Sensor assembly for detecting at least one analyte in a body fluid

Abstract

A sensor assembly for detecting at least one analyte in a body fluid includes an electrochemical sensor, a body mount that attaches to a body of a user and an inserter that transfers the sensor to the body mount. A first adhesive is attached to one or both of the body mount or the sensor, and the first adhesive attaches the sensor to the body mount. A second adhesive is attached to one or both of the sensor or the inserter and releasably attaches the sensor to the inserter. The assembly has an initial position in which the sensor is attached to the inserter via the second adhesive and a final position in which the sensor is attached to the body mount via the first adhesive. Transferring the sensor from the initial position to the final position releases the sensor from the inserter.

Claims

1. A sensor assembly for detecting at least one analyte in a body fluid, comprising: an electrochemical sensor; a body mount configured for attachment to a body of a user; an inserter configured for transferring the sensor to the body mount; a first adhesive configured to attach the sensor to the body mount; a second adhesive configured for releasably attaching the sensor to the inserter; wherein the sensor assembly is positionable in an initial position in which the sensor is attached to the inserter via the second adhesive and is positionable in a final position in which the sensor is attached to the body mount via the first adhesive; wherein transferring the sensor from the initial position to the final position releases the sensor from the inserter; and wherein the second adhesive is configured to seal off contacts of the sensor when an electronics unit is attached to the body mount.

2. The sensor assembly according to claim 1, wherein the first adhesive and the second adhesive are configured to contact the sensor on opposing sides.

3. The sensor assembly according to claim 1, wherein the second adhesive is configured to provide a second adhesive force that adheres the sensor to the inserter, wherein the first adhesive is configured to provide a first adhesive force that adheres the sensor to the body mount, wherein the first adhesive force exceeds the second adhesive force.

4. The sensor assembly according to claim 1, wherein one or both of the first adhesive or second adhesive comprise at least one material selected from the group consisting of: a polymer adhesive; a silicone-based adhesive; silicone material; a silicone-based thermoplastic material; a silicone copolymer; an urea copolymer; at least one solvent-based acrylic pressure-sensitive adhesive.

5. The sensor assembly of claim 4, wherein one or both of the first adhesive or second adhesive comprise at least one silicone and/or a silicone polymer.

6. The sensor assembly of claim 4, wherein one or both of the first adhesive or second adhesive comprise a copolymer of dimethylsiloxane and urea.

7. The sensor assembly of claim 4, wherein one or both of the first adhesive or second adhesive comprise at least one solvent-based acrylic material comprising at least one polymer based on acrylic esters.

8. The sensor assembly according to claim 1, wherein the inserter is configured such that a transfer of the sensor from the inserter to the body mount takes place on insertion of a part of the sensor into a body tissue.

9. The sensor assembly according to claim 1, wherein the inserter comprises a plunger, wherein the second adhesive is configured to attach the sensor to the plunger, wherein, in the initial position, the sensor is attached to the plunger via the second adhesive.

10. The sensor assembly according to claim 1, wherein the sensor assembly further comprises a pressure element located between a surface of the body mount and the sensor, wherein the sensor assembly is configured such that the sensor is pressed against the pressure element or vice versa during the transfer of the sensor from the initial position into the final position.

11. The sensor assembly according to claim 10, wherein the pressure element, on at least one surface, comprises one or more cavities configured to act as suction cups.

12. The sensor assembly according to claim 10, wherein one or both of the first adhesive and second adhesive are integrated into the pressure element or attached to the pressure element.

13. The sensor assembly according to claim 1, wherein the inserter is configured such that a surface of the sensor is pressed onto the body mount at an angle of 0° to 10° relative to a skin surface to which the body mount is adhered.

14. The sensor assembly according to claim 1, wherein the inserter is configured such that a surface of the sensor is pressed onto the body mount at an angle of 0° to 6° relative to a skin surface to which the body mount is adhered.

15. The sensor assembly according to claim 1, wherein the sensor assembly further comprises an electronics unit having at least one electronics component for one or more of controlling the detection of the analyte or transmitting measurement data to another component, wherein the electronics unit is reversibly connectable to the body mount.

16. The sensor assembly according to claim 1, wherein the sensor assembly further comprises a removable liner that fully or partially covers the first adhesive, wherein the removable liner is removable for transfer of the sensor into the final position.

17. The sensor assembly according to claim 1, further comprising: a substrate; at least two electrodes applied to the substrate, the electrodes adapted for detecting the analyte; at least two contact pads applied to the substrate; at least two electrical traces applied to the substrate, the electrical traces electrically connecting the electrodes and the contact pads; and a sealing ring fixedly applied to the substrate, the sealing ring surrounding the contact pads.

18. The sensor assembly according to claim 17, wherein the second adhesive comprises the sealing ring.

19. The sensor assembly of claim 1, wherein the second adhesive comprises a sealing ring.

20. A method of mounting a sensor for detecting at least one analyte in a body fluid to a body mount attachable to a body of a user, comprising: providing an electrochemical sensor; providing a body mount; providing an inserter for transferring the sensor to the body mount; providing a first adhesive attached to one or both of the body mount or the sensor, configured for attaching the sensor to the body mount; providing a second adhesive attached to one or both of the sensor or the inserter, configured for releasably attaching the sensor to the inserter; using the inserter to transfer the sensor from an initial position, in which the sensor is attached to the inserter via the second adhesive, into a final position in which the sensor is attached to the body mount via the first adhesive and released from the inserter; and using the second adhesive to seal off contacts of the sensor when an electronics unit is attached to the body mount.

21. The method of claim 20, wherein the second adhesive is provided as a sealing ring.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The above-mentioned aspects of exemplary embodiments will become more apparent and will be better understood by reference to the following description of the embodiments taken in conjunction with the accompanying drawings, wherein:

(2) FIGS. 1A and 1B show an exemplary embodiment of a sensor for detecting at least one analyte in a body fluid and of a method of manufacturing the same;

(3) FIGS. 2A to 2C show an exemplary embodiment of a sealing ring in a top view (FIG. 2A) and in a cross-sectional view (FIG. 2B), and a height profile measurement of the sealing ring (FIG. 2C);

(4) FIGS. 3A to 3D show various components of an exemplary testing setup for testing the sealing performance of the sealing ring, including a dummy test element for simulating a sensor (FIG. 3A), a first circuit diagram of an electrical setup for measuring an electrical resistance of the contact pads (FIG. 3B), a second circuit diagram of an electrical setup for measuring a vibration resistance (FIG. 3C) and a third circuit diagram of an electrical setup for measuring an insulation resistance (FIG. 3D);

(5) FIGS. 4A to 4C show an exemplary testing setup for testing a sealing ring (FIG. 4A) and schematic representations of an electrical connection between contact pads of a sensor and electrical contacts of an electronics unit without applying pressure (FIG. 4B) and with applying pressure by using a pressure element (FIG. 4C);

(6) FIGS. 5A to 5B show an exemplary embodiment of an electronics unit of a sensor assembly in a cross-sectional view (FIG. 5A) and in a bottom view (FIG. 5B);

(7) FIGS. 6A to 6D show components of an exemplary embodiment of a body mount of a control part of a sensor assembly;

(8) FIGS. 7A to 7C show different embodiments of an insertion element;

(9) FIGS. 8A to 8D show a method of mounting a sensor to a body mount;

(10) FIGS. 9A to 9B show an exemplary embodiment of a sensor assembly in a cross-sectional view (FIG. 9A) and in a side view (FIG. 9B); and

(11) FIGS. 10A to 10B show an exemplary embodiment of a sensor assembly in a perspective view in a fully assembled state (FIG. 10A) and in a disassembled state (FIG. 10B).

DESCRIPTION

(12) The embodiments described below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may appreciate and understand the principles and practices of this disclosure.

(13) In FIGS. 1A and 1B, an exemplary embodiment of a sensor 110 for detecting at least one analyte in a body fluid and of a method of manufacturing the same are shown. FIG. 1A shows an intermediate product 112 of the sensor 110, whereas the sensor 110 is illustrated in FIG. 1B. However, other embodiments of the sensor 110 are feasible.

(14) In a first step, as shown in FIG. 1A, at least one substrate 114 may be provided, at least two electrodes 116 may be applied to the substrate 114, at least two contact pads 118 may be applied to the substrate 114 and at least two electrical traces 120 may be applied to the substrate 114. For potential techniques for application of these elements 116, 118 and 120, reference may be made to the disclosure above and/or to conventional techniques used for manufacturing circuit boards, specifically flexible circuit boards. Elements 116, 118 and 120 may fully or partially be applied in a single step or in separate steps. Various embodiments are feasible, as the skilled person will recognize.

(15) The substrate 114, which specifically may be or may comprise a flexible substrate such as a flexible foil, specifically may comprise a shaft 122 and a contact portion 124. The shaft 122 may have an elongate shape. The contact portion 124 may be widened as compared to the remaining substrate 114. As an example, the contact portion 124 may be a rectangular contact portion 124. The substrate 114 may be a flexible substrate 114. For example, the substrate 114 may comprise at least one polyimide foil.

(16) The electrical traces 120 preferably may have an elongated shape. Further, the electrical traces 120 may fully or partially be located on the shaft 122 of the substrate 114. The electrical traces 120 may electrically interconnect the contact pads 118 and the electrodes 116. The electrical traces 120 may comprise at least one electrically conductive material. Exemplarily, the electrical traces 120 may comprise copper. However, other embodiments are feasible, as outlined in further detail above.

(17) The contact pads 118 may be located inside a contact surface area 126, which may be a surface area covering the contact pads 118. In FIG. 1A the contact surface area 126 is symbolically depicted by a dashed circle. Particularly, the contact surface area 126 may have a circular and/or rectangular shape.

(18) The contact pads 118, as outlined above, may be fully or at least partially made of a metallic material. Specifically, the contact pads 118 may comprise at least one gold layer. The contact pads 118 may be located in the contact portion 124.

(19) The electrodes 116 may comprise at least one working electrode 128 adapted for performing at least one electrochemical detection reaction for detecting the at least one analyte in the body fluid. The working electrode 128 may have at least one test chemical being sensitive to the analyte to be detected. As an example, the at least one test chemical may be deposited on top of a working electrode pad which has electrically conductive properties. Further, the electrodes 116 may comprise at least one counter electrode 130 adapted for performing at least one electrochemical counter reaction adapted for balancing a current flow required by the detection reaction at the working electrode 128. Additionally, the electrodes 116 may further comprise at least one reference electrode 132 which may have a stable and well-known electrode potential. It shall be noted, however, that other electrode setups may be feasible, such as setups having more than three electrodes or less than three electrodes, such as by combining the counter electrode 130 and the reference electrode 132. It also may be feasible to have at least one of the electrodes 116 and at least one of the electrical traces 120 and at least two of the contact pads 118 applied to a first side of the substrate 114 and have at least one of the electrodes 116 and at least one of the electrical traces 120 applied to a second side of the substrate 114 and connected with at least one contact pad 118 on the first side by at least one via. Thus, generally, a more complex geometry or a more complex layer setup of the sensor 110 is generally feasible, such as a layer setup having electrical traces 120 in different planes of the layer setup and, as an example, using contact pads 118 on different sides and/or using vias for providing electrical contact between one or more of the contact pads 118 and one or more of the electrical traces 120.

(20) In a second step, as illustrated in FIG. 1B, at least one electrically insulating material 133 may be applied to the substrate 114. In case at least one insulating material 133 may be applied to the substrate 114, the electrically insulating material 133 itself, after application, may form part of the substrate 114. Thus, in the context of this disclosure, when reference is made to applying one or more elements to the substrate 114, the one or more elements may directly be applied to the substrate 114 or may be applied to the substrate 114 with the insulating material 133 disposed thereon.

(21) For example, the electrically insulating material 133 may comprise an insulating resist. However, other materials are feasible. The electrically insulating material 133 may at least partially cover the electrical traces 120, the electrically insulating material 133 leaving open the electrodes 116 and the contact pads 118. Particularly, the electrically insulating material 133 may comprise at least one insulating cover layer 135 covering the electrical traces 120.

(22) Further, at least one sealing ring 134 may be applied fixedly to the substrate 114. The sealing ring 134 may be fully or partially applied onto the electrically insulating material 133. The sealing ring 134 may exceed the electrically insulating material 133 in height. Particularly at least one insulating layer 136 may be formed by the electrically insulating material 133.

(23) The step of applying the sealing ring 134 may comprise applying at least one sealing material, preferably in a liquid or pasty form, to the substrate 114. The contact pads 118 may be commonly located as a group on a surface 125 of the substrate 114 and the sealing 134 may commonly surround the group. The sealing material may specifically comprise at least one solvent and may further comprise at least one matrix material, such as one of a polymer material, a plastic material or a precursor material capable of cross-linking or polymerizing. The step of applying the sealing ring 134 may comprise at least one application method, such as a dosing method, e.g., a dispensing method. Further, the step of applying the at least one sealing ring 134 may comprise at least one curing step. Consequently, in the curing step, the sealing material may be fully or partially hardened.

(24) The substrate 114 was manufactured by utilizing a polyimide foil with a thickness of 50 μm from Contag AG, Berlin, Germany. The contact portion 124 of the substrate 114 had dimensions of 5 mm×5 mm. The electrical traces 120 were made of copper. Additionally, the electrical traces 120 were galvanized with gold plating. The contact pads 118 and the electrodes 116 were also galvanized with gold plating. The electrical traces 120, the contact pads 118 and the electrodes 116 had an average thickness of 18 μm respectively. The contact pads 118 had an average diameter of 0.6 mm. The electrical traces 120 and the substrate 114 were isolated via the insulating layer 136, which had an average thickness of about 28 μm. The contact surface area 126 had an average diameter of 2.4 mm.

(25) The sealing material was manufactured as follows: 4.357 g of Geniomer® 145 from Wacker Chemie AG were dissolved in 13.43 g of isopropyl alcohol at 80° C. while stirring for 8 hours. After that, the sealing material was filtered by using a syringe filter with an average pore size of 5.0 μm from Whatman, GE-Healthcare UK Limited, Little Chalfont, UK. A slightly turbid solution was received.

(26) The sealing material was put into a 1 ml syringe and the sealing material was deposited onto the contact portion 124 of the substrate 114 as a closed ring via a dosing needle Tip 23 GA.013X.5 Orange 50 PC from GLT, Pforzheim, Germany. The sealing material was dried at 80° C. for 2 hours. After drying, the sealing ring 134 had an average thickness of around 45 μm.

(27) FIGS. 2A to 2C show details of an exemplary embodiment of the sealing ring 134 in various views. Thus, FIG. 2A shows a top view. FIG. 2B shows a cross-sectional view in a plane perpendicular to a surface of the substrate 114 of the sensor 110, oriented radially in the sealing ring 134. FIG. 2C shows a high-profile measurement of the sealing ring 134, also in the plane of the cross-sectional view of FIG. 2B.

(28) The sealing ring 134 as depicted in FIGS. 2A and 2B exemplarily may be manufactured by the method as described above, such as by dispensing. The sealing ring 134 may have a circular shape. Specifically, the sealing ring 134 may have a constant thickness over its circumference. Thus, as depicted in FIGS. 2A to 2C, the points M of maximum height 134 may form a circular or noncircular closed sealing line, which is denoted symbolically by the dashed circle M in FIG. 2A. Along this sealing line, the sealing ring 134 may have a constant thickness. It shall be noted, however, that other embodiments are feasible. Furthermore, the sealing ring 134 may comprise at least one sealing lip 138, which is formed by the local maximum M in the height profile, as seen in FIGS. 2B and 2C. In this embodiment, the sealing lip 138 may be located closer to the inner perimeter 140 of the sealing ring 134 then to the outer perimeter. Thus, the profile of the sealing ring 134 generally may be asymmetrical. Alternatively, however, other profiles are feasible, such as symmetrical profiles or profiles with the sealing lip 138 being located on the outer perimeter 142 of the sealing ring 134.

(29) The sealing ring 134 may comprise at least one silicone material such as an elastomeric silicone material. Particularly, the sealing ring 134 may be designed to be compressed during assembly between two or more elements.

(30) In experiments, 30% to 50% solutions of Geniomer® (Geniomer® 145 or Geniomer® 345) from Wacker Chemie AG, Munich, Germany, dissolved in isopropyl alcohol were deposited onto the substrate 114 via a dosing method. The substrate 114 was manufactured by utilizing a polyimide foil. Further, the substrate 114 comprised the insulating layer 136. As dosing needles Tip 27 GA GP.008x.25 CLEAR and Tip 25 GA GP.010x.25 RED from Nordson EDF, Westlake Ohio, USA, with an outer diameter of 0.4 mm or 0.5 mm respectively and an inner diameter of 0.203 mm or 0.254 mm respectively were applied. The dosing pressure was 2.0 bar to 4.0 bar and the velocity of the dosing needles was 2.6 mm/s to 5.0 mm/s. The diameter of application was 3.0 mm. One or two circulations of the dosing needles were conducted. The sealing ring 134 had a round shape and comprised the sealing lip 138 with a height ranging from 55 μm to 170 μm. Generally, the height of the sealing lip 138 increased with the volume of the dosed sealing material.

(31) Further, when the sealing material was deposited along a straight line, it was found that after the curing step the sealing ring 134 comprised two sealing lips 138 located on both of the inner perimeter 140 and the outer perimeter 142 sides of the sealing ring 134. Consequently, the sealing material generally behaves according to the so called coffee-ring or coffee-stain effect. Generally, the coffee-ring or coffee-stain effect may also be observed in case a spherical shaped drop of a 25% solution of Geniomer® 145 dissolved in isopropyl alcohol with a diameter of around 3.5 mm is dried. In this case, however, a distinctive bead close to a rim of the drop was observed. In contrast, a drop which is deposited as a thin layer may generally dry without forming a distinctive bead. Therefore, surprisingly, it was found that a sealing lip 138 located on the inner perimeter 140 of the sealing ring 134 was formed by applying the elastomeric solution as sealing material.

(32) In FIG. 2C an exemplary embodiment of potential dimensions of the sealing ring 134 is shown. Therein, a horizontal axis, denoted by W, is an axis which radially extends with respect to the sealing ring 134, parallel to a surface of the substrate 114. The vertical axis in FIG. 2C, denoted by H, shows the local height of the sealing ring 134. As can be seen in this high profile, in this embodiment, the width A of the sealing ring 134 may be in the range of, e.g., 400 μm to 700 μm, such as 560 μm, and the maximum height M may be in the range from 50 μm to 80 μm, preferably 65 μm. However, other dimensions are generally feasible.

(33) FIGS. 3A to 3D show various components of an exemplary testing setup for testing the sealing performance of the sealing ring 134. The testing setup specifically may comprise an exemplary test element 144, also referred to as a dummy test element or a dummy sensor, (FIG. 3A), an electrical setup according to a first circuit diagram 146 for measuring an electrical resistance of the contact pads 118 (FIG. 3B), an electrical setup according to a second circuit diagram 148 for measuring a vibration resistance (FIG. 3C) and an electrical setup according to a third circuit diagram 150 for measuring an insulation resistance (FIG. 3D).

(34) The test element 144 as illustrated in FIG. 3A specifically may comprise the substrate 114 comprising the shaft 122 and the contact portion 124, as in a real sensor 110. The shaft 122 specifically may have a length in the range from 20 mm to 70 mm, preferably 50 mm. On one end 152 opposing the contact portion 124 the substrate 114 may comprise a further contact portion 154. The further contact portion 154 may comprise counter contact pads 156. The counter contact pads 156 may be connected to the contacts pads 118. Further, the counter contact pads 156 may be strip-shaped. However, other embodiments are feasible.

(35) For measuring the electrical resistance, the electrical setup according to the first circuit diagram 146 as depicted in FIG. 3B may be applied. The contact pads 118 as depicted in FIG. 3A may be connected to an ohmmeter 158. In this embodiment, all contact pads 118, as illustrated in FIG. 3A, may be connected in series.

(36) For measuring the vibration resistance of the contact pads 118, the electrical setup according to the second circuit diagram 148 as depicted in FIG. 3B may be applied. The second circuit diagram 148 specifically may comprise at least one voltmeter 160, at least one electrical resistor 162 and at least one voltage source 164.

(37) For measuring the insulation resistance, the electrical setup according to the third circuit diagram 150 as depicted in FIG. 3D may be applied. The third circuit diagram 150 specifically may comprise at least one micro-ammeter 166, an electrical resistor 162 and the voltage source 164.

(38) The shaft 122 of the substrate 114 had an average length of around 50 mm. Two test elements 144 were placed opposing each other, particularly the contact pads 118 of the two test elements 144 were placed opposing each other. A maximal discrepancy of ±0.2 mm was tolerated. The two test elements 144 were mechanically secured by applying adhesive strips onto the shaft 122, particularly in a distance of 3 mm to 5 mm to the contact portion 124. Specifically, the two test elements 144 were mechanically secured on a plate. The plate was made of polycarbonate and had a thickness of 2 mm and dimensions from 5 mm×5 mm.

(39) As ohmmeter 158 a Fluke 117 multimeter was applied. As voltmeter 160 an oscilloscope TDS3034 from Tektronix, Beaverton, Oreg., USA was applied. As microammeter, a Keithley 2400 Sourcemeter, Kethley Instruments Inc., Cleveland, Ohio, USA was applied.

(40) For testing the functionality of the sealing ring 134, a simulation testing setup was used, which is schematically shown in FIGS. 4A to 4C. Therein, in FIG. 4A, the testing setup is denoted by reference number 168. For the testing purposes, two test elements 144 as depicted, e.g., in FIG. 3A were used, and their contacts portions 124 were pressed together. In FIGS. 4B and 4C, enlarged cross-sectional views of the contact portions 124 are shown, without applying pressure (FIG. 4B) and with applying pressure to the upper one of the two test elements 144 by using a pressure element 232 (FIG. 4C). With this setup, an electrical connection between contact pads 118 of the sensor 110 and electrical contacts of the electronics unit 186 may be simulated. In order to simulate this situation, only the upper one of the two test elements 114 was configured to comprise a sealing ring 134, and, thus, simulates the sensor 110, whereas the lower one of the test elements 114 did not comprise any sealing ring 134 and, thus, simulates the electronics unit 186.

(41) In FIG. 4A the testing setup 168 is depicted. The testing setup 168 comprises at least one terminal block 170 and at least one clamping screw 172. Between a supporting surface 174 of the terminal block 170 and the clamping screw 172, two plates 176 are located. The plates 176 comprise a first plate 178 in mechanical contact with the clamping screw 172 and a second plate 180 attaching to the first plate 178. The first plate 178, in this setup, is a hard plastic plate, whereas the second plate 180 comprises a deformable material such as an elastomeric material, e.g., a foam, and, thus, acts as a pressure element 232.

(42) The two test elements 144 are located in between the pressure element 232 and the supporting surface 174 and each are electrically contacted in order to perform electrical performance tests, such as by using the electrical setups shown in FIGS. 3B to 3D.

(43) As discussed above in the context of FIG. 3A, the test elements 144 each comprise the substrate 114 and the contact pads 118. The substrates 114 each are covered with the electrically insulating material 133 which, thus, forms part of the substrate 114. In the upper test element 144 in FIGS. 4B and 4C, the sealing ring 134 is positioned on top of the electrically insulating material 133.

(44) As shown in FIG. 4B, representing the state without applying pressure by using the clamping screw 172, the sealing ring 134 comprises the sealing lip 138 which, as the first portion of the sealing ring 134, contacts the lower test element 144. As shown in FIG. 4C, once a force 184 is applied by using the clamping screw 172, the pressure element 232 exerts a pressure onto the upper test element 144. The sealing ring 134 is compressed, and the region in the center of the sealing ring 134 is fully or partially bent downward, towards the lower test element 144. As a consequence, the contact pads 118 of the upper test element 144 are pressed onto the corresponding contact pads 118 of the lower test element 144 and an electrical connection is formed, which can be tested with one or more of the setups shown in FIGS. 3B to 3D.

(45) In order to test the functionality of the pressure element 232, the measurement may also be conducted by applying only the first plate 178, leaving out the deformable second plate 180. Similarly, in order to test the functionality of the sealing ring 134, experiments in which none or both of the test elements 144 may comprise the sealing ring 134. Further, the first plate 178 may be removed from the testing setup 168 and pressure may be applied via a finger of a user. Thereby, the performance of the sealing ring 134 and/or of the pressure element 232 may be tested in various ways.

(46) In an experiment, two contact portions 124 of the two test elements 144 were placed on top of each other without the sealing ring 134. A first plate 176 was placed on top of the two test elements 144. Only when the applied force 184 was at least 20 N an electrical contact between the two test elements 144 was observed.

(47) In a further experiment, the first plate was removed and pressure was applied via the finger onto the contact portions 124 of the two test elements 144. An electrical resistance of <1.1 Ohm was observed starting from an estimated value of 1 N to 2 N.

(48) In a further experiment, the second plate 180 was made of Geniomer® 345 from Wacker Chemie AG, Munich, Germany and the second plate 180 had dimensions of 6 mm×6 mm×1 mm. The first plate 178 was made of polycarbonate, had dimensions of 5 mm×5 mm×2 mm and was placed on top of the second plate 180. An electrical resistance of <1.1 Ohm was observed starting from an estimated value of 2.2 N.

(49) In a further experiment, the test elements 144 comprised sealing rings 134. Herein, the previous experiment was repeated. The second plate 180 was made of Geniomer® 345 from Wacker Chemie AG, Munich, Germany and the second plate 180 had dimensions of 6 mm×6 mm×1 mm. The first plate 178 was made of polycarbonate, had dimensions of 5 mm×5 mm×2 mm and was placed on top of the second plate 180. An electrical resistance of <1.1 Ohm was observed starting from an estimated value of 4 N to 5 N.

(50) In a further experiment, the testing setup 168 as described above was applied. The second plate 180 was made of Geniomer® 345 from Wacker Chemie AG, Munich, Germany and the second plate 180 had dimensions of 6 mm×6 mm×1 mm. The first plate 178 was made of polycarbonate, had dimensions of 5 mm×5 mm×2 mm and was placed on top of the second plate 180. A force of around 8 N was applied via the clamping screw 172. The electrical setup according to the second circuit diagram 148 for measuring a vibration resistance as depicted in FIG. 3C and as described above was applied. It was observed, that an electrical connection existed between all contact pads 118. Further, vibrations of 50 Hz with an amplitude of around 1 mm were applied via a solenoid core. No interruptions of the electrical connection between the contact pads 118 were observed.

(51) Further, the electrical setup according to the third circuit diagram 150 for measuring an insulation resistance as depicted in FIG. 3D was utilized and the testing setup 168 as depicted in FIG. 4A was applied. A voltage of 10 V was applied and a current was measured between two single contact pads 118 respectively. A maximal resolution of 0.00001 μA was reached. As a principle uncertainty of plus or minus one digit existed, it may be assumed, that the current had a maximal value of 0.00002 μA. A value for the isolation resistance between two contact pads 118 was determined to 1 Tera-Ohm. The experiment was continued for 21 days at room temperature and the isolation resistance was measured continuously. Thereby, a test solution of PBS buffer and 0.024% of sodium dodecyl sulfate was applied, so that the first plate 178, the second plate 180 and the two test elements 144 were floated with the test solution at 30 mm water column. Comparing to the initial state, no changes were observed. To make sure, that the high isolation resistance was not attributed to an error with the electrical traces 120, the contact pads 118 were released within the test solution and the sealing was lifted. At the moment of lifting the sealing, a maximal current was observed. Therefore, it was demonstrated, that the sealing ring 134 is able to conserve the isolation resistance of 1 Tera-Ohm over a period of a least 21 days.

(52) FIG. 5A and FIG. 5B show an electronics unit 186 of a sensor assembly 256 (shown below in FIGS. 9A to 10B). The electronics unit 186 may form part of a control part 254 of the sensor assembly 256 and may interact with a body mount 212, which will be shown below in FIGS. 6A to 6C. FIG. 5A shows a cross-sectional view of the electronics unit 186, and FIG. 5B shows a bottom view thereof.

(53) The electronics unit 186 may comprise an essentially flat base 188 and a housing 200 covering the base 188 on an upper side 202 opposing a body mount, which will further be described below in more detail. The housing 200 preferably may be a watertight housing 204 having an essentially round shape. The base 188 may protrude from the housing 200 on at least one side, thereby forming a protruding rim 206 on at least one side of the electronics unit 186. The protruding rim 206 may protrude on one side only or may fully or partially surround the electronics unit 186 and, as will be explained in further detail below, may be used for mounting the electronics unit 186 to a body mount 212, as will be further described below. Specifically, the protruding rim 206 may form part of a guiding structure for mounting the electronics unit 186 to the body mount 212 and, thus, may also be referred to as a “second guiding structure” 211, and interacting with a first guiding structure 230 of the body mount 212, as will be further discussed below in the context of FIGS. 9A to 10B.

(54) The housing 200 may fully or at least partially cover the electronics unit 186 and may provide protection against mechanical influences and moisture. Specifically, the electronics unit 186 may comprise one or more electronics components 208, which are fully or partially covered by the housing 200.

(55) The electronics unit 186, such as by using one or more of the electronics components 208, specifically may be configured for one or more of controlling the detection of the analyte or transmitting measurement data to another component, such as a receiver outside the sensor assembly. Therein, a wireless or a wire bound transmission may take place.

(56) The electronics unit 186, for contacting the sensor 110 as will be explained in further detail below, may comprise at least two electrical contacts 210. The electrical contacts 210 may be electrically connected to the contact pads 118 of the sensor 110, as described above and as described in further detail below in the context of, e.g., FIGS. 9A to 10B, once the electronics unit 186 is mounted to the body mount 212. The electrical contacts 210 may be located on a lower side 209 of base 188 and may be electrically connected to one or more of the electronics components 208 inside the housing 200 by vias 213. Thus, as an example, the base 188 may be or may comprise one or more circuit boards, such as one or more printed circuit boards, such as one or more rigid printed circuit boards, and the vias 213 may penetrate the printed circuit board from the lower side 209, facing the body mount 212, to the upper side 202, facing the interior of the housing 200. The one or more electronics components 208 may be applied to the printed circuit board on the upper side 202. Further, one or more electrical leads or traces may be applied to the printed circuit board. It shall be noted, however, that other setups of the electronics unit 186 are feasible.

(57) FIGS. 6A to 6D show an exemplary embodiment of a body mount 212 of the sensor assembly 256 in a cross-sectional view (FIG. 6A) as well as in partial perspective views of components of the body mount 212 (FIGS. 6B and 6C).

(58) The body mount 212 may be configured for attachment to a body of a user. The body mount 212 may comprise a base 234 as depicted in FIG. 6B in a perspective view, and a lever 218 as depicted in FIG. 6C in a perspective view. The sensor assembly 256 will further be discussed below in more detail in the context of FIGS. 9A to 10B.

(59) The body mount 212 may comprise at least one mounting element 217 for mounting the body mount 212 to the skin of the user. In the exemplary embodiment shown in FIGS. 6A and 6B, the mounting element 217 may comprise at least one plaster 215 having an adhesive surface 214 which may be adhered to the skin of the user. The plaster 215 may have an arbitrary shape, for example a rectangular shape or an oval shape. However, other embodiments are feasible. The adhesive surface 214 may be provided with a protective liner (not shown) which may be removed before adhering the adhesive surface 214 to the skin of the user.

(60) Further, the body mount 212 may comprise a receptacle 228 on a side opposing the lever 218. The receptacle 228 may be capable of receiving a part of the electronics unit 186. As an example, the receptacle 228 may receive the protruding rim 206 of 188 of the electronics unit 186 or a part thereof, which, as outlined above, may act as a second guiding structure 211, as explained above in the context of FIGS. 5B and 5B. The body mount 212 may comprise a first guiding structure 230, and the receptacle 228 may form part of this first guiding structure 230.

(61) Further, the body mount 212, particularly the base 234, may include a locking mechanism 216 having at least one lever 218 pivotably mounted to the body mount 212. Specifically, the lever 218 may be attached to one end 220 of the body mount 212, such as to one end of the base 234. The lever 218 may be permanently or removably mounted to the body mount 212. The lever 218, as an example, may be or may comprise a knee lever 222. A flexible extension 224, specifically a foldable foil 226, may be fixed to an outer end of the lever 218, capable of being gripped by a user for opening the lever 222.

(62) The locking mechanism 216 specifically may be a self-locking mechanism 219. As explained in further detail above, the self-locking may be induced in such a way that, when the electronics unit 186 is inserted into the body mount 212, the electronics unit 186 exerts a force onto the lever 218 which holds the lever in a closed state or closed position. Thus, as will be explained in the context of FIG. 10B below, the locking mechanism 216 may have an open state or open position, such as when the lever 218 is opened or pivoted in a vertical position, in which the electronics unit 186 may be taken out of the body mount 212. When the electronics unit 186 is inserted into the body mount 212, the lever 218 may be pivoted in a horizontal position, as will be shown in the context of FIG. 10A below, in which the locking mechanism 216 is in a closed state or closed position. In this closed state or closed position, the electronics unit 186 may exert a force onto the lever 218 which holds the lever 218 in the closed position.

(63) For this purpose, the lever 218, as depicted in FIG. 6C, may be shaped in a specific way. The lever 218 is connected to the base 234 of the body mount 212 by a hinge 221, comprising, e.g., sleeves 223 on the body mount 212 and corresponding studs 225 on the lever 218, such that the lever 218 may be pivoted. The lever 218 specifically may be designed as a knee-lever 222, having a protrusion 227 which faces inwardly. The protrusion, in conjunction with a main lever arm 229 of the lever 218, may form a further receptacle 231, into which, as depicted in FIG. 10B below, the rim 206 or a part thereof of base 188 may be inserted. The receptacle 231 may also form part of the first guiding structure 230 of the body mount 212.

(64) The first guiding structure 230 and the second guiding structure 211 of the electronics unit 186 as illustrated within FIGS. 5B and 5B may be configured to interact such that the electronics unit 186 may be positioned relative to the body mount 212 in a state in which the electronics unit 186 is locked to the body mount 212.

(65) Further, a pressure element 232 may be integrated into the base 234 of the body mount 212, such as by adhering the pressure element 232 to the base 234 and/or by integrating the base 234 with the pressure element 232 by multicomponent injection molding. The pressure element 232 may be integrated into a cavity 233 of the base 234 as depicted in FIG. 6B. The pressure element 232 may be one or both of flexible or deformable. Particularly, the pressure element 232 may comprise at least one of: an elastomer; a foam; a textile; a spring element; a thermoplastic polymer. Exemplarily, the pressure element 232 may be made of Geniomer® 345 from Wacker Chemie AG, Munich, Germany. The pressure element 232 may have an arbitrary shape. For example, the pressure element 232 may have a cylindrical shape. However, other embodiments are feasible. As shown in FIG. 6D, which is an enlarged view of part of the pressure element 232, the pressure element may have on at least one surface facing the sensor, one or more cavities 249 capable of acting as suction cups. The body mount 212 may further comprise at least one opening 235 which fully penetrates the body mount 212, specifically the base 234 and the adhesive surface 214. The opening 235 may be located next to the pressure element 232. The opening 235 may exemplarily have a round or a rectangular cross-section. However, other embodiments are feasible. As explained in further detail below, such as in the context of FIGS. 8B, 8C, 8D, 9A or 10B, the opening 235 may be used for guiding the cannula 242 and/or the sensor 110 into the body tissue and, thus, the cannula 242 and/or the shaft 122 of the sensor 110 may pass through the opening 235.

(66) FIGS. 7A to 7C show different embodiments of an insertion element 236. The insertion element 236 may be configured for transferring the sensor 110 as described above to the body mount 212. The insertion element 236 may comprise at least one plunger 238. Further, the insertion element 236 may comprise at least one cannula 242, specifically at least one slotted cannula 244. Thus, the transfer of the sensor 110 to the body mount 212, by using the insertion element 236, may take place simultaneously to an insertion of the shaft 122 of the sensor 110 or a part thereof into the body tissue, even though these processes actually are separate processes and may also be performed independently. Thus, as an example, the insertion element 236 may be designed without the cannula 242, and may be used for connecting the sensor 110 to the body mount 212, only. For implanting or inserting the sensor 110 into the body tissue, a separate tool may be used in this case.

(67) The sensor 110 may be partially, specifically with at least one insertable portion 246, received in the cannula 242. Specifically, the contact portion 124 may be located outside the cannula 242 and the insertable portion 146 may comprise the shaft 122 of the sensor 110 or may be part of the shaft 122.

(68) For adhering the sensor 110 to the body mount 212, one or more first adhesive elements 248 may be used. The at least one first adhesive element 248 may be attached to one or both of the body mount 212 and/or to the sensor 110. The first adhesive element 248, as an example, may comprise at least one adhesive, such as at least one pressure sensitive adhesive, like a polymer adhesive or a silicone-based adhesive. Other examples are feasible. Further, the first adhesive element 248 may also fully or partially be integrated or attached to the pressure element 232. The first adhesive element 248 may be designed to keep the sensor 110 in place, fixedly mounted to the body mount 212, once the sensor 110 is transferred onto the body mount 212 by using the insertion element 236.

(69) Further, for preliminarily attaching the sensor 110 to the insertion element 236, such as to the plunger 238, at least one second adhesive element 250 may be used. The second adhesive element 250 may be attached to and/or integrated into one or both of the sensor 110 and/or the insertion element 236, such as the plunger 238. Specifically, however, the second adhesive element 250 may be attached to or part of the sensor 110. This embodiment specifically may be realized by using the sealing ring 134, which may have adhesive properties, as the second adhesive element 250. Thus, during transfer of the sensor 110 to the body mount 212, the sealing ring 134 may stick to the plunger 238 and, thus, may attach the sensor 110 to a bottom side 252 of the plunger 238.

(70) As can be seen in the figures, the first and second adhesive elements 248, 250 may contact the sensor 110, specifically the contact portion 124 of the sensor 110, on opposite sides thereof. The insertion element 236 may be configured such that the sensor 110 may be inserted into the skin of the user in a direction transverse to a direction of extension of the skin, particularly perpendicular to the direction of extension (FIG. 7B) or in an angle in the range from 20° to 70°, preferably from 30° to 50° (FIGS. 7A and 7C). Other embodiments are feasible.

(71) FIGS. 8A to 8D illustrate a method of mounting the sensor 110 to the body mount 212 attachable to the skin of the user. In a first step, as depicted in FIG. 8A, the body mount 212 may be provided, having the base 234 and the pressure element 232 disposed thereon or integrated therein and with the opening 235 penetrating the base 234. The first adhesive element 248 may be attached to or be part of the pressure element 232. Specifically, this may be realized by using the pressure element 232, which may have adhesive properties, as the first adhesive element 248. The body mount 212, in this state, may be attached to the skin of the user by using the mounting element 217, such as the plaster 215, as disclosed above. The body mount 212 may further comprise the locking mechanism 216 as explained above and as will be disclosed in further detail below.

(72) In a next step, as depicted in FIG. 8B, the sensor 110 and the insertion element 236 as illustrated in FIGS. 7A to 7C may be provided. In a next step, as depicted in FIG. 8C, the sensor 110 may be transferred from an initial position, in which the sensor 110 is attached to the insertion element 236, as depicted in FIG. 8B, into a final position in which the sensor 110 is attached to the body mount 212 via the first adhesive element 248 and released from the insertion element 236, by using the insertion element 236. Thus, during the transfer, the adhesion between the sensor 110 and the body mount 212 may be established by the first adhesive element 248 and the adhesion between the sensor 110 and the insertion element 236, established by the second adhesive element 250 is released. Thereafter, the insertion element 236 may be removed.

(73) In a next step, as depicted in FIG. 8D, the electronics unit 186 may be locked onto the body mount 212 by using the at least one locking mechanism 216 as illustrated in FIGS. 6A to 6C. The electronics unit 186 and the body mount 212 may form a control part 254 of a sensor assembly 256.

(74) In an exemplary embodiment, the plunger 238 was made of Eastar™ Copolyester MN021 natural from Eastman Chemical Company, Kingsport, Tenn., USA by injection molding. Thereby, an injection mold for conducting the injection molding was polished at an area attaching the bottom side 252 of the plunger 238. The base 234 was made of Makrolon® 2458 from Bayer AG, Leverkusen, Germany. The substrate 114 was made of polyimide and was covered with the electrically insulating material 133. The electrically insulating material 133 was made of an solder resist from Dyconex AG, Bassersdorf, Swizerland. The sealing ring 134 was made of Geniomer® 145 from Wacker Chemie AG, Munich, Germany or alternatively of Geniomer® 345 from Wacker Chemie AG, Munich, Germany. The pressure element 232 was made of Geniomer® 345 from Wacker Chemie AG, Munich, Germany. The second adhesive material was made of DURO-TAK 87-4287, Henkel Corporation, Bridgewater, N.J., USA, spray application. Furthermore, the first adhesive element was made of DURO-TAK 387-2051/87-2051 from Henkel Corporation, Bridgewater, N.J., USA, spray application.

(75) FIGS. 9A and 9B show an exemplary embodiment of the sensor assembly 256 in a cross-sectional view (FIG. 9A) and in a side view (FIG. 9B). The sensor assembly 256 may comprise the control part 254 having the body mount 212 and the electronics unit 186. For further details, reference can be made to the description of FIGS. 1A to 8D above.

(76) FIGS. 10A and 10B show a further exemplary embodiment of the sensor assembly 256 in a perspective view in a fully assembled state, in which the locking mechanism 216 is locked and in a closed state or closed position (FIG. 10A) and in a disassembled state, in which the locking mechanism 216 is unlocked and in an opened state or opened position (FIG. 10B). As explained above in the context of FIGS. 6A to 6C, this locking or unlocking specifically may be performed by pivoting the lever arm 229 of lever 218.

(77) The sensor assembly 256 may comprise the control part 254 comprising the body mount 212 and the electronics unit 186. Whereas the sensor assembly 256 according to FIGS. 9A and 9B may comprise the electronics unit 186 with an essentially round shape, the sensor assembly 256 may comprise the electronics unit 186 with an essentially flat shape. Thus, however, is simply a design matter, and other embodiments may be feasible. For further details, reference can be made to the descriptions of the FIGS. 1A to 8D.

(78) By mounting the electronics unit 186 onto the body mount 212, the electrical contacts 210 of the electronics unit 186, disposed on the lower side 209 of the electronics unit 186, which in shape and position correspond to the contact pads 118 of the sensor 110, may be pressed onto the contact pads 118 or vice a versa, such that a mutual electrical contact between corresponding contact pads 118 and the electrical contacts 210 may be established. Simultaneously, as symbolically shown in the test setup of FIG. 4C, the sealing ring 134 may be compressed, and a contact region may be isolated from the ambient atmosphere by the sealing ring 134. The pressure element 232 may establish the required deformation of the substrate 114 of the sensor 110 and may provide, in conjunction with the locking mechanism 216, the required pressure for establishing a durable and reliable electrical contact between the sensor 110 and the electronics unit 186.

(79) While exemplary embodiments have been disclosed hereinabove, the present invention is not limited to the disclosed embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

LIST OF REFERENCE NUMBERS

(80) 110 sensor

(81) 112 intermediate product

(82) 114 substrate

(83) 116 electrode

(84) 118 contact pad

(85) 120 electrical trace

(86) 122 shaft

(87) 124 contact portion

(88) 125 surface

(89) 126 contact surface area

(90) 128 working electrode

(91) 130 counter electrode

(92) 132 reference electrode

(93) 133 electrically insulating material

(94) 134 sealing ring

(95) 135 insulating surface area

(96) 136 insulating layer

(97) 138 sealing lip

(98) 140 inner perimeter

(99) 142 outer perimeter

(100) 144 test element

(101) 146 first circuit diagram

(102) 148 second circuit diagram

(103) 150 third circuit diagram

(104) 152 end

(105) 154 further contact portion

(106) 156 counter contact pads

(107) 158 ohmmeter

(108) 160 voltmeter

(109) 162 electrical resistor

(110) 164 voltage source

(111) 166 micro-ammeter

(112) 168 testing setup

(113) 170 terminal block

(114) 172 clamping screw

(115) 174 supporting surface

(116) 176 plate

(117) 178 first plate

(118) 180 second plate

(119) 184 force

(120) 186 electronics unit

(121) 188 base

(122) 200 housing

(123) 202 upper side

(124) 204 watertight housing

(125) 206 rim

(126) 208 electronics component

(127) 209 lower side

(128) 210 electrical contacts

(129) 211 second guiding structure

(130) 212 body mount

(131) 213 vias

(132) 214 adhesive surface

(133) 215 plaster

(134) 216 locking mechanism

(135) 217 mounting element

(136) 218 lever

(137) 219 self-locking mechanism

(138) 220 end

(139) 221 hinge

(140) 222 knee lever

(141) 223 sleeve

(142) 224 flexible extension

(143) 225 stud

(144) 226 foldable foil

(145) 227 protusion

(146) 228 receptacle

(147) 229 lever arm

(148) 230 first guiding structure

(149) 231 further receptacle

(150) 232 pressure element

(151) 233 cavity

(152) 234 base

(153) 235 opening

(154) 236 insertion element

(155) 238 plunger

(156) 242 cannula

(157) 244 slotted cannula

(158) 246 insertable portion

(159) 248 first adhesive element

(160) 250 second adhesive element

(161) 252 bottom side

(162) 254 control part

(163) 256 sensor assembly