DOSE DETECTION SYSTEM MODULE FOR MEDICATION DELIVERY DEVICE
TECHNICAL FIFED

[001] The present disclosure relates to an electronic dose detection system for a medication delivery device, and illustratively to an electronic dose detection module adapted to removably attach to a proximal end portion of a medication delivery device. The dose delivery detection system is operable to detect the amount of a dose of medication delivered by the medication delivery device and/or the type of medication contained in the medication delivery device.

BACKGROUND

[002] Patients suffering from various diseases must frequently inject themselves with medication. To allow a person to conveniently and accurately self-administer medicine, a variety of devices broadly known as pen injectors or injection pens have been developed. Generally, these pens are equipped with a cartridge including a piston and containing a multi-dose quantity of liquid medication. A drive member is movable forward to advance the piston in the cartridge to dispense the contained medication from an outlet at the distal cartridge end, typically through a needle ln disposable or prefilled pens, after a pen has been utilized to exhaust the supply of medication within the cartridge, a user discards the entire pen and begins using a new replacement pen. ln reusable pens, after a pen has been utilized to exhaust the supply of medication within the cartridge, the pen is disassembled to allow replacement of the spent cartridge with a fresh cartridge, and then the pen is reassembled for its subsequent use.

[003] Many pen injectors and other medication delivery devices utilize mechanical systems in which members rotate and/or translate relative to one another in a manner proportional to the dose delivered by operation of the device. Accordingly, the art has endeavored to provide reliable systems that accurately measure the relative movement of members of a medication delivery device in order to assess the dose delivered. Such systems may include a sensor which is secured to a first member of the medication delivery device, and which detects the relative movement of a sensed component secured to a second member of the device.

[004] The administration of a proper amount of medication requires that the dose delivered by the medication delivery device be accurate. Many pen injectors and other medication delivery devices do not include the functionality to automatically detect and record the amount of medication delivered by the device during the injection event ln the absence of an automated system, a patient must manually keep track of the amount and time of each injection. Accordingly, there is a need for a device that is operable to automatically detect the dose delivered by the medication delivery device during an injection event. Further, there is a need for such a dose detection device to be removable and reusable with multiple delivery devices ln other embodiments, there is a need for such a dose detection device to be integral with the delivery device.

[005] lt is also important to deliver the correct medication. A patient may need to select either a different medication, or a different form of a given medication, depending on the circumstances lf a mistake is made as to which medication is in the medication delivery device, then the patient will not be properly dosed, and records of dose administration will be inaccurate. The potential for this happening is substantially diminished if a dose detection device is used which automatically confirms the type of medication contained by the medication delivery device.

SUMMARY

[006] ln one embodiment, a medication delivery device including a rotatable sensed element that may be utilized as part of a dose detection system is disclosed. An annular sensed element, such as a metal ring, a magnetic ring, or others, is positioned on a proximal surface of a dose setting component. The dose setting component is coupled to a device body and rotatable relative thereto in relation to an amount of a set and/or delivered dose. A carrier can axially and rotationally fixed the sensed element to the dose setting component. The carrier includes a proximal overlapping support contactable against the annular sensed element opposite the proximal surface of the dose setting component ln some

embodiments, the carrier may be configured with elements to help in its attachment to the dose setting component ln some embodiments, the sensed element is coupled to the dose setting member without an adhesive.

[007] Another embodiment disclosed is a method of coupling a sensed element to a dose setting component of a medication delivery device. Steps include: providing a carrier and an annular sensed element, the carrier including a tubular body sized to fit within the annular sensed element, a proximal lip extending radially beyond the tubular body, and a plurality of coupling legs extending distally from the tubular body away from the proximal lip; coupling the annular sensed element over the tubular body of the carrier and in contact underneath the proximal lip; and coupling the carrier with the annular sensed element to the dose setting component for sandwiching the annular sensed element between the radial lip and the proximal surface of the dose setting component, where the coupling legs of the carrier is engaged with the dose setting component to rotationally lock the carrier with the annular sensed element to the dose setting component.

BRIEF DESCRIPTION OF THE DRAWINGS

[008] 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 taken in conjunction with the accompanying figures.

[009] FIG. 1 is a perspective view of an exemplary medication delivery device with which the dose detection system of the present disclosure is operable.

[0010] FIG. 2 is a cross-sectional perspective view of the exemplary medication delivery device of F1G. 1.

[0011] FIG. 3 is a perspective view of the proximal portion of the exemplary medication delivery device of F1G. 1.

[0012] FIG. 4 is a partially-exploded, perspective view of the proximal portion of the exemplary medication delivery device of F1G. 1, together with a dose detection system of the present disclosure.

[0013] FIG. 5 is a side, diagrammatic view, partially in cross section, of a dose detection system module according to another exemplary embodiment attached to the proximal portion of a medication delivery device.

[0014] FIG. 6 is a cross-sectional view of a module of a dose detection system according to an exemplary embodiment attached to the proximal portion of a medication delivery device.

[0015] FIG. 7 is a top, diagrammatic view showing rotation sensors positioned to detect magnetic sensed elements attached to a dose setting member in accordance with an exemplary embodiment.

[0016] FIG. 8 is a perspective view of the dose setting member of F1G. 7 including the magnetic sensed elements.

[0017] FIG. 9 is a perspective view of an alternate embodiment of a magnetic dose detection system.

[0018] FIGS. 10A-B and 11A-B show yet other exemplary embodiments of dose detection systems utilizing magnetic sensing.

[0019] FIG. 12 is cross-sectional view of a dose detection system according to another embodiment, in which the sensor and sensed element are integrated into a medication delivery device.

[0020] FIG. 13 is a side, diagrammatic cross-sectional view of a dose detection system module according to another exemplary embodiment attached to the proximal portion of a medication delivery device.

[0021] FIG. 14 is a perspective view of an example of a dose button for a medication delivery device.

[0022] FIG. 15 is a perspective view of a subassembly of a module housing of the dose detection system module in F1G. 13.

[0023] FIG. 16 is a perspective proximal view of a component of the subassembly in F1G. 15.

[0024] FIG. 17 is a distal view of the component in F1G. 15.

[0025] FIG. 18 is a perspective view of another example of a dose button for a medication delivery device.

[0026] FIG. 19 is a perspective view of another example of a dose button for a medication delivery device.

[0027] FIG. 20 is a perspective view of a subassembly of a module housing of another example of a dose detection system module mounted to another example of a dose button for a medication delivery device.

[0028] FIG. 21 is a perspective view of the subassembly of the module housing of the dose detection system module removed from the dose button.

[0029] FIG. 22 is a perspective view of the dose button in F1G. 20.

[0030] FIG. 23 is a cross-sectional view of the subassembly of the module housing in F1G. 20.

[0031] FIG. 24 is a cross-sectional view of the subassembly of the module housing of the dose detection system module mounted to the dose button in F1G. 20.

[0032] FIGS. 25-26 are side, diagrammatic cross-sectional views of a dose detection system module according to another exemplary embodiment attached to the proximal portion of a medication delivery device.

[0033] FIG. 27 is a perspective proximal view of an example of an electronics assembly of a dose detection system module.

[0034] FIG. 28 is a cross-sectional axial view taken along lines 28-28 in F1G. 25.

[0035] FIG. 29 is a perspective distal view of the electronics assembly in F1G. 27.

[0036] FIG. 30 is a perspective piece part exploded view of a subassembly of a proximal portion of a medication delivery device.

[0037] FIG. 31 is a side, diagrammatic view, partially in cross section, of a proximal portion of the subassembly in F1G. 30 assembled.

[0038] FIG. 32 is a perspective proximal view of a flange, a carrier, and a rotation sensor assembled to one another.

[0039] FIG. 33 is a perspective proximal view of the flange, the carrier, the rotation sensor, and a spring assembled.

[0040] FIG. 34 is a proximal view of the flange, the carrier, and the rotation sensor assembled.

[0041] FIG. 35 is a cross-sectional view of another embodiment of a module of a dose delivery detection system attached to the proximal portion of the medication delivery device.

[0042] FIG. 36 is a proximal axial view of the module of FIG. 35, shown with the proximal wall assembly removed.

[0043] FIG. 37 is a perspective proximal view of a unit component of the module of FIG. 35.

[0044] FIG. 38 is a perspective distal partial view of the module in FIG. 35, shown with the delivery device omitted.

[0045] FIG. 39 is a perspective view a light guide member component provided in the module of FIG. 35.

[0046] FIG. 40 is an axial view of yet other exemplary embodiment of the dose delivery detection system utilizing magnetic sensing.

[0047] FIG. 41 is a cross-sectional view of the proximal portion of the medication delivery device and its relative position to the magnetic sensing system.

[0048] FIG. 42 is a graph comparing a measured rotational magnetic flux waveform with a purely sinusoidal model of the magnetic flux waveform during rotational position sensing.

[0049] FIG. 43 is a graph comparing the results of dial/dose errors contributed from magnetic non-uniformity and harmonic distortions from a sample number of N35 grade magnets made from regular production means for 4-, 5- and 6-sensor architectures.

[0050] FIG. 44 is a graph comparing the results of dial/dose errors contributed from magnetic non-uniformity and harmonic distortions from a sample number of N35 high-grade magnets made from customized production for 4-, 5- and 6-sensor architectures.

[0051] FIG. 45 is a graph depicting different orders of percentage of harmonics for lot-to-lot variation of N35 grade magnets made from regular production means.

[0052] FIG. 46 depicts a block diagram of the controller and its components.

[0053] FIG. 47 depicts an exploded view of the module in F1G. 35 with its components axially displaced relative to one another.

DETAILED DESCRIPTION

[0054] 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 lt will nevertheless be understood that no limitation of the scope of the invention is thereby intended.

[0055] The present disclosure relates to sensing systems for medication delivery devices ln one aspect, the sensing system is for determining the amount of a dose delivered by a medication delivery device based on the sensing of relative rotational movement between a dose setting member and an actuator of the medication delivery device. The sensed relative angular positions or movements are correlated to the amount of the dose delivered ln a second aspect, the sensing system is for determining the type of medication contained by the medication delivery device. By way of illustration, the medication delivery device is described in the form of a pen injector. However, the medication delivery device may be any device which is used to set and to deliver a dose of a medication, such as an infusion pump, bolus injector or an auto injector device. The medication may be any of a type that may be delivered by such a medication delivery device.

[0056] Devices described herein, such as a device 10, may further comprise a medication, such as for example, within a reservoir or cartridge 20. ln another embodiment, a system may comprise one or more devices including device 10 and a medication. The term“medication” refers to one or more therapeutic agents including but not limited to insulins, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide , glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), G1P analogs, G1P derivatives, oxyntomodulin analogs,

oxyntomodulin derivatives, therapeutic antibodies and any therapeutic agent that is capable of delivery by the above device. The medication as used in the device may be formulated with one or more excipients. The device is operated in a manner generally as described above by a patient, caregiver or healthcare professional to deliver medication to a person.

[0057] An exemplary medication delivery device 10 is illustrated in FIGS. 1-4 as a pen injector configured to inject a medication into a patient through a needle. Pen injector 10 includes a body 11 comprising an elongated, pen-shaped housing 12 including a distal portion 14 and a proximal portion 16. Distal portion 14 is

received within a pen cap 18. Referring to FIG. 2, distal portion 14 contains the reservoir or cartridge 20 configured to hold the medicinal fluid of medication to be dispensed through its distal outlet end during a dispensing operation. The outlet end of distal portion 14 is equipped with a removable needle assembly 22 including an injection needle 24 enclosed by a removable cover 25. A piston 26 is positioned in reservoir 20. An injecting mechanism positioned in proximal portion 16 is operative to advance piston 26 toward the outlet of reservoir 20 during the dose dispensing operation to force the contained medicine through the needled end. The injecting mechanism includes a drive member 28, illustratively in the form of a screw, axially moveable relative to housing 12 to advance piston 26 through reservoir 20.

[0058] A dose setting member 30 is coupled to housing 12 for setting a dose amount to be dispensed by device 10. ln the illustrated embodiment, dose setting member 30 is in the form of a screw element operative to spiral (i.e., simultaneously move axially and rotationally) relative to housing 12 during dose setting and dose dispensing. FIGS. 1 and 2 illustrate the dose setting member 30 fully screwed into housing 12 at its home or zero dose position. Dose setting member 30 is operative to screw out in a proximal direction from housing 12 until it reaches a fully extended position corresponding to a maximum dose deliverable by device 10 in a single injection.

[0059] Referring to FIGS. 2-4, dose setting member 30 includes a cylindrical dose dial member 32 having a helically threaded outer surface that engages a corresponding threaded inner surface of housing 12 to allow dose setting member 30 to spiral relative to housing 12. Dose dial member 32 further includes a helically threaded inner surface that engages a threaded outer surface of sleeve 34 (FIG. 2) of device 10. The outer surface of dial member 32 includes dose indicator markings, such as numbers that are visible through a dosage window 36 to indicate to the user the set dose amount. Dose setting member 30 further includes a tubular flange 38 that is coupled in the open proximal end of dial member 32 and is axially and rotationally locked to dial member 32 by detents 40 received within openings 41 in dial member 32. Dose setting member 30 may further include a collar or skirt 42

positioned around the outer periphery of dial member 32 at its proximal end. Skirt 42 is axially and rotationally locked to dial member 32 by tabs 44 received in slots 46. Further embodiments described later shown examples of the device without a skirt.

[0060] Dose setting member 30 therefore may be considered to comprise any or all of dose dial member 32, flange 38, and skirt 42, as they are all rotationally and axially fixed together. Dose dial member 32 is directly involved in setting the dose and driving delivery of the medication. Flange 38 is attached to dose dial member 32 and, as described later, cooperates with a clutch to selectively couple dial member 32 with a dose button 56. Skirt 42 provides a surface external of body 11 to enable a user to rotate the dial member 32 for setting a dose.

[0061] Skirt 42 illustratively includes a plurality of surface features 48 and an annular ridge 49 formed on the outer surface of skirt 42. Surface features 48 are illustratively longitudinally extending ribs and grooves that are circumferentially spaced around the outer surface of skirt 42 and facilitate a user’s grasping and rotating the skirt ln an alternative embodiment, skirt 42 is removed or is integral with dial member 32, and a user may grasp and rotate dose button 56 and/or dose dial member 32 for dose setting ln the embodiment of FIG.4, a user may grasp and rotate the radial exterior surface of one-piece dose button 56, which also includes a plurality of surface features, for dose setting.

[0062] Delivery device 10 includes an actuator 50 having a clutch 52 which is received within dial member 32. Clutch 52 includes an axially extending stem 54 at its proximal end. Actuator 50 further includes dose button 56 positioned proximally of skirt 42 of dose setting member 30. ln an alternative embodiment, dose setting member 30 may include a one-piece dose button without the skirt, such as, for example, shown in FIGS. 14, 18, 19, and 22. Dose button 56 includes a mounting collar 58 (FIG. 2) centrally located on the distal surface of dose button 56. Collar 58 is attached to stem 54 of clutch 52, such as with an interference fit or an ultrasonic weld, so as to axially and rotatably fix together dose button 56 and clutch 52.

[0063] Dose button 56 includes a disk-shaped proximal end surface or face 60 and an annular wall portion 62 extending distally and spaced radially inwardly of the outer peripheral edge of face 60 to form an annular lip 64 there between.

Proximal face 60 of dose button 56 serves as a push surface against which a force can be applied manually, i.e., directly by the user to push actuator 50 in a distal direction. Dose button 56 illustratively includes a recessed portion 66 centrally located on proximal face 60, although proximal face 60 alternatively may be a flat surface. Similarly, the alternative one-piece dose button, such as shown in FIG. 22, may include a recessed portion 66 centrally located on proximal face 60 or alternatively may be a flat surface. A bias member 68, illustratively a spring, is disposed between the distal surface 70 of button 56 and a proximal surface 72 of tubular flange 38 to urge actuator 50 and dose setting member 30 axially away from each other. Dose button 56 is depressible by a user to initiate the dose dispensing operation.

[0064] Delivery device 10 is operable in both a dose setting mode and a dose dispensing mode ln the dose setting mode of operation, dose setting member 30 is dialed (rotated) relative to housing 12 to set a desired dose to be delivered by device 10. Dialing in the proximal direction serves to increase the set dose, and dialing in the distal direction serves to decrease the set dose. Dose setting member 30 is adjustable in rotational increments (e.g., clicks) corresponding to the minimum incremental increase or decrease of the set dose during the dose setting operation. For example, one increment or“click” may equal one-half or one unit of medication. The set dose amount is visible to the user via the dial indicator markings shown through dosage window 36. Actuator 50, including dose button 56 and clutch 52, move axially and rotationally with dose setting member 30 during the dialing in the dose setting mode.

[0065] Dose dial member 32, flange 38 and skirt 42 are all fixed rotationally to one another, and rotate and extend proximally of the medication delivery device 10 during dose setting, due to the threaded connection of dose dial member 32 with housing 12. During this dose setting motion, dose button 56 is rotationally fixed relative to skirt 42 by complementary splines 74 of flange 38 and clutch 52 (FIG. 2), which are urged together by bias member 68. ln the course of dose setting, skirt 42 and dose button 56 move relative to housing 12 in a spiral manner from a“start” position to an“end” position. This rotation relative to the housing is in proportion to the amount of dose set by operation of the medication delivery device 10.

[0066] Once the desired dose is set, device 10 is manipulated so the injection needle 24 properly penetrates, for example, a user's skin. The dose dispensing mode of operation is initiated in response to an axial distal force applied to the proximal face 60 of dose button 56. The axial force is applied by the user directly to dose button 56. This causes axial movement of actuator 50 in the distal direction relative to housing 12.

[0067] The axial shifting motion of actuator 50 compresses biasing member 68 and reduces or closes the gap between dose button 56 and tubular flange 38.

This relative axial movement separates the complementary splines 74 on clutch 52 and flange 38, and thereby disengages actuator 50, e.g., dose button 56, from being rotationally fixed to dose setting member 30. ln particular, dose setting member 30 is rotationally uncoupled from actuator 50 to allow back-driving rotation of dose setting member 30 relative to actuator 50 and housing 12. The dose dispensing mode of operation may also be initiated by activating a separate switch or trigger mechanism.

[0068] As actuator 50 is continued to be axially plunged without rotation relative to housing 12, dial member 32 screws back into housing 12 as it spins relative to dose button 56. The dose markings that indicate the amount still remaining to be injected are visible through window 36. As dose setting member 30 screws down distally, drive member 28 is advanced distally to push piston 26 through reservoir 20 and expel medication through needle 24 (FIG. 2).

[0069] During the dose dispensing operation, the amount of medicine expelled from the medication delivery device is proportional to the amount of rotational movement of the dose setting member 30 relative to actuator 50 as the dial member 32 screws back into housing 12. The injection is completed when the internal threading of dial member 32 has reached the distal end of the

corresponding outer threading of sleeve 34 (FIG. 2). Device 10 is then once again arranged in a ready state or zero dose position as shown in FIGS. 2 and 3.

[0070] The start and end angular positions of dose dial member 32, and therefore of the rotationally fixed flange 38 and skirt 42, relative to dose button 56 provide an“absolute” change in angular positions during dose delivery.

Determining whether the relative rotation was in excess of 360° is determined in a number of ways. By way of example, total rotation may be determined by also taking into account the incremental movements of the dose setting member 30 which may be measured in any number of ways by a sensing system.

[0071] Further details of the design and operation of an exemplary delivery device 10 may be found in U.S. Patent No. 7,291,132, entitled Medication Dispensing Apparatus with Triple Screw Threads for Mechanical Advantage, the entire disclosure of which is hereby incorporated by reference herein. Another example of the delivery device is an auto-injector device that may be found in U.S. Patent No. 8,734,394, entitled“Automatic lnjection Device With Delay Mechanism lncluding Dual Functioning Biasing Member,” which is hereby incorporated by reference in its entirety, where such device being modified with one or more various sensor systems described herein to determine an amount of medication delivered from the medication delivery device based on the sensing of relative rotation within the medication delivery device.

[0072] The dose detection systems described herein use a sensing

component and a sensed component attached to members of the medication delivery device. The term“attached” encompasses any manner of securing the position of a component to another component or to a member of the medication delivery device such that they are operable as described herein. For example, a sensing component may be attached to a member of the medication delivery device by being directly positioned on, received within, integral with, or otherwise connected to, the member. Connections may include, for example, connections formed by frictional engagement, splines, a snap or press fit, sonic welding or adhesive.

[0073] The term“directly attached” is used to describe an attachment in which two components, or a component and a member, are physically secured together with no intermediate member, other than attachment components. An

attachment component may comprise a fastener, adapter or other part of a fastening system, such as a compressible membrane interposed between the two components to facilitate the attachment. A“direct attachment” is distinguished from a

connection where the components/members are coupled by one or more

intermediate functional members, such as the way dial member 32 is coupled in FIG. 2 to the dose button 56 by a clutch 52.

[0074] The term“fixed” is used to denote that an indicated movement either can or cannot occur. For example, a first member is“fixed rotationally” with a second member if the two members are required to move together in rotation ln one aspect, a member may be“fixed” relative to another member functionally, rather than structurally. For example, a member may be pressed against another member such that the frictional engagement between the two members fixes them together rotationally, while the two members may not be fixed together absent the pressing of the first member.

[0075] Various sensor systems are contemplated herein ln general, the sensor systems comprise a sensing component and a sensed component. The term “sensing component” refers to any component which is able to detect the relative position of the sensed component. The sensing component includes a sensing element, or“sensor”, along with associated electrical components to operate the sensing element. The“sensed component” is any component for which the sensing component is able to detect the position and/or movement of the sensed component relative to the sensing component. For the dose delivery detection system, the sensed component rotates relative to the sensing component, which is able to detect the angular position and/or the rotational movement of the sensed component. For the dose type detection system, the sensing component detects the relative angular position of the sensed component. The sensing component may comprise one or more sensing elements, and the sensed component may comprise one or more sensed elements. The sensor system is able to detect the position or movement of the sensed component(s) and to provide outputs representative of the position(s) or movement(s) of the sensed component(s).

[0076] A sensor system typically detects a characteristic of a sensed parameter which varies in relationship to the position of the one or more sensed elements within a sensed area. The sensed elements extend into or otherwise influence the sensed area in a manner that directly or indirectly affects the characteristic of the sensed parameter. The relative positions of the sensor and the sensed element affect the characteristics of the sensed parameter, allowing a microcontroller unit (MCU) of the sensor system to determine different rotational positions of the sensed element.

[0077] Suitable sensor systems may include the combination of an active component and a passive component. With the sensing component operating as the active component, it is not necessary to have both components connected with other system elements such as a power supply or MCU.

[0078] Any of a variety of sensing technologies may be incorporated by which the relative positions of two members can be detected. Such technologies may include, for example, technologies based on tactile, optical, inductive or electrical measurements. Such technologies may include the measurement of a sensed parameter associated with a field, such as a magnetic field ln one form, a magnetic sensor senses the change in a sensed magnetic field as a magnetic component is moved relative to the sensor ln another embodiment, a sensor system may sense characteristics of and/or changes to a magnetic field as an object is positioned within and/or moved through the magnetic field. The alterations of the field change the characteristic of the sensed parameter in relation to the position of the sensed element in the sensed area ln such embodiments the sensed parameter may be a capacitance, conductance, resistance, impedance, voltage, inductance, etc. For example, a magneto-resistive type sensor detects the distortion of an applied magnetic field which results in a characteristic change in the resistance of an element of the sensor. As another example, Hall effect sensors detect changes in voltage resulting from distortions of an applied magnetic field.

[0079] ln one aspect, the sensor system detects relative positions or movements of the sensed elements, and therefore of the associated members of the medication delivery device. The sensor system produces outputs representative of

the position(s) or the amount of movement of the sensed component. For example, the sensor system may be operable to generate outputs by which the rotation of the dose setting member during dose delivery can be determined. MCU is operably connected to each sensor to receive the outputs ln one aspect, MCU is configured to determine from the outputs the amount of dose delivered by operation of the medication delivery device.

[0080] The dose delivery detection system involves detecting relative rotational movement between two members. With the extent of rotation having a known relationship to the amount of a delivered dose, the sensor system operates to detect the amount of angular movement from the start of a dose injection to the end of the dose injection. For example, a typical relationship for a pen injector is that an angular displacement of a dose setting member of 18° is the equivalent of one unit of dose, although other angular relationships are also suitable. The sensor system is operable to determine the total angular displacement of a dose setting member during dose delivery. Thus, if the angular displacement is 90°, then 5 units of dose have been delivered.

[0081] One approach for detecting the angular displacement is to count increments of dose amounts as the injection proceeds. For example, a sensor system may use a repeating pattern of sensed elements, such that each repetition is an indication of a predetermined degree of angular rotation. Conveniently, the pattern may be established such that each repetition corresponds to the minimum increment of dose that can be set with the medication delivery device.

[0082] An alternative approach is to detect the start and stop positions of the relatively moving member, and to determine the amount of delivered dose as the difference between those positions ln this approach, it may be a part of the determination that the sensor system detects the number of full rotations of the dose setting member. Various methods for this are well within the ordinary skill in the art, and may include“counting” the number of increments to assess the number of full rotations.

[0083] The sensor system components may be permanently or removably attached to the medication delivery device ln an illustrative embodiment, as least some of the dose detection system components are provided in the form of a module that is removably attached to the medication delivery device. This has the advantage of making these sensor components available for use on more than one pen injector.

[0084] ln some embodiments, a sensing component is mounted to the actuator and a sensed component is attached to the dose setting member. The sensed component may also comprise the dose setting member or any portion thereof. The sensor system detects during dose delivery the relative rotation of the sensed component, and therefore of the dose setting member, from which is determined the amount of a dose delivered by the medication delivery device ln an illustrative embodiment, a rotation sensor is attached, and rotationally fixed, to the actuator. The actuator does not rotate relative to the body of the medication delivery device during dose delivery ln this embodiment, a sensed component is attached, and rotationally fixed, to the dose setting member, which rotates relative to the actuator and the device body during dose delivery. The sensed component may also comprise the dose setting member or any portion thereof ln an

illustrative embodiment, the rotation sensor is not attached directly to the relatively rotating dose setting member during dose delivery.

[0085] Referring to FIG. 5, there is shown in diagrammatic form a dose delivery detection system 80 including one example of a module 82 useful in combination with a medication delivery device, such as device 10. Module 82 carries a sensor system, shown generally at 84, including a rotation sensor 86 and other associated components such as a processor, memory, battery, etc. Module 82 is provided as a separate component which may be removably attached to the actuator.

[0086] Dose detection module 82 includes a body 88 attached to dose button 56. Body 88 illustratively includes a cylindrical side wall 90 and a top wall 92, spanning over and sealing side wall 90. By way of example, in FIG. 5 upper side wall 90 is diagrammatically shown having inwardly-extending tabs 94 attaching module 82 to dose button 56. Dose detection module 82 may alternatively be attached to dose button 56 via any suitable fastening means, such as a snap or press fit,

threaded interface, etc., provided that in one aspect module 82 may be removed from a first medication delivery device and thereafter attached to a second medication delivery device. The attachment may be at any location on dose button 56, provided that dose button 56 is able to move any required amount axially relative to dose setting member 30, as discussed herein. Examples of alternative attachment elements for module 82 are shown in FIGS. 15, 23 and 37 described later.

[0087] During dose delivery, dose setting member 30 is free to rotate relative to dose button 56 and module 82. ln the illustrative embodiment, module 82 is rotationally fixed with dose button 56 and does not rotate during dose delivery.

This may be provided structurally, such as with tabs 94 of FIG. 5, or by having mutually-facing splines or other surface features on the module body 88 and dose button 56 engage upon axial movement of module 82 relative to dose button 56. ln another embodiment, the distal pressing of the module provides a sufficient frictional engagement between module 82 and dose button 56 as to functionally cause the module 82 and dose button 56 to remain rotationally fixed together during dose delivery.

[0088] Top wall 92 is spaced apart from face 60 of dose button 56 and thereby provides a cavity 96 in which some or all of the rotation sensor and other components may be contained. Cavity 96 may be open at the bottom, or may be enclosed, such as by a bottom wall 98. Bottom wall 98 may be positioned in order to bear directly against face 60 of dose button 56. Alternatively, bottom wall 98 if present may be spaced apart from dose button 56 and other contacts between module 82 and dose button 56 may be used such that an axial force applied to module 82 is transferred to dose button 56. ln another embodiment, module 82 may be rotationally fixed to the one-piece dose button configuration, such as shown in FIG. 22.

[0089] ln an alternate embodiment, module 82 during dose setting is instead attached to dose setting member 30. For example, side wall 90 may include a lower wall portion 100 having inward projections 102 that engage with skirt 42 in a position underneath ridge 49. ln this approach, tabs 94 may be eliminated and module 82 effectively engages the proximal face 60 of dose button 56 and the distal side of annular ridge 49. ln this configuration, lower wall portion 100 may be provided with surface features which engage with the surface features of skirt 42 to rotationally fix module 82 with skirt 42. Rotational forces applied to housing 82 during dose setting are thereby transferred to skirt 42 by virtue of the coupling of lower wall portion 100 with skirt 42.

[0090] Module 82 is disengaged rotationally from skirt 42 in order to proceed with dose delivery. The coupling of lower wall portion 100 with skirt 42 is configured to disconnect upon distal axial movement of module 82 relative to skirt 42, thereby allowing skirt 42 to rotate relative to module 82 during dose delivery.

[0091] ln a similar fashion, module 82 may be coupled with both dose button 56 and skirt 42 during dose setting. This has the advantage of providing additional coupling surfaces during rotation of the module in dose setting. The coupling of the module 82 to the skirt 42 is then released prior to dose injection, such as by the axial movement of module 82 relative to skirt 42 as dose delivery is being initiated, thereby allowing dose setting member 30 to rotate relative to module 82 during dose delivery.

[0092] ln certain embodiments, rotation sensor 86 is coupled to side wall 90 for detecting a sensed component. Lower wall portion 100 also serves to reduce the likelihood that a user’s hand inadvertently applies drag to dose setting member 30 as it rotates relative to module 82 and housing 12 during dose delivery. Further, since dose button 56 is rotationally fixed to dose setting member 30 during dose setting, the side wall 90, including lower wall portion 100, provide a single, continuous surface which may be readily grasped and manipulated by the user during dose setting.

[0093] When the injection process is initiated by pressing down on the dose detection module 82, dose button 56 and dose setting member 30 are rotationally fixed together. Movement of module 82, and therefore dose button 56, a short distance, for example less than 2 mm, releases the rotational engagement and the dose setting member 30 rotates relative to module 82 as the dose is delivered. Whether by use of a finger pad or other triggering mechanism, the dose detection system is activated before the dose button 56 has moved a sufficient distance to disengage the rotational locking of the dose button 56 and the dose setting member 30.

[0094] lllustratively, the dose delivery detection system includes an electronics assembly suitable for operation of the sensor system as described herein. Electronics assembly is operably connected to the sensor system to receive outputs from one or more rotational sensors. Electronics assembly may include conventional components such as a processor, power supply, memory,

microcontrollers, etc. contained for example in cavity 96 defined by module body 88. Alternatively, at least some components may be provided separately, such as by means of an external device such as a computer, smart phone or other device.

Means are then provided to operably connect the external controller components with the sensor system at appropriate times, such as by a wired or wireless connection.

[0095] An exemplary electronics assembly 120 comprises a flexible printed circuit board (FPCB) having a plurality of electronic components. The electronics assembly comprises a sensor system including one or more rotation sensors 86 operatively communicating with a processor for receiving signals from the sensor representative of the sensed relative rotation. The electronics assembly further includes the MCU comprising at least one processing core and internal memory.

One example of an electronics assembly schematic is shown in FIG. 46. The system includes a battery, illustratively a coin cell battery, for powering the components. The MCU includes control logic operative to perform the operations described herein, including detecting a dose delivered by medication delivery device 10 based on a detected rotation of the dose setting member relative to the actuator ln one embodiment, the detected rotation is between the skirt 42 and the dose button 56 of a pen injector.

[0096] The MCU is operative to store the detected dose in local memory (e.g., internal flash memory or on-board EEPROM). The MCU is further operative to wirelessly transmit and/or receive a signal representative of the detected dose to a paired remote electronic device, such as a user’s smartphone, over a Bluetooth low energy (BLE) or other suitable short or long range wireless communication protocol lllustratively, the BLE control logic and MCU are integrated on a same circuit. Further description of the electronics arrangement is described further below.

[0097] Much of the sensing electronics is contained in the cavity 96.

However, the rotation sensor may be positioned in a variety of locations in order to sense the relative movement of the sensed component. For example, the rotation sensor may be located within cavity 96, within body 88 but outside of the cavity 96, or in other locations of the body, such as on lower wall portion 100. The only requirement is that the rotation sensor be positioned to effectively detect the rotational movement of the sensed component during dose delivery ln some embodiments, the rotation sensor is integral to the device 10.

[0098] One or more sensed elements are attached to the dose setting member 30. ln one aspect, the sensed elements are directly attached to skirt 42 of the dose setting member. Alternatively, sensed elements may be attached to any one or more of the dose setting components, including the dial member, flange and/or skirt. The only requirement is that the sensed element(s) be positioned to be sensed by the rotation sensor during relative rotational movement during dose delivery ln other embodiments, the sensed component comprises the dose setting member 30 or any portion thereof.

[0099] Further illustrative embodiments of a dose delivery detection system

80 are provided in FIGS. 6-13. The embodiments are shown in somewhat diagrammatic fashion, as common details have already been provided with respect to FIGS. 1-5. ln general, each embodiment includes similar components of the dose detection module 82, including a body 88 having a cylindrical upper wall 90 and a top wall 92. Each embodiment also includes a lower wall 100, although it will be appreciated that variations on these components, including the absence of lower wall 100, are within the scope of the disclosure. Other parts common to the earlier descriptions herein include an electronics assembly 120 contained within cavity 96 of module body 88, dose button 56, dose setting member 32 and device housing 12. Further, in each embodiment the dose detection module 82 is diagrammatically

shown as being attached to the annular side wall 62 of dose button 56, although alternative forms and locations of attachment may be used. For example, dose detection module 82 may be attached to dose button 56 and releasably attached to skirt 42 in some embodiments. Also, dose detection module 82 may be attached to one-piece dose button, such as shown in FIGS. 22 and 35.

[00100] Each example also demonstrates the use of a particular type of sensor system. However, in some embodiments the dose detection system includes multiple sensing systems using the same or different sensing technologies. This provides redundancy in the event of failure of one of the sensing systems lt also provides the ability to use a second sensing system to periodically verify that the first sensing system is performing appropriately.

CLAIMS

We claim:

1 . A dose detection module for removable attachment to a dose button of a medication delivery device, the dose button having a cylindrical button sidewall, the device comprising a sensed component ring rotatable during dose

dispensing, said module comprising:

a housing including a proximal wall assembly, a distal wall, and a module sidewall extending therebetween about a module longitudinal axis to define an interior compartment, the module sidewall extending distally beyond the distal wall, the distal wall defining a plurality of recesses disposed equi-angularly relative to one another, the housing configured to couple around said button sidewall; and

an electronics assembly comprising a processor and a plurality of sensors operably coupled to the processor, wherein each of the sensors are disposed securely within corresponding recesses, wherein the sensors are configured to detect rotational movement of the sensed component ring to generate position signals, the processor configured to receive the position signals in order to determine data indicative of an amount of dose dispensed based on the position signal.

2. The module of claim 1 , wherein the sensed component ring comprises a bipolar magnetic ring, and the sensors comprises magnetic sensors disposed at an arrangement to overlap an outer circumference of said bipolar magnetic ring.

3. The module of claim 2, wherein said magnetic sensors comprise five or six magnetic sensors.

4. The module of claim 1 , wherein the housing includes a light guide member, and the distal wall defining a post opening, the light guide member including a light guide post proximally extending through said post opening beyond the magnetic sensors, wherein the electronics assembly comprises a color sensor disposed over the light guide post and axially spaced therefrom, said color sensor operably coupled to the processor and configured to emit and/or detect color of said dose button.

5. The module of claim 4, wherein the light guide member is fixedly secured to the distal wall.

6. The module of claim 5, wherein the light guide member includes one or more attachment posts radially spaced from the light guide post, the distal wall including an light guide aperture receiving the light guide post, and one or more attachment apertures receiving the corresponding number of attachment post.

7. The module of claim 1 , the electronics assembly further comprises a battery operably coupled to the processor, and an axially compressible battery support element in frictional contact with the proximal side of the battery.

8. The module of claim 7, wherein said battery has a cross-sectional area relative to a radial placement of said sensors and being axially spaced from said sensors to provide shielding to the sensors.

9. The module of claim 1 , further comprising a switch system configured to increase power to the electronics assembly, wherein the proximal wall assembly is axially movable relative to the module sidewall and the distal wall to activate the switch system by a force less than a force required for dose delivery from actuation of the device.

10. The module of claim 9, wherein the switch system comprises at least one set of a biased contacting arm extending between the electronics assembly and the proximal wall assembly, and a corresponding contact pad operably coupled to the processor, wherein the proximal wall assembly is axially movable relative the housing between a first proximal position, wherein the contacting arm and the contact pad are not in contact with one another, and a second distal position, wherein the contacting arm and the contact pad are in a contacting relationship to permit the increase of power to the electronics assembly.

11. The module of claim 10, wherein the switch system comprises a plurality of sets of the contacting arm and the corresponding contact pad, each of the sets circumferentially disposed relative to one another equally apart, wherein one of the sets in the contacting relationship is configured to permit the increase of power to the electronics assembly.

12. The module of claim 9, wherein the housing further comprises an axially compressible member coupled between the proximal wall assembly and a housing portion to bias the proximal wall assembly in a proximal position.

13. The module of claim 1 , wherein the proximal wall assembly includes a light guide ring and a white or reflective surface disposed over an opening defined by the light guide ring, the light guide ring including retention arms coupled to a housing portion of the housing, the electronics assembly including a light indicator element operably coupled to the processor to emit light at the light guide ring.

14. The module of claim 1 , wherein the housing includes a plurality of radially flexible arms extending from the distal wall, angularly spaced from one another, each of the arms having a proximally extending bearing portion.

15. A dose detection system comprising:

a medication delivery device having a magnetic ring fixedly coupled to a dosing member and rotatable during dose setting and dose dispensing; and

an electronics assembly comprising a processor and a plurality of magnetic sensors operably coupled to the processor, the magnetic sensors in an overlapping position relative to an outer circumference of the magnetic ring, wherein the magnetic sensors are securely fixed relative to the processor, the magnetic sensors axially and rotatably locked with the magnetic ring during dose setting, and axially and rotatably free relative to the magnetic ring during dose dispensing, the magnetic sensors being equi-angularly disposed relative to one another to define a ring pattern, wherein in dose dispensing the magnetic sensors are distally moved closer to the magnetic ring and remain stationary relative to the rotating magnetic ring to detect rotational movement of the magnetic ring in order to generate position signals, the processor configured to receive the position signals in order to determine data indicative of an amount of dose dispensed based on the position signal.

16. The system of claim 15, wherein the plurality of magnetic sensors comprises five or six magnetic sensors, and said magnetic ring comprises a bipolar magnetic ring.

17. The system of any one of claims 15-16, wherein each of the magnetic sensors is spaced equi-radially at a radial distance defined from a center of the magnetic sensor to the module axis, the radial distance sized to be equal to a distance of an outer radius of the magnetic ring.

18. The system of claim 15 further comprising a module housing including a proximal wall assembly, a distal wall, and a sidewall coupled therebetween to define an interior compartment in which the electronics assembly is disposed, the distal wall defining a plurality of recesses in which magnetic sensors are disposed.

19. The system of claim 18, wherein the module housing includes a light guide member, and the distal wall defining a post opening, the light guide member including a light guide post proximally extending through said post opening beyond the magnetic sensors, wherein the light guide member is fixedly secured to the distal wall.

20. The system of claim 15, wherein the electronics assembly further comprises a battery disposed proximal to the magnetic sensors and operably coupled to the processor.

21. The system of claim 20 further comprising an axially compressible battery support element in frictional contact with a proximal side of the battery.

22. The system of claim 18, further comprising a switch system configured to increase power to the electronics assembly, wherein the proximal wall assembly is axially movable relative to the sidewall and the distal wall to activate the switch system.

23. The system of claim 22, wherein the switch system comprises at least one set of a biased contacting arm and a corresponding contact pad, the biased contacting arm extends between the electronics assembly and the proximal wall assembly to bias the proximal wall assembly in a proximal position, the contacting arm including an angled joint engaging the proximal wall assembly and a distally extending tip, the contact pad coupled to the electronics assembly and operably coupled to the processor, wherein the proximal wall is axially movable relative the module housing to a distal position so that said tip and the contact pad are in a contacting relationship to permit the increase of power to the electronics assembly.

24. The system of claim 18, wherein the proximal wall assembly includes a light guide ring, and the electronics assembly includes a light indicator element operably coupled to the processor to emit light at the light guide ring.

25. The system of claim 24, wherein the light guide ring includes retention snap arms coupled to a housing portion, wherein the module housing further comprises a compressible gasket coupled between the light guide ring and a first spacer element to bias the proximal wall assembly in a proximal position.

26. The system of claim 24, wherein the proximal wall assembly includes an element having a white or reflective surface disposed over an opening defined by the light guide ring.

27. The system of claim 18, wherein the module housing includes a plurality of radially flexible arms extending from the distal wall, said arms having a proximally extended portion configured to allow for attachment and detachment of the module housing from the device.

28. The system of claim 15, wherein said magnetic ring comprises a bipolar magnetic ring, wherein a contribution to a dial error from the magnetic sensors and bipolar magnetic ring arrangement is two degrees or less, wherein the dial error is a difference between a dialed positon corresponding to a physical rotational position of the bipolar magnetic ring and a detected positon

corresponding to a sensed rotational position of the bipolar magnetic ring sensed by the magnetic sensors.

29. A module for removable attachment to a dose button of a medication delivery device, the dose button having a cylindrical sidewall and a top wall having an upper surface, the dose button further including a radial lip extending outward at the top wall beyond the cylindrical sidewall, said module comprising: a housing including a proximal wall, a distal wall, and a perimetric sidewall extending between and forming a compartment with the proximal and distal walls;

an electronics assembly received within the housing compartment, said electronics assembly including a processor and a measurement sensor operably coupled to the processor; and

a plurality of arms coupled to and extending distally from said housing, each of the arms comprising a bearing portion extending radially-inward of the arm, each of the arms sized to extend distally beyond the radial lip of a dose button to position said bearing portion in engagement with a cylindrical sidewall of said dose button at an engagement location that is distal to the radial lip of said dose button when said module is attached thereto, wherein each of the arms is configured to flex radially outward to clear the radial lip when said module is attached to or detached from said device, wherein each of the arms is configured to apply a radially inward force at said engagement location against the cylindrical sidewall when said module is attached thereto.

30. The module of claim 29 in which the distal wall has a distal surface configured to be received against said upper surface of said dose button when said module is attached thereto.

31. The module of claim 29 in which said arms are equi-radially spaced from one another.

32. The module of claim 31 in which said arms are attached to a wall of said housing.

33. The module of claim 32 in which said arms are formed having a J-shape.

34. The module of claim 31 in which the bearing portions of said arms include a surface configured to be received against or in close proximity to an underside of the radial lip of said dose button when said module is attached thereto.

35. The module of claim 31 in which said arms are integrally formed with said distal wall.

36. The module of claim 29 in which said arms are configured such that a detachment force to remove the module from said dose button is at least twice an attachment force to mount the module to said dose button.

37. The module of claim 29 further comprising a wake-up switch system including a movable segment disposed within and axially movable relative to said proximal wall of said housing, and a wake-up switch operably coupled to the processor.

38. The module of claim 37, wherein said wake-up switch system includes a flexible shroud disposed between the movable segment and the wake-up switch wherein said shroud includes a plurality of radially extending legs.

39. The module of claim 38 wherein said legs include a first set of fixed legs and a second set of free legs.

40. The module of claim 29 further comprising a presence switch system including a presence switch and a biased axial actuator slidably disposed within an opening defined by the distal wall of said housing.

41. The module of claim 40 wherein said axial actuator includes an outer radial rim positioned to trigger a switch arm of said presence switch when the module is detached from said dose button.

42. The module of claim 29 further comprising a medication identification system configured to detect data indicative of a type of medication of said device.

43. The module of claim 42 wherein said medication identification system comprises an RGB sensor operably coupled to the processor, wherein said distal wall of said housing includes an aperture defined therein, said aperture

positioned axially over the RGB sensor to allow color detection of the upper surface of said dial button when the module is attached thereto.

44. The module of claim 29 wherein the electronics assembly includes a first segment, a second segment, and a third segment electrically coupled to one another, wherein the third segment is disposed between the first and second segments.

45. The module of claim 44 wherein the first segment of said electronics assembly includes a wake up switch operably mounted thereon, and said third segment includes a medication identification sensor operably mounted thereon.

46. The module of claim 29 further including sensor recesses defined in the distal wall of said housing, said measurement sensor comprising a plurality of magnet sensors equi-angularly spaced from one another and each magnet sensor disposed within a corresponding sensor recess.

47. A medication delivery system comprising:

a medication delivery device including a device body and a dose button disposed at a proximal portion of said device body, the dose button having a cylindrical sidewall and a top wall having an upper surface, the dose button further including a lip formed by extension of the top wall radially-outward of the cylindrical sidewall, the dose button comprising a rotation sensor and a carrier coupled to the rotation sensor; and

a module mounted to said medication delivery device, said module comprising a housing including a proximal wall, a distal wall, and a perimetric sidewall extending between and forming a compartment with the proximal and distal walls; a sensor assembly received within the housing compartment, the sensor assembly comprising an electronics assembly including a measurement sensor configured to detect movement of the rotation sensor, a battery, a memory, a processor, and a communication assembly; and a plurality of arms coupled to and extending distally from said housing, each of the arms comprising a bearing portion extending radially-inward of the arm,

wherein, when the module is mounted to the dose button, each of the arms extending distally beyond the radial lip of said dose button to position said bearing portion in engagement with the cylindrical sidewall of said dose button at an engagement location that is distal to the radial lip of said dose button, and each of the arms is configured to apply a radially inward force at said

engagement location against the cylindrical sidewall,

wherein each of the arms is configured to flex radially outward to clear the radial lip when said module is removed from said device.

48. The system of claim 47 wherein an axial extension of the arms beyond the distal wall to locate the bearing portion along a proximal portion of the sidewall of the dose button.

49. The system of claim 47 wherein an engagement surface of the bearing portion is sized axially larger than an axial thickness of the radial lip.