JP2017527415A - Adherence monitor for dry powder drug delivery devices - Google Patents

Abstract

Adherence monitor for dry drug dispensers with a rotating base. The monitor has an opening that includes an internal elastic projection, so that the base can be received and held within the opening, and the base can be rotated by rotating the monitor. Also disclosed is a cap detection sensor for use with a monitor or in a dispenser, the cap detection sensor comprising a lever that extends generally parallel to the axis of rotation of the base, the lever extending toward the cap at one end beyond the base. An arrangement that extends and extends into the dispenser or monitor to engage the switch, and when the cap is attached, the lever is engaged by the cap, thereby enabling the switch. [Selection] Figure 1

Description

  The present invention relates to a method, apparatus and system for monitoring adherence to a dosage regime for a dry powder drug.

  The present invention relates to an adherence monitor for a dry powder inhaler. They are often used in the treatment of respiratory diseases such as asthma, COPD, cystic fibrosis and bronchiectasis. However, such devices may be used to deliver other drugs, for example, for the treatment of pain, heart disease, erectile dysfunction, diabetes and other indications.

  There are several different types of dry powder inhalers that are used commercially. One type is in the form of a disc with an external lever. The lever can be actuated by the user to deposit a dose of medication in the inhalation chamber, after which the user can inhale through the mouthpiece.

  Another common type of dry powder inhaler is generally in the form of a tubular body, with a suitable internal storage drug, a rotating base that dispenses a dose into a suitable inhalation chamber, and a user inhalation chamber A mouthpiece capable of inhaling a medicine distributed in the mouthpiece. Such dry powder inhalers are usually equipped with a cap that can be removed and replaced, which is adapted to cover the mouthpiece and tubular body of the inhaler when not in use. Has been.

  An example of such a dry powder inhaler is TURBUHALER ™ manufactured and marketed by AstraZeneca AB. Another example is TWISTHALER ™, manufactured and marketed by Merck & Co. TWISTHALER (TM) is similar to TURBUHALER (TM), except that TWISTHALER (TM) dispenses a dose of drug when the cap is loosened from the tubular body. That is, loosening the cap from the tubular body portion serves to automatically rotate the tubular body relative to the base portion, and it is this action that dispenses a dose of drug into the inhalation chamber.

  A problem associated with the use of all drug inhalers is poor adherence. Many studies have shown that users often do not inhale their medication at a given or prescribed time and / or in the required amount. The consequences of this non-adherence can include reduced disease management, poor quality of life, loss of productivity, hospitalization and preventable death. This represents a significant cost to the user as well as to the insurance system.

  Adherence monitoring devices have been developed that are used in drug inhalers, primarily in pressurized metered dose inhalers, rather than dry powder inhalers. The mechanical structure required for a pressurized metered dose inhaler is significantly different from that required for a dry powder inhaler.

  U.S. Pat. No. 6,057,056 by the present applicant discloses a compliance monitor for a dry powder inhaler formed from two parts screwed into the inhaler. Screwing the two parts of the adherence monitor can be a tedious and time consuming process. In some cases, the screws in that part can be cross-threaded so that the two parts are not properly secured, or the compliance monitor does not function properly or does not function at all.

  Furthermore, the action of screwing or loosening the two parts of the adherence monitor relative to each other can sometimes cause the rotating base of the inhaler to rotate unintentionally at the same time, so that a single dose of medication can be inhaled in the inhalation chamber. May be released into the interior (or released at the other end).

  Applicant's patent document 2 describes a two-part indentation compliance monitor for a dry powder inhaler. While avoiding the complexity of screwing, this still requires the user to assemble the monitor around the inhaler.

  Another problem relates to the correct use of the cap by the user. It is important to replace the cap when not in use to ensure that dust and moisture do not contaminate the drug. Furthermore, it is clinically useful to understand the behavior of a user using an inhaler. Some patients play with their inhalers by repeatedly removing and removing the cap. Other patients are not paying attention and may empty when the inhaler is opened and may return the cap without inhaling the drug.

  The ability to record adherence data, including when caps are removed and replaced, is very useful and important for training purposes or feedback to the user and for the purpose of collecting overall drug compliance data. Information.

  U.S. Patent No. 6,099,056 (Bjorndal et al.) Describes a training device for a dry powder inhaler that prevents the device from operating when the cap remains in place. However, it does not collect adherence data.

  U.S. Patent No. 6,099,056 (Von Hollen et al.) Describes an inhaler adapted to emit an audible indication (and / or provide audible usage feedback) when the cap is removed. However, Von Hollen will collect compliance data regarding the number of times a user has tried to use an inhaler with a cap and / or when the cap has been removed and / or closed and how often. Does not make it possible.

New Zealand Patent No. 614928 New Zealand Patent 622000 US Patent Application Publication No. 2004/0187869 US Patent Application Publication No. 2011/0226242

  An object of the present invention is to provide an effective adherence monitor that can be easily and reliably attached to a dry drug inhaler.

  In a first broad form, the present invention is an adherence monitor for a dry drug dispenser with a rotatable base, comprising an opening with an internal elastic projection, the opening receiving the base within the opening and An adherence monitor is provided that is arranged to be held and operatively rotated by rotating the monitor.

  According to one aspect, the present invention is an adherence monitor for a dry drug dispenser, the dispenser having a rotatable base, the adherence monitor comprising a body having an opening, the opening being operatively An adherence monitor is provided that includes an internal elastic protrusion positioned to receive and hold the base within the opening, and the base can be rotated by rotating the monitor.

  According to another aspect, the present invention is an adherence monitor for a dry drug dispenser, the dispenser comprising a rotating base, a mouthpiece, and a removable cap for the mouthpiece, the adherence monitor comprising: An opening operatively receiving the base of the dispenser and a cap detection sensor for detecting cap removal or engagement, the sensor comprising a lever extending generally parallel to the axis of rotation of the base, the lever One end extends beyond the base toward the cap and extends into the monitor to engage the switch, and the lever is operatively engaged by the attached cap, whereby the switch Providing an adherence monitor that is arranged to change state.

  According to yet another aspect, the present invention is an adherence monitor comprising a dose detection sensor and a cap detection sensor, further comprising a dose detection mechanism, wherein the dose detection mechanism has the cap detection sensor removed from the cap. Provide an adherence monitor that is disabled until it is detected.

  According to another aspect, the present invention is a method of holding a dry drug dispenser in an adherence device, wherein the adherence device is provided with a recess, the recess comprising an elastic protrusion, and the adherence device in the recess. The elastic protrusion is compressed so that the insertion holds the base of the dispenser in the adherence device, so that the rotation of the adherence device also rotates the rotatable base. And a method comprising:

  According to another aspect, the present invention is a cap detection sensor for a dry drug dispenser, the dispenser comprising a rotatable base, a mouthpiece, and a removable cap for the mouthpiece, the sensor comprising: A lever extending generally parallel to the axis of rotation of the base, the lever extending into the dispenser so that one end extends beyond the base toward the cap and engages the switch; Provides a cap detection sensor configured to be operatively engaged by an attached cap, thereby changing the state of the switch.

  Thus, it can be seen that embodiments of the present invention provide an adherence monitor that can be installed without the need for user assembly or screw mounting.

  Furthermore, embodiments of the present invention enable an effective cap detection system that can employ an indentation or similar attachment.

  Exemplary embodiments of the present invention will be described with reference to the accompanying drawings.

1 is a perspective view of a first embodiment of an adherence monitor for monitoring according to the present invention. FIG. 1 is a perspective view of a first embodiment of an adherence monitor for monitoring according to the present invention. FIG. FIG. 2 is a partially exploded view of the embodiment shown in FIGS. 1A and 1B showing how the adherence monitor is attached to the drug delivery device. FIG. 3 is an illustration of the embodiment shown in FIG. 2 with a cap attached to the drug delivery device. It is a top view of the 2nd Embodiment of this invention. It is a perspective view of 3rd Embodiment of an adherence monitor. It is a perspective view of 3rd Embodiment of an adherence monitor. FIG. 3 is an inverted exploded view of one embodiment of the adherence monitor showing a perspective view of each component of the adherence monitor. FIG. 6B is a vertical exploded view of the embodiment shown in FIG. 6A. It is sectional drawing which shows operation | movement of the cap detection sensor in a disengagement state. It is sectional drawing which shows operation | movement of the cap detection sensor in an engagement state. It is a perspective view of the 4th Embodiment of this invention. FIG. 6 is a flowchart of processing steps of an algorithm employed to detect a cap state change event and activate a dosing detection mechanism.

  Throughout this specification, the term “patient” or “user” or “person” or “patient use” as used in connection with the use of a drug delivery device refers to any person using the drug delivery device. Should be understood as such.

  While the invention will be described in connection with various specific embodiments, it will be understood that they are intended to illustrate the invention and limit its scope, as will be understood. Is not intended. In particular, it will be appreciated that a monitor embodying the invention may include a variety of additional features and functions, indicators, and the like. These can be arbitrarily selected by a product designer for a specific application.

  The following embodiments are described primarily with respect to TURBUHALER ™ products and TWISTHALER ™ products because of their wide commercial use. However, the present invention can be applied to other designs of dry powder drug dispensing devices that exist or will be developed with suitable modifications as will be understood by those skilled in the art.

  Similarly, the following discussion is primarily related to respiratory related drugs, but is applicable to any use of a dry powder drug dispensing device, including by way of example only, analgesics, diabetes, erectile dysfunction, or other conditions It is. The present invention relates to monitoring how drugs are used and dispensed and should not be regarded as limited to any particular drug or condition.

  As an overall illustration, the described embodiments are intended to be attached to a dry powder drug dispensing device by a user. Those embodiments detect a single dose dispensed and keep this record, or a system that communicates to a remote system, such as a smartphone, tablet or other device via Bluetooth®, for example. Including. It is intended to automatically create a record of use to aid in clinical management. They can also provide a reminder for the user, detect if the dispensing device is attached, indicate an error, or provide other functions.

  Referring to FIGS. 1A, 1B, 2 and 3, there is shown an adherence monitor 1 used to monitor patient use of a dry powder inhaler, indicated generally by arrow 2. The dry powder inhaler 2 shown is a TURBUHALER ™ manufactured and sold by AstraZeneca AB. For further information regarding TURBUHALER ™, please refer to the material provided by AstraZeneca AB at https://www.symbicort.com/asthma/asthma-symbicort/turbuhaler.html.

  The inhaler 2 includes a stored medicine (not shown) housed in the body portion 3. The inhaler 2 also includes a rotatable base 4 that is rotatable relative to the body portion 3. The inhaler 2 has a mouthpiece 5 through which a user can inhale one dose of medicine. Moreover, the cap 6 which can be removed and can be returned is provided. The inhaler 2 also includes a medicine dispensing means (not shown) for dispensing a single dose of medicine into an inhalation chamber (not shown).

  The stored medicine is in the form of a single solid mass housed within the body portion 3, and the rotating base 4 rotates relative to the body portion 3, resulting in a single internal scraper (not shown). A small amount of drug is rubbed out of the mass, after which the removed drug is directed into the inhalation chamber in the form of a metered amount of dry powder. The dry powder is then inhaled by a user who sucks the mouthpiece 5 strongly.

  The action (not shown) inside the inhaler 2 is usually configured to provide an enhanced internal air flow when the user is sucking the mouthpiece 5. As a result, the dry powder medicine is drawn through the mouthpiece 5 into the user's mouth. It is intended to ensure that the maximum amount of dry powder drug reaches and / or deposits in the user's airways and / or lungs.

  The adherence monitor 1 includes a recess 35 in which the rotor 7 is disposed. The inner surface 9 of the rotor 7 projects into the open center of the rotor 7 and is shaped to include a protrusion 10 so as to be complementary to the outer gripping surface 8 outside the rotary base 4 of the inhaler 1. . The inner surface 9 is coated with an elastic rubber material by, for example, an overmold process. For example, the protrusion can be manufactured by two-stage injection molding, in which case the rigid part is first molded and then inserted into a second injection mold to form a soft protrusion. This provides a set of molded internal elastic projections 10 extending from the inner surface 9 of the rotor 7 into the center. In the form shown, the protrusion 10 is formed as a set of teeth, however, consistent with the gripping surface 8 and the characteristics of the particular inhaler that the adherence monitor is intended to be used for, Other shapes and configurations can be used.

  An alternative way of generating internal elastic protrusions is to mold them as separate parts, which are then clipped over the corresponding openings in the inner surface 9 of the rotor 7 or joined in place. Is.

  The rubber material can be a synthetic rubber material. For example, the rigid portion can be manufactured using an acetal or nylon type material and the soft tooth can be TPU, silicone or natural rubber compound, preferably with a Shore hardness of 40 Shore A-90. Shore A. The preferred Shore hardness depends on the final size and shape of the protrusions (the larger the cross-sectional area, the softer the material is needed to obtain the same compression).

  In order to put the monitor 1 and the inhaler 2 into operation, the rotary base 4 of the inhaler 2 is pushed into the center of the rotor 7 in the recess 35 of the adherence monitor 1. The external gripping surface 8 is oriented to align with the protrusion 10. The molding protrusion 10 is compressed to provide an effective interference fit. However, the interference fit can be released by applying a suitable force, so that the monitor can be easily moved to a new inhaler, for example when the original inhaler 1 is empty. .

  To remove the adherence monitor 1 from the inhaler 2, the patient first removes the cap 6 from the inhaler 2, holds the mouthpiece with one hand and the adherence monitor from the rotary base 4 with the other hand. Pull 1 slowly away.

  When the monitor 1 and the inhaler 2 are attached, the subsequent rotation of the adherence monitor 1 also causes the rotation of the rotary base 4 as required for the discharge of the drug by the inhaler. That is, the adherence monitor 1 effectively acts as an outer rotating grip for the inhaler base 4.

  In some embodiments, the protrusions 10 can be evenly spaced along the inner surface 9 of the rotor 7. In another embodiment, the protrusions 10 can be grouped into two sets located on opposite sides of the inner surface 9. FIG. 4 shows an alternative embodiment of the adherence monitor 1 of the present invention, where there are three sets of projections 10 spaced evenly along the inner surface 9 of the rotor 7. It will be appreciated that other configurations can be used. Further, consistent with the mechanical requirements of the interface with the gripping surface 8 of the inhaler 2, the shape and size of the protrusion can be changed and selected for a particular design.

  2 and 3, a first threaded portion 14 (shown as a dotted line because it is not visible from this angle) is provided on the inner surface of the cap 6. A second threaded portion 15 is provided, whereby the cap 6 is placed on the body portion 3 and the two threads 14, 15 are screwed together so that the cap 6 is attached to the inhaler 2. Can be attached. Similarly, the cap 6 can be removed from the inhaler 2 by loosening the threads 14, 15 from each other and then removing the cap 6.

  Although the adherence monitor is formed as a device that is attached only to the base, a cap detection sensor is still required. WO 2015/030610 by the applicant discloses a cap detection device suitable for a two-part inhaler. However, alternative mechanisms have been developed for this application.

  FIG. 1 shows a protrusion 12 extending from the monitor 1 with a lever 13 inside. It can be seen that the lever 13 is positioned to project into the space occupied by the cap 6 when the monitor 1 is attached to the inhaler 2.

  When the cap 6 reaches an appropriate movement distance along the screw thread 15 by the action of screwing the cap 6 into the main body portion 3, pressure is applied to the lever 13. This pressure causes the lever 13 to pivot and engage the cap detection switch 21 (FIG. 6B). Therefore, the cap detection switch 21 is closed, whereby the cap 6 is detected as being attached to the main body portion 3 of the inhaler 2.

  Similarly, removing the cap 6 by loosening the cap 6 with respect to the main body portion 3 has an effect of releasing the pressure of the cap 6 from the lever 13. Then, the lever 13 pivots away from the cap detection switch 21. Accordingly, the switch 21 is opened, and the removal of the cap 6 from the main body portion 3 is detected.

  7A and 7B show the operation of the cap detection sensor in more detail. In FIG. 7A it can be seen that the lever 13 has a lug 30 at the outer end to help engage the cap 6. The lever 13 is biased so that the lug 30 is pushed into the center of the housing 29 when there is no cap. At the other end portion 31 of the lever 13, the end portion 31 is biased to the outside and therefore does not come into contact with the switch 21. This represents a normal state of the monitor 1 and the lever 13 when the cap 6 is not present.

  FIG. 7B shows the situation when the cap 6 is attached. For clarity, the cap 6 is not shown, but can be assumed to be present and screwed into the mounting position. The cap 66 pushes the lug 30 rearward to pivot the lever 13, thereby moving the inner end 31 inward. This indicates that the lever 31 is engaged with the switch 21 and the cap 6 is attached.

  Cap detection systems can also be applied to other types of adherence monitors, including those having an assembly consisting of two parts or multiple components, in addition to its usefulness associated with an indentation or similarly mounted device. It will be appreciated that can also be applied. For example, it can be used with a device fitted by a squeeze fit, a bayonet-type rotational lock fit, or other such devices.

  When the adherence monitor 1 is attached to the inhaler 2, a single medicine can be dispensed as follows. The cap 6 is loosened from the main body portion 3 of the inhaler 1, and this action is detected by the cap detection mechanism as described above.

  Then, the adherence monitor 1 is rotated back and forth once with respect to the main body portion 3. This has the effect of rotating the rotary base 4 forward and backward with respect to the main body portion 3. As described above, this causes a measured dose of dry powder medicine to be placed in the inhalation chamber, from which the user inhales the dry powder medicine by strongly sucking the mouthpiece 5. Can do. Then, the cap 6 can be screwed again onto the main body part 3 of the inhaler 2, and again, this action is detected by the cap detection mechanism as described above.

  5A and 5B show a further embodiment of the adherence monitor 1 of the present invention, which adherence monitor 1 does not comprise a cap detection mechanism.

  The adherence monitor 1 according to an embodiment of the present invention may also be applied to the body portion 3 to determine whether a dose of medication has been dispensed and / or a rotating base 4 is required to dispense a dose of medication. Also provided is a dose detection means for determining whether or not it has rotated.

  The administration detection means according to this embodiment comprises a calibration torque detection system incorporated in the adherence monitor 1.

  When the rotary base 4 rotates with sufficient torque with respect to the body part 3 of the inhaler 2, the torque detection system activates the electromechanical switch. Then, an “ON” signal is recorded by ECM (described later). A certain minimum torque is also necessary for the rotary base 4 to rotate in the opposite direction (until a click sound is heard). If the correct level of torque for a particular device is used, the torque detection system activates the electromechanical switch, which again records an “on” signal by the ECM.

The ECM does not limit other methods, but for example
(A) If both “on” signals are detected, confirm and log that one dose has been correctly distributed;
(B) If no second “on” signal is detected, confirm and log that one dose has not been correctly distributed;
(C) measure the time delay between the first switch actuation and the second actuation, and if the delay between them exceeds a preset value, confirm that one dose has not been dispensed correctly and Log and / or
(D) detect the occurrence of timeout when the device is clogged at one position;
Can be calibrated.

  In one embodiment, the dose detection means is provided by leaf springs 16, 16 ′ (FIG. 6A) housed in the housing 17 of the adherence monitor 1. The leaf springs 16 and / or 16 'actuate the dosing detection switch 22 by the pressure of rotating the adherence monitor 1 relative to the body part 3 (and thereby rotating the rotatable base 4 relative to the body part 3).

  Referring to FIGS. 6A and 6B, the adherence monitor 1 includes a housing 17, a base 18, a circuit board 19, and leaf springs 16 and 16 ′ held in the housing 17. The rotor 7 is attached to the housing 17 so as to be able to rotate in either direction with respect to the housing 17. The protrusions 20 and 20 'located at the base of the rotor 7 are arranged to abut against the leaf springs 16 and 16' when in the "stop" position. When the adherence monitor 1 and the rotary base 4 are rotated to the resistance point in one direction with respect to the main body part 3, the rotor 7 is separated from the rest of the adherence monitor 1 by the resistance of the rotary base 4. Moving. The protrusion 20 or 20 '(depending on the direction of rotation) pushes the leaf spring 16 or 16', respectively. If the force with which the leaf spring 16 or 16 'is pushed exceeds a preset torque level, the rotor 7 rotates relative to the housing 17 and the leaf spring bends. By movement of the rotor 7, the leaf springs 16, 16 ′ are engaged with the dosing detection switch 22 on the circuit board 19. Each leaf spring 16, 16 'can have its own switch, or a bidirectional switch can be placed between the leaf springs.

  In an alternative embodiment, an additional protrusion at the base of the rotor 7 can engage with a dosing detection switch 22 on the circuit board 19. Other positions of the dosing detection switch 22 on the circuit board 19 and other ways of operating the dosing detection switch 22 via movement of the rotor 7 are also possible. The leaf springs 16, 16 ′ can be adjusted so that the torque required to engage with the dosing detection switch 22 depends on the torque required to dispense a dose of medication from the inhaler 2. .

  In other embodiments of the dosing detection means, other spring systems may be used, such as the dosing detection mechanisms disclosed in various references which are hereby incorporated by reference.

  In another embodiment, the spring system can consist of one leaf spring located on the side closest to the rotation required to dispense the drug. A torque system based on a single leaf spring can include one or more protrusions necessary to detect rotation in one or both directions.

  In one embodiment, the dosing detector means that the adherence monitor 1 (and thus the rotating base 4) records that one dose has been dispensed only when it has made one back and forth rotation relative to the body portion 3. (This is the normal way to dispense a dose in the case of the TURBUHALER ™ device shown). For this reason, the administration detection means plays a role of detecting and / or recording each time one medicine is dispensed.

  Furthermore, the administration detection means can also be set to detect and / or record only when the adherence monitor 1 (and hence the rotary base 4) has rotated once in one direction relative to the body part 3. . Many users inadvertently or mistakenly believe that a single dose of medication has been dispensed by these actions, but if this action is not completed twice (ie, forward, then backward) Not distributed. For this reason, in such an embodiment, the administration detection means can determine the inaccurate use of the inhaler 2 by the user, that is, the inaccurate method of dispensing one dose of medicine.

  In addition, the dosing detection means also has an adherence monitor 1 (and therefore a rotating base 4) relative to the body part 3 when the cap 6 remains attached (as detected or recorded by the cap detection mechanism). ) Can be set to be detected and / or recorded each time an attempt is made to rotate. If the cap 6 remains attached, it is not possible to dispense a single medicine. However, the user may nevertheless mistakenly recognize that one dose of medicine has been dispensed, and may then consider that the cap 6 has been removed, the mouthpiece 5 has been sucked, and one dose of medicine has been received. . For this reason, the administration detection means serves to detect and / or record such erroneous techniques. For example, such an incorrect use of the inhaler 1 can be detected by an adherence monitor 1 comprising an electronic pressure switch, which can be detected (for example by rotating the base 4 because the cap 6 remains attached). Can be closed when sufficient and predetermined rotational pressure is applied (even if this is not actually possible).

  In addition, the dose detection means and / or cap detection allows the user to normalize a single dose of medication as compared to when the dose is unintentionally dispensed when the cap is removed or replaced. It is adapted or can be identified to identify when to dispense. This can be accomplished, for example, by determining that the timing of a single dose of medication was substantially simultaneous with the cap being removed or replaced.

  In a preferred form, the dosing detection mechanism can be disabled from recording a single dose until the cap detection system determines that the cap has been removed. This minimizes the risk of erroneous dose detection.

  FIG. 9 shows one example of an algorithm employed to activate the dosing detection mechanism in response to a cap state change. When the cap detection switch 21 changes state, the electronic control module (ECM or processor) starts executing the algorithm. In response to the cap state change signal in step 101, the ECM checks in step 102 whether the cap status is on. If the cap 6 is on the mouthpiece 5, the algorithm disables the dosing detection mechanism (ie, rotation sensor) at step 103 and checks the inhaler entry / exit status at step 104. If no inhaler is detected in step 105, the algorithm is complete and no log is entered in the adherence monitor memory, i.e. no adherence device is attached to the adherence monitor and the dosing detection mechanism does not operate. . In step 105, if the inhaler is installed in the adherence monitor 1, the ECM checks in step 106 whether the previous cap log stored in the memory was a cap on log. If the preceding cap log is not a cap on log, the ECM stores the cap on log in the adherence monitor memory (107). If the preceding log is a cap-on log, in step 108, the inhaler in / out inspection is performed until a timeout occurs. In both of these cases, the cap 6 remains attached and the dosing detection mechanism is not activated. If, in step 102, the algorithm establishes that the cap 6 is not installed, then in step 109, the inhaler status is checked. If an inhaler is not detected in step 109, the dosing detection mechanism is not activated, and another inhaler entry / exit check is performed in step 110 until timeout. If the inhaler is on, the algorithm establishes whether the previous cap log in memory was cap off. If the preceding log is a cap-off log and no dosing detection mechanism is available, no log is generated. If the previous log was a cap-on log, at step 112, the ECM stores the cap-off log in adherence monitor memory, and at step 113, the ECM enables the dosing detection mechanism (ie, rotation sensor). .

  When the dosing detection mechanism is enabled, some preset rotation procedures are logged as medication events, but other procedures can only be logged as their respective rotation. For example, a medication log is entered into the adherence monitor memory by a counterclockwise rotation of the gripping base with respect to the inhaler body, followed by a clockwise rotation within 60 seconds of the first counterclockwise rotation, and a medication event The log is sent to the paired smartphone and / or web server.

  The adherence monitor 1 can be further adapted to detect the absence or presence of a drug delivery device. The device detection means may include optical element recognition and detection means as described in Applicant's New Zealand Patent Application No. 625105, the contents of which are hereby incorporated by reference. .

  With reference to FIGS. 1A and 1B and FIGS. 6A and 6B, the device detection means 11 can be incorporated in the housing 29 of the adherence monitor 1 below the opening 23 in the rotor 7.

  The adherence monitor 1 comprises an ECM (overall position is indicated by arrow 37), which monitors and / or manipulates and / or manipulates all collected adherence data related to patient use of the drug delivery device. Or adapted to store and / or transmit. The ECM can be a suitable microprocessor device.

  The use of ECM with adherence monitors for drug delivery devices is known and is therefore not intended to be described in considerable detail herein. For example, these systems are generally used commercially in products available from the present applicants and affiliates and are prior to the applicant's prior patent applications, for example, by reference. Is disclosed in a patent application. An example of an adherence monitor for use with an ECM and / or transmitter can be found in Applicant's US Patent No. 8424517 and Applicant's US Patent Application Publication No. 2014/0000598.

  6A and 6B, the adherence monitor 1 and the ECM are powered by a battery 24 and can use either a rechargeable battery or a replaceable battery. The ECM and / or adherence monitor can alternatively be powered by any suitable alternative means, for example by a kinetic charger or by solar power.

  The ECM stores and transmits the collected adherence data so that the analysis can determine whether the user has used and / or did not use the inhaler correctly. The inhaler usage log generated in the adherence monitor is uploaded to and through the smartphone application, PC or central communications hub. In some embodiments, the inhaler usage log can also be uploaded directly from the adherence monitor to the web-based server.

  The adherence monitor 1 includes a memory. In some embodiments, volatile type computer memory can be used including, for example, RAM, DRAM, SRAM. In such cases, the adherence monitor can continuously send information to the adherence monitor or a computing device external to the drug delivery device. In other embodiments, non-volatile memory formats can be used, including, for example, ROM, EEPROM, flash memory, ferroelectric RAM (F-RAM), optical and magnetic computer memory storage devices, and the like.

  The adherence monitor 1 also indicates an indication means, such as an LED 25, that indicates an event when the ECM determines that the user has used the inhaler correctly and / or warns the user when it determines that the user has not used it correctly. Also equipped. For example, the user can be warned using the instruction means when the user rotates the adherence monitor 1 (and hence the rotary base 4) only once in one direction. By using the instruction means, the user can be warned when trying to dispense one dose of medicine while the cap 6 is still attached. Alternatively, the indicating means can be used to alert if the medication has not been dispensed within a predetermined time frame, eg every 12 or 24 hours.

  The indicating means may be in the form of one or more LEDs as shown, or in the form of some other visual and / or audio and / or vibration indicator. The adherence monitor 1 also includes a multi-function user button 26 that monitors and controls several aspects of operation. For example, pressing the button once can provide a green light indicating that the adherence monitor 1 is attached to the inhaler 2 in the correct and normal working sequence. Conversely, red light can indicate a problem. Pressing the button twice can provide another aspect of the adherence monitor to be inspected or recorded, and further pressing or holding the button can cause additional functions or tests to be performed. it can.

  The adherence monitor 1 also allows the user to access the data recorded or received by the adherence monitor and change the adherence monitor settings (eg date / time, visual / audio alert settings). A user interface can also be provided. The user interface can also be used to access any data received (or transmitted) by the adherence monitor or to control the upload of data from the adherence monitor to an external electronic device.

  The adherence monitor 1 and / or ECM embodiments described herein may monitor for any type of non-dose counting information regarding the operation of the inhaler 2 and / or patient use of the inhaler 2. There are cases where it is possible. For example, the ECM can include (or electronically communicate with) a real-time clock that enables adherence monitor 1 to record the date and time for each dose of drug dispensed. Compare the actual dose dispensed to a pre-set dosing time table and warn the user that it is due for dosing if the dose is not dispensed at the pre-set time The ECM can be calibrated to do so.

  Furthermore, by way of example only, the adherence monitor 1 and / or ECM is geographical location, temperature, humidity, inhaler 2 orientation, medication status, amount of medication remaining, battery status or whether it is attached. No, the flow rate or pressure of the user's inhalation, the inhalation can be detected, or a reference such as a voice sensor that determines whether the body portion has been rotated relative to the base portion can be monitored. To this effect, the ECM includes a voice or light inhalation sensor, a thermistor sensor or an accelerometer, or can be connected to a GPS (eg, adherence data from a smartphone paired to the adherence monitor 1 by the smartphone). Can be aligned with GPS data related to the location of the received adherence event).

  The adherence monitor 1 can also include a communication device that transmits adherence data. In one embodiment, this can be a USB port 27 located in the housing 17 of the adherence monitor 1. Any other suitable wired connection or port can be used.

  Alternatively and / or additionally, a wireless transmitter and / or a wireless transceiver, such as Bluetooth Low Energy (registered trademark), capable of transmitting and / or receiving data to the adherence monitor 1 and / or ECM, respectively. ) Module 28 can be provided. For example, the present technology including Wi-Fi (IEEE802.11), Bluetooth (registered trademark), other radio frequencies, infrared (IR), GSM, CDMA, GPRS, 3G, 4G, W-CDMA, EDGE, or DCDMA200, etc. Any other suitable radio technology known in the art can be used.

  Data can be transmitted to a remote computer server or to an adjacent electronic device such as a smartphone or electronic tablet. The adherence monitor can be paired with a smartphone, which is loaded with a software application that allows the smartphone to access, process and / or present data collected by the adherence monitor. ing. The smartphone can be configured to transfer data obtained from the adherence monitor to the web service platform. Data can be sent in real time, manually, or at a predetermined set time.

  Considering FIG. 8, an alternative embodiment of the adherence monitor of the present invention is shown. The adherence monitor 51 includes an alarm function 32. The alarm switch allows the user to select the 12 hour, 24 hour or no alarm option. When the ECM detects the medication log, the real-time clock is reset, and if no subsequent medication log occurs within the current time frame (12 hours or 24 hours), the ECM will cause the indicating means to alarm.

  While the above-described embodiments are presently preferred, it will be understood that a wide range of other changes can be made within the general spirit and scope of the invention.

  For example, each cap detection mechanism can be in the form of an electromechanical, light or pressure switch that activates when the cap is attached to the drug delivery device and stops when it is removed therefrom. The engagement aspect of the present invention is not limited to the specific cap detection system disclosed.

  Preferably, the ECM can utilize the collected adherence data to determine whether the user has used and / or used the drug delivery device correctly. This incorporates the appropriate algorithm (s) to analyze the collected adherence data and / or make appropriate decisions within the ECM or other user device, eg, tablet or smartphone, or remote system Can be achieved.

  Furthermore, the cap detection mechanism of the present invention can be incorporated directly into an electronically usable drug dispenser, eliminating the need for a separate adherence monitor. It will be appreciated that the lever mechanism needs to be placed in or along the thread of the dispenser and a processor, switch, etc. are provided in the dispenser.

  For example, the rotary base of the inhaler can be modified to include a circuit board, ECM, memory, user interface, battery, dosage detection mechanism and cap detection mechanism of the present invention. The rotary base of the inhaler can be modified to include a cap detection sensor. It has one end extending over the rotary base of the inhaler toward the cap and the other end extending into the rotary base so that it engages a cap detection switch built into the rotary base. This can be accomplished by including a lever. The lever can be arranged to be operatively engaged by the cap when the cap is installed, thereby changing the state of the cap detection switch. Alternatively, another form of cap detection sensor can be incorporated into the rotating base.

  References herein to any previous publication (or information derived therefrom) or to any known matter refer to any previous publication (or information derived therefrom) or known matter. It is not an admission, acceptance, or suggestion of any form and should not be construed as forming a part of the common general knowledge in the relevant effort-focusing field.

  All patents and other references mentioned herein, including websites, are hereby incorporated by reference.

Claims (19)

An adherence monitor for dry drug dispensers,
The dispenser has a rotatable base;
The adherence monitor includes a main body having an opening,
The opening includes an internal elastic protrusion, arranged to operatively receive and hold the base in the opening;
An adherence monitor in which the base can be rotated by rotating the monitor. Having a body formed from a first polymeric material;
The elastic protrusion is formed in the opening as an overmold of a second polymer material,
The adherence monitor of claim 1, wherein the second material is more compliant than the first polymer material.   3. The adherence monitor according to claim 1 or 2, wherein the base is held in the opening by compressing the protrusion to form an interference fit. An adherence monitor for dry drug dispensers,
The dispenser comprises a rotatable base, a mouthpiece, and a removable cap for the mouthpiece;
The adherence monitor comprises an opening that operatively receives the base of the dispenser and a cap detection sensor that detects removal or engagement of the cap,
The sensor comprises a lever extending generally parallel to the axis of rotation of the base;
The lever extends one end beyond the base toward the cap and extends into the monitor to engage a switch, and when the cap is attached, the lever is actuated by the cap. An adherence monitor that is arranged to be engaged to thereby change the state of the switch. The monitor comprises a processor;
5. The adherence monitor of claim 4, wherein the processor communicates with the switch to accept an indication of the state of the switch. The monitor is adapted to transmit an external communication indicating use of the dispenser;
6. The adherence monitor of claim 5, wherein the communication selectively includes an indication of whether the cap detection sensor has detected that the cap has been attached or has been removed.   The adherence monitor of claim 6, wherein the indication is associated with a record of a usage event at the dispenser. The adherence monitor further comprises a dose detection mechanism,
The adherence monitor according to any one of claims 4 to 7, wherein the administration detection mechanism is disabled until the cap detection sensor detects that the cap is removed. The opening includes an internal elastic protrusion, arranged to operatively receive and hold the base within the opening;
The adherence monitor according to any one of claims 4 to 8, wherein the base portion can be rotated by rotating the monitor. The monitor has a body formed from a first polymer material;
The elastic protrusion is formed in the opening as an overmold of a second polymer material,
The adherence monitor according to any one of claims 4 to 9, wherein the second material is more compliant than the first polymer material.   11. The adherence monitor according to any one of claims 4 to 10, wherein the base is retained in the opening by compressing the protrusion so as to form an interference fit. An adherence monitor comprising a dose detection sensor and a cap detection sensor, and further comprising a dose detection mechanism,
An adherence monitor wherein the dosing detection mechanism is disabled until the cap detection sensor detects that the cap has been removed. A method of holding a dry drug dispenser in an adherence device comprising:
A recess including an elastic protrusion is provided in the adherence device,
The rotary base of the adherence device is inserted into the recess, and the insertion compresses the elastic protrusion so as to hold the base of the dispenser in the adherence device, and thereby the adherence of the adherence device A method wherein rotation also rotates the rotary base. A cap detection sensor for a dry medicine dispenser,
The dispenser comprises a rotatable base, a mouthpiece, and a removable cap for the mouthpiece;
The sensor comprises a lever extending generally parallel to the axis of rotation of the base;
The lever extends into the dispenser so that one end extends beyond the base toward the cap and engages a switch, and when the cap is attached, the lever is actuated by the cap. A cap detection sensor which is arranged to be engaged to thereby change the state of the switch. The dispenser comprises a processor;
The cap detection sensor of claim 14, wherein the processor communicates with the switch to receive an indication of the state of the switch. The dispenser is adapted to transmit an external communication indicating use of the dispenser;
16. The cap detection sensor of claim 15, wherein the communication selectively includes an indication of whether the cap detection sensor has detected that the cap has been attached or has been removed.   The cap detection sensor of claim 16, wherein the indication is associated with a record of a use event at the dispenser.   A dry medicine dispenser provided with the cap detection sensor according to any one of claims 14 to 17. The dispenser further includes an administration detection mechanism,
19. The dry drug dispenser of claim 18, wherein the dosing detection mechanism is disabled until the cap detection sensor detects that the cap has been removed.