The present invention relates to a medical ventilator, and in particular to a medical ventilator that includes an accessory connector that enables data to be received from an accessory device operatively coupled to the accessory connector and integrated into a data stream being collected and/or generated by the medical ventilator.
A medical ventilator is a machine that is structured to deliver a gas, such as air, oxygen, or a combination thereof, to an airway of patient to augment or substitute for the patient's own respiratory effort. In addition, it is known to operate a conventional medical ventilator in a variety of modes depending upon the particular needs of the patient.
In a life support situation, where there is substantially no spontaneous respiratory effort by the patient, a controlled mode of ventilation is typically provided, where the ventilator assumes full responsibility for ventilating the patient. In this mode of ventilation, a controlled volume of gas is delivered to the patient during each inspiratory phase of the ventilatory cycle, and the trigger point (the transition from the expiratory phase to the inspiratory phase of the ventilatory cycle) and cycle point (the transition from the inspiratory phase to the expiratory phase of the ventilatory cycle) of the ventilator are typically determined based on time. Traditionally, ventilators used in life support situations employ what is known as a dual-limb patient circuit having an inspiratory limb for carrying gas to the patient and an expiratory limb for carrying gas from the patient to an exhaust assembly that includes a selectively controllable valve or similar mechanism for actively controlling the exhaustion of the patient's expired gas to atmosphere (referred to as “active exhaust”).
In non-life support situations, where the patient exhibits some degree of spontaneous respiratory effort, an assist mode or a support mode of ventilation is typically provided in which the ventilator augments or assists in the patient's own respiratory efforts, typically by providing a predetermined pressure to the airway of the patient. Ventilators used in non-life support situations typically employ what is known as a single-limb patient circuit having only one limb that is used for transporting gas both to and from the patient. In addition, such single-limb patient circuits normally include an exhaust port, often in the form of a hole in the limb, to allow the patient's expired gas to be passively vented to atmosphere (referred to as “passive exhaust”).
During operation, current ventilators (both those used in life support situations and those used in non-life support situations) record various types of data, such as certain waveform data relating to the ventilation therapy being provided to the patient and/or certain other detailed operational and event data, so that such data can be viewed, examined and evaluated at a later time by a caregiver. The data storage and data management capabilities of current ventilators, however, are somewhat limited.
Accordingly, it is an object of the present invention to provide a ventilator that overcomes the shortcomings of conventional ventilator. This object is achieved according to one embodiment of the present invention by providing a ventilator that includes (a) a housing having an interior and an exterior; (b) an inlet port extending from the exterior to the interior of the housing; (c) a flow generator, such as, without limitation, a blower, disposed within the housing and that is structured to generate a flow of gas; (d) an outlet port adapted to discharge the flow of gas from the housing; (e) a patient circuit, such as a single-limb or dual-limb patient circuit, in fluid communication with the outlet port that is structured to deliver the flow of gas to an airway of a patient during an inspiratory phase of the ventilatory cycle; (f) a memory device, such as, without limitation, a removable memory device like an SD card or similar device; and (g) a controller operatively coupled to the memory device. The ventilator also includes (h) an accessory connector provided at or about the exterior of the housing.
The controller is adapted to record ventilation data in the memory device that includes at least one of data relating to the operation of the ventilator and data relating to the breathing of the patient while ventilation therapy is being provided to the patient. In addition, the accessory connector is structured to operatively couple the controller to an accessory device, such as, without limitation, an accessory medical device such as a pulse oximeter to a carbon dioxide monitor. The accessory connector is further structured to provide power from the ventilator to the accessory device for powering the accessory device. Furthermore, the accessory connector and serves as a communication bus for enabling the accessory device to communicate accessory device data to the controller. The accessory device data is data this is generated by the accessory device while ventilation therapy is being provided to the patient. The controller is adapted to record the accessory device data in the memory device in a manner wherein the accessory device data is merged with the ventilation data such that the accessory device data is time-synchronized with the ventilation data.
It can thus be appreciated that the present invention enables one or more accessory devices used during patient treatment, such as a pulse oximeter, to be operatively coupled to the ventilator in a manner wherein the data is collected and received from the one or more accessory devices and that data is integrated into the data stream recorded by the ventilator.
The communication bus provided by the accessory connector may be a serial communication bus, such as, without limitation, a serial communication bus that is structured to provide multidrop communications according to a multidrop communications protocol, such as the RS-485 protocol, so that at least one additional accessory device may be operatively coupled to the controller for enabling the at least one additional accessory device to communicate data to the controller. In such as case, power is provided from the ventilator to the at least one additional accessory device through the accessory connector.
In response to the accessory device data being merged with the ventilation data, an output, including a representation of the ventilation data and a representation of the accessory device data, may be generated, wherein the waveform data is time-synchronized with the accessory device data. The ventilation data may be waveform data useable to generate a waveform relating to the operation of the ventilator or the breathing of the patient. Such waveform data may include data selected from the group consisting of (1) patient pressure data, (2) exhaled tidal volume data, (3) uncompensated flow data, (4) leak data, and (5) patient breath rate data.
In another embodiment, the present invention provides a method of operating a ventilator that includes steps of (a) operatively coupling an accessory device to an accessory connector located at or about an exterior of a ventilator, wherein the accessory connector serves as a communication bus to enable the accessory device to communicate with the ventilator; (b) providing power from the ventilator to the accessory device through the accessory connector; (c) providing ventilation therapy to a patient through the ventilator; (d) recording ventilation data, as described above, in a memory device of the ventilator, (e) receiving accessory device data, as described above, in the ventilator through the accessory connector; and (f) recording the accessory device data in the memory device in a manner wherein the accessory device data is merged with the ventilation data such that the accessory device data is time-synchronized with the ventilation data.
These and other objects, features, and characteristics of the present invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention. As used in the specification and in the claims, the singular form of “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.
Directional phrases used herein, such as, for example and without limitation, top, bottom, left, right, upper, lower, front, back, and derivatives thereof, relate to the orientation of the elements shown in the drawings and are not limiting upon the claims unless expressly recited therein.
As employed herein, the term “patient interface” refers to any known or suitable mechanism for transporting gas to and from the airway of a patient and expressly includes, but is not limited to, non-invasive patient interfaces such as masks, nasal canulas, combination nasal/oral masks and removable mouth pieces, and invasive patient interfaces such as tracheal tubes and endotracheal tubes, as well as humidifiers, nebulizers and meter dose inhalers, which can be invasive or non-invasive.
As employed herein, the term “mode” refers to the operation of the ventilator for providing a particular type of ventilation therapy, expressly including but not limited to, pressure support ventilation therapy, volume control ventilation therapy and suitable combinations thereof. Each mode may have one or more attributes such as, for example and without limitation, CPAP, SIMV, S, S/T, AC, PC, PC-SIMV, or CV.
As employed herein, the statement that two or more parts or components are “coupled” together shall mean that the parts are joined or operate together either directly or through one or more intermediate parts or components.
As employed herein, the term “number” shall mean one or an integer greater than one (i.e., a plurality).
The present invention provides a medical ventilator that includes an external interface in the form of an accessory connector that enables data collected and received from an accessory device or devices operatively coupled to the accessory connector to be integrated into the data stream being generated by the medical ventilator.
As described in greater detail below, ventilator 5 in
In
A machine flow sensor 20 is provided in tandem with machine flow element 15 to measure volumetric flow of the flow of gas created by the flow generator 10. In addition, a monitor flow sensor 25 is also provided in tandem with machine flow element 15 to monitor the machine volumetric flow in a redundant manner. Preferably, one or both of machine flow sensor 20 and monitor flow sensor 25 is a differential pressure sensor. Furthermore, machine flow sensor 25 may be used in tandem with a proximal pressure sensor 85 (
A control machine pressure sensor 30 is operatively coupled to the conduit 22 through an auto zero valve 35. Control machine pressure sensor 30 is preferably a static pressure sensor and is used to monitor the pressure at the outlet port 18 of the ventilator 5. In addition, a monitor machine pressure sensor 50 is operatively coupled to the conduit 22 and is also preferably a static pressure sensor used to monitor the pressure at the outlet port 18 of the ventilator 5 in a redundant fashion. It can be appreciated that the ventilator need not have both pressure sensors.
As seen in
Although not employed in the configuration of ventilator 5 shown in
Referring to
As seen in
Active exhalation controller 105 is preferably a pressure control unit that regulates the pilot pressure of active exhalation valve 135 diaphragm in order to control bias flow during patient exhalation. Active exhalation controller 135 preferably includes a dump valve to quickly reduce the pilot pressure from the diaphragm of the active exhalation valve to allow it to fully open at the beginning of exhalation. Active exhalation controller 105 also preferably includes a proportional valve that is used in combination with an orifice provided between the two valves to control bias flow.
In still a further embodiment, the configuration of the ventilator shown in
Again, as noted above, ventilator 5 shown in
Although not shown, the present invention contemplates that ventilator 5 includes an input/output component (e.g., user interface) or components. The input/output component is used, for example, for setting various parameters used by the ventilator as well as for displaying and outputting information and data to a user. The input/output component may be any device suitable to provide information and/or commands to controller 110 via an operative link and to present information to the patient, or another user, in a human perceivable format. Examples of a suitable input/output device includes a keypad, keyboard, touch pad, mouse, visual display (e.g., LCD or LED screen), microphone, speaker, switches, button, dials, lamps, or any other devices that allow a user to input information to and receive information from the ventilation system. The present invention further contemplates providing a wireless link as an input/output component to enable remote communication with the ventilator wirelessly.
As also seen in
In an exemplary embodiment of the prevent invention, ventilator 5 is adapted to record a minimum amount of waveform data, such as 72 hours worth of data, to removable memory card 190 during operation of the ventilator. In addition, ventilator 5 is also adapted to record certain detailed data relating to the operation of the ventilator to removable memory card 190 while flow generator 10 is operating. For example, such detailed data may include, without limitation, average (over some predetermined interval such as 30 seconds) attained pressures (e.g., IPAP (inspiratory positive airway pressure), EPAP (expiratory positive airway pressure), CPAP (continuous positive airway pressure), PEEP (positive end expiratory pressure) as appropriate for therapy mode), average breath rate, average [percentage of patient triggered breaths, average peak inspiratory patient flow, average total leak, average exhaled tidal volume, and average exhaled minute ventilation, among others.
In a further exemplary embodiment, the ventilator is adapted to record a minimum amount, such as one years worth, of such detailed data to removable memory card 190. Furthermore, the ventilator is adapted to record certain annotation data to removable memory card 190 during operation thereof. Such annotation data may include, for example, and without limitation, flow generator on and off events, current prescription settings, prescription setting changes, patient alarm settings, and patient alarm occurrences, among others. Preferably, the ventilator is adapted to record the annotation data to correspond with the recorded detailed data.
As seen in
Furthermore, ventilator 5 includes an Ethernet port 195 that is in electronic communication with controller 110 to enable the ventilator to make a high speed direct connection to an Ethernet network. As will be appreciated, Ethernet port 195 thus enables the ventilator to communicate with devices, such as remotely located devices, which are connected to the Ethernet network.
As seen in
Finally, ventilator 5 includes an accessory connector 200 which both serves as a serial communication bus to enable one or more accessory devices 205, such as, without limitation, a pulse oximeter or a carbon dioxide monitor, to the ventilator and provides a regulated power output, preferably a 24 volt regulated and current limited output, to power accessory devices 205. In the preferred embodiment, accessory connector 200 provides an RS-232/RS-485 serial interface for the ventilator, which is designed for multi-drop communications so that more than one accessory device 205 can share the same connection.
An interface printed circuit assembly (PCA) 210 is provided and is in electronic communication with controller 110, remote alarm port 175, Ethernet port 195, and accessory connector 200 for operatively coupling those components to the controller. In addition, interface PCA 210 provides the regulated voltage output described above to accessory connector 200, and supports RS-232 communications, RS-485 communications, Ethernet communications, and the interface to remote alarm port 175. Interface PCA 210 may also include an oxygen sensor (not shown) for oxygen leak detection.
According to an aspect of the present invention, data is collected from one or more accessory devices 205 through accessory connector 200 and is recorded on removable memory card 190. In particular, the data from accessory devices 205 is recorded in a manner where it is seamlessly and automatically merged with the data described elsewhere herein (the waveform data, the detailed data and/or the annotation data) that is recorded on the removable memory card in a time synchronous manner. As a result, the waveforms and other outputs for data analysis and reporting that are provided from or derived from the data on removable memory card 190 may be selectively accessed based on not only the data that is generated by the by the ventilator relating to the operation thereof (the waveform data, the detailed data and/or the annotation data), but also on the data that is collected from the one or more accessory devices 205. In operation, the software running on controller 110 will automatically detect when an accessory device 205 is operatively coupled to accessory connector 200 and will record the data therefrom to removable memory card 190 as described above. In addition, when an accessory device 205 is removed from accessory connector 200, the software will automatically remove that channel from the data configuration.
For example, in one particular embodiment, accessory devices 205 include both a pulse oximeter and a carbon dioxide monitor. As described above, the oxygen saturation data from the pulse oximeter (SaO2) and the end tidal carbon dioxide data (ETCO2) from the carbon dioxide monitor will be recorded on removable memory card 190 and will be merged with the data that is generated by the by ventilator 5 relating to the operation thereof (the waveform data, the detailed data and/or the annotation data). As a result, an output that includes waveforms for, for example, patient respiratory rate, patient exhaled minute ventilation, and percentage of patient triggered breaths time synchronized with waveforms for SaO2 and ETCO2 such as is shown in
Moreover, it is to be understood that the schematic diagrams of ventilator 5 shown in
Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.
This patent application claims the priority benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 61/105,883 filed on Oct. 16, 2008, the contents of which are herein incorporated by reference.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/IB2009/054450 | 10/9/2009 | WO | 00 | 4/13/2011 |
Number | Date | Country | |
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61105883 | Oct 2008 | US |