Novel aspects of the present disclosure relate to the field of air flow management and more particularly to a system and method for controlling air flow through a tracheostomy tube.
Patients having trouble breathing may be provided with a breathing tube inserted at least partially into the patient's airway. Endotracheal tubes and tracheostomy tubes are two types of breathing tubes currently used to facilitate breathing. Endotracheal tubes are inserted into the mouth and at least partially into the patient's trachea. Tracheostomy tubes are inserted into a hole, i.e., a tracheostomy, in the front of the neck and directly into the trachea. Tracheostomy tubes are preferred for patients requiring long-term mechanical ventilation, often longer than two weeks.
Novel aspects of the present disclosure are directed to a breathing apparatus comprising a lumen defining a flow path for air. The flow path is configured to communicate fluidically with an airway of a patient. A control valve coupled to the lumen automatically and selectively occludes the lumen to control a flowrate of the air passing through the lumen in real time based on respiratory data obtained from the patient.
Novel aspects of the present disclosure are also directed to a system for facilitating breathing. The system includes a breathing apparatus including a lumen defining a flow path for air. The flow path is configured to communicate fluidically with an airway of a patient. The breathing apparatus also includes a control valve coupled to the lumen. The control valve automatically and selectively occludes the lumen to control a flowrate of the air passing through the lumen in real time based on respiratory data obtained from the patient. The system also includes a set of sensors configured to capture the respiratory data from the patient, and a processor communicatively coupled to the set of sensors. The processor determines an amount oxygen in the patient's blood stream, the rate of breathing and the amount of CO2 exhaled by the patient through the lumen based on the respiratory data, and wherein the processor generates control signals for controlling the control valve to automatically control the flowrate of the air passing through the lumen in real time based on the patient's respiratory data.
Novel aspects of present disclosure are also directed to a method for facilitating breathing. The method includes the steps of determining, based on respiratory data of a patient, an amount of CO2 exhaled and oxygen required by the patient; and automatically controlling a degree of occlusion of a lumen of a breathing apparatus in real time by manipulating a control valve housed within the breathing apparatus based on the determined amount of CO2 exhaled and oxygen required.
Other aspects, embodiments and features of the invention will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying figures. In the figures, each identical, or substantially similar component that is illustrated in various figures is represented by a single numeral or notation. For purposes of clarity, not every component is labeled in every figure. Nor is every component of each embodiment of the invention shown where illustration is not necessary to allow those of ordinary skill in the art to understand the invention.
The novel features believed characteristic of the invention are set forth in the appended claims. The invention itself, however, as well as a preferred mode of use, further objectives and advantages thereof, will be best understood by reference to the following detailed description of illustrative embodiments when read in conjunction with the accompanying figures, wherein:
During the weaning process, respiratory rate is manually taken, and finger oxygen saturation is the only parameter monitored. The weaning process is time-intensive, requiring application of several different downsized cannulas to progressively decrease the effective orifice. Patients often experience anxiety and may revert back to larger cannula during the weaning and decannulation process. No other automated parameters are monitored. Physicians rely on nursing personnel to monitor and provide a patient's status during the decannulation process. The process of decannulation is often slow and prolonged, which may lead to increased intensive care unit (ICU) stay, nosocomial infections, and costs. Several studies have emphasized the importance of decannulation within the ICU due to better and focused care compared to a high-dependency care unit (HDU) or ward.
Novel aspects of this disclosure provide for the following benefits: a single automated device to be used to reduce the tracheostomy orifice and replace multiple cannula; incremental and precise closure of the orifice to the tracheostomy cannula; provision of management tools to better manage and possibly accelerate the weaning process, e.g., selectable control of weaning parameters for matching individual needs; provision of various alarms, e.g., ETCO2, respiratory rate, heart rate, and/or SpO2; provision of smart logic to allow for programmable closure; an override system that allows a clinician to manually adjust the degree of occlusion of the lumen in real time based their professional judgement of the alarms and/or the patient's needs; integration of weaning process with EMR; simplified componentry to ensure patient contact elements are disposable and can couple with hardware system; provision of a central hardware unit and interface with multiple disposable modules to achieve multi infusion needs typically seen in ICUs; provision of a simple GUI for user to program sequential infusion delivery; multiple modalities of operation, e.g., pneumatic or electro-mechanical; and a breathing apparatus comprised of a core disposable set.
Breathing apparatus 300 includes a control valve 302 configured to selectively occlude a lumen in fluidic connection with the airway of a patient. The lumen is depicted in more detail in
In some embodiments, the control valve 302 controls the amount of oxygen or oxygen enriched air by controlling the degree of occlusion of the lumen based on respiratory data captured by a set of sensors 304. As used herein, the term “set” means one or more. Thus, the set of sensors 304 can be a single sensor, or two or more sensors. Examples of respiratory data captured by the set of sensors 304 includes, for example and without limitation, end tidal CO2 (ETCO2), respiratory rate, pulse oximetry (sPO2), and/or heart rate.
In one embodiment, the breathing apparatus 300 includes a processor 306 for executing instructions stored in memory 308 for automatically controlling the control valve 302 based on the respiratory data. For example, the control valve 302 can reduce the degree of occlusion of the lumen passing through the breathing apparatus 300 if respiratory data indicates that the patient is not in distress and has an adequate supply of oxygen, and that the degree of occlusion of the control valve 302 has been at its current state for a predetermined period of time.
Embodiments of the breathing apparatus 300 can include a communications interface 310 for transmitting and receiving data, as in the embodiment in which a healthcare provider is remotely monitoring the weaning process from client device 202. The communications interface 310 can include currently existing or later developed wired or wireless communications technologies. The communications interface 310 can also enable the breathing apparatus 300 to integrate with the electronic medical records system to upload patient data into patient profiles. The electronic medical records system can be stored in network accessible storage devices, such as storage 208.
In some embodiments, breathing apparatus 300 can include pneumatic actuator 312 in embodiments where the control valve 302 is operated by pneumatic means. The pneumatic actuator 312 can provide air pressure for inflating and/or deflating the control valve 302 in the embodiments in which the control valve 302 includes a balloon. The pneumatic actuator 312 can include hardware for generating air pressure local to the breathing apparatus 300. Alternatively, the pneumatic actuator 312 can include hardware for selectively controlling the introduction of air pressure to the control valve 302. For example, the pneumatic actuator 312 can include an air coupler fitting that is coupled to an air conduit interfacing with the ventilator 206. The pneumatic actuator 312 can open and close the air coupler fitting to control the degree of occlusion of the lumen of the breathing apparatus 300.
In some embodiments, the breathing apparatus 300 also includes I/O 314. I/O 314 is a set of devices for providing a human-machine interface. I/O 314 can include output devices such as alarms. Alarms can be used to alert health care providers about emergent conditions of their patients. While I/O 314 is depicted as part of breathing apparatus 300, in other embodiments, I/O 314 can be alarms located remotely from the breathing apparatus 300 but triggered to sound by a wired or wireless connection via communications interface 310.
Breathing apparatus 300 can be powered by power supply 316. Power supply 316 can be an AC or DC power supply. When the power supply 316 is in the form of batteries providing DC power, the power supply 316 can be included within the housing of the breathing apparatus 300 or maintained separate from the housing of the breathing apparatus 300 and coupled together with a power cord.
The breathing apparatus 300 includes a housing 318 defining a lumen 320 that allows for oxygen and/or oxygen supplemented air from ventilator 206 to pass to the tracheostomy tube 100 and into the airway of the patient. As already described, a control valve 302 disposed within the housing 318 can be controlled to selectively occlude the lumen 320 to control the amount of oxygen and/or oxygen supplemented air received by the patient. In this illustrative embodiment, the control valve 302 and the corresponding hardware/software for controlling the control valve 302 are located in the middle of the breathing apparatus 300 so that the ends can be attached to one of the tracheostomy tube 100 or the air conduit 207 of the ventilator 206.
A sensor 304 is connected to an end of the breathing apparatus 300 for capturing respiratory data. In the depicted embodiment, the senor 304 is formed from a sensor housing 304a that suspends the sensing element 304b in the flow path of air passing through the breathing apparatus 300. The sensor housing 304a can be sized to receive the end of an air conduit 207 leading to the ventilator 206. In an embodiment in which the sensing element 304b is a wired sensing device, the sensing element 304b can be communicatively coupled to a client device, such as client device 202 for capturing and analyzing the captured respiratory data. In an embodiment in which the sensing element 304b is a wireless sensing device, the sensing element 304b may transmit respiratory data to a client device via the communications interface 310.
The breathing apparatus 300 depicted in
The control valve 302 of the breathing apparatus 300 can be actuated by an actuation source 320 or, in some embodiments, by the client device 202, depending upon the type of control valve 302 implemented. For example, when the control valve 302 is a pneumatic control valve, as described in more detail in
The pneumatically-operated control valve 302 in
In some embodiments, the cylindrically-shaped membrane of control valve 302 can be formed from a sheet of material having varying widths, which can provide a more predictable manner of inflation. For example, thinner membrane approximately equidistant from the ends of the cylindrically-shaped membrane can allow the central portion of the cylindrically-shaped membrane to deform more readily to increase the concavity of the cylindrically-shaped membrane during inflation. Likewise, thinner membrane at the ends of the cylindrically-shaped membrane can allow the ends of the cylindrically-shaped membrane to deform more readily to reduce the concavity of the cylindrically-shaped membrane during inflation.
The embodiment described in
The setpoint parameters can be chosen to control the effective airway path size (larger or smaller airway) according to patient status and may include specific conditions set by the clinician being stable for specific time, including end tidal CO2 (ETCO2), respiratory rate, pulse oximetry (sPO2), and heart rate.
With reference to
With reference to
In this embodiment, control valve 902 is a clamp engaged with an external surface of the lumen of a breathing apparatus which can be used to control a flow rate through the lumen based on a degree of closure of its clamping surfaces 904. For example, when the clamping surfaces 904 of the control valve 902 are spread furthest apart, as shown in
Although embodiments of the invention have been described with reference to several elements, any element described in the embodiments described herein are exemplary and can be omitted, substituted, added, combined, or rearranged as applicable to form new embodiments. A skilled person, upon reading the present specification, would recognize that such additional embodiments are effectively disclosed herein. For example, where this disclosure describes characteristics, structure, size, shape, arrangement, or composition for an element or process for making or using an element or combination of elements, the characteristics, structure, size, shape, arrangement, or composition can also be incorporated into any other element or combination of elements, or process for making or using an element or combination of elements described herein to provide additional embodiments.
Additionally, where an embodiment is described herein as comprising some element or group of elements, additional embodiments can consist essentially of or consist of the element or group of elements. Also, although the open-ended term “comprises” is generally used herein, additional embodiments can be formed by substituting the terms “consisting essentially of” or “consisting of.”
While this invention has been particularly shown and described with reference to preferred embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
This application claims priority to U.S. Provisional Application No. 63/271,564, filed on Oct. 25, 2021, entitled “TRACHEOSTOMY WEANING SYSTEM AND METHOD.” All the applications, publications and patents listed in this paragraph are incorporated herein by reference in their entirety as examples.
Number | Date | Country | |
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63271564 | Oct 2021 | US |