ELECTRONIC MODULE FOR MEDICAL DEVICE

Abstract

An electronic module for a medical device such as an inhaler is disclosed, the electronic module comprising a printed circuit board, and a damper configured to dampen energy transfer to and/or from a battery when a battery is connected to the electronic module and the electronic module is exposed to mechanical shock.

Claims

1. An electronic module for inhaler, the electronic module comprising: a printed circuit board, and a damper configured to dampen energy transfer to and from a battery when a battery is connected to the electronic module and the electronic module is exposed to mechanical shock.

2. An electronic module for an inhaler comprising a medicament, and the electronic module comprising: a printed circuit board, and a battery, wherein the electronic module comprises a gasket, membrane or filter configured to prevent communication of the medicament with the printed circuit board and battery.

3. The electronic module according to claim 1, further comprising a battery connected to the printed circuit board.

4. The electronic module according to claim 3, wherein the battery is mechanically and electronically connected to the printed circuit board by one or more connectors.

5. An electronic module for an inhaler, the electronic module comprising: a printed circuit board, and a battery that is mechanically and electronically connected to the electronic module by one or more connectors, the connectors configured to dampen energy transfer to and from the battery when the electronic module is exposed to mechanical shock.

6. The electronic module according to claim, further comprising a damper configured to dampen energy transfer to and/or from the battery to the printed circuit board when the electronic module is exposed to mechanical shock.

7. The electronic module according to claim 1, wherein the damper comprises a substrate material configured to provide at least part of the damping.

8. The electronic module according to claim 7, wherein the substrate material is a foam material.

9. The electronic module according to claim 7, wherein the substrate comprises rubber, polyurethane, silicone, neoprene, polyethylene-vinyl acetate, or polyethylene.

10. The electronic module according to claim 1, wherein the substrate is from 0.1 to 10 mm thick, preferably from 0.1 to 3 or 5 mm thick.

11. The electronic module according to claim 10, wherein the substrate has a 25% compression force deflection of between 0.1 to 200 KPa.

12. The electronic module according to claim 7, wherein the substrate is adhesively applied to a surface of the battery.

13. The electronic module according to claim 5, wherein one part of each connector is attached to the battery and another part of each connector is attached to the printed circuit board, and wherein at least two connectors are attached to the battery on different or opposed sides thereof.

14. (canceled)

15. The electronic module according to claim 5, wherein the one or more connectors are tabs.

16. The electronic module according to claim 1, wherein the damper is attached to the battery.

17. The electronic module according to claim 1, wherein the printed circuit board is attached to a cap configured to be removably attached to a surface of a medical device, wherein the printed circuit board is attached to the cap by one or more heat stakes.

18. (canceled)

19. The electronic module according to claim 7, wherein the substrate does not cover the entire area of the surface of the battery to which it is applied.

20. The electronic module according to claim 19, wherein the printed circuit board is attached to the cap by one or more heat stakes, and wherein the application of the substrate on the surface of the battery is offset in a direction opposite to the one or more heat stakes.

21. The electronic module according to claim 7, wherein the damper is configured to position the substrate at a surface of the inhaler, thereby enabling the substrate to provide compressive damping against the surface of the inhaler.

22. (canceled)

23. The electronic module according to claim 21, wherein a distance between the substrate and the surface is less than 5 mm when the electronic module is attached to the inhaler.

24. (canceled)

25. (canceled)

26. The electronic module according to claim 21, wherein the substrate is configured to apply from 0 to 100 N of force when loaded against the surface when the electronic module is attached to the inhaler.

27. (canceled)

28. (canceled)

29. (canceled)

Description

BRIEF DESCRIPTION OF DRAWINGS

[0049] The above and other aspects of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0050] FIG. 1 shows a partially-exploded view of an example inhaler with an electronics module;

[0051] FIG. 2 shows a partially-exploded view of the example electronics module from a bottom-up perspective of the components;

[0052] FIG. 3 shows a partially-exploded view of the example electronics module from a top-down perspective of the components;

[0053] FIG. 4 shows a cross-section view of the example inhaler with the example electronics module attached; and

[0054] FIG. 5 shows a view of the example electronic module comprising a damper offset from the heat stakes.

DETAILED DESCRIPTION

[0055] A detailed description of an example electronics module for use in a respiratory drug delivery system shall now be given with respect to use in an inhaler device. It should be understood that use of the example electronics module described herein is not limited only to inhalers, and may be used, for example, in any portable medical device (which includes respiratory drug delivery systems) with similar or equal effect. A non-exhaustive list of portable medical devices includes inhalers, blood glucose monitors, blood oxygen monitors, blood pressure monitors, injection pens and the like.

[0056] FIG. 1 shows a partially-exploded view of an inhaler 100. A housing 190 comprises an upper housing 140 which may interface with a lower housing 150. The upper housing 140 and the lower housing 150 may be removably or permanently attached to one another, thereby forming a seal 125. The inhaler 100 may also include an electronics module 105. The electronics module 105 may have a cap 110 (e.g., an electronics module cap) that interfaces with the upper housing 140. The cap 110 and the upper housing 140 may be removably or permanently attached to one another, thereby forming a seal at point 127. When the cap 110 is attached to the upper housing 140 a side wall 221, a top inner surface 220 and the top of upper housing 140 define an air space. This air space may be configured so that any drug/medicament to be delivered comprised within the inhaler 100 cannot enter (i.e. no fluid or solid particulate communication), although this requirement is not essential.

[0057] The cap 110 of the electronics module 105 may house a printed circuit board (PCB) 118, which may have an edge 117 that defines a notch 119. The PCB 118 may be attached to the cap 110 via a plurality of heat stakes 212, 214, as further described herein as shown in FIGS. 2 and 5. The heat stakes 212, 214 may be configured to retain the PCB 118 within the cap 110. A slider 116 is housed substantially in the cap 110 and may be configured to activate the PCB 118 based on operation of a mouthpiece cover 130. For example, the slider 116 may move axially within the cap 110 to activate a switch 222 (shown in FIGS. 2 and 3) on the PCB 118 when the mouthpiece cover 130 is opened to expose the mouthpiece.

[0058] When the slider 116 is slidably mounted within the cap 110, a first (e.g., upper) portion of the slider 116 may protrude through the notch 119. A second (lower) portion of the slider 116 may protrude through one of the orifices 146 and extend into the upper housing 140. More than one orifice 146 may be provided to permit the upper housing 140 and/or the cap 110 to be rotated axially 180 degrees without affecting the manner in which they are attached to one another. As discussed further herein, a slider spring (e.g. the slider spring 260 shown in FIGS. 1, 2, and 3) within the electronics module 105 may bias the slider 116 in a downward direction, i.e., push the slider towards the lower housing 150. As such, the slider spring may cause the end of the slider 116 within the upper housing 140 to maintain contact with, and continually rest against, a top surface of a yoke inside upper housing 140 (not shown in the FIGs). Thus, the slider 116 may move axially with the yoke along the same axis when the mouthpiece cover 130 is moved between the open and closed positions. The slider may transfer movement of an inhaler's yoke to the electronics module's switch 222. The movement of the inhaler's yoke may be associated with typical inhaler operation, for example the yoke may move in connection with the opening and closing of the inhaler's mouthpiece cover 130. As such, the slider spring may cause the end of the slider 116 within the upper housing 140 to maintain contact with, and continually rest against, a top surface of a yoke inside the upper housing 140 when the mouthpiece cover 130 is in the closed position and may cause the slider to decouple from the yoke when the mouthpiece cover 130 is in the open position. Here, the slider may effectively integrate the electronics module into an operation that is familiar to the user, improving the overall electromechanical integration of the inhaler. That is, activation of the electronics module may be transparent to the user as the user operates the inhaler. Cap 110 may comprise a substantially transparent section 111 configured to be positioned in the vicinity of an LED integrated with the electronics module, whereby the LED may be used to indicate inhaler operation to the user, e.g. the LED may be used to indicate activation of the electronics module due to the cover 130 being in an open position or when one or more doses of medicament have been administered from the inhaler.

[0059] The heat stakes 212 and 214 which fasten the PCB 118 to the cap 110 may be integrally formed with cap 110. FIG. 2 shows two integrally formed heat stakes 212 and 214, however, cap 110 is not limited to only comprising two heat stakes and may comprise more, e.g., 3, 4, 5, 6, 7, 8, 9, 10 etc. heat stakes. The heat stakes 212, 214 may protrude or extend from the top inner surface 220 of the cap 110. Cap 110 may comprise two types of heat stake. Heat stake 212 may have a circular cross sectional shape, but is not limited in this way and may have any other cross section, e.g., square, triangular etc. . . . . Heat stakes 212 may have a diameter that is smaller than a standard heat stake diameter. That is, the diameter of the heat stake 212 may be selected such that the inhaler 100 will successfully pass the drop test without taking up too much space on the PCB 118. Preferably, the heat stake 212 may have a diameter less than 1.4 mm. The PCB 118 may have a plurality of openings 224 and 226, as shown in FIGS. 2 and 3. One or more of the openings (e.g., the opening 226) may correspond to the heat stake 212 such that the heat stake 212 may be adapted to protrude through the PCB 118 via the opening 226 when the PCB 118 is mounted within the cap 110.

[0060] Heat stake 214 may have a non-circular cross-section, for example, such as a rib- shaped cross-section. The notch 224 may correspond to the location of the stake 214, for example. The PCB 118 may define the notch 224 such that the stake 214 may be adapted to protrude through the PCB 118 via the notch 224 when the PCB 118 is mounted within the cap 110. Each of the heat stakes 212 and 214 may define a distal end that is opposite from the top inner surface 220 of the cap 110. The distal end of each of the heat stakes 212 and 214 may be configured to be partially deformed when heated to a predetermined temperature. When partially deformed, the distal end of the heat stakes 212 and 214 may take a substantially dome or semi spherical (e.g. ½ spherical) form. The partially deformed heat stakes 212 and 214 may secure the PCB 118 to the cap 110 and may be loaded in tension when doing so. An additional heat stake 216 (as shown in FIG. 5) may be provided. Heat stake 216 may be integrated with cap 110, protrude through the PCB 118 via an opening on the PCB when the PCB 118 is mounted within the cap 110, but may not be deformed as described above in connection with heat stakes 212 and 214.

[0061] The PCB 118 may further include a processor and a transmitter (not shown in the FIGs). The electronics module 105 may be installed on the upper housing 140 of the inhaler 100 towards the end of manufacture of the inhaler (e.g., following equilibration of the inhaler). Installing the electronics module 105 on the upper housing 140 towards the end of the manufacture of the inhaler 100 may be advantageous since equilibration of the inhaler 100 may damage the sensitive electronics on the PCB 118. Equilibration may involve filing the inhaler 100 with a medicament and storing the inhaler 100 at a predefined temperature and humidity for duration of time (e.g., four weeks) before final packing of the inhaler 100. Installing the electronics module 105 on the upper housing 140 of inhaler 100 avoids assembling electronic components in sterilised clean filling areas of the manufacturing facility.

[0062] A battery 230 (e.g., such as a coin cell) may be attached to the PCB 118 by way of tabs 240, 242 such that the battery 230 maintains contact with the PCB 118. Each of the tabs 240, 242 may comprise a first portion 240a, 242a configured to be attachable to the battery 230 and a second portion 240b, 242b configured to be attachable to the PCB 118, thereby attaching the PCB 118 to the battery 230. The first portion 240a comprises a substantially planar rectangular surface (tabs/strip portion) contiguous with one side 230a of the battery 230, and the first portion 242a comprises a substantially planar rectangular surface contiguous with another side 230b of the battery 230. Tab 240 may be attached to side 230a of battery 230 which is the opposite to side 230b of battery 230 to which tab 242 is attached. The second portion 240b, 242b is substantially perpendicular to the first portion 240a, 240b and comprises a planar rectangular surface (tabs/strip portion) which may be of reduced dimensions—preferably reduced width as shown in FIGS. 2 and 3—with respect to the first portion, but this is not essential. The PCB 118 may have a plurality of openings 229 as shown in FIGS. 2 and 3. The plurality of openings 229 may correspond to the second portion 240b, 242b such that the second portion 240b, 242b may be adapted to protrude through the PCB 118 via the openings 229 when the battery 230 is brought next to the PCB 118. For example, the tabs 240b, 242b may extend through openings 229 defined by the PCB 118 when the battery 230 is brought next to the PCB 118. The tabs 240b, 242b may be compliant such that the tabs deflect and engage the openings 229 such that the battery 230 is removably attached to the PCB 118. The tabs 240 and 242 may be configured such that an electrical connection may be formed between the PCB 118 and the battery 230 in addition to a mechanical connection, wherein the tabs provide an electrical connection between terminals on the battery 230 and electrical contacts on the PCT 118.

[0063] The first portion 240a, 242a and second portion 240b, 242b may be attached to the surface of the battery 230 by any suitable means, e.g., spot welding or adhesive. Once the second portion 240b, 242b has protruded through the openings 229 then the protruded portion may be bent, welded or soldered in place so as to fix the tabs 240, 242 (and therefore the battery 230) to the PCB 118. The battery 230 may alternatively be attached by one tab or more than two tabs in a similar way as shown for tabs 240, 242 in FIGS. 2 and 3, for example there may be two, three, four, five etc. tabs 240, 242 attached to either side 230a, 230b of the battery with a corresponding number of openings 229 to receive them on the PCB 118.

[0064] One or more components of the PCB 118 may be selectively activated based on a position of the mouthpiece cover 130. For example, activation of the switch 222 (e.g., or activation of some other switching means, such as an optical sensor, an accelerometer, or a Hall effect sensor) may wake a processor and/or transmitter from an off state (or a power-conserving sleep mode) to an on state (or an active mode). Conversely, deactivation of the switch 222 may transition the processor and/or transmitter from the on state (or active mode) to an off state or a lower power mode.

[0065] A damper 101 may be attached to the battery 230 (shown in FIGS. 1 to 5) for dampening energy transfer to and/or from the battery 230 when attached to the PCB 118 and when the electronic module is exposed to external mechanical shock. The damper 101 may be a foam substrate layer attached to the battery 230 by adhesive. A similar damper may alternatively (or in addition) be attached to any other components of the electronic module. A suitable adhesive for use in a medical device such as an inhaler to secure the foam substrate layer to the battery holder may be an acrylic adhesive, but any other suitable adhesive safe from a toxicology point of view may be used. The cap 110, battery 230, PCB 118, and/or heat stakes 212, 214 may be configured (shaped and/or positioned) within the electronic module 105 to position the foam substrate layer of damper 101 such that when the cap 110 of electronic module 105 is attached to the upper housing 140 of the inhaler, the foam substrate layer is loaded against a surface of the upper housing 140 i.e. the foam substrate layer is pushed against a surface of the upper housing 140 so as to compress the foam substrate. Although preferred, it is not essential for the foam substrate to be loaded against a surface of the upper housing 140 for the damper to be effective, i.e. there may be a gap between the foam substrate layer and a surface of the upper housing 140 and the gap may be less than 3 mm. A gap between the foam substrate and surface of the upper housing 140 may occur due to manufacturing tolerances.

[0066] When the inhaler 100 is dropped and the components of the electronic module 105 are exposed to a mechanical shock, the heat stakes 212, 214 attaching the PCB 118 to the cap 110 allow a degree of movement of the PCB 118 and the components attached thereto to mitigate against failure or any adverse effects that may occur from an impact. The movement of the PCB 118 occurs from elastic deformation of the heat stakes 212, 214 and/or from movement of the PCB 118 with respect to the heat stakes 212, 214.

[0067] The foam substrate layer of the damper 101 dampens energy transfer to and from the battery 230 by way of compressive damping (i.e. compression of the foam substrate layer against a surface of the upper housing 140) and prevents the battery 230 from vibrating excessively when the electronic module 105 is exposed to mechanical shock. The damper 101 reduces energy transferred to and/or from the battery 230, and accordingly reduces energy transfer to the heat stakes 212, 214,and the PCB 118, and thereby reduces the risk of the heat stakes 212, 214 failing or becoming damaged, the PCB 118 from entering into an erroneous state and draining the battery 230, and/or the tabs holding the PCB 118 or other parts of the device from peeling away from the battery 230.

[0068] The foam substrate layer of the damper 101 is disc shaped and smaller in size than the surface of the battery 230 it is attached to, the battery 230 being a coin cell battery with a diameter of 20 mm and the foam substrate layer having a diameter of 16 mm (i.e. 20% smaller in diameter). The foam substrate layer and may be positioned on the surface of the battery 230 so as to be offset from a central position thereof, as shown in FIG. 5. The foam substrate layer is offset on the surface of the battery 230 away from the heat stakes 212, 214 so that in the final stages of the manufacturing process of the electronics module 105, when the heat stakes 212, 214 are deformed/melted to fix the PCB 118 to the cap 110 the foam substrate layer does not thermally decompose.

[0069] The foam substrate layer of the damper 101 shown in FIGS. 1 to 5 is 3.2 mm thick and is made from ethylene-vinyl acetate (EVA) closed cell foam with a 25% compression deflection of around 10 KPa. The foam substrate layer 101 is approximately 0.2 g which comprises 1.672 mcg/g acetaldehyde, 5.012 mcg/g methanol, 4.254 mcg/g 1-butanol and 57.882 mcg/g 2-ethylhexanol as volatile extractables.

[0070] Other suitable substrate layer with the desired dampening properties may be used, e.g. foams comprising polyurethane, silicone, neoprene, or polyethylene such as low-density polyethylene, so long as they are safe from a toxicology point of view. The foam substrate layer may be ISO 10993 compliant, for example MED 5634 Single-Coated Foam by Vancive™ Medical Technologies.

[0071] Gaskets, membranes (e.g. rubber membranes), filters and the like (not shown in the FIGs) may optionally be used to cover orifices 146 in order to avoid communication between the housing 190 and the PCB 118 and battery 230 in the electronic module 105, thereby preventing any medicament within housing 190 from communicating/interacting with electronic components of the electronic module 105. The means to prevent communication of the medicament with the electronic components of the module as described above are configured to allow the slider 116 to operate as described herein. Any means to prevent communication of the medicament with the electronic components of the module as described above may be configured so as to not inhibit the functionality of any sensors present in the electronic module 105.

[0072] The PCB 118 may include a sensor (not shown) that may provide information to a processor (not shown) about a patient's inhalation. The sensor may be a pressure sensor, such as a MEMS or NEMS pressure sensor (e.g., a barometric pressure sensor, a differential pressure sensor, etc.). The sensor may provide the information for example, using a pressure change and/or a pressure difference. The sensor may provide an instantaneous pressure reading to the processor and/or aggregated pressure readings over time. The processor may use the information to determine an air flow rate associated with the patient's inhalation through an air flow path in the inhaler. The processor may also use the information to determine the direction of air flow. That is, a negative change in air pressure through an air flow path within the inhaler may indicate that the patient has inhaled from the mouthpiece while a positive change in air pressure through the air flow path may indicate that the patient has exhaled into the mouthpiece.

[0073] The electronics module 105 may further include a wireless communication circuit, such as a Bluetooth chipset (e.g., a Bluetooth Low Energy chipset). As such, the electronics module 105 may provide a pressure measurement to an external device (e.g., a smartphone), which may perform additional calculations on the pressure measurement data, provide feedback to the user, and/or the like. The electronics module 105 may include a control circuit, which for example, may be part of the communication circuit.

[0074] Based on the information or signals received from the switch 222 and/or the sensor, the electronics module 105 may determine whether the mouthpiece cover 130 has been open or closed and whether a received pressure measurement exceeds a threshold or is within a specific pressure range, which may be indicative of whether the medication inhaled by a user has reached a predetermined or prescribed level. The pressure measurement threshold(s) and/or range(s) may be stored in a memory of the electronics module 105. When the predetermined threshold or range is met, the electronics module 105 may determine the state of the inhaler 100 and may generate a signal that indicates the state of the inhaler 100.

[0075] The electronics module 105 may include a memory (not shown) for storing data collected by the sensor (e.g., pressure measurements) and/or data generated by the processor (e.g., air flow rates). The stored data may be accessed by the processor and wirelessly communicated to an external device, such as a smartphone, via the wireless communication circuit. The memory may be non-removable memory and/or removable memory. The nonremovable memory may include random-access memory (RAM), read-only memory (ROM), a hard disk, or any other type of memory storage device. The removable memory may include a subscriber identity module (SIM) card, a memory stick, a secure digital (SD) memory card, and the like. The electronics module 105 may access information from, and store data in, a memory that is not physically located within the inhaler 100, such as on a server or a smartphone.

[0076] The processor of the electronics module 105 may comprise a microcontroller, a programmable logic device (PLD), a microprocessor, an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or any suitable processing device, controller, or control circuit. The processor may comprise an internal memory.

[0077] The processor of the electronics module 105 may receive power from the battery 230, and may be configured to distribute and/or control the power to the other components in the electronics module 105. The battery 230 may be any suitable device for powering the electronics module 105. The battery 230 may be directly connected to one or more of the PCB, the sensor, the memory, and/or the transceiver of the electronics module 105.

[0078] The electronic modules and methods according to the invention are notable departures from the conventional electronic modules for use in medical devices and methods for manufacturing the same. The electronic modules disclosed herein provide improved robustness and resistance against damage or failure when dropped. Those skilled in the art will appreciate that the presently disclosed electronic modules and method teach by way of example and not by limitation. Therefore, the matter contained in the above description or shown in the accompanying drawings should be interpreted as illustrative and not in a limiting sense. The following claims are intended to cover all generic and specific features described herein, as well as all statements of scope of the present electronic devices and method, which, as a matter of language, might be said to fall there between.