upper cap and/or the detachable lower cap comprises at least one predetermined breaking point configured for enabling detachment of the detachable upper cap and/or the detachable lower cap by mechanical force.

Example 28: the medical apparatus of any one of the preceding embodiments, wherein the electronics compartment and the sensor compartment are connected to each other via at least one sealed opening, wherein the analyte sensor passes through the sealed opening.

Example 29: the medical apparatus according to the previous embodiment, wherein the analyte sensor is partially received in the electronics compartment and partially received in the sensor compartment, wherein the insertable portion is at least partially received in the sensor compartment.

Example 30: the medical apparatus according to any one of the two preceding embodiments, wherein the sealing opening comprises at least one sealing element, wherein the sealing element seals the sensor compartment from the electronics compartment.

Example 31: the medical device according to the previous embodiment, wherein the sealing element comprises at least one sealing lip.

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

Example 33: the medical device of any one of the preceding embodiments, wherein the insertion sheath includes at least one barb configured to prevent further movement of the insertion sheath after use.

Example 34: the medical apparatus according to any one of the preceding embodiments, wherein the medical apparatus further comprises at least one septum received in the sensor compartment, wherein the insertion cannula passes through the septum.

Example 35: the medical device according to the previous embodiment, wherein the insertion cannula is configured to be pulled through the membrane when the removable upper cap is removed from the housing.

Example 36: the medical device according to any one of the two preceding embodiments, wherein the membrane is configured for sealing the remainder of the sensor compartment after removal of the detachable upper cap.

Example 37: the medical device according to any one of the preceding three embodiments, wherein the septum is manufactured by injection moulding, in particular by two-component injection moulding.

Example 38: the medical device of any one of the preceding embodiments, wherein the removable upper cap and/or the removable lower cap comprises at least one grip.

Example 39: the medical device according to the previous embodiment, wherein the grip comprises at least one hygroscopic material, preferably at least one hygroscopic material, more preferably activated carbon.

Example 40: the medical apparatus of any one of the preceding embodiments, wherein the electronics compartment and the sensor compartment are at least partially formed by one single housing element.

Example 41: the medical device of any one of the preceding embodiments, wherein the housing is manufactured by injection molding.

Example 42: the medical apparatus according to any one of the preceding embodiments, wherein the electronic unit comprises at least one interconnect means, preferably a printed circuit board, more preferably a flexible printed circuit board.

Example 43: the medical device according to the previous embodiment, wherein the analyte sensor is electrically connected to the interconnect means, preferably via at least one of an electrically conductive adhesive material or a plug connection.

Example 44: the medical apparatus according to any one of the two preceding embodiments, wherein the interconnect means is fixedly positioned within the electronics compartment of the housing.

Example 45: the medical apparatus of any one of the preceding embodiments, wherein the electronics compartment comprises at least two housing portions.

Example 46: the medical device according to the previous embodiment, wherein the at least two housing parts comprise at least one lower housing part and at least one upper housing part.

Example 47: the medical device of any one of the preceding embodiments, wherein the lower housing portion comprises at least one lower surface configured for placement on the skin of a user.

Example 48: the medical device according to any one of the two preceding embodiments, wherein the upper housing part comprises one or more of a cap or an adhesive sealing material (more preferably at least one elastic material, in particular an elastic polymeric material).

Example 49: the medical device according to any one of the preceding three embodiments, wherein the upper housing part and the lower housing part are connectable via one or more of a form-fit connection, a force-fit connection or a connection by material bonding (more particularly, a connection achieved by using at least one adhesive and/or at least one bonding agent).

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

Example 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 insertion cannula after insertion of the insertable portion of the analyte sensor into the body tissue.

Example 52: the medical device according to the previous embodiment, wherein the retraction mechanism is at least partially comprised within the removable upper cap.

Example 53: the medical device according to any 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 insertion sleeve and biased so as to retract the insertion sleeve from the body tissue.

Example 54: the medical device according to any one of the preceding embodiments, wherein the medical device further comprises at least one insertion aid configured for enabling a user to drive the insertion cannula into the body tissue and insert the insertable portion of the analyte sensor.

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

Example 56: the medical device according to any one of the two preceding embodiments, wherein the insertion aid is at least partially coupled to the housing.

Example 57: the medical device of any one of the preceding three embodiments, wherein the insertion aid comprises a removable lower cap mechanically coupled to the removable lower cap, wherein the removable lower cap is configured such that removal of the removable lower cap removes the removable lower cap.

Example 58: the medical device of any one of the preceding four embodiments, wherein the insertion aid comprises at least one frame displaceable over the skin of the user and at least partially enclosing the housing and at least one upper cover movable against the frame, wherein the upper cover is directly or indirectly coupled to one or both of the insertion cannula or the removable upper cap such that movement of the upper cover against the frame drives the insertion cannula.

Example 59: a method for assembling a medical device according to any one of the preceding embodiments, wherein the method comprises:

a) providing at least one portion of the housing including at least a portion of the sensor compartment and the electronic device compartment having the removable upper cap and the removable lower cap;

b) placing the analyte sensor at least partially into the sensor compartment, wherein the analyte sensor and at least one portion of the housing provided in step a) form an intermediate product;

c) sterilizing the intermediate product; and

d) placing at least one electronic unit into at least one portion of the electronic equipment compartment provided in step a).

Example 60: the method according to the previous embodiment, wherein the method further comprises operatively connecting, in particular electronically connecting, the analyte sensor with the electronics unit.

Example 61: the method according to any of the two preceding embodiments, wherein the method further comprises attaching at least one further part of the electronic equipment compartment to at least one part of the electronic equipment compartment receiving the electronic unit, thereby forming the electronic equipment compartment with the electronic unit received therein.

Example 62: the method according to any of the preceding three embodiments, wherein the housing is manufactured by injection moulding.

Example 63: the method according to any of the preceding embodiments referring to a method for assembling a medical device, wherein, during step b), at least one further element is placed at least partially into the sensor compartment, the at least one further element comprising at least one element selected from the group consisting of: insertion sleeve, sealing element, in particular septum.

Example 64: the method according to any of the preceding embodiments referring to a method for assembling a medical device, wherein step c) is performed by at least one radiation based sterilization process (in particular, electron beam sterilization).

Example 65: the method according to any of the preceding embodiments referring to a method for assembling a medical device, further comprising at least one step of sterilizing the electronics unit, in particular by gas.

Example 66: the method according to any of the preceding embodiments referring to a method for assembling a medical device, wherein the electronics compartment is sealed by at least one lid after performing step d).

Example 67: a method of using a medical device according to any of the preceding embodiments relating to a medical device, the method comprising:

I. providing the medical device;

removing the detachable lower cap;

inserting the analyte sensor into the body tissue; and

removing the removable upper cap, thereby removing the insertion cannula from the medical device.

Example 68: the method of using a medical device according to the previous embodiment, wherein the medical device further comprises at least one insertion aid, wherein the insertion aid comprises at least one upper cover attached to the removable upper cap, wherein the insertion aid comprises at least one removable lower cover attached to the removable lower cap, wherein the method of using a medical device further comprises:

i. removing the removable lower cover, thereby removing the removable lower cap;

inserting the analyte sensor into the body by applying an insertion mechanism through the removable overcap.

Example 69: the method of using a medical device according to the previous embodiment, wherein the housing comprises at least one adhesive surface covered by at least one protective foil, wherein during step i.

Example 70: the method of using a medical device according to any one of the two preceding embodiments, wherein the removable lower cap is removed by a rotational movement.

Example 71: the method of using a medical device according to any one of the three preceding embodiments, wherein the upper cap comprises at least one spring driver, wherein the spring driver tensions thereby fixing portions of the insertion mechanism before performing step i.

Drawings

Further details of the invention can be taken from the following disclosure of preferred embodiments. The features of the embodiments may be implemented independently or in any arbitrary combination. The present invention is not limited to these examples. These embodiments are schematically depicted in the drawings. The same reference numbers in these figures refer to identical elements or functionally identical elements or elements corresponding to each other with respect to their function.

In the drawings:

1A-1D illustrate an exemplary embodiment of a method for assembling a medical device;

FIGS. 2A-2C illustrate an exemplary embodiment of a method of using a medical device;

FIG. 3 illustrates an exemplary embodiment of a removable upper cap in cross-sectional view;

fig. 4A to 4C show the electronic unit in different perspective views (fig. 4A and 4B) and an exemplary embodiment of the housing in a perspective view (fig. 4C);

FIGS. 5A-5B illustrate in cross-sectional views an exemplary embodiment of a medical device (FIG. 5A) and an exemplary cover (FIG. 5B); and

fig. 6A to 6B show an exemplary embodiment of a medical device in a cross-sectional view (fig. 6A) and a back view (fig. 6B).

Detailed Description

In fig. 1A to 1D, an exemplary embodiment of a method for assembling a medical device 110 is shown. Thus, fig. 1A to 1C show a semi-manufactured product 111 of a medical device 110, while the medical device 110 is illustrated in fig. 1D. However, other embodiments of the medical apparatus 110 are possible.

In a first step, as shown in fig. 1A, at least one portion 112 of a housing 114 is provided. The portion 112 may in particular be a lower housing portion 113 of a housing 114. The housing 114 may in particular be manufactured by injection moulding. The housing 114 may include at least one portion 115 of an electronics compartment 116 configured to at least partially receive an electronics unit 118, as will be described further below. In addition, housing 114 includes at least one sensor compartment 120 configured to at least partially receive an analyte sensor 122, as will be described further below.

The electronics compartment 116 and the sensor compartment 120 may be integrally designed. Thus, the electronics compartment 116 and the sensor compartment 120 may form a single piece. In particular, the electronics compartment 116 and the sensor compartment 120 may share a common wall 124 of the housing 114. The common wall 124 may be at least partially designed as a cylindrical ring 126. The electronics compartment 116 and the sensor compartment 120 may be connected to each other via at least one opening 128. In addition, the housing 114 may include a predetermined breaking point 130, which will be described further below.

In a second step, as shown in fig. 1B, an analyte sensor 122 is placed at least partially into the sensor compartment 120. The analyte sensor 122 may specifically be a transcutaneous sensor 132. Transcutaneous sensor 132 may be adapted to be arranged wholly or at least partially within a body tissue of a patient or user. For this purpose, the analyte sensor 122 includes an insertable portion 134. The insertable portion 134 can be configured to be inserted into body tissue. Furthermore, the analyte sensor 122 may comprise at least one further portion 136, which further portion 136 may be configured to stay outside the body tissue and may be connectable to the electronics unit 118. Accordingly, the further portion 136 may comprise one or more electrodes 138 configured for being connectable to the electronics unit 118. The analyte sensor 122 may pass through the opening 128. In particular, analyte sensor 122 is partially received in electronics compartment 116 and partially received in sensor compartment 120. The insertable portion 134 can be at least partially received in the sensor compartment 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 may seal the sensor compartment 120 from the electronics compartment 116. The sealing element 142 may comprise at least one sealing material, in particular a deformable sealing material, more preferably an adhesive material.

Further, at least one insertion sleeve 144 and at least one septum 146 may be placed at least partially into the sensor compartment 120. The analyte sensor 122 is at least partially disposed within the insertion sleeve 144. Illustratively, the insertion sleeve 144 may be a hollow tube and may have a circular cross-section. However, other embodiments are possible. In particular, the insertion sleeve 144 may be a slotted sleeve 148. The insertion cannula 144 may be configured to be inserted vertically into the body tissue of the user.

The septum 146 may be made of an elastomeric material, such as an elastomer, and may be manufactured by injection molding. The septum 146 may be penetrable by the insertion cannula 144. Further, the diaphragm 146 may be configured to seal the sensor compartment 120 from the surrounding environment. Further, at least two grips 150 may be installed. The first grip 152 may be located on a lower end 154 of the sensor compartment 120 and the second grip 156 may be located at an upper end 158 of the sensor compartment 120. Optionally, the first grip 152 and/or the second grip 156 may comprise at least one hygroscopic material.

The sensor compartment 120 forms a sealed compartment 162. The sealed compartment 162 receives the insertable portion 134 of the analyte sensor 122. Further, the sealed compartment 162 includes at least one removable upper cap 164 and at least one removable lower cap 166. The removable lower cap 166 is configured for removal prior to insertion, thereby leaving the insertable portion 134 open for insertion. The insertion cannula 144 is attached to the removable upper cap 164, and the removable upper cap 164 is configured for removal after insertion, thereby removing the insertion cannula 144. Thus, the removable upper cap 164 may partially surround the insertion sleeve 144. The insertion sleeve 144 may be fixedly attached to the removable upper cap 164.

The sensor compartment 120 may include at least one intermediate member 168. The electronics compartment 116 may at least partially surround the intermediate member 168. In particular, the electronics compartment 116 and the middle section 168 may share at least one common wall 176.

The removable upper cap 164 and the removable lower cap 166 may be removably connected to the intermediate member 168. In particular, the removable upper cap 164 and the removable lower cap 166 may be removably connected to the intermediate member 168 on opposite sides of the intermediate member 168. The removable upper cap 164 may be removably attached to the intermediate member 168 at least one upper predetermined breaking point 170, and the removable lower cap 166 may be removably attached to the intermediate member 168 at least one lower predetermined breaking point 172. The upper predetermined breaking point 170 and/or the lower predetermined breaking point 172 may be an annular breaking point 174.

The analyte sensor 122 and at least one portion 112 of the housing 114 form an intermediate product 178. Intermediate product 178 is sterilized. In particular, at least one radiation-based sterilization process, in particular electron beam sterilization, may be applied. Accordingly, the removable lower cap 166 may be a sterile cap 179 configured to provide a sterile package 181 to the insertable portion 134 of the analyte sensor 122.

In a further step, as illustrated in fig. 1C, at least one electronic unit 116 is placed into at least one portion 115 of the electronic device compartment 116. The electronics unit 118 may include at least one interconnect 180, preferably a printed circuit port 182. The analyte sensor 122 is operatively connected to the electronics unit 118. In particular, analyte sensor 122 may be electrically connected to interconnect 180, preferably via at least one of a conductive adhesive material or a plug connection. The interconnect 180 may be fixedly positioned within the electronics compartment 116 of the housing 114.

The electronics compartment 116 may include at least two housing portions 184. In particular, the electronics compartment 116 may include at least one lower housing portion 186 and at least one upper housing portion 188. In a further step, as shown in fig. 1D, the upper housing portion 188 may be mounted on the lower housing portion 186. The upper housing portion 188 may include a cover 190. The cover 190 may be connected to the lower housing portion 186 via one or more of a form-fit connection, a force-fit connection, or a connection by material bonding (more particularly, a connection achieved through the use of at least one adhesive and/or at least one bonding agent).

The lower housing portion 186 may include at least one lower surface 192 configured for placement on the skin of a user. Thus, at least one adhesive surface 194 may be mounted on the lower surface 192 of the lower housing portion 186. The adhesive surface 194 may be configured for attachment to the skin of a user. Thus, the adhesive surface 194 may include at least one of a plaster 196 or an adhesive strip 198. The binding surface 194 may have the shape of a circular ring that surrounds the analyte sensor 122. The insertable portion 134 and the removable lower cap 166 of the analyte sensor 122 may extend from the lower surface 192 of the electronics compartment 116.

Fig. 2A to 2C show an exemplary embodiment of a method of using a medical apparatus 110. In a first step, a medical apparatus 110 as illustrated in fig. 1D is provided. Accordingly, reference may be made to the description of FIG. 1D above. In fig. 2A to 2C, a multiplicity of intermediate stages 199 of the medical apparatus 110 is shown.

In a first step, as shown in fig. 2A, the removable lower cap 164 is removed. Thus, the insertion cannula 144 may be exposed, the insertion cannula 144 including the insertable portion 134 of the analyte sensor 122. Furthermore, a protective foil covering the adhesive surface 194, not shown in fig. 2A, may be removed and the adhesive surface 194 may be uncovered.

In a further step, as illustrated in fig. 2B, the analyte sensor 122 is inserted into the body tissue 200 of the user. Thereafter, the insertion sheath 144 may be withdrawn such that the insertion sheath 144 may be moved in a direction 202 opposite the insertion direction 160. Thus, the insertion sleeve 144 may be fully seated within the detectable upper cap 164.

In a further step, as shown in fig. 2C, the removable upper cap 164 as illustrated in fig. 2A and 2B is removed, thereby removing the insertion cannula 144 from the medical device 110. The sensor compartment 120 may be sealed by a membrane 146.

Fig. 3 illustrates an exemplary embodiment of a removable upper cap 164 in cross-sectional view. The removable upper cap 164 corresponds at least in large part to the removable upper cap 164 as illustrated in fig. 1A-2C. Accordingly, reference may be made to the description of fig. 1A through 2C above.

The removable upper cap 164 may include a septum 146. The membrane 146 may be located at one end 204 of the removable upper cap 164 opposite the electronics compartment 116. In addition, the insertion sheath 144 may include at least one barb 206. The barbs 206 may be configured to prevent further movement of the insertion sleeve 144 after use. The barbs 206 may surround the insertion sleeve 144 and may be located between the insertion sleeve 144 and the removable upper cap 164.

Fig. 4A and 4B show exemplary embodiments of the electronics unit 118 in different perspective views, and fig. 4C shows the corresponding housing 114 in a perspective view. The electronics unit 118 and housing 114 are at least largely similar to the electronics unit 118 and housing 114 as described in fig. 1A-2C. Therefore, reference may be made to the description of fig. 1A to 2C above.

The upper housing portion 188 of the housing 114 may form an enclosure 208 for electronic components of the electronics unit 118. Thus, the encapsulant 208 may be made of at least one elastomeric material. The encapsulation 208 may in particular be a potted block 210. Thus, the flexible system may be capable of attaching to the body tissue 210 of the user. This may result in improved wearing comfort. The housing 114 (in particular, the lower housing portion 186) may provide at least one hard region 212. The hardened region 212 may be configured for mounting the adhesive surface 194 as depicted in fig. 1A-2C.

Fig. 5A-5B illustrate an exemplary embodiment of the medical device 110 (fig. 5A) and an exemplary cap 220 (fig. 5B) in cross-sectional views. The medical apparatus 110 corresponds at least to a large extent to the medical apparatus 110 as described in fig. 1A to 2C. Therefore, reference may be made to the description of fig. 1A to 2C above.

The medical device 110 further comprises at least one insertion aid 214, the insertion aid 214 being configured for enabling 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 may at least partially surround the housing 114. Further, the insertion aid 214 may be at least partially coupled to the housing 114. In particular, the insertion aid 214 includes a removable lower cover 216 mechanically coupled to the removable lower cap 166. The removable lower cover 216 may be configured such that removal of the removable lower cover 216 removes the removable lower cap 166.

Furthermore, the insertion aid 214 may comprise at least one frame 218 which is displaceable over the skin of the user. The frame 218 may at least partially surround the housing 114. In addition, the insertion aid 214 may include at least one upper cover 220. The upper cover 220 may be coupled directly or indirectly to one or both of the insertion sleeve 144 or the removable upper cap 164 such that movement of the upper cover 220 against the frame 218 may drive the insertion sleeve 144. Thus, the upper cover 220 may be able to move against the frame 218. The frame 218 may require an initial force so that the user can accumulate force during manual insertion of the insertion cannula 144 and can insert quickly. The frame 218 may be configured to trigger the retraction mechanism 222 such that the frame 218 is automatically withdrawn upon compression of the insertion sleeve 144. In particular, the retraction mechanism 222 may include a spring pretensioner mechanism 224. Further details may be described below in fig. 5B.

The upper cover 220 of the insertion aid 214 as illustrated in fig. 5B may include a spring driver 228. The spring driver 228 may be configured to trigger insertion of the insertion sleeve 144. The spring driver 228 can be tensioned during the pressing of the electronic unit 118 into the insertion aid 214. The insertion sheath 144 may snap into the element 230 after insertion, which may be configured to trigger withdrawal of the insertion sheath 144. The insertion aid 214 may be triggered via a release button 232. Furthermore, the insertion aid 214 may comprise at least one spring 234. In particular, the insertion aid 214 may be configured such that the spring 234 may be released at bottom dead center for withdrawing the insertion sleeve 144.

Fig. 6A and 6B show an exemplary embodiment of a medical device 110 in a cross-sectional view (fig. 6A) and a back view (fig. 6B). The medical apparatus 110 corresponds at least to a large extent to the medical apparatus 110 as described in fig. 1A to 2C. Therefore, reference may be made to the description of fig. 1A to 2C above.

Furthermore, an exemplary embodiment of an insertion aid 214 is shown. The insertion aid 214 may include a removable lower cap 216. The removable lower cover 216 may include a base 236, the base 236 being connected to the removable lower cap 166, illustratively via a snap connection 238. The base 236 may comprise a grip 240 for detaching the removable lower cover 216, in particular via a rotational movement schematically illustrated with arrow 242. Base 236 may simultaneously be a cover 244 for adhesive surface 194. During removal of removable lower cap 216, removable lower cap 166 may be opened, insertion sleeve 144 and analyte sensor 122 may be exposed, and adhesive surface 192 may be simultaneously exposed.

List of reference numerals

110: medical device

111: semi-finished product

112: in part

113: lower housing part

114: shell body

115: in part

116: electronic device compartment

118: electronic unit

120: sensor compartment

122: analyte sensor

124: common wall

126: cylindrical ring

128: opening of the container

130: predetermined breaking point

132: transcutaneous sensor

134: insertable portion

136: the other part

138: electrode for electrochemical cell

140: sealed opening

142: sealing element

144: insertion sleeve

146: diaphragm

148: slotted bushing

150: handle of hand grip

152: first handle

154: lower end part

156: second handle

158: upper end part

160: direction of insertion

162: sealed compartment

164: detachable upper cap

166: detachable lower cap

168: intermediate member

170: upper predetermined breaking point

172: lower predetermined breaking point

174: annular breaking point

176: common wall

178: intermediate product

179: sterile cap

180: interconnection device

181: aseptic package

182: printed circuit board

184: housing part

186: lower housing part

188: upper housing part

190: cover

192: lower surface

194: adhesive surface

196: plaster

198: adhesive tape

199: intermediate stage

200: body tissue

202: direction of rotation

204: end part

206: barb

208: packaging part

210: potted block

212: hard region

214: insertion aid

216: detachable lower cover

218: frame structure

220: upper cover

222: retracting mechanism

224: spring pretension mechanism

226: spring driver

228: spring driver

230: component

232: release button

234: spring

236: base part

238: snap-in connector

240: grasping part

242: arrow head

244: and (7) a cover.

Claims (13)

1. A medical device (110) for detecting at least one analyte in a bodily fluid, the medical device (110) comprising:

at least one analyte sensor (122) having an insertable portion (134) adapted to be at least partially inserted into body tissue (200) of a user,

at least one insertion cannula (144), wherein the analyte sensor is at least partially disposed inside the insertion cannula (144);

at least one electronics unit (118), wherein the analyte sensor (122) is operatively connected to the electronics unit (118);

at least one housing (114), wherein the housing (114) comprises at least one electronics compartment (116) configured to at least partially receive the electronics unit (118) and at least one sensor compartment (120) configured to at least partially receive the analyte sensor (122), wherein the sensor compartment (120) forms a sealed compartment (162) that receives at least the insertable portion (134) of the analyte sensor (122), wherein the sealed compartment (162) comprises at least one removable upper cap (164) and at least one removable lower cap (166), wherein the removable lower cap (166) is configured for removal prior to insertion, thereby opening the insertable portion (134) for insertion, wherein the insertion cannula (144) is attached to the removable upper cap (164), wherein, the detachable upper cap (164) is configured for detachment after insertion, thereby removing the insertion cannula (144), wherein the electronics compartment (116) at least partially encloses the sensor compartment (120), wherein the electronics compartment (116) and the sensor compartment (120) are designed integrally.

2. The medical device (110) according to claim 1, wherein the sensor compartment (120) comprises at least one intermediate component (168), wherein the removable upper cap (164) and the removable lower cap (166) are removably connected to the intermediate component (168).

3. The medical device (110) according to claim 2, wherein the detachable upper cap (164) is detachably connected to the intermediate part (168) at least one upper predetermined breaking point (170), and/or wherein the detachable lower cap (166) is detachably connected to the intermediate part (168) at least one lower predetermined breaking point (172).

4. The medical apparatus (110) according to claim 2 or 3, wherein the electronics compartment (116) is connected to the intermediate component (168).

5. The medical apparatus (110) of claim 4, wherein the electronics compartment (116) at least partially encloses the intermediate component (168).

6. The medical device (110) according to claim 1 or 2, wherein the insertion cannula (144) is fixedly attached to the detachable upper cap (164).

7. The medical apparatus (110) according to claim 1 or 2, wherein the electronics compartment (116) and the sensor compartment (120) are connected to each other via at least one sealed opening (140), wherein the analyte sensor (122) passes through the sealed opening (140).

8. The medical apparatus (110) of claim 7, wherein the analyte sensor (122) is partially received in the electronics compartment (116) and partially received in the sensor compartment (120), wherein the insertable portion (134) is received in the sensor compartment (120).

9. The medical device (110) according to claim 1 or 2, wherein the medical device (110) further comprises at least one membrane (146) received in the sensor compartment (120), wherein the insertion cannula (144) passes through the membrane (146), wherein the membrane is configured for sealing a remaining portion of the sensor compartment (120) after removal of the removable upper cap (164).

10. The medical apparatus (110) according to claim 1 or 2, wherein the electronics compartment (116) comprises at least two housing portions (184), wherein the at least two housing portions (184) comprise at least one lower housing portion (186) and at least one upper housing portion (188).

11. The medical device (110) according to claim 1 or 2, wherein the medical device (110) further comprises at least one insertion aid (214), the at least one insertion aid (214) being configured for enabling 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).

12. A method for assembling a medical device (110) according to claim 1 or 2, wherein the method comprises:

a) providing at least one portion (112) of the housing (114), the at least one portion (112) of the housing (114) including at least a portion of the sensor compartment (120) and the electronics compartment (116) with the removable upper cap (164) and the removable lower cap (166);

b) placing the analyte sensor (122) at least partially into the sensor compartment (120), wherein the analyte sensor (122) and the at least one portion (112) of the housing (114) provided in step a) form an intermediate product (178);

c) sterilizing the intermediate product (178); and

d) placing at least one electronic unit (118) into at least one portion of the electronic equipment compartment (116) provided in step a).

13. The method for assembling a medical device (110) according to claim 12, further comprising at least one step of sterilizing the electronics unit (118).