Dose detection with piezoelectric sensing for drug delivery devices

Abstract

The present disclosure relates to a drug delivery device having a dose detection system and an associated control system, the drug delivery device being configured to determine an amount of drug delivered from the drug delivery device based on sensing relative rotation within the drug delivery device. The relative rotation may occur between a dose setting member and an actuator and / or housing of the drug delivery device. The rotation sensing may involve piezoelectric sensing, and more specifically, repeatedly deforming a piezoelectric sensor using a mechanical force. The dose detection system may be modular, or may be an integral component of the drug delivery device.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is a divisional application of Chinese patent application No. 201880056505.6. This application claims priority to U.S. Provisional Patent Application No. 62 / 552,659 filed on August 31, 2017, the disclosure of which is hereby expressly incorporated by reference in its entirety. Technical Field

[0003] The present disclosure relates to electronic dose detection systems for drug delivery devices and illustratively to electronic dose detection modules or integrated dose detection systems with piezoelectric sensing to detect a dose of a drug delivered by a delivery device. Background Art

[0004] Patients with various diseases must often inject themselves with medication. In order to allow personnel to conveniently and accurately self-administer medication, various devices widely known as syringes or injection pens have been developed. In general, these pens are equipped with a cartridge that includes a piston and contains a multi-dose amount of liquid medication. The drive member is movable forward to advance the piston in the cartridge to dispense the contained medication from an outlet at the distal cartridge end, usually through a needle. In disposable or pre-filled pens, after the pen has been used to exhaust the medication supply in the cartridge, the user discards the entire pen and begins to use a new replacement pen. In a reusable pen, after the pen has been used to exhaust the medication supply in the cartridge, the pen is disassembled to allow the used cartridge to be replaced with a new cartridge, and then the pen is reassembled for its subsequent use.

[0005] Many injector pens and other drug delivery devices utilize mechanical systems in which components rotate and / or translate relative to each other in a manner proportional to the dose delivered by operation of the device. Accordingly, there is an effort in the art to provide reliable systems that accurately measure relative movement of components of a drug delivery device in order to assess the delivered dose. Such systems may include a sensor that is secured to a first component of the drug delivery device and detects relative movement of a sensed component secured to a second component of the device.

[0006] The administration of the proper amount of the drug requires that the dose delivered by the drug delivery device is accurate. Many syringe pens and other drug delivery devices do not include the function of automatically detecting and recording the amount of the drug delivered by the device during the injection event. In the absence of an automated system, the patient must manually record the amount and time of each injection. Accordingly, a device is required that is operable to automatically detect the delivered dose during the injection event by measuring a mechanical component that directly corresponds to the dose displayed in the dose window for the user of the drug delivery device. In addition, in certain embodiments, it is required that such a dose detection device is removable and can be reused with multiple delivery devices. In other embodiments, it is required that such a dose detection device is integrated with the delivery device. Summary of the invention

[0007] The present disclosure relates to a drug delivery device having a dose detection system and an associated control system, the drug delivery device being configured to determine an amount of drug delivered from the drug delivery device based on sensing relative rotation within the drug delivery device. The relative rotation may occur between a dose setting member and an actuator and / or housing of the drug delivery device. The rotation sensing may involve piezoelectric sensing, and more specifically, repeatedly deforming a piezoelectric sensor using a mechanical force. The dose detection system may be modular, or may be an integral component of the drug delivery device.

[0008] According to a first aspect of the present disclosure, there is provided a drug delivery device, the drug delivery device comprising: a device body having a longitudinal axis; an actuator that rotates relative to the device body during a dose setting operation and moves axially relative to the device body along the longitudinal axis during a dose dispensing operation to deliver a drug; a dose setting member that rotates relative to the device body during both dose setting and dose dispensing operations; and a dose detection system configured to detect rotation of the dose setting member relative to the actuator during a dose dispensing operation, the dose detection system comprising a piezoelectric sensor.

[0009] According to a second aspect of the present disclosure, there is provided a drug delivery device, the drug delivery device comprising: a device body having a longitudinal axis; an actuator that rotates relative to the device body during a dose setting operation and moves axially relative to the device body along the longitudinal axis during a dose dispensing operation to deliver a drug; a dose setting member that is fixedly coupled to the actuator during a dose setting operation and rotates relative to the actuator during a dose dispensing operation; and a piezoelectric sensor configured to detect a rotation between the dose setting member and the actuator during a dose dispensing operation.

[0010] According to a third aspect of the present disclosure, a drug delivery device is provided, the drug delivery device comprising: a device body having a longitudinal axis; a dose setting member coupled to the device body and rotatable relative to the device body during a dose dispensing operation; an actuator coupled to the device body and movable relative to the device body during a dose dispensing operation; and a dose detection system configured to detect rotation of the dose setting member during a dose dispensing operation. The dose detection system comprises: at least one deformable member; a piezoelectric sensor coupled to the at least one deformable member; and at least one force applicator configured to apply a mechanical force to the at least one deformable member during a dose dispensing operation and deform the piezoelectric sensor.

[0011] The dose detection system described herein has the advantage that it measures a mechanical component that directly corresponds to the dose displayed to the user of the drug delivery device in the dose window. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The features and advantages of the present disclosure will become more apparent to those skilled in the art upon consideration of the following detailed description in conjunction with the accompanying drawings.

[0013] Figure 1 is a perspective view of an exemplary drug delivery device of the present disclosure.

[0014] Figure 2 yes Figure 1 A cross-sectional perspective view of an exemplary drug delivery device.

[0015] Figure 3 yes Figure 1 A perspective view of a proximal portion of an exemplary drug delivery device.

[0016] Figure 4 yes Figure 3 A partially exploded perspective view of a proximal portion of an exemplary drug delivery device.

[0017] Figure 5 is a schematic view of an exemplary piezo film sensor for use with the dose detection system of the present disclosure.

[0018] Figure 6 is with Figure 1 A perspective view of an exemplary modular dose detection system in combination with an exemplary drug delivery device.

[0019] Figure 7 yes Figure 6 A partially exploded perspective view of the modular dose detection system.

[0020] Figure 8 yes Figure 6A perspective view of a frame of a modular dose detection system with a piezo film sensor.

[0021] Fig. 9 yes Figure 8 Far side plan view of the frame and piezoelectric film sensor.

[0022] Fig.10 and Fig.11 yes Figure 6 An exploded perspective view of a first embodiment of a modular dose detection system, wherein a portion of a button is omitted to better illustrate the interior.

[0023] Fig.12 and Fig.13 yes Figure 6 An exploded perspective view of a second embodiment of a modular dose detection system.

[0024] Fig.14 is a schematic axial view of an exemplary dose detection system integrated with a drug delivery device, wherein the dose detection system is shown in a neutral state.

[0025] Fig.15 is similar to Fig.14 Another schematic axial view of FIG. 1 , in which the dose detection system is shown in a deformed state.

[0026] Fig.16 is a partial elevation view of a first embodiment of an exemplary dose detection system integrated with a drug delivery device.

[0027] Fig.17 is Fig.16 Detailed view of the area identified in , with a portion of the housing removed.

[0028] Fig.18 is a partial elevation view of a second embodiment of an exemplary dose detection system integrated with a drug delivery device.

[0029] Fig.19 is Fig.18 Detailed view of the area identified in , with a portion of the housing removed.

[0030] Fig. 20 is a schematic illustration of an exemplary electronic control system for use with the dose detection system of the present disclosure.

[0031] Fig.21 Is displayed by Fig. 20 Diagram of the signal conversion process performed by a control system.

[0032] Fig. 22 Is displayed by Fig. 20 Flow chart of a signal processing method performed by a control system.

[0033] Fig.23 Is Fig. 20 A circuit diagram of the electrical processing circuit implemented by the control system.

[0034] Fig.24 is a perspective view of another exemplary drug delivery device of the present disclosure.

[0035] Fig.25 is a cross-sectional view of a dose detection system attached to a proximal portion of a drug delivery device according to an exemplary embodiment.

[0036] Fig.26 is a cross-sectional side view of another exemplary drug delivery device of the present disclosure.

[0037] Fig. 27 is a cross-sectional side view of another exemplary drug delivery device of the present disclosure.

[0038] Fig.28 is a representative view of a frame upon which a piezoelectric strain sensor may be mounted in one exemplary embodiment of the present disclosure.

[0039] Fig.29 is a representative view of the interaction of the ball spring reader and the recess or depression on the dose dial member.

[0040] Fig.30 is an assembled perspective view of another drug delivery device of the present disclosure including a ratchet-based piezoelectric dose detection system.

[0041] Fig.31 yes Fig.30 Exploded perspective view of the dose detection system.

[0042] Fig.32 yes Fig.30 Cross-sectional view of a dose detection system.

[0043] Fig.33 is a cross-sectional side view of another exemplary drug delivery device of the present disclosure having a dose detection system having a potentiometer.

[0044] Fig.34 yes Fig.33 Another cross-sectional side view of a drug delivery device. DETAILED DESCRIPTION

[0045] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will be understood, however, that no limitation of the scope of the invention is thereby intended.

[0046] exist Figure 1-4 , an exemplary drug delivery device 10 is shown as an injector pen configured to inject a drug into a patient through a needle 24. Although the illustrative drug delivery device 10 is an injector pen, the drug delivery device 10 may be any device for setting and delivering a dose of a drug, such as an infusion pump, a bolus syringe, or an auto-injector device. The drug may be of any type that can be delivered by such a drug delivery device 10.

[0047] The drug delivery device 10 includes a body 11 including an elongated pen-shaped housing 12 including a distal portion 14 and a proximal portion 16 arranged along a longitudinal axis L. The distal portion 14 may be received in a pen cap 18. Figure 2 , the distal portion 14 includes a reservoir or cartridge 20 configured to hold a medicament to be dispensed through a distal outlet end 25 thereof during a dispensing operation.

[0048] The devices described herein (such as device 10) may also include a drug, such as, for example, in the reservoir 20. In another embodiment, the system may include one or more devices (including, for example, device 10) and a drug. The term "drug" refers to one or more therapeutic agents, including but not limited to insulin, 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 peptide (GIP), GIP analogs, GIP derivatives, gastric acid secretion regulating peptide analogs, gastric acid secretion regulating peptide derivatives, therapeutic antibodies, and any therapeutic agent that can be delivered by the above device. The drug used in the device may be formulated with one or more excipients. The device is operated by a patient, a caregiver, or a health professional in a manner generally described above to deliver the drug to the person.

[0049] The outlet end 25 of the distal portion 14 is equipped with a removable needle assembly 22 including an injection needle 24. A piston 26 is positioned in the fluid reservoir 20. An injection mechanism or drive member 28, illustratively a screw, is positioned in the proximal portion 16 and is axially movable along the longitudinal axis L relative to the housing 12 to advance the piston 26 toward the outlet end 25 of the reservoir 20 during a dose dispensing operation to force the contained drug through the needle outlet end 25.

[0050] A dose setting member 30 is coupled to the housing 12 for setting the amount of a dose to be dispensed by the device 10. In the illustrated embodiment, the dose setting member 30 is in the form of a screw element that is operative to helically rotate relative to the housing 12 (i.e. to simultaneously move axially along the longitudinal axis L and rotate about the longitudinal axis L) during dose setting and dose dispensing operations. Figure 1 and Figure 2 The dose setting member 30 is shown fully screwed into the housing 12 in its initial or zero position. The dose setting member 30 is operable to be screwed out of the housing 12 in the proximal direction until it reaches a fully extended position (corresponding to the maximum dose deliverable by the device 10 in a single injection), and to be screwed into the housing 12 in the distal direction until it reaches an initial or zero position (corresponding to the minimum dose deliverable by the device 10 in a single injection).

[0051] refer to Figure 2-4 The dose setting member 30 comprises a cylindrical dial member 32 having a helically threaded outer surface 33 which engages a correspondingly threaded inner surface 13 of the housing 12 to allow helical rotation of the dose setting member 30 relative to the housing 12. The dial member 32 also comprises a helically threaded inner surface which engages a sleeve 34 ( Figure 2 ). The outer surface 33 of the dial member 32 includes dose indicator markings, such as numbers visible through the dose window 36, to indicate to the user the amount of the set dose. The dose setting member 30 also includes a tubular flange 38, which is coupled in the open proximal end of the dial member 32 and is axially and rotationally locked to the dial member 32 by a stopper 40, which is received in an opening 41 in the dial member 32. The dose setting member 30 also includes a skirt or collar 42 positioned around the outer perimeter of the dial member 32 at its proximal end. The skirt 42 is axially and rotationally locked to the dial member 32 by a protrusion 44 received in a slit 46.

[0052] Therefore, the dose setting member 30 can be considered to include any one or all of the dial member 32, the flange 38 and the skirt 42, because they are all rotationally and axially fixed together. The dial member 32 is directly involved in the dose setting and drive delivery of the drug. The flange 38 is attached to the dial member 32 and, as described later, cooperates with the adapter 52 to selectively couple the dial member 32 with the dose button 56. The skirt 42 provides a surface on the exterior of the body 11 to rotate the dial member 32.

[0053] The skirt 42 illustratively includes a plurality of surface features 48 formed on an outer surface 49 of the skirt 42. The surface features 48 are illustratively longitudinally extending ribs and grooves that are circumferentially spaced around the outer surface of the skirt 42 and facilitate gripping and rotation of the skirt by a user. In alternative embodiments, the skirt 42 is removed, or is integral with the dial member 32, and the user may grip and rotate the dose button 56 and / or the dial member 32 for dose setting.

[0054] refer to Figure 3-4 , the delivery device 10 includes an actuator 50 having an adapter 52 received within the dial member 32. The adapter 52 includes an axially extending rod 54 at its proximal end, such as Figure 2 The actuator 50 also includes a dose button 56 positioned proximally of the skirt 42 of the dose setting member 30. Figure 2 The dose button 56 in the embodiment includes a mounting collar 58 centrally located on the distal surface of the dose button 56. The collar 58 is attached to the stem 54 of the adapter 52, such as with an interference fit or ultrasonic welding, thereby axially and rotatably fixing the dose button 56 and the adapter 52 together.

[0055] The dose button 56 includes a disc-shaped proximal end surface or face 60 and an annular wall portion 62 extending distally and spaced radially inwardly from the outer peripheral edge of the face 60 to form an annular lip 64 therebetween ( Figure 2 The proximal side 60 of the dose button 56 serves as a push surface against which a force can be manually applied, i.e. directly by the user, to push the actuator 50 in the distal direction. The dose button 56 illustratively includes a recessed portion 66 ( Figure 3 and Figure 4 ), although the proximal surface 60 may alternatively be a flat surface. A biasing member 68 (illustratively a spring) is disposed between a distal surface 70 of the button 56 and a proximal surface 72 of the tubular flange 38 to urge the actuator 50 and the dose setting member 30 axially away from each other. The dose button 56 may be depressed by a user to initiate a dose dispensing operation.

[0056] The delivery device 10 is operable in both a dose setting mode of operation and a dose dispensing or delivery mode of operation, as further described below.

[0057] In a dose setting mode of operation, the dose setting member 30 is dialed (i.e., rotated) relative to the housing 12 to set a desired dose to be delivered by the device 10. Dialing in the proximal direction is used to increase the set dose, and dialing in the distal direction is used to decrease the set dose. During the dose setting operation, the dose setting member 30 is adjustable in rotational increments (e.g., clicks) that correspond to a minimum increment of the set dose increase or decrease. For example, one increment or "click" is equal to one unit of drug. The amount of the set dose is visible to the user via dial indicator markings displayed through the dose window 36. During dialing in the dose setting mode, the actuator 50 (including the button 56 and the adapter 52) moves axially and rotationally with the dose setting member 30 because the dose button 56 of the actuator 50 is engaged by complementary and mutually facing splines 74 ( Figure 2 ) is rotationally fixed relative to the skirt 42 of the dose setting member 30, with the splines 74 being forced together by the biasing member 68. Thus, as mentioned above, a user can grasp and rotate the dose button 56 and / or the dial member 32. During a dose setting operation, the skirt 42 and the dose button 56 move in a spiral manner from a "start" position to an "end" position relative to the housing 12. This rotation relative to the housing 12 is proportional to the amount of the dose set by the operation of the drug delivery device 10.

[0058] Once the desired dose is set, the device 10 is manipulated so that the injection needle 24 appropriately penetrates, for example, the skin of the user. The dose dispensing mode of operation is initiated in response to an axial distal force applied to the proximal side 60 of the dose button 56 along the longitudinal axis L. This axial distal force causes the actuator 50 to move axially in the distal direction relative to the housing 12 along the longitudinal axis L. The axial force may be applied directly or indirectly to the dose button 56 by the user, as further described below. The dose dispensing mode of operation may also be initiated by activating a separate switch or trigger mechanism.

[0059] The axial displacement movement of the actuator 50 compresses the biasing member 68 and reduces or closes the gap between the dose button 56 and the tubular flange 38. This relative axial movement engages the complementary splines 74 ( Figure 2 ) is disengaged and thereby disengages the actuator 50 from being rotationally fixed to the dose setting member 30. In particular, the dose setting member 30 is rotationally decoupled from the actuator 50 to allow a reverse driven rotation of the dose setting member 30 relative to the actuator 50.

[0060] As the actuator 50 continues to extend axially without rotation relative to the housing 12, the dial member 32 is screwed back into the housing 12 as it rotates relative to the dose button 56. Dose indicia indicating the amount still remaining to be injected are visible through the window 36. As the dose setting member 30 is screwed down distally, the drive member 28 is advanced distally to push the piston 26 through the reservoir 20 and expel the drug through the needle 24 ( Figure 2 ).

[0061] During a dose dispensing operation, as the dial member 32 is screwed back into the housing 12, the amount of drug expelled from the drug delivery device 10 is proportional to the amount of rotational movement of the dose setting member 30 relative to the actuator 50. The injection is complete when the internal thread of the dial member 32 has reached the distal end of the corresponding external thread of the sleeve 34 ( Figure 2 ). The device 10 is then again arranged in the ready state or zero dose position, such as Figure 2 and Figure 3 Displayed in.

[0062] The "start" and "end" angular positions (relative to the dose button 56 of the actuator 50) of the dose dial member 32 of the dose setting member 30 and thus the rotationally fixed flange 38 and skirt 42 described above provide an "absolute" change in angular position during a dose dispensing operation. The determination of the relative rotation angle is determined in several ways. By way of example, the total rotation may also be determined by taking into account incremental movement of the dose setting member 30, which is measured by the sensing system in any of several ways, as further described below.

[0063] exist Figure 6-7 and Fig.24 In other embodiments shown in FIG. 1 , the actuator 50 of each dose button 56 ′ is a one-piece device that combines Figure 1-4 The skirt 42 and the dose button 56 of the embodiment. In each of these embodiments, the flange 38 is attached to the dial member 32 and is in contact with the adapter 52 ( Figure 4 ) cooperate to selectively couple the dial member 32 with the one-piece dose button 56. The radially outer surface of each one-piece dose button 56 provides a surface on the exterior of the housing 12 to rotate the dial member 32. Figure 6-7 and Fig.24 In the embodiment of the present invention, the user can grasp and rotate the radially outer surface of each dose button 56 or 56', and the radially outer surface may include a plurality of surface features for dose setting. Figure 6-7 and Fig.24 In the embodiment shown in FIG. 1 , each one-piece dose button 56 ′ behaves as described above. Figure 1-4The one-piece component button 56' combines features of both the skirt 42 and the dose button 56. In this embodiment, the flange is attached to the dial member and cooperates with an adapter (described below) to selectively couple the dial member with the one-piece dose button. The radially outer surface of the one-piece dose button 56' provides a surface on the exterior of the device body 11 to rotate the dial member.

[0064] Additional details of the design and operation of the exemplary delivery device 10 may be found in U.S. Pat. No. 7,291,132, entitled “Medication Dispensing Apparatus with Triple Screw Threads for Mechanical Advantage,” the entire disclosure of which is hereby incorporated herein by reference. Another example of a delivery device is an automatic injector device, which may be found in U.S. Pat. No. 8,734,394, entitled “Automatic Injection Device With Delay Mechanism Including Dual Functioning Biasing Member,” which is hereby incorporated by reference in its entirety. Such devices may be modified using one or more of the various sensor systems described herein to determine the amount of drug delivered from the drug delivery device based on sensing of relative rotation within the drug delivery device.

[0065] Various sensor systems are contemplated herein. In general, a sensor system includes at least one pair of sensing components—a sensing component and a sensed component. The term "sensing component" refers to any component capable of detecting the relative angular position of a sensed element. The sensing component includes a sensor, together with associated electrical components to operate the sensor. A "sensed element" is any component that moves relative to an associated sensor and for which the sensor is capable of detecting movement relative to the sensor. The sensed component includes one or more sensed elements. Thus, the sensor is capable of detecting the position of (multiple) sensed elements and providing an output representative of the relative position (s) of the sensed elements.

[0066] Next reference Figure 5 , shows an exemplary piezoelectric sensor 100 in the form of a film, comprising a first electrode 102, a second electrode 104, and a polymer core 106. Suitable polymers for use in the core 106 include, for example, fluoropolymers (eg, polyvinylidene fluoride).

[0067] The piezoelectric sensor 100 is a transducer that converts mechanical energy into electrical energy. More specifically, the piezoelectric sensor 100 converts mechanical deformation into a proportional electrical signal (charge or voltage). Therefore, when the piezoelectric sensor 100 is subjected to a mechanical force and experiences deformation, vibration, or strain (such as along a Figure 5 When the piezoelectric sensor 100 is stretched (e.g., stretched by one or more arrows S), the piezoelectric sensor 100 generates a proportional electrical signal between the first electrode 102 and the second electrode 104 for detection by the analog voltage detector 108. The mechanical deformation of the piezoelectric sensor 100 can be elastic (i.e., reversible) such that the piezoelectric sensor 100 can return to its initial neutral shape when the force is removed.

[0068] An exemplary piezoelectric sensor 100 is a Piezo Film Sensor available from TE Connectivity, having a sensitivity of 10 to 15 mV per microstrain (ppm change in length) and a thickness of 28 μm.

[0069] Next reference Figure 6-13 , discloses a dose detection system 200 for use with the drug delivery device 10 of the present disclosure or another suitable drug delivery device. During a dose dispensing operation, the dose detection system 200 can sense the rotation of the dose setting member 30 relative to the actuator 50 and / or another component of the drug delivery device 10. The sensed rotation of the dose setting member 30 can be used to determine the amount of drug delivered from the drug delivery device 10.

[0070] The dose detection system 200 may be a modular component that is removably coupled to the drug delivery device 10, such as, for example, in Fig.25 This removable coupling allows the dose detection system 200 to be removed from the first drug delivery device 10 and thereafter attached to a second drug delivery device (not shown). The removable coupling between the dose detection system 200 and the drug delivery device 10 is further described below.

[0071] exist Figure 6-7In the embodiment of the present invention, the dose detection system 200 includes a frame 210 that is coupled to the drug delivery device 10 at least during a dose dispensing operation to detect a rotation of a dose setting member 30. The illustrative frame 210 is coupled to a dose button 56' of an actuator 50 to detect a rotation of the dose setting member 30 relative to the actuator 50, but this position may vary. During both dose setting and dose dispensing operations, the coupling between the frame 210 and the dose button 56' may be axially and rotationally fixed. During a dose setting operation, the frame 210 may also be rotationally coupled to the dose setting member 30, which may allow the dose detection system 200 to be unaware of or ignore the combined rotation of the frame 210 and the dose setting member 30 during a dose setting operation. However, during a dose dispensing operation, the frame 210 may become decoupled from the dose setting member 30, which may allow the dose detection system 200 to detect a rotation of the dose setting member 30 relative to the frame 210 during a dose dispensing operation.

[0072] The illustrative frame 210 includes a proximal wall 212 having a proximal or upper surface 214 facing the user and a distal or lower surface 216 facing the dose button 56'. Because the proximal wall 212 of the frame 210 can cover the dose button 56', the operator can adjust the dose by moving the proximal wall 214 along the longitudinal axis L ( Figure 7 ) delivers a dose by applying an axial distal force to the upper surface 214 of the frame 210. This axial distal force may be transmitted from the frame 210 to the proximal side 60 of the dose button 56'. The remainder of the dose dispensing operation may continue as described above.

[0073] The illustrative frame 210 also includes a plurality of protrusions 218 extending distally from the wall 212 to engage the dose button 56' in a removable friction fit. For example, the removable coupling between the frame 210 and the dose button 56' may also be achieved by using one or more fasteners, a threaded interface, or another suitable coupling mechanism. The removable coupling between the frame 210 and the dose button 56' allows the dose detection system 200 to be a modular component, as further described above.

[0074] like Figure 8 and Fig. 9 As shown in FIG. 1 , the frame 210 of the dose detection system 200 may include at least one piezoelectric sensor 100, as described above with respect to FIG. Figure 5 The piezoelectric sensor 100 may be bonded, bonded, or otherwise coupled to the lower surface 216 of the frame 210, but this location may vary. The piezoelectric sensor 100 may be coupled to the frame 210 in a neutral (e.g., flat) state and configured to mechanically deform along with the adjacent dose button 56' and / or the frame 210. The frame 210 of the dose detection system 200 may also be configured to maintain the voltage detector 108 ( Figure 5 ) and other electronic components associated with the piezoelectric sensor 100, as further described below.

[0075] like Figure 10-13 As shown in FIG. 1 , the dose detection system 200 further includes one or more rigid force applicators 220 and a plurality of deformable members 222, wherein the deformable members 222 are connected to the force applicators 220 on the frame 210, the piezoelectric sensor 100 ( Figure 8 ) or both mechanically communicate. As the dose setting member 30 rotates relative to the actuator 50 during the dose dispensing operation, the force applicator 220 is configured to engage the deformable member 222 and apply a mechanical force to the deformable member 222. This force can be transmitted from the deformable member 222 to the corresponding piezoelectric sensor 100 to cause the piezoelectric sensor 100 ( Figure 8 ) bend, stretch or otherwise deform as further described below. In one example, the force applicator 220 resembles a finger and is coupled to the rotatable dial member 32 of the dose setting member 30. In one example, the deformable member 222 resembles a ridge or tooth and is coupled to the dose button 56' of the actuator 50. The number, size, position and orientation of the force applicator 220 and the deformable member 222 can be varied. For example, the position of the force applicator 220 and the deformable member 222 can be reversed so that the force applicator 220 will be coupled to the actuator 50 and the deformable member 222 will be coupled to the dose setting member 30.

[0076] exist Fig.10 and Fig.11 In the illustrated embodiment of the present invention, the force applicator 220 extends proximally from the dose member 30, for example, shown as the rotatable dial member 32, and the deformable member 222 extends distally from the dose button 56' of the actuator 50. In an alternative embodiment, the one-piece dose button 56' may be formed by Figure 3 Each time the rigid force applicator 220 rotates across the adjacent deformable member 222, the force applicator 220 applies a mechanical force to the adjacent deformable member 222 in an axial direction A substantially parallel to the longitudinal axis L, such as Fig.11 The dose button 56' of the actuator 50 is flexible so that the mechanical force from the force applicator 220 causes the dose button 56' to deform or bend in the axial direction A. This axial deformation of the dose button 56' can be transmitted to the piezoelectric sensor 100 ( Figure 8 ). Each time the force applicator 220 rotates across an adjacent deformable member 222, a corresponding axial deformation of the piezoelectric sensor 100 may occur.

[0077] exist Fig.12 and Fig.13 In the illustrated embodiment of the present invention, the force applicator 220 extends radially outward from the dose member 30, shown as the rotatable dial member 32, and the deformable member 222 extends radially inward from the dose button 56' of the actuator 50. Each time the rigid force applicator 220 rotates across the adjacent deformable member 222, the force applicator 220 applies a mechanical force to the adjacent deformable member 222 in a radially outward direction R substantially perpendicular to the longitudinal axis L, as shown. Fig.13 . The dose button 56' of the actuator 50 is flexible so that the mechanical force from the force applicator 220 causes the dose button 56' to deform or bend in the radially outward direction R. This radial deformation of the dose button 56' can be transmitted to the protrusion 218 of the frame 210, and then to the piezoelectric sensor 100 ( Figure 8 ). Each time the force applicator 220 rotates across an adjacent deformable member 222, a corresponding radial deformation of the piezoelectric sensor 100 may occur. In an alternative embodiment, the one-piece dose button 56' may be made of Figure 3 The dose button 56 and skirt 42 shown in FIG.

[0078] As described above, the sensed rotation of the dose setting member 30 can be used to determine the amount of drug delivered from the drug delivery device 10. In certain embodiments, each rotation of the force applicator 220 on the dose setting member 30 across the adjacent deformable member 222 on the actuator 50 can be associated with one dose unit. Therefore, based on the information received from the piezoelectric sensor 100, the dose detection system 200 can incrementally count the number of times the force applicator 220 rotates across the deformable member 222 and associate the number with the amount of drug delivered from the drug delivery device 10. However, the size of each deformable member 222 and the distance between adjacent deformable members 222 can be varied to associate with other dose units. The dose detection system involves detecting relative rotational movement between two members. Where the degree of rotation has a known relationship to the amount of delivered dose, the sensor system operates to detect the amount of angular movement from the start of dose injection to the end of dose injection. For example, a typical relationship for a pen injector is that an angular displacement of 18° of the dose setting member is equal to one unit of dose, although other angular relationships are also suitable, such as, for example, 9, 10, 15, 20, 24 or 36 degrees may be used for one unit or 0.5 unit. The system is operable to determine the total angular displacement of the dose setting member during dose delivery. Thus, if the angular displacement is 90°, a dose of 5 units has been delivered. Such a determined total angular displacement of the dose setting member may be related to the amount of the dose delivered.

[0079] The dose detection system 200 may be supplied as a system that is integral to the drug delivery device 10, rather than a modular component that is removably coupled to the drug delivery device 10. In this alternative embodiment, the piezoelectric sensor 100 may be coupled to the housing 12 or other component of the delivery device 10 at any position relative to the dose button 56' at rest during dose delivery, and accurately detect deformation of the piezoelectric sensor 100 without excessive noise. The electronic components associated with the piezoelectric sensor 100 may similarly be attached to any component of the drug delivery device 10, and thus be integral to the delivery device 10.

[0080] exist Fig.25 In the embodiment of the present invention, the dose delivery detection system (now referred to as system 80) is in the form of a module 82 that can be attached to the button 56 of the device. Figure 1-4 Common details are provided and thus the embodiments are shown in a somewhat schematic manner. The dose detection module 82 includes a body 88 having a cylindrical upper wall 90, a top axial wall 92 and a lower axial wall 98, although it will be appreciated that variations to these components (including the absence of the lower wall 98) are within the scope of the present disclosure. Other parts common to the previous description herein include an electronics assembly 111 housed within the chamber 96 of the module body 88, a dose button 56, a dose setting member 32 and the device housing 12. The electronics assembly 111 may include electronic components such as, for example, Fig. 20 and Fig. 22 , including a controller. In addition, the dose detection module 82 is schematically shown as being attached to the annular side wall 62 of the dose button 56, but alternative attachment forms and locations may be used. For example, in some embodiments, the dose detection module 82 may be attached to the dose button 56 and releasably attached to the skirt 42. In addition, the dose detection module 82 may be attached to the one-piece dose button 56 ', as may be understood by those skilled in the art. Attached to the top wall 92 of the module 82 is a finger pad 110. The finger pad 110 is coupled to the top wall 92, which in turn is attached to the upper side wall 90. The finger pad 110 includes a ridge 114 that extends radially inward and is received in a circumferential groove 116 of the wall member 92. The groove 116 allows slight axial movement between the finger pad 110 and the wall member 92. A spring (not shown) generally forces the finger pad 110 upward away from the wall member 92. The finger pad 110 is rotatably fixed to the wall member 92. As the injection process is initiated, axial movement of the finger pad 110 in the distal direction toward the module body 88 can be used to trigger a selected event. One use of the finger pad 110 can be to activate drug delivery device electronic components with initial depression and axial movement of the finger pad 110 relative to the module body 88 when a dose injection is initiated. For example, this initial axial movement can be used to "wake up" the device and particularly components associated with a dose detection system.

[0081] In the absence of a finger pad, the system electronics may be activated in a variety of other ways. For example, at the start of dose delivery, initial axial movement of the module 82 may be detected directly, such as by the closure of contacts or physical engagement of a switch. It is also known to activate a drug delivery device based on a variety of other actions (e.g., removing a pen cap, detecting pen movement using an accelerometer, or setting a dose). In many approaches, the dose detection system is activated before dose delivery begins.

[0082] The dose detection module body 88 is removably attachable to the dose button 56 or 56'. Fig.25 , the upper sidewall 90 is schematically shown as having an inwardly extending protrusion 94 configured to attach the module 82 to the dose button 56. The lower wall 101 of the body 88 may include attachment features for a more distal location. Provided that in one aspect the module 82 is removable from a first drug delivery device and thereafter attached to a second drug delivery device, the dose detection module 82 may optionally be attached to the dose button 56 or 56' via any suitable fastening means such as a snap or press fit, a threaded interface, etc. The attachment may be at any location on the dose button 56 or 56' provided that the dose button 56 or 56' is capable of axially moving any desired amount relative to the dose setting member 30, as discussed herein.

[0083] During dose delivery, the dose setting member 30 is free to rotate relative to the dose button 56 or 56' and the module 82. In the illustrative embodiment, the module 82 is rotationally fixed to the dose button 56 and does not rotate during dose delivery. This may be provided structurally, such as by means of a protrusion 94, or by engaging mutually facing splines or other surface features on the module body 88 and the dose button 56 in the event of axial movement of the module 82 relative to the dose button 56. In another embodiment, distal depression of the module provides sufficient frictional engagement between the module 82 and the dose button 56 to functionally cause the module 82 and the dose button 56 to remain rotationally fixed together during dose delivery. Fig.25 , the piezoelectric sensor 100 is shown disposed within the chamber 96 along the proximal surface of the lower wall 98. One or more openings 103 defined by the lower wall 98 may be included to allow direct sensing of the sensor 100 along the proximal surface 60 of the button 56. Figure 7, the distal side (opposite the proximal side 60) of the button 56 includes a deformable member 222 (shown in phantom). The force applicator 220 is shown extending from the dose setting member 30, shown here as a flange 38, although it may be a dose dial member 32, to contact the member 222. The sensor 100 may detect relative rotational movement between the force applicator 220 and the deformable member 222. Detection may be further enhanced by the portion of the sensor 100 being located within the opening(s) 103 and engaging the proximal side 60 of the button.

[0084] Next reference Figure 14-19 , discloses another dose detection system 200' for use with the drug delivery device 10 of the present disclosure or another suitable drug delivery device. During a dose dispensing operation, the dose detection system 200' can sense rotation of the dose setting member 30 relative to the housing 12 and / or another component of the drug delivery device 10. The sensed rotation of the dose setting member 30 can be used to determine the amount of drug delivered from the drug delivery device 10. In addition to what is described below, Figure 14-19 The second dose detection system 200' is similar to Figure 6-13 1. The first dose detection system 200 of FIG. 1 is shown in FIG. 1, wherein like reference numerals indicate like elements.

[0085] Figure 14-19 The second dose detection system 200' may be an integral component permanently coupled to the drug delivery device 10. This integral coupling eliminates the need to remove the dose detection system 200' from the first drug delivery device 10 and transfer it to the second drug delivery device (not shown). Instead, the dose detection system 200' will be supplied as an integral component of each drug delivery device 10.

[0086] The dose detection system 200' includes a plurality of rigid force applicators 220' and one or more deformable members 222' that are in mechanical communication with the force applicators 220' and the piezoelectric sensor 100, such as Fig.14 and Fig.15. The force applicator 220' is similar to a button or a gear tooth and is coupled to the outer surface 33 of the rotatable dial member 32 of the dose setting member 30. The deformable member 222' is similar to an arm or a tooth and is coupled to the inner surface 13 of the surrounding housing 12. The number, size, position and orientation of the force applicators 220' and the deformable members 222' can be varied. For example, the positions of the force applicators 220' and the deformable members 222' can be reversed so that the force applicator 220' will be coupled to the housing 12 and the deformable member 222' will be coupled to the dose setting member 30. During the dose dispensing operation, as the dose setting member 30 rotates relative to the housing 12, each force applicator 220' is configured to engage with an adjacent deformable member 222' and apply a mechanical force to the adjacent deformable member 222'. This force can be transmitted from the deformable member 222' to the corresponding piezoelectric sensor 100 to cause the piezoelectric sensor 100 to bend, stretch, or otherwise deform, as further described below.

[0087] As described above, the piezoelectric sensor 100 can be arranged to mechanically communicate with each deformable member 222' on the housing 12. More specifically, the piezoelectric sensor 100 can be bonded, bonded, or otherwise coupled to each deformable member 222' on the housing 12, but this position can vary. The piezoelectric sensor 100 can be coupled to the deformable member 222' in a neutral (e.g., flat) state, such as Fig.14 , and is configured to mechanically deform together with the deformable member 222' when the deformable member 222' engages an adjacent force applicator 220', such as Fig.15 The housing 12 may also be configured to hold a voltage detector 108 ( Figure 5 ) and other electronic components associated with the piezoelectric sensor 100, as further described below.

[0088] exist Fig.16 and Fig.17 In the illustrated embodiment, two deformable members 222A'-222B' extend radially inward from the inner surface 13 of the housing 12, each in mechanical communication with a corresponding piezoelectric sensor 100 ( Fig.14 The force applicators 220' extend radially outwardly from the outer surface 33 of the dial member 32 and are arranged in a helical pattern that follows the thread path on the outer surface 33 of the dial member 32. Each time one of the deformable members 222A'-222B' rotates across an adjacent force applicator 220', the force applicator 220' is rotated substantially perpendicular to the longitudinal axis L ( Fig.16 ) in the radially outward direction R ( Fig.15). The deformable members 222A'-222B' may be flexible so that the mechanical force from the force applicator 220' causes adjacent deformable members 222A'-222B' and their corresponding piezoelectric sensors 100 to deform or bend in the radially outward direction R. The radial deformation of the piezoelectric sensor 100 may be related to the amount of drug delivered from the drug delivery device 10.

[0089] exist Fig.18 and Fig.19 In the illustrated embodiment, six deformable members 222A'-222F' extend radially inward from the inner surface 13 of the housing 12, each in mechanical communication with a corresponding piezoelectric sensor 100 ( Fig.14 The force applicators 220' extend radially outwardly from the outer surface 33 of the dial member 32 and are arranged in a helical pattern that follows the thread path on the outer surface 33 of the dial member 32. Each time one of the deformable members 222A'-222F' rotates across an adjacent force applicator 220', the force applicator 220' is rotated substantially perpendicular to the longitudinal axis L ( Fig.18 ) in the radially outward direction R ( Fig.15 ). The deformable members 222A'-222F' may be flexible so that the mechanical force from the force applicator 220' causes adjacent deformable members 222A'-222F' and their corresponding piezoelectric sensors 100 to deform or bend in the radially outward direction R. The radial deformation of the piezoelectric sensor 100 may be related to the amount of drug delivered from the drug delivery device 10.

[0090] Fig.26 An additional embodiment of a dose detection system 200'' is shown in , for use with the drug delivery device 10 of the present disclosure or another suitable drug delivery device. The illustrative device 10 includes a housing 12, a dial member 32, and a dose button 56', which are further described above. The dose detection system 200'' requires only a single piezoelectric strain sensor 100 that measures deformation on the housing 12. During drug administration, this sensor 100 can measure strain on the housing 12, where the strain is a result of direct mechanical deformation or indirect mechanical wave transmission. For example, as Fig.10 As shown in , during relative rotation of the dose button 56' to the rotatable dial member 32, mechanical waves may be generated by the rhythmic movement of the force applicator 220 as it interacts with the successively adjacent deformable members 222. Similar to the previous embodiments, the signal from the piezoelectric sensor 100 may be used to determine the amount of drug delivered from the drug delivery device 10.

[0091] Figure 27-29Another embodiment of a dose detection system 200''' is shown in , for use with the drug delivery device 10 of the present disclosure or another suitable drug delivery device. The illustrative device 10 includes a housing 12, a dial member 32, and a dose button 56', which are further described above. The dose dial member 32 includes a force applicator 220''' in the form of a raised area between recesses or depressions 195, so that strain is generated through a deformable member 222''' to which the sensor 100 is bonded. In Fig. 27 In the embodiment of the present invention, the piezoelectric strain sensor 100 can be mounted on a deformable member 222''', wherein the deformable member 222''' includes a frame 170 having a spherical spring arm 160 ( Fig.28 ), the ball spring arm 160 positions the "reader" ball spring 180 to ride in the recess or depression 195 between the force applicators 220'"' as it rotates in the dose dial member 32. As the ball spring arm 160 performs strain transfer 190 from the ball spring reader 180 moving over the recess or depression 195 between the force applicators 220'"' in the dose dial member 32 through the frame 170, the piezoelectric strain sensor 100 undergoes deformation.

[0092] Fig.28 and Fig.29 The relationship between the ball spring reader 180 attached to the ball spring arm 160 and the recess or depression 195 on the dose dial member 32 is shown. This embodiment has the advantage that the smooth moving wave sensed by the ball spring reader 180 minimizes the resistance on the sliding force for injection. Similar to the previous embodiment, the signal from the piezoelectric sensor 100 can be used to determine the amount of drug delivered from the drug delivery device 10. In an embodiment with a single piezoelectric sensor 100, the signal from the piezoelectric sensor 100 may need to be combined with a second signal to indicate the dose being delivered in order for the system to detect the amount of drug delivered from the drug delivery device 10. The signal for indicating the dose being delivered may include, for example, a signal that the dose button 56' is depressed or a signal that there is increased strain on the lead screw 28 that pushes the piston 26 and the drug out of the device 10.

[0093] Figure 30-322 is another embodiment of a dose detection system 200''' for use with the drug delivery device 10 of the present disclosure or another suitable drug delivery device. The illustrative device includes a housing 12, a dial member 32, and a dose button 56', which are further described above. A flange (now referred to as flange 120) is positioned between the dial member 32 and the dose button 56'. The dose button 56' is shown without a top plate to better illustrate the location of the sensor 100. The flange 120 is axially and rotatably fixed to the dial member 32. In one example, the flange 120 includes a plurality of protrusions 122 that are configured to be received in recesses or openings formed in the dial member 32, thereby axially and rotatably fixing the flange 120 and the dial member 32 together.

[0094] The dose detection system 200'''' includes: a plurality of deformable members 222'''' in the form of ratchet gear teeth extending radially inwardly from the inner wall of the dose button 56'; and a force applicator 222'''' in the form of a ratchet pawl extending radially outwardly from the dose setting member, shown as a flange 120. Each of the gear teeth of the deformable member 222'''' may extend longitudinally along the inner wall 127 of the dose button 56'. The gear teeth include: a first lateral side 123, which is contacted by the force applicator 220'''' in a clockwise direction; and a second lateral side 124, which is contacted by the force applicator in a counterclockwise direction, or vice versa. In one example, the first lateral side 123 has a flat side configuration to hinder movement of the force applicator 220'''' in a corresponding direction, and the second lateral side has an inclined side configuration to assist movement of the force applicator 220'''' in an opposite direction. The dose detection system 200'''' also includes a piezoelectric sensor 100 supported by the dose button 56', such as Fig.30 The position of the sensor is shown in the proximal position and is accommodated by the button; however, the position of the sensor 100 may vary.

[0095] The force applicator 220''' may include a base 130 and a finger portion 132 extending from the base 130. The base 130 may extend proximally from the wall 120A of the flange 120, such as Fig.31 . In other embodiments, the base 130 may be mounted to another dose setting member component, such as, for example, a dial member. The fingers 132 are shown as extending circumferentially and radially outwardly. In one example, the fingers 132 extend circumferentially in a spaced relationship from the lateral sidewalls 130A of the base 130 above the axial surface 131 of the flange 120 to define a gap 133 therebetween. In this configuration, the fingers 132 may be radially curved along their connection to the base 130. As shown in FIG. Fig.32, the fingers 132 are biased radially outwardly so that the tips 135 of the fingers 132 are placed within the voids 137 defined between the sides 123, 124 of the deformable member 222''''. The finger tips 135 can be configured to provide enhanced sliding along the sides 123, 124. The deformable member 222'''' can be molded, machined, or formed by additive manufacturing for attachment to the flange 120. In the example shown, the deformable member 222'''' is integrally formed with the flange 120 as a single unit, and some machining can be used for final shaping.

[0096] The button 56' is shown as having a cylindrical outer wall 140, a proximal upper wall 142, and a distal end opening 144, defining a cup-shaped button. A cylindrical inner wall 146 in spaced relationship with the outer wall 140 can define an annular space 148. The inner wall 146 can extend distally from the upper wall 142 and can have a concave end for mounting in alignment with the axial opening 139 formed in the flange 120 so that the force applicator is placed in a radial position between the inner wall 146 and the outer wall 140 against the deformable member 222'''', as shown. Fig.32 140. The upper wall 142 may be recessed from the top 141 of the outer wall 140 to define a mounting location for the piezoelectric sensor 100. The deformable member 222'''' is shown as extending distally from the distal surface 147 of the upper wall 142 within the annular space 148. In one example, the member 222'''' is in physical contact with the upper wall 142 to better transfer deformation and / or vibration from contact with the force applicator. In another example, the member 222'''' and the upper wall 142 are integrally formed.

[0097] In the dose setting mode of operation, the user grasps the dose button 56' and rotates the dose button 56' relative to the housing 12. The spring 68 biases the dose button 56' and the dial member 32 into fixed rotational engagement so that the rotation of the dose button 56' is transferred to the dial member 32 and the flange 120. Since the dose button 56' and the dial member 32 rotate together during dose setting, the sensor 100 of the dose detection system 200''' may remain inactive.

[0098] In the dose dispensing mode of operation, the user applies an axial distal force to the dose button 56'. The user's force overcomes the biasing force from the spring 68 and releases the dial member 32 to rotate relative to the dose button 56' and the housing 12. Fig.32In the illustrated embodiment of the dial member 32, the dial member 32 rotates counterclockwise relative to the dose button 56, but this direction may vary. Since the flange 120 is rotatably fixed to the dial member 32, the flange 120 also rotates counterclockwise relative to the dose button 56'. Rotation of the flange 120 relative to the dose button 56' causes the deformable member 222'''' (i.e., the ratchet pawl) to bend radially inwardly away from its biased radially outward configuration as it rotates across the continuous force applicator 220'''' (i.e., the gear teeth). Fig.30 In the illustrated embodiment, in which the piezoelectric sensor 100 is coupled to a rigid force applicator 220''', the mechanical wave can be transmitted to the piezoelectric sensor 100 through the dosage button 56'. It is also within the scope of the present disclosure that the piezoelectric sensor 100 is directly coupled to the deformable member 222''', for example, as Fig.15 , such that movement of the deformable member 222''' results in direct mechanical deformation of the piezoelectric sensor 100. Similar to the previous embodiments, the signal from the piezoelectric sensor 100 can be used to determine the amount of drug delivered from the drug delivery device 10.

[0099] Additional information regarding the dose setting and dose dispensing modes of operation of the drug delivery device 10 is provided above and in previously incorporated US Pat. Nos. 7,291,132 and 8,734,394.

[0100] Next reference Fig. 20 An electronic control system 300 is provided for use with a corresponding dose detection system 200, 200', 200", 200''', 200''''. The control system 300 may communicate with each piezoelectric sensor 100 of the dose detection system 200, 200', 200", 200''', 200'''' to receive information about a sensed rotation of the dose setting member 30 relative to the housing 12, the actuator 50 and / or another component of the drug delivery device 10. The control system 300 may use the information from each piezoelectric sensor 100 to determine an amount of drug delivered from the drug delivery device 10.

[0101] exist Fig. 20 In the illustrated embodiment, the control system 300 is shown in combination with the second dose detection system 200'. Therefore, the following description relates to the second dose detection system 200'. However, it should be understood that the control system 300 may also be suitable for use with the first dose detection system 200 and other suitable dose detection systems.

[0102] Fig. 20The illustrative control system 300 of includes a microcontroller unit (MCU) 302 located onboard the housing 12 of the drug delivery device 10. However, the location of the MCU 302 may vary. For example, when the control system 300 is adapted to be used with Figure 6-13 When the first dose detection system 200 is used, the MCU 302 may be located on the actuator 50 of the drug delivery device 10. In other embodiments, at least a portion of the MCU 302 may be located at a remote location relative to the drug delivery device 10, such as on a remote server, a user's computer, or a user's smartphone.

[0103] The illustrative MCU 302 includes a processing core 304, a memory 306 (e.g., internal flash memory, an onboard electrically erasable and programmable read-only memory (EEPROM), etc.), a power source 308 (e.g., a coin cell battery), and a communication port 310. These components may be mounted to, and communicate via, a flexible printed circuit board (FPCB) 312. As discussed above, it is also within the scope of the present disclosure that certain elements of the MCU 302 (such as the processing core 304 and / or the memory 306) are located at a remote location relative to the drug delivery device 10.

[0104] The MCU 302 communicates with the voltage detector 108 of each piezoelectric sensor 100 or a single piezoelectric sensor (when one is employed). The processing core 304 of the MCU 302 is operative to perform the operations described herein, including determining the amount of drug delivered from the drug delivery device 10 based on the information received from the voltage detector 108 of each piezoelectric sensor 100. The MCU 302 may store the detected amount of drug in a memory 306. The MCU 302 may also transmit raw data from the voltage detector 108 or the detected amount of drug from the onboard processing core 304 to a paired remote device, such as a user's computer or smartphone, via a communication port 310. The information may be transmitted from the communication port 310 via a wired or wireless communication protocol, such as a Bluetooth Low Energy (BLE) wireless communication protocol.

[0105] Fig. 20 The system in FIG. 4 is shown as having two signals 402, it should be understood that the system may include only one signal 402. Fig. 20 and Fig.21, the control system 300 can be configured to receive an analog piezoelectric signal 402 from the voltage detector 108 of the piezoelectric sensor 100, which can be a substantially ring-shaped signal. Next, the control system 300 can be programmed to convert the analog piezoelectric signal 402 into an intermediate digital signal 404, which can be a high-frequency signal representing the time of a "click" or deformation event. Finally, the control system 300 can be programmed to convert the intermediate digital signal 404 into a conditioned digital signal 406, which can be a single step / square wave having a predetermined width W representing a predetermined time, as further described below.

[0106] Fig. 22 4 shows a signal processing logic or method 400 for use by the control system 300, and Fig.23 The corresponding signal processing circuit 500 is shown in FIG. Fig. 22 The logic 400 and Fig.23 The corresponding circuit 500 subjects the analog piezoelectric signal 402 to a direct current (DC) voltage offset step 410 using a resistor 510, followed by an amplification step 412 using an amplifier 512, followed by an analog-to-digital conversion step 414 using a comparator 514 to produce an intermediate digital signal 404. The signal 404 may be produced when the input voltage is equal to or greater than a predetermined voltage (e.g., 1.3 V). Optionally, when the input voltage is less than the predetermined voltage, the signal 404 may be ignored at step 416. The intermediate digital signal 404 may be converted to a conditioned digital signal 406 by turning the signal “on” when the timer is started at a timer start step 418, and by turning the signal “off” when the timer expires after a predetermined time at a timer expiration step 420. The timing steps 418, 420 may be performed using a resistor-capacitor (RC) timing loop 518. The predetermined times associated with the timing steps 418, 420 may control the width W ( Fig.21 ) and can be adjusted to match the timing of each rotation and deformation event to minimize errors. Fig. 22 The logic 400 and Fig.23 The corresponding circuit 500 may output a number corresponding to the number of digital signals 406 counted over a period of time.

[0107] In certain embodiments, the control system 300 may be configured to distinguish the direction of rotation of the dose setting member 30. For example, the control system 300 may be configured to distinguish whether the dose setting member 30 is rotated in a first direction during a dose setting operation, or in a second direction during a dose dispensing operation. For the purpose of determining the amount of drug actually delivered from the drug delivery device 10, the control system 300 may ignore the rotation of the dose setting member 30 during the dose setting operation, and only process the rotation of the dose setting member 30 during the actual dose dispensing operation. For example, the control system 300 may distinguish these directions using phase shift or shift register encoding.

[0108] Final Reference Figure 33-34 , another dose detection system 600 is disclosed for use with the drug delivery device 10 of the present disclosure or another suitable drug delivery device. The illustrative device 10 includes a housing 12, a dial member 32, and a dose button 56', which are further described above. The dose detection system 600 includes: a sensed component 602 in the form of gear teeth or surface protrusions extending radially outward from the dial member 32 in a spiral pattern; and a sensing component 604 in the form of a multi-turn potentiometer having a shaft (not shown) extending radially inward from the housing 12 to mesh with the gear 602. In operation, as the dial member 32 rotates relative to the housing 12, the gear 602 causes the shaft of the potentiometer 604 to rotate. Similar to the previous embodiments, the signal from the potentiometer 604 can be used to determine the amount of drug delivered from the drug delivery device 10. The sensor 604 can also be other types of sensors, and the sensing component can include other features that can be detected by the sensor, such as, including tactile, optical, electrical and magnetic properties. For example, the sensor 604 may be a light source / sensor combination that emits light across a surface protrusion of the sensed component 602, and the sensor 604 receives the reflected light and communicates a signal indicating rotational movement to the controller. In one example, the sensor 604 may be a light source that emits light across a sensed component 602 that includes a plurality of photodiodes, and the sensed component 602 coupled to the circuit communicates a signal indicating rotational movement to the controller. In another example, the sensor 604 may include a micro switch coupled to the housing of the device, the micro switch being configured to deflect or switch due to contact with a surface protrusion of the sensed component 602, and the sensor 604 communicates a signal indicating rotational movement to the controller. In one example, the surface feature is a physical feature that allows for detection of incremental movement as the dose setting member rotates relative to the actuator. In one example, the sensed component 602 is disposed in a spiral groove, is a linear potentiometer or a plurality of discrete potentiometers, and the sensing component 604 is a scratch sensor disposed from the housing of the device.

[0109] Although the present invention has been described as having an exemplary design, the present invention may be further modified within the spirit and scope of the present disclosure. Therefore, this application is intended to cover any variation, use or modification of the present invention using its overall principles. In addition, this application is intended to cover such deviations from the present disclosure as fall within known or common practices in the field to which the present invention relates and within the limitations of the appended claims.

[0110] Various aspects are described in this disclosure, including but not limited to the following.

[0111] 1. A drug delivery device comprising:

[0112] a device body having a longitudinal axis;

[0113] an actuator movable relative to the device body during a dose setting operation and movable relative to the device body along the longitudinal axis during a dose dispensing operation to deliver a medicament;

[0114] a dose setting member that rotates relative to the device body during a dose dispensing operation; and

[0115] A dose detection system is configured to detect rotation of the dose setting member relative to the actuator during a dose dispensing operation, the dose detection system comprising a piezoelectric sensor.

[0116] 2. The drug delivery device according to aspect 1, wherein the dose detection system comprises:

[0117] a ratchet finger coupled to the dose setting member; and

[0118] A ratchet gear tooth is coupled to the actuator, the ratchet gear tooth being contactable with the ratchet finger during relative rotation.

[0119] 3. The drug delivery device according to any of the preceding aspects, wherein the piezoelectric sensor is mounted to the actuator.

[0120] 4. A drug delivery device according to any one of the preceding aspects, wherein:

[0121] a ratchet finger having a base coupled to an axial surface of the dose setting member, the ratchet finger extending circumferentially above and in spaced relationship to the axial surface, the ratchet finger being configured to flex radially; and

[0122] Ratchet gear teeth are coupled to a dose button of the actuator, the ratchet gear teeth extending longitudinally along an inner wall of the dose button, the ratchet gear teeth being contactable with the ratchet fingers during relative rotation to cause the ratchet fingers to flex radially inwardly.

[0123] 5. The drug delivery device of aspect 4, wherein the dose detection system comprises a controller in electrical communication with the piezoelectric sensor, the controller being configured to:

[0124] receiving an analog signal generated by the piezoelectric sensor;

[0125] converting the analog signal into a digital signal; and

[0126] A unit rotational movement of the dose setting member is determined from the digital signal, the unit rotational movement being indicative of an amount of a dose dispensed during a dose dispensing operation.

[0127] 6. The drug delivery device according to any one of the preceding aspects, further comprising: a voltage detector configured to receive a signal from the piezoelectric sensor.

[0128] 7. The drug delivery device of aspect 6, further comprising: a communication port configured to send information from the voltage detector to a remote device.

[0129] 8. The drug delivery device according to any one of the preceding aspects, further comprising: a reservoir containing a drug; and a piston coupled to the actuator, the piston traveling through the reservoir in a dose dispensing operation to deliver the drug from the reservoir.

[0130] 9. A drug delivery device comprising:

[0131] a device body having a longitudinal axis;

[0132] an actuator that rotates relative to the device body during a dose setting operation and moves axially relative to the device body along the longitudinal axis during a dose dispensing operation to deliver a medicament;

[0133] a dose setting member fixedly coupled to the actuator during a dose setting operation and rotating relative to the actuator during a dose dispensing operation; and

[0134] A piezoelectric sensor is configured to detect rotation between the dose setting member and the actuator during a dose dispensing operation.

[0135] 10. The drug delivery device of aspect 9, wherein the piezoelectric sensor is inactive during a dose setting operation.

[0136] 11. The drug delivery device according to any one of aspects 9-10, wherein:

[0137] The actuator includes a ratchet gear having a plurality of teeth;

[0138] the dose setting member comprising a ratchet pawl; and

[0139] The piezoelectric sensor detects rotation of the ratchet pawl across each tooth of the ratchet gear.

[0140] 12. A drug delivery device comprising:

[0141] a device body having a longitudinal axis;

[0142] a dose setting member coupled to the device body and rotatable relative to the device body during a dose dispensing operation;

[0143] an actuator coupled to the device body and movable relative to the device body during a dose dispensing operation; and

[0144] A dose detection system configured to detect a rotation of the dose setting member during a dose dispensing operation, the dose detection system comprising:

[0145] at least one deformable member;

[0146] a piezoelectric sensor coupled to the at least one deformable member; and

[0147] At least one force applicator is configured to apply a mechanical force to the at least one deformable member and deform the piezoelectric sensor during a dose dispensing operation.

[0148] 13. The drug delivery device of aspect 12, further comprising: a control system in communication with the dose detection system, the control system being programmed to determine the amount of drug delivered based on the deformation of the piezoelectric sensor.

[0149] 14. The drug delivery device according to any of aspects 12-13, wherein the at least one force applicator is rotatable relative to the at least one deformable member during a dose dispensing operation.

[0150] 15. The drug delivery device according to any of aspects 12-14, wherein the at least one force applicator is rotationally coupled to the dose setting member such that the at least one force applicator and the dose setting member rotate together during a dose dispensing operation.

[0151] 16. The drug delivery device according to aspect 15, wherein the at least one force applicator comprises a plurality of teeth arranged in a helical pattern on an outer surface of the dose setting member.

[0152] 17. The drug delivery device according to aspect 15, wherein the at least one force applicator comprises a finger extending from the dose setting member in one of an axial proximal direction and a radially outward direction.

[0153] 18. The drug delivery device according to any of aspects 12-17, wherein the at least one deformable member is coupled to one of the device body and the actuator.

[0154] 19. The drug delivery device of aspect 18, wherein the at least one deformable member comprises a plurality of teeth arranged on an inner surface of the device body.

[0155] 20. The drug delivery device of aspect 18, wherein the at least one deformable member comprises a plurality of teeth arranged on a distal surface of the actuator.

[0156] 21. The drug delivery device according to any of aspects 12-20, wherein the at least one force applicator deforms the piezoelectric sensor in an axial direction substantially parallel to the longitudinal axis.

[0157] 22. The drug delivery device of any of aspects 12-21, wherein the at least one force applicator deforms the piezoelectric sensor in a radially outward direction substantially perpendicular to the longitudinal axis.

[0158] 23. The drug delivery device according to any of aspects 12-22, wherein the dose detection system is a modular component removably coupled to the device body.

[0159] 24. The drug delivery device according to any of aspects 12-23, wherein the dose detection system is an integral component permanently coupled to the device body.

[0160] 25. The drug delivery device according to any one of aspects 12-24, wherein:

[0161] The at least one deformable member is flexible; and

[0162] The at least one force applicator is rigid.

[0163] 26. The drug delivery device according to any one of aspects 12-25, wherein:

[0164] During a dose setting operation, the dose setting member is rotationally coupled to the actuator such that the dose setting member and the actuator rotate together relative to the device body; and

[0165] During a dose dispensing operation, the dose setting member is rotationally decoupled from the actuator such that the dose setting member rotates relative to the actuator.

[0166] 27. The drug delivery device of any one of aspects 12-26, wherein the device body comprises a reservoir comprising a drug.

Claims

1. A drug delivery device comprising: a device body having a longitudinal axis; a dose setting member coupled to the device body and rotatable relative to the device body during a dose dispensing operation; an actuator coupled to the device body and movable relative to the device body during a dose dispensing operation; as well as A dose detection system configured to detect a rotation of the dose setting member during a dose dispensing operation, the dose detection system comprising: at least one deformable member; at least one piezoelectric sensor coupled to the at least one deformable member; and A plurality of force applicators are arranged in a spiral pattern on an outer surface of the dose setting member, wherein each force applicator is configured to apply a mechanical force to at least one deformable member and deform the piezoelectric sensor during a dose dispensing operation.

2. The drug delivery device according to claim 1, wherein: The at least one piezoelectric sensor includes a piezoelectric sensor disposed on each of the at least one deformable member.

3. The drug delivery device according to claim 1, wherein: The at least one piezoelectric sensor comprises a piezoelectric sensor coupled to the at least one deformable member via the device body, and wherein the piezoelectric sensor is configured to measure strain on the device body due to deformation of the at least one deformable member.

4. The drug delivery device according to any one of claims 1 to 3, wherein: The at least one deformable member includes a spherical spring arm.

5. The drug delivery device according to any one of claims 1 to 4, wherein: The at least one deformable member extends radially inwardly from an inner surface of the device body.

6. The drug delivery device according to any one of claims 1 to 5, wherein: During a dose setting operation, the dose setting member is rotationally coupled to the actuator such that the dose setting member and the actuator rotate together relative to the device body; as well as During the dose dispensing operation, the dose setting member is rotationally disengaged from the actuator such that the dose setting member rotates relative to the actuator.

7. The drug delivery device according to any one of claims 1 to 6, wherein: The piezoelectric sensor is configured to detect deformation of at least one deformable member in a radially outward direction substantially perpendicular to the longitudinal axis.

8. The drug delivery device according to any one of claims 1 to 7, wherein: Also included is a control system in communication with the dose detection system, the control system being programmed to determine an amount of drug delivered based on the deformation of the piezoelectric sensor.

9. The drug delivery device according to any one of claims 1 to 8, wherein: The device body includes a reservoir containing a drug.

10. A drug delivery device comprising: a device body having a longitudinal axis; a dose setting member coupled to the device body and rotatable relative to the device body during a dose dispensing operation; an actuator coupled to the device body and movable relative to the device body during a dose dispensing operation; as well as A dose detection system configured to detect a rotation of the dose setting member during a dose dispensing operation, the dose detection system comprising: a plurality of surface projections arranged in a spiral pattern on an outer surface of the dose setting member; and A multi-turn potentiometer having a shaft engaging the plurality of surface projections such that rotation of the dose setting member drives rotation of the shaft.

11. The drug delivery device according to claim 10, wherein: The shaft of the multi-turn potentiometer extends radially inwardly from the device body.

12. The drug delivery device according to any one of claims 10-11, wherein: Also included is a control system in communication with the dose detection system, the control system being programmed to determine the amount of drug delivered based on the rotation of the shaft of the potentiometer.

13. The drug delivery device according to any one of claims 10 to 12, wherein: The device body includes a reservoir containing a drug.

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