Nasal respiratory devices may be worn to treat many medical conditions, such as sleep disordered breathing (including snoring, sleep apnea, etc.), Cheyne Stokes breathing, UARS, COPD, hypertension, asthma, GERD, heart failure, and other respiratory and sleep conditions. Devices that provide a greater resistance to exhalation than to inhalation may be particularly useful, and may be worn by a subject when the subject is either awake or asleep. Indeed, subjects may apply a nasal device before falling to sleep, so that the device may provide therapeutic benefits during sleep. However, optimal levels of resistance to exhalation (and/or inspiration) may be different for individual users, or for the same user over the course of treatment for a particular user, and even over the course of a single treatment session. In some instances, the optimal resistance may be determined by adjusting the resistance while the subject is sleeping with the device (e.g., without waking the subject).
Examples of nasal respiratory devices have been well-described in the following US patents and 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; U.S. patent application Ser. No. 11/298,339, titled “Respiratory Devices”, filed Dec. 8, 2005; U.S. patent application Ser. No. 11/298,362, titled “Methods of Treating Respiratory Disorders”, filed Dec. 8, 2005; U.S. patent application Ser. No. 11/805,496, titled “Nasal Respiratory Devices”, filed May 22, 2007; U.S. Pat. No. 7,506,649, titled “Nasal Devices”, filed Jun. 7, 2007; U.S. patent application Ser. No. 11/759,916, titled “Layered Nasal Devices” filed Jun. 7, 2007; U.S. patent application Ser. No. 11/811,401, titled “Nasal Respiratory Devices for Positive End-Expiratory Pressure”, filed Jun. 7, 2007; U.S. patent application Ser. No. 11/941,915, titled “Adjustable Nasal Devices”, filed Nov. 19, 2007; and U.S. patent application Ser. No. 11/941,913, titled “Nasal Device Applicators”, filed Nov. 16, 2007.
Such nasal respiratory devices may passively 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. These devices act passively because they do not actively apply positive airflow, but instead regulate the subject's normal breathing, typically using one or more valves to inhibit exhalation more than inspiration. These nasal respiratory devices are adapted to be removably secured in communication with a nasal cavity, and may include a passageway (which may just be an opening) through the device, a valve (or airflow resistor) in communication with the passageway, and a holdfast. The holdfast is configured to removably secure the respiratory device at least partly within (and/or at least partly over and/or at least partly around) the nasal cavity. The airflow resistor (which may be a valve) is typically configured to provide greater resistance during exhalation than during inhalation.
Examples of these devices are shown in
For example, the nasal device shown in
Adjustable-resistance nasal devices may be particularly beneficial to determine (e.g., by a sleep study) the appropriate resistance(s) to exhalation (and/or inhalation) for a respiratory device that inhibits exhalation more than inhalation. Although the majority of devices described herein refer to nasal devices, the invention and principles described herein may be adapted for use with respiratory devices that including oral masks, and combined oral/nasal masks, including PAP valve masks. Adjustable-resistance nasal devices may also be used or by a subject within a single treatment or between treatment days. For example, a subject may increase the resistance to exhalation manually (himself or herself) as the subject acclimates to the device.
The devices and methods described herein address the needs and concerns referred to above.
Described herein are nasal respiratory devices including devices configured to have an adjustable resistance. In general, nasal respiratory devices and nasal devices having an adjustable resistance may allow adjustment of either (or both) the resistance to inhalation and the resistance to exhalation. In particular, described herein are adjustable nasal devices configured to allow adjustment of the resistance to exhalation (“expiratory resistance”). The adjustable nasal respiratory devices described herein may be referred to as “adjustable-resistance nasal devices” or simply “adjustable nasal devices” although they may include additional features in addition to the resistance-adjustment features. The resistance of these adjustable resistance nasal devices may be manually or automatically adjusted. In some variations, the resistance is remotely adjustable (e.g., by a third party), and may be adjusted while the subject is sleeping. The adjustable devices may have their resistance adjusted by altering and controlling the size (e.g., cross-sectional area) of one or more leak pathways through the devices described herein. In particular, the adjustment of the resistance (e.g., the resistance to exhalation) may be adjusted by increasing or decreasing the size or number leak pathways that are independent of the airflow resistor(s) in the device.
In some variations, the adjustable resistance nasal devices described herein are nasal devices having flap valve airflow resistors. As described in greater detail below, a flap valve is generally a flat structure having two opposing faces and a minimal thickness that substantially opens during inhalation and closes during exhalation. Although the airflow resistors described herein are primarily flap-valve type airflow resistors, any appropriate airflow resistor may be used, including non-flap valve airflow resistors.
An adjustable respiratory device as described herein may be continuously adjustable between a range of resistances. For example, the adjustable devices may allow adjustment of expiratory resistance within a range that is between about 0.01 and about 0.25 cm H2O/(ml/sec) when measured at 100 ml/sec. In some variations the resistance to inhalation (“inspiratory resistance”) may be separately adjustable. For example, the resistance to inhalation is less than the resistance to exhalation, and may be adjustable within a range of between about 0.0001 and about 0.02 cm H2O/(ml/sec) when measured at 100 ml/sec. In general, however, the adjustable-resistance nasal devices described herein, the adjustability of the resistance typically refers to adjusting the resistance to exhalation.
In some variations, an adjustable resistance respiratory device is adjustable to predetermined settings or steps. For example, the expiratory resistance of an adjustable resistance nasal device may be adjustable in increments of 0.005 cm H2O/(ml/sec) when measured at 100 ml/sec. In some variations, the device may be adjustable between, two, three, four, five, six, or more expiratory resistance levels.
The adjustable respiratory devices described herein typically include one or more leak pathways that are configured to remain open during both inhalation and exhalation. During operation of the nasal devices described herein, the airflow resistor (e.g., flap valve(s)) are typically closed during exhalation, increasing the resistance within the target range, and the flap valve(s) of the airflow resistor are typically at least partly open during inhalation. In general, the resistance to exhalation may be adjusted by controlling either or both the closing of the airflow resistor and/or the leak pathways. Adjustment of the expiratory resistance by controlling the leak pathways that are independent of the airflow resistor may be particularly useful, since changing the closing state of the airflow resistor may make the expiratory resistance difficult to control. In addition, adjustment of the airflow resistor may be used to adjust the resistance to inhalation, since modification of the airflow resistor may modify the opening of the airflow resistor during inhalation.
In general, adjustable-resistance nasal respiratory devices have a resistance to exhalation that is greater than the resistance to inspiration. In some variations, the resistance to inspiration is relatively constant (i.e., pre-set), while the resistance to exhalation may be adjusted. In other variations, both the resistance to exhalation and the resistance to inspiration are adjustable. In still other variations, the resistance to inspiration is adjustable while the resistance to exhalation is pre-set. Although the majority of examples provided herein refer only to devices and methods for adjusting the expiratory resistance, many of the same principles and techniques described may be applied to allow adjusting of the inspiratory resistance.
As used herein, the term “adjusting” or “adjustable” typically refers to modifying or changing the resistance of a nasal respiratory device. An adjustment may be made dynamically (e.g., while the device is being worn), or it may be made prior to applying the device to a subject or patient. As mentioned above, an adjustable device may be continuously adjustable, so that the resistance (e.g., to exhalation) may be transitioned continuously over a range, or it may be discretely adjustable, so that the resistance may be transitioned in steps. The adjustable devices may be user- or subject-adjustable, and may include one or more controls (e.g., knobs, buttons, dials, wheels, etc.). In some variations the adjustable devices are remotely adjustable. Adjustable devices may be adjusted by the application or removal of a modifying member or component (e.g., a snap-on resistance modifying member, an adhesive resistance modifying member, etc.). Any of the resistance modifying members that attach to the nasal device may also be attached to a nasal cannula or sensor (e.g., thermister, airflow sensor, pressure sensor, etc.) or may be adapted for use with such a sensor or sensing element.
In some variations, the resistance to exhalation may be modified by controlling the number, size and/or shape of a leak pathway (or pathways) through the device. As used herein, the term “leak pathway” may refer to an opening or channel through the device that is open when the airflow resistor is closed. A leak pathway may be independent (and separate from) the airflow resistor. In some variations a leak pathway is formed around the airflow resistor (e.g., flap or membrane valve).
In general, the nasal devices having an adjustable resistance typically include an airflow resistor (which may comprise, for example, a flap valve) that is configured to inhibit exhalation more than inhalation, and a holdfast configured to secure the nasal device in communication with one or more of the subject's nostrils. The nasal devices may also include one or more leak pathways or openings that are typically open during both exhalation and inhalation. As mentioned, an adjustable-resistance nasal device may include any appropriate airflow resistor, including (but not limited to) flap or diaphragm valves, ball valves, duckbill valves, hinge-less valves, balloon valves, stepper valves, slit valves, PEEP valves, threshold valves, etc., or the like. In addition, any of the adjustable-resistance nasal devices described herein may include any appropriate holdfast for securing the device in communication with the subject's nose. For example, any of these devices may be adhesive nasal devices, which include one or more adhesive holdfasts or may be mask devices that fit over the nose and/or the mouth.
The adjustable resistance nasal devices described herein may be adjustable within any appropriate treatment range, including those described above. For example, an adjustable resistance nasal device may be adjustable so that the resistance to exhalation can be set to between about 1 and about 250 cm H2O/(l/sec). In some variations, the resistance to exhalation can be set between about 5 and about 250 cm H2O/(l/sec). The nasal devices described herein may have a very low resistance to inspiration. For example, the resistance to inspiration may be between about 0.01 and about 5 cm H2O/(l/sec) (and in adjustable resistance nasal devices configured to allow adjustment of the inhalational resistance, the resistance to inhalation may be varied within this range). As mentioned below, the adjustment may be continuous (over a range or resistances) or it may be discrete (in steps), or some combination of the two. The adjustment may be linear or non-linear.
In some variations, an adjustable resistance nasal device includes a leak pathway that can be plugged or covered. The leak pathway cover may be integrated as part of the nasal device, or it may be a separate component or structure that can be applied to the nasal device to occlude or partially occlude the leak pathway and thereby increase the resistance to exhalation (or be removed from the nasal device to decrease resistance to exhalation). For example, the device may include a snap-on or adhesive cover for covering one or more leak pathways. In some variations, the cover is adjustable so it only partially occludes the leak pathway. An example of an adhesive plug or cover may be a piece of tape or adhesive strip that can be used to cover the leak pathway. In some variations the cover or plug is attached (e.g., by a tether, hinge, etc.) to the nasal device. In some variations the plug is integral to the device and may be pushed (e.g., by a finger) to activate and increase the resistance (and pulled to decrease the resistance).
In general, in any of the variations described herein, the resistance (e.g., to exhalation) may be modulated by controlling the amount of a leak pathway occluded/opened, or the number of leak pathways opened or occluded. If a device has multiple leak pathways, the resistance may be stepped up by blocking increasing numbers of the leak pathways. In any of these variations, the nasal devices may include adjustable controls that are calibrated as to the resistance (e.g., expiratory resistance). For example, a snap-fit cover to increase resistance may be labeled or otherwise marked to indicate the resistance (or range of resistances) that the nasal device will have after applying the cover. This general principle may be applied to any of the nasal devices or components used to modulate the resistance described herein. For example, a control for continuously or discretely adjusting the resistance may include markings or settings to indicate the resistance.
In some variations, an adjustable resistance nasal device may include a leak pathway that is directly adjustable by changing the size or shape of the leak pathway opening. For example the leak pathway may be adapted to constrict (e.g., by including an inflatable or swellable material). In some variations the leak pathway may include a shutter or cover that may be used to close it off, or partially close it off. For example, the leak pathway may include a louver-type cover or shutter that can be moved to partially or completely occlude the opening of one or more leak pathways. In some variations the leak pathway includes an iris (e.g., a dilating iris) that can be used to cover or open the leak pathway. In any of these embodiments, the device may include one more handles/controls for manually operating the closing and/or opening of the leak pathway or may include electronic means of closing and/or opening the leak pathway, especially from a remote location (for example in the control room of a sleep laboratory).
Also described herein are nasal devices in which the position of all or a part of the airflow resistor may be adjusted to modify the resistance. For example, the position of the airflow resistor may be modified relative to a passageway through the device. In some variations the registration of the airflow resistor relative to the passageway may be changed, to increase/decrease the size of a leak pathway at least partially around the airflow resistor. For example, the airflow resistor may include a flap valve that can be rotated slightly relative to the passageway. In some variations the airflow resistor is a flap valve that can be shifted with respect to the flap valve limiter (e.g., supports or struts) across a passageway, so that the flap valve can be seated in different positions that allow more or less air to pass through the passageway (leak) when the valve is closed during exhalation. In some variations the proximal/distal position of the airflow resistor may be changed. For example, the airflow resistor may be moved proximally or distally along the length of a tapered passageway. As the device moves in the direction of the narrowing of the tapered passageway (e.g., proximally) less air may pass around the device, thereby increasing the leak size and the thus the resistance to exhalation. In some variations movement of the airflow resistor (or a portion of the airflow resistor) may be controlled by a control such as a knob. For example, a worm-screw type control may be used to move the airflow resistor proximally or distally in some variations. In some variations, the nasal device includes one or more leak pathways as part of the nasal device. For example, the airflow resistor may include a flap valve having one or more holes (leak pathways). The expiratory resistance may be adjustable by rotating the flap valve so that the holes on the flap valve are partially occluded (or un-occluded) when the flap valve is closed during exhalation. For example, the holes may be aligned with a portion of the flap valve limiter (e.g., struts, mesh, etc.) that blocks the holes closed when the valve is closed.
Also described herein are adjustable resistance nasal devices in which the operation of the airflow resistor is modified. For example, device may be adapted so that the airflow resistor (e.g., flap valve) is prevented to a controllable degree from closing completely during exhalation. In some variations the device includes one or more adjustable members that prevent the edge of the valve from fully closing during exhalation by propping the valve open. In some variations the device includes an adjustable member that raises or lowers the hinge or pivot portion of the valve so that the valve cannot seat closed (completely) during exhalation.
Also described herein are adjustable resistance nasal devices in which the length of the leak pathway is adjustable (e.g., can be increased and/or decreased). For example, the length of the leak pathway can be decreased by removing a section of the leak pathway to decrease the resistance during exhalation. In some variations the leak pathway is a telescoping channel that can be elongated or shortened.
Methods of adjusting the resistance, and particularly the expiratory resistance, are also described. In general, any of the devices described herein, alone or in combination, can be used to adjust or control (e.g., increase or decrease) the resistance to exhalation through the devices. These devices may be used to optimize treatment of disorders such as sleeping disorders, as described briefly above.
Also described herein are systems for adjusting the resistance of a nasal device. In particular, a system may include any of the nasal devices described herein and any cover for altering the expiratory resistance (e.g., a snap-on cover or plug, etc.).
A system for optimizing the resistance to exhalation may include a plurality of nasal devices having progressively increasing or decreasing resistances to exhalation. Such a system may be used to determine a patient-specific resistance for exhalation. In use, a subject may sequentially wear nasal devices having different expiratory resistance to determine or optimize comfort and/or efficacy of treatment.
In particular, described herein are systems or kits having a plurality of nasal devices each with increasing resistances to exhalation (and/or inspiration). The kit may include instruction to the user indicating the order in which each of the nasal devices is to be worn for a particular number of nights. Such a systems or kits may be referred to as “ramp systems”, “ramp kits,” “acclimation systems ” or “acclimation kits.” For example, a system may include a first device or set of devices having a very low resistance to exhalation (e.g., less than 20 cm H2O/(L/sec)) or range of expiratory resistances, a second device or set of devices having a resistance to exhalation (or range of expiratory resistance) that is slightly higher (e.g., approximately 30 cm H2O/(L/sec)), a third device or set of devices having a slightly higher yet resistance to exhalation (e.g., approximately 40 cm H2O/(L/sec)) or range of expiratory resistance, a fourth device or set of devices having a slightly higher resistance to exhalation than the third device or set of devices (e.g., approximately 50 cm H2O/(L/sec)) or range of expiratory resistance, a fifth device or set of devices having a slightly higher resistance to exhalation than the fourth device or set of devices (e.g., approximately 60 cm H2O/(L/sec)), or range of expiratory resistance, etc. so that the resistance of the next device or set of devices in the series is slightly higher than the previous device or set of devices. These first, second, third, etc. devices or set of devices are marked to indicate their order in the sequence (or are packaged to indicate their order in the sequence). The first device or set of devices in the sequence may be a ‘sham’ device, which does not include a significant resistance to exhalation compared to inhalation. The instructions may indicate the number of nights (or days, hours, minutes, etc.) that the user should wear a device (or devices) at each resistance level. In some variations, a single (e.g., disposable) device may be included for each night that that it should be worn. For example, the user may be instructed to wear the first device (or a device from the set of devices) and each subsequent set of devices for 3 days, in order for them to acclimate to the increasing expiratory resistance level. In another example, the system or kit may just include a series of sequentially labeled devices (or pairs of device if packaged as single-nostril devices) that indicate for each consecutive night which device should be worn; sequentially numbered device may have the same expiratory resistance or the expiratory resistance may increase or decrease slightly, depending on the acclimation strategy.
Thus, described herein are systems for acclimating a subject to a nasal device having a greater expiratory resistance than inspiratory resistance comprising a plurality of nasal devices having increasing resistances to exhalation, wherein most (if not all) of the devices have a resistance to exhalation that is greater than the resistance to inhalation. The plurality of devices are either marked or arranged to indicate the increasing resistance to exhalation corresponding to the order in which the devices are to be used by a subject. These nasal devices typically include an airflow resistor and holdfast, as described herein.
Also described herein are adjustable respiratory devices configured for remote adjustment. For example, any of the variations described above may include a receiver for receiving remote adjustment instructions, and an actuator for modifying the resistance of the device based on the adjustment instructions. For example, the device may include a wireless receiver and actuator (e.g., motor, driver, etc.) configured to modify the expiratory resistance. In some variation the expiratory resistance of the respiratory device may be adjusted by the application of an external magnetic field that acts on the device (e.g., to magnetically move the adjustment member to open/close a leak pathway).
The general principles, and at least some of the variations described above are illustrated in greater detail and described briefly below.
All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety, as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference in its entirety.
FIG. 20As is a perspective view of one variation of a remotely adjustable adjustable-resistance nasal device.
Described herein are adjustable-resistance respiratory devices, and particularly nasal respiratory devices having passive airflow resistors and a control or controls to adjust the resistance to exhalation through the device. These devices may be referred to as adjustable-resistance nasal devices or simply adjustable nasal devices. Adjustable resistance nasal devices typically include an airflow resistor configured to inhibit exhalation more than inhalation; a holdfast configured to secure the device in communication with the subject (e.g., with the subject's nose), a leak pathway that is independent of the airflow resistor, and a control configured to adjust the resistance to exhalation through the device. The control may adjust the resistance to exhalation by increasing or decreasing the size, shape and/or number of the leak pathway(s) in the device. In general, the resistance to exhalation may be adjusted within the range of between about 10 cm H2O*sec/L and about 250 cm H2O*sec/L (e.g., 0.01 and about 0.25 cm H2O/(ml/sec)) when measured at 100 ml/sec.
As used herein, the singular forms “a,” “an,” and “the” include plural reference unless the context clearly dictates otherwise.
The adjustable resistance features described herein may be used with any appropriate nasal devices, particularly those having a flap valve, including nasal devices for use with known PAP (e.g., biPAP, CPAP, etc.) masks.
Any appropriate nasal device may be configured as an adjustable-resistance nasal device, including the adhesive nasal devices described in more detail in
The adjustable-resistance nasal devices described herein may be secured in communication with a subject's nose or nostrils, and specifically with one or both of the subject's nasal cavities. A typical nasal device includes an airflow resistor that is configured to resist airflow in a first direction more than airflow in a second direction, and may also include a holdfast configured to secure the airflow resistor at least partially over, in, and/or across the subject's nose or nostril. The holdfast may include a biocompatible adhesive and a flexible region configured to conform to at least a portion of a subject's nose. The nasal devices described herein are predominantly adhesive nasal devices, however the adjustable-resistance features described may be used with nasal devices that are not adhesive nasal devices, including nasal devices having compressible or expandable holdfasts. Other embodiments include nasal devices in which the holdfast is mask that fits over the nose, the mouth or both the nose and mouth.
Nasal devices may be worn by a subject to modify the airflow thorough one or (more typically) both nostrils. Nasal devices may be secured over both of a subject's nostrils so that airflow through the nostrils passes primarily or exclusively through the nasal device(s). Adhesive nasal devices are removably secured over, partly over, and/or at least partly within the subject's nostrils by an adhesive. The 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. The alignment guide may also include or be configured as a noise-reduction element, as described in greater detail below. The adhesive nasal devices described herein may be composed of layers. Nasal devices composed of layers, which may also be referred to as layered 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 and an adhesive holdfast layer. In some variations, the airflow resistor may be a flap valve layer adjacent to a flap valve limiting layer, and may include 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 an additional layer of biocompatible adhesive.
The nasal devices described herein may be considered as passive nasal devices, because the flap valve may operate to passively regulate a subject's respiration. For example, a nasal device may create positive end expiratory pressure (“PEEP”) and/or expiratory positive airway pressure (“EPAP”) during respiration in a subject wearing the device. In contrast to active nasal devices, such as CPAP machines that apply positive pressure to the subject, the passive devices described herein do not require the addition of pressurized respiratory gas.
The adjustable-resistance nasal devices and methods described herein may be useful to treat a variety of medical conditions, and may also be useful for non-therapeutic purposes. For example, a nasal respiratory device may be used to treat sleep disordered breathing or snoring. The systems, devices and methods described herein are not limited to the particular nasal device embodiments described. Variations of the embodiments described may be made and still fall within the scope of the disclosure.
As used herein, a 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”). Any of the features described for single-nostril nasal devices may be used with whole-nose nasal devices, and vice-versa. In some variations, a 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.
One variation of an adjustable-resistance nasal device may include a noise-reduction feature (e.g., a noise-reduction flap or noise-reduction element). Other modifications, including sensors for detecting and/or reporting airflow through the nasal device or pressure within the user's nose, may also be included.
In some variations, the adjustable-resistance nasal devices are layered nasal device, formed of two or more layers. For example, a layered nasal device may include an adhesive holdfast layer and an airflow resistor layer. These layers may themselves be composed of separate layers, and these layers may be separated by other layers, or they may be adjacent. An adhesive holdfast layer may be 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 a structure having a generally planar geometry (e.g., flat), although it may have a thickness, which may be uniform or non-uniform in section. As mentioned briefly above, the support backing may be formed of one of the layers of a layered nasal device, such as the adhesive substrate layer.
In some variations, an adjustable-resistance nasal device has a body region including a passageway configured to be placed in communication with a subject's nasal passage. The body region may be a stiff or flexible body region, and may secure an airflow resistor therein. In some variations, the body region is at least partially surrounded by a holdfast (i.e., a planar adhesive holdfast). The body region may be modular, meaning that it is formed of two or more component sections that are joined together. Examples of such nasal devices can be found in U.S. Pat. No. 7,506,649, filed on Jun. 7, 2007, and previously incorporated by reference in its entirety. As described therein, the body region may be configured so that it does not irritate a subject wearing the nasal device. For example, the body region may be slightly undersized compared to the size of the average user's nostrils. Thus the body region may fit into the subject's nose, and the seal with the subject's nose is formed by the adhesive holdfast region, rather than the body region. In some variations the body region does not substantially contact the inner walls of the subject's nose. Furthermore, the body region may extend only slightly into the subject's nose.
In some variations, the adhesive nasal device includes a support frame. The support frame may provide structural support to all or a portion of the nasal device, such as the flexible adhesive portion. For example, the support frame may support the adhesive holdfast portion 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. In some variations, the support frame is a support frame layer.
An adjustable-resistance adhesive nasal 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, some device components (e.g., an alignment guide, a body region, noise-reduction element, control, resistance modifying member) 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. These lists of materials are not exclusive, and other (or alternative) materials may be used.
In some versions, the nasal 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 nasal 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.
A nasal device may include 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 exhalation).
As mentioned, the adjustable-resistance nasal devices described herein typically include a holdfast region (or layer) and at least one airflow resistor. As will be apparent from the figures, many of these nasal devices may be removable and insertable by a user without special tools. In some variations, a subject may use an applicator to apply the device (e.g., to help align it).
The holdfast 104 (which adhesively secures the device to the subject) is shown as a layered structure including a backing or adhesive substrate 105. This backing may act as a substrate for an adhesive material, or it may itself be adhesive. The holdfast 104 may have different regions, including two peri-nasal regions surrounding the rim bodies 101. Each rim body has at least one passageway 108 for airflow therethrough. The adhesive holdfast also includes two tabs or grip regions 110 that may make the device easier to grasp, apply, and remove. A bridge region 112 is also shown. In this example, the bridge region is part of the adhesive holdfast (e.g., is formed by the same substrate of the adhesive holdfast) and connects the peri-nasal regions. Although the tab and bridge regions are shown as being formed as part of (integral with) the holdfast material, these regions may also be formed separately, and may be made of different materials.
The rim body regions 101 shown in the exemplary device of
The second, or inner, rim body region 103 shown in the exemplary device of
All of the nasal devices described herein also include an airflow resistor, which is located in one or more passageways formed through the device. In
An adhesive holdfast for a nasal device 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.
Adjustable-resistance nasal devices may be worn to treat any disorder that would benefit from the use of a nasal device, including but not limited to respiratory or sleeping disorders, such as snoring, sleep apnea (obstructive, central, mixed and complex), COPD, cystic fibrosis and the like. Adjustable-resistance nasal device may be particularly beneficial for treatments in which the subject is encouraged or permitted to sleep while wearing the device, because they may be adjusted to allow for comfortable and/or therapeutic use. The adjustable-resistance features of these nasal devices may be used to optimize the effect (e.g., the resistance to exhalation) applied by the device. To use the adjustable-resistance nasal device, it is first placed in communication with the subject's nasal cavity so that airflow from the subject's nose passes through the device as it is worn. In some variations, the resistance is set/adjusted prior to application of the device. The adjustable-resistance feature (e.g., a control and/or a resistance modifying member) may then be used to adjust the expiratory resistance through the device. The nasal device may be placed in communication with the nasal passageway by placing it into or at least partially over or around the subject's nasal cavity. For example, an adhesive holdfast attached to the nasal device may be used to secure the device in position.
Many other materials and structures may be used to achieve the adjustable-resistance features described. This description is not intended to be limited to the structures and materials mentioned, but is intended to also encompass many other materials and structures having similar properties.
In some variations, an adjustable resistance nasal device includes an airflow resistor configured to inhibit exhalation more than inhalation, a holdfast configured to secure the nasal device in communication with a subject's nostril, a leak pathway through the nasal device that is separate from the airflow resistor and is configured to be open during both exhalation and inhalation, and a control configured to adjust the expiratory resistance through the nasal device. The control may be a remote control that can be adjusted by a third party (e.g., physician, technician, sleep partner, or the like) to change the expiratory resistance, or it may be a control that can be manipulated by the wearer or user of the device, or both. For example, a control may include a knob, a dial, a button, a tab, a lever, a pin, a pull cord, a pull tab, or the like. In some variations, the adjustable resistance nasal device includes a resistance modifying member that is configured to modify the leak pathway to adjust the expiratory resistance.
For example, described herein are adjustable resistance nasal devices including: an airflow resistor configured to inhibit exhalation more than inhalation; a holdfast configured to secure the nasal device in communication with a subject's nasal cavity; a leak pathway through the nasal device that is separate from the airflow resistor and configured to be open during both exhalation and inhalation; and a resistance modifying member configured to allow adjustment of airflow through the leak pathway. The resistance modifying member may be coupled to (and controlled by) a controller, as mentioned above.
A resistance modifying member is generally configured to modify the expiratory resistance through the nasal device. For example, the resistance modifying member may change the shape, size (e.g., diameter, length, etc.) and/or number of leak pathways. For example, a resistance modifying member may include a cover or shutter that adjustably occludes all or a portion of a leak pathway. In some variations, the resistance modifying member is an adjustable valve, such as a needle valve or a weighted valve, that can be adjusted to alter the expiratory resistance through the leak path(s) of the nasal device. In some variations, the leak pathway is adjustable. For example, the leak pathway may be constrictable or dilatable to open/close to some degree, thereby decreasing/increasing the expiratory resistance.
As mentioned, in some variations of the adjustable-resistance nasal devices described herein, a nasal device may be adjustable by covering or blocking a leak pathway. The leak pathway (typically a pre-formed leak pathway on any appropriate portion of the nasal device that is separate from the airflow resistor) may be completely or partially covered in a controllable fashion. For example a nasal device may be used with a resistance-modifying member such as that shown in
In some variations of the adjustable-resistance nasal devices described herein, the plugs or covers may be integrated into the nasal device, without the need for a separate resistance-modifying member. For example, a nasal device may include a cover or plug that integral with the nasal device or linked to the nasal device (e.g., by a hinge or tether).
Other variations of adjustable-resistance nasal devices may include adjustable leak pathways. For example, a leak pathway may be constrictable, so that the cross-sectional diameter of the leak pathway may be decreased or increased. In some variations, the leak pathway includes a diaphragm, shutter or other member that may be used to expand or constrict the opening of the leak pathway. For example, the leak pathway may include a louver-type cover which can be opened or closed to various degrees. A leak pathway may include a dilating iris-type shutter which can be closed to increase resistance. In some variations the leak pathway includes an inflatable or swellable material to reduce the diameter of the leak pathway. A control that may be used to open/close the constrictable leak pathway may also be included on the nasal device. For example, the control may be a dial, button, slider, or the like.
In some embodiments, a porous material including but not limited to some formulations of polyethylene or polypropylene (such as Porex® brand products) may find use. These porous plastics have pores that can become filled with condensed water vapor. When such porous materials are used in any of the components of the devices described herein (including the holdfast or rim), the resistance through the device will adjust or increase as the user breathes through the device, as the pores are plugged or filled and therefore resistance will increase in time. For example,
An adjustable-resistance nasal device may also include an adjustable airflow resistor that may be manipulated to adjust the expiratory (and/or inspiratory) resistance. For example, an adjustable airflow resistor may be moved to modify one or more leak pathways through the device. For example, a nasal device may include an airflow resistor that can be rotated to enlarge or reduce a leak pathway. In some variations the airflow resistor is in communication with a central passageway through the device, and the airflow resistor may be moved in or out of register with the central passageway, creating or eliminating a leak pathway adjacent to the airflow resistor. In some variations, moving the airflow resistor may enlarge or contract a leak pathway formed between the nasal device and the subject wearing the device.
In one alternative embodiment, an example of which is illustrated in
In
The resistance of an adjustable resistance nasal device may also be adjusted by deflecting all or a portion of the airflow resistor distally or laterally with respect to the passageway through the nasal device, as illustrated in
In addition to modifying the position or structure of the airflow resistor to modify resistance, and/or changing the opening size of a leak pathway to modify the resistance, the length of the leak pathway may also be modified to change the resistance. For example,
The nasal device shown in
Any of the adjustable resistance nasal devices described herein may include one or more indicators configured to indicate the resistance of the device. In particular, the devices may include one or more indicators that indicate the expiratory resistance (e.g., the resistance to exhalation). For example, an indicator may be a visual indicator, which indicates the resistance to exhalation by an alphanumeric; the indicator may indicate an approximate estimate of the expiratory resistance (as cm H2O/(ml/sec)) when measured at 100 ml/sec), or it may indicate based on the state of the resistance modifying member. In some variations the various settings of the resistance modifying member may be coordinated with pre-determined (or pre-set) values of the expiratory and/or inspiratory resistance. In some variations the indicator is a color indicator, or the like. In some variations the indicator is a digital signal sent by the device. The indicator does not need to be part of (or coupled to) the control or the resistance modifying member, although it may be part of or coupled to either the control and/or the resistance modifying member. In some variations, the indicator is keyed to the position of the resistance modifying member.
For example, in
In
As mentioned above, in some variations the leak pathway is valved to control the expiratory resistance. For example,
Adjustable resistance nasal devices such as those described herein may be adapted so that they may be readily adjusted by a third party who is not the subject or patient wearing the device. For example, the adjustable nasal device (or a nasal device that is adjustable by adding or removing a resistance modifying member) may be adjusted by a doctor, nurse or technician (e.g., sleep technician) without disturbing a sleeping subject wearing the device. This may be particularly useful in adjusting a device worn or operated as part of a sleep study. However, this adjustability may also be useful or significant to other third parties (e.g., sleeping partners, spouses, etc.). In addition, the subject himself or herself may also adjust the resistance, which may be helpful in optimizing the comfort or operation of the nasal device.
For example,
In addition to the adjustable resistance devices described herein, systems or kits including a plurality of nasal devices having fixed expiratory resistances but which increase in resistance relative to each other may also be used. The individual nasal devices may be organized and/or marked in order of increasing expiratory resistance. Such systems or kits may permit a subject to grow accustomed to the increasing expiratory resistance over time by gradually increasing the resistance to exhalation over one or more nights wearing the devices, for some span of time (an acclimation period). The resistance may be increased by any desired amount from a negligible resistance (e.g., a ‘sham’ device) to the final desired expiratory resistance. For example, the resistance of each step may increase by 10% (or 5%, 15%, 20%, 25%, etc.) until the final target expiratory resistance is achieved. This final target expiratory resistance may be approximately 30 cm H2O/(L/sec), approximately 35 cm H2O/(L/sec), approximately 40 cm H2O/(L/sec), approximately 45 cm H2O/(L/sec), approximately 50 cm H2O/(L/sec), approximately 55 cm H2O/(L/sec), approximately 60 cm H2O/(L/sec), approximately 65 cm H2O/(L/sec), approximately 70 cm H2O/(L/sec), approximately 75 cm H2O/(L/sec), approximately 80 cm H2O/(L/sec), approximately 85 cm H2O/(L/sec), approximately 90 cm H2O/(L/sec), approximately 95 cm H2O/(L/sec), approximately 100 cm H2O/(L/sec), approximately 105 cm H2O/(L/sec), approximately 110 cm H2O/(L/sec), approximately 115 cm H2O/(L/sec), although other levels are possible. In one example, the resistance is increased in even steps (e.g., increasing by equivalent amounts between each step), while in some variations the expiratory resistance increases by different amounts between each step, as some increases in expiratory resistance may feel more drastic than others.
Any number of steps of increasing resistance may be used. For example, the number of steps (e.g., the number of different expiratory resistance levels) may depend on the target expiratory resistance, or the period of acclimation. In some variations, two, three, four, five, six, seven, eight, etc. steps may be used. Any number of devices may be used at each step (e.g., any number of devices having the same expiratory resistance) as part of the system or kit. In some variations, each step is ‘held’ for between 1-7 nights. For example, the kit may include three ‘sham’ devices having negligible expiratory resistance, three devices having low expiratory resistance (e.g., 20 cm H2O/(L/sec)), three devices having a resistance to exhalation that is slightly higher (e.g., approximately 40 cm H2O/(L/sec)), three devices having a still slightly higher resistance to exhalation (e.g., approximately 60 cm H2O/(L/sec)), and four devices having an even higher resistance to exhalation (e.g., approximately 80 cm H2O/(L/sec)). In some variations some ‘steps’ may include more than three or less than three devices. In this example, each device is intended to be worn for one night, with devices being worn on consecutive nights. After completing the series of devices, the user may be acclimated to the final resistance and may thereafter use devices having this final (target) resistance.
As mentioned, any of these systems or kits may include instructions for use, indicating that the subject should use the devices in an indicated order which corresponds to an increasing expiratory resistance. The instructions may be included with the devices. In some variations the devices in the kit or system are numbered or otherwise marked to indicate the order to be used. In other variation, the devices are packaged in such a way that they are dispensed or provided in the desired order.
In some variations, there may be excess devices at each step, and the subject may be instructed to remain at a particular step (level of expiratory resistance) until they are comfortable with that level of expiratory resistance, and then proceed to the next higher level. Thus, in any of these variations, the devices corresponding to each step may be labeled sequentially, or marked sequentially via the packaging or dispensing. For example, the devices or set of devices are marked to indicate their order in the sequence (or are packaged to indicate their order in the sequence).
Although the examples of adjustable-resistance nasal devices described above and shown in the figures provided are exemplify the principles taught herein. These same principles may be applied or adapted for use in other nasal device variations. For example, the nasal devices described herein are primarily devices for altering the expiratory resistance of a nasal device. Adjustable nasal devices in which the inspiratory resistance is adjustable (in addition to the expiratory resistance or instead of adjusting the expiratory resistance) are also contemplated as part of this invention. In addition, adjustable-resistance nasal devices may include additional features, which may be combined. For example, an adjustable-resistance nasal device may also include a noise-reducing element and one or more sensor (including a cannula) or the like.
Furthermore, although the nasal devices described herein are configured so that (in normal operation) the resistance through the device is greater during exhalation than during inhalation, other configurations may also be used with the noise-reduced devices or features described herein. For example, a nasal device may be configured with an airflow resistor that inhibits inhalation more than exhalation, which may be used with a noise-reduction element or flap valve configured to inhibit oscillation of the flap (or flaps) during exhalation instead (or in addition to) inhalation. In general a noise-reduced nasal device may limit the oscillation of the flap during both inhalation and exhalation. While the methods and devices have been described in some detail here by way of illustration and example, such illustration and example is for purposes of clarity of understanding only. It will be readily apparent to those of ordinary skill in the art in light of the teachings herein that certain changes and modifications may be made thereto without departing from the spirit and scope of the invention.
This application claims priority to U.S. Provisional Patent Application Ser. No. 61/061,918, titled “Adjustable Resistance Nasal Devices,” filed on Jun. 16, 2008. This application is herein incorporated by reference in its entirety. This application may be related to pending U.S. patent application Ser. No. 11/298,339, titled “Respiratory Devices”, filed Dec. 8, 2005, which claims priority to U.S. Provisional Patent Application Ser. No. 60/634,715, filed Dec. 8, 2004. This application may also be related to pending U.S. patent application Ser. No. 11/805,496, titled “Nasal Respiratory Devices”, filed May 22, 2007, which claims priority to U.S. Provisional Patent Application Ser. No. 60/808,034, filed May 23, 2006.
Number | Date | Country | |
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61061918 | Jun 2008 | US |