Gas sensor module

Abstract

To provide a gas sensor module.SOLUTION: A removable gas sensor module is provided for a therapeutic gas delivery device. The gas sensor module includes a sample chamber which receives a sample gas from the therapeutic gas delivery device. A gas detection unit includes a plurality of sensors operable to measure at least one property of the sample gas. The sensors include two or more of a gas detection sensor, a humidity sensor, and a temperature sensor, or a combination thereof. The gas sensor module is self-contained within the therapeutic gas delivery device and swappable with another gas sensor module.SELECTED DRAWING: None

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to a gas sensor module. In one embodiment, the present disclosure relates to a gas sensor module for a therapeutic gas delivery device. [Background technology]

[0002] Traditionally, gas detection systems must be calibrated by the user at intervals detailed in the user manual. For example, advanced calibration of the gas sampling system may be performed monthly and may require the availability of a calibration gas source at the facility as well as changes to the sample line connections. During advanced calibration of the gas sampling system and changes to the sample line connections, the gas detection system is unable to sample gas. Additionally, incorrect connection of the calibration tubing kit may result in erroneous readings or damage to the device. Summary of the Invention [Means for solving the problem]

[0003] The present invention provides, for example, the following items. (Item 1) 1. A removable gas sensor module for a therapeutic gas delivery device, the gas sensor module comprising: a sample chamber operable to receive a sample gas from the therapeutic gas delivery device; a gas detection unit comprising a plurality of sensors operable to measure at least one characteristic of the sample gas, the plurality of sensors including two or more of a gas detection sensor, a humidity sensor, a temperature sensor, or a combination thereof; The gas sensor module is self-contained within the therapeutic gas delivery device and is swappable with another gas sensor module. (Item 2) 2. The gas sensor module of claim 1, wherein replacement of the gas sensor module results in less than 5 minutes of downtime of the measurement of at least one characteristic of the sample gas. (Item 3) 2. The gas sensor module of claim 1, wherein replacement of the gas sensor module does not result in any downtime in delivery of therapeutic gas from the therapeutic gas delivery device. (Item 4) 2. The gas sensor module of item 1, wherein the gas detection sensor is one or more of a NO sensor, a NO2 sensor, an O2 sensor, or a combination thereof. (Item 5) 2. The gas sensor module according to claim 1, wherein the gas detection unit comprises at least two gas detection sensors. (Item 6) 5. The gas sensor module according to claim 4, wherein the gas detection unit comprises a NO sensor and a NO2 sensor. (Item 7) Item 2. The gas sensor module according to item 1, wherein the gas detection unit comprises two or more different sensors. (Item 8) 7. The gas sensor module according to item 6, wherein the gas detection unit comprises one or more gas detection sensors and one humidity sensor. (Item 9) 2. The gas sensor module of item 1, wherein the at least one characteristic of the sample gas is one or more of NO concentration, NO2 concentration, O2 concentration, humidity, temperature, or a combination thereof. (Item 10) 2. The gas sensor module of claim 1, further comprising a sensing circuit operable to detect and report the at least one characteristic of the sample gas to a gas analyzer controller within the therapeutic gas delivery device. (Item 11) 2. The gas sensor module of item 1, wherein the therapeutic gas delivery device is continuously operable when the gas sensor module is replaced. (Item 12) Item 2. The gas sensor module of item 1, wherein the sample chamber comprises an inner housing and an outer housing. (Item 13) 2. The gas sensor module of claim 1, wherein the gas detection unit is operable to electronically store or transmit the gas sensor module's serial number, calibration data, and / or usage information to the therapeutic gas delivery device. (Item 14) Item 10. The gas sensor module according to item 1, wherein the gas sensor module is pre-calibrated and storage stable for at least one month. (Item 15) Item 14. The gas sensor module according to item 13, wherein the gas sensor module is storage stable for at least three months. (Item 16) 1. A gas sensor assembly comprising: The gas sensor module according to any one of items 1 to 15, an assembly inner housing operable to removably receive the gas sensor module; A gas analyzer unit comprising: a sample tube fluidly connected to the gas delivery device and to the gas sensor module operable to receive the sample gas; a gas analyzer unit comprising a pump connected to the gas sensor module through the sample tube, the pump operable to pump the sample gas through the gas sensor module. (Item 17) Item 17. The gas sensor assembly of item 16, wherein the gas analyzer unit further comprises a gas analyzer controller. (Item 18) Item 17. The gas sensor assembly of item 16, wherein the gas analyzer unit further comprises an assembly main housing operable to receive the assembly inner housing, the assembly main housing being within the therapeutic gas delivery device. (Item 19) Item 17. The gas sensor assembly of item 16, wherein at least a portion of the sample tube is a Nafion tube. (Item 20) An apparatus comprising: A voltage source; 16. An apparatus comprising: the gas sensor module according to any one of claims 1 to 15, wherein when the gas sensor module is in an unattached configuration, the voltage source provides a potential across the multiple sensors of the gas detection unit to maintain calibration of the multiple sensors. (Item 21) 21. The apparatus of claim 20, wherein the voltage source is a battery or a power transformer. (Item 22) 21. The apparatus of claim 20, wherein the voltage source ceases to provide an electrical potential across the plurality of sensors when the gas sensor module is installed within the therapeutic gas delivery device. (Item 23) 21. The apparatus of item 20, wherein the current source is internal to the gas sensor module. (Item 24) A method for providing a gas sensor module, comprising the steps of: Calibrating the sensors in the gas sensor module according to any one of items 1 to 15; providing a potential across the plurality of sensors to maintain the calibration of the plurality of sensors. Implementations of the present technology will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0004] [Figure 1A] FIG. 2 is an exploded view of an exemplary gas sensor assembly according to the present disclosure. [Figure 1B] FIG. 1B is a fully assembled view of the gas sensor assembly of FIG. 1A. [Figure 2A] FIG. 2 is an exploded view of an exemplary gas sensor module. [Figure 2B]FIG. 2 is an exploded view of an exemplary gas sensor module. [Figure 2C] FIG. 2C is a fully assembled view of the gas sensor module of FIG. 2B with the outer and inner housings removed. [Figure 3A] FIG. 2 is a detailed exploded view of an exemplary gas sensor assembly. [Figure 3B] FIG. 2 is a detailed exploded view of an exemplary gas sensor assembly. [Figure 4] FIG. 1 is a schematic diagram of an apparatus including a voltage source electrically coupled to a gas sensor module to maintain calibration stability of the gas sensor module. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0005] It will be appreciated that for simplicity and clarity of illustration, reference numerals are repeated, where appropriate, among different figures to indicate corresponding or identical elements. In addition, numerous specific details are described to provide a thorough understanding of the examples described herein. However, those skilled in the art will appreciate that the examples described herein can be practiced without such specific details. In other instances, methods, procedures, and components have not been described in detail so as not to obscure the relevant features of the described association. Additionally, the description should not be considered as limiting the scope of the embodiments described herein. The drawings are not necessarily to scale, and the proportions of certain parts may be exaggerated to better illustrate the details and features of the present disclosure.

[0006] Below, we present some definitions that apply throughout the disclosure above. The term "coupled" is defined as connected, whether directly or indirectly through an intervening component, and is not necessarily limited to a physical connection. The connection may be such that the objects are permanently connected or removably connected. The term "substantially" is defined as essentially conforming to a particular dimension, shape, or other term that substantially modifies, and thus does not necessarily remain a component. For example, "substantially cylindrical" means that the object resembles a cylinder, but may have one or more deviations from a true cylinder. The terms "comprising," "including," and "having" are used interchangeably in this disclosure. The terms "comprising," "including," and "having" mean to include, but are not necessarily limited to, what is so described. The terms "hot swap," "hot swapped," or "hot swappable" are defined to mean that a sensor can be removed and replaced with a new calibrated sensor such that the downtime of the therapeutic gas delivery device to bring the replacement sensor to operational readiness is less than about 5 minutes. For example, a gas sensor module can be hot swapped with a calibrated gas sensor module, and the downtime of the therapeutic gas delivery device is about 3 minutes. As used herein, "swap" can include "hot swap" or any corresponding variations.

[0007] Disclosed herein is a removable gas sensor module having a plurality of sensors for measuring at least one characteristic of a sample gas in a therapeutic gas delivery device. The sample gas may be a sample of a therapeutic gas being delivered to a patient by the therapeutic gas delivery device. The gas sensor module is built into the therapeutic gas delivery device, thereby facilitating its replacement in the field in a manner that may be considered "plug and play" and / or hot swappable. In some embodiments, the gas sensor module is built into a gas sensor assembly, which is further included in the therapeutic gas delivery device. The gas sensor module may be pre-calibrated and thus is ready for use upon installation into the gas sensor assembly / therapeutic gas delivery device without further calibration. The gas sensor module may be factory calibrated and, in at least one example, may maintain calibration stability during storage for a significant period of time, e.g., six months.

[0008] Conventionally, if a sensor fails any of the calibration tests, it is replaced by trained personnel or a service technician. For example, sensor replacement can be performed by opening a panel on the back of the device casing, removing the failed sensor, and fitting a replacement sensor. After replacing the sensor, the new sensor must be calibrated in the gas flow, causing the sample detection circuit to be out of operation for a period of time; for example, changing sensors for oxygen (O2) and nitrogen dioxide (NO2) may take about 40 minutes, while a nitric oxide (NO) sensor may require about 5 hours of calibration. Once the new sensor is calibrated, a low calibration is then performed, followed by a high calibration, before detection of the gas sample can continue. Thus, replacement of a conventional gas sensor in a therapeutic gas delivery device is time consuming and can result in both interruption of gas sensor detection / analysis and therapeutic gas delivery to the patient, preventing effective treatment of the patient.

[0009] The conventional solution to sensor drift is to periodically perform low and high level calibrations of the sensor. While the low level calibration can be automatically managed and controlled by the device, the high level calibration of the sensor requires the user to disconnect the sampling line from the patient line and then attach a calibration gas source of the appropriate gas before allowing the high calibration protocol. Similarly, performing a high calibration is time consuming and can cause interruptions in the detection / analysis of the gas sensor, preventing effective treatment of the patient.

[0010] The gas sensor module described herein overcomes the limitations of conventional gas sensors. The gas sensor module is pre-calibrated, built-in, and hot-swappable, and thus can be replaced in the therapeutic gas delivery device without interrupting the therapeutic gas delivery to the patient, with minimal downtime in gas sensor detection / analysis. This provides continuous and effective treatment of the patient. In addition, the hot-swappable feature of the built-in gas sensor module provides replacement of the gas sensor module by the user without significant training. The gas sensor module can simply be removed and replaced with a separate pre-calibrated gas sensor module, rather than asking the user to perform a high calibration of the NO and NO2 sensors every month. The first gas sensor module can then be returned to a central facility for recalibration and / or discarded. The gas sensor module is pre-calibrated to a high calibration, and thus only needs to perform a low calibration, which in at least one example can occur automatically upon installation of the gas sensor module.

[0011] The gas sensor module can be utilized in the exemplary gas sensor assembly shown in, for example, FIGS. 1A and 1B. The gas sensor assembly 10 includes a gas sensor module 100 and an assembly inner housing 200 operable to removably receive the gas sensor module 100. The assembly inner housing 200 includes a module receiving portion 202 forming a module receiving recess 204. The gas sensor module 100 is removably received in the module receiving recess 204. Thus, the gas sensor module 100 is removably coupled to the assembly inner housing 200. The gas sensor assembly 10 can also include a gas analyzer unit 300 having an assembly main housing 302 operable to receive the assembly inner housing 200. In some examples, the assembly inner housing 200 is removably coupled to the assembly main housing 302. In other examples, the assembly inner housing 200 is fixedly coupled to the assembly main housing 302. The gas analyzer unit 300 is included in the therapeutic gas delivery device 50. In at least one example, the assembly main housing 302 is coupled to and in fluid communication with the therapeutic gas delivery device 50. In some examples, the gas sensor module 100 is nested within the assembly inner housing 200, which is nested within the assembly main housing 302, such that the gas sensor module 100 is coupled to and in fluid communication with the therapeutic gas delivery device 50. In other examples, the assembly inner housing 200 and the gas analyzer unit 300 can be integrated as a single unit operable to receive the gas sensor module 100. In additional examples, the therapeutic gas delivery device 50 is operable to receive the gas sensor module 100.

[0012] The therapeutic gas delivery device 50 is operable to deliver therapeutic gas to the patient. For example, the therapeutic gas delivery device 50 can deliver therapeutic nitric oxide (NO) gas to the patient. The gas sensor module 100, the assembly inner housing 200, and the assembly main housing 302 are arranged such that gas can flow from the breathing circuit of the therapeutic gas delivery device 50, through a sample tube, through the gas analyzer unit 300, through the assembly inner housing 200, to the gas sensor module 100. In at least one example, the sample tube can be fluidly connected to the breathing circuit of the gas delivery device 50, and the gas sensor module 100 is operable to receive sample gas from the sample tube. In at least one example, the breathing circuit of the therapeutic gas delivery device 50 includes a sample tee operable to receive the sample tube such that at least a portion of the gas in the breathing circuit flows through the sample tube. Additionally, in at least one example, the assembly inner housing 200 can include a port 206 that can be fluidly connected to a port 306 on the gas analyzer unit 300, which can be fluidly connected to a sample tube. The port 206 can receive sample gas from the therapeutic gas delivery device 50 through a port 304 of the gas analyzer unit 300 and provide the sample gas to the gas sensor module 100.

[0013] 2A and 2B illustrate exploded views of the gas sensor module 100. The gas sensor module 100 includes a sample chamber 101. The sample chamber 101 receives sample gas from the therapeutic gas delivery device 50. The sample chamber 101 is fluidly connected to a sample inlet 119. The sample inlet 119 is fluidly connected to the therapeutic gas delivery device and is operable to receive the sample gas. In some examples, the sample inlet 119 is fluidly connected to a port 206 of the assembly inner housing 200, which is fluidly connected to a port 304 of the gas analyzer unit 300, which is fluidly connected to a sample tube of the therapeutic gas delivery device 50. In at least one example, the sample chamber 101 is operable to receive the sample gas from the therapeutic gas delivery device 50. The sample chamber 101 can include an inner housing 102. The inner housing 102 can include a vent 103 through which the sample gas can be removed from the sample chamber 101. The vent 103 can be, for example, an opening formed in the inner housing 102. In at least one example, the gas sensor module 100 includes an outer housing 104 that at least partially surrounds the inner housing 102. In some examples, the outer housing 104 can include at least one of a cam element 106, a cam spindle 108, a handle 110, a handle shaft 114, a vent cap 112, and / or a gasket 113. In at least some examples, the cam element 106, the cam spindle 108, the handle 110, and / or the handle shaft 114 can be used to facilitate ease of installation / removal of the gas sensor module 100 by a user via a locking / unlocking action of the vent cap 112. In some examples, the handle 110 can be a flip-up pull tab, as shown in FIG. 2B. The gasket 113 can help prevent leakage from the air circuit and does not allow the sample gas to interact with the electronics. In at least one example, the gasket 113 can be made of silicone rubber.

[0014] The gas sensor module 100 includes a gas detection unit 121 that includes a plurality of sensors 118. The sensors 118 are operable to measure at least one characteristic of a sample gas. For example, the sensors 118 may include two or more of a gas detection sensor, a humidity sensor, and / or a temperature sensor.

[0015] In at least one example, the gas detection unit 121 can include two or more gas detection sensors 122. In at least one example, the gas detection unit 121 can include two or more different sensors 118. As illustrated in FIGS. 2A and 2B, the gas detection unit 121 can include one humidity sensor 120 and two gas detection sensors 122. In other examples, the gas detection unit 121 can include one or more gas detection sensors 122 and one humidity sensor 120. The gas detection sensor 122 can include one or more of a NO sensor, a NO2 sensor, an O2 sensor, or a combination thereof. In at least one example, the gas detection sensor 122 can include a NO sensor and a NO2 sensor. Although FIGS. 2A and 2B illustrate two gas detection sensors 122, one, three, or more gas detection sensors 122 can be included. The measured sample gas characteristic can be one or more of a concentration of NO, a concentration of NO2, a concentration of O2, humidity, temperature, or a combination thereof. 2A and 2B, the gas sensor module 100 includes a sensor seal 116 coupled to at least one of the sensors 118. As illustrated in FIG. 2B, the gas sensor module 100 can include a humidity sensor seal 130 operable to be coupled to a humidity sensor 120 (not shown), which can be integrated with a sensing circuit 124.

[0016] The gas sensor module 100 includes a sensing circuit 124 coupled to the sensor 118. The sensing circuit 124 is operable to detect and report a measured property of the sample gas from the sensor 118. The sensing circuit 124 can be communicatively coupled to the gas delivery device 50. In one example, the sensing circuit 124 can be operable to report the measured property of the sample gas to a gas analyzer controller 350 of the gas analyzer unit 300. In one example, the gas analyzer controller 350 can be operable to report the measured property of the sample gas to the therapeutic gas delivery device 50. The sensing circuit 124 can be coupled to the gas analyzer controller 350 and / or the gas delivery device 50 by any suitable wired or wireless connection, such as Ethernet, Bluetooth, RFID, or fiber optic cable. In at least one example, the sensing circuit 124 and / or the gas analyzer controller 350 can be operable to store the measured property of the sample gas. The gas detection unit 121 may be operable to electronically retain the serial number, calibration data, and / or usage information of the gas sensor module 100 by the sensing circuit 124. In another example, the gas analyzer controller 350 may be operable to electronically retain the serial, calibration data, and / or usage information of the gas sensor module 100, thereby allowing for continued component tracking and tracing even when the gas sensor module 100 is disconnected from the gas delivery device 50. The sensing circuit 124 may include a connector 125 operable to connect the sensing circuit 124 of the gas sensor module 100 with the gas analyzer controller 350 and thus with the gas delivery device 50. Thus, the gas sensor module 100 may be hot swapped and the connector 125 easily connected with the gas delivery device 50 without additional expertise or tools.

[0017] The gas sensor module 100 additionally includes a cover 126 that can be coupled to the outer housing 104. In at least one example, the cover 126 can be removably coupled to the outer housing 104 by fasteners 128. The fasteners 128 can be, for example, at least one of screws, nails, nuts and bolts, hook-and-loop fasteners, adhesive, and / or any other suitable fasteners.

[0018] The gas sensor module 100 is built into the therapeutic gas delivery device 50 and is swappable with another gas sensor module 100. Housing all of the sensors and / or analytical elements for the gas sample provides hot swap capability in the event of a need for recalibration, component failure, and / or contamination. For example, the gas sensor module 100 can be replaced in the event of a gas sensor module 100 failure, in the event of a sample line filter failure, and / or when the service period of the calibration of the gas sensor module 100 expires. Additionally, the modularization of the gas sensor module 100 simplifies the future addition of sensors 118 for analytes such as O2 or volatile organic compounds (VOCs) without requiring modification of the entire gas delivery device 50, instead of "upgrading" to the next generation of gas sensor modules. The replacement gas sensor module 100 can be easily installed, and then the gas delivery device 50 can be immediately put back into service. The gas sensor module 100 can be quickly replaced with a pre-calibrated gas sensor module 100 by personnel without the need for special tools or equipment. For example, replacement of the gas sensor module 100 may result in less than 5 minutes of downtime in measuring at least one characteristic of the sample gas. In at least one example, replacement of the gas sensor module 100 may result in less than 3 minutes of downtime in measuring at least one characteristic of the sample gas.

[0019] In another example, replacement of the gas sensor module 100 may not result in any downtime in the delivery of therapeutic gas from the therapeutic gas delivery device 50. In this example, because the gas sensor module 100 analyzes the sample gas separately from the therapeutic gas in the breathing circuit, the delivery of therapeutic gas to the patient is not interrupted by replacement of the gas sensor module 100. In addition, because the gas sensor module 100 is self-contained, it does not require shutting off the therapeutic gas delivery device 50 or any cessation of the flow of therapeutic gas to the patient. This allows the therapeutic gas delivery device 50 to continuously deliver therapeutic gas to the patient through the breathing circuit while swapping the gas sensor module 100 for a new pre-calibrated gas sensor module 100. In at least one example, the therapeutic gas delivery device 100 may be continuously operable when replacing the gas sensor module 100. Additionally, detection of samples by the gas sensor module 100 may begin approximately five minutes after completion of a low calibration protocol following installation. In at least one example, the low calibration protocol can be automatically initiated upon installation of a new gas sensor module 100. The hot swap capability of the gas sensor module 100 has a significant positive impact on user experience and equipment downtime. Having the gas sensor module 100 pre-calibrated or calibrated prior to installation eliminates the need for in-situ high calibration of the NO sensor, allows for quick and easy replacement of failed or expired gas sensor modules, and allows for off-site reconditioning and repair, if applicable.

[0020] The gas sensor module 100 can be utilized or used for at least one month and maintain calibration stability. In at least one example, the calibration stability period during use of the gas sensor module 100 can be extended from the conventional one month to about three months. In at least one example, the gas sensor module 100 can have a shelf-life calibration stability period (e.g., stability when not attached to the gas delivery device 50) of at least one month, alternatively at least three months, alternatively at least six months, or alternatively at least one year. In some examples, the shelf-life of the gas sensor module 100 can be extended by including a battery 132 or other voltage source to provide a potential across the sensor during storage to maintain calibration. In at least one example, the gas sensor module 100 can include an expiration date. A user can be provided with a gas sensor module replacement reminder / alarm, for example, via a graphic user interface and / or application and / or program associated with the therapeutic gas delivery device.

[0021] In at least one example, as illustrated in FIG. 4, the gas sensor module 100 can include and / or be electrically connected to an instrument 400 that includes a voltage source 402 that can be used in conjunction with an ultra-low power consumption setting to ensure that the sensor 118 retains calibration stability for a predetermined period of time, for example up to six months. The sensors 118 in the gas sensor module 100 can be pre-calibrated and the instrument 400 can provide a potential across the sensors 118 to maintain the calibration of the sensors 118. For example, the voltage source 402 can provide a potential across the sensors 118 in the gas sensor module 100 at a predetermined time to maintain the calibration stability of the sensors 118 when the gas sensor module 100 is in an unattached configuration. Thus, an end user can order multiple gas sensor modules 100 and store them until they need to replace the gas sensor modules 100 in use when they are due for recalibration and / or replacement. In at least one example, the voltage source 402 can be a battery or a power transformer. In at least one example, the voltage source 402 can be built into the gas sensor module 100, as shown in FIG. 2C. In another example, the voltage source 402 can be external to the gas sensor module 100. The voltage source 402 can cease providing a potential across the sensor 118 when the gas sensor module 100 is attached to the therapeutic gas delivery device 50. In at least one example, the device 400 and the voltage source 402 can be removable from the gas sensor module prior to attachment to the therapeutic gas delivery device 50. In another example, the voltage source 402 can remain connected to the gas sensor module 100 after attachment, but no longer provides a potential across the sensor 118, 122 of the gas sensor module 100. In at least one example, as illustrated in FIG. 2C, the battery 132 can directly connect to the sensing circuitry 124, such that a separate device 400 is not required to connect the battery 132 to the gas sensor module 100.

[0022] The implementation of pre-calibration and / or ex-situ calibration provides accuracy of calibration. For example, a high calibration protocol at one point assumes a single linear function over the range of NO concentrations to be administered. A calibration accuracy of ±20% is sufficient to address current requirements, but can be significantly improved by using a multi-point calibration protocol, one that is not compatible with user-performed calibration but can be performed automatically in a factory calibration scenario. By such an approach, calibration functions for multiple sub-ranges of NO concentrations can be generated and stored for implementation (e.g., in the form of a simple look-up table in the device's memory). The gas sensor module 100 can then determine the appropriate calibration function to use when measuring gas delivery based, for example, on the set volume and seated range. This is particularly important in pediatric or other low concentration applications for NO administration, where many calibration gases are delivered at a set concentration of 45 ppm, which is often more than double the administered NO concentration. This also addresses the issue experienced by certain users who feel uncomfortable with the display of concentrations up to 20% less / more than the set dose.

[0023] Additionally, ex-site (e.g., factory) calibration and / or pre-calibration can utilize a calibration manifold 356 (shown in FIGS. 3A and 3B ) that can control at least one of temperature, relative humidity, and pressure, facilitating the generation of calibration functions that not only provide more accurate measurements of gases such as NO in specific sub-ranges, but also allow compensation for different temperature, pressure, and relative humidity values.

[0024] Additionally, off-site calibration and / or pre-calibration can facilitate accurate measurement of gas concentrations, such as NO, used in the calibration gas mixture. Rather than using calibrated gas cylinders prepared in batches for distribution to end users, the calibration gas can be accurately quantified in terms of gas concentration.

[0025] 3A and 3B illustrate detailed exploded views of the gas sensor assembly 10. As discussed above, the gas sensor assembly 10 includes a gas sensor module 100 that is removably received in an assembly inner housing 200. The gas sensor module 100 can be removably coupled to the assembly inner housing 200 by one or more fasteners, such as, for example, screws, clips, rotatable contact members, or any other suitable fasteners, such that the gas sensor module 100 can be removed from the assembly inner housing 200 without special tools or expertise. The assembly inner housing 200 can be received in and / or coupled to an assembly main housing 302 that is within or in fluid communication with a therapeutic gas delivery device. In one example, the assembly inner housing 200 and the assembly main housing 302 remain fixed within the therapeutic gas delivery device, while the gas sensor module 100 is removably replaced as needed.

[0026] A sample gas is taken from a therapeutic gas delivery device and passed through the gas sensor assembly 10 to the gas sensor module 100 so that the gas sensor module 100 can detect the sample gas and report at least one characteristic thereof. The sample gas can enter the assembly main housing through a port 304. In one example, a luer interface 306 of a two-stage filter can be connected to a port 304 that is external to the assembly main housing 302. The port 304 can be fluidly connected to a pump 308 within the assembly main housing 302. The pump 308 is operable to pump the sample gas through the gas sensor module 100. The pump 308 can draw the sample gas from the gas delivery device, for example, through the port 304 and a pump feeder tube 310. The pump feeder tube 310 can be coupled to the pump 308 using a fastener 314, such as a clip. The pump 308 includes a fan 316 that is operable to rotate to promote a flow of the sample gas. In at least one example, the sample gas can then be received in the restrictor supply tube 318, pass through the restrictor 320 received in the restrictor housing 322, and pass through the restrictor return tube 324. The restrictor 320 can be operable to restrict the flow of gas by creating a pressure differential. In at least some examples, the restrictor 320 can be incorporated into the calibration manifold 356. In other examples, as shown in FIG. 3B, the gas analyzer unit 300 may not include a restrictor supply tube, a restrictor, a restrictor housing, or a restrictor return tube. In this example, as shown in FIG. 3B, the calibration manifold 356 can incorporate the functionality of the restrictor 230 by including a restrictor opening to restrict the flow of the sample gas and create a pressure differential.

[0027] The restrictor 320 and / or the calibration manifold 356 can be utilized to control the rate and / or amount of sample gas that is received by the gas sensor module 100. The sample gas can then pass through the pump 308 and exit the pump delivery tube 312.

[0028] The gas sensor assembly 10 may include a sample tube 352 fluidly connected to the gas delivery device 50 and the gas sensor module 100 operable to receive a sample gas. For example, the sample tube 352 may be fluidly connected to the pump delivery tube 312. In at least one example, at least a portion of the sample tube 352 may be a Nafion tube. As illustrated in FIGS. 3A and 3B, the gas sensor assembly 10 may additionally include a humidity component 354 and a calibration manifold 356. The humidity component 352, the Nafion tube portion of the sample tube 352, the calibration manifold 356, any other suitable components for controlling, for example, temperature and / or pressure, or any combination thereof, may control at least one of temperature, relative humidity, and pressure, facilitating the generation of a calibration function that not only provides a more accurate measurement of a gas, such as NO, in a particular subrange, but also allows compensation for different temperature, pressure, and / or relative humidity values. For example, the humidity component 352, the Nafion tube portion of the sample tube 352, and / or the calibration manifold 356 can reduce humidity of the gas sample to increase calibration stability of the gas sensor module 100. A gas analyzer subframe 357 can be included to accommodate at least a portion of the humidity component 352, the Nafion tube portion of the sample tube 352, and / or the calibration manifold 356. One or more fasteners 358 can hold at least one of the humidity component 352, the Nafion tube portion of the sample tube 352, and / or the calibration manifold 356 within the gas analyzer subframe 357. The fasteners 358 can be, for example, screws, adhesives, and / or nuts and bolts.

[0029] The gas sensor assembly 10 may additionally include a high differential link tube 360 ​​and a low differential link tube 362. In at least one example, the gas sensor assembly 10 may include an ambient air pressure link tube 364 that is fluidly connected to the outside atmosphere or ambient air. To provide ambient air, the gas sensor assembly 10 may include an ambient air inlet tube 368 that is fluidly connected to the outside of the gas sensor assembly 10 to provide ambient air. A filter 372 is coupled to an end of the ambient air inlet tube 368 opposite the end that is connected to the outside of the gas sensor assembly 10. The filter 372 may filter the ambient air to block particles or other substances that may affect the gas sensor module 100 from determining an accurate measurement of the sample gas. A connector tube 366 may be included to fluidly connect the Nafion tube portion of the sample tube 352 to the calibration manifold 356. Additionally, in at least one example, a filter tube 370 may be fluidly connected to the filter 372 to provide a passage of ambient air to the Nafion tube portion of the sample tube 352.

[0030] The sample gas is received through a port 206 in the assembly inner housing 200. The port 206 is fluidly connected to the sample inlet 119 of the gas sensor module 100, and the sample gas is received within the sample chamber 101 of the gas sensor module 100.

[0031] Also provided herein is a method for providing a gas sensor module for use in a therapeutic gas delivery device. In some examples, the method can include calibrating a plurality of sensors in the gas sensor module and providing an electrical potential across the plurality of sensors to maintain the calibration of the plurality of sensors. The calibration of the plurality of sensors can be maintained for at least one month, at least three months, at least six months, or at least one year. The electrical potential can be provided by an instrument having a voltage source, such as a battery. In some examples, the method can further include removing the instrument / voltage source prior to or simultaneously with mounting the gas sensor module to the therapeutic gas delivery device. The gas sensor module can be mounted within an assembly inner housing and an assembly outer housing within the therapeutic gas delivery device. In some examples, mounting the gas sensor module results in less than five minutes of downtime in measuring at least one characteristic of a sample gas from the therapeutic gas delivery device. In other examples, mounting the gas sensor module does not result in any downtime in the delivery of therapeutic gas to a patient.

[0032] The disclosure shown and described above is merely an example. Although numerous characteristics and advantages of the present technology have been described in the above description, the disclosure, together with the details of the structure and function of the disclosure, is merely an example, and changes in details, particularly in matters of shape, size, and arrangement of parts, may be made within the scope of the principles of the disclosure to the maximum extent indicated by the broad general meaning of the terms used in the appended claims. Thus, it will be recognized that the above-described embodiment may be modified within the scope of the appended claims.

[0033] Numerous examples are provided herein to enhance understanding of the present disclosure. A particular set of descriptions is provided below.

[0034] Description 1: A removable gas sensor module for a therapeutic gas delivery device, the gas sensor module comprising: a sample chamber operable to receive a sample gas from the therapeutic gas delivery device; and a gas detection unit comprising a plurality of sensors operable to measure at least one characteristic of the sample gas, the plurality of sensors including two or more of a gas detection sensor, a humidity sensor, a temperature sensor, or a combination thereof, wherein the gas sensor module is built into the therapeutic gas delivery device and is swappable with another gas sensor module.

[0035] Statement 2: The gas sensor module of statement 1, wherein replacement of the gas sensor module results in less than 5 minutes of downtime of measurement of at least one characteristic of the sample gas.

[0036] Statement 3: The gas sensor module of statement 1, wherein replacement of the gas sensor module does not result in any downtime in the delivery of therapeutic gas from the therapeutic gas delivery device.

[0037] Statement 4: The gas sensor module of statement 1, wherein the gas detection sensor is one or more of a NO sensor, a NO2 sensor, an O2 sensor, or a combination thereof.

[0038] Statement 5: The gas sensor module of statement 1, wherein the gas detection unit comprises at least two gas detection sensors.

[0039] Statement 6: The gas sensor module of statement 4, wherein the gas detection unit comprises a NO sensor and a NO2 sensor.

[0040] Statement 7: The gas sensor module of statement 1, wherein the gas detection unit comprises two or more different sensors.

[0041] Statement 8: The gas sensor module of statement 6, wherein the gas detection unit comprises one or more gas detection sensors and a humidity sensor.

[0042] Statement 9: The gas sensor module of statement 1, wherein the at least one characteristic of the sample gas is one or more of a concentration of NO, a concentration of NO2, a concentration of O2, humidity, temperature, or a combination thereof.

[0043] Statement 10: The gas sensor module of statement 1, further comprising a sensing circuit operable to detect and report at least one characteristic of the sample gas to a gas analyzer controller within the therapeutic gas delivery device.

[0044] Statement 11: The gas sensor module of statement 1, wherein the therapeutic gas delivery device is continuously operable when the gas sensor module is replaced.

[0045] Statement 12: The gas sensor module of statement 1, wherein the sample chamber comprises an inner housing and an outer housing.

[0046] Statement 13: The gas sensor module of statement 1, wherein the gas detection unit is operable to electronically store or transmit the gas sensor module's serial number, calibration data, and / or usage information to the therapeutic gas delivery device.

[0047] Statement 14: The gas sensor module of statement 1, wherein the gas sensor module is pre-calibrated and storage stable for at least one month.

[0048] Statement 15: The gas sensor module of statement 13, wherein the gas sensor module is storage stable for at least three months.

[0049] Description 16: A gas sensor assembly comprising: a gas sensor module as described in any one of descriptions 1 to 15; an assembly inner housing operable to removably receive the gas sensor module; a gas analyzer unit comprising a gas delivery device and a sample tube fluidly connected to the gas sensor module operable to receive a sample gas; and a pump connected to the gas sensor module through the sample tube, the pump operable to pump the sample gas through the gas sensor module.

[0050] Statement 17: The gas sensor assembly of statement 16, wherein the gas analyzer unit further comprises a gas analyzer controller.

[0051] Statement 18: The gas sensor assembly of statement 16, wherein the gas analyzer unit further comprises an assembly main housing operable to receive the assembly inner housing, the assembly main housing being within the therapeutic gas delivery device.

[0052] Statement 19: The gas sensor assembly of statement 16, wherein at least a portion of the sample tube is a Nafion tube.

[0053] Description 20: An apparatus comprising: a voltage source; and a gas sensor module as described in any one of descriptions 1 to 15, wherein when the gas sensor module is in an unattached configuration, the voltage source provides a potential across multiple sensors of a gas detection unit to maintain calibration of the multiple sensors.

[0054] Statement 21: The apparatus of statement 20, wherein the voltage source is a battery or a power transformer.

[0055] Description 22: The apparatus of claim 20, wherein the voltage source ceases to provide an electrical potential across the plurality of sensors when the gas sensor module is mounted within the therapeutic gas delivery device.

[0056] Statement 23: The apparatus of statement 20, wherein the current source is internal to the gas sensor module.

[0057] Description 24: A method for providing a gas sensor module, comprising: calibrating a plurality of sensors in the gas sensor module described in any one of descriptions 1 to 15; and providing an electrical potential across the plurality of sensors to maintain calibration of the plurality of sensors.

Claims

[Claim 1] An apparatus, system, method, etc.

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