The present invention pertains to airway pressure support devices, and, in particular, to an airway pressure support device that includes a patient interface device having an integrated gas flow generator that is powered by radio frequency (RF) energy.
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.
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.
It is well known to treat sleep disordered breathing by applying a continuous positive air pressure (CPAP) to the patient's airway. This positive pressure effectively “splints” the airway, thereby maintaining an open passage to the lungs. 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 breathing 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). It is further known to provide a positive pressure therapy in which the pressure is automatically adjusted based on the detected conditions of the patient, such as whether the patient is experiencing an apnea and/or hypopnea. This pressure support technique is referred to as an auto-titration type of pressure support, because the pressure support device seeks to provide a pressure to the patient that is only as high as necessary to treat the disordered breathing.
Pressure support therapies as just described involve the placement of a patient interface device including a mask component having a soft, flexible sealing cushion on the face of the patient. The mask component may be, without limitation, a nasal mask that covers the patient's nose, a nasal/oral mask that covers the patient's nose and mouth, or a full face mask that covers the patient's face. The patient interface device is typically secured to the patient's head by a headgear component. Traditionally, the patient interface device is connected to a separately housed pressure/flow generating device, such as a blower unit, by way of a gas delivery tube or conduit. The pressure/flow generating device generates a flow of positive pressure breathing gas that is delivered to the airway of the patient through the patient interface device for purposes of “splinting” the airway as described above.
A frequent complaint of the users of such pressure support therapies is the discomfort that is associated with sleeping in bed with the gas delivery tube or conduit that connects the patient interface device to the housing that includes the pressure/flow generating device. This discomfort discourages the regular use of such devices, and therefore increases the risk of worsening OSA.
Accordingly, it is an object of the present invention to provide a pressure support device that overcomes the shortcomings of conventional pressure support devices. This object is achieved according to one embodiment of the present invention by providing a patient interface device for delivering a flow of breathing gas to an airway of a patient that a cushion an a frame and housing member directly coupled to the cushion. The frame and housing member includes a pressure generating system provided within the frame and housing member and structured to generate the flow of breathing gas, the pressure generating system being in fluid communication with the cushion, an antenna, and radio frequency (RF) energy harvesting circuitry provided within the frame and housing member and coupled to the antenna. The antenna is structured to receive radio frequency (RF) energy and provide the RF energy to the RF energy harvesting circuitry, and the RF energy harvesting circuitry is structured to convert the RF energy into usable energy for powering the pressure generating system.
In another embodiment, the patient interface device is part of an airway pressure support system that also includes an RF base unit spaced from the patient interface device. The RF base unit in this embodiment is structured and configured to generate the radio frequency (RF) energy received by the patient interface device for powering the patient interface device.
In still another embodiment, a method of generating a flow of breathing gas to be delivered to an airway of a patient is provided. The method includes generating radio frequency (RF) energy in an RF base unit and transmitting the RF energy from the RF base unit, receiving the RF energy in a patient interface device spaced from the RF base unit, the patient interface device including a cushion and a frame and housing member directly coupled to the cushion, the frame and housing member including a pressure generating system provided within the frame and housing member and being in fluid communication with the cushion, converting the RF energy into usable energy, such as, without limitation, a DC voltage, and powering the pressure generating system using the usable energy to generate the flow of breathing gas and provide the flow of breathing gas to the cushion.
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 herein, the singular form of “a”, “an”, and “the” include plural references unless the context clearly dictates otherwise. As used herein, the statement that two or more parts or components are “coupled” shall mean that the parts are joined or operate together either directly or indirectly, i.e., through one or more intermediate parts or components, so long as a link occurs. As used herein, “directly coupled” means that two elements are directly in contact with each other. As used herein, the term “number” shall mean one or an integer greater than one (i.e., a plurality).
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 described in greater detail herein in connection with various particular embodiments, the disclosed concept provides a built-in blower patient interface device (e.g., CPAP mask) that is wirelessly powered by RF energy, such as RF energy transmitted by an associated RF transmitter that is spaced from and not directly coupled or connected to the patient interface device. In addition to transmitting power, such an RF transmitter may also communicate with the built-in blower patient interface device over a wireless network for purposes of controlling the delivery of therapy and/or gathering sleep related or other data over a wireless network. This wireless powering and communication scheme can be done with a certain physical distance between the two devices which separates the patient from the transmitter.
In the exemplary embodiment, the patient interface device (e.g., mask) includes a pressure/flow generating device (e.g., a blower unit) that is built in to the patient interface device (e.g., housed within a housing formed by a frame member of the patient interface device). The patient interface device may also have one or more sensors for detecting certain quantifiable metrics, including, without limitation, one or more of flow rate, humidity, pressure, temperature, and blower fan RPM, including parameters of the patient, such as SpO2, breath rate, body temperature, etc. The patient interface device will also include an antenna device for receiving data/power from the RF transmitter over a wireless network. This antenna device may also be used for sending data generated by the above-described the sensors to the RF transmitter. In addition, the patient interface device will further include an integrated RF harvesting device that converts radio frequency (RF) energy received by the antenna (e.g., from the RF transmitter and/or from the ambient environment) into appropriate AC or DC current for powering the built-in pressure/flow generating device. The patient interface device also includes an accompanying headgear for securing it on the patient's face.
The components described above are, in the exemplary embodiment, designed to fit in one compact housing that is part of the patient interface device (e.g., a combination housing/frame member that is connected to a soft, flexible sealing cushion). In one embodiment, such a compact housing can be designed as an addition to a existing cushion (possibly via snap-fit or magnet fittings). In an alternate embodiment, the disclosed patient interface device can be designed wholesale per cushion type (e.g., full-face, full-face under the nose, nasal, nasal pillows).
In addition, the details for implementing the disclosed RF harvesting device and the set-up between the untethered receiver (i.e., the patient interface device) and the transmitter of RF energy (e.g., the RF transmitter) may, in one particular embodiment, be as described in U.S. Pat. Nos. 9,021,277 and 9,107,579, the disclosures of which are incorporated herein by reference.
Furthermore, as described in detail herein, airway pressure support system 2 is provided with functionality that enables patient interface device 6 to be wirelessly powered by RF energy that is generated by RF base unit 4 and/or that may be present in the ambient environment surrounding patient interface device 6. In addition, in the non-limiting exemplary embodiment, airway pressure support system 2 is further provided with functionality that enables RF base unit 4 and patient interface device 6 to wirelessly communicate with one another over a wireless network (e.g., so that data related to control of patient interface device 6 may be communicated from our base unit 4 to patient interface device 6 and/or so that data relating to operation of patient interface device 6 and metrics measured thereby may be communicated from patient interface device 6 to RF base unit 4). More specifically, in the exemplary embodiment, RF base unit 4 and patient interface device 6 are configured to communicate with one another via and within the operational range of a wireless personal area network (PAN) 9 shown schematically in
In the exemplary embodiment, patient interface device 6 includes a patient sealing assembly 10, which in the illustrated embodiment is a nasal mask. However, other types of patient sealing assemblies, such as, without limitation, a nasal/oral mask, a nasal cushion, nasal pillows, or a full face mask, which facilitate the delivery of the flow of breathing gas to the airway of a patient may be substituted for patient sealing assembly 10 while remaining within the scope of the present invention.
Patient sealing assembly 10 includes a cushion 12 coupled to a frame and housing member 14. In the illustrated embodiment, cushion 12 is defined from a unitary piece of soft, flexible, cushiony, elastomeric material, such as, without limitation, silicone, an appropriately soft thermoplastic elastomer, a closed cell foam, or any combination of such materials. Also in the illustrated embodiment, frame and housing member 14 is structured to house various components described in detail below, and is made of a rigid or semi-rigid material, such as, without limitation, an injection molded thermoplastic or silicone. Frame and housing member 14 includes a faceplate portion 16 to which cushion 12 is fluidly attached, and a forehead support member 18 that is coupled to faceplate portion 16 by a connecting member 20. A forehead cushion 22 is coupled to the rear of forehead support member 18. In the exemplary embodiment, forehead cushion 22 is made of a material that is similar to the material of cushion 12. Patient interface device 10 also includes a headgear component 24 for securing patient interface device 10 to the head of patient 8. Headgear component 24 includes a back member 26, upper strap members 28, and lower strap members 30. In the exemplary embodiment, upper strap members 28 and lower strap members 30 each include a hook and loop fastening system, such as VELCRO®, provided on the end thereof to allow headgear component 24 to be secured in a known manner. It will be understood that the described hook and loop fastening arrangement is meant to be exemplary only, and that other selectively adjustable fastening arrangements are also possible within the scope of the present invention.
In the illustrated embodiment, frame and housing member 14 includes a pressure controller in the form of a valve 36 provided in delivery conduit 34. Valve 36 controls the pressure of the flow of breathing gas from gas flow generator 32 that is delivered to patient 8. For present purposes, gas flow generator 32 and valve 36 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 8. However, it should be apparent that other techniques for controlling the pressure of the gas delivered to patient 8, such as varying the blower speed of gas flow generator 32, either alone or in combination with a pressure control valve, are contemplated by the present invention. Thus, valve 36 is optional depending on the technique used to control the pressure of the flow of breathing gas delivered to patient 8. If valve 36 is eliminated, the pressure generating system corresponds to gas flow generator 32 alone, and the pressure of gas in delivery conduit 34 is controlled, for example, by controlling the motor speed of gas flow generator 32.
Frame and housing member 14 further includes a flow sensor 38 that measures the flow of the breathing gas within delivery conduit 34. In the particular embodiment shown in
In the illustrated embodiment, frame and housing member 14 also further includes a pressure sensor 42 that measures the pressure of the breathing gas within delivery conduit 34. In the particular embodiment shown in
Additional sensors, in place of or in addition to flow sensor 38 and pressure sensor 42, may also be provided within frame and housing member 14 and coupled to controller 40. Such additional sensors may include, without limitation, a humidity sensor, a temperature sensor, and/or a blower fan RPM sensor.
Controller 40 includes a processing portion which may be, for example, a microprocessor, a microcontroller, an application specific integrated circuit (ASIC) or some other suitable processing device. Controller 40 also includes a memory portion, such as a random access memory and/or a read only memory, 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 patient interface device 6.
As seen in
In the exemplary embodiment, RF base unit 4 and patient interface device 6 are structured and configured to communicate with one another wirelessly using either the near-field region or the far-field region. The RFID Handbook by the author Klaus Finkenzeller defines the inductive coupling or near-field region as distance between the transmitter and receiver of less than 0.16 times lambda where lambda is the wavelength of the RF wave, and the far-field region as distances greater than 0.16 times lambda, and those definitions shall be used herein.
As also seen in
In operation, a user will strap patient interface device 6 to his/her face me a headgear component 24. The user then turns on RF base unit 4, and RF base unit 4 begins generating and transmitting RF energy from antenna 62 to PAN 9. The transmitted RF energy is received via PAN 9 by antenna 46 of patient interface device 10 and is converted to usable energy as described herein. That usable energy is then used by patient interface device 6 to power the components thereof. In particular, the energy is used to power gas flow generator 32 to enable gas flow generator 32 to generate a flow of breathing gas that is delivered to the airway of patient 8 through cushion 12 as described herein in order to provide pressure support therapy to patient 8. In addition, RF base unit may wirelessly communicate data (e.g., commands) to patient interface device 10 via PAN 9 for controlling operation of patient interface device 10, including pressure levels to be generated by the pressure generating system of patient interface device 10. In particular, such data will be transmitted by antenna 62 of RF base unit 4 and received by antenna 46 of patient interface device 6. The data signal will then be provided to controller 40 through RF communications module 44 so that controller 40 may then use the information in the data signal to control the operation of patient interface device 6, including control of the pressure generating system patient based device. In addition, a data signal generated by controller 40 based on the outputs of flow sensor 38, pressure sensor 42 and/or any other sensor described herein may be provided to RF communications module 44 for transmission via antenna 46 to PAN 9. That signal may then be received by antenna 62 of RF base 4 for use in (e.g., analysis of) or storage by controller 52 of RF base unit 4.
In the illustrated, non-limiting exemplary embodiment, airway pressure support system 2 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 8. This includes receiving the necessary parameters, via input commands, signals, instructions or other information in patient interface device 6 from RF base unit 4 as described above, 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.
In the exemplary embodiment, RF base unit 4 and patient interface device 6 are structured and configured to communicate with one another wirelessly using either the near-field region or the far-field region. The RFID Handbook by the author Klaus Finkenzeller defines the inductive coupling or near-field region as distance between the transmitter and receiver of less than 0.16 times lambda where lambda is the wavelength of the RF wave, and the far-field region as distances greater than 0.16 times lambda, and those definitions shall be used herein.
In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word “comprising” or “including” does not exclude the presence of elements or steps other than those listed in a claim. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The word “a” or “an” preceding an element does not exclude the presence of a plurality of such elements. In any device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination.
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. 62/734,328, filed on Sep. 21, 2018, the contents of which are herein incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62734328 | Sep 2018 | US |