Electronic Modules for Medical Devices

Abstract

A durable, mechanically shock resistant electronic module for a medical device is provided. [Solution] An electronic module for a medical device such as an inhaler 100 is disclosed, the electronic module comprising a printed circuit board 118, a battery 230 connected to the electronic module, and a damper 101 configured to damp energy transfer to and / or from the battery when the electronic module is subjected to mechanical shock.

Description

[Technical field]

[0001] The present invention relates to an electronic module for use in a medical device such as an inhaler or drug delivery device, a medical device including the electronic module, and a method of manufacturing the electronic module. [Background technology]

[0002] A common problem faced with medication delivery devices, such as respiratory drug delivery devices, is how to monitor patient adherence and compliance, regardless of the device used.

[0003] Adherence deals with the patient following the prescription label, for example, taking the prescribed number of doses per day. If the prescription calls for two doses per day and the patient is taking two doses per day, then there is considered 100% adherence. If the patient is only taking one dose per day, there is only 50% adherence. In the latter case, the patient is not receiving the treatment prescribed by the patient's physician.

[0004] Compliance, on the other hand, is related to how the patient uses the drug delivery device. If it is used in the manner recommended for effective treatment, there is 100% compliance. However, if it is not used properly, there is less than 100% compliance. The use of an inhaler, for example a dry powder inhaler, involves inhalation in a specific manner; for example, the inhalation may need to be long enough and firm enough to draw in the entire dose of the drug. For patients, for example, children and elderly patients, it may be difficult to meet the requirement for full compliance. However, failure to achieve 100% compliance may reduce the effectiveness of the prescribed drug. When a doctor prescribes a drug, the efficacy of the treatment is entirely dependent on the patient using the device properly and the appropriate number of times each day. If the patient cannot do so, they may not experience any improvement in their condition. Without a means of verifying the patient's adherence / compliance, and faced with a patient who does not see any improvement, the doctor may have no choice but to prescribe a stronger dose or a stronger drug. Sometimes this may put the patient at risk. This could be avoided if doctors had some way of verifying that patients were actually getting the medication they were prescribed.

[0005] Inhalers or puffers (manually actuated inhalers) are examples of medicine delivery devices used to deliver medicine into the body via the lungs. They can be used, for example, to treat asthma and chronic obstructive pulmonary disease (COPD). Types of inhalers include metered dose inhalers (MDIs), dry powder inhalers (DPIs), multiple dose powder inhalers (MDPIs), and nebulizers.

[0006] An electronic module comprising electronic components (- printed circuit board (PCB), processor, sensors (e.g., pressure sensors), batteries, transmitters, capacitors, etc. - has been specially developed to be suitable for use with drug delivery devices in terms of complying with regulations for medical devices such as inhalers working with dry powder medications, and has been integrated into the device to develop a method by which patient adherence and compliance can be monitored.

[0007] The introduction of electronics into any drug delivery device may introduce several technical challenges such as durability, electro-mechanical integration, electrostatic effects, extractable volatiles and leachables, and drug delivery performance. One challenge when incorporating electronics into a drug delivery device is to ensure that the device is suitably durable, rugged, and resistant to mechanical shock; it has been found to be important that the electronics incorporated into the drug delivery device are not damaged and / or become intermittently or permanently inoperable as a result of the device being dropped. A particular challenge of introducing electronics into a powder-based drug delivery device is to ensure that the electronics and associated components are compatible with the powder being used, yet still possess the necessary properties to perform their intended function. It is important to ensure that the electronics employed do not adversely interact with the powder in any way that would degrade, alter, or have electrostatic effects on the powder.

[0008] It has been found through drop tests that drug delivery devices such as inhalers that contain electronic components can be damaged, fail, or experience intermittent power issues when dropped and exposed to mechanical shock. Damage to internal components of the drug delivery device is undesirable as the damage can lead not only to eventual failure of the device, but also to the generation of particulate matter before failure occurs. Particulate matter liberated within the drug delivery device can be received (e.g., inhaled or ingested) by the patient as the drug is delivered. Any new materials incorporated into the electronic module must be carefully considered to ensure suitability for the end use and ensure that necessary health and safety requirements are met. For example, they must be safe from a toxicological standpoint.

[0009] The present disclosure aims to alleviate, at least to some extent, one or more of the technical challenges posed by the introduction of electronics into medical devices. Summary of the Invention

[0010] In a first aspect of the invention, there is provided an electronic module for a medical device such as an inhaler, comprising a printed circuit board and a battery connected to the electronic module and a damper configured to damp energy transfer to and / or from the battery when the electronic module is subjected to a mechanical shock.

[0011] The electronic module may be subjected to mechanical shock, for example, when the module (or a medical device comprising the electronic module) is dropped, for example, from a height and strikes / slams into a surface with force. A strike of sufficient force may induce vibrations in the entire electronic module (and the entire medical device including the electronic module), resulting in some deformation at the point of impact. Upon impact, the kinetic energy of the electronic module (and the medical device including the electronic module, if the module is part of a medical device) may be converted into heat and sound energy as a result of some vibration and deformation.

[0012] Damping (i.e., reducing) the energy transfer to and / or from the battery reduces vibrations of the battery that may result from a sudden impact. It has been found that the movement and / or vibration of the battery (often magnified by the flexibility of the battery holder that holds the battery inside the device) can: damage the printed circuit board attached thereto, misaligning the printed circuit board and draining the battery; cause damage and failure of the fasteners or heat stakes that hold the printed circuit board to a part of the device; and cause the battery holder that holds the battery to the printed circuit board or other part of the device to peel off from the printed circuit board. As used herein, "printed circuit board" refers to any form of printed circuit board and encompasses any printed circuit board assembly (PCBA). The electronic module according to the first aspect alleviates the aforementioned problems and is a significant departure from currently known electronic modules for medical devices such as inhalers. At least a portion of the damping may be provided through absorption of kinetic energy from the battery that may result when the electronic module is subjected to mechanical shock, thereby reducing the energy transfer from the battery to the printed circuit board or any other part of the electronic module.

[0013] Preferred and optional features of the first aspect are now described below.

[0014] The electronic module may comprise a battery mounted to the printed circuit board. The battery may be mounted to the printed circuit board by one or more connectors. Preferably, the battery may be mounted to the printed circuit board using two connectors. The one or more connectors may fixedly (non-removably) mount the battery to the printed circuit board. A portion of each connector may be attached to the battery and another portion of each connector may be attached to the printed circuit board. If more than one connector is provided, preferably at least two connectors are attached to the battery on different sides or on both sides of the battery. The one or more connectors may be configured to provide an electronic and / or mechanical connection between the battery and the printed circuit board. The one or more connectors may be tabs or wires, but are preferably tabs.

[0015] It has been found that holding the battery securely to electrical terminals on the printed circuit board using one or more connectors reduces power discontinuities that may occur when the module is subjected to mechanical shock that results in vibrations that temporarily separate the battery from the terminals. Connectors that hold the battery to the printed circuit board would generally be avoided because it is believed that the mass of the battery would cause undesirable stresses on the printed circuit board at the connection points, leading to failure of components on the printed circuit board, such as capacitors. However, it has been found that attaching the battery to the printed circuit board using one or more connectors (e.g., tabs) with dampers as described herein advantageously reduces power discontinuities when the device is subjected to mechanical shock (as opposed to using a conventional battery holder / housing).

[0016] The damper may be attached to the battery and / or to one or more tabs.

[0017] The damper may include a substrate configured to provide at least a portion of the damping. The substrate may be a layer. The substrate may be attached to the surface of the battery connector by an adhesive. Optionally, the adhesive material is acrylic. Any other type of adhesive that is safe from a toxicological point of view may be used.

[0018] Although sticky materials such as adhesives should sometimes be avoided in drug delivery devices, particularly in drug delivery devices for delivering powder-based drugs, due to potential adhesion of stray drugs (e.g., powders) and / or components that may be released during and after curing as extractable volatile components, the use of adhesives as disclosed herein has been found to be a safe and effective method of attaching substrate materials to battery connectors.

[0019] Preferably, the printed circuit board may be attached to a cap or cover configured to be removably attached to a surface of the medical device. The cap may fully or partially cover (or may enclose with the housing of the device) one or more other components of the electronic module when removably attached to the surface. The cap, in combination with the surface, may fully or partially cover the other components of the electronic module when removably attached to the surface, thereby reducing the risk of the other components of the electronic module directly contacting the surface if the medical device is dropped.

[0020] The cap may be configured to allow mechanical and / or electronic connections between the electronic module and electronic components within the medical device, such as pressure sensors, indicators (LEDs, alarms, etc.), temperature sensors, etc.

[0021] The printed circuit board may be attached to the cover or cap by one or more heat stakes, preferably two heat stakes. The one or more heat stakes may penetrate the printed circuit board and enter the cover or cap (or may be integral with the cover or cap) to attach the printed circuit board to the cover or cap. If no cover or cap is present, the one or more heat stakes may be configured to attach the printed circuit board to a surface of the medical device, such as an inner or outer surface of an inhaler, such as an outlet or inlet of the inhaler.

[0022] Fastening the printed circuit board to the cap using fasteners (e.g., screws, rivets, etc.) may result in failure of the drop test because the connection formed is rigid and unacceptable, i.e., if the printed circuit board is attached to the cap using only fasteners, the operation and / or performance of the inhaler may be adversely affected. Using fasteners to fasten the printed circuit board to the cap may also increase manufacturing costs and / or manufacturing time. The heat stakes may be configured to partially deform when fastening the printed circuit board to the cap or surface of the medical device, thereby forming an interference fit to connect the printed circuit board to the cap or surface. The heat stakes are configured to have a degree of flexibility that allows them to attenuate or fully absorb mechanical energy from the PCB and / or cap. Thus, the use of heat stakes improves the durability of the electronic module. Two heat stakes are preferred because providing two provides a strong connection between the printed circuit board and the cap while allowing the heat stakes to flex and absorb mechanical energy from the PCB and / or cap. The use of heat stakes to secure the printed circuit board to the surface of the cap or medical device may reduce manufacturing costs and / or manufacturing time.

[0023] The substrate may be configured such that it does not cover the entire area of ​​the face of the battery to which it is attached, preferably the substrate covers between 95%-40%, more preferably 50%-80%, and most preferably 80% of the face of the battery to which it is attached. The substrate on the face of the battery is preferably offset in a direction opposite the one or more heat stakes. For example, the substrate may be attached to the battery such that it is offset away from the true / complete center on the face of the battery and away from the general direction of the heat stakes.

[0024] In developing the device disclosed herein, the inventors found that due to the compact nature of the device, the process of deforming the heat stakes by heating could degrade or even melt the attached substrate located near the heat stakes if the substrate was sized to be as large as the face of the battery. Substrate degradation or melting could adversely affect the performance, lifespan of the substrate, and could result in unknown or unpredictable safety properties, for example, from a toxicological standpoint (e.g., extractable / leachable properties). Offsetting the substrate and making it smaller, as described herein, was found to circumvent this problem while still effectively acting as a damper.

[0025] The battery connector and / or damper may be configured to position the substrate against a surface such that the substrate can provide compression damping to the surface (e.g., dampening energy transfer to and / or from the battery). The surface may be a surface of a medical device such as an inhaler, or a surface of a cover or cap, if one is present.

[0026] Compressive damping in this case may be when the substrate is pressed against a surface and compressed to absorb mechanical energy transferred to and / or from the battery, thereby preventing the mechanical energy from being transferred to other parts of the electronic module, such as the printed circuit board, the battery connector, and any sensors or indicators that may be provided.

[0027] There may be a gap between the substrate and the surface, which may be less than 5 mm when the electronic module is attached to the medical device, preferably the gap is less than 2 mm. The substrate may alternatively be arranged such that it is loaded against the surface when the electronic module is attached to the medical device, i.e. such that the substrate of the damper contacts (and may optionally press against) the surface when the electronic module is attached to the medical device. Preferably, the substrate may be loaded against the surface in compression.

[0028] Configuring the electronic module such that the substrate is loaded against a surface in this manner applies additional assembly forces to the components of the electronic module. Although increased assembly forces should generally be avoided, especially when attempting to improve the robustness and drop resistance of the electronic module, loading the substrate against a surface in the manner disclosed herein has been found to improve drop resistance without significant adverse effects; when the electronic module is subjected to mechanical shock, the substrate acts against the surface to reduce deflection of the components of the electronic module beyond their neutral point (the position they would be in when unloaded). When one or more heat stakes are present, the substrate loaded against the surface may exert a compressive force on the heat stakes through the printed circuit board, advantageously dampening deflection of the heat stakes beyond their neutral point when subjected to a load (such as when the electronic module is subjected to mechanical shock). Thus, loading the substrate against a surface in the manner described herein has been found to reduce the likelihood of damage and / or failure as a result of the device being dropped.

[0029] The substrate may be loaded against a surface to compress the substrate when the electronic module is attached to the medical device. Preferably, the substrate (when attached to the medical device) is compressed to between 95% and 5%, more preferably less than 50%, more preferably less than 25%, and even more preferably less than 10%, where, for example, 95% compression means that the volume of the substrate under compression is 95% of its volume when uncompressed under atmospheric conditions.

[0030] Once the electronic module is attached to the medical device, the substrate may apply a force (assembly force) of 0N to 100N on the surface, preferably 0N to 20N, more preferably 1N to 15N, and most preferably 2N to 10N.

[0031] It has been found that if the forces between the substrate and the surface are too high, there is a risk of plastically deforming the substrate, which is one reason to avoid excessive assembly forces. The material properties of the substrate (e.g. material strength) should be considered to avoid plastic deformation when the substrate is loaded against the surface. It has been found that plastic deformation of the substrate - especially if the substrate is a foam - has a negative effect on its damping capacity, since the substrate exhibits non-linear damping behavior.

[0032] The substrate may have a 25% compressive force deflection of between 0.1 KPa and 200 KPa, preferably between 1 KPa and 100 KPa, more preferably between 1 KPa and 80 KPa, and even more preferably between 5 KPa and 70 KPa.

[0033] Compression deflection is a measure of the strength of a porous product (e.g., a foam material). 25% compression deflection relates to the force required to compress a material to 25% of its thickness, i.e., the amount of force that the material exerts at 25% compression. The compression deflection of a material may be determined using any suitable method, such as the method described in the ASTM D3574 (test c) or ISO 3386 standards.

[0034] The substrate may have a thickness of 0.1 mm to 10 mm, preferably 0.1 mm to 3 mm or 0.1 mm to 5 mm.

[0035] The material of the substrate may be a foam material. The substrate may comprise rubber, polyurethane, silicone, neoprene, polyethylene-vinyl acetate, or polyethylene, such as low density polyethylene. The substrate may include two or more layers (e.g., 2, 3, 4, 5, 7, 8, 9, 10, etc., multiple layers) formed of any combination of the aforementioned materials.

[0036] The electronic module may be configured to prevent communication of a drug retained within the device with the printed circuit board and the battery (where the medical device includes a drug, e.g., a powder drug). The electronic module may further comprise a gasket, membrane, or filter configured to prevent communication of the drug with the printed circuit board and the battery.

[0037] In a second aspect of the invention, there is provided an electronic module for a medical device such as an inhaler, the electronic module comprising a printed circuit board and a battery mechanically and electronically connected to the printed circuit board by one or more connectors, the connectors being configured to attenuate energy transfer to and / or from the battery when the electronic module is subjected to mechanical shock.

[0038] The advantages of attenuating energy transfer to and / or from the battery and using one or more connectors are discussed above in relation to the first aspect.

[0039] In a third aspect of the invention, there is provided an electronic module for a medical device such as an inhaler, the medical device comprising a medicament, the electronic module comprising a printed circuit board and a battery, the electronic module being configured to prevent communication of the medicament within the medical device with the printed circuit board and the battery.

[0040] Isolating the electronic module from the medication within the medical device advantageously prevents the medication (e.g., powder) from communicating (i.e., physically contacting) and adversely interacting with the printed circuit board and battery.

[0041] The electronic module may further comprise a gasket, membrane, or filter configured to prevent communication of the agent with the printed circuit board and the battery.

[0042] In a fourth aspect of the invention, there is provided a medical device comprising an electronic module as in the first, second or third aspect. The medical device may be a medicine delivery device, a blood glucose monitor, a blood oxygen monitor, a blood pressure monitor and a portable medical device such as an injection pen. Preferably, the medical device is a medicine delivery device such as an inhaler.

[0043] Any of the optional and preferred features described in relation to the first aspect may, to equivalent effect, be regarded as an optional and preferred feature of the second, third and fourth aspects.

[0044] In a fifth aspect of the invention, there is provided a method of manufacturing an electronic module as described herein, the method comprising the steps of providing a printed circuit board and providing a damper configured to damp energy transfer to and / or from the battery when a battery is connected to the electronic module and the electronic module is subjected to a mechanical shock.

[0045] In a sixth aspect of the invention, there is provided a method of manufacturing an electronic module as described herein for a medical device such as an inhaler, the device including a medicament, the method comprising the steps of providing a printed circuit board and a battery, and configuring the electronic module to prevent communication of the medicament with the printed circuit board and the battery.

[0046] In a seventh aspect of the invention, there is provided a method of manufacturing an electronic module as described herein for a medical device such as an inhaler, the method comprising the steps of providing a printed circuit board and a battery mechanically and electronically connected to the electronic module by one or more connectors, the connectors being configured to attenuate energy transfer to and / or from the battery when the electronic module is subjected to mechanical shock.

[0047] Any of the optional and preferred features discussed in relation to the first aspect may, to equivalent effect, be regarded as an optional and preferred feature of the fifth, sixth and seventh aspects. 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: [Brief description of the drawings]

[0048] [Figure 1] FIG. 1 shows a partially exploded view of an exemplary inhaler with an electronic module. [Diagram 2] FIG. 2 shows a partially exploded view of an exemplary electronic module with the components viewed from below. [Diagram 3] FIG. 3 shows a partially exploded view of an exemplary electronic module with the components viewed from above. [Figure 4] FIG. 4 shows a cross-sectional view of an exemplary inhaler with an exemplary electronic module installed. [Diagram 5] FIG. 5 illustrates an example electronic module with a damper offset from the heat stakes. Detailed description of the idea

[0049] A detailed description of an exemplary electronics module for use in a respiratory drug delivery system is provided in relation to its use in an inhalation device. It will be understood that the application of the exemplary electronics module described herein is not limited to inhalers, but may be used, for example, in any portable medical device having similar or equivalent effects, including respiratory drug delivery systems. An exemplary list of portable medical devices includes inhalers, blood glucose monitors, blood oxygen monitors, blood pressure monitors, injection pens, and the like.

[0050] FIG. 1 shows a partial exploded view of the inhaler 100. The housing 190 includes 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 non-removably attached to one another, thereby forming a seal 125. The inhaler 100 may include an electronic module 105. The electronic module 105 may include a cap 110 (e.g., an electronic module cap) that interfaces with the upper housing 140. The cap 110 and the upper housing 140 may be removably or non-removably attached to one another, thereby forming a seal at point 127. When the cap 110 is attached to the upper housing 140, the side wall 221, the top inner surface 220, and the top of the upper housing 140 define an air space. This air space may be configured such that it cannot contain any medicine / drug contained within the inhaler 100 to be delivered (i.e., there is no fluid or solid particulate traffic), although this requirement is not essential.

[0051] The cap 110 of the electronic 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 number of heat stakes 212, 214, as shown in FIGS. 2 and 5 and as further described herein. The heat stakes 212, 214 may be configured to retain the PCB 118 within the cap 110. The slider 116 is substantially housed within the cap 110 and may be configured to activate the PCB 118 based on the movement of the 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.

[0052] 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. Two or more orifices 146 may be provided to allow the upper housing 140 and / or the cap 110 to be rotated 180 degrees about an axis without affecting how they are attached to each other. As described further herein, a slider spring (e.g., slider spring 260 shown in FIGS. 1, 2, and 3) within the electronic module 105 may bias the slider 116 downward, i.e., push the slider toward the lower housing 150. The slider spring may thus cause the end of the slider 116 in the upper housing 140 to maintain contact with and continuously rest against the top surface of the yoke (not shown). The slider 116 may thus 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 transmit the movement of the inhaler yoke to the switch 222 of the electronic module. The movement of the inhaler yoke may be associated with a typical inhaler operation, for example, the yoke may move in association with opening and closing the inhaler mouthpiece cover 130. The slider spring may thus cause the end of the slider 116 in the upper housing 140 to maintain contact with and continuously abut against the top surface of the yoke in the upper housing 140 when the mouthpiece cover 130 is in the closed position, and may cause the slider to disengage from the yoke when the mouthpiece cover 130 is in the open position. Here, the slider may effectively integrate the electronic module into an operation familiar to the user, improving the overall electromechanical integration of the inhaler, i.e. activation of the electronic module may be transparent to the user as they operate the inhaler.The cap 110 may include a substantially transparent portion 111 configured to be positioned near an LED integrated with the electronic module, whereby the LED may be used to indicate operation of the inhaler to a user, for example, the LED may be used to indicate activation of the electronic module due to the cover 130 being in an open position or when one or more doses of medication have been administered from the inhaler.

[0053] The heat stakes 212, 214 that secure the PCB 118 to the cap 110 may be integrally formed with the cap 110. Although FIG. 2 shows two integrally formed heat stakes 212, 214, the cap 110 is not limited to having only two heat stakes, but may have more, e.g., 3, 4, 5, 6, 7, 8, 9, 10, etc. The heat stakes 212, 214 may protrude or extend from a top inner surface 220 of the cap 110. The cap 110 may have two types of heat stakes. The heat stakes 212 may have a circular cross-sectional shape, but are not limited thereto, and may have any other cross-section, e.g., square, triangular, etc. The heat stakes 212 may have a diameter smaller than that of a standard heat stake. That is, the diameter of the heat stakes 212 may be selected so that the inhaler 100 passes a drop test without taking up too much space on the PCB 118. Preferably, the heat stakes 212 may have a diameter of less than 1.4 mm. The PCB 118 may have a number of openings 224, 226, as shown in Figures 2 and 3. One or more openings (e.g., opening 226) may correspond to the heat stakes 212 such that the heat stakes 212 may be adapted to protrude through the PCB 118 via the openings 226 when the PCB 118 is mounted within the cap 110.

[0054] The heat stakes 214 may have a non-circular cross-section, such as, for example, a rib-shaped cross-section. The notches 224 may correspond to the locations of the stakes 214, for example. The PCB 118 may define the notches 224 such that the heat stakes 214 may be adapted to protrude through the PCB 118 via the notches 224 when the PCB 118 is mounted within the cap 110. Each of the heat stakes 212 and 214 may define an end opposite the top inner surface 220 of the cap 110. The end of each of the heat stakes 212 and 214 may be configured to partially deform when heated to a predetermined temperature. When partially deformed, the ends of the heat stakes 212, 214 may assume a substantially dome or hemispherical (e.g., 1 / 2 sphere) shape. The partially deformed heat stakes 212, 214 may secure the PCB 118 to the cap 110 and may be loaded in tension in doing so. Additional heat stakes 216 (as shown in FIG. 5) may be provided. The heat stakes 216 may be integral with the cap 110 and protrude through the PCB 118 through openings in the PCB when the PCB is mounted within the cap 110, but may not be deformed as described above in connection with the heat stakes 212, 214.

[0055] The PCB 118 may further include a processor and a transmitter (not shown). The electronic module 105 may be installed in the upper housing 140 of the inhaler 100 late in the manufacture of the inhaler (e.g., following equilibration of the inhaler). Installing the electronic module 105 in the upper housing 140 late in the manufacture of the inhaler 100 may be advantageous because equilibration of the inhaler 100 may damage sensitive electronics on the PCB 118. Equilibration may include filling the inhaler 100 with medication and storing the inhaler 100 at a predetermined temperature and humidity for a period of time (e.g., four weeks) prior to final packaging of the inhaler 100. Installing the electronic module 105 in the upper housing 140 of the inhaler 100 avoids assembling electronic components in the sterile clean filling area of ​​the manufacturing facility.

[0056] The battery 230 (e.g., a coin cell, etc.) may be attached to the PCB 118 via tabs 240, 242 such that the battery 230 maintains contact with the PCB 118. Each of the tabs 240, 242 may include a first portion 240a, 242a configured for attachment to the battery 230 and a second portion 240b, 242b configured for attachment to the PCB 118, thereby attaching the PCB 118 to the battery 230. The first portion 240a may comprise a substantially flat rectangular surface (tab / strip portion) adjacent one side 230a of the battery 230, and the first portion 242a comprises a substantially flat rectangular surface adjacent the other side 230b of the battery 230. The tab 240 may be attached to the side 230a of the battery 230 opposite the side 230b of the battery 230 to which the tab 242 is attached. The second portion 240b, 242b is substantially perpendicular to the first portion 240a, 240b and has a flat rectangular surface (tab / strip portion) that may have a smaller dimension, preferably a smaller width as shown in Figures 2 and 3, relative to the first portion, but this is not required. The PCB 118 may have a number of openings 229, as shown in Figures 2 and 3. The number 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 the openings 229 defined by the PCB 118 when the battery 230 is brought next to the PCB 118. Tabs 240b, 242b may be flexible such that they may flex to engage openings 229 to removably attach battery 230 to PCB 118. Tabs 240, 242 may be configured such that an electrical connection may be formed between PCB 118 and battery 230 in addition to a mechanical connection, with the tabs providing an electrical connection between terminals on battery 230 and electrical contacts on PCB 118.

[0057] The first portion 240a, 242a and the second portion 240b, 242b may be attached to the face of the battery 230 by any suitable means (e.g., spot welding or adhesive). Once the second portion 240b, 242b protrudes through the opening 229, the protruding portion may be bent, welded, or soldered in place to secure the tabs 240, 242 (and thus the battery 230) to the PCB 118. Alternatively, the battery 230 may be attached by one or more tabs in a manner similar to that shown for the tabs 240, 242 in Figures 2 and 3. For example, there may be multiple tabs 240, 242, such as two, three, four, five, etc., that may be attached to either side 230a, 230b of the battery with a corresponding number of openings 229 to receive them on the PCB 118.

[0058] One or more components of PCB 118 may be selectively activated based on the position of mouthpiece cover 130. For example, activation of switch 222 (e.g., activation of a light sensor, an accelerometer, or some other switching means such as a Hall Effect sensor) may bring the processor and / or transmitter from an OFF state (or power saving sleep mode) to an ON state (or active mode). Conversely, deactivation of switch 222 may transition the processor and / or transmitter from an ON state (or active mode) to an OFF state or low power mode.

[0059] The damper 101 may be attached to the battery 230 (shown in Figs. 1-5) and may dampen energy transfer to and / or from the battery 230 when the battery 230 is attached to the PCB 118 and when the electronic module is exposed to an external mechanical shock. The damper 101 may be a foam substrate layer attached to the battery 230 by adhesive. Alternatively (or additionally), a similar damper may be attached to any other part of the electronic module. An adhesive suitable for use in medical devices such as inhalers, for fixing the foam substrate layer to the battery holder, may be an acrylic adhesive, but may also be any other suitable adhesive that is safe from a toxicological point of view. The cap 110, battery 230, PCB 118, and / or heat stakes 212, 214 may be configured (formed and / or positioned) within the electronic module 105 to position the foam substrate layer of the damper 101 such that when the cap 110 of the electronic module 105 is attached to the upper housing 140 of the inhaler, the foam substrate layer is loaded against the surface of the upper housing 140, i.e., the foam substrate layer is pressed against the surface of the upper housing 140 to compress the foam substrate. It is preferred, but not essential, that the foam substrate be loaded against the 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 the surface of the upper housing 140, which may be less than 3 mm. A gap may occur between the foam substrate and the surface of the upper housing 140 due to manufacturing tolerances.

[0060] If the inhaler 100 is dropped and components of the electronic module 105 are subjected to mechanical shock, the heat stakes 212, 214 attaching the PCB 118 to the cap 110 allow some movement of the PCB 118 and its attached components to mitigate any damage or adverse effects that may result from the shock. Movement of the PCB 118 may result from elastic deformation of the heat stakes 212, 214 and / or movement of the PCB 118 relative to the heat stakes 212, 214.

[0061] The foam substrate layer of the damper 101 dampens the energy transfer to and / or from the battery 230 by compression damping (i.e., compression of the foam substrate layer against the surface of the upper housing 140) to prevent the battery 230 from vibrating excessively when the electronic module 105 is subjected to mechanical shock. The damper 101 reduces the transferred energy to and / or from the battery 230, and thus reduces the energy transfer to the heat stakes 212, 214 and PCB 118, thereby reducing the risk that the heat stakes 212, 214 will fail or be damaged, the PCB 118 will transition to an incorrect state, deplete the battery 230, and / or the tabs holding the PCB 118 or other parts of the device will peel off from the battery 230.

[0062] The foam substrate layer of the damper 101 is disc-shaped and smaller in size than the face of the battery 230 to which it is attached, the battery 230 being a 20 mm diameter coin cell battery and the foam substrate layer having a diameter of 16 mm (i.e., 20% smaller in diameter). The foam substrate layer may be positioned on the face of the battery 230 offset from its center position as shown in FIG. 5. The foam substrate layer is offset on the face of the battery 230 away from the heat stakes 212, 214 to prevent the foam substrate layer from thermally decomposing when the heat stakes 212, 214 are deformed / melted to secure the PCB 118 to the cap 110 during the final stages of the manufacturing process of the electronic module 105.

[0063] The foam substrate layer of the damper 101 shown in Figures 1-5 is made of ethylene-vinyl acetate (EVA) closed cell foam having a thickness of 3.2 mm and a 25% compression deflection of about 10 KPa. The foam substrate layer 101 weighs about 0.2 g and has volatile extractables of 1.672 mcg / g acetaldehyde, 5.012 mcg / g methanol, 4.254 mcg / g 1-butanol, and 57.882 mcg / g 2-ethylhexanol.

[0064] Other suitable substrate layers having the desired damping properties may be used, such as foams with polyurethane, silicone, neoprene, or polyethylene, such as low density polyethylene, as long as they are safe from a toxicological standpoint. The foam substrate layer may be one that complies with ISO 10993, such as MED5634 single coated foam by Vancive™ Medical Technologies.

[0065] A gasket, membrane (e.g., rubber membrane), filter, etc. (not shown) may be optionally used to cover the orifice 146 to prevent communication between the housing 190 and the PCB 118 and battery 230 in the electronic module 105, thereby preventing the agent in the housing 190 from communicating / interacting with the electronic components of the electronic module 105. The means for preventing the agent from communicating with the electronic components of the module as described above is configured to allow the slider 116 to operate as described herein. Any means for preventing the agent from communicating with the electronic components of the module as described above may be configured so as not to interfere with the function of any sensors present in the electronic module 105.

[0066] The PCB 118 may include a sensor (not shown) that may provide information to a processor (not shown) regarding the patient's inhalation. The sensor may be a pressure sensor, such as a MEMS or NEMS pressure sensor (e.g., an air pressure sensor, a differential pressure sensor, etc.). The sensor may provide information, for example, using pressure changes and / or pressure differences. The sensor may provide the processor with instantaneous pressure measurements and / or pressure measurements aggregated over time. The processor may use the information to determine an airflow rate associated with the patient's inhalation through an airflow path in the inhaler. The processor may also use the information to determine the direction of airflow. That is, a negative change in air pressure through an airflow path in the inhaler may indicate that the patient is inhaling through the mouthpiece, and a positive change in air pressure through the airflow path may indicate that the patient is exhaling into the mouthpiece.

[0067] The electronic module 105 may further include wireless communication circuitry, such as a Bluetooth chipset (e.g., a Bluetooth Low Energy chipset). Thus, the electronic module 105 may provide pressure measurements to an external device (e.g., a smartphone), which may perform additional calculations on the pressure measurement data, provide feedback to a user, and / or the like. The electronic module 105 may include control circuitry, which may be, for example, part of the communication circuitry.

[0068] Based on the information or signals received from the switch 222 and / or the sensor, the electronic module 105 may determine whether the mouthpiece cover 130 is open or closed and whether the received pressure measurement exceeds a threshold or is within a particular pressure range, which may indicate whether the medication inhaled by the user has reached a predetermined or prescribed level. The pressure measurement threshold and / or range may be stored in a memory of the electronic module 105. When a predetermined threshold or range is met, the electronic module 105 may determine the status of the inhaler 100 and generate a signal indicative of the status of the inhaler 100.

[0069] The electronic 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., airflow). The stored data may be accessed by the processor and wirelessly communicated to an external device, such as a smartphone, via the wireless communication circuitry. The memory may be non-removable and / or removable. Non-removable memory may include random access memory (RAM), read-only memory (ROM), hard disk, or any other type of memory storage device. Removable memory may include a subscriber identity module (SIM) card, a memory stick, a secure digital (SD) memory card, etc. The electronic module 105 may access information from and store data in memory that is not physically located within the inhaler 100, such as in a server or a smartphone.

[0070] The processor of the electronic 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.

[0071] The processor of the electronic module 105 may receive power from the battery 230 and may be configured to distribute and / or control power to other components within the electronic module 105. The battery 230 may be any suitable device for powering the electronic module 105. The battery 230 may be directly connected to one or more of the PCBs, sensors, memory, and / or transceivers of the electronic module 105.

[0072] The electronic modules and methods of the present invention are a significant departure from conventional electronic modules and methods of manufacture for use in medical devices. The electronic modules disclosed herein provide improved robustness and resistance to damage or failure when dropped. Those skilled in the art will appreciate that the electronic modules and methods disclosed herein are taught by way of example and not by way of limitation. Accordingly, 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 encompass all the general and specific features described herein, as well as all statements of the scope of the present electronic devices and methods that may be said to fall therebetween as a matter of language.

Claims

1. 1. An electronic module for an inhaler, comprising: The electronic module comprises: a cap configured to be attached to an upper housing of the inhaler; a printed circuit board attached to the cap by one or more heat stakes extending from a top inner surface of the cap; a damper arranged to attenuate energy transfer caused by mechanical shock to and / or from the battery when the electronic module is subjected to said mechanical shock and to reduce said energy transfer to the heat stakes and the printed circuit board. Electronic module.

2. further comprising a battery connected to the printed circuit board.

2. The electronic module of claim 1.

3. the battery is mechanically and electronically connected to the printed circuit board by one or more connectors; 3. The electronic module of claim 2.

4. the connectors are arranged to attenuate energy transfer caused by a mechanical shock to and / or from the battery when the electronic module is subjected to the mechanical shock.

4. The electronic module of claim 3.

5. the damper comprises a substrate configured to provide at least a portion of the damping; 2. The electronic module of claim 1.

6. The material of the substrate is a foam material.

6. An electronic module according to claim 5.

7. the substrate comprises rubber, polyurethane, silicone, neoprene, polyethylene-vinyl acetate, or polyethylene; 7. An electronic module according to claim 5 or 6.

8. The substrate has a thickness of 0.1 mm to 10 mm. An electronic module according to any one of claims 5 to 7.

9. The substrate has a 25% compressive force deflection of between 0.1 KPa and 200 KPa. An electronic module according to any one of claims 5 to 8.

10. The substrate is attached to a surface of the battery. An electronic module according to any one of claims 5 to 9.

11. a portion of each connector is attached to the battery and another portion of each connector is attached to the printed circuit board; 5. An electronic module according to claim 3 or 4.

12. At least two connectors are attached to the battery, on different or opposite sides of the battery; 12. The electronic module of claim 11.

13. the one or more connectors are tabs; 13. An electronic module according to claim 3, 4, 11 or 12.

14. The damper is attached to the battery.

2. The electronic module of claim 1.

15. The cap is configured to be removably attached to a surface of the inhaler.

2. The electronic module of claim 1.

16. The printed circuit board is attached to the cap by two heat stakes.

16. The electronic module of claim 15.

17. the substrate does not cover the entire area of ​​the face of the battery to which it is attached; An electronic module according to any one of claims 5 to 10 or any one of claims 11 to 16 dependent on any one of claims 5 to 10.

18. the attachment of the substrate to the face of the battery is offset in a direction opposite the one or more heat stakes; 20. The electronic module of claim 17.

19. the damper comprises a substrate configured to provide at least a portion of the damping, the connector being arranged to position the substrate against a surface of the cap such that the substrate provides compression damping against the surface.

5. An electronic module according to claim 3 or 4.

20. Further comprising a gasket, membrane or filter for preventing contact of a drug with the printed circuit board and the battery.

2. The electronic module of claim 1.

21. An inhaler comprising an electronic module according to any one of the preceding claims.

22. An inhaler with an electronic module according to claim 3 or 4, the damper comprises a substrate configured to provide at least a portion of the damping; the connector is positioned to position the substrate against a surface such that the substrate provides compression damping against the surface; the surface being a surface of the inhaler to which the electronic module is attached; Inhaler.

23. When the electronic module is attached to the inhaler, the distance between the substrate and the surface is less than 5 mm.

23. An inhaler according to claim 22.

24. the substrate is configured to be loaded against the surface when the electronics module is attached to the inhaler.

23. An inhaler according to claim 22.

25. the substrate is configured to be loaded to compress the substrate when the electronic module is attached to the inhaler.

23. An inhaler according to claim 22.

26. the substrate is configured to exert a force of between 0N and 100N when loaded against the surface when the electronic module is attached to the inhaler.

23. An inhaler according to claim 22.

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