Respiratory care system with electronic indicator

Abstract

A respiratory delivery care system is characterized by comprising: a mechanical flow indicator movable in response to a user's inhalation and / or exhalation, and an electronic indicator operable in response to an electronic signal transmitted in response to the movement of the flow indicator. The flow indicator is an inspiratory valve, an expiratory valve, or an axially movable actuator. The delivery device includes a retaining chamber wound with a coil and at least one magnet disposed at the center of the coil, the at least one magnet being reciprocating to sense current and store the current in a supercapacitor connected to the circuitry and the electronic indicator. A respiratory delivery device is characterized by comprising: a flow indicator configured to transmit a first input signal, a metered-dose inhaler in communication with the retaining chamber, a lever for actuating the inhaler and having a sensor to transmit a second input signal, and a processor for receiving these signals to generate an output signal.

Description

[0001] Cross-reference to related applications

[0002] This application is a divisional application of Chinese Patent Application No. 201780019571.1, filed with the Chinese Patent Office on March 23, 2017, entitled "Respiratory Care System with Electronic Indicator". Technical Field

[0003] This invention generally relates to a respiratory care system, and more particularly to a drug delivery device, an accessory device for the drug delivery device, or a respiratory exercise device, each equipped with an electronic indicator that provides the user or caregiver with visual, auditory, or tactile feedback regarding inhalation, exhalation, and / or completion of respiratory cycles, as well as information about the end of the lifespan of the system or device. Background Technology

[0004] Individuals with asthma, COPD, or other respiratory conditions may require medications delivered in aerosol form, inhaled into the lungs to treat or prevent their respiratory illness. In some cases, medications are administered as aerosols from nebulizers, cannulas, dry powder inhalers (DPIs), or metered-dose inhalers (MDIs). Patients with respiratory conditions may also benefit from the use of breathing exercise devices, such as oscillating expiratory pressure devices.

[0005] MDIs require users to time their inhalation upon initiation, which can be difficult for some users, particularly children. Poor coordination can lead to drug deposition in the mouth or throat instead of the lungs. To improve drug delivery from MDIs, an adjunct device such as a valved holding chamber (VHC) can be used to suspend the drug dispensed from the MDI in the chamber until the user inhales. While VHCs aid in proper drug delivery from MDIs, they can be improved, for example, by further instructing the user that the inhalation has been successful. Such feedback provides assurance to the user, whether patient or caregiver, that the patient is using the MDI and VHC correctly and thus receiving the required medication. Electronic MDIs that provide feedback to users or caregivers regarding the correct use of the MDI are known in the art. These MDIs are typically very expensive.

[0006] While various devices can provide indicators to the user that inhalation and / or exhalation is being performed, these indicators are typically located within a chamber or other component housing and may be difficult to observe due to moisture or buildup during treatment. Furthermore, many devices do not provide indications of successful treatment completion. For example, while information about flow is important, these indicators typically do not provide information about whether all medication has been delivered correctly.

[0007] In addition, many known devices have chambers that may degrade over time due to material / coating degradation, which could lead users to continue using VHC for treatment beyond the recommended time period. Summary of the Invention

[0008] To address the aforementioned technical problems, this application provides a user interface for a respiratory care system, comprising: an inlet configured to connect to a breathing device; an outlet configured to interface with a user, wherein a flow path is formed between the inlet and the outlet; a flow indicator disposed outside the flow path, wherein the flow indicator moves from a first position to a second position in response to the user inhaling, exhaling, or inhaling and exhaling through the outlet; an optical sensor pointing to and configured to sense when the flow indicator moves from the first position to the second position, wherein the optical sensor is configured to provide an input signal when the flow indicator moves from the first position to the second position; a controller configured to receive the input signal from the optical sensor and send a feedback signal; and a feedback device operable to provide feedback on inhalation flow rate in response to the feedback signal transmitted from the controller.

[0009] In some embodiments, the flow indicator can be seen by the user.

[0010] In some embodiments, the outlet includes at least one of a face shield and a mask.

[0011] In some embodiments, the feedback device includes an electronic indicator.

[0012] In some embodiments, the electronic indicator includes at least one of a visual indicator, an auditory indicator, and a vibration indicator.

[0013] This application also provides a respiratory care system, including: a breathing device; and a user interface. The user interface includes: an inlet configured to connect to the breathing device; an outlet configured to interface with the user, wherein a flow path is formed between the inlet and the outlet; a flow indicator disposed outside the flow path, wherein the flow indicator moves from a first position to a second position in response to the user inhaling, or exhaling, or inhaling and exhaling through the outlet; an optical sensor pointed to and configured to sense when the flow indicator moves from the first position to the second position, wherein the optical sensor is configured to provide an input signal when the flow indicator moves from the first position to the second position; a controller configured to receive the input signal from the optical sensor and send a feedback signal; and a feedback device operable to provide feedback on inhalation flow rate in response to the feedback signal transmitted from the controller.

[0014] In some embodiments, the outlet includes at least one of a face shield and a mask.

[0015] In some embodiments, the feedback device includes an electronic indicator.

[0016] In some embodiments, the electronic indicator includes at least one of a visual indicator, an auditory indicator, and a vibration indicator.

[0017] In some embodiments, the breathing device includes one of a valved holding chamber, an oscillating positive expiratory pressure device, a nebulizer, and a dry powder inhaler.

[0018] Various aspects and embodiments offer significant advantages over existing known devices. For example, in one embodiment, the holding chamber can be used with an MDI or other drug delivery device (e.g., a dry powder inhaler or nebulizer) and / or a breathing exercise device (e.g., a PEP device or an OPEP device) having indicators that provide electronic feedback, such as, but not limited to, visual feedback via LEDs, regarding when adequate inhalation has been achieved and / or when all medication has been inhaled and treatment is complete. Mechanical feedback can be combined with a flow indicator, where movement between a first and a second position indicates sufficient inhalation. Electronic components can be integrated into the device's components or embodied in modular components that can be mounted or connected to existing valved holding chambers or other drug delivery systems and / or breathing exercise systems. Attached Figure Description

[0019] The accompanying drawings illustrate different embodiments of the drug delivery system, block diagrams / flowcharts, and methods of its use and assembly.

[0020] Figure 1 This is a cross-sectional view of the first embodiment with a valved retaining chamber, wherein the intake valve is in the closed position and the flow indicator is in the intermediate position.

[0021] Figure 2 yes Figure 1 In the cross-sectional view of the valved retaining chamber shown, the inhalation valve is in the open position, the flow indicator is in the operable position, and the electronic indicator indicates correct inhalation.

[0022] Figure 3 yes Figure 1 The diagram shows a cross-sectional view of a valved retaining chamber, with an electronic indicator indicating the end of the valved retaining chamber's lifespan.

[0023] Figure 4 This is a cross-sectional view of a second embodiment of a valved retaining chamber, wherein the intake valve is in the closed position and the flow indicator is in the intermediate position.

[0024] Figure 5 yes Figure 3 The diagram shows a cross-sectional view of a valved retaining chamber with the inhalation valve in the open position, the flow indicator in the operable position, and an electronic indicator indicating correct inhalation.

[0025] Figure 6 yes Figure 1 The diagram shows a cross-sectional view of a valved retaining chamber, with an electronic indicator indicating the end of the valved retaining chamber's lifespan.

[0026] Figure 7 This is a schematic flowchart illustrating the operation of the electronic indicator.

[0027] Figure 8 This is a perspective view of an embodiment of an atomizer having a flow indicator and an electronic indicator.

[0028] Figure 9 This is a perspective view of an embodiment of a positive expiratory pressure device having a flow indicator and an electronic indicator.

[0029] Figure 10 This is a perspective view of an embodiment of a dry powder inhaler having a flow indicator and an electronic indicator.

[0030] Figure 11 This is a partial perspective view of a valved retaining chamber, which has a flow indicator and an electronic indicator.

[0031] Figure 12A and Figure 12B yes Figure 11 The side and top views of the valved retaining chamber are shown.

[0032] Figure 13 This is a perspective view of a releasable end assembly for a valve holding chamber, which includes a flow indicator and an electronic indicator.

[0033] Figure 14yes Figure 13 A partial cross-sectional view of the end component shown.

[0034] Figure 15 yes Figure 13 The front perspective view of the end component shown.

[0035] Figure 16 This is a magnified partial view of the end component, where the flow indicator has been removed.

[0036] Figure 17 yes Figure 13 The diagram shows a perspective view of the end assembly to which the patient interface is attached.

[0037] Figure 18 and Figure 19 yes Figure 1 The front and rear perspective views of the valved retaining chamber are shown.

[0038] Figure 20 This is a cross-sectional view of the end assembly with an electronic flow indicator.

[0039] Figure 21 yes Figure 20 An enlarged view of the end component shown.

[0040] Figure 22 This is an exploded view of the end assembly with the valve.

[0041] Figure 23 It includes Figure 22 A cross-sectional view of the drug delivery device of the end component.

[0042] Figure 24 This is an exploded view of a mask assembly with a valve.

[0043] Figure 25 yes Figure 24 A perspective view of the mask components.

[0044] Figure 26 This is an exploded view of the interface pipe with a valve.

[0045] Figure 27 yes Figure 26 A perspective view of the interface pipe.

[0046] Figure 28 This is a perspective view of an atomizer with a diaphragm.

[0047] Figure 29 yes Figure 28 The diagram shows a cross-sectional view of the atomizer.

[0048] Figure 30A and Figure 30B This is a relative view of the combined inhalation / exhalation valves.

[0049] Figure 31 It includes Figure 30A and Figure 30B The diagram shows a cross-sectional view of a drug delivery device with a valve.

[0050] Figure 32 yes Figure 31 A partial enlarged view of the device shown.

[0051] Figure 33 This is a side view of the atomizer.

[0052] Figure 34 This is a top view of the diaphragm.

[0053] Figure 35 This is a bottom view of the dial.

[0054] Figure 36 This is a side view of the retaining chamber assembly.

[0055] Figure 37 It is a section taken from line 37-37. Figure 36 The cross-sectional view of the retaining chamber assembly shown.

[0056] Figure 38 is a rear view of an intake valve for a valved retaining chamber.

[0057] Figure 39 This is a perspective view of the retainer incorporated into the valved retaining chamber.

[0058] Figure 40 This is a perspective view of the face mask.

[0059] Figures 41A to 41C It is combined with Figure 40 The front, side, and rear views of the valve in the mask shown are illustrated.

[0060] Figure 42 This is a perspective view of the mouthpiece.

[0061] Figures 43A to 43C It is combined with Figure 42 The front, side, and rear views of the valve in the interface pipe shown are illustrated.

[0062] Figure 44 This is a side view of the atomizer.

[0063] Figures 45A to 45C It is combined with Figure 44 Front, side, and rear views of the atomizer actuator in the atomizer.

[0064] Figure 46 It is a perspective view of the chamber.

[0065] Figure 47 It is used for Figure 46 A perspective view of the connector holding the chamber.

[0066] Figures 48A to 48C It is combined with Figure 46 Front, side, and rear views of the combined inhalation / exhalation valve in the retaining chamber.

[0067] Figure 49 This is a schematic diagram of a pressure gauge.

[0068] Figure 50 This is a schematic side view of an optical sensor connected to a mechanical flow indicator.

[0069] Figure 51 This is a perspective view of the flow indicator.

[0070] Figure 52 This is an exploded perspective view of one embodiment of a valved retaining chamber assembly.

[0071] Figure 53 This is an exploded perspective view of another embodiment of the valve-retaining chamber assembly.

[0072] Figure 54 This is a schematic diagram of a microprocessor used in electronic indicators.

[0073] Figure 55 This is a side view of a metered-dose inhaler applied to another embodiment of a valved retention chamber.

[0074] Figure 56 yes Figure 55 The diagram shows an enlarged exploded view of the valved retaining chamber and end components.

[0075] Figure 57 This is a schematic cross-sectional view of the actuation assist device for a metered-dose inhaler.

[0076] Figure 58A and Figure 58B This is a partial cross-sectional view of a drug delivery adapter used in a ventilator system.

[0077] Figure 59 This is a perspective view of a compressor used in conjunction with a drug delivery system.

[0078] Figure 60 This is an exploded view of the pipes and indicators.

[0079] Figure 61 This is a schematic cross-sectional view of a peak flow meter.

[0080] Figure 62 This is a cross-sectional view of one embodiment of a valved retaining chamber.

[0081] Figure 63 Is Figure 62A perspective view of the intake valve used in the valved retaining chamber.

[0082] Figure 64 This is a schematic flowchart illustrating the operation of the metered-dose inhaler's actuation assist device and valved holding chamber.

[0083] Figure 65 This is a cross-sectional view of another embodiment of the valved retaining chamber.

[0084] Figures 66A to 66C It is an enlarged partial cross-sectional view of the mechanical flow indicator and the electronic indicator array.

[0085] Figure 67 This is a flowchart illustrating the sequence of flow detection and its corresponding instructions.

[0086] Figure 68 This is a side view of a metered-dose inhaler adapter with a valved retaining chamber.

[0087] Figure 69 This is a schematic diagram illustrating a system with communication between an MDI applicator and a remote server and / or a local computing device.

[0088] Figure 70 It is shown in Figure 69 A diagram illustrating the computers and networks used in the system.

[0089] Figure 71 It is located in Figure 1 and Figure 2 Rear view of the MDI in the MDI applicator, with the lever in the raised position.

[0090] Figure 72 yes Figure 5 The image shows a front view of an embodiment of the MDI, with the MDI positioned at the actuation point in the MDI applicator.

[0091] Figure 73 This is a perspective view of another embodiment of the MDI located in the MDI applicator. Detailed Implementation

[0092] It should be understood that, as used herein, the term "a plurality of" means two or more. The term "connected" means directly or indirectly joined or joined, for example, by means of an intermediate member, and does not require the joint to be fixed or permanent, although it may be fixed or permanent. It should be understood that the use of the numerical terms "first," "second," "third," etc., as used herein does not refer to any particular order or sequence of components; for example, "first" and "second" annular housing components may refer to any order of these components, and are not limited to first and second annular housing components of a particular construction unless otherwise stated. As used herein, "respiratory care system" includes any one or more of a drug delivery device, an accessory to a drug delivery device, and a respiratory exercise device.

[0093] Referring to the accompanying drawings, various drug delivery systems include a valved holding chamber 2 with an input 12, an output 14 with a user interface 16 having an outlet 18, and an internal volume 20 defining a space between the input and the outlet. A flow indicator 22 is movable in response to a user's inhalation and / or exhalation through the outlet. An electronic indicator 220 is operable in response to an electronic signal transmitted in response to the movement of the flow indicator 22. A housing 23 surrounds the flow indicator and defines an observation window or port. The observation port may be made translucent or transparent, allowing the user to observe the movement of the flow indicator. Alternatively, the observation window containing the mechanical flow indicator 22 may be made opaque or blurred by an opaque coating or color, allowing the user to only observe the electronic indicator 220. In this latter embodiment, the user or caregiver will only see one indicator. Various respiratory care systems may include, but are not limited to, a valved holding chamber 2, a dry powder inhaler 4, a positive expiratory pressure device 6, or a nebulizer 8.

[0094] In one embodiment, such as Figures 1 to 6 , Figures 10 to 19 and Figures 50 to 53 As shown, the mechanical flow indicator 22 functions as an electrical switch when moving between a first and a second position during inhalation, for example, when a flow path (P) is generated along the inhalation path defined between the input end 12 and the output end 14 of the holding chamber 2. The MDI includes a drug canister 13 and an actuator boot 15 having an interface tube fitted within the input end 12, for example, by friction fit. In this embodiment, the mechanical flow indicator 22 may be positioned outside the inhalation path (P), but responds to flow along the flow path, for example, by generating a negative pressure. It should be understood that the flow indicator can also be configured to move during exhalation. Various aspects of the flow indicator are shown, for example but not limited to, in U.S. Patent No. 8,550,067, concerning a "visual indicator for an aerosol drug delivery device and system," the entire disclosure of which is incorporated herein by reference.

[0095] like Figures 1 to 4 , Figure 52 and Figure 53 As shown, the valved retaining chamber 2 includes a front component or patient interface 16 having an adapter 24 or baffle portion (also referred to as a retainer) releasably secured to an end of the valved retaining chamber, for example, by means of a tab. The interface tube portion 26 connects to the baffle portion, for example, by engaging an opening 30 with a tab 28. Figure 22 Figure 38 to Figure 39 , Figure 52 and Figure 53 As shown, the adapter or baffle portion includes an annular connecting collar 32 with a groove 34, a transition piece 36, and a cylindrical outlet 38. The adapter is connected to the chamber by snapping a tab 40 on the chamber into the groove 34 and then twisting the chamber housing or adapter to lock the tab in place within the groove. Optionally, the baffle portion 24 may be integrally formed to retain the end of the chamber.

[0096] An inhalation valve 241 is located on the front surface 42 of a baffle that defines a valve seat. In one embodiment, the inhalation valve is formed as an annular valve. The annular valve 241 has a central opening with an inner circumferential sealing edge 44 that seals against the valve seat 42. An outer circumferential edge 46 of the annular valve defines an exhalation valve that abuts against a valve seat 48 defined by an interface tube. Alternatively, the inhalation valve may be formed as a duckbill valve, a central column valve, a slit petal valve, and / or a flap valve. The valve may be made of a soft plastic, such as silicone or a thermoplastic elastomer.

[0097] The flow indicator 22 can be integrally connected to the intake valve, or as... Figure 51 The flow indicator is formed separately as shown. In any embodiment, the flow indicator is hinged to the valve or base 50, for example, by forming a movable hinge at their joint, or by using a hinge pin. The base 50 may be secured to a valve-retaining chamber or user interface. The elasticity of the flow indicator biases the indicator to a resting position. The flow indicator provides the user or caregiver with a visual indication that the user is inhaling. The flow indicator may be rectangular, but other shapes such as square or oval may also be suitable. For example, a visual flow indicator may have a rounded top edge, such as... Figure 23 and 51 As shown.

[0098] refer to Figure 65 and Figures 66A to 66CIn the illustrated embodiment, the mechanical flow indicator 22 is positioned within a housing 23 located at the input end of the holding chamber 2. The flow indicator may be incorporated into a rear housing 230, which is fixed to the input end of the chamber. In this embodiment, the mechanical flow indicator 22 is configured to provide a series of electrical responses, rather than a simple normally open or closed switch. In one embodiment, the flow indicator 22 is configured with or includes a flexible resistor. When the flow indicator 22 deforms (e.g., bends) to a greater extent, such as... Figures 66A to 66C As shown, the resistance changes, for example, increases (or decreases). The resistor is incorporated into the circuitry connected to the electronic indicator, shown in this embodiment as a lamp array 1040, such as LEDs, as further explained below. In this embodiment, the flow indicator is located outside the flow path P, but ambient air is entrained through an opening in the housing 23, which is either formed as part of the rear component 230 or as part of the holding chamber 2. The airflow through the indicator 22 causes the flow indicator to bend more or less depending on the flow rate or volume. As a starting point, when the system is stationary, the flow indicator is in a stationary state, as... Figure 66A As shown, the resistance of the resistor in the circuit will cause a single lamp to light up, thus providing a marker that the system is ready or not flowing. When the patient inhales, the flow rate will increase to the predetermined desired flow rate, which causes the flow indicator 22 to bend, where the resistance changes to signal the circuit to illuminate an additional lamp.

[0099] For example, a flow indicator that bends between an upper and lower limit can record a range of acceptable flow rates / volumes, where the corresponding resistance changes cause the circuitry to illuminate, for example, between two or three additional lamps. If the flow rate is too high, the flow indicator may bend beyond the acceptable range, causing additional light (e.g., different color, intensity, or flashing) to illuminate and provide feedback that the flow rate is too high. Thus, the electronic indicator provides feedback to the user and / or caregiver regarding the correct use of the device. The array of lamps can provide various markings, such as color changes (green to yellow to red) associated with acceptable boundary lines and unacceptable flow. The circuitry may include a microprocessor or may communicate with a remote computer or processor, as combined below. Figure 69 and Figure 70 As further explained, the length or duration of the inhalation sequence, or the length or duration of inhalation within a predetermined acceptable flow rate range, can also be recorded.

[0100] refer to Figure 55 and Figure 56 The embodiments, and similar to Figure 65Mechanical flow indicator 22 and electronic flow indicator 220 are housed at the input of a valved retaining chamber. In this embodiment, the rear component 820 is configured with a housing 23 that houses the flow indicator. Similarly, ambient air is drawn out through an opening in the housing, causing the flow indicator to deflect / deform / bend. The flow indicator may be a switch-off switch or contain a resistor that changes resistance to provide an input to the circuit and a signal to the electronic indicator 220, which indicates flow is occurring, for example, by suction. The flow indicator can be configured to deflect in either direction. The flow indicator and electronic indicator can also be integrated into a whistle, for example, through a slot in the rear component. By positioning the indicator at the input of the chamber, the system establishes an auxiliary flow path into the chamber while avoiding the possibility of leakage at the output / user interface. Furthermore, the electronic indicator is more visible to the user due to increased visibility.

[0101] In one embodiment, such as Figure 68 As shown, the metered-dose inhaler (MDI) includes an actuator sheath 15, a medication canister 13, and an adapter 802. The adapter 802 has an input end 804 shaped as a receiving portion 806 of the interface tube 806, and an output end 808 shaped to receive within an opening in the input end of a valved holding chamber, such as in a rear component 230. When the canister 13 is discharged, the atomized medication is discharged through the interface tube 806 and the adapter 802 and enters the valved holding chamber 2. The adapter 802 may include a housing 23 and a flow indicator 22. The adapter may be configured with an upright flange or standard / upright member 810 extending radially beyond the outer peripheral surface of the holding chamber, such that an electronic indicator 812 (e.g., a lamp) disposed on the upright member is visible to the user in the holding chamber. It should be understood that the adapter can be used without the holding chamber, and the output end 808 is configured and used as an interface tube that can be inserted into the user's mouth. The flow indicator 22, circuitry, and electronic indicator 812 function as described elsewhere herein with respect to other embodiments. Because the electronic components are integrated into the rear component in this embodiment, the rear component can be removed for cleaning, such as high-temperature cleaning like dishwashing and / or autoclaving, which avoids the need to isolate the component from heat and / or water (e.g., waterproofing). This, in turn, allows the component to be manufactured at a lower cost.

[0102] Now for reference Figure 57This illustration shows an embodiment of an MDI located in an MDI applicator 902. The MDI applicator 902 may include a lever 904 and a housing 906. The structure of various embodiments of the applicator is disclosed in U.S. Publication No. 2014 / 0318534A1, filed March 14, 2014, published October 30, 2014, entitled “Metered-Dose Inhaler Applicator,” the entire disclosure of which is incorporated herein by reference. Components may be made of various materials, including, for example, plastics used in the injection molding industry, such as polypropylene, ABS, and acetal. The lever 904 is movably connected to the housing 906, for example by pivoting about a pivot / axis or hinge, and assists the user (whether a patient or caregiver) in actuating the MDI. The housing is connected to the MDI, for example, by a stretchable seal 908. A flow indicator 22 is positioned within the housing 906, and an electronic indicator 220 is disposed within the housing and visible to the user. Electronic circuitry is further disposed within the housing. Airflow can be entrained through various openings 911 and 913 in the housing, for example... Figure 57 As shown, the flow indicator 22 is moved by being embedded in the top of the shell above the tank or along the side of the shell, and a related signal is sent to the electronic indicator.

[0103] See Figures 71 to 73 As shown, the MDI sheath 15 can be positioned within the applicator 902. The lever 904 is then rotated or pivoted relative to the housing about a pivot axis to a resting position, with the post 934 of the lever 904 positioned against the end of the MDI canister 13. Force can be applied to the lever 904 of the MDI applicator 902, which pivots relative to the housing and the MDI about a pivot axis. The pivoting motion of the lever 904 and post 934 converts the force applied to the lever 904 into a downward force against the MDI canister 13. When the downward force against the MDI canister 13 causes the stem of the MDI to fully compress to open the internal valve of the MDI, the medication within the canister is atomized through the stem and flows from the nozzle of the MDI for inhalation by the patient. The pivot axis is oriented substantially perpendicular to the interface tube or perpendicular to the axis defined by the flow path from which it flows. When sufficient force is applied to the canister 13 of the MDI via lever 904, the MDI dispenses the nebulized medication, for example, through the interface tube, or into the valved holding chamber 2, which can then be inhaled by the patient.

[0104] Specifically, when lever 904 is depressed, the canister 13 of the MDI is forced into actuator sleeve 15, which in one embodiment has a well to receive a valve stem. Once the canister has been sufficiently propelled into sleeve 15, the valve stem is depressed by the well until the valve opens, thereby releasing a dose of the nebulized medication. The MDI may be configured with a dose counter 930, such as a mechanical or electronic dose counter, which records the number of canister actuations.

[0105] refer to Figure 72 In the illustrated embodiment, the lever is pivotally connected to the housing about an axis oriented parallel to or at an acute angle to the flow path axis. This alternative lever position provides improved comfort for at least some users.

[0106] Movement of lever 904 relative to housing 906, can 13, or protective cover 15 provides input to an electronic actuation indicator / tracker, which signals and / or records that actuation of the can has occurred. For example, in Figure 71 and Figure 72 In the illustrated embodiment, a conductive portion (e.g., strip 935) is disposed on the surface of the lever and leads to a microcontroller 940, which may be housed in a housing 942. The lever also includes a conductive portion (e.g., strip 936) leading to a battery 944, which may also be housed in the housing 942. The conductive portion (e.g., strip 932) is disposed on the housing 906, or optionally on a can or protective cover. It should be understood that the lever and housing may include other conductive properties, or be integrally formed of a conductive material, isolated at attachment points by an insulator, or include various conductive portions, whether applied as separate components or integrally formed. The housing 942 may be disposed in and connected to the lever 904. It should be understood that strips 935, 936, and housing 942, as well as battery 944 and controller 940, may be disposed on or connected to housing 906, protective cover 15, or can 13, and strip 932 is disposed on the lever. When the lever is in the raised and / or stationary position, strips 932, 935, and 936 function as (normally open) switches, such as... Figure 71 and Figure 72 As shown. When the lever pivots to the actuated position, strip 932 contacts and is electrically connected to strips 935 and 936, and strips 932, 935, and 936 act as a closed switch. The completion of circuits 936, 932, and 935 signals the microcontroller to record the actuation of the MDI and obtain a timestamp associated with the actuation, storing the data on onboard memory, or transmitting the data to a remote server or local computing device, as further described below. The switch closes (or opens) when the lever has moved a predetermined minimum distance. The switch can alternatively be configured as a limit switch, wherein the switch is activated only when the lever has traveled a certain distance or pivoted a certain angle. The switch can be toggled by contacting the housing, the MDI can, and / or the actuator.

[0107] The applicator may also be configured with an electronic indicator, such as an LED located on one of the levers or housings, providing a marker that actuation has occurred. Activation of the circuit by closing a switch can utilize a low-power circuit (e.g., a controller) enclosed within a portion of the lever or housing to initiate the electronic circuitry. Conductivity can be specific to small areas of the lever and housing, such as a thin strip or other geometry, or the entire end of the housing may be conductive. Alternatively, the system uses capacitive sensing to determine when the lever has reached the actuated position. Feedback from the electronic indicator indicates that sufficient actuation has been achieved.

[0108] In other embodiments, the switch may be a normally closed switch that activates the circuit when the switch is opened (e.g., when the lever pivots). Activation may also be detected by a pressure sensor, capacitive sensor, inductive sensor, or other proximity sensor or switch. Upon reaching a predetermined second position, the conductivity of the lever and / or housing acts as a switch (whether open or closed) to activate electronic feedback using a low-power circuit located on the lever, housing, or MDI, enclosed by housing 942. The switch on the mating surface may be configured as two small conductive contacts or conductive pads formed from an encapsulated, potted, conformally coated, or hermetically sealed printed circuit board (PCB). If a capacitive sensing is used to create the switch, the sensor within the package is a small pad and a ground pad that is minimally matched to the PCB size to improve sensor sensitivity. The ground pad may be incorporated within the package or formed via a conductive path from a conductive area of ​​the indicator or MDI component. A human body may come into contact with the conductive path and act as a ground while holding the applicator.

[0109] Electronic components may be integrated into the device's components or embodied in modular parts or housing 942 that can fit into any MDI or applicator. In either case, the electronic components are encapsulated, packaged, conformally coated, or sealed within housing 942. It should be understood that, in various embodiments, the circuitry is not visible to the user or caregiver.

[0110] refer to Figure 73 In an alternative embodiment, housing 906 is configured with an IR detector 962 and an emitter 960. When the can is in a stationary position, infrared radiation is emitted from the emitter 960 along a radiation path, reflected from the can 13 along the radiation path, and detected by the detector 962. When the MDI is activated, the can moves downwards in response to a force from lever 904 until the can is no longer in the radiation path. In other words, in the actuated position, the can 13 is no longer in the position reflecting the infrared radiation path, and the change in the signal from the detector 962 is used to infer activation.

[0111] In another embodiment, the transmitter 960 and detector 962 may be positioned 180 degrees apart from each other, with the can 13 disrupting the radiation beam between them. In this embodiment, when the lever and can are in a stationary position, the detector 962 does not detect radiation emitted from the transmitter 960. During actuation, the can moves out of the path, causing the detector 962 to detect the radiation beam from the transmitter 960, and thus sense and send a signal associated with the actuation of the MDI. Embodiments and configurations of light curtains and reflection / proximity sensing are also suitable.

[0112] Referring to an alternative embodiment, a force sensor is disposed on the lever. The force sensor can function as column 934, or can be integrated into the column. Actuation of the MDI occurs with a fairly consistent force. Therefore, the force sensor can be associated with the actuation force and send a signal when the lever pivots to apply such a force. For example, actuation is recorded / registered once the sensor records or detects a certain threshold. As described above, the microcontroller, battery, and housing can be integrated into the lever. Alternatively, the force sensor can be applied to housing 906 or the MDI and communicate electronically with its associated electronics.

[0113] It should be understood that different modules and embodiments can record and register actuation individually and cumulatively, including the time and date of actuation, and / or the location when the device is configured with and / or associated with a GPS module, which may be embedded in or installed with the microcontroller. The accumulated data can be analyzed to provide feedback on when and how the device is used, and / or to comply with specific delivery protocols prescribed by caregivers.

[0114] To provide faster and more accurate processing of sensor data generated within the MDI applicator, the data can be wirelessly transmitted to smartphones, local computing devices, and / or remote computing devices for interpreting and manipulating the raw sensor data.

[0115] See Figure 64 For example in Figures 71 to 73 The MDI applicator 902 disclosed herein can be used with a retaining chamber (e.g., Figures 1 to 5 Used together, the retaining chamber is equipped with a flow indicator. The MDI applicator 902 can be configured with a module as described above, which individually and cumulatively records and registers actuation, including the time and date of actuation, and / or the location when the device is configured with and / or associated with a GPS module, which may be embedded in or mounted with a microcontroller disposed on or within the housing. The accumulated data can be analyzed to provide feedback on when and how the device is used, and / or to comply with specific delivery protocols prescribed by caregivers.

[0116] To provide faster and more accurate processing of sensor data generated within an MDI applicator or other device disclosed herein (e.g., a holding chamber, a peak flow meter, a dry powder inhaler, a nebulizer, etc.), the data can be wirelessly transmitted to a smartphone, a local computing device, and / or a remote computing device to interpret and manipulate the raw sensor data.

[0117] See Figure 64 , Figure 69 and Figure 70 As shown, the MDI applicator 902 or other device (e.g., a holding chamber, peak flow meter, dry powder inhaler, nebulizer, etc.) includes circuitry for transmitting raw sensor data in real time to a local device (e.g., a smartphone). The smartphone can display graphics or instructions to the user and execute processing software to interpret and manipulate the raw data. The smartphone may include software that filters and processes the raw sensor data and outputs relevant status information contained in the raw sensor data to a display on the smartphone. Alternatively, the smartphone or other local computing device may use its local resources to contact a remote database or server to retrieve processing instructions or forward raw sensor data for remote processing and interpretation, and receive processed and interpreted sensor data returned from the remote server for display to the user or a caregiver accompanying the smart MDI applicator.

[0118] In addition to simply displaying data, statistics, or instructions on a smartphone or other local computer near the MDI applicator or other device (e.g., holding chamber, peak flow meter, dry powder inhaler, nebulizer, etc.), active management and control of operations related to the MDI applicator can be achieved. For example, if a smartphone or other local computer or other device (e.g., holding chamber, peak flow meter, dry powder inhaler, nebulizer, etc.) near the MDI applicator determines that sensor data indicates a dose has been administered, the smartphone or other local computing device can communicate that information to the user or caregiver.

[0119] In other implementations, real-time data collected in a smart MDI applicator or other device (e.g., a holding chamber, peak flow meter, dry powder inhaler, nebulizer, etc.) and relayed via a smartphone to a remote server can trigger the remote server to track and notify physicians or supervising caregivers about issues in a particular session or patterns in a particular user's past sessions over time. Based on data from one or more sensors in the smart MDI applicator or other device (e.g., a holding chamber, peak flow meter, dry powder inhaler, nebulizer, etc.), the remote server can generate alerts to be sent to the user's physician or other caregiver via text, email, or other electronic communication media. Whenever a mobile device (e.g., a phone, tablet, laptop, etc.) is within range for data synchronization, data can be uploaded to a mobile application via wireless communication (e.g., Bluetooth). The data is then analyzed on the application and presented to the user in a manner conducive to user / patient engagement and compliance. Data can also be forwarded to a cloud service via WiFi or a mobile network so that other caregivers, healthcare providers, and / or payers (e.g., insurance companies) can review the data.

[0120] By combining the applicator 902 with a valved holding chamber equipped with an electronic indicator 220, a more accurate calculation of the end of treatment can be provided to the user or caregiver. For example, as Figure 7 and Figure 64 As shown, the applicator 902 or microcontroller 940 records the actuation of the MDI and transmits this information to the processor or sends a signal to the processor, for example, via wireless communication. In other embodiments, the applicator and the valved retaining chamber can communicate via a direct communication link, such as hardwiring when the applicator is inserted into the valved retaining chamber. In operation, the mechanical flow indicator 22 provides an input or transmitted signal regarding the initiation of inhalation by closing a switch or actuating another sensor, as described above. This information is transmitted to the microcontroller (MCU) or microprocessor. An internal clock records the time, while the processor identifies whether MDI actuation has occurred via communication of a signal from the applicator 902. If actuation has not occurred, the internal clock cycles and / or calculates the actuation time, such that data on the length of inhalation through the valved retaining chamber (which causes the associated flow indicator to move or deform and send a signal) and the length of inhalation after the MDI has been actuated are collected. Once MDI actuation has occurred, as recorded by the applicator 902 and controller 940, volumetric calculations are performed using the data on the inhalation flow before and after actuation, and electronic feedback is provided. In this way, feedback is provided regarding the completion of treatment or the inhalation of sufficient volume after MDI actuation. Data can also be collected and communicated to healthcare providers, as noted.

[0121] The electronic circuitry in an MDI applicator or other device (e.g., a holding chamber, peak flow meter, dry powder inhaler, nebulizer, etc.) may include some or all of the capabilities of computer 500 to communicate with network 526 and / or directly with other computers. For example... Figure 69 and Figure 70 As shown, computer 500 may include processor 502, storage device 516, display or other output device 510, input device 512, and network interface device 520, all of which are connected via bus 508. The computer can communicate with a network. Processor 502 represents a central processing unit of any type of architecture, such as CISC (Complex Instruction Set Computing), RISC (Reduced Instruction Set Computing), VLIW (Very Long Instruction Word), or hybrid architecture, although any suitable processor may be employed. Processor 502 executes instructions and includes the portion of computer 500 that controls the operation of the entire computer. Although not explicitly stated... Figure 70 As shown, processor 502 typically includes a control unit that organizes data and program storage in memory and transfers data and other information between various parts of computer 500. Processor 502 receives input data from input device 512, and network 526 reads and stores instructions (e.g., processor-executable code) 524 and data in main memory 504, such as random access memory (RAM), static memory 506, such as read-only memory (ROM), and storage device 516. Processor 502 can present data to a user via output device 510.

[0122] Although computer 500 is shown as containing only a single processor 502 and a single bus 508, the disclosed embodiments are equally applicable to computers that may have multiple processors and computers that may have multiple buses, some or all of which perform different functions in different ways.

[0123] Storage device 516 represents one or more mechanisms for storing data. For example, storage device 516 may include computer-readable media 522, such as read-only memory (ROM), RAM, non-volatile storage media, optical storage media, flash memory devices, and / or other machine-readable media. In other embodiments, any suitable type of storage device may be used. Although only one storage device 516 is shown, multiple storage devices and various types of storage devices may be present. Furthermore, although computer 500 is drawn to include storage device 516, it may be distributed across other computers, such as on a server.

[0124] Storage device 516 may include a controller (not shown) and a computer-readable medium 522 having instructions 524 executable on processor 502 to perform the functions described below: processing sensor data, displaying sensor data or instructions based on sensor data, controlling aspects of a smart MDI applicator or other device (e.g., a holding chamber, peak flow meter, dry powder inhaler, nebulizer, etc.) to change its operation, or contacting third parties or other remote resources to provide updated information to or retrieve data from such remote resources. In another embodiment, some or all of the functions are performed by hardware instead of a processor-based system. In one embodiment, the controller is a web browser, but in other embodiments, the controller may be a database system, a file system, an email system, a media manager, an image manager, or may include any other functionality capable of accessing data items. Storage device 516 may also contain additional software and data (not shown), which are not essential for understanding the invention.

[0125] Output device 510 is the part of computer 500 that displays output to the user. Output device 510 can be a liquid crystal display (LCD), well-known in the field of computer hardware. In other embodiments, output device 510 can be replaced by a gas or plasma-based flat panel display or a conventional cathode ray tube (CRT) display. In other embodiments, any suitable display device can be used. Although only one output device 510 is shown, in other embodiments, any number of different or the same type of output devices can be present. In one embodiment, output device 510 displays a user interface. Input device 512 can be a keyboard, mouse or other pointing device, trackball, touchpad, touchscreen, keypad, microphone, voice recognition device, or any other suitable mechanism for the user to input data into computer 500 and manipulate the aforementioned user interface. Although only one input device 512 is shown, in another embodiment, any number and type of input devices can be present.

[0126] Network interface device 520 provides connectivity from computer 500 to network 526 via any suitable communication protocol. Network interface device 520 sends and receives data items from network 526 via wireless or wired transceiver 514. Transceiver 514 can be any of cellular frequency, radio frequency (RF), infrared (IR), or multiple known wireless or wired transmission systems capable of communicating with network 526 or having [other communication protocols]. Figure 2The example computer communicates with other intelligent devices 102 using some or all of its features. Bus 508 may represent one or more buses, such as USB, PCI, ISA (Industry Standard Architecture), X-Bus, EISA (Extended Industry Standard Architecture), or any other suitable bus and / or bridge (also known as a bus controller).

[0127] Computer 500 can be implemented using any suitable hardware and / or software, such as a personal computer or other electronic computing device. Computer 500 can be a portable computer, laptop computer, tablet computer, notebook computer, smartphone, PDA, pocket computer, appliance, telephone, and mainframe computer are other possible configurations of computer 500. Network 526 can be any suitable network and can support any suitable protocol suitable for communicating with computer 500. In one embodiment, network 526 can support wireless communication. In another embodiment, network 526 can support hard-wired communication, such as telephone lines or cables. In another embodiment, network 526 can support the Ethernet IEEE (Institute of Electrical and Electronics Engineers) 802.3x specification. In another embodiment, network 526 can be the Internet and can support IP (Internet Protocol). In another embodiment, network 526 can be a LAN or WAN. In another embodiment, network 526 can be a hotspot service provider network. In another embodiment, network 526 can be an intranet. In another embodiment, network 526 can be a GPRS (General Packet Radio Service) network. In another embodiment, network 526 can be any suitable cellular data network or cell-based radio network technology. In another embodiment, network 526 can be an IEEE 802.11 wireless network. In yet another embodiment, network 526 can be any suitable network or combination of networks. Although one network 526 is shown, in other embodiments, any number of networks (of the same or different types) can exist.

[0128] It should be understood that the various techniques described herein can be implemented in combination with hardware or software, or, where appropriate, with a combination of both. Therefore, the methods and apparatus of the currently disclosed subject matter, or certain aspects or parts thereof, can take the form of program code (i.e., instructions) contained in a tangible medium, such as a floppy disk, CD-ROM, hard disk, or any other machine-readable storage medium, wherein when the program code is loaded into and executed by a machine such as a computer, that machine becomes an apparatus for practicing the currently disclosed subject matter. In the case of executing program code on a programmable computer, the computing device typically includes a processor, a storage medium (including volatile and non-volatile memory and / or storage elements) readable by the processor, at least one input device, and at least one output device. One or more programs can execute or use the processes described in connection with the subject matter of this disclosure, for example, through the use of APIs, reusable controls, etc. These programs can be implemented in high-level procedural or object-oriented programming languages ​​to communicate with a computer system. However, if desired, the programs can be implemented in assembly language or machine language. In any case, the language can be a compiled or interpreted language and can be combined with a hardware implementation. While exemplary embodiments may refer to the use of aspects of this disclosure in the context of one or more independent computer systems, this disclosure is not limited thereto and can be implemented in conjunction with any computing environment (e.g., a networked or distributed computing environment). Furthermore, aspects of the currently disclosed subject matter can be implemented in or across multiple processing chips or devices, and storage can be similarly distributed across multiple devices. For example, such devices may include personal computers, web servers, and handheld devices.

[0129] See Figure 58A and Figure 58B The document illustrates adapters 1000 and 1002 for a ventilator circuit, wherein the adapter is inserted into a flow path between the ventilator and the user interface. The structure of the adapter is disclosed in U.S. Publication No. 2014 / 0360498, filed March 14, 2014, and published December 11, 2014, entitled “Ventilator Circuit, Adapter for Ventilator Circuit and Method of Use Thereof,” the entire disclosure of which is incorporated herein by reference. Adapters 1000 and 1002 include drug delivery ports 1004 and 1006 adapted and configured to receive drug delivery devices, including, but not limited to, inhaler 1008 and nebulizer 1010. Adapters 1000 and 1002 are configured with a mechanical flow indicator 22 disposed in the flow path. The adapter may be configured with an electronic indicator 220, such as a light, disposed on an outer surface of the adapter such that the indicator is visible to the user or caregiver. The flow indicator 22, the circuitry, and the electronic indicator 220 function as described herein with respect to other embodiments.

[0130] In a ventilator circuit, medication delivery is preferably performed at the start of the inspiratory cycle, which may be difficult for caregivers to determine solely by listening to the ventilator machine. Indicator 220 provides greater certainty and helps prevent medication delivery from being performed during expiration. In operation, the medication delivery devices 1008, 1010 are actuated when the user-visible mechanical indicator 22 moves and / or when the electronic indicator 220 provides a marker, for example, through illumination. Indicator 22 may be made of silicone and may operate as a switch (normally open or normally closed), or may be configured with a flexible resistor in the circuit, as described elsewhere herein. As shown, when such an adapter is in its normal operating position, indicator 22 is positioned above or extending downwards from the adapter to prevent medication from pooling or accumulating on indicator 22.

[0131] See Figure 59 and Figure 60 As shown, the compressor 1020 or the duct 1022 connected to the compressor or other air supply may be equipped with a mechanical flow indicator that moves or deforms in response to fluid flow (P) (whether gas or liquid). The flow indicator 22 is connected to a circuit that, when actuated, provides a signal to an electronic indicator 220. The electronic indicator provides the user with a marker indicating that flow is occurring. Figure 59 As shown, the flow indicator 22 is embedded in the flow path of the compressor 1020, while the electronic indicator 220 is located on or in the compressor and is visible to the user if it is manifested as a visual indicator.

[0132] like Figure 60 As shown, the flow indicator can be positioned in a connector or adapter having an insertion portion received in an end 1026 of the conduit 1022 and a receiving connector portion 1028 shaped and configured to connect to the same means as the end 1026 of the conduit. Alternatively, the flow indicator can be positioned directly in the conduit 1022 and operatively connected to an electronic indicator, either via direct circuitry or wirelessly.

[0133] See Figure 61As shown, the peak flow meter 1050 is equipped with a mechanical flow indicator 22, such as a flow indicator with a flexible resistor. Flow rate causes the indicator to deflect and the resistor to deform or bend by a change in amount. The amount of deflection or deformation can be correlated with a changing display via electronic indicators (e.g., an array of LEDs 1040; more LEDs are illuminated as flow rate increases). Indicator 1040 can also be configured with lights of different colors, providing markings for different flow levels. Usage data can also be collected and tracked, and connected to a computer or smartphone application, as described above regarding the MDI applicator, allowing the data to be shared with patients, caregivers, or other healthcare providers.

[0134] In one embodiment, such as Figure 24 , Figure 25 and Figures 40 to 41A As shown, the patient interface includes a mask 52 secured to an adapter 62, which in turn can be secured to an end of a valve-retaining chamber or baffle portion. The mask includes an exhalation valve 54, which serves as a flow indicator. Other patient interfaces may include, for example, but not limited to, various interface tubes, masks, endotracheal tubes, etc. The valve may have a central post 56 that engages an opening on the mask and secures the valve to the mask. A protective shield or cover 58 may be provided around the valve. The exhalation valve 54 is inserted into and attached to an outlet formed in the nasal receiving area of ​​the mask. Examples of various mask and exhalation valve embodiments are disclosed in U.S. Patent Nos. 5,988,160 and 5,645,049, the entire disclosure of which is incorporated herein by reference. A cylindrical input port 60 of the mask is placed on the outlet port of the adapter and attached thereto by an interface that engages with a channel or corresponding rib on the mask 52 via a friction fit or through a rib 64 formed on the input port.

[0135] See Figure 26 , Figure 27 and Figures 42 to 43C As shown, for example, it can be incorporated into a dry powder inhaler ( Figure 10 ), atomizer ( Figure 8 ) or oscillating positive expiratory pressure device ( Figure 9 The interface tube 70 includes an exhalation valve 72 fixed to an opening 74 in the interface tube, which defines a valve seat 76. The valve is configured with two flaps 78, such as a butterfly valve in one embodiment, and a central post or protrusion 82 extends through the opening 80 in the valve and secures it to the outside of the interface tube. A protective element (not shown) may be provided above the valve to prevent tampering.

[0136] See Figure 28 , Figure 29 , Figures 33 to 35 and Figures 44 to 45CAs shown, the atomizer 90 includes a chamber 92, a diaphragm 96, and a dial 98 disposed on top of the actuator 94. The actuator 94 and the dial 98 move axially along axis 107 during inhalation. The bottom 104 of the dial 98 engages the inner periphery of the diaphragm 96, and the bottom 102 of the actuator has a surface that engages with the nozzle cap 100 as the actuator moves axially downward during inhalation.

[0137] See Figures 30A to 32 and Figures 46 to 48C Another embodiment of a valved retaining chamber 110 is shown, which can be used, for example, but not limited to, a ventilator circuit. The valved retaining chamber has a connector assembly 112 that defines a ventilator port. The connector has a first channel and second channels 114, 116 separated by a wall 118. An integrally formed inspiratory / expiratory valve 120 has a pair of flaps 122, 124 extending in opposite directions from a base 126. The connector has a valve seat 128 for the inspiratory valve 122, while the chamber has a valve seat 130 for the expiratory valve 124. Various aspects of the valved retaining chamber and connector are disclosed in U.S. Patent No. 8,875,706, the entire disclosure of which is incorporated herein by reference.

[0138] It should be understood that the various components of the aforementioned drug delivery device are flow indicators, particularly mechanical flow indicators, which move dynamically in response to flow. These components, whether visible or not, provide indications of flow, whether during inhalation or exhalation. The user and / or caregiver may or may not see the various components. Movement of the flow indicator provides input to the electronic flow indicator that sufficient inhalation has occurred. For example, the number of movements of the flow indicator 22, whether during inhalation or exhalation (or both), during a respiratory cycle (defined as the number of breaths (N) taken during drug administration), or the cumulative duration (T) of the flow indicator's positional changes during a respiratory cycle, provides input to the circuitry associated with adequate inhalation. Specifically, a predetermined number or duration (whether singular or cumulative) of contacts or sufficiently close contacts between the flow indicator 22 and the support or contact point provide input to and actuate the electronic indicator, for example, by displaying a green light or other markings. If the number of movements of the flow indicator or its duration (singular or cumulative) is not reached, or if sufficient contact or proximity contact is not achieved, the electronic circuitry will not activate the electronic indicator, or may activate the electronic indicator to indicate inadequate drug administration, for example by displaying a yellow or red light, an audible signal, vibration (e.g., tactile) or other markings.

[0139] For example, in one embodiment, such as Figures 1 to 6 , Figures 11 to 21 and Figures 51 to 53As shown, the visual flow indicator 22 defines a mechanical flow indicator with a conductive strip 130 or other conductive properties that, when sealed onto the seat 132, act as a (normally open) switch to close the circuit. The circuit is activated by closing the switch, thereby initiating electronic feedback using low-power circuitry enclosed within a portion of the user interface (e.g., an interface tube or mask adapter). The conductivity can be specific to a small area of ​​the flow indicator, such as a thin strip or other geometry, or the entire surface of the flow indicator can be conductive. Alternatively, the system uses capacitive sensing to determine when the flow indicator reaches a second position corresponding to a predetermined flow rate. Feedback from the electronic indicator 220 indicates that sufficient inhalation flow rate has been achieved and / or that the volume calculated based on the respiratory rate and / or the minimum flow rate required to seal the mechanical flow indicator and / or the length of time the seal (switch) is maintained has been completed for appropriate treatment. The minimum flow rate required to seal the mechanical flow indicator can be between 3 and 5 L / min.

[0140] In other embodiments, the switch may be a normally closed switch that activates the circuit when the switch is open, such as when the inhalation or exhalation valve (flow indicator) is operated. Similarly, the number of movements of the flow indicator (e.g., the inhalation or exhalation valve or actuator) or the duration of the switch's open position can be directed to the circuit ( Figure 54 The circuit provides an input indicating that sufficient drug delivery has been achieved, and then activates the electronic indicator. For example, and refer to... Figure 22 , Figure 23 , Figures 38A to 38C , Figure 39 , Figures 46 to 48C , Figure 62 and Figure 63In the illustrated embodiment, the mechanical flow indicator is defined by intake valves 241, 122, and 1060, which can serve as inputs or switches for electronic feedback. Similarly, the intake valves can be configured with regions 150 and 152 or with conductive materials, such as surrounding the inner or outer periphery 33 of the annular valve, or along the free end 154 of the intake valve disc 122, which mates with mating surfaces, such as valve seats 42 and 128, thereby forming part of an electronic circuit, for example, in a baffle, also with conductive material. In this embodiment, when valves 241 and 122 are in the closed position, flow is insufficient and there is no electronic feedback. For example, during intake, once the valve (normally closed switch) moves to the open position and is no longer in contact with the baffle or valve seat (which, when closed, contacts the valve or valve seat), electronic feedback is activated. In the latter case, movement detection can be performed by a pressure sensor, capacitive sensor, inductive sensor, or other proximity sensor or switch. Upon reaching the predetermined second position, the indicator's conductivity acts as a switch, whether open or closed, to initiate electronic feedback using a low-power circuit enclosed by housing 160 on the chamber housing, interface tube, mask adapter, or other components. The switch on the sealing surfaces 42, 128 of the flow indicator mating in its second position can be configured as two small conductive contacts or pads formed from an encapsulated, packaged, conformally coated, or sealed printed circuit board (PCB) or microcontroller 261.

[0141] If capacitive sensing is used to create a switch, the sensor within the package should have a diameter of no more than 25mm. 2 A small pad in the sensing area and a grounding pad that is minimally matched to the size of the PCB are used to increase the sensor's sensitivity. This grounding pad can be integrated within the package or formed via a conductive path along the chamber body from the conductive area of ​​the indicator. The human body can contact the conductive path while gripping the chamber and act as a ground.

[0142] like Figure 62 and Figure 64 As shown, the mechanical flow indicator is configured as a duckbill valve 1060, which has a pair of vanes 1064 that open in response to flow through the valve to form a central opening 1062. This valve provides unidirectional flow control. The valve disc 1064 may have a conductive strip 1066 in contact, and the valve is normally closed such that opening the valve prompts a circuit to recognize flow and send a signal to an electronic indicator 220 and / or record the opening in a database. Alternatively, the valve disc 1064 may be provided with a flexible resistor 1068 that deflects with the valve disc, providing a marker of flow occurrence in the circuit that signals the electronic indicator 220, for example, through illumination. Alternatively, the sensor may be configured as a capacitive sensor.

[0143] The electronic components in various embodiments may be integrated into the components of the device or embodied in a modular component or housing 160 that can be adapted to any valved holding chamber (or other respiratory device). In either case, the electronic components are encapsulated, packaged, conformally coated, or sealed in an area preferably between 25×25×5mm (L×W×H) and 45×45×20mm (L×W×H). It should be understood that electronic indicators and flow indicators may be incorporated into a removable patient interface, such as a mask, interface tube, adapter, etc., which can be used by the same patient / user with more than one respiratory care system. It should be understood that in various embodiments, the circuitry is not visible to the user or caregiver.

[0144] Other embodiments of the mechanical flow indicator include exhalation valves 54, 72, 124 on a mask, interface tube, or connector, which function as switches (normally open or normally closed) as described above. In each of these embodiments, the valve (or other moving member) is conductive where regions 180 (outer periphery of valve 54), 182 (periphery of valve 72), and 184 (free edge of valve disc 124) contact sealing surfaces 181, 76, whether in a normally open or closed configuration, and also has conductive material or regions. While maintaining contact, the switch opens or closes (depending on desired feedback), and the switch changes state when flow is possible to overcome the valve (or other moving member). Alternatively, a proximity sensor or switch may be incorporated into the chamber receiving the MDI canister to provide indication of canister full insertion into the device. Figure 50 As shown, when the flow indicator 22 has moved to the second position, the optical sensor 190 can be provided to send a signal 192, wherein the sensor 190 provides an input to the circuit. (Reference) Figure 31 , Figure 32 and Figures 46 to 48C As shown, either of the multipurpose inspiratory / expiratory valves 122 and 124 on the chamber may be configured with conductive material or areas 152 and 184 that close during inspiration and / or expiration. The chamber can be used in conjunction with mechanical ventilation, a manual resuscitation bag, or a standard aerosol resuscitation mask.

[0145] Or, such as Figure 28 , Figure 29 and Figures 33 to 35 As shown, the bottom 104 of the dial and the inner periphery 106 of the diaphragm on the atomizer can be configured with conductive material or areas that complete the switching upon contact, for example, during inhalation when the actuator moves axially downward. Alternatively, as... Figures 44 to 45C As shown, the bottom surface of the actuator has a conductive material or area that comes into contact with the conductive material or area on the muzzle cover 100 when the actuator moves axially, thereby turning the switch on or off as described above.

[0146] In other embodiments, such as Figure 49 As shown, the piston 200 on the pressure gauge can be configured with a magnetic or conductive material or region, providing input to an electronic indicator relative to the variable output of pressure. The various steps performed by the system are... Figure 7 The block diagram / flowchart is shown. Sensor or switch inputs can also be associated with mechanical feedback and transmit the information to the microcontroller unit 261. Also... Figure 3 , Figure 12A and Figure 12B , Figure 13 , Figure 20 and 22 The microcontroller 261 shown controls the electronic feedback output and sends signals to the electronic indicator (e.g., LED) 220, and can provide the output as disclosed herein. The light tube can diffuse the light from the LED. A battery 521 provides power to the circuit.

[0147] Users can clean the entire system without special attention to the electronics, which can also be configured to withstand the heat of the washer. Alternatively, the electronics can be removed before washing or exposure to heat. In one embodiment, the battery chemicals are lithium button batteries, particularly lithium polycarbonate fluoride, which are specifically designed to operate at temperatures up to 125°C with an annual degradation rate as low as 0.5% and a relatively flat discharge voltage profile. Incorporating sufficient thermal insulation properties into the encapsulation material allows the entire device to withstand an autoclaving process.

[0148] In alternative embodiments, such as Figures 36 to 37 As shown, linear induction can be used to generate power for the circuit, thus eliminating the need for a battery. The linear generator consists of one or more neodymium magnets 210 that reciprocate back and forth along (or parallel to) a longitudinal axis 51 or within a central space defined by a copper coil 212 wound around the axis 51 when the chamber 602 is shaken. This shaking is necessary before actuating the MDIs 13, 15 and does not imply an additional step in the drug delivery process. The shaking induces a current in the coil 212, which is stored in a supercapacitor 214 to power the circuitry connected to the electronic indicator 220.

[0149] When the device is first removed from its packaging, an internal timer on the device will be activated. For example, a light sensor (or other sensor) will activate the internal clock to begin tracking elapsed time. Alternatively, the timer may be activated upon first use. The device will function as described herein for the device's predetermined recommended lifespan, determined by the timer, at which point the electronic indicator will cease operation or generate a warning signal different from the previously seen signal indicating completion of previous inhalation and / or treatment. This warning signal (e.g., a red LED) will indicate to the user that it is time to clear the chamber. Nevertheless, the mechanical flow indicator will continue to function beyond the predetermined recommended lifespan (e.g., 1 year) to avoid diminishing the safe use of the device.

[0150] The user interface (including, for example, the interface tube or mask adapter, retaining chamber, and retainer) can be made of transparent antistatic material (ABS). The rear component 230, which engages with MDI 13, 15, can be made of ultra-soft thermoplastic elastomer. The intake valve can be made of silicone. The mechanical flow indicator can be made of silicone with magnetic or conductive properties, including conductive areas made of conductive silicone, metal foil, or conductive coating / ink. The conductive material can be silver oxide, carbon black, aluminum, or other known conductive materials. Electronic devices such as the microcontroller 261 can be conformally coated, sealed, or encapsulated in silicone, epoxy, polyurethane, hot melt, or other heat-resistant materials.

[0151] In one embodiment, the electronic indicator 220 is a visual indicator (e.g., an LED or LCD display) that provides electronic feedback. Other electronic indicators may be used, such as audible signals or feedback, such as a buzzer, an LED sequence, or other visual cues displaying the percentage of treatment completion (e.g., an LED bar graph), a segmented digital display showing the percentage of treatment completion, an LED or OLED screen displaying the progress or digital representation of remaining flow or volume, or possible connectivity and communication with a smartphone app via Bluetooth Low Energy (BLE) to display data from inhalation or to incorporate flow data into a game.

[0152] In operation, such as Figure 67As shown, when an MDI or other drug delivery device is actuated, the drug fills the chamber, for example, when the inhalation valve is closed. The mechanical flow indicator, whether configured alone or defined by the inhalation valve or actuator, is in an intermediate position because no inhalation has occurred. Therefore, the electronic indicator (e.g., an LED) is off because no feedback is provided. When the user begins to inhale, the inhalation valve opens, creating a negative pressure and moving the mechanical flow indicator forward from a first position to a second position until the flow indicator forms a seal with the support under a predetermined sufficient inhalation flow. When the flow indicator forms a seal with or is sufficiently close to the support, the circuit closes and electronic feedback is activated, for example, via an LED, which provides feedback to indicate proper inhalation. For example, a green LED would provide positive feedback. The LED will remain lit while the seal is maintained, and will turn off when the seal is broken, for example, at the end of inhalation or during inappropriate inhalation. The circuit and electronic indicator can also be configured to be activated when a predetermined number of movements of the flow indicator have been achieved or the cumulative duration of such movements. As an alternative, or in addition to indicating appropriate individual inhalation, the LED can illuminate and remain lit for an extended period when treatment is complete to convey to the user that treatment, for example, requires multiple breath cycles, has been successfully completed.

[0153] The same process occurs when the exhalation valve or nebulizer actuator is configured as a flow indicator, but the exhalation valve opens or the actuator closes or the circuit opens to provide feedback via an electronic indicator.

[0154] At the end of the predetermined lifespan of the chamber or other components (e.g., 1 year), the LED will be deactivated, or it will provide a warning signal (e.g., turn red), indicating that the device should be replaced. In the previous embodiment, the lack of positive LED feedback during inhalation will alert the user that the device should be replaced.

[0155] Although the invention has been described with reference to preferred embodiments, those skilled in the art will recognize that changes in form and detail may be made without departing from the spirit and scope of the invention. Therefore, the foregoing detailed description is intended to be illustrative rather than restrictive, and the appended claims, including all their equivalents, are intended to define the scope of the invention.

Claims

1. A user interface for a respiratory care system, characterized in that, include: The inlet is configured to connect to a breathing device. An exit, configured to interact with the user, wherein a flow path is formed between the inlet and the exit; A flow indicator is disposed outside the flow path, wherein the flow indicator moves from a first position to a second position in response at least to a user inhaling through the outlet; An optical sensor is pointed to and configured to sense when the flow indicator moves from the first position to the second position, wherein the optical sensor is configured to provide an input signal when the flow indicator moves from the first position to the second position; The controller is configured to receive the input signal from the optical sensor and send a feedback signal; and An electronic indicator may be operated to provide feedback on inhalation flow rate in response to the feedback signal transmitted from the controller.

2. The user interface according to claim 1, characterized in that, The flow indicator can be seen by the user.

3. The user interface according to claim 1, characterized in that, The outlet includes at least one of face shields and masks.

4. The user interface according to claim 1, characterized in that, The electronic indicator includes at least one of a visual indicator, an auditory indicator, and a vibration indicator.

5. A respiratory care system, characterized in that, include: Breathing apparatus; and User interface, including: The inlet is configured to connect to the breathing device; An exit, configured to interact with the user, wherein a flow path is formed between the inlet and the exit; A flow indicator is disposed outside the flow path, wherein the flow indicator moves from a first position to a second position in response at least to a user inhaling through the outlet; An optical sensor is pointed to and configured to sense when the flow indicator moves from the first position to the second position, wherein the optical sensor is configured to provide an input signal when the flow indicator moves from the first position to the second position; The controller is configured to receive the input signal from the optical sensor and send a feedback signal; and An electronic indicator may be operated to provide feedback on inhalation flow rate in response to the feedback signal transmitted from the controller.

6. The respiratory care system according to claim 5, characterized in that, The outlet includes at least one of face shields and masks.

7. The respiratory care system according to claim 5, characterized in that, The electronic indicator includes at least one of a visual indicator, an auditory indicator, and a vibration indicator.

8. The respiratory care system according to claim 5, characterized in that, The breathing device includes one of a valved holding chamber, an oscillating positive expiratory pressure device, a nebulizer, and a dry powder inhaler.

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