Sound propagation in a closure device

Abstract

In general, this disclosure describes techniques for generating sound in a fully sealed medical device. An example technique for generating sound in a medical device includes using a plurality of sound chambers arranged in a stacked configuration that propagate the sound, and one or more diaphragms configured to vibrate in response to the sound propagating through the medical device. In one or more examples, an outer housing including a cover layer may fully enclose the medical device, where the cover layer (e.g., the entire cover layer or a portion of the cover layer) also vibrates to propagate the sound out of the medical device.

Description

Technical Field

[0001] The present disclosure generally relates to systems including medical devices, and more particularly to systems for generating audible alerts using such systems. Background Art

[0002] According to modern medical technology, certain diseases or disorders can be treated by delivering a drug or other substance to a user's body in a continuous manner over a total period of time, at specific times, or at specific time intervals. For example, diabetes is typically treated by delivering a limited amount of insulin to the user at appropriate times. Some modes of providing insulin therapy to a user include delivering insulin via a manually operated syringe and insulin pen. Some other modes employ a programmable fluid infusion device (e.g., an insulin pump) to deliver a controlled amount of insulin to the user.

[0003] Fluid infusion devices include devices designed for use in a generally fixed location (e.g., in a hospital or clinic), and devices configured for mobile or portable use (carried by a user). A fluid flow path from a fluid reservoir of the fluid infusion device to the user can be established via, for example, a kit connector of an infusion kit coupled to the fluid reservoir. Insulin pumps are typically designed to be waterproof so that a user can wear the insulin pump while maintaining normal daily life, which can include exposure to water (e.g., rain, shower, etc.). Insulin pumps may also require audible alerts to notify the user of various situations, such as malfunction situations (e.g., low battery, low insulin level, communication error, etc.). However, waterproof devices generally do not facilitate the effective propagation of sound from a completely sealed device. Summary of the Invention

[0004] Generally speaking, the present disclosure describes techniques for generating sound in a completely sealed medical device. Example techniques for generating sound in a medical device include using a plurality of sound chambers arranged in a stacked configuration that propagate the sound, and one or more diaphragms configured to vibrate in response to the sound propagating through the medical device. In one or more examples, an outer housing including a cover layer can completely enclose the medical device, where the cover layer (e.g., the entire cover layer or a portion of the cover layer) also vibrates to propagate the sound outside of the medical device.

[0005] Exemplary medical devices can be configured to generate sounds with a high enough decibel (dB) level such that the sound propagates outside the medical device even when the medical device is fully encapsulated, by way of a plurality of acoustic chambers, one or more diaphragms, and a cover arranged in a stacked configuration. For example, in a stacked configuration, sound can propagate continuously through the acoustic chambers and thus losses can be limited as compared to a non-stacked configuration. Additionally, it can be advantageous for the medical device to have foreign object protection such that the device can be used under different conditions, such as outdoors. For example, users often carry wearable infusion devices and may need to use them frequently, and diabetic users may be able to perform some daily life activities more easily with a fully sealed fluid infusion device.

[0006] Exemplary techniques are described with respect to medical devices such as fluid infusion devices. However, the exemplary techniques are also applicable to other types of medical devices. Additionally, the exemplary techniques should not be considered limited to medical devices and may be applicable to non-medical devices.

[0007] In one example, a medical device includes: a speaker that includes a diaphragm and is configured to generate sound that propagates through the medical device; a plurality of acoustic chambers arranged in a stacked configuration and configured to propagate the sound generated by the speaker through one or more acoustic tuning holes of the acoustic chambers, wherein in the stacked configuration, the sound propagates continuously through the plurality of acoustic chambers; one or more diaphragms within the medical device, the one or more diaphragms being configured to vibrate in response to the sound propagating through the medical device, wherein each of the one or more diaphragms separates a respective acoustic chamber of the stacked configuration and vibrates in response to sound propagating from a first acoustic chamber of the respective acoustic chambers to a second acoustic chamber of the respective acoustic chambers; and an outer housing that fully encapsulates the medical device and includes a cover layer, wherein the cover layer is configured to vibrate in response to the sound propagating through the plurality of acoustic chambers arranged in a stacked configuration.

[0008] In another example, a method of generating an audible alert includes: determining to output an audible alert; and after determining to output the audible alert, causing a speaker including a diaphragm to generate sound that propagates through a medical device through a plurality of sound chambers in a stacked configuration and is configured to propagate the sound generated by the speaker through one or more sound tuning holes of the sound chambers, wherein in the stacked configuration, the sound propagates continuously through the plurality of sound chambers, wherein the sound chambers in the stacked configuration are separated by a diaphragm of one or more diaphragms, and each of the one or more diaphragms vibrates in response to sound propagating from a first sound chamber in a corresponding sound chamber to a second sound chamber in the corresponding sound chamber, wherein an outer housing completely encloses the medical device and includes a cover layer, wherein the cover layer is configured to vibrate in response to sound propagating through the plurality of sound chambers in a stacked configuration.

[0009] In another example, a method of manufacturing a medical device includes: forming a first sound chamber of a plurality of sound chambers in a stacked configuration, wherein the plurality of sound chambers are configured to propagate sound generated by a speaker through one or more sound tuning holes of the sound chambers, wherein in the stacked configuration, the sound propagates continuously through the plurality of sound chambers; forming a first diaphragm of a plurality of diaphragms within the medical device; forming a second sound chamber of the plurality of sound chambers; wherein each of the one or more diaphragms is configured to vibrate in response to sound propagating through a corresponding sound chamber, and one of the one or more diaphragms separates the corresponding sound chambers in the stacked configuration and vibrates in response to sound propagating from the first sound chamber in the corresponding sound chamber to the second sound chamber in the corresponding sound chamber; and forming an outer housing that completely encloses the medical device, wherein the outer housing includes a cover layer, wherein the cover layer is configured to vibrate in response to sound propagating through the plurality of sound chambers in a stacked configuration.

[0010] This Summary is intended to provide an overview of the subject matter described in this disclosure. It is not intended to provide an exclusive or exhaustive explanation of the devices and methods described in the following figures and description. Further details of one or more examples are set forth in the following figures and description. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 is a perspective view of an exemplary outer housing of a medical device in accordance with one or more techniques of the present disclosure.

[0012] Figures 2A to 2C is a diagram of a cross-sectional view showing an exemplary configuration of stacked sound chambers in accordance with one or more techniques of the present disclosure.

[0013] Figure 3The bottom view of an exemplary outer housing portion configured for user interaction according to one or more techniques of the present disclosure.

[0014] Figure 4 A graphical illustration of the relationship between frequency and sound pressure level according to one or more techniques of the present disclosure.

[0015] Figure 5 A flowchart showing an exemplary operation for initiating sound propagation according to one or more techniques of the present disclosure.

[0016] Figure 6A and Figure 6B A diagram depicting an exemplary geometry of a thermal bonding adhesive according to one or more techniques of the present disclosure.

[0017] Figure 7 A conceptual diagram showing an example sound tuning hole configuration according to one or more techniques of the present disclosure.

[0018] Throughout the drawings and the specification, like reference numerals refer to like elements. Detailed Description

[0019] Many medical device systems include alarm generation components. Alarms can be generated to indicate a user state or a device state that requires the attention of a user, caregiver, or clinician. Some medical device systems include a single device that generates an alarm based on sensed data. Other medical device systems include two or more devices that communicate with each other to sense data and generate an alarm based on the sensed data. The sensed data can include one or more of physiological data or device data. Additionally, some medical device systems include a medical device configured to communicate with a smart device (e.g., a smart phone or a smart watch) via, for example, Bluetooth.

[0020] Certain terms may be used in the following description for reference only, and thus are not intended to be limiting. Similarly, unless the context clearly indicates otherwise, the terms "first," "second," and other such numerical terms referring to structures do not imply an order or sequence. Such terms can include the words specifically mentioned above, their derivatives, and words of similar meaning.

[0021] The present invention relates to various examples of sound propagation techniques for fluid infusion devices, such as for the treatment of diabetes. The fluid infusion devices described herein provide a reduced form factor and / or a simplified user interface, which can reduce complexity and cost while making it easier for a user to carry the fluid infusion device. The non-limiting examples described below relate to medical devices for the treatment of diabetes (such as insulin pumps and / or infusion sets), but examples of the disclosed subject matter are not limited thereto. Examples of the present disclosure can be used with any device that requires or benefits from sound propagation, such as a smart phone. The fluid infusion device is used only as a non-limiting example. Thus, in certain examples, the infused fluid is insulin.

[0022] In one or more examples, the present disclosure describes techniques for stacking sound chambers to propagate sound outside of a fully enclosed device. For example, a medical device can include a speaker having a vibrating diaphragm (e.g., a piezoelectric speaker, an electromechanical buzzer, a piezoelectric buzzer). The speaker is configured to generate sound that propagates through the medical device (e.g., such as due to an alert). The medical device also includes a plurality of sound chambers in a stacked configuration and is configured to propagate the sound generated by the speaker through one or more sound tuning holes of the sound chambers. For example, in the stacked configuration, the sound propagates serially through the plurality of sound chambers.

[0023] The medical device also includes one or more diaphragms that vibrate in response to sound propagating through the medical device. Each of the one or more diaphragms can separate a corresponding sound chamber in the stacked configuration and vibrates in response to sound propagating from a first sound chamber in the corresponding sound chamber to a second sound chamber in the corresponding sound chamber. In one or more examples, there can be a restricted air volume between the sound chambers such that the corresponding diaphragm can vibrate in place.

[0024] In the case where a plurality of sound chambers are in a stacked configuration and the corresponding diaphragms separate the sound chambers, when sound propagates through the medical device, each diaphragm vibrates, thereby causing air to be pushed to the next diaphragm so that the sound can propagate through the medical device in a manner that minimizes sound loss. Additionally, the medical device can include an outer housing that fully encloses the medical device. To ensure that the sound level is high enough even when the medical device is enclosed, the outer housing includes a cover layer, where the cover layer is configured to vibrate in response to sound propagating through the plurality of sound chambers in the stacked configuration. In this way, the medical device can be fully enclosed, but the sound (e.g., from an alert) can propagate and be heard by the user.

[0025] Various parameters such as the shape and size of the chamber and diaphragm, and the material may affect the sound propagation ability. This disclosure describes examples of shapes, sizes, and materials that facilitate sound propagation. In addition to achieving optimized chamber and diaphragm shapes and sizes for sound output, the techniques of this disclosure also describe examples for minimizing the chamber and diaphragm sizes to facilitate a compact device design. Such minimization of the chamber and diaphragm sizes while still propagating sufficient sound, e.g., more than 45 dB, can be particularly advantageous for portable devices.

[0026] Current methods for generating sound from a waterproof medical device typically include a hydrophobic membrane that covers any electrical portion of the device having a non-stacked sound chamber exposed to external air to enable sound propagation. Such current methods may result in a less stringent water seal than required in some applications. The techniques disclosed herein result in a more stringent water seal than in devices using current sound propagation methods, e.g., meeting International Electrotechnical Commission (IEC) IP28.

[0027] Figure 1 is a perspective view of an exemplary outer housing in accordance with one or more techniques of this disclosure. Specifically, Figure 1 is a perspective view of a fluid infusion device 100. In this example, the fluid infusion device 100 includes a housing 108. Generally, the housing 108 has a small form factor that is convenient to carry, and is about 3 inches (in.) to about 4 inches (in.) long, about 1 (in.) to about 2 inches (in.) wide, and about 0.5 inches (in.) to about 1.5 inches (in.) thick. The weight of the fluid infusion device 100 is also generally less than about 80 grams (g). In some examples, the housing 108 includes a first housing portion 112 and a second housing portion 106 that are coupled together to form the housing 108. In some examples, the first housing portion 112 of the housing 108 is made of a plastic having properties including chemical resistance, durability, and impact resistance. In other examples, the first housing portion 112 of the housing 108 is made of a metal or metal alloy, such as aluminum, titanium, stainless steel, etc., and is formed by casting, stamping, additive manufacturing, etc. By forming the first housing portion 112 of the housing 108 with plastic, metal, or metal alloy, the larger first housing portion 112 of the housing 108 resists environmental factors and chemical exposure, such as water, sunscreen, etc. Using plastic, metal, or metal alloy can also protect the fluid infusion device 100 from accidental drops, vibrations, and static loads during use, thereby improving reliability. In addition, the size and configuration of the housing 108 enable the fluid infusion device 100 to be more easily carried, and, for example, can be attached in different orientations (such as longitudinally) via a clip. Thus, the size and shape of the fluid infusion device 100 are designed to be easy to use, which increases user satisfaction and convenience.

[0028] The second housing portion 106 of the housing 108 is received within the passage of the first housing portion 112 such that the first housing portion 112 surrounds most of the second housing portion 106. The first housing portion 112 is coupled to the second housing portion 106. The first housing portion 112 may be coupled to the second housing portion 106 via laser welding, adhesives, mechanical fasteners, etc. In some examples, the first housing portion 112 defines an outer shell while the second housing portion 106 forms part of a cover assembly (which will be discussed in more detail below) that also includes a frame. The second housing portion 106 may include a transparent material such as liquid silicone rubber (LSR). In some examples, an in-mold label (IML) layer is added for aesthetic reasons.

[0029] The second housing portion 106 includes a user interface. In this example, the user interface includes action buttons 104 and light-emitting elements 114, such as light-emitting diodes (LEDs). The user interface may not have a display, which can reduce the size of the fluid infusion device 100 and lower its cost. The status button 102 enables a user to press the status button 102 to turn on one or more lights indicating the pump status. The action buttons 104 enable a user to clear an alarm or alert generated by the fluid infusion device 100 and pair the fluid infusion device 100 with a remote device or a portable electronic device associated with the user, such as the user's smart phone, tablet computer, smart watch, computer, continuous glucose monitor, etc. In some examples, the user may select both buttons simultaneously to initiate a software restart or turn off the entire fluid infusion device 100. In this example, the light-emitting element 114 surrounds the status button 102. However, the light-emitting element 114 may be located at other positions on the second housing 106. The light-emitting element 114 may be integral with the status button 102 or may be coupled to the status button 102 by any suitable technique, such as press fit, adhesive, in-mold electronics, light guides, etc. Additionally, in certain examples, the status button 102 may include a metal dome to provide tactile feedback. In other examples, the status button 102 may be a decorative surface coupled to a force-sensitive resistor (FSR) or a pressure sensor having a linear resonant actuator (LRA) that is programmed to vibrate and simulate the effect of a button press to provide tactile feedback. The light-emitting element 114 provides a visual indicator of the status associated with the fluid infusion device 100. For example, the light-emitting element 114 may include a multicolor LED that is controlled to light up in different colors based on the status of the fluid infusion device 100. For example, when the fluid infusion device 100 is operating normally, the light-emitting element 114 may light up green, when there is an alarm or alert associated with the fluid infusion device 100 it may light up red, and when the fluid infusion device 100 is paired with the user's portable electronic device, etc., it may light up blue. In some examples, the action buttons 104 may also include a light-emitting element similar to the light-emitting element 114.

[0030] The fluid infusion device 100 may also include a power source (not shown). The power source is any suitable device for supplying power to the fluid infusion device 100, including but not limited to a battery. In some examples, the power source is a rechargeable battery fixed within the housing 108. The power source may include a planar rectangular battery or a planar cylindrical battery. In these examples, the power source can be charged via USB, wireless charging, etc. In the example of wireless charging, the charging coil of the fluid infusion device 100 can be configured such that the fluid infusion device 100 can be placed on a charging pad for general charging, or can be set in a form-fit wireless charging socket with a pre-determined position. This charging socket itself can be battery-powered and can slide over the fluid infusion device 100 to charge it while in motion, such that the fluid infusion device 100 remains functional during charging. Generally, it may be desirable for the power source to be rechargeable for at least 7 days of use.

[0031] Within the housing 108, the fluid infusion device 100 includes a processing circuit (e.g., at least one processor) and a computer-readable storage device or medium mounted to a printed circuit board (PCB) (not shown). The processing circuit can be any custom or commercially available processor, central processing unit (CPU), graphics processing unit (GPU), auxiliary processor among several processors, semiconductor-based microprocessor (in the form of a microchip or chipset), macroprocessor, any combination thereof, or any device generally used for executing instructions. In certain examples, the fluid infusion device 100 includes more than one processor. The computer-readable storage device or medium can include, for example, volatile and non-volatile memories such as read-only memory (ROM), random access memory (RAM), and keep-alive memory (KAM). KAM is a persistent or non-volatile memory that can be used to store various operating variables when the processor is powered off. The computer-readable storage device or medium can be implemented using any of a variety of known memory devices, such as PROM (programmable read-only memory), EPROM (electric PROM), EEPROM (electrically erasable PROM), flash memory, or any other electrical, magnetic, and / or optical memory device capable of storing data, some of which represent executable instructions used by the processing circuit to control components associated with the fluid infusion device 100.

[0032] The instructions can include one or more individual programs, each program including an ordered list of executable instructions for implementing a logical function. When executed by the processor, the instructions can receive and process input signals; execute logic, calculations, methods, and / or algorithms for controlling components of the fluid infusion device 100; and generate signals to components of the fluid infusion device 100 based on the logic, calculations, methods, and / or algorithms to control the drive system and / or the light-emitting element 114.

[0033] The fluid infusion device 100 may include any number of hardware components that communicate via any suitable communication medium or combination of communication mediums and cooperate to process signals from a user interface including a status button 102 and an action button 104; process signals received from a portable electronic device, perform logic, calculations, methods, and / or algorithms; and / or generate control signals to control features of the fluid infusion device 100.

[0034] Additionally or alternatively, one or more instructions, when executed by a processor, may be capable of receiving and processing signals from a user interface including a status button 102 and an action button 104 to generate one or more control signals to clear an alarm or alert associated with the fluid infusion device 100.

[0035] In some examples, a sensing circuit of a wearable medical device (e.g., a continuous glucose monitor) associated with the fluid infusion device 100 senses interstitial glucose data and other physiological data, and a processor of the fluid infusion device 100 determines whether an alarm is needed based on this data. In other examples, the fluid infusion device 100 determines that an alarm is needed due to a system issue (e.g., low battery, device pairing problem, pump failure, or high temperature).

[0036] A speaker within the housing 108 of the fluid infusion device 100 generates a sound indicative of an alarm in response to one or more signals from the processor. For example, different alarms may be associated with different sounds (e.g., different frequencies, durations, tone patterns, etc.). A processor of the fluid infusion device 100 may determine the alarm and cause the speaker to generate a sound associated with the alarm. One example of a speaker is a piezoelectric speaker, but other examples of speakers are possible.

[0037] As described above, in one or more examples, the fluid infusion device 100 may be fully enclosed, which may mask the sound generated by the speaker. Additionally, the sound generated by the speaker may be dispersed within the fluid infusion device 100, thereby reducing the volume of the sound.

[0038] According to examples described in the present disclosure, the fluid infusion device 100 may include a plurality of sound chambers in a stacked configuration (e.g., in a stacked configuration, sound propagates continuously through the plurality of sound chambers). Each sound chamber may be separated by a respective diaphragm of one or more diaphragms. The respective diaphragm may vibrate in response to sound propagating through the fluid infusion device 100, which in turn causes the sound to propagate in a manner that maintains the sound volume (e.g., minimizes sound dispersion).

[0039] In addition, the housing 108 may include a cover 110 that can also vibrate. Sound propagating through the fluid infusion device 100 causes the housing 108 (e.g., the cover 110) to vibrate, thereby providing an audible alert, warning, or notification to the user. Because the cover 110, which is part of the second housing 106 of the housing 108, is capable of vibrating, the user can hear the sound propagating through the fluid infusion device 100.

[0040] For example, a speaker may generate a relatively high volume so that the user can hear the sound. However, in this case, the speaker may consume more power than desired. Through an exemplary technique, the speaker can generate sound at a reasonable volume, and the exemplary technique enables the sound to propagate in a manner that the user can still hear.

[0041] In some examples, a portion of the housing 108 (e.g., the cover 110) is configured to vibrate for the purpose of sound propagation. A sound propagation system of a stacked sound chamber is located within the housing 108 and may be aligned or nearly aligned with the cover 110. Isolating the vibration to a specific portion of the housing 108 can be beneficial for achieving additional reinforcement of the housing 108. In addition, the ability to isolate vibration to the cover 110 can contribute to aesthetic design choices.

[0042] The action button 104 and the status button 102 may be sealed by gaskets made of materials such as elastomers, semi-solids, or similar compliant materials, including but not limited to silicone, ethylene propylene diene monomer (EPDM), polytetrafluoroethylene (PTFE), synthetic or natural rubber, or fluoropolymers. Alternatively, the seal can be achieved by a material that exhibits or includes a high surface tension that binds the gaps between components such that the combined gaps do not allow water or dust to enter to the level expected for the fluid infusion device 100, e.g., about 8 feet to about 12 feet for water and dust, such as the level associated with an IP28 rating. The gasket can be compressed to form an airtight seal between the housing 108 and the action button 104 and the status button 102. The airtight seal prevents fluid or other debris from flowing into the housing 108, thereby protecting the internal components of the housing 108. The seal associated with the IP28 rating can achieve the expected foreign object protection associated with the fluid infusion device 100. In certain examples, dust foreign objects may not be tested, and the IP rating may include IPX6, IPX7, or IPX8. In other examples, the device is associated with a higher foreign object protection rating of IP68, where the device is considered dustproof.

[0043] The fluid infusion device 100 can operate in many different external environments, such as at home, in the office, outdoors, etc. Due to the optimized size and shape of the outer housing and the water-tight and dust-proof properties, the fluid infusion device 100 can be safely used in various environments.

[0044] Figures 2A to 2C FIG. is a schematic cross-sectional view showing an exemplary configuration of a stacked sound chamber according to one or more techniques of the present disclosure. Figures 2A to 2C They may be configured substantially similarly to each other, and the differences between them are discussed herein. For example, these differences include the differences between the second sound tuning holes 216A ( Figure 2A ), the second sound tuning holes 216B ( Figure 2B ), and the second sound tuning holes 216C ( Figure 2C )(collectively referred to as "the second sound tuning holes 216") and the resulting differences between the sound propagation paths 224A ( Figure 2A ), 224B ( Figure 2B ), and 224C ( Figure 2C )(collectively referred to as "the sound propagation paths 224"). For example, Figures 2A to 2C The dashed lines in show examples of the sound propagation paths identified as 224A to 224C, respectively.

[0045] As described in more detail, a first sound chamber 230A and a second sound chamber 230B are shown in Figures 2A to 2C . For example, the first sound chamber 230A includes a first sound tuning hole 208. The first sound chamber 230A may also include restricted air volumes 204 and 210. The second sound chamber 230B includes a second sound tuning hole 216. The second sound chamber 230B may also include restricted air volumes 214 and 218. Generally, the smaller the volumes of the restricted air volumes 210, 214, and 218, the more the pressure increases because each diaphragm vibrates and displaces a prescribed air volume. A relatively large pressure increase is associated with a larger propagation of the sound pressure wave. In some examples, the first air volume 204 is about 21.5 cubic millimeters. Other air volumes are also possible. For the purposes of the present disclosure, the term "about" describes manufacturing tolerances, e.g., ±10%. As described in more detail, a first diaphragm 212 separates the first sound chamber 230A and the second sound chamber 230B. There may be additional sound chambers stacked similar to the first sound chamber 230A and the second sound chamber 230B, where corresponding diaphragms separate the sound chambers.

[0046] For example, in Figures 2A to 2C , the second sound chamber 230B is stacked on the first sound chamber 230A such that in the stacked configuration, sound propagates continuously through multiple sound chambers, as shown by the sound propagation path 224. That is, sound propagates from one sound chamber to the next in a serial manner.

[0047] Regarding Figures 2A to 2C, the speaker 202, for example, a surface-mounted piezoelectric speaker, starts sound propagation. Other examples of the speaker 202 are also possible. The surface-mounted piezoelectric speaker is described only for ease of description. In some examples, the speaker 202 can be attached to a PCB (printed circuit board). The PCB can also include the above-mentioned processing circuit (e.g., a processor), and the processing circuit outputs a signal that causes the speaker to vibrate. In the example of the fluid infusion device 100, sound propagation can be started to create an alarm related to the operation of the fluid infusion device or to notify the user of the glucose level.

[0048] The sound generated by the vibration of the speaker 202 travels through the first air volume 204. The first air volume 204 is a confined air volume encapsulated by the volume constraint device 232. In some examples, the volume constraint device 232 can include rubber. The first air volume 204 provides a path from the speaker 202 to the first sound tuning hole 208. The first sound tuning hole 208 can be cylindrical, and its size is set to propagate sound at the dB level provided by the speaker 202. Different shapes are possible. However, a cylinder can be suitable and can cause the desired sound propagation due to the acoustic properties of the circular opening. Generally, a circular opening can make the sound distribution more uniform, thus minimizing the effects of diffraction and turbulence relative to other shapes. In addition, a circular opening is easy to manufacture and can be formed using standard tools and methods. The first sound tuning hole 208 is in contact with the second air volume 210. The second air volume 210 enables the vibration caused by the sound to propagate from the first sound tuning hole 208 to the first vibration membrane 212.

[0049] As shown in the figure, in a stacked configuration, the first diaphragm 212 separates the corresponding sound chambers 230A and 230B. The first vibration membrane 212 vibrates in response to the sound propagating from the first sound chamber 230A in the corresponding sound chamber to the second sound chamber 230B in the corresponding sound chamber.

[0050] The first diaphragm 212 is thermally bonded to the cover 225. The cover 225 may be substantially similar or identical to the first housing portion 112. Methods other than thermal bonding may be used to attach the first diaphragm 212 to the cover 225. Thermal bonding may be more advantageous than some other bonding methods for creating a chemical-resistant and waterproof device. In some examples, the first diaphragm 212 comprises polyetherimide (PEI). Other materials, such as, aluminum plates, embossed aluminum plates, paper laminates, polyester (PET), and polypropylene, are also possible, but PEI may be suitable because PEI retains its vibratory ability after thermal bonding, i.e., its glass transition temperature is higher than the thermal bonding temperature even at a minimum thickness (e.g., 0.001 in). PEI can withstand cyclic loading and does not tend to exhibit fatigue or stress-relief fracture under cyclic loading conditions. Additionally, PEI is associated with high tear strength. Further, PEI is a transparent, colorless material. In an example of the fluid infusion device 100, one or more LEDs (e.g., the light-emitting element 114) may be used to provide an indication to the user. Since PEI is transparent, light can travel through the PEI, enabling the use of LEDs. The fluid infusion device 100 is used only as an example. Many medical devices use LEDs and other lights to provide notifications to the user.

[0051] The first diaphragm 212 may have a diameter of about 8 millimeters (mm). The diameter of the first diaphragm 212 may vary from 4 mm to 12 mm. Smaller and more aesthetically pleasing devices may improve the user experience. In an example of the fluid infusion device 100, the user may have to wear the fluid infusion device 100 at all times. Determining the minimum diaphragm size results in a smaller overall device, making it easier for the user to wear the fluid infusion device 100 and potentially improving user comfort and compliance. An 8 mm diameter is approaching the minimum diameter to successfully achieve sound propagation via the vibration of the first diaphragm 212. Larger diaphragm diameters are also possible and may be desirable in certain applications.

[0052] The first diaphragm 212 may have a thickness of 0.001 (in.). The thickness of the first diaphragm 212 may vary from about 0.0005 in. to 0.005 in. The thickness of the diaphragm may be based in part on the properties of the selected material. In the example of PEI and at the frequencies desired for the alarm output of this example, the diaphragm must be thin enough to vibrate but also thick enough to resist tearing or other damage caused by cyclic vibration. If a material other than PEI is selected for the first diaphragm, different thickness ranges may be employed due to differences in material properties. For example, PEI is relatively flexible, allowing the PEI layer to be thicker than some other potential materials while still being able to vibrate. Other materials may be too flexible and may therefore require a thinner thickness to vibrate. In some cases, it may be necessary to test multiple layer thicknesses to determine the optimal thickness of the first diaphragm for the selected material.

[0053] The first diaphragm 212 is in contact with the third air volume 214. The third air volume 214 and the second air volume 210 enable the first diaphragm 212 to vibrate and provide a path for the vibrations generated in the first diaphragm 212 to travel through the second sound tuning holes 216. The second sound tuning holes 216 are constrained by the sound spacer 220 and include one or more through-holes in the sound spacer 220. The sound spacer 220 is connected to the first diaphragm 212 by an adhesive 226 (e.g., a double-sided foam tape). The adhesive 226 adheres the covering assembly including the sound spacer 220, the frame 234, and the outer cover 222 to the first diaphragm 212. The outer cover 222 may be the same as the second housing portion 106. Other types of adhesives are possible and may be equally effective. The vibrations propagating through the second sound tuning holes 216 via the fourth air volume 218 cause the outer cover 222 to vibrate. The frame 234 provides the main structure of the covering assembly. In some examples, the frame 234 is made of an opaque polyamide (e.g., nylon). Regarding Figures 2A to 2C , the frame 234 includes through-holes for the status button 102, the action button 104, the arrow icons, and the sound spacer 220. In these examples, the sound spacer 220 is press-fitted into the corresponding through-holes of the frame 234. The corresponding through-holes of the sound spacer 220 and the frame 234 are keyed to prevent rotation, thereby fixing the sound spacer 220 relative to the frame 234. The sound spacer 220 is installed in the frame 234 until it reaches a defined stop on the inner surface of the frame 234. The sound spacer 220 may be formed of an opaque polyamide (e.g., nylon).

[0054] In some examples, the geometry of the frame 234 takes a form other than the form depicted in Figures 2A to 2C . For example, the frame 234 may include one or more air channels or chambers to create a restricted air volume within the fluid infusion device 100. For example, the frame 234 may include an air channel between the sound spacer 220 and the action button 104 to form a restricted air volume. There may be wiring and other components within the restricted air volume, but the action button 104 may be formed of a material soft enough to allow the action button 104 to vibrate and transmit sound. As another example, the frame 234 may include a plurality of shallow chambers having sound reflectors to focus the sound pressure onto the action button 104 and the status button 102. The action button 104 and the status button 102 may vibrate freely like a diaphragm in response to the sound pressure generated by the speaker 202.

[0055] In other examples, the frame 234 includes a plurality of small through-holes to replace or supplement the through-holes of the acoustic spacer 220 to achieve sound propagation. The small through-holes are covered by the outer cover 222. In some examples, the small through-holes are not visible through the outer cover 222. As another example, the frame 234 includes a plurality of independently movable elements and a body. The movable elements can move relative to the body and are capable of vibrating the outer cover 222 in response to the sound pressure generated by the speaker 202. In other examples, the frame 234 can be configured such that the status button 102 and / or the action button 104 can vibrate like a diaphragm. The wall of the frame 234 around the status button 102 and / or the action button 104 can be removed. In other examples, the rear surface of the frame 234 can have a shallow chamber that enables the first diaphragm 212 to vibrate freely, where only the perimeter of the frame 234 is adhered to the covering assembly. The frame 234 can have or not have support ribs. In some examples, the outer cover 222 includes LSR. In other examples, different materials can be used. The LSR can be formulated to resist various chemicals, which can protect the fluid infusion device 100 from any damage. In an example of the fluid infusion device 100, the fluid can include chemicals that can damage certain materials in the event of a leak. Additionally, the fluid infusion device 100 may be subject to substances and chemicals in the external environment, such as sunscreen, pesticides, hand sanitizer, etc. The chemical resistance of the LSR can be advantageous in protecting the fluid infusion device 100 from various environmental effects. The hardness of the LSR can also vary, and the hardness of the LSR can be optimized to achieve button presses while still having a high enough tear strength to prevent tearing, such as tearing inadvertently caused by the user. Additionally, the LSR can withstand cyclic loading and does not exhibit fatigue or stress relaxation fracture under load conditions.

[0056] Furthermore, the LSR is transparent, which can be advantageous in devices having a user interface that includes an LED or other lighting system. As described above, in some examples, the outer cover 222 includes the cover 110, and the cover 110 is a material separate from the outer cover 222, where the cover 110 forms part of the outer cover 222. In other examples, the outer cover 222 and the cover 110 are formed of the same material, in which case the outer cover 222 and the cover 110 become one cover.

[0057] Thus, in some examples, a portion of the outer cover 222 (e.g., the cover 110) serves as a second type of diaphragm. In other examples, the entire outer cover 222 or the entire housing 108 ( Figure 1is used as a second type of diaphragm. In this way, the outer cover 222 can be a part of the outer housing 108 that completely encloses the fluid infusion device 100 and includes the cover 110. The cover 110 can be configured to vibrate in response to sound propagating through a plurality of acoustic chambers 230A, 230B in a stacked configuration. The outer cover 222, including the cover 110, can be formed of LSR.

[0058] In some examples, for instance, in examples where all outer covers 222 are configured to vibrate, the thickness of the outer cover 222 varies. For example, the outer cover 222 can include a relatively thick layer of material, such as LSR, above the action button 104 and the status button 102 and around the perimeter of the outer cover 222. The relatively thick layer of the outer cover 222 above the action button 104 and the status button 102 can maintain the desired tear-resistant quality of the outer cover 222, and the relatively thin layer elsewhere (e.g., above the stacked acoustic chambers 230A, 230B) can reduce any sound damping associated with the layers of the outer cover 222.

[0059] In some examples, for aesthetic reasons, it may be desirable for some portions of the outer cover 222, namely the portions other than the cover 110, the action button 104, and the status button 102 ( Figure 1 ) to be opaque rather than transparent. One way to make the exterior of the fluid infusion device 100 appear opaque includes applying an IML layer, i.e., an ink-coated polyethylene terephthalate (PET) sheet, to the outer cover 222. For example, this can make most of the device appear opaque while allowing light to pass through certain areas, such as LEDs and buttons. Adding the IML layer can result in an aesthetically pleasing and uniform device. The IML layer can be printed with graphic ink, which can be opaque in areas not intended to allow light to pass through and translucent in areas to be illuminated. The frame 234 can be overmolded onto the printed ink surface of the IML layer via injection molding, and at the same time, the opposite side of the IML layer can be thermoformed into the desired geometry. Then, the outer cover 222 can be liquid injection overmolded onto the opposite surface of the IML layer, i.e., the non-printed surface.

[0060] Adding the IML to the outer cover 222 may limit the ability of the outer cover 222 to vibrate. In some examples, the IML is not applied to the 8 - mm diameter circular portion (i.e., the cover 110) of the outer cover 222 to maintain the vibration ability of the cover 110.

[0061] Regarding Figure 2A , the sound propagation path 224A indicates a possible path of sound propagation generated by the examples described in Figure 2A . The sound path 224A travels through the sound tuning hole 216A to cause the vibration of the outer cover 222 that generates sound.

[0062] In some examples, the sound tuning holes 216 can be slightly offset, as depicted in the example of Figures 2A to 2C . In other examples, the sound tuning holes may not be offset, i.e., the first sound tuning hole 208 can be aligned with the second sound tuning hole 216A, i.e., the axes of the first sound tuning hole 208 and the second sound adjustment hole 216A can be aligned. The arrangement of the sound tuning holes can depend on spacing constraints. For example, the sound tuning holes can be offset to provide space within the housing 108 for the keyboard or another part of the device.

[0063] Regarding Figure 2B , the sound propagation path 224B indicates a possible path of sound propagation associated with the example depicted in Figure 2B . At the third air volume 214, the sound propagation path divides into multiple directions associated with multiple second sound tuning holes 216B. The second sound tuning holes 216B include multiple through-holes in the sound spacer 220. In some examples, multiple relatively small sound tuning holes are advantageous, both to prevent tearing of the outer cover 222 and for aesthetic reasons. Due to the minimum thickness required for vibration, the outer cover 222 may be prone to tearing. In some examples, the outer cover 222 has a nominal thickness of 0.4 mm. Additionally, in some examples, the outer cover 222 is transparent at the cover 110, the action button 104, and the status button 102 ( Figure 1 ), such that the sound spacer 220 is visible to the user. Thus, the transparent cover 110 can provide additional graphical and aesthetic options. In some examples, the second sound tuning holes 216 in the sound spacer 220 can be patterned to simulate the appearance of a speaker ( Figure 7 ).

[0064] Regarding Figure 2C , the sound propagation path 224C indicates a possible path of sound propagation associated with the example depicted in Figure 2C . The second sound tuning hole 216C ends with a curve 228, thereby forming a concave sound spacer 220. The curve 228 can reduce stress concentration by removing any sharp edges associated with other forms of the second sound tuning hole 216. The second sound tuning hole 216C can be beneficial in preventing tearing due to the user repeatedly pressing the second diaphragm of the outer cover 222 (i.e., the cover 110). Additionally or alternatively, the outer cover 222 includes a curved geometry to likewise prevent tearing.

[0065] Therefore, Figures 2A to 2CAn example of a medical device (e.g., fluid infusion device 100) including a speaker 202 is shown. The speaker includes a diaphragm and is configured to generate sound that propagates through the medical device. For example, speaker 202 is a surface-mounted piezoelectric body. The medical device also includes a plurality of sound chambers 230A, 230B in a stacked configuration, which are configured to propagate the sound generated by speaker 202 through one or more sound tuning holes 208, 216 of sound chambers 230A, 230B. In the stacked configuration, sound propagates continuously through the plurality of sound chambers 230A, 230B.

[0066] One or more diaphragms (e.g., first diaphragm 212) within the medical device can be configured to vibrate in response to sound propagating through the medical device. For example, each of the one or more diaphragms separates a corresponding one of the sound chambers 230A, 230B in the stacked configuration and vibrates in response to sound propagating from a first sound chamber (e.g., sound chamber 230A) in the corresponding sound chamber to a second sound chamber (e.g., sound chamber 230B) in the corresponding sound chamber.

[0067] In one or more examples, the material of at least one of the one or more diaphragms (including some or all) can be PEI. At least one of the one or more diaphragms can be circular (e.g., having a diameter of 8 millimeters). In some examples, at least one of the one or more diaphragms has a thickness of 0.0005 in. to 0.005 in.

[0068] Although two sound chambers 230A, 230B are shown, additional sound chambers similar to the stacked sound chambers 230A, 230B can also be present. For example, as shown, the sound propagation path 224 shows sound propagating continuously through the sound chambers 230A, 230B. In examples where additional sound chambers are present, the sound propagation path 224 will flow through these additional sound chambers. Additionally, corresponding diaphragms, such as diaphragm 212, can separate these additional sound chambers and vibrate in response to sound propagating through the corresponding sound chambers separated by the corresponding diaphragm.

[0069] Furthermore, there can be a restricted air volume that forms part of the corresponding sound chambers 230A, 230B such that the corresponding diaphragm 212 can vibrate. That is, each of the plurality of sound chambers 230A, 230B can include a corresponding restricted air volume. Each of the corresponding diaphragms (e.g., like diaphragm 212) can be configured to vibrate within the corresponding restricted air volume.

[0070] For example, the first sound tuning hole 208 is separated from the speaker 202 by the first air volume 204. The second sound tuning hole 216 is separated from the first sound tuning hole 208 by the second air volume 210, the first diaphragm 212, and the third air volume 214. The first diaphragm 212 is in contact with the second air volume 210 and the third air volume 214 and is configured to vibrate. And the second sound tuning hole 216A is separated from the second diaphragm by the fourth air volume 218. The fourth air volume is in contact with the second diaphragm, and wherein the second diaphragm includes the cover 110. In one or more examples, the sound tuning hole 208 and / or the sound tuning hole 216 may be in a circular configuration.

[0071] The outer housing 108 may completely enclose the medical device including the second housing portion 106. The second housing portion 106 may include the cover 110 formed of LSR, but other materials are possible. In some examples, the entire second housing portion 106 is formed of LSR. At least a portion of the second housing portion 106 (e.g., the cover 110) may be configured to vibrate in response to sound propagating through the plurality of sound chambers 230A, 230B in a stacked configuration.

[0072] Figure 3 is a bottom view of an exemplary outer housing portion 300 configured for user interaction according to one or more techniques of the present disclosure. The housing portion 300 is an example of the second housing portion 106 ( Figure 1 ), and includes spaces for the status button 302, the arrow icon 304, the action button 306, and the sound spacer 308. In some examples, the status button 302, the arrow icon 304, the action button 306, and the sound spacer 308 are all covered by the outer cover 222 ( Figures 2A to 2C ), and the IML layer surrounds them, so that the fluid infusion device 100 looks color uniform.

[0073] The sound spacer 308 may be press-fitted and bonded into the frame 234 that supports the outer housing portion 300 to prevent rotation. The sound spacer 308 may be installed into the housing 108 (e.g., the second housing portion 106) until the sound spacer 308 reaches a defined stop on the inner surface of the second housing portion 106. In one or more examples, the sound spacer 308 is composed of opaque polyamide (nylon). The front surface of the sound spacer 308 may include a graphic to indicate that the sound spacer 308 does not represent a button, but other techniques for indicating that the sound spacer 308 is not a button are possible. In some examples, the graphic may be created via in-mold labeling by printing the graphic on a transparent polyester graphic sheet and co-molding the graphic with the sound spacer material of the sound spacer 308. Alternatively, the graphic is added to the front surface of the sound spacer 220 by pad printing, transfer printing, or laser marking.

[0074] The status button 302 and the action button 306 may have corresponding through-holes in the frame 234 to enable the force associated with button presses to interact with the keyboard located below the frame 234. In some examples, the status button 302 and the action button 306 may be sealed using a respective one of the gaskets 310. Examples of the gasket 310 include elastomers, semi-solids, or similar compliant materials, including but not limited to silicone, ethylene propylene diene monomer (EPDM), polytetrafluoroethylene (PTFE), synthetic or natural rubber, or fluoropolymers. The arrow icon 304 may provide an indication to the user related to an alert or other device operation. The arrow icon 304, the status button 302, and the action button 306 may optionally include a light-emitting element, such as an LED, to provide further guidance or indication to the user. In some examples, the status button 302 may enable a user to check the status of the fluid infusion device 100. For example, the user may press the status button 302 to cause a light to indicate the status of the fluid infusion device 100. The action button 306 may enable a user to pair the fluid infusion device 100 with another device, such as the user's smart phone, tablet computer, smart watch, computer, continuous glucose monitor, etc. The status button 302 and the action button 306 may additionally enable a user to restart the fluid infusion device 100 software. Other purposes for the status button 302 and the action button 306 are possible. The outer cover 222 ( Figures 2A to 2C ) is generally compressible to enable the user to press the buttons. Some users may suffer from arthritis or other conditions that limit fine motor skills and / or strength, so it may be advantageous for the status button 302 and the action button 306 to be large and soft enough for these users to easily interact with the device.

[0075] Figure 4 is a graphical illustration of the relationship between frequency and sound pressure level according to one or more techniques of the present disclosure. In an example of a fluid infusion device that is not optimized for sound output using the exemplary techniques described in the present disclosure, the line 402 represents the output sound pressure level (dBA). Specifically, the example of the fluid infusion device represented by the line 402 includes the speaker 202 within the housing 108 and does not include stacked sound chambers. After optimizing the sealant geometry, the sound spacer geometry, the material selection, and the volume-constrained device, the sound output increased at all test frequencies, as indicated by the line 404. The line 404 represents the same as Figure 2A or Figure 2BSound output associated with the stacked sound chamber configuration in []. To generate an alert, it may be advantageous to ensure that a desired sound pressure level is achieved and maintained consistently between 2 kilohertz (kHz) and 3 kHz. In some applications, the minimum sound pressure may be based on standard requirements, such as FDA requirements, e.g., IEC standard 60601-2-42. For example, a high-priority alert may require a minimum sound pressure of 45 dB. Using the method of the present disclosure, a sound pressure between 55 dBA and 65 dBA is consistently achieved between 2 kHz and 3 kHz.

[0076] In other examples, there may be different requirements regarding sound pressure output and frequency. To adjust the performance of the sound propagation system of the fluid infusion device 100 to fit different requirements, the sound tuning holes 208 and 216, and the volumes of the constrained air volumes 204, 210, and 214 can be adjusted as needed.

[0077] Figure 5 is a flowchart showing an exemplary operation for initiating sound propagation according to one or more techniques of the present disclosure. The fluid infusion device 100 can continuously monitor the user and / or device status (510). In some examples, a separate monitoring device (e.g., a continuous glucose monitor) continuously monitors interstitial glucose levels. The two medical devices include a medical device system that communicates with each other. The medical devices can communicate via one or more of near field communication (NFC), radio frequency (RF), Bluetooth, etc. The user status can be related to any one or more physiological conditions of the user, e.g., interstitial glucose level, SPO2, blood pressure, respiratory rate, etc.

[0078] If the user and / or device is experiencing a state that meets the alert condition, such as a low glucose level, low battery, pump failure, high temperature, or pairing problem (the "yes" in 520), the device system will initiate the vibration of the speaker (e.g., speaker 202) to start sound propagation, and continue to monitor the user and / or device status. In some examples, in addition to warning the user by initiating sound propagation, the processing circuit of the fluid infusion device 100 can also illuminate the light-emitting element 114 or other light-emitting elements, vibrate the linear resonant actuator (LRA) within the fluid infusion device 100, or control the communication circuit to communicate with another device (e.g., the user's smartphone) to initiate a smartphone notification scheme. In an example where the medical device system monitors physiological data, the continuous glucose monitor of the device system can include a processor configured to determine whether the collected data indicates a state that requires an alert. Then, the communication circuit of the continuous glucose monitor can send a communication to the fluid infusion device 100. Additionally or alternatively, the communication circuit of the continuous glucose monitor can transmit data (e.g., interstitial glucose data) to the fluid infusion device 100 for processing, and the fluid infusion device 100 determines whether an alert is needed.

[0079] Additionally or alternatively, the fluid infusion device 100 monitors the device status. Examples of device status that may cause the fluid infusion device 100 to generate an alert include, but are not limited to: low battery, pump failure, high temperature, and pairing issues.

[0080] In an example of a low battery alert, the processor of the fluid infusion device 100 can determine that the battery level is low and that charging is required to prevent interruption of insulin delivery. A low battery level alert can be generated when the battery level drops below a threshold, e.g., 5%, or when the estimated battery duration drops below a threshold, e.g., 8 hours. The alert can advise the user to charge the device.

[0081] In an example of a pump failure alert, the processor of the fluid infusion device 100 can determine that the pump has failed. For example, the determination of pump failure can be related to a blockage of the pump. Multiple pump problems can cause the pump to become blocked. The processor of the fluid infusion device 100 can determine pump blockage by analyzing the force required to pump a certain volume of insulin via the motor of the fluid infusion device 100. In an operating fluid infusion device 100, the motor can generate a certain force to pump a certain volume of insulin. If a greater force than expected is required to pump that volume of insulin, the processor can determine that there is a pump blockage. In some examples, the pump is blocked to the extent that no insulin is being provided to the user via the fluid infusion device 100. In such a case, the processor can determine that an alert for the device and low blood sugar levels is required.

[0082] In an example of a high temperature alert, the processor of the fluid infusion device 100 can determine that the fluid infusion device 100 is being exposed to high temperature, which may reduce device performance and / or render the insulin in the pump ineffective. High temperature can be caused by the external environment, e.g., placing the device in direct sunlight, or due to charging or other actions that can cause overheating. The fluid infusion device 100 can include a temperature sensor configured to transmit data to the processor. The processor can determine that the device is overheating by comparing the temperature sensor data to a threshold over a period of time, e.g., the device has been above the threshold for more than 5 minutes. The processor determines that an alert is needed to advise the user to take action to cool the device, e.g., unplug the fluid infusion device 100 or move to a cooler area.

[0083] In an example of a pairing problem, the fluid infusion device 100 can communicate with a user's smartphone or other computing device. Since the fluid infusion device 100 does not include a display, some notifications or details about an alert can be transmitted to the user's smartphone. The fluid infusion device 100 can communicate with the smartphone via one or more of near field communication (NFC), radio frequency (RF), far field communication, Bluetooth, or any other communication method. In an example where the fluid infusion device 100 communicates with the smartphone via Bluetooth, the fluid infusion device 100 and the smartphone may occasionally disconnect. The processor of the fluid infusion device 100 can determine that a disconnection has occurred and can determine that an alert is needed to notify the user of the disconnection.

[0084] Based on one or more determinations that an alert is needed, the processor of the fluid infusion device 100 activates the vibration of the speaker 202 ( Figures 2A to 2C ) to start sound propagation (530). If the user and / or the device do not experience a user and / or device state that requires an alarm (the "no" of 520), the device system continues to monitor the user and / / or device state.

[0085] Figure 6A and Figure 6B are diagrams depicting exemplary geometries of a thermally bonded adhesive in accordance with one or more techniques of the present disclosure. In some examples, the first diaphragm 212 is part of a sealing sheet applied on top of the lid 225 to seal any circuitry within the device and to isolate the sound propagation system from the external air. The thermally bonded adhesive is applied to the lid and the sealing sheet and is shaped to maintain the circular shape of the first diaphragm 212, thereby substantially forming an edge-mounted diaphragm. In some examples, the thermally bonded adhesive adheres to the first diaphragm 212 through a relatively low-temperature lamination process, thereby forming an assembly of the thermally bonded adhesive and the first diaphragm 212. Then, the assembly can be placed on the lid 225 and bonded through relatively high temperature and pressure.

[0086] Reference Figure 6A , the thermally bonded adhesive 610 is shaped to seal the perimeter of the sealing sheet to the lid 225. The bridge 620 forms a circular opening such that the thermally bonded agent does not cover the vibrating portion of the diaphragm and only contacts the portion of the diaphragm that adheres to the device. Figure 6B is Figure 6A substantially similar but with the differences described herein. Figure 6B An enlarged view of the thermally bonded adhesive 610 is provided. Figure 6BIt includes an arch bridge 630. Depending on the selected adhesive, different bonding adhesive geometries may be required. In some examples, a bonding adhesive geometry with a larger surface area may be associated with a stronger adhesion. Additionally, the thermal bonding adhesive geometry can be optimized to ensure repeatability in manufacturing, i.e., the geometry can be optimized to ensure that the behavior of the adhesive during assembly is predictable.

[0087] Figure 7 An exemplary second sound tuning hole configuration is depicted. Figure 7 can be Figure 2B a top view of, wherein a plurality of second sound tuning holes 216B include a plurality of through holes in a sound spacer 220. The plurality of second sound tuning holes 216B may be patterned in a circular configuration 710. The circular configuration 710 is visible through an outer cover 222 (FIG. 2). The circular configuration 710 can prevent accidental user interaction, e.g., pressing on the speaker portion, by making it clear that the speaker portion is not a button. Other patterns can also be used, and other patterns can equally be used to prevent the user from thinking that the speaker portion is a button.

[0088] Various examples have been described. These and other examples are within the scope of the appended claims.

Claims

1. A medical device, comprising: a speaker including a diaphragm and configured to generate sound that propagates through the medical device; a plurality of sound chambers in a stacked configuration and configured to propagate the sound generated by the speaker through one or more sound tuning holes of the sound chambers, wherein in the stacked configuration the sound propagates serially through the plurality of sound chambers; one or more diaphragms within the medical device, the one or more diaphragms configured to vibrate in response to the sound propagating through the medical device, wherein each of the one or more diaphragms separates a respective sound chamber in the stacked configuration and vibrates in response to the sound propagating from a first sound chamber of the respective sound chambers to a second sound chamber of the respective sound chambers; An outer housing completely encapsulates the medical device and includes a cover layer, wherein the cover layer is configured to vibrate in response to the sound propagating through the plurality of sound chambers in the stacked configuration.

2. The medical device of claim 1 , wherein at least a first sound tuning hole is separated from the speaker by a first air volume, wherein the first air volume is adjacent to the speaker and initiates a sound propagation path, a second sound tuning hole is separated from the first sound tuning hole by a second air volume, a first diaphragm, and a third air volume, the first diaphragm is in contact with the second air volume and the third air volume and is configured to vibrate, and the second sound tuning hole is separated from the second diaphragm by a fourth air volume, the fourth air volume is in contact with the second diaphragm, and wherein the second diaphragm includes the covering layer.

3. The medical device of any one of claims 1 or 2, wherein each of the plurality of sound chambers comprises a respective confined air volume, and wherein each of the respective diaphragms is configured to vibrate within the respective confined air volume.

4. The medical device according to any one of claims 1 to 3, further comprising: A processing circuit, the processing circuit being configured to: Determines that an audible alarm is to be output; as well as Upon determining that the audible alarm is to be output, the speaker is caused to generate the sound, which propagates through the medical device through the plurality of sound chambers in the stacked configuration.

5. The medical device of any one of claims 1 to 4, wherein the speaker is a surface mounted piezoelectric device. 6 . The medical device according to claim 1 , wherein a material of at least one of the one or more diaphragms is polyetherimide (PEI) or liquid silicone rubber (LSR). 7 . The medical device according to claim 1 , wherein the material of the cover layer is liquid silicone rubber (LSR).

8. The medical device of any one of claims 1 to 7, wherein at least one of the one or more septa is circular.

9. The medical device of claim 8, wherein at least one of the one or more septa has a diameter between approximately 4 mm and 12 mm.

10. The medical device of any one of claims 1 to 9, wherein at least one of the one or more septa has a thickness between 0.0005 inches and 0.005 inches.

11. The medical device according to any one of claims 1 to 10, wherein the medical device is a handheld insulin pump device.

12. The medical device of any one of claims 1 to 11, wherein at least one of the plurality of sound chambers in the stacked configuration comprises a plurality of the sound tuning holes in a circular configuration.

13. The medical device according to any one of claims 1 to 12, wherein the first septum completely seals the medical device to achieve a watertight medical device.

14. The medical device according to any one of claims 1 to 13, wherein the medical device has an ingress protection rating of IP28, IP38, IP48, IP58, IP68, IPX8, IPX7, IPX6 or IPX5.

15. The medical device of any one of claims 1 to 14, wherein a heat bond adhesive is applied to seal the first septum to the outer housing, and wherein the heat bond adhesive geometry comprises an arch bridge.

16. The medical device of any one of claims 1 to 15, wherein the sound tuning holes are axially offset.

17. A method of generating an audible alarm, the method comprising: Determines that an audible alarm is to be output; as well as After determining that the audible alarm is to be output, a speaker including a vibrating membrane is caused to generate a sound, the sound propagating through the medical device through multiple sound chambers in a stacked configuration and configured to propagate the sound generated by the speaker through one or more sound tuning holes of the sound chambers, wherein in the stacked configuration, the sound propagates continuously through the multiple sound chambers, wherein the sound chambers in the stacked configuration are separated by one of one or more diaphragms, and each of the one or more diaphragms vibrates in response to the sound propagating from a first sound chamber of the corresponding sound chambers to a second sound chamber of the corresponding sound chamber, wherein an outer shell completely encloses the medical device and includes a covering layer, wherein the covering layer is configured to vibrate in response to the sound propagating through the multiple sound chambers in the stacked configuration.

18. The method of claim 17, wherein the medical device comprises the features of any one of claims 2 to 16.

19. A method of manufacturing a medical device, the method comprising: forming a first sound chamber of a plurality of sound chambers in a stacked configuration, wherein the plurality of sound chambers are configured to propagate sound generated by a speaker through one or more sound tuning holes of the sound chamber, wherein in the stacked configuration the sound propagates continuously through the plurality of sound chambers; forming a first septum of a plurality of septa within the medical device; forming a second sound chamber among the plurality of sound chambers; wherein each of the plurality of diaphragms is configured to vibrate in response to the sound propagating through the respective sound chamber, and a diaphragm of the one or more diaphragms separates the respective sound chambers in the stacked configuration and vibrates in response to the sound propagating from the first of the respective sound chambers to the second of the respective sound chambers; as well as An outer housing is formed that completely encloses the medical device, wherein the outer housing includes a cover layer, wherein the cover layer is configured to vibrate in response to the sound propagating through the plurality of sound chambers in the stacked configuration.

20. The method of claim 19, wherein at least a first sound tuning hole is separated from the speaker by a first air volume, wherein the first air volume is adjacent to the speaker and initiates a sound propagation path, a second sound tuning hole is separated from the first sound tuning hole by a second air volume, a first diaphragm, and a third air volume, the first diaphragm is in contact with the second air volume and the third air volume and is configured to vibrate, and the second sound tuning hole is separated from the second diaphragm by a fourth air volume, the fourth air volume is in contact with the second diaphragm, and wherein the second diaphragm includes the cover layer.

21. The method of any one of claims 19 or 20, wherein each sound chamber of the plurality of sound chambers comprises a respective confined air volume, and wherein each diaphragm of the respective diaphragms is configured to vibrate within the respective confined air volume.

22. The method of any one of claims 19 to 21, wherein forming at least one of the plurality of separators comprises forming at least one of the plurality of separators using polyetherimide (PEI).

23. The method of any one of claims 19 to 22, wherein forming the cover layer comprises using liquid silicone rubber (LSR).

24. The method of any one of claims 19 to 23, wherein forming at least one of the plurality of diaphragms comprises forming at least one of the plurality of diaphragms into a circular shape.

25. The method of claim 24, wherein forming at least one of the plurality of diaphragms into a circular shape comprises forming at least one of the plurality of diaphragms to have a diameter of 4 mm to 12 mm.

26. The method of any one of claims 19 to 25, wherein forming at least one diaphragm of the plurality of diaphragms comprises forming at least one diaphragm of the plurality of diaphragms to have a thickness between 0.0005 inches and 0.005 inches.

27. The method of any one of claims 19 to 26, wherein forming at least one of the plurality of sound chambers in the stacked configuration comprises forming one of the plurality of sound chambers in the stacked configuration into a plurality of sound tuning holes arranged in a circular configuration.

28. The method of any one of claims 19 to 27, wherein the first septum completely seals the medical device to achieve a watertight medical device.

29. The method of any one of claims 19 to 28, wherein the medical device has an ingress protection rating of IP28, IP38, IP48, IP58, IP68, IPX8, IPX7, IPX6 or IPX5.

30. The method of any one of claims 19 to 29, wherein forming the outer housing comprises forming a thermal bond adhesive, wherein the thermal bond adhesive is applied to seal the first diaphragm to the outer housing, and wherein the thermal bond adhesive geometry comprises an arch bridge.

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