Patent Application
20220031957
The present disclosure relates to techniques for an electronic dose detection system for a medication delivery device, and in particular to techniques for detecting a connection to a medication delivery device, determining the type of medication delivery device, and monitoring battery life.
Patients suffering from various diseases must frequently inject themselves with medication. To allow a person to conveniently and accurately self-administer medicine, a variety of devices broadly known as pen injectors or injection pens have been developed. Generally, these pens are equipped with a cartridge including a piston and containing a multi-dose quantity of liquid medication. A drive member is movable forward to advance the piston in the cartridge to dispense the contained medication from an outlet at the distal cartridge end, typically through a needle. In disposable or prefilled pens, after a pen has been utilized to exhaust the supply of medication within the cartridge, a user discards the entire pen and begins using a new replacement pen. In reusable pens, after a pen has been utilized to exhaust the supply of medication within the cartridge, the pen is disassembled to allow replacement of the spent cartridge with a fresh cartridge, and then the pen is reassembled for its subsequent use.
Many pen injectors and other medication delivery devices utilize mechanical systems in which members rotate and/or translate relative to one another in a manner proportional to the dose delivered by operation of the device. Accordingly, the art has endeavored to provide reliable systems that accurately measure the relative movement of members of a medication delivery device in order to assess the dose delivered. Such systems may include a sensor which is secured to a first member of the medication delivery device, and which detects the relative movement of a sensed component secured to a second member of the device.
The administration of a proper amount of medication requires that the dose delivered by the medication delivery device be accurate. Many pen injectors and other medication delivery devices do not include the functionality to automatically detect and record the amount of medication delivered by the device during the injection event. In the absence of an automated system, a patient must manually keep track of the amount and time of each injection. Accordingly, there is a need for a device that is operable to automatically detect the dose delivered by the medication delivery device during an injection event. Further, there is a need for such a dose detection device to be removable and reusable with multiple delivery devices. In other embodiments, there is a need for such a dose detection device to be integral with the delivery device.
In one embodiment, what is disclosed are systems and methods configured to generate a light indication pattern for a dose detection system. For example, the system can include one or more light emitting diodes (LEDs), one or more batteries, and a processing circuit. The processing circuit may be configured to, or the method steps may, determine a use case type from a plurality of use case types for the dose detection system, determine a battery life status of the one or more batteries from a plurality of battery life status, and provide a light indication pattern via the one or more LEDs. The light indication pattern can include (i) a first light indication segment based on the determined use case type, and (ii) a second light indication segment based on the determined battery life status after a period of delay after completion of the first light indication segment.
In another embodiment, what is disclosed are systems and methods configured to reduce drainage of a battery for a dose detection system. For example, the system can include a power-on module switchable between an activated state and a deactivated state; a battery; a processing circuit. The processing circuit may be configured to, or the method steps may, increase power drawn from the battery by the system to an increased power state when the power-on module is switched from the deactivated state to the activated state; and measure how long the power-on module is continuously maintained in the activated state. If the power-on module is continuously in the activated state for a first period of time, reduce power drawn from the battery by the system to a low-power state. Subsequently. If the power-on module is continuously in the activated state for a second period of time in addition to the first period of time, increase power drawn from the battery by the system from the low-power state to the increased power state and generate an event, and store data indicative of the event into a memory of the dose detection system.
Additional embodiments of the disclosure, as well as features and advantages thereof, will become more apparent by reference to the description herein taken in conjunction with the accompanying drawings. The components in the figures are not necessarily to scale. Moreover, in the figures, like-referenced numerals designate corresponding parts throughout the different views.
For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended.
It is important to deliver the correct medication. A patient may need to select either a different medication, or a different form of a given medication, depending on the circumstances. If a mistake is made as to which medication is in the medication delivery device, then the patient will not be properly dosed, and records of dose administration will be inaccurate. The potential for this happening is substantially diminished if a dose detection device is used which automatically confirms the type of medication contained by the medication delivery device.
The present disclosure relates to sensing systems for medication delivery devices. In one aspect, the sensing system is for generating a single light indication pattern for a dose detection system. The inventors have discovered and appreciated that it can be desirable to have a light indication strategy when the dose detection system does not have a display, although the inventors recognize that the light indication strategy may still have advantages with a dose detection system having a display. However, the inventors have discovered and appreciated that given the various hardware, firmware and/or software desired to be included in such dose sensing systems, and a desire to keep the dose sensing system small, user friendly, and limited to only include components with a low likelihood of failure due to repeated use, it can be challenging to also incorporating additional components (e.g., switches, latches, and/or the like) to indicate to the user information when the dose sensing system is connected to a remote computing device or whether the injection was successful. The techniques described herein provide for leveraging existing components of the dose sensing device to determine whether the dose sensing device is coupled to a medication delivery device, whether the sensed element is moving, and how long the power-on module is activated to determine different use case types. For example, a dose sensing device can include sensors (such as Hall effect sensors) and related hardware and/or software to determine the size of a dose administered by the medication delivery device. The techniques can leverage such hardware and/or software used to perform dose detection to also determine whether (or not) the dose sensing system is coupled to a medication delivery device.
In a second aspect, the sensing system may be for reducing drainage from the battery of the sensing system. The inventors discovered and appreciated that when the power-on module is activated for long periods of time complete depletion of the battery may occur much sooner than expected. The inventors developed techniques to monitor the continuous activation of the power-on module to provide techniques to store events and/or communicate to a remote computing system that is configured to provide some indication to the user of this event. The term “event” used herein is defined to include any one or more of the following: (i) a processor interrupt, (ii) generation of an electrical signal propagated along a circuit, (iii) setting or unsetting of one or more bits in a register, (iv) changing the value of a programming variable.
By way of illustration, the medication delivery device is described in the form of a pen injector. However, the medication delivery device may be any device which is used to set and to deliver a dose of a medication, such as an infusion pump, bolus injector or an auto injector device. The medication may be any of a type that may be delivered by such a medication delivery device.
While various embodiments have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible. Accordingly, the embodiments described herein are examples, not the only possible embodiments and implementations. Furthermore, the advantages described above are not necessarily the only advantages, and it is not necessarily expected that all of the described advantages will be achieved with every embodiment.
Devices described herein, such as a device 10, may further comprise a medication, such as for example, within a reservoir or cartridge 20. In another embodiment, a system may comprise one or more devices including device 10 and a medication. The term “medication” refers to one or more therapeutic agents including but not limited to insulins, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies and any therapeutic agent that is capable of delivery by the above device. The medication as used in the device may be formulated with one or more excipients. The device is operated in a manner generally as described above by a patient, caregiver or healthcare professional to deliver medication to a person.
As described further herein, the sensing system 103 can be configured to determine illumination data indicative of a color of an object. The sensing system 103 includes a processing unit 108 (e.g., an MCU), in communication with a light sensor 110 and a control unit 112. The light sensor 110 is in optical communication with the object 116 (e.g., a portion of a medication delivery device). In some embodiments, the light sensor 110 is an Ambient Light Sensor (ALS), e.g., working in reflective mode. The LED driver 112 is in communication with a set of light emitting diodes (LEDs) 114A, 114B and 114C (collectively LEDs 114) in optical communication with the object 116. For example, the LEDs 114 can include a red LED, a blue LED, and/or a green LED. The light sensor 110, the LEDs 114, or both, are optionally in optical communication with the object 116 through an optional light guide 118. The light guide 118 can be a transparent light guide, such as a Makrolon 2458 LightGuide. In some embodiments, the color sensor is made of separate LEDs, a single package RGB LEDs, or a combination thereof.
Sensing module 1400 includes MCU that can be operably coupled to one or more of dose sensing elements 1402A-E, memory 1408, identification sensor 1404, counter 1414, light driver 1411 and light indicators 1412, power-on module 1406, communication module 1410, display driver/display 1416, power source 1418, and presence module 1420. Sensing module 1400 may include any number of sensing elements, such as, for example, five magnetic sensors 1402A-E (shown) or six sensors. The dose sensors can be used to determine the total units of rotation of components within the medication delivery device that can be used to determine an administered dose amount (e.g., as discussed further herein in conjunction with
With additional reference to
In some embodiments, as discussed further in conjunction with
The exemplary aspects of a dose detection system described in conjunction with
Referring to
Referring to step 202, the sensing system can be configured to capture first illumination data when the object is not illuminated by the set of LEDs, second illumination data when the object is illuminated by each LED of the set of LEDs, or both. For example, the apparatus can be configured to capture illumination data for the object when the object is illuminated just by ambient light when the LEDs are not turned on. In some embodiments, the sensing system can include an exposure time during which to capture the dark illumination data.
As another example, if the set of LEDs comprises different color LEDs, the apparatus can be configured to capture illumination data of the object when the object is illuminated by each LED. For example, as shown in
Referring to step 204, the illumination data can be adjusted based on temperature. In some embodiments, the temperature is taken of the ambient air, the sensing system, and/or of the medication delivery device. In some embodiments, the sensing system can capture a plurality of temperature measurements and average the values to determine and averaged temperature to use for adjusting the illumination data. In some embodiments, the sensing system can adjust each illumination data value (X) using Equation 1:
rgbTempX=rgbX*(1−TempCoefficientX*(Temp−CalTemp)) (Equation 1)
Referring to step 206, the sensing system can normalize the (temperature adjusted) illumination data based on the dark illumination data captured without illumination of the LEDs. In some embodiments, the sensing system can normalize the illumination data based on one or more illumination measurements determined during calibration. For example, Equation 2 can be used to normalize each illumination data value (X):
Referring to step 210, the remote device can be configured to determine lightness A B (LABc) values. The system can determine the LABc values based on any of the illumination values, whether it be the raw illumination data or illumination data that is temperature adjusted and/or normalized illumination data. For illustrative purposes, the following examples refer to normalized illumination data for simplicity. The A value can be calculated depending on the normalized illumination values. For example, depending on whether rgbNormRed determined using Equation 2 is greater than rgbNormGreen, then one of either Equations 3 or 4 is used to determine the A value:
The B value can also be calculated depending on the normalized illumination values. For example, depending on whether rgbNormBlue determined using Equation 2 is greater than rgbNormGreen, then one of either Equations 5 or 6 is used to determine the B value. For equations 3-6, Kn is a coefficient used for the RGB to LABc transformation so that the A and B values will be in the range of −100 to 100, and that L is in the range 0 to 100 (e.g., 20, 21.5, 23, etc.).
The L value can be calculated using Equation 7:
In some embodiments, the remote device can include a table of metrics used for determining whether the illumination data meets a color. The remote device can include a set of colors (e.g., grey, blue, dark blue, red, and/or other colors), where each color has an associated set of data. The data associated with each color can include average data and/or sigma variation data determined during calibration and/or design of the system. In some embodiments, each color can include an average for each of the A, B and L values and a sigma variation value for each of the A, B and L values. The remote device can determine the sigma distance for the illumination data and each color in the stored set of colors. For example, Equation 8 can be used to determine the sigma distance for each color in the set of colors:
The remote device can determine whether the illumination data matches a color in the set of colors using the sigma distances. For example, the remote device can select the minimum among the sigma distance values (Min1) as the most likelihood matched color. The second smallest value (Min2) can be used for a match color check, as discussed further herein.
The sensing system and/or remote device can be configured to perform one or more checks for the illumination data. For example, the dark illumination data can be checked to determine whether the subsequent measurements under LED illumination are interfered with by ambient light. As another example, the acquired illumination data for the LEDs can be checked to ensure the illumination data is within an expected threshold between a lowest black value and a highest white value. As a further example, the LABc values can be checked to determine whether they are within acceptable ranges (e.g., −100 to 100 for A or B, 0 to 100 for L). As another example, a match color check can be performed to ensure that Min1 and/or Min2 are within acceptable values. For example, Min1 can be checked to ensure Min1 is below a maximum sigma distance for an expected color match, and/or the ratio of Min2/Min1 can be compared to a minimum ratio between the two minimum values for an acceptable match.
During calibration, the sensing device can take various measurements that can be used to calibrate the real-time measurements of an object. The calibration measurements can include the temperature and various light measurements, such as measurements using a white target, a black target, and dark illumination without any LEDs on.
As described herein, the dose sensing system includes a sensing module with various components, including a processor/MCU, sensors, LEDs, among other components. In some embodiments, the sensing module can be powered by a power source, such as, for example, one or more batteries. Referring to
The inventors have discovered and appreciated that estimating battery life, such as by using battery voltage measurements, can be complicated due to the fact that the battery behavior can depend on a number of variables, such as temperature, relaxation time from measure to measure, duration of an injection of an attached medication delivery device, load variation, battery brand, battery variability, and other parameters. To address such issues, which are often not controllable by the device provider, the inventors have developed techniques to monitor the battery based on the device architecture in a manner that provides sufficient margin on the battery life to compensate for the potential error(s) and variabilities that the inventors have appreciated can otherwise occur during battery measurement.
Referring to step 402, the apparatus (e.g., the MCU) can obtain various voltage measurements when the battery is under different loads and/or at different operating states of the apparatus. The electrical power drawn from the battery is lower in a low power state (which may be referred to as a sleep state) compared to an increased power state (which may be referred to as an awake state). Lower power state may be implemented by (a) operating some or all components in a system at a lower clock speed than they would operate at in the increased power state, (b) shutting down some or all components that would have been operating and consuming power in the increased power state, or (c) both. In some embodiments, the apparatus obtains (a) a startup battery voltage when the apparatus is powered on, (b) a high current battery voltage when the processor is running at a maximum speed, (c) a low current battery voltage when the processor is running in a low-power mode, or some combination thereof. The startup battery voltage can be determined, for example, by obtaining a high current battery voltage within a certain amount of time from the sensing module being powered on. For example, when the apparatus is woken up (e.g., following a press of a button (see ref. number 139 in
The high current battery voltage can capture a high (e.g., maximum) current peak, e.g., which can be used to measure the voltage drop at that point. The high current battery voltage can be determined, for example, by running the microcontroller at maximum speed and all the other loads in low-power mode for a predetermined time (e.g., in ms), and measuring the high current battery voltage. In some embodiments, the high current battery voltage is an average voltage computed based on a set of measurements. In some embodiments, the high current battery voltage can be calculated at the beginning of and/or at the end of the magnetic sensor activity. For example, a maximum voltage drop of the system may be obtained when the magnetic sensor(s) have completed a measurement.
The low current battery voltage can be used to measure the voltage drop with a lowest current load, e.g., to simulate an open circuit voltage check for the battery. The low current battery voltage can be determined, for example, by having the firmware running on the MCU put all the loads (e.g., including the MCU) in low-power mode for a predetermined time (e.g., a rest period specified in ms), and measuring the low current battery voltage. In some embodiments, the low current battery voltage is an average voltage computed by averaging a set of measurements. In some embodiments, the low current battery voltage is determined after determining the high current battery voltage measurement.
As described herein, one or more voltage measurements can be used for step 402. For example, in some embodiments the voltages can be taken in a manner designed to obtain a voltage reading at a high and/or maximum current consumption (e.g., the point with a maximum voltage drop) and a representative open circuit voltage measurement for a low/lowest current consumption. The voltages can be used, as described herein, to estimate the remaining battery energy. In some embodiments, the techniques may use, for example, a single voltage drop, such as the maximum voltage drop, to estimate the remaining battery energy (e.g., since the maximum voltage drop may be more dependent on battery status compared to other voltage drops, which may be more capacitive driven). For example, the power-on/start-up voltage drop can simply be used for comparison with the maximum voltage drop. For example, if the voltage drop during power on is bigger than a measured maximum drop of the system, the comparison can indicate there is a risk that the component may reset.
Referring to step 406, the apparatus can store battery indication tables at various temperatures. For example, the apparatus can store a set of low temperature battery indications that includes a set of battery indications that each have an associated voltage for a low temperature. Table 1 is an example of a set of low temperature battery indications (e.g., at 0° C.):
As another example, the apparatus can store a set of high temperature battery indications that includes a set of high temperature battery indications that each have an associated voltage for a high temperature. Table 2 is an example of a set of high temperature battery indications (e.g., at 22-24° C.):
The sensing system can determine, based on the set of low temperature battery indications, the set of high temperature battery indications, and the temperature measurement(s) obtained at step 402, a set of temperature-adjusted battery indications. In some embodiments, the sensing system (e.g., via firmware executing on the MCU) can determine a correction factor based on the temperature measured at step 404. For example, the sensing system can determine a correction factor based on the measured temperature and one or more correction factors. A logarithmic (shown below) and/or linear relationship may be developed to characterize the correction factor. For example, the sensing system can use Equation 9 to determine the correction factor:
corrFactor=A*log2(Temp+LogOffset)+Temp*B+C (Equation 9)
The sensing system can determine a corrected set of battery indications (e.g., a corrected battery table) based on the temperature correction factor. In some embodiments, the sensing system can determine the corrected battery indications based on both the low and high temperature battery table. For example, the sensing system can use Equation 10 to determine each corrected battery voltage associated with each indicator:
corrBatCurvex={(VoltageTEMPHIx−VoltageTEMPLOx)/(TEMPHI−TEMPLO)}*(corrFactor−TEMPHI)+VoltageTEMPHIx (Equation 10)
Referring to step 408, the apparatus can determine the battery indicator based on a previous battery indicator. For example, the apparatus can obtain the previous battery indicator for the battery, determine a current battery indicator for the battery based on the temperature-adjusted battery indications in the corrected battery table and the set of voltage measurements, and determine the battery indicator based on the previous battery indicator and the current battery indicator.
In some embodiments, the sensing system can determine the current battery indicator based on the stored battery tables and/or corrected battery table. For example, the sensing system can interpolate the points in the corrected battery table with the high current battery voltage (e.g., measured at step 402 in
In some embodiments, the sensing system can determine a new battery indicator based on the previous battery indicator (e.g., which can be stored in storage on the sensing system, such as in EEPROM). For example, the sensing system can use Equation 11 to determine the new battery indicator:
newBatInd=(FILTER*batInd+curBatInd)/(FILTER+1) (Equation 11)
The sensing system can store the determined new battery indicator (e.g., into EEPROM). In some embodiments, additional data can be stored with the new battery indicator, such as a timestamp, a number of remaining injections, and/or the like. For example, an initial injection number can be configured by the system that is associated with a new sensing system and/or new battery, and the sensing system can be configured to decrease the injection number for each sensed injection through the medication delivery device.
The apparatus can transmit the battery indicator to a remote device (e.g., remote computing device 104). The remote device can process the new battery indicator. For example, the remote device can be configured to determine a battery status based on the battery indicator. As an example, the following Table 3 illustrates exemplary battery statuses and associated battery indicators (as a percent of the designed capacity to deliver the maximum number of injections):
In some embodiments, the sensing device can enter a low battery state once the sensing device raises a low battery flag for the first time (e.g., when the device is unlikely to be able to provide more than a certain number of injections, such as 120 injections). The sensing device, once entering a low battery state, can avoid changing out of the low battery state for that battery (e.g., to avoid moving back-and-forth from a low battery state and a non-low battery state). In some embodiments, the sensing device can be configured to decrease the battery indicator by one for each new operation (e.g., a sync, bonding, or dose event) of the sensing device once it is in a low-power state. In some embodiments, the sensing device can be configured to decrease the number of remaining injections by one for each new operation of the sensing device once it is in a low-power state. Once the battery indicator equals zero, the sensing system can enter an end of life state. In some embodiments, the battery can be changed, and the sensing system can reset upon detecting a new battery. In some embodiments, the sensing system is disposable and can be disposed upon reaching and end of life state.
In some embodiments, the sensing system can perform one or more checks on data obtained and/or measurements made during the battery monitoring processes. For example, the MCU can raise a low battery warning once the new battery indicator falls below a predetermined threshold. As another example, the sensing system can check whether sensed voltages are within predetermined acceptable ranges, whether temperature measurements are within predetermined acceptable ranges, and/or the like.
As described herein, the techniques can be used with various types of medication delivery devices, including medication delivery devices that incorporate the aspects described herein, as well as add-on components that can be attached to a medication delivery device. For illustrative purposes,
A dose setting member 30 is coupled to housing 12 for setting a dose amount to be dispensed by device 10. In the illustrated embodiment, dose setting member 30 is in the form of a screw element operative to spiral (e.g., simultaneously move axially and rotationally) relative to housing 12 during dose setting and dose dispensing.
Referring to
Dose setting member 30 therefore may be considered to comprise any or all of dose dial member 32, flange 38, and skirt 42, as they are all rotationally and axially fixed together. Dose dial member 32 is directly involved in setting the dose and driving delivery of the medication. Flange 38 is attached to dose dial member 32 and, as described later, cooperates with a clutch to selectively couple dial member 32 with a dose knob 56. Skirt 42 provides a surface external of body 11 to enable a user to rotate the dial member 32 for setting a dose. For embodiments without the skirt, the dosage knob 56 includes an outer wall that extends distally to form a surface to for the user to rotate.
Skirt 42 illustratively includes a plurality of surface features 48 and an annular ridge 49 formed on the outer surface of skirt 42. Surface features 48 are illustratively longitudinally extending ribs and grooves that are circumferentially spaced around the outer surface of skirt 42 and facilitate a user's grasping and rotating the skirt. In an alternative embodiment, skirt 42 is removed or is integral with dial member 32, and a user may grasp and rotate dose knob 56 and/or dose dial member 32 for dose setting. In the embodiment of
Delivery device 10 includes an actuator 50 having a clutch 52 which is received within dial member 32. Clutch 52 includes an axially extending stem 54 at its proximal end. Actuator 50 further includes dose knob 56 positioned proximally of skirt 42 of dose setting member 30. Dose knob 56 includes a mounting collar 58 (
Dose knob 56 includes a disk-shaped proximal end surface or face 60 and an annular wall portion 62 extending distally and spaced radially inwardly of the outer peripheral edge of face 60 to form an annular lip 64 there between. Proximal face 60 of dose knob 56 serves as a push surface against which a force can be applied manually, i.e., directly by the user to push actuator 50 in a distal direction. Dose knob 56 illustratively includes a recessed portion 66 centrally located on proximal face 60, although proximal face 60 alternatively may be a flat surface. A bias member 68, illustratively a spring, is disposed between the distal surface 70 of knob 56 and a proximal surface 72 of tubular flange 38 to urge actuator 50 and dose setting member 30 axially away from each other. Dose knob 56 is depressible by a user to initiate the dose dispensing operation.
Delivery device 10 is operable in both a dose setting mode and a dose dispensing mode. In the dose setting mode of operation, dose setting member 30 is dialed (rotated) relative to housing 12 to set a desired dose to be delivered by device 10. Dialing in the proximal direction serves to increase the set dose, and dialing in the distal direction serves to decrease the set dose. Dose setting member 30 is adjustable in rotational increments (e.g., clicks) corresponding to the minimum incremental increase or decrease of the set dose during the dose setting operation. For example, one increment or “click” may equal one-half or one unit of medication. The set dose amount is visible to the user via the dial indicator markings shown through dosage window 36. Actuator 50, including dose knob 56 and clutch 52, move axially and rotationally with dose setting member 30 during the dialing in the dose setting mode.
Dose dial member 32, flange 38 and skirt 42 are all fixed rotationally to one another and rotate and extend proximally of the medication delivery device 10 during dose setting, due to the threaded connection of dose dial member 32 with housing 12. During this dose setting motion, dose knob 56 is rotationally fixed relative to skirt 42 by complementary splines 74 of flange 38 and clutch 52 (
Once the desired dose is set, device 10 is manipulated so the injection needle 24 properly penetrates, for example, a user's skin. The dose dispensing mode of operation is initiated in response to an axial distal force applied to the proximal face 60 of dose knob 56. The axial force is applied by the user directly to dose knob 56. This causes axial movement of actuator 50 in the distal direction relative to housing 12.
The axial shifting motion of actuator 50 compresses biasing member 68 and reduces or closes the gap between dose knob 56 and tubular flange 38. This relative axial movement separates the complementary splines 74 on clutch 52 and flange 38, and thereby disengages actuator 50, e.g., dose knob 56, from being rotationally fixed to dose setting member 30. In particular, dose setting member 30 is rotationally uncoupled from actuator 50 to allow back-driving rotation of dose setting member 30 relative to actuator 50 and housing 12. The dose dispensing mode of operation may also be initiated by activating a separate switch or trigger mechanism.
As actuator 50 is continued to be axially plunged without rotation relative to housing 12, dial member 32 screws back into housing 12 as it spins relative to dose knob 56. The dose markings that indicate the amount still remaining to be injected are visible through window 36. As dose setting member 30 screws down distally, drive member 28 is advanced distally to push piston 26 through reservoir 20 and expel medication through needle 24 (
During the dose dispensing operation, the amount of medicine expelled from the medication delivery device is proportional to the amount of rotational movement of the dose setting member 30 relative to actuator 50 as the dial member 32 screws back into housing 12. The injection is completed when the internal threading of dial member 32 has reached the distal end of the corresponding outer threading of sleeve 34 (
The start and end angular positions of dose dial member 32, and therefore of the rotationally fixed flange 38 and skirt 42, relative to dose knob 56 provide an “absolute” change in angular positions during dose delivery. Determining whether the relative rotation was in excess of 360° is determined in a number of ways. By way of example, total rotation may be determined by also taking into account the incremental movements of the dose setting member 30 which may be measured in any number of ways by a sensing system.
Various sensor systems are contemplated herein. In general, the sensor systems comprise a sensing element and a sensed element. The term “sensing element” refers to any component which is able to detect the relative position of the sensed element. The sensing element includes a sensing element, or “sensor”, along with associated electrical components to operate the sensing element. The “sensed element” is any component for which the sensing element is able to detect the position and/or movement of the sensed element relative to the sensing element. For the dose delivery detection system, the sensed element rotates relative to the sensing element, which is able to detect the angular position and/or the rotational movement of the sensed element. For the dose type detection system, the sensing element detects the relative angular position of the sensed element. The sensing element may comprise one or more sensing elements, and the sensed element may comprise one or more sensed elements. The sensor system is able to detect the position or movement of the sensed element(s) and to provide outputs representative of the position(s) or movement(s) of the sensed element(s).
A sensor system typically detects a characteristic of a sensed parameter which varies in relationship to the position of the one or more sensed elements within a sensed area. The sensed elements extend into or otherwise influence the sensed area in a manner that directly or indirectly affects the characteristic of the sensed parameter. The relative positions of the sensor and the sensed element affect the characteristics of the sensed parameter, allowing a microcontroller unit (MCU) of the sensor system to determine different rotational positions of the sensed element.
Suitable sensor systems may include the combination of an active component and a passive component. With the sensing element operating as the active component, it is not necessary to have both components connected with other system elements such as a power supply or MCU.
Any of a variety of sensing technologies may be incorporated by which the relative positions of two members can be detected. Such technologies may include, for example, technologies based on tactile, optical, inductive or electrical measurements. Such technologies may include the measurement of a sensed parameter associated with a field, such as a magnetic field. In one form, a magnetic sensor senses the change in a sensed magnetic field as a magnetic component is moved relative to the sensor. In another embodiment, a sensor system may sense characteristics of and/or changes to a magnetic field as an object is positioned within and/or moved through the magnetic field. The alterations of the field change the characteristic of the sensed parameter in relation to the position of the sensed element in the sensed area. In such embodiments the sensed parameter may be a capacitance, conductance, resistance, impedance, voltage, inductance, etc. For example, a magneto-resistive type sensor detects the distortion of an applied magnetic field which results in a characteristic change in the resistance of an element of the sensor. As another example, Hall effect sensors detect changes in voltage resulting from distortions of an applied magnetic field.
In one aspect, the sensor system detects relative positions or movements of the sensed elements, and therefore of the associated members of the medication delivery device. The sensor system produces outputs representative of the position(s) or the amount of movement of the sensed element. For example, the sensor system may be operable to generate outputs by which the rotation of the dose setting member during dose delivery can be determined. MCU is operably connected to each sensor to receive the outputs. In one aspect, MCU is configured to determine from the outputs the amount of dose delivered by operation of the medication delivery device.
The dose delivery detection system involves detecting relative rotational movement between two members. With the extent of rotation having a known relationship to the amount of a delivered dose, the sensor system operates to detect the amount of angular movement from the start of a dose injection to the end of the dose injection. For example, a typical relationship for a pen injector is that an angular displacement of a dose setting member of 18° is the equivalent of one unit of dose, although other angular relationships are also suitable. The sensor system is operable to determine the total angular displacement of a dose setting member during dose delivery. Thus, if the angular displacement is 90°, then 5 units of dose have been delivered.
One approach for detecting the angular displacement is to count increments of dose amounts as the injection proceeds. For example, a sensor system may use a repeating pattern of sensed elements, such that each repetition is an indication of a predetermined degree of angular rotation. Conveniently, the pattern may be established such that each repetition corresponds to the minimum increment of dose that can be set with the medication delivery device.
An alternative approach is to detect the start and stop positions of the relatively moving member, and to determine the amount of delivered dose as the difference between those positions. In this approach, it may be a part of the determination that the sensor system detects the number of full rotations of the dose setting member. Various methods for this are well within the ordinary skill in the art and may include “counting” the number of increments to assess the number of full rotations.
The sensor system components may be permanently or removably attached to the medication delivery device. In an illustrative embodiment, as least some of the dose detection system components are provided in the form of a module that is removably attached to the medication delivery device. This has the advantage of making these sensor components available for use on more than one pen injector.
In some embodiments, a sensing element is mounted to the actuator and a sensed element is attached to the dose setting member. The sensed element may also comprise the dose setting member or any portion thereof. The sensor system detects during dose delivery the relative rotation of the sensed element, and therefore of the dose setting member, from which is determined the amount of a dose delivered by the medication delivery device. In an illustrative embodiment, a rotation sensor is attached, and rotationally fixed, to the actuator. The actuator does not rotate relative to the body of the medication delivery device during dose delivery. In this embodiment, a sensed element is attached, and rotationally fixed, to the dose setting member, which rotates relative to the actuator and the device body during dose delivery. The sensed element may also comprise the dose setting member or any portion thereof. In an illustrative embodiment, the rotation sensor is not attached directly to the relatively rotating dose setting member during dose delivery.
Referring to
Dose detection module 82 includes a body 88 attached to dose knob 56 (shown in dashed lines). Body 88 illustratively includes a cylindrical side wall 90 and a top wall 92, spanning over and sealing side wall 90. Dose detection module 82 may alternatively be attached to dose knob 56 via any suitable fastening means, such as a snap or press fit, threaded interface, etc., provided that in one aspect module 82 may be removed from a first medication delivery device and thereafter attached to a second medication delivery device. The attachment may be at any location on dose knob 56, provided that dose knob 56 is able to move any required amount axially relative to dose setting member 30, as discussed herein.
During dose delivery, dose setting member 30 is free to rotate relative to dose knob 56 and module 82. In the illustrative embodiment, module 82 is rotationally fixed with dose knob 56 and does not rotate during dose delivery. This may be provided structurally, such as with tabs, or by having mutually-facing splines or other surface features on the module body 88 and dose knob 56 engage upon axial movement of module 82 relative to dose knob 56. In another embodiment, the distal pressing of the module provides a sufficient frictional engagement between module 82 and dose knob 56 as to functionally cause the module 82 and dose knob 56 to remain rotationally fixed together during dose delivery.
Top wall 92 is spaced apart from face 60 of dose knob 56 and thereby provides a cavity 96 in which some or all of the rotation sensor and other components may be contained. Cavity 96 may be open at the bottom, or may be enclosed, such as by a bottom wall 98. Bottom wall 98 may be positioned in order to bear directly against face of dose knob 56. Alternatively, bottom wall 98 if present may be spaced apart from dose knob 56 and other contacts between module 82 and dose knob 56 may be used such that an axial force applied to module 82 is transferred to dose knob 56. In another embodiment, module 82 may be rotationally fixed to the one-piece dose knob configuration.
In an alternate embodiment, module 82 during dose setting is instead attached to dose setting member 30. For example, side wall 90 may include a lower wall portion 100 having inward projections in the form of coupling arms 102 that engage with knob sidewall. In this approach, module 82 may effectively engage the proximal face 60 of dose knob 56 and the distal side of annular ridge 49. In this configuration, lower wall portion 100 may be provided with surface features which engage with the surface features of dose knob to rotationally fix module 82 with dose knob. Rotational forces applied to housing 82 during dose setting are thereby transferred to dose knob by virtue of the coupling of lower wall portion 100 with sidewall of the dose knob. Light guide 118 is shown disposed between the LEDs 114A-C and light sensor 110, shown collectively at a single location of the electronics assembly, and the face of the dosage knob 56 when present. Battery 138 is shown disposed above the light system 89 and part of the electronics assembly.
An exemplary electronics assembly 120 comprises a flexible printed circuit board (FPCB) having a plurality of electronic components. The electronics assembly comprises a sensor system including one or more rotation sensors 86 operatively communicating with a processor for receiving signals from the sensor representative of the sensed relative rotation. The electronics assembly further includes the MCU comprising at least one processing core and internal memory. One example of an electronics assembly schematic is shown in
Referring to
Sensor system 150 further includes a measurement sensor 158 including one or more sensing elements 160 operatively connected with sensor electronics (not shown) contained within module 82. The sensing elements 160 of sensor 158 are shown in
In one embodiment, magnetic sensor system 150 includes four sensing elements 160 equi-radially spaced within module 82 to define a ring pattern as shown. Alternative numbers and positions of the sensing elements may be used. For example, in another embodiment, shown in
For purposes of illustration, magnet 152 is shown as a single, annular, bi-polar magnet attached to flange 38. However, alternative configurations and locations of magnet 152 are contemplated. For example, the magnet may comprise multiple poles, such as alternating north and south poles. In one embodiment the magnet comprises a number of pole pairs equaling the number of discrete rotational, dose-setting positions of flange 38. Magnet 152 may also comprise a number of separate magnet members. In addition, the magnet component may be attached to any portion of a member rotationally fixed to flange 38 during dose delivery, such as skirt 42 or dose dial member 32.
Alternatively, the sensor system may be an inductive or capacitive sensor system. This kind of sensor system utilizes a sensed element comprising a metal band attached to the flange similar to the attachment of the magnetic ring described herein. Sensor system further includes one or more sensing elements, such as the four, five, six or more independent antennas or armatures equi-angularly spaced along the distal wall of the module housing or pen housing. These antennas form antenna pairs located 180 degrees or other degrees apart and provide a ratio-metric measurement of the angular position of metal ring proportional to the dose delivered.
The metal band ring is shaped such that one or more distinct rotational positions of metal ring relative to the module may be detected. Metal band has a shape which generates a varying signal upon rotation of metal ring relative to antennas. Antennas are operably connected with electronics assembly such that the antennas function to detect positions of metal ring relative to sensors, and therefore relative to housing 12 of pen 10, during dose delivery. Metal band may be a single, cylindrical band attached to the exterior of the flange. However, alternate configurations and locations of the metal band are contemplated. For example, the metal band may comprise multiple discrete metal elements. In one embodiment the metal band comprises a number of elements equal to the number of discrete rotational, dose-setting positions of flange. The metal band in the alternative may be attached to any portion of a component rotationally fixed to flange 38 during dose delivery, such as dial member 32. The metal band may comprise a metal element attached to the rotating member on the inside or the outside of the member, or it may be incorporated into such member, as by metallic particles incorporated in the component, or by over-molding the component with the metal band. MCU is operable to determine the position of the metal ring with the sensors.
MCU is operable to determine the start position of magnet 152 by averaging the number of sensing elements 160 (for example, four) at a maximum sampling rate according to standard quadrature differential signals calculation. During dose delivery mode, sampling at a targeted frequency is performed by MCU to detect the number of revolutions of magnet 152. At end of dose delivery, MCU is operable to determine the final position of magnet 152 by averaging the number of sensing elements 160 (for example, four) at a maximum sampling rate according to standard quadrature differential signals calculation. MCU is operable to determine from calculation of the total rotational angle of travel from the determined start position, number of revolutions, and the final position. MCU is operable to determine the number of dose steps or units by dividing the total rotational angle of travel by a predetermined number (such as 10, 15, 18, 20, 24) that is correlated with the design of device and medication.
Referring further to
In some embodiments, the sensing system is configured to determine whether the sensing system is coupled to a medication delivery device.
The sensing system (via its processor, MCU, etc.) is configured to execute computer-readable instructions that cause the processor to execute the computerized method 1300. At step 1302, the sensing system obtains a set of voltage measurements from each of the plurality of sensing elements. At step 1304, the sensing system determines two-dimensional data representative of a magnetic field of a magnetic component of the medication injection device. At step 1306, the sensing system determines one-dimensional data based on the two-dimensional data. At step 1308, the sensing system determines, based on the one-dimensional data, whether the set of voltage measurements is indicative of the apparatus being coupled to the medication injection device.
Referring to step 1302, when a power-on button (see button 139 and switch 137 in
Referring to step 1304, in some embodiments the sensing system determines a quadrature signal comprising an inphase (I) part and a quadrature (Q) part. The system can determine the I and Q values based on a summation of each sensor value. In some embodiments, the sensing system uses coefficients when summing the sensor values. For example, the system can store one or more coefficients for each sensor. In some embodiments, the sensing system stores one coefficient for each sensor that the sensor value is multiplied by during the summation to determine the I value, and a second coefficient for each sensor that the sensor value is multiplied by during the summation to determine the value. In some embodiments, the coefficients can be used to combine the results of the multiple sensors (e.g., such as five sensors equally spaced at 72 degrees from each other) for the I and Q calculation. In some embodiments, the coefficients can be obtained by solving a system of equations that force the results of the quadrature calculation to have zero error compared to the nominal angle, in front of offset, 2nd harmonic distortion, 3 harmonic distortion in the measured signal, and/or the like.
Referring to step 1306, in some embodiments the sensing system determines a scale factor based on the two-dimensional signal (e.g., the quadrature signal) determined at step 1304. In some embodiments, the sensing system determines the scale factor based on the quadrature signal and one or more of a predetermined offset and a predetermined gain. For example, the processor can determine the scale factor based on the following Equation 12:
Such exemplary I and Q offsets and gains can be used since quadrature works well when I and Q are well balanced, such as with an offset equal to zero and a gain equal to one. The calibration process can be used to determine offsets/gains that balance the measured I and Q to achieve sufficient values, to remove skew between I and Q, and/or the like. In some embodiments, the sensing system can be configured to normalize the I and Q values, and to use the I and Q values to determine the normalized angle of the Z component of the magnetic field. After a dose is administered, the sensing system can then monitor the ending position of the magnetic component of the medication delivery device to determine the amount of injected dose (e.g., using similar techniques as described herein to monitor the rotation of the magnet and/or to determine the ending position of the magnet).
Referring to step 1308, the sensing system can determine whether the one-dimensional data is indicative of the sensing system being coupled (or not being coupled) to a medication delivery device. The sensing system can use the scale factor to determine whether the sensing system is mounted or coupled to the medication delivery device. For example, if the scale factor is between predetermined thresholds, then the sensing system can determine that the sensing system is mounted to the medication delivery device. If the scale factor is not between the predetermined thresholds, the sensing system can determine that the sensing system is likely not mounted to the medication delivery device. In some embodiments, the sensing system can check the scale factor against a low amplitude margin and a high amplitude margin to determine whether the magnet that the module is monitoring is the expected magnet (e.g., where +/−25% around nominal is acceptable) so that only a desired amplitude will be accepted by the module.
The user interface of the system 80 can be further enhanced to provide the user information during operation of the system 80 based on its onboard capability, which may or may not be combined with the offboard capability of the remote computing system 104. To this end, the system 80 is provided with one or more light indicators for generating light indication patterns. System 80 may also be provided with a display, audible, or other known indication systems. In one embodiment, system 80 does not include a display. The light indicators 1412 (which, as discussed above, may comprise one or more LEDs) may use various patterns of color and blinking to indicate various use case types. As used herein, a ‘use case type’ is a state or status of the system 80. System 80 may occupy one of a plurality of different use case types. Each use case type can be indicative of a status of the device, such as, for example, successful or unsuccessful pairing with the remote computing device, successful or unsuccessful injection, successful or unsuccessful manual synching with the remote computing device, and battery status. In some embodiments, the system may be configured to indicate one of the use case types. In other embodiments, the system may be configured to indicate a combination or two or more use case types in sequence. In other embodiments, the system may be configured to indicate a combination of two or more use case types in with a single indication notice, such as with light indicators 1412, without an onboard display.
In one embodiments, the sensing system may be configured to indicate a combination of the battery status and one of the other use case types in with a light indication, such as with light indicators 1412, without an onboard display. The light indication pattern may be a combination of a first segment of the pattern indicative of one of the use case types, a delay segment of the pattern indicative of a delay in time, and a second segment of the pattern indicative of another of the use case types. The patterns of colors and blinking may be same or different in each segment. In one embodiment, the sensing system can check the scale factor against a low amplitude margin and a high amplitude margin to determine whether the magnet that the module is monitoring is the expected magnet (e.g., where +/−25% around nominal is acceptable) so that only a desired amplitude will be accepted by the module.
At step 1610, if the sensing system determines that the sensed element is not moving and the power-on module is continuously activated for a first time range, the sensing system is configured to provide a first pattern for the first light indication segment. Optionally, determination of whether the sensed element is present prior to the sensing system's determination that the sensed element is not moving may also occur. In such cases, the sensing system may also need to determine that the sensed element is present before it provides the first pattern. At 1612, if the sensing system determines that the sensed element is not moving and the power-on module is continuously activated for a second time range, the sensing system is configured to provide a second pattern for the first light indication segment. Optionally, determination of whether the sensed element is present prior to the sensing system's determination that the sensed element is moving may also occur. In such cases, the sensing system may also need to determine that the sensed element is present before it provides the second pattern. At 1614, if the sensing system determines that the sensed element is moving, the sensing system is configured to provide a third light indication pattern for the first light indication segment. Optionally, determination of whether the sensed element is present prior to the sensing system's determination that the sensed element is moving may also occur. In such cases, the sensing system may also need to determine that the sensed element is present before it provides the third pattern.
In one example, if there is no sensed element moving and the power-on module is continuously activated for a first time range, then the sensing system may be configured to implement a use case type configuration for manual data synchronization with the remote computing system to, for example, push data from the sensing system to the remote computing system. This is the use case type configuration corresponding to 1610 in
In one example, if there is no sensed element moving and the power-on module is continuously activated for a second time range, the use case type configuration may be in the operation of pairing with the remote computing system. This is the use case type configuration corresponding to 1612 in
Within the second time range, the sensing system can provide a first version of the second patterns for the first light indication segment, such as, for example, blinking a green LED of the light indicators 1412 on (such as, for example, 1000 ms on) for a single cycle, or which may be for multiple of cycles. This can be used to notify the user of successful pairing initiation and to release the button. The sensing system may then store data indicative of the event of successful pairing initiation in its memory 1408. After the button is released, the communication unit 1410 of the sensing system may begin to signal advertising to the remote computing system, at which after successful bonding, the communication device 1467 of the remote computing system transmits a signal to the sensing system. After successful receipt by the sensing system of the remote computing system's transmission, the sensing system can provide a second version of the second patterns for the first light indication segment that is different than the first version of the second patterns, such as, for example, blinking a green LED of the light indicators 1412 on and off (such as, for example, 300 ms on/300 ms off) for a multiple of cycles, such as, for example, three cycles. The color of the LED, the amount of length on and off and number of cycles may vary. The sensing system may then store data indicative of the event of successful pairing in its memory 1408.
If pairing is unsuccessful or pairing has been lost, that is, the communication unit 1410 of the sensing system begins signal advertising to the remote computing system, and for whatever reason does not successfully connect, the sensing system fails to receive a signal for successful bonding from the communication device 1467 of the remote computing system. After unsuccessful pairing, the sensing system can provide a third version of the second patterns for the first light indication segment that is different than the first and second of second patterns, such as, for example, blinking an amber LED of the light indicators 1412 on and off (such as, for example, 100 ms ON/100 ms OFF/100 ms ON/100 ms OFF/100 ms ON/400 ms OFF) for a multiple cycles (such as, for example, three cycles). The color of the LED, the amount of length on and off and number of cycles may vary. The sensing system may then store data indicative of the event of successful or unsuccessful pairing (whatever is determined) in its memory 1408.
In one example, if there is a sensed element moving and present, the use case type configuration may be in the operation of a typical injection state. This is the use case type configuration corresponding to 1614 in
For steps 1702, 1704, 1706, 1708, there may be various ways to determine the remaining battery life status by checking an electrical characteristic of the power source and comparing it to a full charge to determine some percentage of full charge. In one embodiment,
In one embodiment, if the sensing system determines the remaining battery life status is in the high first state described above, the sensing system at step 1704 can provide a first pattern of the second light indication segment, such as, for example, not blinking. This can indicate to the user that the remaining battery life status is “normal.” In other embodiments, the first pattern of the second light indication segment may include a blinking sequence of color of the LED, by which the length of on and off and number of cycles may vary. In one embodiment, if the sensing system determines the remaining battery life status is in the low second state described above, the sensing system at step 1706 can provide a second pattern of the second light indication segment that is different than the first pattern, such as, for example, blinking a green LED and an amber LED of the light indicators 1412 on and off for one or more cycles. In one example, the on and off may be 100 ms ON/100 ms OFF/100 ms ON/100 ms OFF/100 ms ON/400 ms OFF for a multiple cycles (such as, for example, three cycles). This can indicate to the user that the remaining battery life status is “end of life.” In some embodiments, the color of the LED, the amount of length on and off and number of cycles may vary. In one embodiment, if the sensing system determines the remaining battery life status to be in the medium third state described above, the sensing system at step 1708 can provide a third pattern of the second light indication segment that is different than the first and second patterns, such as, for example, an amber LED and/or green LED of the light indicators 1412 on and off (such as, for example, 150 ms Amber ON/150 ms Green ON) for a multiple cycles (such as, for example, three cycles). This can indicate to the user that the remaining battery life status is “short remaining life.” The color of the LED, the amount of length on and off and number of cycles may vary.
As described herein, the sensing system provides a single light indication (LI) with a pattern of first light indication segment (S1) and a pattern of second light indication segment (S2), with a delay (D) in between the segments (or LI=S1+D+S2). In one embodiment, the maximum total cycle time for the single light indication (LIt) may be 6.4 seconds, with the first segment (S1t) including 2.7 seconds, the second segment (S2t) including 2.7 seconds and a delay (Dt) of an one second delay between (or LIt=S1t+Dt+S2t). In one embodiment, the total cycle time for the single light indication (LIt), such as for example, for injection use case for successful injection and high battery life remaining status, may be 1.8 seconds, with the first segment (S1t) including 1.8 seconds, the second segment (S2t) including 0 seconds (or no second segment) and a delay (Dt) of an one second delay between. In one embodiment, the total cycle time for the single light indication (LIt), such as for example, for first pairing use case for successful pairing and high battery life remaining status, may be 2.0 seconds, with the first segment (S1t) including 1.0 seconds, the second segment (S2t) including 0 seconds (or no second segment) and a delay (Dt) of an one second delay between.
At step 1806, the sensing system provides an increase in power drawn from the battery to power the electronics of the sensing system in the increased power state. Optionally at step 1802 (shown as dashed), the sensing system may determine whether dose detection system is coupled to the delivery device prior to step 1804. Determining whether dose detection system is coupled is described herein. At step 1808, if the sensing system determines the power-on module is activated continuously for a first period of time while the system is in the increased power state, reduce power drawn from the battery by electronics of sensing system to put it in a low-power state. At step 1810, if the sensing system determines the power-on module is activated continuously for a second period of time in addition to the first period of time, increase power drawn from the batter by the electronics of sensing system to the increased power state to store data indicative of an event and/or communicate an event signal to a remote computing system. After such event is stored, the system may return to the low-power state such that the power drawn from the battery is reduced. Optionally, at step 1812, remote computing system can provide an indication to the user based on the event signal received from the sensing system. This indication may be in the form of a sound, light, image, and/or alphanumeric text via a mobile app to the user of system 80 via the display 1461 of the remote computing system. For example, the user may be reminded about the correct handling and care of the dose detection system and/or a warning message, such as, for example, “remove the pressure from the button.” The kind of warning may include, in addition to the app warning, generating a message for communication via a messaging system on the user's smartphone display or another smartphone's as designated by the user.
The sensing system may continue to monitor the continuous activation of the power-on module beyond the second time period (after which the system returns to the low-power state) for additional periods of time until action is done by the user to address the problem. For example, if the power-on module is continuously in the activated state for a third period of time in addition to the first and second periods of time, the sensing system may increase power drawn from the battery by the system from the low-power state to the increased power state and generate another event. The third period of time may be greater than the first period of time. In one example, the third period of times may be the same amount of time as the second period of time described above. In other examples, periods of time after the second time may increasingly become smaller in the form of escalating the subsequent warnings to the user.
In one embodiment, to determine how long the power-on module is activated, in step 1807 the system is configured to measure how long the power-on module is continuously maintained in the activated state. If the button 139 is pressed axially down into the dose body 88 and the power-on module 1406 is continuously activated for a first period of time, measured by the RTC 1414, in the range of, for example, about 20 to 60 seconds, and, in one embodiment, 60 seconds, then the system may consider this an accidental press. This time may be modified to be lesser or greater than 60 seconds. The initial pressing of the button 139 will to activate the switch 137 to increase the power drawn from the battery by the electronics of the sensing system to the increased power state, as in step 1806. When in the increased power state, the sensing system allows power to the sensing component(s), for example, the Hall Effect sensors, to sense any movement of the sensed element of the injection device. If no movement, then the activation may have been accidental. After, such as, for example, 60 seconds of continuous activation, the sensing system may reduce power drawn from the battery by the electronics of sensing system to a low-power state. The sensing system may then store data indicative of the event such as, for example, “button still pressed”, in its memory 1408. In one embodiment, if the power-on module remains continuously activated for a second period of time that is greater than the first period of time (after the system has returned to the low-power state), the system may return to the increased power state. The second period of time may be in the range of, such as, for example, one to nine minutes, and in one embodiment, nine minutes as measured by the RTC 1414. The total combined minutes of continuously activation would the sum of the first period of time and second period of time, after which the expiration of the second period, the sensing system provides an increase in power drawn from the battery by electronics of sensing system to the increased power state from the low-power state to store data indicative of the event. The event stored may be for example, “button still pressed” and/or transmit the event signal via the communication unit 1410 of dose detection system 80 to the communication device 1467 of the remote computing system 104. For example, the total combined time may be ten minutes of continuous activation (1 minute for the first period of time and 9 minutes for the second period of time. For example, the total combined time may be five minutes of continuous activation (1 minute for the first period of time and 4 minutes for the second period of time. The transmission of the event may occur at any time there is the storage of the event or may occur during the next connection to the remote computing system. If the sensing system in monitoring the continuous activation of the power-on module beyond the second period of time, additional events may be triggered and stored. In one embodiment, the system may go through the steps once to transmit only one event signal to the remote computing device.
In addition to, or rather than, generating an event signal based on monitoring the amount of time the power-on module is activated, the event signal may be generated in method 1800 by monitoring the number of times the power-on module is activated within a period of time or in between injection events in steps 1804 and 1807. For example, system may generate the event signal when the system determines the number of presses is in the range of, such as for example, 10-40 times/minute for a total of time of in the range of, such as, for example, 1 to 5 minutes. In one example, system may generate the event signal when the number of presses is 30 times/minute for a total of time of 2 minutes, or a total number of 60 presses for two minutes. When the numbers of presses over the selected time period is reached, the system may increase the power drawn from the battery by the system to the increased power state to store an event and/or communicate the event from the device to the remote computing system that is configured to generate an warning indication. An exemplary computerized method for generating an indication of a sound, light, image, or alphanumeric text via the mobile app to the user of system 80 if the power-on module 1406 of dose detection system is activated intermittently for a number of times that may lead to premature drainage of the battery or power source, according to some embodiments.
The dose detection systems have been described by way of example with particular designs of a medication delivery device, such as a pen injector. However, the illustrative dose detection systems may also be used with alternative medication delivery devices, and with other sensing configurations, operable in the manner described herein. For example, any one or more of the various sensing and switch systems may be omitted from the module.
The various methods or processes outlined herein may be coded as software that is executable on one or more processors that employ any one of a variety of operating systems or platforms. Additionally, such software may be written using any of numerous suitable programming languages and/or programming or scripting tools, and also may be compiled as executable machine language code or intermediate code that is executed on a virtual machine or a suitable framework.
In this respect, various inventive concepts may be embodied as at least one non-transitory computer readable storage medium (e.g., a computer memory, one or more floppy discs, compact discs, optical discs, magnetic tapes, flash memories, circuit configurations in Field Programmable Gate Arrays or other semiconductor devices, etc.) encoded with one or more programs that, when executed on one or more computers or other processors, implement the various embodiments of the present invention. The non-transitory computer-readable medium or media may be transportable, such that the program or programs stored thereon may be loaded onto any computer resource to implement various aspects of the present invention as discussed above.
The terms “program,” “software,” and/or “application” are used herein in a generic sense to refer to any type of computer code or set of computer-executable instructions that can be employed to program a computer or other processor to implement various aspects of embodiments as discussed above. Additionally, it should be appreciated that according to one aspect, one or more computer programs that when executed perform methods of the present invention need not reside on a single computer or processor, but may be distributed in a modular fashion among different computers or processors to implement various aspects of the present invention.
Computer-executable instructions may be in many forms, such as program modules, executed by one or more computers or other devices. Generally, program modules include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types. Typically, the functionality of the program modules may be combined or distributed as desired in various embodiments.
Also, data structures may be stored in non-transitory computer-readable storage media in any suitable form. Data structures may have fields that are related through location in the data structure. Such relationships may likewise be achieved by assigning storage for the fields with locations in a non-transitory computer-readable medium that convey relationship between the fields. However, any suitable mechanism may be used to establish relationships among information in fields of a data structure, including through the use of pointers, tags or other mechanisms that establish relationships among data elements.
Various inventive concepts may be embodied as one or more methods, of which examples have been provided. The acts performed as part of a method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.
The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.” As used herein in the specification and in the claims, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This allows elements to optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified.
The phrase “and/or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and/or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and/or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and/or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.
As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and/or” as defined above. For example, when separating items in a list, “or” or “and/or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of” or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e. “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.” “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law.
Use of ordinal terms such as “first,” “second,” “third,” etc., in the claims to modify a claim element does not by itself connote any priority, precedence, or order of one claim element over another or the temporal order in which acts of a method are performed. Such terms are used merely as labels to distinguish one claim element having a certain name from another element having a same name (but for use of the ordinal term).
The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” “having,” “containing”, “involving”, and variations thereof, is meant to encompass the items listed thereafter and additional items.
Having described several embodiments of the invention in detail, various modifications and improvements will readily occur to those skilled in the art. Such modifications and improvements are intended to be within the spirit and scope of the invention. Accordingly, the foregoing description is by way of example only, and is not intended as limiting.
Various aspects are described in this disclosure, which include, but are not limited to, the following aspects:
1. A system configured to generate a light indication pattern for a dose detection system, the system comprising: one or more light emitting diodes (LEDs); one or more batteries; and a processing circuit configured to: determine a use case type from a plurality of use case types for the dose detection system; determine a battery life status of said one or more batteries from a plurality of battery life status; and provide a light indication pattern via the one or more LEDs comprising: (i) a first light indication segment based on the determined use case type, and (ii) a second light indication segment based on the determined battery life status after a period of delay after completion the first light indication segment.
2. The system of aspect 1, further comprising a power-on module switchable between an activated state and a deactivated state, wherein the processing circuit is caused to determine whether the power-on module is continuously in the activated state for a period of time, wherein the use case type is determined based at least partly on the determined period of time of continuous activation of the power-on module.
3. The system of any one of aspects 1-2, further comprising a sensing element configured to sense movement of a sensed element used during a dose injection, wherein the processing circuit is caused to determine whether the sensed element is present via the sensing element, and determine the use case type based on the determined presence of the sensing element.
4. The system of aspect 4, wherein the processing circuit is caused to determine whether the sensed element is moving via the sensing element, and determine the use case type based on the determined movement of the sensing element.
5. The system of aspect 1, further comprising a power-on module switchable between an activated state and a deactivated state, a sensing element configured to sense movement of a sensed element used during a dose injection, wherein the processing circuit is caused to: (a) determine whether the power-on module is continuously in the activated state for a period of time; and (b) determine whether the sensed element is moving via the sensing element; wherein the use case type is determined based on the determined period of time of continuous activation of the power-on module, and the determined movement of the sensing element.
6. The system of aspect 5, wherein, when the period of time of continuous activation of the power-on module is in a first time range, and when the processing circuit determines the sensed element is not moving, the processing circuit is caused to provide a first pattern of the first light indication segment of the single light indication pattern via the set of LEDs.
7. The system of any one of aspects 5-6, wherein, when the period of time of continuous activation of the power-on module is in a second time range, and when the processing circuit determines the sensed element is not moving, the processing circuit is caused to provide a second pattern of the first light indication segment of the single light indication pattern via the set of LEDs.
8. The system of any one of aspects 5-7, wherein, when the sensed element is determined to be moving, the processing circuit is caused to provide a third pattern of the first light indication segment of the single light indication pattern via the set of LEDs.
9. The system of any one of aspects 5-8, wherein the determined battery life status comprises a first state, a second state, a third state, or any combination thereof.
10. The system of aspect 9, wherein the processing circuit is caused to:
provide a first pattern of the second light indication segment in response to the determination of the battery life status being the first state; provide a second pattern of the second light indication segment in response to the determination of the battery life status being the second state; and provide a third pattern of the second light indication segment in response to the determination of the battery life status being the third state.
11. The system of aspect 1, further comprising a power-on module switchable between an activated state and a deactivated state, a sensing element configured to sense movement of a sensed element used during a dose injection, wherein the processing circuit is caused to: (a) determine whether the power-on module is continuously in the activated state for a period of time; (b) determine whether the sensed element is present via the sensing element; and (c) determine whether the sensed element is rotating via the sensing element, wherein the use case type is determined based on the determined period of time of continuous activation of the power-on module, the determined presence of the sensing element, and the determined rotational movement of the sensing element, wherein the dose detection system is removably attached to a pen injection device, wherein the dose detection system includes the sensing element, the power-on module, and the LEDs, and the pen injection device includes the sensed element.
12. The system of aspect 11, wherein the sensing element comprises a plurality of magnetic sensors, and the sensed element comprises a rotatable magnetic ring.
13. A method for generating a single light indication pattern for a dose detection system, the dose detection system including one or more light emitting diodes (LEDs) and one or more batteries, comprising: determining a use case type from a plurality of use case types for the dose detection system; determining a battery life status of said one or more batteries from a plurality of battery life status; and providing a light indication pattern via the one or more LEDs comprising a first light indication segment based on the determined use case type, and a second light indication segment based on the determined battery life status after a period of delay after completion of the first light indication segment.
14. The method of aspect 13, wherein the determining a use case type step comprises at least one of: determining a period of time of continuous activation of a power-on module; determining whether the sensed element is present via the sensing element; and determining whether the sensed element is moving via the sensing element.
15. The method of aspect 14, wherein when the period of time of continuous activation of the power-on module is in a first time range, and when the sensed element is determined to not be moving, the providing a light indication pattern step comprises providing a first pattern of the first light indication segment of the light indication pattern via the one or more LEDs; wherein when the period of time of continuous activation of the power-on module is in a second time range, and when the sensed element is determined to not be moving, the providing the light indication pattern step comprises providing a second pattern of the first light indication segment via the one or more LEDs; or wherein when the sensed element is determined to be moving, the processing circuit is caused to provide a third pattern of the first light indication segment via the one or more LEDs.
16. The method of aspect 15, wherein the determining one battery life status step comprises differentiating the battery life status between a first state, a second state, a third state, wherein the providing the single light indication pattern step comprises: providing a first pattern of the second light indication segment when the battery life status is in the first state; providing a second pattern of the second light indication segment when the battery life status is in the second state; or providing a third pattern of the second light indication segment when the battery life status is in the third state.
17. A system configured to reduce drainage of a battery for a dose detection system, the system comprising: a power-on module switchable between an activated state and a deactivated state; a battery; a processing circuit configured to execute computer-readable instructions that cause the processing circuit to: increase power drawn from the battery by the system to an increased power state when the power-on module is switched from the deactivated state to the activated state; measure how long the power-on module is continuously maintained in the activated state; if the power-on module is continuously in the activated state for a first period of time, reduce power drawn from the battery by the system to a low-power state; subsequently, if the power-on module is continuously in the activated state for a second period of time in addition to the first period of time, increase power drawn from the battery by the system from the low-power state to the increased power state and generate an event; and store data indicative of said event into a memory of the dose detection system.
18. The system of aspect 17, wherein the processing circuit is further caused to: communicate said data indicative of said event to a remote computing system that is configured to generate a notice indicative of said event to a user of the remote computing system.
19. The system of any one of aspects 17-18, wherein the processing circuit is further caused to: reduce power drawn from the battery to the low-power state after the said data indicative of said event is stored; subsequently, if the power-on module is continuously in the activated state for a third period of time in addition to the first and second periods of time, increase power drawn from the battery from the low-power state to the increased power state and generate a second event; and store data indicative of said second event into said memory.
20. The system of aspect 19, wherein the processing circuit is further caused to: communicate said data indicative of the second event to the remote computing system that is configured to generate a second notice indicative of said second event to the user of the remote computing system.
21. The system of any one of aspects 19-20, wherein the first period of time is in a range of 20 seconds to one minute, and each of the second period of time and the third period of time is greater than a time of the first period of time.
22. The system of any one of aspects 17-18, wherein the first period of time is in a range of 20 seconds to one minute, and the second period of time is greater than a time of the first period of time.
23. A method for reducing drainage of a battery for a dose detection system, the system including a power-on module and a battery, comprising: increasing power drawn from said battery by the system to an increased power state when said power-on module is switched to an activated state; measuring how long the power-on module is continuously maintained in the activated state; reducing power drawn from said battery by the system from the increased power state to a low-power state if the power-on module is continuously in the activated state for the period of time when the period of time comprises a first period of time; subsequently, increasing power drawn from said battery by the system from the low-power state to the increased power state and generating an event if the power-on module is continuously in the activated state when the period of time comprise a second period of time in addition to the first period of time; and storing data indicative of said event into a memory of the dose detection system.
24. The method of aspect 23, further comprising: communicating the data indicative of said event to a remote computing system that is configured to generate a notice indicative of said event to a user of the remote computing system.
25. The method of aspect 24, further comprising: reducing power drawn from the battery by the system to the low-power state after the data indicative of said event is stored; subsequently, increasing power drawn from the battery by the system from the low-power state to the increased power state and generating a second event if the power-on module is continuously in the activated state for a third period of time in addition to the first and second periods of time; and storing data indicative of said second event into said memory.
26. The method of aspect 25, further comprising: communicating the data indicative of said second event to the remote computing system that is configured to generate a second notice indicative of said second event to the user of the remote computing system.
27. The method of any one of aspects 25-26, wherein the first period of time is in a range of 20 seconds to one minute, and each of the second period of time and the third period of time is greater than the first period of time.
28. The method of aspect 23, wherein the first period of time is a range of 20 seconds to one minute, and the second period of time is greater than the first period of time.
29. The system of aspect 1 or aspect 17, further comprising a medication delivery device to which the dose detection system is coupled to, wherein the medication delivery device comprises a medication.
30. A system configured to reduce drainage of a battery for a dose detection system, the system comprising: a power-on module switchable between an activated state and a deactivated state; a battery; a processing circuit configured to execute computer-readable instructions that cause the processing circuit to: increase power drawn from the battery by the system to an increased power state when the power-on module is switched from the deactivated state to the activated state; measure how many times the power-on module is in the activated state for a period of time; if the power-on module is in the activated state for a first number of times for a first period of time, increase power drawn from the battery by the system from the low-power state to the increased power state and generate an event; and store data indicative of said event into a memory of the dose detection system.
31. A method for reducing drainage of a battery for a dose detection system, the system including a power-on module and a battery, comprising: increasing power drawn from said battery by the system to an increased power state when said power-on module is switched to an activated state; measuring how many times the power-on module is in the activated state for a period of time; reducing power drawn from said battery by the system from the increased power state to a low-power state if the power-on module is continuously in the activated state for the period of time when the period of time comprises a first period of time; if the power-on module is in the activated state for a first number of times for a first period of time, increasing power drawn from the battery by the system from the low-power state to the increased power state and generate an event; and storing data indicative of said event into a memory of the dose detection system.
| Number | Date | Country | |
|---|---|---|---|
| 63057645 | Jul 2020 | US |
