EA039706B1 - Injection device - Google Patents

Abstract

An injection device assembly including a housing, a syringe, a drive mechanism and one or more sensing systems is proposed. The drive mechanism advances the syringe from a storage position to an injection position, and a plunger advances the syringe piston from an initial position to a final position. The status sensing system may include one or more main PCB(s) disposed in an end portion of the injection device assembly's housing. The system may determine various parameters related to an operational status of the injection device, including the location of the devices components, an amount of medication remaining in the device, a temperature of the medication, and whether or not the device is properly contacting the users skin before injection. The system may communicate such determined parameters to an external device via a wireless communication link.

Description

State of the art

The present invention relates to drug delivery devices, and in particular to status determination systems used in attachable drug delivery devices.

Injection devices in the form of a syringe or containing a syringe are widely used by medical professionals and self-medicated patients. Patients suffering from a number of different diseases often have to self-medicate, and a variety of devices have been developed to facilitate such self-medication. In one example, the use of an automatic injection device containing mechanisms for carrying out certain steps of the injection process makes self-medication more convenient for the patient, in particular for patients with limited fine motor skills. Automated injection devices are usually a disposable device that is discarded after use.

The essence of the invention

In one exemplary embodiment, the injection device assembly may comprise a device body, a syringe assembly, a drive mechanism, and one or more main printed circuit boards (PCBs). The device body may have a proximal end and a distal end and may define an internal volume extending along a longitudinal axis between the proximal end and the distal end and a proximal opening at the proximal end of the body in communication with the internal volume. The body of the device may include a user gripped portion configured to be held by the user's hand, the user gripped portion extending a first radial distance outward from the longitudinal axis, and an outwardly expanding end portion at the proximal end of the housing near the proximal opening. The outwardly expanding end portion extends a second radial distance outward from the longitudinal axis, which is greater than the first radial distance.

The syringe assembly may be at least partially located within the internal volume and may contain (i) a cylinder configured to hold the drug, (ii) a plunger configured to slide along a longitudinal axis inside the cylinder, and (iii) an injection needle, coming from the cylinder. The syringe assembly can be configured to move relative to the housing along the longitudinal axis between a storage position in which the injection needle extending from the cylinder is hidden inside the housing, and an injection position in which the injection needle protrudes in the proximal direction beyond the proximal opening. .

The drive mechanism may be configured to move the syringe assembly from a storage position to an injection position and to move the piston in a proximal direction within the barrel to dispense drug from the barrel in a dispense operation.

Said one or more main PCBs may be located perpendicular to the longitudinal axis within the outwardly expanding end section of the device body. Said one or more base PPs may form an opening through which at least a portion of the syringe assembly may be configured to pass during a dispensing operation. The specified one or more main PP can move to a radial distance from the longitudinal axis, which is greater than the first radial distance. Said one or more base PPs may comprise at least one wireless radio frequency (RF) antenna and a data processing circuit capable of transmitting data wirelessly to an external device via said at least one wireless RF antenna.

In another exemplary embodiment, the non-volatile computer-readable medium may store instructions that, when executed by at least one processor of the mobile device, cause said at least one processor to perform the operations described herein. These operations may include receiving a wireless RF transmission from the injection device host. The injection device assembly may include a device body and one or more sensors. The body of the device may have a proximal end, a distal end, and a longitudinal axis between the proximal end and the distal end, wherein the body comprises a user-gripped portion configured to be held by the user's hand, wherein the user-gripped portion extends a first radial distance outward from the longitudinal axis, and the proximal the end defines a proximal opening through which the injection needle is made to pass. Said one or more sensors may be positioned adjacent to the proximal orifice, with each sensor configured to detect contact with skin tissue based on measured electrical resistance or capacitance. If there are a plurality of sensors, said plurality of sensors may surround the proximal opening. Each sensor may be located at a radial distance outward from the longitudinal axis, which is greater than the first radial

- 1 039706 distances.

In the presence of multiple skin contact sensors, the RF transmission from the injection device assembly (and received by said at least one processor of the mobile device) may contain data indicating which individual sensors of the plurality of sensors detect contact with skin tissue and which individual sensors from multiple sensors do not detect contact with skin tissue. The operations may further include displaying on the display of the mobile device a schematic representation of a plurality of sensors indicating which individual sensors of the displayed plurality of sensors detect contact with skin tissue and which individual sensors of the displayed plurality of sensors do not detect contact with skin tissue. In another exemplary implementation, the method may guide the user on how to properly position the injection device assembly. The method may include receiving, on the mobile device, a wireless RF transmission from an injection device host. The injection device assembly may include a device body and one or more sensors. The body of the device may have a proximal end, a distal end, and a longitudinal axis between the proximal end and the distal end, wherein the body comprises a user-gripped portion configured to be held by the user's hand, wherein the user-gripped portion extends a first radial distance outward from the longitudinal axis, and the proximal the end defines a proximal opening through which the injection needle is made to pass. Said one or more sensors may be positioned adjacent to the proximal orifice, with each sensor configured to detect contact with skin tissue based on measured electrical resistance or capacitance. If there are a plurality of sensors, said plurality of sensors may surround the proximal opening. Each sensor may be located at a radial distance outward from the longitudinal axis that is greater than the first radial distance.

In the presence of multiple skin contact sensors, the RF transmission from the injection device assembly (and received by said at least one mobile device processor) may contain data indicating which individual sensors of the plurality of sensors are detecting contact with skin tissue and which individual sensors of the plurality of sensors are detecting contact with skin tissue. sensors do not detect contact with skin tissue. The method may further include displaying on the display of the mobile device a schematic representation of a plurality of sensors indicating which individual sensors of the displayed plurality of sensors detect contact with skin tissue and which individual sensors of the displayed plurality of sensors do not detect contact with skin tissue. In another exemplary embodiment, the injection device assembly may comprise a housing, a syringe assembly at least partially located within the housing, a drive mechanism configured to move the syringe assembly from a storage position to an injection position, one or more sensors. skin contact, wherein each sensor is configured to detect contact with skin tissue, and an accelerometer located inside the housing and configured to output a signal expressing the detected acceleration. The device assembly may further comprise a data processing circuit configured to analyze the signal output from the accelerometer to detect acceleration pulses and determine that the first acceleration pulse detected in the signal output from the accelerometer is due to the initiation of a dispensing operation in which the drive mechanism moves the syringe the node from the storage position to the injection position only when at least one of said one or more skin contact sensors detects contact with skin tissue at the time of detection of the first acceleration pulse. The device assembly may also comprise a retract mechanism configured to move the syringe assembly from an injection position to a retracted position, wherein the processing circuitry is further configured to determine that the second acceleration pulse detected by the accelerometer after the first acceleration pulse is caused by retraction movement upon completion. a dispensing operation, in which the retracting mechanism moves the syringe assembly from the injection position to the retracted position only when at least one of said one or more skin contact sensors detects contact with skin tissue at the time of detecting the second acceleration pulse.

In another exemplary embodiment, a method for determining the initiation of a dispensing operation may include providing an injection device assembly, the assembly comprising a housing, a syringe assembly at least partially located in the housing, a drive mechanism configured to move the syringe assembly from a position for stored in an injection position, one or more skin contact sensors, each sensor configured to detect contact with skin tissue, and an accelerometer located within the device assembly and configured to output a signal representing the detected acceleration. The method may further include determining, by at least one processing circuitry, whether at least one of said one or more skin contact sensors detects contact with skin tissue; analysis by at least one processing scheme

- 2 039706 accelerometer output signal data for detecting the first acceleration pulse; determining by said at least one data processing circuit that the first acceleration pulse is due to the initiation of a dispense operation in which the drive mechanism moves the syringe assembly from the storage position to the injection position only when at least one of said one or more sensors skin contact detects contact with skin tissue at the time of detection of the first acceleration pulse. The injection device assembly may further comprise a retracting mechanism configured to move the syringe assembly from an injection position to a retracted position. The method may further include parsing the at least one data processing circuitry of a signal output from the accelerometer to detect a second acceleration pulse after the first acceleration pulse; and determining, by said at least one data processing circuit, that the second acceleration pulse is due to retraction movement after completion of the dispensing operation, in which the retracting mechanism moves the syringe assembly from the injection position to the retracted position only when at least one of said one or more skin contact sensors detect contact with skin tissue during detection of the second acceleration pulse.

In another embodiment, the injection device assembly may include a housing, a syringe assembly at least partially located within the housing, a drive mechanism configured to move the syringe assembly from a storage position to an injection position for metered delivery of a drug, one or more skin contact sensors, each sensor configured to detect contact with skin tissue, and an accelerometer located within the device assembly and configured to output a signal expressing the detected acceleration. The injection device assembly may further comprise a data processing circuit operatively coupled to one or more skin contact sensors and an accelerometer configured to analyze the signal output from the accelerometer to detect a first acceleration pulse and a second acceleration pulse after the first acceleration pulse. The data processing circuit may also be configured to determine that the dispensing operation has been completed upon satisfaction of a set of one or more conditions, the set of conditions including the following condition: at least one of said one or more skin contact sensors detects contact with the skin tissue at least once within the time period beginning with the first acceleration pulse and ending with the second acceleration pulse. The data processing circuit may also be configured to determine that the dispensing operation has not been completed if at least one condition in the set of conditions is not satisfied. The injection device assembly may further comprise a retracting mechanism configured to retract the syringe assembly from the injection position to the retracted position upon completion of the dispensing operation. In some embodiments, the retract mechanism may be the same mechanism as the drive mechanism, or have components in common with it. In another embodiment, a method for determining completion of a dispensing operation may include providing an injection device assembly, the assembly comprising a housing, a syringe assembly at least partially located within the housing, a drive mechanism configured to move the syringe assembly from a storage position to a injection for metered delivery of a drug, one or more skin contact sensors, each sensor configured to detect contact with skin tissue, and an accelerometer located inside the device assembly and configured to output a signal representing the detected acceleration. The method may further include parsing the signal output from the accelerometer to detect the first acceleration pulse and the second acceleration pulse following the first acceleration pulse, and determining whether the dispensing operation has been completed. This determination may include determining that the dispensing operation has been completed upon satisfaction of a set of one or more conditions, wherein the set of conditions includes the following condition: at least one of said one or more skin contact sensors detects contact with skin tissue at least once within a time period starting with the first acceleration pulse and ending with the second acceleration pulse, and determining that the dispensing operation has not been completed if at least one condition of the set of conditions is not satisfied. The injection device assembly may further comprise a retracting mechanism configured to retract the syringe assembly from the injection position to the retracted position upon completion of the dispensing operation. In some embodiments, the retract mechanism may be the same mechanism as the drive mechanism or have components in common with it.

In another embodiment, the injection device assembly may comprise a housing; a syringe assembly, at least partially located in the housing, and the syringe assembly contains a cylinder configured to hold the drug; a drive mechanism configured to dispense the medicament from the barrel upon activation; ter

- 3 039706 electrical ballast; a temperature sensor configured to measure the temperature of the thermal ballast; and at least one data processing circuit configured to calculate the temperature of the drug in the cylinder based on the temperature of the thermal ballast.

In yet another embodiment, a method for estimating the temperature of a drug in an injection device assembly may include: providing an injection device assembly, wherein the assembly comprises a housing, a syringe assembly at least partially located within the housing, the syringe assembly comprising a cylinder configured to hold drug, a drive mechanism configured to dose the drug from the cylinder upon activation, a thermal ballast and a temperature sensor configured to measure the temperature of the thermal ballast. The method may further include receiving on one or more processing circuits the measured temperature of the thermal ballast; and estimating the temperature of the drug in the cylinder based on the measured temperature of the thermal ballast.

Brief description of the drawings

The above and other features of the present invention, as well as the method of providing them, will become more apparent, and the invention will be better understood by reference to the following description of embodiments of the present invention, considered together with the accompanying drawings.

In FIG. 1 shows a sectional view of the injection device prior to use.

In FIG. 2 shows a sectional view of the injection device with the syringe assembly in storage position and ready for injection operation.

In FIG. 3 is a sectional view of an injection device with the syringe assembly in the injection position.

In FIG. 4 shows a perspective view of the stem.

In FIG. 5 is a perspective view of the syringe holder.

In FIG. 6 shows a perspective view of the top shuttle.

In FIG. 7 shows a perspective view of the lower shuttle.

In FIG. 8 is a sectional view of an injection device illustrating the placement of one or more main PCBs within an end portion of the body of an injection device in accordance with a first set of embodiments.

In FIG. 9A shows a top (ie, distal) perspective view of a primary PV and an additional PV according to the first set of embodiments.

In FIG. 9B shows a lower (ie, proximal) perspective view of the primary PV and the secondary PV of the first set of embodiments.

In FIG. 10A shows a top view of the main PCB and the additional PCB of the first set of embodiments.

In FIG. 10B shows a bottom view of the main PCB and the additional PCB of the first set of embodiments.

In FIG. 11 is a side sectional view of an injection device and depicts the spatial relationship between a magnet and two magnetometers according to a first set of embodiments.

In FIG. 12 is a block diagram of an electrical component system in an injection device and an external device according to the first set of embodiments.

In FIG. 13 is a flowchart depicting a pairing or session establishment process between an injection device and an external device in accordance with any of the first set of embodiments, as well as any of the second and third sets of embodiments.

In FIG. 14A and 14B are flow charts depicting a process carried out by a mobile medical application running on an external device, in accordance with any of the first, second, and third sets of embodiments.

In FIG. 15 is a schematic representation of the display of the status of the skin contact sensors on the display of the external device.

In FIG. 16A-16C are views of alternative shapes for an outwardly expanding end portion of an injection device body, in accordance with any of the first, second, and third sets of embodiments.

In FIG. 17A is a top perspective view of the main PCB and syringe position detector switch according to the second set of embodiments.

In FIG. 17B is a bottom perspective view of the main PCB and syringe position detector switch according to the second set of embodiments.

In FIG. 18A is a plan view of the main PCB and syringe position detector switch according to the second set of embodiments.

- 4 039706

In FIG. 18B is a bottom view of the main PCB and syringe position detector switch according to the second set of embodiments.

In FIG. 19 is a side view of the injection device with the syringe assembly in the storage position or in the retracted position, in accordance with a second set of embodiments.

In FIG. 20 is a side view of the injection device with the syringe assembly in the injection position according to the second set of embodiments.

In FIG. 21A shows a top perspective view of the main PCB according to the third set of embodiments.

In FIG. 21B shows a bottom perspective view of the main PCB according to the third set of embodiments.

In FIG. 22A is a plan view of the main PCB according to the third set of embodiments.

In FIG. 22B shows a bottom view of the main PCB according to the third set of embodiments.

In FIG. 23A and 23B are perspective views of a lower cap removal sensor according to a third set of embodiments.

In FIG. 24A is a perspective view illustrating the main PCB and bottom cap removal sensor relative to the removable end cap when the end cap is detached from an injection device according to a third set of embodiments.

In FIG. 24B is a perspective view illustrating the main PCB and bottom cap removal sensor in relation to the removable end cap when the end cap is attached to an injection device according to a third set of embodiments.

In FIG. 25A is a side view showing the lower cap removal sensor when the end cap is detached from the injection device according to the third set of embodiments.

In FIG. 25B is a side view showing a lower cap removal sensor when an end cap is attached to an injection device according to a third set of embodiments.

In FIG. 26 is a graph illustrating an exemplary signal output from an accelerometer located on an injection device according to a third set of embodiments.

In FIG. 27 is a block diagram of an electrical component system in an injection device according to a third set of embodiments.

In FIG. 28 is a flowchart showing an exemplary method carried out by a data processing circuit on an injection device according to a third set of embodiments.

In FIG. 29 is a schematic diagram depicting exemplary logic for determining whether a dispensing operation has been initiated and completed, according to a third set of embodiments.

In FIG. 30 is a flowchart showing an exemplary method for determining the initiation and completion of a dispense operation according to a third set of embodiments.

In FIG. 31 is a flowchart showing another exemplary method for determining the initiation and completion of a dispensing operation according to a third set of embodiments.

In FIG. 32 is a flowchart depicting yet another exemplary method for determining the initiation and completion of a dispense operation according to a third set of embodiments.

In FIG. 33 is a flowchart showing an exemplary method for determining acceleration pulses according to a third set of embodiments.

In FIG. 34 shows an exemplary sequence of steps performed by a user to use an injection device, in accordance with any of the first, second, or third sets of embodiments.

The corresponding item numbers designate the corresponding parts in all individual views. Although the example provided herein illustrates embodiments of the present invention in several forms, the embodiments disclosed below are not intended to be exhaustive or construed as limiting the scope of the invention to the exact forms disclosed.

Implementation of the invention

The present invention relates to measurement systems for drug delivery devices. Measuring systems can be built into the delivery device or built into the pickup

- 5 039706 module attached to the delivery device. Such measuring systems can be configured to determine the current functional status of the device by reading various parameters or signals expressing the functional status of the device.

In some embodiments, measurement systems may sense the location or movement of device components relative to other device components. For example, such measurement systems may track the position and/or movement of a rod used to expel a drug from a drug delivery device. By monitoring the position or movement of the stem, the drug delivery device can determine how much drug has been ejected, the rate at which the drug is ejected, and/or the complete delivery of the drug in the delivery device. Various types of sensors can be used in such measurement systems, such as a video sensor that monitors the movement of the specified components of the device, an optical sensor or radiation sensor that detects the penetration of a device component into the detection zone to which the measurement system is directed, or the exit from such a detection zone, a magnetic field sensor , which detects changes in the read magnetic field due to movement of device components, or one or more accelerometers that detect movement of device components.

In some embodiments, measurement systems may determine the orientation of a device. The defined orientation can be used to determine if a drug delivery device is properly oriented for drug delivery; for example, the delivery device may alert the user or prevent drug delivery when the device is in an inverted orientation or in any orientation that makes it difficult or impossible to deliver the drug safely and reliably. Such measurement systems may use one or more accelerometers located at one or more sites on the device and which are configured to determine the direction of gravity. Measurement systems may also include a data processing circuit configured to determine the orientation of the device along one, two or three orientation axes based on readings taken by the accelerometers.

In some embodiments, the measurement systems may measure the temperature of a drug stored in a drug delivery device.

Some medicinal products may require storage in the first (eg, lower) temperature range to prevent spoilage and bring them to the second (eg, higher) temperature range before being delivered to the patient's body. Temperature measurement systems can be used to monitor the temperature of the drug in the delivery device during storage and prevent it from being exposed to unsafe temperatures that could render the drug unfit for consumption. Temperature measuring systems may also be used to alert users when the temperature of a medicinal product reaches unsafe levels. When preparing the device for use, measurement systems can be used to determine when the temperature of the drug has been brought within the second temperature range. The drug delivery device may then notify the user that the drug is ready for delivery, for example, by using a visual indicator (for example, by turning on and/or turning off one or more LEDs), an audible indicator (for example, an alert or an audible speaker signal) or a wireless signal transmitted to an external mobile device, which in turn notifies the user. Such temperature measurement systems may use any of a variety of types of sensors to measure the temperature of the drug, such as an infrared sensor or a thermistor. In some embodiments, the measurement systems may include one or more sensors configured to determine when and/or which areas of the drug delivery device are in contact with the patient's skin. A drug delivery device may use such measurement systems to determine when the device is properly positioned to inject a drug into a patient's body. Such measurement systems may include one or more sensors configured to measure electrical resistance or capacitance, and data processing circuits configured to determine when a particular sensor is in contact with human tissue, such as skin, based on the measured resistance or capacitance. In cases where the measurement systems comprise a plurality of sensors, the systems may be configured to determine which individual sensors of the plurality of sensors are in contact with human tissue. Such measurement systems may also include temperature sensors, such as those described above, that are configured to detect when the sensor is in contact with human tissue.

Measurement systems can determine the current functional status of a device. This current status can be communicated to the user, for example, through visual, audible or

- 6 039706 tactile indicators embedded in or physically connected to a delivery device such as one or more displays, LEDs, speakers or vibrators. This current status can also be reported to the user by sending the current status data to an external device via a wired or wireless communication channel, and the external device, in turn, can report the current status to the user. For example, in some embodiments, a drug delivery device may comprise a short-range wireless communication interface, such as an NFC (NFC), Bluetooth, and/or Bluetooth Low Energy (BLE) circuit, that communicates current functional status. delivery device to an external device. This external device may be an electronic computing device capable of executing software and/or firmware for receiving and processing data, as well as reporting to the user the functional status of the delivery device. Exemplary external devices include a mobile hand-held device (e.g., smartphone, mobile phone, pager, personal digital assistant (PDA), tablet, etc.), a wearable device (e.g., a smart watch or augmented or virtual device). reality), a portable mainframe computer (such as a laptop), or a desktop mainframe computer. When the user is informed of the functional status of the device, there is less likelihood that the user will perform an action that could adversely affect the effective use of the device, such as removing the device from the injection site before drug delivery is complete, or delivering the drug before it has been warmed to the appropriate delivery temperature. By way of illustration, a drug delivery device is described in the form of a self-injection device. However, a drug delivery device can be any device that is used to deliver a dose of a drug, such as pens, infusion pumps, and syringes. The drug may be any type of drug that can be delivered by such a drug delivery device. It may be advantageous to provide a measurement system along the device to record at least one of the following states: a needle guard present state, an injection ready state, a needle insertion state, a drug delivery state, and a needle retract state, or a combination thereof.

It may be advantageous to determine whether a dose has been delivered and/or functional statuses during the injection process by means of the module without the need to change the mechanical configuration of the delivery device drive mechanism.

In FIG. 1-3 show the drug injection device 20 in various functional states. One example of such a device and its operation is described in US Pat. No. 8,734,394 B2, filed May 27, 2014, by Adams et al., the entire contents of which are incorporated herein by reference. Device 20 includes syringe assembly 22, drive mechanism 24, and retract mechanism 26, and may include one or more main printed circuit boards (PCBs) 82 and/or one or more additional PCBs 84 depicted below, for example, in FIG. 8, 9A, 9B, 10A and 10B. The syringe assembly 22 includes a barrel 30 forming a container body for holding a drug, and a plunger 32 located in the barrel 30 for withdrawing the drug from the barrel. The syringe assembly 22 also includes a needle assembly 33 comprising a hollow injection needle 34 and a needle cannula 35 that positions the needle 34 onto the syringe barrel 30. Progression of piston 32 within barrel 30 toward needle 34 provides metered delivery of drug through needle 34. The devices described herein, such as device 20, may further contain drug, for example, within barrel 30 of a syringe. In another implementation, the system may contain one or more devices, including device 20 and drug. The term drug refers to one or more therapeutic agents, but is 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) , such as ixekizumab, therapeutic agents for the treatment associated with pain, such as galkanzeumab or lasmiditan, and any therapeutic agent that can be delivered using the devices described herein. The drug used in the device may be manufactured using one or more excipients. The device is actuated in the manner generally described above by a patient, caregiver, or healthcare professional to deliver a drug to a human.

In FIG. 1 shows the device 20 in its original configuration prior to use. In this case, the end cap 36 is attached to the injection device body 38 and covers the proximal end opening 40 in the body 38. As used herein, the terms distal and pro

- 7 039706 ximal refers to the axial portions relative to the injection site when the device is in orientation for use at that site, while, for example, the proximal end of the housing refers to the end of the housing closest to such an injection site, and the distal end of the housing refers to the end of the housing furthest from such an injection site. The housing 38 may be made of a plastic material and is shown extending generally in the longitudinal direction between the distal end adjacent to the actuating button 52 and the proximal end adjacent to the proximal end opening 40 along the longitudinal axis 48. As shown in FIG. 2 and 8, the housing 38 may include a user-grip portion 37 configured to be held by the user's hand, the user-grip portion 37 extending a radial distance 41 outward from the longitudinal axis 48. In some embodiments, the radial distance 41 may be between 5 and 10 mm in length (for example, in some implementations, a suitable length may be 5-8 mm). Just as shown in FIG. 2 and 8, the body 38 may also include an outwardly expanding end portion 39 at the proximal end of the body adjacent to the proximal opening 40. The end portion extends outward from the longitudinal axis 48 by a radial distance 43 that is greater than the radial distance 41. In some embodiments, the radial distance 43 may be more than 10 mm in length. For example, in some embodiments, the radial distance 43 may be 10 to 20 mm in length (eg, in some embodiments, 15 to 20 mm may be a suitable length). The end portion 39 may slope gently radially outward from the user gripped portion 37 as shown in FIG. 1-3. In other embodiments, end portion 39 may have other shapes. In FIG. 16A16C, several exemplary alternative shapes are shown for the end portion 39, but the end portion 39 may be any shape that extends from the longitudinal axis 48 by a radial distance 43 greater than the radial distance 41 of the user gripped portion.

Needle guard 42 is mounted on syringe assembly 22, covering and surrounding needle 34. End cap 36 and needle guard 42 protect the user from accidental needle sticks and also protect needle 34 from damage. When using the device 20 for metered delivery of a medicinal product, for example for injection of a medicinal product, the end cap 36 and the needle shield 42 are first removed to the patient.

In FIG. 2 shows the device 20 after removal of the end cap 36 and needle guard 42 from the syringe assembly 22 with the syringe assembly in the storage position, and the device 20 is ready for dispensing. The syringe assembly 22 is movable relative to the injection device 20 between a storage position and an injection position.

In FIG. 3 shows the device 20 after the syringe assembly 22 has moved relative to the device 20 to the injection position from the storage position shown in FIG. 2. In the storage position (FIGS. 1 and 2), the needle 34 is retracted to such a position that the needle 34 is in the body 38 of the device 20. In the injection position (FIGS. 3), the needle 34 protrudes outward from the body 38 beyond the proximal opening 40 in the proximal direction parallel to the longitudinal axis 48, and the needle 34 can be inserted into the patient.

The drive mechanism 24 includes a rod 44 configured to engage with the piston 32. The drive mechanism 24 includes a spring 46 that moves the rod 44 in translational motion. In one illustrated embodiment, the implementation of the spring 46 advances the rod 44 along a linear path defined by the longitudinal axis 48 of the device 20. As the rod 44 advances, the base 50 of the rod 44 contacts the piston 32. With further advancement of the rod 44, the syringe assembly 22 of the syringe is advanced along the axis 48 of storage position to injection position. After advancing the syringe assembly 22 to its injection position, continued proximal advancement of the stem 44 advances the piston 32 proximally in the barrel 30 from its initial piston position (shown in FIGS. 1 and 2) to its piston end position (shown in FIGS. .3) providing metered delivery of drug from the delivery needle 34 via a metered delivery event. Prior to any metered delivery of drug, and when the syringe barrel 30 holds the full initial volume of drug, the plunger 32 will be in its original plunger position. After the plunger 32 has advanced its full travel length towards the needle assembly 33, the plunger 32 will be in its final piston position next to the needle assembly 33 and, by that time, the drug will have been dispensed from the cylinder 30. In a single use, the syringe assembly 22 will hold one dose of drug to be delivered in one injection operation, and piston 32 will be moved from its initial piston position to its final piston position in that one injection operation, to thereby deliver the entire contents of one dose of syringe assembly 22. Although the device is shown as a disposable device, indication of device status may also provide benefits for reusable devices during a single use.

Advancement of stem 44 will generally not result in metered delivery of drug from syringe assembly 22 until syringe assembly 22 has been moved to the injection position. Su

- 8 039706 There are factors that can make it difficult to dose the drug before moving the syringe into the injection position. Friction between piston 32 and cylinder 30 may be a factor. Typically, the piston 32 will be made of a rubber material and the cylinder 30 will be made of glass. Frictional resistance between these two components may be sufficient to prevent advancement of piston 32 in barrel 30 until syringe assembly 22 is moved to its injection position, and engagement with a suitable stop member prevents further advancement of syringe assembly 22. In addition, the drug in the syringe can be quite viscous and therefore quite resistant to flow out of the needle 34. If necessary, modifying the plunger 32 and syringe barrel 30 to change the frictional resistance of the dispensing movement of the interaction member 32 relative to the syringe barrel 30 can limit or prevent premature dispensing of the drug. drug before container 22 reaches its injection position.

Stem 44 may include a magnet 25 near base 50. As shown in FIG. 1-3, magnet 25 is configured to maintain a constant axial distance from piston 32. Magnet 25 emits a magnetic field read by magnetometers 118 and 112, described below with reference to FIG. 9A, 9B and 11.

To activate the drive mechanism 24, a person presses an actuating button 52 at the distal end of the device 20. Pressing the button 52 disconnects one or two elongated pins 54 on the stem 44 (shown in Fig. 4) from the shuttle assembly 60, thereby allowing the stem 44 to be advanced into axially through spring 46. Spring 46 is helically shaped and surrounds pins 54. The proximal end of spring 46 engages flange 56 on stem 44.

Shuttle assembly 60 may include an upper shuttle element 62 shown in FIG. 6 and the lower shuttle 64 shown in FIG. 7. Shuttle elements 62, 64 are connected to each other in the assembled node. In the assembled assembly, the upper shuttle 62 engages the button 52 and the spring 46, limiting the axial movement of these parts in the distal direction. Pins 54 engage surfaces on top shuttle 62 when the device is in the state shown in FIG. 1 and 2. Depressing button 52 engages tabs on button 52 with tabs 55 on pins 54 to move pins 54 inward to disengage pins 54 from upper shuttle 62. After pins 54 are disengaged , spring 46 applies a biasing force to flange 56 to advance stem 44 from the position shown in FIG. 2 to the position shown in FIG. 3. As the rod 44 advances, it moves the syringe assembly 22 to the injection position and then advances the plunger 32 to dispense the drug as described above.

After completion of the dispensing operation, the retracting mechanism 26 moves the syringe assembly 22 from the injection position shown in FIG. 3, back to the retracted position. More specifically, the retracting mechanism is configured to move the drug container from the injection position to the retracted position by retracting movement. The retracted position may be similar to the storage position in that the syringe assembly is retracted back into the housing 38 so that the needle 34 no longer protrudes proximally from the proximal opening 40 and is located completely inside the housing 38. In some embodiments, the retracted position may be identical to the position for storage. However, in other embodiments, the syringe assembly 22 in the retracted position may be positioned slightly proximal to or distal to the syringe assembly in the storage position. In the depicted embodiment, the retraction mechanism includes a spring 66, a syringe holder 68 shown in FIG. 5 and a rotating element 70 which acts as a pusher. In other embodiments, the device 20 may not include a retracting mechanism 26 so that the syringe assembly always remains in its injection position after dispensing the drug until manual removal or movement of the syringe assembly by the user.

The stem 44 may include a cantilever 58 that unlocks the rotating member 70 as the stem 44 approaches the end of its proximal travel. Rotating member 70 is rotatably attached to lower shuttle member 64 by engaging between a latch and a latch slot in lower shuttle member 64. Console 58 unlocks member 70 by depressing the latch. Spring 66 is pre-rolled and has one end in engagement with element 70 and an opposite end in engagement with shuttle assembly 60. When the latch is depressed, spring 66 rotates element 70. With additional reference to FIG. 7, element 70 may include a slot that receives tab 78 on lower shuttle 64. At one end of the slot, element 70 defines an axially extending channel. When element 70 is rotated, tongue 78 can move within the slot on element 70 until tongue 78 reaches the channel extending in the axial direction.

Element 70 is rotatable within housing 38, but not axially rotatable relative to housing 38. Other embodiments may include element 70 that is also axially movable. Radial flange on swivel

member 70 may engage a protrusion within body member 38 to limit proximal movement of member 70. Spring 66 may apply an axial force, a torsional force, or both, to member 70 to displace member 70 in the proximal direction, thereby retaining member 70 in an axial position, which ensures the engagement of the radial flange of the element 70 with the internal protrusion of the element 38 of the body. Shuttle assembly 60 may include axially extending channels or ribs configured to engage with corresponding elements on housing member 38 that allow shuttle assembly 60 to move axially within housing 38 but prevent relative rotation of shuttle assembly 60 relative to member 38 corps.

Spring 66 is also axially preloaded and exerts a distally biasing force on shuttle assembly 60. When tongue 78 reaches the axially extending channel, spring 66 moves shuttle assembly 60 distally within housing 38 while sliding tongue 78 axially through channel. A damping compound may be positioned adjacent to the rotating element 70 to slow the rotation of the element 70 and allow the dispensing event to complete before the tongue 78 reaches the axially extending channel. For example, pivot member 70 may include a skirt with a plurality of axially extending tabs located in a cushioning layer of lubrication.

As the shuttle assembly 60 moves distally, it moves the syringe assembly 22 distally and moves it back to the storage position shown in FIG. 2. Spring 66 pushes retractor 26 distally and thus maintains syringe assembly 22 in its retracted position after the injection operation. A locking mechanism, such as a latch on the shuttle assembly 60 and a recess on the body member 38, may further provide a locking engagement to lock the syringe assembly 22 in a retracted position with the needle 34 located within the body 38 after the injection operation, whereby the user may then dispose of the device. 20 or otherwise handle it safely.

The syringe holder 68 is shown in FIG. 5. The arcuate arms 84 of the holder can hold the barrel 30 of the syringe assembly 22. The syringe holder 68 also includes a flange 86. The flange on the syringe barrel 30 is fixed between the arms 84 and the flange 86. A portion of the underside 88 of the flange 86 engages with a small flange 90 on the stem 44 and thereby prevents proximal axial movement of syringe assembly 22 prior to advancement of stem 44. When shuttle assembly 60 is retracted, lower shuttle member 64 engages arms 84 to move syringe assembly 22 distally to its retracted position.

Although in FIG. 1-7 show and describe an exemplary drive mechanism 24 and an exemplary retract mechanism 26 for moving the syringe assembly 22 from a stored position to an injection position and/or from an injection position to a retracted position, others may also be used. mechanisms. Such actuating and/or retracting mechanisms may (but need not) comprise one or more springs or deformable parts which store energy when held in a pre-actuation state and upon actuation release said stored energy to move the syringe assembly from a storage position to a position for injection and/or from the injection position to the retracted position. Such mechanisms may (but need not) include mechanisms that generate motive power using chemical reactions or processes, for example by generating gas by mixing two or more reactants, or by igniting a small amount of fuel or explosive. Such chemical reaction actuated mechanisms may comprise one or more storage containers for chemical reagents, a trigger mechanism that pierces or opens said storage containers to allow mixing of said reagents, and/or that provides a spark or other source of ignition. to initiate a chemical reaction, and a movable piston or other component configured to move in response to the increasing gas pressure generated by the resulting chemical reaction. Such mechanisms may (but need not) include mechanisms that use stored electrical power (eg, in a battery) to operate electric motors to move and/or retract the syringe assembly, or to actuate other physical or chemical mechanisms. Such mechanisms may (but need not) contain hydraulic or pneumatic systems (eg, tubes), gears, cables, rollers, or other known components for transferring kinetic energy from one component to another. In some embodiments, instead of having separate mechanisms for moving the syringe assembly and then retracting the syringe assembly, one mechanism may be configured to move and then retract the syringe assembly.

In FIG. 8 shows an exemplary arrangement of one or more main FPs 82 within an end portion 39 in accordance with a first set of embodiments of device 20. Said one or more main FPs may be perpendicular to the longitudinal axis 48 and may be stacked on top of each other. , and/or may be

- 10 039706 are located next to each other on the same plane perpendicular to the longitudinal axis 48. The main (main) PP forms an opening 83 through which the needle 34 for injection of the syringe assembly 22 is made with the possibility of passing, for example, when removing the end cover 36 and moving the needle for injection in the proximal direction for injection into the body of the patient during the operation of dosed delivery. As shown, the main PV(s) extend from the longitudinal axis 48 by a radial distance 45 that is greater than the radial distance 41 of the user gripped portion 37. FIG. 8 also shows one or more additional CBs 84 extending substantially perpendicular to the main CBs and parallel to the longitudinal axis 48, wherein the additional CB(s) may be communicatively connected to the main CB(s) via one or more connectors. 114 PP. While additional metering systems may be installed on the additional sensor(s) 84, such additional sensor(s) are optional and may be omitted in some implementations to reduce manufacturing complexity and cost.

The end section 39 may have a preferred location and size within the device 20 to accommodate the main (main) PP. The increased area of the end section 39 is formed by the radial extension of the end section outward from the longitudinal axis 48 by a radial distance 43 which is greater than the radial distance 41 of the user gripped section. Due to the increased area, more space is provided for housing the main PCB(s) and its various components than in other areas of the device 20. Thus, many components can be pre-assembled with the main PCB located in the advantageous area of the end section 39. As a result , the incorporation of the main PCB(s) into the end portion 39 may require little or no change to the shape of the known body of self-injection devices, which reduces disruption to manufacturing processes and lowers manufacturing costs. In addition, the placement of the main sensor(s) in the end portion 39 allows the skin contact sensors 122, 123 and 124 to be further away from the longitudinal axis 48, which increases the reliability of the skin contact reading data obtained from these sensors.

In FIG. 9A is a top perspective view of the main PV(s) and additional PV(s), and FIG. 9B shows a bottom perspective view of the same PCB(s) according to the first set of embodiments of device 20.

In FIG. 10A and 10B show top and bottom views of identical PCBs, respectively. The main PCB(s) 82 (shown in FIG. 8) may have a top surface 82a (shown in FIGS. 9A and 10A—it should be understood that the top surface 82a is part of the printed circuit board(s) (PCB) 82) that contains or supports power source 102, which in some implementations may include a battery, such as a coin cell battery. The power supply 102 supplies power to the electrical components built into or connected to the injection device 20 . The main (main) PP 82 may also contain circuit 108 data processing. In some embodiments, data processing circuitry 108 may be in the form of a system-on-a-chip (SOC) integrated circuit that includes a processor, storage, and I/O ports. However, the data processing circuit 108 may also be implemented using other types of components, such as a microcontroller or an application specific integrated circuit (ASIC). The data processing circuit 108 may be configured to execute computer-executable instructions stored on non-volatile storage media. The main PCB(s) may also include a variety of different types of sensors, such as a microswitch sensor 110, a magnetometer 112, an accelerometer 140, an ambient light sensor 106, and/or one or more skin contact resistance sensors 122, 123, and 124. In embodiments containing additional (additional) PP, additional (additional) PP may additionally contain other sensors, such as another sensor 116 microswitch, magnetometer 118, infrared temperature sensor 120.

The microswitch sensors 110 and 116 may be connected to the data processing circuit 108 in an communicable manner. Each microswitch sensor may include a physical switch coupled to an electrical circuit that outputs electrical signals to the data processing circuit 108 depending on the physical position or orientation of the physical switch. The microswitch sensors 110 and 116 can be used to determine the positions of the components of the injection device 20. For example, microswitch sensor 110 can be used to determine whether end cap 36 is attached to the proximal end of device body 38 or not. As described in more detail below, depending on the output of the microswitch sensor 110, the processing circuit 108 may notify the user whether the end cap 36 is attached to the device 20 or not. Similarly, the microswitch sensor 116 can be used to detect if the syringe assembly 22 is in one of two states, such as (i) a storage position or (ii) an injection position. The microswitch sensor 116 may also be configured to detect that the syringe assembly 22 is in one of three states, such as (i) storage position, (ii) injection position, or (iii) retracted position. Depending on the

- 11 039706 microswitch sensor output 116, the data processing circuit 108 can notify the user of the position of the syringe assembly 22. The ambient light sensor 106 can be connected to the data processing circuit 108 with the ability to communicate and can determine the amount or intensity of the external light, to which the injection device 20 is subjected. Excessive exposure to ambient light can result in ineffective or unsafe injection of the drug stored in cylinder 30. In some embodiments, data processing circuitry 108 may record the intensity and/or duration of ambient light detected by ambient light sensor 106. If the intensity and/or duration of exposure to external light exceeds predetermined thresholds, the user may be informed that the drug should not be used.

Accelerometer 140 may be coupled to data processing circuitry 108 and may determine the orientation of injection device 20 (eg, facing up, down, or sideways). This may be important for certain types of drugs where gravity can be significant due to particle settling, etc., which may require the drug to be delivered in a particular orientation. The data processing circuit 108 may also use the output of the accelerometer 140 to alert the user if the injection device 20 is not properly oriented (eg, if the device is upside down). As described in more detail below, the accelerometer 140 may be used to detect vibrations from an external device to facilitate wireless pairing of the injection device 20 with the external device.

Many types of drugs require storage at a first relatively cool temperature (eg, between 36 and 46°F, or 2 and 8°C) to prevent spoilage, but then require heating to a second warmer temperature (eg, room temperature or 65 to 75°F, or 18 to 24°C) before injection into the patient's body. To ensure that the drug is stored within the cylinder 30 at a suitable storage temperature and/or to ensure that the drug is heated to a suitable temperature for injection, the injection device 20 may be equipped with a mechanism for estimating the temperature of the drug. By verifying that the drug has been heated to the correct temperature, this information can be communicated to the phone, or the device itself can signal to the patient that the device is ready for use. In some implementations, this temperature measurement function may be performed by an infrared (IR) temperature sensor 120 on an additional PCB 84. The IR sensor 120 may be connected to the data processing circuit 108 with the ability to communicate. As best shown in FIG. 8, IR sensor 120 may be positioned adjacent to and facing cylinder 30. IR sensor 120 can detect and measure IR electromagnetic radiation from cylinder 30 and output an electrical signal based on the detected IR radiation. By sampling the electrical signal output from the IR sensor 120, the data processing circuit 108 can estimate the temperature of the drug within the cylinder 30.

The main PC(s) may also be equipped with one or more antennas to send or receive wireless communications. For example, in FIG. 9A and 9B show a Bluetooth Low Energy BLE (BLE) antenna 104 located on the top surface 82a of the main PCB(s), and an NFC (NFC) near field communication (NFC) antenna 126 (shown as a feature surrounded by a thick black line) located on the bottom. surface 82b of the main (main) PP. Other implementations are also possible, in which the main (main) PP is equipped with only one antenna or only one type of antenna. As described in more detail below, these antenna(s) may allow the injection device 20 to establish a wireless communication link with an external device.

The main PP(s) may also be connected or integrated in communication with a plurality of sensors configured to detect contact with skin tissue. Skin contact sensors may be used to verify proper contact with the user's skin prior to activation of the injection device 20 by the user. The injection device 20 may also indicate to the user which sensors are detecting skin contact and which are not; with this information, the user can know which way he should tilt or move the injection device 20 before injecting. This feature reduces the likelihood of failed injections in which the needle 34 fails to pierce the user's skin or punctures it at an inappropriately low angle.

In FIG. 9B and 10B show an exemplary embodiment comprising three skin contact sensors 122, 123, and 124 located on the bottom surface 82b of the main PCB(s) and formed in a symmetrical three-lobe shape. In this exemplary embodiment, each skin contact sensor 122, 123 and 124 contains two separate electrical clips—sensor 122 contains clips 122a and 122b, sensor 123 contains clips 123a and 123b, and sensor 124 contains clips 124a and 124b. Although only two electrical clamps are shown for each sensor, other implementations are also possible in which each sensor has more than two

- 12 039706 electrical clamps. Each skin contact sensor can measure the electrical resistance between its electrical terminals and output an electrical signal to the processing circuit 108 based on the measured resistance. The electrical resistance of skin tissue is generally lower than the electrical resistance of air, and therefore, the processing circuit 108 can determine that a particular skin contact sensor is in contact with skin tissue when the measured resistance is below a predetermined threshold.

Although in FIG. 9B and 10B each skin contact sensor 122, 123 and 124 is shown as containing two electrical clips, other embodiments are possible in which each skin contact sensor contains only one electrical clip. In such cases, the electrical clamp of one skin contact sensor (eg, sensor 122) may function as a reference electrode outputting a predetermined voltage. An electrical clip on each of the other two skin contact sensors (eg, sensors 123 and 124) can function as a measuring electrode, measuring the electrical resistance of the current path between itself and the reference electrode. When the measured resistance between the reference electrode and the specific measurement electrode is below a predetermined threshold, the processing circuit 108 may determine that the reference electrode and the specific measurement electrode are in contact with human tissue such as skin. When both measurement electrodes (eg, at sensors 123 and 124) indicate measured resistance values below a predetermined threshold, the processing circuit 108 may determine that the reference electrode and both measurement electrodes are in contact with human tissue. Exemplary embodiments of device 20 incorporating capacitive sensors are described below with reference to FIGS. 17A, 17B, 18A and 18B and a second set of device 20 embodiments.

As best shown in FIG. 10B, each skin contact sensor 122, 123, and 124 may be located at a radial distance 128, 130, and 132, respectively, outward from the longitudinal axis 48 (which extends into the page in the view shown in FIG. 10B). Sensors 122, 123 and 124 may optionally be positioned to symmetrically surround opening 83 such that the radial distances 128, 130 and 132 are equal to each other and the angular separation between each sensor is also the same (e.g. 120° in this case). The radial distances 128, 130 and 132 are greater than the radial distance 41 of the user gripped portion 37 (as shown in FIGS. 2 and 9) and may be greater than 10 mm in length. For example, in some embodiments, each of the radial distances 128, 130 and 132 may be 10 to 20 mm in length, in some cases a distance of 15 to 20 mm may be appropriate. While three skin sensors are depicted, other embodiments are also possible with only one or two skin sensors. On the other hand, implementations with more than three skin contact sensors are also possible; in such embodiments, the skin sensors may be symmetrically surrounding the opening 83 (but this is not required). For example, other embodiments are also contemplated, comprising from four to twenty skin sensors.

Although the skin contact sensors 122, 123 and 124 have been described above as measuring electrical resistance, these skin contact sensors may alternatively be configured to detect skin contact by measuring electrical capacitance. Capacitive sensors can be configured to detect the proximity of human tissue by detecting the effect of the tissue on the electric field generated by the sensor (for example, by detecting the effect of such tissue on the capacitance of a circuit observed or measured by the sensor). Capacitive sensors do not require a metal electrical clip in direct contact with skin tissue and can therefore be partially or completely covered with a protective, non-conductive coating (eg made of plastic). This can increase the reliability of the capacitive sensor by reducing the infiltration of moisture or foreign matter into sensitive electrical components. Capacitive sensors can also reduce the risk of ESD damage to sensitive electrical components in a device, since capacitive sensors do not require exposed metal contacts. Exemplary embodiments of device 20 incorporating capacitive sensors are described below with reference to FIGS. 21A, 21B, 22A and 22B and a third set of embodiments of device 20.

The injection device 20 may also be equipped with means for estimating the axial position or movement of the piston 32 in the cylinder 30. The estimated axial position and/or movement may be used by the data processing circuit 108 to estimate the amount of drug remaining in the cylinder 30 and/or the amount the drug that has been dispensed, if it has been dispensed. In some embodiments, this may be accomplished by providing a magnet at or near piston 32 as it slides along longitudinal axis 48 and one or more magnetometers that measure the magnetic field emitted by the magnet as it slides along longitudinal axis. In FIG. 1-3 and 11 show an exemplary magnet 25 positioned on rod 44 such that it maintains a constant axial distance from piston 32 as the piston slides along longitudinal axis 48 in cylinder 30. FIG. 9A, 9B, 10A and 10B also show an exemplary arrangement of two magnetometers: magnetometer 112 on the main(s)

- 13 039706

RT 82 and magnetometer 118 on additional RT(s) 84. As shown, magnetometer 112 may be positioned further away from longitudinal axis 48 in the radial direction compared to magnetometer 118. In addition, magnetometer 118 may be located at a midpoint along the length of cylinder 30 instead of being located next to one end of cylinder 30.

In FIG. 11 is a side view of the injection device 20 and shows the spatial relationship between the magnet 25 and the magnetometers 112 and 118 according to the first set of embodiments of the device 20. FIG. 11, injection device 20 is shown with syringe assembly 22 in the storage position and end cap 36 fixed to device body 38 to cover proximal opening 40. Magnet 25 creates a magnetic field that can be detected by magnetometers 112 and 118 when magnet 25 is close enough to these magnetometers. Each magnetometer can send a signal to the processing circuit 108 based on the strength of the detected magnetic field. The strength of the magnetic field detected by the magnetometers 112 and 118 varies depending on the position of the magnet 25 as it slides along the longitudinal axis 48 in the direction of the arrow 1102. For example, when the syringe assembly 22 is in the storage position and when the piston 32 is in its original position piston at the distal end of cylinder 30 (as shown in FIG. 11 as well as FIGS. 1 and 2), magnetometers 118 and 112 can only detect a very weak or no magnetic field. When the syringe assembly 22 has advanced to the injection position and the plunger 32 is still in its original plunger position, the magnetometer 112 may continue to detect only a weak or no magnetic field, but the magnetometer 118 may detect a stronger magnetic field than when the syringe assembly is in position. in storage position. By sampling the strength of the magnetic field measured by magnetometers 112 and 118, in some embodiments, the data processing circuitry 108 may determine whether the syringe assembly 22 is in a storage position or an injection position.

With syringe assembly 22 in the injection position, and as piston 32 advances from its home position in the direction of arrow 1102 toward its final piston position (shown in FIG. 3), magnetometer 118 detects an increasing and then decreasing magnetic field as as magnet 25 approaches, passes, and moves away from magnetometer 118. At the same time, advancement of piston 32 in the direction of arrow 1102 causes magnetometer 112 to detect an increasing magnetic field as magnet 25 approaches magnetometer 112. By sampling the strength of the magnetic field detected by magnetometer 118 and 112, the data processing circuit 108 may estimate the position of the magnet 25 along the longitudinal axis 48. Based on this position estimate, the data processing circuit 108 may estimate the position of the piston 32 as well as the amount of drug remaining inside the cylinder 30.

In FIG. 12 shows a block diagram of the system of electrical components in the device 20, as well as a communication channel with an exemplary external device 1250 in accordance with the first set of embodiments of the device 20. As described above, the data processing circuit 108 can be powered by a battery 102 and may include a processor core 1208 and a storage device 1210 (eg, internal flash memory, on-board electrically erasable and programmable read-only memory (EEPROM), etc.). Memory 1210 may store instructions that, when executed by processor core 1208, cause data processing circuitry 1208 to perform the operations described herein. The data processing circuit 108 may also be coupled to a plurality of communicable sensors such as an ambient light sensor 106, an end cap microswitch 110, a magnetometer 112, an accelerometer 140, and skin contact sensors 122, 123, and 124. The data processing circuit 108 may also be connected to one additional PW or a plurality of additional PBs via a flexible connector 114 in an communicable manner, if desired. Additional (additional) PP may optionally include a microswitch 116, a magnetometer 118 and an IR temperature sensor 120. The data processing circuit 108 may also be coupled to a user feedback means 1208 built into the device 20. The user feedback means may comprise one or more indicator lights (eg, implemented using LEDs), a display, a tactile indicator such as vibration actuator, and/or an audible indicator such as a loudspeaker). The data processing circuit 108 may be communicatively coupled to each of the above components via one or more physical, electrical channels such as (but not limited to) a general purpose input/output pin (GPIO), an IC interconnect bus (I2C), a serial peripheral interface (SPI) connection, a universal asynchronous transceiver (UART) connection, and/or a controller area network (CAN) bus. In some cases, the signals received by the processing circuit 108 from some or all of the sensors may also be converted from an analog to a digital signal using an analog-to-digital converter (ADC).

The data processing circuitry 108 may also be configured to allow the injection device 20 to communicate wirelessly with an external device (such as, for example, a mobile phone, wearable device, laptop, and/or database server). To promote

- 14 039706 wireless communication, the data processing circuit 108 may comprise an NFC near field communication (NFC) circuit 1204 communicatively coupled to an NFC near field communication antenna 1205, such as the NFC near field communication antenna 126 shown in FIG. 9B and 10B. The NFC near field communication circuit 1204 and the NFC near field communication antenna 1205 enable the data processing circuit 108 to establish the NFC near field communication wireless channel 1232 with the external device 1250. Alternatively or additionally, the processing circuit 108 may comprise a Bluetooth Low Energy BLE circuit 1206 ( BLE) communicatively coupled to a Bluetooth low energy BLE antenna 1207, such as the Bluetooth low energy BLE antenna 104 shown in FIG. 9A and 10A. The Bluetooth low energy BLE circuit 1206 and the Bluetooth low energy BLE antenna 1207 enable the data processing circuit 108 of the wireless BLE channel 1234 to establish a Bluetooth low energy BLE communication with an external device 1250. FIG. 12 also shows an exemplary external device 1250 that is physically separate from the injection device 20. In this embodiment, an exemplary external device 1250 may be in the form of a mobile smartphone comprising a processor 1252 (e.g., microprocessor or CPU) and a memory 1258. The memory 1258 may include a non-volatile computer-readable medium that stores computer-executable instructions that, when executed, processor 1252 cause device 1250 to perform the operations described herein. These computer-executable instructions may include a mobile application, such as a medical mobile application. The device 1250 may further comprise a display 1260 and a user input device 1262. User input device 1262 may include physical buttons or switches built into a smartphone. Despite the separate depiction in FIG. 12, all or part of the user input device 1262 may be incorporated into the display 1260, such as a touchscreen display. Device 1250 may also include a vibration source 1264, such as a vibrator.

Device 1250 may be configured to establish a wireless communication link with injection device 20. For example, the external device 1250 may include an NFC NFC proximity circuit 1254 coupled to an NFC proximity antenna 1255 that communicates with the processing circuit 108 via a communication channel 1232. The device 1250 may also include a Bluetooth Low Energy BLE circuit 1256 coupled to a Bluetooth Low Energy BLE antenna 1207 that communicates with the processing circuit 108 via a communication channel 1234.

In FIG. 13 is a flow diagram depicting an exemplary process 1300 for pairing or establishing a communication session between injection device 20 and external device 1250. Process 1300 may be used in any of the first set of embodiments of device 20, as well as any of the second. and a third set of embodiments of device 20, described below. To conserve power, the injection device 20 may initially be stored in a low power sleep mode 1326. While in this sleep mode 1326, some or all of the components connected to or incorporated in the data processing circuit 108 may be turned off or put into a low power state to conserve power. For example, some or all of the sensors coupled to data processing circuitry 108 may be turned off, Bluetooth Low Energy BLE circuitry 1206 and Bluetooth Low Energy BLE antenna 1207 may be turned off, and part or all of processor core 1208 may be turned off or operational. at a lower clock frequency. When the device 20 is in a low power sleep mode 1326, the device may need to wake up before it can connect to the external device 1250.

One way to wake up the injection device 20 is to configure the external device 1250 to emit an NFC NFC field (e.g., an electromagnetic field) using its NFC NFC circuit 1254 and NFC antenna 1255 (step 1328). When the external device 1250 is in close proximity to the injection device 20 (e.g., within a few centimeters), the NFC NFC radiated field causes an electric current to flow in the NFC NFC antenna 1205 coupled to the data processing circuit 108. The processing circuit 108 can in turn be configured to wake up the injection device 20 from a low power sleep mode upon detection by the processing circuit 108 of this induced electrical current. The data processing circuit 108 may also be configured to wake up the device 20 only upon detecting an induced electrical current corresponding to an expected code or pattern, to prevent the injection device 20 from being awakened by random background electromagnetic radiation. Another way to wake up the injection device 20 is to set the device 20 to wake up when a particular vibration pattern is detected (also step 1328). For example, to wake up device 20, the user can position device 20 so that it contacts external device 1250,

- 15 039706 for example, the device 20 can be placed on top of the external device 1250. The user can then command the external device 1250 to vibrate in accordance with a particular predetermined pattern using the vibration source 1264. Vibrations from external device 1250 can be detected by accelerometer 120 in injection device 20. When the detected vibrations match the expected pattern, the processing circuitry 108 can be configured to wake up the injection device 20 from its low power sleep mode.

When the injection device 20 wakes up from its low energy sleep mode, the processing circuitry 108 may first initiate a pairing process 1330 with the external device 1250 via Bluetooth Low Energy BLE technology. The Bluetooth Low Energy BLE pairing process 1330 may be similar or identical to the Bluetooth Low Energy BLE pairing process defined in the Bluetooth Base Specification v5.0 published by the Bluetooth SIG on December 6, 2016, the full content of which is included in this document by reference. The Bluetooth Low Energy BLE pairing process 1330 may begin with the injection device 20 transmitting one or more Bluetooth Low Energy BLE announcement packets using the Bluetooth Low Energy BLE circuit 1206 and the Bluetooth Low Energy BLE antenna 1207. When the external device 1250 receives the transmitted Bluetooth Low Energy BLE announcement packets via the Bluetooth Low Energy BLE circuit 1256 and the Bluetooth Low Energy BLE antenna 1257, it may respond with a Bluetooth Low Energy BLE wireless transmission that starts with the flow of information between the device 20 injection device and external device 1250. The end result of this flow of information is an established Bluetooth Low Energy BLE session between the injection device 20 and external device 1250 through which the two devices can exchange data.

In FIG. 14A and 14B is a flow diagram depicting an exemplary method 1400 implemented by a mobile medical application running on an external device 1250. Method 1400 may be used in combination with any of the first set of device 20 implementations, as well as any of the second. and a third set of embodiments of device 20, described below. Method 1400 begins when a Bluetooth Low Energy BLE connection is established between injection device 20 and external device 1250 (step 1402). At step 1404, the external device 1250 receives data from the injection device 20 via an established Bluetooth Low Energy BLE connection. The data obtained from the injection device 20 may include data or measurements from some or all of the above-described sensors in the injection device 20, or information derived from or based on such data or measurements. The data received from the injection device 20 may also include data stored on the storage device of the device 20 or information derived from such data; for example, the data may include the type of drug stored in the injection device 20, the expiration date of the drug, the identification of the treating physician, the place or date of manufacture of the drug, the model of the injection device, and the like. At 1406, method 1400 determines if the drug has expired. This can be done by comparing the drug expiration date obtained in step 1404 with the current date. If the drug has expired, method 1400 proceeds to step 1414, where the external device 1250 notifies the user that the drug has expired, such as through a message on the display of the device 1250 or through an audible message. If the drug product has not expired, method 1400 proceeds to step 1408.

At 1408, method 1400 determines if the drug has been exposed to unsafe conditions. This step may include checking the data stored in or derived from an external light exposure log stored in the data processing circuit 108 . If the intensity and/or duration of exposure to ambient light exceeds predetermined thresholds, method 1400 may proceed to 1414 and notify the user that the drug should not be used. Logic for comparing data from an external light exposure log with predetermined exposure intensity and/or duration limits may be implemented by the data processing circuit 108 of the injection device 20, the processor 1252 of the external device 1250, or a combination thereof. Alternatively or additionally, step 1408 may include determining if the drug product has been exposed to unsafe temperatures during storage or transport. This can be done by checking the data stored in or derived from the drug temperature log stored by the data processing circuit 108 . If the drug product has been exposed to temperatures outside the ideal storage range (for example, 36 to 46°F (2.22 to 7.78°C)) or if the drug product has been exposed to temperatures outside the ideal storage range for a period of

- 16 039706 long period of time, method 1400 may also proceed to step 1414 and notify the user that the drug should not be used. Logic for comparing temperature log data and predetermined temperature limits may also be implemented by the data processing circuit 108 of the injection device 20, the processor 1252 of the external device 1250, or a combination thereof.

At 1410, method 1400 determines if the drug temperature is safe for injection. Although the drug in injection device 20 may require storage at a cooler temperature (e.g., 36-46°F (2.22 to 7.78°C)) to prevent spoilage, the drug may require warming up to warmer temperature (eg, approximately room temperature or 65 to 75°F (18.33 to 23.89°C)) prior to its injection. At 1410, method 1400 determines if the drug has been heated to the target temperature for injection. If not, method 1400 proceeds to block 1416, where method 1400 notifies the user that the drug is still being heated, and then returns to block 1410. If yes, method 1400 proceeds to block 1422 (shown in FIG. 14B).

With reference to FIG. 14B, at 1422, method 1400 may instruct the user to remove end cap 36. At 1424, method 1400 determines whether end cap 36 has been removed. As described above, processing circuitry 108 may determine whether end cap 36 has been removed using sensor 110. end cap microswitch, and can notify an external device 1205 via a Bluetooth Low Energy BLE link 1234. If the end cover has not been removed, method 1400 returns to block 1422. If the end cover has been removed, method 1400 proceeds to block 1426.

At 1426, method 1400 may instruct the user to position the injection device 20 in an injection position. This may include instructing the user to position the proximal opening 40 of the device 20 against an area of the user's body, such as the abdomen or one of the user's thighs. At 1428, method 1400 determines if all of the skin contact sensors (eg, sensors 122, 123, and 124) detect contact with skin tissue. If fewer than all of the skin contact sensors detect skin contact, method 1400 proceeds to step 1430. If all of the skin contact sensors detect skin contact, method 1400 proceeds to step 1432.

At 1430, method 1400 can notify the user which individual sensors of the plurality of skin contact sensors (eg, sensors 122, 123, and 124) are detecting contact with skin tissue and which individual sensors are not detecting contact with skin tissue. As shown in FIG. 15, this may be accomplished by displaying the schematic 1502 on the display 1260 of the external device 1250. The schematic 1502 may include three separate indicators 1522, 1523, and 1524 that correspond to the skin contact sensors 122, 123, and 124, respectively. As shown, the indicators 1522, 1523, and 1524 may be positioned to follow the physical location of the skin contact sensors 122, 123, and 124, for example, the indicators may be positioned symmetrically around a central opening. In embodiments that include fewer or more than three skin contact sensors, schematic 1502 may also include an appropriate number of indicators. When the skin contact sensor detects no contact with skin tissue, the schematic 1502 may change the appearance of that skin sensor corresponding to the indicator. In the example shown in FIG. 15, skin contact sensors 122 and 123 detect skin contact, but skin contact sensor 124 does not detect contact with skin tissue. Accordingly, the indicator 1524 corresponding to the skin contact sensor 124 was filled with a different color, texture, or visual pattern from the color, texture, or visual pattern of the indicators 1522 and 1523, which correspond to the skin contact sensors 122 and 123 (as indicated by the cross bars for the indicator 1524). Other ways of indicating the presence or absence of skin contact are also possible, for example, the shape of the indicator may change, or the icon or symbol may appear or disappear, depending on whether a particular skin contact sensor detects any contact with skin tissue or not.

Alternatively or additionally, device 20 may be equipped with visual indicators (eg, light emitting diodes) that notify the user which skin contact sensors are detecting skin contact and which are not. For example, device 20 may be provided with a plurality of LEDs on the upper surface of the main PCB(s) 82a, with each LED corresponding to one of the skin contact sensors. The physical arrangement of the LEDs may correspond to the location of the skin contact sensors so that it is clear to the user which LED corresponds to which skin contact sensor, for example, each LED may be located on the skin contact sensor to which it corresponds. One such exemplary LED has been depicted as LED 142 in FIG. 11. Depending on whether the sensor detects skin contact or not, its corresponding LED may turn on, turn off and/or change color. This provides another intuitive way for the user to quickly determine which skin contact sensors are not detecting contact.

- 17 039706 step with skin tissue and in which direction the user should tilt or move the device 20 to achieve better contact with the skin.

In FIG. 17A is a top perspective view of the main PCB 1782, and FIG. 17B shows a perspective view from below of the same 1782 PCB in accordance with the second set of embodiments of the device 20. FIG. 18A and 18B show top and bottom views of the same PCB, respectively. Similar to the main RTD 82 described above, in the first set of embodiments, the main RTD 1782 may also be located in the end portion 39 of the housing 38 of the device 20, as shown in FIG. 8. Also, similar to the main SP 82 described above, the main SP 1782 defines an opening 1703 (similar to the opening 83 in the SP 82) through which the injection needle 34 of the syringe assembly 22 is configured to pass. The main PCB 1782 has a top surface 1782a and a bottom surface 1782b (assuming that the top surface 1782a and the bottom surface 1782b are part of the PCB 1782). The top surface 1782a contains or supports a power source 1702, which in some implementations may contain a battery, such as a coin cell battery. The power supply 1702 supplies power to the electrical components built into or connected to the injection device 20 . The main PP 1782 may also contain a data processing circuit 1708, which can be configured similar to the data processing circuit 108 described above.

The main SP 1782 in the second set of implementation options may differ in several respects from the main SP 82 in the first set of implementation options. As best shown by comparing FIG. 9A and 17A, the syringe position detector switch 1710, which allows the processing circuit 1708 to determine whether the syringe assembly 22 is in the stored position, the injection position, or the retracted position, is installed on the main PCB 1782 instead of the secondary PCB 84. The syringe position detector switch 1710 includes two outgoing in the proximal direction of the shoulder 1710a, 1710b. In one example, the arm 1710a is an inclined arm 1710a and the arm 1710b is adjacent to the arm 1710a. In one example, each of the arm 1710a and the arm 1710b has a distal end connected to the RH 1782 (in an illustrative example, the distal end contains the main configuration for mounting on the RH), and the arms can extend in a proximal direction parallel to each other. The inclined arm 1710a includes an inclined radial portion protruding inwardly towards the longitudinal axis 48 for contact with the movable syringe barrel to provide deflection of the arm 1710a and a laterally extending portion overlapping the contact portion of the arm 1710b for selective electrical contact with the arm 1710b. Both arms may be made of metal or any other relatively flexible, electrically conductive material, and may be electrically coupled to data processing circuitry 1708. When the contact portion of the arm 1710a contacts the arm 1710b, the contact completes an electrical circuit between the tilted arm 1710a and 1710b. When the inclined arm 1710a is not in contact with the straight arm 1710b, the electrical circuit between said two arms is interrupted. Continuous or periodic monitoring of whether the two arms 1710a and 1710b are in contact with each other allows the processing circuitry 1708 to determine whether the syringe assembly is in the storage position, the injection position, or the retracted position.

In FIG. 19 shows a side view of the device 20 with the syringe assembly 22 in the stored or retracted position. As shown, when the syringe assembly 22 is in one or both of these positions, the inclined arm 1710a and the straight arm 1710b are spaced apart from each other and not in contact with each other. In FIG. 20 shows a side view of the device 20 with the syringe assembly 22 in the injection position. Moving the syringe assembly 22 to the injection position causes the cylinder 30 of the syringe assembly 22 to move downward in a distal direction, as shown by arrow 1902. with the inclined portion of the inclined arm 1710a and pushes the inclined arm 1710a in the radial direction away from the longitudinal axis 48 to contact the straight arm 1710b. This completes the electrical circuit between the inclined arm 1710a and the straight arm 1710b. Thus, when the processing circuit 1708 detects an open circuit between the arms 1710a and 1710b, it can determine that the syringe assembly 22 is either in the stored position or in the retracted position. Upon detection by processing circuit 1708 of a closed circuit between arms 1710a and 1710b, it may determine that the syringe assembly is in the injection position.

The main SR 1782 may also differ from the main SR 82 in the configuration of the skin contact sensors. As best shown by comparing FIG. 9B and 17B, instead of using three skin contact sensors each containing two electrodes (e.g., in the first set of embodiments, sensor 122 contains electrodes 122a and 122b, sensor 123 contains electrodes 123a and 123b, and sensor 124 contains electrodes 124a and 124b ), the bottom surface 1782b of the main RI 1782 in the second set of embodiments contains only three separate electrodes 1722, 1723 and 1724 facing distally from the distal surface of the RI. These electrodes can be equidistant from the longitudinal axis 48 in the radial direction and can also be located at an equal

- 18 039706 distance from each other along the circumference. One of these three electrodes, for example electrode 1722, can be connected to a voltage source that provides a reference voltage V. Each of the other two electrodes can be connected to separate voltage sensors. The output of both voltage sensors can be connected to the circuit 1708 data processing. If a voltage sensor connected to electrode 1723 detects a positive voltage above a reference threshold, processing circuitry 1708 may determine that both electrodes 1722 and 1723 are in contact with skin tissue. If a voltage sensor connected to electrode 1724 detects a positive voltage above a threshold, processing circuitry 1708 may determine that both electrodes 1722 and 1724 are in contact with skin tissue. If voltage sensors coupled to electrodes 1722 and 1723 detect a voltage above a threshold, processing circuitry 1708 may determine that all three electrodes 1722, 1723, and 1724 are in contact with skin tissue. Compared to the main PCB 82 in the first set of embodiments, this configuration of electrodes 1722, 1723, and 1724 reduces the number of electrodes required, thus reducing the complexity and cost of manufacturing and assembly.

Although the following description of the second set of embodiments of device 20 describes the differences between this second set of implementations and the first set of implementations described above, it should be understood that the second set of implementations may also contain features present in the first set of implementations, as well as other signs. For example, certain embodiments in the second set of embodiments may comprise an additional RB 84 from the first set of embodiments, instead of or in addition to the proximally extending arms 1710a, 1710b. This additional PP 84 in the second set of implementation options may contain one, more or all of the sensors described above as installed on the additional PP 84 in the first set of implementation options. Other configurations of skin contact sensors may also be used in the second set of embodiments of device 20, including configurations identical or similar to those described in connection with the first set of embodiments. As an example, the main PCB 1782 in the second set of embodiments may, in some embodiments, comprise pairs of electrodes similar to those described in the first set of embodiments (e.g., electrodes 122a and 122b, 123a and 123b, etc., as shown in FIG. 9B). The main PCB 1782 may contain one, two, three or more sets of such pairs of electrodes.

In FIG. 21A shows a top perspective view of the main PCB 2082, and FIG. 21B shows a bottom perspective view of the same PCB 2082 according to the third set of embodiments. In FIG. 22A and 22B show top and bottom views of one PCB, respectively. Similar to the main RB 82 described above, in the first set of embodiments, the main RB 2082 may also be located in the end section 39, as shown in FIG. 8. Also, similar to the main SP 82 in the first set of embodiments described above, the main SP 2082 defines an opening 2003 (similar to the opening 83 in the SP 82) through which the injection needle 34 of the syringe assembly 22 is configured to pass. The main PCB 2082 includes a top surface 2082a and a bottom surface 2082b (assuming that the top surface 2082a and the bottom surface 2082b are part of the PCB 2082). The top surface 2082 contains or supports a power source 2002, which in some implementations may contain a battery, such as a coin cell battery. The power supply 2002 supplies power to the electrical components built into or connected to the injection device 20 . A battery cover (not shown) in housing 38 may be hinged or pivotable to allow access to power supply 2002. The main PP 2082 may also contain a data processing circuit 2008, which can be configured similar to the data processing circuit 108 described above.

If necessary, the main SP 2082 may differ from the main SP 82 (in the first set of implementation options) and the main SP 1782 (in the second set of implementation options) in several aspects.

First, the main PCB 2082 may not include an additional PCB 84 or syringe position detector switch 1710. The position of the syringe assembly 22 can be detected by other means (eg, using an accelerometer), which eliminates the need for an additional sensor 84 and/or a syringe position detector switch 1710. Removal of the additional sensor 84 and/or the syringe position detector switch 1710 may reduce the complexity and/or cost of manufacturing and assembly.

Secondly, the temperature check button 2001 can be installed or maintained on the main PCB 2082. This temperature test button 2001 may protrude from a hole or notch (not shown) in the body 38 of device 20. As described in more detail below, this button 2001 may be a physical button that, when actuated by a user, sends an electrical and/or digital signal that causes the data processing circuit 2008 to turn on, check the temperature of the device 20 and notify the user whether the temperature of the device 20 is suitable for drug delivery.

Thirdly, instead of using NFC tracing antennas or

- 19 039706

Bluetooth Low Energy BLE located on the top and/or bottom surface of the PCB, NFC or Bluetooth Low Energy BLE compatibility can be provided by one or more chip antennas 2004 installed on the PCB 2082. Such chip antennas 2004 can receive signals from the data processing circuitry 2008 that direct the wireless antennas to external devices. Although in FIG. 21A shows only one crystal antenna 2004, some embodiments in the third set of embodiments may include two or more crystal antennas, such as one Bluetooth low energy BLE crystal antenna and a separate near proximity NFC crystal antenna. In some implementations, the processing circuitry 2008 may itself include an integrated Bluetooth Low Energy BLE antenna, while the crystalline antenna 2004 may include an NFC proximity antenna. In some embodiments, the third set of embodiments may also use SP trace antennas (similar to those described above for the first set of embodiments) instead of crystal antennas.

Fourth, the main PCB 2082 may include a lower cap removal sensor 2010 to allow the processing circuitry 2008 to detect whether the lower cap 36 is attached to the body 38 or has been removed by the user. The lower cap removal sensor 2010 may be communicatively or electrically connected to the data processing circuit 2008. In FIG. 23A and 23B show a more detailed perspective view of the lower cap removal sensor 2010. The sensor 2010 includes a base 2302 supporting the first arm 2304 and the second arm 2306. The base 2302 may be connected to the RH and may be positioned circumferentially along the proximal surface of the RH. The arms extend proximally from the base 2302 and may run parallel to each other. The first arm 2304 is connected to the horizontal arm 2310. In one example, the arm 2304 and arm 2310 form an L-shape and may be integral. In turn, the lever 2310 supports the tilted tab 2308 and the first contact surface 2309. The surface 2309 can be tilted away from the lever 2307 in a distal direction and/or in a radially inward direction. The tongue 2308 is shown hanging from the lever 2310 and located between the arms 2304 and 2306. The tongue 2308 may include an inclined section extending radially inward towards the longitudinal axis 48. The lever 2310 is shown as having a multi-planar design, in which the first section associated with the shoulder 2304, extends along the first radial plane, and the second portion mating with the contact surface 2309 extends along the second radial plane farther from the longitudinal axis 48 than the first radial plane. The second arm 2306 is connected to the second contact surface 2307. The contact surface 2307 can be inclined from the body of the shoulder 2306 and move at some angles in the proximal direction and/or in the radial direction outward. The contact surfaces 2307, 2309 are shaped and configured to contact in one configuration, such as when the bottom cap is detached, and spaced apart in another configuration, such as, for example, when the bottom cap is attached, or vice versa. The first arm 2304, the second arm 2306, and the tongues and contact surfaces mounted on both arms may be formed from metal or any other suitable flexible and electrically conductive material. In FIG. 24A shows the RTD 2082 and bottom cap removal sensor 2010 relative to the end cap 36 when the end cap 36 is detached from the rest of the device 20. For clarity, the housing 38 surrounding and supporting the RTD 2082 has been removed. When the sensor 2010 is installed on the RH 2082, the inclined tab 2308 faces inward towards the longitudinal axis 48. The end cap 36 includes an internal tab 2402. The end cap 36 can be attached to the body 38 by moving the end cap 36 in the direction of arrow 2404. FIG. 24B shows the PW 2082 and end cap 36 when end cap 36 is attached. When the end cap 36 is attached, the inner tab 2402 extends upward through the hole 2003 in the BF 2082 and pushes the tilted tab 2308. This pushes the tilted tab 2308 and the horizontal arm 2310, on which the tilted tab 2308 is mounted, radially outward in the direction of arrow 2406.

In FIG. 25A and 25B show the lower cap removal sensor 2010 as viewed from the axis direction 2312 in FIG. 23A and 23B. In FIG. 25A shows the lower cap removal sensor 2010 when the sensor is in its neutral state, such as when the end cap 36 is detached and therefore the inner tab 2402 is not in contact with any portion of the sensor 2010. With the sensor 2010 in this neutral state, the first the contact surface 2309 into contact with the second contact surface 2307 via the horizontal arm 2310. The contact between the first contact surface 2309 and the second contact surface 2307 closes an electrical circuit between the first leg 2304 and the second leg 2306. processing data may determine that the end cap 36 is detached.

In FIG. 25B shows the bottom cap removal sensor 2010 when the end cap 36 is attached. When the end cap 36 is attached, the inner tab 2402 contacts the tilted

- 20 039706 tongue 2308 of the sensor 2010 and pushes it. This pushing force biases the tilted tab 2308, as well as the horizontal arm 2310 on which the tilted tab 2308 is mounted, outward in the direction of the arrow 2406. This causes the first contact surface 2309 to move relative to the fixed second contact surface 2307 out of contact with the second contact surface 2307, thus interrupting the electrical circuit between the first leg 2304 and the second leg 2306. When the processing circuit 2008 detects an interruption of this electrical circuit, the processing circuit 2008 may determine that the end cap 36 is connected.

Fifth, instead of using electrodes that detect skin contact by measuring electrical resistance (as in the first and second set of embodiments), the main PCB 2082 uses two capacitive plates 2022 and 2023 to detect skin contact. Plates 2022, 2023 are shown as discrete planar structures located along the distal surface of the RH.

The capacitance plates 2022 and 2023 can be configured to detect the proximity of human tissue by such an effect of the tissue on the electrical field generated by the sensor, for example, by measuring the effect of such human tissue on the capacitance of an electrical circuit observed or measured by the sensor. Capacitive sensors do not require a metal electrical clip in direct contact with skin tissue and can therefore be partially or completely covered with a protective, non-conductive coating (eg made of plastic). This can increase the reliability of the capacitive sensor by reducing the infiltration of moisture or foreign matter into sensitive electrical components. Capacitive sensors can also reduce the risk of ESD damage to sensitive electrical components in a device, since capacitive sensors do not require exposed metal contacts. Each of the capacitive plates 2022 and 2023 can separately detect contact with skin tissue to allow the processing circuit 2008 to determine when one plate detects contact and the other does not. Although in FIG. 21B and 22B show only two capacitance plates 2022 and 2023, other embodiments in the third set of embodiments may include fewer or more capacitance plates. For example, the main PCB 2082 may contain only one capacitance plate, or it may contain three, four, five, six or more capacitance plates.

Sixth, the main PCB 2082 in this third set of embodiments includes an accelerometer 2012 detecting pulses or accelerations caused by initiating a dispensing operation in which the drive mechanism 24 moves the syringe assembly 22 from a storage position to an injection position. The accelerometer 2012 can also detect pulses or accelerations caused by the retract movement after the dispensing operation is completed, in which the retract mechanism 26 moves the syringe assembly 22 from the injection position to the retracted position. The accelerometer 2012 may send an output signal to the processing circuitry 2008 via one or more electrical connections to allow the processing circuitry to analyze the output signal. In FIG. 26 is a graph showing an exemplary signal output from the accelerometer 2012 according to the third set of embodiments. The vertical Y-axis of graph 2600 shows the amplitude of the signal in volts. The x-axis of the graph 2600 shows the passage of time, for example in seconds. In this example, the signal from the accelerometer 2012 is centered around a voltage of approximately 1.75 V. This 1.75 V signal may represent a constant downward acceleration due to gravity.

Deviations from this constant value indicate accelerations or impulses (other than gravity) transmitted to or acting on the device 20 and which are detected by the accelerometer 2012 mounted on the main PCB 2082. For example, accelerations, vibrations or impulses caused by the removal of the lower cap 36 (labeled 2062) or by releasing the drive button 52 (labeled 2064) can be detected by the accelerometer 2012.

In some embodiments, the data processing circuit 2008 may analyze the signal output from the accelerometer 2012 to determine a certain condition or state of the device 20, or to detect the occurrence of a certain event or action. For example, the processing circuitry 2008 may analyze the output signal to recognize the removal of the bottom cap 36 (eg, as indicated by signal at 2062) or the release of the actuating button 52 (eg, as indicated by label 2064). The data processing circuit 2008 may also be configured to determine the initiation or completion of a dispensing operation based on the enable signals from the accelerometer 2012 alone or in combination with signals from one or more skin contact sensors.

When the dispensing operation is initiated, the drive mechanism 24 is activated to move the syringe assembly 22 from the storage position to the injection position. This drive movement causes one or more accelerations that can be detected in the signal generated by the accelerometer 2012. For example, the push force applied by the drive mechanism 24 as it moves the syringe assembly 22 from the storage position

- 21 039706 proximal direction, may allow the accelerometer 2012 to detect acceleration in the distal direction along the longitudinal axis 48. When the syringe assembly 22 reaches its stop position at its injection position at the end of the drive movement, the sudden stop of the syringe assembly 22 may allow the accelerometer 2012 to detect acceleration in the proximal direction along the longitudinal axis 48. This acceleration in the proximal or distal direction (or both) may allow the accelerometer 2012 to output the first acceleration pulse (labeled 2606) that can be detected by the data processing circuit 2008. This first acceleration pulse may indicate the initiation of a dispense operation.

Likewise, upon completion of the dispensing operation, the retract mechanism 26 is activated to move the syringe assembly 22 from the injection position to the retracted position. This driving movement causes one or more accelerations, which can also be detected in the signal produced by the accelerometer 2012. For example, the pushing force applied by the retractor 26 as it moves the syringe assembly 22 from the injection position in the distal direction, can allow the accelerometer to detect 2012 accelerations in the proximal direction along the longitudinal axis 48. When the syringe assembly reaches the retracted position, the sudden stop of the syringe assembly 22 may allow accelerometer 2012 to detect acceleration in the distal direction along the longitudinal axis 48. This acceleration in the proximal or distal direction (or both) may enable the accelerometer 2012 to output a second acceleration pulse (labeled 2068) that can be detected by the data processing circuit 2008. This second acceleration pulse may indicate the completion of the dispensing operation. As used herein, the term acceleration pulse is defined as any artifact in an acceleration or vibration signal output by an accelerometer or vibration sensor (eg, a piezoelectric sensor) that indicates the initiation and/or completion of a dispensing operation.

Seventh, instead of using the IR sensor 120 mounted on the secondary PCB 84 to measure the temperature of the drug in the cylinder 30 (as shown and described in FIGS. 8 and 9A), the main PCB 2082 in this third set of embodiments uses a temperature sensor 2025 , directly installed on the main PCB 2082 to evaluate the temperature of the medicinal product. This temperature sensor can be connected to the data processing circuit 2008 with the possibility of communication or electrical connection and output the temperature output received and analyzed by the data processing circuit. In one example, the temperature sensor 2025 is mounted on the distal surface of the PP, and in some cases it is located at a distance from the plates 2022, 2023 around the circumference. By using a temperature sensor 2025 mounted directly on the main PCB 2082 and completely eliminating the additional PCB 84, the main PCB 2082 in this third set of embodiments reduces the cost and complexity of manufacturing and assembly. The temperature sensor 2025 may comprise any of a variety of types of temperature sensors that can be installed on the PCB, such as, but not limited to, a thermistor (e.g., an NTC thermistor or a resistance temperature sensor (RTD)), a thermocouple, or a temperature sensor. temperature based semiconductor. The temperature sensor 2025 may be configured and located to measure the temperature of the thermal ballast.

Thermal ballast may contain the entire silicon substrate of the main PCB 2082 or a portion of it. Alternatively, the thermal ballast may include a suitable heat sink made of other materials (eg, polymer) installed on the main PCB 2082. The thermal ballast may contact or surround all or portion of the temperature sensor 2025.

The materials, size, shape and position of the thermal ballast can be chosen such that the thermal ballast has a thermal time constant (T _ballast ) that is approximately equal to the thermal time constant of the drug in cylinder 30 (T _drug ). As used herein and in the claims, the term thermal time constant (τ) of a housing (such as a thermal ballast or drug inside cylinder 30) should be understood to mean a constant that satisfies Equation 1:

chl 1 1(1)- Too -Tt

Equation!: -----= e ъ T--T ¹ I '00 where T(t) = body temperature at time t;

T, = temperature of the environment (eg atmosphere) surrounding the case; And

Ti = case reference temperature.

In other words, the thermal time constant τ of the case characterizes the rate at which the case temperature adjusts to the ambient temperature - a high thermal constant means that the case temperature adjusts quickly, and a low thermal constant means that the case temperature adjusts slowly. Therefore, when the thermal time constant (Tballast)

- 22 039706 thermal ballast approximately equals the thermal time constant of the drug in cylinder 30 (T _drug ), it can be considered that the temperature of the thermal ballast increases or decreases to match the ambient temperature at approximately the same rate as the temperature of the drug. Since the thermal ballast can be located on the main PCB 2082, the thermal ballast is generally exposed to the same ambient temperature as the drug in cylinder 30. Therefore, the data processing circuit 2008 can estimate the temperature of the drug in cylinder 30 by measuring the temperature of the thermal ballast and assume that the temperature of the drug in cylinder 30 is equal to the measured temperature. Thus, the main PCB 2082 in this third set of embodiments can estimate the temperature of the drug in cylinder 30 without the need for an infrared (IR) sensor or other type of temperature sensor to be located directly adjacent to (or in physical contact with) cylinder 30. This reduces cost and manufacturing and assembly complexity, and reduces the space and form factor requirements of the device 20. In some embodiments, the materials, size, shape, and/or position of the thermal ballast may be chosen such that x _ba ii _as t is within 10%. T _drug . In other embodiments, the materials, size, shape, and/or position of the thermal ballast may be chosen such that the T _ballast is within 5% of T _drug . In some embodiments that require highly accurate drug temperature determination, the materials, size, shape, and/or position of the thermal ballast may be chosen such that the T _ballast is within 2% of T _drug . In other embodiments, the materials, size, shape, and/or position of the thermal ballast may be chosen such that the temperature of the ballast is always within a few degrees (e.g., ±2°C or ±5°C) of the drug in cylinder 30 when the ballast and the drug is moved from a first relatively cool storage temperature (eg 36 to 46°F or 2 and 8°C) to a second relatively warmer temperature (eg room temperature or 65 to 75°F or 18 to 24 °C).

In FIG. 27 shows a block diagram of the system of electrical components in the device 20 in accordance with the third set of embodiments of the device 20. Some or all of these components can be installed on the main PCB 2082, shown above in FIG. 21A, 21B, 22A and 22B. As described above and depicted in the figures above, these electrical components may comprise a data processing circuit 2008. In some embodiments, the processing circuitry 2008 may be in the form of a Bluetooth low energy (BLE) system on a chip (SOC). Such a Bluetooth Low Energy BLE system-on-a-chip may include a chip containing computing circuits (e.g., a mini-processor or arithmetic logic unit (ALU)), on-board storage (e.g., non-volatile computer-readable media such as non-persistent or read-only memory). ) used to store programmable instructions executed by computing circuits, and a 2714 Bluetooth low energy BLE antenna. The data processing circuit 2008 is configured to control and coordinate the functions of the electrical components shown in FIG. 27. According to a third set of implementations, the data processing circuit 2008 can be powered in one of two ways: it can be powered from the battery 2002 via the battery enable circuit 2718, or it can be powered from the battery 2002 via the power supply trigger circuit 2716. The battery enabling circuit 2718 may be one or more physical circuits that direct power from the battery 2002 to the processing circuit 2008 when certain conditions are met and turn off the power supply to the processing circuit 2008 if those conditions are not met. In other words, the battery enabling circuit 2718 may energize and de-energize the processing circuit 2008 depending on the detected conditions. For example, in some embodiments, the battery enabling circuit 2718 may direct power to the processing circuit 2008 if either of two conditions is met: (i) the bottom cap removal sensor 2010 detects that the bottom cap 36 has been removed, and/or (ii) a button 2001 temperature check, installed on the main PP 2082, was pressed and held down by the user, or the temperature check button 2001 was pressed within a certain time period in the past, for example, within the past 45 minutes. The battery enabling circuit 2718 may also direct power to the processing circuit 2008 when both conditions are satisfied. In some embodiments, the accumulator enabling circuit 2718 may only consider condition (i) or (ii) and not consider the other of conditions (ii) or (i). The battery enabling circuitry 2718 may be configured to consider other conditions in addition to or instead of the conditions described above, such as device orientation, detected pulse, or acceleration, or temperature. If none of the conditions are met, the battery enabling circuit 2718 may be configured to shut off power to the processing circuit 2008.

The power supply trigger circuit 2716 may be one or more

- 23 039706 physical circuits that receive output signals from the data processing circuit 2008 via a universal input/output pin (GPIO). The power supply trigger circuit 2716 may be configured to direct power from the battery 2002 to the processing circuit 2008 upon receipt of a power supply trigger signal from the processing circuit 2008 via the universal input/output contact. This power trigger signal may be a high voltage level or a low voltage level, or it may be a more complex encoded signal containing several high voltage levels and/or low voltage levels. After the power supply trigger circuit 2716 receives the power supply trigger signal, the power supply trigger circuit 2716 will operate, i. it will continue to direct power from the battery 2002 to the data processing circuit 2008 whether or not the power supply trigger circuit 2716 continues to receive the power supply trigger signal. In other words, once the power supply trigger circuit 2716 has fired, it will continue to supply power to the data processing circuit 2008 until the battery 2002 is depleted (or a timer indicating the expected runtime of the battery 2002 has expired, thus indicating that the battery 2002 is about to discharge). The data processing circuit 2008 may be configured to direct the power trigger signal to the power trigger circuit 2716 under different circumstances, depending on the implementation.

While the battery enable circuit 2718 and power trigger circuit 2716 may be in the form of one or more physical circuits that perform the above functions, they may also be in the form of software or firmware instructions stored on a non-volatile computer readable storage medium (for example, read-only memory) which, when executed by the data processing circuit, perform the above functions. For example, the main PCB 2082 may have an additional low power processor, separate and remote from the processing circuitry 2008, which determines when to power the processing circuitry 2008 from the battery 2002.

The data processing circuit 2008 may also be connected to the IC bus 2724. In turn, the IC interconnect bus may be communicatively coupled to several electrical components, including an NFC proximity circuit 2004, one or more touch sensors 2706, an accelerometer 2012, and a battery sensor 2710.

The NFC circuit 2004 may include an NFC antenna and an on-board ROM, and may also support passive near proximity and active near proximity. Passive near proximity communication occurs when the NFC near proximity circuit 2004 communicates with an external device when power is not supplied to the NFC near proximity circuit 2004, and the NFC near proximity circuit 2004 relies entirely on power supplied by the external device wirelessly. Active near proximity communication occurs when the NFC near proximity circuit 2004 communicates with an external device when power is applied to the NFC near proximity circuit 2004 from an internal power source such as a battery 2002. In embodiments in which the NFC near proximity circuit 2004 supports active near proximity communication, the NFC circuit 2004 may be coupled to the battery 2002. The NFC circuit 2004 may also be configured to store data and/or programmable instructions received via its NFC proximity antenna on its on-board ROM in a passive manner, i. e. not receiving power from the 2002 battery.

The touch sensor(s) 2706 may be in the form of capacitive plates 2022 and 2023 as shown and described above in FIG. 21B and 22B. However, touch sensor(s) 2706 may also be in the form of any other type of sensors capable of detecting contact with skin tissue, including electrical resistance sensors 122, 123, and 124 depicted and described above in FIG. 9B and/or the electrical resistance sensors 1722, 1723, and 1724 depicted and described above in FIG. 17b. In other words, touch sensor(s) 2706 is not limited to the touch sensors described in connection with the third set of embodiments, but may include some or all of the skin contact sensor features described in connection with the first and second set of embodiments.

Accelerometer 2012 may be in the form of any circuit capable of detecting pulses, vibrations, and/or accelerations associated with the initiation and/or completion of a dispensing operation, as described above. For example, accelerometer 2012 may be in the form of an accelerometer capable of detecting accelerations along one, two, or three axes, or it may be in the form of a piezoelectric vibration sensor.

Battery sensor 2710 may be physical circuitry, software, and/or firmware that monitors remaining power.

- 24 039706 stored in the battery 2002 and notifying the processing circuit 2008 of this level of remaining power supply. The data processing circuitry 2008 may also be connected to other electronic components via channels other than the IC connection bus 2724. For example, the data processing circuit 2008 may be connected to the temperature sensor 2025 described above via an analog input terminal. The data processing circuit can also be connected to the 2722 watchdog integrated circuit (IC) via a universal input/output pin (GPIO pin). The 2722 watchdog IC can be a continuous counter integrated circuit. The integrated circuit may be configured to reset or reset the data processing circuit 2008 (eg, by sending a reset signal or power interruption to the data processing circuit 2008) when the counter completes a count. The counter can be restarted by a registration signal from the data processing circuit 2008. In turn, the processing circuit 2008 can be configured to periodically send a registration signal to the watchdog IC 2722. With this configuration, the watchdog IC 2722 eliminates the possibility of the processing circuit 2008 being erroneously stuck in a program loop. By periodically sending a registration signal to the watchdog IC 2722, the data processing circuit 2008 demonstrates that it is not stuck in an erroneous program loop or some other faulty condition. If the watchdog IC 2722 does not receive a registration signal from the data processing circuit 2008 by the time the counter expires, the watchdog IC 2722 will send a reset (and/or power cut) signal to the data processing circuit 2008, forcing the processing circuit 2008 to restart.

In FIG. 28 is a flowchart depicting an exemplary method 2800 implemented by the processing circuit 2008 when it receives power according to the third set of embodiments of device 20. In this exemplary embodiment, if the processing circuit 2008 stops receiving power at any time, all progress in method 2800 is lost. at 2802. Method 2800 begins at 2802 when the battery enabling circuit 2718 supplies power to the data processing circuit 2008. As described above, this occurs when (i) the bottom cap removal sensor 2010 detects that the bottom cap 36 has been removed, and/or (ii) the temperature test button 2001 installed on the main PW 2082 has been pressed within a certain amount of time (e.g. , within the past 45 minutes) or held down by the user. Once the processing circuitry 2008 begins to receive power, it proceeds to step 2804. At step 2804, the processing circuitry 2008 reads the universally unique identifier (UUID) and/or drug type from a storage device, such as a persistent and non-volatile computer-readable medium. . This storage device may be a read-only storage device connected to or built into the data processing circuit 2008 and programmed during manufacture or assembly of the device 20. In some implementations, this storage device may be connected to the NFC proximity circuit 2004 or built into it.

UUID (UUID) may contain a serial number or a sequence of alphanumeric characters. Depending on the implementation, the UUID may be unique to a particular device 20, a particular production batch of the device 20 (eg, a batch of devices manufactured on a particular production line on a particular date), and/or a particular device configuration. The UUID may also indicate the type of drug contained in the device 20. Alternatively, the storage device may store a data field separate from the UUID that indicates the type of drug contained in the device 20. In some embodiments, the data processing circuit 2008 may also read other data and /or programmable instructions from a storage device.

Some or all of this data (eg, UUID, drug type, programmable instructions, and/or other data) may be stored on a storage device connected to or embedded in the NFC circuit 2004 instead of the data processing circuit 2008 to simplify manufacturing processes and assemblies. In some implementations, depending on the configuration of the device 20, programming the storage device connected to or embedded in the data processing circuit 2008 may require powering the data processing circuit 2008. This programming operation may consume valuable electrical power stored in the battery 2002, thus reducing the useful battery life of the finished device. On the other hand, a storage device connected to or built into the NFC circuit 2004 can be programmed with some or all of these data via passive proximity without requiring any power from the battery 2002. Therefore, to save power supply, the instructions to be executed by the data processing circuit 2008 may be programmed into the NFC circuit 2004 via the passive near proximity communication during manufacture. In such a case, when power is supplied to the data processing circuit 2008, it can be performed with

- 25 039706 the ability to read stored data/instructions from the storage device of the NFC circuit 2004 near contactless communication. After the data processing circuit 2008 has read the UUID, drug type, and/or any other data or programmable instructions from the storage device, the data processing circuit 2008 proceeds to step 2805.

At 2805, the processing circuit 2008 begins to periodically transmit wireless signals via the Bluetooth low energy BLE antenna 2714 that transmit the status of the injection device 20. These wireless signals may be Bluetooth Low Energy BLE Advertisement Packets in some implementations, although other types of wireless signals and wireless communication protocols may be used. This wireless signal may be broadcast at certain periodic intervals, such as once per second or once every 5 s, and may contain data on some or all of the following parameters or fields: (i) device UUID, (ii) drug type indication, (iii) an indication that the bottom cap is still attached to the device, that the bottom cap has been removed from the device, and/or that the bottom cap has been removed and reattached to the device, (iv) the amount of time that has elapsed since the bottom cap was first removed (e.g. in seconds), (v) the duration of skin contact (e.g., the amount of time the device was in contact with the skin) (vi) an indication that a dose delivery was initiated and/or that a dose delivery was initiated and completed, (vii) detecting the start time of dose delivery and/or the amount of time that has elapsed since the completion of the initiated dose delivery, (viii) the duration of dose delivery, which in some In other implementations, it can be defined as the amount of time between the initiation and completion of a dose delivery operation, (ix) the temperature detected by the temperature sensor 2025, (x) the orientation of the device as measured by the accelerometer, (xi) the number of temperature checks, e.g., the number of times the user pressed the temperature test button, (xii) orientation of the device during dose delivery, (xiii) a detected malfunction or error condition related to any or all of the temperature sensor, accelerometer, skin contact sensors, and/or lower cap removal sensor, (xiv ) any data derived or calculated from one or more of the fields (i)-(xiii) and/or (xv), or any other device or environmental conditions detected or measured by the device. These wireless signals may be periodically broadcast by data processing circuitry 2008 throughout method 2800. At this point in step 2805, some or all of the fields contained in the wireless signal may be empty or blank before data processing circuitry 2008 begins to receive and process data from the on-board sensors of the device 20. When the data processing circuit 2008 receives and processes signals from the on-board sensors of the device 20 (for example, the lower cap removal sensor 2010, the touch sensor(s) 2706, the accelerometer 2012, the temperature sensor 2025, etc.), it will continuously update the transmitted wireless signals to display the latest device status. The data processing circuit 2008 then proceeds to block 2806.

At step 2806, the data processing circuitry 2008 determines whether the drug stored in the device 20 requires temperature checks based on the UUID, drug type, and/or other data and programmable instructions. Some types of drugs that can be delivered by device 20 may require a temperature check, while other types of drugs may not require a temperature check. If the stored drug does not require a temperature check, the data processing circuit 2008 proceeds to block 2810. If the medicine requires a temperature check, the data processing circuit 2008 proceeds to block 2808.

At step 2808, the data processing circuit 2008 checks the temperature measured by the temperature sensor 2025. As described above, this temperature may be indicative of the temperature of the drug in cylinder 30. The detected temperature is then included in a continuous, periodically broadcast stream of wireless signals. In step 2812, the processing circuitry compares the measured temperature against predetermined thresholds to determine if the measured temperature satisfies certain predetermined and prestored ideal injection temperatures. For example, the measured temperature may meet the ideal injection temperatures when the measured temperature is in the ideal injection temperature range, such as 65 to 75°F, or 18 to 24°C. In other such implementations, the data processing circuitry may simply determine if the measured temperature is above a certain minimum temperature threshold (eg, above 65°F, or 18°C), without determining whether the measured temperature is below a certain maximum temperature threshold. If the measured temperature satisfies the ideal temperature for injection, the data processing circuit 2008 proceeds to step 2814 where it sets up an indicator to notify the user of its determination. Such an indicator may comprise one or more LEDs, a ring of light, a message on a display or a panel that slides open to display a message, or a color on the body of the injection device. After setting such an indicator, the data processing circuit 2008 proceeds to step 2810. If the measured temperature does not satisfy the ideal injection temperature parameters, the data processing circuit 2008 proceeds to

- 26 039706 step 2810 without setting the indicator.

At 2810, the processing circuitry 2008 checks to see if the touch sensor(s) 2706 detect contact with skin tissue. If the touch sensor(s) 2706 detects contact, the processing circuit 2008 proceeds to block 2816. If the touch sensor(s) 2706 detects no contact, the processing circuit 2008 continuously and cycles back to block 2810 until skin contact is detected. Again, the circuit 2008 data automatically updates the wireless signals in accordance with the output of the sensor (sensors) 2706 touch.

At step 2816, the data processing circuit 2008 reads the output of the accelerometer 2012. In some embodiments of the method 2800, the data processing circuit 2008 does not read or evaluate the output of the accelerometer 2012 if no skin contact is detected. This can be done by turning off the power supply to the accelerometer 2012 if no skin contact is detected to prevent the accelerometer 2012 from outputting any acceleration signal if no skin contact is detected. Alternatively, the accelerometer 2012 may be powered and output an acceleration signal even if no skin contact is detected, and the processing circuitry 2008 may be configured to log the time and duration of skin contact to a memory device, but otherwise perform no action on the based on any output from accelerometer 2012 until skin contact is detected. By requiring skin contact detection prior to determining that a dispensing operation has been detected, the processing circuit 2008 prevents false signal detections in which the processing circuit 2008 registers a dispensing operation even though no dispensing operation has occurred.

At step 2818, the processing circuitry 2008 determines whether a dispensing operation has been initiated and completed based on the output of the accelerometer 2012. This determination can be made in several different ways, and an exemplary logic for making this determination is explained in more detail below in FIG. 29-32. If a completed dispense operation is not detected, the data processing circuit 2008 proceeds to step 2810. If the data processing circuit 2008 determines that the dispense operation has been initiated and completed at step 2818, the data processing circuit 2008 records the initiation and/or completion of the dispense operation in storage device. The data processing circuitry 2008 may also inform the user of the initiation and/or completion of a dispensing operation by setting an indicator, such as one or more LEDs, light rings, or other visual and/or audible indicators. The data processing circuit 2008 then proceeds to block 2820.

At 2820, the data processing circuit sends a signal to the power trigger 2716, which causes the power trigger 2716 to turn on.

As described above, after power supply trigger circuit 2716 is turned on, it will continue to direct power from battery 2002 to data processing circuit 2008 until battery 2002 is discharged. After power supply trigger circuit 2716 is turned on, data processing circuit 2008 proceeds to step 2822.

At step 2822, the data processing circuit 2008 starts a counter of time elapsed since dose delivery. This elapsed time counter from dose delivery may be an internal or external counter of the data processing circuitry 2008 that continuously counts up at regular periodic intervals, such as every second, every 30 seconds, or every minute. In some embodiments, the elapsed time counter from dose delivery may only start counting when the processing circuitry 2008 reaches step 2822 (or when the power supply trigger circuit 2716 is turned on at step 2820). In other embodiments, the time elapsed timer from dose delivery may start counting from the moment data processing circuitry 2008 receives power (e.g., at a battery on event 2802), and data processing circuitry 2008 registers the current value of the time elapsed counter from dose delivery, in while the processing circuitry 2008 reaches block 2822. At block 2824, the processing circuitry 2008 updates the wireless broadcast signals to indicate successful initiation and completion of the dispense operation. As described above, the wireless signals may include the detected dose delivery start time and/or the amount of time elapsed since the initiated dose delivery was completed. In embodiments where the elapsed dose counter starts counting when the data processing circuitry 2008 reaches step 2822, the broadcast signals may include the current reading of the elapsed dose counter. In embodiments where the elapsed time counter counts continuously upstream since the data processing circuitry 2008 receives power, the broadcast signals may include the difference between the current elapsed time counter reading and the elapsed time counter reading. from dose delivery, at the time the data processing circuit reaches step 2822.

Periodically broadcast wireless signals can be received by an external device, such as mobile device 1250. These wireless signals allow the external device to

- 27 039706 determine the type or configuration of the device 20, the type of drug administered to the patient, the temperature of the drug at the time of administration (or whether the temperature of the drug satisfies the ideal temperature for injection at the time of administration) and/or the amount of time that has elapsed since administration medicinal product. By subtracting the amount of time that has elapsed since the drug was administered from the current absolute time (for example, as determined by a clock built into or communicating with the external device), the external device is also configured to determine the absolute time at which the drug was delivered. For example, if the external device receives a wireless signal from device 20 indicating that the drug was delivered 1 hour ago, and if the external device clock indicates that it is 2:00 pm EDT on December 21, 2018, the external device can determine that the drug was delivered at 1:00 pm EST on December 21, 2018 by subtracting the elapsed time (1 hour) from the current absolute time.

After each translation, the data processing circuit 2008 monitors the remaining power level in the battery 2002 via the battery sensor 2710 (step 2826). The data processing circuit 2008 then compares the remaining power level to the minimum battery low threshold (block 2828). If the remaining power level is greater than the low battery threshold, the processing circuit 2008 returns to block 2824 where it continues to broadcast wireless signals. If the remaining power level is less than or equal to the low battery threshold, the processing circuitry 2008 may determine that it will soon run out of power to continue actively broadcasting wireless signals. As a result, the data processing circuit 2008 proceeds to block 2830.

In step 2830, the data processing circuit 2008 writes its latest state to the NFC proximity circuit 2004. This last state may contain information indicating that (i) the dispense operation has been initiated and completed and (ii) the current value of the time counter since dose delivery (e.g., X hours, minutes, or seconds) at the time the scheme was data processing has reached step 2830. Since a request to the near proximity NFC circuit 2004 can be made even when it is not receiving power from the battery 2002, writing this last state to the near proximity circuit 2004 NFC ensures that the external device will still be able to to determine at least these two pieces of information by querying the NFC proximity circuit 2004. In other words, the external device will still be able to determine that the device 20 (i) successfully dispensed the contained drug and (ii) dispensed that drug at least X hours, minutes, or seconds ago.

Method 2800 may be modified by rearranging, deleting, adding, or rearranging certain steps. For example, in some embodiments, method 2800 may be configured to refrain from broadcasting wireless signals until a successful dispense operation is detected, i. no earlier than step 2824. By holding back from broadcasting wireless signals until a dispense operation is detected, method 2800 can conserve battery power and also minimize signal interference or entanglement in environments where other devices also broadcast and receive wireless signals. In some embodiments, method 2800 may not continuously check the level of battery 2826, but may instead use a timer to determine when to write the last state to NFC proximity circuit 2004 and turn off again. Such a timer may be configured to instruct the processing circuit 2008 to record the last state and turn off after a certain amount of time has elapsed since the processing circuit 2008 was first turned on or since the processing circuit 2008 began transmitting wireless signals for the first time. In FIG. 29 is an exemplary circuit diagram depicting the logic for determining whether a dispense operation has been initiated and completed (ie, step 2818 in method 2800). While this logic is depicted and described in circuit diagram form, it should be understood that this logic may be implemented as a hardware logic circuit, as software or firmware instructions executed on a data processing circuit, or as some combination of hardware, software, and /or firmware.

As shown in FIG. 29, the output of the accelerometer 2012 first passes through a high pass filter comprising a capacitor 2904 and a resistor 2906 connected to ground 2908. to initiate or complete a dispensing operation. The output of the high pass filter is fed to the first input of the comparator 2912 signals. The second input of the signal comparator 2912 is connected to the reference voltage threshold 2910. The signal comparator 2912 outputs an ON signal (for example, a high voltage level) if the output of the low-pass filter is greater than or equal to the reference threshold 2910

- 28 039706 voltage; otherwise, the signal comparator 2912 outputs an OFF signal (eg, low voltage level). In other words, the output of the signal comparator 2912 becomes ON when an acceleration pulse is detected, i.e., if the high-pass filtered accelerometer 2012 signal is greater than or equal to the reference voltage threshold 2910. Otherwise, the signal comparator 2912 outputs an OFF signal.

The output of the signal comparator 2912 is connected to the first input and the AND circuit 2916. The second input of the AND circuit 2916 is connected to the actual touch signal 2914. The valid touch signal 2914 may become ON or OFF based on the output of the touch sensor(s) 2706 - an ON signal may indicate actual skin contact has been detected and an OFF signal may indicate no actual skin contact has been detected. Some embodiments of device 20 with multiple skin contact sensors may require valid skin contact to be detected by all skin contact sensors before valid touch signal 2914 becomes ON. Alternatively, some embodiments of device 20 may require actual skin contact to be detected by only one of the plurality of skin contact sensors, or by a certain number or a certain subset of the plurality of skin contact sensors before the actual touch signal 2914 becomes ON. Therefore, the output of the AND circuit 2916 is ON only when two conditions are met: (i) an acceleration pulse is detected (ie, the output of the signal comparator 2912 is ON), and (ii) a valid touch signal 2914 is detected. The simultaneous fulfillment of both conditions (i) and (ii) indicates that a dispensing operation has been initiated in which the drive mechanism 24 moves the syringe assembly 22 from the storage position to the injection position. By requiring both conditions (i) and (ii) to be met prior to determining the initiation of a dispensing operation, this logic prevents false signal recognition cases in which a dispensing operation is recorded that did not actually occur.

The output of AND circuit 2916 is connected to the first input of OR circuit 2918, which functions as a trigger for the trigger event. The second input of OR circuit 2918 is connected to the output of OR circuit 2918. The output of OR circuit 2918 remains OFF until the output of AND circuit 2916 turns ON. Then, the OR circuit 2918 will remain ON indefinitely until restarted (eg, by removing power to the OR circuit 2918). If the output of AND circuit 2916 becomes OFF again after ON, the output of OR circuit 2918 will remain ON. Therefore, the OR circuit 2918 is referred to as an initiation event trigger because it fires and stays on indefinitely after a triggered event (eg, initiation of a dispense operation) is detected.

The output of the OR circuit 2918 is connected to the debounce circuit 2932. The chatter prevention circuit 2932 outputs an OFF signal until two conditions are met: (i) the initiation event trigger outputs an ON signal, indicating the detection of the initiation of a dispensing operation, and (ii) the output of the AND circuit 2916 outputs an OFF signal. In other words, the chatter prevention circuit 2932 becomes ON only after detecting the first acceleration pulse indicating the initiation of the dispense operation, and the field of how said first acceleration pulse has passed and is no longer detected. Once both conditions are met, the debounce circuit will remain ON indefinitely until restarted.

The debouncing circuit 2932 includes an inverter 2920, an AND circuit 2922, and an OR circuit 2924. The output of the AND circuit 2916 is converted by the inverter 2920 before being routed to the first input of the AND circuit 2922. The trigger event trigger output (OR circuit 2918) is routed to the second input of the AND circuit 2922. Therefore, the output of the AND circuit 2922 will become ON only if (i) the trigger output of the trigger event is ON and (ii) the output of the AND circuit 2916 is OFF. The output of AND circuit 2922 is connected to the first input of OR circuit 2924. The second input of OR circuit 2924 is connected to the output of OR circuit 2924. Therefore, the output of OR circuit 2924 is OFF until the output of AND circuit 2922 is ON. Then, OR circuit 2924 remains ON indefinitely until restarting it, for example, by removing power to the OR circuit 2924. If the output of the AND circuit 2922 becomes OFF again after ON, the output of the OR circuit 2924 will remain ON. The output of the debounce circuit 2932 is connected to the first input of the AND circuit 2926. The second input of the AND circuit 2926 is connected to the output of the AND circuit 2916. Therefore, the output of the AND circuit 2926 will become ON only when two conditions are met: (i) the debounce circuit 2932 is in the state ON, indicating the detection of the first acceleration pulse, indicating the initiation of the dispensing operation, and said first acceleration pulse has already passed, and (ii) the output of the AND circuit 2916 is ON, indicating the detection of the second acceleration pulse when an actual skin contact is detected. This second acceleration pulse indicates the completion of the dispensing operation, in which the retracting mechanism 26 moves the syringe assembly 22 from the injection position to the retracted position by retracting movement. Likewise, by requiring simultaneous skin contact and acceleration pulse detection prior to detecting a retract movement, this logic prevents false signal recognition cases in which kill movement is detected.

- 29 039706 wounds, but in reality the removal operation did not take place.

The output of AND circuit 2926 is connected to the first input of OR circuit 2928, which functions as a clear event trigger. The second input of the OR circuit 2928 is connected to the output of the OR circuit 2928. Therefore, the output of the OR circuit 2928 remains OFF until the output of the AND circuit 2926 changes to ON, indicating that a second acceleration pulse has been detected indicative of a retracting movement at the completion of the dispensing operation. After changing the output of AND circuit 2926 to ON, the OR circuit 2928 is operated to remain ON indefinitely until it is restarted by removing power to the OR circuit 2928 (even if the output of AND circuit 2926 then changes to OFF). Therefore, the OR circuit 2928 is referred to as a retract event trigger because it fires and remains on indefinitely until a retract event is detected, such as a retract move in which the retract mechanism 26 moves the syringe assembly 22 from the injection position to the retracted position. The output of the OR circuit 2928 is connected to the output signal 2930 of the dispensing operation.

Finally, therefore, the dispense operation output 2930 becomes ON and remains ON only when the following conditions are met: (i) the first acceleration pulse is detected at the same time as actual skin contact, thus indicating that the dispense operation is has been initiated, (ii) said first acceleration pulse has passed, and (iii) a second acceleration pulse is detected at the same time as actual skin contact, thus indicating that the dispensing operation has been completed and a retracting movement has been detected. When all of these conditions (i)-(iii) are met, the dispense operation output signal 2930 is set to ON, thus indicating that the dispense operation has been initiated and completed. As described above in FIG. 28, after the data processing circuit 2008 determines that the dispensing operation has been initiated and completed, the data processing circuit 2008 may record the initiation and/or completion of the dispensing operation to a storage device and also inform the user of the completion of the dispensing operation. In FIG. 29 shows an exemplary method for detecting acceleration pulses, which consists in passing the accelerometer output signal through a high-pass filter and then comparing the filtered signal with a reference voltage threshold - an acceleration pulse is detected if the filtered signal is greater than the reference threshold. However, it should be understood that other methods of detecting acceleration pulses may be used instead of the method depicted above in FIG. 29, or in addition to it.

Another exemplary acceleration pulse detection method 3300 is described and depicted in FIG. 33. In step 3302, the data processing circuit 2008 registers the skin contact patterns, denoted as C[n], into a first-in-first-out (FIFO) buffer. The data processing circuit 2008 also registers the raw accelerometer output samples from the accelerometer 2012, denoted as S _raw [n], in another FIFO buffer. In this exemplary method 3300, C[n] and S _raw [n] are discrete digital sampled signals. For example, C[n] may include data expressing whether skin contact was detected at each sampling time of touch sensor(s) 2706 . Depending on the implementation, C[n] may include a separate sample for each sampling time for each sensor in the touch sensor(s), one sample expresses whether any of the sensors detected skin contact, one sample expresses whether all or a subset of skin contact sensors, or other data derived or computed from the output of one or more touch sensors 2706. C[n] may contain a binary indication of whether contact was detected or not, or data indicating the validity of skin contact. S _raw [n] may contain the output signal of the accelerometer 2012 at each sampling time. The sampling rate for C[n] and S _raw [n] may differ according to different implementations. For example, C[n] may be sampled at 20 Hz, and S _raw [n] may be sampled at 1600 Hz. As the FIFO buffers for C[n] and S _raw [n] fill up, the latest samples are removed to make room for new samples. In step 3304, the data processing circuit 2008 calculates the filtered acceleration signal Sf[n] by passing S _raw [n] through a filter, such as a high-pass filter or a band pass filter, and then setting S _f [n] to a value equal to the amplitude of the filtered signal. In some embodiments, the data processing circuit 2008 may also further process the filtered signal to remove any acceleration detected due to gravity.

At step 3306, the data processing circuit calculates the integrated signal S _int [n] by integrating S _f [n]. This integrated signal S _lnt [n] can be calculated by adding a certain number of samples Sf[n] within a sliding window before, after, or both before and after time n. The integrated signal S _int [n] can also be scaled, if necessary, using a scaling factor varying according to Sfn]. One exemplary way of calculating S _int [n] is described in Equation 1 below:

- 30 039706

Equation 1

C _Ί ί(%ταχ-M¥ ^X £%(M ^{P + /} ¥ ^if M ^P ] - ^min ^int ”( o if S _f [η] < S _min

According to Equation 1, if S _f [n] is less than a certain minimum acceleration signal threshold S _min (for example, 3.5 Gs), then S _mt [n] should be set to 0. However, if S _f [n] is greater than S min, then S _mt [n] must be derived by integrating (eg adding) the following W patterns of S _f [n] (eg S _f [n]+S _f [n+1]+S _f [n+2], . .., +S _f [n+W]) and then multiplying the integration output by the scaling factor. The W parameter can be changed depending on the implementation, for example W can be set to 150 samples.

A scaling factor can be used to allow the processing circuitry 2008 to adjust its sensitivity depending on how tightly the user holds the device 20. The scaling factor can be calculated based on the amplitude S _f [n]. For example, in this embodiment, the scaling factor is calculated using the expression S _max -S _f [n], where S _max is a constant value. In some embodiments, S _max may be set to equal the maximum acceleration signal measured by the accelerometer 2012 (eg, 8 gauss). The scaling factor helps the processing circuit 2008 adapt its sensitivity to the detected acceleration under different circumstances. For example, when the user holds the device 20 tightly, the detected acceleration signals may be greatly muted, in which case the zoom factor will be higher. When the device 20 is held loosely, the detected acceleration may be less strongly muted, in which case the zoom factor will be smaller. Other ways to calculate the scaling factor are also possible. In general, any scaling factor calculation method can be used in which an increase in S _f [n] results in a smaller scaling factor (and vice versa).

At step 3308, the data processing circuit 2008 detects or registers an acceleration pulse for each time n that satisfies the following conditions:

(1) Sf[n]>Smin, (2) Dmin<S _m t[n]<Dmax, (3) No acceleration pulse is detected within the number of samples N to n.

The purpose of condition (1) is to ensure that an acceleration pulse is only detected at the time when the filtered acceleration signal S _f [n] is greater than a minimum threshold (eg 3.5 gauss).

The purpose of condition (2) is to ensure that the integrated signal S _int [n] is between a certain minimum threshold D _min (eg 2.5) and a certain maximum threshold D _max (eg 8). Values 2.5 and 8 are given as an example only and may be changed depending on the implementation. If the value of S _int [n] is too small (i.e. less than D _min ), it is unlikely that the acceleration detected at S[n] corresponds to the acceleration pulse, since it is too short and/or not powerful enough to be caused by initiation and/or completing the dispensing operation. If the value of S _mt [n] is too large (i.e. greater than D _max ), it is also unlikely that the acceleration detected at S[n] corresponds to an acceleration pulse, since the device is subjected to acceleration forces that are too strong or too long, to be caused by the initiation and/or completion of a dispense operation. Instead, such powerful and/or long-term accelerations may be caused, for example, by a user dropping the device 20 on a hard surface, or by pushing the device 20 during handling or transport.

The purpose of condition (3) is to ensure that once an acceleration pulse is detected, the data processing circuit 2008 stops looking for another acceleration pulse for at least N number of samples. For example, the processing circuitry 2008 may be configured to stop searching for acceleration pulses for one second after detecting the first acceleration pulse. This prevents cases of false signal detection, in which noise or vibration from a single actuation or deactivation event results in the detection of multiple acceleration pulses.

Method 3300 is provided as an example only and may be modified in many ways. For example, step 3304 can be omitted, with the integrated signal S _mt [n] calculated directly from S _raw [n] instead of S _f [n]. Step 3306 can be modified by calculating S _mt [n] without using a scaling factor, or by using a scaling factor other than that specified in Equation 1. Step 3306 can also be modified by calculating S _mt [n] for all values of n, not just for values for which S _f [n] is greater than S _min . In some embodiments, when screening S _mt [n] in condition 2, only the maximum threshold D _max may be used, and the minimum threshold D _min may be absent; in other implementations, only the minimum threshold D _min may be used, and the maximum threshold D _max may be absent. Besides,

- 31 039706 the value of S _int [n] can also be calculated by integrating or summing the values of Sf[n] that precede time n, in addition to integrating or summing the values of Sf[n] that follow time n, or instead of him.

The method 3300 can also be modified so that the value of S _int [n] is calculated by integrating (and scaling if necessary) the value of Sf[n] in step 3306 only when the current received value of Sf[n] represents a recent peak. The current received sample Sf[n] represents the recent top when it is the highest value sample obtained within the recent number of N samples (eg, N can be set per 1000 accelerometer samples). This requirement to calculate the value of S _int [n] only if Sf[n] is a recent top can be set in addition to or instead of the above conditions for calculating the value of Sj _nt [n], for example the condition that Sf[n] must be greater than or equal to S _min . By requiring the value of S _int [n] to be computed only when a recent peak for S _f [n] is obtained, method 3300 can prevent false signal recognition cases in which pulse or vibration echoes from a device drop or impact are falsely perceived as acceleration pulses indicating initiation and /or completion of the dispense operation. In other words, patterns for S,[n] that do not reflect recent peak values and therefore may indicate pulse echoes or damped vibrations from dropping or impacting the device are considered unsuitable for consideration as potential acceleration pulses indicative of initiation and/ or completion of the dispensing operation. In some implementations, step 3306 may be further modified so that the number N of samples may be expanded by receiving additional samples Sf[n] that are greater than S _min but less than the recent top. This means that instead of strictly considering only the last N number of samples when calculating the recent peak, method 3300 may consider more recent samples if the last few samples were greater than Smin ^.

Other methods for determining acceleration pulses may also be used. For example, such acceleration pulses can be detected by analyzing the frequency content of the signal output by the accelerometer 2012, for example by processing the output signal using a Fast Fourier Transform (FFT). If the frequency content of the accelerometer output signal is above a certain frequency threshold, or within a certain frequency range, exceeds a predetermined threshold, the data processing circuit 2008 may determine that an acceleration pulse has been detected. Another way to detect acceleration pulses can be to differentiate the output signal of the accelerometer. If the amplitude of the output signal difference is greater than a certain threshold, the data processing circuit may determine that an acceleration pulse has been detected. In general, any method or algorithm for detecting an acceleration pulse indicative of a sharp pulse or vibration being experienced by the device 20 may be used by the data processing circuit 2008. Any of these acceleration pulse detection methods or algorithms can be used in the methods depicted and described in FIG. 30-32.

In FIG. 30 is a flowchart depicting another exemplary method 3000 that may be implemented by data processing circuitry 2008 to detect the initiation and completion of a dispense operation (e.g., step 2818 in method 2800) in accordance with a third set of implementation options. Method 3000 may be similar to the logic depicted in FIG. 29, but may differ in some respects.

After starting at 3002, the processing circuit 2008 proceeds to 3004 where it evaluates whether at least one skin contact sensor (eg, at least one, a certain number, a certain subset, or all of the sensor(s) 2706 is detecting touch) skin contact. If yes, then the processing circuit 2008 proceeds to step 3006 where the processing circuit reads or analyzes the acceleration signal output from the accelerometer 2012 to detect acceleration pulses. If not, then the processing circuit 2008 continuously and cycles back to step 3004 until skin contact is detected. The data processing circuit 2008 does not read or analyze any signal output from the accelerometer 2012 before skin contact is detected, thus preventing false signal recognitions. Similarly, this can be done by turning off the power supply to the accelerometer 2012 so that it does not output any signal if no skin contact is detected. Alternatively, the accelerometer 2012 may be powered and output an acceleration signal to the processing circuit 2008 even if no skin contact is detected, but the processing circuit 2008 may be configured to proceed to step 3006 only if skin contact is detected.

In step 3006, the data processing circuit 2008 reads or parses the acceleration signal output from the accelerometer 2012 to detect acceleration pulses. This can be done using any of the above processes or methods for detecting acceleration pulses. After analyzing the accelerometer output signal, the processing circuit 2008 may proceed to block 3008. At block 3008, the processing circuit 2008 determines whether the first acceleration pulse was detected during skin contact detection. If not, the data processing circuit 2008 proceeds to

- 32 039706 to step 3004. If yes, the data processing circuit proceeds to step 3010, where the data processing circuit 2008 determines that the first acceleration pulse was probably caused by initiating a dispense operation. Therefore, the circuit 2008 records the initiation of the dispensing operation by setting the indicator in the memory or by setting the logic circuit, and proceeds to step 3012. At step 3012, the data processing circuit 2008 again evaluates whether at least one skin contact sensor detects (for example, by at least one, a certain number, a certain subset, or all of the touch sensor(s) 2706) skin contact. If yes, the processing circuit 2008 proceeds to block 3014. If not, the processing circuit 2008 continuously and cycles back to block 3012 until skin contact is detected. Similarly, the data processing circuit 2008 does not read or evaluate any signal output from the accelerometer 2012 until skin contact is detected. In step 3014, the processing circuit reads or analyzes the acceleration signal output from the accelerometer 2012 again to detect acceleration pulses. This analysis can be carried out by any of the methods described above. At 3016, the processing circuitry 2008 determines whether a second acceleration pulse was detected during skin contact detection. If not, the data processing circuit 2008 returns to step 3012. If yes, the data processing circuit 2008 proceeds to step 3018, where the data processing circuit 2008 determines that the second acceleration pulse was likely caused by a retract motion at the completion of the dispense operation. Therefore, the data processing circuit 2008 records the completion of the dispensing operation and proceeds to step 3020.

At 3020, the data processing circuit 2008 registers and/or reports the initiation and completion of the dispensing operation. This can be done by storing the dispensing operation on a memory device and/or broadcasting wireless signals notifying the completion of the dispensing operation, as described above. Alternatively or additionally, the processing circuitry 2008 may indicate the completion of the dispense operation by turning on or off one or more LEDs, emitting a sound, or any other visual, tactile, or audible indicator to the user.

In FIG. 31 is a flow diagram depicting another exemplary method 3100 that may be implemented by data processing circuitry 2008 to detect the initiation and completion of a dispense operation (e.g., step 2818 in method 2800) in accordance with a third set of implementation options. Method 3100 may be similar to the logic depicted in FIG. 29 and 30, but may differ in some respects. In particular, the method 3100 employs a timer to ensure that the second acceleration pulse is detected within a predetermined time after the detection of the first acceleration pulse before determining the completion of the dispense operation. If the second acceleration pulse is not detected within a predetermined time, the data processing circuit 2008 ignores or deletes the first acceleration pulse. Method 3100 also reverses the order of operations described in FIG. 29 and 30: Instead of continuously monitoring for skin contact from at least one touch sensor(s) 2706 and reading/evaluating the signal from the accelerometer 2012 only when skin contact is detected, method 3100 continuously reads/evaluates the signal from the accelerometer 2012 for presence acceleration pulse and only reads/evaluates the signal(s) from said at least one touch sensor(s) 2706 when an acceleration pulse is detected.

After starting at step 3102, the data processing circuit 2008 proceeds to step 3104, where it continuously or periodically reads, observes and/or evaluates the signal output from the accelerometer 2012, regardless of whether any skin contact was detected or not. . This is different from the logic described above in FIG. 30 where the processing circuit does not read, observe and/or evaluate the signal from the accelerometer 2012 prior to detecting skin contact. The data processing circuit 2008 may analyze the signal from the accelerometer 2012 for the presence of acceleration pulses using any of the techniques described above. Upon detection of the first acceleration pulse, the processing circuit 2008 proceeds to step 3105. The processing circuit 2008 may also optionally store the event of this first acceleration pulse in a memory.

At 3105, the processing circuitry 2008 determines whether at least one skin contact sensor (e.g., at least one, a certain number, a certain subset, or all of the touch sensor(s) 2706) has detected skin contact at the time the first pulse is detected. acceleration. If not, the data processing circuit 2008 proceeds to block 3108, where it ignores the first acceleration pulse or deletes the memory record of the first acceleration pulse event, and then returns to block 3104. If yes, the data processing circuit 2008 proceeds to block 3106.

At 3106, the processing circuitry 2008 determines that the first acceleration pulse has been caused by initiating a dispense operation in which the drive mechanism 24 moves the syringe assembly 22 from the storage position to the injection position. The data processing circuit 2008 also starts a timer counting down from a predetermined duration, such as a certain number of seconds. After the timer starts, the processing circuit 2008 proceeds to this

- 33 039706 n 3110. In step 3110, the data processing circuit 2008 determines whether the timer has expired. If yes, the data processing circuit 2008 proceeds to block 3108. If not, the data processing circuit 2008 proceeds to block 3112.

At 3112, the processing circuitry 2008 continuously or periodically reads, observes, and/or evaluates the signal output from the accelerometer 2012 for the presence of a second acceleration pulse, whether or not any skin contact has been detected. If the second acceleration pulse has not been detected, the processing circuit 2008 proceeds back to step 3110 where it evaluates whether the timer has expired. If a second acceleration pulse is detected, the data processing circuit 2008 proceeds to step 3114. The data processing circuit 2008 may also optionally log the event of this second acceleration pulse to memory. Thus, the data processing circuit 2008 loops continuously between steps 3110 and 3112 either until the timer expires (in which case the data processing circuit 2008 proceeds to step 3108) or until the second acceleration pulse is detected (in which case the data processing circuit 2008 proceeds to step 3114).

At 3114, the processing circuitry 2008 determines whether at least one skin contact sensor (e.g., at least one, a certain number, a certain subset, or all of the touch sensor(s) 2706) has detected skin contact at the time the second pulse is detected. acceleration. If not, the data processing circuit 2008 proceeds to block 3116, where it ignores the second acceleration pulse or deletes the memory record of the second acceleration pulse event, and then returns to block 3110. If so, the data processing circuit 2008 proceeds to block 3118. At 3118, the processing circuitry 2008 determines that the second acceleration pulse was caused by a retract movement at the completion of the dispensing operation. The data processing circuit 2008 then stops the timer, registers the initiation and completion of the dispense operation in the memory, and/or informs the external device or user of the initiation and/or completion of the dispense operation.

In FIG. 32 is a flow diagram depicting yet another exemplary method 3200 that may be implemented by data processing circuitry 2008 to detect the initiation and completion of a dispense operation (e.g., step 2818 in method 2800) in accordance with a third set of implementation options. Method 3200 may be similar to the logic depicted in FIG. 29, 30 and 31, but may differ in some respects. In particular, method 3200 requires that two acceleration pulses be within a certain time window before determining that a dispense operation has been initiated and completed. The method 3200 also requires detection of skin contact by at least one skin contact sensor during the time period between the first and second acceleration pulses before determining that the dispensing operation has been successfully initiated and completed. After starting at step 3202, the data processing circuit 2008 proceeds to step 3204 where it continuously reads, observes and/or evaluates the signal output from the accelerometer 2012 for the presence of acceleration pulses. The data processing circuit 2008 may analyze the signal from the accelerometer 2012 to detect acceleration pulses using any of the techniques described above.

At step 3206, the data processing circuit 2008 determines whether two acceleration pulses have been detected within a certain time window. If yes, the processing circuit proceeds to block 3212, and if not, the processing circuit 2008 returns to block 3204. itself, which is not less than the minimum threshold T _min time (for example, 1 second). Alternatively or additionally, the processing circuitry 2008 may proceed to step 3212 only if two acceleration pulses have been detected that have occurred with a time interval between them that is no greater than the maximum time threshold T _max (eg, 5 to 10 seconds). In some embodiments, the time window may include a maximum time threshold T _max and no minimum time threshold; in other words, the minimum time threshold T _min can be set to 0 seconds.

At 3212, the processing circuitry 2008 determines whether at least one skin contact sensor (e.g., at least one, a certain number, a certain subset, or all of the touch sensor(s) 2706) has detected skin contact during the time interval between first and second acceleration pulses. The following are some illustrative criteria for evaluating skin contact:

(1) Skin contact is detected during the entire time period between the first and second acceleration pulses.

(2) Skin contact is detected at a certain point in time, no matter how short it was, between the first and second acceleration pulses.

(3) Skin contact is detected for a certain length of time at a certain time between the first and second acceleration pulses, for example 1 to 3 seconds, or 50 to 100% of the time between the first and second acceleration pulses.

(4) Skin contact is detected, no matter how brief, only during

- 34 039706 of the first acceleration pulse.

(5) Skin contact is detected for a certain length of time at the time of the first acceleration pulse.

(6) Skin contact is detected, no matter how short, only during the second acceleration pulse.

(7) Skin contact is detected for a certain length of time before the second acceleration pulse.

Depending on the implementation, the data processing circuit 2008 may evaluate any detected skin contact according to any one or more of the criteria (1)-(7) above. For example, processing circuitry 2008 may maintain a registry or buffer of times and/or durations of recently detected skin contacts in memory, and then query that registry at 3212 to determine if there was a skin contact that met the applicable criteria. If the processing circuit detects a skin contact that meets the applicable criteria, the processing circuit 2008 proceeds to block 3216. If the applicable criteria are not met, the processing circuit 2008 proceeds to block 3204.

At step 3216, the processing circuitry 2008 determines that the first acceleration pulse was caused by initiating the dispense operation and that the second acceleration pulse was caused by the retracting movement at the completion of the dispense operation. The data processing circuit 2008 then registers the initiation and completion of the dispense operation in the memory and/or informs the external device or user of the initiation and/or completion of the dispense operation.

Methods 3000 (FIG. 30), 3100 (FIG. 31), and 3200 (FIG. 32) have each been described above as being implemented by the processing circuit 2008 in device 20. However, in some implementations, some or all of the steps in each of these The methods may be implemented by or in conjunction with a data processing circuit on an external device separate from device 20, such as processor 1252 on external device 1250 (see FIG. 12). For example, some or all of the steps in each of these methods 3000, 3100, and 3200 may be performed by a processor in a mobile device (eg, smartphone or laptop) or a server that receives skin contact and accelerometer data from device 20. Such skin contact and accelerometer data may be derived from measurements or signals output from skin contact sensors 2706 and/or accelerometer 2012 and may be received via a wireless communication link between device 20 and an external device, or via a network communication link (e.g., via Internet or cellular network). The external device may then record the completion of the dispense operation in a memory or report, notify and/or inform the user of the dispense operation, or perform other actions or steps based on the completion of the dispense operation. The steps performed by the external device may be performed in real time, such as during the measurement of data by the device 20, or they may be performed some time (eg, hours, days, or years) after the skin contact and accelerometer data are measured and recorded by the device. 20.

Although the following description of the third set of embodiments of device 20 describes the differences between this third set of embodiments and the first and second sets of implementations described above, it should be understood that the third set of embodiments may also contain features present in the first and second sets of embodiments. implementation, and other features. For example, some of the implementations in this third set of implementation options may contain additional PP 84 of the first set of implementation options, including some or all of the sensors described above as installed on it. Certain embodiments in this third set of embodiments may also comprise proximally extending arms 1710a, 1710b of the second set of embodiments.

In FIG. 34 shows an exemplary sequence 3400 of user steps for using the drug injection device 20. This exemplary sequence 3400 may be applicable to any of the first, second, or third sets of device 20 embodiments described herein. The device 20 may begin at 3402, where the device is held at a colder storage temperature (eg, 36 to 46°F, or 2 to 8°C) in a storage environment (eg, refrigerator) to protect the stored drug. in it, from damage. At step 3404, the user takes the device 20 from the storage medium. At 3406, the user may optionally press a temperature check button to cause the processing circuitry on the device 20 to wake up and check its temperature. For devices belonging to the first set of implementation options, this can be done by pressing a button to cause the processing circuit 108 to wake up and reading the IR sensor 120. For devices related to the third set of implementation options, this can be done by pressing the temperature check button 2001 and ensure reading

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Claims (13)

temperature sensor 2025 by processing circuit 2008. At 3408, one or more LEDs mounted on device 20 may light up or flash to indicate temperature status, thereby notifying the user if the temperature of the drug stored in device 20 is close to the ideal range or in the ideal range for administration. (for example, at room temperature, or 65 to 75°F, or 18 to 24°C). For drugs that do not require a temperature check, steps 3406 and 3408 can be omitted. At 3410, device 20 may return to sleep to conserve battery power if no further activity is detected. The device 20 may enter a sleep mode by turning off some or all of its electrical components or placing some of its components into a low power mode. For example, in some implementations, device 20 enters sleep mode by cutting off power to its processing circuitry. In some cases, the power supply to the processing circuit may be cut off when the user releases the temperature test button. In other cases, the power supply to the processing circuit is turned off within a certain predetermined length of time after the user releases the temperature test button (eg, a few seconds or minutes). Other electrical components such as LEDs and/or sensors can also be disabled to save power. At 3412, the device 20 detects when the user removes the bottom cap 36. For devices in the third set of embodiments, the device 20 can detect when the bottom cap 36 has been removed using the bottom cap removal sensor 2010. This action causes device 20 to be re-awakened, for example by energizing its processing circuitry. In step 3414, the user presses the device 20 against their body (eg, their abdomen) and activates the device by unlocking and depressing the actuator button 52 at the distal end of the device 20. Unlocking and depressing the button 52 causes the syringe assembly 22 to be moved by the actuator 24 from the storage position. into position for injection. For devices in the third set of embodiments, device 20 detects contact with the user's skin as well as an acceleration pulse associated with movement of syringe assembly 22. As described above, these two detected parameters can be interpreted by device 20 as indicating the initiation of a dispensing operation. In step 3416, the retract mechanism 26 moves the syringe assembly 22 from the injection position to the retracted position at the end of the dispensing operation. For devices in a third set of embodiments, device 20 detects contact with the user's skin as well as an acceleration pulse associated with retract movement of syringe assembly 22. As described above, these two detected parameters can be interpreted by device 20 as indicating completion of the dispensing operation. At step 3418, the device 20 lights one or more LEDs mounted on the device body to notify the user that the dispensing operation has been successfully initiated and completed. At 3420, device 20 retransmits the injection data. This data may be received by an external device (eg, mobile device 1250) and indicates the successful initiation and completion of the dispense operation, the amount of time elapsed since the completion of the dispense operation, the type and/or configuration of device 20, the type of drug being administered, or any other data or parameters detected by or stored by the device 20. An application running on an external device can optionally acknowledge receipt of data to device 20 by sending an acknowledgment message. At 3422, the device 20 may be disposed of in any suitable manner, such as in a sharps container as shown. While this invention has been described as having an exemplary design, embodiments of the present invention may be further modified within the spirit and scope of this disclosure. Thus, this application is intended to cover any variation, application, or adaptation of the disclosed embodiments using its general principles. CLAIM 1. An injection device comprising a device body having a proximal end and a distal end, wherein the body defines an internal volume extending along a longitudinal axis between the proximal end and the distal end, and a proximal opening at the proximal end of the body in communication with the internal volume, with In this case, the body of the device includes a user-gripped portion configured to be held by the user's hand, wherein the user-gripped portion extends a first radial distance outward from - 36 039706 of the longitudinal axis, and an outwardly expanding end section at the proximal end of the body near the proximal opening, and the outwardly expanding end section extends a second radial distance outward from the longitudinal axis, which is greater than the first radial distance; a syringe assembly at least partially located within the internal volume, wherein the syringe assembly comprises (i) a cylinder configured to hold a drug, (ii) a piston slidable along a longitudinal axis within the cylinder, and (iii) an injection needle , extending from the cylinder; a drive mechanism configured to move the syringe assembly from a storage position to an injection position and to move the piston in a proximal direction within the barrel to dispense the drug from the barrel in the dispense operation; and one or more main printed circuit boards (PCBs) located in the outwardly expanding end section of the device body, while said one or more main PCBs form an opening through which at least a section of the syringe assembly is configured to pass during operation dosed issuance, wherein said one or more main PPs extend from the longitudinal axis to a radial distance exceeding the first radial distance, and said one or more main PPs contain at least one wireless radio frequency (RF) antenna and a data processing circuit made with the ability to transmit data wirelessly to an external device through the specified at least one wireless RF antenna. 2. The injection device according to claim 1, wherein the first radial distance is 10 mm or less. 3. The injection device according to claim 1, wherein the first radial distance is 8 mm or less and said one or more PPs extend 15 mm or more radially outward from the longitudinal axis. 4. The injection device according to claim 1, wherein said one or more main PPs further comprise one or more sensors located near the proximal orifice, each sensor being configured to detect contact with skin tissue. 5. The injection device of claim 4, wherein said one or more sensors comprise a plurality of sensors surrounding a proximal orifice, each sensor is configured to detect contact with skin tissue based on a measured electrical resistance, and each sensor is located at a radial distance along outward from the longitudinal axis, which is greater than the first radial distance. 6. The injection device of claim 5, wherein each sensor is 10 mm or more radially outward from the longitudinal axis. 7. The injection device of claim 5, wherein each sensor is 15 mm or more radially outward from the longitudinal axis. 8. The injection device according to claim 5, further comprising one or more light-emitting diodes (LEDs) built into the body of the device, and the data processing circuit is configured to provide an indication to the user depicting which individual sensors of the plurality of sensors detect contact with skin tissue, and which individual sensors of the plurality of sensors do not detect contact with skin tissue using said one or more LEDs. 9. The injection device according to claim 5, wherein the data processing circuit is configured to transmit data indicating which individual sensors of the plurality of sensors detect contact with skin tissue, and which individual sensors of the plurality of sensors do not detect contact with skin tissue , to an external device via a wireless data link. 10. The injection device according to claim 1, additionally containing one or more additional PP, connected with the possibility of data exchange with the specified one or more main PP, and said one or more additional PP run parallel to the longitudinal axis and contain one or more number of sensors. 11. The injection device of claim 1, further comprising a temperature sensor disposed proximate the barrel, wherein the processing circuitry is configured to estimate the temperature of the drug based on the output of the temperature sensor. 12. The injection device of claim 1, further comprising a microswitch sensor configured to detect if the syringe assembly is in at least one of a stored position, an injection position, and a retracted position. 13. An injection device according to claim 12, wherein the microswitch sensor is located on said one or more main PCBs. -