1. Field of the Invention
The present invention relates to gas delivery systems, such as, without limitation, PAP therapy systems for treating sleep apnea, ventilators, oxygen delivery systems, or other respiratory devices, and more particularly to methods of sanitizing the gas flow path within such gas delivery systems.
2. Description of the Related Art
Many individuals suffer from disordered breathing during sleep. Sleep apnea is a common example of such sleep disordered breathing suffered by millions of people throughout the world. One type of sleep apnea is obstructive sleep apnea (OSA), which is a condition in which sleep is repeatedly interrupted by an inability to breathe due to an obstruction of the airway; typically the upper airway or pharyngeal area. Obstruction of the airway is generally believed to be due, at least in part, to a general relaxation of the muscles which stabilize the upper airway segment, thereby allowing the tissues to collapse the airway. Another type of sleep apnea syndrome is a central apnea, which is a cessation of respiration due to the absence of respiratory signals from the brain's respiratory center. An apnea condition, whether OSA, central, or mixed, which is a combination of OSA and central, is defined as the complete or near cessation of breathing, for example a 90% or greater reduction in peak respiratory air-flow.
Those afflicted with sleep apnea experience sleep fragmentation and complete or nearly complete cessation of ventilation intermittently during sleep with potentially severe degrees of oxyhemoglobin desaturation. These symptoms may be translated clinically into extreme daytime sleepiness, cardiac arrhythmias, pulmonary-artery hypertension, congestive heart failure and/or cognitive dysfunction. Other consequences of sleep apnea include right ventricular dysfunction, carbon dioxide retention during wakefulness, as well as during sleep, and continuous reduced arterial oxygen tension. Sleep apnea sufferers may be at risk for excessive mortality from these factors as well as by an elevated risk for accidents while driving and/or operating potentially dangerous equipment.
Even if a patient does not suffer from a complete or nearly complete obstruction of the airway, it is also known that adverse effects, such as arousals from sleep, can occur where there is only a partial obstruction of the airway. Partial obstruction of the airway typically results in shallow breathing referred to as a hypoapnea. A hypopnea is typically defined as a 50% or greater reduction in the peak respiratory air-flow. Other types of sleep disordered breathing include, without limitation, upper airway resistance syndrome (UARS) and vibration of the airway, such as vibration of the pharyngeal wall, commonly referred to as snoring. Thus, in diagnosing a patient with a breathing disorder, such as OSA, central apneas, or UARS, it is important to detect accurately the occurrence of apneas and hypoapneas of the patient.
It is well known to treat sleep disordered breathing by applying a positive air pressure (PAP) to the patient's airway. This positive pressure effectively “splints” the airway, thereby maintaining an open passage to the lungs. In one type of PAP therapy, known as continuous positive air pressure (CPAP), the pressure of gas delivered to the patient is constant throughout the patient's breathing cycle. It is also known to provide a positive pressure therapy in which the pressure of gas delivered to the patient varies with the patient's breathing cycle, or varies with the patient's effort, to increase the comfort to the patient. This pressure support technique is referred to as bi-level pressure support, in which the inspiratory positive airway pressure (IPAP) delivered to the patient is higher than the expiratory positive airway pressure (EPAP).
In known gas delivery systems, an unclean gas flow path can lead to organisms, such as bacteria, viruses, fungi, or mold, being inhaled by the patient. These organisms, which usually grow in warm and moist locations, can cause harm to the patient. This often occurs when the same gas delivery system is used by multiple patients, such as in the PAP therapy system rental market, where the risk for the spread of disease is increased. One known method is to use a bacterial filter at the outlet of the device to prevent the backflow of bacteria from a patient into the PAP device. Another known method which addresses this problem involves using steam autoclaves or other gas sterilization devices to sterilize the gas flow path of a gas delivery system. However, the use of such devices is not cost efficient, and can also damage sensitive components within the gas delivery system. A further known method of sterilizing the gas flow path of a gas delivery system involves using cleaning agents, such as a cold sterilant, vinegar, alcohol, or soap and water, to clean the gas delivery system. However, such agents can likewise damage sensitive components of gas delivery systems and can also leave harmful residue that can be inhaled by the patient.
Furthermore, the problems just described are not limited to gas delivery systems in the form of PAP therapy systems for treating sleep apnea. Rather, such problems exist in connection with any type of gas delivery system used to deliver a flow of breathing gas to a patient, such as, without limitation, ventilators, oxygen delivery systems, or other respiratory devices.
There is thus room for improvement in field gas delivery systems, and in particular to the methods used to sterilize such gas delivery systems.
In one embodiment, a gas delivery system is provided for delivering a flow of breathing gas to a patient. The gas delivery system includes a blower assembly structured to generate the flow of breathing gas. The blower assembly includes a gas flow path including an inlet manifold, an assembly, such as an impeller assembly, for adjusting the pressure and/or flow rate of the breathing gas, and an outlet manifold structured to be coupled to a patient circuit. The gas delivery system additionally includes a light system structured to generate sanitizing light and deliver the sanitizing light to one or more internal surfaces of at least one of the inlet manifold, the impeller assembly and the outlet manifold for sanitizing the one or more internal surfaces.
In another embodiment, a method of sanitizing a gas flow path within a gas delivery system including a blower assembly is provided. The gas flow path includes an inlet manifold, an assembly, such as an impeller assembly, for adjusting the pressure and/or flow rate of the breathing gas, and an outlet manifold structured to be coupled to a patient circuit. The blower assembly is structured to generate a flow of breathing gas and includes the gas flow path. The method includes the steps of: providing a light system as part of the gas delivery system, generating sanitizing light using the light system, and delivering the sanitizing light to one or more internal surfaces of at least one of the inlet manifold, the impeller assembly, and the outlet manifold for sanitizing the one or more internal surfaces.
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 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).
As employed herein, the term “manifold” shall mean a member having one or more tubes or chambers through which a liquid or gas may be distributed.
In an exemplary embodiment, gas flow generator 52 is capable of providing a flow of breathing gas ranging in pressure from 3-30 cm H2O. The pressurized flow of breathing gas, generally indicated by arrow D from gas flow generator 52, is delivered via a delivery conduit 56 to a breathing mask or patient interface 58 of any known construction, which is typically worn by or otherwise attached to patient 54 to communicate the flow of breathing gas to the airway of patient 54. Delivery conduit 56 and patient interface device 58 are typically collectively referred to as a patient circuit.
Pressure support system 50 shown in
The present invention also contemplates that pressure support system 50 can be a two-limb system, having a delivery conduit and an exhaust conduit connected to patient 54. In a two-limb system (also referred to as a dual-limb system), the exhaust conduit carries exhaust gas from patient 54 and includes an exhaust valve at the end distal from patient 54. The exhaust valve in such an embodiment is typically actively controlled to maintain a desired level or pressure in the system, which is commonly known as positive end expiratory pressure (PEEP).
Furthermore, in the illustrated exemplary embodiment shown in
In the illustrated embodiment, pressure support system 50 includes a pressure controller in the form of a valve 60 provided in delivery conduit 56. Valve 60 controls the pressure of the flow of breathing gas from flow generator 52 that is delivered to patient 54. For present purposes, flow generator 52 and valve 60 are collectively referred to as a pressure generating system because they act in concert to control the pressure and/or flow of gas delivered to patient 54. However, it should be apparent that other techniques for controlling the pressure of the gas delivered to patient 54, such as varying the blower speed of flow generator 52, either alone or in combination with a pressure control valve, are contemplated by the present invention. Thus, valve 60 is optional depending on the technique used to control the pressure of the flow of breathing gas delivered to patient 54. If valve 60 is eliminated, the pressure generating system corresponds to flow generator 52 alone, and the pressure of gas in the patient circuit is controlled, for example, by controlling the motor speed of flow generator 52.
Pressure support system 50 further includes a flow sensor 62 that measures the flow of the breathing gas within delivery conduit 56. In the particular embodiment shown in
Techniques for calculating Qpatient based on Qmeasured well known, and take patient measured are into consideration the pressure drop of the patient circuit, known leaks from the system, i.e., the intentional exhausting of gas from the circuit as indicated by arrow E in
Of course, other techniques for measuring the respiratory flow of patient 54 are contemplated by the present invention, such as, without limitation, measuring the flow directly at patient 54 or at other locations along delivery conduit 56, measuring patient flow based on the operation of flow generator 52, and measuring patient flow using a flow sensor upstream of valve 60.
Controller 64 includes a processing portion which may be, for example, a microprocessor, a microcontroller or some other suitable processing device, and a memory portion that may be internal to the processing portion or operatively coupled to the processing portion and that provides a storage medium for data and software executable by the processing portion for controlling the operation of pressure support system 50, including controlling the emission of ultraviolet light as described in greater detail herein.
In the illustrated embodiment, pressure support system 50 also includes humidifier 68 provided in the main housing of pressure support system 50. Alternatively, humidifier 68 may be separate from and located external to the main housing. Humidifier 68 is controlled by controller 64. Humidifier 68 further improves comfort by providing moisture in the supplied gas. In the exemplary embodiment, humidifier 68 is a passover type humidifier. U.S. Patent Application Publication No. 2007/0169776, incorporated herein by reference in its entirety, discloses an exemplary humidifier device suitable for use in the present invention. Humidifier devices having alternative designs, such as a non-passover type humidifier that employs nebulization, atomization, vaporization or a combination thereof, may also be used.
In the illustrated, non-limiting embodiment of the present invention, pressure support system 50 essentially functions as a CPAP pressure support system, and, therefore, includes all of the capabilities necessary in such systems in order to provide appropriate CPAP pressure levels to patient 54. This includes receiving the necessary parameters, via input commands, signals, instructions or other information, for providing appropriate CPAP pressure, such as maximum and minimum CPAP pressure settings. It should be understood that this is meant to be exemplary only, and that other pressure support methodologies, including, but not limited to, BiPAP AutoSV, AVAPS, Auto CPAP, and BiPAP Auto, are within the scope of the present invention.
Referring to
Referring to
In operation, breathing gas, such as, without limitation, air or oxygen, enters lower housing 110 through inlet opening 111. The gas is then directed by directing wall 112 to the area defined by the bottom of body portion 113 and containment wall 114. From there, the gas flows through port 115 to the area defined by chamber 123 of upper housing 120. The gas then flows down over the exterior of impeller assembly 130 to the top of body portion 113 where it is directed into inlet port 133 of impeller assembly 130. Inside impeller assembly 130, the pressure and/or flow rate of the gas is increased by operation of impeller 134. The gas is then expelled from impeller assembly 130 through the outlet conduit formed by outlet member 135, partial conduit portion 137 and partial conduit portion 138. The expelled gas is received in the conduit member formed by partial conduits 116,121, coupling portions 117,122 and outlet conduit 140, and thereafter delivered to the patient through the patient circuit as described herein.
Thus, as just described, blower assembly 100 has three main portions: (i) an “inlet manifold” for delivering breathing gas to impeller assembly 130 that includes inlet opening 111, directing wall 112, body portion 113, containment wall 114, port 115 and chamber 123, (ii) impeller assembly 130 for adjusting the pressure and/or flow rate of the breathing gas, and (iii) an “outlet manifold” for delivering the breathing gas to the patient circuit that includes partial conduits 116,121, coupling portions 117,122 and outlet conduit 140.
Furthermore, as seen in
As will be appreciated, blower assembly 100 and ultraviolet light system 70 may be implemented in a number of different ways in order to provide a safer and healthier air path for a user of pressure support system 50. A number of non-limiting, alternative exemplary implementations of blower assembly 100 and ultraviolet light system 70 are described below in connection with
Additionally, it is within the scope of the disclosed concept to have any number, configuration and/or combination of UVc light sources, including but not limited to LEDs, light pipes, reflective surfaces, and/or transparent surfaces to allow for optimal sanitation within blower assembly 100. It is also within the scope of the disclosed concept to employ alternative UVc light sources not mentioned herein, such as, for example and without limitation, UVc light bulbs.
Thus, in accordance with the disclosed concept, the gas flow path (e.g., without limitation, “inlet manifold”, impeller assembly 130, and “outlet manifold”) within blower assembly 100 can be quickly and safely sanitized by an ultraviolet light system that emits sanitizing UVc light (e.g., without limitation, ultraviolet light systems 70-10,70-11,70-12,70-13,70-14,70-15).
Furthermore, ultraviolet light systems 70-10, 70-11, 70-12, 70-13, 70-14, and 70-15 as described herein may be energized and thereby caused to emit sanitizing light according to any of a number of suitable schemes or mechanisms. For example, and without limitation, ultraviolet light systems 70-10, 70-11, 70-12, 70-13, 70-14, and 70-15 may be structured to be energized manually (e.g., by a button) or automatically based on any of a number of conditions, such as expiration of a set timer, after a certain number of hours of use the pressure support system 50 is used, or whenever the pressure support system 50 is in use or is not in use.
The invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical exemplary embodiments. However, 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 and without limitation, the present invention is not limited to PAP therapy systems such as pressure support system 50, but rather ultraviolet light system 70 in the various embodiments described herein may be used with any type of gas delivery system used to deliver a flow of breathing gas to a patient, such as, without limitation, ventilators, oxygen delivery systems, or other respiratory devices.
This application is the U.S. National Phase application under 35 U.S.C. § 371 of International Application Serial No. PCT/IB2014/066994, filed on Dec. 17, 2014, which claims the benefit of U.S. Application Ser. No. 61/917,394, filed on Dec. 18, 2013. These applications are hereby incorporated by reference herein.
Filing Document | Filing Date | Country | Kind |
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PCT/IB2014/066994 | 12/17/2014 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
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WO2015/092695 | 6/25/2015 | WO | A |
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