Flow resistor and respiratory treatment device

Abstract

To provide a respiratory treatment device that realizes oscillating pressure therapy, and a flow resistor used therefor.SOLUTION: A flow resistor 550 is shaped and sized to be removably connectable to an opening of an oscillating positive expiratory pressure (OPEP) device. The flow resistor 550 includes: a housing 551 defining a conduit for the flow of air; a one-way valve 554 positioned in the conduit, and configured to open in response to the flow of air through the conduit in a first direction and close in response to the flow of air through the conduit in a second direction; and an opening 555 disposed in the conduit and configured for the flow of air into or out of the conduit. The housing 551 has a first section 552 and a second section 553, a position of the first section 552 relative to a position of the second section 553 is selectively adjustable. Selective adjustment of the first section 552 relative to the second section 553 adjusts a cross-sectional area of the opening 555.SELECTED DRAWING: Figure 66A

Description

[Technical field]

[0001] Related Applications This application claims the benefit of pending U.S. Provisional Patent Application No. 62 / 199,113, filed July 30, 2015, which is hereby incorporated by reference in its entirety.

[0002] The present disclosure relates to respiratory treatment devices, and in particular to combined respiratory muscle training ("RMT") and expiratory positive pressure oscillation ("OPEP") devices. [Background technology]

[0003] Each person produces more than 30 milliliters of phlegm, a type of bronchial secretion, every day. Usually, an effective cough is enough to loosen the secretions and clear them from the body's airways. However, for people who suffer from more severe bronchial obstruction, such as airway collapse, a single cough is not enough to clear the obstruction.

[0004] OPEP therapy represents an effective bronchial hygiene technique for the removal of bronchial secretions in the human body and is an important aspect of the treatment and continuing care of patients suffering from bronchial obstruction, such as those suffering from chronic obstructive pulmonary disease. OPEP therapy, the oscillation of expiratory pressure at the mouth during exhalation, is believed to effectively transmit oscillatory counter pressure to the lungs, thereby opening up obstructed airways and loosening secretions that contribute to bronchial obstruction. Benefits of OPEP therapy include a decrease in sputum viscoelasticity, an increase in the force that separates sputum from the air passages, and an increase in sputum expectoration.

[0005] OPEP therapy is an attractive form of treatment because it can be easily taught to most patients and they can be responsible for administering it throughout their hospital stay and also from home. To that end, a number of portable OPEP devices have been developed.

[0006] Like OPEP therapy, RMT has been shown to improve lung health in both healthy individuals and patients with various lung diseases. RMT involves a pressure threshold resistance that requires the user to achieve and maintain a set pressure during inspiration or expiration, and a flow resistance that restricts airflow during inspiration or expiration. Benefits of RMT include strengthening respiratory muscles, reducing dyspnea (shortness of breath), improving exercise performance, and improving quality of life.

[0007] Like OPEP therapy, RMT is an attractive form of treatment because it can be easily taught to most patients and such patients can assume responsibility for implementing RMT therapy throughout their entire hospital stay and also from home.

[0008] In this regard, a need exists for a single device that performs both OPEP therapy and RMT, yet maintains the capabilities of individual devices to deliver only OPEP or only RMT. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] U.S. Provisional Patent Application No. 62 / 199,113 [Patent Document 2] U.S. Patent No. 4,566,452 [Patent Document 3] U.S. Patent No. 5,012,803 [Patent Document 4] U.S. Patent No. 5,012,804 [Patent Document 5] U.S. Patent No. 5,312,046 [Patent Document 6] U.S. Patent No. 5,497,944 [Patent Document 7] U.S. Patent No. 5,622,162 [Patent Document 8] U.S. Patent No. 5,823,179 [Patent Document 9] U.S. Patent No. 6,293,279 [Patent Document 10] U.S. Patent No. 6,435,177 [Patent Document 11] U.S. Patent No. 6,484,717 [Patent Document 12] U.S. Patent No. 6,848,443 [Patent Document 13] U.S. Patent No. 7,360,537 [Patent Document 14] U.S. Patent No. 7,568,480 [Patent Document 15] U.S. Patent No. 7,905,228 [Patent Document 16] U.S. Patent No. 6,776,159 [Patent Document 17] U.S. Patent No. 7,059,324 [Patent Document 18] U.S. Patent Application Serial No. 13 / 489,894 [Patent Document 19] U.S. Patent No. 9,358,417 [Patent Document 20] U.S. Patent Application Serial No. 14 / 092,091 Summary of the Invention

[0010] In one aspect, a respiratory treatment device includes a housing including multiple chambers, the housing having a first opening configured to deliver exhaled air into the housing and inhaled air from the housing, a second opening configured to allow exhaled air into the first opening to exit the housing, and a third opening configured to allow air outside the housing to enter the housing during inspiration at the first opening. An exhalation flow path is defined between the first opening and the second opening, and an inhalation flow path is defined between the third opening and the first opening. A throttling member is disposed in the exhalation and inhalation flow paths and is movable between a closed position in which air flow along the exhalation or inhalation flow path is throttling, and an open position in which the flow of exhaled air along the exhalation or inhalation flow path is less throttling. A vane is in fluid communication with the exhalation and inhalation flow paths and is connected to the throttling member and configured to reciprocate between a first position and a second position in response to the flow of exhaled air along the exhalation or inhalation flow path.

[0011] In another aspect, the second opening may include a one-way exhalation valve configured to allow exhaled air exhaled into the housing upon exhalation at the first opening to exit the housing. The one-way exhalation valve may be configured to open at a positive threshold pressure. The threshold pressure may be selectively adjustable. The one-way exhalation valve may include a spring configured to bias the one-way valve toward a closed position. The level of bias may be selectively adjustable. A cross-sectional area of ​​the second opening may be selectively adjustable to control resistance to air flow therethrough.

[0012] In another aspect, the third opening may include a one-way inhalation valve configured to allow air outside the housing to enter the housing upon inhalation at the first opening. The one-way inhalation valve may be configured to open at a negative threshold pressure. The threshold pressure may be selectively adjustable. The one-way inhalation valve may include a spring configured to bias the one-way valve toward a closed position. The level of bias may be selectively adjustable. A cross-sectional area of ​​the second opening may be selectively adjustable to control resistance to air flow therethrough.

[0013] In yet another aspect, a one-way valve is disposed along the exhalation flow path between the first and second openings, and may be configured to open in response to exhaled air being exhaled into the first opening and to close in response to inhaled air being inhaled through the first opening.

[0014] In another embodiment, a one-way valve is disposed along the inhalation flow path between the third opening and the first opening. The one-way valve may be configured to open in response to inhalation air being drawn through the first opening and to close in response to exhalation air being exhaled into the first opening.

[0015] In another aspect, the throttle member is disposed in a first chamber of the plurality of chambers and the vane is disposed in a second chamber of the plurality of chambers. Air flow through the first chamber is throttled when the throttle member is in a closed position and air flow through the first chamber is less throttled when the throttle member is in an open position. The first and second chambers may be connected by an orifice. The vane may be disposed adjacent the orifice and configured to move the throttle member between the closed and open positions in response to an increase in pressure adjacent the vane.

[0016] In another aspect, the exhalation and inhalation flow paths form an overlap. Air flow along the exhalation and inhalation flow paths may be in the same direction along the overlap. The throttling member may be disposed in the overlap, and the vane may be in fluid communication with the overlap.

[0017] In another aspect, the size of the orifice is configured to increase in response to a flow of exhaled air through the orifice. The orifice may be formed in a variable nozzle. The orifice may be configured to close in response to negative pressure from a flow of inhaled air along the inhalation flow path.

[0018] In another aspect, the vane is operatively connected to the throttle member by a shaft, the face of the throttle member being rotatable about an axis of rotation.

[0019] In yet another aspect, a flow resistor for a respiratory device includes a conduit for directing a flow of air. The conduit has a cross-sectional area. A one-way valve is disposed within the conduit and configured to open in response to air flow in a first direction and close in response to air flow in a second direction. The one-way valve may have a cross-sectional area smaller than the cross-sectional area of ​​the conduit. A throttle plate is disposed within the conduit and defines an open portion and a closed portion. The closed portion may have a cross-sectional area smaller than the cross-sectional area of ​​the conduit. An orientation of the throttle plate relative to the conduit may be selectively adjustable. An orientation of the open portion relative to the cross-sectional area of ​​the one-way valve may be selectively adjustable. The throttle plate may be disposed within the conduit adjacent to the one-way valve. Air flow in the second direction may be permitted to flow through the open portion and around the one-way valve. The throttle plate may be disposed within the conduit adjacent to the one-way valve. The one-way valve may be configured to open in response to a user inhaling at a first end of the conduit and to close in response to a user exhaling at the first end of the conduit.

[0020] In yet another aspect, a flow resistor for a respiratory device includes a housing defining a conduit for passing a flow of air therethrough, and a one-way valve disposed in the conduit. The one-way valve is configured to open in response to air flow through the conduit in a first direction and to close in response to air flow through the conduit in a second direction. An opening in the conduit permits air flow into and out of the conduit. A cross-sectional area of ​​the opening is selectively adjustable. The housing may include a first portion and a second portion, and a position of the first portion of the housing relative to a position of the second portion of the housing may be selectively adjustable. Selective adjustment of the first portion relative to the second portion adjusts a cross-sectional area of ​​the opening. The one-way valve may be disposed in the first portion of the housing. The opening may be disposed in the first portion of the housing.

[0021] In yet another aspect, a pressure threshold resistor includes a housing having a first portion and a second portion, the first portion and the second portion defining a conduit for passing a flow of air. A one-way valve is disposed in the conduit and is movable between a closed position in which air flow through the conduit is blocked and an open position in which air is permitted to flow through the conduit. A biasing member may be configured to bias the one-way valve toward the closed position. The one-way valve may be configured to move from the closed position to the open position when pressure in the conduit exceeds a threshold pressure.

[0022] In another aspect, the biasing member is a spring. The position of the first housing portion relative to the second housing portion may be selectively adjustable. Adjusting the position of the first housing portion relative to the second housing portion may adjust the bias on the one-way valve. Adjusting the position of the first housing portion relative to the second housing portion may adjust the threshold pressure. The biasing member may be a spring and adjusting the position of the first portion relative to the second housing portion may adjust compression of the spring.

[0023] In yet another aspect, a respiratory treatment device includes a housing including at least one chamber, a first opening in the housing configured to deliver exhaled air into the housing and inhaled air from the housing, a second opening in the housing configured to allow exhaled air into the first opening to exit the housing, and a third opening in the housing configured to allow air outside the housing to enter the housing upon inspiration at the first opening. An exhalation flow path is defined between the first and second openings, and an inhalation flow path is defined between the third and first openings. A throttling member is disposed in the exhalation flow path and is movable between a closed position in which air flow along the exhalation flow path is throttled and an open position in which the flow of exhaled air along the exhalation flow path is less throttled.

[0024] In another aspect, a vane is in fluid communication with the exhalation flow path, operatively connected to the throttling member, and configured to reciprocate between a first position and a second position in response to a flow of exhaled air along the exhalation flow path. The throttling member need not be disposed in the inhalation flow path.

[0025] In another aspect, the third opening includes a one-way inhalation valve configured to allow air outside the housing to enter the housing upon inhalation at the first opening. The one-way inhalation valve may be configured to open at a negative threshold pressure. The threshold pressure may be selectively adjustable. The one-way inhalation valve may include a spring configured to bias the one-way valve toward a closed position. The level of bias may be selectively adjustable. A cross-sectional area of ​​the third opening may be selectively adjustable to control resistance to air flow therethrough. [Brief description of the drawings]

[0026] [Figure 1] FIG. 2 is a front perspective view of the OPEP device. [Diagram 2] FIG. 2 is a rear perspective view of the OPEP device of FIG. 1. [Diagram 3]FIG. 2 is a cross-sectional perspective view of the OPEP device taken along line III of FIG. 1, shown without the internal components of the OPEP device. [Figure 4] FIG. 2 is an exploded view of the OPEP device of FIG. 1, along with the internal components of the OPEP device. [Diagram 5] 2 is a cross-sectional perspective view of the OPEP device taken along line III of FIG. 1, shown with the internal components of the OPEP device. [Figure 6] 2 is a different cross-sectional perspective view of the OPEP device taken along line VI of FIG. 1, shown with the internal components of the OPEP device. FIG. [Figure 7] 7 is a different cross-sectional perspective view of the OPEP device taken along line VII of FIG. 1, shown with the internal components of the OPEP device. FIG. [Figure 8] FIG. 13 is a front perspective view of an aperture member operatively connected to the vanes. [Figure 9] FIG. 9 is a rear perspective view of the aperture member operatively connected to the vanes shown in FIG. 8. [Figure 10] FIG. 9 is a front view of the aperture member operatively connected to the vanes shown in FIG. 8. [Figure 11] FIG. 9 is a top view of the aperture member operatively connected to the vanes shown in FIG. 8. [Figure 12] FIG. 2 is a front perspective view of a variable nozzle shown without the exhaled air flow passing therethrough. [Figure 13] FIG. 13 is a rear perspective view of the variable nozzle of FIG. 12 shown without the exhaled air flow passing therethrough. [Figure 14] FIG. 13 is a front perspective view of the variable nozzle of FIG. 12 shown passing a high flow of exhaled air. [Figure 15A] 2 is a top-down phantom view of the OPEP device of FIG. 1 showing an illustrative illustration of the operation of the OPEP device of FIG. 1; [Figure 15B] 15A is a top-down virtual view of the OPEP device of FIG. 1, which together with FIG. 15A shows an illustrative illustration of the operation of the OPEP device. [Figure 15C]15A and 15B show an illustrative illustration of the operation of the OPEP device. FIG. [Figure 16] 11A-11C are front perspective views of different embodiments of a variable nozzle shown without the exhalation flow passing therethrough. [Figure 17] FIG. 17 is a rear perspective view of the variable nozzle of FIG. 16 shown without the exhaled air flow passing therethrough. [Figure 18] FIG. 2 is a front perspective view of a second embodiment of an OPEP device. [Figure 19] FIG. 19 is a rear perspective view of the OPEP device of FIG. [Figure 20] FIG. 19 is an exploded view of the OPEP device of FIG. 18, shown with the internal components of the OPEP device. [Figure 21] 18 along line I of the OPEP device, along with the internal components of the OPEP device. FIG. [Figure 22] 18 along line II of the OPEP device, along with the internal components of the OPEP device. FIG. [Figure 23] 18 along line III of the OPEP device, along with the internal components of the OPEP device. [Figure 24] FIG. 19 is a front perspective view of the adjustment mechanism of the OPEP device of FIG. [Diagram 25] FIG. 25 is a rear perspective view of the adjustment mechanism of FIG. [Figure 26] FIG. 20 is a front perspective view of an aperture member operatively connected to a vane for use in the OPEP device of FIG. 18. [Figure 27] FIG. 27 is a front perspective view of the adjustment mechanism of FIG. 24 assembled together with the throttle member and blade of FIG. 26. [Figure 28] 27 within the OPEP device of FIG. 18. FIG. [Figure 29A] 27 within the OPEP device of FIG. 18. FIG. 28 is a partial cross-sectional view showing an illustration of the assembly of FIG. [Figure 29B]29A and 29B are partial cross-sectional views showing an illustration of the assembly of FIG. 27 within the OPEP device of FIG. 18. [Diagram 30] FIG. 19 is a front view of the OPEP device of FIG. 18 illustrating an adjustable aspect of the OPEP device. [Diagram 31] 27 within the OPEP device of FIG. 18. FIG. [Figure 32A] 18, depicting a possible configuration of the OPEP device. FIG. [Figure 32B] 32A is a partial cross-sectional view of the OPEP device taken along line III of FIG. 18, which, together with FIG. 32A, illustrates a possible configuration of the OPEP device. [Figure 33A] FIG. 19 is a top-down virtual view illustrating the adjustability of the OPEP device of FIG. 18. [Figure 33B] 33A and 33B are top-down virtual views illustrating the adjustability of the OPEP device of FIG. 18. [Figure 34A] FIG. 19 is a top phantom view of the OPEP device of FIG. 18 illustrating the adjustability of the OPEP device. [Figure 34B] 34A is a top phantom view of the OPEP device of FIG. 18, which, together with FIG. 34A, illustrates the adjustability of the OPEP device. [Diagram 35] FIG. 13 is a front perspective view of another embodiment of an OPEP device. [Diagram 36] FIG. 36 is a rear perspective view of the OPEP device of FIG. 35. [Figure 37] FIG. 36 is a perspective view of the bottom of the OPEP device of FIG. 35. [Figure 38] FIG. 36 is an exploded view of the OPEP device of FIG. [Figure 39] FIG. 36 is a cross-sectional view taken along line I of FIG. 35, shown without the internal components of the OPEP device. [Diagram 40] FIG. 36 is a cross-sectional view taken along line I of FIG. 35, along with the internal components of the OPEP device. [Diagram 41] FIG. 36 is a front perspective view of the inner casing of the OPEP device of FIG. [Diagram 42]FIG. 42 is a cross-sectional view of the inner casing taken along line I in FIG. 41. [Diagram 43] FIG. 36 is a perspective view of a wing of the OPEP device of FIG. 35. [Diagram 44] FIG. 36 is a front perspective view of the throttle member of the OPEP device of FIG. 35. [Diagram 45] FIG. 45 is a rear perspective view of the aperture member of FIG. 44. [Figure 46] FIG. 45 is a front view of the aperture member of FIG. 44. [Figure 47] FIG. 36 is a front perspective view of the adjustment mechanism of the OPEP device of FIG. 35. [Figure 48] FIG. 48 is a rear perspective view of the adjustment mechanism of FIG. 47. [Figure 49] FIG. 49 is a front perspective view of the adjustment mechanism of FIGS. 47-48 assembled together with the throttle member of FIGS. 44-46 and the blade of FIG. 43. [Figure 50] FIG. 36 is a front perspective view of the variable nozzle of the OPEP device of FIG. 35. [Figure 51] FIG. 51 is a rear perspective view of the variable nozzle of FIG. 50. [Figure 52] FIG. 36 is a front perspective view of a one-way valve of the OPEP device of FIG. [Diagram 53] FIG. 1 is a perspective view of another embodiment of a respiratory treatment device. [Figure 54] FIG. 54 is an exploded view of the respiratory treatment device of FIG. 53. [Figure 55] FIG. 54 is a cross-sectional perspective view of the respiratory treatment device taken along line I of FIG. 53 shown with its internal components. [Figure 56] FIG. 54 is a cross-sectional perspective view of the respiratory treatment device taken along line II of FIG. 53, shown with its internal components. [Figure 57] 54 is a different cross-sectional perspective view of the respiratory treatment device taken along line I of FIG. 53, showing a portion of an example exhalation flow path. [Figure 58] 54 is a different cross-sectional perspective view taken along line II of FIG. 53, showing a portion of an example exhalation flow path. [Figure 59] FIG. 54 is another cross-sectional perspective view taken along line I of FIG. 53, illustrating a portion of an example inhalation flow path. [Figure 60] 54 is another cross-sectional perspective view taken along line II of FIG. 53, showing a portion of an example inhalation flow path. [Figure 61A] FIG. 2 is a perspective view of a pressure threshold resistor. [Figure 61B] FIG. 2 is a side view of a pressure threshold resistor. [Figure 61C] FIG. 13 is a top view of a pressure threshold resistor. [Figure 61D] FIG. 2 is a cross-sectional view of a pressure threshold resistor. [Figure 61E] FIG. 13 is an exploded view of a pressure threshold resistor. [Figure 62A] 61A-61E are side views of the pressure threshold resistor of FIG. 61A-E illustrating the adjustability of the threshold pressure required to open the valve of the pressure threshold resistor. [Figure 62B] 62A is a side view of the pressure threshold resistor of FIGS. 61A-61E, which together with FIG. 62A show the adjustability of the threshold pressure required to open the valve of the pressure threshold resistor. [Figure 63A] 61A-61E are cross-sectional views of the pressure threshold resistors of FIGS. 61A-61E illustrating the adjustability of the threshold pressure required to open the valve of the pressure threshold resistor. [Figure 63B] 61A-61E are cross-sectional views of the pressure threshold resistors of FIGS. 61A-61E, which, together with FIG. 63A, illustrate the adjustability of the threshold pressure required to open the valve of the pressure threshold resistor. [Fig. 64A] FIG. 61B is a side view of the pressure threshold resistor of FIGS. 61A-61E connected to the OPEP device of FIG. 35. [Fig. 64B] FIG. 61B is a perspective view of the pressure threshold resistor of FIGS. 61A-61E connected to the OPEP device of FIG. 35. [Fig. 64C] FIG. 61B is a partial cross-sectional view of the pressure threshold resistor of FIGS. 61A-61E connected to the OPEP device of FIG. 35. [Fig.64D] FIG. 61B is a partial cross-sectional view of the pressure threshold resistor of FIGS. 61A-61E connected to the OPEP device of FIG. 35. [Figure 65A] FIG. 61C is a side view of the pressure threshold resistor of FIGS. 61A-61E connected to another commercially available OPEP device. [Figure 65B]FIG. 61C is a perspective view of the pressure threshold resistor of FIGS. 61A-61E connected to another commercially available OPEP device. [Figure 66A] FIG. 13 is a side view of another pressure threshold resistor. [Figure 66B] FIG. 66B is a cross-sectional view of the pressure threshold resistor of FIG. 66A. [Figure 66C] FIG. 66B is a cross-sectional view of the pressure threshold resistor of FIG. 66A. [Figure 66D] FIG. 66B is a cross-sectional view of the pressure threshold resistor of FIG. 66A. [Figure 66E] FIG. 66B is a cross-sectional view of the pressure threshold resistor of FIG. 66A. [Figure 67A] 66A-66E are side views of the pressure threshold resistors of FIGS. 66A-66E illustrating the adjustability of the threshold pressure required to open the valve of the pressure threshold resistor. [Figure 67B] FIG. 67A is a side view of the pressure threshold resistor of FIGS. 66A-66E, which together with FIG. 67A show the adjustability of the threshold pressure required to open the valve of the pressure threshold resistor. [Figure 68A] 66A-66E are cross-sectional views of the pressure threshold resistors of FIGS. 66A-66E illustrating the adjustability of the threshold pressure required to open the valve of the pressure threshold resistor. [Figure 68B] 68A is a cross-sectional view of the pressure threshold resistor of FIGS. 66A-66E, which together with FIG. 68A show the adjustability of the threshold pressure required to open the valve of the pressure threshold resistor. [Figure 69A] FIG. 2 is a perspective view of a flow resistor. [Figure 69B] FIG. 69B is a cross-sectional view of the flow resistor of FIG. 69A. [Figure 69C] FIG. 69B is a cross-sectional view of the flow resistor of FIG. 69A. [Figure 69D] FIG. 69B is a cross-sectional view of the flow resistor of FIG. 69A. [Figure 69E] FIG. 69B is a cross-sectional view of the flow resistor of FIG. 69A. [Figure 70A] FIG. 13 is a perspective view of another flow resistor. [Figure 70B] FIG. 70B is a cross-sectional view of the flow resistor of FIG. 70A. [Figure 70C] FIG. 70B is a front view of the flow resistor of FIG. 70A. [Figure 71]FIG. 36 is a side view of the flow resistor of FIGS. 70A-70C connected to the OPEP device of FIG. 35. [Figure 72A] FIG. 1 is a perspective view of a combined RMT and OPEP device. [Fig. 72B] FIG. 72B is a front view of the combined RMT and OPEP device of FIG. 72A. [Fig. 72C] FIG. 72B is a side view of the combined RMT and OPEP device of FIG. 72A. [Figure 73A] FIG. 72A-72C are general cross-sectional views of the combined RMT and OPEP device, showing the delivery of RMT and OPEP therapy during exhalation. [Figure 73B] FIG. 72B is a partial cross-sectional view of the combined RMT and OPEP device of FIGS. 72A-72C, illustrating the delivery of RMT and OPEP therapy during exhalation. [Figure 73C] FIG. 72B is a partial cross-sectional view of the combined RMT and OPEP device of FIGS. 72A-72C, illustrating the delivery of RMT and OPEP therapy during exhalation. [Fig. 73D] FIG. 72A-72C are general cross-sectional views of the combined RMT and OPEP device, showing the delivery of RMT and OPEP therapy during exhalation. [Figure 73E] FIG. 72A-72C are general cross-sectional views of the combined RMT and OPEP device, showing the delivery of RMT and OPEP therapy during exhalation. [Fig. 73F] FIG. 72B is a partial cross-sectional view of the combined RMT and OPEP device of FIGS. 72A-72C, illustrating the delivery of RMT and OPEP therapy during exhalation. [Fig. 74A] FIG. 72A-72C are general cross-sectional views of the combined RMT and OPEP device, showing the delivery of RMT and OPEP therapy during inspiration. [Fig. 74B] FIG. 72B is a partial cross-sectional view of the combined RMT and OPEP device of FIGS. 72A-72C, illustrating the delivery of RMT and OPEP therapy during inspiration. [Fig. 74C] FIG. 72A-72C are general cross-sectional views of the combined RMT and OPEP device, showing the delivery of RMT and OPEP therapy during inspiration. [Fig. 74D]FIG. 72A-72C are general cross-sectional views of the combined RMT and OPEP device, showing the delivery of RMT and OPEP therapy during inspiration. [Fig. 74E] FIG. 72B is a partial cross-sectional view of the combined RMT and OPEP device of FIGS. 72A-72C, illustrating the delivery of RMT and OPEP therapy during inspiration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] OPEP therapy OPEP therapy is effective within a range of operating conditions. For example, adults have expiratory flow rates ranging from 10 to 60 liters per minute and maintain static expiratory pressures ranging from 8 to 18 cmH2O. Within these parameters, OPEP therapy has been found to be most effective when the change in expiratory pressure (i.e., amplitude) is in the range of 5 to 20 cmH2O oscillating at frequencies of 10 to 40 Hz. In contrast, adolescents have much lower expiratory flow rates and maintain lower static expiratory pressures. Thus, the most effective operating conditions for the administration of OPEP therapy will vary. Similarly, the ideal operating conditions for those suffering from respiratory illnesses, or in contrast, healthy athletes, will differ from those of the average adult. As described below, components of the disclosed OPEP device are selectable and / or adjustable so that ideal operating conditions (e.g., amplitude and frequency of oscillatory pressure) are identified and maintained. Each of the various embodiments described herein achieves frequencies and amplitudes that fall within the desired ranges set forth above. Each of the various embodiments described herein can also be configured to achieve frequencies and amplitudes that fall outside of the ranges set forth above.

[0028] First OPEP embodiment 1-4, there are shown front perspective, rear perspective, cross-sectional front perspective, and exploded views of the OPEP device 100. For illustrative purposes, the internal components of the OPEP device 100 are omitted in FIG. 3. The OPEP device 100 generally comprises a housing 102, a chamber inlet 104, a first chamber outlet 106, a second chamber outlet 108 (best seen in FIGS. 2 and 7), and a mouthpiece 109 in fluid communication with the chamber inlet 104. Although the mouthpiece 109 is shown in FIGS. 1-4 as being integrally formed with the housing 102, it is also envisioned that the mouthpiece 109 may be removable and replaced with a mouthpiece 109 of a different size or shape as needed to maintain optimal operating conditions. Generally, the housing 102 and the mouthpiece 109 could be constructed of any sturdy material, such as a polymer. One such material is polypropylene. Alternatively, acrylonitrile butadiene styrene (ABS) may be used.

[0029] Alternatively, other or additional interfaces, such as a breathing tube or gas mask (not shown), may be attached in fluid communication with the mouthpiece 109 or associated with the housing 102. For example, the housing 102 may have an inhalation port (not shown) having a separate one-way inhalation valve (not shown) in fluid communication with the mouthpiece 109 to allow a user of the OPEP device 100 to both inhale ambient air through the one-way valve and exhale through the chamber inlet 104 during inhalation and exhalation periods without withdrawing the mouthpiece 109 of the OPEP device 100. In addition, the OPEP device 100 may have multiple aerosol delivery devices connected to it, for example, through the inhalation port described above, when aerosol therapy and OPEP therapy are performed simultaneously. As such, the inhalation port may include, for example, an elastomeric or other flexible adapter capable of accepting a different mouthpiece or the outlet of a particular aerosol delivery device that the user intends to use with the OPEP device 100. As used herein, the term aerosol delivery device is to be understood to include, for example, but not limited to, any nebulizer, soft mist inhaler, pressurized metered dose inhaler, dry powder inhaler, combination holding chamber and pressurized metered dose inhaler, and the like. Suitable commercially available aerosol delivery devices include, but are not limited to, AEROCLIPSE nebulizer, RESPIMAT soft mist inhaler, LC Sprint nebulizer, AEROCHAMBER PLUS holding chamber, MICRO MIST nebulizer, SIDESTREAM nebulizer, Inspiration Elite nebulizer, FLOVENT pMDI, VENTOLIN pMDI, AZMACORT pMDI, BECLOVENT pMDI, QVAR pMDI and AEROBID PMDI, XOPENEX pMDI, PROAIR pMDI, PROVENT pMDI, SYMBICORT pMDI, TURBOHALER DPI, and DISKHALER DPI.Descriptions of suitable aerosol delivery devices can be found, but are not limited to, U.S. Pat. Nos. 4,566,452, 5,012,803, 5,012,804, 5,312,046, 5,497,944, 5,622,162, 5,823,179, 6,293,279, 6,435,177, 6,484,717, 6,848,443, 7,360,537, 7,568,480, and 7,905,228, which are incorporated by reference in their entireties.

[0030] 1-4, the housing 102 is generally box-shaped; however, any shape of the housing 102 may be used. Additionally, the chamber inlet 104, the first chamber outlet 106, and the second chamber outlet 108 may be any shape or series of shapes, such as multiple (i.e., two or more) circular passages or linear slots. More importantly, it should be understood that the cross-sectional areas of the chamber inlet 104, the first chamber outlet 106, and the second chamber outlet 108 are only some of the factors that affect the ideal operating conditions described above.

[0031] The housing 102 is preferably openable so that the components contained therein can be periodically accessed, cleaned, replaced, or reconfigured as necessary to maintain ideal operating conditions. As such, the housing 102 is shown in Figures 1-4 as comprising a front portion 101, a middle portion 103, and a rear portion 105. The front portion 101, the middle portion 103, and the rear portion 105 may be releasably connected to one another by any suitable means, such as a snap fit, a press fit, or the like, such that a sufficient seal is formed between the associated portions to enable the OPEP device 100 to properly administer an OPEP therapy.

[0032] As shown in FIG. 3, an exhalation flow path 110, shown in dashed lines, is defined between the mouthpiece 109 and at least one of the first chamber outlet 106 and the second chamber outlet 108 (best seen in FIG. 7). More specifically, the exhalation flow path 110 begins at the mouthpiece 109, passes through the chamber inlet 104, and enters the first or entry chamber 114. At the first chamber 114, the exhalation flow path turns 180 degrees and passes through the chamber passageway 116 into the second or exit chamber 118. At the second chamber 118, the exhalation flow path 110 exits the OPEP device 100 through at least one of the first chamber outlet 106 and the second chamber outlet 108. Thus, the exhalation flow path 110 "turns around," i.e., it reverses its longitudinal direction between the chamber inlet 104 and at least one of the first chamber outlet 106 or the second chamber outlet 108. However, those skilled in the art will appreciate that the exhalation flow path 110 identified by the dashed line is only one example, and that exhaled air exhaled into the OPEP device 100 may flow in any number of directions or paths as it travels from the mouthpiece 109 or chamber inlet 104 across the first chamber outlet 106 or second chamber outlet 108.

[0033] 3 also illustrates various other features of the OPEP device 100 associated with the housing 102. For example, a stop 122 prevents a restrictor member 130 (see FIG. 5), described below, from opening in the wrong direction, a seat 124 is formed about the chamber entrance 104 that is shaped to receive the restrictor member 130, and upper and lower bearings 126 and 128 are formed within the housing 102 and configured to receive a shaft rotatably mounted therebetween. One or more guide walls 120 are disposed within the second chamber 118 to direct exhaled air along the exhalation flow path 110.

[0034] 5-7, various cross-sectional perspective views of the OPEP device 100 are shown along with its internal components. The internal components of the OPEP device 100 include a throttling member 130, vanes 132, and an optional variable nozzle 136. As shown, the throttling member 130 and vanes 132 are operatively connected using a shaft 134 that is rotatably mounted between an upper bearing 126 and a lower bearing 12f8 such that the throttling member 130 and vanes 132 can rotate in unison about the shaft 134. As described in more detail below, the variable nozzle 136 includes an orifice 138 that is configured to increase in size in response to the flow of exhaled air passing therethrough.

[0035] 4-6 further illustrate the division of the first chamber 114 and the second chamber 118 within the housing 102. As previously described, the chamber inlet 104 defines an entrance to the first chamber 114. A restrictor member 130 is disposed in the first chamber such that it is movable relative to a seat 124 about the chamber inlet 104 between a closed position in which the flow of exhaled air along the exhalation flow path 110 through the chamber inlet 104 is restricted, and an open position in which the flow of exhaled air through the chamber inlet is less restricted. Similarly, an optional variable nozzle 136 is mounted about or disposed in the chamber passageway 116 such that the flow of exhaled air entering the first chamber 114 exits the first chamber 114 through an orifice 138 of the variable nozzle 136. Exhaled air exiting the first chamber 114 through the orifice 138 of the variable nozzle 136 enters a second chamber defined by the space occupied by the vanes 132 and the guide wall 120 within the housing 102. The exhaled air may then exit the second chamber 118 through at least one of the first chamber outlet 106 and the second chamber outlet 108, depending on the position of the vanes 132.

[0036] 8-14 show the internal components of the OPEP device 100 in greater detail. Turning first to FIGS. 8-9, the front and rear perspective views show the throttling member 130 operatively connected to the vanes 132 by a shaft 134. As such, the throttling member 130 and the vanes 132 are rotatable about the shaft 134 such that rotation of the throttling member 130 causes a corresponding rotation of the vanes 132, and vice versa. Like the housing 102, the throttling member 130 and the vanes 132 can be made or constructed of any durable material, such as a polymer. They are preferably constructed of a low-shrink, low-friction plastic. One such material is acetal.

[0037] As shown, the throttling member 130, vanes 132 and shaft 134 are formed as a unitary component. The throttling member 130 is generally disk-shaped and the vanes 132 are flat. The throttling member 130 includes a generally circular surface 140 axially offset from the shaft 134 and a beveled or chamfered edge 142 configured to engage a seat 124 formed about the chamber inlet 104. This allows the throttling member 130 to move about an axis of rotation defined by the shaft 134 relative to the chamber inlet 104 such that in a closed position the throttling member 130 engages the seat 124 to substantially seal and throttle the flow of exhaled air through the chamber inlet 104. However, it is envisioned that the throttling member 130 and vanes 132 may be formed as separate components connectable by any suitable means and maintained independently replaceable with the throttling member 130 or vanes 132 of different shapes, sizes or weights selected to maintain ideal operating conditions. For example, the throttling member 130 and / or the vanes 132 may include one or more contoured surfaces. Alternatively, the throttling member 130 may be configured as a butterfly valve.

[0038] 10, a front view of the throttle member 130 and vanes 132 is shown. As previously described, the throttle member 130 has a generally circular surface 140 that is axially offset from the shaft 134. The throttle member 130 further has a second offset designed to facilitate movement of the throttle member 130 between the closed and open positions. More specifically, the center 144 of the surface 140 of the throttle member 130 is radially offset and offset from the plane defined by the shaft 134 or the axis of rotation. In other words, the surface 140 of the throttle member 130 has a larger surface area disposed on one side of the shaft 134 than on the other side of the shaft 134. The pressure at the chamber inlet 104 caused by the exhaled air generates a force acting on the surface 140 of the throttle member 130. Because the center 144 of the surface 140 of the throttle member 130 is offset as previously described, the resulting force differential creates a torque around the shaft 134. As discussed further below, this torque urges the movement of the throttle member 130 between its closed and open positions.

[0039] 11, a top view of the throttle member 130 and vanes 132 is shown. As depicted, the vanes 132 are connected to the shaft 134 at an angle of 75° relative to the surface 140 of the throttle member 130. While the angle is preferably to be kept between 60° and 80°, it is envisioned that the angle of the vanes 132 may be selectively adjusted to maintain ideal operating conditions as discussed above. Additionally, the vanes 132 and throttle member 130 are preferably configured such that when the OPEP device 100 is fully assembled, the angle between the centerline of the variable nozzle 136 and the vanes 132 is between 10° and 25° when the throttle member 130 is in a closed position. Additionally, regardless of the configuration, the throttle member 130 and vanes 132 combination preferably has a center of gravity aligned with the shaft 134 or axis of rotation. In light of this entire disclosure, it will be apparent to one of ordinary skill in the art that the angle of the vanes 132 will be limited by the size or shape of the housing 102 and will generally be less than half a full rotation of the vanes 132 and throttle member 130.

[0040] 12 and 13, front and rear perspective views of the variable nozzle 136 are shown without the exhaled air flow passing therethrough. Generally, the variable nozzle 136 includes upper and lower walls 146, a side wall 148, and a V-shaped slit 150 formed therebetween. As shown, the variable nozzle is generally shaped like a duckbill valve. However, it should be understood that nozzles or valves of other shapes and sizes may be used. The variable nozzle 136 further includes a lip 152 configured to mount the variable nozzle 136 between the first chamber 114 and the second chamber 118 within the housing 102. The variable nozzle 136 may be constructed or molded of any suitable flexible material, such as silicone, and preferably has a wall thickness between 0.50 millimeters and 2.00 millimeters, and an orifice width between 0.25 millimeters and 1.00 millimeters, or less depending on manufacturing capabilities.

[0041] As explained above, the variable nozzle 136 is optional in the operation of the OPEP device 100. It is understood that the OPEP device 100 may alternatively omit both the chamber passageway 116 and the variable nozzle 136, thus comprising a single chamber embodiment. Although it will function without the variable nozzle 136, the performance of the OPEP device 100 over a wider range of exhalation flow rates is improved when the OPEP device 100 is operated with the variable nozzle 136. The chamber passageway 116, when used without the variable nozzle 136, or the orifice 138 of the variable nozzle 136, when included, serves to produce 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 118 proportionally increases the force exerted by the exhaled air on the vanes 132, thereby increasing the torque about the shaft 134, all of which affect ideal operating conditions.

[0042] Without the variable nozzle 136, the orifice between the first chamber 114 and the second chamber 118 would be fixed according to the size, shape, and cross-sectional area of ​​the chamber passageway 116, and would be selectively adjustable by any suitable means, such as by replacing the middle section 103 or the rear section 105 of the housing. On the other hand, when the variable nozzle 136 is included in the OPEP device 100, the orifice between the first chamber 114 and the second chamber 118 would be defined by the size, shape, and cross-sectional area of ​​the orifice 138 of the variable nozzle 136, and would vary according to the exhaled air flow rate and the pressure within the first chamber 114.

[0043] 14, a front perspective view of the variable nozzle 136 is shown with an exhaled air flow passing therethrough. One aspect of the variable nozzle 136 shown in FIG. 14 is that the cross-sectional shape of the orifice 138 remains generally rectangular as it opens in response to the exhaled air flow passing therethrough, which results in a lower pressure drop through the variable nozzle 136 from the first chamber 114 (see FIGS. 3 and 5) to the second chamber 118 during OPEP therapy. The generally constant rectangular shape of the orifice 138 of the variable nozzle 136 during increased flow is achieved by a V-shaped slit 150 formed between the top and bottom walls 146 and the side wall 148, which acts to allow the side wall 148 to flex without restraint. It is desirable for the V-shaped slit 150 to be as narrow as possible to minimize leakage of exhaled air therethrough. For example, the V-shaped slit 150 may be approximately 0.25 millimeters wide, but could range between 0.10 millimeters and 0.50 millimeters depending on manufacturing capabilities. Exhaled air that does leak through the V-shaped slit 150 is ultimately directed along the exhalation flow path by a guide wall 120 that protrudes from the housing 102 of the second chamber 118.

[0044] It should be appreciated that numerous factors, including the shape and material of the variable nozzle 136, contribute to the effect that the variable nozzle 136 has on the performance of the OPEP device 100. By way of example only, to achieve a target oscillatory pressure frequency between 10 Hz and 13 Hz at an exhalation flow rate of 15 liters per minute, one embodiment may utilize a passageway or orifice of 1.0 millimeter by 20.0 millimeters. However, as the exhalation flow rate increases, the embodiment also increases the frequency of the oscillatory pressure, but at a rate that is too rapid compared to the target frequency. To achieve a target oscillatory pressure frequency between 18 Hz and 20 Hz at an exhalation flow rate of 45 liters per minute, the embodiment may utilize a passageway or orifice of 3.0 millimeter by 20.0 millimeters. Such a relationship demonstrates the desirability of a passageway or orifice that expands in cross-sectional area as the exhalation flow rate increases in order to limit the pressure drop across the variable nozzle 136.

[0045] 15A-15C, a phantom view from above of the OPEP device 100 shows an illustrative illustration of the operation of the OPEP device 100. Specifically, FIG. 15A shows the throttling member 130 in an initial or closed position where the flow of exhaled air through the chamber inlet 104 is throttled, with the vanes 132 in a first position directing the flow of exhaled air toward the first chamber outlet 106. FIG. 15B shows the throttling member 130 in a partially open position where the flow of exhaled air through the chamber inlet 104 is less throttled, with the vanes 132 aligned directly with the jet of exhaled air exiting the variable nozzle 136. FIG. 15C shows the throttling member 130 in an open position where the flow of exhaled air through the chamber inlet 104 is even less throttled, with the vanes 132 in a second position directing the flow of exhaled air toward the second chamber outlet 108. It should be understood that the cycle described below is only one example of operation of the OPEP device 100, and that numerous factors may affect operation of the OPEP device 100 in ways that result in deviations from the cycle described, although during operation of the OPEP device 100, the throttle member 130 and vanes 132 will generally reciprocate between the positions shown in Figures 15A and 15C.

[0046] During administration of OPEP therapy, the restrictor 130 and vanes 132 may initially be positioned as shown in FIG. 15A. In this position, the restrictor 130 is in a closed position, and the flow of exhaled air along the exhalation flow path through the chamber inlet 104 is substantially restricted. As such, the exhalation pressure at the chamber inlet 104 begins to increase as the user exhales into the mouthpiece 109. As the exhalation pressure at the chamber inlet 104 increases, a corresponding force acting on the face 140 of the restrictor 130 increases. As previously explained, because the center 144 of the face 140 is radially offset and offset from the plane defined by the shaft 134, the resulting net force creates a negative torque, or opening torque, about the shaft. The opening torque then urges the restrictor 130 to rotate open to allow exhaled air to enter the first chamber 114 and urges the vanes 132 away from their first position. As the restrictor 130 opens and exhaled air passes into the first chamber 114, the pressure at the chamber inlet 104 begins to decrease, the force acting on the restrictor face 140 begins to decrease, and the torque biasing the restrictor 130 open begins to decrease.

[0047] As the exhaled air continues to enter the first chamber 114 through the chamber inlet 104, it is directed by the housing 102 along the exhalation flow path until it reaches the chamber passage 116, which is disposed between the first chamber 114 and the second chamber 118. When the OPEP device 100 is operating without the variable nozzle 136, the exhaled air accelerates as it passes through the chamber passage 116 due to a reduced cross-sectional area, forming a jet of exhaled air. Similarly, when the OPEP device 100 is operating with the variable nozzle 136, the exhaled air accelerates as it passes through the orifice 138 of the variable nozzle 136, where pressure through the orifice 138 causes the sidewall 148 of the variable nozzle 136 to deflect outward, thereby increasing the size of the orifice 138 and the resulting flow of exhaled air through the orifice. To the extent that some of the exhaled air escapes through the V-shaped slit 150 of the variable nozzle 136, it is directed along the exhalation flow path back to the jet of exhaled air by the guide wall 120 protruding into the housing 102.

[0048] The exhaled air then exits the first chamber 114 through the variable nozzle 136 and / or chamber passageway 116 into the second chamber 118, where it is directed by the vanes 132 towards the front portion 101 of the housing 102 where it is forced to reverse direction before exiting the OPEP device 100 through the open first chamber outlet 106. As a result of the change in direction of the exhaled air towards the front portion 101 of the housing 102, pressure builds up in the second chamber 118 near the front portion 101 of the housing 102, which creates a force on the adjacent vanes 132, creating an additional negative or opening torque about the shaft 134. The combined opening torque created about the shaft 134 from the forces acting on the face 140 of the throttling member 130 and the forces acting on the vanes 132 causes the throttling member 130 and the vanes 132 to rotate about the shaft 134 from the position shown in FIG. 15A towards the position shown in FIG. 15B.

[0049] When the throttling member 130 and vane 132 rotate to the position shown in Figure 15B, the vane 132 intersects with the jet of exhaled air exiting the variable nozzle 136 or chamber passage 116. Initially, the jet of exhaled air exiting the variable nozzle 136 or chamber passage 116 provides a force on the vane 132 which, together with the momentum of the vane 132, shaft 134 and throttling member 130, propels the vane 132 and throttling member 130 to the position shown in Figure 15C. However, around the position shown in Figure 15B, the force acting on the vane 132 from the exhaled air exiting the variable nozzle 136 also switches from a negative or opening torque to a positive or closing torque. More specifically, as the exhaled air exits the first chamber 114 through the variable nozzle 136 and enters the second chamber 118, it is directed by the vanes 132 towards the front portion 101 of the housing 102 where it is forced to reverse direction before exiting the OPEP device 100 through the open second chamber outlet 108. As a result of the change in direction of the exhaled air towards the front portion 101 of the housing 102, pressure builds up in the second chamber 118 near the front portion 101 of the housing 102, which creates a force on the adjacent vanes 132, creating a positive or closing torque about the shaft 134. As the vanes 132 and throttling member 130 continue to move closer to the position shown in FIG. 15C, the pressure building up near the front portion 101 of the housing 102 in the partial chamber 118, and therefore the positive or closing torque about the shaft 134, continues to increase, causing the flow of exhaled air along the exhalation flow path 110 and through the chamber inlet 104 to become even less throttled. Meanwhile, the torque about shaft 134 from the forces acting on throttling member 130 also switches from a negative or opening torque to a positive or closing torque around the position shown in FIG. 15B, but to an essentially negligible extent as throttling member 130 and vanes 132 rotate from the position shown in FIG. 15B to the position shown in FIG. 15C.

[0050] After reaching the position shown in Figure 15C, the increasing positive or closing torque about shaft 134 causes vanes 132 and throttling member 130 to reverse direction and rotate back towards the position shown in Figure 15B. As vanes 132 and throttling member 130 approach the position shown in Figure 15B, and the flow of exhaled air through chamber inlet 104 becomes increasingly restricted, the positive or closing torque about shaft 134 begins to decrease. When throttling member 130 and vanes 132 reach the position shown in Figure 15B, vanes 132 intersect with the jet of exhaled air exiting variable nozzle 136 or chamber passageway 116, thereby creating a force on vanes 132 which, together with the momentum of vanes 132, shaft 134 and throttling member 130, urges vanes 132 and throttling member 130 back towards the position shown in Figure 15A. After the throttle member 130 and vanes 132 return to the position shown in FIG. 15A, the flow of exhaled air through the chamber inlet 104 is throttled and the cycle described above is repeated.

[0051] It should be appreciated that the above-described cycle may be repeated multiple times during one exhalation period, and thus, by repeatedly moving the restrictor member 130 between a closed position, in which the flow of exhaled air through the chamber inlet 104 is restricted, and an open position, in which the flow of exhaled air through the chamber inlet 104 is less restricted, an oscillatory counter pressure is delivered to a user of the OPEP device 100 to perform OPEP therapy.

[0052] 16-17, an alternative embodiment of a variable nozzle 236 is shown. The variable nozzle 236 may be used in the OPEP device 100 as an alternative to the variable nozzle 136 previously described. As shown in FIGS. 16-17, the variable nozzle 236 includes an orifice 238, top and bottom walls 246, a sidewall 248, and a lip 252 configured to mount the variable nozzle 236 between the first chamber 114 and the second chamber 118 within the housing 102 of the OPEP device 100 in the same manner as the variable nozzle 136. Similar to the variable nozzle 136 shown in FIGS. 12-13, the variable nozzle 236 may be constructed or molded from any suitable flexible material, such as silicone.

[0053] During OPEP therapy, when the orifice 238 of the variable nozzle 236 opens in response to the flow of exhaled air passing therethrough, the cross-sectional shape of the orifice 238 remains substantially rectangular, which results in a lower pressure drop through the variable nozzle 236 from the first chamber 114 to the second chamber 118. The constant substantially rectangular shape of the orifice 238 of the variable nozzle 236 during increased flow is achieved by the thin pleated walls formed by the top and bottom walls 246 allowing the side walls 248 to flex more easily and with less resistance. A further advantage of this embodiment is that while exhaled air flows through the orifice 238 of the variable nozzle 236, there is no leakage from the top and bottom walls 246, as there is through the V-shaped slits 150 of the variable nozzle 136 shown in Figures 12-13.

[0054] Those skilled in the art will also appreciate that in some applications positive expiratory pressure only (no oscillations) may be desired, in which case OPEP device 100 may be operated without throttling member 130, but instead with a fixed or manually adjustable orifice. Positive expiratory pressure embodiments may further include variable nozzle 136 or variable nozzle 236 to maintain a relatively constant counter pressure within a desired range.

[0055] Second OPEP embodiment 18-19, there are shown front and rear perspective views of an OPEP device 200 according to a second embodiment. The construction and operation of the OPEP device 200 are similar to that of the OPEP device 100. However, the OPEP device 200 further includes an adjustment mechanism 253 adapted to change the relative position of the chamber inlet 204 with respect to the housing 202 and the throttling member 230, thereby changing the range of rotation of the vanes 232 operably connected to the throttling member 230, as best seen in FIGS. 20-24. As will be described below, a user may thereby advantageously adjust both the frequency and amplitude of the OPEP therapy delivered by the OPEP device 200 without opening the housing 202 and disassembling the components of the OPEP device 200.

[0056] The OPEP device 200 generally comprises a housing 202, a chamber inlet 204, a first chamber outlet 206 (best seen in FIGS. 23 and 32), a second chamber outlet 208 (best seen in FIGS. 23 and 32), and a mouthpiece 209 in fluid communication with the chamber inlet 204. As with the OPEP device 100, the front 201, middle 203, and rear 205 sections of the housing 202 are separable so that the components contained therein can be periodically accessed, cleaned, replaced, or reconfigured as necessary to maintain optimal operating conditions. The OPEP device further includes an adjustment dial 254, described below.

[0057] As discussed above in relation to the OPEP device 100, the OPEP device 200 may be adapted for use with other or additional interfaces, such as an aerosol delivery device. In this regard, the OPEP device 200 includes an inhalation port 211 (best seen in FIGS. 19, 21, and 23) in fluid communication with the mouthpiece 209 and the chamber inlet 204. As discussed above, the inhalation port includes a separate one-way valve (not shown) that allows a user of the OPEP device 200 to both inhale ambient air through the one-way valve and exhale through the chamber inlet 204 during inhalation and exhalation periods without withdrawing the mouthpiece 209 of the OPEP device 200. In addition, the aerosol delivery device described above may be connected to the inhalation port 211 for simultaneous administration of aerosol and OPEP therapy.

[0058] An exploded view of the OPEP device 200 is shown in Figure 20. In addition to the housing components described above, the OPEP device 200 includes a throttle member 230 operably connected to a vane 232 by a pin 231, an adjustment mechanism 253, and a variable nozzle 236. As shown in the cross-sectional view of Figure 21, when the OPEP device 200 is in use, the variable nozzle 236 is disposed between the mid-section 203 and rear section 205 of the housing 202, and the adjustment mechanism 253, throttle member 230, and vane 232 form an assembly.

[0059] 21-23, various cross-sectional perspective views of the OPEP device 200 are shown. Similar to the OPEP device 100, an exhalation flow path 210, shown in dashed lines, is defined between the mouthpiece 209 and at least one of the first chamber outlet 206 and the second chamber outlet 208 (best seen in FIGS. 23 and 32). The exhalation flow path 210 originates from the mouthpiece 209 and is directed towards the chamber inlet 204, which may or may not be blocked by the throttling member 230 during operation, by a one-way valve (not shown) and / or an aerosol delivery device (not shown) attached to the inhalation port 211. After passing through the chamber inlet 204, the exhalation flow path 210 enters the first chamber 214 and makes a 180° turn towards the variable nozzle 236. After passing through the orifice 238 of the variable nozzle 236, the exhalation flow path 210 enters the second chamber 218. At the second chamber 218, the exhalation flow path 210 will exit the OPEP device 200 through at least one of the first chamber outlet 206 or the second chamber outlet 208. Those skilled in the art will appreciate that the exhalation flow path 210 shown in dashed lines is an example, and that exhaled air exhaled into the OPEP device 200 can flow in any number of directions or paths as it crosses from the mouthpiece 209 or chamber inlet 204 to the first chamber outlet 206 or the second chamber outlet 208.

[0060] 24-25, front and rear perspective views of the adjustment mechanism 253 of the OPEP device 200 are shown. Generally, the adjustment mechanism 253 includes an adjustment dial 254, a shaft 255, and a frame 256. A protrusion 258 is disposed on a rear surface 260 of the adjustment dial to limit selective rotation of the adjustment mechanism 253 by a user, as described in more detail below. The shaft 255 includes a key portion 262 that is adapted to fit within an upper bearing 226 and a lower bearing 228 formed in the housing 202 (see FIGS. 21 and 28-29). The shaft further includes an axial bore 264 that is adapted to receive a pin 231 that operably connects the throttle member 230 and the vane 232. As shown, the frame 256 is spherical and is configured to rotate relative to the housing 202 while forming a sufficient seal between the housing 202 and the frame 256 to allow for administration of an OPEP therapy, as described below. The frame 256 includes a circular opening defined by a seat 224 that is adapted to receive the throttle member 230. In use, the circular opening functions as the chamber entrance 204. The frame 256 also includes a stop 222 to prevent the throttle member 230 from opening in the wrong direction.

[0061] 26, a front perspective view of the throttle member 230 and vanes 232 is shown. The design, materials, and construction of the throttle member 230 and vanes 232 may be the same as those described above with respect to the OPEP device 100. However, the throttle member 230 and vanes 232 of the OPEP device 200 are operatively connected by a pin 231 that is adapted to pass through an axial bore 264 of the shaft 255 of the adjustment mechanism 253. The pin 231 may be constructed of stainless steel, for example. Thus, rotation of the throttle member 230 causes a corresponding rotation of the vanes 232, and vice versa.

[0062] 27, there is shown a front perspective view of the adjustment mechanism 253 integrally assembled with the restrictor member 230 and vane 232. In this configuration, it can be seen that the restrictor member 230 is arranged relative to the frame 256 and the seat 224 such that it can rotate between a closed position (as shown) in which the flow of exhaled air along the exhalation flow path 210 through the chamber inlet 204 is restricted, and an open position (not shown) in which the flow of exhaled air through the chamber inlet 204 is less restricted. As previously mentioned, the vane 232 is operatively connected to the restrictor member 230 by a pin 231 extending through a shaft 255 for movement in unison with the restrictor member 230. It can further be seen that the restrictor member 230 and vane 232 are supported by the adjustment mechanism 253, which itself is rotatable within the housing 202 of the OPEP device 200, as described below.

[0063] 28 and 29A-29B are partial cross-sectional views depicting the adjustment mechanism 253 mounted within the housing 202 of the OPEP device 200. As shown in FIG. 28, the adjustment mechanism 253, together with the throttle member 230 and the vane 232, is rotatably mounted within the housing 202 around the upper and lower bearings 226 and 228, such that a user can rotate the adjustment mechanism 253 using the adjustment dial 254. FIG. 29A-29B further illustrates the process of mounting and locking the adjustment mechanism 253 within the lower bearing 228 of the housing 202. More specifically, the key portion 262 of the shaft 255 is aligned with and inserted through a rotation lock portion 266 formed on the housing 202, as shown in FIG. 29A. Once the key portion 262 of the shaft 255 is inserted through the rotation lock 266, the shaft 255 is rotated 90 degrees to the locked position, but the shaft 255 remains free to rotate. The adjustment mechanism 253 is similarly installed and locked into the upper bearing 226.

[0064] Once the housing 202 and internal components of the OPEP device 200 are assembled, the shaft 255 is constrained from rotating by being held in the locked position by the rotation lock 266. As shown in the front view of the OPEP device 200 in FIG. 30, the housing 202 is provided with two stoppers 268, 288 that are arranged to engage with the projections 258 formed on the rear surface 260 of the adjustment dial 254 when the user rotates the adjustment dial 254 into position. For illustrative purposes, the OPEP device 200 is shown in FIG. 30 without the adjustment dial 254 or adjustment mechanism 253 that would extend from the housing 202 through the opening 269. This allows the adjustment dial 254, adjustment mechanism 253, and key portion 262 of the shaft 255 to be appropriately constrained from rotating.

[0065] 31, a partial cross-sectional view of the adjustment mechanism 253 mounted within the housing 202 is shown. As previously mentioned, the frame 256 of the adjustment mechanism 253 is spherical and configured to rotate relative to the housing 202 while forming a sufficient seal between the housing 202 and the frame 256 to allow for the administration of OPEP therapy. As shown in FIG. 31, a flexible cylinder 271 extending from the housing 202 completely surrounds a portion of the frame 256 to form a sealing edge 270. Like the housing 202 and the restrictor member 230, the flexible cylinder 271 and the frame 256 could be constructed of a low-shrink, low-friction plastic. One such material is acetal. This allows the sealing edge 270 to contact the frame 256 over a full 360°, forming a seal throughout the entire allowable rotation of the adjustment member 253.

[0066] The selective adjustment of the OPEP device 200 will now be described with reference to Figures 32A-32B, 33A-33B, and 34A-34B. Figures 32A-32B are partial cross-sectional views of the OPEP device 200, Figures 33A-33B are diagrams illustrating the adjustability of the OPEP device 200, and Figures 34A-34B are phantom views of the OPEP device 200 from above. As previously described with respect to the OPEP device 100, the vanes 232 and the restrictor 230 are preferably configured such that when the OPEP device 200 is fully assembled, the angle between the centerline of the variable nozzle 236 and the vanes 232 is between 10° and 25° when the restrictor 230 is in the closed position. However, it should be understood that the adjustability of the OPEP device 200 is not limited to the parameters described herein, and any number of configurations may be selected for the purpose of implementing an OPEP therapy within ideal operating conditions.

[0067] FIG 32A shows the vanes 232 at an angle of 10° from the centerline of the variable nozzle 236, while FIG 32B shows the vanes 232 at an angle of 25° from the centerline of the variable nozzle 236. FIG 33A illustrates the required position of the frame 256 (shown in phantom) relative to the variable nozzle 236 such that the angle between the centerline of the variable nozzle 236 and the vanes 232 is 10° when the restrictor 230 is in the closed position. On the other hand, FIG 33B illustrates the required position of the frame 256 (shown in phantom) relative to the variable nozzle 236 such that the angle between the centerline of the variable nozzle 236 and the vanes 232 is 25° when the restrictor 230 is in the closed position.

[0068] 34A-34B, a virtual top view of the OPEP device 200 is shown. The configuration shown in FIG. 34A corresponds to the illustrations shown in FIG. 32A and FIG. 33A, where the angle between the center line of the variable nozzle 236 and the vane 232 when the throttling member 230 is in the closed position is 10°. On the other hand, FIG. 34B corresponds to the illustrations shown in FIG. 32B and FIG. 33B, where the angle between the center line of the variable nozzle 236 and the vane 232 when the throttling member 230 is in the closed position is 25°. In other words, the frame 256 of the adjustment member 253 has been rotated counterclockwise by 15° from the position shown in FIG. 34A to the position shown in FIG. 34B, whereby the allowable rotation of the vane 232 has also increased.

[0069] This allows a user to turn the adjustment dial 254 to selectively adjust the orientation of the chamber inlet 204 relative to the throttle member 230 and the housing 202. For example, a user can increase the frequency and amplitude of the OPEP therapy delivered by the OPEP device 200 by turning the adjustment dial 254, and thus the frame 256, towards the position shown in FIG. 34A. Alternatively, a user can decrease the frequency and amplitude of the OPEP therapy delivered by the OPEP device 200 by turning the adjustment dial 254, and thus the frame 256, towards the position shown in FIG. 34B. Also, as shown in the embodiments of FIGS. 18 and 30, indicia may be provided to assist a user in setting the appropriate configuration of the OPEP device 200.

[0070] For an OPEP device based on OPEP device 200, operational states similar to those described below for OPEP device 800 may also be possible.

[0071] Third OPEP embodiment 35-37, an OPEP device 300 according to another embodiment is shown. The OPEP device 300 is similar to the OPEP device 200 in that it is selectively adjustable. As best seen in FIGS. 35, 37, 40, and 49, the OPEP device 300, like the OPEP device 300, further includes an adjustment mechanism 353 adapted to change the relative position of the chamber inlet 304 with respect to the housing 302 and the throttling member 330, thereby varying the range of rotation of the vanes 332 operably connected to the throttling member 330. As previously described with respect to the OPEP device 200, a user may thereby advantageously adjust both the frequency and amplitude of the OPEP therapy delivered by the OPEP device 300 without opening the housing 302 and disassembling the components of the OPEP device 300. The delivery of an OPEP therapy using the OPEP device 300 is otherwise the same as described above with respect to the OPEP device 100.

[0072] The OPEP device 300 comprises a housing 302 having a front portion 301, a rear portion 305, and an inner casing 303. As with the previously described OPEP devices, the front portion 301, the rear portion 305, and the inner casing 303 are separable so that the components contained therein can be periodically accessed, cleaned, or reconfigured as necessary to maintain optimal operating conditions. For example, as shown in Figures 35-37, the front portion 301 and the rear portion 305 of the housing 302 are releasably connected via a snap-fit ​​engagement.

[0073] The components of the OPEP device 300 are further depicted in an exploded view in Figure 38. Generally, the OPEP device 300 includes a front portion 301, a rear portion 305, and an inner casing 303, as well as a mouthpiece 309, an inhalation port 311, a one-way valve 384 disposed therebetween, an adjustment mechanism 353, a restrictor member 330, vanes 332, and a variable nozzle 336.

[0074] As can be seen in Figures 39-40, the inner casing 303 is configured to fit between the front section 301 and the rear section 305 within the housing 302 and defines, in part, a first chamber 314 and a second chamber 318. The inner casing 303 is shown in more detail in the perspective and cross-sectional views shown in Figures 41-42. A first chamber outlet 306 and a second chamber outlet 308 are formed within the inner casing 303. One end 385 of the inner casing 303 is adapted to receive the variable nozzle 336 and maintain the variable nozzle 336 between the rear section 305 and the inner casing 303. An upper bearing 326 and a lower bearing 328 for supporting the adjustment mechanism 353 are formed, at least in part, within the inner casing 303. Like the flexible cylinder 271 and sealing edge 270 described above with respect to the OPEP device 200 , the inner casing 303 also includes a flexible cylinder 371 having a sealing edge 370 for engaging around the frame 356 of the adjustment mechanism 353 .

[0075] The vane 332 is shown in further detail in the perspective view shown in Figure 43. A shaft 334 extends from the vane 332 and is keyed to engage a corresponding keyed portion in a bore 365 of the throttle member 330. The shaft 334 thereby operatively connects the vane 332 to the throttle member 330 such that the vane 332 and the throttle member 330 rotate in unison.

[0076] The throttle member 330 is shown in more detail in the perspective views shown in Figures 44-45. The throttle member 330 includes a key hole 365 for receiving the shaft 334 extending from the vane 832, and further includes a stop 322 that limits the allowable rotation of the throttle member 330 relative to the seat 334 of the adjustment member 353. As shown in the front view of Figure 46, the throttle member 330, like the throttle member 330, further includes an offset designed to facilitate movement of the throttle member 330 between the closed and open positions. More specifically, the face 340 of the throttle member 330 has a larger surface area disposed on one side of the hole 365 for receiving the shaft 334 than on the other side of the hole 365. As explained above with respect to the throttle member 130, this offset creates an opening torque around the shaft 334 during exhalation.

[0077] The adjustment mechanism 353 is shown in more detail in the front and rear perspective views of Figures 47 and 48. Generally, the adjustment mechanism includes a frame 356 adapted to engage a sealing edge 370 of a flexible cylinder 371 formed in the inner casing 303. A circular opening in the frame 356 defines a seat 324 shaped to receive the throttle member 330. In this embodiment, the seat 324 further defines the chamber inlet 304. The adjustment mechanism 353 further includes an arm 354 configured to extend from the frame 356 to a position beyond the housing 302 to allow a user to adjust the orientation of the adjustment mechanism 353, and thus the chamber inlet 304, when the OPEP device 300 is fully assembled. The adjustment mechanism 353 further includes an upper bearing 385 and a lower bearing 386 for receiving the shaft 334.

[0078] The assembly of the vane 332, the adjustment mechanism 353, and the throttle member 330 is shown in a perspective view in FIG. 49. As previously discussed, the vane 332 and the throttle member 330 are operatively connected by the shaft 334 such that rotation of the vane 332 causes rotation of the throttle member 330, and vice versa. In contrast, the adjustment mechanism 353, and thus the seat 332 defining the chamber inlet 304, are configured to rotate about the shaft 334 relative to the vane 332 and the throttle member 330. This allows a user to rotate the arm 354 to selectively adjust the orientation of the chamber inlet 304 relative to the throttle member 330 and the housing 302. For example, a user can increase the frequency and amplitude of the OPEP therapy delivered by the OPEP device 800 by rotating the arm 354, and thus the frame 356, in a clockwise direction. Alternatively, the user can decrease the frequency and amplitude of the OPEP therapy delivered by the OPEP device 300 by rotating the adjustment arm 354, and thus the frame 356, in a counterclockwise direction. Also, as shown in Figures 35 and 37, for example, the housing 302 may be provided with indicia to assist the user in setting the appropriate configuration of the OPEP device 300.

[0079] The variable nozzle 336 is shown in further detail in the front and rear perspective views of Figures 50 and 51. The variable nozzle 336 of the OPEP device 300 is similar to the variable nozzle 236 described above with respect to the OPEP device 200, except that the variable nozzle 336 further includes a substrate 387 configured to fit within one end 385 (see Figures 41-42) of the inner casing 303 to maintain the variable nozzle 336 between the rear section 305 and the inner casing 303. Like the variable nozzle 236, the variable nozzle 336 and the substrate 387 may be made of silicon.

[0080] The one-way valve 384 is shown in more detail in the front perspective view of FIG. 52. Generally, the one-way valve 384 comprises a post 388 adapted to be attached to the front portion 301 of the housing 302 and a flap 389 adapted to bend or pivot relative to the post 388 in response to a force or pressure on the flap 389. Those skilled in the art will appreciate that other one-way valves may be used in this embodiment and other embodiments described herein without departing from the teachings of the present disclosure. As can be seen in FIGS. 39-40, the one-way valve 384 is disposed within the housing 302 between the mouthpiece 309 and the inhalation port 311.

[0081] As discussed above in relation to the OPEP device 100, the OPEP device 300 may be adapted for use with other or additional interfaces, such as an aerosol delivery device. In this regard, the OPEP device 300 includes an inhalation port 311 (best seen in FIGS. 35-36 and 38-40) in fluid communication with the mouthpiece 309. As discussed above, the inhalation port may include a separate one-way valve 384 (best seen in FIGS. 39-40 and 52) configured to allow a user of the OPEP device 300 to both inhale ambient air through the one-way valve 384 and exhale through the chamber inlet 304 during inhalation and exhalation periods without withdrawing the mouthpiece 309 of the OPEP device 300. In addition, a commercially available aerosol delivery device, as described above, may be connected to the inhalation port 311 for simultaneous administration of aerosol therapy (during inhalation) and OPEP therapy (during exhalation).

[0082] The OPEP device 300 and components described above are further illustrated in the cross-sectional views shown in Figures 39-40. For purposes of illustration, the cross-sectional view of Figure 39 is shown without all of the internal components of the OPEP device 300.

[0083] The front section 301, rear section 305 and inner casing 303 are assembled to form a first chamber 314 and a second chamber 318. As with the OPEP device 100, an exhalation flow path 310, shown in dashed lines, is defined between the mouthpiece 309 and at least one of a first chamber outlet 306 (best seen in Figs. 39-40 and 42) and a second chamber outlet 308 (best seen in Fig. 41), both of which are formed in the inner casing 303. As a result of the inhalation port 311 and the one-way valve 348, the exhalation flow path 310 originates from the mouthpiece 309 and is directed towards the chamber inlet 304, which may or may not be blocked by the restrictor member 330 during operation. After passing through the chamber inlet 304, the exhalation flow path 310 enters the first chamber 314 and makes a 180° turn towards the variable nozzle 336. After passing through the orifice 338 of the variable nozzle 336, the exhalation flow path 310 enters the second chamber 318. In the second chamber 318, the exhalation flow path 310 exits the second chamber 318 and ultimately the housing 302 through at least one of the first chamber outlet 306 or the second chamber outlet 308. Those skilled in the art will appreciate that the exhalation flow path 310 shown in dashed lines is an example, and that exhaled air exhaled into the OPEP device 300 can flow in any number of directions or paths as it crosses from the mouthpiece 309 or chamber inlet 304 to the first chamber outlet 306 or the second chamber outlet 308. As previously noted, the administration of OPEP therapy using the OPEP device 300 is otherwise the same as that described above with respect to the OPEP device 100.

[0084] By way of example only, the following operating conditions or performance characteristics may be achieved by an OPEP device based on OPEP device 300 with adjustment dials 354 set to frequency and amplitude increase: [Table 1] For example, the frequency and amplitude are decreased by approximately 20% with the adjustment dial 354 set to decrease frequency and amplitude. Other frequency and amplitude targets can be achieved by varying the specific configuration and sizing of the elements, for example, increasing the length of the vanes 332 will result in a slower frequency, decreasing the size of the orifice 338 will result in a higher frequency. The above example is but one possible set of operating conditions for an OPEP device based on the embodiments described above.

[0085] Fourth OPEP embodiment 53-56, another embodiment of a respiratory treatment device 400 is shown. Unlike the previously described OPEP devices, the respiratory treatment device 400 is configured to deliver oscillatory pressure therapy during both exhalation and inhalation. Those skilled in the art will appreciate that the concepts described below with respect to the respiratory treatment device 400 may be applied to any of the previously described OPEP devices to deliver oscillatory pressure therapy during both exhalation and inhalation. Similarly, the respiratory treatment device 400 may incorporate any of the above concepts with respect to the previously described OPEP devices, including, for example, a variable nozzle, an inhalation port adapted for use with an aerosol delivery device to deliver aerosol therapy, an adjustment mechanism, etc.

[0086] 53 and 54, respiratory treatment device 400 includes a housing 402 having a front portion 401, a middle portion 403, and a rear portion 405. Similar to the OPEP devices described above, housing 402 is openable to provide access to the contents of housing 402 for cleaning and / or selectively replacing or adjusting the components contained therein to maintain optimal operating conditions. Housing 402 further includes a first opening 412, a second opening 413, and a third opening 415.

[0087] 53 and 54 in association with the mouthpiece 409, the first opening 412 may alternatively be associated with other user interfaces, such as a gas mask or a breathing tube. The second opening 413 includes a one-way exhalation valve 490 configured to allow exhaled air exhaled into the housing 402 to exit the housing 402 upon exhalation at the first opening 412. The third opening 415 includes a one-way inhalation valve 484 configured to allow air outside the housing 402 to enter the housing 402 upon inhalation at the first opening 412. As shown in more detail in FIG. 54, the respiratory treatment device 400 further includes a manifold plate 493 having an exhalation passageway 494 and an inhalation passageway 495. A one-way valve 491 is adapted to be mounted within the manifold plate 493 adjacent an exhalation passageway 494 so as to open in response to exhalation air being exhaled into the first opening 412 and close in response to inhalation air being inhaled through the first opening 412. A separate one-way valve 492 is adapted to be mounted within the manifold plate 493 adjacent an inhalation passageway 495 so as to close in response to exhalation air being exhaled into the first opening 412 and open in response to inhalation air being inhaled through the first opening 412. The respiratory treatment device 400 further includes a throttle member 430 and vanes 432 operably connected by a shaft 434, the assembly of which may be adapted to operate in the same manner as described with respect to the OPEP device disclosed above.

[0088] 55 and 56, which are cross-sectional perspective views taken along lines I and II of FIG. 53, respectively. The respiratory treatment device 400 performs oscillatory pressure therapy during both inspiration and expiration in a manner similar to that shown and described above with respect to the OPEP device. As described in more detail below, the OPEP device 400 includes multiple (i.e., more than one) chambers. Air delivered through the first opening 412 of the housing 402, whether inhaled or exhaled, traverses at least a portion of a flow path past a restrictor member 430 housed in the first chamber 414 and through a second chamber 418 housing a vane 432 operatively connected to the restrictor member 430. In this regard, at least a portion of the flow paths overlap and are in the same direction for both exhaled air exhaled into the first opening 412 and inhaled air inhaled from the first opening 412.

[0089] For example, an exemplary flow passage 481 is shown in dashed lines in FIGS. 55 and 56. Similar to previously described OPEP devices, the throttle member 430 is disposed within the first chamber 414 and is movable relative to the chamber inlet 404 between a closed position in which airflow through the chamber inlet 404 is throttled and an open position in which airflow through the chamber 404 inlet is less throttled. After passing through the chamber inlet 404 and into the first chamber 414, the exemplary flow passage 481 rotates 180 degrees and reverses its longitudinal direction (i.e., the flow passage 481 turns back) where the exemplary flow passage 481 passes through an orifice 438 and enters the second chamber 418. Similar to previously described OPEP devices, the vane 432 is disposed within the second chamber 418 and is moved back and forth between a first position and a second position in response to increasing pressure adjacent the vane such that the operably connected throttle member 430 is repeatedly moved between the closed and open positions. Air flowing along example flow path 481 is directed to either first chamber outlet 406 or second chamber outlet 408 depending on the position of vanes 432. As a result, the pressure at chamber inlet 404 oscillates as inhalation or exhalation passes through example flow path 481.

[0090] Oscillatory pressure at the chamber inlet 404 is efficiently transmitted through the series of chambers and returned to a user of the respiratory treatment device 400, i.e., through the first opening 412. As can be seen in Figures 55 and 56, the respiratory treatment device includes a first additional chamber 496, a second additional chamber 497, and a third additional chamber 498, as described in more detail below.

[0091] The mouthpiece 409 and a first additional chamber 496 communicate through a first opening 412 in the housing 402. The first additional chamber 496 and a second additional chamber 497 are separated by a manifold plate 493 and communicate through an exhalation passage 494. A one-way valve 491 mounted adjacent to the exhalation passage 494 is configured to open in response to exhaled air being exhaled into the first opening 412 and to close in response to inhaled air being inhaled through the first opening 412.

[0092] A first additional chamber 496 and a third additional chamber 498 are also separated by a manifold plate 493 and communicate with each other via an inhalation passage 495. A one-way valve 492 mounted adjacent to the inhalation passage 495 is configured to close in response to exhaled air being exhaled into the first opening 412 and to open in response to inhaled air being inhaled through the first opening 412.

[0093] The air surrounding the respiratory treatment device 400 and the second additional chamber 497 are in communication through a third opening 415 in the housing 402. The one-way valve 484 is configured to close in response to air being exhaled into the first opening 412 and to open in response to air being inhaled through the first opening 412.

[0094] The third additional chamber 498 is in communication with the air surrounding the respiratory treatment device 400 via a second opening 413 in the housing 402. A one-way valve 490 mounted adjacent the second opening 413 is configured to open in response to exhaled air being exhaled into the first opening 412 and to close in response to inhaled air being inhaled through the first opening 412. The third additional chamber 498 is further in communication with the second chamber 418 via the first chamber outlet 406 and the second chamber outlet 408.

[0095] 57-58, cross-sectional perspective views taken along lines I and II, respectively, of FIG. 53 depict an exemplary exhalation flow path 410 formed between the first opening 412 or mouthpiece 409 and the second opening 413. Generally, upon exhalation by a user into the first opening 412 of the housing 402, pressure increases in the first additional chamber 496, causing the one-way valve 491 to open and the one-way valve 492 to close. Exhaled air then passes through the exhalation passage 494 into the second additional chamber 497, causing the pressure in the second additional chamber 497 to increase, causing the one-way valve 484 to close and the throttling member 430 to open. The exhaled air then passes through the chamber inlet 404 into the first chamber 414, reverses its longitudinal direction, and accelerates through the orifice 438 separating the first chamber 414 and the second chamber 418. The exhaled air then exits the second chamber 418 through either the first chamber outlet 406 or the second chamber outlet 408, depending on the orientation of the vanes 432, and enters the third additional chamber 498. As pressure increases in the third additional chamber 498, the one-way valve 490 opens, allowing the exhaled air to exit the housing 402 through the second opening 413. Once the flow of exhaled air along the exhalation flow path 410 is established, the vanes 432 are moved back and forth between the first and second positions, and the restrictor member 430 is moved between the closed and open positions as described above with respect to the OPEP device. The respiratory treatment device 400 thereby provides vibrational therapy during exhalation.

[0096] 59-60, another cross-sectional perspective view taken along lines I and II, respectively, of FIG. 53 illustrates an example inhalation flow path 499 formed between the third opening 415 and the first opening 412 or mouthpiece 409. Generally, when a user inhales through the first opening 412, pressure drops in the first additional chamber 496, one-way valve 491 closes, and one-way valve 492 opens. As air is drawn from the third additional chamber 498 through the inhalation passageway 495 and into the first additional chamber 496, pressure within the third additional chamber 498 begins to drop, causing one-way valve 490 to close. As pressure continues to drop in the third additional chamber 498, air is drawn from the second chamber 418 through the first chamber outlet 406 and the second chamber outlet 408. As air is drawn from the second chamber 418, air is also drawn from the first chamber 414 through an orifice 438 connecting the second chamber 418 and the first chamber 414. As air is drawn from the first chamber 414, air is also drawn from the second additional chamber 497 through the chamber inlet 404, reducing the pressure in the second additional chamber 497 and opening the one-way valve 484, thereby allowing air to enter the housing 402 through the third opening 415. The pressure difference between the first additional chamber 496 and the second additional chamber 497 keeps the one-way valve 491 closed. Once inhalation flow along the inhalation flow path 499 is established, the vane 432 reciprocates between the first and second positions and the restrictor member 430 is moved between the closed and open positions as described above with respect to the OPEP device. The respiratory treatment device 400 thereby provides vibration therapy during inhalation.

[0097] Respiratory muscle training The RMT includes a pressure threshold resistor that requires the user to achieve and maintain a set pressure to inhale or exhale through the pressure threshold resistor and / or an attached breathing device. Generally, the pressure threshold resistor includes a one-way valve that is biased toward a closed position. When the pressure caused by the user breathing in through or out into the device overcomes the bias, the valve opens, allowing inhalation or exhalation. To continue inhalation or exhalation, the user must generate and maintain a pressure that meets or exceeds the pressure threshold that overcomes the bias on the valve. The pressure threshold resistor can be used to generate a negative pressure during inhalation for the performance of the RMT, and a positive pressure during exhalation for the performance of the RMT.

[0098] The RMT further includes a flow resistor. The flow resistor restricts the flow of air through it and / or an attached breathing device during inspiration or expiration to generate negative or positive pressure for RMT implementation. Generally, the flow resistor restricts the flow of air through an orifice. The pressure generated by the flow resistor can be controlled by changing the size of the orifice and / or the inhalation or exhalation flow rate.

[0099] Pressure Threshold Resistor 61A-61E, there are shown perspective, side, top, cross-sectional and exploded views of a pressure threshold resistor 500. Generally, as shown in FIGs. 61D and 61E, the pressure threshold resistor 500 includes a spring seat 501, a spring 502, an adjuster 503, a connector 504, and a valve 505.

[0100] Connector 504 may be shaped and sized to be releasably connectable to the inhalation port of any number of respiratory devices, including, for example, inhalation port 311 of OPEP device 300. Connector 504 may be adapted to be releasably connectable to the respiratory device by any suitable means, including friction fit, threaded fit, snap fit, etc.

[0101] A central cylinder 509 of the connector 504 is configured to receive the adjuster 503 by threaded engagement. An end of the central cylinder 509 also serves as a seat for the valve 505.

[0102] The adjuster 503 functions as a thumb screw and is adapted for threaded engagement with the connector 504. The adjuster 503 can then be rotated by a user relative to the connector 504 to raise or lower the position of the adjuster 503 relative to the connector 504. As discussed below, the adjuster 503 may be selectively rotated by a user to increase or decrease the threshold pressure required to open the valve 505. The adjuster 503 further includes a central cylinder 506 sized to slidingly engage the spring 502. The central cylinder 506 further includes an interior sized to slidingly engage a post 508 of the valve 505. The base of the central cylinder 506 serves as a stop for the spring 502.

[0103] Valve 505 includes a valve face 507 and a post 508. Valve face 507 is configured to engage a seat defined by an end of a cylinder 509 of connector 504. As described above, post 508 is configured to fit within and slidingly engage a central cylinder 506 of adjuster 503. An end of post 508 is connected to spring seat 501. In an alternative embodiment, an end of post 508 may be removably connected to spring seat 501.

[0104] Spring seat 501 is shaped and sized to fit within adjuster 503. Generally, spring seat 501 is cylindrical and includes an interior that receives spring 502 and post 508 of valve 505. The base of the interior of spring seat 501 also serves as a stop for spring 502.

[0105] Spring 502 may be a coil spring. Springs of different lengths and different spring constants (k) may be selected and / or substituted as desired to increase or decrease the threshold pressure required to open valve 505. When assembled into pressure threshold resistor 500 as shown, spring 502 is in a compressed state.

[0106] In operation, pressure threshold resistor 500 is connected to the inhalation port of the breathing apparatus via connector 504. When a user breathes in through the breathing apparatus, negative pressure is created at the inhalation port. The negative pressure necessarily creates a force pulling on valve face 507 of valve 505. However, because valve 505 and valve face 507 are biased towards the closed position by spring 502 (via post 508 and spring seat 501), they remain closed until a threshold pressure is reached that opens valve 505. As the user continues to breathe, or breathes harder, the negative pressure created at the inhalation port increases until the threshold pressure is reached, at which point valve face 507 is pulled away from its seat formed by central cylinder 509 of connector 504, opening valve 505. Once valve 505 is open, the user can inhale air around pressure threshold resistor 500 and the breathing apparatus as long as the negative pressure created at the inhalation port by the user's inhalation maintains or exceeds the threshold pressure required to open valve 505. If the user stops breathing or the negative pressure created by the user's inhalation drops below the threshold pressure, the biasing force of spring 502 closes valve 505.

[0107] 62A-62B and 63A-63B are side and cross-sectional views of pressure threshold resistor 500, further illustrating the selective adjustment of the pressure threshold required to open valve 505. FIGS. 62A and 63A depict pressure threshold resistor 500 at a "low setting," while FIGS. 62B and 63B depict pressure threshold resistor 500 at a "high setting." Pressure threshold resistor 500 may be selectively adjusted between a low setting, shown in FIG. 62A, and a high setting, shown in FIG. 62B, by rotating adjuster 503 relative to connector 504. As shown in FIGS. 63A and 63B, rotating adjuster 503 effectively increases the compression of spring 502, thereby increasing the bias of spring 502 acting on valve 505. Naturally, the pressure threshold required to open valve 505 also increases. This allows the pressure threshold to be selectively adjusted by the user.

[0108] As previously mentioned, the pressure threshold resistor 500 can be connected to the inhalation port of any number of breathing devices, including, for example, the inhalation port 311 of the OPEP device 300 shown in Figures 64A-64D. The operation of the OPEP device 300 together with the pressure threshold resistor 500 is illustrated in Figures 64C-64D. Generally, when a user exhales into the OPEP device 300, the one-way valve 384 remains closed due to positive exhalation pressure, forcing the exhaled air along the exemplary flow path shown in dashed lines in Figure 64C through the OPEP device 300 for delivery of OPEP therapy. On the other hand, when a user inhales, the one-way valve 384 opens due to negative inhalation pressure. At the same time, the orifice of the variable nozzle 336, described above with respect to the OPEP device 300, closes due to the negative inhalation pressure. With the orifice of the variable nozzle 336 closed and the one-way valve 384 open, as the user continues to inhale or inhale more forcefully, the negative pressure created at the inhalation port 311 increases until a pressure threshold is reached, at which point the valve 505 of the threshold pressure resistor 500 opens, allowing air around the pressure threshold resistor 500 and the OPEP device 300 to flow along an exemplary flow path shown by the dashed line in FIG. 64D.

[0109] The pressure threshold resistor 500, as well as other RMT devices disclosed herein, may also be sized and shaped for use with other respiratory treatment devices. By way of example only, Figures 65A-65B show a pressure threshold resistor 500 connected to the inhalation port of an OPEP device 599 commercially available under the trade name ACAPELLA® from Smith Medical, Inc., St. Paul, Minnesota, and described in U.S. Patent Nos. 6,776,159 and 7,059,324, which are incorporated herein by reference in their entireties. The RMT devices disclosed herein may also be used with the OPEP devices described in U.S. Patent Application No. 13 / 489,894, filed June 6, 2012, U.S. Patent No. 9,358,417, and pending U.S. Patent Application No. 14 / 092,091, filed November 27, 2013, which are incorporated herein by reference in their entireties.

[0110] 66A-66E, side and cross-sectional views of another embodiment of a pressure threshold resistor 520 are shown. The pressure threshold resistor 520 is shaped and sized to be removably connected to an inhalation port of a respiratory device, including, for example, the inhalation port 311 of the OPEP device 300. The pressure threshold resistor 520 may also be shaped and sized to be removably connected to an exhalation port of a respiratory treatment device, including, for example, those shown and described below with respect to the OPEP device 700. The pressure threshold resistor 520 may be adapted to be removably connected to a respiratory device by any suitable means, including friction fit, threaded fit, snap fit, and the like. Generally, the pressure threshold resistor 520 includes a housing 521 having a first portion 522 and a second portion 523, a spring seat 524, a spring 525, and a valve 526 having a valve face 528.

[0111] The first portion 522 and the second portion 523 of the housing 521 are detachably connected to one another by a threaded engagement. Furthermore, the relative position of the first portion 522 with respect to the second portion 523 may be selectively increased or decreased by rotating the first portion 522 with respect to the second portion 523. As described below, one portion of the housing 521 may be rotated with respect to another portion of the housing 521 to selectively increase or decrease the threshold pressure required to open the valve 526 of the pressure threshold resistor 520. The first portion 521 further includes a valve seat 527, while the second portion 523 further includes a spring seat 524 that functions as a stop for the spring 525.

[0112] Pressure threshold resistor 520 functions in a similar manner to pressure threshold resistor 500, except that pressure threshold resistor 520 is configured to provide the RMT during exhalation or inhalation. As noted above, pressure threshold resistor 520 is connectable to the exhalation port of any number of breathing devices. A first portion 522 of pressure threshold resistor 520 is connected to the exhalation port of the breathing device to provide the RMT during exhalation.

[0113] As shown in FIG 66B, when the user exhales into the breathing apparatus, creating a positive exhalation pressure at the exhalation port of the breathing apparatus, the positive pressure creates a force pushing against the valve face 528 of the valve 526. However, because the valve 526 and valve face 528 are also biased toward the closed position by the spring 525, they remain closed until the pressure threshold required to open the valve 526 is reached. As the user continues to exhale or exhale more forcefully, the positive pressure created at the exhalation port increases until the pressure threshold is reached, at which point the valve 526 is pushed away from the valve seat 527 formed in the first portion 522 of the housing 521, opening the valve 526 as shown in FIG 66C. Once the valve 526 is open, the user may exhale through the pressure threshold resistor 520 and the breathing apparatus as long as the positive pressure created at the exhalation port by the user's exhalation maintains or exceeds the threshold pressure required to open the valve 526. Once the user stops exhaling or the positive pressure created by the user's exhalation drops below the threshold pressure, the biasing force of spring 525 closes valve 526 as shown in FIG. 66B.

[0114] The pressure threshold resistor 520 can further be connected to the inhalation port of a number of breathing devices. To provide the RMT upon inhalation, a second portion 523 of the pressure threshold resistor 520 is connected to the inhalation port of the breathing device. As shown in FIG. 66D, when the user draws air into the breathing device, creating a negative inhalation pressure at the inhalation port of the breathing device, the negative pressure creates a force pulling on the valve 526. However, because the valve 526 is biased toward a closed position by the spring 525, it remains closed until a pressure threshold required to open the valve 526 is reached. As the user continues to inhale or inhale more strongly, the negative pressure created at the inhalation port increases until the pressure threshold is reached, at which point the valve 526 is pulled away from the valve seat 527 formed in the first portion 522 of the housing 521, and the valve 526 opens, as shown in FIG. 66E. Once valve 526 is open, the user can inhale air around the respiratory apparatus through pressure threshold resistor 526 and the respiratory apparatus as long as the negative pressure created at the inhalation port by the user's inhalation maintains or exceeds the threshold pressure required to open valve 526. If the user stops breathing or the negative pressure created by the user's inhalation drops below the threshold pressure, the biasing force of spring 525 closes valve 526 as shown in FIG.

[0115] 67A-67B and 68A-68B are side and cross-sectional views of pressure threshold resistor 520 further illustrating the selective adjustment of the pressure threshold required to open valve 526. FIGS. 67A and 68A depict pressure threshold resistor 520 at a "high setting," while FIGS. 67B and 68B depict pressure threshold resistor 520 at a "low setting." Pressure threshold resistor 500 may be selectively adjusted between a high setting, shown in FIG. 67A, and a low setting, shown in FIG. 67B, by rotating first portion 522 of housing 521 relative to second portion 523 of housing 521. As shown in FIGS. 68A and 68B, rotating first portion 522 of housing 521 relative to second portion 523 of housing 521 effectively reduces the compression of spring 525, reducing the bias of spring 525 acting on valve 526. Naturally, this also reduces the pressure threshold required to open valve 526. This allows the pressure threshold to be selectively adjustable by the user.

[0116] Flow Resistor 69A-69E, there are shown perspective and cross-sectional views of a flow resistor 550. As with the pressure threshold resistor 520, the flow resistor 550 can be shaped and sized to be releasably connectable to the inhalation or exhalation ports of any number of breathing devices, including the inhalation port 311 of the OPEP device 300. The flow resistor 550 may be adapted to be releasably connectable to the breathing device by any suitable means, including friction fit, threaded engagement, snap fit, and the like.

[0117] Generally, the flow resistor 550 includes a housing 551 having a first portion 552 and a second portion 553, a one-way valve 554, and at least one orifice (opening) 555. The first portion 552 of the housing 551 is connectable to a breathing apparatus. The one-way valve 554 is disposed in the first portion 552 of the housing 551. If the flow resistor 550 is to be used during inspiration, the one-way valve 554 will be positioned to open toward the first portion 552 of the housing 551 during inspiration, as shown in Figures 69B-69C. If the flow resistor 550 is to be used during expiration, the one-way valve 554 will be positioned to open toward the second portion 553 of the housing 551 during expiration, as shown in Figures 69D-69E. The first portion 552 of the housing 551 has one or more orifices 555 formed therein.

[0118] A first portion 552 of the housing 551 is removably connected to a second portion 553 of the housing 551 by a threaded engagement. The position of the first portion 552 relative to the second portion 553 may be selectively increased or decreased by rotating the first portion 552 relative to the second portion 553. As described below, one portion of the housing 551 may be rotated relative to another portion of the housing 551 to selectively increase or decrease resistance to the flow of air through the flow resistor 550.

[0119] In operation, the flow resistor 550 throttles the flow of air through the orifice(s) 555 of the flow resistor 550. As shown in FIGURE 69B, during inspiration, negative pressure is created in the first portion 552 of the housing 551, causing the one-way valve 554 to open towards the first portion 552, allowing air around the flow resistor 550 and the attached breathing apparatus to pass through the one or more orifices 555. Throttle the flow of air through the flow resistor 550, and thus the attached breathing apparatus, results in a greater negative inspiration pressure within the attached breathing apparatus. As shown in Fig. 69C, the flow resistor 550 may be selectively adjusted to increase or decrease the restriction to the air flow through one or more orifices 550, and thus the negative inhalation pressure of an attached breathing apparatus, by rotating a first portion 552 of the housing 551 relative to a second portion 553 of the housing 551, thereby incrementally increasing or decreasing the cross-sectional area of ​​the orifice(s) 550. In Fig. 69B, the flow resistor 550 is in a low airflow and high inhalation pressure configuration. In Fig. 69C, the flow resistor 550 is in a high airflow and low inhalation pressure configuration.

[0120] As shown in FIG. 69D, during exhalation, positive pressure is created in the first portion 552 of the housing 551, causing the one-way valve 554 to open towards the second portion 553, allowing air in the attached breathing apparatus to flow through the flow resistor 550 and out of the one or more orifices 555. Restricting the flow of air through the flow resistor 550, and thus the attached breathing apparatus, results in greater positive exhalation pressure in the attached breathing apparatus. As shown in FIG. 69E, the flow resistor 550 may be selectively adjusted to increase or decrease the restriction to the flow of air through the one or more orifices 555, and thus the positive exhalation pressure of the attached breathing apparatus, by rotating the first portion 552 of the housing 551 relative to the second portion 553 of the housing 551, thereby incrementally increasing or decreasing the cross-sectional area of ​​the orifice(s) 555. In FIG. 69D, the flow resistor 550 is in a low airflow and high exhalation pressure configuration. In FIG. 69E, flow resistor 550 is in a high airflow and low exhalation pressure configuration.

[0121] 70A-70C, perspective, cross-sectional, and front views of a flow resistor 570 according to another embodiment are shown. Generally, the flow resistor 570 includes a housing 571 having a first portion 576 and a second portion 577, a one-way valve 572, a throttle plate 573, and an adjustment ring 574. The housing 571 is generally tubular. The one-way valve 572, like the one-way valve 384, includes a flap configured to open with negative or positive pressure depending on the direction of air flow. The one-way valve 572 differs from the one-way valve 384 in that the flap is shaped and sized to cover only a portion of the interior cross-sectional area of ​​the tubular housing 571. As shown, the flap may be in the shape of a semicircle. The throttle plate 573 is disposed within the housing 571 adjacent to the one-way valve 572 and is shaped and sized to cover only a portion of the interior cross-sectional area of ​​the tubular housing 571. As shown, the throttle plate 573 may also be semicircular in shape. The throttle plate 573 is connected to an adjustment ring 574, both of which are selectively rotatable relative to the housing 571. This allows the adjustment ring 574 and throttle plate 573 to be rotated relative to the housing 571 to increase or decrease the cross-sectional area of ​​the orifice 575 formed in the tubular housing 571. In the embodiment shown in Figures 70B-70C, the one-way valve 572 and throttle plate 573 are both semicircular in shape, so that the cross-sectional area of ​​the orifice 575 can be selectively adjusted from a low setting, where the one-way valve 572 and throttle plate 573 are fully aligned, leaving a semicircular orifice 575, to a high setting, where the one-way valve 572 and throttle plate 573 are positioned opposite each other, completely covering the interior cross-sectional area of ​​the tubular housing 571, thereby generally closing off the orifice 575.

[0122] Similar to flow resistor 550, flow resistor 570 may be adapted to connect to an inhalation or exhalation port of a breathing apparatus, including, for example, inhalation port 311 of OPEP device 300. Flow resistor 570 may be adapted to be removably connected to the breathing apparatus by any suitable means, including friction fit, threaded fit, snap fit, etc. A first portion 576 of housing 571 may be adapted to connect to an inhalation port of a breathing apparatus, while a second portion 577 of housing 571 may be adapted to connect to an exhalation port of a breathing apparatus. Flow resistor 570 otherwise operates in the same manner as described above with respect to flow resistor 550.

[0123] However, flow resistor 570 differs from flow resistor 550 in that flow resistor 570 may also be attached to a mouthpiece or inlet of a respiratory treatment device, including, for example, OPEP device 300, as shown in FIG. 71. Flow resistor 550 may be selectively adjusted to maintain orifice 575 unobstructed by one-way valve 572 or restrictor plate 573, such that flow resistor 550 may be used at the mouthpiece or inlet of a respiratory treatment device to perform RMT during either inspiration or expiration. However, if flow resistor 550 is selectively adjusted such that one-way valve 572 and restrictor plate 573 are opposite each other and completely cover the cross-sectional area of ​​tubular housing 571, thereby eliminating orifice 575, exhalation is completely prevented, thereby preventing use of the attached respiratory device.

[0124] Combined implementation of RMT and OPEP 72A-72C, 73A-73F, and 74A-74E, a combined RMT and OPEP device 600 is shown. FIGS. 72A-72C show isometric, front, and side views of device 600. FIGS. 73A-73F show full and partial cross-sectional views of device 600, illustrating the combined delivery of RMT and OPEP therapy during exhalation. FIGS. 74A-74E show full and partial cross-sectional views of device 600, illustrating the combined delivery of RMT and OPEP therapy during inhalation.

[0125] Device 600 is similar to OPEP device 400 in that device 600 is configured to deliver OPEP therapy during both exhalation and inhalation. Although the shape and configuration of device 600 differs from that of OPEP device 400, the general components for delivering OPEP therapy are otherwise the same. However, device 600 replaces one-way exhalation valve 490 of OPEP device 400 with pressure threshold resistor 520A configured to provide RMT during exhalation, and replaces one-way inhalation valve 484 with pressure threshold resistor 520B configured to provide RMT during inhalation. Alternatively, pressure threshold resistors 520A and 520B may be replaced with flow resistors, such as flow resistor 550.

[0126] Similar to the OPEP device 400, the device 600 includes a housing 602 that includes a first opening 612 (mouthpiece), a second opening 613 (exhalation port), and a third opening 615 (inhalation port). Although the first opening 612 is shown as a mouthpiece, the first opening 612 may alternatively be associated with another user interface, such as a gas mask or a breathing tube. As described above, a pressure threshold resistor 520A is connected to the device 600 at the second opening 613 (exhalation port) to provide the RMT upon exhalation at the first opening 612, while a pressure threshold resistor 520B is connected to the device 600 at the third opening 615 (inhalation port) to provide the RMT upon inhalation at the first opening 612.

[0127] The device 600 further includes a manifold plate 693 having an exhalation passage 694 and an inhalation passage 695. A one-way valve 691 is mounted within the manifold plate 693 adjacent the exhalation passage 694 and adapted to open in response to exhalation air being exhaled into the first opening 612 and to close in response to inhalation air being inhaled through the first opening 612. A separate one-way valve 692 is mounted within the manifold plate 693 adjacent the inhalation passage 695 and adapted to close in response to exhalation air being exhaled into the first opening 612 and to open in response to inhalation air being inhaled through the first opening 612. Although the one-way valves 691 and 692 are shown as separate components, they could also be designed as a single piece having two flaps adapted to fit within the manifold plate 693.

[0128] The device 600 further includes a throttling member 630 and vanes 632 operatively connected by a shaft 634, and the assembly may be adapted to operate in a similar manner as described above with respect to the previously disclosed OPEP device and variable nozzle 636. The device further includes a plurality of chambers. Air delivered through the first opening 612 of the housing 602, whether inhaled or exhaled, passes at least in part through a flow path that passes past the throttling member 630 housed in the first chamber 614 and through a second chamber 618 that houses vanes 632 operatively connected to the throttling member 630. In this regard, at least a portion of the flow paths overlap and are in the same direction for both exhaled air exhaled into the first opening 612 and inhaled air inhaled from the first opening 612.

[0129] 73A-73F, the operation of the device 600 will now be described during an exhalation period. When the user exhales into the first opening 612, the exhaled air enters the diversion chamber 638. In the diversion chamber 638, the positive exhalation pressure generated by the exhaled air keeps the one-way valve 692 in a closed position while pushing the one-way valve 691 open to allow the exhaled air to enter the third chamber 640. The third chamber 640 is in fluid communication with the third opening 615 (the inhalation port) and with the first chamber 614 via opening 642. The pressure threshold resistor 520B is inserted into the third opening 615 and configured to provide the RMT upon inhalation, so that the third chamber 640 directs the exhaled air to flow through opening 642 into the first chamber 614. As exhaled air flows through the first chamber 614, past the restrictor member 630, through the variable nozzle 636, and past the vanes 632 in the second chamber 618, rotation of the vanes 632 causes rotation of the restrictor member 630 to deliver OPEP therapy as described above with respect to the OPEP device previously described.

[0130] The exhaled air then exits the second chamber 618 through a pair of openings 644 and flows into a fourth chamber 646. The fourth chamber is further in fluid communication with a fifth chamber 648 through an opening 650. The fifth chamber is itself in fluid communication with a one-way valve 629 and a pressure threshold resistor 520A that is connected to the device 600 through a second opening 613 (the exhalation port). At this point, the positive exhalation pressure in the diversion chamber 638 is greater than the positive exhalation pressure in the fifth chamber 648, keeping the one-way valve 692 closed and preventing exhaled air from re-entering the diversion chamber 638. The exhaled air in the fifth chamber 648 is directed to exit the device 600 through the second opening 613 and the pressure threshold resistor 520A for the implementation of RMT.

[0131] 74A-74F, the operation of the device 600 will now be described during inspiration. When the user inhales through the device 600 through the first opening 612, a negative inspiration pressure is created in the diversion chamber 638, which pulls open the one-way valve 692 while maintaining the one-way valve 691 in a closed position. As the user continues to inhale with the one-way valve 692 open, a negative inspiration pressure is created in the fifth chamber 648. The fifth chamber is in fluid communication with a pressure threshold resistor 520A connected to the device 600 through a second opening 613 (the exhalation port) and is in fluid communication with the fourth chamber 646 through an opening 650. Because the pressure threshold resistor 520A is configured to perform RMT upon exhalation, the negative inspiration pressure is delivered through the opening 650 to the fourth chamber 646 and, consequently, to the second chamber 618. The negative inhalation pressure in the second chamber 618 draws open the variable nozzle 636, thereby sending negative pressure to the first chamber 614, past the restrictor member 630, and into the third chamber 640 through the opening 642. The third chamber 640 is in fluid communication with the one-way valve 691 and the pressure threshold resistor 520B. At this point, the negative exhalation pressure in the diversion chamber 638 is greater than the negative exhalation pressure in the third chamber 640, keeping the one-way valve 691 closed and preventing the inhaled air from re-entering the diversion chamber 638. The negative inhalation pressure in the third chamber 640 is directed to draw air into the device 600 through the third opening 615 and the pressure threshold resistor 520B for the implementation of RMT.

[0132] As the user continues to inhale and reaches the pressure threshold, air flows through pressure threshold resistor 520B and into device 600, and along the subsequent inhalation flow path, inhaled air first enters third chamber 640, then through opening 642 into first chamber 614, past restrictor 630, through variable nozzle 636 into second chamber 618, past vanes 632 into fourth chamber 646, through opening 650 into fifth chamber 648, through inhalation passageway 695 into split chamber 638, and then out first opening 612. As inhaled air flows through first chamber 614, past restrictor 630, through variable nozzle 636, through second chamber 618, and past vanes 632, rotation of vanes 632 causes rotation of restrictor 630 for delivery of OPEP therapy, as described above in connection with the previously described OPEP device. This allows the device 600 to provide RMT and OPEP therapy during both inspiration and expiration.

[0133] The foregoing description has been provided for purposes of illustration and description, and is not intended to be exhaustive or to limit the invention to the precise form disclosed. Those skilled in the art will recognize that the invention is susceptible to many variations and modifications that are within the scope of the appended claims. [Explanation of symbols]

[0134] 100 OPEP (Oscillatory Positive Pressure) Device 101 Front part of housing 102 Housing 103 Housing middle part 104 Room entrance 105 Rear part of housing 106 Room 1 exit 108 2nd room exit 109 Mouthpiece 110 Exhalation channel 114 Room 1 116 room passage 118 Room 2 120 Guide Wall 122 Stopper 124 seats 126 Upper Bearing 128 Lower Bearing 130 Squeezing member 132 Feather 134 Shaft 136 Variable Nozzle 138 Orifice 140 Nearly circular surface of the aperture member 142 Edge of a nearly circular surface 144 Center of nearly circular surface 146 Upper and lower walls of variable nozzle 148 Variable Nozzle Sidewall 150 Variable nozzle V-shaped slit 152 Lip 200 OPEP equipment 201 Front part of housing 202 Housing 203 Middle part of housing 204 Room entrance 205 Rear part of housing 206 Room 1 exit 208 2nd room exit 209 Mouthpiece 210 Exhalation channel 211 Inhalation port 214 Room 1 218 Room 2 222 Stopper 224 seats 226 Upper Bearing 228 Lower Bearing 230 Squeezing member 231 Pin 232 Feather 236 Variable Nozzle 238 Orifice 246 Upper and lower walls of variable nozzle 248 Variable Nozzle Sidewall 252 Lip 253 Adjustment mechanism 254 Adjustment Dial 255 Shaft 256 frames 258 Adjustment dial protrusion 260 Rear of adjustment dial 262 Key part 264 Axial hole 266 Rotation lock part 268, 288 Stopper 269 ​​Opening 270 Seal Edge 271 Flexible Cylinder 300 OPEP equipment 301 Front part of housing 302 Housing 303 Inner casing 304 Room entrance 305 Rear housing 306 Room 1 exit 308 2nd room exit 309 Mouthpiece 310 Exhalation channel 311 Inhalation port 314 Room 1 318 Room 2 322 Stopper 324 seats 326 Upper Bearing 328 Lower Bearing 330 Squeezing parts 332 Feather 334 Shaft 336 Variable Nozzle 338 Orifice 340 Surface of the drawing part 353 Adjustment mechanism 354 Adjustment dial, arm 356 frames 365 Hole in aperture member 370 Seal edge 371 Flexible Cylinder 384 One-way valve 385 One end of casing, upper bearing 386 Lower Bearing 387 Substrate 388 Pillars 389 Flap 400 OPEP equipment 401 Front part of housing 402 Housing 403 Housing middle part 404 Room entrance 405 Rear housing 408 2nd room exit 409 Mouthpiece 410 Exhalation channel 412 First Opening 413 Second Opening 414 Room 1 415 3rd Opening 418 Room 2 430 Squeezing parts 432 Feather 434 Shaft 438 Orifice 481 Flow Path 484 One-way intake valve 490 One-way exhalation valve 491, 492 One-way valve 493 Manifold plate 494 Breathing passageway 495 Inhalation Passage 496 1st additional room 497 2nd additional room 498 Third additional room 499 Inhalation channel 500 Pressure Threshold Resistor 501 Spring seat 502 Spring 503 Adjuster 504 Connector 505 Valve 506 Central Cylinder 507 Valve face 508 Pillars 509 Central Cylinder 520, 520A, 520B Pressure Threshold Resistors 521 Housing 522 Part 1 523 Part 2 524 Spring seat 525 Spring 526 Valve 527 Valve seat 528 Valve face 550 Flow Resistor 551 Housing 552 Part 1 553 Part 2 554 One-way valve 555 Orifice 570 Flow Resistor 571 Housing 572 One-way valve 573 Aperture plate 574 Adjustment Ring 575 Orifice 576 Part 1 577 Part 2 599 OPEP equipment 600 RMT and OPEP combined equipment 602 Housing 612 First opening 613 Second Opening 614 Room 1 615 Third Opening 618 Room 2 630 Squeezing parts 632 Feather 634 Shaft 636 Variable Nozzle 638 Diversion room 640 Room 3 642 Opening 644 Opening 646 Room 4 648 Room 5 650 opening 691 One-way valve 692 One-way valve 693 Manifold plate 694 Breathing passageway 695 Inhalation Passage

Claims

[Claim 1] A flow resistor shaped and sized to be removably connectable to an opening of an OPEP (oscillating positive expiratory pressure) device, a housing defining a conduit for the flow of air therethrough; a one-way valve disposed in the conduit adapted to open in response to air flow through the conduit in a first direction and to close in response to air flow through the conduit in a second direction; an opening in the conduit for air flow into or out of the conduit; Equipped with the housing having a first portion and a second portion, the position of the first portion relative to the second portion being selectively adjustable; A flow resistor wherein a cross-sectional area of ​​the opening is adjusted by selectively adjusting the first portion relative to the second portion.

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