JP2021058653A - Dose control system for injectable drug delivery devices and associated methods of use - Google Patents

Abstract

To provide a dose control system adapted for an injectable drug delivery device.SOLUTION: A drug delivery device comprises a substantially elongate drug delivery body and at least one injectable drug held by the body, the body having a distal and proximal extremities, wherein a dose control system comprises: three-dimensional magnetic field producing means for producing a magnetic field along three axes (x, y, z); magnetic field detection means configured to detect changes in at least the magnetic field produced by the three-dimensional magnetic field producing means; displacement detection means configured to measure a relative displacement or relative movement of the drug delivery device; and an integrated control unit that is connected to the magnetic field detection means and the displacement detection means for processing information received from both the magnetic field detection means and the displacement detection means.SELECTED DRAWING: Figure 1

Description

The present invention relates to the field of injectable drug delivery devices, and specifically to the dosage control systems provided for such injectable drug delivery devices.

Delivery devices for injectable drugs have been known for many years. Various that allow users to self-inject their medications as demands evolve and evolve as patients become more responsible in managing their own personalized treatments and dosing regimens. Drug delivery devices have been developed. This is especially true in the case of insulin, which is intended, for example, to treat the consequences of diabetes. However, for example, other drugs needed to deal with potentially life-threatening situations also fall into this category, and those suffering from or susceptible to such illnesses Allows immediate emergency injections of required drugs such as anaphylactic shock treatments, anticoagulants, opioid receptor agonists and antagonists, as long as carrying the device at all times has become a common occurrence. Become.

One of the known issues with existing autoinjector systems was the issue of dose control. In the previous generation of injectable substance delivery devices, such devices are severely overdose injections, or overuse of the device, and such abuse, misuse, or simple user error. Mechanical means were provided in an attempt to prevent or limit the possible consequences. In addition, users may be informed of the amount of drug they self-injected so that there are at least some visible cues as the amount injected, which can facilitate the management of treatment plans. I felt it was desirable to be able to do it.

The main problem associated with the proposed mechanical solution was that the structure of the drug delivery device was inevitably overly complex, imposing very rigorous or complex usage on the user quite often. This usage can often differ from what the user is accustomed to, which also leads to further operational errors, loss of drug dose, patient non-compliance, and numerous other difficulties.

To counter these difficulties, attempts have been made to address the complex nature of purely mechanical solutions, with the movement of mechanical parts and the mechanical interaction of small, fragile components. This attempt is a non-contact sensor and information incorporated into the device to indicate the frequency and dose of injectable drug administered, consumed, purged, or otherwise exhaled from the drug delivery device. This is due to the use of the processing system. This has led to a number of different technical solutions. However, each of these solutions was intended for the corresponding range of specifications of a particular manufacturer of injectable drug delivery devices.

For example, in US8708957B2, drug delivery devices for self-injection of injectable drugs are disclosed, including sensors adapted to generate pulses during injection as delivery transfer progresses. The number of pulses accumulated during dose delivery corresponds to the size of the dose delivered, and the frequency of the detected pulses is proportional to the dose speed during injection.

In other embodiments, the sensor circuit can include a position sensor adapted to monitor a particular component of the driving mechanism moving during injection. The position sensor can be either a linear sensor or a rotation sensor, and the particular choice of sensor is selected according to the particular design of the dosage setting and injection mechanism. For example, a linear position sensor that monitors the movement of the piston rod during injection can be provided. Alternatively, a position sensor is provided that records the movement of the component that moves in synchronization with the piston rod during injection. For example, a component that is rotatably attached to a device and rotates during injection can be monitored by a rotational position sensor, thereby calculating the dosing speed from the rotational movement of the rotatably attached component during injection. it can.

EP1646844B2 discloses an injectable device for administering an injectable drug. The device includes a non-contact measuring unit for measuring the position between the elements of the mutually movable dosing device, the measuring unit being fixed to the first element and movable with respect to the first element. The magnetic device includes a magnetoresistive sensor, which faces the second magnetic field element and is embodied as a rotating element for measuring the rotational position, and the magnetic device is a permanent magnet on the first element and a predetermined surface. Formed from a second magnetically magnetized element with a profile, when the first and second elements are moved to each other, the surface of the second element changes the distance of the first element from the permanent magnets. As a result, a measurable change in resistance occurs in the reluctance sensor due to changes in the magnetic field. This is a fairly complex system with many additional moving parts built into the barrel or body of the injectable drug delivery device, which increases the risk of potential failure of various components. , Or the interaction between the movements of the magnet and the magnetizing element, and the respective signals generated may be disturbed.

EP2428238A1 discloses a device for measuring a dose in a syringe. This device is a number sleeve that penetrates the syringe body and is movably connected to the syringe body in a spiral manner, in which a pattern for dose measurement is formed on the outer circumference of the number sleeve. The sleeve; and the syringe body, which includes a sensor to detect the pattern formed on the number sleeve as the number sleeve moves spirally; and to measure the dose according to the spiral movement distance of the number sleeve through the sensor. Includes the controller. In this device, magnets are spirally displaced along the body of the drug delivery device. The body is provided with corresponding sensors installed at various points along and around the longitudinal axis of the body of the drug delivery device. Again, this solution is extremely complex, adding to the complexity of already complex drug delivery devices.

WO 02/064196 A1 discloses an injection device controlled by a closed switch unit, including an integrated sensor that monitors selected parameters of the device. The closed switch unit is fixed in the injection device. At least two pairs of integrated Hall elements are used as sensors. The Hall element cooperates with a magnetized ring that alternates between the North Pole and the South Pole. The ring is placed within the means of administration and is moved around the longitudinal axis of the injection device in accordance with a rotational movement to set the product dose. To measure the volume of the dose setting, it is necessary to determine the rotational movement of the magnetic ring with respect to the closed switch unit.

US20060175427A1 discloses an injection device that includes at least one passive, non-contact sensor capable of generating a signal to detect the position of a setting element. The at least one passive, non-contact sensor includes a magnetic switch or lead contact. According to some embodiments of the present invention, passive components such as magnetic switches or lead contacts may be used as sensors, as opposed to active components such as optical recorders or Hall sensors. No power flows when the passive sensor is in its resting state due to the circuit being cut off by a magnetic switch or lead contact. A passive, non-contact sensor switches on or operates the measurement circuit and switches it off again to detect the position of the setting element by counting the switch-on and switch-off processes, that is, a digital signal, ie. Generates on and off. In order to confirm whether or not the setting element has been changed, the position of the setting element such as the rotation position of the administration unit can be detected without energy such as electric power.

WO2013050535A3 is a sensor assembly adapted to measure a magnetic field and a sensor assembly between two positions by combined axial and rotational movement (rotational movement has a predetermined relationship with axial movement). Discloses a system that includes moving elements adapted to be moved against. Magnets are attached to moving elements and are configured to generate a spatial magnetic field. This spatial magnetic field varies with respect to the sensor assembly, corresponding to both axial and rotational movements of the magnet and thus the moving elements. The processor is configured to determine the axial position of the moving element based on the measured magnetic field. In this system, the magnetic field generating means is installed on a longitudinal drive screw installed within the body of the injectable drug delivery device, and the sensor is installed along the longitudinal axis of the drug delivery device. The entire system will be installed again within the body of the drug delivery device so that the magnetic field is generated as close as possible to the longitudinal axis (the magnet moves along it) and the sensor. Please be careful.

WO2014161954A1 discloses a drug delivery system. Here, the housing of the drug delivery device is a first rotating member integrated inside the housing that rotates relative to the housing in response to a set and / or released dose. A first rotating member, a second rotating member, including a first force transfer surface, that rotates relative to the housing in response to a set and / or released dose. A second rotating member, which is adapted as such and includes a second force transfer surface, is further included. Here, at least a portion of the first and second force transfer surfaces are adapted to engage with each other during dose setting and / or release, and the first rotating member is the first rotating member. The first rotating member is completely formed from a polymer material containing magnetic particles, and the polymer material is magnetized and magnetic, including a magnet that creates a magnetic space field that changes in response to the rotational movement of the rotating member. Provided is a magnet that creates a space field.

All of the above solutions include a fairly complex arrangement of various sensors and / or tissue of elements within the body of the drug delivery device, which further modifies the drug delivery device in a fairly substantial manner. It generally implies that it must be done.

Accordingly, it is an object of the present invention to provide a dosage control system that can function with any of the currently available injectable drug delivery devices, but also with future designs of such injectable drug delivery devices. To provide, where the injectable drug delivery device relies on a common pen-shaped self-injector design, in this design the drug delivery device is held by a substantially elongated drug delivery body, body. Includes at least one injectable drug, body with distal and proximal tips. In addition, another object of the invention is a substantial modification of an injectable drug delivery device when compared to a similar, off-the-shelf drug delivery device, or a method by which it works for the user, ie. It is to provide a dosage control system that does not require substantial modification of its usage. Yet another object of the present invention is to provide a dose control system detachably attached to said injectable drug delivery device, whereby, for example, damage to the drug delivery device or malfunction of the drug delivery device. In the case of, or simply, some drug delivery device is configured to deliver only a small range of available doses of the drug and has a different range of available doses of the drug. The drug delivery device can be replaced because it is desirable to be able to switch to the drug delivery device. These and other objectives will become apparent from the various embodiments shown and described in detail below.

Therefore, one embodiment of the invention is a dosage control system suitable for an injectable drug delivery device. The drug delivery device comprises a substantially elongated drug delivery body, at least one injectable drug held by the body, a body having distal and proximal tips, and a dosage control system.
-Three-dimensional magnetic field generation means for generating a magnetic field along the three axes (x, y, z);
-At least a magnetic field detecting means configured to detect changes in the magnetic field generated by the three-dimensional magnetic field generating means;
-Displacement detecting means configured to measure the relative displacement or movement of the drug delivery device, and-an integrated control unit that captures information received from both the magnetic field detecting means and the displacement detecting means. An integrated control unit for processing comprises an integrated control unit coupled to a magnetic field detecting means and a displacement detecting means.
A three-dimensional magnetic field generating means is configured to generate a rotational coaxial displacement around the longitudinal axis of the drug delivery system and optionally along the longitudinal axis of the drug delivery system;
-Magnetic field detecting means are installed along the longitudinal axis; and -three-dimensional magnetic field generating means are detachably installed at or near the proximal tip of the body of the drug delivery device.

According to another embodiment of the dose control system of the present invention, the dose control system is detachably attached to the outer peripheral surface of the injectable drug delivery device.

According to yet another embodiment of the dose control system of the present invention, the drug delivery device comprises a dose selector shaft and a three-dimensional magnetic field generating means is around the dose selector shaft at its proximal tip. ,It is attached.

In yet another embodiment of the invention, the dose selector shaft is configured to cause displacement of the three-dimensional magnetic field generating means with respect to the drug delivery device, whereby the three-dimensional magnetic field generating means is displaced from the body of the drug delivery device. It is configured to move away proximally and distally towards the body of the drug delivery device.

In another embodiment of the invention, the magnetic field detecting means and the displacement detecting means are detachably attached to the body of the drug delivery device.

In yet another embodiment of the dosage control system according to the invention, the magnetic field detecting means and the displacement detecting means are detachably attached to the body of the drug delivery device, substantially at its distal tip.

In yet another embodiment of the invention, the magnetic field detecting means is further configured to detect the earth's magnetic field (EMF).

In another embodiment of the invention, the magnetic field detecting means comprises at least one magnetometer.

According to another embodiment of the invention, the magnetic field detecting means comprises at least two magnetometers.

In yet another embodiment of the invention, the magnetic field detecting means comprises at least a first magnetic field meter and a second magnetic field meter so that the first magnetic field meter and the second magnetic field meter operate in parallel. Both magnetic field meters simultaneously detect changes in the magnetic field as they are configured and the three-dimensional magnetic field generating means are displaced proximally away from them or distally towards them.

According to yet another embodiment, the magnetic field detecting means comprises at least a first magnetic field meter and a second magnetic field meter, and the first magnetic field meter and the second magnetic field meter are configured to operate sequentially. , Thereby, when the three-dimensional magnetic field generating means are displaced proximally away from them or distally towards them, the first magnetic field meter detects a given value of the magnetic field. Up to, the change in the magnetic field is detected, and then the second magnetic field meter is operated to detect the change in the magnetic field exceeding the predetermined value.

In yet another embodiment of the invention, the displacement detecting means comprises at least one accelerometer, the at least one accelerometer.
-Relative movement of acceleration caused by vibration of the dose selector shaft; and / or-is configured to detect the movement of the drug delivery device between the injection and purge positions.

In a further embodiment of the invention, the dosage control system further comprises a communication means, which allows communication of information from an integrated control unit with a remote and / or local data processing system. It is configured to do.

In yet another embodiment of the invention, the remote and / or local data processing system includes a smartphone application.

In yet another embodiment of the invention, the dosage control system further comprises a unique identifier, the unique identifier being transmitted to a remote and / or local data processing system.

In another embodiment of the invention, the dosage control system further comprises temperature detecting means.

In another embodiment of the invention, the dosage control system further comprises a time determining means.

In a further embodiment of the invention, the dosage control system further comprises an autonomous power source.

In yet another embodiment of the invention, the dosage control system is configured so that it does not interfere with or modify the use of the drug delivery system when compared to off-the-shelf injectable drug delivery devices. Will be done.

In yet another embodiment of the invention, the magnetic field detecting means, the displacement detecting means, the integrated control unit, the autonomous power supply means, and the communication means are all detachably attached to the first. Installed within the housing, the first detachable housing is configured to be detachably attached to the body of the injectable drug delivery device and wrap around the body of the injectable drug delivery device. The three-dimensional magnetic field generating means is installed in a second housing, the second housing is detachably attached to the dose selector shaft of the body of the injectable drug delivery device, and the injectable drug. It is configured to surround the dose selector shaft of the body of the delivery device.

In yet another embodiment of the invention, a method for improving treatment compliance in an injectable drug dosing regimen is provided, said method.
-A step of providing a dosage control system detachably attached to the outer peripheral surface of an injectable drug delivery device, wherein the injectable drug delivery device is held by a substantially elongated drug delivery body, body. Including at least one injectable drug, body with distal and proximal tips;
-The step of determining the dose set by the user through the operation of the dose control system; and-The step of determining the operational status of the drug delivery device;
-Contains the step of relaying the information obtained from the dose determination or the action status determination to a remote and / or local data processing system.

In yet another embodiment, methods for improving treatment compliance in injectable drug dosing regimens are provided.
-Additional steps to verify the actual injectable dose of injectable drug.

In yet another embodiment, a method for improving treatment compliance in an injectable drug dosing regimen comprises determining a user-configured dose, said determination.
-A step of rotating a 3D magnetic field generating means detachably attached to a dose selector shaft around the longitudinal axis of the body of the drug delivery device;
-Detect changes in magnetic fields generated in at least two orthogonal dimensions, preferably three orthogonal dimensions (x, y, z) via magnetic field detection means detachably attached to the body of the drug delivery device. Steps to do;
-A step that correlates the change in the magnetic field detected by the magnetic field detecting means with the angular position of the rotated three-dimensional magnetic field generating means through the integrated control unit;
-Performed by the step of correlating the angular position with the corresponding dose.

In another embodiment of a method for improving treatment compliance in an injectable drug dosing regimen, determining the operational status of a drug delivery device comprises one or more of the following steps:
-The step of detecting the position movement of the drug delivery device via a displacement detecting means detachably attached to the body of the drug delivery device to determine whether the device is in the purge position or the injection position;
-The step of detecting the temperature of the drug held by the body of the drug delivery device via temperature sensing means and determining if the temperature is within the acceptable operating limits for administration of the drug;
-The step of detecting the level of autonomous power supply; and-The step of detecting whether the dose control system is in a dormant or awake state.

In yet another embodiment of the method for improving treatment compliance in an injectable drug dosing regimen, verification of the actual injectable dose of the injectable drug
-Verification of the dose setting is a step of detecting via a displacement detecting means detachably attached to the body of the drug delivery device, said verification being a user click at the distal tip of the dose selector shaft. Steps caused by actions;
-The step of measuring the elapsed time between the user's click action and the actual injection of the drug;
-The elapsed time between the user's click action and the time at which the actual injection occurs is correlated with the acceptable set of memorized values, and the selected dose is the actual injection of the injectable drug. It is done by the step of verifying as a dose.

In yet another embodiment, methods are further defined to improve treatment compliance in the dosing regimen of injectable drugs, where user-configured dose determinations are detachably attached to the dose selector shaft. In the step of rotating the three-dimensional magnetic field generating means around the longitudinal axis of the body of the drug delivery device, each rotational movement produces a series of one or more audible clicks, and each rotational click is also , Produce vibrations and corresponding relative displacement movements in the device, steps;
-Relative displacement movement in the device generated by each rotating click is performed by a step detected by the displacement detecting means.

In another embodiment of the method for improving treatment compliance in an injectable drug dosing regimen, each rotational click of the dose selector shaft corresponds to the rotational displacement of the magnetic field generating means around the longitudinal axis of the device. To do.

In yet another embodiment of the method for improving treatment compliance in an injectable drug dosing regimen, the displacement detecting means has the maximum resolution included in 1 Hz to 2 KHz.

In yet a further embodiment of the method for improving treatment compliance in an injectable drug dosing regimen, displacement detecting means are configured to detect acceleration displacements of about 0.5 G to about 16 G.

In another embodiment of the method for improving treatment compliance in an injectable drug dosing regimen, magnetic field detection means are configured to detect changes in the magnetic field from about 0.5 gauss to about 32 gauss. ..

As described in various embodiments of the invention, the dosage control system includes means for generating a three-dimensional magnetic field. The magnetic field generating means generates a magnetic field extending over three axes perpendicular to each other, x, y and z. As can be seen in the detailed description of the invention, this three-dimensional magnetic field is used to calculate the angular rotation position in the dose control system of the magnetic field generating means in relation to the longitudinal axis of the body of the injectable drug delivery device. Once used and its angular rotation position is known, the corresponding dose is calculated.

In the present invention, various means for generating a magnetic field can be used, such as classical magnets, electromagnets, mixed material magnets, etc., all of which are generally known in the art. .. Such magnets are typically magnetic or paramagnetic (whether this is natural or electrical or other exciting currents cross or affect the material to generate a magnetic field in the material. Or made from a magnetically magnetized material with (whether inducing or not). Suitable materials can be appropriately selected from the following.
-Ferrite magnets, especially sintered ferrite magnets containing crystalline compounds of iron, oxygen and strontium, for example.
-A composite material consisting of a thermoplastic matrix and isotropic neodymium-iron-boron powder.
-A composite material composed of a thermoplastic matrix and a strontium-based hard ferrite powder, the resulting magnet of which is isotropic, i.e. unoriented, or anisotropic, i.e. oriented, ferrite. A composite material that can contain particles.
-Composite material made of thermosetting matrix and isotropic neodymium-iron-boron powder.
-For example, a magnetic elastomer mixed with synthetic rubber or PVC and subsequently produced with a strongly charged strontium ferrite powder that has been extruded into the desired shape or calendared into a fine sheet.
-Flexible calendar-molded composite (which generally has the appearance of a brown sheet and is more or less flexible depending on its thickness and its composition). These composites are by no means elastic like rubber and tend to have a shore hardness in the range of 60-65 shore D ANSI. Such composites are generally formed from synthetic elastomers charged with strontium ferrite granules. The resulting magnet can be anisotropic or isotropic, and the variety of sheets generally has magnetic particle alignment due to calendering.
-A laminated composite material, generally comprising a flexible composite material as described above, laminated with a soft iron plate.
-Neodymium-Iron-Boron magnet.
Magnetized steel made of -aluminum-nickel-cobalt alloy.
-Alloy of samarium and cobalt.

Of the above list of magnetic field generating means, those containing a polymer matrix, such as a thermal polymer matrix, and the magnetic or magnetically magnetized particles embedded therein, can be injection molded into a variety of desired configurations and are suitable. It has been found to give particularly good results because it can provide a strong magnetic field, which is a magnet for the present invention that produces a magnetic field of about 0.5 gauss to about 32 gauss. These products are also commonly known as plast magnets, and a variety of plast magnets are available from Arelek (France).

As can be seen from the detailed description given below, the three-dimensional magnetic field generating means has a substantially annular shape. It is understood that the phrase "substantially annular shape" defines a general ring shape in which the magnetic field generating means can be circular, elliptical, or any more suitable polygonal shape. Should be. In some examples, the magnetic field generating means has at least one pair of opposing magnetic poles, respectively, eg, arched, quarter spherical, or hemispherical, one or more separate or non-spherical magnetic field generating materials. It can consist of continuous segments. However, it is preferable that the three-dimensional magnetic field generating means in the shape of a substantially annular ring is made of a single block of magnetic or magnetically magnetic material, and a multipolar block of the magnetic field generating means can be provided. In the three-dimensional magnetic field generating means, it is preferable to have only two magnetic poles (one having the opposite polarity to the other).

The three-dimensional magnetic field generating means of the present invention is configured to generate a rotational coaxial displacement around the longitudinal axis of the drug delivery system and optionally along the longitudinal axis of the drug delivery system. This rotational displacement coincides with the rotational displacement of the dose selector shaft, which means that by rotating the magnetic field generating means around a longitudinal axis, the shaft rotates in the same direction, producing a click sound. means. In addition, as the dose to be injected is increased, as is generally applicable to drug delivery devices with such dose selector shafts, the magnetic field generating means is from the proximal tip of the body of the drug delivery device. It can be translated longitudinally with the dose selector shaft, i.e., proximally. Conversely, when the dose is reduced, the magnetic field generator rotates in the opposite direction and translates distally and longitudinally along the longitudinal axis of the device back towards the proximal tip of the device. can do. In another embodiment of the invention, the dose selector shaft is not configured to allow longitudinal translation. It is configured so that the dose selector shaft simply rotates about the longitudinal axis, defining the selected dose, whether this rotational movement is clockwise or counterclockwise. Means. This dosage control system can be adapted accordingly for such drug delivery devices.

In addition, the magnetic field generating means is sized to provide a magnetic field sufficient to be detected by the magnetic field detecting means, but adds an extra volume to the dosage control system, thereby according to the present invention. It is also sized so that it does not interfere with the user or use of the drug delivery device in normal operation when compared to a drug delivery device that does not have such a dosage control system.

In the dose control system according to the present invention, a magnetic field detecting means exists and is configured to detect at least a change in the magnetic field generated by the three-dimensional magnetic field generating means. In addition, the magnetic field detecting means can be configured to detect the Earth's magnetic field (EMF), which is always present on the earth and varies slightly from place to place. One of the reasons for including the detection of the earth's magnetic field is to be able to exclude the interference caused by the magnetic field and the changes detected in the magnetic field generated by the magnetic field generating means. Magnetic field sensing means were primarily used to measure changes in the magnetic field generated by the movement of magnetic field generating means and, as can be seen from the detailed description, were selected for administration via an injectable drug delivery device. It is used to calculate the angular rotation position of the magnetic field generating means for the purpose of determining the dose. Of course, there are other means suitable for detecting angular positions associated with rotational movement, such as potentiometers, coding wheels, and the like. However, especially with respect to the fact that the systems according to the invention are intended to be detachably attached to an injectable drug delivery device, such as a self-injector pen, and therefore cumbersome and bulky additional components are generally preferred. Both of the coding wheels are generally too bulky for a dose control system such as the dose control system according to the present invention.

Other means for detecting the magnetic field to determine the angle of rotation position are also known in the art. Reluctances, for example, are well-known means, some of which are used in prior art systems. Such magnetoresistors are often specified by their abbreviations, such as AMR, GMR, TMR sensors. Such abbreviations specify a physical mechanism by which these sensor components function. Giant magnetoresistance (GMR) is a quantum magnetoresistive effect observed in a thin film structure composed of alternating ferromagnetic and non-magnetic conductive layers. Anisotropic magnetoresistance, or AMR, is said to be present in materials in which the dependence of electrical resistance on the angle between the direction of current and the direction of magnetization is observed. Tunnel magnetoresistance (TMR) is the magnetoresistive effect that occurs in a magnetic tunnel junction (MTJ), which is a component consisting of two ferromagnetic materials separated by a thin insulator. Resistors that use these various properties are known in their own right. Although they can be used in this dose control system as a means for detecting the magnetic field and the displacement of the magnetic field generating means and / or the change in the magnetic field caused by the Earth's magnetic field, they correspond. The magnetic field generating means of equivalent dimensions and magnetic field strength is limited to a dose control system that is moved away from the GMR, AMR, or TMR sensor by about 25 mm or less. This is why most of the known prior art solutions always have their sensors and magnetic field generating means integrated within the body of the drug delivery device, grouped over a short distance. , Or all possible detectable and use of drug delivery devices, which can often have a maximum path length of up to 40 mm, covering the entire available distance of the piston length. It will explain why four or more reluctance sensors had to be provided to cover possible doses.

In light of the above, the dosage control system of the present invention preferably uses a magnetometer, such as at least one magnetometer, and more preferably at least two magnetometers. These magnetometers differ from GMR, AMR or TMR sensors in that they directly measure the magnetic field strength and its changes. A magnetic field meter measures a magnetic field in two main ways: a vector magnetic field meter measures the vector component of a magnetic field, and a total magnetic field magnetic field meter or a scalar magnetic field meter measures the magnitude of a vector magnetic field. Another type of magnetometer is an absolute magnetometer, which measures an absolute magnitude or vector magnetic field using the internal calibration of a magnetic sensor or known physical constants. Relative magnetometers measure magnitude or vector magnetic fields against a fixed but uncalibrated baseline, also called variometers, and are used to measure magnetic field fluctuations. A suitable and preferred magnetometer for use in the dosage control system according to the present invention is an ultra-low power, high performance 3-axis magnetometer (eg, LIS3MDL) available from STMicroelectronics. It is preferable that the magnetometer can detect the change of the magnetic field over the three vertical axes, but the change of the magnetic field is measured over only two of the three axes of the magnetic field generated by the three-dimensional magnetic field generating means. It is also assumed that it can be done. Devices such as the LIS3MDL can be configured to detect magnetic fields up to ± 4 / ± 8 / ± 12 / ± 16 gauss over full scale. However, it may also be useful and advantageous to use a magnetometer capable of detecting even higher magnetic fields, such as 32 gauss. Therefore, in the present invention, it is preferable that the magnetometer is configured to detect a magnetic field of about 0.5 gauss to about 32 gauss.

As mentioned above, the dosage control system of the present invention also includes displacement detecting means configured to measure the relative displacement or movement of the drug delivery device. Such displacement detecting means can typically use sound, for example, as a means of recording the movement of the dose selector shaft. This is because such dose selector shafts are often configured to make a clicking sound through a toothed cylinder. The toothed cylinder ratchets, for example, with respect to the inner wall or the corresponding recess or cavity of the inner wall that fits the tooth, and when rotated about the longitudinal axis of the drug delivery device, inside and outside the recess or cavity. Drives teeth and causes audible clicks. Thereby, the click sound facilitates any other visual cues that can be given to the user. Each click generally represents the angle of rotation of the shaft around the longitudinal axis, regardless of the direction of rotation, and corresponds to the dose selected. However, when the dose selector shaft was rotated very quickly, continuously clockwise and counterclockwise, or vice versa, which dose was selected by click audible cues alone. It becomes almost impossible to know. Therefore, the applicant has chosen to measure the vibration-induced movement of the dose selector shaft as it is rotated to generate one or more clicks. This is because vibration provides a detectable relative movement. These movements can be appropriately detected and measured by using a corresponding accelerometer, which corresponds to a slight acceleration and is a preferable means as the displacement detecting means of the present invention. Because they can be configured to detect acceleration movements along three vertical axes, and an injectable product for the drug delivery device, corresponding to the normal use of the device. This is because the time between movements can be measured for comparison with a given standard set of acceleration movements at various stages of its use for administration. For example, when the drug delivery device is in a substantially horizontal position, or in a substantially vertical position, i.e. either a purge position or an injection position, the accelerometer delivers a substantially constant signal of low frequency vibrations. It can be detected and used as a baseline for the device. As soon as the dose selector shaft, or end button for preparing or injecting the syringe, is activated or rotated, the resulting vibrations are captured as high frequency spikes compared to the low frequency baseline. Will be done. These high frequency vibrations can be sampled and analyzed, and the results can then be used to determine which action was performed by the user. Although there are many different types of accelerometers on the market, applicants prefer low g 3-axis accelerometers, such as those available from STMicroelectronics under trade number LIS331DLH. In addition, such accelerometers also advantageously include means for determining temperature. That is, they have a built-in temperature sensor. The built-in temperature sensor can help determine if the drug product contained in the drug delivery device has been exposed to excessive temperatures that may make the use of the drug product unsafe. .. It has been found to be particularly advantageous if the displacement detecting means are installed as close as possible to the source of vibration emitted by the device.

As also shown in the previous paragraph, the magnetic field detection means is installed along the longitudinal axis of the injectable drug delivery device. In this way, by arranging the various detection means along their longitudinal axis, it is possible to reduce the overall volume of the dose control system. A further advantage is that the axial alignment avoids potential distortion of the magnetic field. Potential distortion of the magnetic field can be found if the magnetic field detecting means is installed, for example, perpendicular to or at an angle to the longitudinal axis, which interferes with the measurement or otherwise. It would require more complex calculations to take into account any such distortion.

The interaction between the displacement detecting means, the magnetic field detecting means and the magnetic field generating means is one of the interesting combinations of features of the present invention.

The dosage control system also advantageously integrates control linked to the magnetic field detecting means and to the displacement detecting means to process the information received from both the magnetic field detecting means and the displacement detecting means. Includes units. The integrated control unit can be mounted, for example, on a printed circuit board of appropriately reduced dimensions, eg, approximately 45 mm long x 15 mm wide and 1.5 mm deep. The integrated control unit handles all telecommunications and signaling between the different electronic components of the dosage control system. It also allows the execution of dose management systems and the calculation and determination of the exact location of magnetic field generation means, as well as movement detection means, autonomous power means, communication means (which, for example, on a smartphone). Is involved in the processing of signals from local or remote data processing systems). It can be remotely programmed for first use, or receive information and updates, as well as other electronic devices today, including integrated control units. Such integrated control units are known in their own right and often include central processing units, real-time clocks, one or more memory storage systems, and optionally communication systems or subsystems. Integrate with the desired component.

The dosage control system of the present invention is not only detachably attached to the body of the drug delivery device, but also provides accurate detection of changes in angular position due to subtle changes in the magnetic field, thereby providing accurate detection. It breaks away from past solutions in that it provides a dosage control system that can also calculate the corresponding selected dosage without having to place all of the components inside the body of the drug delivery device. is there. In fact, the dosage control system of the present invention is a variety of different drug delivery devices currently on the market (specifically, but not exclusively, and insulin self, which is currently wholesaled for patient self-medication. It has made it possible for the applicant to provide a detachable and attachable system that can be used with the syringe pen).

The present invention will be further described in the context of the accompanying figures. The accompanying figures are provided for exemplary and non-limiting purposes, exemplifying embodiments of the present invention.

FIG. 1 is a schematic diagram of an example of a dose control system according to the present invention.

FIG. 2 is a schematic flowchart of some functions of the system.

FIG. 3 is a schematic cross-sectional view of a dose control system according to the present invention attached to an injectable drug delivery device (in this case, an insulin self-injector pen).

FIG. 4 is a close-up schematic cross-sectional view of a detachably attachable dosage control system according to the invention, in a non-attached or "free" state.

<Detailed explanation>
Here, referring to FIG. 1, a schematic diagram of the components of the dose control system (1) according to the present invention is shown. Such a dosage control system includes, for example, an integrated control unit (2), which is, for example, a printed circuit board or equivalent (on top of which various components). Are mounted and interconnected). As is known, the integrated control unit (2) can also be composed of a circuit carved or etched in silicon or the like. In fact, as needed, virtually the entire dosage control system, as is generally known in the art, is a interconnected block of single or multiple silicon or other similar semiconductor material. Can be engraved in. The integrated control unit (2) includes a central processing unit (CPU, 3). The central processing unit (CPU, 3) is involved in the processing and management of signals and communications between various components of the system and is stored in the system or capable of operating remotely on the system. It is also involved in the calculation and execution of program code. The integrated control unit (2) also includes a real-time clock (RTC, 4) for maintaining and measuring time within the dosage control system. The real-time clock (RTC, 4) can also be integrated with the central processing unit (CPU, 3), for example, various in the system while the central processing unit (CPU, 3) is being fed energy. Use frequency measurements to calculate the time and time difference of events. Dosage control systems also include communication subsystems (COM, 5), such as low power consumption Bluetooth wireless devices. This communication subsystem allows the dosage control system to communicate with local or remote data processing systems (not shown). Local or remote data processing systems include, for example, smartphones and corresponding smartphone applications, which are used to provide information and feedback to users when using dose control systems. In addition, the system also has some form of memory storage device (MEM, 6) for storing information in the system, either transiently or permanently. Such information comes from a variety of sources, such as values or signals measured or determined from other endpoints of the system, values calculated or stored by a central processor (CPU, 3), remote or remote such as smartphones. There are values or data received from the local data processing system, factory settings for system calibration, unique identifier means or data that uniquely identify the device, and the like. Such a memory storage system (MEM, 6) is known to those skilled in the art.

With the integrated control unit (2) and its extensions, the central processing unit (CPU, 3) also communicates with at least one accelerometer (ACC, 7) and at least one magnetometer (MGR, 8). Accelerometers (ACC, 7) are involved in the detection and / or measurement of changes in relative movement due to acceleration of drug delivery devices. A dose control system is mounted on the drug delivery device at a horizontal to vertical position held by the user, or any position in between, with respect to a predetermined set of programmed reference positions. The accelerometer (ACC, 7) also sets the dose by the user via the dose selector shaft (this is the vibration of the drug delivery device, i.e. the relative acceleration detected by the accelerometer (ACC, 7)). It is also involved in the detection and / or measurement of changes in relative movement due to acceleration of the drug delivery device when (causing movement). The intensity and frequency of relative movement of acceleration transmitted from the accelerometer (ACC, 7) to the central processing unit (CPU, 3) is used to determine the type of motion performed by the user. Such relative movement of acceleration may include vibrations caused by clicks caused by the drug delivery device. For example, in the majority of self-injector drug delivery devices (eg pens) for self-injection of various drugs (eg insulin, ATP, etc.), these clicks provide the user with an audible signaling signal by the user. Although showing the various actions taken, this click also produces vibrations within the drug delivery device that can be properly picked up by the accelerometer.

The magnetometer (MGR, 8) is also connected to the central processing unit (CPU, 3). This component is involved in detecting changes in the magnetic field generated by the movement of a magnet (MAG, 9) that is in a movable distance from the magnetometer (MGR, 8). The magnetometer can detect changes in the magnetic field along a plurality of axes, such as one, two, three, or more axes, but can detect changes in the magnetic field along two or three axes. preferable. Normally, these axes are perpendicular to each other to provide a three-dimensional magnetic field detection zone. At least one, and preferably two, magnetometers are installed so that the corresponding change in magnetic field as the magnet (MAG, 8) is displaced can be detected. Since the drug delivery device to which the dosage control system is attached has a longitudinal axis, it is preferred that at least one magnetometer (MGR, 7) is also installed along the longitudinal axis. In a preferred embodiment, the system comprises two magnetometers, which are axially aligned and installed along the longitudinal axis of the drug delivery device when the dose control system is attached to the device. Will be done. This allows the dosage control system to remain small in size and size, which does not negatively affect or interfere with the normal habitual operation of the drug delivery device by the user. .. Magnetometers also include the Earth's magnetic field, and its changes, because the Earth's magnetic field and its changes can affect the measurements made by the magnetometer (MGR, 7) with respect to the magnetic field generating means of the dose control system. It is also well configured to detect any changes that may occur when the user travels with the drug delivery device.

Magnetic field generation means in this exemplary device include magnets (MAG, 9). In one particularly preferred embodiment, the magnet creates a three-dimensional magnetic field along three vertically arranged axes (x, y, z). As mentioned above, the magnetometer (MGR, 7) has a magnet (MAG, 9) proximal away from the proximal tip of the drug delivery device, or distal towards the proximal tip of the drug delivery device. Detects changes in the magnetic field generated by the magnet (MAG, 9) when displaced. The detection of this magnetic field change is performed without forming electrical, electronic or physical contact between the magnetometer (MGR, 7) and the magnet (MAG, 9), and the dose control system as a non-contact system. Will lead to the specification. The magnet preferably has a substantially annular shape with a central hole and can be made of any suitable magnetic or magnetically charged material. Details of these materials are described elsewhere herein. Therefore, a magnet (MAG, 9) can be attached to the dose selector shaft of the drug delivery device. The dose selector shaft is aligned with the longitudinal axis of both the drug delivery device and the magnetometer along the longitudinal axis. The dose selector shaft is approximately rod-shaped. As such, a substantially annular magnet can be slid back and forth on the shaft to generate a three-dimensional magnetic field around the proximal tip of the drug delivery device. The magnet is detachably attached to the dose selector shaft so that it can impart rotational movement to the shaft when rotated by the user. Rotation can occur in both clockwise and counterclockwise directions. The magnet has two counterpoles, each of which substantially constitutes a half or hemispherical portion of the annular magnet. As the magnet rotates, these counterpoles also rotate around the longitudinal axis of the device. A first reference point of known magnetic field strength along one, two or three axes is detected by a magnetometer and this information is sent to the dose control system, eg, to the memory (MEM, 6), to the central processing unit ( It is stored via the CPU and 3). In general, this first position will correspond to the position of the magnet (MAG, 9) closest to the proximal tip of the drug delivery device, and the dose selector shaft will go beyond that position and further in a predetermined direction. Cannot rotate. When the user rotates the magnet (MAG, 9) in the permissible direction of rotation and the rotational movement of the dose selector shaft is indexed correspondingly, the magnet and the proximal tip of the dose selector shaft are charged with the drug. It travels proximally away from the proximal tip of the body of the delivery device, but generally along the longitudinal axis of the device. As the magnet (MAG, 9) rotates around the longitudinal axis and translates along it, changes in magnetic field and polarity are detected by a properly placed magnetometer (MGR, 8). The fluctuation of the magnetic field can be decomposed into mathematical components including vectors and coefficients by the central processing device (CPU, 3), from which the angular position of rotation is calculated and the magnet of the magnet with respect to the magnetometer (MGR, 8). The angular position and distance can be determined very accurately. These positions correlate with the dose selected or selectable by the user in the look-up table. This look-up table is preferably stored in the system or, instead, in a remote data processing unit (eg, a smartphone). Here, the maximum and minimum distances of movement and rotation of the magnet (MAG, 9) along the longitudinal axis correspond to the maximum and minimum doses allowed by the drug delivery device. In this way, the dosage control system does not interfere with or alter the normal use of the drug delivery device, at any predetermined rotation and translational movement point of the magnet (MAG, 9), the administration selected by the user. An accurate display of the quantity can be presented to the user. In the exemplary dosage control system of the present invention, the magnetometer is configured to be capable of detecting a magnetic field of ± 4 gauss to ± 16 gauss, with a sensitivity or resolution of approximately 6842 LSB / gauss at ± 4 gauss. ± 16 gauss is about 1711 LSB / gauss. This means that the dose control system preferably has a resolution capable of detecting changes in the magnetic field corresponding to the angular rotation of the 0.9 ° magnet around the longitudinal axis and the dose selector shaft. To do. However, as mentioned above, the resolution and sensitivity of the various components can be configured to accommodate any drug delivery device that functions similarly via a rotatable dose selector shaft.

The power supply (POW, 10) is also shown in FIG. This is generally a portable, autonomous power source, such as one or more batteries, or a rechargeable power device, which is sufficient for the entire system, for example, even when the device is not directly operated. It can supply power. The integrated control unit (2) can additionally include a power management unit. This power management unit regulates the power supply voltage to the system including various components in order to maximize the life of the autonomous power supply. The power supply can also communicate with a user-operated wake-up button (WAK, 11), which allows the user to wake up the dosage control system from hibernation or sleep.

Dosage control systems can also further include light emitting signals (LIGHT, 12), such as LEDs. This emission signal indicates the status of the device according to the detected event or condition and is controlled by the central processing unit (CPU, 3), for example, each color of green, red, blue and white emission is the dose. Corresponds to a particular state or condition of the control system.

In a further embodiment, the dosage control system can also include an alarm (ALA, 13) system that communicates with a central processing unit (CPU, 3). The alarm system can be configured to raise an audible alarm, for example, in the event of a system malfunction, or in the event of an injection failure, or for any other suitable condition or event detected within the system. ..

FIG. 2 is a schematic block diagram of the function of the dose control system according to the present invention. In the first step, when the click generates a vibration picked up by the accelerometer (ACC, 7), the accelerometer detects the wheel click on the rotary dose selector shaft (14). Next, the magnetic field value (15) detected by the magnetometer (MGR, 8) of the magnet (MAG, 9) rotating at the same time as the dose selector shaft is read into the central processing unit (CPU, 3). Next, the angle and coefficient of the magnetic field are calculated by the central processing unit (CPU, 3) (16). These values are correlated or compared with a predetermined set of values pre-programmed into the dose control system (17). Finally, the selected dose determination (18) is made. These steps are repeated as needed each time the user rotates the dose selector shaft around the longitudinal axis. When the user decides which dose he or she wants to inject, the click caused by the user pressing the end button of the proximally placed syringe causes vibration and movement of the corresponding acceleration within the drug delivery device. Causes and is recorded by the accelerometer. The frequency, or interval, between each end button click is used to determine if the syringe button click is compared to a known list of predetermined acceleration movements, and the end button click is intentional. Determine if it was or was the result of accidental activation of the end button or movement in the drug delivery device. If the movement and frequency of the acceleration correspond to a situation in which the dose is deliberately selected and perceived as ready for injection, this dose is recorded in the system, eg in memory, and said event. Is transmitted to the data processing unit (for example, a smartphone application) via the communication means together with the time when the is generated. In this way, the smartphone application can process this information and provide it to the user in the form of tracking or compliance information.

FIG. 3 is a schematic cross-sectional view of a dosage control system attached to an injectable drug delivery device, commonly shown at reference number 20. The injectable drug delivery device (20) is generally a substantially elongated drug delivery body (21) having a longitudinal axis (25), at least one injectable drug usually held in a cartridge by the body (21). (Not shown), includes a body (21) with a distal tip (23) and a proximal tip (22), and an outer peripheral surface (24). In FIG. 3, a pen cap is similar to the distal tip (23) to cover the otherwise exposed needle and prevent the user from accidentally stabbing or otherwise injuring himself. Cap (26) is provided. The drug delivery device further includes, at the proximal tip (22), a dose selector shaft (27) connected to a dose selector wheel (28) that is rotatable about a longitudinal axis, and an end button. The user can press the end button to equip the device, thereby verifying the selected dose and injecting the drug via conventional, known methods and means. This type of drug delivery device is similar to the majority of drug delivery devices known to those of skill in the art.

The dosage control system is shown in FIG. 3 with general reference number 30. As is apparent from FIG. 3, the dosage control system (30) is substantially located at the proximal tip of the drug delivery device (20) and is located on and around the outer peripheral surface (24) of the body of the device. Will be done. In this particular example, the central processing unit (CPU, 3), real-time clock (RTC, 4), storage device memory (MEM, 6) and communication subsystem or communication means (COM, 5) are on the printed circuit board. It forms an integrated control unit (2) that is installed and wrapped within a polymer resin block (31). In this example and in FIGS. 3 and 4, the dosage control system has an autonomous power source (POW, 10), which is shown as two batteries (32, 33), such as a lithium ion battery. The dosage control system further includes a magnetic field generating means (MAG, 9), which is shown in FIG. 3 as a substantially annular shaped object placed at the proximal tip (22) of the device. Proximal to the tip (22), the magnet (MAG, 9) is detachably attached to the dose selector wheel (28). The dose selector wheel (28) is connected to the dose selector shaft. The magnet (MAG, 9) is such that the wheel (28), shaft (27) and magnet (MAG, 9) can be rotated around the longitudinal axis (25) of the drug delivery device (20). Displaced to rotate around an axis, and by axis, proximally away from the proximal tip of the body (21) of the drug delivery device (20), or, in alternative, of the drug delivery device (20). Translational movement is triggered towards the proximal tip of the body (21), i.e. distally. The maximum distance of linear movement of the wheel (28), shaft (27) and magnet (MAG, 9) generally corresponds substantially to the maximum permissible dose that can be injected, and therefore the drug, it. Corresponds to the maximum distance of movement of the piston, which is usually provided to eject from the cartridge in which the is held. As an example, the location closest to the proximal tip of the body of the drug delivery device will correspond to either no dose or minimum dose. The wheel (28), shaft (27) and magnet (MAG, 9) are prevented from rotating in a direction that would bring the magnet closer to the proximal tip (22) of the body (21). However, in the opposite direction, i.e. proximally, the wheels (28), shafts and magnets are allowed by, for example, the configuration of the system, and the number of times the user corresponds to the maximum dose that can be injected. It can be rotated by rotating the 9) and the wheel (28) with a finger. When the magnet and wheel rotate, the shaft also rotates, producing an audible click sound. This audible click corresponds to the movement of the acceleration, which is transmitted through the body of the device and detected by the accelerometer (7). The rotation and longitudinal displacement of the movement of the magnet (MAG, 9) causes a change in the generated magnetic field, which is detected by a magnetometer (34, 35). The values detected by the magnetometers (34, 35) are transmitted to the central processing unit (CPU, 3) to determine the angular positions of the magnets (MAG, 9) and wheels (28) on the dose selector shaft (27). Used to calculate, thereby determining the dose selected by the user. The preparation of the syringe system by the user pressing the end button (29), which also results in an audible click and a linear movement of the corresponding acceleration along the longitudinal axis of the device (20), is ready for the accelerometer (7). ). The central processing unit (CPU, 3) calculates the frequencies generated and the number of clicks and compares them to the values stored in the look-up table to see if the device is effectively prepared for injection. Decide whether or not. Then, when the central processing unit determines that such a case applies, the calculated dose value obtained from the change in magnetic field is stored in memory (MEM, 6) for injection. Validated as the dose of choice. This value is then transmitted to the smartphone application via the communication means (COM, 5).

The magnetic field detector can be configured to function in a variety of ways. For example, in a continuous configuration of magnetometers, i.e., when the magnetometers are axially aligned along the longitudinal axis in a spaced relationship, and the magnets (MAG, 9) are the body of the drug delivery device. When closest to the proximal tip of (21), the force of the magnetic field generated by the magnet may exceed the upper limit of the magnetometer (8a) closest to the magnet. In such cases, the magnetometer (8a) is considered "saturated". At this point, it is not necessary to take into account any value detected by the second magnetometer (8b). This is because the saturation of the first proximal magnetometer (8a) allows for a complete decomposition of the angular moments and coefficients as the magnet rotates about its longitudinal axis. If the dose selector shaft is also designed to cause lateral displacement along the longitudinal axis, proximally and away from the proximal tip, the magnet will also move proximally. The saturation of the first proximal magnetometer (8a) is also reduced. Upon reaching a given level of magnetic field, the system is configured to operate a second, more distal magnetometer (8b), so using both magnetometers (8a, 8b), the earth. Skillfully detect smaller changes in magnetic field and angular moments, including taking into account any effects due to its own magnetic field, which is generally 0.25 to 0.65 gauss on the surface of the earth. can do. In a similar and vice versa manner, when the dose selector shaft and magnet move distally back towards the proximal tip of the body of the device, a second higher level of magnetic field is detected. The more distal magnetometer (8b) can be automatically switched off. On the other hand, in an alternative parallel configuration, both magnetometers (8a, 8b), which are stationary and aligned along the longitudinal axis of the drug delivery device, are both all of the magnet displacement. It is operational over and all magnetic field changes are detected by both magnetometers (8a, 8b).

FIG. 4 is a schematic cross-sectional view of a housing suitable for containing the dosage control system of the present invention, which allows the dose control system to be attached to an injectable drug delivery device as is currently known. It shows one of the methods. For similar elements of the dosage control system, the reference numbers remain the same between FIGS. 3 and 4. The housings (35a, 35b) are designed to wrap and surround the drug delivery device (20) around its longitudinal axis (25) along the outer peripheral surface (24) of the device (20). In addition, it sits on and off. The housing is designed to snap or push fit into the device (20) and preferably includes at least two mating components. The mating components engage with each other and wrap the device along its body (21), along its longitudinal axis (25), at its proximal tip (22). The housing (35a, 35b) further includes a gripping facilitation means, eg, a compressible elastomer zone (36a, 36b), which is located on the inner wall of the housing. This grip facilitating means facilitates and increases grip of the housing, including the dosage system, on the outer peripheral surface (24) of the body (21) of the drug delivery device (20) to provide a snug fit. .. This fit is when the housing should be removed (eg, if the drug delivery device is malfunctioning or the cartridge is empty, or very simply, the dosage control system is another drug delivery device (20). ), Preventing the housings (35a, 35b) from moving relative to the body of the drug delivery device. The housing is preferably designed to be snap-fitted so that it can be removed according to a set of predetermined steps. Here, each part (35a, 35b) of the housing is sequentially removed without destroying or damaging the dose control system (30) or drug delivery device (20) contained therein. The compressible elastomer zones (36a, 36b) can further include compression-enhancing ridges or depressions (37a, 37b). That is, the elastomers are spaced apart along the length and width of the zones (36a, 36b) in order to increase or decrease the grip of the housings (35a, 35b) on the outer peripheral surface (24) of the device (20). Material is added or removed. The housings (35a, 35b) also provide a window (39) that allows the user to see an analog or digital display of the selected dose. It is generally installed and displayed on the outer peripheral surface (24) of the body (21) of the drug delivery device (20). The dose control system, including the magnetic field generating means (MAG, 9), is mounted on the wheel (28) and housed in a separate housing (38) that fits snugly. The magnet housing (38), like the housings (35a, 35b) of other components of the dose control system, can be detachably snap-fitted or pushed into the wheel (28) of the dose selector shaft (27). It may also preferably include a zone of elastomeric material that allows the easy-to-grip means, for example, the magnet housing (38) to surround and envelop the wheel (28).

Claims (30)

A dosage control system suitable for injectable drug delivery devices,
The drug delivery device comprises a substantially elongated drug delivery body, at least one injectable drug held by the body, and the body having distal and proximal tips.
The dose control system
-Three-dimensional magnetic field generation means for generating a magnetic field along the three axes (x, y, z);
-At least, a magnetic field detecting means configured to detect a change in the magnetic field generated by the three-dimensional magnetic field generating means;
-Displacement detecting means configured to measure the relative displacement or movement of the drug delivery device, and-an integrated control unit received from both the magnetic field detecting means and the displacement detecting means. The integrated control unit comprises an integrated control unit coupled to the magnetic field detecting means and to the displacement detecting means in order to process the information.
-The three-dimensional magnetic field generating means is configured to generate a rotational coaxial displacement around and along the longitudinal axis of the drug delivery system;
-The magnetic field detecting means is installed along the longitudinal axis; and-The three-dimensional magnetic field generating means is installed at or near the proximal tip of the body of the drug delivery device.
Dosage control system. The dose control system according to claim 1, wherein the dose control system is detachably attached to the outer peripheral surface of the injectable drug delivery device. The administration according to claim 1 or 2, wherein the drug delivery device comprises a dose selector shaft and the three-dimensional magnetic field generating means is mounted around the dose selector shaft at its proximal tip. Quantity control system. The dose selector shaft is configured to cause displacement of the three-dimensional magnetic field generating means with respect to the drug delivering device, whereby the three-dimensional magnetic field generating means is proximally away from the body of the drug delivering device. The dose control system according to any one of claims 1 to 3, which is configured to move distally toward the body of the drug delivery device. The dose control system according to any one of claims 1 to 4, wherein the magnetic field detecting means and the displacement detecting means are detachably attached to the main body of the drug delivery device. The dose according to any one of claims 1 to 5, wherein the magnetic field detecting means and the displacement detecting means are detachably attached to the main body of the drug delivery device at a substantially distal tip thereof. Control system. The dose control system according to any one of claims 1 to 6, wherein the magnetic field detecting means is further configured to detect the earth's magnetic field (EMF). The dose control system according to any one of claims 1 to 7, wherein the magnetic field detecting means includes at least one magnetometer. The dose control system according to any one of claims 1 to 8, wherein the magnetic field detecting means includes at least two magnetometers. The magnetic field detecting means includes at least a first magnetic field meter and a second magnetic field meter, and the first magnetic field meter and the second magnetic field meter are configured to operate in parallel, and the three-dimensional magnetic field. Any one of claims 1-9, both magnetometers simultaneously detect changes in the magnetic field when the generating means are displaced proximally away from them or distally towards them. Dosage control system according to. The magnetic field detecting means includes at least a first magnetic field meter and a second magnetic field meter, and the first magnetic field meter and the second magnetic field meter are configured to operate in sequence, whereby the above 3 When the dimensional magnetic field generating means are displaced proximally away from them or distally towards them, the magnetic fields of the magnetic field until the first magnetic field meter detects a predetermined value of the magnetic field. The dosage control system according to any one of claims 1 to 9, wherein the second magnetic field meter is then operated to detect a change and then to detect a change in a magnetic field that exceeds the predetermined value. The displacement detecting means includes at least one accelerometer.
The at least one accelerometer
-The relative movement of acceleration caused by the vibration of the dose selector shaft; and / or-configured to detect the position movement of the drug delivery device between the injection position and the purge position.
The dose control system according to any one of claims 1 to 11. The dosage control system further comprises a communication means, the communication means being configured to allow communication of information from the integrated control unit with a remote and / or local data processing system. , The dose control system according to any one of claims 1 to 12. The dose control system according to any one of claims 1 to 13, wherein the remote and / or local data processing system includes a smartphone application. The dose control system according to any one of claims 1 to 14, wherein the dose control system further includes a unique identifier, the unique identifier being transmitted to the remote and / or local data processing system. The dose control system according to any one of claims 1 to 15, wherein the dose control system further includes a temperature detecting means. The dose control system according to any one of claims 1 to 16, wherein the dose control system further includes a time determining means. The dose control system according to any one of claims 1 to 17, wherein the dose control system further includes an autonomous power supply means. The dose according to claim 1, wherein the dose control system is configured so that it does not interfere with or modify the use of the drug delivery system when compared to a ready-made injectable drug delivery device. Control system. The magnetic field detecting means, the displacement detecting means, the integrated control unit, the autonomous power supply means, and the communication means are all installed in a first detachable housing, and the first detachable housing is installed. A detachable housing is configured to be detachably attached to the body of the injectable drug delivery device and wrap around the body of the injectable drug delivery device.
The three-dimensional magnetic field generating means is installed in a second housing, the second housing being detachably attached to the dose selector shaft of the body of the injectable drug delivery device and injectable. It is configured to surround the dose selector shaft of the body of the drug delivery device.
The dose control system according to any one of claims 1 to 19. A method for improving treatment compliance in injectable drug dosing regimens,
The above method
-A step of providing a dosage control system detachably attached to the outer peripheral surface of an injectable drug delivery device, wherein the injectable drug delivery device is substantially elongated by the drug delivery body, said body. A step comprising at least one injectable drug retained, said body having distal and proximal tips;
-A step of determining the dose set by the user through the operation of the dose control system; and-A step of determining the operational status of the drug delivery device;
-A method comprising relaying information obtained from the dosage determination or the behavioral status determination to a remote and / or local data processing system. The above method
-Additional steps to verify the actual injectable dose of injectable drug,
A method for improving treatment compliance in the dosing regimen of an injectable drug according to claim 21. User-set dose determination
-A step of rotating a three-dimensional magnetic field generating means detachably attached to a dose selector shaft around the longitudinal axis of the body of the drug delivery device;
-Changes in the magnetic field generated in at least two orthogonal dimensions, preferably three orthogonal dimensions (x, y, z) via magnetic field detection means detachably attached to the body of the drug delivery device. Steps to detect;
-A step of correlating the change in the magnetic field detected by the magnetic field detecting means with the angular position of the rotated three-dimensional magnetic field generating means via an integrated control unit;
-Performed by the step of correlating the angular position with the corresponding dose,
A method for improving treatment compliance in the dosing regimen of an injectable drug according to claim 21 or 22. Determining the operational status of the drug delivery device enhances compliance with the procedure in the dosing regimen of the injectable drug according to any one of claims 21 to 23, comprising one or more of the following steps. The way for.
-Position movement of the drug delivery device is detected via displacement detecting means detachably attached to the body of the drug delivery device to determine whether the device is in the purge position or the injection position. Steps to decide;
-The temperature of the drug held by the body of the drug delivery device is detected via a temperature detecting means to determine if the temperature is within acceptable operating limits for administration of the drug. Step;
-Steps to detect the level of autonomous power; and-Steps to detect whether the dose control system is dormant or awake Verification of the actual injectable dose of injectable drug,
-Verification of the dose setting is a step of detecting via a displacement detecting means detachably attached to the body of the drug delivery device, wherein the verification is at the distal tip of the dose selector shaft. Steps caused by the user's click action;
-A step of measuring the elapsed time between the user's click action and the actual injection of the drug;
-The selected dose is an injectable drug, correlating the elapsed time between the user's click action and the time at which the actual injection occurs with an acceptable set of stored values. Performed by the step of verifying as the actual injection dose of
A method for improving treatment compliance in an injectable drug dosing regimen according to any one of claims 21-24. User-set dose determination
-A step of rotating the three-dimensional magnetic field generating means detachably attached to a dose selector shaft about the longitudinal axis of the body of the drug delivery device, where each rotational movement is a series of 1's or A step that generates multiple audible clicks, and each rotating click also produces vibrations and corresponding relative displacement movements in the device;
-The relative displacement movement in the device generated by each rotation click is performed by a step detected by the displacement detecting means.
A method for improving treatment compliance in an injectable drug dosing regimen according to any one of claims 21-25. A method for improving compliance with a procedure in an injectable drug dosing regimen according to claim 26, wherein each click corresponds to a rotational displacement of the magnetic field generating means around the longitudinal axis of the device. The method of any one of claims 21-27, wherein the displacement detecting means has a maximum resolution included in 1 Hz to 2 KHz, for improving compliance with the procedure in an injectable drug dosing regimen. Compliance with the procedures in the dosing regimen of an injectable drug according to any one of claims 21-28, wherein the displacement detecting means is configured to detect an acceleration displacement of about 0.5 G to about 16 G. How to improve. The dosing regimen of an injectable drug according to any one of claims 21-29, wherein the magnetic field detecting means is configured to detect a change in magnetic field of about 0.5 gauss to about 32 gauss. Methods for improving compliance with procedures.

Images