JP2020036902A - Rotary sensor assembly with axial switch and redundancy feature - Google Patents

Abstract

To provide a drug delivery device as well as components and assemblies thereof being safe and cost-effective and reliably allowing detection and storage of dose data related to the use of the drug delivery device.SOLUTION: A sensor assembly comprises a first rotary sensor part 320 with a plurality of individual electrically conducting axial position sensor segments 322 arranged in a circumferential pattern, and a second rotary sensor part arranged rotationally relative to a first portion and comprising a plurality of circumferentially arranged electrically interconnected axial position contacts adapted to be arranged in contact with axial position sensor segments 323. The axial position contacts and the axial position sensor segments are arranged such that for a given rotational position at least two axial position contacts are each in contact with a different axial position sensor segment.SELECTED DRAWING: Figure 5

Description

  The present invention relates to devices, assemblies, and systems adapted to capture information about both rotational and axial movement. In certain aspects, the present invention addresses the issue of capturing electronic dose data for a drug delivery device in a drug delivery device.

  Although the disclosure of the present invention mostly refers to the treatment of diabetes by delivering insulin using a drug delivery device, this is only an exemplary use of the present invention.

  Drug injection devices have greatly improved the lives of patients who have to self-administer drugs and biological agents. Drug injection devices may take many forms, including simple disposable devices similar to ampules with injection means, or are durable devices adapted for use with pre-filled cartridges. You may. Regardless of form and type, devices have proven to be of great help in helping patients self-administer injectable drugs and biological agents. The device also greatly assists caregivers in administering injectable drugs to those who cannot perform self-injection.

  Providing the necessary insulin injections in the right size at the right time is essential for diabetes management, ie compliance with the specified insulin therapy is important. Diabetic patients are prompted to log the size and time of each injection to enable healthcare professionals to determine the effectiveness of the prescribed dosage pattern. However, such logs are usually attached to handwritten notes, as logged information may not be easily uploaded to a computer for data processing. In addition, since only the events that the patient wrote down are logged, the system of notes reminds the patient to log every injection if the logged information has any value in treating the patient's disease. Takes to take. Missing or erroneous records in the logs may lead to erroneous injection histories, thereby misleading healthcare professionals in making decisions regarding future medications. Therefore, it may be desirable to automate the logging of excretion information from drug therapy delivery systems.

  Correspondingly, a number of injection devices with a dose monitoring / acquisition mechanism have been provided (see, for example, US 2009/0318865, WO 2010/052275, and US 7,008,399). However, most devices today do not have such a mechanism. A rotation sensor may be utilized to detect dose related activity. For example, WO 96/19872 discloses a rotation sensor comprising a first fixed part with a rotary position segment and a ring-shaped grounded connector ring, and a second rotary rotor part with multiple contact arms. I have. The rotor portion can be moved axially, thereby disengaging the contact arm engaging the ground connector ring, indicating a second axial position / state.

  In view of the above, one object of the present invention is to provide a drug delivery device that is safe, cost-effective, and can reliably detect and store dose data regarding the use of the drug delivery device. Providing its components and assemblies. A further object is to provide such components and assemblies that can be used for other applications having the same type of input.

  In the present disclosure, embodiments and aspects are described that address one or more of the above-mentioned objects or address objects that are apparent from the following disclosure and description of the exemplary embodiments.

  Accordingly, in a first aspect of the present invention, there is provided a sensor assembly comprising first and second portions, the first portion comprising a plurality of individual conductive axial position sensors arranged in a circumferential pattern. A first rotation sensor unit having a surface having segments is provided. The second portion comprises a second rotation sensor portion arranged to rotate with respect to the first portion, the second rotation sensor portion comprising a conductive switch sensor segment on the first rotation sensor portion And a plurality of circumferentially arranged electrically interconnected axial position contact structures adapted to be placed in contact with the contact. Each of the axial position contact structures comprises an axial position contact having a connection position at which the axial position contact contacts the axial position sensor segment and a disconnection position at which the axial position contact does not contact the axial position sensor segment. The sensor assembly further comprises actuator means for axially moving the axial position contact between the connected position and the disconnected position, wherein the axial position contact and the axial position sensor segment are, for a given rotational position, At least two axial position contacts are arranged such that they each contact another axial position sensor segment. The connection position and disconnection position may represent, for a given system, for example, a given mode or a given state of the system.

  This arrangement allows the proper functioning of the axial position sensor system to be tested individually and to determine error conditions before all contacts fail. The term "given rotational position" refers to the usual switch position where a given switch contact is in contact with a single switch sensor segment, i.e., outside the gap formed between two adjacent switch sensor segments. It shall include the operating state.

  The gap formed between two adjacent axial position sensor segments is such that the axial position contact structure electrically connects them when two adjacent axial position sensor segments are positioned corresponding to the gap. May be sized. This arrangement provides a "special" condition in which the contacts are positioned exactly in correspondence with the gap between two adjacent axial position sensor segments, assuming that both connected segments are connected to switch contacts It can be detected and treated as a normal state.

  The sensor assembly detects whether electrical contact has been established between the individual axial position sensor segments and the axial position contacts and, when the axial switch contacts are in the connection position, the axial switch contacts. Electronic circuitry may be further provided, adapted to detect a fault condition when electrical contact is not established for one, i.e., the electronic circuitry is connected to the switch contacts under normal conditions. It detects that one of the switch segments to be connected is not connected, which indicates that the switch contact is defective.

  The first rotation sensor section surface may further comprise a plurality of individual conductive rotation position sensor segments arranged in a pattern, and the second rotation sensor section may include a conductive layer on the first rotation sensor section. Further comprising a plurality of rotational position contact structures adapted to contact the position sensor segments. In such an arrangement, the rotational position contact structure is configured to engage and connect another rotational position sensor segment as the first and second portions of the rotational sensor rotate relative to each other, and the connection made is , The rotational position between the first and second parts. Correspondingly, the sensor assembly may also include electronic circuitry adapted to determine a rotational position between the first and second portions based on a given pattern of connections made. Good. The rotational position contact structure may be arranged to engage the rotational position sensor segment in both the connected position and the disconnected position.

  The second rotation sensor section may be in the form of a metal disc member comprising a plurality of integrally formed flexible contact arms forming a contact structure, at least two of the flexible contact arms comprising: It is axially movable to form flexible switch arms each having an axial position contact.

  In one exemplary embodiment, the sensor assembly is provided in combination with a housing, the first portion being arranged to rotate with respect to the housing, and the second portion being arranged to rotate with respect to the housing. , At least one of the first and second parts is arranged to be axially movable with respect to the housing. The actuator means is located between the housing and the second part. The actuator means may be in the form of a mechanical connection formed between the housing and the flexible switch arm, whereby the relative axial movement between the housing and the second rotation sensor part This causes the axial position contact to move between the connected position and the disconnected position.

  In a further exemplary embodiment, a sensor assembly as described above comprises a housing and a drug-filled cartridge or means for receiving a drug-filled cartridge, the cartridge comprising an axially displaceable piston and a distal outlet portion. There is provided a drug delivery device comprising a drug-filled cartridge or a combination of a drug-filled cartridge receiving means and a drug releasing means. The drug release means comprises dose setting means for allowing a user to set the dose of the drug to be released, and an axial direction adapted to release the drug from the cartridge by moving the piston of the cartridge in a distal direction. A piston rod displaceable at a predetermined position, an indicator member adapted to rotate in response to a set dose and / or a discharge dose, and adapted to release a set dose of the drug by activating the drug release means. , An operating member movable in the axial direction. The first and second rotation sensor portions are arranged to rotate with respect to each other during setting and / or release of the dose of the drug, and the axial switch contact causes the actuation member to move axially when the actuating member is moved in the axial direction. It is arranged to operate between two positions.

  A first portion of the sensor assembly may be attached to the indicator member and rotated together, the first portion rotating between the first and second portions corresponding to a set dose and / or a discharge dose. Electronic circuitry adapted to estimate the amount of released drug based on the detection of The indicator member may be adapted to move axially between an initial position and an actuated position, and the first portion of the sensor assembly is mounted for axial movement with the indicator member. The second portion may be mounted for axial movement with the indicator member. In the context of the present disclosure, the term "indicator member" is used to identify the actual member at which rotation is detected, wherein the detected rotation indicates a set dose and / or a discharge dose of the drug.

  The electronic circuitry may comprise logging means adapted to create a log of a dose of the drug released from the cartridge by the drug release means, wherein the dose is during setting of the dose of the drug and / or It is calculated based on the relative rotation between the first and second rotation sensor units during ejection. The first portion may include a display that may be turned off while the first portion is rotating.

  As used herein, the term "drug" is a liquid, solution, gel, or microsuspension, such as a cannula or hollow needle in a controlled manner, containing one or more drugs. And any flowable pharmaceutical formulation that can be flowed to the delivery means. The drug may be a single drug compound or multiple drug compound drugs premixed or co-formulated from a single reservoir. Representative drugs include peptides (eg, insulin, insulin-containing drugs, GLP-1-containing drugs, and their derivatives), proteins, and hormones, biologically-derived or bioactive drugs, hormones or genes. And pharmaceuticals such as nutrient formulations and other substances, both solid (dispensed) or liquid. The description of the exemplary embodiments refers to the use of insulin and GLP-1 containing drugs, including their analogs, and combinations with one or more other drugs.

  Hereinafter, the present invention will be further described with reference to the drawings.

FIG. 2 shows a front-loading drug delivery device without a drug cartridge attached. FIG. 2 shows a front-loading drug delivery device without a drug cartridge attached. FIG. 3 is an exploded view showing a drug delivery device subassembly with a logging module. FIG. 4 is an exploded view of the logging module of FIG. 3. FIG. 4 is a diagram illustrating a first rotation sensor unit of the module in FIG. 3. FIG. 4 is a diagram illustrating a second rotation sensor unit of the module in FIG. 3. FIG. 5 shows the logging module of FIG. 4 in an assembled state. FIG. 4 is a sectional view showing the subassembly of FIG. 3 in an assembled state. FIGS. 4A to 4C are diagrams illustrating the operation of the axial switch of the logging module in various operation states. FIG. 3 is a schematic diagram showing how the tracks and contacts of a rotation sensor can be arranged. FIG. 3 is a further schematic diagram showing how the tracks and contacts of a rotation sensor can be arranged. FIG. 4 is a schematic diagram showing an alternative arrangement of tracks and contacts of a rotation sensor. FIG. 2 shows a drug delivery pen with a logging module in communication with a smartphone. FIG. 3 is an exploded view showing the display assembly.

  In the drawings, similar structures are primarily identified by similar reference numerals.

  Hereinafter, when terms such as “upper” and “lower”, “right” and “left”, “horizontal” and “vertical”, or similar related expressions are used, reference will be made only to the accompanying drawings. It does not necessarily refer to actual usage. The drawings shown are only schematic representations, and thus the configuration of the various structures as well as the associated dimensions are intended to serve only for illustrative purposes. When the term member or element is used for a given component, the described embodiment generally indicates that the component is an integral component, but may alternatively be described as a component. The same member or element may comprise multiple sub-components, such that two or more of the components can be provided as an integral component, for example, manufactured as a single injection molded part. When members are defined as being freely mounted axially relative to each other, they generally indicate that they can typically be moved relative to each other between defined stop positions, while the members rotate relative to each other. When defined as being freely mounted in a direction, it generally indicates that they can be rotated relative to each other, either freely or between defined stop positions. The terms "assembly" and "subassembly" indicate that the required components described can be assembled during a given assembly procedure to provide an integral or functional assembly or subassembly. Rather, it is merely used to describe components grouped as being more closely related in functionality.

  Referring to FIG. 1, a pen-type drug delivery device 100 will be described. The device refers to a “generic” drug delivery device that provides an example of a device, and is intended for use in combination with embodiments of the present invention, such a device corresponding to a set dose and / or release dose of a drug. And an indicator member adapted to rotate.

  More specifically, the pen device includes a cap portion (not shown) and a main portion, the main portion having a proximal body or drive assembly having a housing 121 with a drug release mechanism disposed or integrated therein. The distal cartridge, wherein the portion 120 and the cartridge holder 110 are attached to the proximal portion to allow the drug-filled transparent cartridge 180 having a septum pierceable by a distal needle to be positioned and held in place. And a holder portion, wherein the cartridge holder has an opening that allows a portion of the cartridge to be inspected. The cartridge may contain, for example, an insulin, GLP-1, or growth hormone formulation. The device is designed for the user to load a new cartridge through the distal receiving opening of the cartridge holder, the cartridge comprising a piston driven by a piston rod 128 forming part of the ejection mechanism. The most proximal rotatable dose ring member 125 helps to manually set the desired dose of the drug shown in the display window 126, and the actuation of the release button 127 allows the release of the desired dose. . Depending on the type of release mechanism embodied in the drug delivery device, the release mechanism may comprise a spring that is pulled during dose setting and then released upon actuation of the release button to drive the piston rod. . Alternatively, the release mechanism may be completely manual, in which case the dose ring member and release button will move proximally during dose setting, corresponding to the size of the set dose, and then distally by the user. Side to release the set dose. The cartridge comprises, in the example shown, distal engagement means in the form of a needle hub mount 182 having external threads 185 adapted to engage the internal threads of the corresponding hub of the needle assembly. In an alternative embodiment, the threads may be combined or replaced with other connecting means, for example a bayonet coupling.

  The cartridge holder has a distal opening adapted to receive the cartridge. More specifically, the cartridge holder is operated by a user to control the movement of the gripping means, thereby opening and closing an outer rotatable gripper 145 configured to grip and hold the cartridge. A tube member 170 is provided. FIG. 2 shows the device in which the cartridge has been removed and the grip shoulders are in the "open" position with the cartridge removed and a new cartridge can be inserted.

  As shown, FIG. 1 shows a front-loading drug delivery device in which a cartridge is inserted through a distal opening of a cartridge holder that is permanently attached to a main portion of the device, but with a drug The delivery device may alternatively comprise a cartridge holder adapted to be removed from the main part of the device and the cartridge being received and removed through the proximal opening.

  With reference to FIG. 3, a drug delivery device sub-assembly 200 comprising a logging module in combination with parts of the drug delivery device that are directly functionally related to the incorporation and operation of the logging section will be described. More specifically, the subassembly includes an electronically controlled logging module 300, an inner tube member 210, a generally cylindrical inner housing member 220, a dial ring member 230, a button ring 240, a button ring A window 241 and a button assembly including a button spring 242. The inner housing member is configured to be disposed within an outer housing member that provides an exterior of the drug delivery device.

  Various components of the logging module 300 are shown in FIG. More specifically, the logging module includes a housing member 310 having a tubular proximal main portion 311 with a distally extending tube portion 312, a mounting foil member 313, and a first connector 329. Is mounted, a disk-shaped second rotation sensor unit 330, a disk-shaped second rotation sensor unit 330, a rotation sensor holder 339 provided with a lateral projection 337, and folded into a multilayer stack to form a second rotation sensor unit 339. A connector 349, a flexible PCB 340, a battery 345 and a battery clip 346, a number of mounting rings 350, 351, 352, an antenna 360, an LCD 370, and an LCD frame 371. Electronic circuit components, such as a microcontroller, display driver, memory, and wireless communication means are mounted on the PCB. As will be described in more detail below, the first rotation sensor section 320 comprises a plurality of arc-shaped individual contact areas, and the second rotation sensor section 330 comprises a plurality of flexible contact arms, of which the outer ones. The result is a flexible switch arm 333 having a laterally extending switch projection 334.

  FIG. 5 shows a ring-shaped disk formed from circuit board material and having a number of contact areas (or segments) plated thereon to form three concentric rings: an inner ring, an intermediate ring, and an outer ring. 1 shows a first rotation sensor unit 320 provided. The disc has a central opening 327 with two opposing cut-outs 328 that allow the disc to be non-rotatably attached to the tube section 312, for example. In the illustrated embodiment, the inner ring is a single contact area 321 that is used as ground (ie, a reference), and the intermediate ring is a four-point arrangement with a particular circumferential distance in between. The outer ring comprises three individual arcuate axial position sensor segments 323 disposed with only a small circumferential gap therebetween; The segments are individually connected to given contact terminals of a multi-terminal connector 329 mounted on the rear (proximal) surface of the disk. If a given segment is not connected to a terminal, it can be considered a passive segment.

  The second rotation sensor section 330 shown in FIG. 6 is in the form of a metal disk with a number of flexible arcuate contact arms protruding in the proximal direction, the distal end of each contact arm 331, 332, 333. The end comprises a dome-shaped contact 335 with a contact point (facing down in the drawing) adapted to create a galvanic connection with a given contact area. The contact arms are arranged corresponding to the three concentric rings of the first rotation sensor unit. More specifically, the second rotation sensor unit includes two inner contact arms 331, three intermediate contact arms 332, and two outer contact arms 333.

  Thus, a given pair of contact arms provides a combined contact structure adapted to create electrical contact between the two sensor segments. In the illustrated embodiment, two inner ground contact arms 331 are provided in contact with a single ground contact area 321 of the inner concentric ring, and three rotational position contact arms 332 are connected to four of the intermediate concentric rings. The two outer axial position contact arms 333 provided in contact with the rotational position sensor segment 322 are provided in contact with the three axial position sensor segments 323 of the outer concentric ring, and the outer axial position contact arm 333 is provided. Supports a switch projection 334 extending in the lateral direction. In fact, for intermediate and outer contact arms, the rotational position between the two sensor parts determines which sensor segment is engaged with a given contact arm.

  In the illustrated embodiment, the gap between two adjacent outer sensor segments is dimensioned such that the dome-shaped contact makes contact with both segments as it moves from one segment to the next; This will be described in more detail later. The second rotation sensor section further comprises a grip 336 adapted to engage the projections 337 on the rotation sensor holder 339 to prevent rotational movement therebetween.

  In the illustrated embodiment, the intermediate arm and intermediate sensor segment provide a rotational position sensor system, while the outer arm and outer sensor segment provide an axial position sensor system as described in more detail below.

  FIG. 7 shows the logging module 300 in an assembled state. The component mounted flexible PCB 340 and antenna are mounted in a sandwich-like configuration with mounting rings 350, 351, 352 to provide the necessary spacing and provide adhesion, for example, by gluing or adhesive. The battery 345 is attached to the PCB via a battery clip 346. The PCB sandwich is mounted using a "tongue-like" threading through the distal opening of the button portion of the housing 311 and held in place using an adhesive mounting foil member 325 (see FIG. 4) during assembly. Is done. The first rotation sensor section 320 is non-rotatably mounted on the tube portion 312 and is connected to the PCB via connectors 329 and 349. The second rotation sensor section 330 is non-rotatably and axially fixedly mounted on a rotation sensor holder 339 which is free in the rotation direction but fixed in the axial direction on the tube portion 312 in a fixed manner. . With this arrangement, the flexible rotation sensor arm is held in slidable contact with the contact surface. The LCD 370 is mounted on a PCB sandwich, both held in place by a display frame 371 in a housing tube, and the display frame 371 is permanently attached to the housing, for example, by welding. As shown, an electronic logging module with a rotatable sensor located distally is thus provided. As shown in FIG. 4, the housing main portion 311 includes a circumferential distal flange 313 with a number of proximally projecting teeth 314 and a circumferential proximal groove 315. Tube portion 312 includes a distal snap connector 316 adapted to engage a corresponding opening 211 in inner tube member 210.

  FIG. 8 shows a cross-sectional view of the subassembly 200 in an assembled state. The term "subassembly" does not imply that the required parts shown are assembled to provide a subassembly, as shown, that can be used in a given drug delivery device assembly process. In contrast, the illustrated logging module of FIG. 7 may be provided in the illustrated form as a "real" subassembly. Referring to the components shown in FIGS. 3 and 4, the inner tube member 210 is rotationally and axially locked and connected to the distal tube portion 312 of the logging module. This arrangement is primarily for molding and subsequent assembly. The dial ring member 230 is mounted on the proximal portion of the housing member 220 and can rotate freely but does not move in the axial direction. The dial ring member 230 includes an inner circumferential coupling flange 231 with a plurality of distally facing teeth adapted to engage the proximally facing teeth 314 of the logging module; This locks the two components in engagement in the rotational direction. The housing member 220 includes first and second openings or cutouts 221, 222 adapted to engage the lateral protrusion 336 and the switch protrusion 334 of the rotation sensor holder, respectively, whereby the first It ensures a non-rotating engagement between the two rotation sensors and the housing and still allows axial movement.

  The button 240 with the window 241 attached is mounted on the module housing in gripping engagement with the circumferential groove 315, which allows the button to rotate relative to the module housing. An axially compressed button assembly spring 242 is located within the circumferential gap between the module housing and the dial ring member, and is disposed on the distally facing ring portion of the button ring and proximally of the coupling flange. It is held in place between the facing parts. Thus, the spring provides an axial force that biases the module proximally to non-rotatably engage the dial ring member 230 via the coupling flange, but with a distally directed force. Is added to the module via the button, the module can be moved in a distal direction, thereby removing the rotational coupling with the dial ring member, thereby moving the main housing of the logging module to the dial ring member. Can be rotated.

As mentioned above, the illustrated rotation sensor comprises an axial position sensor system that serves to detect the axial position of the logging module with respect to the housing member 220 (here). More specifically, FIG. 9A shows a logging module 300 which is urged to its initial proximal position by button spring 242, FIG. 9B, been moved to the partial distal distance H ₁ intermediate shows a logging module in position, FIG. 9C shows a logging module at the distal position after actuation has been moved to the partial distal distance H _2. In all three states, switch projections 334 are positioned within corresponding housing openings 221 and are rotationally locked to the housing via rotation sensor holders 339. As shown, in FIG. 9A, the switch protrusion 334 engages the proximal edge of the opening, and the flexible switch arm 333 with the contact 335 is thereby moved to the first rotation sensor section 320. 9B, the switch projection 334 remains engaged with the proximal edge of the opening, but the logging module is moving in the distal direction, thereby causing the first rotation. The sensor unit 320 has moved into contact with the switch arm 333, which has placed the axial switch in an “on” state where the logging module circuitry can be detected, and in FIG. It has moved further distally to a distal position. The switch protrusion 334 has moved out of engagement with the proximal edge of the opening, so that the axial position sensor system remains "on." In one exemplary embodiment, the axial movement between the different positions may be, for example, 1.5 mm, so that the release mode is such that the dosing mechanism is actually released before the axial position sensor system is released. Ensures that it is securely registered. The axial position sensor system can also be used to control the function of the logging module when no dose is set (see below).

  Returning to the first and second rotation sensor portions of FIGS. 5 and 6, the intermediate arm and the sensor segment provide a rotational position sensor system, while the outer arm and the sensor segment are axially oriented as described in more detail below. Provide a position sensor system. This is shown in FIG. 10, where the middle sensor segment provides a "gray code track", the sensor segment is labeled "GC", the middle arm provides a "gray code contact", and the outer The sensor segment provides a "mode switch track", the segment is labeled "MS", and the outer arm provides a "mode switch contact". As also shown in FIG. 10, the rotation sensor described has a resolution of 15 °, ie, since only steps 1 to 9 of the 24 steps for a full revolution are numbered in the drawing, For each rotation angle of 15 °, a predetermined change is created in which the individual rotation position sensor segments are on and off. The illustrated sensor segments are each connected to an electronic circuitry 340, so that the relative rotational position between the two rotational sensor units can be determined (see below).

  For the axial position sensor system described above, if only one switch arm is used, there will be a single point of failure when the information is to be detected by electronic means. Correspondingly, two axial position switch arms are provided, as shown in FIG. 6, but by providing redundancy by simply adding additional contacts, in the event that one of the contacts fails. A new single point of failure will be introduced. Thus, the axial position sensor system of the described embodiment is designed to be able to detect the failure of one of the two axial position switches, so that before the system actually malfunctions, for example, The system can take appropriate action, such as indicating an error condition.

アームが押し下げられなかった場合、３つのセグメントに対する値は１，１，１である。 More specifically, as shown in FIG. 5, the conductive outer ring is divided into three sensor segments 323, identified in FIG. 10 as MS1, MS2, and MS3. When the flexible outer switch 333 moves into contact with the conductive ring, the arms and segments are positioned such that conductive contacts with at least two of the three segments are established. During a full revolution, when the arm is depressed, the arm moves over the three sensor segments, so that a value of "0" means that the arm and the segment are in contact, the following code pattern ( 24 steps per full rotation) are given.

If the arm was not depressed, the values for the three segments would be 1,1,1.

  If either the axial position sensor segment or the contact arm is defective, the code pattern will be different from the above pattern. For example, if MS1 with value "1" is defective when the arm is depressed, the first code would be 1,0,1. The defect is that only one of the sensor segments has the value "0" (a healthy system is expected to have at least two "0" s), thereby detecting a single contact failure. It can be detected by becoming possible. In theory, if one working contact arm fills the gap between two adjacent sensor segments and another contact arm is defective, this will result in a non-error with two "0" values. It represents a condition. However, if the error detection occurs during rotation, this special condition can be detected and ignored. If the MS1 with value "0" is defective when the arm is not depressed, this defect is detected because the values for the three segments when the arm is not depressed should be 1,1,1. It is possible.

  Although not implemented in the described embodiment, the outer contacts can also be used to provide additional rotational position information to the system.

  Returning to the first and second rotation sensor portions of FIGS. 5 and 6, the intermediate arm and the sensor segment provide a rotational position sensor system, while the inner arm and a single circumferential segment provide a ground contact. . This is shown in FIG. 11A, where the middle segment provides a "code track", the segment is labeled "GC", and the middle arm provides a "code contact" as in FIG. The inner segment provides a "ground reference track" labeled "GND" and the inner arm provides a "ground contact."

  In an alternative embodiment, shown schematically in FIG. 11B, the code track and ground reference track GND are combined by “overlapping” the code segment 622 on the ground track 621 at the same time that the dedicated ground contact is removed. Into a single "cord and ground track", with the previous cord contacts serving as combined cord and ground contacts 632. More specifically, the code segments are arranged as isolated "islands" on the ground track, whereby a given circumferential portion is simply represented by either the code segment or the ground segment. A combined cord and ground track is provided such that a given combined cord and ground contact is in contact with the cord segment or one of the ground segments. As shown in FIG. 11B, the ground segments are connected to electrically form a single combined ground segment. In the illustrated embodiment, the individual ground segments are connected by a narrow strip of plating surrounding the radial side of the code segment, which gives the code segment an "island" appearance, but the ground segment is For example, the connection can be made only on one side of the code segment or via a connection formed on the opposite side of the disc.

  In the illustrated embodiment, the cord segments, ground segments, and individual combined cord and ground contact arms are such that, for a given rotational position, at least one of the arms is in contact with the ground segment and the remaining arm is It is arranged to contact the code segment to provide location information. As shown, this arrangement makes it possible to maintain the same functionality as two separate tracks and an arm dedicated to each track.

  In systems of the type described above, where the movement of the mechanical component is detected by an electronic system that detects the specific nature of the movement of the mechanical part, it is important that the electronic sensor system is accurately synchronized with the mechanical system It is. The conventional way of ensuring that the two systems are synchronized is to provide an absolute reference point on which to base a decision. For example, WO 2012/140097 discloses a drug delivery device comprising a dose sensing system provided with a dose end contact, whereby the two systems are synchronized at the end of any out-dosing event. ing.

  If the synchronization provided by such a system is not regular and the electronic sensor system is out of sync with the mechanical system for some reason, i.e. the movement of the mechanical parts is more or less than the electronic sensor system. If detected, the electronic sensor system must (i) understand that it is out of sync, and (ii) when it is connected to the mechanical system, to provide reliable information about the amount of movement detected. It is necessary to understand what will be synchronized again. Detection of an out-of-sync condition can be performed electronically, for example, by analyzing the stream of sensed code locations and identifying "illegal" codes or sequences that indicate an error condition.

Hereinafter, an example of error detection for a system having the following specifications will be given.
A mechanical system that operates bi-directionally between a mechanical minimum position and a mechanical maximum position in a number of predetermined steps, for example from 0 to 100 dose units for an insulin delivery device.
It is adapted to detect each incremental mechanical step and has a relative repeating positioning of 0-7, i.e. mechanical position 0, 8, 16 etc. gives electronic sensor position 0 and mechanical position 1 , 9, 17 etc. provide an electronic sensor position 1.
One or more counters that increment and decrement, for example, from 0 to 100, in response to changes in electronic sensor position and position at other inputs. When the electronic sensor position increases by one, the counter increases by one.

In such a system, rules 1-5 are implemented and checked whenever a sensor change occurs. Each time at least one of the rules is satisfied, one or more counters are reset (eg, set to 0) and the system is determined to be out of synchronization.
1. Invalid sensor code (sensor information does not include position indication)
2. Invalid sensor code sequence (eg jump directly from electronic sensor position 2 to 5 with one sensor value change)
3. 3. Counter <minimum machine position Counter> Maximum machine position5. The sensor code is not correlated with the counter (eg, the sensor code is associated with position 3 of the electronic sensor system, but the counter value is 5)

  If delivery of a drug dose occurs and a synchronization error is detected during that time, the system may not record a dose log entry for that event and may indicate to the user that a detection error has occurred after delivery.

  To help the system resynchronize, the user of the system may be required to take certain actions on the system to bring the electronic system back into synchronization. Alternatively, the drug delivery device described above is adapted to be resynchronized with the mechanical system based on information specific to external standard operations performed on the system, i.e., without user involvement, A dose detection system may be provided.

  More specifically, this feature is based on the fact that the user performs standard operations on the electronic sensor system designed to detect the system. In this case, the detection of the movement amount of the mechanical component at the start and end of the standard operation is positioned at the absolute reference point. After the user first performs a standard operation on the system and the system is out of synchronization, the resulting mechanical movement is accurately detected by the electronic sensor system and the electronic system at the end of the standard operation Is automatically determined to be synchronized with the mechanical system.

  For example, the sensor means (i) detects the number of rotation increments for a set dose, (ii) in the release state, detects the number of rotation increments for a subsequent discharge dose, and (iii) if the two increment numbers are the same. , May be adapted to automatically resynchronize by resetting the reference point corresponding to the current rotational position of the indicator member.

  Although the resynchronization process described is based on the assumption that the detected values represent a certain behavior, the described concept is considered to provide reliable resynchronization in a user-friendly manner.

  The components of the subassembly 200 as shown in FIG. 3 represent, apart from the module 300, a “generic” component of the drug release mechanism having properties relevant to the implementation of an embodiment of the present invention. More specifically, the illustrated module 300 comprises a housing, dose setting means for allowing a user to set the dose of the drug to be released, and to rotate in response to the set dose and / or the discharge dose. Adapted to be implemented in the form of a drug delivery device having an adapted indicator member. In the illustrated subassembly, inner tube member 210 represents an "overall" indicator member.

  Although not part of the present invention, a short description of the drug release mechanism that can integrate the illustrated inner tube member 210 will now be described. In setting the delivered dose, the user rotates the dial ring member 230, thereby rotating the inner tube member 210 to a given rotational position representing the desired dose, thereby causing the torsion spring member to pull. And disposed around the tube member and attached at a proximal end to a proximal portion of the housing and at a distal end to a distal portion of the tube member. The ratchet coupling located at the distal end of the inner tube member serves to hold the now rotationally biased tube member in a set position. The scale drum is coupled to the tube member and rotates together, and the scale drum has a threaded connection with the housing (eg, thread 226 of FIG. 3), whereby a series of helically arranged numerical values is provided. Moves relative to the housing window (eg, opening 225 in FIG. 3), and the number shown indicates the current set dose. To release the set and loaded mechanism, the user presses the proximal release button, which causes the inner tube member to move distally. This action releases the ratchet coupling (acting as a release member) and moves the inner tube member into direct or indirect engagement with the rotary drive member, which is screwed into the housing. The engagement is thereby arranged to rotate the piston rod by moving distally to the set dose. As the tube member rotates rearwardly, it drives the piston rod distally, causing the scale drum to rotate rearwardly and reach its initial "zero" position with the tube member. For example, this type of mechanism is known by the FlexTouch® drug delivery pen device marketed by Novo Nordisk, for example for injecting insulin preparations.

  As shown, in the exemplary mechanism described, the inner tube member 210 (where the main portion of the logging module 300 is rigidly attached) is attached to the housing 220 both during set and discharge of a given dose. Rotate against. Since the second rotation sensor section 330 is rotationally locked with respect to the housing, the two rotation sensor sections 320, 330 also rotate relative to each other both during setting and delivery of a given dose. . Since this is only an exemplary mechanism, other mechanisms can be envisioned in which a given member rotates only during setting or ejection.

  Nevertheless, in the illustrated embodiment, the logging module is adapted to detect rotation in both directions corresponding to the set dose and the emitted dose. In the embodiment shown, the logging module further comprises an axial switch that allows the module to detect whether the mechanism is in a set mode or a release mode, but this is an optional mechanism. In the embodiment shown, the code pattern has a step “resolution” of 15 ° rotation angle, where a given drug formulation and delivery device combination may correspond to one unit of insulin (IU). In fact, for a drug formulation with twice the concentration, a rotational resolution of 7.5 ° is required to register a dose step corresponding to 1 IU of insulin. Rotation sensors with rotating contacts and associated electronics can be designed to detect the amount of rotation using a number of designs, and may be counted, for example, in 15 ° increments, or A given position within a 120 ° or 360 ° sector may be absolutely detected and the counter may register the number of sectors completed. Such a counter can be realized using the switch arms and outer contact areas described with reference to FIGS. It is important in the "counting" design that the first increment is registered, but modern electronics operate in the low power "on" state to transition from the "sleep" state to the "on" state. Delays, which are usually associated with the activation change of the wakeup, can be avoided.

  In one exemplary embodiment, the rotation sensor is designed to count the number of steps during setting and count down the number of steps during ejection, and the ejection step is logged as the dose to be ejected . By counting in both directions, proper registration and functioning of the logging module can be guaranteed to a high degree. Since a given drug dose may be split, especially if it is large, and injected with a given pause, the logging module will provide two doses released within a given time window, eg, 15 minutes. May be programmed to log the amount of a single dose.

  The logging module may be configured to store and indicate data in various ways. For many users, the time since the last dose and the size of that dose are the most important values. For other users and / or practitioners, it may be important to have an overview of all logs for a given period of time, eg, a week or month. To enable such an overview, the logging module comprises an output means which allows the dose log to be transferred to an external display device, for example a smartphone or a computer, for a better schematic overview, for example by NFC transfer. (See below).

  To ensure that the complete dose is released, the logging module may be set to display the last released dose only when the release mechanism is returned to zero. Alternatively, a given "half" dose is stored in the log but not displayed. For example, if a dose of 40 IU has been dialed and 20 IU has been released shortly thereafter, the display will not show data for that delivery. To show the dose on the display, the user may release the remaining dose, and the 40 IU combined dose is shown on the display with a time stamp. Alternatively, the user may dial the release mechanism back to zero and the display will show 20 IU, or the user may dial the release mechanism back to 10 IU and release 10 IU and the display will display 30 IU Will be shown. Indeed, if the released doses are combined, two (or more) doses must be released within the time window described above, for example in 15 minutes. Alternatively, only the last part of the dose is displayed and the first part is simply stored in the log as input.

  The display can be configured to show data in various formats. For example, the display 411 of FIG. 10 is a two-stage display in which the time is shown using a stopwatch design of HH: MM: SS, thereby moving the time since the last dose was released from the device. It can be shown together with a second counter, and can be easily identified by the user as a time value counting the indicated information. After 24 hours, the display will continue to display the time in HH: MM: SS format or change to date and time format.

  To save energy, the display may disappear after a predetermined amount of time, for example, 30 seconds. To turn on the display, the user may, for example, press a button and thereby turn on the display using an axial switch, or the display may be turned away from zero and then turned back to zero. You may follow it.

  The user may want to check the dose log directly on the module display. Toggling through the dose log can also be controlled by an axial switch, for example, pressing the button 412 twice quickly puts the module in log display mode, with each subsequent button press recalling the next log entry. The module may automatically leave the log display mode after a predetermined amount of time, or the user may place the module in the normal display mode, for example, by turning the dial back and forth as described above. Alternatively, the electronic module may provide other types of input means, such as a motion sensor that allows the user to turn on the display by shaking or tapping, or a user swiping the display across the display. There may be a touch sensor integrated into the display that can be turned on, for example as is well known by smartphones.

  FIG. 12 includes a logging module 410 as described above and is located next to a smartphone 430 configured to receive logging data from the logging module via wireless communication, for example, via NFC or Bluetooth. Also, a drug delivery pen 400 is shown. As shown, the logging module includes a display configured to show the size of the last dose and the time since the last dose using a stopwatch display mode.

  In order to communicate with the logging module, the smartphone is equipped with predefined "insulin history" software. When the software is activated to initiate data transfer, the smartphone's NFC transmitter sends a predefined code that activates any nearby logging module, which then sends a unique code identifying the predefined module. Resubmit the code. If the predefined code is first received, the user is asked to confirm the pairing and from the list a given drug to be associated with a given logging module, e.g. You will be asked to select "30". In this way, the smartphone can create an insulin history that covers more than one drug. In the simple "manual" setting described, the user must ensure that the correct cartridge containing, for example, Mix 30 insulin is loaded into the drug delivery pen associated with that type of drug. In practice, other settings can be recalled, for example, a given pen is (mechanically) coded to only accept a given type of cartridge containing a specified type of drug Alternatively, the pen and logging module may have the ability to distinguish between different types of cartridges, and thus different types of medication.

  In the illustrated embodiment, log data from a logging module associated with Mix 30 insulin has been transferred. In the example user interface, the user can toggle back and forth between various date displays, each showing a different amount of drug delivered along with the actual time value. In FIG. 12, on a given day 431, first and second volumes 432 of mix 30 have been delivered at the times and volumes indicated for each delivery.

  While the embodiment of FIG. 7 uses conventional ACF (anisotropic conductive film) bonding to attach the LCD to the PCB, FIG. 13 shows an alternative solution for attaching the LCD to the PCB. . More specifically, FIG. 13 shows a PCB 510 with a flexible connector 511, a curved elastomeric connector 520 (eg, a Zebra® connector), and a segmented LCD (eg, a number or dot matrix). ) 530, a mounting ring 540, and a housing ring 550 are shown in an exploded view. The LCD includes a connector array with a plurality of connectors arranged in a first curved configuration along a portion of a curved circumference, for example, 300 °, and the PCB is configured in a first curved configuration. A corresponding connector array having a plurality of connectors arranged in a second curved configuration, at least partially corresponding. The curved elastomeric connector is adapted to establish a plurality of electrical connections between the connectors of the two connector arrays when the LCD, PCB, and elastomeric connectors are placed in conductive contact. In the assembled state, the housing ring is attached to the PCB, thereby holding the remaining components in forced engagement with each other.

  In the exemplary embodiments described above, various structures and means for achieving the desired functionality for the different components have been described to a degree that would be apparent to those skilled in the art as a concept of the present invention. . Structural details and specifications for the various components are within the spirit of the present specification and are within the purview of a design procedure typically performed by those skilled in the art.

Claims (15)

(I) a surface comprising a first rotation sensor section (320), said first rotation sensor section having a plurality of individual conductive axial position sensor segments (323) arranged in a circumferential pattern; A first portion comprising:
(Ii) a second rotation sensor unit (330) that is arranged to rotate with respect to the first portion, wherein the second rotation sensor unit is configured to rotate the conductive member on the first rotation sensor unit. A second portion comprising a plurality of circumferentially arranged electrically interconnected axial position contact structures (333) adapted to be placed in contact with the axial position sensor segment. So,
The axial position contacts (335) each having a connection position where the axial position contacts contact the axial position sensor segment and a disconnection position where the axial position contacts do not contact the axial position sensor segment. A) a second part comprising:
(Iii) actuator means for axially moving the axial position contact between the connection position and the disconnection position,
Actuator means wherein said axial position contact and said axial position sensor segment are arranged such that, for a given rotational position, at least two axial position contacts each contact another axial position sensor segment A sensor assembly comprising:   The gap formed between two adjacent axial position sensor segments is such that when the two axial position sensor segments are arranged corresponding to the gap formed between two adjacent axial position sensor segments. The sensor assembly according to claim 1, wherein the gaps are dimensioned to electrically connect them by an axial position contact structure. (I) detecting whether electrical contact has been established between the individual axial position sensor segments and the axial position contacts,
(Ii) an electronic circuit adapted to detect a fault condition if electrical contact is not established with one of the axial position contacts when the axial position contact is in the connection position; The sensor assembly according to claim 1, further comprising a configuration. The first rotation sensor unit surface further includes a plurality of individual conductive rotation position sensor segments (322) arranged in a pattern;
The second rotation sensor section further comprises a plurality of rotation position contact structures (332) adapted to contact conductive rotation position sensor segments of the first rotation sensor section;
The rotational position contact structure is configured to engage and connect another rotational position sensor segment as the first and second portions of the rotational sensor rotate relative to each other, wherein the connection made is: 4. The sensor assembly according to claim 1, wherein the sensor assembly indicates a rotational position between the first and second portions.   5. The sensor assembly according to claim 4, wherein said rotational position contact structure engages said position sensor segment in both said connection position and said disconnection position.   6. The electronic device of claim 4, further comprising an electronic circuitry configured to determine a rotational position between the first and second portions based on a given pattern of connections made. 7. A sensor assembly as described.   The second rotation sensor section is in the form of a metal disc member (330) comprising a plurality of integrally formed flexible contact arms (331, 332, 333) forming the contact structure; 7. A method according to any of the preceding claims, wherein at least two of the flexible contact arms (333) are axially movable to form respective flexible switch arms with axial position contacts. Sensor assembly. The first portion is arranged to rotate relative to the housing;
The second portion is disposed so as not to rotate with respect to the housing;
At least one of the first and second portions is disposed so as to be movable in the axial direction with respect to the housing,
The sensor assembly according to any of the preceding claims, wherein the actuator means is arranged between the housing and the second part, in combination with a housing (220).   The actuator means is in the form of a mechanical connection (334) formed between the housing and the flexible switch arm, thereby providing a relative position between the housing and the second rotation sensor portion. 9. The combination according to claim 8, wherein the axial position contact moves between the connection position and the disconnection position by a specific axial movement. A drug delivery device (100) comprising a sensor assembly (300) according to any of the preceding claims,
Housings (220, 121);
Means for receiving a drug-filled cartridge (180) or drug-filled cartridge, said cartridge comprising an axially displaceable piston and a distal outlet portion; and ,
Drug release means,
Dose setting means (125) allowing the user to set the dose of the drug to be released;
An axially displaceable piston rod (128) adapted to move the piston of the cartridge in a distal direction, thereby releasing drug from the cartridge;
An indicator member (210) adapted to rotate in response to the set dose and / or the emitted dose; and
Drug release means further comprising an axially movable actuation member (127) adapted to release said set dose of drug by activating said drug release means;
During setting and / or release of the dose of the drug, the first and second rotation sensor units rotate relative to each other;
A drug delivery device (100), wherein moving the actuating member in the axial direction activates the axial position contact between the two positions.   The first portion (310) of the sensor assembly is attached to the indicator member and rotates together, the first portion corresponding to a set dose and / or a discharge dose. The drug delivery device of claim 10, comprising an electronic circuitry (340) adapted to estimate an amount of released drug based on detection of rotational movement therebetween.   The indicator member is adapted to move axially between an initial position and an actuated position, and the first portion of the sensor assembly is mounted to move axially with the indicator member. 12. The drug delivery device according to claim 10 or claim 11, wherein   The drug delivery device according to claim 12, wherein the second portion (320) is mounted for axial movement with the indicator member.   The electronic circuitry comprises logging means adapted to create a log of a dose of the drug released from the cartridge by the drug releasing means, wherein the dose is set during and / or during the setting of the drug dose. The drug delivery device according to any one of claims 10 to 13, wherein the drug delivery device is calculated based on a relative rotation between the first and second rotation sensor units in. 15. The drug delivery device according to any one of claims 10 to 14, wherein the first part comprises a display (370, 530) and may be turned off during rotation of the first part.

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