Nasal respiratory devices have been well-described in the following US patent applications, each of which is incorporated herein in its entirety: U.S. patent application Ser. No. 11/298,640 (titled “NASAL RESPIRATORY DEVICES”) filed Dec. 8, 2005, now U.S. Pat. No. 7,735,492; U.S. patent application Ser. No. 11/298,339 (titled “RESPIRATORY DEVICES”) filed Dec. 8, 2005, now U.S. Pat. No. 7,798,148; and U.S. patent application Ser. No. 11/298,362 (titled “METHODS OF TREATING RESPIRATORY DISORDERS”) filed Dec. 8, 2005, now U.S. Pat. No. 7,735,491.
These patent applications generally describe nasal respiratory devices and methods for treating a variety of medical conditions through the use of such devices. These medical conditions include but are not limited to snoring, sleep apnea (obstructive, central, complex and mixed), Cheyne Stokes breathing, UARS, COPD, hypertension, asthma, GERD, heart failure, and other respiratory and sleep conditions. Such nasal respiratory devices typically induce positive end-expiratory pressure (“PEEP”) or expiratory positive airway pressure (“EPAP”), and are adapted to be removably secured in communication with a nasal cavity. Similarly, the respiratory devices described herein may include any devices having one or more expiratory resistor valves. These devices may include a passageway with an opening at a proximal end and an opening at a distal end, a valve (or airflow resistor) in communication with the passageway, and a holdfast in communication with the outer walls forming the passageway. The holdfast is configured to removably secure the respiratory device within (or over or around) the nasal cavity. Examples of the valves or resistors may also be found in previously incorporated U.S. provisional patent application Ser. No. 60/811,814.
Although general descriptions of these devices have been described both functionally and by example, some specific variations of nasal respiratory devices have not previously been described. Thus, it would be beneficial to improve upon the devices, kits and methods previously described, and particularly to more fully develop certain embodiments of nasal devices and methods of arranging, using, manufacturing, inserting and removing nasal respiratory devices. Described below are specific variations of nasal devices, accessories for nasal devices, methods of using nasal devices and kits including nasal devices.
Described herein are specific variations of nasal devices, accessories for nasal devices, methods of using nasal devices and kits including nasal devices. In particular, adhesive nasal device are described. Adhesive nasal devices may be worn by a subject to modify the airflow thorough one or (more typically) both nostrils. As described in more detail below, an adhesive nasal device may be secured over the subject's nostrils so that airflow through the nostrils passes primarily (or exclusively) through the nasal device. Generally, the adhesive nasal device is removably secured over, partly over and/or at least partly within the subject's nostrils by an adhesive.
As used herein the term “adhesive nasal device” may refer to a device for covering one or both of a subject's nostrils. Thus, the description herein may apply to nasal respiratory devices adapted to fit over both of a subject's nostrils.
The adhesive nasal devices described herein may be completely flexible, or partially rigid, or completely rigid. For example, the devices described herein may include an adhesive holdfast region that is at least partially flexible, and an airflow resistor. The airflow resistor may be flexible, or rigid. In some variations, the devices described herein also include one or more alignment guides for helping a subject to orient the device when securing it over the subject's nose. For example, an alignment guide may be used to position the airflow resistor so that it is approximately centered over the subject's nostril opening.
In general, an adhesive nasal device may be secured in communication with a subject's nose, and specifically with one or both of the subject's nasal cavities. A typical adhesive nasal device may include an airflow resistor configured to resist airflow in a first direction more than airflow in a second direction and an adhesive holdfast configured to secure the airflow resistor at least partially across the subject's nose. The holdfast may comprise a biocompatible adhesive and a flexible region configured to conform to at least a portion of a subject's nose.
An airflow resistor may regulate flow of air into and out of the nostril, through the device. In some variations, the adhesive nasal device includes two airflow resistors, configured so that one airflow resistor is in fluid communication with each nostril. In addition, an adhesive nasal device includes an adhesive holdfast (e.g., holdfast region or layer) configured to secure the adhesive nasal device in communication with the subject's nasal passageway(s).
The adhesive nasal devices described herein may be composed of layers. Layered nasal devices (which may also be referred to as layered adhesive nasal devices) may be completely or partially flexible, as previously mentioned. For example, a layered nasal device may include an airflow resistor configured to resist airflow in a first direction more than airflow in a second direction (wherein the airflow resistor comprises a flap valve layer adjacent to a flap valve limiting layer), and an adhesive holdfast layer comprising an opening across which the airflow resistor is operably secured. The airflow resistor may be disposed substantially in the plane of the adhesive holdfast layer. The adhesive holdfast layer may be made of a flexible substrate that includes a biocompatible adhesive.
Any of the adhesive nasal devices described herein may include one or more leak pathways, through which air may pass even when the airflow resistor is closed. Thus, there may be a basal (“leak”) flow of air (e.g., during exhalation). The leak pathway may be present on any portion or region of the nasal respiratory device. For example, the airflow resistor may include at least one leak pathway.
The flap valve (or flap valve layer) may include a plurality of valve leaflets. Thus, the flap valve may be a flexible layer of silicone or polyurethane (or any other appropriate material) that is divided up into a plurality of movable flaps, as described in more detail below. For example, the flap valve layer may include a plurality of valve leaflets that are spaced across the flap valve layer. Each valve leaflet may open and close (e.g., open during inhalation and close during expiration). In some variations, the flap valve includes a plurality of valve leaflets that open from a central point. For example, the flap valve may be formed by cutting spokes that radiate from a single point (or region) to form triangular leaflets.
An airflow resistor may include a flap valve and a flap valve limiter. A flap valve limiter may be configured as a flap valve limiting layer. This limiting layer may be adjacent to (directly adjacent or functionally adjacent) to the flap valve, and may limit the ability of the flap valve to open in one direction. The flap valve limiter (or limiting layer) may completely prevent opening of the flap valve in one direction, or it may partially prevent opening of the flap valve in one direction. For example, a flap valve limiter may be a mesh or a plurality of cross struts. Cross-struts may also be referred to as support members or cross-beams. Cross struts or cross beams may extend only partially across the passageway regulated by the airflow resistor (e.g., flap valve). For example, cross struts may be partial struts that do not completely extend across the passageway but still support one or more leaflets of the flap valve.
In some variations, the adhesive respiratory devices described herein include one or more alignment guides. An alignment guide typically helps the subject to apply the device to one (or both) nostrils in the proper orientation (e.g., so that the airflow resistor is aligned to communicate with the nasal opening). Any appropriate alignment guide may be used. For example, and alignment guide may comprise a visual alignment guide that a subject can look at to align the device (e.g., in a mirror), such as a color or shape that can be matched to one or both nasal openings. Thus, in some variations, at least a region of the device may be transparent or opaque, allowing at least a portion of the nasal opening to be seen through the device. The alignment guide may be a tactile alignment guide. A tactile alignment guide may be felt by the subject (e.g., by the subject's fingers and/or nose). For example, the alignment guide may be a ring, ridge, bump, post, or the like. In some variations, the alignment guide extends at least partially into the subject's nose when the device is worn. For example, an alignment guide may be a cone or conical region.
Also described herein are layered nasal device adapted to be adhesively secured in communication with a subject's nasal cavity that include a layered airflow resistor configured to resist airflow in a first direction more than airflow in a second direction (wherein the layered airflow resistor comprises a flap valve adjacent to a flap valve limiting layer), and an adhesive holdfast layer configured to secure the layered airflow resistor in communication with the subject's nasal cavity. These devices may include at least one leak pathway. For example, the leak pathway may be through the layered airflow resistor. In some variations, the airflow resistor layer is disposed substantially in the plane of the adhesive holdfast layer.
The adhesive holdfast layer may include a flexible substrate and a biocompatible adhesive.
In some variations, the flap valve is made of a plurality of valve leaflets. The flap valve may include a plurality of valve leaflets configured to open from a central point. In some variations, the flap valve is part of a flap valve layer. Thus, the flap valve may be include a plurality of valve leaflets formed in a flap valve layer. In some variations, the flap valve is formed in the adhesive holdfast layer. In general, a flap valve may be made of any appropriate material, including silicone or polyurethane.
Any appropriate flap valve limiting layer may be used. For example, the flap valve limiting layer may comprise a mesh. In some variations, the flap valve limiting layer comprises a plurality of struts. In some variations, the flap valve limiting layer comprises a plurality of partial struts.
Any of the devices described herein may also include an alignment guide, such as a ring, a conical alignment guide, a tactile alignment guide, or a visual alignment guide.
In some variations, the device may further include a support frame. The support frame may be removable. For example, the support frame may support the device, including the holdfast region of the device, and be completely or partially removable after the device has been applied to the subject. In some variations, the support frame remains on the nasal device after application.
Also described herein are layered nasal devices adapted to be adhesively secured in communication with a subject's nasal cavity that include a layered airflow resistor configured to resist airflow in a first direction more than airflow in a second direction (wherein the layered airflow resistor comprises a flap valve adjacent to a flap valve limiter), and a layered adhesive holdfast comprising a substrate layer, a layer of biocompatible adhesive, and a removable protective cover layer at least partially covering the biocompatible adhesive. The layered adhesive holdfast may at least partially surround the layered airflow resistor. An alignment guide may also be used as part of these devices. The flap valve may be formed from the substrate layer of the layered holdfast. In some variations, the flap valve comprises a plurality of valve leaflets configured to open from a central point.
As mentioned, any of these devices may also include a support frame. In some variations, the support frame is a support frame layer. Also described herein are methods of treating a subject that include the steps of removing a protective cover from a layered adhesive holdfast of an adhesive nasal device (wherein the adhesive nasal device comprises a layered airflow resistor), and placing the layered airflow resistor in communication with at least one of the subject's nasal cavities, and adhesively securing the adhesive nasal device to the subject's nose.
Also described herein are methods of fabricating a layered nasal device, including the steps of forming an adhesive layer comprising a biocompatible adhesive, forming a flap valve, forming a flap valve limiter, and securing the flap valve limiter to the flap valve and the adhesive layer so that the flap valve limiter is adjacent to the flap valve. The method may also include the step of securing an alignment guide in communication with the flap valve limiter, the flap valve and the adhesive layer.
In some variations, the method also includes the steps of forming an opening through the adhesive layer and securing the flap valve limiter adjacent to the flap valve in communication with the opening. Also described herein are methods of making an adhesive nasal device including the steps of forming an opening through a flexible adhesive substrate and securing an airflow resistor across the opening by securing a flap valve limiter adjacent to a flexible valve across the opening.
Layered device may also be fabricated by batch (or mass) fabrication methods. Furthermore, the layered devices described herein may be contrasted with previously described nasal (including adhesive nasal) devices that include a rim body region that forms a passageway. Although the layered devices may include a passageway, the layered devices may be substantially flat. Thus, these layered devices may not include a rim body region.
An adhesive nasal device may be adapted to be removably secured in communication with a subject's nasal cavity. The adhesive holdfast may include a biocompatible adhesive that is configured to secure the nasal device across a subject's nose or nostril(s) so that the airflow resistor is in communication with the subject's nasal opening. When placing the device in communication with the subject's nasal opening (or nasal orifice), the airflow resistor (e.g., the airflow resistor layer) may be aligned with the nasal opening (or both nasal openings). In any of the devices described herein, the adhesive holdfast region may be configured so that it does not substantially cover the subject's mouth when the device is worn by a subject. Thus, the devices may be configured so that the adhesive holdfast secures the device in communication only with one of the subject's nostrils, or with both of the subject's nostrils.
In some variations of the adhesive nasal devices described herein (particularly those variations configured to cover both of a subject's nostrils), the device may also include a bridge region in the adhesive holdfast. The bridge region may be located between the airflow resistors configured to fit over, partly over and/or at least partly within each of the subject's nostrils.
As mentioned, an adhesive holdfast may include a flexible adhesive substrate, and/or a protective cover (configured to be removed, for example, by peeling off to expose the adhesive of the adhesive layer). The device may also include a tab or handle configured to be grasped by a subject applying the device. In some variations, this tab or handle is formed of a region of the layered adhesive holdfast.
The various components of the device may be made of any appropriate materials, as described in greater detail below. For example, various components of the device (e.g., alignment guide) may be made of medical grade plastic, such as Acrylonitrile Butadiene Styrene (ABS), polypropylene, polyethylene, polycarbonate, polyurethane or polyetheretherketone. The airflow resistor may be a flap valve and the flap may be made of silicone or thermoplastic urethane. The adhesive holdfast may include an adhesive substrate made of silicone, polyurethane or polyethylene. Examples of biocompatible adhesive on the adhesive holdfast may include hydrocolloids or acrylics.
In some versions, the respiratory device further comprises an active agent. In some versions, this active agent is a drug (e.g., a medicament). In some versions, this active agent comprises an odorant, such as a fragrance. In some versions, the active agent comprises menthol, eucalyptus oil, and/or phenol. In other versions, the respiratory device may be used with other pulmonary or medical devices that can administer medication or other medical treatment, including but not limited to inhalers and nebulizers.
In some versions, the respiratory device further comprises a filter. This filter may be a movable filter, such as a filter that filters air flowing through the passageway in one direction more than another direction (e.g., the device may filter during inhalation but not expiration).
All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety, to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference in its entirety.
An adhesive nasal respiratory device is one variation of a general nasal respiratory device in which an adhesive holdfast region is used to secure the device in fluid communication with one or both of a subject's nostrils. A nasal respiratory device, including an adhesive respiratory device, may be used to regulate a subject's respiration. For example, the device may create positive end expiratory pressure (“PEEP”) or expiratory positive airway pressure (“EPAP”) during respiration in a subject wearing the device. The adhesive respiratory devices and methods described herein may be useful to treat a variety of medical conditions, and may also be useful for non-therapeutic purposes. The devices and methods described herein are not limited to the particular embodiments described. Variations of the particular embodiments described may be made and still fall within the scope of the disclosure. Examples and particular embodiments described are not intended to be limiting.
As used herein, an adhesive nasal device may be configured to fit across partly across, at least partly within, in, over and/or around a single nostril (e.g., a “single-nostril nasal device”), or across, in, over and/or around both nostrils (“whole-nose nasal device”). Both single-nostril nasal devices and whole-nose nasal devices may be referred to herein as “adhesive nasal devices,” and (unless the context indicates otherwise), any of the features described for single-nostril nasal devices may be used with whole-nose nasal devices, and vice-versa. In some variations, an adhesive nasal device is formed from two single-nostril nasal devices that are connected to form a unitary adhesive nasal device that can be applied to the subject's nose. Single-nostril nasal devices may be connected by a bridge (or bridge region, which may also be referred to as a connector). The bridge may be movable (e.g., flexible), so that the adhesive nasal device may be adjusted to fit a variety of physiognomies. The bridge may be integral to the nasal devices. In some variations, single-nostril nasal devices are used that are not connected by a bridge, but each include an adhesive region, so that (when worn by a user) the adhesive holdfast regions may overlap on the subject's nose.
Layered nasal devices are of particular interest, and are described more fully below. Layered adhesive nasal devices may include two or more layers. For example, a layered nasal device may include an adhesive holdfast layer and an airflow resistor layer. These layers may be composed of separate layers, and these layers may be separated by other layers, or they may be adjacent. The adhesive holdfast layer may be itself formed of layers (optionally: a substrate layer, a protective covering layer, an adhesive layer, etc), and thus may be referred to as a layered adhesive holdfast. Similarly, the airflow resistor may be formed of multiple layers (optionally: a flap valve layer, a valve limiter layer, etc.), and thus may be referred to as a layered airflow resistor. In some variations, the layered adhesive holdfast and the layered airflow resistor share one or more layers. For example, the flap valves layer and the adhesive substrate layer may be the same layer, in which the leaflets of the flap valve layer are cut from the substrate layer material. As used herein, a “layer” may be generally planar geometry (e.g., flat), although it may have a thickness, which may be uniform or non-uniform in section.
As used in this specification, the singular forms “a,” “an,” and “the” include plural reference unless the context clearly dictates otherwise. The following descriptions including various design parameters or goals, and methods and devices which fit the design parameters or goals. The devices and methods described herein (and recited by any claims) are not limited to any particular theory of operation.
In general, the adhesive nasal devices described herein include a holdfast region (or layer) and at least one airflow resistor. As will be apparent from the figures, many of these devices may be removable and insertable by user without special tools. In some variations, a subject may use an applicator to apply the device (e.g., to help align it).
In operation, an adhesive nasal device is placed in communication with one or both of a subject's nostrils to modify the flow of air through the subject's nose. Thus, the respiratory devices described herein include one or more airflow resistors for modifying the flow of air through the nose in at least one direction. In most variations of the devices described herein, the airflow resistor is configured to occlude airflow through a passageway in one direction more than it occludes airflow in the opposite direction. For example, an airflow resistor may occlude airflow during exhalation more than inhalation. Resistance to inhalation may be increased minimally, negligibly, or not at all. Examples of airflow resistors are described below, but any appropriate airflow resistor may be used. For example, airflow resistors may be valves for regulating airflow (e.g., flap valves, hinge-less valves, balloon valves, stepper valves, ball valves, etc.) or the like. In the examples shown in the figures and described herein, the airflow resistor is typically a flap valve having one or more flaps or leaves that move to regulate flow through the resistor. The airflow resistor may also include a valve limiter, such as a flap valve limiter. For example, a valve limiter restricts the ability of a valve to open in one or more directions. As described in more detail below, the flap valve limiter may prevent the valve from substantially opening in one direction (e.g., expiration) or may allow some degree of opening or partial opening, but not complete opening
Any of the nasal devices described herein may also include one or more leak pathways through which air can pass when the valve is otherwise closed. The leak pathway may be separate from the airflow resistor, or it may be part of the airflow resistor (e.g., passing through a region of the flap valve, etc.). In some variations, the airflow resistor is configured so that a leak pathway is formed when the valve is closed. For example, the flap(s) of the flap valve may not seal when the valve is closed. A leak pathway may pass through any appropriate region of the device, including the holdfast region.
An adhesive nasal device may be configured to treat snoring, or any other sleep disordered breathing, as described briefly above. For example, a subject may apply an adhesive respiratory device over his nose (one or both nostrils) by exposing an adhesive on the holdfast of the device (e.g., by removing a protective cover material from an adhesive region of the holdfast) and applying gentle pressure to adhere the device around the nostrils. In this way, the device may be seated around the nasal orifice (and may project at least partly into the nostrils) and form at least a partial seal between the nostrils and the device so that the majority of flow into and out of the nostrils passes through the passageways of the nasal device. Once the device is applied to the subject's nose, respiration through the nostrils may be regulated. In some variations, the adhesive nasal device is configured so that there is only nominal resistance through the nasal device during inhalation (e.g., less than about 2 cm H2O, less than about 1 cm H2O less than about 0.5 cm H2O, less than about 0.4 cm H2O, less than about 0.3 cm H2O, less than about 0.2 cm H2O, etc.), but increased resistance to airflow during exhalation (e.g., greater than about 2 cm H2O, greater than about 3 cm H2O, greater than about 4 cm H2O, greater than about 5 cm H2O, greater than about 6 cm H2O, greater than about 7 cm H2O, greater than about 8 cm H2O, greater than about 9 cm H2O, greater than about 10 cm H2O, greater than about 12 cm H2O, etc.). During inhalation in a subject wearing such a device, the subject may breathe through the nose (and thus through the nasal device). During exhalation, the adhesive nasal device provides greater resistance to airflow through the device. Resistance to exhalation may be limited (or set) by a leak pathway. Thus, the subject may still breathe predominantly though the nose (and the nasal device) during exhalation, but may also breathe at least partly through the mouth.
It may also be beneficial for a subject to wear a nasal respiratory device over an extended period of time (e.g., during a period of sleep). Described below are variations of adhesive nasal devices (including layered nasal devices) that may be comfortably worn and secured in or over the subject's nose or nasal passages. In some variations, a grip (e.g., a tab, handle, strap, or other additional interface region) may be included to help secure the device to the subject's nostril, nose or face, and may additionally or alternatively be helpful in positioning or manipulating (e.g., gripping) the device, particularly when it is being applied. This additional interface region may be formed of the same material as the adhesive holdfast region, or it may be a separate region, as described in more detail below.
In some embodiments, one or more components of the device are impregnated with, contain or are coated with one or more compounds that may be inhaled during use. The presence of airflow, heat or other conditions may facilitate the release of the compound into the inhaled air or surrounding tissues. The compound may be herbal (such as menthol or lavender), chemical or pharmaceutical (such as an antihistamine or anti asthma drug) in nature. Depending on the compound, the user might experience a pleasant aroma (which may soothe or promote sleep or activity) or medical benefits, such as nasal decongestion or asthma relief. The compound may be inhaled during all or at least a portion of the time the user is wearing the device. The compounds may be used as part of treatment of a sleep apnea, snoring, or may find use in other embodiments for other medical conditions.
In still other embodiments, the device may include a filter that removes particulate matter from external air upon inhalation. Particulate matter that would be removed may include dust and allergens. This invention may be embodied within a sleep apnea device, snoring device, a respiratory device, or comprise a stand alone device.
Other materials of interest include any materials that can serve as filters for allergens, pollen, dander, smog, etc. By providing a filter within the device, sinusitis, sleep apnea, snoring, hay fever, allergic rhinitis, and other allergic respiratory conditions may be reduced or prevented. This filter may in fact be part of the airflow resistor (e.g., the valve limiter) or may be a separate component of the device. Any suitable filtering material known to those skilled in the art may be used with the respiratory devices described herein. Such materials include, but are not limited to, activated carbon charcoal filters, hollow-fiber filters, and the like.
In some versions, the respiratory device may comprise a filter that remains in the path of inhalation and/or exhalation during use. In some versions, the filter material remains in the path of both inspiratory and expiratory airflow. This filter material may not appreciably alter resistance to airflow in either direction, or it may alter airflow to substantially the same degree in both directions (inhalation and exhalation). In some versions, the filter comprises a material having a large pore size so that airflow is not significantly inhibited.
In some versions, the device is used with an active agent. In some versions, the active agent comprises a drug. An active agent (e.g., a medicament) or other compound can be placed in or on the device to deliver the active agent into the mouth, tongue, hard and soft palates, sinuses, nose, nasal cavity, pharynx, vocal cords, larynx, airways, lungs, trachea, bronchi, bronchioles, alveoli, air sacs, or any tissues that are exposed to inspiratory or expiratory airflow. In some cases, the active agent may be embedded or impregnated in the device or components of the device. In some cases the active agent is a coating. An active agent may comprise any compound that is in some way useful or desirable for the patient. For example, the active agent may be any odorant, including: menthol, phenol, eucalyptus, or any agent that provides a fragrance in the inspired air. Alternatively, an active agent may comprise a drug with beneficial effects, such as beneficial vasculature effects. For example, an active agent may comprise a drug that effects the blood vessels (oxymetazoline or any other vasoactive compound), nasopharynx, airways or lungs (albuterol, steroids, or other bronchoconstriction or bronchodilation compounds). An active agent may comprise, for example, an antibiotic or a steroid. The above list of active agents is not meant to be limiting.
An active agent may be placed in or on any portion of the device. Furthermore, the location of the active agent within the respiratory device may specifically guide the delivery of the active agent. For example, in versions of the respiratory device configured to be placed inside a respiratory cavity, when the holdfast comprises an active agent (e.g., coated, embedded or otherwise part of the holdfast), the drug may be delivered through the mucus membranes of the respiratory cavity. In another example, an active agent may be included as a powder or releasable coating that may be aerosolized and delivered within the respiratory system. Thus, an active agent may be on a surface of the device (e.g., the passageway, holdfast or airflow resistor) or embedded within any surface of the device. A separate drug-containing region may also be included in the device. The addition of an active agent may be of particular interest in treating allergies and sinusitis. Respiratory devices (with or without airflow resistors) may therefore comprise active agents such as menthol or other fragrant compounds.
In some variations of the device an aligner is used to help align the device (e.g., the airflow resistor) with one or both of a subject's nostrils. An aligner may include a tactile aligner that may be felt by the subject's nose or hands, a visual aligner (e.g., a color, pattern, or other marking) that may be seen by the subject, or a structural aligner that inserts at least partly in or around the subject's nostril(s), or any combination of these. Aligners are described more fully below. In some variations, an aligner may also help maintain the alignment of the device with the subject's nostril(s), for example, by helping maintain the patency of the nostril opening.
Airflow Resistors
An airflow resistor is typically placed in communication with one or both of the subject's nostrils, so that at least some of the air flowing into and out of the nostrils passes through the airflow resistor. In general, an adhesive nasal device is sealed at least partly over, at least partly within, or at least partly in or around the subject's nostril(s), and the airflow resistor may control the amount of resistance, the degree of airflow, or the pressure differential across the nasal device. Any appropriate airflow resistor may be used as part of the adhesive nasal devices described herein. The airflow resistors described herein typically restrict airflow in one direction more than they restrict airflow in the opposite direction. For example, an airflow resistor may occlude airflow during exhalation more than inhalation. Examples of airflow resistors may be found in published U.S. patent application Ser. No. 11/298,640, titled “NASAL RESPIRATORY DEVICES” (filed Dec. 8, 2005), herein incorporated by reference in its entirety.
In some embodiments, the pressures created by the airflow resistor during exhalation may be between 0.01 and 100 cm of H2O measured at a flow rate of 100 ml/sec. In some variations of the adhesive devices described herein adapted to be used for snoring, the airflow resistor creates a resistance to exhalation that relatively low (compared to 100 cm of H2O). For example, the resistance to exhalation may be between about 0.5 cm of H2O and about 10 cm H2O, or between about 2 cm H2O and about 8 cm H2O, or between about 3 cm H2O and about 8 cm H2O, or about 4 cm H2O. The resistance in terms of cm of H2O may be measured at a flow rate of 100 ml/sec.
Valve-type airflow resistors are particularly suitable. In particular, valves that may be used include flap valves (having one or more flaps or leaflets), hingeless valves, stopper-type valves, membrane-type valves, ball valves, balloon-type valves, and the like. This list is not intended to be exhaustive, and other types of selective airflow resistors may be used. Moreover, multiple airflow resistors may also be used, which may include combinations of different types of airflow resistors. Flap valves are of particular interest. An airflow resistor configured as a flap valve typically includes one or more hinged or flexible flaps (or leaves) that is movably secured so that the flap may open when air flows in one direction, and close when air flows in the opposite direction, or when air is not flowing. The opening and closing of the flap may allow air to flow across the valve, and thereby regulate airflow within a passageway in which the flap valve is positioned. In operation, the flap portion of the flap valve can thus selectively occlude airflow in one direction more than in other directions.
Valves configured for PEEP (positive end expiratory pressure) may also be used with any of the devices described herein. For example, a valve may be configured to have a non-zero threshold pressure for opening during expiration so that the valve is closed during expiration when the pressure across the valve is below the threshold pressure for opening during expiration, but the valve opens during expiration when the valve exceeds the threshold pressure for opening during expiration.
In some variations, an airflow resistor for use in an adhesive respiratory device includes a flap valve and a flap valve limiter that limits the movement of the flap valve. For example, a flap valve may be a flexible material (e.g., silicone) that can bend or flex to create an opening for airflow during inspiration (in a first direction). The flap valve may be prevented from opening for airflow during exhalation (in a second direction) by a flap valve limiter. Thus, a flap valve limiter may be a structure having a flap valve engagement surface (such as a bar, post, mesh, etc.) that limits the flap valve from opening in the second direction. In some variations, the flap valve limiter is a tether or hinge that is connected to the flap and prevents it from substantially extending beyond a predetermined position. Other flap valve limiters may be configured as valve supports (e.g., cross-bars) that prevent the valve from collapsing when air flows in one direction through the passageway. The airflow limiter may also include a valve seal region (e.g., a rim or ridge) against which the flap may be seated or abut when the valve is “closed.”
As mentioned above, one or more leak pathways may be included as part of the adhesive respiratory device. A leak pathway typically allows air to flow through the passageway even when the valve is closed. Thus a minimum basal level of airflow may be permitted through the passageway regardless of the state of the airflow resistor. In some variations, the leak pathway is a hole or unoccluded passage. A leak pathway may be a part of any region of the nasal respiratory device. For example a leak pathway may be part of the airflow resistor, part of the holdfast (or some combination thereof). In some embodiments, the leak pathway arises from an intentional lack of perfect sealing or abutment of various components of the device (e.g., between leaflets of a flap valve, etc). A nasal respiratory device may be configured to have multiple leak pathways.
The flap of a flap valve may be made of a flexible material, or a hinged stiff material. In some variations, the flap comprises a thin sheet of flexible material that is shaped to fit across an opening and at least partially occlude airflow through the opening when the flap is closed. The flap may be shaped so that it does not occlude airflow through one or more leak pathways.
In
The shape of the flap valves may help determine the resistance (to both expiration and inspiration) for the airflow resistor. For example, the table in
Thus, a flap valve (especially the flap region) may comprise any appropriate material, including those previously mentioned. For example, the flap may comprise polymeric materials, rubber (natural and synthetic), paper, fabric, or the like. For example, materials which may be used include: latex, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride, polyvinyl acetate, polyacrylate, styrene-butadiene copolymer, chlorinated polyethylene, polyvinylidene fluoride, ethylene-vinyl acetate copolymer, ethylene-vinyl acetate-vinyl chloride-acrylate copolymer, ethylene-vinyl acetate-acrylate copolymer, ethylene-vinyl acetate-vinyl chloride copolymer, nylon, acrylonitrile-butadiene copolymer, polyacrylonitrile, polyvinyl chloride, polychloroprene, polybutadiene, thermoplastic polyimide, polyacetal, polyphenylene sulfide, polycarbonate, thermoplastic polyurethane, thermoplastic resins, thermosetting resins, natural rubbers, synthetic rubbers (such as a chloroprene rubber, styrene butadiene rubber, nitrile-butadiene rubber, and ethylene-propylene-diene terpolymer copolymer, silicone rubbers, fluoride rubbers, and acrylic rubbers), elastomers (such as a soft urethane, water-blown polyurethane), and thermosetting resins (such as a hard urethane, phenolic resins, and a melamine resins), and injection moldable materials such as polyether block amide (e.g., PEBAX®), and the like.
An airflow resistor, including a flap valve, may be formed as a layered airflow resistor. Further, a flap valve layer may be formed in any appropriate manner. For example, a flap valve may be fashioned by cutting, molding, or otherwise forming a flap valve leaflet (or a plurality of flap valve leaflets) from a layer of material. In one variation, a layer of material (e.g., silicone, polyurethane, etc.) is die cut to form the flap valve leaflets as part of a flap valve layer. Other methods of cutting may be used to form the valve or each valve leaflets, including laser cutting, jet cutting, or the like. In some variations, the flap valve is formed by molding. For example, the flap valve may be formed by thermoforming, injection molding, or the like. In some variations, the flap is made out of silicone or thermoplastic urethane. For example, the flap may be a thin and flexible piece of silicone. This flap may be any appropriate thickness that allow it to be flexible (e.g., to move from the open and closed positions). For example, the flap may comprise silicone that is between 0.0001 and 0.1 inches thick. In some embodiments, the silicone is approximately 0.002 inches thick.
In variations in which the flap valve is made of a flexible material it may be particularly advantageous to include a flap valve limiter as part of the airflow resistor to regulate the motion of the flap valve. As described above, a flap valve limiter is typically an air-permeable structure that limits the range of motion of the flap valve, preventing it from opening (or limiting it to partially opening) in at least one direction. For example, the flap valve limiter may be a mesh, grid, bar, peg, or other structure that does not substantially inhibit the passage of air, but can limit the movement of the flap valve leaflet(s) in at least one direction.
A flap valve limiter may be formed in any appropriate manner, including molding (e.g., injection molding), cutting (e.g., die cutting, stamping, laser cutting, etc.) or thermosetting. In some variations the flap valve limiter is a flap valve layer that is formed from a mesh. Thus, the flap valve limiter may be formed by cutting, molding, etc. For example, a flap valve limiter may be formed by cutting a mesh material. Other examples of airflow resistors having a flap valve and a flap valve limiter are shown in
Although the flap valve and flap valve limiter shown in
In some variations, the flap valves or the flap valve limiter (or both) is coated with a material to increase or decrease friction between the two layers (e.g., to prevent the flap leaflets from sticking to each other and/or to the flap valve limiter). In some variations of the airflow resistor, the flap layer (forming the flap valves) is positioned immediately adjacent to a layer forming the flap valve limiter, as shown in
An airflow resistor may be assembled so that the flap valve is free to open in at least one direction (e.g., inhalation) and constrained in a second direction (e.g., exhalation).
As mentioned above, any of the devices described herein may also include one or more alignment guide. For example, an alignment guide may comprise a visual alignment guide that a subject can look at to align the device (e.g., in a mirror). For example, the device may be marked by a shape, a text, or a color to help align the device with one or both nasal openings. In one variation, the opening to the airflow resistor is marked by a circle that can be aligned with the subject's nose. In some variations, at least a region of the device may be transparent or opaque, allowing at least a portion of the nasal opening to be seen through the device. In some variations, the alignment guide is a tactile alignment guide. A tactile alignment guide may be felt by the subject (e.g., by the subject's fingers and/or nose). For example, the alignment guide may be a ring, ridge, bump, post, or the like. In some variations, the alignment guide extends at least partially into the subject's nose when the device is worn. For example, an alignment guide may be a cone or conical region.
The device shown in
The adhesive nasal device shown in
During exhalation (as shown in
Biocompatible materials may be used, particularly for those portions of the device which may contact a user. In addition to some of the materials described above, the biocompatible materials may also include a biocompatible polymer and/or elastomer. Suitable biocompatible polymers may include materials such as: a homopolymer and copolymers of vinyl acetate (such as ethylene vinyl acetate copolymer and polyvinylchloride copolymers), a homopolymer and copolymers of acrylates (such as polypropylene, polymethylmethacrylate, polyethylmethacrylate, polymethacrylate, ethylene glycol dimethacrylate, ethylene dimethacrylate and hydroxymethyl methacrylate, and the like), polyvinylpyrrolidone, 2-pyrrolidone, polyacrylonitrile butadiene, polyamides, fluoropolymers (such as polytetrafluoroethylene and polyvinyl fluoride), a homopolymer and copolymers of styrene acrylonitrile, cellulose acetate, a homopolymer and copolymers of acrylonitrile butadiene styrene, polymethylpentene, polysulfones polyimides, polyisobutylene, polymethylstyrene and other similar compounds known to those skilled in the art. Teflon, Mylar, PFA, LDPE, Hytrel, HDPE and polyester may also find use in any components of the devices.
Materials that biocompatible and/or sterilizable may also be preferred, for example, medical grade plastics such as Acrylonitrile Butadiene Styrene (ABS), latex, polypropylene, polycarbonate, and polyetheretherketone. The forgoing materials are intended as illustrations only.
Adhesive Holdfast
The adhesive nasal devices described herein may also include an adhesive holdfast for securing the device in communication with a nasal cavity. The adhesive holdfast may include one or more adhesive surfaces that are suitable for use against a subject's body (e.g., skin and/or nasal cavity). Thus, the adhesive holdfast may include a biocompatible adhesive. The adhesive holdfast may facilitate the positioning and securing of the device in a desired location with respect to the subject's nose, such as over, partially over, partially within, or within (e.g., substantially within) a nostril. An adhesive holdfast may be configured to secure the device to any appropriate region of the subject's nose, nasal passage, or nasal cavity, including the nostrils, nares or nasal chambers, limen, vestibule, greater alar cartilage, alar fibrofatty tissue, lateral nasal cartilage, agger nasi, floor of the nasal cavity, turbinates, sinuses (frontal, ethmoid, sphenoid, and maxillary), and nasal septum. The term “nasal cavity” may refer to any sub-region of the Nasal Fossa (e.g., a single nostril, nare, or nasal chamber) and includes or is defined by any of the anatomical terms listed above.
In general, the adhesive holdfast is configured to be applied predominantly to the outside of the nose (e.g., the skin surrounding the nasal opening or nostril). In some versions, the holdfast may also form a seal between the respiratory device and the nose, so that at least some of the air exchanged between the outside of the patient and the nostril must pass through the respiratory device. In some versions, the holdfast seals the device in communication with the nose completely, so that all air through the nostril (or nostrils) must be exchanged through the device. In some versions, the holdfast seal is incomplete, so that only some of the air exchanged between the patient and the external environment passes through the device. As used herein, “air” may be air from environment external to the patient, or it may be any respiratory gas (e.g., pure or mixed oxygen, CO2, heliox, or other gas mixtures provided to the user).
The adhesive holdfast may be flexible so that it conforms to the surface of the subject's skin, which may be relatively irregularly shaped, and may include hair and the like. In some variations, the adhesive holdfast is made of a material that permits the passage of water vapor, liquid water, sweat and/or oil, which may enhance comfort. The adhesive holdfast may also include a texture or patterned relief surface to enhance bonding to the subject's nose region.
The adhesive holdfast may be made of layers. Thus, the adhesive holdfast may be referred to as a layered holdfast (or layered adhesive holdfast) For example, the adhesive holdfast may include a substrate layer to which a biocompatible adhesive is applied. The substrate is typically a flat (predominantly 2-sided) material that is flexible. An adhesive may be present on at least one surface of the substrate, allowing it to adhere to the subject's nasal region. In some variations, the substrate layer is itself adhesive without needing an additional adhesive. An additional protective cover may also be removably attached to the adhesive of the adhesive layer. The protective cover may allow the device (and particularly the adhesive holdfast) to be manipulated without inadvertently sticking the device to the fingers or other parts of the body and it may also prevent contamination of the adhesive. The liner may be a removable paper or other film that can be peeled off or otherwise removed to expose the adhesive. In some variations, the adhesive of the adhesive holdfast is activatable. For example, the adhesive becomes ‘sticky’ only after exposure to an activator (e.g., water, air, light, etc.). In some variations, an adhesive could be applied to the nose in a liquid form first, than the device is applied.
In some variations, a protective cover is not used. As already mentioned, in some variations, the substrate and adhesive are a single layer, so that the substrate comprises an adhesive material, or a material that can be activated to become adhesive. The adhesive holdfast may comprise any appropriate material. For example, the adhesive substrate may be a biocompatible material such as silicone, polyethylene, or polyethylene foam. Other appropriate biocompatible materials may include some of the materials previously described, such as biocompatible polymers and/or elastomers. Suitable biocompatible polymers may include materials such as: a homopolymer and copolymers of vinyl acetate (such as ethylene vinyl acetate copolymer and polyvinylchloride copolymers), a homopolymer and copolymers of acrylates (such as polypropylene, polymethylmethacrylate, polyethylmethacrylate, polymethacrylate, ethylene glycol dimethacrylate, ethylene dimethacrylate and hydroxymethyl methacrylate, and the like), polyvinylpyrrolidone, 2-pyrrolidone, polyacrylonitrile butadiene, polyamides, fluoropolymers (such as polytetrafluoroethylene and polyvinyl fluoride), a homopolymer and copolymers of styrene acrylonitrile, cellulose acetate, a homopolymer and copolymers of acrylonitrile butadiene styrene, polymethylpentene, polysulfones polyimides, polyisobutylene, polymethylstyrene and other similar compounds known to those skilled in the art. Structurally, the substrate may be a film, foil, woven, non-woven, foam, or tissue material (e.g., poluelofin non-woven materials, polyurethane woven materials, polyethylene foams, polyurethane foams, polyurethane film, etc.).
In variations in which an adhesive is applied to the substrate, the adhesive may comprise a medical grade adhesive such as a hydrocolloid or an acrylic. Medical grade adhesives may include foamed adhesives, acrylic co-polymer adhesives, porous acrylics, synthetic rubber-based adhesives, silicone adhesive formulations (e.g., silicone gel adhesive), and absorbent hydrocolloids and hydrogels.
In some variations, the adhesive is a structural adhesive. For example, the adhesive may adhere based on van der Walls forces. Patents no. U.S. Pat. No. 7,011,723, U.S. Pat. No. 6,872,439, U.S. Pat. No. 6,737,160, and U.S. Pat. No. 7,175,723 describe setal-like structures whose shape and dimension provide adhesive force. These patents are herein incorporated by reference in their entirety.
The removable liner layer may be made of any appropriate matter that may be released from the adhesive. For example, the liner material may comprise craft paper. In some variations, the liner material comprises polyethylene film, or polyethylene coated paper (e.g. kraft paper). The liner may be any of the other materials described herein.
In general, any of the materials commonly used in the manufacture of bandages (particularly disposable bandages such as BAND-AIDS™), ostomy kits, and wound care products may be used in any or all components of devices described herein. An adhesive layer (or an adhesive holdfast layer) may be formed in any appropriate method, particularly those described herein. For example, an adhesive layer may be formed by cutting (stamping, die cutting, laser cutting, etc.) the adhesive substrate, biocompatible adhesive, and protective cover into the desired shape. Multiple steps may be used to form the adhesive layer. For example, the adhesive layer may be formed by cutting (or otherwise forming) the outer perimeter, then by cutting (or otherwise forming) an inner opening.
In general, the adhesive holdfast may comprise any appropriate shape that allows the airflow resistor to be positioned with respect to one or both nasal passages so that some (or most) of the airflow through the nasal passages must pass through the adhesive nasal device. In some variations, the adhesive holdfast attaches to the nose (or nasal passage) and forms a partial or complete seal therewith, thereby channeling airflow into or out of the nasal passageway through the device, and also securing the device in position. Thus, there are many designs that would achieve these criterions, many of which are described below.
It is not necessary that the entire adhesive holdfast region include an adhesive, although many of the substantially flat holdfast regions described in the preceding figures may have a biocompatible adhesive over much of the skin-contacting surface (although it may be covered by a protective cover that can be at least partially removed later). In some variations only a subset of the holdfast region (including the outer layer) includes an adhesive. For example the region adjacent to the rim body may not include an adhesive, or the region beneath the tabs or grips may not include an adhesive.
In some variations, the adhesive nasal devices described herein are adapted to fit different users having a diversity of sizes and shapes, particularly the shapes and sizes of their noses. As already described, the devices, including particularly the adhesive holdfast region, may be configured to that it is adaptable to different nose shapes. In some variations, the holdfast region may extend into the nostril, rather than just adhering around the outer surface of the nasal passages. For example, the adhesive holdfast may include a region that projects into the nostril, and can be secured against the walls of the nostril. In some variations, the internally-projecting regions may comprise a compressible material (e.g., a foam or the like) so that they may be secured within the nasal passages, and/or may cushion the inner rim base region (or any other portion of the adhesive nasal device) that projects into the subject's nostrils. Thus, in some variations, the inwardly-projecting portion of the holdfast is smaller than the nasal opening, and does not necessarily contact the sides of the subject's nasal passage.
Exemplary Laminate of Adhesive Nasal Devices
The adhesive nasal device may be formed by sequentially layering onto a backing layer that protects one side of double-sided adhesive (forming the adhesive holdfast), cutting out (e.g., die-cutting) an opening through this adhesive holdfast substrate, applying the flap valve layer (which may be any of the flap valves described above, but is shown here as a silicone S-cut flap valve) so that the flap valve spans the opening, applying the pre-trimmed mesh (over the flap valve spanning the opening, and securing another (single-sided) adhesive layer having a corresponding opening over the sandwiched flap valve and mesh.
The adhesive nasal device shown in
This device may be formed by sequentially layering a backing layer protecting one side of double-sided adhesive (forming the adhesive holdfast), cutting out (e.g., via die-cutting) an opening through this substrate, applying a flap valve layer (e.g., any of the valves described above, shown here as a fish-scale flap valve) spanning this opening, and applying the un-trimmed mesh over the flap valve layer to sandwiched the flap valve with the mesh.
Similar to the devices above, this device may be formed by sequentially layering a backing layer protecting one side of double-sided adhesive (forming the adhesive holdfast), cutting out (e.g., via die-cutting) an opening through this substrate, inserting the alignment guide cone into the opening, applying a flap valve layer (e.g., any of the valves described above, shown here as a silicone six pie-cut flap valve) spanning this opening, applying the pre-trimmed mesh over the flap valve spanning the opening, and securing another (single-sided) adhesive layer having a corresponding opening over the sandwiched flap valve and mesh.
The adhesive nasal device shown in
This variation of the adhesive nasal device may be formed by sequentially layering onto a backing layer protecting one side of double-sided adhesive (forming the adhesive holdfast), inserting the pre-molded alignment guide cone into the opening, applying a flap valve layer (e.g., any of the valves described above, shown here as a silicone six pie-cut flap valve), inserting the pre-molded mesh, and securing another (single-sided) adhesive layer having a corresponding opening to secure the mesh, valve and cone into position.
One possible method of assembling the adhesive nasal device shown in
This variation of the adhesive nasal device may be formed by cutting an opening into a backing layer that protects one side of double-sided adhesive (forming the adhesive holdfast), inserting the pre-molded flap valve and cone subassembly into the opening, applying the flap valve limiter (mesh) over the flap valve, and securing another (single-sided) adhesive layer having a corresponding opening around the airflow resistor to secure the mesh, valve and cone in position.
The devices described herein may be batch fabricated, or fabricated by hand. In particular, the layered devices described herein may be fabricated by sequentially layering various to form the final device. A layer maybe pre-processed by cutting, trimming, etc., or otherwise modifying it. Batch processing may be performed by layering strips or sheets corresponding to the different layers, and cutting or stamping the devices out of the strips or sheets after they have been at least partially assembled.
In one variation, a nasal adhesive device may be fabricated by forming each layer (e.g., but cutting the adhesive holdfast substrate, the flap leaflets, etc.), and by placing the positing the flap valve limiter adjacent to the flap valve layer and adhesively securing the layers (using, for example, an adhesive ring). As described in one of the examples below, the flap valve leaflets may be formed of the adhesive substrate layer. A continuous fabrication process may include layering the device as part of a rolling strip of materials that are sequentially layered, as shown in
This adhesive nasal device may be placed in communication with a subject's nostril(s) so that when the subject inhales, the elastomeric bands forming the valve flex away from the air-permeable layer (the valve limiting layer), and open to allow air to flow with only minimal resistance. This is illustrated in
The device shown in
The device in
A layer of adhesive 3331 may be applied or otherwise secured to the opposite side of the thin film adhesive substrate. In some variations, both sides of the adhesive substrate are adhesive (or include an adhesive layer), or the thin film adhesive substrate is itself adhesive. An alignment guide 3313 may then be attached around the airflow resistor and secured to the layered adhesive holdfast by a ring of adhesive 3337 (e.g., a two-sided adhesive ring).
Method of Use
As previously mentioned, any of the layered adhesive devices described herein may be used to treat snoring or other sleep disordered breathing. A subject may apply the device to his or her own nose. For example, the devices may be first removed from clean or sterile packaging. The devices described herein may be sized (e.g., child/adult, small, medium, large, etc.), or one-size-fits-all. Placement of an adhesive nasal device may be done in front of a mirror or can occur without looking at a mirror. A device having an adhesive holdfast with a protective cover may be prepared for application by first removing the protective cover, and then aligning the airflow resistor (or alignment guide) with one or both nostrils (depending on the device). The device may then be applied to the nostril (e.g., over the nostril) by pushing the adhesive holdfast against the nostril to secure the airflow resistor in communication with the nostril(s). After placement of the adhesive nasal devices, the user may test whether an adequate seal has been created or has been maintained between the adhesive holdfast and the region in, on, over or around the nostrils through a variety of methods. On exhalation for example, it will be clear to the user whether a good seal has been created between the device and his nasal cavity because exhalation will be more difficult. Similarly, the device may be removed by peeling the adhesive holdfast away from the nostril.
An adhesive nasal device is typically worn over each nostril so that the airflow resistor allows airflow through the nostrils to be substantially unaffected by inspiration, but provides resistance to expiratory airflow through the nose. However, it may be advantageous to reverse this arrangement to inhibit inspiratory airflow and allow expiratory airflow to occur through the nose without substantial resistance. In some variations, an airflow resistor may be worn on only one nostril so that there is a resistance to airflow during expiration in only one nostril and there is no significant resistance to inspiration or exhalation through the other nostril. In one variation, a device having a fixed resistance (to both inspiration and expiration) could be worn by over, around or in one nostril, while the other nostril is in communication with an airflow resistor configured to have little inspiratory resistance and significant expiratory resistance. In some variation the device(s) may be worn or configured so that there is a greater resistance to airflow during inspiration in one nostril, and a greater resistance to airflow during exhalation in the other nostril. In general, however, it is believed that providing a slight resistance to airflow during expiration in both nostrils may be used to treat snoring or other sleep disordered breathing.
Once a single-nostril device has been applied over one nostril (as shown in
This application claims priority to U.S. Provisional Patent Applications: Ser. No. 60/905,850 (titled “NASAL DEVICES”) filed Mar. 7, 2007; Ser. No. 60/859,715 (titled “Nasal Devices”) filed Nov. 16, 2006; Ser. No. 60/811,814 (titled “RESPIRATORY DEVICES”) filed Jun. 7, 2006. Each of these provisional patent applications is incorporated herein by reference in its entirety.
Number | Name | Date | Kind |
---|---|---|---|
69396 | Curtis | Oct 1867 | A |
628111 | McHatton | Jul 1899 | A |
669098 | Overshiner | Mar 1901 | A |
675275 | Gunning | May 1901 | A |
718785 | McNary | Jan 1903 | A |
746869 | Moulton | Dec 1903 | A |
774446 | Moulton | Nov 1904 | A |
810617 | Carence | Jan 1906 | A |
1819884 | Fores | Aug 1931 | A |
2198959 | Clarke | Apr 1940 | A |
2237954 | Wilson | Apr 1941 | A |
2264153 | Rowe | Nov 1941 | A |
2274886 | Carroll | Mar 1942 | A |
2282681 | Stotz | May 1942 | A |
2335936 | Hanlon | Dec 1943 | A |
2433565 | Korman | Dec 1947 | A |
2448724 | McGovney | Sep 1948 | A |
2593315 | Kraft | Apr 1952 | A |
2672138 | Carlock | Mar 1954 | A |
2751906 | Irvine | Jun 1956 | A |
2777442 | Zelano | Jan 1957 | A |
3145711 | Beber | Aug 1964 | A |
3315701 | Stilwell | Apr 1967 | A |
3370305 | Goott et al. | Feb 1968 | A |
3451392 | Cook et al. | Jun 1969 | A |
3463149 | Albu | Aug 1969 | A |
3513839 | Vacante | May 1970 | A |
3556122 | Laerdal | Jan 1971 | A |
3616802 | Marinaccio | Nov 1971 | A |
3657855 | Swezey | Apr 1972 | A |
3695265 | Brevik | Oct 1972 | A |
3710799 | Caballero | Jan 1973 | A |
3722509 | Nebel | Mar 1973 | A |
3747597 | Olivera | Jul 1973 | A |
3802426 | Sakamoto | Apr 1974 | A |
3884223 | Keindl | May 1975 | A |
3902621 | Hidding | Sep 1975 | A |
4004584 | Geaney | Jan 1977 | A |
4030491 | Mattila | Jun 1977 | A |
4040428 | Clifford | Aug 1977 | A |
4054134 | Kritzer | Oct 1977 | A |
4062358 | Kritzer | Dec 1977 | A |
4094316 | Nathanson | Jun 1978 | A |
4143872 | Havstad et al. | Mar 1979 | A |
4212296 | Schaar | Jul 1980 | A |
4220150 | King | Sep 1980 | A |
4221217 | Amezcua | Sep 1980 | A |
4226233 | Kritzer | Oct 1980 | A |
4240420 | Riaboy | Dec 1980 | A |
4267831 | Aguilar | May 1981 | A |
4327719 | Childers | May 1982 | A |
RE31040 | Possis | Sep 1982 | E |
4354489 | Riaboy | Oct 1982 | A |
4403616 | King | Sep 1983 | A |
4456016 | Nowacki et al. | Jun 1984 | A |
4487207 | Fitz | Dec 1984 | A |
4533137 | Sonne | Aug 1985 | A |
4582058 | Depel et al. | Apr 1986 | A |
4584997 | Delong | Apr 1986 | A |
4601465 | Roy | Jul 1986 | A |
4640277 | Meyer et al. | Feb 1987 | A |
4651873 | Stolcenberg et al. | Mar 1987 | A |
4702374 | Kelner | Oct 1987 | A |
4718554 | Barbato | Jan 1988 | A |
4739987 | Nicholson | Apr 1988 | A |
4822354 | Elosegui | Apr 1989 | A |
4854574 | Larson et al. | Aug 1989 | A |
4860766 | Sackner | Aug 1989 | A |
4862903 | Campbell | Sep 1989 | A |
4908028 | Colon et al. | Mar 1990 | A |
4913138 | Yoshida et al. | Apr 1990 | A |
4919138 | Nordenstroom | Apr 1990 | A |
4973047 | Norell | Nov 1990 | A |
4979505 | Cox | Dec 1990 | A |
4984302 | Lincoln | Jan 1991 | A |
4984581 | Stice | Jan 1991 | A |
5016425 | Weick | May 1991 | A |
5033312 | Stupecky | Jul 1991 | A |
5038621 | Stupecky | Aug 1991 | A |
5052400 | Dietz | Oct 1991 | A |
5059208 | Coe et al. | Oct 1991 | A |
5074293 | Lott et al. | Dec 1991 | A |
5078739 | Martin | Jan 1992 | A |
5092781 | Casciotti et al. | Mar 1992 | A |
5117820 | Robitaille | Jun 1992 | A |
5197980 | Gorshkov et al. | Mar 1993 | A |
5255687 | McKenna | Oct 1993 | A |
5383470 | Kolbly | Jan 1995 | A |
5385542 | Rawlings | Jan 1995 | A |
5391205 | Knight | Feb 1995 | A |
5392773 | Bertrand | Feb 1995 | A |
5394867 | Swann | Mar 1995 | A |
5414627 | Wada et al. | May 1995 | A |
5415660 | Campbell et al. | May 1995 | A |
5425359 | Liou | Jun 1995 | A |
5459544 | Emura | Oct 1995 | A |
5522382 | Sullivan et al. | Jun 1996 | A |
5535739 | Rapoport et al. | Jul 1996 | A |
5562641 | Flomenblit et al. | Oct 1996 | A |
5568808 | Rimkus | Oct 1996 | A |
5572994 | Smith | Nov 1996 | A |
5607469 | Frey | Mar 1997 | A |
5649533 | Oren | Jul 1997 | A |
5665104 | Lee | Sep 1997 | A |
5727546 | Clarke et al. | Mar 1998 | A |
5730122 | Lurie | Mar 1998 | A |
5740798 | McKinney | Apr 1998 | A |
5743256 | Jalowayski | Apr 1998 | A |
5763979 | Mukherjee et al. | Jun 1998 | A |
5775335 | Seal | Jul 1998 | A |
5782896 | Chen et al. | Jul 1998 | A |
5797920 | Kim | Aug 1998 | A |
5803121 | Estes | Sep 1998 | A |
5823187 | Estes et al. | Oct 1998 | A |
5848590 | Smith | Dec 1998 | A |
5865170 | Moles | Feb 1999 | A |
5876434 | Flomenblit et al. | Mar 1999 | A |
5890998 | Hougen | Apr 1999 | A |
5899832 | Hougen | May 1999 | A |
5910071 | Hougen | Jun 1999 | A |
5911756 | Debry | Jun 1999 | A |
5947119 | Reznick | Sep 1999 | A |
5954766 | Zadno-Azizi et al. | Sep 1999 | A |
5957978 | Blom | Sep 1999 | A |
5992006 | Datsikas | Nov 1999 | A |
6004342 | Filis | Dec 1999 | A |
6058932 | Hughes | May 2000 | A |
6083141 | Hougen | Jul 2000 | A |
D430667 | Rome | Sep 2000 | S |
6119690 | Pantaleo | Sep 2000 | A |
6165133 | Rapoport et al. | Dec 2000 | A |
6177482 | Cinelli et al. | Jan 2001 | B1 |
6189532 | Hely et al. | Feb 2001 | B1 |
6213955 | Karakasoglu et al. | Apr 2001 | B1 |
6219997 | Friberg et al. | Apr 2001 | B1 |
6258100 | Alferness et al. | Jul 2001 | B1 |
6287290 | Perkins et al. | Sep 2001 | B1 |
6293951 | Alferness et al. | Sep 2001 | B1 |
6311839 | Lo | Nov 2001 | B1 |
6328038 | Kessler et al. | Dec 2001 | B1 |
6369126 | Cinelli et al. | Apr 2002 | B1 |
6398775 | Perkins et al. | Jun 2002 | B1 |
6439233 | Geertsema | Aug 2002 | B1 |
6484725 | Chi | Nov 2002 | B1 |
6500095 | Hougen | Dec 2002 | B1 |
6510846 | O'Rourke | Jan 2003 | B1 |
6527761 | Soltesz et al. | Mar 2003 | B1 |
6561188 | Ellis | May 2003 | B1 |
6562057 | Santin | May 2003 | B2 |
6568387 | Davenport et al. | May 2003 | B2 |
6573421 | Lemaire | Jun 2003 | B1 |
6581598 | Foran et al. | Jun 2003 | B1 |
6585639 | Kotmel et al. | Jul 2003 | B1 |
6592594 | Rimbaugh et al. | Jul 2003 | B2 |
6592995 | Topolkaraev et al. | Jul 2003 | B2 |
6595215 | Wood | Jul 2003 | B2 |
6609516 | Hollander et al. | Aug 2003 | B2 |
6626172 | Karow et al. | Sep 2003 | B1 |
6626179 | Pedley | Sep 2003 | B1 |
6631721 | Salter et al. | Oct 2003 | B1 |
6679264 | Deem et al. | Jan 2004 | B1 |
6694979 | Deem et al. | Feb 2004 | B2 |
6722360 | Doshi | Apr 2004 | B2 |
6726598 | Jarvis et al. | Apr 2004 | B1 |
6737160 | Full et al. | May 2004 | B1 |
6769432 | Keifer | Aug 2004 | B1 |
6776162 | Wood | Aug 2004 | B2 |
6776163 | Dougill et al. | Aug 2004 | B2 |
6811538 | Westbrook et al. | Nov 2004 | B2 |
6841716 | Tsutsumi | Jan 2005 | B1 |
6848446 | Noble | Feb 2005 | B2 |
6863066 | Ogle | Mar 2005 | B2 |
6866652 | Bierman | Mar 2005 | B2 |
6872439 | Fearing et al. | Mar 2005 | B2 |
6913017 | Roberts | Jul 2005 | B2 |
6921574 | Cinelli et al. | Jul 2005 | B2 |
6997177 | Wood | Feb 2006 | B2 |
7011723 | Full et al. | Mar 2006 | B2 |
7013896 | Schmidt | Mar 2006 | B2 |
7047969 | Noble | May 2006 | B2 |
7156098 | Dolezal et al. | Jan 2007 | B2 |
7175723 | Jones et al. | Feb 2007 | B2 |
7178524 | Noble | Feb 2007 | B2 |
7201169 | Wilkie et al. | Apr 2007 | B2 |
D542407 | Stallard et al. | May 2007 | S |
7263996 | Yung Ho | Sep 2007 | B2 |
D566834 | Barton | Apr 2008 | S |
7422014 | Smith | Sep 2008 | B1 |
7559326 | Smith et al. | Jul 2009 | B2 |
7578294 | Pierro et al. | Aug 2009 | B2 |
7640934 | Zollinger et al. | Jan 2010 | B2 |
7880051 | Madsen et al. | Feb 2011 | B2 |
7992566 | Pflueger et al. | Aug 2011 | B2 |
20010051799 | Ingenito | Dec 2001 | A1 |
20010056274 | Perkins et al. | Dec 2001 | A1 |
20020062120 | Perkins et al. | May 2002 | A1 |
20020077593 | Perkins et al. | Jun 2002 | A1 |
20020112729 | DeVore et al. | Aug 2002 | A1 |
20020157673 | Kessler et al. | Oct 2002 | A1 |
20030024527 | Ginn | Feb 2003 | A1 |
20030050648 | Alferness et al. | Mar 2003 | A1 |
20030070682 | Wilson et al. | Apr 2003 | A1 |
20030106555 | Tovey | Jun 2003 | A1 |
20030106556 | Alperovich et al. | Jun 2003 | A1 |
20030140925 | Sapienza et al. | Jul 2003 | A1 |
20030149387 | Barakat et al. | Aug 2003 | A1 |
20030154988 | DeVore et al. | Aug 2003 | A1 |
20030158515 | Gonzalez et al. | Aug 2003 | A1 |
20030195552 | Santin | Oct 2003 | A1 |
20030209247 | O'Rourke | Nov 2003 | A1 |
20040016432 | Genger et al. | Jan 2004 | A1 |
20040020489 | Gillespie et al. | Feb 2004 | A1 |
20040020492 | Dubrul et al. | Feb 2004 | A1 |
20040020493 | Wood | Feb 2004 | A1 |
20040055606 | Hendricksen et al. | Mar 2004 | A1 |
20040112379 | Djupesland | Jun 2004 | A1 |
20040123868 | Rutter | Jul 2004 | A1 |
20040149615 | Eisenbraun | Aug 2004 | A1 |
20040194779 | Doshi | Oct 2004 | A1 |
20040254491 | Ricciardelli | Dec 2004 | A1 |
20040261791 | Horian | Dec 2004 | A1 |
20040261798 | Rimkus | Dec 2004 | A1 |
20050010125 | Joy et al. | Jan 2005 | A1 |
20050011524 | Thomlinson et al. | Jan 2005 | A1 |
20050033344 | Dillard et al. | Feb 2005 | A1 |
20050051170 | Koo | Mar 2005 | A1 |
20050066965 | Cronk et al. | Mar 2005 | A1 |
20050133039 | Wood | Jun 2005 | A1 |
20050279351 | Lewis et al. | Dec 2005 | A1 |
20050284479 | Schrader et al. | Dec 2005 | A1 |
20060000472 | Fenton | Jan 2006 | A1 |
20060016450 | Pearson et al. | Jan 2006 | A1 |
20060085027 | Santin et al. | Apr 2006 | A1 |
20060144398 | Doshi et al. | Jul 2006 | A1 |
20060150978 | Doshi et al. | Jul 2006 | A1 |
20060150979 | Doshi et al. | Jul 2006 | A1 |
20060169285 | Bovo | Aug 2006 | A1 |
20060266361 | Hernandez | Nov 2006 | A1 |
20060283461 | Lubke et al. | Dec 2006 | A1 |
20070016123 | Jensen | Jan 2007 | A1 |
20070051364 | Jacobson et al. | Mar 2007 | A1 |
20070095349 | Hansmann et al. | May 2007 | A1 |
20070175478 | Brunst | Aug 2007 | A1 |
20070227542 | Kashmakov et al. | Oct 2007 | A1 |
20070277832 | Doshi et al. | Dec 2007 | A1 |
20070287976 | Sherrill | Dec 2007 | A1 |
20070295338 | Loomas et al. | Dec 2007 | A1 |
20080023007 | Dolezal et al. | Jan 2008 | A1 |
20080032119 | Feldhahn et al. | Feb 2008 | A1 |
20080041397 | Hirs | Feb 2008 | A1 |
20080053460 | Wilson | Mar 2008 | A1 |
20080087286 | Jones | Apr 2008 | A1 |
20080099021 | Moore | May 2008 | A1 |
20080135044 | Freitag et al. | Jun 2008 | A1 |
20080142014 | Jiang | Jun 2008 | A1 |
20090145441 | Doshi et al. | Jun 2009 | A1 |
20090145788 | Doshi et al. | Jun 2009 | A1 |
20090188493 | Doshi et al. | Jul 2009 | A1 |
20090194100 | Minagi | Aug 2009 | A1 |
20090194109 | Doshi et al. | Aug 2009 | A1 |
20100326447 | Loomas et al. | Dec 2010 | A1 |
20110005520 | Doshi et al. | Jan 2011 | A1 |
20110005528 | Doshi et al. | Jan 2011 | A1 |
20110005529 | Doshi et al. | Jan 2011 | A1 |
20110005530 | Doshi et al. | Jan 2011 | A1 |
20110240032 | Doshi | Oct 2011 | A1 |
20110240038 | Doshi et al. | Oct 2011 | A1 |
20120055488 | Pierce et al. | Mar 2012 | A1 |
Number | Date | Country |
---|---|---|
0434258 | Jun 1991 | EP |
1157663 | Nov 2001 | EP |
1205203 | May 2002 | EP |
1481702 | Dec 2004 | EP |
2862614 | May 2005 | FR |
2096574 | Oct 1982 | GB |
2324729 | Apr 1998 | GB |
52-123786 | Oct 1977 | JP |
55-122742 | Sep 1980 | JP |
58-136345 | Aug 1983 | JP |
63-189257 | Dec 1988 | JP |
7-47126 | Feb 1995 | JP |
3059270 | Mar 1999 | JP |
2001-299916 | Oct 2001 | JP |
2002-153489 | May 2002 | JP |
2002-219174 | Aug 2002 | JP |
2002-345963 | Dec 2002 | JP |
2002-345966 | Dec 2002 | JP |
0540589 | Feb 2005 | JP |
2005-505355 | Feb 2005 | JP |
2008-136496 | Jun 2008 | JP |
2008-522763 | Jul 2008 | JP |
2048820 | Nov 1995 | RU |
1586709 | Aug 1990 | SU |
WO 9012614 | Nov 1990 | WO |
WO 9308777 | May 1993 | WO |
WO 9517220 | Jun 1995 | WO |
WO 9533520 | Dec 1995 | WO |
WO 9846310 | Oct 1998 | WO |
WO 9903395 | Jan 1999 | WO |
WO 0029066 | May 2000 | WO |
WO 0050121 | Aug 2000 | WO |
WO 0067848 | Nov 2000 | WO |
WO 0102042 | Jan 2001 | WO |
WO 0113839 | Mar 2001 | WO |
WO 0113908 | Mar 2001 | WO |
WO 0149371 | Jul 2001 | WO |
WO 0187170 | Nov 2001 | WO |
WO 0189381 | Nov 2001 | WO |
WO 0238038 | May 2002 | WO |
WO 03022124 | Mar 2003 | WO |
WO 03034927 | May 2003 | WO |
WO 2004084998 | Oct 2004 | WO |
WO2005000805 | Jan 2005 | WO |
WO2006040585 | Apr 2006 | WO |
WO 2006063339 | Jun 2006 | WO |
WO2007023607 | Mar 2007 | WO |
WO 2007129814 | Nov 2007 | WO |
WO 2007134458 | Nov 2007 | WO |
WO 2007146133 | Dec 2007 | WO |
Entry |
---|
Doshi et al.; U.S. Appl. No. 12/884,140 entitled “Sealing nasal devices for use while sleeping,” filed Sep. 16, 2010. |
Doshi et al.; U.S. Appl. No. 12/884,146 entitled “Nasal devices for use while sleeping,” filed Sep. 16, 2010. |
Doshi et al.; U.S. Appl. No. 12/955,633 entitled “Nasal respiratory devices,” filed Nov. 29, 2010. |
Sather et al.; U.S. Appl. No. 12/941,734 entitled “Nasal devices having a safe failure mode and remotely activatable,” filed Nov. 8, 2010. |
Doshi et al.; U.S. Appl. No. 12/711,782 entitled “Respiratory devices,” filed Feb. 24, 2010. |
Favet et al.; U.S. Appl. No. 13/035,524 entitled “Nasal devices including layered nasal devices and delayed resistance adapters for use with nasal devices,” filed Feb. 25, 2011. |
Lai et al.; U.S. Appl. No. 13/062,888 entitled “Nasal devices, systems and methods,” filed Mar. 8, 2011. |
Sather et al.; U.S. Appl. No. 12/044,868 entitled “Respiratory sensor adapters for nasal devices,” filed Mar. 7, 2008. |
Pierce et al.; U.S. Appl. No. 12/141,875 entitled “Adhesive nasal respiratory devices,” filed Jun. 18, 2008. |
Sather et al.; U.S. Appl. No. 12/405,837 entitled “Nasal devices with noise-reduction and methods of use,” filed Mar. 17, 2009. |
Ferdinand et al.; U.S. Appl. No. 12/485,750 entitled “Adjustable resistance nasal devices,” filed Jun. 16, 2009. |
Hakel et al.; Nasal obturator for velopharyngeal dysfunction in dysarthria: technical report on a one-way valve; Journal of Medical Speech-Language Pathology; vol. 12; No. 4; pp. 155-159; 2004. |
Doshi et al.; U.S. Appl. No. 13/212,948 entitled “Packaging and dispensing nasal devices,” filed Aug. 18, 2011. |
Sather et al.; U.S. Appl. No. 13/117,933 entitled “Layered nasal respiratory devices,” filed May 27, 2011. |
Doshi et al., U.S. Appl. No. 13/545,865 entitled “Nasal Devices,” filed Jul. 10, 2012. |
Witt et al.; U.S. Appl. No. 61/141,251 entitled “System, Method, and Respiration Appliance for Supporting the Airway of a Subject,” filed Dec. 30, 2008. |
Doshi et al; U.S. Appl. No. 11/811,339 entitled “Nasal devices,” filed Jun. 7, 2007. |
Doshi et al; U.S. Appl. No. 11/941,913 entitled “Nasal device applicators,” filed Nov. 16, 2007. |
Doshi et al; U.S. Appl. No. 11/941,915 entitled “Adjustable nasal devices,” filed Nov. 16, 2007. |
Doshi, Rajiv; U.S. Appl. No. 12/014,060 entitled “Methods and devices for improving breathing in patients with pulmonary disease,” filed Jan. 14, 2008. |
Mahadevia, A. K. et al., Effects of expiratory positive airway pressure on sleep-induced respiratory abnormalities in patients with hypersomnia-sleep apnea syndrome, Am Rev Respir Dis 1983, vol. 128, pp. 708-711, Oct. 1983. |
http://chinookmed.com/index.cfm/fa/product.display&Product—ID=275. |
Dillard, D. et al., Evaluation of a novel intra-bronchial valve to produce lung volume reduction, World Congress of Bronchology, Jun. 2002 (figs. 1-4 available upon request). |
Number | Date | Country | |
---|---|---|---|
20070283962 A1 | Dec 2007 | US |
Number | Date | Country | |
---|---|---|---|
60905850 | Mar 2007 | US | |
60859715 | Nov 2006 | US | |
60811814 | Jun 2006 | US |