Patent Description:
Each day, humans may produce upwards of <NUM> milliliters of sputum, which is a type of bronchial secretion. Normally, an effective cough is sufficient to loosen secretions and clear them from the body's airways. However, for individuals suffering from more significant bronchial obstructions, such as collapsed airways, a single cough may be insufficient to clear the obstructions.

OPEP therapy represents an effective bronchial hygiene technique for the removal of bronchial secretions in the human body and is an important aspect in the treatment and continuing care of patients with bronchial obstructions, such as those suffering from chronic obstructive lung disease. It is believed that OPEP therapy, or the oscillation of exhalation pressure at the mouth during exhalation, effectively transmits an oscillating back pressure to the lungs, thereby splitting open obstructed airways and loosening the secretions contributing to bronchial obstructions. The benefits of OPEP therapy include decrease in sputum viscoelasticity, increase in forces disconnecting sputum from airway passages, and increase in sputum expectoration.

OPEP therapy is an attractive form of treatment because it can be easily taught to most patients, and such patients can assume responsibility for the administration of OPEP therapy throughout a hospitalization and also from home. To that end, a number of portable OPEP devices have been developed: <CIT> and <CIT>.

Like OPEP therapy, RMT has been shown to improve lung hygiene in both healthy individuals and patients with a variety of lung diseases. RMT includes pressure threshold resistance, which requires a user to achieve and maintain a set pressure during inhalation or exhalation, and flow resistance, which restricts the flow of air during inhalation or exhalation. The benefits of RMT include increased respiratory muscle strength, reduced dyspnea (breathlessness), increased exercise performance, and improved quality of life.

Like OPEP therapy, RMT is an attractive form of treatment because it can be easily taught to most patients, and such patients can assume responsibility for the administration of RMT therapy throughout a hospitalization and also from home.

In this regard, there is a need for a single device that performs both OPEP therapy and RMT, while maintaining the performance of individual devices that deliver only OPEP therapy or only RMT.

In one aspect, a respiratory treatment device includes a housing enclosing a plurality of chambers, with a first opening in the housing configured to transmit air exhaled into and air inhaled from the housing, a second opening in the housing configured to permit air exhaled into the first opening to exit the housing, and a third opening in the housing configured to permit air outside the housing to enter the housing upon inhalation at the first opening. An exhalation flow path is defined between the first opening and the second opening, and an inhalation flow path is defined between the third opening and the first opening. A restrictor member is positioned in the exhalation flow path and the inhalation flow path and is movable between a closed position, where a flow of air along the exhalation flow path or the inhalation flow path is restricted, and an open position, where the flow of exhaled air along the exhalation flow path or the inhalation flow path is less restricted. A vane is in fluid communication with the exhalation flow path and the inhalation flow path, and is connected to the restrictor member and configured to reciprocate between a first position and a second position in response to a flow of exhaled air along the exhalation flow path or the inhalation flow path.

In another aspect, the second opening may include a one-way exhalation valve configured to permit air exhaled into the housing to exit the housing upon exhalation at the first opening. The one-way exhalation valve may be configured to open in response to a positive threshold pressure. The threshold pressure may be selectively adjustable. The one-way exhalation valve may include a spring configured to bias the one-way valve toward a closed position. A level of bias may be selectively adjustable. A cross-sectional area of the second opening may be selectively adjustable to control a resistance to the flow of air therethrough.

In another aspect, the third opening may include a one-way inhalation valve configured to permit air outside the housing to enter the housing upon inhalation at the first opening. The one-way inhalation valve may be configured to open in response to a negative threshold pressure. The threshold pressure may be selectively adjustable. The one-way inhalation valve may include a spring configured to bias the one-way valve toward a closed position. A level of bias may be selectively adjustable. A cross-sectional area of the second opening may be selectively adjustable to control a resistance to the flow of air therethrough.

In yet another aspect, a one-way valve is positioned along the exhalation flow path between the first opening and the second opening. The one-way valve may be configured to open in response to air exhaled into the first opening, and close in response to air inhaled through the first opening.

In another aspect, a one-way valve is positioned along the inhalation flow path between the third opening and the first opening. The one-way valve may be configured to open in response to air inhaled through the first opening, and close in response to air exhaled into the first opening.

In another aspect, the restrictor member is positioned in a first chamber of the plurality of chambers, and the vane is positioned in a second chamber of the plurality of chambers. The flow of air through the first chamber is restricted when the restrictor member is in the closed position, and the flow of air through the first chamber is less restricted when the restrictor member is in the open position. The first chamber and the second chamber may be connected by an orifice. The vane is positioned adjacent the orifice and may be configured to move the restrictor member between the closed position and the open position in response to an increased pressure adjacent the vane.

In another aspect, the exhalation flow path and the inhalation flow path form an overlapping portion. The flow of air along the exhalation flow path and the inhalation flow path along the overlapping portion may be in the same direction. The restrictor member may be positioned in the overlapping portion, and the vane may be in fluid communication with the overlapping portion.

In another aspect, a size of the orifice is configured to increase in response to the flow of exhaled air through the orifice. The orifice may be formed within a variable nozzle. The orifice may be configured to close in response to a negative pressure from the flow of inhaled air along the inhalation flow path.

In another aspect, the vane is operatively connected to the restrictor member by a shaft. A face of the restrictor member is rotatable about an axis of rotation.

In yet another aspect, a flow resistor for a respiratory device includes a conduit for transmitting a flow of air. The conduit has a cross sectional area. A one-way valve is positioned within the conduit and is configured to open in response to the flow of air in a first direction, and close in response to the flow of air in a second direction. The one-way valve may have a cross-sectional area less than the cross sectional area of the conduit. An adjustment plate is positioned within the conduit forming an open section and a blocking section. The blocking section may have a cross-sectional area less than the cross-sectional area of the conduit. An orientation of the adjustment plate relative to the conduit may be selectively adjustable. The orientation of the open section relative to the cross-sectional area of the one-way valve is selectively adjustable. The adjustment plate may be positioned within the conduit adjacent to the one-way valve. A flow of air in the second direction may be permitted to flow around the one-way valve through the open section. The adjustment plate may be positioned within the conduit adjacent to the one-way valve. The one-way valve may be configured to open in response to inhalation by a user at a first end of the conduit, and close in response to exhalation by a user at the first end of the conduit.

In yet another aspect, a flow resistor for a respiratory device includes a housing defining a conduit for the flow of air therethrough, and a one-way valve positioned in the conduit. The one-way valve is configured to open in response to the flow of air through the conduit in a first direction and close in response to the flow of air through the conduit in a second direction. An opening in the conduit permits the flow of air into or out of the conduit. A cross-sectional area of the opening is selectively adjustable. The housing may include a first section and a second section, wherein a position of the first section of the housing relative to a position of the second section of the housing is selectively adjustable. Selective adjustment of the first section relative to the second section adjusts a cross-sectional area of the opening. The one-way valve may be positioned in the first section of the housing. The opening may be positioned in the first section of the housing.

In yet another aspect, a pressure threshold resistor includes a housing having a first section and a second section, the first section and the second section defining a conduit for the flow of air therethrough. A one-way valve is positioned in the conduit and is movable between a closed position, where the flow of air through the conduit is blocked, and an open position, where air is permitted to flow through the conduit. A biasing member may be configured to bias the one-way valve toward the closed position. The one-way valve may be configured to move from the closed position to an open position when a pressure in the conduit exceeds a threshold pressure.

In another aspect, the biasing member is a spring. A position of the first section of the housing relative to the second section of the housing may be selectively adjustable. Adjustment of the position of the first section of the housing relative to the second section of the housing may adjust the bias on the one-way valve. Adjustment of the position of the first section of the housing relative to the second section of the housing may adjust the threshold pressure. The biasing member may be a spring, and adjustment of the position of the first section of the housing relative to the second section may adjust a compression of the spring.

In yet another aspect, a respiratory treatment device includes a housing enclosing at least one chamber, a first opening in the housing configured to transmit air exhaled into and air inhaled from the housing, a second opening in the housing configured to permit air exhaled into the first opening to exit the housing, and a third opening in the housing configured to permit air outside the housing to enter the housing upon inhalation at the first opening. An exhalation flow path is defined between the first opening and the second opening, and an inhalation flow path defined between the third opening and the first opening. A restrictor member is positioned in the exhalation flow path and is movable between a closed position, where a flow of air along the exhalation flow path or is restricted, and an open position, where the flow of exhaled air along the exhalation flow path is less restricted.

In another aspect, a vane is in fluid communication with the exhalation flow path, is operatively connected to the restrictor member, and is configured to reciprocate between a first position and a second position in response to a flow of exhaled air along the exhalation flow path. The restrictor member may not be positioned in the inhalation flow path.

In another aspect, the third opening comprises a one-way inhalation valve configured to permit air outside the housing to enter the housing upon inhalation at the first opening. The one-way inhalation valve may be configured to open in response to a negative threshold pressure. The threshold pressure may be selectively adjustable. The one-way inhalation valve may include a spring configured to bias the one-way valve toward a closed position. The level of bias may be selectively adjustable. A cross-sectional area of the third opening may be selectively adjustable to control a resistance to the flow of air therethrough.

OPEP therapy is effective within a range of operating conditions. For example, an adult human may have an exhalation flow rate ranging from <NUM> to <NUM> liters per minute, and may maintain a static exhalation pressure in the range of <NUM> to <NUM> H<NUM>O. Within these parameters, OPEP therapy is believed to be most effective when changes in the exhalation pressure (i.e., the amplitude) range from <NUM> to <NUM> H<NUM>O oscillating at a frequency of <NUM> to <NUM>. In contrast, an adolescent may have a much lower exhalation flow rate, and may maintain a lower static exhalation pressure, thereby altering the operating conditions most effective for the administration of OPEP therapy. Likewise, the ideal operating conditions for someone suffering from a respiratory illness, or in contrast, a healthy athlete, may differ from those of an average adult. As described below, the components of the disclosed OPEP devices are selectable and/or adjustable so that ideal operating conditions (e.g., amplitude and frequency of oscillating pressure) may be identified and maintained. Each of the various embodiments described herein achieve frequency and amplitude ranges that fall within the desired ranges set forth above. Each of the various embodiments described herein may also be configured to achieve frequencies and amplitudes that fall outside the ranges set forth above.

Referring first to <FIG>, a front perspective view, a rear perspective view, a cross-sectional front perspective view, and an exploded view of an OPEP device <NUM> are shown. For purposes of illustration, the internal components of the OPEP device <NUM> are omitted in <FIG>. The OPEP device <NUM> generally comprises a housing <NUM>, a chamber inlet <NUM>, a first chamber outlet <NUM>, a second chamber outlet <NUM> (best seen in <FIG> and <FIG>), and a mouthpiece <NUM> in fluid communication with the chamber inlet <NUM>. While the mouthpiece <NUM> is shown in <FIG> as being integrally formed with the housing <NUM>, it is envisioned that the mouthpiece <NUM> may be removable and replaceable with a mouthpiece <NUM> of a different size or shape, as required to maintain ideal operating conditions. In general, the housing <NUM> and the mouthpiece <NUM> may be constructed of any durable material, such as a polymer. One such material is Polypropylene. Alternatively, acrylonitrile butadiene styrene (ABS) may be used.

Alternatively, other or additional interfaces, such as breathing tubes or gas masks (not shown) may be attached in fluid communication with the mouthpiece <NUM> and/or associated with the housing <NUM>. For example, the housing <NUM> may include an inhalation port (not shown) having a separate one-way inhalation valve (not shown) in fluid communication with the mouthpiece <NUM> to permit a user of the OPEP device <NUM> both to inhale the surrounding air through the one-way valve, and to exhale through the chamber inlet <NUM> without withdrawing the mouthpiece <NUM> of the OPEP device <NUM> between periods of inhalation and exhalation. In addition, any number of aerosol delivery devices may be connected to the OPEP device <NUM>, for example, through the inhalation port mentioned above, for the simultaneous administration of aerosol and OPEP therapies. As such, the inhalation port may include, for example, an elastomeric adapter, or other flexible adapter, capable of accommodating the different mouthpieces or outlets of the particular aerosol delivery device that a user intends to use with the OPEP device <NUM>. As used herein, the term aerosol delivery devices should be understood to include, for example, without limitation, any nebulizer, soft mist inhaler, pressurized metered dose inhaler, dry powder inhaler, combination of a holding chamber a pressurized metered dose inhaler, or the like. Suitable commercially available aerosol delivery devices include, without limitation, the AEROECLIPSE nebulizer, RESPIMAT soft mist inhaler, LC Sprint nebulizer, AEROCHAMBER PLUS holding chambers, MICRO MIST nebulizer, SIDESTREAM nebulizers, Inspiration Elite nebulizers, FLOVENT pMDI, VENTOLIN pMDI, AZMACORT pMDI, BECLOVENT pMDI, QVAR pMDI and AEROBID PMDI, XOPENEX pMDI, PROAIR pMDI, PROVENT pMDI, SYMBICORT pMDI, TURBOHALER DPI, and DISKHALER DPI. Descriptions of suitable aerosol delivery devices may be found in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>;<CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and, <CIT>.

In <FIG>, the housing <NUM> is generally box-shaped. However, a housing <NUM> of any shape may be used. Furthermore, the chamber inlet <NUM>, the first chamber outlet <NUM>, and the second chamber outlet <NUM> could be any shape or series of shapes, such as a plurality (i.e., more than one) of circular passages or linear slots. More importantly, it should be appreciated that the cross-sectional area of the chamber inlet <NUM>, the first chamber outlet <NUM>, and the second chamber outlet <NUM> are only a few of the factors influencing the ideal operating conditions described above.

Preferably, the housing <NUM> is openable so that the components contained therein can be periodically accessed, cleaned, replaced, or reconfigured, as required to maintain the ideal operating conditions. As such, the housing <NUM> is shown in <FIG> as comprising a front section <NUM>, a middle section <NUM>, and a rear section <NUM>. The front section <NUM>, the middle section <NUM>, and the rear section <NUM> may be removably connected to one another by any suitable means, such as a snap-fit, a compression fit, etc., such that a seal forms between the relative sections sufficient to permit the OPEP device <NUM> to properly administer OPEP therapy.

As shown in <FIG>, an exhalation flow path <NUM>, identified by a dashed line, is defined between the mouthpiece <NUM> and at least one of the first chamber outlet <NUM> and the second chamber outlet <NUM> (best seen in <FIG>). More specifically, the exhalation flow path <NUM> begins at the mouthpiece <NUM>, passes through the chamber inlet <NUM>, and enters into a first chamber <NUM>, or an entry chamber. In the first chamber <NUM>, the exhalation flow path makes a <NUM>-degree turn, passes through a chamber passage <NUM>, and enters into a second chamber <NUM>, or an exit chamber. In the second chamber <NUM>, the exhalation flow path <NUM> may exit the OPEP device <NUM> through at least one of the first chamber outlet <NUM> and the second chamber outlet <NUM>. In this way, the exhalation flow path <NUM> is "folded" upon itself, i.e., it reverses longitudinal directions between the chamber inlet <NUM> and one of the first chamber outlet <NUM> or the second chamber outlet <NUM>. However, those skilled in the art will appreciate that the exhalation flow path <NUM> identified by the dashed line is exemplary, and that air exhaled into the OPEP device <NUM> may flow in any number of directions or paths as it traverses from the mouthpiece <NUM> or chamber inlet <NUM> and the first chamber outlet <NUM> or the second chamber outlet <NUM>.

<FIG> also shows various other features of the OPEP device <NUM> associated with the housing <NUM>. For example, a stop <NUM> prevents a restrictor member <NUM> (see <FIG>), described below, from opening in a wrong direction; a seat <NUM> shaped to accommodate the restrictor member <NUM> is formed about the chamber inlet <NUM>; and, an upper bearing <NUM> and a lower bearing <NUM> are formed within the housing <NUM> and configured to accommodate a shaft rotatably mounted therebetween. One or more guide walls <NUM> are positioned in the second chamber <NUM> to direct exhaled air along the exhalation flow path <NUM>.

Turning to <FIG>, various cross-sectional perspective views of the OPEP device <NUM> are shown with its internal components. The internal components of the OPEP device <NUM> comprise a restrictor member <NUM>, a vane <NUM>, and an optional variable nozzle136. As shown, the restrictor member <NUM> and the vane <NUM> are operatively connected by means of a shaft <NUM> rotatably mounted between the upper bearing <NUM> and the lower bearing <NUM>, such that the restrictor member <NUM> and the vane <NUM> are rotatable in unison about the shaft <NUM>. As described below in further detail, the variable nozzle <NUM> includes an orifice <NUM> configured to increase in size in response to the flow of exhaled air therethrough.

<FIG> further illustrate the division of the first chamber <NUM> and the second chamber <NUM> within the housing <NUM>. As previously described, the chamber inlet <NUM> defines an entrance to the first chamber <NUM>. The restrictor member <NUM> is positioned in the first chamber <NUM> relative to a seat <NUM> about the chamber inlet <NUM> such that it is moveable between a closed position, where a flow of exhaled air along the exhalation flow path <NUM> through the chamber inlet <NUM> is restricted, and an open position, where the flow of exhaled air through the chamber inlet <NUM> is less restricted. Likewise, the variable nozzle <NUM>, which is optional, is mounted about or positioned in the chamber passage <NUM>, such that the flow of exhaled air entering the first chamber <NUM> exits the first chamber <NUM> through the orifice <NUM> of the variable nozzle <NUM>. Exhaled air exiting the first chamber <NUM> through the orifice <NUM> of the variable nozzle <NUM> enters the second chamber, which is defined by the space within the housing <NUM> occupied by the vane <NUM> and the guide walls <NUM>. Depending on the position of the vane <NUM>, the exhaled air is then able to exit the second chamber <NUM> through at least one of the first chamber outlet <NUM> and the second chamber outlet <NUM>.

<FIG> show the internal components of the OPEP device <NUM> in greater detail. Turning first to <FIG>, a front perspective view and a rear perspective view shows the restrictor member <NUM> operatively connected to the vane <NUM> by the shaft <NUM>. As such, the restrictor member <NUM> and the vane <NUM> are rotatable about the shaft <NUM> such that rotation of the restrictor member <NUM> results in a corresponding rotation of the vane <NUM>, and vice-versa. Like the housing <NUM>, the restrictor member <NUM> and the vane <NUM> may be made of constructed of any durable material, such as a polymer. Preferably, they are constructed of a low shrink, low friction plastic. One such material is acetal.

As shown, the restrictor member <NUM>, the vane <NUM>, and the shaft <NUM> are formed as a unitary component. The restrictor member <NUM> is generally disk-shaped, and the vane <NUM> is planar. The restrictor member <NUM> includes a generally circular face <NUM> axially offset from the shaft <NUM> and a beveled or chamfered edge <NUM> shaped to engage the seat <NUM> formed about the chamber inlet <NUM>. In this way, the restrictor member <NUM> is adapted to move relative to the chamber inlet <NUM> about an axis of rotation defined by the shaft <NUM> such that the restrictor member <NUM> may engage the seat <NUM> in a closed position to substantially seal and restrict the flow of exhaled air through the chamber inlet <NUM>. However, it is envisioned that the restrictor member <NUM> and the vane <NUM> may be formed as separate components connectable by any suitable means such that they remain independently replaceable with a restrictor member <NUM> or a vane132 of a different shape, size, or weight, as selected to maintain ideal operating conditions. For example, the restrictor member <NUM> and/or the vane <NUM> may include one or more contoured surfaces. Alternatively, the restrictor member <NUM> may be configured as a butterfly valve.

Turning to <FIG>, a front view of the restrictor member <NUM> and the vane <NUM> is shown. As previously described, the restrictor member <NUM> comprises a generally circular face <NUM> axially offset from the shaft <NUM>. The restrictor member <NUM> further comprises a second offset designed to facilitate movement of the restrictor member <NUM> between a closed position and an open position. More specifically, a center <NUM> of the face <NUM> of the restrictor member <NUM> is offset from the plane defined by the radial offset and the shaft <NUM>, or the axis of rotation. In other words, a greater surface area of the face <NUM> of the restrictor member <NUM> is positioned on one side of the shaft <NUM> than on the other side of the shaft <NUM>. Pressure at the chamber inlet <NUM> derived from exhaled air produces a force acting on the face <NUM> of the restrictor member <NUM>. Because the center <NUM> of the face <NUM> of the restrictor member <NUM> is offset as described above, a resulting force differential creates a torque about the shaft <NUM>. As further explained below, this torque facilitates movement of the restrictor member <NUM> between a closed position and an open position.

Turning to <FIG>, a top view of the restrictor member <NUM> and the vane <NUM> is shown. As illustrated, the vane <NUM> is connected to the shaft <NUM> at a <NUM>° angle relative to the face <NUM> of restrictor member <NUM>. Preferably, the angle will remain between <NUM>° and <NUM>°, although it is envisioned that the angle of the vane <NUM> may be selectively adjusted to maintain the ideal operating conditions, as previously discussed. It is also preferable that the vane <NUM> and the restrictor member <NUM> are configured such that when the OPEP device <NUM> is fully assembled, the angle between a centerline of the variable nozzle <NUM> and the vane <NUM> is between <NUM>° and <NUM>° when the restrictor member <NUM> is in a closed position. Moreover, regardless of the configuration, it is preferable that the combination of the restrictor member <NUM> and the vane <NUM> have a center of gravity aligned with the shaft <NUM>, or the axis of rotation. In full view of the present disclosure, it should be apparent to those skilled in the art that the angle of the vane <NUM> may be limited by the size or shape of the housing <NUM>, and will generally be less than half the total rotation of the vane <NUM> and the restrictor member <NUM>.

Turning to <FIG>, a front perspective view and a rear perspective view of the variable nozzle <NUM> is shown without the flow of exhaled air therethrough. In general, the variable nozzle <NUM> includes top and bottom walls <NUM>, side walls <NUM>, and V-shaped slits <NUM> formed therebetween. As shown, the variable nozzle is generally shaped like a duck-bill type valve. However, it should be appreciated that nozzles or valves of other shapes and sizes may also be used. The variable nozzle <NUM> may also include a lip <NUM> configured to mount the variable nozzle <NUM> within the housing <NUM> between the first chamber <NUM> and the second chamber <NUM>. The variable nozzle <NUM> may be constructed or molded of any material having a suitable flexibility, such as silicone, and preferably with a wall thickness of between <NUM> and <NUM> millimeters, and an orifice width between <NUM> to <NUM> millimeters, or smaller depending on manufacturing capabilities.

As previously described, the variable nozzle <NUM> is optional in the operation of the OPEP device <NUM>. It should also be appreciated that the OPEP device <NUM> could alternatively omit both the chamber passage <NUM> and the variable nozzle <NUM>, and thus comprise a single-chamber embodiment. Although functional without the variable nozzle <NUM>, the performance of the OPEP device <NUM> over a wider range of exhalation flow rates is improved when the OPEP device <NUM> is operated with the variable nozzle <NUM>. The chamber passage <NUM>, when used without the variable nozzle <NUM>, or the orifice <NUM> of the variable nozzle <NUM>, when the variable nozzle <NUM> is included, serves to create a jet of exhaled air having an increased velocity. As explained in more detail below, the increased velocity of the exhaled air entering the second chamber <NUM> results in a proportional increase in the force applied by the exhaled air to the vane <NUM>, and in turn, an increased torque about the shaft <NUM>, all of which affect the ideal operating conditions.

Without the variable nozzle <NUM>, the orifice between the first chamber <NUM> and the second chamber <NUM> is fixed according to the size, shape, and cross-sectional area of the chamber passage <NUM>, which may be selectively adjusted by any suitable means, such as replacement of the middle section <NUM> or the rear section <NUM> of the housing. On the other hand, when the variable nozzle <NUM> is included in the OPEP device <NUM>, the orifice between the first chamber <NUM> and the second chamber <NUM> is defined by the size, shape, and cross-sectional area of the orifice <NUM> of the variable nozzle <NUM>, which may vary according to the flow rate of exhaled air and/or the pressure in the first chamber <NUM>.

Turning to <FIG>, a front perspective view of the variable nozzle <NUM> is shown with a flow of exhaled air therethrough. One aspect of the variable nozzle <NUM> shown in <FIG> is that, as the orifice <NUM> opens in response to the flow of exhaled air therethrough, the cross-sectional shape of the orifice <NUM> remains generally rectangular, which during the administration of OPEP therapy results in a lower drop in pressure through the variable nozzle <NUM> from the first chamber <NUM> (See <FIG> and <FIG>) to the second chamber <NUM>. The generally consistent rectangular shape of the orifice <NUM> of the variable nozzle <NUM> during increased flow rates is achieved by the V-shaped slits <NUM> formed between the top and bottom walls <NUM> and the side walls <NUM>, which serve to permit the side walls <NUM> to flex without restriction. Preferably, the V-shaped slits <NUM> are as thin as possible to minimize the leakage of exhaled air therethrough. For example, the V-shaped slits <NUM> may be approximately <NUM> millimeters wide, but depending on manufacturing capabilities, could range between <NUM> and <NUM> millimeters. Exhaled air that does leak through the V-shaped slits <NUM> is ultimately directed along the exhalation flow path by the guide walls <NUM> in the second chamber <NUM> protruding from the housing <NUM>.

It should be appreciated that numerous factors contribute to the impact the variable nozzle <NUM> has on the performance of the OPEP device <NUM>, including the geometry and material of the variable nozzle <NUM>. By way of example only, in order to attain a target oscillating pressure frequency of between <NUM> to <NUM> at an exhalation flow rate of <NUM> liters per minute, in one embodiment, a <NUM> by <NUM> millimeter passage or orifice may be utilized. However, as the exhalation flow rate increases, the frequency of the oscillating pressure in that embodiment also increases, though at a rate too quickly in comparison to the target frequency. In order to attain a target oscillating pressure frequency of between <NUM> to <NUM> at an exhalation flow rate of <NUM> liters per minute, the same embodiment may utilize a <NUM> by <NUM> millimeter passage or orifice. Such a relationship demonstrates the desirability of a passage or orifice that expands in cross-sectional area as the exhalation flow rate increases in order to limit the drop in pressure across the variable nozzle <NUM>.

Turning to <FIG>, top phantom views of the OPEP device <NUM> show an exemplary illustration of the operation of the OPEP device <NUM>. Specifically, <FIG> shows the restrictor member <NUM> in an initial, or closed position, where the flow of exhaled air through the chamber inlet <NUM> is restricted, and the vane <NUM> is in a first position, directing the flow of exhaled air toward the first chamber outlet <NUM>. <FIG> shows this restrictor member <NUM> in a partially open position, where the flow of exhaled air through the chamber inlet <NUM> is less restricted, and the vane <NUM> is directly aligned with the jet of exhaled air exiting the variable nozzle <NUM>. <FIG> shows the restrictor member <NUM> in an open position, where the flow of exhaled air through the chamber inlet <NUM> is even less restricted, and the vane <NUM> is in a second position, directing the flow of exhaled air toward the second chamber outlet <NUM>. It should be appreciated that the cycle described below is merely exemplary of the operation of the OPEP device <NUM>, and that numerous factors may affect operation of the OPEP device <NUM> in a manner that results in a deviation from the described cycle. However, during the operation of the OPEP device <NUM>, the restrictor member <NUM> and the vane <NUM> will generally reciprocate between the positions shown in <FIG>.

During the administration of OPEP therapy, the restrictor member <NUM> and the vane <NUM> may be initially positioned as shown in <FIG>. In this position, the restrictor member <NUM> is in a closed position, where the flow of exhaled air along the exhalation path through the chamber inlet <NUM> is substantially restricted. As such, an exhalation pressure at the chamber inlet <NUM> begins to increase when a user exhales into the mouthpiece <NUM>. As the exhalation pressure at the chamber inlet <NUM> increases, a corresponding force acting on the face <NUM> of the restrictor member <NUM> increases. As previously explained, because the center <NUM> of the face <NUM> is offset from the plane defined by the radial offset and the shaft <NUM>, a resulting net force creates a negative or opening torque about the shaft. In turn, the opening torque biases the restrictor member <NUM> to rotate open, letting exhaled air enter the first chamber <NUM>, and biases the vane <NUM> away from its first position. As the restrictor member <NUM> opens and exhaled air is let into the first chamber <NUM>, the pressure at the chamber inlet <NUM> begins to decrease, the force acting on the face <NUM> of the restrictor member begins to decrease, and the torque biasing the restrictor member <NUM> open begins to decrease.

As exhaled air continues to enter the first chamber <NUM> through the chamber inlet <NUM>, it is directed along the exhalation flow path <NUM> by the housing <NUM> until it reaches the chamber passage <NUM> disposed between the first chamber <NUM> and the second chamber <NUM>. If the OPEP device <NUM> is being operated without the variable nozzle <NUM>, the exhaled air accelerates through the chamber passage <NUM> due to the decrease in cross-sectional area to form a jet of exhaled air. Likewise, if the OPEP device <NUM> is being operated with the variable nozzle <NUM>, the exhaled air accelerates through the orifice <NUM> of the variable nozzle <NUM>, where the pressure through the orifice <NUM> causes the side walls <NUM> of the variable nozzle <NUM> to flex outward, thereby increasing the size of the orifice <NUM>, as well as the resulting flow of exhaled air therethrough. To the extent some exhaled air leaks out of the V-shaped slits <NUM> of the variable nozzle <NUM>, it is directed back toward the jet of exhaled air and along the exhalation flow path by the guide walls <NUM> protruding into the housing <NUM>.

Then, as the exhaled air exits the first chamber <NUM> through the variable nozzle <NUM> and/or chamber passage <NUM> and enters the second chamber <NUM>, it is directed by the vane <NUM> toward the front section <NUM> of the housing <NUM>, where it is forced to reverse directions before exiting the OPEP device <NUM> through the open first chamber exit <NUM>. As a result of the change in direction of the exhaled air toward the front section <NUM> of the housing <NUM>, a pressure accumulates in the second chamber <NUM> near the front section <NUM> of the housing <NUM>, thereby resulting in a force on the adjacent vane <NUM>, and creating an additional negative or opening torque about the shaft <NUM>. The combined opening torques created about the shaft <NUM> from the forces acting on the face <NUM> of the restrictor member <NUM> and the vane <NUM> cause the restrictor member <NUM> and the vane <NUM> to rotate about the shaft <NUM> from the position shown in <FIG> toward the position shown in <FIG>.

When the restrictor member <NUM> and the vane <NUM> rotate to the position shown in <FIG>, the vane <NUM> crosses the jet of exhaled air exiting the variable nozzle <NUM> or the chamber passage <NUM>. Initially, the jet of exhaled air exiting the variable nozzle <NUM> or chamber passage <NUM> provides a force on the vane <NUM> that, along with the momentum of the vane <NUM>, the shaft <NUM>, and the restrictor member <NUM>, propels the vane <NUM> and the restrictor member <NUM> to the position shown in <FIG>. However, around the position shown in <FIG>, the force acting on the vane <NUM> from the exhaled air exiting the variable nozzle <NUM> also switches from a negative or opening torque to a positive or closing torque. More specifically, as the exhaled air exits the first chamber <NUM> through the variable nozzle <NUM> and enters the second chamber <NUM>, it is directed by the vane <NUM> toward the front section <NUM> of the housing <NUM>, where it is forced to reverse directions before exiting the OPEP device <NUM> through the open second chamber exit <NUM>. As a result of the change in direction of the exhaled air toward the front section <NUM> of the housing <NUM>, a pressure accumulates in the second chamber <NUM> near the front section <NUM> of the housing <NUM>, thereby resulting in a force on the adjacent vane <NUM>, and creating a positive or closing torque about the shaft <NUM>. As the vane <NUM> and the restrictor member <NUM> continue to move closer to the position shown in <FIG>, the pressure accumulating in the section chamber <NUM> near the front section <NUM> of the housing <NUM>, and in turn, the positive or closing torque about the shaft <NUM>, continues to increase, as the flow of exhaled air along the exhalation flow path <NUM> and through the chamber inlet <NUM> is even less restricted. Meanwhile, although the torque about the shaft <NUM> from the force acting on the restrictor member <NUM> also switches from a negative or opening torque to a positive or closing torque around the position shown in <FIG>, its magnitude is essentially negligible as the restrictor member <NUM> and the vane <NUM> rotate from the position shown in <FIG> to the position shown in <FIG>.

After reaching the position shown in <FIG>, and due to the increased positive or closing torque about the shaft <NUM>, the vane <NUM> and the restrictor member <NUM> reverse directions and begin to rotate back toward the position shown in <FIG>. As the vane <NUM> and the restrictor member <NUM> approach the position shown in <FIG>, and the flow of exhaled through the chamber inlet <NUM> is increasingly restricted, the positive or closing torque about the shaft <NUM> begins to decrease. When the restrictor member <NUM> and the vane <NUM> reach the position <NUM> shown in <FIG>, the vane <NUM> crosses the jet of exhaled air exiting the variable nozzle <NUM> or the chamber passage <NUM>, thereby creating a force on the vane <NUM> that, along with the momentum of the vane <NUM>, the shaft <NUM>, and the restrictor member <NUM>, propels the vane <NUM> and the restrictor member <NUM> back to the position shown in <FIG>. After the restrictor member <NUM> and the vane <NUM> return to the position shown in <FIG>, the flow of exhaled air through the chamber inlet <NUM> is restricted, and the cycle described above repeats itself.

It should be appreciated that, during a single period of exhalation, the cycle described above will repeat numerous times. Thus, by repeatedly moving the restrictor member <NUM> between a closed position, where the flow of exhaled air through the chamber inlet <NUM> is restricted, and an open position, where the flow of exhaled air through the chamber inlet <NUM> is less restricted, an oscillating back pressure is transmitted to the user of the OPEP device <NUM> and OPEP therapy is administered.

Turning now to <FIG>, an alternative embodiment of a variable nozzle <NUM> is shown. The variable nozzle <NUM> may be used in the OPEP device <NUM> as an alternative to the variable nozzle <NUM> described above. As shown in <FIG>, the variable nozzle <NUM> includes an orifice <NUM>, top and bottom walls <NUM>, side walls <NUM>, and a lip <NUM> configured to mount the variable nozzle <NUM> within the housing of the OPEP device <NUM> between the first chamber <NUM> and the second chamber <NUM> in the same manner as the variable nozzle <NUM>. Similar to the variable nozzle <NUM> shown in <FIG>, the variable nozzle <NUM> may be constructed or molded of any material having a suitable flexibility, such as silicone.

During the administration of OPEP therapy, as the orifice <NUM> of the variable nozzle <NUM> opens in response to the flow of exhaled air therethrough, the cross-sectional shape of the orifice <NUM> remains generally rectangular, which results in a lower drop in pressure through the variable nozzle <NUM> from the first chamber <NUM> to the second chamber <NUM>. The generally consistent rectangular shape of the orifice <NUM> of the variable nozzle <NUM> during increased flow rates is achieved by thin, creased walls formed in the top and bottom walls <NUM>, which allow the side walls <NUM> to flex easier and with less resistance. A further advantage of this embodiment is that there is no leakage out of the top and bottom walls <NUM> while exhaled air flows through the orifice <NUM> of the variable nozzle <NUM>, such as for example, through the V-shaped slits <NUM> of the variable nozzle <NUM> shown in <FIG>.

Those skilled in the art will also appreciate that, in some applications, only positive expiratory pressure (without oscillation) may be desired, in which case the OPEP device <NUM> may be operated without the restrictor member <NUM>, but with a fixed orifice or manually adjustable orifice instead. The positive expiratory pressure embodiment may also comprise the variable nozzle <NUM>, or the variable nozzle <NUM>, in order to maintain a relatively consistent back pressure within a desired range.

Turning now to <FIG>, a front perspective view and a rear perspective view of a second embodiment of an OPEP device <NUM> is shown. The configuration and operation of the OPEP device <NUM> is similar to that of the OPEP device <NUM>. However, as best shown in <FIG>, the OPEP device <NUM> further includes an adjustment mechanism <NUM> adapted to change the relative position of the chamber inlet <NUM> with respect to the housing <NUM> and the restrictor member <NUM>, which in turn changes the range of rotation of the vane <NUM> operatively connected thereto. As explained below, a user is therefore able to conveniently adjust both the frequency and the amplitude of the OPEP therapy administered by the OPEP device <NUM> without opening the housing <NUM> and disassembling the components of the OPEP device <NUM>.

The OPEP device <NUM> generally comprises a housing <NUM>, a chamber inlet <NUM>, a first chamber outlet <NUM> (best seen in <FIG> and <FIG>), a second chamber outlet <NUM> (best seen in <FIG> and <FIG>), and a mouthpiece <NUM> in fluid communication with the chamber inlet <NUM>. As with the OPEP device <NUM>, a front section <NUM>, a middle section <NUM>, and a rear section <NUM> of the housing <NUM> are separable so that the components contained therein can be periodically accessed, cleaned, replaced, or reconfigured, as required to maintain the ideal operating conditions. The OPEP device also includes an adjustment dial <NUM>, as described below.

As discussed above in relation to the OPEP device <NUM>, the OPEP device <NUM> may be adapted for use with other or additional interfaces, such as an aerosol delivery device. In this regard, the OPEP device <NUM> is equipped with an inhalation port <NUM> (best seen in <FIG>, <FIG>, and <FIG>) in fluid communication with the mouthpiece <NUM> and the chamber inlet <NUM>. As noted above, the inhalation port may include a separate one-way valve (not shown) to permit a user of the OPEP device <NUM> both to inhale the surrounding air through the one-way valve and to exhale through the chamber inlet <NUM> without withdrawing the mouthpiece <NUM> of the OPEP device <NUM> between periods of inhalation and exhalation. In addition, the aforementioned aerosol delivery devices may be connected to the inhalation port <NUM> for the simultaneous administration of aerosol and OPEP therapies.

An exploded view of the OPEP device <NUM> is shown in <FIG>. In addition to the components of the housing described above, the OPEP device <NUM> includes a restrictor member <NUM> operatively connected to a vane <NUM> by a pin <NUM>, an adjustment mechanism <NUM>, and a variable nozzle <NUM>. As shown in the cross-sectional view of <FIG>, when the OPEP device <NUM> is in use, the variable nozzle <NUM> is positioned between the middle section <NUM> and the rear section <NUM> of the housing <NUM>, and the adjustment mechanism <NUM>, the restrictor member <NUM>, and the vane <NUM> form an assembly.

Turning to <FIG>, various cross-sectional perspective views of the OPEP device <NUM> are shown. As with the OPEP device <NUM>, an exhalation flow path <NUM>, identified by a dashed line, is defined between the mouthpiece <NUM> and at least one of the first chamber outlet <NUM> and the second chamber outlet <NUM> (best seen in <FIG> and <FIG>). As a result of a one-way valve (not-shown) and/or an aerosol delivery device (not shown) attached to the inhalation port <NUM>, the exhalation flow path <NUM> begins at the mouthpiece <NUM> and is directed toward the chamber inlet <NUM>, which in operation may or may not be blocked by the restrictor member <NUM>. After passing through the chamber inlet <NUM>, the exhalation flow path <NUM> enters a first chamber <NUM> and makes a <NUM>° turn toward the variable nozzle <NUM>. After passing through the orifice <NUM> of the variable nozzle <NUM>, the exhalation flow path <NUM> enters a second chamber <NUM>. In the second chamber <NUM>, the exhalation flow path <NUM> may exit the OPEP device <NUM> through at least one of the first chamber outlet <NUM> or the second chamber outlet <NUM>. Those skilled in the art will appreciate that the exhalation flow path <NUM> identified by the dashed line is exemplary, and that air exhaled into the OPEP device <NUM> may flow in any number of directions or paths as it traverses from the mouthpiece <NUM> or chamber inlet <NUM> to the first chamber outlet <NUM> or the second chamber outlet <NUM>.

Referring to <FIG>, front and rear perspective views of the adjustment mechanism <NUM> of the OPEP device <NUM> are shown. In general, the adjustment mechanism <NUM> includes an adjustment dial <NUM>, a shaft <NUM>, and a frame <NUM>. A protrusion <NUM> is positioned on a rear face <NUM> of the adjustment dial, and is adapted to limit the selective rotation of the adjustment mechanism <NUM> by a user, as further described below. The shaft <NUM> includes keyed portions <NUM> adapted to fit within upper and lower bearings <NUM>, <NUM> formed in the housing <NUM> (see <FIG> and <FIG>). The shaft further includes an axial bore <NUM> configured to receive the pin <NUM> operatively connecting the restrictor member <NUM> and the vane <NUM>. As shown, the frame <NUM> is spherical, and as explained below, is configured to rotate relative to the housing <NUM>, while forming a seal between the housing <NUM> and the frame <NUM> sufficient to permit the administration of OPEP therapy. The frame <NUM> includes a circular opening defined by a seat <NUM> adapted to accommodate the restrictor member <NUM>. In use, the circular opening functions as the chamber inlet <NUM>. The frame <NUM> also includes a stop <NUM> for preventing the restrictor member <NUM> from opening in a wrong direction.

Turning to <FIG>, a front perspective view of the restrictor member <NUM> and the vane <NUM> is shown. The design, materials, and configuration of the restrictor member <NUM> and the vane <NUM> may be the same as described above in regards to the OPEP device <NUM>. However, the restrictor member <NUM> and the vane <NUM> in the OPEP device <NUM> are operatively connected by a pin <NUM> adapted for insertion through the axial bore <NUM> in the shaft <NUM> of the adjustment mechanism <NUM>. The pin <NUM> may be constructed, for example, by stainless steel. In this way, rotation of the restrictor member <NUM> results in a corresponding rotation of the vane <NUM>, and vice versa.

Turning to <FIG>, a front perspective view of the adjustment mechanism <NUM> assembled with the restrictor member <NUM> and the vane <NUM> is shown. In this configuration, it can be seen that the restrictor member <NUM> is positioned such that it is rotatable relative to the frame <NUM> and the seat <NUM> between a closed position (as shown), where a flow of exhaled air along the exhalation flow path <NUM> through the chamber inlet <NUM> is restricted, and an open position (not shown), where the flow of exhaled air through the chamber inlet <NUM> is less restricted. As previously mentioned the vane <NUM> is operatively connected to the restrictor member <NUM> by the pin <NUM> extending through shaft <NUM>, and is adapted to move in unison with the restrictor member <NUM>. It can further be seen that the restrictor member <NUM> and the vane <NUM> are supported by the adjustment mechanism <NUM>, which itself is rotatable within the housing <NUM> of the OPEP device <NUM>, as explained below.

<FIG> and <FIG> are partial cross-sectional views illustrating the adjustment mechanism <NUM> mounted within the housing <NUM> of the OPEP device <NUM>. As shown in <FIG>, the adjustment mechanism <NUM>, as well as the restrictor member <NUM> and the vane <NUM>, are rotatably mounted within the housing <NUM> about an upper and lower bearing <NUM>, <NUM>, such that a user is able to rotate the adjustment mechanism <NUM> using the adjustment dial <NUM>. <FIG> further illustrates the process of mounting and locking the adjustment mechanism <NUM> within the lower bearing <NUM> of the housing <NUM>. More specifically, the keyed portion <NUM> of the shaft <NUM> is aligned with and inserted through a rotational lock <NUM> formed in the housing <NUM>, as shown in <FIG>. Once the keyed portion <NUM> of the shaft <NUM> is inserted through the rotational lock <NUM>, the shaft <NUM> is rotated <NUM>° to a locked position, but remains free to rotate. The adjustment mechanism <NUM> is mounted and locked within the upper bearing <NUM> in the same manner.

Once the housing <NUM> and the internal components of the OPEP device <NUM> are assembled, the rotation of the shaft <NUM> is restricted to keep it within a locked position in the rotational lock <NUM>. As shown in a front view of the OPEP device <NUM> in <FIG>, two stops <NUM>, <NUM> are positioned on the housing <NUM> such that they engage the protrusion <NUM> formed on the rear face <NUM> of the adjustment dial <NUM> when a user rotates the adjustment dial <NUM> to a predetermined position. For purposes of illustration, the OPEP device <NUM> is shown in <FIG> without the adjustment dial <NUM> or the adjustment mechanism <NUM>, which would extend from the housing <NUM> through an opening <NUM>. In this way, rotation of the adjustment dial <NUM>, the adjustment mechanism <NUM>, and the keyed portion <NUM> of the shaft <NUM> can be appropriately restricted.

Turning to <FIG>, a partial cross-sectional view of the adjustment mechanism <NUM> mounted within the housing <NUM> is shown. As previously mentioned, the frame <NUM> of the adjustment mechanism <NUM> is spherical, and is configured to rotate relative to the housing <NUM>, while forming a seal between the housing <NUM> and the frame <NUM> sufficient to permit the administration of OPEP therapy. As shown in <FIG>, a flexible cylinder <NUM> extending from the housing <NUM> completely surrounds a portion of the frame <NUM> to form a sealing edge <NUM>. Like the housing <NUM> and the restrictor member <NUM>, the flexible cylinder <NUM> and the frame <NUM> may be constructed of a low shrink, low friction plastic. One such material is acetal. In this way, the sealing edge <NUM> contacts the frame <NUM> for a full <NUM>° and forms a seal throughout the permissible rotation of the adjustment member <NUM>.

The selective adjustment of the OPEP device <NUM> will now be described with reference to <FIG>, <FIG>, and <FIG>. <FIG> are partial cross-sectional views of the OPEP device <NUM>; <FIG> are illustrations of the adjustability of the OPEP device <NUM>; and, <FIG> are top phantom views of the OPEP device <NUM>. As previously mentioned with regards to the OPEP device <NUM>, it is preferable that the vane <NUM> and the restrictor member <NUM> are configured such that when the OPEP device <NUM> is fully assembled, the angle between a centerline of the variable nozzle <NUM> and the vane <NUM> is between <NUM>° and <NUM>° when the restrictor member <NUM> is in a closed position. However, it should be appreciated that the adjustability of the OPEP device <NUM> is not limited to the parameters described herein, and that any number of configurations may be selected for purposes of administering OPEP therapy within the ideal operating conditions.

<FIG> shows the vane <NUM> at an angle of <NUM>° from the centerline of the variable nozzle <NUM>, whereas <FIG> shows the vane <NUM> at an angle of <NUM>° from the centerline of the variable nozzle <NUM>. <FIG> illustrates the necessary position of the frame <NUM> (shown in phantom) relative to the variable nozzle <NUM> such that the angle between a centerline of the variable nozzle <NUM> and the vane <NUM> is <NUM>° when the restrictor member <NUM> is in the closed position. <FIG>, on the other hand, illustrates the necessary position of the frame <NUM> (shown in phantom) relative to the variable nozzle <NUM> such that the angle between a centerline of the variable nozzle <NUM> and the vane <NUM> is <NUM>° when the restrictor member <NUM> is in the closed position.

Referring to <FIG>, side phantom views of the OPEP device <NUM> are shown. The configuration shown in <FIG> corresponds to the illustrations shown in <FIG> and <FIG>, wherein the angle between a centerline of the variable nozzle <NUM> and the vane <NUM> is <NUM>° when the restrictor member <NUM> is in the closed position. <FIG>, on the other hand, corresponds to the illustrations shown in <FIG> and <FIG>, wherein the angle between a centerline of the variable nozzle <NUM> and the vane <NUM> is <NUM>° when the restrictor member <NUM> is in the closed position. In other words, the frame <NUM> of the adjustment member <NUM> has been rotated counter-clockwise <NUM>°, from the position shown in <FIG>, to the position shown in <FIG>, thereby also increasing the permissible rotation of the vane <NUM>.

In this way, a user is able to rotate the adjustment dial <NUM> to selectively adjust the orientation of the chamber inlet <NUM> relative to the restrictor member <NUM> and the housing <NUM>. For example, a user may increase the frequency and amplitude of the OPEP therapy administered by the OPEP device <NUM> by rotating the adjustment dial <NUM>, and therefore the frame <NUM>, toward the position shown in <FIG>. Alternatively, a user may decrease the frequency and amplitude of the OPEP therapy administered by the OPEP device <NUM> by rotating the adjustment dial <NUM>, and therefore the frame <NUM>, toward the position shown in <FIG>. Furthermore, as shown for example in <FIG> and <FIG>, indicia may be provided to aid the user in the setting of the appropriate configuration of the OPEP device <NUM>.

Operating conditions similar to those described below with reference to the OPEP device <NUM> may also be achievable for an OPEP device according to the OPEP device <NUM>.

Turning to <FIG>, another embodiment of an OPEP device <NUM> is shown. The OPEP device <NUM> is similar to that of the OPEP device <NUM> in that is selectively adjustable. As best seen in <FIG>, <FIG>, <FIG>, and <FIG>, the OPEP device <NUM>, like the OPEP device <NUM>, includes an adjustment mechanism <NUM> adapted to change the relative position of a chamber inlet <NUM> with respect to a housing <NUM> and a restrictor member <NUM>, which in turn changes the range of rotation of a vane <NUM> operatively connected thereto. As previously explained with regards to the OPEP device <NUM>, a user is therefore able to conveniently adjust both the frequency and the amplitude of the OPEP therapy administered by the OPEP device <NUM> without opening the housing <NUM> and disassembling the components of the OPEP device <NUM>. The administration of OPEP therapy using the OPEP device <NUM> is otherwise the same as described above with regards to the OPEP device <NUM>.

The OPEP device <NUM> comprises a housing <NUM> having a front section <NUM>, a rear section <NUM>, and an inner casing <NUM>. As with the previously described OPEP devices, the front section <NUM>, the rear section <NUM>, and the inner casing <NUM> are separable so that the components contained therein can be periodically accessed, cleaned, replaced, or reconfigured, as required to maintain the ideal operating conditions. For example, as shown in <FIG>, the front section <NUM> and the rear section <NUM> of the housing <NUM> are removably connected via a snap fit engagement.

The components of the OPEP device <NUM> are further illustrated in the exploded view of <FIG>. In general, in addition to the front section <NUM>, the rear section <NUM>, and the inner casing <NUM>, the OPEP device <NUM> further comprises a mouthpiece <NUM>, an inhalation port <NUM>, a one-way valve <NUM> disposed therebetween, an adjustment mechanism <NUM>, a restrictor member <NUM>, a vane <NUM>, and a variable nozzle <NUM>.

As seen in <FIG>, the inner casing <NUM> is configured to fit within the housing <NUM> between the front section <NUM> and the rear section <NUM>, and partially defines a first chamber <NUM> and a second chamber <NUM>. The inner casing <NUM> is shown in further detail in the perspective and cross sectional views shown in <FIG>. A first chamber outlet <NUM> and a second chamber outlet <NUM> are formed within the inner casing <NUM>. One end <NUM> of the inner casing <NUM> is adapted to receive the variable nozzle <NUM> and maintain the variable nozzle <NUM> between the rear section <NUM> and the inner casing <NUM>. An upper bearing <NUM> and a lower bearing <NUM> for supporting the adjustment mechanism <NUM> is formed, at least in part, within the inner casing <NUM>. Like the flexible cylinder <NUM> and sealing edge <NUM> described above with regards to the OPEP device <NUM>, the inner casing <NUM> also includes a flexible cylinder <NUM> with a sealing edge <NUM> for engagement about a frame <NUM> of the adjustment mechanism <NUM>.

The vane <NUM> is shown in further detail in the perspective view shown in <FIG>. A shaft <NUM> extends from the vane <NUM> and is keyed to engage a corresponding keyed portion within a bore <NUM> of the restrictor member <NUM>. In this way, the shaft <NUM> operatively connects the vane <NUM> with the restrictor member <NUM> such that the vane <NUM> and the restrictor member <NUM> rotate in unison.

The restrictor member <NUM> is shown in further detail in the perspective views shown in <FIG>. The restrictor member <NUM> includes a keyed bore <NUM> for receiving the shaft <NUM> extending from the vane <NUM>, and further includes a stop <NUM> that limits permissible rotation of the restrictor member <NUM> relative to a seat <NUM> of the adjustment member <NUM>. As shown in the front view of <FIG>, like the restrictor member <NUM>, the restrictor member <NUM> further comprises an offset designed to facilitate movement of the restrictor member <NUM> between a closed position and an open position. More specifically, a greater surface area of the face <NUM> of the restrictor member <NUM> is positioned on one side of the bore <NUM> for receiving the shaft <NUM> than on the other side of the bore <NUM>. As described above with regards to the restrictor member <NUM>, this offset produces an opening torque about the shaft <NUM> during periods of exhalation.

The adjustment mechanism <NUM> is shown in further detail in the front and rear perspective views of <FIG> and <FIG>. In general, the adjustment mechanism includes a frame <NUM> adapted to engage the sealing edge <NUM> of the flexible cylinder <NUM> formed on the inner casing <NUM>. A circular opening in the frame <NUM> forms a seat <NUM> shaped to accommodate the restrictor member <NUM>. In this embodiment, the seat <NUM> also defines the chamber inlet <NUM>. The adjustment mechanism <NUM> further includes an arm <NUM> configured to extend from the frame <NUM> to a position beyond the housing <NUM> in order to permit a user to selectively adjust the orientation of the adjustment mechanism <NUM>, and therefore the chamber inlet <NUM>, when the OPEP device <NUM> is fully assembled. The adjustment mechanism <NUM> also includes an upper bearing <NUM> and a lower bearing <NUM> for receiving the shaft <NUM>.

An assembly of the vane <NUM>, the adjustment mechanism <NUM>, and the restrictor member <NUM> is shown in the perspective view of <FIG>. As previously explained, the vane <NUM> and the restrictor member <NUM> are operatively connected by the shaft <NUM> such that rotation of the vane <NUM> results in rotation of the restrictor member <NUM>, and vice versa. In contrast, the adjustment mechanism <NUM>, and therefore the seat <NUM> defining the chamber inlet <NUM>, is configured to rotate relative to the vane <NUM> and the restrictor member <NUM> about the shaft <NUM>. In this way, a user is able to rotate the arm <NUM> to selectively adjust the orientation of the chamber inlet <NUM> relative to the restrictor member <NUM> and the housing <NUM>. For example, a user may increase the frequency and amplitude of the OPEP therapy administered by the OPEP device <NUM> by rotating the arm <NUM>, and therefore the frame <NUM>, in a clockwise direction. Alternatively, a user may decrease the frequency and amplitude of the OPEP therapy administered by the OPEP device <NUM> by rotating the adjustment arm <NUM>, and therefore the frame <NUM>, in a counter-clockwise direction. Furthermore, as shown for example in <FIG> and <FIG>, indicia may be provided on the housing <NUM> to aid the user in the setting of the appropriate configuration of the OPEP device <NUM>.

The variable nozzle <NUM> is shown in further detail in the front and rear perspective views of <FIG>. The variable nozzle <NUM> in the OPEP device <NUM> is similar to the variable nozzle <NUM> described above with regards to the OPEP device <NUM>, except that the variable nozzle <NUM> also includes a base plate <NUM> configured to fit within one end <NUM> (see <FIG>) of the inner casing <NUM> and maintain the variable nozzle <NUM> between the rear section <NUM> and the inner casing <NUM>. Like the variable nozzle <NUM>, the variable nozzle <NUM> and base plate <NUM> may be made of silicone.

The one-way valve <NUM> is shown in further detail in the front perspective view of <FIG>. In general, the one-way valve <NUM> comprises a post <NUM> adapted for mounting in the front section <NUM> of the housing <NUM>, and a flap <NUM> adapted to bend or pivot relative to the post <NUM> in response to a force or a pressure on the flap <NUM>. Those skilled in the art will appreciate that other one-way valves may be used in this and other embodiments described herein without departing from the teachings of the present disclosure. As seen in <FIG>, the one-way valve <NUM> may be positioned in the housing <NUM> between the mouthpiece <NUM> and the inhalation port <NUM>.

As discussed above in relation to the OPEP device <NUM>, the OPEP device <NUM> may be adapted for use with other or additional interfaces, such as an aerosol delivery device. In this regard, the OPEP device <NUM> is equipped with an inhalation port <NUM> (best seen in <FIG> and <FIG>) in fluid communication with the mouthpiece <NUM>. As noted above, the inhalation port may include a separate one-way valve <NUM> (best seen in <FIG> and <FIG>) configured to permit a user of the OPEP device <NUM> both to inhale the surrounding air through the one-way valve <NUM> and to exhale through the chamber inlet <NUM>, without withdrawing the mouthpiece <NUM> of the OPEP device <NUM> between periods of inhalation and exhalation. In addition, the aforementioned commercially available aerosol delivery devices may be connected to the inhalation port <NUM> for the simultaneous administration of aerosol therapy (upon inhalation) and OPEP therapy (upon exhalation).

The OPEP device <NUM> and the components described above are further illustrated in the cross-sectional views shown in <FIG>. For purposes of illustration, the cross-sectional view of <FIG> is shown without all the internal components of the OPEP device <NUM>.

The front section <NUM>, the rear section <NUM>, and the inner casing <NUM> are assembled to form a first chamber <NUM> and a second chamber <NUM>. As with the OPEP device <NUM>, an exhalation flow path <NUM>, identified by a dashed line, is defined between the mouthpiece <NUM> and at least one of the first chamber outlet <NUM> (best seen in <FIG> and <FIG>) and the second chamber outlet <NUM> (best seen in <FIG>), both of which are formed within the inner casing <NUM>. As a result of the inhalation port <NUM> and the one-way valve <NUM>, the exhalation flow path <NUM> begins at the mouthpiece <NUM> and is directed toward the chamber inlet <NUM>, which in operation may or may not be blocked by the restrictor member <NUM>. After passing through the chamber inlet <NUM>, the exhalation flow path <NUM> enters the first chamber <NUM> and makes a <NUM>° turn toward the variable nozzle <NUM>. After passing through an orifice <NUM> of the variable nozzle <NUM>, the exhalation flow path <NUM> enters the second chamber <NUM>. In the second chamber <NUM>, the exhalation flow path <NUM> may exit the second chamber <NUM>, and ultimately the housing <NUM>, through at least one of the first chamber outlet <NUM> or the second chamber outlet <NUM>. Those skilled in the art will appreciate that the exhalation flow path <NUM> identified by the dashed line is exemplary, and that air exhaled into the OPEP device <NUM> may flow in any number of directions or paths as it traverses from the mouthpiece <NUM> or chamber inlet <NUM> to the first chamber outlet <NUM> or the second chamber outlet <NUM>. As previously noted, the administration of OPEP therapy using the OPEP device <NUM> is otherwise the same as described above with regards to the OPEP device <NUM>.

Solely by way of example, the follow operating conditions, or performance characteristics, may be achieved by an OPEP device according to the OPEP device <NUM>, with the adjustment dial <NUM> set for increased frequency and amplitude:.

The frequency and amplitude may decrease, for example, by approximately <NUM>% with the adjustment dial <NUM> set for decreased frequency and amplitude. Other frequency and amplitude targets may be achieved by varying the particular configuration or sizing of elements, for example, increasing the length of the vane <NUM> results in a slower frequency, whereas, decreasing the size of the orifice <NUM> results in a higher frequency. The above example is merely one possible set of operating conditions for an OPEP device according to the embodiment described above.

Turning to <FIG>, another embodiment of a respiratory treatment device <NUM> is shown. Unlike the previously described OPEP devices, the respiratory treatment device <NUM> is configured to administer oscillating pressure therapy upon both exhalation and inhalation. Those skilled in the art will appreciate that the concepts described below with regards to the respiratory treatment device <NUM> may be applied to any of the previously described OPEP devices, such that oscillating pressure therapy may be administered upon both exhalation and inhalation. Likewise, the respiratory treatment device <NUM> may incorporate any of the concepts above regarding the previously described OPEP devices, including for example, a variable nozzle, an inhalation port adapted for use with an aerosol delivery device for the administration of aerosol therapy, an adjustment mechanism, etc..

As shown in <FIG> and <FIG>, the respiratory treatment device <NUM> includes a housing <NUM> having a front section <NUM>, a middle section <NUM>, and a rear section <NUM>. As with the OPEP devices described above, the housing <NUM> is openable so that the contents of the housing <NUM> may be accessed for cleaning and/or selective replacement or adjustment of the components contained therein to maintain ideal operating conditions. The housing <NUM> further includes a first opening <NUM>, a second opening <NUM>, and a third opening <NUM>.

Although the first opening <NUM> is shown in in <FIG> and <FIG> in association with a mouthpiece <NUM>, the first opening <NUM> may alternatively be associated with other user interfaces, for example, a gas mask or a breathing tube. The second opening <NUM> includes a one-way exhalation valve <NUM> configured to permit air exhaled into the housing <NUM> to exit the housing <NUM> upon exhalation at the first opening <NUM>. The third opening <NUM> includes a one-way inhalation valve <NUM> configured to permit air outside the housing <NUM> to enter the housing <NUM> upon inhalation at the first opening <NUM>. As shown in greater detail in <FIG>, the respiratory treatment device <NUM> further includes a manifold plate <NUM> having an exhalation passage <NUM> and an inhalation passage <NUM>. A one-way valve <NUM> is adapted to mount to within the manifold plate <NUM> adjacent to the exhalation passage <NUM> such that the one-way valve <NUM> opens in response to air exhaled into the first opening <NUM>, and closes in response to air inhaled through the first opening <NUM>. A separate one-way valve <NUM> is adapted to mount within the manifold pate <NUM> adjacent to the inhalation passage <NUM> such that the one-way valve <NUM> closes in response to air exhaled into the first opening <NUM>, and opens in response to air inhaled through the first opening <NUM>. The respiratory treatment device <NUM> also includes a restrictor member <NUM> and a vane <NUM> operatively connected by a shaft <NUM>, the assembly of which may operate in the same manner as described above with regards to the disclosed OPEP devices.

Referring now to <FIG> and <FIG>, cross-sectional perspective views are shown taken along lines I and II, respectively, in <FIG>. The respiratory treatment device <NUM> administers oscillating pressure therapy upon both inhalation and exhalation in a manner similar to that shown and described above with regards to the OPEP devices. As described in further detail below, the OPEP device <NUM> includes a plurality of chambers (i.e., more than one). Air transmitted through the first opening <NUM> of the housing <NUM>, whether inhaled or exhaled, traverses a flow path that passes, at least in part, past a restrictor member <NUM> housed in a first chamber <NUM>, and through a second chamber <NUM> which houses a vane <NUM> operatively connected to the restrictor member <NUM>. In this regard, at least a portion of the flow path for both air exhaled into or inhaled from the first opening <NUM> is overlapping, and occurs in the same direction.

For example, an exemplary flow path <NUM> is identified in <FIG> and <FIG> by a dashed line. Similar to the previously described OPEP devices, the restrictor member <NUM> is positioned in the first chamber <NUM> and is movable relative to a chamber inlet <NUM> between a closed position, where the flow of air through the chamber inlet <NUM> is restricted, and an open position, where the flow of air through the chamber <NUM> inlet is less restricted. After passing through the chamber inlet <NUM> and entering the first chamber <NUM>, the exemplary flow path <NUM> makes a <NUM>-degree turn, or reverses longitudinal directions (i.e., the flow path <NUM> is folded upon itself), whereupon the exemplary flow path <NUM> passes through an orifice <NUM> and enters the second chamber <NUM>. As with the previously described OPEP devices, the vane <NUM> is positioned in the second chamber <NUM>, and is configured to reciprocate between a first position and a second position in response to an increased pressure adjacent the vane, which in turn causes the operatively connected restrictor member <NUM> to repeatedly move between the closed position and the open position. Depending on the position of the vane <NUM>, air flowing along the exemplary flow path <NUM> is directed to one of either a first chamber outlet <NUM> or a second chamber outlet <NUM>. Consequently, as inhaled or exhaled air traverses the exemplary flow path <NUM>, pressure at the chamber inlet <NUM> oscillates.

The oscillating pressure at the chamber inlet <NUM> is effectively transmitted back to a user of the respiratory treatment device <NUM>, i.e., at the first opening <NUM>, via a series of chambers. As seen in <FIG> and <FIG>, the respiratory treatment device includes a first additional chamber <NUM>, a second additional chamber <NUM>, and a third additional chamber <NUM>, which are described in further detail below.

The mouthpiece <NUM> and the first additional chamber <NUM> are in communication via the first opening <NUM> in the housing <NUM>. The first additional chamber <NUM> and the second additional chamber <NUM> are separated by the manifold plate <NUM>, and are in communication via the exhalation passage <NUM>. The one-way valve <NUM> mounted adjacent to the exhalation passage <NUM> is configured to open in response to air exhaled into the first opening <NUM>, and close in response to air inhaled through the first opening <NUM>.

The first additional chamber <NUM> and the third additional chamber <NUM> are also separated by the manifold plate <NUM>, and are in communication via the inhalation passage <NUM>. The one-way valve <NUM> mounted adjacent to the inhalation passage <NUM> is configured to close in response to air exhaled into the first opening <NUM>, and open in response to air inhaled through the first opening <NUM>.

Air surrounding the respiratory treatment device <NUM> and the second additional chamber <NUM> are in communication via the third opening <NUM> in the housing <NUM>. The one-way valve <NUM> is configured to close in response to air exhaled in to the first opening <NUM>, and open in response to air inhaled through the first opening <NUM>.

Air surrounding the respiratory treatment device <NUM> and the third additional chamber <NUM> are in communication via the second opening <NUM> in the housing <NUM>. The one way-valve <NUM> mounted adjacent the second opening <NUM> is configured to open in response to air exhaled into the first opening <NUM>, and close in response to air inhaled through the first opening <NUM>. The third additional chamber <NUM> is also in communication with the second chamber <NUM> via the first chamber outlet <NUM> and the second chamber outlet <NUM>.

Referring now to <FIG>, cross-sectional perspective views taken along lines I and II, respectively, of <FIG>, illustrate an exemplary exhalation flow path <NUM> formed between the first opening <NUM>, or the mouthpiece <NUM>, and the second opening <NUM>. In general, upon exhalation by a user into the first opening <NUM> of the housing <NUM>, pressure builds in the first additional chamber <NUM>, causing the one-way valve <NUM> to open, and the one-way valve <NUM> to close. Exhaled air then enters the second additional chamber <NUM> through the exhalation passage <NUM> and pressure builds in the second additional chamber <NUM>, causing the one-way valve <NUM> to close and the restrictor member <NUM> to open. The exhaled air then enters the first chamber <NUM> through the chamber inlet <NUM>, reverses longitudinal directions, and accelerates through the orifice <NUM> separating the first chamber <NUM> and the second chamber <NUM>. Depending on the orientation of the vane <NUM>, the exhaled air then exits the second chamber <NUM> through one of either the first chamber outlet <NUM> or the second chamber outlet <NUM>, whereupon it enters the third additional chamber <NUM>. As pressure builds in the third additional chamber <NUM>, the one-way valve <NUM> opens, permitting exhaled air to exit the housing <NUM> through the second opening <NUM>. Once the flow of exhaled air along the exhalation flow path <NUM> is established, the vane <NUM> reciprocates between a first position and a second position, which in turn causes the restrictor member <NUM> to move between the closed position and the open position, as described above with regards to the OPEP devices. In this way, the respiratory treatment device <NUM> provides oscillating therapy upon exhalation.

Referring now to <FIG>, different cross-sectional perspective views taken along lines I and II, respectively, of <FIG>, illustrate an exemplary inhalation flow path <NUM> formed between the third opening <NUM> and the first opening <NUM>, or the mouthpiece <NUM>. In general, upon inhalation by a user through the first opening <NUM>, pressure drops in the first additional chamber <NUM>, causing the one-way valve <NUM> to close, and the one-way valve <NUM> to open. As air is inhaled from the third additional chamber <NUM> into the first additional chamber <NUM> through the inhalation passage <NUM>, pressure in the third additional chamber <NUM> begins to drop, causing the one-way valve <NUM> to close. As pressure continues to drop in the third additional chamber <NUM>, air is drawn from the second chamber <NUM> through the first chamber outlet <NUM> and the second camber outlet <NUM>, As air is drawn from the second chamber <NUM>, air is also drawn from the first chamber <NUM> through the orifice <NUM> connecting the second chamber <NUM> and the first chamber <NUM>. As air is drawn from the first chamber <NUM>, air is also drawn from the second additional chamber <NUM> through the chamber inlet <NUM>, causing the pressure in the second additional chamber <NUM> to drop and the one-way valve <NUM> to open, thereby permitting air to enter the housing <NUM> through third opening <NUM>. Due to the pressure differential between the first additional chamber <NUM> and the second additional chamber <NUM>, the one-way valve <NUM> remains closed. Once the flow of inhaled air along the inhalation flow path <NUM> is established, the vane <NUM> reciprocates between a first position and a second position, which in turn causes the restrictor member <NUM> to move between the closed position and the open position, as described above with regards to the OPEP devices. In this way, the respiratory treatment device <NUM> provides oscillating therapy upon inhalation.

RMT includes pressure threshold resistance. A pressure threshold resistor requires a user to achieve and maintain a set pressure in order to inhale or exhale through the pressure threshold resistor and/or the attached respiratory device. In general, a pressure threshold resistor includes a one way valve that is biased toward a closed position. As a pressure force created by a user inhaling through or exhaling into the device overcomes the biasing force, the valve opens and permits inhalation or exhalation. In order to continue with inhalation or exhalation, the user must generate and maintain a pressure that matches or exceeds the pressure threshold that overcomes the biasing force on the valve. A pressure threshold resistor may be use during inhalation to generate a negative pressure for administration of RMT, and during exhalation to generate a positive pressure for administration of RMT.

RMT also include flow resistance. A flow resistor limits the flow of air during inhalation or exhalation through the flow resistor and/or the attached respiratory device in order to generate negative or positive pressure for administration RMT. In general, a flow resistor restricts the flow of air through an orifice. The pressure generated by the flow restrictor may be controlled by changing the size of the orifice and/or an inhalation or exhalation flow rate.

Turning to <FIG>, perspective, side, top, cross-sectional, and exploded views of a pressure threshold resistor <NUM> are shown. In general, as shown in <FIG> and <FIG>, the pressure threshold resistor <NUM> includes a spring seat <NUM>, a spring <NUM>, an adjuster <NUM>, a connector <NUM>, and a valve <NUM>.

The connector <NUM> may be shaped and size to be removably connectable to the inhalation port of any number of respiratory devices, including for example, the inhalation port <NUM> of OPEP device <NUM>. The connector <NUM> may be removabaly connectable to respiratory devices by any suitable means, including a friction fit, threaded engagement, a snap fit, or the like.

A center cylinder <NUM> of the connector <NUM> is configured to receive the adjuster <NUM> via a threaded engagement. An end of the center cylinder <NUM> also functions as a seat for the valve <NUM>.

The adjuster <NUM> functions as a thumb screw and is configured for threaded engagement with the connector <NUM>. In this way, the adjuster <NUM> may be rotated by a user relative to the connector <NUM> to raise or lower the position of the adjuster <NUM> relative to the connector <NUM>. As discussed below, the adjuster <NUM> may be selectively rotated by a user to increase or decrease the threshold pressure required to open the valve <NUM>. The adjuster <NUM> also includes a center cylinder <NUM> sized for sliding engagement with the spring <NUM>. The center cylinder <NUM> also includes an interior portion sized for sliding engagement with a post <NUM> of the valve <NUM>. The base of the center cylinder <NUM> acts as stop for the spring <NUM>.

The valve <NUM> includes a valve face <NUM> and a post <NUM>. The valve face <NUM> is configured to engage the seat defined by an end of the cylinder <NUM> of the connector <NUM>. As stated above, the post <NUM> is configured to fit within and be in sliding engagement with the center cylinder <NUM> of the adjuster <NUM>. An end of the post <NUM> is connected to the spring seat <NUM>. In an alternative embodiment, the end of the post <NUM> may be removably connected t the spring seat <NUM>.

The spring seat <NUM> is shaped and sized to fit within the adjuster <NUM>. In general, the spring seat <NUM> is cylindrical and includes an interior portion that receives the spring <NUM> and the post <NUM> of the valve <NUM>. A base of the interior portion of the spring seat <NUM> also acts as stop for the spring <NUM>.

The spring <NUM> may be a coil spring. Springs of different lengths and spring constants (k) may be selected and/or replaced, as desired, to increase or decrease the threshold pressures required to open the valve <NUM>. When assembled in the pressure threshold resistor <NUM> as shown, the spring <NUM> is under compression.

In operation, the pressure threshold resistor <NUM> is connected to an inhalation port of a respiratory device via the connector <NUM>. When a user inhales through the respiratory device, a negative pressure is created at the inhalation port. Consequently, the negative pressure creates a force that pulls on the valve face <NUM> of the valve <NUM>. However, the valve <NUM> and the valve face <NUM> are also biased by the spring <NUM> (via the post <NUM> and spring seat <NUM>) toward a closed position, and therefore, remain closed until the pressure threshold required to open the valve <NUM> is reached. As a user continues to inhale, or inhale with greater strength, the negative pressure created at the inhalation port increases, until the pressure threshold is reached, at which point the valve face <NUM> is pulled away from the seat formed by the center cylinder <NUM> of the connector <NUM>, and the valve <NUM> opens. Once the valve <NUM> is opened, a user is able to inhale air surrounding the pressure threshold resistor <NUM> and the respiratory device, so long as the negative pressure generated at the inhalation port by the user's inhalation maintains or exceeds the threshold pressure required to open the valve <NUM>. If the user stops inhaling, or if the negative pressure generated by the user's inhalation drops below the threshold pressure, the biasing force of the spring <NUM> closes the valve <NUM>.

<FIG> and <FIG> are side and cross-sectional views of the pressure threshold resistor <NUM>, further illustrating selective adjustment of the pressure threshold required to open the valve <NUM>. <FIG> and <FIG> illustrate the pressure threshold resistor <NUM> at a "low setting," while <FIG> and <FIG> illustrate the pressure threshold resistor <NUM> at a "high setting. " The pressure threshold resistor <NUM> may be selectively adjusted between a low setting, as shown in <FIG>, and a high setting, as shown in <FIG>, by rotating the adjuster <NUM> relative to the connector <NUM>. As shown in <FIG>, rotation of the adjuster <NUM> effectively increases the compression of the spring <NUM>, which in turn increases the bias of the spring <NUM> acting on the valve <NUM>. Consequently, the pressure threshold required to open the valve <NUM> also increases. In this way, the pressure threshold is selectively adjustable by a user.

As previously noted, the pressure threshold resistor <NUM> is connectable to the inhalation port of any number of respiratory devices, including for example, the inhalation port <NUM> of OPEP device <NUM>, as shown in <FIG>. Operation of the OPEP device <NUM> with the pressure threshold resistor <NUM> is illustrated in <FIG>. In general, when a user exhales into the OPEP device <NUM>, the one way valve <NUM> remains closed due to positive exhalation pressure, forcing exhaled air along the exemplary flow path identified by dashed line in <FIG> through the OPEP device <NUM> for administration of OPEP therapy. On the other hand, when a user inhales, the one way valve <NUM> opens due to negative inhalation pressure. At the same time, the orifice of the variable nozzle <NUM> described above in relation to the OPEP device <NUM> closes due to the negative inhalation pressure. With the orifice of the variable nozzle <NUM> closed and the one-way valve <NUM> open, as the user continues to inhale, or inhale with greater strength, a negative pressure created at the inhalation port <NUM> increases until the pressure threshold is reached, at which point the valve <NUM> of the threshold pressure resistor <NUM> opens, allowing air surrounding the pressure threshold resistor <NUM> and the OPEP device <NUM> to flow along the exemplary flow path identified by dashed line in <FIG>.

The pressure threshold resistor <NUM>, as well as the other RMT devices disclosed herein, may also be sized and shaped for use on other respiratory treatment devices. Solely by way of example, <FIG> show the pressure threshold resistor <NUM> connected to an inhalation port an OPEP device <NUM> described in <CIT> and <CIT> and commercially available under the trade name ACAPELLA® from Smiths Medical of St. Paul, Minnesota. The RMT devices disclosed herein may also be used with the OPEP devices described in <CIT>, now <CIT>, and <CIT>, pending.

Turning to <FIG>, side and cross-sectional views of another embodiment of a pressure threshold resistor <NUM> are shown. The pressure threshold resistor <NUM> is shaped and sized to be removably connectable to an inhalation port of a respiratory device including, for example the inhalation port <NUM> of OPEP device <NUM>. The pressure threshold resistor <NUM> may also be shaped and sized to be removably connectable to an exhalation port of a respiratory treatment device, including for example, as shown and described below with regard to the OPEP device <NUM>. The pressure threshold resistor <NUM> may be removabaly connectable to respiratory devices by any suitable means, including a friction fit, threaded engagement, a snap fit, or the like. In general, the pressure threshold resistor <NUM> includes a housing <NUM> comprising a first section <NUM> and a second section <NUM>, a spring seat <NUM>, a spring <NUM>, and a valve <NUM> having a valve face <NUM>.

The first section <NUM> and the second section <NUM> of the housing <NUM> are removably connected to one another by a threaded engagement. The relative positon of the first section <NUM> to the second section <NUM> may also be selectively increased or decreased by rotating the first section <NUM> relative to the second section <NUM>. As discussed below, one section of the housing <NUM> may be rotated relative to the other section of the housing <NUM> to selectively increase or decrease the threshold pressure required to open the valve <NUM> of the pressure threshold resistor <NUM>. The first section <NUM> also includes a valve seat <NUM>, while the second section <NUM> also includes a spring seat <NUM> that functions as a stop for the spring <NUM>.

The pressure threshold resistor <NUM> functions in a manner similar to the pressure threshold resistor <NUM>, except that the pressure threshold resistor <NUM> is configured to provide RMT upon exhalation or inhalation. As previously noted, the pressure threshold resistor <NUM> is connectable to an exhalation port of any number of respiratory devices. To provide RMT upon exhalation, the first section <NUM> of the pressure threshold resistor <NUM> is connected to an exhalation port of a respiratory device.

As shown in <FIG>, when a user exhales into a respiratory device such that a positive exhalation pressure is created at an exhalation port of the respiratory device, the positive pressure creates a force that pushed on the valve face <NUM> of the valve <NUM>. However, the valve <NUM> and the valve face <NUM> are also biased by the spring <NUM> toward a closed position, and therefore, remain closed until the pressure threshold required to open the valve <NUM> is reached. As a user continues to exhale, or exhale with greater strength, the positive pressure created at the exhalation port increases, until the pressure threshold is reached, at which point the valve <NUM> is pushed off the valve seat <NUM> formed in the first section <NUM> of the housing <NUM>, and the valve <NUM> opens, as shown in <FIG>. Once the valve <NUM> is opened, a user is able to exhale through the pressure threshold resistor <NUM> and the respiratory device, so long as the positive pressure generated at the exhalation port by the user's exhalation maintains or exceeds the threshold pressure required to open the valve <NUM>. If the user stops exhaling, or if the positive pressure generated by the user's exhalation drops below the threshold pressure, the biasing force of the spring <NUM> closes the valve <NUM>, as shown in <FIG>.

The pressure threshold resistor <NUM> is also connectable to an inhalation port of any number of respiratory devices. To provide RMT upon inhalation, the second section <NUM> of the pressure threshold resistor <NUM> is connected to the inhalation port of a respiratory device. As shown in <FIG>, when a user inhales into a respiratory device such that a negative inhalation pressure is created at an inhalation port of the respiratory device, the negative pressure creates a force that pulls on the valve <NUM>. However, the valve <NUM> is also biased by the spring <NUM> toward a closed position, and therefore, remain closed until the pressure threshold required to open the valve <NUM> is reached. As a user continues to inhale, or inhale with greater strength, the negative pressure created at the inhalation port increases, until the pressure threshold is reached, at which point the valve <NUM> is pulled off the valve seat <NUM> formed in the first section <NUM> of the housing <NUM>, and the valve <NUM> opens, as shown in <FIG>. Once the valve <NUM> is opened, a user is able to inhale air surrounding the respiratory device through the pressure threshold resistor <NUM> and the respiratory device, so long as the negative pressure generated at the inhalation port by the user's inhalation maintains or exceeds the threshold pressure required to open the valve <NUM>. If the user stops inhaling, or if the negative pressure generated by the user's inhalation drops below the threshold pressure, the biasing force of the spring <NUM> closes the valve <NUM>, as shown in <FIG>.

<FIG> and <FIG> are side and cross-sectional views of the pressure threshold resistor <NUM>, further illustrating selective adjustment of the pressure threshold required to open the valve <NUM>. <FIG> and <FIG> illustrate the pressure threshold resistor <NUM> at a "high setting," while <FIG> and <FIG> illustrate the pressure threshold resistor <NUM> at a "low setting," The pressure threshold resistor <NUM> may be selectively adjusted between a high setting, as shown in <FIG>, and a low setting, as shown in <FIG>, by rotating the first section <NUM> of the housing <NUM> relative to the second section <NUM> of the housing <NUM>. As shown in <FIG>, rotation of the first section <NUM> of the housing <NUM> relative to the second section <NUM> of the housing <NUM> effectively decreases the compression of the spring <NUM>, which in turn decreases the bias of the spring <NUM> acting on the valve <NUM>. Consequently, the pressure threshold required to open the valve <NUM> also decreases. In this way, the pressure threshold is selectively adjustable by a user.

Turning to <FIG>, a perspective and cross-sectional views of a flow resistor <NUM> are shown. As with the pressure threshold resistor <NUM>, the flow resistor <NUM> may be shaped and size to be removably connectable to the inhalation port or the exhalation port of any number of respiratory devices, including, for example, the inhalation port <NUM> of the OPEP device <NUM>. The flow resistor <NUM> may be removabaly connectable to respiratory devices by any suitable means, including a friction fit, threaded engagement, a snap fit, or the like.

In general, the flow resistor <NUM> includes a housing <NUM> having a first section <NUM> and a second section <NUM>, a one-way valve <NUM>, and at least one orifice <NUM>. The first section <NUM> of the housing <NUM> is connectable to the respiratory device. The one-way valve <NUM> is positioned in the first section <NUM> of the housing <NUM>. If the flow resistor <NUM> is to be used during inhalation, as shown in <FIG>, the one-way valve <NUM> may be positioned to open upon inhalation toward the first section <NUM> of the housing <NUM>. If the flow resistor <NUM> is to be used during exhalation, as shown in <FIG>, the one-way valve <NUM> may be positioned to open upon exhalation toward the second section <NUM> of the housing <NUM>. One or more orifices <NUM> are formed in the first section <NUM> of the housing <NUM>.

The first section <NUM> of the housing <NUM> is removably connected to the second section <NUM> of the housing <NUM> via a threaded engagement. The positon of the first section <NUM> relative to the second section <NUM> may be selectively increased or decreased by rotating the first section <NUM> relative to the second section <NUM>. As discussed below, one section of the housing <NUM> may be rotated relative to the other section of the housing <NUM> to selectively increase or decrease the resistance to the flow of air through the flow resistor <NUM>.

In operation the flow resistor <NUM> restricts the flow of air through the orifice(s) <NUM> of the flow resistor <NUM>. As shown in <FIG>, during inhalation, a negative pressure is generated in the first section <NUM> of the housing <NUM>, causing the one-way valve <NUM> to open toward the first section <NUM>, and permitting air surrounding the flow resistor <NUM> and the attached respiratory device through the one or more orifices <NUM>. Restriction of the flow of air through the flow restrictor <NUM>, and therefore the attached respiratory device, results in a greater negative inhalation pressure within the attached respiratory device. As shown in <FIG>, the flow resistor <NUM> may be selectively adjusted to increase or decrease the restriction on the flow of air through the one or more orifices <NUM>, and therefore the negative inhalation pressure in the attached respiratory device, by rotating the first section <NUM> of the housing <NUM> relative to the second section <NUM> of the housing <NUM>, thereby causing the cross-sectional area of the orifice(s) <NUM> to gradually increase or decrease. In <FIG>, the flow resistor <NUM> is configured for low air flow and high inhalation pressure. In <FIG>, the flow resistor <NUM> is configured for high air flow and low inhalation pressure.

As shown in <FIG>, during exhalation, a positive pressure is generated in the first section <NUM> of the housing <NUM>, causing the one-way valve <NUM> to open toward the second section <NUM>, and permitting air in the attached respiratory device to flow through the flow resistor <NUM> and out the one or more orifices <NUM>. Restriction of the flow of air through the flow restrictor <NUM>, and therefore the attached respiratory device, results in a greater positive exhalation pressure within the attached respiratory device. As shown in <FIG>, the flow resistor <NUM> may be selectively adjusted to increase or decrease the restriction on the flow of air through the one or more orifices <NUM>, and therefore the positive exhalation pressure in the attached respiratory device, by rotating the first section <NUM> of the housing <NUM> relative to the second section <NUM> of the housing <NUM>, thereby causing the cross-sectional area of the orifice(s) <NUM> to gradually increase or decrease. In <FIG>, the flow resistor <NUM> is configured for low air flow and high exhalation pressure. In <FIG>, the flow resistor <NUM> is configured for high air flow and low exhalation pressure.

Turning to <FIG>, perspective, cross-sectional, and front views of another embodiment of a flow resistor <NUM> are shown. In general, the flow resistor <NUM> includes a housing <NUM> having a first section <NUM> and a second section <NUM>, a one-way valve <NUM>, a restrictor plate <NUM>, and an adjustment ring <NUM>. The housing <NUM> is generally tubular. The one way valve <NUM>, like the one-way valve <NUM>, includes a flap configured to open in response to negative or positive pressure, depending on the direction of air flow. The one way valve <NUM> is different than the one-way valve <NUM> in that the flap is shaped and sized to cover only a portion of the internal cross-sectional area of the tubular housing <NUM>. As shown, the flap may be shaped as a semi-circle. The restrictor plate <NUM> is positioned in the housing <NUM> adjacent the one-way valve <NUM> and is shaped and sized to cover only a portion of the internal cross-sectional area of the tubular housing <NUM>. As shown, the restrictor plate <NUM> may also be shaped as a semi-circle. The restrictor plate <NUM> is connected to the adjustment ring <NUM>, both of which may be selectively rotated relative to the housing <NUM>. In this way, the adjustment ring <NUM> and the restrictor plate <NUM> may be rotated relative to the housing <NUM> to increase or decrease the cross sectional area of an orifice <NUM> formed in the tubular housing <NUM>. In the embodiment shown in <FIG>, because the one way valve <NUM> and the restrictor plate <NUM> are both shaped as semi-circles, the cross-sectional area of the orifice <NUM> may be selectively adjusted from a low setting, where the one-way valve <NUM> and the restrictor plate <NUM> are fully aligned, leaving a semicircular orifice <NUM>, to a high setting, where the one-way valve <NUM> and the restrictor plate <NUM> are opposite one another, completely covering the internal cross-sectional area of the tubular housing <NUM>, and therefore altogether closing the orifice <NUM>.

Like the flow resistor <NUM>, the flow resistor <NUM> may be connected to an inhalation port or an exhalation port of a respiratory device, including for example, the inhalation port <NUM> of the OPEP device <NUM>. The flow resistor <NUM> may be removabaly connectable to respiratory devices by any suitable means, including a friction fit, threaded engagement, a snap fit, or the like. The first section <NUM> of the housing <NUM> may be connected to an inhalation port of a respiratory device, whereas the second section <NUM> of the housing <NUM> may be connected to an exhalation port of a respiratory device. The flow resistor <NUM> otherwise operates in the same manner as described above with regard to the flow resistor <NUM>.

The flow resistor <NUM> differs from the flow resistor <NUM>, however, in that it may also be attached to the mouthpiece or inlet of a respiratory treatment device, including for example, the OPEP device <NUM>, as shown in <FIG>. Because the flow resistor <NUM> may be selectively adjusted to maintain an orifice <NUM> unobstructed by the one-way valve <NUM> or the restrictor plate <NUM>, the flow resistor <NUM> may be used at the mouthpiece or inlet of a respiratory treatment device to perform RMT upon both inhalation or exhalation. If, however, the flow resistor <NUM> is selectively adjusted such that the one-way valve <NUM> and the restrictor plate <NUM> are opposite one another, completely covering the cross-sectional area of the tubular housing <NUM>, thereby eliminating the orifice <NUM>, exhalation may be entirely prevented, thus preventing use of the attached respiratory device.

Turning to <FIG>, <FIG>, and <FIG>, a combined RMT and OPEP device <NUM> is shown. <FIG> are perspective, front, and side views of the device <NUM>. <FIG> are full and partial cross-sectional views of the device <NUM>, illustrating combined administration of RMT and OPEP therapy during exhalation. <FIG> are full and partial cross-sectional views of the device <NUM>, illustrating combined administration of RMT and OPEP therapy during inhalation.

The device <NUM> is similar to the OPEP device <NUM> in that the device <NUM> is configured to administer OPEP therapy upon both exhalation and inhalation. While the shape and configuration of the device <NUM> differs from that of the OPEP device <NUM>, the general components for performing OPEP therapy are otherwise the same. The device <NUM>, however, substitutes the one-way exhalation valve <NUM> in in the OPEP device <NUM> with a pressure threshold resistor 520A configured to provide RMT upon exhalation, and substitutes the one-way inhalation valve <NUM> with a pressure threshold resistor 520B configured to provide RMT upon inhalation. Alternatively, the pressure threshold resistors 520A and 520B may be replaced with flow resistors, such as for example, the flow resistor <NUM>.

Like the OPEP device <NUM>, the device <NUM> includes a housing <NUM> including a first opening <NUM> (a mouthpiece), a second opening <NUM> (an exhalation port), and a third opening <NUM> (an inhalation port). Although the first opening <NUM> is shown as a mouthpiece, the first opening <NUM> may alternatively be associated with other user interfaces, for example, a gas mask or a breathing tube. As stated above, a pressure threshold resistor 520A is connected to the device <NUM> at the second opening <NUM> (an exhalation port) to provide RMT upon exhalation at the first opening <NUM>, while a pressure threshold resistor 520B is connected to the device <NUM> at the third opening <NUM> (an inhalation port) to provide RMT upon inhalation at the first opening <NUM>.

The device <NUM> further includes a manifold plate <NUM> having an exhalation passage <NUM> and an inhalation passage <NUM>. A one-way valve <NUM> is adapted to mount within the manifold plated <NUM> adjacent to the exhalation passage <NUM> such that the one-way valve opens in response to air exhaled into the first opening <NUM>, and closes in response to air inhaled through the first opening <NUM>. A separate one-way valve <NUM> is adapted to mount within the manifold plate <NUM> adjacent to the inhalation passage <NUM> such that the one-way valve <NUM> closes in response to air exhaled into the first opening <NUM>, and opens in response to air inhaled through the first opening <NUM>. Although the one-way valve <NUM> and one-way valve <NUM> are shown as separate components, it should be appreciated that they could be designed as a single part with two flaps adapted to fit within the manifold plate <NUM>.

The device <NUM> further includes a restrictor member <NUM> and a vane <NUM> operatively connected by a shaft <NUM>, the assembly of which may operate in the same manner as described above with regard to the previously disclosed OPEP devices, as well as a variable nozzle <NUM>. The device also includes a plurality of chambers. Air transmitted through the first opening <NUM> of the housing <NUM>, whether inhaled or exhaled, traverses a flow path that passes, at least in part, past the restrictor member <NUM> housed in a first chamber <NUM>, and through a second chamber <NUM> which houses the vane <NUM> operatively connected to the restrictor member <NUM>. In this regard, at least a portion of the flow path for both air exhaled into or inhaled from the first opening <NUM> is overlapping, and occurs in the same direction.

Turning to <FIG>, operation of the device <NUM> will now be described during a period of exhalation. As a user exhales into the first opening <NUM>, exhaled air enters a diverter chamber <NUM>. In the diverter chamber <NUM>, a positive exhalation pressure generated by the exhaled air maintains the one-way valve <NUM> in a closed position, while forcing the one-way valve <NUM> open, allowing exhaled air to enter a third chamber <NUM>. The third chamber <NUM> is in fluid communication with the third opening <NUM> (an inhalation port), and via an opening <NUM>, the first chamber <NUM>. In the third chamber <NUM>, exhaled air is forced to flow through the opening <NUM> into the first chamber <NUM>, since the pressure threshold resistor 520B is inserted in the third opening <NUM> and configured to provide RMT on inhalation. As the exhaled air flows through the first chamber <NUM>, past the restrictor member <NUM>, through the variable nozzle <NUM>, and past the vane <NUM> in the second chamber <NUM>, rotation of the vane <NUM> causes rotation of the restrictor member <NUM> for administration of OPEP therapy, as described above with regard to the previously described OPEP devices.

Exhaled air then exits the second chamber <NUM> through a pair of openings <NUM> and flows into a forth chamber <NUM>, which is also in fluid communication with a fifth chamber <NUM> via an opening <NUM>. The fifth chamber itself is in fluid communication with the one-way valve <NUM> and the pressure threshold resistor 520A connected to the device <NUM> via the second opening <NUM> (an exhalation port). At this point, the positive exhalation pressure in the diverter chamber <NUM> is greater than the positive exhalation pressure in the fifth chamber <NUM>, keeping the one-way valve <NUM> closed, and preventing exhaled air from re-entering the diverter chamber <NUM>. As such, the exhaled air in the fifth chamber <NUM> is forced to exit the device <NUM> through the second opening <NUM> and the pressure threshold resistor 520A for the administration of RMT.

Turning to <FIG>-F, operation of the device <NUM> will now be described during a period of inhalation. As a user inhales through the device <NUM> through the first opening <NUM>, a negative inhalation pressure is generated in the diverter chamber <NUM>, maintaining the one-way valve <NUM> in a closed position, while pulling the one-way valve <NUM> open. As a user continues to inhale with the one-way valve <NUM> open, a negative inhalation pressure is generated in the fifth chamber <NUM>. The fifth chamber is in fluid communication with the pressure threshold resistor 520A connected to the device <NUM> via the second opening <NUM> (exhalation port) and the forth chamber <NUM> via opening <NUM>. Since the pressure threshold resistor 520A is configured for administration of RMT on exhalation, the negative inhalation pressure is transmitted to the forth chamber <NUM> via the opening <NUM>, and consequently, the second chamber <NUM>. The negative inhalation pressure in the second chamber <NUM> draws open the variable nozzle <NUM>, thereby transmitting the negative pressure to the first chamber <NUM>, past the restrictor member <NUM>, and into the third chamber <NUM> via the opening <NUM>. The third chamber <NUM> is in fluid communication with the one-way valve <NUM> and the pressure threshold resistor 520B. At this point, the negative exhalation pressure in the diverter chamber <NUM> is greater than the negative exhalation pressure in the third chamber <NUM>, keeping the one-way valve <NUM> closed, and preventing inhaled air from re-entering the diverter chamber <NUM>. As such, the negative inhalation pressure in third chamber <NUM> is forced to draw air into the device <NUM> through the third opening <NUM> and the pressure threshold resistor 520B for the administration of RMT.

As a user continues to inhale and the pressure threshold is reached, air flows through the pressure threshold resistor 520B and into the device <NUM>, along the follow inhalation flow path: inhaled air first flows into the third chamber <NUM>, then through the opening <NUM> into the first chamber <NUM>, past the restrictor member <NUM>, through the variable nozzle <NUM> into the second chamber <NUM>, past the vane <NUM>, into the forth chamber <NUM>, through the opening <NUM> into the fifth chamber <NUM>, through the inhalation passage <NUM> into the diverter chamber <NUM>, then out the first opening <NUM>. As inhaled air flows through the first chamber <NUM>, past the restrictor member <NUM>, through the variable nozzle <NUM>, and through the second chamber <NUM>, past the vane <NUM>, rotation of the vane <NUM> causes rotation of the restrictor member <NUM> for administration of OPEP therapy, as described above with regard to the previously described OPEP devices. In this way, the device <NUM> provides RMT and OPEP therapy during both inhalation and exhalation.

Claim 1:
A respiratory treatment device (<NUM>) comprising:
a housing (<NUM>) enclosing a plurality of chambers;
a first opening (<NUM>) in the housing (<NUM>) configured to transmit air exhaled into and air inhaled from the housing (<NUM>);
a second opening (<NUM>) in the housing (<NUM>) configured to permit air exhaled into the first opening (<NUM>) to exit the housing (<NUM>);
a third opening (<NUM>) in the housing (<NUM>) configured to permit air outside the housing (<NUM>) to enter the housing (<NUM>) upon inhalation at the first opening (<NUM>);
an exhalation flow path (<NUM>) defined between the first opening (<NUM>) and the second opening (<NUM>), and an inhalation flow path (<NUM>) defined between the third opening (<NUM>) and the first opening (<NUM>);
a vane (<NUM>) in fluid communication with the exhalation flow path (<NUM>) and the inhalation flow path (<NUM>), the vane (<NUM>) being operatively connected to a restrictor member (<NUM>) and configured to reciprocate between a first position and a second position in response to a flow of air along the exhalation flow path (<NUM>) or the inhalation flow path (<NUM>); and
the restrictor member (<NUM>) positioned along the exhalation flow path (<NUM>) and the inhalation flow path (<NUM>), the restrictor member (<NUM>) being movable in response to a flow of air along the exhalation flow path (<NUM>), during a single period of exhalation, or the inhalation flow path (<NUM>), during a single period of inhalation, repeatedly between a closed position, where the flow of air along the exhalation flow path (<NUM>) or the inhalation flow path (<NUM>) is restricted, and an open position, where the flow of exhaled air along the exhalation flow path (<NUM>) or the inhalation flow path (<NUM>) is less restricted;
wherein the third opening (<NUM>) comprises a one-way inhalation valve (<NUM>) configured to permit air outside the housing (<NUM>) to enter the housing (<NUM>) upon inhalation at the first opening (<NUM>), wherein the second opening (<NUM>) comprises a one-way exhalation valve (<NUM>) configured to permit air exhaled into the housing (<NUM>) to exit the housing (<NUM>) upon exhalation at the first opening (<NUM>), and
characterised in that
a cross-sectional area of the second opening (<NUM>) is selectively adjustable to control a resistance to the flow of air therethrough.