阅读说明：本技术 具有磁激活的连续分析物传感器 (Continuous analyte sensor with magnetic activation ) 是由 H·利斯特 F·韦霍夫斯基 于 2020-04-27 设计创作，主要内容包括：公开了一种分析物测量套件(1),其具有：a)传感器组件(100),传感器组件(100)包括经皮传感器元件(110)和控制单元(120)；控制单元(120)包括用于为传感器组件(100)供电的电池(121)和被设计成根据磁场产生电激活信号的磁传感器(122),其中控制单元(120)被设计成在产生激活信号时从操作前状态切换到操作状态；b)插入装置(200),其中插入装置(200)和传感器组件(100)包括用于可释放联接的互补联接结构(130、230)；其中插入装置(200)被设计用于执行插入例程,插入例程包括使传感器组件(100)从回缩位置推进到推进位置,并且随后使插入装置(200)与传感器组件(100)分离,在回缩位置,经皮传感器元件(100)位于插入装置(200)的皮肤接触表面(220)后面,在推进位置,传感器元件(100)伸出超过皮肤接触表面(220)。插入装置(200)包括激活磁体(240),并且执行插入例程与激活磁体(240)和传感器组件(100)之间的磁耦合的变化相关联,从而产生激活信号。(An analyte measurement kit (1) is disclosed having: a) a sensor assembly (100), the sensor assembly (100) comprising a transcutaneous sensor element (110) and a control unit (120); the control unit (120) comprises a battery (121) for powering the sensor assembly (100) and a magnetic sensor (122) designed to generate an electrical activation signal depending on the magnetic field, wherein the control unit (120) is designed to switch from a pre-operational state to an operational state upon generation of the activation signal; b) an insertion device (200), wherein the insertion device (200) and the sensor assembly (100) comprise complementary coupling structures (130, 230) for releasable coupling; wherein the insertion device (200) is designed for performing an insertion routine comprising advancing the sensor assembly (100) from a retracted position, in which the transcutaneous sensor member (100) is located behind the skin contacting surface (220) of the insertion device (200), to an advanced position, in which the sensor member (100) protrudes beyond the skin contacting surface (220), and subsequently detaching the insertion device (200) from the sensor assembly (100). The insertion device (200) includes an activation magnet (240), and performing the insertion routine is associated with a change in magnetic coupling between the activation magnet (240) and the sensor assembly (100) to generate the activation signal.)

1. An analyte measurement kit (1), the analyte measurement kit (1) comprising:

a) a sensor assembly (100), the sensor assembly (100) comprising a transcutaneous sensor element (110) and a control unit (120);

the control unit (120) comprises a battery (121) for powering the sensor assembly (100) and a magnetic sensor (122) designed to generate an electrical activation signal depending on a magnetic field, wherein the control unit (120) is designed to switch from a pre-operational state to an operational state upon generation of the activation signal;

b) an insertion device (200), wherein the insertion device (200) and the sensor assembly (100) comprise complementary coupling structures (130, 230) for releasable coupling;

wherein the insertion device (200) is designed for performing an insertion routine comprising advancing the sensor assembly (100) from a retracted position, in which the transcutaneous sensor element (100) is located behind a skin contacting surface (220) of the insertion device (200), into an advanced position, in which the sensor element (100) protrudes beyond the skin contacting surface (220), and subsequently detaching the insertion device (200) from the sensor assembly (100),

wherein the insertion device (200) comprises an activation magnet (240) and the execution of the insertion routine is associated with a change in magnetic coupling between the activation magnet (240) and the sensor assembly (100) to thereby generate the activation signal.

2. The analyte measurement kit (1) according to claim 1, wherein the sensor assembly (100) comprises a sensor housing (140), the sensor housing (140) enclosing the control unit (120), wherein the transcutaneous sensor element (110) protrudes from the sensor housing (140).

3. The analyte measurement kit (1) according to any one of the preceding claims, wherein said insertion device (200) comprises an elongated piercing element (260), wherein said piercing element (260) is structurally coupled with said sensor element (110) in said retracted position, wherein said insertion routine comprises advancing said piercing element (260) together with said sensor assembly (100) from said retracted position into said advanced position, followed by retracting only said piercing element (260) into said retracted position.

4. The analyte measurement kit (1) according to any one of the preceding claims, wherein the insertion device (200) comprises an insertion device housing (250), wherein the activation magnet (240) is rigidly coupled to the insertion device housing (250).

5. The analyte measurement kit (1) of claim 4, wherein the activation magnet (240) is positioned such that upon advancement of the sensor assembly (100) into the advanced position, a distance between the activation magnet (240) and the magnetic sensor (122) increases, thereby generating the activation signal.

6. The analyte measurement kit (1) of claim 4, wherein the activation magnet (240) is positioned such that upon advancement of the sensor assembly (100) into the advanced position, a distance between the activation magnet (240) and the magnetic sensor (122) decreases, thereby generating the activation signal.

7. The analyte measurement kit (1) of claim 3, wherein the activation magnet (240) is coupled with the piercing element (260) to move relative to the sensor assembly (100) upon retraction of the piercing element (260) into the retracted position.

8. The analyte measurement kit (1) according to claim 7, wherein the activation magnet (240) is rigidly coupled to or comprised in the piercing element (260).

9. The analyte measurement kit (1) according to any one of the preceding claims, wherein the magnetic sensor (122) comprises a coil.

10. The analyte measurement kit (1) of any one of claims 1-8, wherein the magnetic sensor (122) comprises a Hall effect sensor.

11. Analyte measurement kit (1) according to any one of the preceding claims, wherein the activation magnet (240) and the magnetic sensor (122) are aligned, in particular coaxially aligned, with each other in the coupled state of sensor assembly (100) and insertion device (200).

12. Analyte measurement kit (1) according to any of the preceding claims, wherein the control unit (120) comprises a wireless communication interface (123), and wherein the control unit (120) is configured to pair with a remote device (300) for data communication via the wireless communication interface (123) when switched into the operational state.

13. Analyte measurement kit (1) according to any of the preceding claims, wherein the sensor assembly (100) is configured to perform an analyte measurement in the operational state.

14. Analyte measurement kit (1) according to any of the preceding claims, wherein the analyte is glucose.

15. A method for switching a sensor assembly (1) from a pre-operative state into an operative state, the method comprising:

(a) providing an analyte measurement kit according to any one of the preceding claims;

(b) performing an insertion routine that includes altering a magnetic coupling between the activation magnet (240) and the sensor assembly (100) to thereby generate the activation signal.

Technical Field

The present invention belongs to the field of in vivo analyte measurement technology. In particular, the present invention relates to an analyte measurement kit for continuous subcutaneous analyte monitoring. The analyte may be glucose, for example.

Background

Monitoring characteristic parameters of substances in the human body is crucial for maintaining the health of people suffering from certain diseases. For example, people with diabetes (diabetics, PwD) rely heavily on monitoring glucose concentration to avoid hypoglycemia and hyperglycemia. Glucose concentrations may be measured at different locations, in particular body fluids such as blood and/or interstitial fluid.

It has long been possible to monitor blood glucose levels with traditional needle stick finger test methods, however these methods only allow PwD to measure blood glucose levels at a single point in time (so-called single point measurement). To achieve real-time or near real-time continuous monitoring, continuous glucose monitoring devices have been developed. In a typical design, an electrical, electrochemical or enzyme based sensor element is introduced into tissue percutaneously and connected with an electronic control unit carried outside the body (usually attached to the skin via an adhesive). This combination of sensor element and control unit is generally referred to as sensor assembly hereinafter. The sensor assembly is typically used continuously for an application time of days to weeks or even months. For introducing the sensor element into the tissue, an insertion device is usually provided.

After the time of use, PwD may simply remove the sensor assembly from the skin, thereby also withdrawing the sensor element from the tissue. In this design, the sensor assembly is designed as a single-use device and is discarded at the end of its use time.

The control unit includes all analog circuitry and/or digital circuitry required for analyte measurement and a power source in the form of a battery, as discussed further below. The control unit is typically enclosed in a completely closed and hermetically sealed housing and does not have any user interface. The measured analyte values and other relevant information (e.g., status information, error conditions, etc.) may be stored in a memory of the control unit and/or transmitted to a remote device via a wireless communication interface. Similarly, data, such as calibration data, may typically be received from a remote device via a wireless communication interface. The remote device may be, for example, a dedicated control device or a general-purpose device, in particular a smartphone. The wireless communication may be, for example, via Bluetooth^®Other general or special purpose wireless communication means.

To provide power for wireless communication and overall operation of the device, the control unit contains a small battery. However, the size of the battery and therefore its capacity is limited, since the monitoring device should be as small as possible for reasons of caution and carrying comfort. The lifetime of the sensor assembly is limited, inter alia, by the battery that powers the sensor assembly. The battery is usually an integral part of the control unit and cannot be replaced.

Disclosure of Invention

Batteries of suitable size and electrical characteristics are available that have sufficient capacity to provide power to the sensor assembly during its lifetime. However, the sensor assemblies are typically transported and stored in warehouses for extended periods of time (referred to as storage time), typically months and possibly even years. Thus, any energy consumed during the storage time reduces the electricityThe service life of the cell, and thus the sensor assembly, is reduced. For example, some known devices emit Bluetooth every 300 seconds^®Signal for discovery and connection to a remote device (pairing). Thus, these devices have a very limited shelf life of only up to 3 months. Thus, if a device is stored for a longer period of time, it is likely that the initial battery capacity has been consumed in large quantities or even completely before the device has been used for its dedicated purpose. In addition, a disadvantage of this type of device is that the connection to the remote device may take several minutes, which is annoying for the user.

In view of the above, it is therefore desirable to provide a continuous monitoring system, and in particular a sensor assembly device with a sensor, which sensor assembly device is initially in an inactive state after its manufacture and during storage time, wherein the power consumption is minimal and advantageously negligible.

WO 2014/179343 discloses various arrangements for switching from a pre-operative state to an operative state. In one embodiment, an activation circuit having an optical sensor is provided, the activation circuit being exposed to light to initialize sensor electronics. However, for this type of design, suitable lighting conditions are required. In another variation, a reed switch or hall effect sensor is provided. To initialize the sensor electronics, a magnet is brought into temporary proximity to a reed switch or hall effect sensor. For this type of design, the initialization process requires a dedicated user action. Furthermore, if the device, in particular the reed switch or the hall effect sensor, is exposed to a magnetic field for any reason, for example due to electromagnetic interference, the initialization may occur unintentionally.

WO 2012/050926 discloses switching the sensor from the storage mode to the normal operation mode by pulling the magnet away from the sensor electronics module. Thereby triggering an interrupt wire or changing the state of the reed switch.

It is therefore an object of the present invention to improve the prior art with respect to continuous analyte measurement techniques, such that the disadvantages of the prior art are preferably avoided in whole or in part.

In general, this object is achieved by the subject matter of the independent claims. Exemplary and/or particularly advantageous embodiments are described by the dependent claims, the description and the drawings.

Advantageously, an analyte measurement kit with a sensor assembly is provided which does not require any energy or at least only a small amount of energy in a pre-operative state and which can be easily brought into an operative state by a patient shortly before or during transcutaneous introduction of the sensor. Preferably, little or no additional treatment effort is required for the patient. It is further advantageous that the analyte measurement kit can be manufactured in a cost-effective manner.

According to a first aspect of the invention, the entire object is achieved by an analyte measurement kit comprising a sensor assembly and an insertion device. The sensor assembly comprises a sensor element (preferably a transcutaneous sensor element) and a control unit. The control unit includes a battery for powering the sensor assembly, and a magnetic sensor designed or configured to generate an electrical activation signal based on the magnetic field. The control unit is designed or configured to switch from the pre-operational state to the operational state upon generation of the activation signal. The sensor assembly and the insertion device comprise complementary coupling structures for releasable coupling. Furthermore, the insertion device is designed or configured to execute an insertion routine (route). The insertion routine includes advancing the sensor assembly from a retracted position, in which the sensor element is behind the skin contact surface of the insertion device, to an advanced position, in which the sensor element extends beyond the skin contact surface, and then separating the insertion device from the sensor assembly. The insertion device includes an activation magnet. The execution of the insertion routine is associated with a change in magnetic coupling between the activation magnet and the sensor assembly, thereby generating an activation signal. The activation magnet is typically a permanent magnet.

An analyte module of the above-described type has the advantage that during the insertion routine an activation signal is generated, upon which the control unit switches from a pre-operative state, i.e. an inactive state, to an operative state, i.e. an active state. It should be understood that the pre-operational state includes a state in which the control unit is not using or only using a small amount of battery power. This pre-operational state may specifically correspond to a low energy mode or a sleep mode of the control unit or its circuitry. In the pre-operational state, the control unit has no or only limited functionality. For example, it is not possible for a control unit in a pre-operational state to communicate with another device (such as a receiving device), or to perform and/or process an analyte measurement.

In some embodiments, the change in magnetic coupling may be caused by changing the distance between the activation magnet and the sensor assembly, particularly the magnetic sensor. Alternatively or additionally, the magnetic field direction of the activation magnet may be changed, for example, by providing a rotatable or turnable activation magnet such that the activation magnet rotates or pivots when performing the insertion routine. Furthermore, the magnetic coupling may be altered by shielding the magnetic field of the activation magnet from the sensor assembly (in particular the magnetic sensor). For example, the insertion device may comprise a magnetic shield, for example made of soft ferrite or soft steel, which is brought from an initial non-shielding position to a shielding position and vice versa when the insertion routine is performed.

Providing an activation magnet as part of the insertion device and generating the activation signal as a result of executing the insertion routine is particularly advantageous, since the insertion routine is a step that needs to be executed anyway. Thus, the switching from the pre-operational state to the operational state does not require PwD to perform any specific steps or take any measures. Further, the handover is directly performed at a point of time when the handover is required without an inevitable delay. That is, upon switching to the active state, pairing with the remote apparatus can be performed immediately. In contrast, typical known systems repeatedly transmit a signal to detect the presence of a remote device to be connected during the shelf life, i.e., the pre-operational state. In order to limit the amount of energy consumed in the pre-operative state, the time period elapsed between successive signal transmissions is relatively long, e.g. 1 minute or even longer, resulting in a time-consuming and often annoying process for the user.

Since the generation of the activation signal is associated with a change in the magnetic coupling between the activation magnet already present in the insertion device and the sensor assembly, external accidental activation, for example during transport, may be prevented in some embodiments, as explained further below.

A change in magnetic coupling between the activation magnet and the magnetic sensor may result in an increase or decrease in the magnetic field in which the magnetic sensor is applied, depending on the particular implementation, as explained further below. Furthermore, the magnetic field sensor may be configured to react to the presence or strength of a magnetic field, or to a change in the strength of a magnetic field, in particular to a time derivative of the strength of a magnetic field.

Typically, the sensor component, in particular the sensor element, comprises one or more electrodes, such as enzyme-based electrodes, which may be based on or comprise glucose oxidase. The sensor element is typically implemented in the form of an elongated element, such as a rod, wire or needle, and carries one or more electrodes that are placed in subcutaneous tissue or interstitial fluid during an insertion routine.

Typically, the sensor assembly includes an adhesive element, such as an adhesive pad or patch, for mounting the sensor assembly skin to the patient's skin for an extended period of time. The adhesive element may be directly or indirectly connected to the control unit. For example, the adhesive element may be realized by an adhesive layer or coating arranged at the bottom surface of the control unit, in particular the skin contact surface or the bottom surface of the sensor housing, as explained further below. In the advanced position of the sensor assembly, the adhesive element contacts the skin, thereby securing the sensor assembly.

Alternatively, an adhesive element, such as an adhesive layer or coating, may be provided on the skin contacting surface of a separate adapter (also commonly referred to as a stent). Such a separate adapter may have a coupling structure for coupling with a sensor assembly, which may have a corresponding complementary counter-coupling structure. Further, the adapter and insertion device may include complementary adapter-inserter coupling structures for releasable coupling. In such embodiments, the stent or adapter may be attached to the skin in a first step. Subsequently, an insertion routine is executed in a coupled state of the adapter and the inserter, thereby coupling the sensor assembly and the holder or the adapter. Subsequently, the insertion device is removed.

In typical embodiments, the insertion device and sensor assembly are configured to be easily coupled and in sterile packaging. After the insertion process, the insertion device is discarded. Alternatively, however, the coupling of the sensor assembly and the insertion device via their complementary coupling structures may be established only by the user prior to application. In such embodiments, the insertion device may in principle be reusable.

In some embodiments, the sensor assembly includes a sensor housing enclosing the control unit, wherein the sensor element extends from the sensor housing. In such embodiments, the sensor housing with the control unit may be advanced by the insertion device together with the sensor element from the retracted position to the advanced position during the insertion process. In performing the insertion routine, the sensor element pierces the skin of the PwD and is introduced into the tissue such that the one or more electrodes are placed in the subcutaneous tissue or interstitial fluid. Furthermore, in the advanced position, the adhesive layer or coating on the bottom surface of the sensor housing rests on the skin of the PwD, thereby fixing the control unit on the skin. Alternatively, the sensor assembly may be coupled with the adapter or bracket via complementary coupling structures as previously described when in the advanced position. The sensor element may protrude perpendicularly from the bottom surface of the housing. With this design, the insertion movement is substantially perpendicular to the skin. In an alternative design, the sensor element and the plane defining the bottom surface have an angle in the range of, for example, 30 to 60 degrees. For such embodiments, the insertion movement is typically oblique or skewed relative to the skin surface.

In some embodiments, the insertion device further comprises an elongate piercing element structurally coupled to the sensor element in the retracted position. The insertion routine includes advancing the penetrating member with the sensor assembly from a retracted position to an advanced position, and then retracting only the penetrating member to the retracted position. Such an embodiment is particularly advantageous if the sensor element introduced into the tissue is flexible or not stiff enough to pierce the skin without bending or rotating and/or has a blunt rather than pointed tip. Rather, the piercing element is rigid and pointed to be easily pushed through the skin. During the insertion routine, the piercing element remains coupled with the sensor element such that the sensor element is guided into the tissue together with the piercing element and stabilized by the piercing element. The piercing element and the sensor element are advantageously in mechanical contact over substantially their entire length, for example in a side-by-side arrangement, in a coaxial arrangement (wherein the sensor element is arranged in the central lumen of the piercing element). Alternatively, the sensor element may be hollow and have a central lumen in which the piercing element is arranged. The piercing element may be an insertion needle or cannula and may be separated from the sensor element before retraction of the piercing element. However, in alternative embodiments, the sensor element may be sufficiently rigid to pierce the skin and be introduced into the tissue without the need for an additional piercing element.

In some embodiments, the insertion device comprises an insertion device housing. The activation magnet is rigidly coupled to the insertion device housing. Depending on the position of the activation magnet, different kinds of embodiments regarding the magnetic coupling and its variations can be achieved when performing the insertion routine, as described below.

In some embodiments, the activation magnet is positioned such that when the sensor assembly, in particular the magnetic sensor, is advanced to the advanced position, the distance between the activation magnet and the magnetic sensor increases, thereby generating the activation signal. Increasing the distance between the activation magnet and the magnetic sensor results in a continuous decrease of the magnetic coupling between the activation magnet and the magnetic sensor and, thus, in a continuous decrease of the magnetic field strength at the magnetic sensor. For this type of embodiment, the activation magnet is positioned, for example by attachment to the insertion device housing, in a position where the activation magnet is in close proximity to the magnetic sensor in the retracted position, resulting in a magnetic coupling that is greatest in the initial retracted position of the sensor assembly. For this type of embodiment, a magnetic sensor that reacts to magnetic field strength and/or changes may be used. The latter is particularly advantageous in typical embodiments, wherein the insertion device comprises an arrangement of one or more resilient elements, such as one or more springs, for rapidly moving the sensor assembly from the retracted position to the advanced position. This movement typically results in a sufficient change in the magnetic field (time derivative of the magnetic field strength) to cause the magnetic sensor to react and generate an activation signal. It should be noted that the greater the change in magnetic field strength, the less sensitivity is required of the magnetic sensor. A relatively low sensitivity is advantageous because it results in a less critical design and reduced tolerance with respect to disturbing magnetic fields.

In some embodiments, the activation magnet is positioned such that, upon advancing the sensor assembly to the advanced position, a distance between the activation magnet and the magnetic sensor decreases, thereby generating the activation signal. Reducing the distance between the activation magnet and the magnetic sensor results in a continuous increase of the magnetic coupling between the activation magnet and the magnetic sensor and thus in a continuous increase of the magnetic field strength at the magnetic sensor. For this type of embodiment, the activation magnet is positioned, for example by attachment to the insertion device housing, in a position in which the activation magnet is in close proximity to the magnetic sensor in the retracted position, resulting in a magnetic coupling that is greatest in the advanced position of the sensor assembly. This type of embodiment is similar in principle to the previous type of embodiment, but is complementary in that the magnetic coupling increases rather than decreases when moving the sensor assembly from the retracted position to the advanced position.

In another type of embodiment, the variation of the magnetic coupling and the generation of the corresponding activation signal occurs with a reduction and eventual elimination of the magnetic coupling when the insertion device is disassembled and removed at the end of the insertion routine. In such embodiments, the activation magnet may be disposed on the inserter device housing at a location where the activation magnet is proximate to the magnetic sensor in the advanced position, as in embodiments of the type described above. Similarly, the activation magnet may be arranged at or in the coupling structure of the insertion device for coupling with the sensor assembly.

In some embodiments, the activation magnet is coupled to the penetrating member to move relative to the sensor assembly when the penetrating member is retracted to the retracted position as previously described. In embodiments where retraction is performed quickly, for example, by a resilient element such as a spring, the rate of change of the magnetic coupling is large. Therefore, the sensitivity required of the magnetic sensor is reduced, and the occurrence of malfunction is also reduced, as explained above. For this type of embodiment, the activation signal is generated when the penetrating member is retracted after the sensor element is placed in the tissue.

In some of the foregoing embodiments, the activation magnet is rigidly coupled to or included in the piercing element. If the activation magnet is included in the piercing element, no additional structural features are required that further complicate the overall arrangement of the analyte measurement kit. The piercing element may for example be made partially or completely of a permanent magnetic material.

In some embodiments, the magnetic sensor comprises a coil. The coil may be, for example, a planar coil and is implemented as part of the printed circuit board of the control unit. Alternatively, the coil may be an elongated cylindrical coil. This type of embodiment is based on the fact that: if the magnetic flux through the coil changes, a voltage is induced in the coil, wherein the voltage is used as an activation signal. Advantageously, the coil is connected to a microprocessor or microcontroller of the control unit, for example at an interrupt port or a wake-up port. This type of embodiment is particularly advantageous in embodiments where the magnetic coupling between the activation magnet and the magnetic sensor varies rapidly, for example, in spring-driven advancement of the sensor assembly from the retracted position to the advanced position or spring-driven retraction of the piercing element, since the voltage is proportional to the first time derivative of the magnetic field according to the law of induction. In all of these embodiments, the voltage induced in the coil and used as the activation signal is peak or pulse shaped. A particular advantage of using a coil as the magnetic sensor in this context is that the voltage used as the activation signal is generated by the coil and therefore no additional power supply is required to power the magnetic sensor, which is advantageous for the desired minimum power consumption during storage and before use. However, the magnetic field needs to be relatively strong.

In some embodiments, the magnetic sensor comprises a hall effect sensor. As is known in the art, hall effect sensors measure the strength of a magnetic field in which the sensor is applied. In contrast to the coils explained previously in the context of other embodiments, the hall effect sensors react to the magnetic field strength rather than to its rate of change and are capable of measuring both static and changing (dynamic) magnetic fields. The use of hall effect sensors is therefore particularly advantageous in cases where the change in magnetic coupling between the activation magnet and the magnetic sensor is relatively slow. Prior art hall effect sensors are typically implemented as micro-machined semiconductor components. It should be noted that in order to detect a change in magnetic coupling with the activation magnet, the hall effect sensor needs to be continuously powered via a DC power supply. However, hall effect sensors that require only about 350nA of current to operate are available. When using such hall effect sensors, standard small button cells as power sources for the sensor assembly are only consumed to a small extent during storage times of months up to years, so that sufficient battery capacity is maintained to power the sensor assembly during its application time. In another embodiment, a reed switch is provided as the magnetic sensor, which opens or closes depending on the magnetic field. A particular advantage of hall effect sensors or reed switches is that the magnetic field can be relatively weak. Thus, the activation magnet can be small and inexpensive. For example, the activation magnet may be a resin bond type magnet.

In some embodiments, the activation magnet and the magnetic sensor are aligned, in particular coaxially aligned, with each other in the coupled state of the sensor assembly and the insertion device. This type of arrangement advantageously maximizes magnetic coupling. For embodiments in which the magnetic sensor is a coil, the relative arrangement of the activation magnet and the coil is advantageously such that the lines of magnetic flux are parallel to the coil axis to achieve maximum magnetic coupling. In embodiments in which the magnetic sensor is a hall effect sensor, the arrangement is advantageously such that the lines of magnetic flux correspond to the direction of maximum sensitivity of the hall effect sensor (perpendicular to the plane defined by the hall probe of the hall effect sensor).

In some embodiments, the control unit includes a wireless communication interface. Further, the control unit is configured to pair with a remote device for data communication via the wireless communication interface when switching to the operational state. In particular, the remote device may comprise a smartphone, a portable computer, or any other suitable device. In an alternative embodiment, the control unit is connected with the means for data communication via a communication interface and a cable.

In some embodiments, the sensor assembly is configured to perform an analyte measurement in an operational state, for example by an electrochemical measurement or an electro-enzymatic measurement. In some particular embodiments, the analyte is glucose. In contrast, in the pre-operative state, no analyte measurement is performed, and the control unit is in a low energy mode or sleep mode, and only the magnetic sensor is powered (in the case where the magnetic sensor is a hall effect sensor, as explained above), and those parts of the control unit (in particular those parts of the microcontroller or microprocessor) which are required to detect the generation of the activation signal and react thereto are powered. In the operating state, the control unit may be configured to transmit the glucose measurement directly to the remote device and/or to store the measurement temporarily in a memory of the control unit and to transmit the measurement upon request by the remote device and/or according to a transmission schedule.

According to another aspect, the overall object is achieved by a method for switching a sensor assembly from a pre-operational state to an operational state. The method comprises the following steps: (a) providing an analyte measurement kit according to any embodiment described herein; and (b) executing an insertion routine that includes altering a magnetic coupling between the activation magnet and the sensor assembly, thereby generating the activation signal.

Drawings

Figure 1 shows a schematic view of an analyte measurement kit according to a first embodiment of the invention;

FIG. 2 shows a schematic view of an analyte measurement kit according to another embodiment of the invention;

fig. 3 shows a schematic view of an analyte measurement kit according to another embodiment of the present invention.

Fig. 4 shows another embodiment according to the present invention in a first configuration.

Fig. 5 shows another embodiment according to the present invention in a second configuration.

Fig. 6 shows another embodiment in accordance with the present invention in a third configuration.

Fig. 7 shows the sensor assembly of the embodiment of fig. 4-6 after removal of the insertion device.

Detailed Description

The analyte measurement kit 1 shown in fig. 1 includes a sensor assembly 100 releasably coupled with an insertion device 200 via corresponding coupling structures 130 and 230. The sensor assembly 100 comprises a control unit 120 and a sensor element 110. In addition, the sensor assembly 100 is enclosed in a sensor housing 140, while the sensor element 110 protrudes or protrudes from the sensor housing 140. The control unit 120 includes a battery 121 for powering the sensor assembly 100 and a magnetic sensor 122 designed to generate an electrical activation signal from a magnetic field and may be a hall effect sensor or coil. The sensor assembly 100 is shown in its retracted position prior to insertion of the sensor element 110 into the patient' S skin S, and thus the control unit is in a pre-operative state. The insertion device 200 is designed for performing an insertion routine comprising advancing the sensor assembly 100 from the shown retracted position, in which the sensor element 110 is located behind the skin contact surface 220 of the insertion device 200 in the insertion direction I, to an advanced position beyond the skin contact surface 220. The insertion device 200 is then separated from the sensor assembly 100 by releasing the coupling of the coupling structures 130 and 230. The insertion device 200 includes an activation magnet 240, which in this embodiment is rigidly attached to the insertion device housing 250 in a fixed position. The housing 250 comprises an elastic element 251 which contracts at the start of the insertion routine and expands after the sensor element 110 has protruded the skin and the sensor assembly 100 and the insertion device 200 have been separated. In addition, the housing 250 includes a spring element 252 that contracts and is thus loaded at the beginning of the insertion routine. If the user operates the activator 253 (which may be a button), the spring 252 is unloaded and the sensor assembly is advanced to an advanced position in which the elastic assembly 251 is contracted and thus loaded. In this embodiment, the activation magnet 240 and the magnetic sensor 122 are coaxially aligned in the coupled state shown in fig. 1. If the insertion routine is executed, i.e., when the sensor assembly 100 is brought into the advanced position, the sensor assembly 100, and thus the magnetic sensor 122, is moved away from the activation magnet 240. Thus, in the illustrated embodiment, the distance between the activation magnet 240 and the magnetic sensor 122 increases as the insertion routine is executed, i.e., as the sensor assembly is advanced to the advanced position. Thus, the magnetic coupling between the activation magnet 240 and the magnetic sensor is reduced and eventually eliminated. Thus, an activation signal is generated, upon which the control unit switches from the pre-operation state to the operation state. The control unit 100 further comprises a wireless communication interface 123 with which the control unit 120 can pair with the remote device 300 for data communication when the control unit switches to the operational state.

Fig. 2 shows a further embodiment of the analyte measurement kit 1. The analyte measurement kit 1 further includes a sensor assembly 100 coupled to the insertion device 200 via complementary coupling structures 130 and 230. In contrast to the embodiment shown in fig. 1, the insertion device 200 comprises an activation magnet 240, which is however arranged in a different position, i.e. in close proximity to the skin contact surface 220. Fig. 2 shows the analyte measurement kit 1 coupled during an insertion routine. In contrast to the embodiment shown in fig. 1, the insertion device 200 has been compressed to a certain level, e.g. by the pressure exerted by the patient on the top surface of the insertion device housing 250, and the sensor assembly 100 is advanced in the insertion direction I. In the particular embodiment shown, the two legs of the insertion device slide into each other, which brings the sensor assembly 100 to an advanced position in which the sensor element 110 may protrude from the skin contact surface 220 and pierce the patient' S skin S. Concomitantly, the distance between the magnetic sensor 122 and the activation magnet decreases. In this embodiment, the magnetic coupling between the sensor assembly 100 and the activation magnet 240 changes, thereby generating an activation signal, as the distance between the sensor assembly 100 and the activation magnet 240 decreases as the sensor assembly is advanced to the advanced position. Similar to the embodiment of fig. 1, the magnetic sensor 122 may be a hall effect sensor or a coil.

Fig. 3 shows a further embodiment of an analyte measurement kit 1 according to the invention. The analyte measurement kit 1 comprises a sensor assembly 100 having a sensor element 110 and a control unit 120. Further, the sensor assembly 100 comprises an adhesive element 150, such as an adhesive pad, at the lower surface for skin mounting the sensor assembly 100 to the patient's skin for an extended period of time. The analyte measurement kit 1 further comprises an insertion device 200 having an insertion device housing 250 and a skin contact surface 220. In contrast to the embodiment shown in fig. 1 and 2, the insertion device 200 additionally comprises a piercing element 260 structurally coupled to the sensor element 110. For example, the sensor element 110 may be tubular and/or cylindrical, and the piercing element is circumferentially surrounded by the sensor element 110. In addition, an activation magnet 240 (drawn in an exaggerated manner for better illustration) is rigidly coupled to the piercing element 260. During the insertion routine, the penetrating member 260 is advanced with the sensor assembly 100 from the retracted position to the advanced position along the insertion direction I, and then only the penetrating member 260 is retracted to the retracted position along the retraction direction R while the sensor assembly 100 remains in the advanced position. For example, the insertion routine may include a decoupling step in which the structural coupling of the sensor element 110 and the penetrating element 260 is released. Thus, while advancing the sensor assembly with the piercing element and activation magnet does not result in a change in magnetic coupling between the activation magnet 240 and the sensor assembly 100, merely retracting the piercing element 260 with the activation magnet 240 does trigger a change in magnetic coupling, thereby generating an activation signal. Thereby, the control unit 120 switches from the pre-operation state to the operation state in which the control unit can communicate with the remote device via the communication interface 123. It should be noted that the piercing element 260 may also be present in other embodiments, however, in these embodiments, the piercing element does not participate in generating the activation signal.

In the embodiment of fig. 1-3, the magnetic sensor 122 may also be implemented as a reed switch. In the embodiment of fig. 1, the advancing movement of the sensor assembly causes the distance between the activation magnet 240 and the magnetic switch to increase, thereby opening the reed switch. The same is true for the embodiment according to fig. 3. In contrast, in the embodiment of fig. 2, as the sensor assembly 100 moves from the retracted position to the advanced position, the decrease in distance to the activation magnet causes the reed switch to close.

Fig. 4 to 7 show a further embodiment of the analyte measurement kit 1. The base portion 202 is received in the lid portion 201 and is displaceable in the insertion direction in a telescopic manner relative to the lid portion 201. Similarly, the piercing element carrier 203 is received in the cap portion 201 in a coaxial manner, as explained further below. The puncture element carrier 203 can be displaced in the insertion direction relative to the cover part 201. The piercing element carrier 203 carries piercing elements 260 (best seen in fig. 6) that extend from the piercing element carrier 203.

The sensor assembly carrier 201a protrudes from the top wall of the cover member 201 and is connected to the sensor assembly 100 at its lower skin-facing side, the sensor assembly being further circumferentially surrounded by the sensor assembly carrier 201 a. The sensor assembly carrier 201a is rigidly connected to the cover element 201 and can be considered as a functional part thereof. Fig. 4 shows an initial configuration in which the base portion 202 projects beyond the cover portion 201 on the underside towards the skin S. Further, the base portion 202 is releasably locked to the cover portion 201. The sensor element 110 protrudes from the skin-facing side of the sensor assembly 100 and is located behind the skin contact surface 220. Furthermore, a generally tubular piercing element carrier guide 201b protrudes from and is rigidly connected to the top portion of the cap element 201. The puncturing element carrier guide 201b can be considered as a functional part of the cover element 201. In its inner space, the puncturing element carrier guide 201b receives the puncturing element carrier in a longitudinally displaceable manner. Furthermore, the piercing element carrier guide 201b carries on its exterior a locking structure for locking the base portion 202 in two alternative positions (see e.g. fig. 4, 5). The piercing element carrier guide extends toward the top surface of the sensor assembly 100.

Insertion is performed by placing the skin contacting surface 220 on the skin and manually depressing the capping element 201. Thereby, the lock between the cover member 201 and the base portion 202 is released. Accordingly, the cover portion 201 and the sensor assembly 100 move downward. In the inserted configuration, the base portion 202 is again locked on the lid portion 201. In the insertion configuration, the sensor element 110 is introduced into the skin and the sensor assembly is placed on the skin. The insertion configuration is shown in fig. 5.

In the final configuration, the gland member 201 is released by the user. As best seen in fig. 6, a compression spring 252 is disposed between the base member 202 and the piercing member carrier 203. In the initial configuration (fig. 4), the spring 252 is released. Upon moving from the initial configuration to the final configuration (fig. 5), the spring 252 is compressed and stressed accordingly. When the cover member 201 is released in the configuration of fig. 5, the spring 252 is unstressed, thereby pushing the puncturing element carrier 203 upwardly. Since the piercing member 260 is rigidly connected to the piercing member carrier 203, the piercing member also moves upward and the piercing member 260 retracts. This configuration is shown in fig. 6. Fig. 7 shows the sensor assembly 100 in a use state after detachment and removal of the insertion device 200.

The activation magnet is disposed in the piercing member carrier guide 201b proximate the top surface of the sensor assembly 100 and laterally spaced from the central axis. The magnetic orientation corresponds to the insertion direction. Thus, the magnetic flux passes through the sensor assembly 100. The magnetic sensor 122 is a hall effect sensor whose active surface is arranged in correspondence with the magnetic flux of the magnet 240. The magnetic sensor 122 continuously senses the magnetic field during the entire storage time and until the insertion device 200 is removed (turning from fig. 6 to fig. 7). With the insertion device 200 removed, the magnetic field of the activation magnet 240 is no longer detected, causing the sensor assembly 100 to switch from the pre-operative state to the operative state.

Name list

1 analyte measurement kit

100 sensor assembly

110 sensor element

120 control unit

121 cell

122 magnetic sensor

123 wireless communication interface

130 coupling structure

140 sensor housing

150 adhesive element

200 insertion device

201 cover part

201a sensor assembly carrier

201b piercing element carrier guide

202 base part

203 puncture element carrier

220 skin contact surface

230 coupling structure

240 activated magnet

250 insertion device housing

251 elastic element

252 spring

253 activator

260 piercing element

300 remote device

I direction of insertion

R direction of retraction

S skin of the patient.