Devices and methods for using a medicament device

Abstract

Disclosed herein are devices and methods for using a medicament device. The devices and methods can be used to detect or sense one or more parameters of a medicament device, such as a shaking parameter, an actuation parameter, or an inhalation airflow parameter. The devices and methods can be used to indicate to a user that a medicament device is in an appropriate condition for actuation of the medicament device. The devices and methods can be used to indicate to a user that a medicament device is in a condition to deliver a formulation in an expected dose range. The devices and methods can also be used to guide a user in the proper use of a medicament device.

Description

[0001] This application is a divisional application of Chinese patent application filed on May 26, 2017, with application number 202310711974.X and entitled "Apparatus and Method for Using a Pharmaceutical Device".

[0002] The application filed on May 26, 2017, with application number 202310711974.X and entitled "Apparatus and Method for Using a Pharmaceutical Device", is a divisional application of Chinese patent application filed on May 26, 2017, with application number 201780046962.2 and entitled "Apparatus and Method for Using a Pharmaceutical Device" (the corresponding PCT application was filed on May 26, 2017, with application number PCT / US2017 / 034824).

[0003] Cross-referencing This application claims the benefit of U.S. Provisional Application No. 62 / 342,843, filed May 27, 2016; U.S. Provisional Application No. 62 / 439,595, filed December 28, 2016; and U.S. Provisional Application No. 62 / 465,701, filed March 1, 2017, the entire contents of which are incorporated herein by reference. Background Technology

[0004] Inhalers and nasal devices may require specific handling, such as proper shaking and actuation, to release the medication within the intended dose range. Inadequate handling by caregivers and patients, as well as incorrect inhalation technique, are associated with overdose and underdose medication delivery, and poor disease control. User error with inhalers and nasal devices is a significant public health issue, with an estimated 92% of patients using pressurized metered-dose inhalers (pMDIs) and up to 54% of patients using dry powder inhalers potentially using their inhalers incorrectly. Correct inhaler technique involves some common steps for all devices (e.g., dose preparation, device orientation, complete exhalation, deep inhalation, and breath-holding). However, dose preparation, such as filling and refilling the device, shaking the device, and device orientation, differs between devices. Furthermore, the characteristics of the device and the formulation of the medication (which varies between products) can be important factors in determining the correct handling technique to ensure delivery of the intended dose of medication. Furthermore, instructions such as "shake well" or "shake for 5 seconds" are interpreted differently among device users in practice, increasing the likelihood of dosage problems caused by inappropriate dose preparation and device usage techniques. Similar types of errors can occur with caregivers and patients using nasal devices to deliver medications. Summary of the Invention

[0005] In one aspect, a sensor device is provided for guiding the use of a medicament device, the sensor device comprising: a coupler for coupling to the medicament device, wherein the medicament device is selected from a variety of different types of medicament devices; one or more sensors for detecting the use of the medicament device; a processor configured to: automatically process one or more parameters associated with the medicament device; and output a signal based on the one or more parameters; and an indicator configured to: operably receive the signal; and output guidance to a user of the medicament device, wherein the guidance varies depending on the type of medicament device selected. The guidance can vary within the duration of shaking the medicament device, the shaking-to-emission interval, the waiting time between actuations, multiple filling steps, multiple refilling steps, and the duration until the refilling step. The duration of shaking the medicament device can vary between 0 and 30 seconds. The waiting time between actuations can vary between 0 and 60 seconds. The number of filling steps can vary between 0 and 5. The number of refilling steps can vary between 0 and 5. The duration until the refilling step can vary between 0 and 30 days. The shake-to-launch interval can vary between 0 and 30 seconds. The guidance may include an audible indication. The guidance may include a visual indication. The coupler may include a receiving port. The receiving port may include an electrical interface. The receiving port may be configured to detachably receive complementary protrusions of an adapter, which includes a memory storing one or more parameters associated with the pharmaceutical device. The coupler may include one or more latching points for receiving one or more latches of the adapter, including an adhesive configured to couple to the pharmaceutical device. The sensor device may be configured for use with five or more different types of pharmaceutical devices. The sensor device may be configured for use for a duration exceeding six months. The one or more sensors may include an accelerometer, barometer, temperature sensor, magnetometer, ambient light sensor, or Global Positioning System (GPS). The one or more sensors may include the accelerometer, and the accelerometer may be configured to be positioned along the central axis of the pharmaceutical device. The barometer may be located within a pressure sensing chamber. The pressure sensing chamber may allow bidirectional airflow into and out of the pressure sensing chamber. The bidirectional airflow may pass through a single opening in the pressure sensing chamber. The pressure sensing chamber may include approximately 10 mm. 3The volume of the pressure sensing chamber may include an opening for coupling to a pressure connector tube. The sensor device may include elements for opening or closing the sensor device. These elements may be located at the proximal end of the sensor device. The indicator may include a speaker. The indicator may include a light-emitting diode (LED). The indicator may include a visual display. The sensor device may include an interface for communicating with external devices. The sensor device may include approximately 10 cm. 3 The size of the device. The medication device may include a canister for use with an inhaler. The inhaler may be a pressurized dose-measuring inhaler.

[0006] On the other hand, a kit is provided comprising: any of the aforementioned sensor devices, and instructions for coupling the sensor devices to and / or decoupling them from an adapter, the adapter including a memory storing one or more parameters associated with the pharmaceutical device.

[0007] On the other hand, an adapter for guiding the use of a pharmaceutical device is provided, the adapter comprising: a first coupler for coupling to the pharmaceutical device; a memory for storing one or more parameters associated with the pharmaceutical device; and a second coupler for coupling to a sensor device configured to output guidance to a user of the pharmaceutical device. On the other hand, a kit is provided comprising: the adapter; and instructions for coupling the adapter to and / or decoupling from a pharmaceutical device selected from a variety of different types of pharmaceutical devices. The adapter may be configured to guide the use of a single type of pharmaceutical device. The second coupler may include a protrusion. The protrusion may include an electrical interface. The protrusion may be complementary to a receiving port of a sensor device including one or more sensors for detecting the use of the pharmaceutical device. The first coupler may include an adhesive. The adapter may also include one or more processors operatively coupled to the memory. The adapter may include a pressure fitting tube. The pressure fitting tube may be hollow. The pressure fitting tube may include a proximal portion located on a first surface of the adapter and a distal portion located away from a second surface opposite to the first surface. The proximal portion may include a sealing element. The sealing element may be an O-ring. The distal portion may include one or more holes. The one or more holes may be located on a side surface of the pressure connector tube. The pressure connector tube may be configured to extend along the longitudinal axis of the medication device. The adapter may include an authenticator. The authenticator may be configured to authenticate the sensor device and / or the adapter. The adapter may be configured to couple to the sensor device via a snap-fit ​​mechanism. The adapter may be configured for at least 60 actuations. The medication device may include a canister for use with an inhaler.

[0008] In another aspect, a method for using a sensor device configured to be coupled to multiple different types of pharmaceutical devices is provided, the method comprising: coupling the sensor device to a first pharmaceutical device; processing one or more parameters associated with the first pharmaceutical device; guiding the use of the first pharmaceutical device based on the processed one or more parameters associated with the first pharmaceutical device; decoupling the sensor device from the first pharmaceutical device; coupling the sensor device to a second pharmaceutical device, wherein the pharmaceutical device type of the second pharmaceutical device is different from that of the first pharmaceutical device; processing one or more parameters associated with the second pharmaceutical device; and guiding the use of the second pharmaceutical device based on the processed one or more parameters associated with the second pharmaceutical device, wherein guiding the use of the second pharmaceutical device differs from guiding the use of the first pharmaceutical device. Guiding the use of the second pharmaceutical device may differ from guiding the use of the first pharmaceutical device during the duration of shaking the pharmaceutical device, the shaking-to-launch interval, the waiting time between actuations, multiple filling steps, multiple refilling steps, or the duration up to a refilling step. The duration of shaking the pharmaceutical device may vary between 0 and 30 seconds. The waiting time between actuations may vary between 0 and 60 seconds. The number of filling steps can vary between 0 and 5. The number of refilling steps can vary between 0 and 5. The duration until a refilling step can vary between 0 and 30 days. The shake-to-fire interval can vary between 0 and 30 seconds. Coupling the sensor device to the first medication device can include coupling the sensor device to a first adapter already coupled to the first medication device, wherein the first adapter includes a first memory storing a first set of parameters associated with the first medication device. Coupling the sensor device to the second medication device can include coupling the sensor device to a second adapter already coupled to the second medication device, wherein the second adapter includes a second memory storing a second set of parameters associated with the second medication device, wherein the second set of parameters is different from the first set of parameters. The medication device can include a canister for use with an inhaler.

[0009] In another aspect, a method for measuring inhaler use using one or more sensors is provided, the method comprising: using the one or more sensors to: measure the duration of shaking the inhaler; measure the duration of time following the shaking; measure the inhalation of a user using the inhaler; measure the actuation of the inhaler; and measure the duration of the actuation holding time. When a predetermined threshold is reached, the one or more sensors may output an indication after each measurement step. The output may be a visual output instructing the user of the inhaler to move to the next step. The output may be an auditory output instructing the user of the inhaler to move to the next step. The one or more sensors may also be configured to measure the orientation of the inhaler. When the inhaler is outside a predetermined orientation, the sensors may output an indication of incorrect orientation. The one or more sensors may also be configured to track the remaining number of actuations of the inhaler. When the inhaler is at or below a predetermined number of remaining doses, the sensors may output an indication of a low number of remaining doses for the inhaler. The one or more sensors may include an accelerometer, a barometer, a temperature sensor, a magnetometer, an ambient light sensor, or a Global Positioning System (GPS). The inhaler may include a medication device. The medication device may be the canister of the inhaler. The one or more sensors may include sensors located outside the inhaler. The one or more sensors may be located on the mobile device.

[0010] On the other hand, an apparatus for monitoring the use of a medication device is provided, the apparatus comprising: a) an adapter including a memory storing a set of parameters specific to the type of the medication device; and b) a sensor device detachable from and operatively communicatively with the adapter, wherein the sensor device is configured to be used with a plurality of different types of adapters, each adapter including a unique set of parameters specific to the different types of medication devices, wherein the device is configured to generate an output based on the set of parameters. The apparatus may also include a medication device. The medication device may be a canister for use with an inhaler. The adapter may be configured to be coupled to the exterior of the canister, and the sensor device may be configured to be indirectly coupled to the canister via the adapter. The sensor device may include an accelerometer configured to be positioned along the central axis of the medication device when the adapter and the sensor device are coupled to the medication device. The sensor device may include a pressure sensing chamber including a single opening. The adapter may include a pressure connector tube configured to be coupled to the single opening. The pressure sensing chamber may include a barometer. The sensor device may include a receiving port, and the adapter may include a protrusion complementary to the receiving port. The receiving port and the protrusion may each include an electrical interface. The output may be feedback provided to the user based on the use of the medication device. The feedback may guide the user in real time on how to correctly administer the medication device. The output may be generated when at least one of the set of parameters meets a predetermined threshold. The output may be generated when at least one of the set of parameters is outside the threshold range. The sensor device may be configured to operate with one or more different medication devices. The sensor device may be reusable. The adapter may be disposable. The medication device may be used with an inhaler or nasal device. The inhaler or nasal device may be a pressurized metered dose inhaler (pMDI) or a dry powder inhaler. The set of parameters may include one or more shaking parameters. The one or more shaking parameters may include: shaking duration, shaking angle, shaking frequency, shaking-to-emission interval, shaking orientation, and any combination thereof. The set of parameters may include one or more actuation parameters. The one or more actuation parameters may include: compression rate, compression acceleration, actuation hold time, decompression rate, decompression acceleration, actuation stroke length, and any combination thereof. The set of parameters may include one or more inhalation airflow parameters. The one or more inhalation airflow parameters may include: inhalation airflow rate, inhalation volume, inflow velocity, and any combination thereof.The pharmaceutical device may contain a pharmaceutical formulation. The output may be generated when at least one of the set of parameters meets a predetermined threshold, and the predetermined threshold may be determined based on the composition of the pharmaceutical formulation, one or more characteristics of the pharmaceutical device, or both. The formulation may contain one or more excipients. The formulation may not contain excipients. The adapter may be attached to the housing or canister of the pharmaceutical device. The adapter may be permanently attached to the surface of the housing or canister. The adapter may be detachably attached to the surface of the housing or canister. The sensor device may be attached to the adapter. The one or more outputs may include visual indications, auditory indications, or both. The visual indications may include: the presence or absence of light, changes in the color of light, flashing of light, and any combination thereof. The visual indications may be generated by light-emitting diodes (LEDs). The visual indications may be generated by an LCD or LED display. The output may include data. The data may be collected and stored by the device. The data may be transmitted to a mobile device, a computer, a cloud application, or any combination thereof, or read from the mobile device, the computer, the cloud application, or any combination thereof. The one or more sensors may be selected from the following: accelerometer, barometer, temperature sensor, magnetometer, ambient light sensor or Global Positioning System (GPS).

[0011] In another aspect, a method of using an inhaler or nasal device with the aid of a sensor is provided, the method comprising: a) shaking the inhaler or nasal device; b) using the sensor to measure a shaking-to-emission interval for actuating the inhaler or nasal device; c) actuating the inhaler or nasal device when the sensor generates an output, wherein the sensor generates the output when it detects the start of the shaking-to-emission interval.

[0012] In another aspect, a method of using an inhaler or nasal device with the aid of a sensor is provided, the method comprising: a) compressing the inhaler or nasal device for a period of time, wherein the period of time includes an actuation hold time window; and b) decompressing the inhaler or nasal device when the sensor generates an output, wherein the sensor generates the output when the sensor detects the end of the actuation hold time window.

[0013] On the other hand, an apparatus for monitoring the use of a pharmaceutical device is provided, comprising: a) an adapter, including: a distal end including a first adapter coupler for coupling to the pharmaceutical device; a memory storing one or more parameters associated with the pharmaceutical device; a proximal end including a second adapter coupler for coupling to a sensor device, wherein the second adapter coupler includes a protrusion including an electrical interface; and a pressure connector tube including a first end located on the proximal side of the adapter and a second end located distally away from the distal side of the adapter; and b) a sensor device detachably coupled to the adapter, wherein the sensor device includes: a mating surface for engaging with the proximal end of the adapter, including: a receiving port including... An electrical interface, wherein the receiving port is complementary to the protrusion and configured to receive the protrusion; and an opening configured to receive the first end of the pressure connector tube; a pressure sensing chamber operatively coupled to the opening, the pressure sensing chamber defining a closed chamber having the opening and including a barometer; a processor operatively coupled to the receiving port, the processor being configured to: receive one or more parameters associated with the medication device from the adapter; automatically process the one or more parameters associated with the medication device; and output a signal based on the one or more parameters; and an indicator configured to: operatively receive the signal; and output guidance to a user of the medication device, wherein the guidance varies according to the received one or more parameters.

[0014] On the other hand, a kit is provided, comprising: any of the aforementioned sensor devices; any of the aforementioned adapters; and instructions for coupling the sensor devices and the adapters to and / or decoupling them from a variety of different types of pharmaceutical devices.

[0015] In one aspect, a system is provided comprising a sensor for detecting one or more parameters of an inhaler or nasal device, wherein the sensor is in contact with the inhaler or nasal device, and wherein the system generates one or more outputs when each of at least one of the one or more parameters meets a predetermined threshold. In some cases, when each of at least one of the one or more parameters meets the predetermined threshold, the inhaler or nasal device delivers a drug within a desired dose range upon actuation. In some cases, the one or more parameters include one or more shaking parameters. In some examples, the one or more shaking parameters are selected from: shaking duration, shaking angle, shaking frequency, shaking-to-emission interval, and any combination thereof. In some cases, the one or more parameters include one or more actuation parameters. In some examples, the one or more actuation parameters are selected from: compression rate, compression acceleration, actuation hold time, decompression rate, decompression acceleration, actuation stroke length, and any combination thereof. In some cases, the one or more parameters include one or more inhalation airflow parameters. In some examples, the one or more inhalation airflow parameters are selected from: inhalation airflow rate, inhalation volume, inflow rate, and any combination thereof. In some cases, the inhaler or nasal device is a pressurized metered-dose inhaler (pMDI) or a dry powder inhaler. In some cases, the inhaler or nasal device contains a pharmaceutical formulation. In some cases, a predetermined threshold is determined based on the composition of the pharmaceutical formulation, one or more characteristics of the inhaler or nasal device, or both. In some cases, the formulation contains one or more excipients. In some cases, the formulation does not contain excipients. In some cases, the sensor is attached to a retainer or canister of the inhaler or nasal device. In some cases, the sensor is permanently attached to the retainer or canister. In some cases, the sensor is detachably attached to the retainer or canister. In some cases, the sensor is attached to a surface of the retainer or canister. In some cases, the sensor is embedded in the retainer or canister. In some cases, the one or more outputs include an indication. In some cases, the indication is a visual indication, an auditory indication, or both. In some cases, the visual indication is selected from the following: the presence or absence of light, a change in the color of light, the flickering of light, and any combination thereof. In some examples, the indication is generated by a light-emitting diode (LED). In some cases, the sensor is operatively coupled to the inhaler or nasal device. In some cases, the one or more outputs include data. In some cases, the data is collected and stored by the sensor. In some cases, the data is transmitted to, or read from, a mobile device, a computer, a cloud application, or any combination thereof.

[0016] In another aspect, a system is provided including a sensor for detecting a shake-to-fire interval for actuating an inhaler or nasal device, wherein the sensor is in contact with the inhaler or nasal device, and wherein the system generates one or more outputs when the sensor detects the shake-to-fire interval. In some cases, the shake-to-fire interval indicates the time period during which the inhaler or nasal device delivers a drug within a desired dose range when actuated. In some cases, the shake-to-fire interval includes a first time point at the start of the shake-to-fire interval and a second time point at the end of the shake-to-fire interval. In some cases, the inhaler or nasal device contains a pharmaceutical formulation. In some cases, the shake-to-fire interval is determined based on the composition of the pharmaceutical formulation, one or more characteristics of the inhaler or nasal device, or both. In some cases, the formulation contains one or more excipients. In some cases, the formulation does not contain excipients. In some cases, the one or more outputs include indications. In some cases, the one or more outputs are generated upon reaching the first time point. In some cases, one or more additional outputs are generated upon reaching the second time point. In some cases, the indication is a visual indication, an auditory indication, or both. In some cases, the visual indication is selected from the following: the presence or absence of light, a change in the color of light, the flickering of light, and any combination thereof. In some cases, the visual indication is generated by a light-emitting diode (LED). In some cases, the sensor further detects one or more parameters of the inhaler or nasal device. In some cases, the one or more parameters include one or more shaking parameters. In some cases, the shaking-to-emission interval is a period of time after a predetermined threshold of the one or more parameters is met. In some examples, the one or more shaking parameters are selected from the following: shaking duration, shaking angle, shaking frequency, shaking-to-emission interval, and any combination thereof. In some cases, the sensor is operatively coupled to the inhaler or nasal device. In some cases, the inhaler or nasal device cannot be actuated outside the shaking-to-emission interval. In some cases, the inhaler or nasal device is automatically actuated when the shaking-to-emission interval is detected. In some cases, the inhaler or nasal device is automatically actuated when the one or more outputs are generated. In some cases, the sensor is attached to the retainer or canister of the inhaler or nasal device. In some cases, the sensor is permanently attached to the retainer or canister. In some cases, the sensor is detachably attached to the retainer or canister. In some cases, the sensor is attached to the surface of the retainer or canister. In some cases, the sensor is embedded in the retainer or canister. In some cases, the inhaler or nasal device is a metered-dose inhaler (pMDI) or a dry powder inhaler.In some cases, the one or more outputs include data. In some cases, the data is collected and stored by the sensor. In some cases, the data is transmitted to a mobile device, a computer, a cloud application, or any combination thereof, or read from the mobile device, the computer, the cloud application, or any combination thereof.

[0017] On another front, a method is provided for using an inhaler or nasal device comprising a system, wherein the system includes a sensor in contact with the inhaler or nasal device, the method comprising: a) shaking the inhaler or nasal device, wherein the shaking includes one or more shaking parameters; and b) actuating the inhaler or nasal device when a predetermined threshold of the one or more shaking parameters is met, wherein the system generates one or more outputs when the sensor detects that the predetermined threshold is met. In some cases, the one or more shaking parameters are selected from: shaking duration, shaking angle, shaking frequency, shaking-to-emission interval, and any combination thereof. In some cases, the one or more outputs include an indication. In some cases, the indication is a visual indication, an auditory indication, or both. In some cases, the actuation releases a desired dose of drug. In some cases, the method further includes, during actuation, the sensor or an additional sensor detecting one or more actuation parameters. In some cases, the system generates one or more additional outputs when the sensor or the additional sensor detects a predetermined threshold of the one or more actuation parameters. In some cases, the one or more actuation parameters are selected from the following: compression rate, compression acceleration, actuation hold time, decompression rate, decompression acceleration, actuation stroke length, and any combination thereof. In some cases, the inhaler or nasal device is a metered-dose inhaler (pMDI) or a dry powder inhaler. In some cases, the inhaler or nasal device contains a pharmaceutical formulation. In some cases, the predetermined threshold is determined based on the composition of the pharmaceutical formulation, one or more characteristics of the inhaler or nasal device, or both. In some cases, the formulation contains one or more excipients. In some cases, the formulation does not contain excipients. In some cases, the sensor is attached to a retainer or canister of the inhaler or nasal device. In some cases, the sensor is permanently attached to the retainer or canister. In some cases, the sensor is detachably attached to the retainer or canister. In some cases, the sensor is attached to the surface of the retainer or canister. In some cases, the sensor is embedded in the retainer or canister. In some cases, the visual indication is selected from the following: the presence or absence of light, changes in the color of light, flashing of light, and any combination thereof. In some cases, the visual indication is generated by a light-emitting diode (LED). In some cases, the sensor is operatively coupled to the inhaler or nasal device. In some cases, the one or more outputs include data. In some cases, the data is collected and stored by the sensor. In some cases, the data is transmitted to a mobile device, a computer, a cloud application, or any combination thereof, or read from the mobile device, the computer, the cloud application, or any combination thereof.

[0018] In another aspect, a system is provided comprising a sensor for detecting an actuation-hold time window of an inhaler or nasal device, wherein the sensor is in contact with the inhaler or nasal device, and wherein the system generates one or more outputs when the sensor detects the actuation-hold time window. In some cases, the actuation-hold time window comprises a period of time after which, when actuated, the inhaler or nasal device delivers a drug within a desired dose range. In some cases, the actuation-hold time window comprises a first time point at the start of the actuation-hold time window and a second time point at the end of the actuation-hold time window. In some cases, the inhaler or nasal device contains a pharmaceutical formulation. In some cases, the actuation-hold time window is determined based on the composition of the pharmaceutical formulation, one or more characteristics of the inhaler or nasal device, or both. In some cases, the formulation contains one or more excipients. In some cases, the formulation does not contain excipients. In some cases, the one or more outputs include an indication. In some cases, the indication is a visual indication, an auditory indication, or both. In some cases, the visual indication is selected from the following: the presence or absence of light, a change in the color of light, the flickering of light, and any combination thereof. In some cases, the visual indication is generated by a light-emitting diode (LED). In some cases, the output is generated when a second time point of the actuation hold time window is detected. In some cases, the sensor further detects one or more parameters of the inhaler or nasal device. In some cases, the one or more parameters include one or more shaking parameters. In some cases, the one or more shaking parameters are selected from the following: shaking duration, shaking angle, shaking frequency, shaking-to-emission interval, and any combination thereof. In some cases, the one or more parameters include one or more actuation parameters. In some cases, the one or more actuation parameters are selected from the following: compression rate, compression acceleration, actuation hold time, decompression rate, decompression acceleration, actuation stroke length, and any combination thereof. In some cases, the sensor is operatively coupled to the inhaler or nasal device. In some cases, the sensor is attached to the retainer or canister of the inhaler or nasal device. In some cases, the sensor is permanently attached to the retainer or canister. In some cases, the sensor is detachably attached to the retainer or canister. In some cases, the sensor is attached to the surface of the retainer or canister. In some cases, the sensor is embedded in the retainer or canister. In some cases, the inhaler or nasal device is a pressurized metered-dose inhaler (pMDI) or a dry powder inhaler. In some cases, the one or more outputs include data. In some cases, the data is collected and stored by the sensor.In some cases, the data is transmitted to a mobile device, a computer, a cloud application, or any combination thereof, or read from the mobile device, the computer, the cloud application, or any combination thereof.

[0019] On another front, a method is provided for using an inhaler or nasal device comprising a system, wherein the system includes a sensor in contact with the inhaler or nasal device, the method comprising: a) compressing the inhaler or nasal device for a period of time, wherein the period of time includes an actuation hold time window; b) depressurizing the inhaler or nasal device when the system produces an output, wherein the system produces the output when the sensor detects the end of the actuation hold time window. In some cases, the compression releases a certain amount of medication. In some cases, the method further includes shaking the inhaler or nasal device before compression. In some cases, the shaking includes one or more shaking parameters. In some cases, the one or more shaking parameters are selected from the following: shaking duration, shaking angle, shaking frequency, shaking-to-emission interval, and any combination thereof. In some cases, the system produces additional output when a predetermined threshold of the one or more shaking parameters is met. In some cases, depressurization occurs after the release of a drug within a desired dose range from the inhaler or nasal device. In some cases, the method further includes the sensor detecting one or more actuation parameters during actuation. In some cases, the sensor generates an additional output when a predetermined threshold of one or more of the actuation parameters is met. In some cases, the one or more actuation parameters are selected from: compression rate, compression acceleration, actuation hold time, decompression rate, decompression acceleration, actuation stroke length, and any combination thereof. In some cases, the inhaler or nasal device is a pressurized metered-dose inhaler (pMDI) or a dry powder inhaler. In some cases, the inhaler or nasal device contains a pharmaceutical formulation. In some cases, the actuation hold time window is determined based on the composition of the pharmaceutical formulation, one or more characteristics of the inhaler or nasal device, or both. In some cases, the formulation contains one or more excipients. In some cases, the formulation does not contain excipients. In some cases, the sensor is attached to a retainer or canister of the inhaler or nasal device. In some cases, the sensor is permanently attached to the retainer or canister. In some cases, the sensor is detachably attached to the retainer or canister. In some cases, the sensor is attached to a surface of the retainer or canister. In some cases, the sensor is embedded in the retainer or canister. In some cases, the output includes an indication. In some cases, the indication is a visual indication, an auditory indication, or both. In some cases, the visual indication is selected from the following: the presence or absence of light, a change in the color of light, the flickering of light, and any combination thereof. In some cases, the visual indication is generated by a light-emitting diode (LED). In some cases, the sensor is operatively coupled to the inhaler or nasal device. In some cases, the output includes data.In some cases, the data is collected and stored by the sensor. In other cases, the data is transmitted to a mobile device, a computer, a cloud application, or any combination thereof, or read from the mobile device, the computer, the cloud application, or any combination thereof.

[0020] On the other hand, this disclosure provides an apparatus or a component thereof, such as Figure 1 , Figure 2 , Figure 12 or Figure 15 Any one of them is shown.

[0021] Incorporation All publications, patents and patent applications mentioned in this specification are incorporated herein by reference to the extent that each individual publication, patent or patent application is specifically and individually indicated to be incorporated by reference. Attached Figure Description

[0022] The novel features of the invention are specifically set forth in the appended claims. A better understanding of the features and advantages of the invention will be obtained by referring to the following detailed description and accompanying drawings, which illustrate illustrative embodiments utilizing the principles of the invention, in which: Figure 1 Small Figure A depicts a non-limiting example of a sensor and adapter as described herein. Figure 1 Small Figure B depicts a non-limiting example of a method for attaching a sensor and adapter to a pharmaceutical device as described herein. Figure 1 Small Figure C depicts a non-limiting example of a sensor and adapter attached to a pharmaceutical device as described herein.

[0023] Figure 2 Small Figure A depicts a non-limiting example of a method for attaching a sensor to an adapter as described herein. Figure 2 Small Figure B depicts a non-limiting example of the sensor as described herein, as well as one or more product-specific adapters.

[0024] Figures 3A-3D Multiple views of a sensor package described according to various embodiments of this disclosure are depicted. Figure 3A An exploded top view depicting a non-limiting example of a sensor package according to an embodiment of this disclosure is shown. Figure 3B An exploded bottom view depicting a non-limiting example of a sensor package according to an embodiment of this disclosure is shown. Figure 3C A top view depicting a non-limiting example of a sensor package implemented according to this disclosure is shown. Figure 3D A bottom view depicting a non-limiting example of a sensor package according to an embodiment of this disclosure is shown.

[0025] Figures 4A-4C Non-limiting examples of adapters described in various embodiments of this disclosure are depicted. Figure 4A A top view depicting a non-limiting example of an adapter before being coupled to an inhaler device, according to an embodiment of this disclosure. Figure 4B A top view depicting a non-limiting example of an adapter coupled to an inhaler device according to an embodiment of the present disclosure is shown. Figure 4C A non-limiting example of a unfolded view of a pressure connector tube embodied on an adapter, according to an embodiment of the present disclosure, is depicted.

[0026] Figures 5A-5B Non-limiting examples of sensor devices and adapters coupled to an inhaler device are depicted. Figure 5A A non-limiting example of an adapter coupled to an inhaler device prior to coupling a sensor device, according to an embodiment of the present disclosure, is depicted. Figure 5B Non-limiting examples of sensor devices and adapters coupled to an inhaler device according to embodiments of the present disclosure are depicted.

[0027] Figures 6A-6B A non-limiting example of the coupling between the sensor device and the adapter is depicted. Figure 6A Non-limiting examples of sensor devices and adapters prior to coupling, according to embodiments of this disclosure, are depicted. Figure 6B Non-limiting examples of sensor devices coupled to an adapter according to embodiments of the present disclosure are depicted.

[0028] Figure 7 A non-limiting example of an unfolded view of a pressure sensing cavity according to an embodiment of the present disclosure is shown.

[0029] Figure 8 A non-limiting example of a pressure sensing cavity according to an embodiment of the present disclosure is depicted, wherein a barometer is located on the bottom surface of a circuit board.

[0030] Figure 9 Non-limiting examples of product-specific operating parameters of a particular pharmaceutical device according to embodiments of this disclosure are described.

[0031] Figure 10 Non-limiting examples of placing sensors and visual indicators (e.g., LEDs) on an inhaler device are depicted.

[0032] Figure 11 A non-limiting example of the positioning of an accelerometer that coincides with the long axis of the inhaler canister, according to an embodiment of this disclosure, is depicted.

[0033] Figure 12Small figures A-D depict non-limiting examples of instructions from the system output of this disclosure.

[0034] Figure 13 A non-restricted example workflow of the system described herein is depicted.

[0035] Figure 14 A non-restrictive example workflow for using the system described in this paper is depicted.

[0036] Figure 15 Small figures A-E depict non-limiting examples of methods using the apparatus as described herein.

[0037] Figure 16 Non-limiting examples of computer systems suitable for use with the apparatus described herein are depicted.

[0038] Figures 17A-17D Various views of the exemplary system described herein are depicted. Figure 17A A non-limiting example of a top view of a system as described herein is presented. Figure 17B A non-limiting example of a side view of the system as described herein is depicted. Figure 17C A non-limiting example of a bottom view of a system as described herein is depicted. Figure 17D Non-limiting examples of systems assembled onto pMDI tanks as described herein are depicted. Detailed Implementation

[0039] This document discloses methods and apparatus for sensing or detecting one or more parameters related to the use of a medication device. In some cases, the medication device is an inhaler or nasal device. For example, the methods and apparatus can be used to sense or detect when the medication device is in a state suitable for delivering a desired dose of medication. Additionally or alternatively, the methods and apparatus described herein can guide a user through one or more steps of using the medication device, for example, by providing feedback to the user based on one or more usage parameters of the medication device. Generally, guidance can be provided to the user who is given the medication device to assist the user in the correct use of the device. The apparatus and methods described herein may include any number of medication devices, sensor devices, and / or product-specific adapters.

[0040] As used herein, the term "medication device" can refer to any device or apparatus configured to deliver a medicine or therapeutic agent to a user. Optionally, a medication device can refer to a container or device containing a medicine. In some non-limiting instances, as used herein, the term "medication device" can refer to an inhaler device or a nasal device. In some cases, the term "medication device" can refer to an orally inhaled and nasal drug product (OINDP) or any component thereof. As used herein, the term "medication device" can refer to the entire medication device or any component of a medication device. By way of example only, the term "medication device" can refer to an inhaler device or a component of an inhaler device, such as the housing of the inhaler device, the actuator of the inhaler device, the mouthpiece of the inhaler device, or the medication container housed within the housing of the inhaler device.

[0041] The terms “sensor package” and “sensor device” are used interchangeably herein and can refer to a device that can be used in conjunction with a pharmaceutical device for sensing one or more usage parameters of the pharmaceutical device. A sensor device may include one or more sensors and may additionally include any number of electronic components, batteries, microprocessors, switches, buttons, circuit boards, and feedback systems, such as auditory or visual outputs. Various non-limiting examples of sensor devices are described herein.

[0042] The terms “adapter,” “connector,” “product-specific adapter,” and “product-specific connector” are used interchangeably herein and can refer to a device that can be used to attach or couple a sensor device to a pharmaceutical device. An adapter or connector may be configured to couple a sensor device to a pharmaceutical device and may additionally include any number of electronic components. In some cases, an adapter may include one or more product-specific operating parameters (PSOPs) specific to a particular pharmaceutical device. Various non-limiting examples of adapters are described herein.

[0043] The terms “Product-Specific Operating Parameter” or “PSOP” are used interchangeably herein and can refer to specific parameters associated with a particular pharmaceutical device for its proper use. For example, PSOP may refer to the number of times the pharmaceutical device should be shaken before actuation, or the number of actuations required to fill the pharmaceutical device before initial use. While various PSOPs have been described herein, it should be understood that the PSOP for a particular pharmaceutical device will vary depending on a number of factors, and therefore the various embodiments described herein should be considered as non-limiting examples only. The PSOP for a particular pharmaceutical device may be provided by the manufacturer of the pharmaceutical device (e.g., in the device's instruction manual or on the device's box) or may need to be determined empirically. In some cases, the PSOP is programmed or loaded onto a product-specific adapter as described herein.

[0044] The amount of medication released by a drug delivery device can depend on many factors, such as whether the device has been properly shaken before activation or whether the user has correctly activated the device. Furthermore, the composition of the formulation contained within the device (e.g., drug, excipients, propellant) and the characteristics of the device itself can be key factors determining how much the device needs to be shaken before activation or how long it needs to be in an activated state to deliver the intended dose range. The use of drug delivery devices, particularly inhalers and nasal devices, is prone to user error, often resulting in incorrect drug dosage delivery. This can be particularly relevant because different drug formulations, even when used in the same context (e.g., with an inhaler), can include very different usage parameters, such as… Figure 9 As shown in the diagram. The apparatus and methods provided herein can be used to instruct a user of a pharmaceutical device that the device is in a state suitable for delivering a formulation within a desired dose range. The methods and apparatus described herein can guide or instruct a user on how to properly operate the pharmaceutical device, thereby improving the use of the device. In some cases, the methods and apparatus described herein can guide or instruct a user on how to properly operate the pharmaceutical device, thereby improving the accuracy of the delivered dose. The methods and apparatus described herein can allow a user to properly operate different pharmaceutical devices including different recommended parameters (e.g., shaking parameters, inhalation parameters, etc.) using a single sensor device, because the sensor devices described herein can be customized for a specific type of pharmaceutical device, for example, via an adapter. In one aspect, the device may include one or more sensors for detecting one or more usage parameters of the pharmaceutical device.

[0045] In one particular aspect, a sensor device for guiding the use of a pharmaceutical device is provided, the sensor device comprising: (a) a coupler for coupling to a pharmaceutical device, wherein the pharmaceutical device is selected from a variety of different types of pharmaceutical devices; (b) one or more sensors for detecting the use of the pharmaceutical device; (c) a processor configured to: (i) automatically process one or more parameters associated with the pharmaceutical device; and (ii) output a signal based on the one or more parameters; and (d) an indicator configured to: (i) operably receive the signal; and (ii) output guidance to a user of the pharmaceutical device, wherein the guidance varies depending on the type of pharmaceutical device selected.

[0046] In another particular aspect, a kit is provided comprising: a sensor device as described herein, and instructions for coupling the sensor device to and / or decoupling it from an adapter, the adapter including a memory for storing one or more parameters associated with the pharmaceutical device.

[0047] On the other hand, an adapter is provided for guiding the use of a pharmaceutical device, the adapter comprising: (a) a first coupler for coupling to the pharmaceutical device; (b) a memory storing one or more parameters associated with the pharmaceutical device; and (c) a second coupler for coupling to a sensor device, wherein the sensor device is configured to output guidance to a user of the pharmaceutical device.

[0048] On the other hand, a kit is provided, comprising: an adapter as described herein; and instructions for coupling the adapter to and / or decoupling from a pharmaceutical device selected from a variety of different types of pharmaceutical devices.

[0049] In another aspect, a method of using a sensor device configured to be coupled to multiple different types of pharmaceutical devices is provided, the method comprising: (a) coupling the sensor device to a first pharmaceutical device; (b) processing one or more parameters associated with the first pharmaceutical device; (c) guiding the use of the first pharmaceutical device based on the processed one or more parameters associated with the first pharmaceutical device; (d) decoupling the sensor device from the first pharmaceutical device; (e) coupling the sensor device to a second pharmaceutical device, wherein the pharmaceutical device type of the second pharmaceutical device is different from that of the first pharmaceutical device; (f) processing one or more parameters associated with the second pharmaceutical device; and (g) guiding the use of the second pharmaceutical device based on the processed one or more parameters associated with the second pharmaceutical device, wherein guiding the use of the second pharmaceutical device is different from guiding the use of the first pharmaceutical device.

[0050] In another aspect, a method for measuring the use of an inhaler using one or more sensors is provided, the method comprising: by means of one or more sensors: (a) measuring the duration of shaking the inhaler; (b) measuring the duration of time after shaking; (c) measuring the inhalation of a user using the inhaler; (d) measuring the actuation of the inhaler; and (e) measuring the duration of the duration of the actuation.

[0051] On the other hand, an apparatus for monitoring the use of a pharmaceutical device is provided, the apparatus comprising: (a) an adapter, wherein the adapter includes a memory storing a set of parameters specific to the type of pharmaceutical device; and (b) a sensor device detachable from and operatively connected to the adapter, wherein the sensor device is configured to be used with a plurality of different types of adapters, each adapter including a unique set of parameters specific to the different types of pharmaceutical devices, wherein the sensor device is configured to generate an output based on the set of parameters.

[0052] In another aspect, a method of using an inhaler or nasal device with the aid of a sensor is provided, the method comprising: (a) shaking the inhaler or nasal device; (b) using a sensor to measure a shake-to-fire interval for actuating the inhaler or nasal device; and (c) actuating the inhaler or nasal device when the sensor generates an output, wherein the sensor generates the output when the sensor detects the end of the shake-to-fire interval.

[0053] In another aspect, a method of using an inhaler or nasal device with the aid of a sensor is provided, the method comprising: (a) compressing the inhaler or nasal device for a period of time, wherein the period of time includes an actuation hold time window; and (b) depressurizing the inhaler or nasal device when the sensor generates an output, wherein the sensor generates the output when the sensor detects the end of the actuation hold time window.

[0054] On the other hand, an apparatus for monitoring the use of a pharmaceutical device is provided, comprising: (a) an adapter including: (i) a distal end including a first adapter coupler for coupling to the pharmaceutical device; (ii) a memory storing one or more parameters associated with the pharmaceutical device; (iii) a proximal end including a second adapter coupler for coupling to a sensor device, wherein the second adapter coupler includes a protrusion comprising an electrical interface; and (iv) a pressure connector tube including a first end located on the proximal side of the adapter and a second end located distally on the distal side of the adapter; and (b) a sensor device detachably coupled to the adapter, wherein the sensor device includes: (i) a mating surface for engaging with the proximal end of the adapter, including: receiving The device comprises: (i) a port, including an electrical interface, wherein a receiving port is complementary to and configured to receive the protrusion; and an opening configured to receive a first end of a pressure connector tube; (ii) a pressure sensing chamber operatively coupled to the opening, the pressure sensing chamber defining a closed chamber having the opening and including a barometer; (iii) a processor operatively coupled to the receiving port, the processor being configured to: receive one or more parameters associated with the pharmaceutical device from an adapter; automatically process the one or more parameters associated with the pharmaceutical device; and output a signal based on the one or more parameters; and (iv) an indicator configured to: operatively receive a signal; and output guidance to a user of the pharmaceutical device, wherein the guidance varies according to the received one or more parameters.

[0055] In some cases, the methods and devices described herein can be used with virtually any pharmaceutical device. In specific cases, the methods and devices described herein can be used with inhaler devices. Inhaler devices can be used, for example, to deliver a drug or substance directly to the lungs of a subject. The methods and devices described herein are suitable for use with any inhaler device that requires shaking and / or actuation. In some cases, the inhaler device is a metered-dose inhaler (MDI), such as a pressurized metered-dose inhaler (pMDI). Non-limiting examples of MDIs may include AeroChamber® and Autohaler®. In some cases, the MDI includes a spacer or aerosol compartment. The inhaler device may be a dry powder inhaler, and non-limiting examples include: Aerolizer®, Diskus®, Ellipta™, Flexhaler®, Handihaler®, Neohaler®, Pressair™, Twisthaler®, Rotahaler®, and Turbuhaler®.

[0056] In other specific applications, the methods and apparatus may be used with nasal devices, for example, for the local delivery of medication to the nose or paranasal sinuses. Non-limiting examples of nasal devices may include: mechanical spray pumps (e.g., squeeze bottles, multi-dose metered spray pumps, single / dual-dose spray pumps, bidirectional multi-dose spray pumps), pneumatic spray systems / nebulizers, mechanical powder nebulizers, respiratory-actuated inhalers, and blowpipes. In other specific applications, the methods and apparatus may be used with sprayers and / or other devices.

[0057] Inhalers or nasal devices can be orally inhaled and nasal drug products (OINDP). Non-limiting examples of OINDPs suitable for use with the devices described herein may include: adecyl bromide inhalation powder (Tudorza® Pressair®), ipratropium bromide inhalation aerosol (Atrovent® HFA), tiotropium bromide inhalation powder (Spiriva® Handihaler®), tiotropium bromide inhalation solution (Spiriva® Respimat®), decyl bromide inhalation powder (Incruse® Ellipta®), salbutamol / ipratropium bromide inhalation solution (DuoNeb®), salbutamol / ipratropium bromide inhalation spray (Combivent® Respimat®), budesonide / formoterol fumarate dihydrate inhalation aerosol (Symbicort®), fluticasone / salmeterol inhalation powder (Advair® Diskus®), fluticasone / salmeterol inhalation aerosol (Advair® HFA), fluticasone furoate / vilanterol inhalation powder (Breo® Ellipta®, mometasone furoate / formoterol fumarate inhaler (Dulera®), tiotropium bromide / olodaterol inhaler (Stiolto™ Respimat®), urothelial bromide / vilanterol inhaler powder (Anoro®Ellipta®), beclomethasone dipropionate HFA inhaler (Qvar®), beclomethasone dipropionate nasal spray (QNASL®), budesonide inhaler powder (Pulmicort® Flexhaler®), budesonide inhaler suspension (Pulmicort® Respules®), cistanosine inhaler inhaler (Alvesco®), flunisolone inhaler inhaler (Aerospan®), fluticasone furoate inhaler powder (Arnuity™ Ellipta®), fluticasone propionate inhaler aerosol (Flovent® HFA), fluticasone propionate inhaler powder (Flovent®) Diskus®, mometasone furoate inhalation powder (Asmanex® Twisthaler®), mometasone furoate inhalation aerosol (Asmanex® HFA), arfurot tartrate inhalation solution (Brovana®), formoterol fumarate inhalation powder (Foradil®), formoterol fumarate inhalation solution (Perforomist®), indomethacin inhalation powder (Arcapta™ Neohaler™), olodaterol inhalation spray (Striverdi® Respimat®), salmeterol benzoate inhalation powder (Serevent® Diskus®), salbutamol sulfate inhalation powder (Proair®)Respiclick®, Salbutamol Sulfate Inhalation Aerosol (Proair® HFA), Salbutamol Inhalation Solution (AccuNeb®), Salbutamol Sulfate Inhalation Aerosol (Proventil® HFA), Salbutamol Sulfate Inhalation Aerosol (Ventolin® HFA), L-Salbutamol Tartrate Inhalation Aerosol (Xopenex® HFA), and Cicsolone Nasal Inhaler (Zetonna®).

[0058] Pharmaceutical devices may include formulations of, for example, drugs or active ingredients. In some cases, the formulation contains one or more excipients. In some cases, the formulation does not contain any excipients. In some cases, the formulation includes one or more propellants. The formulation may be a suspension, solution, or dry powder.

[0059] The methods and apparatus described herein may involve one or more sensors. These sensors may contact a dosage device. In some cases, the sensors may be in direct contact with the dosage device; for example, one or more sensor assemblies may directly contact or touch components of the dosage device. The sensors may contact any part of the dosage device, such as the housing or canister of the dosage device. In some cases, the sensors may contact the housing of the dosage device. The housing may be a plastic component of the dosage device, such as an actuator, a mouthpiece, or both. In some cases, the sensors may contact the canister of the dosage device. The canister may be a metal component (e.g., stainless steel or aluminum) of the dosage device containing the formulation. In cases where the dosage device is a metered-dose inhaler, the sensors may contact a metering valve.

[0060] In some cases, one or more sensors may be attached to the holder or canister of the medication device. In the case where the medication device is an inhaler device, one or more sensors may be attached to the actuator and / or mouthpiece of the inhaler device. In the case where the medication device is a nasal device, one or more sensors may be attached to the bottle, pump, or actuator nozzle tip of the nasal device. In some cases, one or more sensors are permanently attached or affixed to the holder or canister of the medication device. For example, one or more sensors may not be removable or decoupled from the medication device. One or more sensors may be glued, welded, embedded, adhered, or otherwise attached to the medication device such that one or more sensors cannot be removed. In other cases, one or more sensors may be detachably attached to the holder or canister of the medication device. In this example, one or more sensors may be removable from the holder or canister of the medication device. In some cases, one or more sensors may be removed from a medication device and attached to a separate medication device. In some cases, one or more sensors may be attached to an adapter that provides detachable attachment of the sensor to the medication device. In some cases, a medication device may be provided and / or obtained with one or more sensors already attached. In other cases, a medication device may be provided and / or obtained without one or more sensors attached. In certain circumstances, one or more sensors may be sold and / or purchased separately from the medication device. In such cases, one or more sensors may be attached to the medication device, for example, by a user (e.g., a patient), a healthcare provider, or a manufacturer.

[0061] In some cases, one or more sensors are contained within a sensor device or sensor package configured for attachment to a pharmaceutical device. The sensor device may include a housing for accommodating one or more sensors. The sensor device may also include one or more sensors housed within the housing. The one or more sensors may include any type of sensor that can be used to monitor the use of the pharmaceutical device. Non-limiting examples of sensors that may be provided in the sensor device include: airflow sensors (e.g., thermistors, pressure sensors, barometers), integrated flow sensors, position or displacement sensors, rate sensors, tilt sensors, touch sensors (e.g., electrode, capacitive, or resistive touch sensors), shake sensors (e.g., accelerometers), magnetometers, temperature sensors, global positioning system (GPS) chips, ambient light sensors, sensors capable of detecting more than one parameter, and any combination thereof.

[0062] In some cases, the sensor device can be used with virtually any pharmaceutical device. In specific cases, the sensor device can be universally configured such that it can operate with any number and type of pharmaceutical devices. In one particular aspect, the sensor device can be coupled to and used with a first pharmaceutical device, and subsequently decoupled from that pharmaceutical device, and subsequently attached to and used with a different second pharmaceutical device. The first and second pharmaceutical devices can be of the same or different types. The type of pharmaceutical device mentioned herein can depend on the specifications of the pharmaceutical device. For example, the type can depend on the active ingredient, inactive ingredient, strength, recommended shaking duration, and so on. Figure 9 As shown in the column. In some cases, the sensor device can be reused multiple times, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, 100, 200, 500, 1000, 2000, 5000 or more.

[0063] In some cases, the sensor device can be directly coupled to the medication device (e.g., via a coupler that allows attachment to the medication device) or via an adapter. For example, the sensor device may include a communication unit (e.g., a wireless communication unit, RFID chip, optical reader, etc.). The medication device (e.g., a canister for use with an inhaler) may include another communication unit (e.g., a wireless communication unit, RFID chip, readable barcode, etc.) that can communicate with the communication unit of the sensor device. In such cases, the medication device can be configured to transmit relevant parameters (e.g., shaking parameters, etc.) that can be processed by the sensor device to guide the user in the proper use of the medication device.

[0064] In some cases, the sensor device may be coupled to the pharmaceutical device via one or more intermediate means. For example, the sensor device may be coupled to the pharmaceutical device via an adapter. The adapter may be configured for direct coupling to the pharmaceutical device or its components. In one such example, the adapter may be specific to a particular pharmaceutical device, allowing a general-purpose sensor device to be coupled to virtually any pharmaceutical device using a product-specific adapter. The sensor device may include a coupler for coupling to the pharmaceutical device and / or the adapter. The coupler may include a receiving port for receiving complementary protrusions of the adapter. In such cases, the coupler may also include an electrical interface for electrical coupling to the adapter. In some cases, the coupler may include one or more latching points for receiving one or more latches of the adapter, and the coupler may include an adhesive configured for coupling to the pharmaceutical device.

[0065] Figure 1 Non-limiting examples of how a sensor device coupled to an adapter can be attached to a pharmaceutical device are described in accordance with this disclosure. Figure 1 Small figure A depicts the sensor device 101 coupled to the adapter 103. In some cases, the sensor device 101 can be attached to the medication device 105 by attaching the adapter 103 (with the sensor device 101 attached) 107 to the retainer or canister of the inhaler device 105, such as... Figure 1 small picture B and Figure 1 As shown in small figure C.

[0066] In some cases, the adapter may be designed to fit onto the holder or canister of a specific pharmaceutical device product. In other cases, the sensor device 201 may be attached to 205, for example, by snap-fitting or sealing, onto the adapter 203, such as... Figure 2 As depicted in small figure A. The sensor device (i.e., the sensor device and adapter) can then be attached to the inhaler device as described above. In some cases, the sensor device and product-specific adapter may be supplied separately or as a unit or kit comprising one or more sensor devices and one or more adapters. For example, as Figure 2 As shown in small figure B, the sensor device 201 may be equipped with one or more product-specific adapters 201a, 201b, 201c, which can be attached to the sensor device as described above.

[0067] In some cases, the sensor device can be reusable; for example, it can be configured to be used 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, 100, 200, 500, 1000, 2000, 4000, or more times. Optionally, the sensor device can be configured for indefinite use. It can be configured to be used for at least 1 month, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, or longer. The sensor device can be rechargeable; for example, it can include a battery that can be recharged once or multiple times. In some cases, the battery can be recharged at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, or more times. In some cases, the battery can be removed from the sensor device and recharged. In some cases, the battery can be replaced at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50 or more times.

[0068] In some cases, the adapter may be disposable. In some cases, the adapter may be configured for use with a single pharmaceutical device product. In some cases, the adapter may be used for the entire lifespan of the pharmaceutical device and then discarded. The reusability of the sensor device can advantageously allow a user to use a single sensor device with multiple different adapters as needed. In some cases, a single user with different product requirements may use a single sensor device with multiple different adapters. For example, the sensor device may be used in conjunction with a first adapter that is capable of being used with the first pharmaceutical device for the entire lifespan of the first pharmaceutical device. After the first pharmaceutical device is depleted, the user may remove the adapter and sensor device from the first pharmaceutical device, discard the first adapter, and then use the same sensor device with a second adapter that is capable of being used with the second pharmaceutical device for the entire lifespan of the second pharmaceutical device. In some cases, the first and second pharmaceutical devices are of the same type (e.g., the same pharmaceutical product) and the same type of adapter (i.e., an adapter capable of being used with either the first or second pharmaceutical device) may be used. In other cases, the first and second reagent devices are different and can use different types of adapters (i.e., the first adapter can be used with the first reagent device but not with the second reagent device; while the second adapter can be used with the second reagent device but not with the first reagent device). In both cases, the sensor device can be configured to work with both adapters, allowing the sensor device to be reused with different adapters.

[0069] The sensor device may also include additional operational components. For example, the sensor device may include a processor configured to automatically process one or more parameters associated with the drug delivery device and output signals based on those parameters. In some cases, the sensor device may include a microcontroller that can be used to manage and control system functions, including but not limited to firmware logic and data processing algorithms, a timer for providing a precise time base for sensor data acquisition functions, and an audio feedback sequence. The sensor device may include an audio player, amplifier, and / or speaker for providing auditory feedback to the user of the drug delivery device. The sensor device may include a battery, such as a rechargeable lithium-ion battery. Such a battery may be able to power the sensor device for up to 60 days before recharging. The sensor device may include LEDs for indicating battery charge status and PC application connectivity. The sensor device may include a fixed amount of non-volatile memory for storing usage history data and other system settings. The sensor device may include a real-time clock for providing accurate date and timestamps for entries in the usage history. The real-time clock is able to provide accurate timing even when connected to a fully discharged battery. The sensor device may include a push-button switch to turn the system on or off. The push-button switch can be located anywhere on the sensor device, and in some cases, at the distal end of the sensor device. It can be touched, pushed, or otherwise contacted by the user of the device. The push-button switch can perform additional functions, such as enabling the user to acknowledge feedback received from the sensor device or to command system operation. The sensor device may also include a USB connector interface for recharging the battery, communicating with PC applications, and / or achieving wireless interface compatibility (e.g., Bluetooth® functionality). In such cases where the sensor device is used in conjunction with an adapter, the sensor device may include an electromechanical interface for connecting to the adapter.

[0070] Figure 3A The illustration shows an exploded view of the sensor device viewed from top, according to an embodiment. Figure 3CThe illustration shows a perspective view of a sensor device 300 viewed from above, according to an embodiment. The sensor device may include an upper body 302 and a lower body 304. Each of the upper body 302 and the lower body 304 may or may not be circular. Each of the upper body 302 and the lower body 304 may or may not be substantially flat. In some cases, the upper body 304 or the lower body 304 may include interactive components. For example, the surface 306 of the upper body 302 may include a movable component. The movable component may be actuable by a user. The movable component may be used to control the functionality of the sensor device 300, such as turning the sensor device on or off, or changing the operating mode of the sensor device 300. As another example, the surface 306 of the upper body 302 may include a visual display. As described herein, the visual display may be used to give instructions or guidance to a user. As another example, the surface 306 of the upper body 302 may include a touch-sensitive button. The touch-sensitive button may be used to control the functionality of the sensor device 300, such as turning the sensor device on or off, or changing the operating mode of the sensor device 300. Optionally, the touch-sensitive button may be configured to also function as a visual display as described above. While, by way of example, the interactive components of the sensor device 300 are illustrated as being located on the top surface of the upper body, it should be understood that it can be located anywhere, such as on one side, on the lower body, etc. The lower body 304 may include a sound chamber 316. The sound chamber can help transmit auditory instructions generated from the sensor device 300. In some cases, the lower body 304 may include a sound port 318, which can allow auditory commands to be transmitted to a user using the sensor device 300.

[0071] The upper body 302 and lower body 304 may include the housing or exterior of the sensor device 300. The housing may include a diameter equal to or less than 4 cm. 2 6 cm 2 8 cm 2 10 cm 2 12 cm 2 14 cm 2 16 cm 2 18 cm 2 20 cm 2 25 cm 2 30cm 2 35 cm 2 40 cm 2 50 cm 2The volume of the sensor device 300 or any value thereof. The small size of the housing ensures that the sensor device 300 remains inconspicuous to the user. The upper body 302 and the lower body 304 may be configured to be permanently coupled to each other. Alternatively, the upper body 302 and the lower body 304 may be configured to be detachably coupled to each other, allowing the user to remove the upper body 302 from the lower body 304, or vice versa.

[0072] In some cases, the upper body 302 and lower body 304 may surround or enclose the electronic component 310. The upper body 302 and lower body 304 may partially or completely surround or enclose the electronic component 310. The electronic component 310 of the sensor device 300 may include one or more circuit boards 311, batteries 312, interfaces 314, or other elements 308. The electronic component 310 of the sensor device 300 may include speakers, one or more processors, one or more additional sensors, etc., as further described elsewhere. The circuit board 310 may be rigid and / or flexible. The circuit board 310 may include two rigid components coupled together by a flexible component. In some cases, the two rigid components may be sandwiched between one or more batteries 312. Advantageously, this configuration may allow the barometer 320 to be operatively coupled to the pressure connector tube 410, as further described elsewhere, while allowing interactive components of the sensor device 300 (e.g., switch 306) to be located on top of the device 300. The circuit board 310 may enable various other electronic components to be coupled to and / or communicate with each other. Battery 312 provides power to sensor device 300. Battery 312 allows sensor device 300 to operate for a period of time equal to or greater than about 1 hour, 2 hours, 5 hours, 10 hours, 16 hours, 24 hours, 2 days, 5 days, 1 week, 2 weeks, 4 weeks, 1 month, 2 months, 4 months, 6 months, 8 months, 1 year, 2 years, or more. Optionally, battery 312 may be rechargeable. Interface 314 allows sensor device 300 to communicate with one or more external devices. In some cases, the interface may be a USB port 314. In some cases, the sensor device is configured for wireless interface compatibility (e.g., Bluetooth®). Optionally, interface 314 may allow recharging of battery 312 of sensor device 300. Other elements 308 may include various additional elements. In some cases, other elements 308 may include buttons or switches. Switches may be used to control the functionality of sensor device 300, such as turning sensor device 300 on or off, or changing the operating mode of sensor device 300. For example, a user of the surface 306 of the actuating sensor device 300 can press a button 308 to affect the sensor device 300 (e.g., turn it on or off).

[0073] In some cases, other components may include sensors such as accelerometers, barometers 320, temperature sensors, magnetometers, ambient light sensors, or Global Positioning System (GPS). Accelerometers can allow the sensing device to measure various parameters throughout the description, such as oscillation parameters and / or the orientation of the pharmaceutical device. In some cases, the accelerometer may be located on the sensor device 300 such that when the sensor device is coupled to the pharmaceutical device, it is positioned along the central axis of the pharmaceutical device, for example, as... Figure 11 As shown in the diagram. The barometer 320 allows the sensor device to measure various parameters throughout the description, such as inhalation parameters. The temperature sensor allows the sensor device to measure various parameters throughout the description, such as the temperature of the environment surrounding the sensor device and / or the medication device. This can advantageously allow the sensor device to adjust the guidance for using the medication device or inhaler, for example, by changing the guidance according to environmental factors. As an example, if it is determined that the medication device is being used in a very cold environment, the sensor device can adjust its guidance (e.g., adjust parameters) or even advise the user to avoid using the medication device until a predetermined temperature is reached. The predetermined temperature can be equal to or less than about 0°C, 2°C, 4°C, 6°C, 8°C, 10°C, 12°C, 14°C, 16°C, 18°C, 20°C, 22°C, 24°C, 26°C, 28°C, 30°C, 32°C, 34°C, 36°C, 38°C, or 40°C. A magnetometer allows the sensor device to measure various parameters throughout the description, such as the true orientation of the sensor device and / or the medication device. This can advantageously allow the sensor device to adjust the guidance used for using the medication device or inhaler, for example, by changing the guidance according to environmental factors. As an example, if it is determined that a person will be facing the sun, the sensor device can adjust its guidance from visual (e.g., light) guidance to auditory guidance. An ambient light sensor allows the sensor device to measure the ambient light level of the environment in which the sensor device is being used and automatically adjust its indication settings (e.g., increase / decrease the brightness level of the visual indicator). GPS allows the sensor device to measure various parameters throughout the description, such as the global coordinates in which the sensor device is being used. This can advantageously allow the sensor device to adjust the guidance used for using the medication device or inhaler, for example, by changing the guidance according to environmental factors such as the altitude of the device being used, humidity, etc.

[0074] Figure 3B The figure shows an exploded view of the sensor device 300 from the bottom, according to an embodiment. Figure 3D The diagram shows a perspective view of the sensor device 300 from the bottom, according to an embodiment. The sensor device 300 can be the sensor device 300 described throughout the text, for example, such as... Figure 3AAs shown in the diagram. The lower body 304 of the sensor device 300 may include one or more couplers 328, 330. Optionally, the lower body 304 of the sensor device 300, together with electronic components, may include one or more couplers. These one or more couplers may be configured for coupling to a pharmaceutical device, for example, directly or indirectly via other intermediate means. Although in Figure 3B The illustration shows couplers in the form of receiving ports 328, 330, but it should be understood that any form of coupling (e.g., adhesive, protrusion, shape-fitting mechanism, hook, etc.) may be used as examples of couplers. One or more couplers may include receiving ports 328, 330. In some cases, one or more couplers or one or more receiving ports 328, 330 may include or lead to an electrical interface 324. The electrical interface 324 may be an electrical contact. In some cases, the electrical interface 324 may allow the sensor device 300 to communicate (e.g., electrically) with other devices (e.g., the adapter 400 described herein). Optionally, receiving ports 328, 330 may be configured (e.g., molded) to detachably receive complementary protrusions of the adapter 408 described herein. Optionally, receiving ports 328, 330 may be configured to allow communication with the adapter 400 described herein, which may include a memory storing one or more parameters associated with the pharmaceutical device. In some cases, one or more couplers may include one or more latching points 328. Latch point 328 allows sensor device 300 to fit securely into one or more other devices, such as the pharmaceutical device and / or adapter 400 described herein. One or more latch points 328 may be configured to receive one or more latches 402 of other devices, such as the pharmaceutical device and / or adapter 400. Advantageously, including one or more latch points 328 for greater integrity (e.g., in the structure) allows sensor device 300 to be used for extended periods without failure, while other more disposable components, such as adapter 400, are used for shorter time periods (e.g., with protrusions).

[0075] The lower body 304 of the sensor device 300 may include an opening 326. The opening 326 may also be referred to herein as an interface to a pressure connector. The opening 326 may be configured to receive a pressure connector tube 410 of the adapter 400. The opening 326 may lead to a sensor, such as a barometer 320 and / or a pressure sensing chamber (see, for example, see...). Figure 7 Alternatively, opening 326 may be a single opening (e.g., a unique opening) leading to the pressure sensing cavity. Therefore, the pressure sensing cavity may be isolated (e.g., apart from the opening). Figure 7The illustration shows a pressure sensing cavity 320 of a pressure connector tube 410 coupled to an adapter 400 according to an embodiment. As described throughout, the pressure connector tube 410 may include a proximal portion 702 located on a first surface (e.g., the top surface) of the adapter 400. The proximal portion 702 may include a sealing element 704. In some cases, the sealing element may be an O-ring. The pressure sensing cavity may include one or more sensors, such as a barometer 320. The pressure sensing cavity may have a minimal size to allow the barometer 320 to sense pressure changes due to user inhalation as quickly as possible. In some cases, the pressure sensing cavity may include an area equal to or less than about 2 cm. 3 4 cm 3 6 mm 3 8 mm 3 10 mm 3 12 mm 3 14 mm 3 16 mm 3 20 mm 3 22mm 3 24 mm 3 26 mm 3 28 mm 3 30 cm 3 Or any value in between. In some cases, the pressure sensing chamber may allow air to flow in and out bidirectionally, for example, through an opening. Each of the pressure sensing chambers and / or barometers 320 may be located or positioned on the aforementioned circuit board 310. Although the barometers 320 are illustrated as suspended from the top or bottom of the circuit board, it should be understood that this configuration is illustrative and not limiting. Figure 8 The illustration shows a pressure sensing cavity according to an embodiment, which has a barometer located on the bottom surface of a circuit board. As shown, the barometer or the sensing area of ​​the barometer may be exposed on the silicon substrate itself.

[0076] Referring back to Figure 3, electronic component 310 may include an indicator. The indicator may include a speaker, a light source (e.g., a light-emitting diode), or a visual display as mentioned above. The indicator may be configured to operatively receive signals generated, processed, or output from a processor. In some cases, the indicator may be configured to provide guidance to a user of the pharmaceutical device described herein, for example, via visual or auditory indication. In such cases where an auditory indicator is used, the auditory indicator may be adjustable or customizable by the user. For example, the volume may be adjusted, or the style of the voice or sound may be changed or customized. Similarly, when using a visual indicator, the color of the light, the pattern of the light indication, and / or the brightness of the light may be adjusted. In some cases, the user may have the ability to switch the device from auditory indication to visual indication, and vice versa. In some cases, the guidance may vary depending on the type of pharmaceutical device selected or used. The type of pharmaceutical apparatus used may depend on the apparatus's target indication, spray rating, active ingredient, inactive ingredient, strength, propellant, recommended time between actuations, weight of can contents, spray weight, formulation type, recommended number of filling steps, recommended time intervals between timings, recommended number of refilling steps, or recommended shaking duration, for example, such as Figure 9 As shown in the diagram. In some cases, guidance can be customized so that the sensor provides guidance based on recommended parameters. In some cases, depending on the type of reagent device, guidance can vary in the duration of shaking the reagent device, the shake-to-fire interval, the waiting time between actuations, multiple filling steps, multiple refilling steps, or the duration until a refilling step. In some cases, the duration of shaking the reagent device can vary between 0 and 30 seconds. In some cases, the waiting time between actuations varies between 0 and 60 seconds. In some cases, the number of filling steps varies between 0 and 5. In some cases, the number of refilling steps varies between 0 and 5. In some cases, the duration until a refilling step varies between 0 and 30 days. In some cases, the shake-to-fire interval varies between 0 and 30 seconds.

[0077] The sensor device 300 may include one or more processors or microcontrollers 322. The processor may be configured to automatically process one or more parameters associated with the pharmaceutical device. These one or more parameters may be recommended parameters for the pharmaceutical device (e.g., recommended shaking parameters), such as... Figure 9 As shown in the diagram. In some cases, the processor can be configured to receive one or more parameters from another device (such as adapter 400 mentioned herein). For example, once the sensor device is connected to the adapter (such as... Figures 5A-5B and Figures 6A-6BAs shown in the diagram (e.g., and is turned on and / or authenticated), sensor device 300 can be configured to automatically receive one or more parameters associated with a medication device from adapter 400. Therefore, the sensor device can be configured to be used with multiple different medication devices and output appropriate guidance depending on the type of medication device. A processor can be configured to output signals based on one or more processed processor signals. In some cases, the sensor device can be configured to provide different guidance depending on the type of medication device. In some cases, the sensor device can be configured to provide different guidance in terms of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more parameters (e.g., shaking parameters) depending on the type of medication device (or adapter) to which it is coupled. As described throughout, medication device can refer individually or collectively to a canister or inhaler. The inhaler can be a pressurized dose-measuring inhaler. Optionally, a kit may be provided. The kit may include the sensor device described throughout, as well as instructions for coupling and / or decoupling the sensor device to the adapter. Alternatively, the kit may include the sensor device described throughout the document, the adapter device described throughout the document, and instructions for coupling the sensor device to and / or decoupling it from the adapter.

[0078] In some implementations, the adapter includes electronics and / or operating components. In some cases, the adapter is programmed with product-specific operating parameters (PSOPs), such as operating parameters for the correct use of a particular pharmaceutical device. For example, the adapter may be programmed with specific shaking parameters, actuation parameters, etc., specific to the pharmaceutical device. The PSOP may be provided by the manufacturer of the pharmaceutical device (e.g., provided in the instruction manual) or may be determined empirically. Figure 9 A non-limiting example of a PSOP for a specific pharmaceutical device is depicted, which can be programmed into an adapter for use with such a device. When used in conjunction with a sensor device, the adapter can receive data from the sensor device, including but not limited to actuation date and / or time, number of sprays (corresponding to the number of times the device has been actuated), and sensor ID. The adapter programmed with the PSOP can determine when one or more predetermined thresholds for shaking parameters, actuation parameters, etc., have been reached. The adapter can then relay the signal to the sensor device and can activate a light or audible or other indicator in the sensor device, as further described herein. The adapter may include an encrypted authentication device for uniquely identifying the adapter and preventing cloning or counterfeiting of the adapter. The adapter may also include a secure memory block for storing the PSOP, which can be exclusively accessed by the adapter after successful authentication by the authentication device.

[0079] Figures 4A-4CA non-limiting example of a product-specific adapter 400 as envisioned herein is depicted, which can be used in conjunction with a sensor device 300 to couple to a pharmaceutical device, such as the pharmaceutical device shown in FIG. 3. The product-specific adapter 400 may include one or more latches 402 to allow coupling to the sensor device 300 as described herein. The one or more latches 402 may, for example, be a protrusion on the base of the adapter 400 that complements one or more receiving ports 328 on the sensor device 300. The one or more latches 402 may be inserted into the complementary receiving ports 328 of the sensor device 300, thereby allowing the adapter 400 to attach to the sensor device 300. The one or more latches 402 may allow for detachable coupling of the adapter 400 to the sensor device 300. The adapter 400 may also include a hollow, non-invasive pressure connector tube 410 for acquiring air flowing between the inhaler canister 401 and the actuator body 403 during inhalation. The pressure connector tube may be hollow. In some cases, the pressure connector tube may be configured to be located on one side of the adapter and / or sensor device. The pressure connector tube may be configured to extend alongside or parallel to the medication device. The pressure connector tube may be configured to be positioned toward the mouthpiece or inhaler of the medication device such that the user's inhalation can affect the air within the pressure connector tube. The pressure connector tube may include one or more pressure connector ports 412. Pressure connector ports allow air to flow in or out through the pressure connector tube, which can be sensed by a pressure sensor (e.g., located on the sensor device). The pressure connector ports may be located on one side of the pressure connector tube to allow sensing of the pressure of moving air passing through the pressure connector tube. The pressure connector tube 410 may be configured such that it mates with the sensor device 300 via a mating surface 404 and provides a sealed interface to the barometer 320 of the sensor device, allowing the system to accurately detect inhalation. In such a case, the barometer signal can be directly correlated with the user's inhalation. The pressure connector tube 410 may be positioned in the gap between the inhaler canister 401 and the actuator 403. Adapter 400 may additionally include an encryption authentication device 406 for uniquely identifying adapter 400 and preventing cloning or counterfeiting of adapter 400. Adapter 400 may also include a secure memory block for storing PSOPs for exclusive access by the adapter after successful authentication by authentication device 406. Adapter 400 may also include an electromechanical coupler 408 that allows adapter 400 to be electrically connected to sensor device 300 to receive data from and / or transmit data to one or more sensors, and to relay outputs to indicators on sensor device 300. For example, the adapter may be configured to transmit one or more parameters described herein to the sensor device.In some cases, when an electrical connection is established between the sensor device and the adapter, the adapter can automatically transmit one or more parameters related to the drug delivery device stored in its memory. Optionally, when the sensor device and / or the adapter is authenticated, the adapter can transmit one or more parameters related to the drug delivery device stored in its memory. Figure 4B An adapter 400 coupled to an inhaler device is described. Figure 4C An unfolded view of the distal end of the pressure fitting tube 410 is depicted, which includes the pressure fitting port 412 and the pressure fitting cap 414.

[0080] In one example, the sensor device may be product-independent (i.e., not customized for a specific medication device). The sensor device may be used in conjunction with multiple product-specific adapters, each including different PSOPs, or multiple product-specific adapters, each including the same PSOP. In this example, the sensor device may be detachably attached to a disposable adapter, and the adapter may then be attached to a specific medication device. Alternatively, in this example, the sensor device may be detachably attached to a disposable adapter already attached to a specific medication device. After the medication device has been depleted, the sensor device can be removed from the adapter, the product-specific adapter can be discarded along with the empty medication device, and the sensor device can be attached to a different product-specific adapter. In a non-limiting example, a user may purchase a kit or bundle including one or more sensor devices and multiple product-specific adapters, each product-specific adapter including a PSOP for a specific medication device. During normal use or after the user has used up the medication, the user may discard the medication device and adapters and attach the sensor device to a new adapter and medication device. In this way, the sensor device can be reused multiple times.

[0081] The sensor device can be attached to any component of the pharmaceutical device, and typically, it will be attached such that one or more sensors contained within it can sense or detect one or more parameters of the pharmaceutical device. For example, the sensor device can be attached to the holder of the pharmaceutical device to, for example, detect the frequency of shaking of the pharmaceutical device. In another example, the sensor device can be attached to the canister of the pharmaceutical device to, for example, detect the angle of shaking (of the canister relative to its vertical axis). The sensor device can be attached such that it does not interfere with the functionality of the pharmaceutical device. In some cases, the sensor device is attached to the surface of the holder or canister of the pharmaceutical device. This surface can be located on the outside or inside of the holder or canister. In some cases, the sensor device can be embedded in the holder or canister of the pharmaceutical device, for example, embedded in a plastic or metal component of the pharmaceutical device. A portion or the entire sensor device can be embedded in the holder or canister of the pharmaceutical device. Figure 10A pharmaceutical device 1000 is depicted, illustrating three non-limiting examples of the positioning of sensor devices on the device. The sensor devices can be attached to the pharmaceutical (e.g., with adhesive tape or via a product-specific adapter) 1001, 1003, 1005. The sensor devices can be operatively coupled to indicators or signaling mechanisms, such as LEDs 1002, 1004, 1006. The LEDs can be positioned at the front of the device, for example, at the front of the housing or canister 1002, 1004, 1006, so that the user of the device can see the visual indicator (e.g., light).

[0082] In some examples, the adapter can be configured to position one or more sensors contained within the sensor device to the pharmaceutical device in a predetermined relationship or manner. Figure 11 A non-limiting example is shown of how a product-specific adapter can position one or more sensors contained within a sensor device relative to a pharmaceutical device. In this example, the sensor device includes an accelerometer and a barometer. For the accelerometer to properly measure, for example, the shaking parameters of the pharmaceutical device, it may need to be positioned along the centerline of the pharmaceutical canister. Among other things, the adapter can function to position the accelerometer along the centerline of the pharmaceutical canister. Advantageously, the product-specific adapter can be designed in such a way that the accelerometer is positioned along the centerline of a particular pharmaceutical canister, regardless of the arrangement of the accelerometer within the sensor device. Therefore, the invention allows for the use of a universal sensor device with any sensor configuration or arrangement with virtually any pharmaceutical device. Although a specific example of using an accelerometer has been described, it should be understood that the adapter can be used in a similar manner to position any sensor in a particular configuration with any pharmaceutical device.

[0083] In some cases, the method and apparatus include one or more sensors for detecting one or more parameters of the pharmaceutical device. These one or more parameters may include one or more shaking parameters, one or more actuation parameters, one or more inhalation airflow parameters, or any combination thereof. In some cases, one or more sensors included within the sensor device detect whether the pharmaceutical device meets or exceeds a predetermined threshold of one or more parameters. For example, one or more sensors may sense or detect whether the pharmaceutical device has been properly shaken before actuation, for example, by detecting one or more shaking parameters. In another example, one or more sensors may sense or detect whether the pharmaceutical device has been properly actuated, for example, by detecting one or more actuation parameters. In some cases, when each of the one or more parameters meets its corresponding threshold, the pharmaceutical device can deliver a drug within a desired dose range when actuated. In some cases, one or more sensors may be used to detect when a predetermined threshold of one or more parameters is met. Each of the one or more parameters may have a predetermined threshold specific to a particular pharmaceutical device; therefore, in some cases, one or more sensors may be used to detect whether each of the one or more parameters has individually reached its corresponding threshold. In some cases, when a predetermined threshold of each of the one or more parameters is met or exceeded, the apparatus provides one or more outputs. In some cases, the device will not provide an output unless each of one or more parameters individually reaches its corresponding threshold. Different pharmaceutical devices may have different requirements for proper shaking and actuation. Therefore, sensor devices, either alone or in combination with an adapter, can be pre-programmed and customized to operate with a specific pharmaceutical device. Individual sensor devices or sensor devices in combination with an adapter can be pre-programmed to detect a specific set of thresholds based on the pharmaceutical device and the formulation contained therein.

[0084] Any type of sensor can be used with the sensor device described herein. For example, the sensor can be an airflow sensor (e.g., a thermistor or pressure sensor), an integrated flow sensor, a position or displacement sensor, a rate sensor, a tilt sensor, a touch sensor (e.g., an electrode, capacitive, or resistive touch sensor), a shake sensor (e.g., an accelerometer), a magnetometer, a Global Positioning System (GPS) chip, an ambient light sensor, a sensor capable of detecting more than one parameter, and any combination thereof. The selection of one or more sensors to be used with the pharmaceutical device will depend on the parameter to be detected.

[0085] In some cases, one or more sensors detect one or more shaking parameters of the pharmaceutical device. In other cases, one or more sensors detect whether the pharmaceutical device meets or exceeds a predetermined threshold for each of one or more shaking parameters of the pharmaceutical device. One or more shaking parameters may include shaking duration, shaking angle, shaking frequency, shaking-to-emission interval, or any combination thereof. As used herein, the term "shaking duration" may refer to the length of time the pharmaceutical device is shaken. Shaking duration may range from about 1 second to about 30 seconds. For example, shaking duration may include about 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, 6 seconds, 7 seconds, 8 seconds, 9 seconds, 10 seconds, 11 seconds, 12 seconds, 13 seconds, 14 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, or longer.

[0086] As used herein, the term "shaking angle" can refer to the angle of the canister of a pharmaceutical device measured from its vertical axis during shaking. For example, a shaking angle of 90 degrees would include horizontal shaking of the canister. Shaking angles can range from about 50 degrees to about 150 degrees. For example, shaking angles can include about 50 degrees, 60 degrees, 70 degrees, 80 degrees, 90 degrees, 100 degrees, 110 degrees, 120 degrees, 130 degrees, 140 degrees, 150 degrees, or greater.

[0087] The term "shaking frequency" as used herein can refer to the number of times (cycles) a pharmaceutical device is shaken within a given time period. Shaking frequency can be measured in Hertz (Hz), and is defined as the number of cycles per second. Shaking frequencies can range from about 1.0 Hz to about 5.0 Hz. For example, shaking frequencies can be about 1.0 Hz, 1.5 Hz, 2.0 Hz, 2.5 Hz, 3.0 Hz, 3.5 Hz, 4.0 Hz, 4.5 Hz, 5.0 Hz, or higher.

[0088] As used herein, the term "shake-to-fire interval" can refer to the length of time that occurs between the end of a shaking program and the actuation of the agent device. The shake-to-fire interval can range from approximately 0 seconds to approximately 30 seconds. For example, the shake-to-fire interval can be approximately 0 seconds (i.e., actuation immediately after shaking), 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, 6 seconds, 7 seconds, 8 seconds, 9 seconds, 10 seconds, 11 seconds, 12 seconds, 13 seconds, 14 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, or longer.

[0089] In some cases, one or more sensors, as described herein, can be used to monitor the shaking pattern. The shaking pattern may include one or more shaking parameters, including shaking duration, shaking angle, shaking frequency, and shaking-to-launch interval. The shaking pattern may be a specific combination of one or more shaking parameters required to be performed on the pharmaceutical device to deliver a desired dose range of the drug when the device is actuated. The shaking pattern may be specific to a particular pharmaceutical device and may depend at least in part on the formulation of the drug, one or more characteristics of the pharmaceutical device, the volume of the metering valve, the relative mixing efficiency of drug particles in the suspension with one or more excipients and / or one or more propellants, or any combination thereof. The shaking pattern may be affected by the composition of the formulation present in the canister (e.g., the number of excipients present with the drug in the formulation or the specific composition of the excipients present in the formulation). Therefore, different products, each containing the same drug, may require very different shaking patterns to deliver the desired dose range.

[0090] In some respects, the methods described herein involve executing a shaking protocol on a drug delivery device, monitoring one or more shaking parameters of the shaking protocol, and actuating the drug delivery device when a predetermined threshold of one or more shaking parameters is reached or exceeded. For example, if the shaking protocol includes a shaking duration of 5 seconds, a shaking angle of 60 degrees, and a shaking frequency of 2.0 Hz, then the drug delivery device will ideally be actuated after all three shaking parameters of the shaking protocol have been met. In some cases, if one or more shaking parameters are not met before actuating the drug delivery device, the delivered dose of the drug may differ from the intended target dose, and in some cases, significantly.

[0091] In some cases, one or more sensors can detect one or more actuation parameters of a pharmaceutical device. For example, one or more sensors can detect whether the pharmaceutical device has been properly actuated (e.g., held in a fully actuated state for a defined time). The term "actuation" can refer to the act of compressing the canister of a pharmaceutical device for a period of time to release the substance contained within the canister or holder. For example, actuation of a pharmaceutical device can release a single dose of formulation contained therein. One or more sensors can be designed to detect whether the pharmaceutical device is only partially actuated, which can indicate that the intended dose range of the drug has not yet been released. One or more actuation parameters can include, but are not limited to, compression rate, compression acceleration, actuation hold time, decompression rate, decompression acceleration, actuation stroke length, and any combination thereof.

[0092] As used herein, “compression speed” can refer to the speed at which a pharmaceutical device is compressed (e.g., the speed at which a user pushes or compresses the canister or nasal actuator during actuation). Compression speeds can range from about 10 mm / s to about 100 mm / s. For example, compression speeds can be about 10 mm / s, 15 mm / s, 20 mm / s, 25 mm / s, 30 mm / s, 35 mm / s, 40 mm / s, 45 mm / s, 50 mm / s, 55 mm / s, 60 mm / s, 65 mm / s, 70 mm / s, 75 mm / s, 80 mm / s, 85 mm / s, 90 mm / s, 95 mm / s, 100 mm / s, or greater than 100 mm / s.

[0093] The term "compression acceleration" as used in this article can refer to the rate of change of velocity of the canister or nose actuator per unit time during compression. Compression acceleration can range from approximately 500 mm / s². 2 Approximately 4000 mm / s 2 For example, the compressive acceleration can be approximately 500 mm / s². 2 600 mm / s 2 700 mm / s 2 800 mm / s 2 900 mm / s 2 1000 mm / s 2 1100 mm / s 2 1200 mm / s 2 1300 mm / s 2 1400 mm / s 2 1500 mm / s 2 1600 mm / s 2 1700 mm / s 2 1800 mm / s 2 1900 mm / s 2 2000 mm / s 2 2100 mm / s 2 2200 mm / s 2 2300 mm / s 2 2400 mm / s 2 2500 mm / s 2 2600 mm / s 2 2700 mm / s 2 2800 mm / s 2 2900 mm / s 2 3000 mm / s 2 3100 mm / s2 3200 mm / s 2 3300 mm / s 2 3400 mm / s 2 3500 mm / s 2 3600 mm / s 2 3700 mm / s 2 3800 mm / s 2 3900 mm / s 2 4000 mm / s 2 or greater than 4000 mm / s 2 .

[0094] As used herein, "actuated hold time" can refer to the amount of time a pharmaceutical device is held in its fully actuated state. "Fully actuated" can refer to the maximum compression of the pharmaceutical device's canister. Actuation of the pharmaceutical device can include compression of the pharmaceutical device and can include an "actuated hold time window," for example, the period of time during which the pharmaceutical device is held in its fully actuated state. The actuated hold time window can be from about 0 seconds to about 30 seconds. For example, the actuated hold time window can be about 0 seconds (immediate release), 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, 6 seconds, 7 seconds, 8 seconds, 9 seconds, 10 seconds, 11 seconds, 12 seconds, 13 seconds, 14 seconds, 15 seconds, 16 seconds, 17 seconds, 18 seconds, 19 seconds, 20 seconds, 21 seconds, 22 seconds, 23 seconds, 24 seconds, 25 seconds, 26 seconds, 27 seconds, 28 seconds, 29 seconds, 30 seconds, or greater than 30 seconds.

[0095] In some cases, one or more sensors can detect the decompression rate. As used herein, "decompression rate" can refer to the rate at which the medication device is decompressed (e.g., the rate at which the user releases or decompresses the canister or nasal actuator after actuation). Decompression rates can range from about 10 mm / s to about 100 mm / s. For example, decompression rates can be about 10 mm / s, 15 mm / s, 20 mm / s, 25 mm / s, 30 mm / s, 35 mm / s, 40 mm / s, 45 mm / s, 50 mm / s, 55 mm / s, 60 mm / s, 65 mm / s, 70 mm / s, 75 mm / s, 80 mm / s, 85 mm / s, 90 mm / s, 95 mm / s, 100 mm / s, or greater than 100 mm / s.

[0096] In some cases, one or more sensors can detect decompression acceleration. As used herein, "decompression acceleration" can refer to the rate of change of velocity per unit time during decompression of the tank or nose actuator. Decompression acceleration can range from approximately 500 mm / s². 2 To approximately 4000 mm / s2 For example, the decompression acceleration can be about 500 mm / s 2 , 600 mm / s 2 , 700 mm / s 2 , 800 mm / s 2 , 900 mm / s 2 , 1000 mm / s 2 , 1100 mm / s 2 , 1200 mm / s 2 , 1300mm / s 2 , 1400 mm / s 2 , 1500 mm / s 2 , 1600 mm / s 2 , 1700 mm / s 2 , 1800 mm / s 2 , 1900 mm / s 2 , 2000mm / s 2 , 2100 mm / s 2 , 2200 mm / s 2 , 2300 mm / s 2 , 2400 mm / s 2 , 2500 mm / s 2 , 2600 mm / s 2 , 2700mm / s 2 , 2800 mm / s 2 , 2900 mm / s 2 , 3000 mm / s 2 , 3100 mm / s 2 , 3200 mm / s 2 , 3300 mm / s 2 , 3400mm / s 2 , 3500 mm / s 2 , 3600 mm / s 2 , 3700 mm / s 2 , 3800 mm / s 2 , 3900 mm / s 2 , 4000 mm / s 2 or greater than 4000 mm / s 2 。

[0097] In some cases, one or more sensors can detect the actuation stroke length. As used herein, "actuation stroke length" can refer to the maximum amount of compression of the pharmaceutical device during actuation. In some cases, the actuation stroke length is the mechanical compression limit of the pharmaceutical device. The actuation stroke length can range from about 3 mm to about 20 mm. For example, the actuation stroke length can be about 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, or greater than 20 mm.

[0098] In some cases, one or more sensors may detect one or more inhalation airflow parameters. For example, one or more sensors may detect one or more inhalation airflow parameters, for instance, during the inhalation of a delivered dose of formulation by a user of the pharmaceutical device. In some cases, one or more sensors may detect the inhalation airflow rate. As used herein, "inhalation airflow rate" may refer to the airflow velocity during inhalation. The inhalation airflow rate may be, for example, a reading of the intensity of breathing or nasal inhalation. Depending on the flow resistance of the pharmaceutical device and the user's breathing capacity, the inhalation airflow rate may be from about 30 liters per minute to about 100 liters per minute. For example, the inhalation airflow rate may be about 30 liters per minute, 35 liters per minute, 40 liters per minute, 45 liters per minute, 50 liters per minute, 55 liters per minute, 60 liters per minute, 65 liters per minute, 70 liters per minute, 75 liters per minute, 80 liters per minute, 85 liters per minute, 90 liters per minute, 95 liters per minute, 100 liters per minute, or greater than 100 liters per minute.

[0099] In some cases, one or more sensors can detect the inhaled volume. As used herein, “inhaled volume” can refer to the volume of air inhaled during breathing or nasal inhalation. Inhaled volume can range from about 0.5 liters to about 5 liters. For example, inhaled volume can be about 0.5 liters, about 1.0 liter, about 1.5 liters, about 2.0 liters, about 2.5 liters, about 3.0 liters, about 3.5 liters, about 4.0 liters, about 4.5 liters, about 5.0 liters, or greater than 5.0 liters.

[0100] In some cases, one or more sensors can detect the inflow velocity. As used herein, "inflow velocity" can refer to the velocity measured at a single point in the airflow inhaled during breathing or nasal inhalation. In some cases, the inflow velocity can range from approximately 0.1 m / s to approximately 3.0 m / s. For example, the inflow velocity can be approximately 0.1 m / s, 0.2 m / s, 0.3 m / s, 0.4 m / s, 0.5 m / s, 0.6 m / s, 0.7 m / s, 0.8 m / s, 0.9 m / s, 1.0 m / s, 1.1 m / s, 1.2 m / s, 1.3 m / s, 1.4 m / s, 1.5 m / s, 1.6 m / s, 1.7 m / s, 1.8 m / s, 1.9 m / s, 2.0 m / s, 2.1 m / s, 2.2 m / s, 2.3 m / s, 2.4 m / s, 2.5 m / s, 2.6 m / s, 2.7 m / s, 2.8 m / s, 2.9 m / s, 3.0 m / s, or greater than 3.0 m / s.

[0101] The device described herein can further guide users in the proper use and / or maintenance of the medication device. In some cases, the device described herein can detect the expiration date of the medication contained within the medication device. For example, the device described herein can determine whether the actual use date of the medication falls within or outside its expiration date. For instance, the device can indicate to the user that the medication contained in the medication device has expired and can instruct the user to stop using the medication or replace it. The expiration date of the medication can be determined by the medication manufacturer and can be marked on the medication product itself or on the medication product box.

[0102] In some cases, the apparatus described herein can detect whether the medication device has been properly filled before use. The apparatus can detect the number of times the medication device should be actuated before initial use and can determine whether the user has correctly filled the medication device. In some cases, the apparatus described herein can provide guidance on how to correctly fill the medication device, for example, by informing the user how many times the medication device should be actuated before initial use. When the apparatus detects that the medication device is not correctly filled, it can warn the user. The filling scheme for a particular medication device can be provided by the manufacturer of the medication device and can range from 2 to 10 actuations, and in some cases from 0 to 5 actuations. Optionally, the filling scheme can be equal to about 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 actuations or steps.

[0103] In some cases, the device described herein can detect whether a pharmaceutical device has been properly refilled, for example, after a period of inactivity. The device can detect whether a pharmaceutical device has not been used for a specified period of time and can then instruct the user to refill the device by actuating it multiple times before resuming use. After approximately 5 to 7 days of inactivity, a refill program may include 2 to 10 actuations. In some cases, the number of refill actuations is from 0 to 5. Optionally, a refill program may be equal to approximately 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 actuations or steps. In some cases, the duration until refill is from 0 to 30 days. Depending on the type of pharmaceutical device, the duration until refill (e.g., a recommended duration) may be equal to approximately 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 30 days, or any value in between.

[0104] In some cases, the devices described herein can provide guidance to the user, such as a waiting period between actuations. Proper administration of medication from some pharmaceutical devices may require the user to wait for a period of time after the actuation event prior to inhalation. In such cases, the device can instruct the user to actuate the device, wait for a defined time period, and then inhale. In some cases, the waiting period between actuations can be from about 0 to about 60 seconds. For example, the waiting time between actuations can be from approximately 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, or 60 seconds.

[0105] In some cases, the device described herein can instruct the user to clean the medication device after a specified period of use. For example, the device can detect when a specified number of actuations have occurred and then instruct the user to perform a cleaning procedure on the medication device.

[0106] In some cases, the device described herein generates one or more outputs when one or more parameters meet predetermined thresholds. In some cases, the device is operatively coupled to an indicator or signaling mechanism and provides a user with an indication that the medication delivery device is in a state suitable for delivering the intended dosage range of medication. For example, when a sensor device detects that one or more parameters of the medication delivery device have reached or exceeded a predetermined threshold, the sensor device may generate one or more outputs, including indications indicating that the medication delivery device is in a specific state or condition. For example, the sensor device may provide a user with an indication that the medication delivery device has been properly shaken. In another example, the sensor device may provide a user with an indication that the medication delivery device has been properly actuated. This indication may be a visual indication, an auditory indication, or both. For example, as... Figure 12 As shown in small figure A, the device may include a light source, such as a light-emitting diode (LED), which generates a visual indication 1201 (e.g., light) when one or more predetermined thresholds of parameters are met or exceeded. The visual indication may be a change in the color of the light (e.g., a red light indicating the device has not been properly shaken, while a green light indicates the device has been properly shaken). The visual indication may be the presence or absence of light (e.g., the light is off when the device has not been properly shaken, and on after the device has been properly shaken). In some cases, the visual indication may be a flashing light. The light may be located on any component of the sensor device, on the adapter, or on the medication device itself, although the light is generally positioned so that it is easily visible to the user. For example, the light may be located on the holder of the medication device (e.g., a nasal spray device, or the actuator or mouthpiece of an inhaler). In some cases, the light is positioned on the medication device such that the user can see it when the medication device has been placed in the user's mouth without having to first remove the medication device from the mouth. In some cases, the indication is an auditory indication. Auditory cues can be used, for example, when the device user has visual impairments (e.g., blindness, color blindness). Auditory cues can be beeps, chimes, buzzing, music, or any other auditory cues, such as... Figure 12 As shown in small figure B. In some cases, auditory instructions can be spoken words that give the user a command, such as... Figure 12 As shown in small figure C. In some cases, the indication shown is the vibration of the device, such as... Figure 12 As shown in small figure D. In some cases, the device includes both visual and auditory indicators. In some cases, the device includes multiple different visual indicators or multiple different auditory indicators, which can indicate different conditions of the device (e.g., one indicator indicates that the device has been properly shaken, and another indicator indicates that the device has been properly actuated).

[0107] In some respects, one or more outputs include data. Data may be collected by the sensor device, stored by the sensor device, or both. In some cases, data may be transmitted to or read from a mobile device (e.g., a cellular phone, tablet), a computer, a cloud application, or any combination thereof. Data may be transmitted by any means of data transmission, including but not limited to downloading data from the sensor (e.g., USB, RS-232 serial, or other industry-standard communication protocols) and wireless transmission (e.g., Bluetooth®, ANT+, NFC, or other similar industry standards). Data may include information about the condition and / or state of the device when actuated. For example, data may include information about how the device is shaken, how the device is actuated, how the formulation is delivered to the device user (e.g., the amount of air inhaled, etc.), environmental conditions of the device (e.g., temperature, humidity), the date, time, and geographic location of the device, etc. This information may be displayed as a report. The report may be displayed on the screen of a mobile device or computer. The report may be transmitted to a healthcare provider or caregiver. In some cases, the device described herein can provide data, including but not limited to, information about: how the medication device is shaken (e.g., one or more shaking parameters, such as shaking angle, shaking frequency, etc.), when the medication device is actuated (e.g., during the shaking-to-emission interval, etc.), how the medication device is actuated (e.g., one or more actuation parameters, such as compression rate, actuation hold time, etc.), and when and how the medication device is depressurized. This data can then be downloaded and provided to healthcare providers or caregivers to assess whether the patient is using the medication device correctly and delivering the correct dose of medication. In some cases, the data can be downloaded to an electronic health record. Optionally, the data may include an electronic health record or a portion thereof. For example, the data may be uploaded to the electronic health record of a user of the device and methods described herein.

[0108] The apparatus described herein may include one or more additional components. In some cases, the apparatus may include a power source (e.g., a battery), one or more timers, a local data storage medium, and other supporting electronics (e.g., resistors, capacitors, connectors, wireless antennas, switches, etc.). Figure 13 A non-limiting example of the workflow of the system described herein is presented.

[0109] On the other hand, methods and apparatus are provided for detecting a shake-to-fire interval for actuating an inhaler or nasal device, wherein a sensor device, adapter, or medication device generates one or more outputs when one or more sensors detect the shake-to-fire interval. In some cases, the shake-to-fire interval indicates a period of time during which the medication device can deliver a desired dose range of medication when actuated. For example, an indication may be provided to the user of the medication device that the device has been properly shaken and is in a state suitable for delivering a desired dose range of medication when properly actuated (i.e., the shake-to-fire interval has not yet expired). In some cases, the shake-to-fire interval detected by one or more sensors includes a first time point at the start of the shake-to-fire interval and a second time point at the end of the shake-to-fire interval. In some cases, one or more sensors detect the first time point (e.g., immediately after one or more sensors detect that the medication device has been properly shaken) and the device generates an output, such as an indicator that the medication device is ready to be actuated. One or more sensors may also detect the second time point, for example, at the end of the shake-to-fire interval, indicating that the medication device is no longer in a suitable state for delivering a desired dose range of medication when actuated. For example, if the drug delivery device is not actuated within a specified timeframe after shaking, the formulation contained within the device may not be homogeneous, and actuation of the device may not deliver the intended dose range of the drug. For instance, suspended formulations may require proper shaking before actuation because insoluble drug particles may settle to the bottom of the container. Proper shaking can resuspend the insoluble drug particles, allowing actuation of the device to deliver the intended dose range of the drug. However, after a period of time, the insoluble drug particles will again settle to the bottom of the container. Therefore, actuation outside the shake-to-fire interval may fail to deliver the intended dose range of the drug. In some cases, one or more sensors detect this second timeframe (i.e., at the end of the shake-to-fire interval) and the device generates an output. In some cases, this output is another indication that the drug delivery device is no longer in a state suitable for delivering the intended dose range of the drug. This indication may be a visual indication or an auditory indication, or both, as described herein. In some cases, the presence of light may indicate that the drug delivery device is ready to be actuated, while the absence of light may indicate that the drug delivery device is not ready to be actuated. In some cases, the indication is a color change (e.g., from green to red). In some cases, one or more sensors can detect one or more parameters of the pharmaceutical device as described herein, such as one or more shaking parameters (e.g., shaking angle, shaking frequency, shaking duration, shaking-to-emission interval). In some cases, one or more sensors can detect when a predetermined threshold for one or more parameters is met or exceeded. In some cases, if the shaking-to-emission interval is not detected, the pharmaceutical device may not be actuated.For example, the pharmaceutical device can be locked or otherwise prevented from being actuated outside the shake-to-fire interval. In some cases, the pharmaceutical device can be automatically actuated when a shake-to-fire interval is detected. The shake-to-fire interval can vary and depends on the type of pharmaceutical device used, the formulation of the drug, and other factors. The devices described herein can be pre-programmed and customized to detect the appropriate shake-to-fire interval for each pharmaceutical device.

[0110] On the other hand, methods and apparatus are provided including one or more sensors for detecting an actuation-hold time window of a pharmaceutical device, wherein the apparatus generates one or more outputs when the one or more sensors detect the actuation-hold time window. As described herein, the actuation-hold time window may include a period of time during which the pharmaceutical device is held in a fully actuated position. The actuation-hold time window may indicate the length of time after the pharmaceutical device has delivered a drug within a desired dose range while held in the actuated state. In some cases, the actuation-hold time window may include a first time point at the start of the actuation-hold time window and a second time point at the end of the actuation-hold time window. In some cases, the one or more sensors may detect one or more actuation parameters, as described herein. In some cases, the one or more sensors may detect when a predetermined threshold of one or more actuation parameters is met or exceeded, and this may indicate that the pharmaceutical device is being held in a fully actuated state. The actuation-hold time window may depend on the type of pharmaceutical device, the formulation of the drug, and other factors. In some cases, when the second time point of the actuation-hold time window is detected (e.g., at the end), the apparatus described herein may generate one or more outputs, such as an indication. The indication may be a visual indication, an auditory indication, or both, as described herein. One or more sensors may also detect one or more additional parameters of the medication device, such as shaking parameters or inhalation airflow parameters.

[0111] In some aspects, methods of using the apparatus described herein are provided. In one aspect, a method is provided comprising: (a) shaking a pharmaceutical device, wherein the shaking includes one or more shaking parameters; and (b) actuating the pharmaceutical device when a predetermined threshold of one or more shaking parameters is satisfied, wherein the device generates one or more outputs when one or more sensors detect that the predetermined threshold has been satisfied.

[0112] In another aspect, a method is provided comprising: (a) compressing a pharmaceutical device for a period of time, wherein the period of time includes an actuation hold time window; and (b) decompressing the pharmaceutical device when the device generates an output, wherein the device generates an output when one or more sensors detect the end of the actuation hold time window.

[0113] Figure 14A non-limiting workflow for methods using the apparatus described herein is presented. It should be understood that... Figure 14 This is merely illustrative, and variations in the methods of using the described apparatus are also contemplated herein. Variations in method may depend on various aspects of the apparatus, as described in detail throughout the disclosure. For example, the order of the workflow may be modified, or steps may be added to or subtracted from the method to suit the system.

[0114] The sensor device can guide or instruct the user through each of one or more parameters of the pharmaceutical device described throughout the text, thereby improving the accuracy of the delivery dose when the user follows the device's instructions. Figure 15 Non-limiting examples are depicted illustrating how a sensor device provided by this disclosure can guide a user of a pharmaceutical device to deliver the correct dose of medicine. Figure 15 Small figure A depicts a medication device 1500, which has a sensor device and an adapter 1501 attached thereto. The sensor device 1501 can provide an output 1505 (e.g., an auditory indication) to the user, readily indicating that the medication device 1500 is ready to be shaken, such as... Figure 15 As shown in small diagram B. The user can then shake the 1503 medicine device 1500. Figure 15 As shown in small figure C, sensor device 1501 can sense when the medication device has been properly shaken (e.g., one or more predetermined thresholds of shaking parameters have been met). The device can then provide output 1507 to the user, indicating that shaking has begun until the dispensing interval has started and the user should begin inhalation. Figure 15 As shown in small figure D, the sensor device can then provide an output 1509 to the user, thereby instructing the user to actuate the medication device 1500. The user can then actuate the medication device by compressing and pressing down the canister, thereby delivering a dose 1511 of medication to the user. Figure 15 As shown in small figure E, the sensor device 1501 can then provide an output 1513 to the user to indicate that the tank should be depressurized.

[0115] This disclosure also provides a computer control system that is programmed to implement the methods of this disclosure. Figure 16A computer system 1601, programmed or otherwise configured to operate a sensor device, is shown. The computer system 1601 can regulate various aspects of the sensor devices, systems, and methods of this disclosure, for example, automatically processing parameters associated with the pharmaceutical device currently described herein. The computer system 1601 can execute a bootstrap configured to guide a user in the proper use of the pharmaceutical device. The computer system 1601 can be a user's electronic device (e.g., a sensor device, adapter, etc.) or a computer system located remotely relative to the electronic device. The computer system 1601 can be, individually or collectively, part of the sensor device or adapter. The electronic device can be a mobile electronic device, such as a telephone, iPad, tablet computer, etc.

[0116] Computer system 1601 includes a central processing unit (CPU, also referred to herein as a “processor” and “computer processor”) 1605, which may be a single-core or multi-core processor, or multiple processors for parallel processing. Computer system 1601 also includes memory or memory location 1610 (e.g., random access memory, read-only memory, flash memory), electronic storage unit 1615 (e.g., hard disk), communication interface 1620 (e.g., network adapter) for communicating with one or more other systems, and peripheral devices 1625, such as cache, other memory, data storage, and / or electronic display adapters. Memory 1610, storage unit 1615, interface 1620, and peripheral devices 1625 communicate with CPU 1605 via a communication bus (solid line) such as a motherboard. Storage unit 1615 may be a data storage unit (or data repository) for storing data. Computer system 1601 may be operatively coupled to computer network (“network”) 1630 by means of communication interface 1620. Network 1630 may be the Internet, the Internet of Things, and / or an extranet, or an intranet and / or extranet communicating with the Internet. In some cases, network 1630 is a telecommunications and / or data network. Network 1630 may include one or more computer servers that can implement distributed computing, such as cloud computing. In some cases, with the aid of computer system 1601, network 1630 can implement a peer-to-peer network that enables devices coupled to computer system 1601 to act as clients or servers.

[0117] CPU 1605 can execute a series of machine-readable instructions, which may be embodied in a program or software. The instructions may be stored in a memory location, such as memory 1610. The instructions may be directed to CPU 1605, which may then be programmed or otherwise configured to implement the methods of this disclosure. Examples of operations performed by CPU 1605 may include reading, decoding, executing, and writing back.

[0118] The CPU 1605 may be part of a circuit, such as an integrated circuit. One or more other components of the system 1601 may be included in the circuit. In some cases, this circuit is an application-specific integrated circuit (ASIC).

[0119] Storage unit 1615 may store files, such as drivers, libraries, and saved programs. Storage unit 1615 may store user data, such as user preferences and user programs. In some cases, computer system 1601 may include one or more additional data storage units located outside of computer system 1601, such as on a remote server communicating with computer system 1601 via an intranet or the Internet.

[0120] Computer system 1601 can communicate with one or more remote computer systems via network 1630. For example, computer system 1601 can communicate with a remote computer system of a user (e.g., someone who needs medication). Examples of remote computer systems include personal computers (e.g., portable PCs), tablet computers (e.g., Apple® iPad, Samsung® Galaxy Tab), telephones, smartphones (e.g., Apple® iPhone, Android-enabled devices, Blackberry®), or personal digital assistants. The user can access computer system 1601 via network 1630.

[0121] The methods described herein can be implemented by machine (e.g., computer processor) executable code stored in an electronic storage location of computer system 1601 (e.g., in memory 1610 or electronic storage unit 1615). The machine-executable code or machine-readable code can be provided in software form. During use, the code can be executed by processor 1605. In some cases, the code can be retrieved from storage unit 1615 and stored in memory 1610 for access by processor 1605. In some cases, electronic storage unit 1615 can be excluded, and machine-executable instructions are stored in memory 1610.

[0122] The code can be pre-compiled and configured for use with machines having processors suitable for executing the code, or it can be compiled during runtime. The code can be provided in a programming language, which can be selected to enable the code to be executed in a pre-compiled or on-site compiled manner.

[0123] Various aspects of the systems and methods provided herein, such as computer system 1601, can be embodied in programming. These aspects of the technology can be considered "products" or "artifacts," typically in the form of machine (or processor) executable code and / or associated data carried or embodied in some machine-readable medium. Machine-executable code can be stored on electronic storage units, such as memory (e.g., read-only memory, random access memory, flash memory) or hard disks. "Storage" type media can include any or all of the tangible memory or related modules of computers, processors, etc., such as various semiconductor memories, tape drives, disk drives, etc., which can provide non-transitory storage for software programming at any time. All or part of the software can communicate from time to time via the Internet or various other telecommunications networks. For example, such communication enables the software to be loaded from one computer or processor to another, such as from a management server or host computer to a computer platform for an application server. Therefore, another type of medium that can carry software elements includes light waves, radio waves, and electromagnetic waves, used, for example, through physical interfaces between local devices, through wired and optical terrestrial networks, and through various air links. Physical elements carrying such waves, such as wired or wireless links, optical links, etc., can also be considered as media carrying software. As used herein, unless limited to non-transitory tangible "storage" media, terms such as "computer or machine-readable medium" refer to any medium involved in providing instructions to a processor for execution.

[0124] Therefore, machine-readable media, such as computer-executable code, can take many forms, including but not limited to tangible storage media, carrier media, or physical transmission media. Non-volatile storage media include, for example, optical discs or disks, any storage device such as any computer, such as a storage device that can be used to implement a database as shown in the accompanying drawings. Volatile storage media include dynamic memory, such as the main memory of such a computer platform. Tangible transmission media include coaxial cables; copper wires and optical fibers, including wires that form buses within a computer system. Carrier transmission media can take the form of electrical or electromagnetic signals, or sound or light waves, such as those generated during radio frequency (RF) and infrared (IR) data communications. Therefore, common forms of computer-readable media include, for example, flexible disks, floppy disks, hard disks, magnetic tapes, any other magnetic media, CD-ROMs, DVDs or DVD-ROMs, any other optical media, punched paper tapes, any other physical storage media with a perforated pattern, RAM, ROM, PROM and EPROM, FLASH-EPROM, any other memory chips or cartridges, carrier-transmitted data or instructions, cables or links that transmit such carriers, or any other medium from which a computer can read programming code and / or data. Many of these forms of computer-readable media may involve passing one or more sequences of one or more instructions to a processor for execution.

[0125] Computer system 1601 can communicate with various other devices 1635. Although one device 1635 is shown, computer system 1601 can communicate with multiple other devices, such as adapters or pharmaceutical devices. For example, a pharmaceutical device may include wired or wireless communication capabilities (e.g., RFID chips, etc.). In such cases, the sensor devices mentioned herein (e.g., with or without adapters) can communicate with the pharmaceutical device.

[0126] Computer system 1601 may include an electronic display (not shown) or communicate with an electronic display, the electronic display including a user interface (UI) for providing, for example, one or more control or input elements to enable a user to control sensor device 1635. Examples of UIs include, but are not limited to, graphical user interfaces (GUIs) and web-based user interfaces.

[0127] The methods and systems disclosed herein can be implemented using one or more algorithms. The algorithms can be implemented using software executed by the central processing unit 1605. In some cases, the algorithm can be executed upon receiving an instruction from a user (e.g., via computer system 1601), and can enable the operation of the sensor device 1635. The algorithm can receive one or more signals through one or more sensors of the sensor device 1635, and in some cases, adjust the manner in which guidance is provided to the user via the sensor device 1635.

[0128] The algorithm can execute or implement various aspects of the methods provided herein. For example, the algorithm can be executed to generate guidance (e.g., in the form of data or signals), which can then be conveyed to a user through a visual or auditory mode. The sensor device (e.g., the processing unit of the sensor device) can further process the instructions to implement or execute various aspects of the methods.

[0129] In some cases, algorithms may be programmed or otherwise configured to determine or select appropriate parameters for using the medication device to provide an effective use session (e.g., a use session involving the use of the medication device or the dispensing of a drug formulation). In some cases, algorithms may be executed to provide or guide the user with manufacturer-recommended parameters, making the inhalation process provided to the user better or more effective in achieving the desired effect (e.g., according to manufacturer standards). Optionally, algorithms may be executed to provide further instructions to the sensor device. For example, by executing an algorithm, instructions may be generated that direct the processor on the sensor device to receive parameters for guiding the user's use of the medication device from an adapter, for example, via a wireless or wired mode. As another example, by executing an algorithm, instructions may be generated that direct the processor on the sensor device to receive parameters from other sources, such as directly from the medication device (e.g., via an RFID chip, etc.) or from the Internet. For example, the sensor device may be programmable or may communicate with a server (e.g., a cloud-based server) that includes parameters configurable by the user, guardian, or healthcare provider. Users, guardians, or healthcare providers may be able to store appropriate parameters online, which can be read by a sensor device described throughout the text, and which can process and use the parameters to guide the user.

[0130] In some cases, the algorithm can be executed by a third party. For example, the algorithm can be executed by a healthcare provider. The healthcare provider can provide input (e.g., instructions) to a cloud-based platform, which can generate parameters transmitted to the sensor devices (and / or mobile devices communicating with the sensor devices) of the user who then executes the algorithm. The execution of the algorithm can also generate instructions transmitted to the sensor devices. The instructions can direct the processor on the sensor device to run a user guidance program, and indicators (e.g., visual or auditory indicators) can then output instructions to guide the user.

[0131] Computer system 1601 can execute algorithms to provide a set of instructions. For example, relevant parameters of the pharmaceutical device can be transmitted (e.g., wired or wirelessly) to the communication module of sensor device 1635 and received by a processing unit (e.g., the processing unit of the sensor device). The processing unit can process or not process the set of parameters and further instruct indicators to transmit one or more instructions to guide the user in using the pharmaceutical device.

[0132] As used herein, A and / or B includes one or more of A or B, as well as combinations thereof, such as A and B. It should be understood that although the terms “first,” “second,” “third,” etc., may be used herein to describe various elements, components, regions, and / or segments, these elements, components, regions, and / or segments should not be limited by these terms. These terms are used only to distinguish one element, component, region, or segment from another. Therefore, the first element, component, region, or segment discussed below may be referred to as the second element, component, region, or segment without departing from the teachings of the invention.

[0133] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention. As used herein, the singular forms “a,” “an,” and “the” are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that, when used in this specification, the terms “comprising” and / or “including” specify the presence of the described features, regions, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and / or groups thereof.

[0134] Furthermore, as illustrated in the figures, this document may use relative terms such as “down” or “bottom” and “up” or “top” to describe the relationship of an element to other elements. It should be understood that, in addition to the orientation depicted in the figures, relative terms are intended to encompass different orientations of elements. For example, if an element in a figure is flipped, it is described as an element located “down” to other elements and thus oriented “up” to other elements. Therefore, the exemplary term “down” can include both “down” and “up” orientations, depending on the specific orientation of the figure. Similarly, if an element in a figure is flipped, it is described as an element located “below” or “under” other elements and thus oriented “above” to other elements. Therefore, the exemplary terms “below” or “under” can include both “up” and “down” orientations.

[0135] While preferred embodiments of the invention have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided by way of example only. Many variations, modifications, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in the practice of the invention. Many different combinations of the embodiments described herein are possible, and such combinations are considered part of this disclosure. Furthermore, all features discussed in connection with any embodiment herein can be readily applied to other embodiments herein. The following claims are intended to define the scope of the invention and thereby cover the methods and structures within the scope of these claims and their equivalents.

[0136] This invention provides, but is not limited to, the following embodiments: 1. A sensor device for guiding the use of a pharmaceutical device, the sensor device comprising: A coupler for coupling to the pharmaceutical device, wherein the pharmaceutical device is selected from a variety of different types of pharmaceutical devices; One or more sensors are used to detect the use of the pharmaceutical device; The processor, which is configured to: Automatically process one or more parameters associated with the pharmaceutical device; and Output signal based on one or more parameters; and An indicator that is configured to: Operable to receive the signal; and The user of the pharmaceutical device is given instructions that vary depending on the type of pharmaceutical device selected.

[0137] 2. The sensor device as described in Embodiment 1, wherein the guidance varies over the duration of shaking the drug device, the shaking-to-emission interval, the waiting time between actuation, multiple filling steps, multiple refilling steps, and the duration up to the refilling step.

[0138] 3. The sensor device as described in Embodiment 2, wherein the duration of shaking the pharmaceutical device varies between 0 and 30 seconds.

[0139] 4. The sensor device as described in Embodiment 2, wherein the waiting time between actuations varies between 0 and 60 seconds.

[0140] 5. The sensor device as described in Embodiment 2, wherein the number of the filling steps varies between 0 and 5.

[0141] 6. The sensor device as described in Embodiment 2, wherein the number of refilling steps varies between 0 and 5.

[0142] 7. The sensor device as described in Embodiment 2, wherein the duration of the refilling step varies between 0 and 30 days.

[0143] 8. The sensor device as described in Embodiment 2, wherein the shaking-to-emission interval varies from 0 to 30 seconds.

[0144] 9. The sensor device as described in Embodiment 1, wherein the guidance includes auditory indication.

[0145] 10. The sensor device as described in Embodiment 1, wherein the guidance includes visual indication.

[0146] 11. The sensor device as described in Embodiment 1, wherein the coupler includes a receiving port.

[0147] 12. The sensor device as described in embodiment 11, wherein the receiving port includes an electrical interface.

[0148] 13. The sensor device of embodiment 11, wherein the receiving port is configured to detachably receive a complementary protrusion of an adapter, the adapter including a memory storing the one or more parameters associated with the pharmaceutical device.

[0149] 14. The sensor device of embodiment 1, wherein the coupler includes one or more latch points for receiving one or more latches of an adapter, including an adhesive configured for coupling to the pharmaceutical device.

[0150] 15. The sensor device as described in Embodiment 1, wherein the sensor device is configured for use with five or more different types of pharmaceutical devices.

[0151] 16. The sensor device as described in Embodiment 1, wherein the sensor device is configured to be used for a duration of more than 6 months.

[0152] 17. The sensor device as described in Embodiment 1, wherein the one or more sensors include an accelerometer, a barometer, a temperature sensor, a magnetometer, an ambient light sensor, or a global positioning system (GPS).

[0153] 18. The sensor device of embodiment 17, wherein the one or more sensors include the accelerometer, and wherein the accelerometer is configured to be positioned along the central axis of the pharmaceutical device.

[0154] 19. The sensor device of embodiment 17, wherein the barometer is located in a pressure sensing chamber.

[0155] 20. The sensor device of embodiment 19, wherein the pressure sensing cavity allows air to flow in and out of the pressure sensing cavity in both directions.

[0156] 21. The sensor device of embodiment 20, wherein the bidirectional airflow passes through a single opening in the pressure sensing chamber.

[0157] 22. The sensor device as described in embodiment 19, wherein the pressure sensing cavity comprises approximately 10 mm 3 The volume.

[0158] 23. The sensor device of embodiment 19, wherein the pressure sensing chamber includes an opening for coupling to a pressure connector tube.

[0159] 24. The sensor device as described in Embodiment 1, wherein the sensor device includes elements for turning the sensor device on or off.

[0160] 25. The sensor device as described in embodiment 24, wherein the element is located at the proximal end of the sensor device.

[0161] 26. The sensor device as described in Embodiment 1, wherein the indicator includes a speaker.

[0162] 27. The sensor device as described in Embodiment 1, wherein the indicator includes a light-emitting diode (LED).

[0163] 28. The sensor device as described in Embodiment 1, wherein the indicator includes a visual display.

[0164] 29. The sensor device as described in Embodiment 1, wherein the sensor device includes an interface for communicating with an external device.

[0165] 30. The sensor device as described in Embodiment 1, wherein the sensor device comprises approximately 10 cm 3 The size.

[0166] 31. The sensor device as described in Embodiment 1, wherein the drug delivery device includes a canister for use with an inhaler.

[0167] 32. The sensor device as described in embodiment 31, wherein the inhaler is a pressurized dose-measuring inhaler.

[0168] 33. A kit comprising: a sensor device as described in Embodiment 1, and a specification for guiding the coupling and / or decoupling of the sensor device to and / or to an adapter, the adapter including a memory storing one or more parameters associated with the pharmaceutical device.

[0169] 34. An adapter for guiding the use of a pharmaceutical device, the adapter comprising: A first coupler is used to couple to the pharmaceutical device; A memory that stores one or more parameters associated with the pharmaceutical device; and A second coupler is used to couple to a sensor device, wherein the sensor device is configured to output guidance to the user of the medication device.

[0170] 35. A kit comprising: an adapter as described in embodiment 34; and a specification for instructing the coupling and / or decoupling of the adapter to and from a pharmaceutical device selected from a variety of different types of pharmaceutical devices.

[0171] 36. The adapter as described in embodiment 34, wherein the adapter is configured to guide the use of a single type of pharmaceutical device.

[0172] 37. The adapter as described in embodiment 34, wherein the second coupler includes a protrusion.

[0173] 38. The adapter as described in embodiment 37, wherein the protrusion includes an electrical interface.

[0174] 39. The adapter as described in embodiment 37, wherein the protrusion is complementary to the receiving port of the sensor device, the sensor device including one or more sensors for detecting the use of the pharmaceutical device.

[0175] 40. The adapter as described in embodiment 34, wherein the first coupler comprises an adhesive.

[0176] 41. The adapter as described in embodiment 34 further includes one or more processors operatively coupled to the memory.

[0177] 42. The adapter as described in embodiment 34, wherein the adapter includes a pressure connector tube.

[0178] 43. The adapter as described in embodiment 42, wherein the pressure connector tube is hollow.

[0179] 44. The adapter as described in embodiment 42, wherein the pressure connector tube includes a proximal portion located on a first surface of the adapter and a distal portion located away from a second surface opposite to the first surface.

[0180] 45. The adapter as described in embodiment 44, wherein the proximal portion includes a sealing element.

[0181] 46. ​​The adapter as described in embodiment 45, wherein the sealing element is an O-ring.

[0182] 47. The adapter as described in embodiment 44, wherein the distal portion includes one or more holes.

[0183] 48. The adapter as described in embodiment 47, wherein one or more holes are located on the side surface of the pressure connector tube.

[0184] 49. The adapter as described in embodiment 42, wherein the pressure connector tube is configured to extend along the longitudinal axis of the pharmaceutical device.

[0185] 50. The adapter as described in embodiment 34, wherein the adapter includes an authenticator.

[0186] 51. The adapter as described in embodiment 50, wherein the authenticator is configured to authenticate the sensor device and / or the adapter.

[0187] 52. The adapter as described in embodiment 34, wherein the adapter is configured to be coupled to the sensor device via a snap-fit ​​mechanism.

[0188] 53. The adapter as described in embodiment 34, wherein the adapter is configured for at least 60 actuations.

[0189] 54. The adapter as described in embodiment 34, wherein the medication device includes a canister for use with an inhaler.

[0190] 55. A method of using a sensor device configured to be coupled to multiple different types of pharmaceutical devices, the method comprising: The sensor device is coupled to the first pharmaceutical device; Process one or more parameters associated with the first pharmaceutical device; The use of the first pharmaceutical device is guided based on one or more processed parameters associated with the first pharmaceutical device; Decouple the sensor device from the first pharmaceutical device; The sensor device is coupled to a second pharmaceutical device, wherein the type of the pharmaceutical device in the second pharmaceutical device is different from that in the first pharmaceutical device; Processing one or more parameters associated with the second pharmaceutical device; and The use of the second pharmaceutical device is guided based on one or more processed parameters associated with the second pharmaceutical device, wherein guiding the use of the second pharmaceutical device is different from guiding the use of the first pharmaceutical device.

[0191] 56. The method of embodiment 55, wherein guiding the use of the second pharmaceutical device differs from guiding the use of the first pharmaceutical device during the duration of shaking the pharmaceutical device, the shaking-to-emission interval, the waiting time between actuation, multiple filling steps, multiple refilling steps, or the duration up to the refilling step.

[0192] 57. The method as described in embodiment 56, wherein the duration of shaking the pharmaceutical device varies between 0 and 30 seconds.

[0193] 58. The method of embodiment 56, wherein the waiting time between actuations varies between 0 and 60 seconds.

[0194] 59. The method as described in embodiment 56, wherein the number of filling steps varies between 0 and 5.

[0195] 60. The method as described in embodiment 56, wherein the number of refilling steps varies between 0 and 5.

[0196] 61. The method as described in embodiment 56, wherein the duration of the until-refill step varies between 0 and 30 days.

[0197] 62. The method of embodiment 56, wherein the shaking-to-emission interval varies between 0 and 30 seconds.

[0198] 63. The method of embodiment 55, wherein coupling the sensor device to the first pharmaceutical device includes coupling the sensor device to a first adapter already coupled to the first pharmaceutical device, wherein the first adapter includes a first memory storing a first set of parameters associated with the first pharmaceutical device.

[0199] 64. The method of embodiment 63, wherein coupling the sensor device to the second pharmaceutical device includes coupling the sensor device to a second adapter already coupled to the second pharmaceutical device, wherein the second adapter includes a second memory storing a second set of parameters associated with the second pharmaceutical device, wherein the second set of parameters is different from the first set of parameters.

[0200] 65. The method of embodiment 55, wherein the pharmaceutical device includes a canister for use with an inhaler.

[0201] 66. A method for measuring the use of an inhaler using one or more sensors, the method comprising: Using the one or more sensors mentioned above: Measure the duration of shaking the inhaler; Measure the duration of the time following the shaking; Measure the inhalation of users using inhalers; Measuring the actuation of the inhaler; and The duration of the holding time of the actuation is measured.

[0202] 67. The method as described in embodiment 66, wherein when a predetermined threshold is reached, the one or more sensors output an indication after each measurement step.

[0203] 68. The method of embodiment 67, wherein the output is a visual output that instructs the user of the inhaler to move to the next step.

[0204] 69. The method of embodiment 67, wherein the output is an auditory output that instructs the user of the inhaler to move to the next step.

[0205] 70. The method of embodiment 66, wherein the one or more sensors are further configured to measure the orientation of the inhaler.

[0206] 71. The method of embodiment 70, wherein when the inhaler is outside a predetermined orientation, the sensor outputs an indication of incorrect orientation.

[0207] 72. The method of embodiment 66, wherein the one or more sensors are further configured to track the remaining number of actuations of the inhaler.

[0208] 73. The method of embodiment 72, wherein when the inhaler is at or below a predetermined number of remaining doses, the sensor outputs an indication that the number of remaining doses for the inhaler is low.

[0209] 74. The method of embodiment 66, wherein the one or more sensors include an accelerometer, a barometer, a temperature sensor, a magnetometer, an ambient light sensor, or a global positioning system (GPS).

[0210] 75. The method of embodiment 66, wherein the inhaler includes a drug delivery device.

[0211] 76. The method of embodiment 75, wherein the pharmaceutical device is the canister of the inhaler.

[0212] 77. The method of embodiment 66, wherein the one or more sensors include sensors located outside the inhaler.

[0213] 78. The method of embodiment 77, wherein the one or more sensors are located on the mobile device.

[0214] 79. An apparatus for monitoring the use of a pharmaceutical device, the apparatus comprising: a) An adapter, wherein the adapter includes a memory storing a set of parameters specific to the type of the pharmaceutical device; and b) A sensor device detachable from and operatively communicable with the adapter, wherein the sensor device is configured for use with multiple different types of adapters, each adapter including a unique set of parameters specific to a different type of pharmaceutical device. The device is configured to generate an output based on the set of parameters.

[0215] 80. The apparatus as described in embodiment 79 further includes a pharmaceutical device.

[0216] 81. The device as described in embodiment 80, wherein the pharmaceutical device is a canister for use with an inhaler.

[0217] 82. The apparatus of embodiment 81, wherein the adapter is configured to be coupled to the outside of the tank, and wherein the sensor device is configured to be indirectly coupled to the tank via the adapter.

[0218] 83. The apparatus of embodiment 80, wherein the sensor device includes an accelerometer configured to be positioned along the central axis of the pharmaceutical device when the adapter and the sensor device are coupled to the pharmaceutical device.

[0219] 84. The apparatus of embodiment 79, wherein the sensor device includes a pressure sensing chamber having a single opening.

[0220] 85. The apparatus of embodiment 84, wherein the adapter includes a pressure connector tube configured to couple to the single opening.

[0221] 86. The apparatus of embodiment 84, wherein the pressure sensing chamber comprises a barometer.

[0222] 87. The apparatus of embodiment 79, wherein the sensor device includes a receiving port, and wherein the adapter includes a protrusion complementary to the receiving port.

[0223] 88. The apparatus of embodiment 87, wherein the receiving port and the protrusion each include an electrical interface.

[0224] 89. The apparatus of embodiment 79, wherein the output is feedback provided to the user based on the use of the pharmaceutical device.

[0225] 90. The apparatus of embodiment 89, wherein the feedback guides the user in real time on how to correctly administer the medication.

[0226] 91. The apparatus of embodiment 79, wherein the output is generated when at least one of the set of parameters satisfies a predetermined threshold.

[0227] 92. The apparatus of embodiment 79, wherein the output is generated when at least one of the set of parameters is outside a threshold range.

[0228] 93. The apparatus of embodiment 79, wherein the sensor device is configured to operate with one or more different pharmaceutical devices.

[0229] 94. The apparatus of embodiment 79, wherein the sensor device is reusable.

[0230] 95. The apparatus of embodiment 79, wherein the adapter is disposable.

[0231] 96. The device as described in embodiment 79, wherein the pharmaceutical device is used in conjunction with an inhaler or a nasal device.

[0232] 97. The device as described in embodiment 96, wherein the inhaler or nasal device is a pressurized metered-dose inhaler (pMDI) or a dry powder inhaler.

[0233] 98. The apparatus of embodiment 79, wherein the set of parameters includes one or more rocking parameters.

[0234] 99. The apparatus of embodiment 98, wherein the one or more shaking parameters include: shaking duration, shaking angle, shaking frequency, shaking-to-emission interval, shaking orientation, and any combination thereof.

[0235] 100. The apparatus of embodiment 79, wherein the set of parameters includes one or more actuation parameters.

[0236] 101. The apparatus of embodiment 100, wherein the one or more actuation parameters include: compression speed, compression acceleration, actuation hold time, decompression speed, decompression acceleration, actuation stroke length, and any combination thereof.

[0237] 102. The apparatus of embodiment 79, wherein the set of parameters includes one or more inhalation airflow parameters.

[0238] 103. The apparatus of embodiment 102, wherein the one or more inhalation airflow parameters include: inhalation airflow rate, inhalation volume, inflow velocity, and any combination thereof.

[0239] 104. The apparatus of embodiment 79, wherein the pharmaceutical apparatus comprises a pharmaceutical preparation.

[0240] 105. The apparatus of embodiment 104, wherein the output is generated when at least one of the set of parameters satisfies a predetermined threshold, and wherein the predetermined threshold is determined based on the composition of the pharmaceutical preparation, one or more characteristics of the pharmaceutical device, or both.

[0241] 106. The apparatus of embodiment 105, wherein the formulation comprises one or more excipients.

[0242] 107. The apparatus of embodiment 105, wherein the formulation does not contain excipients.

[0243] 108. The apparatus of embodiment 79, wherein the adapter is attached to the housing or canister of the pharmaceutical device.

[0244] 109. The apparatus of embodiment 108, wherein the adapter is permanently attached to the surface of the housing or can.

[0245] 110. The apparatus of embodiment 108, wherein the adapter is detachably attached to the surface of the housing or can.

[0246] 111. The apparatus of embodiment 79, wherein the sensor device is attached to the adapter.

[0247] 112. The apparatus of embodiment 79, wherein the one or more outputs include visual indications, auditory indications, or both.

[0248] 113. The apparatus of embodiment 112, wherein the visual indication includes: the presence or absence of light, a change in the color of light, a flickering of light, and any combination thereof.

[0249] 114. The apparatus of embodiment 112, wherein the visual indication is generated by a light-emitting diode (LED).

[0250] 115. The apparatus of embodiment 112, wherein the visual indication is generated by an LCD or LED display.

[0251] 116. The apparatus of embodiment 79, wherein the output includes data.

[0252] 117. The apparatus of embodiment 116, wherein the data is collected and stored by the apparatus.

[0253] 118. The apparatus of embodiment 116, wherein the data is transmitted to a mobile device, a computer, a cloud application, or any combination thereof, or read from the mobile device, the computer, the cloud application, or any combination thereof.

[0254] 119. The apparatus of embodiment 79, wherein the one or more sensors are selected from the following: accelerometer, barometer, temperature sensor, magnetometer, ambient light sensor or global positioning system (GPS).

[0255] 120. A method of using an inhaler or nasal device with the aid of a sensor, the method comprising: a) Shake the inhaler or nasal device; b) Use the sensor to measure the oscillation interval used to actuate the inhaler or nasal device to the firing interval; c) When the sensor generates an output, it actuates the inhaler or nasal device. The sensor generates the output when it detects the start of the shaking at the beginning of the transmission interval.

[0256] 121. A method of using an inhaler or nasal device with the aid of a sensor, the method comprising: a) compressing the inhaler or nasal device for a period of time, wherein the period of time includes an actuation hold time window; and b) When the sensor generates an output, depressurize the inhaler or nasal device. The sensor generates the output when it detects the end of the actuation hold time window.

[0257] 122. An apparatus for monitoring the use of a pharmaceutical device, comprising: a) Adapter, including: The distal end includes a first adapter coupler for coupling to the pharmaceutical device; A memory that stores one or more parameters associated with the pharmaceutical device; The proximal end includes a second adapter coupler for coupling to a sensor device, wherein the second adapter coupler includes a protrusion that includes an electrical interface; and A pressure connector tube, wherein the pressure connector tube includes a first end located on the proximal side of the adapter and a second end positioned distally away from the distal side of the adapter; and b) A sensor device detachably coupled to the adapter, wherein the sensor device includes: A mating surface for engaging with the proximal end of the adapter includes: A receiving port, comprising an electrical interface, wherein the receiving port is complementary to the protrusion and configured to receive the protrusion; and An opening configured to receive the first end of the pressure fitting tube; A pressure sensing cavity operatively coupled to the opening, the pressure sensing cavity defining a closed chamber having the opening and including a barometer; A processor, operably coupled to the receiving port, is configured to: Receive one or more parameters associated with the pharmaceutical device from the adapter; Automatically process one or more parameters associated with the pharmaceutical device; and Output signal based on one or more parameters; and An indicator that is configured to: Operable to receive the signal; and The device outputs instructions to the user of the pharmaceutical device, wherein the instructions vary according to one or more parameters received.

[0258] 123. A kit comprising: a sensor device as described in Embodiment 1; an adapter as described in Embodiment 34; and a specification for guiding the coupling and / or decoupling of the sensor device and the adapter to and / or from a pharmaceutical device selected from a variety of different types of pharmaceutical devices.

[0259] Example The following examples are provided to illustrate various embodiments of the invention and are not intended to limit the invention in any way. The examples and methods described herein are currently representative of preferred embodiments and are exemplary, and are not intended to limit the scope of the invention. Variations and other uses within the spirit of the invention as defined by the claims will be apparent to those skilled in the art.

[0260] Example 1. Sensor device for use with inhaler devices Figures 17A-17D A non-limiting example of a sensor device 1700 suitable for use with an inhaler device is depicted. Figure 17AA top view of the sensor device is depicted. The sensor device 1700 may include one or more sensors, such as a flow sensor 1710 (e.g., a thermistor) and a touch sensor 1702 (e.g., an electrode). The sensor device 1700 may also include one or more indicators, such as a multicolor LED 1704 for providing visual indication. One or more indicators 1704 may be operatively coupled to the sensor device 1700 such that when one or more sensors 1702, 1710 detect a predetermined threshold for one or more parameters of the device, the sensor device 1700 transmits an output to the indicator 1704. The sensor device 1700 may also include one or more contacts for downloading or retrieving data from the sensor device 1708. The electronics and operating components of the sensor device 1700 may be found, for example, in the original printed circuit board 1706. Figure 17B A side view of sensor device 1700 is depicted. Sensor device 1700 may include potting material 1712 to protect and / or conceal the electronics and operating components of sensor device 1700. Figure 17C A bottom view of sensor device 1700 is depicted. The sensor device may include a high-viscosity adhesive coating 1714, a microcontroller unit (MCU) 1716, additional sensors such as a shake sensor 1718 (e.g., a 3-axis accelerometer), and a power supply 1720 (e.g., a solid-state battery). Figure 17D An example of a sensor device 1700 attached to the canister of an inhaler device 1701 is depicted.

[0261] In one example, the user picks up the inhaler device, which includes a sensor unit attached to the top of the inhaler, and touches the touch sensor to activate it. If the inhaler device contains a suspension formulation, the user then begins to shake the inhaler device. In some cases, as the user shakes the inhaler device at an angle, frequency, and duration suitable for a particular formulation, the sensor device stores data reflecting the shaking parameters used by the user and generates an output that indicates via an indicator that the inhaler device is ready to be actuated. In one example, the indicator is a light, such as an LED. In one instance, the indicator is an LED that remains lit during the shake-to-fire interval. In another instance, the indicator is an LED that flashes during the shake-to-fire interval. In some cases, when the sensor device generates an output indicating the start of the shake-to-fire interval via the indicator, the user then compresses the inhaler device canister to actuate the inhaler device. In some cases, the sensor device captures and stores actuation parameter data generated when the user actuates the inhaler device during the shake-to-fire interval. In some cases, when the user has fully compressed the canister, the sensor device generates an output, which may be a second indicator indicating the start of the actuation hold time window. In some cases, this indicator is a light, such as an LED. In one example, the indicator is an LED that remains lit during the actuation hold time window. In another example, the indicator is an LED that flashes during the actuation hold time window. In yet another example, the output is an audible indicator, such as a chirping, beeping, tone, or vibration. In some cases, the audible indicator remains open during the actuation hold time window. In some cases, at the end of the actuation hold time window, the sensor device generates an output via an indicator indicating that the inhaler device canister valve has been held open by compression for a sufficient duration during the duration of the actuation hold time window to allow the delivery of the intended dose range of medication from the inhaler device. In one example, this output may be the off or absence of an LED that is lit or flashing during the actuation hold time window. In another example, the output may be audible, or the off or absence of a sound. In another instance, the output could be vibration or the absence of vibration.

[0262] In some cases, the sensor device includes a counter to record the number of times the inhaler device has been actuated. In one example, the user picks up the inhaler device, which includes the sensor device attached to the top of the inhaler device, and touches the sensor device to activate it. In some cases, the sensor device generates an output indicating that the inhaler device should be refilled. In some cases, the sensor device generates an output indicating that the inhaler device should be refilled if the sensor device is not activated within a specified amount of time. In some cases, the sensor device generates an output indicating that the user should reorient the inhaler device if the user holds the inhaler device at an angle or orientation that will negatively affect the delivery of the drug within the intended dose range—for example, the user holds the inhaler device upside down. In some cases, the generated indication is a visual, auditory indicator, or a lack of visual or auditory indicators.

[0263] In another example, the user picks up the inhaler device, which includes a sensor device attached to the top of the inhaler unit, and touches the touch sensor of the sensor device to wake it. In some cases, the sensor device stores the number of times the inhaler device has been actuated. In some cases, the sensor device generates an output indicating when the inhaler device has expired, should be cleaned, has a limited remaining dose, exceeds the dose available in the device, and any combination of one or more of these. In some cases, the indication is visual, auditory, or a combination thereof. In some cases, the visual indication is light or the absence of light. In some cases, the indication is sound or the absence of sound. In some cases, the indication is vibration or the absence of vibration.

[0264] In some cases, the output of a sensor device is data collected and stored by the sensor device. In other cases, the data is transmitted to or read from a mobile device, computer, cloud application, or any combination thereof.

[0265] Example 2. Sensor device for use with nasal devices The user picks up the nasal spray device, which includes a bottle, pump, or actuator nozzle tip attached to the nasal cavity, and touches the touch sensor to activate it. If the nasal cavity device contains a suspension formulation, the user then begins to shake the device. In some cases, as the user shakes the nasal cavity device at an angle, frequency, and duration suitable for a particular formulation, the sensor device stores data reflecting the shaking parameters used by the user and generates an output indicating via an indicator that the nasal cavity device is ready to be actuated. In some cases, the indicator is a light, such as an LED. In one example, the indicator is an LED that remains lit during the shake-to-fire interval. In another example, the indicator is an LED that flashes during the shake-to-fire interval. In some cases, when the sensor device generates an output indicating the start of the shake-to-fire interval via the indicator, the user then actuates the nasal cavity device by pressing the bottom of the bottle relative to the nozzle tip of the nasal cavity device to compress the pump. In some cases, the sensor device captures and stores actuation parameter data generated when the user actuates the nasal cavity device during the shake-to-fire interval. In some cases, when the user fully compresses the pump, the sensor device produces an output that can be a second indicator indicating the start of the actuation hold time window. In some cases, the indicator is a light, such as an LED. In one instance, the indicator is an LED that remains lit during the actuation hold time window. In another instance, the indicator is an LED that flashes during the actuation hold time window. In some cases, the output is an audible indicator, such as a chirping, beeping, tone, or vibration. In some cases, the audible indicator remains on during the actuation hold time window. In some cases, at the end of the actuation hold time window, the sensor device produces an output that indicates, via an indicator, that the pump of the nasal device has been kept on by compression for a sufficient duration during the duration of the actuation hold time window to allow the delivery of the intended dose range of medication from the nasal device. In some cases, the output can be the off or absence of an LED that was on or flashing during the actuation hold time window. In some cases, the output can be audible, or the sound can be off or absent. In some cases, the output may be vibration or the absence of vibration.

[0266] In another example, the sensor device includes a dose counter to record the number of times the nasal spray device has been actuated. In some cases, the user picks up the nasal spray device, which includes the sensor device attached to the bottle, pump, or actuator nozzle tip of the nasal spray device, and touches the sensor device to activate it. In some cases, the sensor device generates an output indicating that the nasal spray device should be refilled. In some cases, the sensor device generates an output indicating that the nasal spray device should be refilled if the sensor device is not activated within a specified time period. In some cases, the sensor device generates an output indicating that the user should reorient the nasal spray device if the user holds the nasal spray device at an angle or orientation that will negatively affect the delivery of the intended dose range of the medication, such as holding the nasal spray device upside down. In some cases, the generated indication is a visual, auditory indication, or a lack of visual or auditory indication.

[0267] In another example, the user picks up the nasal spray device, which includes a bottle, pump, or actuator nozzle tip attached to the nasal spray device, and touches the sensor device to activate it. In some cases, the sensor device stores the number of times the nasal device has been actuated. In some cases, the sensor device generates an output indicating when the nasal device has expired, should be cleaned, has a limited remaining dose, exceeds the dose available in the nasal device, and any combination of one or more of these. In some cases, the indication is visual, auditory, or a combination thereof. In some cases, the visual indication is light or the absence of light. In some cases, the indication is sound or the absence of sound. In some cases, the indication is vibration or the absence of vibration.

[0268] In some cases, the output of a sensor device is data collected and stored by the sensor device. In other cases, the data is transmitted to or read from a mobile device, computer, cloud application, or any combination thereof.

[0269] While preferred embodiments of the invention have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided by way of example only. Many variations, modifications, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in the practice of the invention. The following claims are intended to define the scope of the invention and thereby cover the methods and structures within the scope of these claims and their equivalents.

Claims

1. A sensor device for guiding the use of a pharmaceutical device, the sensor device comprising: A coupler for coupling to the pharmaceutical device, wherein the pharmaceutical device is selected from a variety of different types of pharmaceutical devices; One or more sensors are used to detect the use of the pharmaceutical device; The processor, which is configured to: Automatically process one or more product-specific operating parameters associated with the pharmaceutical device; and Output signals based on one or more product-specific operating parameters; as well as An indicator that is configured to: Operable to receive the signal; as well as The user of the pharmaceutical device is given instructions that vary depending on the type of pharmaceutical device selected.

2. The sensor device of claim 1, wherein the guidance varies over the duration of the shaking of the drug device, the shaking-to-emission interval, the waiting time between actuation, the plurality of filling steps, the plurality of refilling steps, and the duration up to the refilling step.

3. The sensor device of claim 2, wherein the duration of shaking the pharmaceutical device varies between 0 and 30 seconds.

4. The sensor device of claim 2, wherein the waiting time between actuations varies between 0 and 60 seconds.

5. The sensor device of claim 2, wherein the number of the filling steps varies between 0 and 5.

6. The sensor device of claim 2, wherein the number of refilling steps varies between 0 and 5.

7. The sensor device of claim 2, wherein the duration of the until-refill step varies between 0 and 30 days.

8. The sensor device of claim 2, wherein the shaking-to-emission interval varies from 0 to 30 seconds.

9. The sensor device of claim 1, wherein the guidance includes auditory indication.

10. The sensor device of claim 1, wherein the guidance includes visual indication.

11. The sensor device of claim 1, wherein the coupler includes a receiving port.

12. The sensor device of claim 11, wherein the receiving port includes an electrical interface.

13. The sensor device of claim 11, wherein the receiving port is configured to detachably receive a complementary protrusion of an adapter, the adapter including a memory storing the one or more product-specific operating parameters associated with the pharmaceutical device.

14. The sensor device of claim 1, wherein the coupler includes one or more latch points for receiving one or more latches of an adapter, the adapter including an adhesive configured for coupling to the pharmaceutical device.

15. The sensor device of claim 1, wherein the sensor device is configured for use with five or more different types of pharmaceutical devices.

16. The sensor device of claim 1, wherein the sensor device is configured to be used for a duration of more than 6 months.

17. The sensor device of claim 1, wherein the one or more sensors include an accelerometer, a pressure sensor, a temperature sensor, a magnetometer, an ambient light sensor, or a global positioning system (GPS).

18. The sensor device of claim 17, wherein the one or more sensors include the accelerometer, and wherein the accelerometer is configured to be positioned along the central axis of the pharmaceutical device.

19. The sensor device of claim 17, wherein the pressure sensor is located in the pressure sensing chamber.

20. The sensor device of claim 19, wherein the pressure sensing cavity allows air to flow in and out of the pressure sensing cavity in both directions.

21. The sensor device of claim 20, wherein the bidirectional airflow passes through a single opening in the pressure sensing chamber.

22. The sensor device of claim 19, wherein the pressure sensing chamber comprises 10 mm 3 The volume.

23. The sensor device of claim 19, wherein the pressure sensing chamber includes an opening for coupling to a pressure connector tube.

24. The sensor device of claim 1, wherein the sensor device includes elements for turning the sensor device on or off.

25. The sensor device of claim 24, wherein the element is located at the proximal end of the sensor device.

26. The sensor device of claim 1, wherein the indicator includes a speaker.

27. The sensor device of claim 1, wherein the indicator comprises a light-emitting diode (LED).

28. The sensor device of claim 1, wherein the indicator comprises a visual display.

29. The sensor device of claim 1, wherein the sensor device includes an interface for communicating with an external device.

30. The sensor device of claim 1, wherein the sensor device comprises 10 cm 3 The size.

31. The sensor device of claim 1, wherein the drug delivery device includes a canister for use with an inhaler.

32. The sensor device of claim 31, wherein the inhaler is a pressurized dose-measuring inhaler.

33. The sensor device of claim 13, wherein the adapter includes a pressure connector tube.

34. The sensor device of claim 13, wherein the sensor device is configured to be used with a variety of different types of adapters, each of the different types of adapters including a unique set of product-specific operating parameters specific to the different type of pharmaceutical device.

35. The sensor device of claim 1, wherein the pharmaceutical device comprises an oral inhaler device or a nasal device.

36. The sensor device of claim 1, wherein the guidance is feedback provided to the user based on the use of the pharmaceutical device.

37. The sensor device of claim 36, wherein the feedback guides the user in real time on how to correctly administer the medication.

38. The sensor device of claim 13, wherein the adapter is attached to the housing or canister of the pharmaceutical device.

39. The sensor device of claim 38, wherein the adapter is permanently attached to the housing or canister of the pharmaceutical device.

40. The sensor device of claim 38, wherein the adapter is detachably attached to the housing or canister of the pharmaceutical device.

41. The sensor device of claim 10, wherein the visual indication includes the presence or absence of light, a change in the color of light, a flicker of light, or any combination thereof.

42. A kit comprising: The sensor device as claimed in claim 1, and the specification thereof, wherein the specification is for guiding the coupling and / or decoupling of the sensor device to and / or to an adapter, the adapter including a memory storing the one or more product-specific operating parameters associated with the pharmaceutical device.

43. An adapter for guiding the use of a pharmaceutical device, the adapter comprising: A first coupler is used to couple to the pharmaceutical device; A memory that stores one or more product-specific operating parameters associated with the pharmaceutical device; as well as A second coupler is used to couple to a sensor device, wherein the sensor device is configured to output guidance to the user of the medication device.

44. The adapter of claim 43, wherein the adapter is configured to guide the use of a single type of pharmaceutical device.

45. The adapter of claim 43, wherein the second coupler includes a protrusion.

46. ​​The adapter of claim 45, wherein the protrusion includes an electrical interface.

47. The adapter of claim 45, wherein the protrusion is complementary to the receiving port of the sensor device, the sensor device comprising one or more sensors for detecting the use of the pharmaceutical device.

48. The adapter of claim 43, wherein the first coupler comprises an adhesive.

49. The adapter of claim 43, further comprising one or more processors operatively coupled to the memory.

50. The adapter of claim 43, wherein the adapter includes a pressure fitting tube.

51. The adapter of claim 50, wherein the pressure connector tube is hollow.

52. The adapter of claim 50, wherein the pressure connector tube includes a proximal portion located on a first surface of the adapter and a distal portion located away from a second surface opposite to the first surface.

53. The adapter of claim 52, wherein the proximal portion includes a sealing element.

54. The adapter of claim 53, wherein the sealing element is an O-ring.

55. The adapter of claim 52, wherein the distal portion includes one or more holes.

56. The adapter of claim 55, wherein one or more holes are located on the side surface of the pressure connector tube.

57. The adapter of claim 50, wherein the pressure connector tube is configured to extend along the longitudinal axis of the pharmaceutical device.

58. The adapter of claim 43, wherein the adapter includes an authenticator.

59. The adapter of claim 58, wherein the authenticator is configured to authenticate the sensor device and / or the adapter.

60. The adapter of claim 43, wherein the adapter is configured to be coupled to the sensor device via a snap-fit ​​mechanism.

61. The adapter of claim 43, wherein the adapter is configured for at least 60 actuations.

62. The adapter of claim 43, wherein the medication device includes a canister for use with an inhaler.

63. A kit comprising: The adapter as described in claim 43; And instructions for use in guiding the coupling and / or decoupling of the adapter to and from pharmaceutical devices selected from a variety of different types of pharmaceutical devices.

64. An apparatus for monitoring the use of a pharmaceutical device, comprising: a) Adapter, including: The distal end includes a first adapter coupler for coupling to the pharmaceutical device; A memory that stores one or more product-specific operating parameters associated with the pharmaceutical device; The proximal end includes a second adapter coupler for coupling to a sensor device, wherein the second adapter coupler includes a protrusion that includes an electrical interface; and A pressure connector tube, wherein the pressure connector tube includes a first end located on the proximal side of the adapter and a second end positioned distally on the distal side away from the adapter; and b) A sensor device detachably coupled to the adapter, wherein the sensor device includes: A mating surface for engaging with the proximal end of the adapter, the mating surface comprising: A receiving port, comprising an electrical interface, wherein the receiving port is complementary to the protrusion and configured to receive the protrusion; and An opening configured to receive the first end of the pressure fitting tube; A pressure sensing cavity operatively coupled to the opening, the pressure sensing cavity defining a closed chamber having the opening and including a barometer; A processor, operably coupled to the receiving port, is configured to: Receive the one or more product-specific operating parameters associated with the pharmaceutical device from the adapter; Automatically process one or more product-specific operating parameters associated with the pharmaceutical device; and Output signals based on one or more product-specific operating parameters; and An indicator that is configured to: Operable to receive the signal; and The device outputs instructions to the user of the pharmaceutical device, wherein the instructions vary according to the received one or more product-specific operating parameters.

65. A kit comprising: The sensor device as described in claim 1; The adapter as described in claim 43; And instructions for use in guiding the coupling and / or decoupling of the sensor device and the adapter to and / or from a variety of different types of pharmaceutical devices.

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