Improved handling device for a pen

Abstract

The invention relates to a handling device (1) for a delivery device and to a delivery device for parenterally delivering a medicament, having a rotary element (9) which can be rotated about an axis by an angle proportional to the dose volume relative to a device housing (7), a push-through element (11) which can be moved relative to the device housing (7) and which acts on a drive device, a magnetic element (14) which is connected to the rotary element (9) and / or the push-through element (11) in such a way that it performs its movement(s), in particular relative to the device housing (7), together with the rotary element (9) and / or the push-through element (11), a sensor device (20) which consists of at least three magnetic field sensors, wherein each of the magnetic field sensors has a directional effect on the direction of a magnetic field component, and an evaluation device (30), wherein at least a first magnetic field sensor and a second magnetic field sensor of the magnetic field sensors are mounted in such a way that they selectively detect a change in the field component in the circumferential direction and at least a third magnetic field sensor is mounted in such a way that it selectively detects a change in the field component in the axial direction.

Description

Technical Field

[0001] This invention relates to the field of delivery devices and systems, for which the generation, evaluation, storage, and communication of data are of paramount importance. In embodiments or modifications, this invention relates to apparatuses, systems, and methods for the reliable and accurate detection and evaluation of data, combined with drug use-friendly and reliable metrology and delivery. Background Technology

[0002] The present invention relates first to a delivery device having a threaded piston rod that can be advanced by a rotating drive. Such a delivery device is used, for example, for treating diabetes by delivering insulin.

[0003] WO2018 / 160425A1 describes a module or system for detecting the delivery dose of a drug using a pen. This disclosure relates to a dose recognition system for use in conjunction with a drug delivery device. In one aspect, the system includes a module coupled to a device and containing a sensor capable of detecting the relative angular position of an element mounted on the drug delivery device. The system determines the type of drug contained in the device and / or the type of device based on the detected angular position of the element being detected. In another aspect, the dose recognition system is used in conjunction with a drug delivery device containing a dose-adjusting element that rotates relative to an actuator during dose delivery. This dose recognition system includes a sensor and is capable of detecting the relative angular position of the element being detected, fastened to the dose-adjusting element, during dose delivery and determining the quantity of the delivered dose. Similar methods have also been disclosed. Quantitative detection of the delivery dose is performed using multiple sensors and a magnetic ring that moves relative to the sensors during delivery. No detection is performed in this system during dose preselection.

[0004] WO2019 / 001919A1 describes an add-on device suitable for detachable mounting on a drug dispensing device, wherein the add-on device is adapted to determine the magnitude of movement of a display element when mounted on the housing of the drug dispensing device, wherein the add-on device includes a model identification mechanism adapted to detect a predefined model identifier on the drug dispensing device. Furthermore, the add-on device is designed such that it can be activated from an initial non-operating state to a persistent operating state, which is a predefined state corresponding to an identified predefined model identification code. No detection is performed in the add-on device during dose preselection.

[0005] WO2019 / 170429 describes a drug delivery system comprising: an elongated housing including an adjustment structure for adjusting the dosage of a drug via angular position; and a sensor structure for determining the dosage, the sensor structure including a magnet and a magnetic sensor arranged such that at least one of the angular position and displacement of the magnetic sensor relative to the magnet can be determined as a function of the resistance of the magnetic sensor. The sensor structure is arranged relative to the adjustment structure such that the angular position of the adjustment structure is determined as a function of the angular position and / or displacement of the magnetic sensor. A sensor structure is also described, comprising: a flexible membrane having a magnetic sensor with a cylindrical shape, the flexible membrane including an axis; and a magnet arranged on a line parallel or collinear with the axis. The disclosed sensor structure is based on the magnetoresistive effect and is a simple alternative to optical or potentiometric measurement devices, in which resistance changes are similarly evaluated or interpolated. What remains unresolved is how to distinguish between movement and rotation or how to ensure error-free results.

[0006] The concepts of “product,” “drug,” or “medical substance” in this context include every flowable medical composition suitable for controlled delivery, such as a liquid, solution, gel, or fine suspension containing one or more medically active substances, into subcutaneous or intramuscular tissue via cannula or needle. A drug can therefore be a component having a single active ingredient or a premixed or co-formuliert of multiple active ingredients from a single container. This concept particularly includes pharmaceutical preparations not only in solid (suspended) or liquid form, such as peptides (e.g., insulin, insulin-containing drugs, GLP-1-containing and derived or similar formulations), proteins and hormones, bio-derived or active active substances, hormone- or gene-based active substances, nutritional formulations, enzymes, and other substances. Furthermore, this concept also includes polysaccharides, vaccines, DNS or RNS or nucleotides, antibodies or portions of antibodies, and suitable base materials, excipient materials, or substrate materials.

[0007] The concept of "distal" refers to the front end of the delivery device, the side of which is inserted, or the side or direction toward the tip of the injection needle. In contrast, the term "proximal" refers to the rear end of the delivery device, the side or direction opposite to the end of which is inserted.

[0008] In this specification, the concept of "injection system" or "syringe" is understood as a device in which an injection needle is removed from the tissue after a controlled amount of medical substance has been delivered. Thus, unlike an infusion system, the injection needle does not remain in the tissue for an extended period of several hours. Summary of the Invention

[0009] The objective of this invention is to provide an actuation device for a delivery apparatus for administering drugs without passing through the gastrointestinal tract, wherein the actuation device should include a measuring device having only a few individual components required for non-contact measurement. Furthermore, it should ensure high accuracy, fail-safety, uncomplicated operation, low energy consumption, reduced susceptibility to interference, and lower manufacturing costs.

[0010] This task is accomplished by the operating mechanism of the delivery device for administering drugs without passing through the gastrointestinal tract, as described in claim 1. Advantageous modifications are known from the dependent claims.

[0011] Delivery devices for administering medications without passing through the gastrointestinal tract, particularly automatic pens or injection devices such as those upon which this invention is based, possess various mechanical devices, such as metering and dispensing devices constructed from multiple elements. For example, to dispense the product, a piston rod, in the form of a threaded rod with a flange, can be driven along the longitudinal axis of the injection device relative to the product container, device housing, or other guiding and / or driving elements. The driving motion can be generated manually, for example, via a threaded transmission mechanism or via a motor, particularly a spring motor.

[0012] A delivery device for non-gastrointestinal drug administration can have an operating mechanism according to the invention. For example, a sleeve-shaped or cylindrical rotating element with an axis is used to adjust the dose volume of the product to be administered. This rotating element is coaxial with respect to the device housing and about the longitudinal axis of the injection device at an angle proportional to the pre-selected and / or given dose volume. The rotating element can be rotated, for example, by an external knob and can be coupled to a spring motor such that the spring motor can be tensioned by rotation and / or driven together with the rotating element. Furthermore, a push element can be provided, operable externally, for example by a button, and movable relative to the device housing along the longitudinal axis of the injection device. This push element acts on a motor or coupling and triggers, releases, or prevents the drive movement. The push element can rotatably and axially fixedly support the rotating element, thereby enabling the rotating element to move along with it. Alternatively, the push element and the rotating element can be integrally formed and supported in the injection device such that it can not only rotate relative to the device housing but also move along the longitudinal axis. Furthermore, the pushing element can be supported in the appliance housing in a manner that allows it to move collinearly or coaxially relative to the longitudinal axis without depending on the rotating element. Preferably, the pushing element can be coupled to the rotating element in a manner that allows it to move and rotate axially relative to the rotating element. During operation, the pushing element can perform linear, particularly axially oriented, positional changes, which can be limited by an axial end stop. Furthermore, the pushing element can be operated by a spring force that overcomes the axial action of a return spring, which allows the pushing element to move back to its original position. When rotated from the outside and / or by a motor, the rotating element performs angular changes, where the maximum possible angular change can be limited, for example, by a radial end stop. Furthermore, the rotating element can be effectively connected to a stop device that can force-lock the rotating element into a predetermined, particularly regularly distributed, stop position or rotation angle. For example, this stop device can be implemented by a ratchet-type elastic fastener (Schnapper) or by a spring-loaded locking disc (Klickscheibe). The stop position or rotation angle of the rotating element can correspond to the pre-defined dose step of the drug to be delivered.

[0013] Furthermore, a measuring device is provided on the operating device according to the invention, which has a permanently magnetized magnetic element, particularly a hollow cylindrical or toroidal magnetic element, for example, in the form of a hollow shaft. This magnetic element can be magnetized alternately and, more specifically, regularly in a fan-shaped distribution, such that the pole angles about the axis of rotation are all the same size. For example, the permanent magnetization of each sector can be radially oriented, with N or S poles correspondingly constructed on the outer surface and the corresponding inner surface of the hollow cylindrical sector. Correspondingly, regions of N or S poles are also constructed on the axially oriented end faces of the hollow cylindrical sector. Alternatively, magnetization can also be implemented as a so-called Halbach array, which has the advantage that the magnetic flux almost cancels out on the inner surface of the magnetic element and is correspondingly enhanced on the outer surface. Advantageously, the axis of rotation of the magnetic element can coincide with the longitudinal axis of the injection device and / or the axis of the rotating element. For example, the magnetic element can be a toroidal magnet with 10 poles, a sector, or a pole angle distributed around its periphery, wherein, in a regular distribution, an N pole follows an S pole every 36°. More or fewer poles can also be provided, preferably 2 to 40 or more. The magnetic element can be effectively connected to rotating and / or pushing elements such that the magnetic element moves together with them, particularly relative to the appliance housing. For example, the magnetic element is torsionally and coaxially supported on the rotating element and axially fixed but rotatably connected relative to the pushing element, or the magnetic element is fixedly connected to the pushing element, which moves together with the rotating element. The magnetic element can be locked to the rotating or pushing element, for example, by means of ribs and grooves. Magnetic fields of varying intensities and orientations are generated in the space above the outer surface of the magnetic element by magnetization. On the one hand, alternating polarized magnetic flux density or field components are formed circumferentially, or in other words, along the circumferential direction, especially transversely or tangentially to the axis of rotation, and correspondingly have a maximum value at the center of the axially extending pole boundary. Simultaneously, alternating polarized magnetic flux density or field components are formed pointing towards the axis of rotation, especially parallel to the axis of rotation, or in other words, along the axial direction, but with a phase shift of half a pole angle relative to the axially extending pole boundary, and correspondingly have maximum values ​​at the proximal and distal end faces.

[0014] Advantageously, the stopping device can also operate magnetically, wherein at least one stator, which is torsionally connected to the device housing, is suitably shaped and magnetized, and / or magnetizable, can move and hold a magnetic element or a rotating element torsionally connected to the magnetic element in a stopped position by magnetic force. These stopped positions of the rotating element, or the rotation angle between the stopped positions, can correspond to a predetermined dosage step of the drug to be administered. For example, in addition to a magnetic element that can rotate relative to the device housing, a magnetically operating stopping device for an actuating or delivery device for non-gastrointestinal drug administration can also have the following structure for the stator element: a magnet fixed to the housing, formed as a complete or partial ring, having the same or complementary permanent magnetization structure in a fan-shaped manner like the magnetic element, preferably acting on the magnetic element through an air gap at the proximal or distal end side, radially or circumferentially. Such an arrangement achieves stopping (rasten) by a double pole angle or fan-shaped angle. Alternatively, at least one soft magnetic stator element, fixed to the housing in a rod-like or bent shape, is mounted in the magnetic field of at least one pole of the magnetic element and spaced apart from the magnetic element by an air gap. Preferably, such a stator element can be constructed, for example, as a U-shaped yoke made of soft magnetic material, which allows two different poles of the magnetic element to be connected. Such a soft magnetic arrangement is stopped by a simple pole angle or sector angle.

[0015] Furthermore, the measuring device has a sensor unit on the operating device according to the invention, which consists of at least three magnetic field sensors. Each of these magnetic field sensors has a prominent sensitivity or directional effect with respect to the direction and / or polarization of the magnetic field relative to a sensor axis called the switching axis. A digital output terminal of each magnetic field sensor, equipped with a memory or latch, is turned on or set when the magnetic flux density polarized from N to S along the switching axis reaches or exceeds an on value, and is turned off or reset when the magnetic flux density polarized from S to N reaches or exceeds an off value. Alternatively, the magnetic field sensor is turned on or set when the magnetic flux density polarized from S to N along the switching axis reaches or exceeds an on value, and is turned off or reset when the magnetic flux density polarized from N to S reaches or exceeds an off value. This characteristic of the magnetic field sensor as a bipolar switching feature is known. Alternative sensors that provide analog output signals can also be used, which can be evaluated accordingly. Preferably, the magnetic field sensors have an integrated arrangement that operates according to the magnetoresistive principle, particularly preferably according to the tunneling magnetoresistive principle. Such structural elements are also known as TMR sensors. TMR sensors offer advantages in terms of energy consumption and the degree of freedom in the structural arrangement of the elements of the actuation device according to the invention due to their high sensitivity to magnetic field strength. The high sensitivity of TMR sensors also allows for the abandonment of rare-earth magnets, and enables the use of inexpensive, corrosion-resistant materials, such as ferrite, for magnetic elements.

[0016] The sensor device is connected to or can be connected to the evaluation device, particularly a computer-implemented or software-implemented evaluation device, for example, one with a microcontroller and / or a field-programmable gate array (FPGA). Here, the outputs of at least three magnetic field sensors can be connected to the corresponding inputs of the evaluation device, wherein each magnetic field sensor has at least one output that is connected to or can be connected to the corresponding input of the evaluation device. At least one first and second magnetic field sensor are mounted such that they selectively detect changes in the field component along the circumferential direction, and at least a third magnetic field sensor is mounted such that it selectively detects changes in the field component along the axial direction. This selective detection based on the field components enables reliable and easy differentiation between rotational and pushing motions. The evaluation device advantageously implements at least one first decoder, which is capable of evaluating at least the first and second inputs of the orthogonally encoded signals to quantitatively detect the rotation of the rotating element. Signal changes at at least the third input can be decoded as changes in the position of the pushing element, and especially as rotation of the rotating element. Here, signal changes at the input terminals can be used for further processing either directly in real time or by intermediate storage in a FIFO buffer. In this way, a suitable state machine or storage logic circuit can reflect or mimic the movement or state of the control device and provide it as state information for further evaluation. This state information can be used to calculate, in particular, the dosage, injection volume, and injection time, especially the set dosage, the corrected dosage, and / or the dispensed dosage. Faults in the control device or the measuring device can also be detected based on specific signal states or sequences at the input terminals, and the functional reliability of the control device or the connected system can be improved. Preferably, the evaluation device implements a second decoder capable of evaluating the third and fourth inputs, which are orthogonally encoded signals, to quantitatively detect the rotation of the rotating element and, together with the first decoder, improve the detection accuracy and the distinction between changes in the position of the pushing element. Furthermore, the evaluation device can have an input terminal that wakes the evaluation device from a power-saving state and can connect other system components when the signal changes.

[0017] Preferably, the magnetic field sensor can be switched on and off by the evaluation device. Preferably, at least one magnetic field sensor can be modified or switched in terms of its sampling rate by the evaluation device. For example, this allows only one of at least three magnetic field sensors to be switched on and a lower sampling rate to be selected in the stationary state of the manipulator, thereby resulting in lower power consumption in the stationary state of the manipulator. A suitable high sampling rate for the operating state of the manipulator is determined by the maximum expected angular velocity in the operating state of the manipulator and the number of poles distributed on the periphery of the magnetic element. Preferably, at least one sampling is performed for each quadrant of the pole channel. A suitable high sampling rate is, for example, between 1 kHz and 100 kHz or higher, preferably between 5 kHz and 20 kHz, for example, about 10 kHz.

[0018] In the non-operated state of the control device, the first magnetic field sensor and the second magnetic field sensor are mounted on the sensor layer of the magnetic element along a first axial segment oriented in the circumferential direction on the magnetic element and relative to each other at a first sensor angle with respect to the axis of rotation and radially spaced relative to the magnetic element. The switching axes of the first magnetic field sensor and the second magnetic field sensor are oriented in the circumferential direction or tangentially to the first segment or the sensor layer and are oriented in the same or opposite directions. And / or at least one of the first magnetic sensor or the second magnetic sensor has a reverse switching feature or a reverse output signal.

[0019] In an advantageous modification, the first sensor angle is smaller than the polar angle or a polar angle that is an integer multiple thereof. Preferably, the magnetic element is positioned relative to the magnetic field sensor in such a way that the switching axes of the first and second magnetic field sensors are oriented in such a way or their outputs are switched, such that when the rotating element or the magnetic element is in a stopped position, or when the first and second magnetic field sensors are in a magnetic field of the same polarization, one of the two outputs is set accordingly and the other of the two outputs is reset. This enables a space-saving structure for the sensor device, particularly a space-saving sensor device at the sensor level, in which optimal utilization of the magnetic field is achieved, thereby achieving an improved signal-to-noise ratio relative to the external field.

[0020] In the non-operated state of the control device, a third magnetic field sensor is mounted on the sensor layer along a second axial segment extending in the circumferential direction and radially spaced relative to the magnetic element. This second axial segment is axially offset relative to and / or overlaps with the first segment. The switching axis of the third magnetic field sensor points in the axial direction or is oriented transversely to, and especially orthogonally to, the switching axes of the first and second magnetic field sensors. Here, the third magnetic field sensor or the second axial segment is positioned relative to the magnetic element such that its output can be set or reset when the pushing element moves axially and / or when the rotating element rotates. The output signal of the third magnetic field sensor can be used by the evaluation device to detect changes in the position of the pushing element and / or changes in the angle of the rotating element. This third magnetic field sensor can be turned on in particular when the control device is stationary and a low sampling rate can be selected. Therefore, when the signal indicates a change in the position of the pushing element and / or a change in the angle of the rotating element, the evaluation device can identify the operation of the control device and accordingly turn on the rest of the sensor device and select a high sampling rate suitable for the operating state of the control device, thereby enabling the control device to transition from an energy-saving stationary state to an operating state. By employing a suitable high sampling rate during the operation of the control device, the third magnetic sensor can detect position and angular changes accurately and with minimal time delay. The suitable high sampling rate is derived based on the maximum expected angular velocity of the rotating element during the operation of the control device and the number of poles distributed on the periphery of the magnetic element. Preferably, at least one sampling is performed for each quadrant of the pole channel. A suitable high sampling rate can be, for example, between 1 kHz and 100 kHz or higher, preferably between 5 kHz and 20 kHz, for example, approximately 10 kHz. For the stationary state of the control device, the sampling rate can be expected to be at least 100 times lower, resulting in correspondingly lower power consumption for the third magnetic field sensor while still being able to detect state changes reliably and quickly enough.

[0021] In an advantageous modification, a fourth magnetic field sensor is mounted on the second section and on the sensor layer of the magnetic element at a second sensor angle relative to the third magnetic field sensor about the axis of rotation and radially spaced from the magnetic element. The switching axis of the fourth magnetic field sensor is oriented axially, or transversely to, and particularly orthogonally to, the switching axes of the first and second magnetic field sensors. The switching axes of the third and fourth magnetic field sensors are oriented in the same or opposite directions, and / or one of the third or fourth magnetic field sensors has opposite output terminals. Here, the fourth magnetic field sensor is positioned relative to the magnetic element such that its output terminal can be set or reset when the pushing element moves axially and / or when the rotating element rotates. The output signal of the third magnetic field sensor can be used by the evaluation device to detect changes in the position of the pushing element and / or changes in the angle of the rotating element.

[0022] In an advantageous modification, preferably at least one of the first and second magnetic field sensors is mounted on the sensor layer along the axial direction or at the same angular position about the axis of rotation, together with at least one of the third and fourth magnetic field sensors.

[0023] In an advantageous modification, the second sensor angle is smaller than the polar angle or a polar angle that is an integer multiple thereof. Preferably, the magnetic element is positioned relative to the magnetic field sensor in such a way that the switching axes of the third and fourth magnetic field sensors are oriented in such a way or their outputs are switched, such that when the rotating element or the magnetic element is in a stopped position, or when the third and fourth magnetic field sensors are in magnetic fields of different polarizations, one of the two outputs is set accordingly and the other of the two outputs is reset. This enables a space-saving structure for the sensor device, particularly a space-saving sensor device at the sensor level, in which the magnetic field is optimally utilized and thereby an improved signal-to-noise ratio relative to the external field is achieved.

[0024] In an advantageous modification, the second sensor angle has the same value as the first sensor angle. This enables a space-saving structure for the sensor device, particularly an area-saving sensor device at the sensor level, in which the magnetic field is optimally utilized, thereby achieving an improved signal-to-noise ratio relative to the external field.

[0025] In an advantageous modification, the first and third magnetic field sensors can be integrated into the first housing and / or the second and fourth magnetic field sensors can be integrated into the second housing.

[0026] In one advantageous modification, the sensor layer can be flat or curved and / or segmentedly bent, especially in the form of a cylindrical shell. This allows for optimization of the radial position of the magnetic field sensor and thus optimized utilization of the magnetic field, resulting in an improved signal-to-noise ratio relative to the external field.

[0027] In an advantageous modification, the sensor layer can be formed by a circuit board and / or a conductive film, which can be fixedly connected to the device housing or the pushing element.

[0028] Furthermore, a fifth magnetic field sensor can be mounted on the sensor layer along the first axial segment and / or the second axial segment, wherein the switching axis of the fifth magnetic field sensor is oriented in the axial direction or transverse to, and particularly orthogonal to, the switching axes of the first and second magnetic field sensors. Here, the fifth magnetic field sensor can be positioned relative to the magnetic element such that its output can be set or reset when the pushing element moves axially and / or when the rotating element rotates. The output signal of the fifth magnetic field sensor can be used by the evaluation device to detect changes in the position of the pushing element and / or changes in the angle of the rotating element. This fifth magnetic field sensor can be activated and a low sampling rate selected, particularly when the operating device is stationary. Therefore, when the signal indicates a change in the position of the pushing element and / or a change in the angle of the rotating element, the evaluation device can identify manipulation of the operating device and accordingly activate the rest of the sensor device and select a high sampling rate suitable for the operating state of the operating device, thereby allowing the operating device to transition from an energy-efficient stationary state to an operating state. The fifth magnetic field sensor can be used solely for this wake-up function or it can be used in conjunction with the other magnetic field sensors for extended credibility verification.

[0029] Furthermore, if the fifth magnetic field sensor and / or the other magnetic field sensors among the first to fourth magnetic field sensors do not show any signal change at their respective output terminals for a predetermined duration, the operating device can transition from the operating state to the stationary state.

[0030] The described measuring device and its modifications according to the invention detect the rotation or rotation angle of a rotating element during dosage adjustment and / or product dispensing. From the logical sequence of the sensed position of the pushing element or from the manipulation of the button and the sensed movement of the rotating element, the absolute position of the rotation of the rotating element or the rotation angle relative to the device housing can be derived and determined, or stored as a reference position. For example, a button manipulated during a predetermined period of time when there is no rotation of the rotating element can indicate the zero position of the rotating element. Furthermore, this requires, for example, a reference stroke within a predetermined range of rotation angles along a predetermined direction of rotation, or a user-predefined manipulation sequence at the beginning or after a malfunction. Alternatively, additional sensors or terminal switches can signal the arrival and / or excess of one or more absolute reference positions, particularly the position of the rotating element relative to the device housing.

[0031] A modified embodiment of the present invention also includes a delivery device for administering drugs without passing through the gastrointestinal tract, comprising:

[0032] -The operating device according to the present invention;

[0033] - A piston rod in the form of a threaded rod with a flange;

[0034] -Product containers retained within the appliance housing;

[0035] The driving movement of the piston rod along the longitudinal axis of the device housing can be preselected and / or controlled by an actuating device and can be generated manually, for example by a threaded drive mechanism or automatically by a motor, especially an electric motor or a spring motor, thereby discharging the drug from the product container, for example by a needle. Attached Figure Description

[0036] Preferred embodiments of the present invention will now be described with reference to the accompanying drawings. These embodiments should be interpreted as illustrating the basic feasible aspects of the invention and should not be construed as limiting.

[0037] Figure 1 This shows the automatic pen's control mechanism in an inactive state;

[0038] Figure 2 This shows the automatic pen's control mechanism in operation.

[0039] Figure 3 The components of the control device are shown in an exploded view;

[0040] Figure 4 The magnetic element is shown;

[0041] Figure 5 The diagram shows the magnetic field strength By (mT) along the circumferential direction.

[0042] Figure 6 The magnetic field strength Bx (mT) along the axial direction is shown as an unfolded diagram;

[0043] Figure 7 A top view of the measuring device in an unoperated state is shown;

[0044] Figure 8 A longitudinal section of the measuring device in operation is shown;

[0045] Figure 9 A circuit board with a magnetic field sensor is shown (viewed from the axis of rotation);

[0046] Figure 10 The positions of the magnetic components, sensors, and appliance housing relative to each other are shown in the unmanipulated state;

[0047] Figure 11 The positions of the magnetic components, sensors, and appliance housing relative to each other are shown in the maneuvering state;

[0048] Figure 12 A state event diagram for biorthogonal coded signals is shown;

[0049] Figure 13 A flowchart is shown for evaluating the biorthogonal coded signal in the current state of the automatic pen;

[0050] Figure 14 A state event diagram for power-on is shown. Detailed Implementation

[0051] Figures 1 to 3An embodiment of the operating device 1 according to the invention in a dispensing device, exemplified by an automatic pen 2, is shown. The automatic pen 2 has a product container 6 filled with medicine, which is held in a device housing 7. Using a drive sleeve 35 that can be driven by a spring motor 8, a piston rod with a flange 5 can be pushed distally through a threaded portion, wherein a plug in the product container 6 pushes the medicine through a syringe (not shown) located in a diaphragm 36, until a rotating element 9 that rotates together with the drive sleeve 35 comes to rest at the device housing 7 by a radial stop 37. The rotating element 9 is provided with a scale that can be read through a scale window 33. To set an additional amount or dose of medicine to be administered, the rotating element 9 can be moved away from the stop 37 by a distance or rotation angle proportional to the dose by turning a knob 34 through a threaded connection to the device housing 7. Here, the rotational movement is transmitted from the knob 34 to the rotating element 9 via a pusher element 11, wherein the rotational movement tensions the spring motor 8 acting between the pusher element 11 and the device housing. The stop device 13 is capable of maintaining the torque of the spring motor 8 in a predetermined rotational position or dosage step when the operating device is not operated. By operating the button 10, the push element 11 moves towards the distal end against the force of the return spring 12, thereby reconnecting the torque of the spring motor 8 to the drive sleeve 35 and enabling the drive sleeve to rotate together with the rotating element. If the button 10 is released, the push element 11 moves back to its proximal original position by the return spring 12, and the torque of the spring motor 8 is reconnected to the stop device. For example, such a feeding device in the form of an automatic pen is disclosed in publication WO2009 / 105910A1, the teachings of which are incorporated herein by reference in their entirety.

[0052] Now, as Figure 3 As shown, the improved control device according to the present invention, in addition to the components described above—button 10, knob 34, stop device 13, push element 11, rotating element 9 and device housing 7—also includes the following components: a magnetic element 14 mounted on the push element, in the form of a hollow column magnetized in a fan-shaped segment, the magnetic element being made of a material with permanent magnet properties, such as ferrite; a sensor device 20; and an evaluation device 30. Figure 4The magnetic element 14 is shown along with its axis of rotation 18, which coincides with the longitudinal axis of the rotating element 9, because the magnetic element 4 can be coaxially secured to that rotating element by means of a form-locking connection. Thus, the magnetic element participates in all the movements of the pushing element 11. Magnetization is achieved by alternating radial polarization in a fan shape, thereby forming ten poles separated by pole angles 15 on the outer surface 16 of the magnetic element 14, these poles being separated by pole boundaries 19. The magnetic field between adjacent poles is clearly oriented circumferentially at the pole boundaries 16. Figure 5 The diagram shows the circumferential magnetic field strength Bx, measured in mT, on a coaxial plane spaced radially from the outer surface 16. Magnetization also creates corresponding poles on the near and far end faces 17. However, these poles on the aforementioned coaxial plane of the magnetic element 14 result in a magnetic field that is clearly oriented axially. Figure 6 The diagram shows the axial magnetic field strength By, measured in mT, on a coaxial plane spaced radially from the outer surface 16. The maximum value of this field component By is phase-shifted by half a polar angle relative to the maximum value of the field component Bx and is correspondingly located on the near-end face 17.

[0053] Figure 7 The sensor device 20 is shown in its unoperated state in this embodiment, and... Figure 8 The same device in its operational state in this embodiment is shown in a longitudinal section rotated 90°. Here, five magnetic field sensors 21…25 are arranged on a substrate or circuit board 29. Embodiments with three or four sensors are readily derived from the embodiments with five sensors described herein and from the overall specification of the invention. The magnetic field sensors 21…25 are TMR sensors with bipolar switching characteristics of the RR122 series manufactured by RedRock, housed in an LGA housing. The magnetic element 14, together with its peripheral surface 16, is capable of rotating about its axis of rotation and moving axially relative to the sensor device 20 fixed to the housing without contact. Here, the switching axes of the magnetic field sensors 21 and 22, referred to below as sensors A and B, are oriented such that they sense the field component By, and in particular switch its output, when the polarity of the field component By changes due to the relative movement of the magnetic element 14 relative to the sensor. The switching axes of magnetic field sensors 23 and 24, referred to below as sensors B and C, are oriented such that they sense the field component Bx, and in particular switch its output, when the polarity of the field component Bx changes due to the relative motion of the magnetic element 14 with respect to the sensor. This is important in sensors such as... Figure 9This is achieved when the components are arranged on circuit board 29 as shown. Therefore, sensors A and B sense only the rotational motion of the rotating element 9, regardless of its axial position. Conversely, when button 10 is operated and the axial position of the rotating element 9 changes, sensors B and C move from the field component Bx on the distal end face 17 of the magnetic element 14 to the oppositely polarized field component Bx on the proximal end face 17 of the magnetic element 14. Thus, sensors B and C sense not only the rotation of the rotating element 9 but also its axial position change. Figure 10 The diagram illustrates how sensors A and B are mounted along axial segment 31 and how sensors B and C are mounted along axial segment 32 in the embodiment of the actuation device according to the invention described herein. Here, sensor pairs A and B, or C and D, are mounted radially spaced on the enclosure 16 at a sensor angle 26 about the rotation axis 18, wherein the sensor angle 26 is smaller than the polar angle 15. The output of sensor A is reversed, or its switching axis is rotated 180° relative to the switching axis of sensor B. This compensates for the phase shift of half a polar angle of field components Bx and By, and sensors A and C, as well as B and C, can be compactly mounted on the circuit board at the same angular position, saving space. A fifth magnetic field sensor 25 is mounted on the circuit board 29 further tangentially from the magnetic field element 14. The switching axis 28 of this fifth magnetic field sensor is oriented such that its output is switched by the change in the polarity of the field component Bx as the magnetic element 14 changes relative to the sensor. Figure 11 It shows Figure 10 The state of the device in the operating state of the operating device.

[0054] also, Figure 8 An evaluation device 30 is shown, with a corresponding output of the magnetic field sensor connected to the input of the evaluation device. Furthermore, the evaluation device 30 is capable of activating or deactivating the magnetic field sensor and / or changing its sampling rate. Additionally, the evaluation device is capable of controlling a display element such as an LED or a monitor and / or wirelessly communicating with other systems in the drug delivery system, such as a remote control, a mobile phone, or a system that measures blood glucose and determines an appropriate dosage.

[0055] Figure 12 A state machine for the biorthogonal encoded signals of sensors A / B and B / C is shown. This logic structure allows for the description of rotation direction, relative rotation position, manipulation state "press," and fault state (not shown) by comparing the states or changes of the four signals within a four-step interval.

[0056] Figure 13A flowchart is shown for evaluating the biorthogonal encoded signal in the current state of the autopen. For this purpose, a state machine is executed to reflect the current pen state. This state machine does not operate in real-time. An event buffer stores sensor signals. Here, sensor signals are written to this buffer via interrupts. Processing of the buffer is performed periodically, for example, every 10ms. That is, the state machine sequentially processes all sensor signals written to the buffer within the most recent 10ms. Additionally, during the processing cycle, the state machine is queried in different states and relevant information is derived. Here, the QDEC state is either updated or the button state is checked, depending on whether a QDEC sensor event (sensor A or B) or a button event (sensors C and D) is present. The current pen state (CurrentState) and whether the button is pressed or released are described by the step position. Furthermore, the state of the orthogonal steps (QDEC state: 0-3) for the QDEC-signal and ButtonPos-signal must always be known. The moment of the current step (the last change in step position or button position) must also be stored. Once a sensor event is evaluated, the current pen state is always updated. If the button is pressed at a position greater than 0 (potentially initiating delivery), StartDeliveryState is activated. Here, the current step and time are stored. If the button is released, EndDischargeState and EndDeliveryState are activated. Here, the end-discharge state occurs when the rotation step is reached (the last moment before the button is released), and the end-delivery state occurs when the button is released.

[0057] Using information from different delivery states, the injection volume and injection time can be calculated. In addition to identifying the current pen state, the algorithm also checks for sensor malfunctions. Errors in the QDEC signal and button signal can be identified based on orthogonal steps. If a malfunction is identified in the algorithm, or if the final pen state is not correctly established for other reasons (e.g., battery discharge), the absolute position of the automatic pen will be lost. To find the correct position again, the state machine must be reset. Here, the user must participate to find the absolute zero position again. The user must perform an operation that is physically defined and cannot be unintentionally performed differently. For example, the user must rotate knob 34 continuously decreasing from a predetermined number of steps to 0 and then press button 10. If the evaluation device counts this predetermined number of steps, the correct position can be determined, and the current state of the automatic pen can be determined as the absolute position or established in the algorithm.

[0058] Figure 14A state event diagram for activating the pen is shown. Wake-up from sleep mode is triggered by a fifth magnetic field sensor (activation sensor), which measures the same magnetic field as the TMR sensor C. If the sensing device is activated from sleep mode, no steps can be missed. That is, if the knob 34 is turned, the first step must be recognized, and if button 10 is pressed, this must also be recognized promptly. Therefore, a sampling frequency of, for example, 500 Hz is necessary for the activation sensor.

[0059] List of reference numerals in the attached diagram:

[0060] 1. Control device

[0061] 2. Feeding device

[0062] 3. Measuring device

[0063] 4. Piston rod

[0064] 5 flanges

[0065] 6 Product Containers

[0066] 7. Appliance housing

[0067] 8 Spring Motor

[0068] 9 Rotating elements

[0069] 10 buttons

[0070] 11. Pushing element

[0071] 12 Return Springs

[0072] 13. Stopping device

[0073] 14 Magnetic components, toroidal magnets

[0074] 15 Polar Angle

[0075] 16. Outer surface, pole, sector area

[0076] 17. End face, pole, sector area

[0077] 18. Axis of rotation

[0078] 19 Polar Boundaries

[0079] 20 Sensor Devices

[0080] 21 First magnetic field sensor, sensor A

[0081] 22 Second magnetic field sensor, sensor B

[0082] 23 Third magnetic field sensor, sensor C

[0083] 24. Fourth magnetic field sensor, sensor D

[0084] 25. Fifth magnetic field sensor

[0085] 26 Sensor angle (first or second)

[0086] 27. Sensor Level

[0087] 28. Switching axis of the magnetic field sensor (Schaltachse)

[0088] 29 Circuit Boards

[0089] 30 Evaluation Device

[0090] 31. First axial segment at the sensor level

[0091] 32. Second axial section at the sensor level

[0092] 33 Scale Window

[0093] 34 knobs

[0094] 35 drive sleeve

[0095] 36. Diaphragm

[0096] 37 Stop

[0097] Longitudinal section from AA to KK

Claims

1. An operating device (1) for a drug delivery device that delivers drugs without passing through the gastrointestinal tract, comprising: - A sleeve-shaped or cylindrical rotating element (9) having an axis, the rotating element (9) being able to rotate about the axis coaxially or collinearly with respect to the device housing (7) and with respect to the longitudinal axis of the operating device (1) at an angle proportional to a pre-selected or given dose volume; - A manipulable push element (11) that is movable relative to the appliance housing (7) along the longitudinal axis of the manipulative device (1), the push element acting on a drive device or coupling; - A single magnetic element (14) with permanent magnetization, the magnetic element (14) being effectively connected to the rotating element (9) and the pushing element (11) such that the magnetic element together performs the movement of the rotating element (9) and the pushing element (11) relative to the appliance housing (7); - A sensor device (20) consisting of at least three magnetic field sensors, wherein, Each of these magnetic field sensors has a prominent sensitivity or directional effect with respect to the direction of the magnetic field component relative to the sensor axis known as the switching axis (28); - Evaluation device (30), wherein each magnetic field sensor has at least one output terminal, the at least one output terminal being connected to or capable of being connected to a corresponding input terminal of the evaluation device; Its features are, At least one of the magnetic field sensors, the first and second magnetic field sensors, are mounted such that their switching axis (28) points in the circumferential direction to selectively detect changes in the field component along the circumferential direction, and at least one third magnetic field sensor is mounted such that its switching axis (28) points in the axial direction to selectively detect changes in the field component along the axial direction.

2. The operating device (1) according to claim 1, wherein the pushing element (11) is operable by a button (10) and / or the rotating element (9) is operable by a knob (34) and / or by a motor (8).

3. The operating device (1) according to any one of the preceding claims, wherein the magnetic element (14) is magnetized alternately and regularly in a fan-shaped manner, such that the polar angle (15) about the axis of rotation (18) is all the same size.

4. The operating device (1) according to any one of the preceding claims, wherein in the unoperated state of the operating device (1), the first magnetic field sensor and the second magnetic field sensor (21, 22) are mounted on the sensor layer (27) along a first axial segment (31) oriented in the circumferential direction on the magnetic element (14) and spaced apart from each other by a first sensor angle (26) and radially relative to the magnetic element (14), and wherein the switching axis (28) of the first magnetic field sensor and the second magnetic field sensor (21, 22) is tangentially oriented to the first axial segment (31) or the sensor layer (27), and wherein the switching axis (28) of the first magnetic field sensor and the second magnetic field sensor (21, 22) points in the same direction or in opposite directions.

5. The control device (1) according to the preceding claims, wherein the first sensor angle (26) is less than the polar angle (15) or less than an integer multiple of the polar angle (15) increased by the polar angle (15).

6. The operating device (1) according to any one of the preceding claims, wherein in the unoperated state of the operating device (1), a third magnetic field sensor (23) is mounted on the sensor layer along a second axial segment (32) extending in the circumferential direction and spaced radially relative to the magnetic element (14), wherein the second axial segment (32) is offset axially relative to and / or overlaps with the first segment (31), wherein the switching axis (28) of the third magnetic field sensor (23) is oriented transversely to the switching axis (28) of the first magnetic field sensor and the second magnetic field sensor (21, 22).

7. The manipulation device (1) according to the preceding claim, wherein the fourth magnetic field sensor (24) is mounted on the second section (32) and on the sensor layer (27) of the magnetic element (14) at a second sensor angle relative to the third magnetic field sensor (23) and spaced radially relative to the magnetic element (14), wherein the switching axis (28) of the fourth magnetic field sensor (24) is oriented in an axial direction or laterally to the switching axes (28) of the first magnetic field sensor and the second magnetic field sensor (21, 22), wherein the switching axes (28) of the third magnetic field sensor and the fourth magnetic field sensor (23, 24) are oriented in the same or opposite directions.

8. The control device (1) according to the preceding claim, wherein the second sensor angle is less than the polar angle (15) or less than an integer multiple of the polar angle (15) increased by the polar angle (15).

9. The control device (1) according to any one of the preceding claims, wherein the second sensor angle has the same value as the first sensor angle (26).

10. The control device (1) according to any one of claims 4, 6, and 7, wherein the sensor layer (27) is planar or curved and / or segmented.

11. The manipulation device (1) according to claim 10, wherein the sensor layer (27) is curved in a cylindrical shell shape.

12. The manipulation device (1) according to any one of the preceding claims, wherein the evaluation device (30) implements at least one first decoder, the first decoder being capable of evaluating at least a first input and a second input of the input as orthogonally encoded signals in order to quantitatively detect the rotation of the rotating element.

13. The manipulation device (1) according to the preceding claims, wherein the signal change at at least a third input terminal of the evaluation device (30) can be decoded as a position change of the pushing element (11) and / or as a rotation of the rotating element (9).

14. The manipulation device (1) according to any one of claims 12 to 13, wherein the evaluation device (30) implements a second decoder, the second decoder being capable of evaluating a third and a fourth input in the input of a signal as orthogonal encoding in order to quantitatively detect the rotation of the rotating element (9).

15. The manipulation device (1) according to any one of claims 7 to 14, wherein a fifth magnetic field sensor (25) is mounted along a first axial section and / or a second axial section (31, 32), and the evaluation device (30) has an additional input that wakes the evaluation device (30) from a power-saving state when the signal changes.

16. A delivery device (2) for delivering drugs without passing through the gastrointestinal tract, comprising: - The operating device (1) according to any one of the preceding claims; - A piston rod (4) in the form of a threaded rod with a flange (5); - Product container (6) held in appliance housing (7); The driving motion of the piston rod (4) along the longitudinal axis of the device housing (7) can be preselected and / or controlled by the operating device (1) and can be generated manually or automatically by a motor, thereby discharging the drug from the product container through the needle.

17. The feeding device (2) according to claim 16, wherein, The driving motion of the piston rod (4) along the longitudinal axis of the appliance housing (7) can be manually generated by a threaded transmission mechanism.

18. The feeding device (2) according to claim 16, wherein, The driving motion of the piston rod (4) along the longitudinal axis of the appliance housing (7) can be automatically generated by the spring motor (8).

Images