WO2025238030A1

WO2025238030A1 - Sealing element for sensor fixation in cgm patch

Info

Publication number: WO2025238030A1
Application number: PCT/EP2025/063110
Authority: WO
Inventors: Olaf Roscher
Original assignee: Roche Diabetes Care GmbH
Current assignee: Roche Diabetes Care GmbH
Priority date: 2024-05-16
Filing date: 2025-05-14
Publication date: 2025-11-20
Anticipated expiration: 2026-11-16

Abstract

The invention relates to a medical device (100) for detecting at least one analyte in a body fluid, the medical device (100) comprising: an analyte sensor (104) having an insertable portion (104a) adapted for at least partially being inserted into a body tissue of a user; an insertion cannula, wherein the analyte sensor (104) is at least partially placed inside the insertion cannula; a detachable cannula head (107), wherein the insertion cannula is attached to the detachable cannula head (107), wherein the detachable cannula head (107) is configured for detachment after insertion, thereby removing the insertion cannula; at least one housing (110), wherein the housing (110) comprises at least one sensor fixation component (103) configured to at least partially receive the analyte sensor (104) and configured to at least partially receive the detachable cannula head (107); and at least one sealing element (108) configured for providing a sealing between the at least one sensor fixation component (103) and the detachable cannula head (107).

Description

Sealing element for sensor fixation in CGM patch

Field of the invention

The invention relates to a medical device for detecting at least one analyte in a body fluid and to a method for assembling said medical device. The device and method according to the present invention may be used for long-term monitoring of an analyte concentration in a body fluid, such as for long-term monitoring of a blood glucose level or of the concentration of one or more other types of analytes in a body fluid. The invention may be applied in the field of home care as well as in the field of professional care, such as in hospitals. Other applications are also feasible.

State of the art

For medical devices that provide long-term monitoring of an analyte concentration in a body fluid, such as continuous glucose monitoring (CGM) systems, the protection of the analyte sensor during manufacturing and use is a challenge. In particular, it is a challenge to seal the analyte sensor during assembling.

Current approaches for sealing the analyte sensor are cumbersome, not sufficiently robust and require difficult manufacturing processes.

For example, current approaches require the use of two-component parts with rather intricate geometries and small sizes that are difficult to manufacture and to handle.

Furthermore, current approaches can involve not environmentally friendly techniques and materials, since they inter alia require the use of glue to provide sealing effects.

Problem

It is therefore an objective of the present invention to provide improved means for protecting the analyte sensor of a medical device during manufacturing and use.

In particular, it is an objective to provide a medical device comprising an analyte sensor for detecting at least one analyte in a body fluid, which has an improved protection of the analyte sensor.

Furthermore, it is an objective to facilitate and simplify the assembly and use of a medical device comprising an analyte sensor.

Solution

According to the present invention, at least one of said objectives is achieved by the subjectmatter of the independent claims. Advantageous embodiments and further developments are the subject-matter of the dependent claims.

Further advantageous embodiments and further developments are disclosed throughout the specification.

For example, a medical device for detecting at least one analyte in a body fluid may comprise:

• an analyte sensor having an insertable portion adapted for at least partially being inserted into a body tissue of a user

• an insertion cannula, wherein the analyte sensor is at least partially placed inside the insertion cannula or is at least partially placeable inside the insertion cannula;

• a detachable cannula head, wherein the insertion cannula is attached to the detachable cannula head and wherein the detachable cannula head is configured for detachment after insertion, thereby removing the insertion cannula;

• at least one housing, wherein the housing comprises at least one sensor fixation component configured for at least partially receiving the analyte sensor and configured for at least partially receiving the detachable cannula head; and

• at least one sealing element configured for providing a sealing between the at least one sensor fixation component and the detachable cannula head.

The above exemplary described medical device allows dispensation with the need of using any glue to establish a sealing between the at least one sensor fixation component and the detachable cannula head. In particular, in mass production processes it is beneficial that the use of glue can be avoided, as the use of such glue in mass production processes is complicated, resourceintensive and error-prone and last but not least not environmentally friendly.

Furthermore, the risk of the glue contaminating or damaging sensitive parts of the medical device, such as electronic components inside the housing, can be eliminated.

Furthermore, the above exemplary described medical device allows to dispense with the need of integrating a sealing element into the cannula head, thereby avoiding the need for complicated and intricate manufacturing processes of two-component parts, such as a cannula head with integrated sealing element, which are difficult to handle due to their small sizes and complex geometries.

Hence, the above and herein exemplary described medical device and the above and herein exemplary described sealing element of said medical device can fully replace current complex and costly techniques for providing sealings or sterile barriers in medical devices, in particular in detecting at least one analyte in a body fluid. Hence, the assembly and manufacturing process can be simplified and can be made more robust and more cost-efficient.

The above and herein exemplary described sealing element can easily be inserted or mounted to the at least one sensor fixation component during the assembly or manufacturing process and provides a robust protection for the analyte sensor against the environment and also against mechanical stress, e.g. against mechanical stress occurring during transport and/or use of the medical device.

In particular, the sealing element can provide a sterile barrier, in particular a sterile barrier against unwanted contaminants, e.g. gaseous and/or solid and/or liquid contaminants, from the environment of the medical device that may be harmful to the analyte sensor, e.g. may be harmful to the sterility of the analyte sensor, and that may jeopardize the safe use of the medical device.

The term “sensor fixation component” can inter alia refer to a component of the medical device that is configured for fixating and securing a part of the analyte sensor, in particular the insertable portion of the analyte sensor, in a desired position inside the housing for optimal insertion of the insertable portion of the analyte sensor into a body tissue of a user. Furthermore, the sensor fixation component can inter alia refer to a component that is configured to receive and guide the cannula head such that the insertion cannula attached to said cannula head can engage with the insertable portion of the analyte sensor in a well-defined and precise manner to facilitate the accurate insertion of the insertable portion of the analyte sensor into a body tissue of a user.

The sensor fixation component can have any shape that allows it to carry out the above described functions of fixating or securing part of the analyte sensor, in particular the insertable portion of the analyte sensor, in a desired position inside the housing, and of receiving and guiding the cannula head such that the insertion cannula attached to said cannula head can engage with the insertable portion of the analyte sensor.

For example, the sensor fixation component can comprise a sleeve, e.g. a guide sleeve, that can have a tubular shape and that can have two ends, e.g. a first end, e.g. a distal end, and a second end, e.g. a proximal end, wherein one end is configured for receiving and guiding the cannula head and wherein the second end is configured for fixating or securing part of the analyte sensor, in particular the insertable portion, in a desired position inside the housing such that the insertion cannula attached to said cannula head can engage with the insertable portion of the analyte sensor.

The sensor fixation component can further be configured such as to allow the insertion cannula to be inserted vertically or at an angle of 90° to 30° to the body tissue of the user. Furthermore, the sensor fixation component can have flanges and/or protrusions and/or grooves at at least one of its ends that can facilitate mounting the sensor fixation component inside the housing and/or that can facilitate fixating or securing part of the analyte sensor, in particular the insertable portion of the analyte sensor and/or that can facilitate receiving or mounting of fitting the sealing element to the sensor fixation component.

Furthermore, the end of the sensor fixation component that is facing the skin of a user during use of the medical device, i.e. the proximal end, can comprise a funnel-like structure that can further facilitate the insertion of the insertable portion of the analyte sensor into body tissue of a user via the insertion cannula of the cannulate head that is received and guided by the sensor fixation component.

The term “cannula head” or “needle head” may refer to an arbitrarily shaped component to which the insertion cannula can be fixedly attached and which can be gripped or handled by a hand of a user or by a machine, e.g. by a mechanical gripper, in order to handle the insertion cannula.

The term "insertion cannula" may generally refer to an arbitrary element which may be insertable into the body tissue of the user, particularly in order to deliver or to transfer a further element, in particular the insertable portion of the analyte sensor. The insertion cannula may specifically be or may comprise a hollow tube or a hollow needle that can have a lateral opening or slit for receiving and accommodating the insertable portion of the analyte sensor.

Said medical device can inter alia be a wearable medical device that the user can wear on his body. For example, the medical device can be a patch-type device, wherein at least some part of the housing can be realized as a patch unit that is placeable and wearable on the skin of the user.

The housing of the medical device can have an arbitrary shape which allows accommodating at least parts of the analyte sensor and the sensor fixation component. The housing can further accommodate further components, such as an electronics component. The analyte sensor can be operably connected to the electronics unit. The electronics unit can comprise at least one interconnect device, e.g. a printed circuit board (PCB), with at least one electronic component, e.g. a processor and/or transmitter and/or transceiver and/or battery, attached thereto.

Furthermore, the housing can comprise a base, e.g. a flat base, wherein the base may directly or indirectly be attached to the skin of the user. For example, the bottom side of the base of the housing may comprise at least one adhesive element, e.g. a plaster or adhesive strip, for attaching the housing to the skin of the user.

As further used herein, the term “body fluid” generally may refer to a fluid which typically is present in a body or body tissue of the user or the patient and/or which may be produced by the body of the user or the patient. As an example for body tissue, interstitial tissue may be named. Thus, as an example, the body fluid may be selected from the group consisting of blood and interstitial fluid. However, additionally or alternatively, one or more other types of body fluids may be used, such as saliva, tear fluid, urine or other body fluids. During detection of the at least one analyte, the body fluid may be present within the body or body tissue. Thus, specifically, the analyte sensor may be configured for detecting at least one analyte in a body tissue.

As further used herein, the term “analyte” may refer to an arbitrary element, component or compound which may be present in the body fluid and the presence and/or the concentration of which may be of interest for the user, the patient or medical staff such as a medical doctor. Particularly, the analyte may be or may comprise an arbitrary chemical substance or chemical compound which may take part in the metabolism of the user or the patient, such as at least one metabolite. As an example, the at least one analyte may be selected from the group consisting of glucose, cholesterol, triglycerides, lactate. Additionally or alternatively, however, other types of analytes may be used and/or any combination of analytes may be determined. The detection of the at least one analyte specifically may be an analyte-specific detection.

The medical device can specifically be configured as a continuous analyte monitoring system, e.g. as a continuous glucose monitoring (CGM) system.

As further used herein, the term “analyte sensor” may generally refer to an arbitrary element which is adapted to perform the above-mentioned process of the detection and/or which is adapted to be used in the above-mentioned process of the detection. Thus, the analyte sensor specifically may be adapted to determine the concentration of the analyte and/or a presence of the analyte.

The analyte sensor specifically may be an electrochemical sensor. As used herein, an “electrochemical sensor” generally is a sensor which is configured to conduct an electrochemical measurement in order to detect the at least one analyte contained in the body fluid. The term “electrochemical measurement” refers to a detection of an electrochemically detectable property of the analyte, such as an electrochemical detection reaction. Thus, for example, the electrochemical detection reaction may be detected by comparing one or more electrode potentials. The electrochemical sensor specifically may be adapted to and/or may be usable to generate at least one electrical sensor signal which directly or indirectly indicates the presence and/or the extent of the electrochemical detection reaction, such as at least one current and/or at least one voltage. The detection may be analyte-specific. The measurement may be a qualitative and/or a quantitative measurement. Still, other embodiments are feasible.

The analyte sensor may particularly be a transcutaneous sensor. As used herein, the term "transcutaneous sensor" generally refers to an arbitrary sensor which is adapted to be fully or at least partially arranged within the body tissue of the patient or the user. For this purpose, the analyte sensor comprises the insertable portion. Furthermore, the analyte sensor, in particular its insertable portion, can be flexible.

The insertion cannula e.g. may comprise at least one cross-section selected from the group consisting of: round, elliptical, U-shaped, V-shaped. Still, other embodiments are feasible. Specifically, the insertion cannula may be a slotted cannula. The insertion cannula may be configured to be inserted vertically or at an angle of 90° to 30° to the body tissue of the user.

The sealing element that is configured for providing a sealing between the at least one sensor fixation component and the detachable cannula head of the medical device may be made of or comprise an elastic material, e.g. an elastomer material.

Stated differently, the sealing element is neither stiff nor rigid but flexible.

For example, the sealing element and/or the detachable cannula head may comprise an elastomer material with a shore hardness in the range between Shore A 30 to 80 according to ISO 7619-1.

Hence, the sealing element can be deformed to adapt to the shape of the sensor fixation component.

This can facilitate providing a tighter sealing that can better seal any gaps between the cannula head and the sensor fixation component.

Furthermore, this can facilitate protecting the analyte sensor from mechanical stress due to vibrations or impact shocks or movements, as the flexible sealing element can absorb some of the mechanical stress when it is deformed.

It is further noted that the thickness, e.g. the wall thickness, of the sealing element can be in the range of 0.05 mm - 1.00 mm, in particular in the range of 0.10 mm - 0.50 mm.

The sealing element can be realized as an insert, wherein said insert can be inserted between the at least one sensor fixation component and the detachable cannula head.

Furthermore, it is possible that the sealing element can also be realized as a two-component-part inside the sensor fixation component.

This can facilitate assembly and manufacturing of the medical device, as the step of inserting the sealing element into the housing of the medical device is simplified.

The surface of the sealing element that is configured to be in contact with the detachable cannula head can have a contour that is complementary to the contour of the surface of the detachable cannula head the sealing element is configured to be in contact with. Exemplary complementary surface contours may for example refer to corresponding surface contour pairs, where one component, e.g. the sealing element or the sensor fixation component, has a positive surface contour, e.g. a convex surface contour, and the other component, e.g. the sealing element or the sensor fixation component, has a negative surface contour, e.g. a concave surface contour.

This can further improve the tightness of the fit between the sealing element and the cannula head, thereby providing a better sealing between the cannula head and the sensor fixation component.

Stated differently, the sealing element can be formed with a contour or profile, e.g. surface profile, that is complementary to the contour or profile, e.g. surface profile, of the cannula head.

For example, the sealing element can be formed with a negative contour or negative profile, e.g. negative surface profile, of the cannula head.

Furthermore, the detachable cannula head and the at least one sealing element can be connected to each other via an interference fit connection when the sealing element is providing the sealing between the at least one sensor fixation component and the detachable cannula head.

Herein, an interference fit connection, that can also be referred to as a pressed fit or friction fit connection, can be understood as a form of fastening between the cannula head and the sealing element that produces a connection which is held together by friction after the cannula head and the sealing element are pushed together when the cannula head is inserted into the sensor fixation component.

Stated differently, the tolerance field of the detachable cannula head and the tolerance field of the sensor fixation component with sealing element are defined in such a way that the dimension of the cannula head, in this case its minimum dimension, is higher than the highest tolerated dimension of the sensor fixation component with sealing element. Hence, the cannula head must then be inserted into the sensor fixation component with the sealing element using energy, i.e. exerting a force.

Consequently, a tight and sealed interference fit can be achieved between the cannula head and the sensor fixation component.

The surface of the sealing element that is configured to be in contact with the detachable cannula head can comprise at least one bulge or lip.

This can further facilitate the tightness of the fit between the sealing element and the cannula head, thereby providing a better sealing between the cannula head and the sensor fixation component. In particular, the presence of said bulge or lip of the sealing element can further facilitate obtaining a tight and sealed interference fit between the cannula head and the sensor fixation component.

Alternatively or in addition, the detachable cannula head may also comprise at least one bulge or lip.

For example, the surface of the detachable cannula head that is configured to be in contact with the sealing element can comprise at least one bulge or lip. Said least one bulge or lip can be made of or comprise a similar material as the sealing element, e.g. an elastic material, e.g. an elastomer material.

The possible presence of said bulge or lip of the cannula head can further contribute to obtaining a tight and sealed fit, e.g. interference fit, between the sealing element and the cannula head, thereby providing a better sealing between the cannula head and the sensor fixation component.

For example, in case both the cannula head and the sealing element have bulges, said bulges can be arranged such that the bulge of the detachable cannula head can engage behind the bulge of the sealing element when the sealing element is providing the sealing between the at least one sensor fixation component and the detachable cannula head, i.e. when the detachable cannula head is inserted into the sensor fixation component.

In other words, when the detachable cannula head is in a/its final insertion position in the sensor fixation component, the bulge of the cannula head can be positioned at a different position, e.g. different vertical position, than the position, e.g. the vertical position, of the bulge of the sealing element. For example, the bulge of the cannula head can be positioned below the bulge of the sealing element when the detachable cannula head is inserted into or mated with the sensor fixation component.

This can further contribute to establishing a tighter and better sealed fit, e.g. interference fit, between the cannula head and the sensor fixation component.

The possible bulges or lips of the sealing element and/or the possible bulges or lips of the detachable cannula head can take on various shapes.

For example, said bulges or lips from the sealing element and/or from the cannula head can have a rectangular shape or circular shape or half-circular shape or elliptical shape or half-elliptical shape.

The sealing element can be an annular element that can be configured to at least partially or fully surround the cannula head. Stated differently, the sealing element can comprise a central opening for receiving the insertion cannula and wherein said central opening can at least partially or fully surround the detachable cannula head.

Furthermore, said bulges or lips can be annular bulges or annular lips that can fully surround the cannula head.

However, it is also possible that said bulges or lips are configured for only partially surrounding the cannula head.

The sealing element may further comprise a septum or membrane that is pierceable by the insertion cannula.

Said pierceable septum or pierceable membrane can be self-sealing or re-sealing septum or membrane that can self-seal or re-seal when the insertion cannula is retracted, e.g. retracted from the body tissue of a user.

The possible septum or membrane can inter alia provide an additional protection of the analyte sensor after the insertable portion of the analyte sensor has been inserted into body tissue of a user and/or after the insertion cannula has been removed.

The possible septum or membrane can provide an environmental protection against moisture and/or an ambient atmosphere, and/or unwanted gaseous and/or liquid and/or solid contaminants.

The possible septum or membrane can be made of or comprise the same material as the sealing element. Hence, it can comprise an elastic material, e.g. an elastomer material

The possible septum or membrane can be an integral part of the sealing element or can be a separate part.

The periphery of the sealing element, i.e. the non-central part or the part that is distal to/far from the part of the sealing element that faces the cannula head can have a surface contour shape, e.g. a U-shape, that can engage with a groove of the at least one sensor fixation component via a press-fit connection. Said possible groove of the at least one sensor fixation component can optionally further be filled with glue to further improve the connection with the sealing element.

As previously indicated, the sensor fixation component can have two ends. Furthermore, as also previously indicated, the sensor fixation component can have flanges and/or protrusions and/or grooves at at least one of its ends.

Said possible flanges can partially or fully surround the sensor fixation component, e.g. can partially or fully surround a central part of the sensor fixation component At least one of said possible grooves of the sensor fixation component, e.g. a groove at a flange, can serve as said possible groove that can engage with the periphery of the sealing element, e.g. with a surface contour shape, e.g. a U-shape, of the periphery of the sealing element to provide a press-fit connection between the sealing element and the sensor fixation component.

This can facilitate and ensure a robust and tight connection between the sealing element and the sensor fixation component.

Furthermore, the surface profile of the sealing element can follow at least partially or fully the surface profile of the at least one sensor fixation component.

For example, the sealing element can at least partially or fully cover the surface of the at least one sensor fixation component.

In other words, the sealing element can be configured and shaped to sit like a glove on the at least one sensor fixation component, i.e. the dimensions and shape of the sensor fixation component and the sealing element can be adapted to each other.

As previously indicated, the at least one housing of the medical device may comprises multiple parts. For example, the housing may comprise a cover and a base, wherein the at least one sensor fixation component can be mountable or attachable to the base.

The cover can then cover the base and can cover partially or fully the sensor fixation component.

The sensor fixation component can be dimensioned/sized such that it can be fully covered by the cover.

However, it is also possible that the sensor fixation component can be dimensioned/sized such that a part of the sensor fixation component protrudes from the housing, e.g. the cover of the housing may comprise an opening/through hole that can allow the sensor fixation component to protrude from the housing.

The at least one sealing element may then further be configured for or dimensioned such as to provide a sealing, e.g. a radial sealing and/or axial sealing, between the at least one sensor fixation component and the cover of the housing.

Hence, the at least one sealing element can also provide a sealing for the cover, i.e. for the housing, in particular both a radial and axial sealing, of the medical device to protect it from the environment against unwanted gaseous or liquid or solid contaminants. In addition, a/the sealing element can protect the cover, i.e. the housing, against harmful external forces and mechanical stress, e.g. vibrations or impact shocks or other harmful movements. For example, a part of the possible external forces and mechanical stresses the medical device may be subjected to during assembly or transport or use could be absorbed by movement and/or deformation of the sealing element.

Hence, the herein exemplary described sealing element for use in a medical device provides numerous advantages regarding the protection of the medical device.

The at least one sealing element may further be configured or dimensioned such that it also protrudes from the housing, e.g. is protruding outward from the housing via an opening in the cover of the housing.

The at least one sealing element may also be configured or dimensioned such that its height does not extend beyond the height of the housing of the medical device.

The possible cover of the housing may also serve to retain the sealing element in place and to avoid that the sealing element is removed when the cannula head and its insertion cannula are removed or retracted.

An exemplary method for assembling a medical device for detecting at least one analyte in a body fluid and that can have any of the above exemplary described features may comprise one, some or all of the following exemplary steps, wherein said steps are provided in chronological order:

• providing the housing of the medical device, the housing comprising the at least one sensor fixation component,

• placing the analyte sensor at least partially into the at least one sensor fixation component,

• mounting the sealing element onto the at least one sensor fixation component to at least partially cover the at least one sensor fixation component,

• and mounting the detachable cannula head with the insertion cannula onto the at least one sensor fixation component, e.g. inserting the detachable cannula head with the insertion cannula into the sensor fixation component.

The following figures illustrate exemplary the following aspects of the invention. It is emphasized again that the figures merely serve to illustrate certain aspects of the invention and, in particular, merely serve to foster the technical understanding of some features of the claims.

Fig. 1a: Exemplary medical device

Fig. 1b: Exemplary zoom of Fig. 1a with exemplary sealing element

Fig. 1 c: Alternative exemplary sealing element

Fig. 1d: Further alternative exemplary sealing element

Fig. 1 e: Further alternative exemplary sealing element

Fig. 1f: Exemplary alternative cannula head

Fig. 1a shows an exemplary cross-section of an exemplary medical device 100, e.g. across a longitudinal central axis of a patch-type medical device, which can have any of the above described features. In the shown example, the medical device 100 has a housing 110 that comprises two parts, a cover 101 and a base 102, that can be mounted to each other in a detachable or non-detachable manner.

It is to be noted that all figures Fig. 1a, Fig. 1 b, Fig. 1c, Fig. 1 d, Fig. 1e and Fig. 1f show the same exemplary medical device 100, and identical reference signs across said figures can denote the same/identical components. The only differences between the figures relate to different implementations of the sealing element and the cannula head. It is further noted that Fig. 1a does not show a sealing element and does not show a cannula head, since Fig. 1a merely intends to show an exemplary general overview of the housing 110 of the medical device 100.

The medical device 100 comprises an exemplary flexible analyte sensor 104 having an insertable portion 104a that is adapted for at least partially being inserted into a body tissue of a user (not shown). It is to be noted that for easier readability of Fig. 1a, only a part of the insertable portion 104a is shown, i.e. the part that engages first with the insertion cannula (not shown) when the insertion cannula is inserted to insert the insertable portion 104a into a body tissue of a user.

The analyte sensor 104 can be operably connected to an electronics unit 105, e.g. a printed circuit board, which can be accommodated in the housing 110 and that can comprise one or more electronic components (not shown), e.g. a processor and/or transmitter and/or transceiver and/or battery.

The lower side or bottom side 102b of the base 102 can be configured for contact with or attachment to the skin of a user, such that the medical device 100 can be worn on the skin by a user during use. For example, said bottom side 102b may comprise an adhesive for attaching the medical device 100 to the skin of a user.

The housing 110 exemplary further accommodates an exemplary sensor fixation component 103 that is mounted to the base over an exemplary opening 102a, i.e. a through hole or passageway, in the base for allowing the insertion cannula (not shown) to pass through when inserting the insertable portion 104a of the analyte sensor into the body tissue of a user.

In the shown example, the sensor fixation component 103 and the exemplary opening 102a are arranged at a central position in the housing 110. This arrangement is exemplary only; other noncentral arrangements of the sensor fixation component 103 and the exemplary opening 102a are conceivable too.

The cover 101 may comprise an opening 101a that allows the cannula head (not shown) to be inserted into the sensor fixation component 103.

The reference sign 106 marks an exemplary section of Fig. 1a, i.e. of the medical device 100 that is shown enlarged in Fig. 1 b, Fig. 1c, Fig. 1d, Fig. 1e and Fig. 1f.

Fig. 1 b exemplary shows an enlarged view of the section of Fig. 1a denoted with reference sign 106, and wherein the exemplary sensor fixation component 103 of the exemplary medical device 100 can be seen in more detail.

Fig. 1 b additionally shows an exemplary sealing element 108 that is mounted to the sensor fixation component 103.

Furthermore, Fig. 1 b shows an exemplary cannula head 107. In the shown exemplary configuration, the cannula head 107 is shown in a position wherein it is inserted into/received by the sensor fixation component 103. The exemplary cannula head 107 can be a detachable cannula head 107 configured for being attached to or inserted into the sensor fixation component 103 and configured for being detachable from the sensor fixation component 103, e.g. configured for being retracted from the sensor fixation component 103, i.e. from the medical device 100, after insertion of the insertable portion 104a of the analyte sensor 104 into a body tissue of a user via the insertion cannula (not shown) attached to the cannula head 107.

It is noted that an insertion cannula which could be attached, e.g. fixedly attached, to the cannula head 107 is not shown for better readability, since the focus of Fig. 1b lies in showing an exemplary geometry and arrangement of the sealing element 108 and the sensor fixation component 103. However, it is, for example, possible that such an insertion cannula could be attached to the cannula head 107 by mounting the insertion cannula inside the exemplary cavity 107a of the cannula head. The shown geometry and shape of the sensor fixation component 103 is exemplary only.

The sensor fixation component 103 in general can have any shape that allows it to carry out the further above described functions of fixating or securing a part of the analyte sensor 104, in particular the insertable portion 104a of the analyte sensor 104, in a desired position inside the housing 110, and of receiving and guiding the cannula head 107 such that the insertion cannula (not shown) attachable to said cannula head 107 can engage with the insertable portion 104a of the analyte sensor 104.

The exemplary sensor fixation component 103 can comprise a sleeve 103h, e.g. a guide sleeve, that can have a tubular shape and that can have two ends, e.g. a first end 103i, e.g. a distal end, and a second end 103j, e.g. a proximal end.

For example, the first end 103i can be configured for receiving and guiding the cannula head 107 and the second end 103j can be configured for fixating or securing part of the analyte sensor 104, in particular the insertable portion 104a, in a desired position inside the housing 110 such that the insertion cannula (not shown) attached to said cannula head 107 can engage with the insertable portion 104a of the analyte sensor 104 for insertion of the insertable portion 104a of the analyte sensor 104 into the body tissue of a user.

Furthermore, the detachable cannula head 107 with its insertion cannula (not shown) can be inserted into the sensor fixation component 103 via the exemplary opening 101a in the cover 101 that can provide access to the sensor fixation component 103.

In the shown example, the lateral wall of the sleeve-shaped exemplary sensor fixation component 103 is denoted by reference sign 103e.

Fig. 1b inter alia further allows a better view of an exemplary part of sensor fixation component 103, i.e. of the exemplary fixation component 103b that can be configured for facilitating the function of the sensor fixation component 103 for fixating or supporting or holding a part of the analyte sensor 104 in a desired position that is suitable for inserting the insertable portion 104a of the analyte sensor in a body tissue of a user.

Said exemplary fixation component 103b can be implemented as a guiding channel and/or supporting channel for the analyte sensor. Furthermore, said fixation component 103b may have a curved surface for guiding or bending the flexible analyte sensor 104 towards the opening 102a in the base 102 of the housing 110 of the medical device.

Fig. 1 b further shows an exemplary protrusion 103f of the sensor fixation component 103 that can facilitate mounting the sensor fixation component 103 to the base 102 of the housing 110. Furthermore, the exemplary sensor fixation component 103 can comprise an exemplary flange or rim 103a. Said optional flange or rim 103a can at least partially or fully surround the central part of the sensor fixation component 103. Said exemplary flange 103a may further comprise a groove 103c, wherein said groove can at least partially or fully surround the central part of the sensor fixation component 103.

The exemplary base 103g of the sensor fixation component 103 can further comprise a funnel or funnel-like structure 103d that can further facilitate the insertion of the insertable portion of the analyte sensor 104a into body tissue of a user via the insertion cannula (not shown) of the cannula head 107 that can be received and guided by the sensor fixation component 103.

Fig. 1 b further shows an exemplary sealing element 108 realized as an exemplary insert that is mounted to the sensor fixation component 103.

The exemplary sealing element 108 is configured for providing a sealing between the sensor fixation component 103 and the detachable cannula head 107 of the medical device 100.

Said exemplary sealing element 108 can have any of the properties or features described further above.

The sealing element 108 is adapted to at least partially or fully follow the shape of the sensor fixation component 103.

In other words, the surface profile of the sealing element 108 can follow at least partially or fully the surface profile of the sensor fixation component 103.

Furthermore, the sealing element 108 can at least partially or fully cover the surface of the sensor fixation component 103.

Stated differently, the sealing element 108 can sit on the sensor fixation component 103 similar to a dental crown sitting on a tooth or similar to a glove sitting on a hand.

The surface 108c of the sealing element 108 that is configured to be in contact with the detachable cannula head 107 can have a contour that is complementary to the contour of the surface 107b of the detachable cannula head 107 the sealing element 108 is configured to be in contact with.

Stated differently, the sealing element 108 can be formed with a contour or profile, e.g. surface profile, that is at least partially or fully complementary to the contour or profile, e.g. surface profile, of the cannula head 107.

The fit connection between the detachable cannula head 107 and the sealing element 108 can be an interference fit connection, i.e. cannula head 107 is to be inserted into the sensor fixation component 103 by exerting a force such that the connection between the cannula head 107, the sealing element 108 and the sensor fixation component 103 can be held together by friction.

As illustrated, the surface 108c of the sealing element that is configured to be in contact with the detachable cannula head 107 can comprise a bulge 108a or lip. Said optional bulge 108a can at least partially or fully surround the cannula head 107.

The illustrated exemplary shape of said optional bulge 108a is elliptical or half-elliptical. More precisely, the original undeformed shape of the bulge 108a can be elliptical or half-elliptical and said elliptical or half-elliptical shape can be slightly deformed, e.g. compressed, due to the exerted force when the cannula head 107 is pushed into the sensor fixation component 103 and against the sealing element 108, and thereby against bulge 108a. The shape of bulge 108a is exemplary only; other shapes are conceivable too.

As further exemplary illustrated, the periphery of the sealing element 108 has a surface contour shape, e.g. a U-shape 108b, that can engage with the groove 103c of the said exemplary flange 103a of the sensor fixation component, e.g. via a press-fit connection.

Furthermore, the outermost part 108d or ending of the periphery of the sealing element 108 can partially or fully cover the periphery of groove 103c. However, also other shapes of said outermost part 108d or ending of the periphery of the sealing element 108 are conceivable, e.g. wherein the periphery of groove 103c is not covered by the outermost part or ending of the periphery of the sealing element 108.

As also exemplary shown, the sealing element 108 can be an annular element that can be configured to at least partially or fully surround the cannula head 107. Stated differently, the sealing element 108 can comprise a central opening 108e for receiving the insertion cannula (not shown) and wherein said central opening 108e can at least partially or fully surround the detachable cannula head 107.

In the shown example, the sealing element 108 is also in contact with the cover 101 and, aside from providing a sealing between the sensor fixation component 103 and the detachable cannula head 107, can therefore also provide a radial sealing and/or axial sealing, between the at least one sensor fixation component 103 and the cover 101 of the housing 110.

Fig. 1c exemplary shows again an enlarged view of the section of Fig. 1a denoted with reference sign 106, but for an exemplary alternative configuration 106a of a sealing element in the form of sealing element 109.

As previously noted, all other elements of the exemplary medical device 100 of Fig. 1c can be/are identical to the elements and components of exemplary medical device 100 of Fig. 1a, i.e. the exemplary sensor fixation component 103, the housing 110, the cover 101 and the base 102 of the housing 110 and the analyte sensor 104 of Fig. 1c can be/are identical to the sensor fixation component 103, the housing 110, the cover 101 and the base 102 of the housing 110 and the analyte sensor 104 of Fig. 1a and Fig. 1b.

Also the detachable cannula head (not shown) that can engage with the sensor fixation component 103 of Fig. 1c can be the same as the cannula head 107 shown in Fig. 1 b. However, it is also possible that other cannula heads, e.g. according to Figs. 1d, 1e or 1f, could be used or implemented to engage with the sensor fixation component 103 of Fig. 1c.

The only difference between the sealing element 109 of Fig. 1c and the sealing element 108 of Fig. 1 b lies in that the sealing element 109 has a differently shaped bulge 109a on the surface of the sealing element 109 that is configured to be in contact with the detachable cannula head (not shown), i.e. in the illustrated example, the bulge 109a has a rectangular shape.

Said exemplary bulge 109a can at least partially or fully surround the cannula head (not shown) in the same or similar manner as the bulge 108a of the sealing element 108 of Fig. 1b.

Similar or identical to the sealing element 108 of Fig. 1b, the sealing element 109 can be adapted to at least partially or fully follow the shape of the sensor fixation component 103.

In other words, the surface profile of the sealing element 109 can follow at least partially or fully the surface profile of the sensor fixation component 103.

Furthermore, the sealing element 109 can at least partially or fully cover the surface of the sensor fixation component 103.

Similar or identical to the sealing element 108 of Fig. 1b, the surface 109c of the sealing element 109 that is configured to be in contact with the detachable cannula head (not shown) can have a contour that is complementary to the contour of the surface of the detachable cannula head (not shown) the sealing element 109 is configured to be in contact with.

Stated differently, the sealing element 109 can be formed with a contour or profile, e.g. surface profile, that is at least partially or fully complementary to the contour or profile, e.g. surface profile, of the cannula head (not shown), e.g. cannula head 107 of Fig. 1 b.

The fit connection between the detachable cannula head (not shown) and the sealing element 109 can be an interference fit connection.

Hence, a cannula head (not shown) is to be inserted into the sensor fixation component 103 by exerting a force such that the connection between the cannula head (not shown), the sealing element 109 and the sensor fixation component 103 can be held together by friction. Similar or identical to the sealing element 108 of Fig. 1b, the periphery of the sealing element 109 has a surface contour shape, e.g. a U-shape 109b, that can engage with a possible groove 103c of the exemplary flange 103a of the sensor fixation component 103, e.g. via a press-fit connection.

Furthermore, the outermost part 109d or ending of the periphery of the sealing element 109 can partially or fully cover the periphery of groove 103c. However, also other shapes of said outermost part 109d or ending of the periphery of the sealing element 109 are conceivable, e.g. wherein the periphery of groove 103c is not covered by the outermost part or ending of the periphery of the sealing element 108.

Similar to the case shown in Fig. 1b, the sealing element 109 can also be in contact with the cover 101 and, aside from providing a sealing between the sensor fixation component 103 and the detachable cannula head (not shown), can therefore also provide a radial sealing and/or axial sealing, between the at least one sensor fixation component 103 and the cover 101 of the housing 110.

Similar to sealing element 108, the sealing element 109 can be an annular element that can be configured to at least partially or fully surround the cannula head (not shown). Stated differently, the sealing element 109 can comprise a central opening 109e for receiving the insertion cannula (not shown) and wherein said central opening 109e can at least partially or fully surround the detachable cannula head (not shown).

Fig. 1d exemplary shows again an enlarged view of the section of Fig. 1a denoted with reference sign 106, but for an exemplary alternative configuration 106b of a sealing element in the form of sealing element 111 and an exemplary alternative configuration of a cannula head in the form of cannula head 113.

As previously indicated, all other elements of the exemplary medical device 100 of Fig. 1d can again be/are identical to the elements and components of exemplary medical device 100 of Fig. 1a, i.e. the exemplary sensor fixation component 103, the housing 110, the cover 101 and the base 102 of the housing 110 and the analyte sensor (not shown) of Fig. 1d can be/are identical to the sensor fixation component 103, the housing 110, the cover 101 and the base 102 of the housing 110 and the analyte sensor 104 of Fig. 1a and Fig. 1b and Fig. 1c.

The exemplary alternative detachable cannula head 113 which can comprise an insertion cannula (not shown) has an exemplary alternative shape, wherein a part 113b of the surface of the cannula head 113 that is configured to be in contact with sealing element 111 has a concave shape.

The exemplary surface of the sealing element 111 that is configured to be in contact with the detachable cannula head 113 can be adapted to follow that shape of the surface of the cannula head 113 in a complementary manner. For example, the sealing element 111 can have a bulge 111a that has a complementary shape, e.g. a half-circular and convex shape, that can be received by or engage with the concave shape of part 113b of the surface of the cannula head 113.

Hence, the sealing element 111 can be formed with a contour or profile, e.g. surface profile, that is at least partially or fully complementary to the contour or profile, e.g. surface profile, of the cannula head 113.

The fit connection between the detachable cannula head 113 and the sealing element 111 can again be an interference fit connection.

Hence, a cannula head 113 is to be inserted into the sensor fixation component 103 by exerting a force such that the connection between the cannula head 113, the sealing element 111 and the sensor fixation component 103 can be held together by friction.

Furthermore, the thickness of the sealing element 111 can be thicker than the thickness of the sealing elements 108 or 109 in Fig. 1 b and Fig. 1c. This can enable an even tighter fit and tighter connection between the sensor fixation component 103 and the detachable cannula head 113.

For example, the thickness, e.g. the wall thickness, of the sealing element 111 can be in the range of 0.05 mm - 1.00 mm, in particular in the range of 0.10 mm - 0.50 mm.

Similar or identical to the sealing element 108 of Fig. 1 b, the periphery of the sealing element 111 has a surface contour shape, e.g. a U-shape 111b, that can engage with a possible groove 103c of the exemplary flange 103a of the sensor fixation component 103, e.g. via a press-fit connection.

However, unlike for sealing elements 108 or 109, the periphery of the sealing element 111 in the shown example does not extend such as to cover the periphery of groove 103c. Stated differently, the outermost part of the periphery 111d of the sealing element 111 can be entirely received or seated inside the groove 103c of flange 103a of the sensor fixation component 103.

However, it is also possible that the periphery of the sealing element 111 can be further extended to also partially or fully cover the periphery of groove 103c as in the case of the sealing elements 108 and 109.

A further exemplary possible difference between the sealing element 111 and the sealing elements 108, 109 can lie in that the part 111e of the sealing element 111 which covers a side wall or lateral wall 103e of sensor fixation component 103 is partially shaped as a wedge.

Similar to the cases shown in Fig. 1b and Fig. 1c, the sealing element 111 can also be in contact with the cover 101 of the housing 110 of the medical device 100 and, aside from providing a sealing between the sensor fixation component 103 and the detachable cannula head, can therefore also provide a radial sealing and/or axial sealing between the at least one sensor fixation component 103 and the cover 101 of the housing 110 of the medical device 100.

Further, similar to the sealing elements 108, 109, the sealing element 111 can be an annular element that can be configured to at least partially or fully surround the cannula head 113. Stated differently, the sealing element 111 can comprise a central opening 111 f for receiving the insertion cannula (not shown) and wherein said opening 111f can at least partially or fully surround the detachable cannula head 113.

Fig. 1e exemplary shows again an enlarged view of the section of Fig. 1a denoted with reference sign 106, but for an exemplary alternative configuration 106c of a sealing element in the form of sealing element 112.

The cannula head 113 is identical to the cannula head of Fig. 1d.

For completeness, it is noted that also all other elements of the exemplary medical device 100 of Fig. 1e can be/are identical to the elements and components of exemplary medical device 100 of Fig. 1a, Fig. 1b, Fig. 1c and Fig. 1 d, i.e. the exemplary sensor fixation component 103, the housing 110, the cover 101 and the base 102 of the housing 110 and the analyte sensor 104 of Fig. 1c can be/are identical to the sensor fixation component 103, the housing 110, the cover 101 and the base 102 of the housing 110 and the analyte sensor 104 of Fig. 1a, Fig. 1 b, Fig. 1c and Fig. 1d.

Also the sealing element 112 can in almost every aspect be identical to the sealing element 111 of Fig. 1 d, i.e. it can have a bulge 112a that is identical to the bulge 111a of sealing element 111 and it can have the same shape of its periphery, i.e. same as U-shape 112b as U-shape 111 b, it can have a central opening 112f that is identical to the central opening 111 f, and its surface shape covering the sensor fixation component 103 can be the same as that of the surface shape of sealing element 112 aside from the following difference.

The sealing element 112 can, in difference to the sealing element 111 , additionally comprise an exemplary septum or membrane 112c that can be pierced by the insertion cannula (not shown) of the detachable cannula head 113.

The reference sign 112d exemplary marks a position or opening in the septum 112c where the insertion cannula (not shown) can pierce or penetrate the septum 112c.

Said exemplary position or opening 112d in the septum 112a can be arranged such as to be located above the exemplary possible opening or funnel or funnel-like structure 103d in the bottom of the sensor fixation component 103 that can facilitate guiding the insertion cannula (not shown) during insertion of the insertable portion of the analyte sensor (not shown) into a body tissue of a user.

Fig. 1f exemplary shows again an enlarged view of the section of Fig. 1a denoted with reference sign 106, but for an exemplary alternative configuration 106d of a cannula head in the form of cannula head 114.

The configuration of the medical device 100 shown in Fig. 1f is identical to the configuration of the medical device shown in Fig. 1d aside from the following difference.

The cannula head 114 comprises an exemplary bulge 114a. Said optional bulge 114a can at least partially or fully surround the cannula head 114 and can, as shown in Fig. 1f, engage behind the bulge 111a of the sealing element 111 when the sealing element 111 is providing the sealing between the sensor fixation component 103 and the detachable cannula head 114, i.e. when the detachable cannula head is inserted into the sensor fixation component.

The shown optional bulge 114a of the cannula head has an exemplary half-elliptical or half-circular shape, but can have also other shapes.

All other components visible in Fig. 1 f, e.g. the sensor fixation component 103, the sealing element 111 , the cover 101 and the base 102 of housing 110 of the medical device 100 can be/are identical to the sealing element 111 , the cover 101 and the base 102 of housing 110 shown in Fig. 1d. For completeness, it is noted that the cannula head 114 could engage also in the same manner as described above with a sealing element having a septum, e.g. with a sealing element 112 according to Fig. 1e.

Followed by Fig. 1a, Fig. 1b, Fig. 1c, Fig. 1d, Fig. 1e and Fig. 1f, wherein the reference signs denote the following exemplary aspects or features of a herein described exemplary medical device.

100 Exemplary medical device, exemplary patch-type medical device

101 Exemplary cover, exemplary cover of exemplary housing of medical device

101a Exemplary opening/through hole/passageway in the cover of the housing for allowing the cannula head to be mounted to/inserted into the sensor fixation component

102 Exemplary base, exemplary base of exemplary housing of medical device

102a Exemplary opening/through hole/passageway in the base of the housing for allowing the insertion cannula to pass through when inserting the insertable portion of the analyte sensor into a body tissue of a user b Exemplary lower side or bottom side of base, which can be configured for contact with or attachment to the skin of a user Exemplary sensor fixation component a Exemplary optional flange or rim of sensor fixation component b Exemplary fixation component, e.g. for fixating or supporting or holding a part of the analyte sensor c Exemplary optional groove of sensor fixation component d Exemplary opening or funnel or funnel-like structure at bottom of sensor fixation componente Exemplary side wall or lateral wall of sensor fixation component f Exemplary optional protrusion g Exemplary base of sensor fixation component h Exemplary sleeve of sensor fixation component i Exemplary first end of sensor fixation component j Exemplary second end of sensor fixation component Exemplary analyte sensor, exemplary flexible analyte sensor a Exemplary insertable portion of analyte sensor Exemplary electronics unit, e.g. printed circuit board Exemplary zoom section, exemplary section for enlarged views in Figs. 1b, 1c, 1d, 1e and 1fa Exemplary zoom section with alternative sealing element, exemplary alternative configuration of sealing element b Exemplary zoom section with further exemplary alternative sealing element and exemplary alternative cannula head, exemplary alternative configuration of sealing element and cannula head c Exemplary zoom section with further exemplary alternative sealing element, exemplary alternative configuration of sealing element d Exemplary zoom section with exemplary alternative cannula head, exemplary alternative configuration of detachable cannula head Exemplary detachable cannula head a Exemplary cavity in cannula head for receiving insertion cannula for fixedly attaching the insertion cannula to the detachable cannula head b Exemplary surface of the detachable cannula head that is configured to be in contact with sealing element 108 or exemplary part of the surface of the detachable cannula head that is configured to be in contact with sealing element 108 Exemplary sealing element a Exemplary bulge or lip of sealing element b Exemplary U-shape of part, e.g. periphery, of the sealing element c Exemplary surface of the sealing element 108 that is configured to be in contact with the detachable cannula head 107 d Exemplary outermost part or ending of the periphery of the sealing element 108e Exemplary central opening of sealing element Exemplary alternative sealing element a Exemplary alternative bulge or lip of sealing element b Exemplary U-shape of part, e.g. periphery, of the sealing element c Exemplary surface of the sealing element 109 that is configured to be in contact with the detachable cannula head d Exemplary outermost part or ending of the periphery of the sealing element 109e Exemplary central opening of sealing element Exemplary housing of medical device Exemplary alternative sealing element a Exemplary alternative bulge or lip of sealing element b Exemplary U-shape of part of the sealing element c Exemplary surface of the sealing element 111 that is configured to be in contact with the detachable cannula head 113 d Exemplary outermost part or ending of the periphery of the sealing element 111e Exemplary part of the sealing element covering side wall or lateral wall 103e of sensor fixation component 103 f Exemplary central opening of sealing element Exemplary alternative sealing element a Exemplary alternative bulge or lip of sealing element b Exemplary U-shape of part of the sealing element c Exemplary septum or membrane d Exemplary position or opening where the insertion cannula can pierce or penetrate the septum 112c f Exemplary central opening of sealing element Exemplary alternative detachable cannula head b Exemplary surface of the detachable cannula head that is configured to be in contact with sealing element 111 or exemplary part of the surface of the detachable cannula head that is configured to be in contact with sealing element 111 Exemplary alternative detachable cannula head a Exemplary bulge or lip of detachable cannula head

Claims

1. A medical device (100) for detecting at least one analyte in a body fluid, the medical device (100) comprising: an analyte sensor (104) having an insertable portion (104a) adapted for at least partially being inserted into a body tissue of a user; an insertion cannula, wherein the analyte sensor (104) is at least partially placed inside the insertion cannula; a detachable cannula head (107), wherein the insertion cannula is attached to the detachable cannula head (107), wherein the detachable cannula head (107) is configured for detachment after insertion, thereby removing the insertion cannula; at least one housing (110), wherein the housing (110) comprises at least one sensor fixation component (103) configured to at least partially receive the analyte sensor (104) and configured to at least partially receive the detachable cannula head (107); and at least one sealing element (108) configured for providing a sealing between the at least one sensor fixation component (103) and the detachable cannula head (107).

2. The medical device (100) according to the preceding claim, wherein the sealing element (108) comprises an elastic material, e.g. an elastomer material.

3. The medical device (100) according to one of the preceding claims, wherein the sealing element (108) is realized as an insert, wherein said insert is insertable between the at least one sensor fixation component (103) and the detachable cannula head (107).

4. The medical device (100) according to any one of the preceding claims, wherein the surface of the sealing element (108) that is configured to be in contact with the detachable cannula head (107) has a contour that is complementary to the contour of the surface of the detachable cannula head (107) the sealing element (108) is configured to be in contact with.

5. The medical device (100) according to any one of the preceding claims, wherein the detachable cannula head (107) and the at least one sealing element (108) can be connected to each other via an interference fit connection when the sealing element is providing the sealing between the at least one sensor fixation component (103) and the detachable cannula head (107).

6. The medical device (100) according to any one of the preceding claims, wherein the surface of the sealing element (108) that is configured to be in contact with the detachable cannula head (107) comprises at least one bulge (108a) and/or wherein the surface of the detachable cannula head (107) that is configured to be in contact with the sealing element (108) comprises at least one bulge (114a).

7. The medical device (100) according to the preceding claim, wherein the at least one bulge (108a) of the surface of the sealing element (108) and/or the at least one bulge (114a) of the surface of the detachable cannula head (107) has a rectangular or circular or half-circular or elliptical or half-elliptical shape.

8. The medical device (100) according to claim 6 or 7, wherein both the surface of the sealing element that is configured to be in contact with the detachable cannula head comprises a bulge and the surface of the detachable cannula head that is configured to be in contact with the sealing element comprises a bulge, and wherein said bulges are arranged such that the bulge of the detachable cannula head can engage behind the bulge of the sealing element when the sealing element is providing the sealing between the at least one sensor fixation component and the detachable cannula head.

9. The medical device (100) according to any one of the preceding claims, wherein the sealing element (112) comprises a septum (112a) that is pierceable by the insertion cannula.

10. The medical device (100) according to any one of the preceding claims, wherein the periphery of the sealing element (108) has a surface contour shape, e.g. a U-shape (108b), that can engage with a groove (103c) of the at least one sensor fixation component (103) via a press- fit connection.

11 . The medical device (100) according to any one of the preceding claims, wherein the surface profile of the sealing element (108) follows at least partially or fully the surface profile of the at least one sensor fixation component (103).

12. The medical device (100) according to any one of the preceding claims, wherein the sealing element (108) at least partially or fully covers the surface of the at least one sensor fixation component (103).

13. The medical device (100) according to any one of the preceding claims, wherein the at least one housing (110) comprises a cover (101) and a base (102), wherein the at least one sensor fixation component (103) is mountable to the base (102).

14. The medical device (100) according to the preceding claim, wherein the at least one sealing element (108) is further configured for providing a sealing, e.g. a radial sealing and/or axial sealing, between the at least one sensor fixation component (103) and the cover (101) of the housing (110).

15. Method for assembling a medical device (100) according to any one of the preceding claims, wherein the method comprises: providing the housing (110), the housing (110) comprising the at least one sensor fixation component (103); placing the analyte sensor (104) at least partially into the at least one sensor fixation component (103); mounting the sealing element (108) onto the at least one sensor fixation component (103) to at least partially cover the at least one sensor fixation component (103); and mounting the detachable cannula head (107) with the insertion cannula onto the at least one sensor fixation component (103).