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.

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.

The Huff Cough is also an effective technique for clearance of pulmonary secretions from the airways. It is often utilized in the treatment of COPD, or Chronic Obstructive Pulmonary Disease, although it may also be useful in other respiratory treatments. In general, the Huff Cough involves a patient using his or her diaphragm to breathe in slowly, holding the breath for two to three seconds, and forcing the breath out of his or her mouth in one quick burst of air, making sure the back of the throat is kept open. This technique is typically repeated multiple times during a single treatment. The length and force of the breath may be varied in order to treat different portions of a patient's airways. Despite its efficacy, the Huff Cough may be difficult for some populations to effectively perform, requiring coaching from respiratory professionals. To that end, a number of portable Huff Cough simulation devices have been developed.

As both OPEP therapy and Huff Cough simulation devices may be used to treat similar conditions or ailments, a portable, user friendly device capable of performing both OPEP therapy and simulating a Huff Cough is desirable.

Patent documents <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT> are hereby acknowledged.

In one aspect, a respiratory treatment device includes: an OPEP (oscillating positive expiratory pressure) mechanism having a restrictor member repeatedly moveable in response to air flow between a closed position where air flow through the OPEP mechanism is restricted, and an open position where air flow through the OPEP mechanism is less restricted; a Huff Cough mechanism having a valve moveable in response to a threshold exhalation pressure from a closed position where air flow through the Huff Cough mechanism is restricted, to an open position where air flow through the Huff Cough mechanism is less restricted; a user interface; and, a conduit leading from the user interface to the OPEP mechanism and the Huff Cough mechanism.

Air flow through the conduit may be selectively directed to the OPEP mechanism and the Huff Cough mechanism. Or, air flow through the conduit may be selectively directed to the OPEP mechanism, the Huff Cough mechanism, or both the OPEP mechanism and the Huff Cough mechanism. Airflow through the conduit may pass through the Huff Cough mechanism, followed by the OPEP mechanism. A valve may be positioned in the conduit to selectively direct air flow to the OPEP mechanism and the Huff Cough mechanism.

The OPEP mechanism may be positioned along a first segment of the conduit and the Huff Cough mechanism may positioned along a second segment of the conduit, such that air flow through the first segment does not traverse the second segment, and air flow through the second segment does not traverse the first segment.

A valve may be positioned in the first segment. The valve may be selectively moveable between an open position where air flow through the first segment to the OPEP device is permitted, and a closed position where air flow through the first segment to the OPEP device is not permitted. The valve may be selectively moveable between the open position to provide OPEP therapy, and the closed position to provide a Huff Cough simulation.

The valve of the Huff Cough mechanism may be configured to open in response to inhalation at the user interface.

The user interface may be moveable relative to the conduit between a first position, where the flow of air through the conduit to the OPEP mechanism is permitted, and a second position where the flow of air to the OPEP device is not permitted.

The valve may be positioned along a first segment of the conduit and the Huff Cough mechanism may be positioned along a second segment of the conduit, where airflow along the first segment does not traverse the second segment, and airflow along the second segment does not traverse the first segment. The OPEP mechanism may be positioned along a third segment of the conduit where the first segment and the second segment are joined. Again, the valve may be selectively moveable between an open position where air flow along the first segment is permitted, and a closed position where airflow along the first segment is not permitted. The valve may be selectively moveable between the open position to provide OPEP therapy, and the closed position to provide a Huff Cough simulation followed by OPEP therapy.

The Huff Cough mechanism and a finger within the device may be selectively moveable relative to one another to open the valve of the Huff Cough mechanism.

The OPEP mechanism may be positioned along a third segment of the conduit where the first segment and the second segment are joined, with a second valve positioned along a fourth segment of the conduit where the first segment and the second segment are joined, such that airflow along the third segment does not traverse the fourth segment, and airflow along the fourth segment does not traverse the third segment. The valve may be selectively moveable between an open position where air flow along the first segment is permitted, and a closed position where airflow along the first segment is not permitted. The second valve may be selectively moveable between an open position where air flow along the fourth segment is permitted, and a closed position where airflow along the fourth segment is not permitted.

The device may be selectively configured to provide a Huff Cough simulation without OPEP therapy when the valve is in the closed position and the second valve is in the open position. Alternatively, the device may be selectively configured to provide OPEP therapy without any Huff Cough simulation when the valve is in the open position and the second valve is in the closed position. Alternatively, the device may be selectively configured to provide a Huff Cough simulation followed by OPEP therapy when the valve is in the closed position and the second valve is in the closed position.

An inhalation valve may be positioned along the conduit. Airflow between the inhalation valve and the user interface may not pass through the OPEP mechanism or the Huff Cough mechanism. A switch may be moveable relative to the inhalation valve between a first position where the switch engages and maintains the inhalation valve in an open position, and a second position where the switch is not engaged with the inhalation valve.

Described herein are various embodiments and configurations of devices capable of selectively administering OPEP therapy and simulating a Huff Cough, both individually and in combination. It should be appreciated that existing OPEP devices and Huff Cough simulation devices may be used and/or modified for use in a combined OPEP and Huff Cough simulation device, as described herein. Exemplary OPEP devices and Huff Cough simulation devices suitable for use and/or modified for use in a combined OPEP and Huff Cough simulation device according to the present disclosure are described below.

Solely by way of example, suitable OPEP device include those shown and described in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and, <CIT>, Suitable commercially available OPEP devices include AEROBIKA® from Trudell Medical International of London, Canada, ACAPELLA® from Smiths Medical of St. Paul, Minnesota, FLUTTER® from Axcan Scandipharm Inc. of Birmingham, Alabama, and RC-CORONET® from Curaplex of Dublin, Ohio.

Similarly, and solely by way of example, suitable Huff Cough simulation devices include those shown and described in <CIT> and International Appl.

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>.

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>.

Described herein is an embodiment of a respiratory treatment device that replicates or simulates a Huff Cough. In general, this treatment device prevents the flow of exhaled air through the device until a threshold pressure is reached at a user interface. Once a threshold pressure is reached, the device releases the exhaled air, causing a rapid increase in the flow of exhaled air through the device. This sharp increase in airflow translates directly to high air velocities in the user's airways, and therefore higher shear forces on secretions lining the airways, similar to that experienced during a Huff Cough.

The embodiment described herein is notable in that the threshold pressure at which exhaled air is released is selectively adjustable. This embodiment is also notable in that the release of exhaled air at a threshold pressure is dependent on a user's exhalation and easily repeatable by a user without coaching or supervision from a respiratory professional. Moreover, this embodiment is notable in that it does not include any metallic components (e.g., magnets, springs, etc.), which tend to increase production costs, and may be susceptible to corrosion.

<FIG> show a Huff Cough simulation device <NUM>. <FIG> is a perspective view of the device <NUM>. Is an exploded view of the device <NUM>. <FIG> is a cross-sectional view of the device <NUM>. In general, the device <NUM> includes a top housing portion <NUM>, a middle housing portion <NUM>, a bottom housing portion <NUM>, a mucus trap <NUM>, a valve <NUM>, and a valve brace <NUM>.

As seen in <FIG>, the top housing portion <NUM>, the middle housing portion <NUM>, and the bottom housing portion <NUM> are removably connectable such that the components of the device <NUM> may be periodically accessed for cleaning and/or replacement. The housing portions may be removably connectable by any suitable means, including for example, threading, compression fit, or snap fit. When connected, the top housing portion <NUM> and the middle housing portion <NUM> form an interior chamber <NUM>.

<FIG> is a cross-sectional view of the top housing portion <NUM>. The top housing portion may be made of any suitable plastic material, including for example, a high-temperature polypropylene (PP). The top housing portion <NUM> includes an inlet or mouthpiece <NUM> for receiving exhaled air from a user. Preferably, the mouthpiece is circular and roughly <NUM> inch in diameter in order to promote glottal patency throughout a user's exhalation. However, it should be appreciated that other user interfaces may form, or may be in fluid communication with the inlet or mouthpiece <NUM>, including for example, gas masks, breathing tubes, or the like. Moreover, it should be appreciated that the device <NUM> may be used in conjunction or combination with other respiratory treatment devices that administer therapy upon inhalation, including for example, a nebulizer, a metered dose inhaler with a valved holding chamber, or a dry powder inhaler. In this way, the device <NUM> may administer therapy upon a user's exhalation, while the aforementioned devices may administer therapy upon a user's inhalation.

<FIG> is a cross-sectional view of the mucus trap <NUM>. The mucus trap <NUM> may also be made of any suitable plastic material, such as a high-temperature polypropylene (PP). The mucus trap <NUM> is sized and shaped to fit around and within the mouthpiece <NUM>, as shown in <FIG>. The mucus trap <NUM> and the mouthpiece <NUM> may be removably connectable by any suitable means, including for example, snap fit (as shown in <FIG>), compression fit, or threading. The mucus trap <NUM> includes a grate <NUM> having plurality of small openings, and is configured to capture any secretions expelled out of a user's mouth during exhalation, while permitting exhaled air to pass through the grate into the device <NUM>.

<FIG> are perspective and cross-sectional views of the middle housing portion <NUM>. The middle housing portion <NUM> may also be made of a suitable plastic material, such as high-temperature polypropylene (PP). The middle housing portion <NUM> includes a mount <NUM> having an opening <NUM> for receiving a barb <NUM> molded with the valve <NUM>, a ledge <NUM> extending into the interior of the middle housing portion <NUM>, and a rim <NUM> formed around the periphery of the middle housing portion <NUM>. Together, the ledge <NUM> and the rim <NUM> form a valve seat for the valve <NUM> and define an opening <NUM> through which exhaled air passes through the middle housing portion <NUM> when the valve <NUM> is in an open position, as discussed below. The middle housing portion <NUM> also includes a slot <NUM> for receiving the valve brace <NUM>, and a support structure <NUM> extending into the interior of the middle housing portion <NUM>, having a cylindrical support <NUM> adapted to receive a rod extending from the reset button, as discussed below.

<FIG> are perspective and cross-sectional views of the valve <NUM>. In general, the valve <NUM> is configured as a flap valve having a flap <NUM> and a post <NUM> that includes a barb <NUM> for securing the valve <NUM> to the mount <NUM> in the middle housing portion <NUM>. It should be appreciated that other means of securing the valve <NUM> to the middle housing portion <NUM> may be used, including for example, heat staking, living hinges, and other barb designs. The flap <NUM> is sized to cover the opening <NUM> and rest on the valve seat formed by the ledge <NUM> and rim <NUM> in the middle housing portion <NUM>. The flap <NUM> is configured to bend relative to the post <NUM> between an open position (shown in <FIG>) in a first direction, and during a valve reset, in the opposite direction (shown in <FIG>). The flap <NUM> is also configured to open in the opposite direction toward an open inhalation position (e.g., as shown in <FIG>) during a period of inhalation, or in response to an inhalation pressure at the inlet or mouthpiece <NUM>. The valve may be made of a rubber material, for example, a silicone rubber, having a hardness of <NUM>-<NUM> Shore A durometer.

The interaction of the valve <NUM> with the valve seat formed by the ledge <NUM> and the rim <NUM> affects the threshold pressure at which the valve will blow through the opening <NUM>, and move from the closed position, shown in <FIG>, to an open position, shown in <FIG>. For example, the diameter of the flap <NUM>, the diameter of the opening <NUM>, the stiffness or hardness of the valve material, the valve thickness, and the friction between the valve and valve seat and/or the valve brace <NUM>, all affect the threshold pressure at which the valve will blow through the opening <NUM>. The valve <NUM> may be accessed and selectively replaced with a valve having different properties in order to increase or decrease the threshold pressure.

<FIG> is a perspective view of the valve brace <NUM>. The valve brace <NUM> is sized and shaped to fit in a sliding engagement within the slot <NUM> formed in the middle housing portion <NUM>. The valve brace <NUM> further includes a support face <NUM> and series or a rack of teeth <NUM> extending therefrom configured to engage a corresponding series of gear teeth <NUM> (e.g., a pinion) on the lower housing portion <NUM>. The valve brace <NUM> may also be made of a suitable plastic material, such as Acetal (POM) or poly (p-phylene oxide) (PPO).

<FIG> are perspective and cross-sectional views of the lower housing portion <NUM>. The lower housing portion <NUM> may also be made of a suitable plastic material, such as Acetal (POM). The lower housing portion <NUM> includes a reset button <NUM> connected to the lower housing portion <NUM> via a molded-in spring <NUM> comprised of a plurality of spiraling segments extending between the lower housing portion <NUM> and the reset button <NUM>. An open end of the lower housing portion <NUM> functions as an outlet <NUM>. Exhaled air is permitted to exit the device <NUM> through the openings formed between the spiraling segments of the molded-in spring <NUM>, and ultimately, the outlet <NUM>.

The reset button <NUM> further includes a rod <NUM> extending into the lower housing portion <NUM> that has a series of gear teeth <NUM> (e.g., a pinion) for engaging a corresponding series or a rack of teeth <NUM> on the valve brace <NUM>. The reset button <NUM> may also include additional protrusions, wings, or markings (not shown) to aid a user in depressing and/or rotating the reset button <NUM>. The molded-in spring <NUM> is configured to permit a user to push the reset button <NUM> and move the reset button <NUM> and rod <NUM> relative to the lower hosing portion <NUM> to reset the valve <NUM> to the closed position, as described further below. The series of gear teeth <NUM> on the rod <NUM> is configured to engage the rack of teeth <NUM> on the valve brace <NUM> such that rotation of the reset button <NUM> advances or retracts the valve brace <NUM> relative to the valve <NUM>, as described further below.

Operation of the device <NUM> will now be described. <FIG> are cross-sectional side views illustrating simulation of a Huff cough during a period of exhalation, and reset of the valve <NUM>. <FIG> and <FIG> are side and perspective views of the lower portion of the housing <NUM>, illustrating operation of the reset button <NUM> and the molded-in spring <NUM> to reset the valve <NUM>.

Operation of the device <NUM> begins with the valve <NUM> in a closed position, as shown in <FIG>, where the flow of air through the opening <NUM> is restricted. As a user begins to exhale into the device <NUM> through the inlet or mouthpiece <NUM>, exhalation pressure begins to build within the device <NUM>, and specifically, against the valve <NUM>. As exhalation pressure builds, the flap <NUM> on the valve <NUM> begins to deform into a bowl shape, bringing the periphery of the flap <NUM> closer to the edges of the valve seat formed by the ledge <NUM> and the rim <NUM> that define the opening <NUM>. As the exhalation pressure continues to build, the periphery of the flap <NUM> continues to move closer to the edges of the valve seat. When a threshold exhalation pressure is achieved, the periphery of the flap <NUM> is no longer supported by the valve seat, and the flap <NUM> is free to quickly blow through the opening <NUM>, as shown in <FIG>, thereby resulting in a rapid flow of air through the device <NUM>, from the mouthpiece <NUM> to the outlet <NUM>. The rapid flow of air through the device <NUM> also results in high air flow velocities in the user's airways. In the event that secretions are loosened within the user's respiratory system and expelled out of the user's mouth, the mucus trap <NUM> may capture the discharge and prevent it from entering the device <NUM>.

Upon completion of exhalation, the valve <NUM> may be reset to the closed position, shown in <FIG>, by depressing the reset button <NUM>, as shown in <FIG> and <FIG>. <FIG> show the reset button <NUM> and the molded-in spring <NUM> in a default, or "at-rest" position. In this position, the rod <NUM> is not in engagement with the valve <NUM>, as seen in <FIG>. <FIG> show the reset button <NUM> and the molded-in-spring <NUM> in a depressed position. In this position, the rod <NUM> is in an extended position, such that it may engage the flap <NUM> of the valve <NUM>, pushing the flap <NUM> back through the opening <NUM>, as shown in <FIG>. Depression of the reset button <NUM> also creates a tension in the molded-in spring <NUM>. When the reset button <NUM> is released in the depressed position, the tension in the molded-in spring <NUM> returns the reset button <NUM>, the rod <NUM>, and the molded-in spring <NUM> to the default or "at-rest" position, shown in <FIG>, as well as <FIG>. Similarly, pushing the flap <NUM> to the position shown in <FIG> creates a tension or a bias in the valve <NUM>, such that when the rod <NUM> returns to the "at-rest" position, the flap <NUM> returns to the closed position, shown in <FIG>. The aforementioned process may then be repeated by the user. A user may also inhale through the inlet or mouthpiece <NUM>, causing the flap <NUM> of the valve <NUM> to move from the closed position, as shown in <FIG>, to an open inhalation position, for example, as shown in <FIG>.

A user may selectively adjust the threshold exhalation pressure at which the valve <NUM> blows through the opening <NUM> by rotating the reset button <NUM>, as illustrated in <FIG>. Specifically, <FIG> are bottom views of the device <NUM>, illustrating rotation of the reset button <NUM> to selectively adjust the position of the valve brace <NUM> relative to the opening <NUM> and the valve <NUM>. As noted above, the reset button <NUM> includes a rod <NUM> having a series of gear teeth <NUM> (e.g., a pinion) for engaging a corresponding series or a rack of teeth <NUM> on the valve brace <NUM>. Therefore rotation of the reset button <NUM>, and consequently the rod <NUM> and gear teeth <NUM>, results in linear movement of the valve brace <NUM>, as shown in <FIG>. As shown in <FIG>, a plurality of detents <NUM> on the middle housing portion <NUM> are configured to engage at least one detent <NUM> on the lower housing portion <NUM> to provide the user with tactile feedback as the user rotates the reset button <NUM> to adjust the threshold exhalation pressure in discrete intervals. The engagement of the at least one detent <NUM> with the plurality of detents <NUM> also operates to fix the reset button <NUM> to the extent the reset button <NUM> is rotationally biased by the molded-in spring <NUM> after rotation by a user.

<FIG> shows the valve brace <NUM>, and therefore the support face <NUM>, in a retracted position in which the support face <NUM> is not supporting the flap <NUM> of the valve <NUM>, and the opening <NUM> remains unobstructed by the support face. <FIG> shows the valve brace <NUM> in a partially extended position in which the support face <NUM> is supporting a portion of the flap <NUM> and partially obstructing the opening <NUM>. <FIG> shows the valve brace <NUM> in a further extended position in which the support face <NUM> is supporting a larger portion of the flap <NUM>, and obstructing a larger portion of the opening <NUM>. By rotating the reset button <NUM> to advance the position of the valve brace <NUM> relative to the opening <NUM> and the valve <NUM>, the user is able to selectively increase the portion of the valve brace supporting the flap <NUM>, and also reduce the area of the flap <NUM> exposed to the exhalation pressure that is subject to blow through the opening <NUM>. Likewise, by rotating the reset button <NUM> in the opposite direction to retract the position of the valve brace <NUM> relative to the opening <NUM> and the valve <NUM>, the user is able to selectively decrease the portion of the valve brace supporting the flap <NUM>, and also increase the area of the flap <NUM> exposed to the exhalation pressure that is subject to blow through the opening <NUM>. In this way, the use may selectively increase or decrease the threshold exhalation pressure.

<FIG> and <FIG> are schematics illustrating the primary components of a combined OPEP and Huff Cough simulation device <NUM>. <FIG> and <FIG> are partial cross-sectional views illustrating an exemplary combined OPEP and Huff Cough device <NUM>' according to this embodiment. In this embodiment, the device <NUM> and <NUM>' is configured to selectively provide OPEP therapy without any Huff Cough simulations (illustrated in <FIG>), or Huff Cough simulation without OPEP therapy (illustrated in <FIG>).

As shown in <FIG> and <FIG>, a device <NUM> according to this embodiment generally includes a mouthpiece <NUM>, a Huff Cough mechanism <NUM> or simulation device, an OPEP mechanism <NUM> or OPEP device, and a valve <NUM>. The mouthpiece <NUM>, the Huff Cough mechanism <NUM>, the OPEP mechanism <NUM>, and the valve <NUM> are interconnected via a conduit <NUM> in the configuration shown in <FIG> and <FIG>. That is, the conduit <NUM> from the mouthpiece <NUM> branches into one segment leading to the valve <NUM>, followed by the OPEP mechanism <NUM>, while another segment leads to the Huff cough mechanism <NUM>.

The OPEP mechanism <NUM> may comprise any suitable OPEP device, including any of the previously described or identified OPEP devices. Likewise, the Huff Cough mechanism <NUM> may comprise any suitable Huff Cough simulation device, including any of the previously described or identified Huff Cough simulation devices. The valve <NUM> may comprise any suitable means for selectively opening and closing the flow of air through the conduit segment leading to the OPEP mechanism, including for example, a gate valve, a ball valve, or a butterfly valve. The valve may be selectively opened and closed by the user, for example, via a thumb screw, a lever, a switch, or the like. Alternatively, the valve <NUM> may be achieved by selective movement of the mouthpiece <NUM>, as shown and described below with regard to <FIG> and <FIG>. A user may inhale air through the Huff Cough mechanism <NUM>.

In <FIG>, the valve <NUM> is open, such that exhaled air is free to flow past the valve <NUM> into the OPEP mechanism <NUM> for the administration of OPEP therapy. In this configuration, air exhaled by a user into the mouthpiece <NUM> flows into the OPEP mechanism <NUM>, rather than the Huff Cough mechanism <NUM>, because the Huff Cough mechanism <NUM> is designed to remain closed, or prevent the flow of air therethrough, until a threshold pressure is met. Typically, the oscillating pressures generated by the OPEP mechanism <NUM> will remain below the threshold pressure of the Huff Cough mechanism <NUM>, such that the flow of exhaled air through the Huff Cough mechanism <NUM> will be prevented.

In <FIG>, the valve <NUM> is closed, such that exhaled air is blocked from flowing past the valve <NUM> into the OPEP mechanism <NUM>, forcing the exhaled air into the Huff Cough mechanism <NUM> for simulating a Huff Cough. In this configuration, as air is exhaled by a user into the mouthpiece <NUM>, pressure increases within the conduit <NUM> and the Huff Cough mechanism <NUM>, until a threshold pressure is reached, at which point a valve or blocking member within the Huff Cough mechanism <NUM> opens, thereby allowing the flow of air through the Huff Cough mechanism <NUM>.

<FIG> and <FIG> are partial cross-sectional views illustrating an examplary combined OPEP and Huff Cough simulation device <NUM>' according to the configuration of <FIG> and <FIG>. The device includes an OPEP mechanism (not shown), a Huff Cough mechanism <NUM>', a housing <NUM>', and a mouthpiece <NUM>'. The OPEP mechanism may function in the same manner as shown and described above with regard to the OPEP device <NUM>. Similarly, the Huff Cough mechanism <NUM>' functions in the same manner as shown and described above with regard to the Huff Cough device <NUM>. Like the Huff Cough device <NUM>, the Huff Cough mechanism <NUM>' of device <NUM>' includes a valve <NUM>', a valve brace <NUM>', a rim <NUM>', a reset button <NUM>', and a rod <NUM>'. Unlike in the Huff Cough device <NUM>, the reset button <NUM>' of the Huff Cough mechanism <NUM>' is shaped and sized to fit in sliding engagement within the housing <NUM>', such that a user may selectively move the reset button <NUM>' relative to the housing <NUM>' to reset the valve <NUM>' to a closed position. Like in the Huff Cough device <NUM>, the reset button <NUM>' may also be rotated relative to the housing <NUM>' in order to selectively adjust a position of the valve brace <NUM>' relative to the valve <NUM>', thereby selectively increasing or decreasing the threshold exhalation pressure at which the Huff Cough mechanism <NUM>' opens.

As previously noted the mouthpiece <NUM>' may serve as the valve <NUM>. That is the mouthpiece <NUM>' may be shaped and sized to fit in sliding engagement within the housing <NUM>', such that a user may selectively move the mouthpiece <NUM>' between open and closed positions (e.g. by sliding into and out of the housing <NUM>', as shown in <FIG> and <FIG>, or by rotation of an opening in the mouthpiece <NUM>' relative to the conduit segment leading to the OPEP mechanism). In <FIG>, the mouthpiece <NUM>' is in an open position, such that exhaled air is free to flow from the mouthpiece <NUM>' into the OPEP mechanism for the administration of OPEP therapy. In this configuration, air exhaled by a user into the mouthpiece <NUM>' flows into the OPEP mechanism, rather than the Huff Cough mechanism <NUM>', because the valve <NUM>' of the Huff Cough mechanism <NUM>' remains closed, preventing the flow of air therethrough. However, the valve <NUM>' of the Huff Cough mechanism <NUM>' may serve as an inhalation valve, permitting inhalation at the mouthpiece <NUM>' through the Huff Cough mechanism <NUM>'. In <FIG>, the mouthpiece <NUM>' is in a closed position, such that exhaled air is blocked from flowing into the OPEP mechanism, forcing the exhaled air into the Huff Cough mechanism <NUM>' for simulating a Huff Cough. In this configuration, as air is exhaled by a user into the mouthpiece <NUM>', pressure increases within the housing <NUM>' and the Huff Cough mechanism <NUM>', until a threshold pressure is reached, at which point the valve <NUM>' of the Huff Cough mechanism <NUM>' blows open, thereby allowing the flow of air through the Huff Cough mechanism <NUM>'. Upon completion of exhalation, the valve <NUM>' may be reset to the closed position by pressing the reset button <NUM>' and extending the rod <NUM>', for performing subsequent Huff Cough simulations.

<FIG> and <FIG> are schematics illustrating the primary components of a combined OPEP and Huff Cough simulation device <NUM>. <FIG> and <FIG> are partial cross-sectional views illustrating an exemplary combined OPEP and Huff Cough device <NUM>' according to this embodiment. In this embodiment, the device <NUM> and <NUM>' is configured to selectively provide OPEP therapy without any Huff Cough simulation (illustrated in <FIG>), or a Huff Cough simulation followed by OPEP therapy (illustrated in <FIG>).

As shown in <FIG> and <FIG>, a device <NUM> according to this embodiment generally includes a mouthpiece <NUM>, a Huff Cough mechanism <NUM> or simulation device, an OPEP mechanism <NUM> or OPEP device, a valve <NUM>, and an inhalation valve <NUM>. The mouthpiece <NUM>, the Huff Cough mechanism <NUM>, the OPEP mechanism <NUM>, the valve <NUM>, and the inhalation valve <NUM> are interconnected via a conduit <NUM> in the configuration shown in <FIG> and <FIG>. That is, the conduit <NUM> leading from the mouthpiece <NUM> branches into a segment having the valve <NUM> in parallel with a segment having the Huff Cough mechanism <NUM>. The parallel segments then reconnect and feed into the OPEP mechanism <NUM>. The conduit leading from the mouthpiece <NUM> also leads to the inhalation valve <NUM>.

The OPEP mechanism <NUM> may comprise any suitable OPEP device, including any of the previously described or identified OPEP devices. Likewise, the Huff Cough mechanism <NUM> may comprise any suitable Huff Cough simulation device, including any of the previously described or identified Huff Cough simulation devices. The valve <NUM> may comprise any suitable means for selectively opening and closing the flow of air through the conduit segment having the valve, including for example, a gate valve, a ball valve, or a butterfly valve. The valve <NUM> may be selectively opened and closed by the user, for example, via a thumb screw, a lever, a switch, or the like. A suitable inhalation vale <NUM>, for example, is shown and described with reference to <FIG>. Alternatively, the valve <NUM> may be achieved by selectively opening and closing the valve or blocking member of the Huff Cough mechanism, as shown an described below with regard to <FIG> and <FIG>.

In <FIG>, the valve <NUM> is open, such that exhaled air is free to flow past the valve <NUM> into the OPEP mechanism <NUM> for the administration of OPEP therapy (without Huff Cough). In this configuration, the air exhaled by a user into the mouthpiece <NUM> flows into the OPEP mechanism <NUM>, rather than the Huff Cough mechanism <NUM>, because the Huff Cough mechanism <NUM> is designed to remain closed, or prevent the flow of air therethrough, until a threshold pressure is met. Typically, the oscillating pressures generated by the OPEP mechanism <NUM> will remain below the threshold pressure of the Huff Cough mechanism <NUM>, such that the flow of exhaled air through the Huff Cough mechanism <NUM> will be prevented. Similarly, the inhalation valve <NUM> is configured to remain closed during a period of exhalation, opening only during a period of inhalation.

In <FIG>, the valve <NUM> is closed, such that exhaled air is blocked from flowing past the valve <NUM> into the OPEP mechanism <NUM>, forcing the exhaled air into the Huff cough mechanism <NUM> for simulating a Huff Cough (without OPEP). Similarly, the inhalation valve <NUM> is configured to remain closed during a period of exhalation, opening only during a period of inhalation. In this configuration, as air is exhaled by a user into the mouthpiece <NUM>, pressure increases within the conduit <NUM> and the Huff Cough mechanism <NUM>, until a threshold pressure is reached, at which point a valve or blocking member within the Huff Cough mechanism <NUM> opens, thereby allowing the flow of air through the Huff Cough mechanism <NUM>.

<FIG> and <FIG> are partial cross-sectional views illustrating an exemplary combined OPEP and Huff Cough simulation device <NUM>' according to the configuration of <FIG> and <FIG>. The device <NUM>' includes an OPEP mechanism (not shown), a Huff Cough mechanism <NUM>', a housing <NUM>', a mouthpiece <NUM>', and an inhalation valve <NUM>'. The OPEP mechanism may function in the same manner as shown and described above with regard to OPEP device <NUM>. Similarly, the Huff Cough mechanism <NUM>' functions in the same manner as shown and described above with regard to the Huff Cough device <NUM>. Like the Huff Cough device <NUM>, the Huff Cough mechanism <NUM>' of device <NUM>' includes a valve <NUM>', a valve brace <NUM>', and a rim <NUM>'. Like in the Huff Cough device <NUM>, a position of the valve brace <NUM>' relative to the valve <NUM>' may be adjusted to selectively increase or decrease the threshold exhalation pressure of the Huff Cough mechanism <NUM>'.

Similar to the reset button <NUM> and the rod <NUM> of the Huff Cough device <NUM>, the Huff Cough mechanism <NUM>' includes a reset finger <NUM>' extending from the housing <NUM>' toward the valve <NUM>'. The mouthpiece <NUM>' may be shaped and sized to fit in sliding engagement within the housing <NUM>' or a portion of the housing, such that a user may selectively move the mouthpiece <NUM>' between a first position (shown in <FIG>), where the valve <NUM>' is opened by the finger <NUM>', and a second position (shown in <FIG>), where the finger <NUM>' is retracted and the valve <NUM>' is closed. The mouthpiece <NUM>' may be biased toward the second position (shown in <FIG>), for example, by a spring <NUM>'. In this way, after performing a Huff Cough simulation, when the valve <NUM>' is in an open position, as illustrated by the dashed line in <FIG>, a user may selectively move the mouthpiece <NUM>' relative to the housing <NUM>' from the second position (shown in <FIG>) to the first position (shown in <FIG>), thereby moving the valve <NUM>' to the position illustrated by the dashed line in <FIG>. As the mouthpiece <NUM>' returns to the position shown in <FIG> under the biasing force of the spring <NUM>', the valve <NUM>' returns to a closed position (shown in <FIG>), for performing another Huff Cough simulation. Moreover, the inhalation valve <NUM>'and the valve <NUM>' of the Huff Cough mechanism <NUM>' are configured to open upon inhalation at the mouthpiece.

As explained above, the valve <NUM> of the device <NUM> may be achieved by selectively opening and closing the valve <NUM>' of the Huff Cough mechanism <NUM>'. In this regard, the mouthpiece <NUM>' and/or the housing <NUM>' may also include a detent <NUM>' configured to retain the mouthpiece <NUM>' in the first position (shown in <FIG>) when the mouthpiece <NUM>' is depressed beyond the detent <NUM>', thereby also maintaining the valve <NUM>' of the Huff Cough mechanism <NUM>' in the open position shown in <FIG>. In this way, when the valve <NUM>' of the Huff Cough mechanism <NUM>' is maintained in the open position shown in <FIG>, exhaled air flows freely through the Huff Cough mechanism <NUM>' and into the OPEP mechanism for the administration of OPEP therapy. When the valve <NUM>' of the Huff Cough mechanism <NUM>' is in the closed position shown in <FIG>, exhaled air is prevented from flowing through the Huff Cough mechanism <NUM>' until a threshold pressure is reached, at which point the valve <NUM>' opens, permitting the flow of air through the Huff Cough mechanism <NUM>' and into the OPEP mechanism for the administration of OPEP therapy.

<FIG>, <FIG>, and <FIG> are schematics illustrating the primary components of a combined OPEP and Huff Cough simulation device <NUM>. <FIG> and <FIG> are partial cross-sectional views illustrating modifications to the combined OPEP and Huff Cough simulation device <NUM>' shown and described with reference to <FIG> and <FIG>, showing selective opening and closing of the inhalation valve <NUM>'. In this embodiment, the device <NUM> is configured to selectively provide Huff Cough simulations without OPEP therapy (illustrated in <FIG>), OPEP therapy without any Huff Cough simulation (illustrated in <FIG>), or a Huff Cough simulation followed by OPEP therapy (illustrated in <FIG> and <FIG>).

As shown in <FIG>, <FIG>, and <FIG>, a device <NUM> according to this embodiment generally includes a mouthpiece <NUM>, a Huff Cough mechanism <NUM> or simulation device, an OPEP mechanism <NUM> or OPEP device, a first valve <NUM>, a second valve <NUM>, and an inhalation valve <NUM>. The mouthpiece <NUM>, the Huff Cough mechanism <NUM>, the OPEP mechanism <NUM>, the first valve <NUM>, the second valve <NUM>, and the inhalation valve <NUM> are interconnected via a conduit <NUM> in the configuration shown in <FIG>, <FIG>, and <FIG>. That is the conduit <NUM> leading from the mouthpiece <NUM> branches into a segment having the first valve <NUM> in parallel with a segment having the Huff Cough mechanism <NUM>. The parallel segments then reconnect and feed into either the OPEP mechanism <NUM> or the second valve <NUM>, which are also arranged in parallel segments. The conduit <NUM> leading from the mouthpiece also leads to the inhalation valve <NUM>.

As with the prior embodiment, the OPEP mechanism <NUM> may comprise any suitable OPEP device, including any of the previously described or identified OPEP devices. Likewise, the Huff Cough mechanism <NUM> may comprise any suitable Huff Cough simulation device, including any of the previously described or identified Huff Cough simulation devices. The first valve <NUM> and the second valve <NUM> may comprise any suitable means for selectively opening and closing the flow of air through the conduit segments having the valves <NUM> and <NUM>, including for example, a gate valve, a ball valve, or a butterfly valve. The valves <NUM> and <NUM> may be selectively opened and closed by the user, for example, via a thumb screw, a lever, a switch, or the like. A suitable inhalation vale <NUM>, for example, is shown and described with reference to <FIG>. Alternatively, the first valve <NUM> may be achieved by selectively opening and closing the valve or blocking member of the Huff Cough mechanism <NUM>, as shown and described above with regard to <FIG> and <FIG>. The second valve <NUM> may alternatively be achieved by selectively opening and closing the inhalation valve <NUM>, as shown and described below with regard to <FIG> and <FIG>.

In <FIG>, the first valve <NUM> is closed, such that exhaled air is blocked from flowing past the first valve <NUM> into the OPEP mechanism <NUM>, forcing the exhaled air into the Huff Cough mechanism <NUM> for simulating a Huff Cough (without OPEP). Similarly, the inhalation valve <NUM> is configured to remain closed during a period of exhalation, opening only during a period of inhalation. In this configuration, as air is exhaled by a user into the mouthpiece <NUM>, pressure increases within the conduit <NUM> and the Huff Cough mechanism <NUM>, until a threshold pressure is reached, at which point a valve or blocking member within the Huff Cough mechanism <NUM> opens, thereby allowing the flow of air through the Huff Cough mechanism <NUM>. In <FIG>, the second valve <NUM> is open, such that air flowing through the Huff Cough mechanism <NUM> is free to flow past the second valve <NUM> and exit the device <NUM>, rather than into the OPEP mechanism <NUM>.

In <FIG>, the first valve <NUM> is open while the second valve <NUM> is closed, such that exhaled air is free to flow past the first valve <NUM> into the OPEP mechanism <NUM> for the administration of OPEP therapy (without Huff Cough). In this configuration, air exhaled by a user into the mouthpiece <NUM> flows into the OPEP mechanism <NUM>, rather than through the Huff Cough mechanism <NUM>, because the Huff Cough mechanism <NUM> is designed to remain closed, or prevent the flow of air therethrough, until a threshold pressure is met. Typically, the oscillating pressures generated by the OPEP mechanism <NUM> will remain below the threshold pressure of the Huff Cough mechanism <NUM>, such that the flow of exhaled air through the Huff Cough mechanism will be prevented. Similarly, the inhalation valve <NUM> is configured to remain closed during a period of exhalation, opening only during a period of inhalation.

In <FIG>, the first valve <NUM> is closed, such that exhaled air is blocked from flowing past the first valve <NUM> into the OPEP mechanism <NUM>, forcing the exhaled air into the Huff Cough mechanism <NUM> for simulating a Huff Cough. Similarly, the inhalation valve <NUM> is configured to remain closed during a period of exhalation, opening only during a period of inhalation. In this configuration, as air is exhaled by a user into the mouthpiece <NUM>, pressure increases within the conduit <NUM> and the Huff Cough mechanism <NUM>, until a threshold pressure is reached, at which point a valve or blocking member within the Huff Cough mechanism <NUM> opens, thereby allowing the flow of air through the Huff Cough mechanism <NUM>. In <FIG>, the second valve <NUM> is closed, such that air flowing through the Huff Cough mechanism <NUM> is blocked from flowing past the second valve <NUM>, instead flowing into the OPEP mechanism <NUM> for administration of OPEP therapy.

<FIG> and <FIG> are partial cross-sectional views illustrating modifications to the combined OPEP and Huff Cough simulation device <NUM>' shown and described with reference to <FIG> and <FIG>. That is, an exemplary device according to the configuration of <FIG>, <FIG>, and <FIG> may include the combined OPEP and Huff Cough simulation device <NUM>', modified as described below with reference to <FIG> and <FIG>.

Specifically, as noted above, the second valve <NUM> may be achieved by selectively opening and closing the inhalation valve <NUM>. As shown in <FIG> and <FIG>, a switch <NUM>' located on the outside of the housing <NUM>' may be positioned relative to the inhalation valve <NUM>' such that a finger <NUM>' extending from the switch <NUM>' toward the inhalation valve <NUM>' may be selectively moved between a first position (shown in <FIG>), where the finger <NUM>' holds the inhalation valve <NUM>' in an open position, and a second position (shown in <FIG>), where the finger <NUM>' is retracted from the inhalation valve <NUM>', allowing the inhalation valve <NUM>' to remain closed, opening only during a period of inhalation.

Claim 1:
A respiratory treatment device (<NUM>, <NUM>', <NUM>, <NUM>', <NUM>) comprising:
an OPEP (oscillating positive expiratory pressure) mechanism (<NUM>, <NUM>', <NUM>, <NUM>', <NUM>) having a restrictor member repeatedly moveable in response to air flow between a closed position where air flow through the OPEP mechanism (<NUM>, <NUM>', <NUM>, <NUM>', <NUM>) is restricted, and an open position where air flow through the OPEP mechanism (<NUM>, <NUM>', <NUM>, <NUM>', <NUM>) is less restricted;
a Huff Cough mechanism (<NUM>, <NUM>', <NUM>, <NUM>', <NUM>) having a valve (<NUM>') moveable in response to a threshold exhalation pressure from a closed position where air flow through the Huff Cough mechanism (<NUM>, <NUM>', <NUM>, <NUM>', <NUM>) is restricted, to an open position where air flow through the Huff Cough mechanism (<NUM>, <NUM>', <NUM>, <NUM>', <NUM>) is less restricted
a user interface (<NUM>, <NUM>', <NUM>, <NUM>', <NUM>);
a conduit (<NUM>) leading from the user interface to the OPEP mechanism (<NUM>, <NUM>', <NUM>, <NUM>', <NUM>) and the Huff Cough mechanism (<NUM>, <NUM>', <NUM>, <NUM>', <NUM>), and wherein airflow through the conduit (<NUM>) is selectively directed to the OPEP mechanism (<NUM>, <NUM>', <NUM>, <NUM>', <NUM>), the Huff Cough mechanism, or both the OPEP mechanism (<NUM>, <NUM>', <NUM>, <NUM>', <NUM>) and the Huff Cough mechanism.