EA044504B1 - DEVICE FOR DRUG DELIVERY WITH SYRINGE SENSOR SYSTEM - Google Patents

Description

State of the art

The present invention relates to drug delivery devices and, in particular, to a sensor system in a drug delivery device.

Drug delivery devices containing a syringe are widely used by healthcare professionals and patients who self-medicate. Patients suffering from a number of different diseases often need to self-administer medications, and a variety of devices have been developed to facilitate such self-medication. Such devices typically comprise a syringe having a syringe barrel in which the drug is stored, and a drive system for expelling the drug from the syringe barrel through the needle opening and into the patient's body. The device may be an automatic injection device that includes mechanisms to automatically perform certain steps of the injection process, making it more convenient for the patient to self-medicate. Due to the design and layout of such devices, it is difficult to determine the operating status of the device. Although a number of functional drug delivery devices are currently available, there is a need for improvements in such drug delivery devices.

The essence of the invention

According to an embodiment of the present invention, a drug delivery device includes a housing, a drug container, a drive mechanism, a return mechanism, and a sensor system. The container for the medicinal product contains a container body for storing the medicinal product and a movable piston functionally connected to the container body. The movable piston is movable relative to the container body to deliver the drug from the drug container. The drug container is movable relative to the housing between a storage position and a delivery position. The drive mechanism contains a rod that is engaged with a movable piston. The drive mechanism is configured to actuate the rod in the longitudinal direction, move the drug container from a storage position to a delivery position, and move the movable piston to dispense the drug from the drug container when dispensed. The return mechanism is configured to move the container with the medicinal product from the delivery position to the storage position during the return movement. The return mechanism contains a rotating element configured to rotate during the return movement. The sensor system includes a first sensor located within the drug delivery device. The first sensor is configured to generate a plurality of first signals indicative of a first measured parameter. The sensor system includes a second sensor located within the drug delivery device and positioned to measure the rotational motion of the rotating member. The second sensor is configured to generate a plurality of second signals indicative of the measured rotational motion of the rotating element. The controller is operatively coupled to the first sensor and the second sensor. The controller is configured to determine the initiation of a feed event based on a plurality of first signals generated by the first sensor, and is configured to determine at least one of a feed event and a return movement execution based on a plurality of second signals generated by the second sensor.

According to an embodiment of the present invention, a method for determining the operating state of a drug delivery device is provided. The device contains a needle, a first sensor, a second sensor, a rotation sensor and a return mechanism. The method includes one or more of the following steps. The step includes determining the initiation of a feed event from a needle in an extended position based on a peak value of a signal from a plurality of first signals generated by the first sensor. The step includes determining the end of a feed event from said needle in an extended position based on an initial peak of a plurality of second signals generated by a second sensor measuring rotation of a rotating member of the return mechanism. The step includes determining the retraction end of said needle from an extended position based on a predetermined peak of second signals subsequent to an initial peak of second signals generated by the second sensor. The step includes informing the user interface of at least one detected feed event initiation, detected feed event execution, and detected needle return execution. According to an embodiment of the present invention, a drug delivery device includes a housing, a drug container, a drive mechanism, a return mechanism, an accelerometer, and a controller. The drug container includes a container body for storing the drug and a movable piston operatively connected to the container body, wherein the movable piston moves relative to the container body to supply the drug from the drug container. The drug container is movable relative to said housing between a storage position and a delivery position. When a delivery event is initiated, the drive mechanism is configured to drive the drug container out of the storage position until the drug container stops in the delivery position. When the return movement is initiated, the return mechanism is configured to drive the drug container from the delivery position until the drug container stops in the storage position. The accelerometer is located within the drug delivery device and is configured to detect a first acceleration caused by the drug container when it is moved from a storage position to a delivery position by the drive mechanism, and is configured to detect a second acceleration caused by the drug container when it is moved from the delivery position to the storage position by means of a return mechanism. The controller is operatively coupled to the accelerometer and configured to determine initiation of a feed event based on the detected first acceleration and perform a return movement based on the detected second acceleration.

Brief description of graphic materials

The foregoing and other features of the present invention, as well as the method for achieving them, will become more apparent and better understood by reference to the following description of embodiments of the present invention when taken in conjunction with the accompanying drawings.

Fig. 1 is a side cross-sectional view of an exemplary drug delivery device containing an exemplary sensor system prior to use.

Fig. 2 is a cross-sectional side view of the drug delivery device shown in FIG. 1, with the drug container in the storage position and ready for the dispensing event.

Fig. 3 is a cross-sectional side view of the drug delivery device shown in FIG. 1, with the drug container in the delivery position.

Fig. 4 is a perspective view of an example of a rod equipped with the drug delivery device shown in FIG. 1.

Fig. 5 is a perspective view of an example of a syringe holder equipped with the drug delivery device shown in FIG. 1.

Fig. 6 is a perspective view of an example of an upper shuttle member equipped with the drug delivery device shown in FIG. 1.

Fig. 7 is a perspective view of an example of a lower shuttle member equipped with the drug delivery device shown in FIG. 1.

Fig. 8 is a perspective view of the exemplary drug delivery device shown in FIG. 1.

Fig. 9 is a partially cut away perspective view of the exemplary drug delivery device shown in FIG. 1.

Fig. 10 is a partial cross-sectional perspective view of the drug delivery device shown in FIG. 1, illustrating an exemplary sensor system and a rotating member of the return mechanism in a first position.

Fig. 11 is another perspective view, partially cut away, of the drug delivery device shown in FIG. 1, illustrating a sensor system with the rotating return member in a different position.

Fig. 12, 13 are perspective views of the sensor system and rotating element depicting the operation of the respective components with remote surrounding components of the drug delivery device depicted in FIG. 1.

Fig. 14 is a schematic view of a sensor system transmitting data to an external separate device as an example.

Fig. 15 is a graph illustrating signals generated by the sensors of the sensor system.

Corresponding reference symbols indicate corresponding parts on all individual graphics. Although the example set forth herein illustrates an embodiment of the invention, the following description of the embodiment of the invention is not exhaustive or should not be construed as the precise form described and limiting the scope of the present invention.

Detailed Description of the Invention

An automatic injection device, generally designated 20, has a trigger that, when activated by a user, causes the syringe and needle of the device to automatically move downwards such that the injection needle projects beyond the lower end of the body of the device to penetrate the user's body. The device then begins automatic administration

- 2 044504 medicinal contents of the syringe through the needle, after which the syringe is automatically retracted so that the injection needle returns inside the housing. The delay mechanism of this device helps to divide the operation into stages to ensure that the medicinal contents are properly delivered before the syringe and needle are withdrawn. If the device contains a hidden needle, the user may be provided with information about the operating status of the device through an indicator display or indicator lights and/or sounds for each step of the process throughout the drug delivery cycle. In addition, using the device, recording and/or reporting of drug delivery events or failures can be provided to patients and healthcare professionals. As used herein, the terms distal and proximal refer to axial locations relative to the user and opposite the injection site when the device is oriented for use at that location. For example, the proximal end of the housing refers to the upper end of the housing that is furthest away from such injection site, and the distal end of the housing refers to the base of the housing or injection end that is closest to such injection site.

An example of a drug delivery device 20 is shown in FIG. 1-3. The device 20 includes a syringe system 22, a drive mechanism generally designated 24, a return mechanism 26, and a sensor system 28 (shown in FIGS. 10-11) coupled within a tubular body 38 of the device. The device 20 includes a delay mechanism including a shuttle assembly 60 to help divide the operation into steps to ensure that the medicinal contents are properly delivered before the syringe and needle are withdrawn. The syringe system 22 includes a container barrel body 30, such as made of glass or other suitable material, configured to hold a medicinal product, a movable piston element 32, such as a rubber sealing member, operatively coupled to the container body 30, and a hollow injection needle 34. The proximal end of the injection needle 34 is mounted on the nose of the distal end of the cylinder body 30. The injection needle 34 is hydraulically connected to the medicinal contents in the syringe barrel body 30 and is initially covered by a needle guard 42. The distal portion advances the piston element 32 within the cylinder body 30 towards the injection needle 34, delivering the drug through the needle 34. The drive mechanism 24 is operatively coupled to the piston element 32. The movable movement of the piston element 32 relative to the container body 30 results from the operation of the drive mechanism 24, as will be described that delivers medication from the syringe system 22. The operation of the drive mechanism 24 and the return mechanism 26 in the device 20 and other descriptions of the components of the exemplary device are described in US Pat. No. 8,734,394 to Adams et al., filed February 24, 2011. , the description of which is incorporated herein by reference. Fig. 1 illustrates a drug delivery device 20 in a storage configuration. The syringe cap 36 is attached to the body 38 and covers the distal opening 40 in the body 38. The needle guard 42 is mounted on the end of the distal end of the barrel 30 of the syringe 22, covering the needle 34. The top cap 36 and the needle guard 42 protect the user from accidental needle sticks. , and also protect the needle 34 from damage. When using the drug delivery device 20, for example, to inject a drug into a patient, the top cover 36 and needle guard 42 are first removed to expose the distal opening 40. FIG. 2 illustrates device 20 with top cap 36 and guard 42 removed, syringe 22 in storage position, and device 20 ready for dispensing.

The syringe system 22 is movable relative to the drug delivery device 20 between the storage position shown in FIG. 1-2, and the delivery position shown in FIG. 3. Fig. 3 illustrates device 20 after the syringe system 22 has been moved relative to device 20 to a delivery position from a storage position. In the storage position, the injection needle 34 is in a retracted position within the device 20 such that the distal tip of the needle 34 does not extend beyond the distal opening 40. In the delivery position, the distal tip of the needle 34 projects distally beyond the distal opening 40 relative to the device 20 in the extended position. position for surgical administration to the patient.

The drive mechanism 24 includes a rod 44 that engages the piston element 32. The drive mechanism 24 includes a drive spring 46 which, when released, drives the rod 44 in a distal translational manner. In one example, spring 46 propels rod 44 along a linear path defined by the central axis 48 of device 20. Rod 44 includes a distal area with a disc-shaped base 50 (FIG. 4) at one end that serves to operatively seal piston 32 against rod advance time. As the rod 44 is further advanced, the syringe 22 moves along the axis 48 from the storage position to the delivery position. The drive spring 46 directly biases the rod 44 downward to drive it and thereby the piston 32 distally, which causes the syringe 22 to move distally relative to the shuttle assembly 60 and body 38, causing the tip of the needle 34 to protrude beyond the distal end. housing to penetrate the user's skin and then pushes the medicinal contents in the syringe through this injection needle. After advancing the 22 syringe into his polo

- 3 044504 action for delivery, the continued advance of the rod 44 advances the piston 32 in the cylinder 30, causing the drug to be delivered from the needle 34 if delivered. Advancement of the rod 44 will generally not dispense medication from the syringe 22 until the syringe 22 is moved into the delivery position. Two main factors prevent the medication from being delivered before the syringe is moved to the delivery position for delivery. First is the friction between the piston 32 and the cylinder 30. Typically, the piston 32 will be made of rubber material and the cylinder 30 will be glass. The frictional resistance between these two components may be sufficient to prevent the piston 32 from advancing in the barrel 30 until the syringe 22 is moved to its delivery position, and engagement with a suitable stop member prevents the syringe 22 from further advancing. In addition, the drug in the syringe can be quite viscous and therefore quite resistant to leakage from the needle 34. If necessary, modification of the piston element 32 and container body 30 to change the frictional resistance of the piston element 32 relative to the container body 30 can limit or prevent premature delivery of the drug before as syringe 22 reaches its delivery position.

At the upper or proximal end of the housing 38 and protruding axially from it, a button 52 is provided for safety reasons and is part of a user-controlled trigger. When the housing safety sleeve is positioned in the correct angular orientation relative to housing 38, rotatably adjustable by the user, button 52 will be unlocked and can be pressed to initiate the device's automatic injection function. To activate the actuator 24, a person presses an actuator button 52 on the proximal end of the device 20. The pressed button 52 disengages one or more extension pins 54 of the rod 44 from the shuttle assembly 60, thereby allowing the spring 46 to move the rod 44 axially. The spring 46 is helical in shape and surrounds the pins 54. The distal end of the spring 46 engages the flange 56 on the rod 44.

Fig. 4 illustrates an example of a rod 44. The proximal region of the rod contains one or more pins (a pair of pins 54 is shown). The pins 54 are configured to bend inward in a radial direction. In another example, the rod contains a single pin. The base 50 is located along the distal end of the rod. Beveled surfaces 55 may be formed along the tops of the pins. The console 58 protrudes distally from the flange 56 of the rod 44 at a distance depending on the rod body. The arm 58 directly engages the locking member during injection to unlock the rotating delay mechanism member 70 (shown in FIG. 3). The rotary member 70 is also part of the return mechanism 26. The position of the arm 58 relative to the rod 44 and the rotating member 70 is such that the engagement between the arm and the rotating member corresponds to the completion of the feed event. Pressing the button 52 causes the tabs on the button 52 to engage the tabs 55 on the pins 54, displacing the pins 54 inward, disengaging the pins 54 from the upper shuttle member 62 (shown in FIG. 6) of the shuttle assembly 60 (shown in FIG. 2), which corresponds to the start of the feed event. After the pins 54 have been disengaged, the spring 46 applies a bias force to the flange 56 to push the rod 44 out of the first position shown in FIG. 2, where the piston is located at the proximal end of the container cylinder body 30, to the final fully extended position shown in FIG. 3, where the piston is located at the distal end of the container body 30.

The delay mechanism of the device 20 includes a shuttle assembly 60 (indicated in FIG. 2), a rotating element 70 (indicated in FIG. 3) that is removably fixed to the shuttle assembly 60, and a spring 66 (indicated in FIG. 1) that operates between the shuttle and rotating element. The shuttle unit 60 can be made in the form of a one-piece shuttle. In the embodiment shown, the shuttle assembly 60 is made up of an upper shuttle 62 and a lower shuttle 64, further illustrated in FIG. 6 and fig. 7 respectively. The shuttle portions 62 and 64 may be fixedly connected during manufacturing assembly, for example, using a snap connection or other suitable connection method, to together serve as a shuttle assembly. The multi-part design facilitates the molding and assembly of the shuttle, as well as the assembly of device components within the shuttle interior. Suitable materials for any part of the shuttle are plastic, such as polycarbonate or an alloy thereof, which is transparent. During final assembly, the upper shuttle 62 retains the button 52 and spring 46, limiting the axial movement of these parts in the proximal direction. Each upper and lower shuttle element 62, 64 contains a tubular cylindrical body. A central hole 63 extends through the top and bottom of the shuttle body to allow passage of the latching portion of the rod pins 54. Guide members, such as pawls, protrude proximally from the top surface of the upper shuttle 62 around the opening 63 and help guide the actuation projections of the button 52 into the opening 63 during use. The pins 54 engage the upper surfaces of the upper hook 62 when the device is in the state shown in FIG. 1 and 2. Pressing the button 52 distally moves the projections of the button 52 to engage the tabs 55 on the pins 54 to move the pins 54 inward to disengage the pins 54 from the top member.

- 4 044504 shuttles. After the pins 54 are disengaged and positioned in the cross-sectional region of the hole 63, the spring 46 applies a bias force to the flange 56 to advance the rod 44 from the first position shown in FIG. 2 to the second position shown in FIG. 3. As the rod 44 advances, the syringe 22 is advanced into the delivery position, and then the plunger 32 is advanced distally in the syringe 22 to deliver the medication, as discussed above.

After the delivery event is completed, the return mechanism 26 is configured to move the syringe 22 proximally from the delivery position shown in FIG. 3 back to the storage position shown in FIG. 2 or more proximally so that the body covers the needle. In the illustrated embodiment, the return mechanism having a delay mechanism includes a spring 66, a syringe holder 68 shown in FIG. 5, and a rotating member 70 that acts as a pusher.

The arm 58 of the rod 44 unlocks the rotating element 70 when the rod 44 approaches the end of its distal movement. With further reference to FIG. 12, 13, the rotating member 70 is rotatably attached to the lower shuttle member 64 by engagement between a latch 72 and a snap groove in the lower shuttle member 64. The arm 58 unlocks the member 70 by pressing the latch 72. The spring 66 is pre-coiled and has a distal end engaged with a rotating member 70, and an opposite proximal end engaged with a shuttle assembly 60. When the latch 72 is pressed, a spring 66 causes rotation of the rotating member 70. The element 70 includes a slot 74 (shown in FIG. 12) into which a protrusion 78 of the lower shuttle member 64 ( shown in Fig. 7). At one end of the annular slot 74 formed in the rotating member body 70, a channel 76 extending in the axial direction is formed in the rotating member body. Relative rotation of the rotating element 70 with respect to the lower shuttle element 64 moves the protrusion 78 within the slot 74 until the protrusion 78 reaches the channel 76 extending in the axial direction. In this position, the bias spring 66 promotes axial separation between the rotating member 70 and the lower shuttle member.

Element 70 is rotatable within housing 38 about axis 48, but is fixed longitudinally relative to housing 38 and shuttle assembly 60. An outer radial flange 82 formed along the housing section of the rotating element 70 is configured to engage an internal projection formed along the inner surface of the housing element 38 to limit axial movement of the element 70. A spring 66 applies an axial force and/or a torsional force to the element 70 k. biasing element 70 distally, thereby holding element 70 in an axial position in which flange 82 engages the internal projection of housing element 38. The shuttle assembly 60 includes axially extending channels and/or grooves that engage with corresponding guide members formed along the interior of the housing member 38 that allow the shuttle assembly 60 to move axially within the housing 38 and prevent relative rotation of the shuttle assembly 60 relative to the member 38 buildings. The spring 66 is also axially preloaded and exerts a proximally directed displacement force on the shuttle assembly 60. Rotation of the rotating element 70 about the lower shuttle element 64 is provided by the spring 66 until the channel 76 is aligned with the shuttle projections 78 respectively. In this design, the projections 78 do not have shoulders that define the groove 74, so the shuttle assembly 60 and the rotating member 70 are unlocked. When the projection 78 reaches the channel 76, the spring 66 moves the shuttle assembly 60 proximally within the housing 38 as the projection 78 slides axially through the channel 76. A damping composition may be positioned adjacent the rotating element 70 to control, for example, deceleration of the rotating element. element 70, and allowing the feed event to complete before the projection 78 reaches the channel 76. In the illustrated embodiment of the invention, the rotating element 70 includes a skirt with a plurality of projections 80 in the axial direction extending under the projection 82, which are located in a layer of lubricant providing damping. As the shuttle assembly 60 moves proximally, it moves the syringe 22 proximally and moves it back to the storage position shown in FIG. 2. Spring 66 biases return mechanism 26 proximally and thereby maintains syringe 22 in its storage position following a delivery event. A locking mechanism, such as a detent on the shuttle assembly 60 and a notch on the housing member 38, may further provide a snap engagement to secure the syringe 22 in a storage position following a dispensing event, whereby the user can then dispose of or otherwise safely handle the device 20. Holder 68 of the syringe is shown in FIG. 5. Arc-shaped arms 84 hold the barrel 30 of the syringe 22. The syringe holder 68 also includes a radial flange 86 raised above the arms 84 by a circular base. A flange on the syringe barrel 30 is secured between the brackets 84 and the flange 86. A portion of the underside 88 of the flange 86 engages a small flange 90 on the rod 44 and thereby prevents proximal axial movement of the syringe 22 before the rod 44 advances. The shuttle 60 is retracted and the lower shuttle member 64 engages the arms 84 to move the syringe 22 proximally rearward to its storage position.

The sensor system 28 is designed to detect and/or display or inform

- 5 044504 user or other person about the status of the work stages. In one example, sensor system 28 includes a sensor for determining the initial state of the injection process. In another example, sensor system 28 includes a sensor for determining the intermediate and final states of the injection process. In another example, sensor system 28 includes a sensor for detecting all of the above injection process conditions. In another example, sensor system 28 includes a first sensor for detecting an initial state of an injection process and a second sensor for detecting an intermediate and final state of an injection process. In one example in FIG. 14, the first sensor includes an accelerometer 92, and the second sensor includes an optical sensor 94. The optical sensor 94 includes a light emitter 96 and a light sensor 98. In one example, the accelerometer 92 is coupled to the device body 38 at a location where the acceleration and/or movement of the corresponding component can be measured without interfering with moving components. For example, the accelerometer may be built into the device body 38 or otherwise attached along the interior of the device body 38. In one example, the optical sensor 94 is coupled to the device body 38 at a location where the encoded structure of the corresponding component can be measured without interfering with moving components. For example, the optical sensor 94 may be built into the device housing 38 or otherwise attached along the interior of the device housing 38. In another example, accelerometer 92 and optical sensor 94 may be coupled to a single control module, such as that shown in FIG. 14.

This document discusses various sensor systems. In general, sensor systems contain one or more measurement components and one or more measured components. The term measurement component refers to any component that is capable of determining the relative position of the component being measured. The sensing component contains one or more sensing elements or sensors along with associated electrical components for operating the sensing element. A measured component is any component for which the measurement component is capable of detecting the position and/or movement of the measured component relative to the measurement component. For example, the component being measured may be axially movable and/or rotated relative to a measurement component that is capable of detecting linear and/or angular position and/or linear and/or rotational motion of the component being measured. The measurement component may include one or more sensing elements, and the measurement component may contain one or more measurement elements. One or more measurement components of the sensor system are capable of determining the position or movement of the component(s) being measured and outputting data representing the position(s) or movement(s) of the component(s) being measured. A sensor system typically determines a characteristic of the parameter being measured that varies depending on the position of one or more measured elements in the measured area. Measured elements pass through the measured area or otherwise affect the measured area in a way that directly or indirectly affects the characteristic of the measured parameter. The relative positions of the measuring component(s) and the component(s) being measured influence the characteristics of the parameter being measured, which allows the sensor system controller to determine different positions of the component(s) being measured. Suitable sensor systems may include a combination of an active component (eg, powered or connected to a power source or controller) and a passive component (eg, unpowered or not connected to a power source or controller). The active component can be either a measuring component or a component to be measured. If one component operates as an active component, the other component does not need to operate as an active component and can instead operate as a passive component. Any of a variety of measurement technologies may be included by which the relative positions of two elements can be determined. Such technologies may include, for example, technologies based on tactile, optical, inductive or electrical measurements. Such technologies may include monitoring a measured parameter associated with a field or an electrical parameter such as an electric/magnetic field. In one embodiment of the invention, the magnetic sensor senses a change in the measured magnetic field as the magnetic component moves relative to the sensor. In another embodiment of the invention, the sensor system can detect characteristics and/or changes in the magnetic field while an object is located within and/or moves through the magnetic field. Field changes change the characteristic of the measured parameter in relation to the position of the measured element in the measured area. In such embodiments, the measured parameter may be capacitance, conductance, resistance, characteristic impedance, voltage, inductance, etc. For example, a magnetoresistive type sensor detects distortion in the applied magnetic field, which leads to a characteristic change in the resistance of the sensor element. As another example, Hall effect sensors detect voltage changes resulting from distortions in an applied magnetic field. In one example, the second sensor is a magnetic sensor and the rotating component contains a magnetic property.

In fig. 12, 13, a rotation angle sensor strip 112 is formed along the outer circular surface

- 6 044504 of the rotating element 70. In one example, the rotation angle sensor strip is located axially along the outer body of the rotating element 70 between the projection 82 and the slot 74. The rotation angle sensor strip 112 includes a plurality of marks 114 spaced apart from each other in a circumferential manner. and recognized by the optical sensor 94 of the sensor system 28. For example, the marks 114 may be designed as discretely recognizable marks, using a different color for the marks and a distance between the marks. In another example, the marks contain a continuous gradient of two different colors to provide a variable signal. Alternatively, the marks 114 may be subjected to a different surface treatment. For example, the marks 114 may be subject to a rough surface finish to diffuse light, while the spaces between the marks 114 are smooth and reflective.

The sensor system 28 also includes a controller 100 having electronic circuitry including a processor 102, a clock or timer (not illustrated) for tracking a date and time stamp, and a memory device (not illustrated). The data may be stored in a storage device such as, for example, RAM, ROM, optical storage device, flash memory device, hardware storage device, magnetic storage device, or any suitable computer-readable storage medium. Data may be accessed and processed according to instructions from processor 102.

The accelerometer 92 and the optical sensor 94 are both electronically coupled to the controller 100, and operably coupled to the processor 102. The sensor system 28 may further include a user interface 104. The user interface 104 may take the form of a liquid crystal display or, in a more simplified embodiment, one or more several LED indicators. System 28 also includes a power supply 110 that powers sensors 92, 94, processor 102, and user interface 104, if present. The user interface may be a separate display screen located along the body of the device. If the device 20 is designed as a disposable device intended for one injection procedure, the power source 110 may be sized to provide sufficient power for only one injection procedure. If device 20 is intended for repeated use, a rechargeable or easily replaceable power source, such as a rechargeable or disposable battery, may be used. In the illustrated embodiment of the invention, device 20 is a disposable, single use device. The controller 100 may include a communication device (eg, a transmitter and/or receiver or transceiver) for communicating with a separate device 106, as schematically depicted in FIG. 14. The separate device 106 may take the form of a smartphone having a user interface 108. The data communication device (not illustrated) is configured to communicate in one or two directions with the separate device 106, which includes a user interface 108 that can report the occurrence of these events. .

In one example, the data communication device comprises a low power RF wireless transceiver using a wireless data technology standard, for example, based on IEEE 802.15 standards, including, but not limited to, Bluetooth (eg, Bluetooth Low Energy and Smart standard) and Zigbee, ANT protocols and ANT+ or near field communication (NFC) using an NFC chip. Other suitable wireless communication protocols such as WI-FI may be used. Although it is usually more convenient to communicate wirelessly with a standalone device, you can also use a wired connection for this communication. The device housing may include an electrical connector (not illustrated) operably coupled to the controller. The electrical connector can be configured as a USB connector (such as Standard-A, Standard-B, Standard-C, Mini-A, Mini-B, Micro-A or Micro-B connectors), serial connector, video matrix connector (VGA), D-subminiature connector, BNC connector or mini-DIN connector. Additionally, the electrical connector may be a plug or socket connector.

As can be easily seen in FIG. 8-11, the sensor system 28 is mounted on the housing such that the accelerometer 92 is located on the drug delivery device and can measure the movement and speed of the housing 38 or a component within the housing 38. When the spring 46 acts on the rod 44 after the user presses the start button 52 to initiate a delivery event, the drive spring 46 accelerates the rod 44 and the syringe distally until the syringe 22 reaches the axial stop in its delivery position, abruptly stopping any more distal movement. This change in acceleration generates movement and forces that are detected by the accelerometer 92. The time of arrival of the syringe 22 at its delivery position and the movement of the piston 32 to deliver the drug through the needle can be predetermined and precise. In other words, the initiation of a delivery event may be associated with the arrival and sudden stop of the syringe in its delivery position. The return event occurs to move the syringe from the delivery position to the storage position. The upward (proximal) acceleration of the syringe during the return event imparts a slight acceleration in the direction opposite to the syringe body. By detecting and analyzing the timing and magnitude of these signs, the initiation of an event can be detected

- 7 044504 delivery and initiation and/or completion of a retract event, and changes in the syringe retract and retract characteristics can be detected.

The graph presented in Fig. 15 provides a simplified representation of the output of sensors 92, 94. Line 120 displays signals generated by accelerometer 92 that indicate measured acceleration and is transmitted to processor 102. Peak 122 in accelerometer signals represents initiation of a delivery event when movement of syringe 22 is abruptly stopped in position For delivery. The further advancing rod 44 moves the piston 32 to deliver the drug from the syringe 22. When the delivery event begins, the vibration of the body 38 caused by the stop of the syringe 22 decreases in magnitude, as shown by line 120. As the rod 44 approaches the end of its distal advance, the arm 58 on the rod 44 unlocks the rotating element 70, which then begins to rotate about the axis 48, as described in more detail above. An optical sensor 94 may be positioned to detect rotational motion of the rotating member 70 by measuring the passage of individual marks 114. The optical sensor 94 generates signals indicative of such measured rotational motion of the rotating member 70 and transmits these signals to the processor 102. The dotted line 124 in the graph of FIG. 15 displays the signals generated by the optical sensor 94. In addition, when the rod 44 unlocks the rotating element 70 and allows the element 70 to begin to rotate, which initiates the return movement of the return mechanism 26. This return movement causes the syringe 22 to move from its delivery position (FIG. 3) to its storage position (Fig. 2).

As best seen in FIG. 12 and 13, an optical sensor 94 is positioned to monitor the rotational movement of the member 70. FIG. 12 depicts the position of the optical sensor 94 relative to element 70 at the time the initial rotational movement of element 70 begins. Arrow 116 indicates the direction in which element 70 will rotate relative to sensor assembly 28. As element 70 rotates, strip markings 114 of rotation angle sensor 112 are sensed by optical sensor 94 as individual markings 114 rotate past optical sensor 94. FIG. 13 illustrates member 70 when it has completed its rotational movement and protrusion 78 is aligned with channel 76 such that shuttle 60 is retracted distally by spring 66 and returns syringe 22 to its storage position. Line 124 in FIG. 15 displays the signals transmitted by the optical sensor 94. In one example, the optical sensor signals are binary signals such that the absence of a signal (value 0 in FIG. 15) indicates that the sensor does not recognize the mark 114, and the transmission of a signal (value 1 in Fig. 15) indicates that the sensor recognizes the mark. Thus, the lines of peak portions 126 of the sensor signal in FIG. 15 depict the passage of mark 114 past optical sensor 94. In another example, the rotation sensor strip 112 may comprise a continuous gradient from black to white such that the optical sensor signals are variable signals. In one example, optical sensor 94 may be configured to transmit an analog value selected by controller 100 to provide finer resolution for position and rotation speed.

When the optical sensor 94 first detects the passage of the mark 114, as represented by the starting point 128 of the peak of the line 124, it means that the rotating element 70 has been unlocked and has just begun to rotate. Thus, this point also corresponds to the end of the feed event. In this regard, it should be noted that the completion of a feed event may directly correspond to the point in time represented by point 128, or have a known correlation with that point in time, for example, the completion of a feed event may occur 0.2 seconds after the point in time represented by point 128. B In any case, point 128 means that the return movement of the retractor of the return mechanism 26 has begun, for example, the rotation of the rotating element 70.

The arc along which element 70 must rotate to complete its rotational motion and align channel 76 with protrusion 78 is known in advance. Thus, the number of marks 114 that must pass through the optical sensor 94 for the element 70 to complete its rotational movement may also be known in advance. In the illustrated embodiment, when the fifth mark 114 is sensed by the sensor 94, as indicated by reference numeral 130 in FIG. 15, the rotating member 70 will complete its rotational movement and align the channel 76 with the projection 78. Once this occurs, the shuttle member 60 will be moved proximally and the syringe 22 will be moved to its storage position to complete the return movement. In this regard, it should be noted that the completion of the return event may directly correspond to the point in time represented by point 130, which may also correspond to the complete completion of the operating cycle of the device. Alternatively, completion of the return event may have a known correlation with the instant of time represented by point 130, for example, completion of the return event may occur 0.2 s after the instant of time represented by point 130.

In the illustrated embodiment of the invention, and as described above, the controller 100 is configured to detect the initiation of a feed event based on signals generated by the accelerometer 92. More specifically, the controller 100 is configured to determine the initiation of a feed event based on the peak 122 of the signal generated by the accelerometer 92. The controller 100

- 8 044504 is also configured to determine the completion of the feed event and the completion of the return movement based on the signals generated by the optical sensor 94. For example, the controller 100 is configured to determine the initial rotational motion recognition based on the starting point 128 of the signal line 124 as the completion of the feed event (or with or without correction). The controller 100 is configured to determine the final rotational motion recognition based on the point 130 of the signal line 124 as the completion of the return event (either with or without correction). In one example, the controller 100 may also count the number of marks detected by the sensor 94, and when the corresponding number of marks are counted, inform that the element 70 has completely completed its rotational movement, wherein the controller 100 interprets this as completion of the return movement and successful return of the syringe 22 storage position. The controller 100 may be configured to detect the end of a feed or return event based on signals generated by the accelerometer 92, which may be independent of or in addition to the optical measurement signal at point 130. As the needle is retracted by the spring, depending on the position of the rotating member 70, the sudden stop of the assembly within the device upon reaching the final retracted position causes a detectable acceleration. More specifically, controller 100 is configured to determine an end event based on a peak or valley (not illustrated in FIG. 15, but approximately located at time 26 s) of the signal generated by the accelerometer 92. By using both the accelerometer and the optical sensor to determine end of the delivery cycle, controller 100 may compare each of the signals for reliability or redundancy in detecting syringe position or movement failure. Other characteristics of the accelerometer 92 may be useful in detecting syringe position or movement failure. This occurs before the syringe 22 encounters the hard stop when moving to the extended position. When the drive spring 46 initially accelerates the syringe 22 forward, a small acceleration is transmitted to the injector body 38 and can be detected. Another characteristic occurs when the rotating element 70 allows the double-acting bias element 66 to operate. The upward acceleration of the syringe 22 creates a slight acceleration in the direction opposite to the injector body 38. By controller 100 detecting and analyzing the timing and magnitude of these features, the start of a dispensing event and the start and/or completion of a retract event can be detected, and changes in the syringe's advance and retract characteristics can be detected and/or communicated.

The operating state of the device determined by such information can also be communicated to the user. To this end, controller 100, in response to measurement steps, is configured to generate an output signal for each of the determined steps to display or otherwise indicate feedback to the user. For example, sensor system 28 may generate a signal indicating the detected start of a feed event. The sensor system 28 may generate another signal indicating the detected completion of a feed event. The sensor system 28 may generate another signal indicating that the start of a return motion has been detected. The sensor system 28 may also generate another signal indicating that completion of the return movement has been detected. Any of these output signals, or a combination thereof, may be provided to the user interface 104 to thereby inform the user of the occurrence of a feed event, the completion of a feed event, the start of a return motion, and/or the completion of a return motion. For example, an LCD screen or LED lights on device 20 may indicate the occurrence of these events.

In addition to simply recognizing when certain events occur, controller 100 may also be configured to analyze sensor signals to identify failures. In one example, the controller 100 is configured to monitor signals from the optical sensor 94 to ensure that the rotating member 70 has completely completed its rotation, facilitating the return of the syringe 22 to the storage position. If the rotating element 70 does not rotate through a sufficiently large rotational arc (eg, only three of the five lines 126 of the signal line 124 in FIG. 15 are being monitored), the controller 100 may be configured to determine such a situation as a failure in the return motion. If the signals generated by the optical sensor 94 indicate that the rotating member 70 has not completely completed its rotational motion, the controller 100 may be configured to determine that the drug container has not been successfully moved from the delivery position to the storage position during return movement. The controller 100 may also be configured to determine the duration of a feed event based on the time interval between the peak 122 of the accelerometer signal 120 and the trigger point 128 of the optical sensor signal 124 (or detection of acceleration associated with a return event, as discussed above).

If the duration of a feed event is shorter or longer than the specified threshold range, the processor can detect such an event and mark it as a failure. Alternatively, if the duration is within an acceptable range for the amount of drug delivered, it may be considered successful delivery of the drug. When a failure occurs, the controller 100 may be configured to communicate with a user interface to display a warning or flash LEDs (red LEDs). Such an event may be recorded and reported to a healthcare professional.

Information obtained through such signals may be stored in memory along with the time and date of the drug delivery event. This recorded data can then be transmitted to a separate remote device 106 (such as, for example, a cell phone, laptop, and/or database server) or a caregiver via a wireless connection and/or the Internet. The device 106 may maintain a log of all such drug delivery events, including the date and time of the drug delivery event, and whether any malfunctions were detected. The device 106 may also transmit such information via the network to a healthcare professional, who may also maintain a log of such drug delivery events. The controller 100 may also be configured to store and transmit information about the type and amount of drug supplied. For single-use, single-use devices, this information will be known in advance, and thus the recording effectively facilitates the communication of information about the type and amount of drug delivered at the delivery event. The ability for a user to automatically generate a log of drug delivery events can be extremely useful for those users who regularly administer medication and find it inconvenient or difficult to maintain a log of such drug delivery events.

As can be seen in the figures, with the exception of the rotation angle sensor strip 112 located on the rotating element 70, the sensor system 28 is packaged in one small housing mounted on the housing 38. Thus, it can be permanently mounted on the device 20 or detached and reused with multiple devices, provided that such devices have a rotating member 70 with a rotation angle sensor strip 112, and a mounting interface to accommodate the sensor system 28.

In one example, an exemplary method of determining the operating state of device 20 is provided. The method may include determining whether a dispensing event has been triggered. The controller 100 is configured to determine the initiation of a feed event based on the first signals generated by the first sensor. When the first sensor is an accelerometer, the initial signal peak may be caused by a sudden stop of the syringe as it moves from the storage position to the delivery position. Another step may include determining the end of the feed event. The arrangement of the rod arm and the rotary pusher is such that there is engagement between the arm and the rotary pusher and thus the start of rotation of the pusher occurs at the moment when the feed event is completed. The controller 100 is configured to determine completion of a feed event based on the initial peak of the second signals generated by the second sensor. Another step may include determining the end of the return cycle and/or completion of the drug delivery cycle. The controller 100 is configured to detect completion of the return motion based on a predetermined peak of second signals generated by the second sensor or upon detection of acceleration caused by retraction of the syringe into the device body. The method may include detecting the initiation of a delivery event, detecting the completion of a delivery event, detecting the start of a return, detecting the completion of a return or delivery cycle, or any combination thereof. The controller may be further configured to transmit any of these events to an integrated user indicator or to a remote user indicator external to the device. The method may include determining if the device has malfunctioned. The controller may be configured to analyze sensor parameters based on the first and/or second signals from the respective sensors, compare such parameters to threshold ranges stored in a memory device, and, if outside the threshold range, report any detected fault to an on-board user indicator or remote user indicator external to the device.

Although the present invention has been described as having an exemplary construction, the present disclosure may be further modified within the spirit and scope of this disclosure. Thus, this application is intended to cover any variations, applications or adaptations of the invention by its general principles.

This disclosure describes various aspects, which include, but are not limited to, the following aspects.

1. A device for drug delivery, comprising: a housing; a medicinal product container comprising a medicinal product storage container body and a movable piston operatively coupled to the container body, wherein the movable piston is movable relative to the container body for supplying medicinal product from the medicinal product container, wherein the medicinal product container is movable relative to said body between the storage position and the delivery position; a drive mechanism comprising a rod in engagement with a movable piston, wherein the drive mechanism is released

- 10 044504 is filled with the possibility of axial drive of the rod, for moving the container with the medicinal product from the storage position to the delivery position, and for moving the movable piston for supplying the medicinal product from the container with the medicinal product in case of delivery; a return mechanism configured to move the drug container from a delivery position to a storage position during movement of the retract, the return mechanism comprising a rotating member configured to rotate during the return movement; and a sensor system including a first sensor located in the drug delivery device, wherein the first sensor is configured to generate a plurality of first signals indicative of a first measured parameter, the second sensor is located in the drug delivery device and is located to detect rotational motion of the rotating element, wherein the second sensor is configured to generate a plurality of second signals indicative of the measured rotational motion of the rotating element, a controller operatively coupled to the first sensor and the second sensor, wherein the controller is configured to determine the initiation of a feed event based on the plurality of first signals generated by the first sensor , and configured to determine at least one of the completion of the feed event and the completion of the return movement based on a plurality of second signals generated by the second sensor.

2. The apparatus of aspect 1, comprising a user interface operatively coupled to the controller, wherein the controller is configured to transmit initiation of a feed event and at least one of completion of a feed event and completion of a retract movement to said user interface.

3. The device of aspect 2, characterized in that the user interface is located on the device.

4. The apparatus of aspect 2, wherein the user interface is separate from the apparatus, wherein the controller is configured to transmit the initiation of a feed event and at least one of the completion of a feed event and the completion of a return movement wirelessly to the user interface.

5. The apparatus of any one of aspects 1-4, wherein the controller is configured to determine a failure based on analysis of at least one of the first signals and the second signals.

6. The apparatus of any one of aspects 1 to 5, wherein the controller is configured to determine the duration of the firing event based on the first signals and the second signals.

7. The device as in any one of aspects 1-6, wherein the controller is configured to determine a failure based on analysis of second signals that determine whether the drug container was unsuccessfully moved from a delivery position to a storage position while the device was performing return movement.

8. The apparatus of aspect 7, wherein the second sensor is an optical sensor and the rotating member detects a plurality of touch marks recognized by the optical sensor.

9. The apparatus of any one of aspects 1-8, wherein the sensor system is configured to record data for a supply event based on the first signals and the second signals.

10. The device of aspect 9, characterized in that the sensor system is configured to transmit recorded data to a separate device.

11. The apparatus of aspect 10, wherein the recorded data transmitted by the sensor system includes the date and time of the feed event.

12. The apparatus of aspect 10, wherein the controller is configured to detect a failure by analyzing at least one of the first signals and the second signals.

13. The device as in any one of aspects 1-12, wherein the drive mechanism includes a spring for driving the rod and the drug container, wherein the controller is configured to detect a failure by analyzing the second signals to determine whether the container has been with the drug is unsuccessfully moved from the delivery position to the storage position when the device performs a return movement.

14. A device for delivering a medicinal product, comprising a syringe having a cylinder containing a medicinal product and a piston located inside the cylinder, wherein the syringe further comprises a hollow needle, and wherein movement of the piston relative to the cylinder delivers the medicinal product through the needle, wherein the movement of the piston relative to the cylinder delivers the drug through the needle, wherein the syringe is moved relative to the drug delivery device between a storage position and a delivery position, in which the needle protrudes from the device in the delivery position and is retracted into the device in the storage position; a drive mechanism having a rod for advancing a piston, the drive mechanism comprising a spring adapted to drive the rod in translational motion, move the syringe from a storage position to a delivery position, and advance the piston in the barrel for dispensing the drug from the syringe when dispensed; a return mechanism configured to move the syringe from a delivery position to a storage position when moving

-

Claims (14)

retraction, wherein the return mechanism contains a rotating element configured to rotate during the return movement; and a sensor system including an accelerometer located on the drug delivery device, wherein the accelerometer is configured to generate a plurality of first signals indicative of the measured acceleration, an optical sensor located on the drug delivery device and configured to detect rotational motion of the rotating element, an optical sensor , configured to generate a plurality of second signals indicative of the measured rotational motion of the rotating element, and a controller operatively coupled to the accelerometer and the optical sensor, wherein the controller is configured to determine the initiation of a feed event based on the plurality of first signals generated by the accelerometer and is configured to determine completion of the feed event and completion of the retraction movement based on a plurality of second signals generated by the optical sensor. 15. The apparatus of aspect 14, wherein the sensor system is configured to record data about each feed event based on the plurality of first and second signals, and transmit the recorded data to a separate device. 16. The apparatus of any one of aspects 14-15, wherein the controller is configured to detect a failure through at least one of the first signals and the second signals. 17. The device as in any one of aspects 14-16, wherein the outer circular surface of the rotating member includes a plurality of touch marks recognized by the optical sensor, wherein the controller is configured to determine, by analyzing the plurality of second signals, whether the drug container has been successfully moved from the delivery position to the storage position when the device performs a return movement. 18. The apparatus as in any one of aspects 14-17, wherein the controller is configured to determine the duration of the supply event based on the signal peak of the first signals and the initial peak of the second signals. 19. The apparatus as in any one of aspects 14-18, wherein the sensor system reports the initiation of a feed event, the completion of a feed event, and the completion of a return motion through a user interface, thereby informing the user of the occurrence of the initiation of a feed event, the completion of a feed event and completion of the return movement. 20. The apparatus of aspect 19, wherein the user interface is located on a separate device that receives the recorded data. 21. A method for determining the operating state of a drug delivery device having a needle, a first sensor, a second sensor, a rotation sensor and a return mechanism, comprising the steps of: determining the initiation of a delivery event from the needle in an extended position based on a signal peak from a plurality of first signals, generated by the first sensor; determining the end of a feed event from said needle in an extended position based on an initial peak of a plurality of second signals generated by a second sensor measuring rotation of the rotating member of the retraction mechanism; determining a retraction end of said needle from the extended position based on a predetermined peak of second signals subsequent to an initial peak of second signals generated by the second sensor; and displaying on the user interface at least one of the detected feed event initiation, the detected feed event execution, and the detected needle return completion. CLAIM 1. A device for delivering a medicinal product, comprising a housing; a medicinal product container comprising a medicinal product storage container body and a movable piston operatively coupled to the container body, wherein the movable piston is movable relative to the container body for supplying medicinal product from the medicinal product container, wherein the medicinal product container is movable relative to said body between the storage position and the delivery position; a drive mechanism comprising a rod in engagement with a movable piston, wherein the drive mechanism is configured to axially drive the rod to move the drug container from a storage position to a delivery position, and to move the movable piston to dispense the drug from the container with a medicinal product at a supply event; a return mechanism configured to move the drug container from a delivery position to a storage position during the return movement, the return mechanism comprising a rotating element configured to rotate during the return movement; and a sensor system comprising an accelerometer located on the drug delivery device - 12 044504 drug, wherein the accelerometer is configured to generate a plurality of first signals indicative of the acceleration being measured, an optical sensor located on the drug delivery device and disposed to measure the rotational motion of the rotating element, wherein the optical sensor is configured to generate a plurality of second signals indicating the measured rotational motion of the rotating element, and a controller operatively coupled to the accelerometer and the optical sensor, wherein the controller is configured to determine the initiation of a feed event through a plurality of first signals generated by the accelerometer, and is configured to determine at least one of the completion return movement initiation and completion events via a plurality of second signals generated by the optical sensor. 2. The apparatus of claim 1, comprising a user interface operatively coupled to the controller, wherein the controller is configured to communicate to said user interface at least the initiation of a feed event, and the completion of a feed event, and the completion of a return movement, thus , inform the user about the occurrence of at least one of the initiation of a feed event, the completion of a feed event, and the completion of a return motion. 3. The device according to claim 2, characterized in that the user interface is located on the device. 4. The apparatus of claim 2, wherein the user interface is separate from the apparatus and the controller is configured to wirelessly transmit to the user interface at least the initiation of a feed event, the completion of a feed event, and the completion of a return movement. 5. The device according to any one of claims 1 to 4, characterized in that the controller is configured to determine a failure by analyzing at least one of the first signals and the second signals. 6. The device according to any one of claims 1 to 5, characterized in that the controller is configured to determine the duration of the supply event based on the first signals and the second signals. 7. The device according to any one of claims 1 to 6, wherein the controller is configured to detect a failure by analyzing the second signals to determine that the drug container has not been successfully moved from the delivery position to the storage position when the device performs a return movement. 8. The device according to claim 7, characterized in that the rotating element determines a plurality of touch marks recognized by the optical sensor. 9. The device according to any one of claims 1 to 7, characterized in that the controller is configured to record feed event data based on the first signals and the second signals. 10. The device according to claim 9, characterized in that the controller is configured to transfer recorded data to a separate device. 11. The device according to claim 10, characterized in that the recorded data transmitted by the sensor system contains the date and time of the feed event. 12. The device according to any one of claims 1 to 11, characterized in that the drive mechanism includes a spring for driving the rod and the container with the medicinal product, and the controller is configured to determine a failure based on the analysis of the second signals to determine that the container the drug has not been successfully moved from the delivery position to the storage position when the device performs the return movement. 13. The device according to any one of claims 1 to 12, wherein the container with the medicinal product is a syringe, and the container body is a cylinder in which the medicinal product is located, wherein the syringe additionally contains a hollow needle, and the movement of the piston relative to the cylinder delivers the medicinal product through the needle, wherein the needle protrudes from the device when the drug container is in the delivery position, and the needle is retracted into the device when the drug container is in the storage position. 14. A method for determining the operating state of a drug delivery device according to claim 1, further comprising a needle, comprising the steps of determining the start of a delivery event through said needle in an extended position based on a signal peak from a plurality of first signals generated by the accelerometer; determining the end of a feed event from said needle in an extended position based on an initial peak of a plurality of second signals generated by an optical sensor measuring rotation of the rotating member of the return mechanism; determining a retraction end of said needle from the extended position based on a predetermined peak of second signals following an initial peak of second signals generated by the optical sensor; and informing the user interface of at least one detected initiation of a dispensing event, a detected completion of a dispensing event, and a detected completion of a needle retraction. -