Patent Application
20150040908
Obstructive sleep apnea (OSA) occurs when tissue in the upper airway blocks the airway during sleep. The brain will sense the rise in CO2, and will wake up the person so that breathing resumes. Such an event is called an apnea. A partial airway blockage causing an awakening is called a hypopnea. A person is unlikely to remember such awakenings, but sleep is disrupted. The severity of obstructive sleep apnea is measured by the frequency of awakenings, as shown in the table below.
Untreated, OSA not only leaves patients chronically fatigued, but it also carries significant cardiovascular consequences.
Positive Airway Pressure, or PAP, is the most widely used and the most effective treatment for OSA. In PAP, a bedside compressor supplies pressurized air to the patient's airway through a hose and mask. The air pressure is set sufficiently high to maintain an open airway during sleep. Examples of PAP devices may be found, e.g., in U.S. Pat. No. 8,316,848; U.S. Pat. No. 8,453,640; and U.S. Pat. No. 8,353,290, the disclosures of which are incorporated herein by reference.
Many OSA patients who use PAP have difficulty using their PAP systems when traveling. Most PAP systems are both bulky and too fragile to pack in checked luggage. For travel, patients prefer small, light PAP systems. Despite recent introduction of some portable PAP systems, there remain significant shortcomings in their design.
Many patients will keep a second, smaller PAP system just for travel. But there is a downside to decreasing size. A smaller, lighter PAP system is more likely to get pulled off a bedside table when tugged by the hose connecting the console to the patient's mask. Some small PAP systems have some sort of heavy docking station to prevent the PAP system from being pulled off the bedside table. However, such docking systems add weight and bulk, which may cause patients to forego them when traveling.
The airway hose commonly used in PAP systems is quite large to pack and transport. In many cases, the hose itself is larger in volume than the PAP flow generator unit. This significant volume inhibits travel and portability of the entire system. As the airway hose is a necessary component of the typical PAP system, it is required for most use. Standard hose technology has not evolved significantly in many years. Typical construction consists of an inner membrane of plastic, surrounded by a spiral of thicker, stiffer plastic to give the hose structure. This structural surrounding is intended to prevent the kinking and crushing of the hose in use. This structural element also inhibits portability.
Smaller, more travel-friendly CPAP machines are being introduced to the market. However, they either lack humidification or, if they include it, it requires extra bulk. Many travelers leave their humidification systems at home when they travel. The humidification units for many PAP systems are just as large as the flow generator. Humidification units are comprised of a large reservoir for holding water, and technology to convert the fluid water into a mist or vapor. The bulk of the water chamber is not compressible, and therefore inhibits portability and travel.
In some aspects a hose for a portable PAP system is provided. The hose comprises a flexible air conduit; and a fluid expandable support member positioned around and extending longitudinally along at least a portion of the flexible air conduit, the fluid expandable support member having an expanded state and a collapsed state.
The fluid expandable support member can comprise at least two radial wraps connected by a longitudinal portion. The fluid expandable support member can comprise a tubular shape helically wound around the flexible air conduit. In some embodiments, the flexible air conduit comprises plastics, plastic materials, elastomers, thermosets, polymers, fabrics, woven fibers, woven plastics, heat-treated materials, and material composites. The flexible air conduit can comprise a diameter of about 12-25 mm when the fluid expandable support member is in the expanded state. In some embodiments, the hose weighs about 10-100 g when the fluid expandable support member is in the collapsed state. The hose can have a volume of about 50 cc when the fluid expandable support member is in the collapsed state. The hose can further comprise a valve. The valve can comprise an actuator configured to allow airflow from the flexible air conduit to the fluid expandable support member when pressed.
In other aspects, a hose for a portable PAP system is provided. The hose comprises a flexible air conduit; and a fluid expandable support member helically wound around the flexible air conduit, the fluid expandable support member having an expanded state and a collapsed state.
The support member can comprise narrow portions and wide portions.
In other aspects, a method of using a hose for a portable PAP system is provided. The method comprises inflating a fluid expandable support member positioned around and extending longitudinally along at least a portion of a flexible air conduit, thereby changing the flexible air conduit from a collapsed state to an at least partially open state.
Inflating can comprise providing fluid to the support member via a valve positioned on the support member. In some embodiments, inflating comprises pressing an actuator on a valve positioned on the support member. Inflating can comprise opening a valve positioned on the support member, thereby allowing air to flow from the air conduit to the support member. The method can comprise sealing an end of the air conduit during inflation of the support member. In some embodiments, the method comprises connecting the hose to a pump of a portable PAP system. Inflating can comprise providing air to the support member.
The current invention uses various means to secure a PAP console in the sleeping environment. This will help prevent the console from being moved by tugging of the hose when the patient is wearing the system. Several attachers or means for securing a PAP console are disclosed. Most are reversible. In some embodiments, an attacher is positioned on the PAP device. The attacher can be used to fix the PAP device to a surrounding surface. In some embodiments, a first attacher is positioned on the PAP device, and a second attacher is attached to a surrounding surface. The first and second attachers can be configured to be reversibly attached to one another. Different mechanisms and means may be more appropriate for different sleeping environments, depending on the fixturing surfaces available.
Surfaces to which a PAP device can be secured in typical sleeping environments include: walls, ceiling, floor, headboards, bed frames, bed side boards, underside of beds, bedside tables, electrical outlets, lamps, bedposts, mattresses, pillows.
Suction is an embodiment of an attacher that can be used to reversibly adhere a PAP device to a bed or bedside surface. Such suction can be achieved manually using a suction device on the PAP console that the patient engages. Suction can be achieved using one suction structure, or a multitude of suction structures. Suction can be created by pressing the PAP device onto a surface, forcing the air out of the suction elements. Alternatively, a manage device, for instance a pump or syringe, can be used to remove air from the suction elements. In another embodiment, suction is provided by an array of suction structures located on the underside of the PAP device.
Alternatively, suction can be created and/or maintained using the compressor within the PAP console. In this latter system, there can be communication, either temporary or permanent, between a PAP air inlet passage and an area on the surface of the PAP console in which a lower pressure is created to achieve suction adhesion.
In another embodiment, attachers can comprise clip and/or hook elements that are provided to secure the PAP device to the bed, headboard, sideboard, or bedside table. These elements can be made of bent wire, metal, plastics, or similar materials. These elements are used to hang the PAP device securely but reversibly in the sleep environment. Hooks are used to hang the PAP device using gravity to provide the force to keep the device in place.
In another embodiment, hook and loop fasteners are used as embodiments of attachers to attach the PAP device securely to a surface in the sleeping environment. One side has the hook structure, consisting of many small hooked elements, densely arranged. The other side has the loop structure, consisting of many small looped elements, densely arranged. One side of the hook and loop fastener is placed on the PAP device. Adhesives or a physical capturing mechanism can be used to achieve this. The other side of the hook and loop fastener is placed on the bed or bedside surface to which one would like to attach the PAP device. The PAP device can be repositioned at the hook and loop interface. In a preferred embodiment, the hook side of the combination is attached to the PAP device such that the device can be attached to various bedding and bedside materials, such as blankets, carpeting, table cloth, or similar fabrics, which inherently function as the loop fastener without necessitating the addition of a separate loop surface. In one embodiment, hook fasteners are attached in multiple areas on the underside of the PAP device using adhesive. Loop fasteners are attached to a surface in the sleeping environment using adhesives as well. In one example, these loop fasteners could be minimal in size and could be attached to the top surface of a bedside table, to prevent the movement of the device when the airway tube is pulled.
In another embodiment, a clamp attacher provides the means to attach the PAP device in the sleeping environment. The clamp can attach to a bedpost, headboard, sideboard, bed frame, lamp, or other sleeping environment object. The clamp can be easily attached and detached from the PAP device via a quick release design. Clamps can be actuated using CAM devices, spring loaded, or threaded posts.
In another embodiment, an anchoring tongue attacher is attached to the PAP device. This tongue apparatus is relatively thin. In some embodiments, it has a thickness between 0.020″ and 0.500″. It can be long and narrow or short and wide, or some combination thereof. Increasing the surface area of the tongue apparatus increases its holding ability. The surface area provides the friction which resists movement forces placed on the PAP device. The tongue apparatus is relatively rigid. It is placed horizontally between two mattresses, between a mattress and a box spring, between a mattress and bed slats, or between a mattress and a bed frame to secure the PAP device. It can also be placed vertically between a mattress and a sideboard or headboard of a bed. The tongue-like apparatus can be easily attached and detached from the PAP device via a quick release mechanism, described elsewhere herein. This design is lightweight and secure. As it is very thin, it can easily be packed for travel. In some embodiments, the tongue-like anchor has a tacky surface treatment that helps to prevent it from sliding. In further embodiments, the tongue anchor device can be made to be collapsible, such that it can fold up into a smaller form for transport, and then unfold for use. For instance, in one embodiment the anchoring tongue could form the shape of a “T”, with a joint at the intersection of the two parts. The upper part is able to rotate into a locked position orthogonal and be placed between two mattresses. For travel, the upper part is rotated to be parallel with the lower part. In some embodiments, the anchoring tongue is sized to fit conveniently in a laptop case or at the bottom of a suitcase so that it is easy to transport for travel.
In another embodiment, the PAP device is configured to plug directly into a wall outlet. This provides the support and location of the PAP device. The prongs of the electrical leads on the PAP device act as an attacher and are placed directly into the wall outlet, holding the device securely in place. The lightweight nature of travel devices makes this approach even more secure. Although this approach requires a wall electrical outlet in proximity of the head of the bed, this is the case in most sleeping environments, where the outlet is already powering alarm clocks, bedside lamps, etc. This feature has the advantage of simplifying the setup and fixturing of the PAP device. Additionally, no power cord would be required, which is a significant advantage when traveling.
In another embodiment, the PAP device is hung from the underside of the bed. Attachers such as hooks can be used to hang the PAP device from the bed frame or mattress. Hook and loop fasteners, or a mounted plate can be used to secure the PAP device under the bed. This attachment means has the advantage of keeping the PAP device out of sight, but also off the floor. CPAP users sometimes place their machines on the floor under their beds. However, the floor underneath beds is commonly neglected and infrequently cleaned, and thus accumulates dust, hair, and other undesirable material for a respiratory environment. Hanging the PAP device off the ground separates it from this environment.
In another embodiment, an inflatable member provides the support to cradle the device, holding it securely in place while also insulating sound and vibration when inflated. This inflatable member is secured to the sleeping environment using any of the methods described herein. When not in use, such as for travel, the inflatable member is deflated and takes up very little room. It can have its own inflation/deflation pump integrated into the member, or a separate pump to use to inflate and deflate the member. This configuration offers several advantages. All PAP devices create noise and vibration. The inflatable element helps limit those. Further, the inflatable element snugly holds the PAP device. In one embodiment, the inflatable element is tubular in form, allowing the device to be placed within it. In another embodiment, the inflatable element forms a cavity when inflated, and the device fits into the cavity.
The inflatable element can be secured by means described elsewhere herein to the sleeping environment. Or, the inflatable element can secure both the device, and inflate around an element in the sleeping environment to hold it in place. This could be done around a bedpost or lamp, for example.
In another embodiment, the PAP device is secured to a surface in the sleeping environment using an elastic band as an attacher. The elastic band can be attached to a bedpost. The elasticity of the band allows it to fit securely around materials of different dimensions, making it very versatile for the traveler. The elastic band can be provided with a pocket for the device. Once the device slips into this pocket, it is securely held in place by the elasticity of the material. The band can have two function loops: one to attach to a sleeping environment element, and one to allow for the insertion and removal of the device. The loop for the insertion of the device can be made of an air-permeable fabric, such as a mesh with open loop weaving. This material will allow the flow of air to the device during use. Alternatively, the elastic band can attach to the device in 2 or more places. These attachment points could be enhanced with quick connect clips. The ends of the elastic band could have fastening elements shaped to fit into the receiving elements on the device, securing the elastic band to the device.
In another embodiment, adhesives can be used as an attacher to secure the PAP device in the sleeping environment. In one embodiment, the adhesive used can be of sufficient bond strength to prevent sliding and movement of the PAP device during normal use, but insufficient to prevent the user from removing and repositioning the device as desired. This adhesive could be permanently attached to the PAP device, and adhere to typical bedside surfaces like a bedside table. In one embodiment, the adhesive has a lower tack force, designed to resist lateral forces more than perpendicular forces. Alternatively, a gel pad could be placed between the PAP device and the bedside table to prevent lateral movement. This gel pad or pads could be tacky to a matched gel surface on the bottom of the PAP device, but not tacky to other materials common to the sleeping environment.
In another embodiment, magnets are used as attachers to secure the PAP device in the sleeping environment. One magnet is mounted on the PAP device, preferably on the underside. The other magnet is attached to a surface in the sleeping environment. The PAP device can be reversibly attached to the sleeping surface with the magnetic force. With a powerful magnet, such as a neodymium magnet, placed under the top surface of the bedside table, and held in place with adhesive, tape, or the like, the device could be held securely in place on the bedside without any visible trace of the securing mechanism when the device is removed. This offers significant aesthetic advantages, particularly for users who do not wish to display their PAP devices in their bedrooms when not in use.
In another embodiment, a flexible ratcheting element is used as an attacher to attach the PAP device to the sleeping environment. The element includes a band with steps or teeth formed in it. The band is inserted into a ratcheting fitting, which allows it to slip into place, and tighten as each step is passed through the ratchet. When desired, a separate element is activated to reduce the contact between the ratchet and the teeth, so that the mechanism is loosened and/or removed.
The mechanism can be reusable or disposable. In a preferred embodiment, the mechanism is reusable. In one embodiment, the mechanism is disposable and must be cut to be removed. In one embodiment, the flexible ratcheting mechanism is made of an elastomeric material, and includes a line of holes through which a post, also from the band, can be placed to secure the device in place.
In another embodiment, a hook or a series of hooks acts as an attacher, and is secured to the PAP device by a removable means. The hook(s) penetrate the outer layer of the mattress or other soft material without damaging the material in a way that would negatively affect its use. In one embodiment, the hooks are thin enough to pass without disturbing the weave of the fabric, but not so sharp as to penetrate human skin under normal use. The hooks can also be hooked in between the mattress and another bedroom furnishing, such as a box spring or bed frame, for added holding strength. The hooks can be made from thin plastic with blunt tips for safety. Such a design can pass through the fabric layer covering mattresses and bedding, but would not penetrate human skin under similar forces.
Several approaches are provided for attaching the PAP device to the fixturing means. One or more threaded posts could be used to quickly secure the PAP device to any of the herein described fixturing means. Further, a combination of threaded posts and non-threaded posts may be used, such as a single non-threaded post for resisting rotation and a single threaded post for secure attachment.
Another manner of quickly and reversibly attaching the PAP device to the fixturing means is by way of posts and slots. A 90 degree turn of the post within the slot can push it beyond a detent and secure it into place.
In another embodiment, a cradle is provided to secure the PAP device in place. The cradle can then be attached to various attachment means. The cradle contains a degree of flexibility which allows it to grasp the PAP device and hold it securely with the tension of the cradle.
This device comprises a small apparatus that is specially adapted to interface with the standard threading on widely available drinking water bottles. In this way, the user is not required to travel with a water reservoir. Water bottles can be found nearly anywhere one might travel. With the standard fitting, (such as SPI 28MM thread specs), simply procuring one of these bottles at the destination thereby outfits the user with a full humidification system. The fitting can be designed to fit the majority of flatwater bottles in the marketplace. Additional fittings and adaptors can be provided to fit different thread designs for different bottles in different markets. Further, once done with the CPAP and humidifier, the water bottle that has served as the reservoir can simply be discarded or recycled. This significantly reduces the amount of material volume and weight with which the CPAP user must travel. In one embodiment, the micro-humidifier is integrated into the CPAP base unit.
In another embodiment, the micro humidifier is an attachment unit that can be connected to any CPAP machine to provide humidity to the airflow. This connection could occur through the classic tubing fittings. The humidification unit can work using several different mechanisms well known in the art, including: evaporation, steam, ultrasonic, diffuser. The unit can be powered through a standard wall plug or with batteries.
In a further embodiment, the humidification unit to which the bottle is attached can deliver its humidified air through a small tube that is connected to the tubing or mask interface near the patient to humidify the air.
The bottle could be connected to sit upright, upside down, or lay on its side. It could have a tube extending into it for the sourcing of the water. Bottles of various sizes could be used with the same standardized fitting. The bottle and device could also be fashioned to conveniently attach to the sleeping environment. They could attach to the headboard, sideboards, mattress, under the bed, side table, lamp or other attachments means.
In a further embodiment, the humidification apparatus can also heat the water, providing heated humidification.
In a further embodiment, a kit is provided with multiple methods for securing a PAP device. The most appropriate method can be chosen depending on the sleeping environment conditions, which may vary nightly during travel.
Collapsible Airway Hose
Described here is a collapsible hose that takes up minimal space when not in use. In some embodiments, the hose comprises a flexible conduit (e.g., a thin tube), which is the sealed conduit for airflow. The hose can comprise a generally circular or ovular cross section. Other configurations are also possible (e.g., rectangular). Though it forms the barrier and corridor for the airflow, the tube lacks structure. Around this conduit is a second element, which is a support member that provides the structure for the hose. In some embodiments, this structured portion includes an expandable or inflatable chamber. This support member can be tubular and comprise a generally circular cross section. In other embodiments, the cross section is not circular. For example the cross section can be ovular or rectangular. The support member can be wound in a spiral fashion around the outside of the sealed conduit. The support member has a port for the introduction of fluid (e.g., air) into its chamber, perhaps at one end of the tube. This port could be augmented with a one-way inlet valve to prevent back flow. This valve allows the inflow of air from the flow generator or other source. The air fills the support member, bringing it into a fully expanded (or partially expanded) state from a collapsed (or partially collapsed). Alternatively, instead of a one-way valve, this part could be a stop cock or similar controlled valve, which is actuated by the user. Once the inflatable chamber is filled, the control valve can be actuated to shut off the inflatable chamber. Optionally, at the other end of the inflatable chamber another valve can be placed to allow for the exit of the fill air at the discretion of the user.
In some embodiments, the user wraps the deflated tube up into a small ball of deflated material, which could be smaller than a fist. The deflated tube can be transported easily and takes up very little room. The deflated tube can also be lightweight. When desired, the tube is connected to the flow generator. The airflow fills up the structure bladder of the tube. This can be aided by blocking the distal opening of the tube with the hand or other means. Once the structure bladder is inflated, the entry valve can be closed off Or, if it is the one-way valve, it will close itself off Now the tube has structure and is ready to function as a normal CPAP tubing conduit for airflow. Because of the closed off air structure chamber, it is resistant to kinking and blockage. Flexibility of the hose can be altered by material choice, spacing and geometric arrangement of the air chamber, and inflation pressure. Further, a fluid such as water could be used to inflate the structural element to provide greater resistance to kinking. Additionally, a combination of inflation fluids could be used, with lighter weight air near the user and more durable liquid near the flow generator.
The air flow lumen 81 can have a diameter, when expanded, of about 4-35 mm, with a typical diameter range of 15-22 mm. The thin air barrier 85 can comprise plastics, plastic materials, elastomers, thermosets, polymers, fabrics, woven fibers, woven plastics, heat-treated materials, and material composites. In some embodiments, the thin air barrier 85 has a thickness of about 0.003-0.100″, with typical thickness in the range of about 0.005-0.015″. As noted above, when deflated, the entire assembly collapses to occupy a very small amount of space. For example, in some embodiments, the entire deflated assembly can comprise about 25-150 cc, but typically 50 cc or less. By contrast, the assembly in the inflated state may have a volume of 1000 cc or more. The entire assembly can also be lightweight in the deflated state. In some embodiments, the deflated assembly weighs about 10 g or less, but may weigh up to 150 g or more.
Variations and modifications of the devices and methods disclosed herein will be readily apparent to persons skilled in the art. As such, it should be understood that the foregoing detailed description and the accompanying illustrations, are made for purposes of clarity and understanding, and are not intended to limit the scope of the invention, which is defined by the claims appended hereto. Any feature described in any one embodiment described herein can be combined with any other feature of any of the other embodiment whether preferred or not.
It is understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application and scope of the appended claims. All publications, patents, and patent applications cited herein are hereby incorporated by reference for all purposes.
This application claims the benefit of U.S. Provisional Patent Application No. 61/864,191, filed Aug. 9, 2013, entitled “DEVICES FOR PORTABLE AIRWAY PRESSURE SYSTEMS”, the entire disclosure of which is hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61864191 | Aug 2013 | US |
