Not applicable.
1. Field of the Invention
Embodiments of the present invention are directed to positive airway pressure devices and methods, for example continuous positive airway pressure (CPAP) devices. More particularly, some embodiments of the invention are directed to positive airway pressure devices and methods where the flow and/or pressure through each nostril or naris may be individually controlled.
2. Background of the Invention
Sleep disordered breathing is common throughout the population, and some sleep disorder breathing may be attributable to disorders of the respiratory tract. For example, sleep apnea is a situation where a person temporarily stops breathing during sleep. A hypopnea is a period of time where a person's breathing becomes abnormally slow or shallow. In some cases, a hypopnea may precede an apnea event.
Although hypopneas and apneas may have multiple causes, one trigger for these type events may be full or partial blockages in the respiratory tract. In particular, in some patients the larynx may collapse due to forces of gravity and/or due to forces associated with lower pressure in the upper airway than outside the body. A collapse of the pharynx, larynx, upper airway or other soft tissue in the respiratory tract may thus cause the full or partial blockage, which may lead to a hypopnea or apnea event.
One method to counter collapse of the larynx is the application of constant positive airway pressure to the nostrils generally, possibly by using a CPAP machine. Application of positive airway pressure may be accomplished in the related art by placing a mask over (and sealing around) the patient's nose, and providing within the mask a pressure communicated to the pharynx, larynx, or upper airway. The pressure within the pharynx, larynx, or upper airway may be greater than the pressure outside the body, thus pneumatically splinting open the airway.
Some CPAP machines have the ability to adjust the pressure applied to the patient. In particular, some patients may have difficulty exhaling against the applied pressure, and thus some machines may implement a bi-level CPAP, with a higher pressure applied during inhalation and a lower pressure applied during exhalation. Lowering the pressure reduces the amount of pressure against which the patient must breathe during exhalation. Other CPAP machines continuously adjust the positive airway pressure applied to the mask during inhalation (even if such devices implement a bi-level system), and may be referred to in the related art as “auto titration” devices. With auto titration CPAP devices, as the patient sleeps the positive airway pressure applied is adjusted, cycling between hypoventilating (over pressuring the patient, thus causing a brain arousal) and reducing pressure to the point that the patient experiences apneas, hypopneas and/or snoring.
CPAP machines of the related art are concerned only with the pressure of the gas supplied to the mask over the patient's nose. However, gases flowing from a region of high pressure to a region of low pressure take the path of least resistance. Thus, breathable gases provided to a patient in the related art may flow only or predominantly through an open nostril or naris. Forcing or allowing gas flow to move through a single naris may cause patient discomfort, both because of the volume of the flow and because of the drying effects experienced by the naris through which the gas moves.
The problems noted above are solved in large part by a method and related system of controlling therapeutic gas provided to a patient in positive airway pressure applications. Some of the illustrative embodiments may be a method comprising supplying therapeutic gas at a first pressure to a first naris of patient during a current respiratory cycle and a subsequent respiratory cycle, selecting a second pressure based on an attribute of airflow through a second naris of the patient, and supplying therapeutic gas at the second pressure to the second naris during the current respiratory cycle.
Other illustrative embodiments are a system comprising a first blower configured to fluidly couple to a first naris of a patient, a second blower configured to fluidly couple to a second naris of a patient, and a processor electrically coupled to the first and second blowers. The processor is configured to command the first blower to a first motor speed over a previous and current respiratory cycle, and wherein the processor is configured to command the second blower a second motor speed during the current respiratory cycle, the second motor speed selected based on an attribute of airflow through the second naris.
Yet still other illustrative embodiments are a method comprising individually measuring an attribute of inhalation airflow through each naris of a patient while the patient is supplied positive airway pressure; and determining if a reduction in airflow is attributable to collapse of the patient's upper airway or a reduced airflow of one of the nares.
Other illustrative embodiments are system comprising a first blower configured to fluidly couple to a first naris of a patient, a second blower configured to fluidly couple to a second naris of the patient, and a processor. The processor is configured to command the system to supply a first pressure to the first naris over a previous and current respiratory cycle, and wherein the processor is configured to command the system to supply a second pressure to the second naris during the current respiratory cycle, the second pressure selected based on an attribute of airflow through the second naris.
Finally, other illustrative embodiments are a nasal mask comprising a nose portion configured to cover and pneumatically seal around a patient's nose (the nose portion defining an internal cavity), a supply hose fluidly coupled to the internal cavity and configured to couple to a positive airway pressure device, a first airflow attribute sensing device mechanically coupled to the nose portion configured to be within inhaled airflow of a first naris of the patient when the nose portion positioned proximate to the patient's nose, and a second airflow attribute sensing device mechanically coupled to the nose portion configured to be within inhaled airflow of a second naris of the patient when the nose portion positioned proximate to the patient's nose.
The disclosed devices and methods comprise a combination of features and advantages which enable it to overcome the deficiencies of the prior art devices. The various characteristics described above, as well as other features, will be readily apparent to those skilled in the art upon reading the following detailed description, and by referring to the accompanying drawings.
For a detailed description of the various embodiments of the invention, reference will now be made to the accompanying drawings in which:
Certain terms are used throughout the following description and claims to refer to particular system components. This document does not intend to distinguish between components that differ in name but not function.
In the following discussion and in the claims, the terms “including” and “comprising” are used in an open-ended fashion, and thus should be interpreted to mean “including, but not limited to . . . ”. Also, the term “couple” or “couples” is intended to mean either an indirect or direct connection. Thus, if a first device couples to a second device, that connection may be through a direct connection, or through an indirect connection via other devices and connections.
Further, use of the terms “pressure,” “applying a pressure,” and the like shall be in reference herein, and in the claims, to gauge pressure rather than absolute pressure.
Consider, for purposes of explanation of the relationship between pressure and airflow, the system illustrated in
Further consider that each tube 18, 22 has coupled thereto a pressure transducer 26, 28 respectively. Each of the pressure transducers 26, 28 may be capable of reading a pressure within the respective tube 18, 22, and blowers 10, 12 may be operated in a pressure control mode based on pressure sensed by the pressure transducers 26, 28. While the controlled pressure within each tube may be different, for purposes of explanation consider that the pressure within each tube 18, 22 are controlled to be the same. Further consider that the common chamber 20 is at a low pressure, such as vented to atmosphere. Because of the pressure differentials between the tubes 18, 22 and the common chamber 20, there may be airflow from the tubes 18, 22 into the chamber 20 (as indicated by the arrows in
Now consider that the blowers 10, 12 are operated in a flow control mode, with each blower attempting to maintain equivalent airflow regardless of required pressure. In order to maintain the desired flow, blower 10 develops a higher pressure to overcome the restriction of orifice 24 than the pressure that required of blower 12 for the same airflow. With these principles in mind, the specification now turns to a discussion of the method and related systems for providing positive airway pressure to a patient.
In accordance with embodiments of the invention, the positive airway pressure device 30 controls pressure and/or flow to each naris of a patient individually. In some embodiments, therapeutic gas flow to the patient may be divided among the nares so as not to force any one naris to carry all the therapeutic gas flow. In order to ensure that each naris is carrying at least part of the therapeutic gas flow, the flow path for each naris may need individual pressure and/or flow control. Control of the pressure, and therefore the therapeutic gas flow, may take many forms. In some embodiments, the pressure may be controlled by selectively controlling blower speed, e.g by controlling the speed of the motor coupled to the blower. In alternative embodiments, the blowers 32, 40 may be operated at a constant speed and the pressure provided to the patient may be controlled by pressure control valves 48, 50 for the blowers 32, 40 respectively. In yet other embodiments, a combination of controlling the blower speed in a pressure control valve may be utilized. Further still, some embodiments may comprise dump valves 49 and 51, which in some embodiments vent to atmosphere during exhalation of the patient, thus reducing the pressure against which the patient exhales making exhalation less difficult.
The control system 60 also comprises a microcontroller 70 coupled to the motor speed control circuits 66, 68 and the valve actuators 67. The microcontroller 70 may be any suitable microcontroller or microprocessor programmed to provide an indication to each of the motor speed control circuits 66, 68 of a desired motor speed, and to provide an indication of valve position to the valve actuators 67. Although microprocessor control is preferred, the positive airway pressure device may be equivalently implemented with an analog control system. Setting motor speed and/or valve position for a flow circuit to a naris may be based, in some embodiments, on pressures read by the microcontroller 70 from the pressure transducers 36 and 44. In other embodiments, setting motor speed and/or valve position for a flow circuit to a naris may be based on gas flows measured by the flow sensors 34 and 42.
In accordance with some embodiments of the invention, the microcontroller 70 is provided with a doctor prescribed titration pressure, possibly by way of a dial-type input (not shown) or some other form of user interface (not shown). Based on the prescribed titration pressure, and over several minutes, the microcontroller ramps the speed control signal passed to each of the motor speed control circuits 66 and 68 and/or the valve position indications to the valve actuators 67 to achieve the prescribed titration pressure. If a naris is severely congested or otherwise blocked, however, therapeutic gas flow may move only through an open naris at the prescribed titration pressure. Moreover, throughout the night, the restriction or resistance to airflow experienced within each naris may change (e.g. as a function of congestion experienced within each naris, as a function of an amount of swelling of the soft tissue within each naris, or as a function of nasal cycle (which may be caused by brain triggered muscle contractions)). Thus, even at the prescribed titration pressure applied to each naris the patient may receive inadequate therapeutic gas.
Regardless of the precise ramping system used, the next step is to observe an attribute of inhalation airflow through each naris of the patient (block 404). The observation may be as short as one inhalation, or may span several breaths. In the embodiments illustrated in
Next, a determination is made as to whether the left naris measured attribute of airflow is greater than the right naris measured attribute of airflow (block 406). In the illustrative case of measuring instantaneous airflow, the determination in illustrative block 406 may be a determination of which naris exhibited the highest peak instantaneous airflow. In alternative embodiments where volume is calculated using a series of instantaneous airflow measurements, the illustrative determination of block 406 may be a comparison of the total volumes carried by each naris during the inhalation.
For the same applied pressure, one naris carrying less airflow means the naris has a higher resistance to airflow than the open or unblocked naris. This may be caused, for example, by congestion and/or physical abnormalities of the patient. Controlling application of positive airway pressure in accordance with embodiments of the invention involves selecting a naris whose measured and/or calculated attribute of airflow is greater to be the primary naris. Thus, if the attribute of airflow of the left naris is greater, then the left naris is selected as the primary naris (block 408). If the attribute of airflow of the right naris is greater, then the right naris is selected as the primary naris (block 410). Broadly speaking, and in accordance with embodiments of the invention, control positive airway pressure with respect to the primary naris remains in a pressure control mode, while the control with respect to secondary naris shifts to a flow control mode, attempting to equalize inhalation airflow carried by each naris.
Returning to
If the inhalation attributes are different by more than the predetermined threshold (indicating one naris is carrying a disproportionate share of the inhalation airflow), a determination is made as to whether the secondary naris attribute of airflow is higher or lower than the primary naris attribute of airflow (block 418). If the secondary naris attribute of inhalation airflow is lower (by at least the predetermined threshold), then the inhalation set point pressure for the secondary naris is increased (block 422) in an attempt to better equalize, in the next respiratory cycle, the airflow as carried between the nares. If the secondary naris attribute of airflow is higher than the primary naris attribute of airflow, the inhalation set point pressure for the secondary naris is decreased (block 420). Having the secondary naris airflow higher than the primary naris is indicative of either an overcorrection of inhalation set point pressure for the secondary naris, or that the blockage of the secondary naris that initially caused the naris to carry less airflow has subsided (congestion has gone away, or the patient has changed physical position of the head, thus, physiologically, opening the naris).
Throughout the course of sleeping overnight, or any situation where application of positive airway pressure is desirable, the ability of each naris to carry airflow may change with time. For example, a patient may experience a full or partial blockage of one naris due to mucous accumulations, and because of head position and gravity the mucous may migrate to and fully or partially block the second naris. Likewise, some patients have physical attributes which affect airflow through each naris differently depending, for example, on head position. Thus, it is possible that a naris initially selected as the primary naris develops a resistance to airflow. As the initially selected primary naris develops resistance to airflow and therefore a drop in airflow, the illustrative control system 60 likewise decreases the inhalation set point pressure for the secondary naris to track the decrease in airflow of the primary naris. However, when the inhalation set point pressure of the secondary naris falls to the prescribed titration pressure, the primary and secondary naris designations are swapped. That is, if the left naris was previously selected as the primary naris but has developed a resistance to airflow, when the inhalation set point pressure for the right naris falls to the prescribed titration pressure, then the right naris is selected as the primary naris (and placed on pressure control) and the left naris is designated at the secondary naris whose airflow is thus controlled to match the new primary naris. Thus, if the secondary naris inhalation set point pressure is decreased (block 420), then a determination is made as to whether the secondary naris inhalation set point pressure is the same or less than the primary naris inhalation set point pressure (block 424) (which is, in some embodiments, the prescribed titration pressure). If so, then the primary and secondary designations of the nares are swapped (block 426), and the next step is to increase the inhalation set point pressure for the new secondary naris (again block 412). If, on the other hand, the secondary naris inhalation set point is greater than the primary naris inhalation set point (again block 424) (preferably the prescribed titration pressure), or there was an increase in secondary naris inhalation pressure (block 422), then the illustrative control system 60 begins the process anew by observing at least a portion of a respiratory cycle (again block 414).
Summarizing before continuing, a control system 60 in accordance with embodiments of the invention selects a primary naris (the selection based on which naris carries the most inhalation airflow when both nares are provided the same pressure), controls the primary naris applied pressure to be the prescribed titration pressure, and controls inhalation airflow of the secondary naris (somewhat without regard to pressure required to achieve the airflow) in an attempt to evenly distribute the airflow carried by each naris during inhalation.
Referring again to
Next, a determination is made as to whether the left naris measured attribute of exhalation airflow is greater than the right naris measured attribute of airflow (block 704). In the illustrative case of measuring instantaneous exhalation airflow, the determination in illustrative block 704 may be a determination of which naris exhibited the lowest peak (largest negative value if no flow is zero and exhalation airflows are negative relative to positive going inhalation airflows) instantaneous airflow. In alternative embodiments where volume is calculated using a series of instantaneous airflow measurements, the illustrative determination of block 704 may be a comparison of the total volumes carried by each naris during the exhalation.
For the same applied pressure during exhalation, one naris carrying less airflow means the naris has a higher resistance to exhalation airflow than the open or unblocked naris. This may be caused, for example, by congestion and/or physical abnormalities of the patient. Controlling application of positive airway pressure to attempt to equalize airflow during exhalation involves selecting a naris whose attribute is greater (e.g., more negative if using peak values of airflow with no flow taking on a zero value, or greater exhalation volume) to be the control naris. In most cases the control naris for exhalation purposes and the primary naris for inhalation purposes will be the same, but this is not necessary always the case. Thus, if the attribute of airflow of the left naris is greater, then the left naris is selected as the control naris (block 706). If the attribute of airflow of the right naris is greater, then the right naris is selected as the control naris (block 708). The naris not selected as the control naris is termed the “burdened naris.” Broadly speaking, and in accordance with some embodiments of the invention, control of positive airway pressure applied during exhalation with respect to the control naris remains in a pressure control mode, while the control with respect to burdened naris shifts to a flow control mode, attempting to equalize exhalation inhalation airflow carried by each naris.
Returning to
If the exhalation attributes are different by more than the predetermined threshold (indicating one naris is carrying a disproportionate share of the exhalation airflow), a determination is made as to whether the burdened naris attribute of airflow is greater or lesser than the control naris attribute of airflow (block 716). If the burdened naris attribute of exhalation airflow is lower by at least the predetermined threshold (that is, e.g., having a peak airflow that is less negative than the control naris, or a total volume that is less than the control naris), then the inhalation set point pressure for the burdened naris is decreased (block 718) in an attempt to better equalize, in the next respiratory cycle, the airflow as carried between the nares. If the burdened naris attribute of airflow is greater than the control naris attribute of airflow (that is, e.g., having a peak airflow that is more negative than the control naris, or a total volume that is greater than the control naris), the inhalation set point pressure for the burdened naris is increased (block 720) (raising the pressure applied during exhalation makes it more difficult to breath out the burdened naris). Having the burdened naris exhalation airflow greater than the control naris is indicative of either an overcorrection of exhalation set point pressure for the burdened naris, or that the blockage of the burdened naris that initially caused the naris to carry less airflow has subsided (congestion has gone away, or the patient has changed physical position of the head, thus, physiologically, opening the naris).
When the exhalation set point pressure of the burdened naris rises to a preselected exhalation set point pressure (discussed more below), the control and burdened naris designations are swapped. That is, if the left naris was previously selected as the control naris but has developed a resistance to exhalation airflow, when the exhalation set point pressure for the right naris rises to the preselected exhalation set point pressure, then the right naris is selected as the control naris (and placed on pressure control) and the left naris is designated at the burdened naris whose airflow is thus controlled to match the new control naris. Thus, if the burdened naris exhalation set point pressure is increased (block 720), then a determination is made as to whether the burdened naris exhalation set point pressure is the same or greater than the control naris exhalation set point pressure (block 722). If so, then the control and burdened designations of the nares are swapped (block 724), and the next step is to decrease the exhalation set point pressure for the new burdened naris (again block 710). If, on the other hand, the burdened naris exhalation set point is less than the control naris exhalation set point (again block 722), or there was a decrease in burdened naris exhalation pressure (block 720), then the illustrative control system 60 begins the process anew by observing at least a portion of a respiratory cycle (again block 712).
The preselected exhalation set point pressure, to which the pressure of the control naris is controlled, may take several values. In some embodiments, the preselected exhalation set point pressure is the same as the prescribed titration pressure. In other embodiments, the preselected exhalation set point pressure is lower than the prescribed titration pressure, and thus a device 30 in accordance with these embodiments may lower the pressure applied to the control naris during exhalation, and yet also attempt to equalize exhalation airflow by lower further still the pressure applied during exhalation to the burdened naris. One or both of the pressures applied to the nares during exhalation could be below atmospheric.
Returning to
Thereafter, the illustrative method makes a determination of whether the inhalation is approaching a small respiratory volume (block 806). This illustrative step may take many forms. In some embodiments, detecting instantaneous inhalation airflow maxima is indicative of an approaching small respiratory volume. Alternative embodiments may use the slope of the instantaneous airflow curve, or reaching a predetermined airflow, as indications of an approaching small respiratory volume. Once the small respiratory volume is approaching, a determination is made as to whether the particular system implements exhalation control (block 808). If no exhalation control is implemented (e.g., the patient may not need exhalation relief), then the illustrative system applies the prescribed titration pressure to the secondary naris (block 810) (region 616 of
If the system implements exhalation control (again block 808), then the pressures applied to each naris are made equal and lowered to the preselected exhalation set point pressure (block 812). The preselected exhalation set point pressure could be the same as the prescribed titration pressure or below, including below atmospheric pressure (ventilator-type applications). When the exhalation is sensed (block 814), the illustrative method then applies the burdened naris exhalation set point pressure to the burdened naris (block 816). Sensing the exhalation could be anything from predictive (predicted based on tapering of inhalation airflow) to reactive (sensed only when actual exhalation airflow is sensed). The waveforms 600 of
As discussed in the Background section, some related art “auto titration” CPAP machines adjust the pressure applied to a mask over the patient's nose in an attempt to lower the applied pressure (thus increasing patient comfort) at times when a lower pressure will suffice. Further, the auto titration CPAP machines raise applied pressure when the patient experiences apneas, hypopneas, snoring and/or upper airway collapse. However, the inventors of the present specification have found that cyclic congestion and clearing of a naris can be falsely interpreted by related art auto titration CPAP machines as an upper airway collapse, which in turn precipitates an increase in the applied pressure by the auto-titration machines. Referring to
If the comparison of the sum of the current inhalation attributes of airflow to the sum of the running average inhalation attributes shows a reduction in the airflow (again block 1010), then a comparison is made as between the current left naris attribute of airflow and the running average left naris attribute of airflow (block 1016). If a reduction in airflow is noted in the left naris (block 1018), then a comparison is made between the current right naris attribute of airflow and the running average right naris attribute of airflow (block 1020). Embodiments of the illustrative method then determine whether there is reduced right naris airflow (block 1022). Thus, if both the right and left naris have reduced airflow, this is indicative of a collapse of at least the patient's upper airway, which triggers an increase in the inhalation set point pressures for both nares (block 1024), and the process begins anew by observation of the inhalation cycle (block 1002).
Still referring to
Thus, by separately monitoring the airflow of each naris, and likewise being able to independently control the pressure applied to each naris, an illustrative control system 60 in accordance with embodiments of the invention is able to selectively increase pressure in both nares to compensate for upper airway collapse, or adjust the inhalation set point pressure for a single naris to compensate for congestion and/or blockage present within that naris. Alternative embodiments of the invention, however, sense individual attributes of airflow through each naris, yet provide only a single controllable pressure to the nares. In particular, in these alternative embodiments of the invention, an attribute of the airflow through each naris is independently measured. By comparing current individual naris attributes of airflow to running average individual naris attributes of airflow, these embodiments determine whether a reduction in airflow is attributable to an upper airway collapse, or congestion and/or blockage in a single naris.
Alternative embodiments of the invention may thus determine whether a reduction in airflow is an upper airway collapse (airflow in both nares drops proportionately) or whether the reduction in airflow is caused by congestion and/or blockage in a single naris. In this latter case, while a reduction in airflow may be noted, increasing the positive airway pressure to both nares would have the detrimental effect of further increasing the airflow through the open naris, and possibly over pressuring and thus hypoventilating the patient.
Dividing the airflow substantially evenly between the nares may be more comfortable for the patient. A device that is capable of adjusting its pressure to ensure airflow may more accurately provide that airflow in spite of the fact that the resistance to flow through a naris may change significantly over the course of a night. Further, dividing the therapeutic gas flow among the nares substantially evenly may reduce discomfort associated with drying of the nasal cavities by the airflow through the nares (in comparison to forcing the airflow through a single naris).
From the description provided herein, those skilled in the art are readily able to combine software created as described with appropriate general purpose or a special purpose computer hardware to create a computer system and/or computer subcomponents embodying aspects of the invention, to create a computer system and/or computer subcomponents for carrying out the method embodiments of the invention, and/or to create a computer-readable medium storing a software program to implement method aspects of the various embodiments. Moreover, the embodiments of the illustrative methods could be implemented together in a single program (with various subroutines), or split up into two or more programs executed on the processor.
The above discussion is meant to be illustrative of the principles and various embodiments of the present invention. Numerous variations and modifications will become apparent to those skilled in the art once the above disclosure is fully appreciated. For example, the various embodiments discuss setting set point pressures based on a current attribution of respiration to make flow corrections in a subsequent respiration; however, pressure set points may be adjusted to make flow corrections within the same inhalation or exhalation. It is intended that the following claims be interpreted to embrace all such variations and modifications.
This application is related to application Ser. No. 10/851,952 filed May 21, 2004 titled, “Method and System of Individually Controlling Airway Pressure of a Patient's Nares,” which application is incorporated by reference herein as if reproduced in full below. Moreover, this application claims the benefit of provisional application Ser. No. 60/650,796, filed Feb. 8, 2005 titled, “Method and related system to control applied pressure in CPAP systems,” which application is also incorporated by reference herein as if reproduced in full below.
Number | Date | Country | |
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60650796 | Feb 2005 | US |