Patent Application
20060096596
Obstructive sleep apnea (OSA) is a breathing disorder suffered by an estimated 12 million people in the United States. This disorder is caused by a blockage of the airway, usually when the soft tissue in the rear of the throat collapses and closes during sleep. This causes interruptions in breathing and results in serious sleep deprivation, which in turn adversely affects the daily activities of individuals suffering from this disorder. The most common and effective treatment for sleep apnea is continuous positive airway pressure (CPAP) therapy. In this procedure, a patient wears a mask over the nose during sleep, and pressure from an air blower forces air through the nasal passages at prescribed pressures up to 25 cm water to prevent the patient's airway from collapsing. Some patients may use nasal prongs instead of a nasal mask, while other patients may require a full face mask covering both the nose and mouth.
Variations of CPAP therapy are available to improve patient treatment and comfort. In one variation, a higher pressure is applied during inhalation and a lower pressure is applied during exhalation. Alternatively, the pressure may be varied continuously in response to the patient's breathing pattern. In any of these options, the air pressure may be ramped up slowly over a period of time while the patient is falling asleep.
Numerous devices are commercially available to provide positive airway pressure therapy for sleep apnea patients. These airway pressure therapy devices use a base unit housing an air blower and air delivery control system, and may include air filtration, air heating, and/or humidification systems. Compliance and performance data logging options are also available. The base unit is placed at the patient's bedside and a flexible air hose connects the base unit with the patient's mask to deliver pressurized air at the proper pressure and flow rate. The flexible hose can be awkward and may limit a patient's ability to move about during sleep. Discomfort in the use of airway pressure devices can lead to dissatisfaction by patients and may cause reduced compliance in the use of the devices.
New positive airway pressure therapy devices are needed to provide improved sleeping comfort for sleep apnea patients and to increase compliance in the use of the devices by these patients. This need is addressed by embodiments of the invention described below and defined by the claims that follow.
One embodiment of the invention relates to an apparatus for providing positive airway pressure therapy comprising a mask adapted for the delivery of pressurized air to maintain positive airway pressure in a patient's airway and an air pump system including a plurality of pump elements adapted to supply pressurized air to the mask, wherein the air pump system is attached directly to the mask or is adapted to be worn on a part of the patient's body spaced apart from the mask.
The plurality of pump elements may be selected from the group consisting of piezoelectric pumps, thermopneumatic pumps, ultrasonically-driven pumps, electrostatic pumps, electro-osmosis pumps, electrohydrodynamic pumps, electromagnetic pumps, rotary pumps, shape memory alloy pumps, bimetallic pumps, diaphragm pumps, rotary vane pumps, scroll pumps, solenoid pumps, stepper-motor actuated pumps, piston pumps, and linear pumps. When the pump elements are diaphragm pumps, they may be adapted for parallel operation, series operation, or both parallel and series operation. The diaphragm pumps may be electrostatically activated or piezoelectrically activated.
The apparatus may further comprise a rechargeable power supply unit wearable by the patient and adapted to supply power to drive the air pump system, wherein the rechargeable power supply unit may comprise one or more batteries; alternatively, the rechargeable power supply unit may comprise one or more fuel cells.
The apparatus may further comprise a rechargeable power supply unit wearable by the patient and adapted to supply power to drive the air pump system and a base unit adapted to couple with the apparatus for providing positive airway pressure when the apparatus is not in use by the patient, wherein the base unit may include a recharging system adapted to recharge the power supply unit. The apparatus also may include a data monitoring and storage system to monitor and store operating data when the apparatus is in use by the patient. The base unit may include a data logging system adapted to download and store the data from the apparatus for providing positive airway pressure while the base unit is coupled with the apparatus for providing positive airway pressure.
The apparatus may further comprise a data monitoring and wireless transmission system adapted to monitor and transmit operating data while the apparatus is in use by the patient and the base unit may include a receiver adapted to receive and store the data transmitted by the wireless transmission system.
The apparatus may further comprise any of (1) a humidification system adapted to humidify inlet air to the air pump system or the pressurized air supplied to the mask; (2) a heating system adapted to heat inlet air to the air pump system or the pressurized air supplied to the mask; and (3) a filtration system adapted to filter inlet air to the air pump system or the pressurized air supplied to the mask.
The air pump system may be attached to and mounted on the mask to form an integrated mask and air pump system. The apparatus may further comprise a rechargeable power supply unit wearable by the patient and adapted to supply power to drive the air pump system and an electric supply wire to provide power from the power supply unit to the air pump system. The integrated mask and air pump system may comprise one or more straps adapted to secure the mask to the patient's face, and the rechargeable power supply may be mounted on at least one of the one or more straps. Alternatively, the rechargeable power supply unit may be mounted on an arm pack adapted to be worn on the patient's arm, a cap or headpiece adapted to be worn on the patient's head, a vest adapted to be worn on the patient's torso, or a waist pack adapted to be worn around the patient's waist. Alternatively, instead of a rechargeable power supply unit, the apparatus may include an electrical supply line attached at one end to the air pump system for supplying electric power thereto and an electrical plug at the other end for insertion into an external power outlet.
The apparatus for providing positive airway pressure therapy may further comprise a cap or headpiece adapted to be worn on the patient's head, wherein the air pump system is mounted on the cap or headpiece; a rechargeable power supply unit wearable by the patient and adapted to supply power to drive the air pump system, wherein the rechargeable power supply unit is mounted on the cap or headpiece; and a hose adapted to carry air from the air pump system to the mask. Alternatively, instead of a rechargeable power supply unit, the apparatus may include an electrical supply line attached at one end to the air pump system for supplying electric power thereto and an electrical plug at the other end for insertion into an external power outlet.
In another embodiment, the apparatus for providing positive airway pressure therapy may further comprise (c) a vest adapted to be worn about the patient's torso, wherein the air pump system is mounted on the vest; (d) a rechargeable power supply unit wearable by the patient and adapted to supply power to drive the air pump system, wherein the rechargeable power supply unit is mounted on the vest; and (e) a hose adapted to carry air from the air pump system to the mask. Alternatively, instead of a rechargeable power supply unit, the apparatus may include an electrical supply line attached at one end to the air pump system for supplying electric power thereto and an electrical plug at the other end for insertion into an external power outlet.
In an alternative embodiment, the apparatus for providing positive airway pressure therapy may further comprise (c) a waist pack adapted to be worn about the patient's waist, wherein the air pump system is mounted on the waist pack; (d) a rechargeable power supply unit wearable by the patient and adapted to supply power to drive the air pump system, wherein the rechargeable power supply unit is mounted on the waist pack; and (e) a hose adapted to carry air from the air pump system to the mask. Alternatively, instead of a rechargeable power supply unit, the apparatus may include an electrical supply line attached at one end to the air pump system for supplying electric power thereto and an electrical plug at the other end for insertion into an external power outlet.
In another alternative embodiment, the apparatus for providing positive airway pressure therapy may further comprise (c) an arm pack adapted to be worn about the patient's arm, wherein the air pump system is mounted on the arm pack; (d) a rechargeable power supply unit wearable by the patient and adapted to supply power to drive the air pump system, wherein the rechargeable power supply unit is mounted on the arm pack; and (e) a hose adapted to carry air from the air pump system to the mask. Alternatively, instead of a rechargeable power supply unit, the apparatus may include an electrical supply line attached at one end to the air pump system for supplying electric power thereto and an electrical plug at the other end for insertion into an external power outlet.
In a related embodiment, the apparatus for providing positive airway pressure therapy may further comprise (c) a data monitoring system adapted to monitor operating data when the apparatus is in use by the patient; (d) an electrical supply line attached at one end to the air pump system for supplying electric power thereto and an electrical plug at the other end for insertion into an external power outlet; and (e) a data transmission wire adapted to transmit operating data from the data monitoring system to a base unit or other data receiving means, wherein the data transmission wire is generally parallel with the electrical line and optionally is enclosed together with the electrical line in a common sheath.
In another related embodiment, the apparatus for providing positive airway pressure therapy may further comprise connector means adapted for coupling the mask and the air pump system and for decoupling the mask from the air pump system such that the air pump system provides air to the mask when coupled with the mask.
In the above embodiments, the air pump system may comprise 4 to 100 individual elements, may comprise 100 to 1,000 individual elements, or may comprise greater than 1,000 individual elements.
A different embodiment of the invention relates to an apparatus for providing positive airway pressure comprising (a) a mask adapted for the delivery of pressurized air to maintain positive air pressure in a patient's airway; (b) an air pump system comprising a plurality of pump elements and adapted to supply pressurized air to the mask; and(c) a power supply unit adapted to drive the pump elements. The mask, air pump system, and power supply unit are combined in an integrated unit adapted to be worn on the patient's head.
In this embodiment, the apparatus may further comprise a base unit adapted to couple with the integrated unit when the integrated unit is not in use by the patient, wherein the base unit includes a recharging system adapted to recharge the power supply unit. The integrated unit may include a data monitoring and storage system to monitor and store operating data during use of the integrated unit by the patient. The base unit may include a data logging system adapted to download and store the data from the integrated unit while the base unit is coupled with the integrated unit. The integrated unit may include a data monitoring and wireless transmission system adapted to monitor and transmit operating data during use of the integrated unit by the patient and wherein the base unit includes a receiver adapted to receive and store the data transmitted by the wireless transmission system of the integrated unit.
In this embodiment, the apparatus may further comprise any of (1) a humidification system adapted to humidify inlet air to the air pump system or the pressurized air supplied to the mask; (2) a heating system adapted to heat inlet air to the air pump system or the pressurized air supplied to the mask; and (3) a filtration system adapted to filter inlet air to the air pump system or the pressurized air supplied to the mask.
Another embodiment of the invention includes an apparatus for providing positive airway pressure comprising (a) a mask for the delivery of pressurized air to maintain positive air pressure in a patient's airway; (b) an air pump system comprising a plurality of pump elements and adapted to supply pressurized air to the mask; and (c) a power supply unit connected to the air pump system by an electrical power supply line. The air pump system may be mounted on one of the mask, an arm pack adapted to be worn on the patient's arm, a cap or headpiece adapted to be worn on the patient's head, a vest adapted to be worn on the patient's torso, and a waist pack adapted to be worn around the patient's waist; the power supply unit may be mounted on one of the arm pack, the cap or headpiece, the vest, and the waist pack.
An optional embodiment of the invention relates to an apparatus for the supply of pressurized air to a mask comprising (a) an air pump system including a plurality of pump elements adapted to supply pressurized air to the mask; and (b) means for coupling the air pump system to the mask and for decoupling the integrated air pump system from the mask. In this embodiment, the air pump system may comprise 4 to 100 individual pump elements, or 100 to 1,000 individual pump elements, or greater than 1,000 individual pump elements. The apparatus may further comprise a power supply system adapted to provide power to drive the pump elements.
Another optional embodiment relates to a docking station for a positive airway pressure therapy device consisting essentially of (a) means for coupling and uncoupling the docking station and the device; (b) means for setting operating parameters for the device and means for transferring the operating parameters to the device; (c) means for downloading operating data from the device to the docking station; and (d) means for connecting the docking station to a source of electric power. The means for coupling and uncoupling the docking station and the device may include means for connecting and disconnecting an electrical power connector between the docking station and the device. The docking station may further comprise recharging means adapted to recharge a rechargeable power supply in the device when the device is coupled with the docking station.
A final embodiment of the invention relates to a method for providing positive airway pressure comprising
The pressure of the pressurized air in the mask during inhalation and exhalation may be controlled at a pressure between 4 and 25 cm water. Alternatively, the pressure of the pressurized air in the mask may be controlled at a first pressure during inhalation and a second pressure during exhalation, wherein the second pressure is less than the first pressure. The first and second pressures may be between 4 and 25 cm water.
The method may further comprise providing power to operate the air pump system by an electrical supply line from an external source. Alternatively, the method may further comprise providing power to operate the air pump system by an electrical supply line from a rechargeable power source worn on the patient's body.
Embodiments of the invention are illustrated by the following drawings, which are not necessarily to scale.
The embodiments of the present invention provide improved comfort and ease of use of positive airway pressure devices by utilizing a compact, lightweight air pump system that utilizes a plurality of small individual air pump elements. This compact air pump system may be combined with a rechargeable power supply and the combined air pump-power supply system may be worn by the user to eliminate or reduce the length of the air hose, thereby providing a more comfortable user experience. In one embodiment, the compact air pump system may be directly combined with the mask and a lightweight rechargeable power supply to form an integrated unit that can be worn directly on the user's face and head. In this embodiment, the patient is not tethered to a base unit and there is no air hose. Alternatively, the air pump system and mask may be integrated so that the mask can be worn by the patient in the same manner as a conventional mask is worn, and power may be supplied by a thin electrical wire to the air pump system from a base unit or an electrical wall socket. In this embodiment, the thin electrical wire replaces the conventional air hose for increased patient comfort. In the first of these two alternatives, the compact air pump system and rechargeable power supply may be combined into a unit that can be attached to and detached from any conventional mask. In the second of these alternatives, the compact air pump system may be attached to and detached from any conventional mask.
In another embodiment, the air pump system may be combined with a rechargeable power supply to form an integrated air pump system that can be worn on the patient's body at a location spaced apart from the mask. The integrated air pump system may be installed, for example, in a vest designed to be worn about the patient's torso or in a belt assembly designed to be worn around the patient's waist. Alternatively, the integrated air pump system may be installed in a cap or headpiece designed to be worn on the patient's head. In another embodiment, the integrated air pump system may be designed to strap on the patient's upper arm. In each of these embodiments, a short hose from the integrated air pump system to the mask is used to provide pressurized air to the patient's nose and/or mouth, and a long air hose connecting the patient to a base unit is not required. When using the integrated air pump system of this embodiment, the patient may move about more freely during sleep and may walk to the bathroom without disconnecting the system from a base unit.
In an alternative embodiment, the air pump system may be designed to be worn by the patient at a location on the patient's body spaced apart from the mask. The air pump system may be installed, for example, in a vest designed to be worn about the patient's torso or in a belt assembly designed to be worn around the patient's waist. Alternatively, the air pump system may be installed in a cap or headpiece designed to be worn on the patient's head. In another embodiment, the air pump system may be designed to strap on the patient's arm. In each of these embodiments, a short hose from the air pump system to the mask is used to provide pressurized air to the patient's nose and/or mouth. Power may be supplied a thin electrical wire to the air pump system from a base unit or an electrical socket, and the patient is not tethered to a base unit by long air hose.
In the present disclosure, the term “airway” has the usual anatomical meaning of any passage which conducts air from the atmosphere to the patient's lungs. The term “positive airway pressure” means that the pressure at any location in the patient's airway at a point in the breathing cycle when the patient is using an embodiment of the present invention is greater than the pressure in the patient's airway at that location and that point in the breathing cycle when the patient is not using the embodiment of the present invention. The term “pressurized air” means air at a pressure above the atmospheric pressure surrounding the patient.
In the present disclosure, the term “mask” means a full face mask, a nasal mask, nasal prongs, a mouth mask, an oral mouthpiece, or any other noninvasive interface device designed and used to provide pressurized gas to the patient's airway. The peripheral edges of the mask form a seal or seals against the appropriate parts of the patient's face, mouth, and/or nose to maintain a superatmospheric pressure within the mask. Some air leakage may occur through the seal or seals in normal operation. As used herein, the face includes the nose and mouth, and the head includes any part of the patient above the neck. The terms “wearable”, “worn on the patient's body”, and “worn by the patient” mean that the devices described herein are attached directly to the patient, for example, as a mask attached with straps, an arm pack secured about the patient's arm, or a waist pack secured around the patient's waist. The terms also mean that the devices may be mounted on, i.e., attached to or inserted into, an article worn by the patient. Such an article may be, for example, a cap or headpiece worn on the patient's head or a vest worn on the patient's torso.
The terms “power supply”, “power supply unit”, and “power supply system” used herein are equivalent and may utilize batteries or fuel cells to generate electrical power to drive the air pump system. The air pump system may be driven by either AC or DC, and the electrical power may be supplied to the air pump system as either AC or DC.
A first embodiment of the invention is illustrated schematically by the exemplary system of
Air pump system 5, as well as the air pump systems in other embodiments of the invention, comprise a plurality of pump elements as described in more detail below. The air pump system also may include the necessary structure to the hold pump elements together in a stable assembly, air inlets and outlets for each pump element, power supply wiring to each pump element, a housing surrounding the pump elements, an optional on/off switch, and one or more manifolds or plenums to connect the outlets of the pump elements to a common pressurized air outlet.
Integrated positive airway pressure unit 1 may include an exhalation vent or port (not shown) of any type known in the art for the purpose of venting exhaled gas from the patient while maintaining an elevated pressure in the mask at an appropriate pressure for proper therapy. Alternatively, the design of air pump system 5 may include a period during the pump operating cycle for a patient's exhalation at the appropriate pressure.
The schematic drawing in
In the embodiment of
In a related alternative embodiment illustrated in
In the embodiments of
Design variations of the exemplary pressure therapy systems characterized by
Embodiments described in
A variation of the system of
In alternative embodiments of the invention, the air pump system may be combined with a rechargeable power supply to form an integrated air pump system that can be worn on the patient's body at a location spaced apart from the mask. In these embodiments, the air pump system may designed and adapted to be worn, for example, in a vest about the patient's torso, in a belt assembly around the patient's waist, in a cap or headpiece on the patient's head, or in a module strapped on the patient's arm. In any of these embodiments, pressurized air is transferred from the integrated air pump system to the mask by a short, detachable, flexible hose of the proper diameter, for example, up to 2.5 cm in diameter. Any commercially-available mask may be used in these embodiments, which allows the patient to choose from a large number of available masks and to change mask type if necessary.
One of these alternative embodiments is illustrated in
The vest in this embodiment may be a garment-type vest as illustrated in
Another alternative embodiment is illustrated in
A related embodiment is illustrated in
Alternatives to the embodiments illustrated above are possible wherein power to drive the air pump system is provided by a thin electrical line to the pump and a wearable power supply system is not used. For example,
If desired in the embodiment of
In related embodiments, the system of
While the embodiments described above utilize specific locations of the air pump system and power supply system mounted on the cap, vest, arm pack, or waist pack worn by the patient, any other combination for the locations of the air supply system and power supply system is possible. In one example, the air pump system may be mounted on the arm pack and the power supply system may be mounted on the vest. In another example, the air pump system may be mounted on the mask and the power supply system may be mounted on the vest. In the most general description of all possible combinations, the air pump system may be mounted on the mask, the arm pack adapted to be worn on the patient's arm, the cap or headpiece adapted to be worn on the patient's head, the vest adapted to be worn on the patient's torso, or the waist pack adapted to be worn around the patient's waist; the power supply unit may be mounted on the arm pack, the cap or headpiece, the vest, or the waist pack.
Optionally, any of the embodiments described above that provide power to the air pump system via an electrical line from an external source may include a data transmission wire adapted to transmit operating data from the pump system to a base unit or other data receiving means, wherein the data transmission wire may be generally parallel with, i.e., following approximately same path as, the electrical line and may be enclosed together with the electrical line in a common sheath.
Pressurized air may be supplied to the mask in the embodiments described above by the air pump system in a typical pressure range of 4 to 25 cm water. Appropriate pressure control means known in the art may be used to provide constant pressure, dual pressure, or variable pressure therapy as required. The flow rate of pressurized air delivered to the mask will depend on the air leakage rate around the edges of the mask. Typically, the air pump system may be designed to supply 10 to 120 liter/min (specified at 23° C. and atmospheric pressure) to the mask.
The embodiments of the invention described above are characterized by a common feature wherein the air pump system is adapted to be worn by the patient at various body locations. This feature eliminates the need for a long air hose from the mask to a base unit at the patient's bedside. In some embodiments, a power supply system also may be worn by the patient to supply power to the air pump system.
A compact, wearable air pump system for these embodiments may be designed using a plurality of small pump elements in an array that can be interconnected in series and/or parallel flow operation to provide the required air pressure and flow rates. The plurality of pump elements may be combined in relatively thin arrays or configurations that can be shaped to fit the various locations on the patient's body as described above. The individual pump elements may be any type of small or miniaturized pump selected from, but not limited to, piezoelectric pumps, thermopneumatic pumps, ultrasonically-driven pumps, electrostatic pumps, electro-osmosis pumps, electrohydrodynamic pumps, electromagnetic pumps, rotary pumps, shape memory alloy pumps, bimetallic pumps, diaphragm pumps, rotary vane pumps, scroll pumps, solenoid pumps, stepper-motor actuated pumps, piston pumps, and linear pumps.
Arrays of air pump elements suitable for use with embodiments of the present invention include a plurality of individual pump elements, i.e., include two or more elements. An array may comprise at least 4 individual pump elements and may include up to 20, up to 100, up to 1,000, or even more than 1,000 individual pump elements. For example, the plurality of pump elements may comprise 4 to 100 individual elements, 100 to 1,000 Individual elements, or greater than 1,000 individual elements. The individual pump elements should be capable of starting or stopping the flow of pressurized gas very quickly, for example, in 2 seconds or less, 0.5 second or less, or even 0.1 second or less.
The individual pump elements in a given array may be arranged in a parallel configuration wherein each pump element has the same or nearly the same inlet and discharge pressure, and the elements may have common inlet and/or outlet plenums or manifolds in certain design configurations. The number of parallel elements may be selected to produce any desired pressurized gas flow rate. Alternatively, individual pump elements may be arranged in a series configuration wherein the discharge of a given element feeds the inlet of the next element and the number of series elements may be selected to produce any desired gas pressure. Advantageously, the pump elements may be arranged in a matrix array comprising both parallel and series elements such that any combination of product flow rate and product pressure can be attained. The number of operating elements in the array may be varied with time to meet changing product flow and pressure requirements. Higher flow rates may require a greater number of operating parallel elements and higher pressures may require a greater number of operating series elements; conversely, lower flow rates may require a smaller number of operating parallel elements and lower pressures may require a smaller number of operating series elements. The numbers of both series and parallel elements in operation may be varied simultaneously when both flow and pressure requirements change with time to provide efficient turn-down and minimize power consumption.
In embodiments of the invention described above with reference to
A non-limiting example of a multiple diaphragm-type pump element that may be used with embodiments of the present invention is illustrated in
The voltage potentials for driving the membranes are provided by voltage control unit 821 via electrical leads 823 to lower membrane 805, 825 to upper membrane 803, 827 to lower body section 802, and 829 to upper body section 801. By appropriate control of these voltage potentials by means of voltage control unit 821, the membranes can be moved independently. Exemplary dimensions of pump element 800 may include a width of 0.5 to 3 cm and a height of 0.05 to 0.2 cm; the pump element may provide 10 to 50 std cc/min of compressed gas at pressures up to about 25 cm water. Higher pressures may be generated as required.
Pump element 800 may be operated in an exemplary gas compression cycle wherein air or any other gas is drawn through inlet 817 into the lens-shaped cavity and discharged as compressed gas through outlet 819. One exemplary cycle comprises intake and compression steps defined by the phases of membrane positions and movement as follows.
Phases (1) through (4) are repeated in a cyclic manner at a high frequency, for example, between about 30 and 100 cycles per second. While this exemplary compression cycle utilizes vertical movement of the membranes and is described in terms of upper and lower elements relative to the horizontal, the pump element and membranes may have any orientation relative to the horizontal and may be operated in any orientation relative to the horizontal.
A plurality of the individual pump elements of
A section of an exemplary parallel combination of multiple pump elements of
A plurality of parallel pump elements having the orientation illustrated in
In the embodiments of
Small fuel cell systems powered by hydrogen or methanol may be used to produce power to operate the air pump system. The fuel cell system would include a refillable fuel vessel and would typically hold enough fuel to operate the air pump system for at least 5 hours and optionally greater than 8 hours.
The embodiments of the present invention may be operated according to any pressure-time profile known in the art of positive airway pressure therapy. In one mode of operation, continuous positive airway pressure (CPAP) is maintained at a selected relatively constant pressure during the breathing cycle. In another mode, bi-level positive airway pressure air is supplied to the patient at two selected pressures—a higher pressure during inhalation and a lower pressure during exhalation. In another operating mode, the air pressure may be varied during the breathing cycle to meet a patient's specific needs as described in U.S. Pat. No. 6,530,372, which is incorporated herein by reference. For the current embodiments, the pressure drop measurement may be taken by a relative pressure transducer located either on the mask or near the discharge point of the air pump system. The reading from the relative pressure transducer would be compared against the relative pressure set point (which may be constant or varying, depending upon the selected operating mode). The air pump system would then be adjusted to achieve a flow rate which moved the relative pressure towards the set point. The adjustment may be a change in the speed of the individual pump elements, activation or deactivation of series or parallel sections of the array, or a combination of these two methods.
The embodiments of the present invention may include a data monitoring and storage system to monitor and store operating and compliance data during use of the positive airway pressure therapy device by the patient. This data monitoring and storage system may include the capability to track date and time, and may be integrated with the mask or air pump system to measure and store gas pressures and flow rates as a function of time during the patient's sleep period. As is common with conventional positive airway pressure devices, the data monitoring system can provide date and time stamp, mask-off events, individual apnea events, and pressure requirements. Optionally, this data monitoring system may include a wireless transmission system adapted to monitor and transmit real-time operating data during use of the integrated unit by the patient.
An embodiment of the invention includes a system for the supply of pressurized air to a mask comprising (1) an air pump system that includes a plurality of pump elements adapted to supply pressurized air to the mask and (2) means for coupling the air pump system to the mask and for decoupling the integrated air pump system from the mask. This allows the pressurized air supply system to be used with any commercially-available mask. The apparatus may comprise 4 to 100 individual pump elements, or may comprise 100 to 1,000 individual elements, or may comprise greater than 1,000 individual elements. The apparatus may also include a power supply system adapted to provide power to drive the pump elements.
Another embodiment of the invention includes a docking station for the positive airway pressure therapy device consisting essentially of (a) means for coupling and uncoupling the docking station and the device; (b) means for setting operating parameters for the device and means for transferring the operating parameters to the device; (c) means for downloading operating data from the device to the docking station; and (d) means for connecting the docking station to a source of electric power. In contrast with prior art devices, this docking station does not include a blower, air pump, or any other air moving device.
The positive airway pressure therapy device may be adapted to couple with the docking station or base unit when the device is not in use by the patient. This docking station may include a data logging system adapted to download and store the operating data from the integrated unit while coupled with the docking station. Data storage capability of the docking station can hold 365 nights or more of monitoring results. The docking station may include a recharging system adapted to recharge the power supply unit when the air supply system is coupled with the docking station. The recharging system will be a battery charger when the air supply system is driven by a battery-operated pump system. Alternatively, when the air supply system is driven by power generated by a fuel cell system, the docking station may include a fuel storage tank and means for transferring fuel to the fuel vessel of the fuel cell system. When the data monitoring system associated with the mask or air pump system includes a wireless transmission system adapted to monitor and transmit real-time operating data, the docking station will include a receiver adapted to receive and store the data transmitted by the wireless transmission system of the mask or air pump system. The docking station may include a power outlet socket adapted to receive a plug on electrical supply wire 211, 317, 415, 515, or 605 in embodiments of
The docking station also may include means to set operating parameters for the integrated air supply unit and transmit these settings to the air supply system for storage when it is coupled with the docking station. These operating parameters may include, for example, the pressurized air flow rate, the air pressure if operating in the CPAP mode, the upper and lower air pressures if operating in the bi-level positive airway pressure mode, and other parameters as necessary.
A humidification system may be included in any of the embodiments of
Optionally, a heating system may be included to heat the air before or after pressurization. The heat may be provided by a simple resistive heating element placed in the air flow path or by other means known in the art. A thermocouple or other temperature measuring device may be placed after the heater to provide control feedback to regulate power to the heater.
Altitude compensation may be included in the operating control system so that the pressure of the air delivered to the patient can be changed in response to an increase or decrease in atmospheric pressure. In another option, an air filtration system may be included to filter the air before or after pressurization.
To minimize weight on the mask for embodiments represented in
The following Example illustrates embodiments of the present invention and does not limit these embodiments to any of the specific details described therein.
A pressurized air supply system utilizing the embodiment of
The batteries in power supply 311 are Ultralife model UBP103450/PCM, each of which has a nominal capacity of 6.7 watt-hr at an average of 3.7 volts and weighs 40 grams. For 8 hours of operation at 31.7 watts, 37.9 batteries would be required in parallel. In practice, batteries are discrete units, so the configuration in this Example uses 7 parallel sets of 6 batteries in series for a total of 42 batteries having a total weight of 1.68 kilograms. The total volume of the batteries is 898 ml and the 42 batteries are arranged in a layer 0.11 cm thick mounted on the lower portion of vest 301.
