High frequency oscillation respiratory therapy device

(54) Title: DEVICE AND SYSTEM

RESPIRATORY THERAPY (51) Int. Cl .: A61M 16/00; A61M 16/20 (30) Unionist Priority: 02/04/2007 US 60/921414 (73) Holder (s): ALLEGIANCE CORPORATION (72) Inventor (s): THOMAS J. DUNSMORE; THOMAS C. WILSCHKE; GEOFFREY C. WISE (74) Attorney (s): MOMSEN, LEONARDOS & CIA.

(86) International Application: PCT US2008059162 of 02/04/2008 (87) International Publication: WO

2008/122045 of 10/09/2008

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“RESPIRATORY THERAPY SYSTEM AND DEVICE” Cross Reference to Related Orders

This application claims priority under 35 USC §119 (e) (l) for US Serial Provisional Patent Application No. 60 / 291,414, filed on April 2, 2007, entitled, “Continuous High Frequency Oscillation Respiratory Therapy Device”, the teachings integers which are hereby incorporated by reference.

Background of the Invention

The present invention relates to respiratory therapy devices. More particularly, it relates to percussion breathing devices that deliver high frequency air pulses to a patient during the patient's inspiratory and expiratory cycles.

A wide variety of respiratory therapy devices are currently available to help, treat or improve a patient's respiratory health. For example, positive airway pressure (PAP) has long been recognized as an effective tool in promoting bronchial hygiene by facilitating improved oxygenation, increased lung volumes, and reduced venous return in patients with congestive heart failure. More recently, positive airway pressure has been recognized as useful in promoting mobilization and release of secretions (eg, mucus) from a patient's lungs. In this regard, positive airway pressure in the form of high frequency oscillation (HFO) in the patient's air column is a recognized technique that facilitates secretion removal. In general terms, HFO reduces sputum viscosity in vitro which, in turn, has a positive effect on simulated cough-induced release in vitro. HFO can be dispensed with or created by a force applied to the patient's chest wall (ie, physical chest therapy (CPT), such as an electrically operated block that vibrates against the patient's chest), or by applying forces directly to the patient's airway. (ie, breathing treatment, such as high-frequency airway swaying). Many patients and therapists prefer the breathing treatment approach as it is less obstructive and more easily administered. To this end, bronchial hygiene techniques from PAP have emerged as an effective alternative to CPT to expand the lungs and mobilize secretions.

Various treatment systems are available to provide the respiratory therapy described above (as well as other therapies and / or ventilation). For example, intrapulmonary percussion ventilation (IPV) therapy relates to HFO devices that dispense air pulses at the patient's airway opening. In general terms, an IPV system includes a hand held device establishing a patient breathing circuit to which a positive pressure gas source (eg, air, oxygen, etc.) is fluidly connected. The pressure source and / or the device additionally includes appropriate mechanisms (for example, control valves provided as part of an excitation unit apart from the hand held device) that effect intermittent gas flow in the patient breathing circuit, and so on. percussion ventilation of the patient's lungs. With this approach, the patient breathes through a mouthpiece that dispenses “mini-strokes” of high flow gas. During these percussion bursts, a continuous airway pressure above ambient is maintained, while the pulsatile percussion gas flow periodically increases airway pressure (for example, the gas flow cycles the dispensed pressure). Each percussion cycle can be programmed by the patient or therapist with certain systems, and can be used throughout both the inspiratory and expiratory phases of the breathing cycle. Examples of IPV devices include an IPV® fan device (from PercussionAire Corp. of Sandpoint, ID), IMP 2 ™ (from Breas Medical from Molnlycke, Sweden), and PercussiveNeb ™ System (from Vortran Medical Technology, Inc., from Sacramento, CA). Also, US Patent No. 7,191,780 describes an IPV type treatment apparatus, connectable to a source of pressurized gas, which requires a fixed covered venturi tube to deliver the desired therapy.

Due to the promising nature of IPV therapy devices, any improvement to known designs, such as increased performance, long-term reliability, reduced manufacturing costs, ease of operation, etc., will be welcomed.

summary

Some aspects according to the principles of the present exhibition relate to a respiratory therapy device including a housing, a flow diverter structure, a high-frequency pressure port (HF port), and a drag port. The housing defines a primary passageway having a patient interface side. The flow diverter structure is maintained by the housing in fluid communication with the primary passage opposite the patient interface side. In this regard, the flow diverter structure is characterized by the absence of a venturi tube. The HF orifice is maintained by the housing and is configured for fluid connection to an oscillatory gas flow source. In addition, the HF orifice is fluidly associated with the flow diverter structure. The drag hole is also maintained by the housing, is open to ambient air, and is fluidly associated with the flow diverter structure. With this construction, the device is configured such that the flow characteristics of gas flow from an external source are altered when interacting with the flow diverter structure to create a pressure drop to draw in ambient air through the drag port in delivering a therapy pressure percussion at the patient's side of the primary passage. In some embodiments, the HF orifice is connected or forms a nozzle having a nozzle end that confronts the flow diverter structure, with the flow diverter structure including a neck region forming a reduced-sized passageway immediately adjacent to the passageway primary. In other embodiments, the device additionally includes a continuous positive pressure orifice (CPP orifice) configured for fluid connection to a continuous positive pressure gas flow source. With this construction, the flow diverter structure moves in response to pressure pulses delivered by the HF port to affect gas flow from the CPP port to the primary passage. Alternatively, the CPP orifice may be the same orifice as the HF orifice in some constructions.

Other aspects according to the principles of the present exhibition are related to a respiratory therapy system including an oscillatory gas flow source and a respiratory therapy device. The respiratory therapy device includes the housing, flow diverter structure, HF port, and drag port as described above. The oscillatory gas flow source is fluidly connected to the HF orifice. During operation of the system, oscillatory gas flow from the source is dispensed to the respiratory therapy device and impacted by the flow diverter structure to cause ambient air entrainment with the pressure pulses dispensed next to the patient interface, and thus to the patient.

Still other aspects according to the principles of the present exhibition relate to a respiratory therapy device including a housing, a continuous positive pressure orifice (CPP orifice), a flow diverter structure, a high frequency pressure orifice (orifice). HF), and a drag hole. The housing defines a primary passageway having a patient interface side. The CPP orifice is maintained by the housing and is configured for fluid connection to a continuous positive pressure gas flow source. The flow diverter structure includes an obstruction body maintained movably within the housing, fluidly between the CPP orifice and the primary passage. The HF orifice is also maintained by the housing and is fluidly connected to the flow diverter structure. Additionally, the HF orifice is configured for fluid connection to an oscillatory gas flow source such that a pressure pulse delivered to the HF orifice causes movement of the obstruction body. Finally, the drag hole is maintained by the housing and is open to ambient air, with the drag hole being fluidly associated with the flow diverter structure. With the prior construction, the device is configured such that flow characteristics of gas flow from the CPP orifice are selectively altered in interaction with the obstruction body to deliver percussive pressure therapy alongside the patient interface of the primary passageway. In some embodiments, the obstruction body is movable longitudinally relative to a central axis of the CPP orifice. In other embodiments, the obstruction body is rotatably mounted within the housing.

Brief Description of Drawings

Figure 1 is a block diagram of a percussion respiratory therapy device according to aspects of the present exhibition;

Figure 2 is a simplified cross-sectional illustration, with schematically drawn portions, of an embodiment of a respiratory therapy device;

Figures 3 A and 3B are simplified cross-sectional illustrations, with portions drawn schematically, of an alternative configuration of the device in Figure 2 and showing use of this in generating percussion therapy;

Figure 4 is a simplified cross-sectional illustration, with schematically drawn portions, of another embodiment of a respiratory therapy device;

Figure 5 is a simplified cross-sectional illustration, with schematically drawn portions, of another embodiment of a respiratory therapy device;

Figures 6A and 6B are simplified cross-sectional illustrations, with portions schematically drawn, of another embodiment of a respiratory therapy device; and

Figures 7A and 7B are simplified cross-sectional illustrations, with schematically drawn portions, of another embodiment of a respiratory therapy device.

Detailed Description

General characteristics of a respiratory therapy device 20 according to aspects of the present exposure are shown in block form in Figure 1. In general terms, the respiratory therapy device 20 operates to deliver high-frequency pulses of air to a patient during inspiratory cycles and patient expiration when connected to an oscillatory gas flow source 22. In this regard, the oscillatory gas flow source 22 can take a variety of forms known in the art, and generally includes a flow stop valve or similar structure capable of generating an oscillatory flow of positive pressure gas (e.g., air, oxygen , etc.), such as that described in US Patent No. 4,805,613, the teachings of which are hereby incorporated by reference. In other embodiments, the therapy device 20 can be configured to establish an oscillatory flow by acting on a constant flow of gas such that the source 22 can be a source of constant gas flow. With this in mind, the respiratory therapy device 20 includes a housing 24 holding and / or forming various components such as a high frequency flow orifice (HF orifice) 26, one or more entrainment orifices 28, a flow diverter structure 30, one or more discharge openings 32, and a nozzle 34. In addition, the respiratory therapy device 20 may optionally include a constant positive pressure port (CPP port) 36 and / or a nebulizer port 38.

Details on the various components are provided below with respect to embodiments being described. In general terms, however, the flow diverter structure 30 as per the present disclosure can take a variety of forms as described below, and in some embodiments it is generally characterized as not being or including a venturi tube (fixed or sliding), where a “venturi tube” is defined to be a body including a nozzle section of gradually decreasing or converging diameter that extends to a throat, followed by a diffuser section of gradually increasing or expanding diameter. The flow diverter structure 30 is fluidly connected to a primary passage formed by the housing 24, as is the nozzle 34. The nozzle 34 serves as a patient interface through which the patient breathes and can take a variety of forms. More generally, then, the primary passage of housing 24 can be defined as having a patient interface side 40 to which the nozzle 34 is connected.

During use, high frequency oscillatory gas flow is directed from the source 22 to the HF orifice 26 and then to the flow diverter structure 30 (represented by arrows in Figure 1). High-speed flow from the HF orifice 26 (e.g., a nozzle) creates a pressure drop within the housing 24 which, in turn, draws ambient air through the entrainment holes 28. Interaction between high speed flow and the flow diverter structure 30 causes gas flow to be directed to the nozzle 34. In some embodiments, the flow diverter structure 30 operates to affect gas flow from the HF orifice 24 in a manner pulsating, creating a percussion gas flow / pressure effect for the nozzle 34. With these embodiments, then, a constant inlet pressure flow to housing 24 can be used, thus eliminating a need for the oscillatory gas flow source 22. In other embodiments, flow diverter 30 operates in response to flow of dispensed oscillatory gas, in turn acting in a separate constant gas flow to generate oscillatory pressure pulses that are dispensed to the 34 / patient nozzle. Regardless of this, oscillatory pressure pulses (including entrained ambient air) are delivered to the patient by the nozzle 34. Between pulses, the discharge openings 32 and the drag holes 28 allow the patient to breathe in and out of the device 20 without significant resistance.

Where provided, the CPP port 36 may be connected to a positive pressure gas source (not shown) to increase the respiratory therapy provided by device 20 (eg, generate appropriate positive expiratory pressure (PEP), etc.), provide a flow of primary gas that is actuated by flow diverter 30, and / or to provide other therapies (for example, constant positive airway pressure (CPAP)). Similarly, the optional nebulizer orifice 38 can be connected to a nebulizer (not shown) to introduce aerosolized medication into the gas flow delivered to the patient. In some embodiments, the nebulizer orifice 38 is physically positioned between the flow diverter structure 30 and the nozzle 34, such that the aerosol airflow does not directly interact with the flow diverter structure 30 in a way that it could otherwise. otherwise result in interruption of undesirable aerosol.

With the previous general construction in mind, Figure 2 schematically illustrates an embodiment of a respiratory therapy device 50 in accordance with the principles of the present exhibition. Device 50 includes a housing 52 holding or connectable to a mouthpiece 54 (generally referenced) adapted for placement in a patient's mouth and through which the patient can breathe. Housing 52 additionally forms a primary passageway 56 through which gas flow from a flow diverter structure 58 is fluidly directed to nozzle 54. In this regard, housing 52 additionally includes or forms an HF orifice 60, a CPP orifice 62 , and one or more trailing holes 64. Gas flow through holes 60-64 is directed to the flow diverter structure 58. Finally, device 50 optionally includes one or more discharge openings 66 and / or a nebulizer orifice 68. As described below, the discharge aperture 66 and nebulizer orifice 68 can be combined and / or provided as part of a structure that can include one or more additional valves.

The flow diverter structure 58 includes, in some embodiments, a neck region 70 formed within or by the housing 52. The neck region 70 defines a reduced size passage 72, and fluidly connects primary passage 56 with a chamber 74. More particularly, the reduced size passageway 72 has a smaller cross-sectional area (e.g., diameter) when compared to that of chamber 74 and primary passageway 56. The reduced size passage 72 is defined by an inlet side 76 and an outlet side 78. As shown in Figure 2, the inlet side 76 tapers in the cross-sectional area (or diameter) of chamber 74 to which the holes 60-64 are formed. The outlet side 78 has a constant diameter extending from the inlet side 76 to the primary passage 56. In addition, the flow diverter structure 58 may include a diverter body 80 centrally positioned within the reduced size passage 72, adjacent to the inlet side 76. The diverter body 80 includes or defines a front end 82 and a rear end 84, with the diverter body 80 tapering in size or diameter from the rear end 84 to the front end 82. With this construction, the diverter body 80 affects airflow from the HF orifice 60 and the CPP orifice 62 as described below. In other embodiments, the diverter body 80 can be eliminated.

The HF 60 orifice is adapted to be fluidly connected to the oscillatory gas flow source 22 (Figure 1), for example by appropriate piping (not shown). In addition, the HF orifice 60 is fluidly connected or forms an HF 86 nozzle. The HF 86 nozzle terminates at a nozzle end 88, and is configured to generate jet gas flow. In this regard, the nozzle end 88 "confronts" the diverter body 80 such that jet stream from the HF orifice 60 (and thus from the oscillatory gas flow source 22) falls on the diverter body 80.

The CPP 62 port is similarly constructed for fluid connection to a continuous or constant positive pressure gas source (not shown). The CPP nozzle 62 is fluidly connected or forms a CPP nozzle 90 ending at a nozzle end 92. The CPP nozzle 90 converts gas flow through the CPP nozzle 62 into a jet stream, with the nozzle end 92 “facing ”The diverter body 80. Thus, gas flow through and from the CPP nozzle 90 affects the diverter body 80.

Drag holes 64 are, in some embodiments, formed along chamber 74, and allow gas to pass into and out of chamber 74, and thus housing 52. In this regard, drag holes 64 are fluidly associated with the structure of flow diverter 58 to promote drag of ambient air in the gas flow otherwise generated in the flow diverter structure 58. In other embodiments, drag holes 64 can be located in other locations relative to housing 52. For example, drag holes 64 can be formed or located along neck region 70.

With the previous configuration, the nozzles / jets 86, 90 converge to or along the flow diverter structure 58. Thus, and as described below, the flow diverter structure 58 ensures that gas flows from the nozzles 86, 90 are directed to primary passage 56 (and thus to the patient) and that adequate ambient air entrainment (through the entrainment holes 64) is produced.

The discharge opening 66 can simply be a hole formed in the housing 52 adjacent to the nozzle 54, establishing an ambient opening to the primary passage 56. In some embodiments, a valve (not shown), such as a one-way valve, can be fitted to the opening discharge 66, operating to selectively control gas flow to and / or from primary passage 56. For example, the valve can operate to allow only gas release from primary passage 56 during a patient's expiratory breath.

Where provided, nebulizer orifice 68 is adapted for connection to a nebulizer (not shown), such as a high performance trailing nebulizer available under the trade name Pari LC Star, although any other nebulizer arrangement capable of generating aerosol medicine may be employed. Regardless of this, nebulizer orifice 68 is formed adjacent to nozzle 54 (and thus "downstream" of flow diverter structure 58). With this positioning, aerosol entrainment within the gas stream being dispensed to the nozzle 54 / patient can occur without resulting in significant aerosol obstruction within the flow diverter structure 58. Additionally, a one-way valve (not shown) can be provided for ensure desired airflow from the nebulizer in primary passage 56. Alternatively, the nebulizer, and thus nebulizer orifice 68, can be eliminated.

Operation of the respiratory therapy device 50 is shown in the illustrations of Figures 3A and 3B. A constant flow of positive pressure gas is delivered to the flow diverter structure 58 through the CPP nozzle

90. Similarly, oscillatory (i.e. pulsed) gas flow is provided to the flow diverter structure 58 through the HF 86 nozzle. In this regard, gas flow through the HF 86 nozzle (as created, for example, by the flow source of HF 86). oscillatory gas 22 (Figure 1)) is characterized as intermittent positive pressure pulses, and thus has “active pulse” and “inactive pulse” phases. During the “active pulse” phase (Figure 3A), gas flow from the HF 86 nozzle and CPP 90 nozzle converge into the flow diverter structure 58, and are directed along the reduced size passage 72 and then the passage primary 56 (shown by arrows in Figure 3A). Due to the reduced area in the reduced size passage 72 (when compared to a chamber area 74 and the primary passage 56), the gas flow thus dispensed increases in speed along the reduced size passage 72, thus aspirating or dragging ambient air in the gas flow through the drag holes

64. Where the diverter body 80 (Figure 2) is provided, an additional reduction in flow area, and thus an increase in speed is created. In the “inactive pulse” phase (Figure 3B), gas flow to the flow diverter structure 58 is provided only through the CPP 90 nozzle. However, once again, the flow diverter structure 58 directs the gas flow along the reduced passage 72 and into the primary passage 56 such that ambient air is drawn through the entrainment holes 64 as described above. As a result, a high baseline pressure is provided to the patient on a continuous basis. Providing CPP flow (through the CPP 90 nozzle), flow to the patient continues to occur during the “inactive pulse” phase, and thus serves to maintain high baseline pressure during high frequency oscillatory therapy.

Other respiratory therapies can also be performed with the device 50. For example, gas flow through the CPP 90 nozzle can be removed where high frequency oscillatory therapy without a high baseline pressure is desired. Conversely, gas flow through the HF 86 nozzle can be omitted where only constant positive airway pressure therapy (CPAP) is desired.

During the delivery of high frequency oscillatory pressure therapy, the patient breathes in and out of the therapy device 50 through the mouthpiece 54. In this regard, the drag holes 64 and the discharge openings 66 (in combination with a one-way valve, in some embodiments) allows the patient to breathe in and out of the device 50 without significant resistance during at least the "inactive pulse" phase.

Throughout the high frequency oscillatory flow dispensing, aerosol medication can be introduced into the flow in primary passage 56 through nebulizer orifice 68. As described above, aerosol flow is entrained in the gas flow generated in primary passage 56 through the structure of flow diverter 58 and thus dispensed to the patient by the nozzle 54.

Yet another embodiment of a respiratory therapy device 100 is shown schematically in Figure 4. As with previous embodiments, device 100 includes a housing 102 holding or forming or connectable to a mouthpiece 104 (generally designed) through which a patient breathes. Housing 102 establishes a primary passageway 106 through which airflow in and out of nozzle 104 is directed. In this regard, HF flow in primary passage 106 is established by a flow diverter structure 108 formed in front of the nozzle 104 and fluidly associated with an HF orifice 110 and one or more entrainment orifices 112.

With the configuration of Figure 4, the flow diverter structure 108 includes a plate 114 that forms a hole 116. The plate 114 is positioned or formed within the housing 102 so as to establish or define a chamber 118 opposite the primary passage 106, with orifice 116 fluidly connecting passage 106 and chamber 118. Orifice 116 has an area (i.e., diameter) that is less than that of chamber 118 as well as passage 106. In addition, a diameter of hole 116 is uniform across a thickness of plate 114 in some configurations. Although only the single hole 116 is shown in Figure 4, in other embodiments, the plate 114 can form two or more holes.

The HF 110 port is associated with chamber 118, and is configured to establish a fluid connection with the oscillatory gas flow source 22 (Figure 1). In addition, the HF orifice 110 is fluidly connected to or forms a nozzle 120 terminating at a nozzle end 122. As with previous embodiments, the HF nozzle 120 is configured to establish gas jet flow, and the nozzle end 122 it is generally aligned with or "confronts" orifice 116. As shown, at least one light opening exists between the nozzle end 122 and the plate 114 / orifice 116.

Trailing holes 112 establish a fluid opening between chamber 118 and ambient air. While drag holes 112 are shown to be formed adjacent to HF hole 110, any other location in fluid communication with chamber 118 is also acceptable.

With the previous construction, oscillatory gas flow is dispensed to the HF 110 orifice and the “pulsed active” flow is directed through the nozzle end 122 to the orifice 116. Due to the reduced size of the orifice 116 (when compared to an area of ​​the chamber 118), a pressure drop is generated inside chamber 118 when gas flow from nozzle end 122 passes through orifice 116. In other words, the reduced size of orifice 116 increases the speed of gas flowing through it, thereby lowering the surrounding pressure to generate the pressure drop. The pressure drop, in turn, aspirates and drags ambient air into the gas flow through the entrainment holes 112. As a result, a significant volume of high-frequency pulsed gas flow is dispensed at primary passage 106, and thus at nozzle 104 /patient.

To facilitate the inspiratory and expiratory phases of the patient's breaths, device 100 may additionally include one or more discharge openings 124. Between pulses of the high frequency oscillating gas flow being generated within primary passage 106, discharge openings 124 and the drag holes 112 allow the patient to breathe in and out of the device 100 without significant resistance. Optionally, a valve structure (not shown), such as a one-way valve, can be mounted in the discharge openings 124.

Finally, the respiratory therapy device 100 may include an optional nebulizer orifice 126 adapted for connection to a nebulizer (not shown). As with previous embodiments, nebulizer orifice 126 is preferably located along primary passage 106, between flow diverter structure 108 and nozzle 104. With this position, aerosol medication being dispensed at primary passage 106 (and thus dragged into the gas stream being dispensed to nozzle 104 / patient) is not required to pass through flow diverter structure 108 (or any other structure that could result if otherwise in significant aerosol obstruction). In addition, although not shown, a valve mechanism may be associated with nebulizer orifice 126, operating to allow influx of aerosol medication through nebulizer orifice 126 only during the patient's inspiratory breath and / or between the oscillatory pulses that occur during a patient's inspiratory breathing. In this regard, drag holes 112 and discharge openings 124 can be balanced with the nebulizer valve (and / or appropriate valve arrangement can be placed in drag holes 112 and / or discharge openings 124) to ensure “ activation ”of nebulizer drag during the patient's inspiratory breathing and / or between the oscillatory pulses that occur during a patient's inspiratory breathing.

Yet another embodiment of a respiratory therapy device 140 is shown in Figure 5. Device 140 includes a housing 142 holding or forming or connectable to a mouthpiece 144 (generally designed) through which a patient can breathe. The housing 142 forms a primary passageway 146 through which gas flow to and from the nozzle 144 is established. A flow diverter structure 148 (generally referred to) is fluidly connected to primary passage 146 opposite nozzle 144, with gas flow being directed to flow diverter structure 148 through an HF orifice 150. In addition, housing 142 forms or includes one or more entrainment holes 152 through which ambient air is sucked in and entrained with the flow generated in the flow diverter structure 148.

The flow diverter structure 148 separates the primary passage 146 from a chamber 154, and includes a ring hole 156 and a neck region 158. Ring hole 156 is fluidly connected to the HF hole 150, and establishes a wraparound opening 160 to chamber 154. Thus, gas flow from the HF orifice 150 is directed in chamber 154 through ring orifice 156.

The neck region 158 includes an entrance portion 162 and a reduced size passage 164. The entrance portion 162 has a tapered diameter in extension of the chamber 154 (and more particularly, the opening 160 of the ring hole 156) for the passage small size

164. As described below, this relationship promotes the formation of an effect of

Coanda in the gas stream exiting ring orifice 156. The reduced size passage 164 has a uniform diameter in length from the inlet portion 162 to the primary passage 146, with a reduced size passage diameter 164 being less than that of the chamber 154 and the primary passage 146 such that the gas flow undergoes an increase in speed when directed from the chamber 154 to the primary passage 146.

The HF 150 port is configured for attaching fluid to the oscillatory gas flow source 22 (Figure 1), and is fluidly opened to the ring port 156 as described above. Drag holes 152 can be positioned at a "back" of chamber 154, or they can be spatially closer to the flow diverter structure 148.

During use, oscillatory gas flow is provided to the ring orifice 156 through the HF orifice. When the pulses of oscillatory flow coming out of the orifice 160 interact with the inlet portion 162, an effect of

Coanda is created, causing the flow to “lock in” to the inlet portion 162 and be forced into the reduced size passage 164. Additionally, when the gas flow thus directed then passes through the reduced size passage 164, flow velocity increases (due to to the reduced area or diameter of the passage 164 when compared to the chamber 154), generating a pressure drop in the chamber 154. The pressure drop, in turn, sucks ambient air through the drag hole 152. As a result, significant entrainment of ambient air in the gas stream dispensed at primary passage 146 occurs. In this regard, the gas flow dispensed to primary passage 146 has oscillating pressure characteristics reflected in Figure 5 by waves.

To facilitate ease of patient breathing, the respiratory therapy device 140 may additionally include an optional discharge opening 170 that fluidly connects primary passage 146 with the environment. With this configuration, between pulses of gas flow being dispensed to the HF orifice 150, the discharge opening 170 and the drag orifice 152 effectively allow the patient to breathe in and out of device 140 without significant resistance. An optional valve structure (not shown) can be mounted to the discharge opening 170.

The respiratory therapy device 140 may additionally include optional nebulizer orifices 172 adapted for fluid connection to a nebulizer (not shown) as previously described. Again, nebulizer orifice 172 is fluidly open to primary passage 146, and can be positioned or formed between the nozzle 144 and the flow diverter structure 148 to minimize interaction between the aerosol drug and the flow diverter structure 148. Regardless, where provided, nebulizer orifice 172 provides a channel through which aerosolized medication can be entrained in the gas stream being dispensed to the patient through nozzle 144. Although not shown, additional valve structures may be associated with nebulizer orifice 172 to increase aerosol dispensing efficiency. Drag holes 152 and discharge opening 170 can be balanced with the nebulizer drag valve (or other valve arrangement) to ensure that nebulizer drag is "activated" during the patient's inspiratory breath and between the oscillatory pulses that occur during a patient's inspiratory breathing.

Another embodiment of a respiratory therapy device 200 as per aspects of the present exhibit is shown in Figures 6A and 6B. The device 200 again includes a housing 202 forming or maintaining or connectable to a mouthpiece 204 (illustrated generally) through which a patient breathes. In this regard, gas flow to and from the nozzle 204 is provided by a primary passage 206 defined by housing 202. A flow diverter structure 208 is fluidly connected to primary passage 206 opposite nozzle 204, flow diverter structure 208 separating primary passage 206 from a chamber 209. Flow diverter structure 208 operates in response to gas flow to an HF orifice 210 to affect gas flow directed to chamber 209 / flow diverter structure 208 through a CPP 212 orifice. In addition, housing 202 forms or includes one or more entrainment holes 214 through which ambient air is sucked in and entrained with the flow generated in the flow diverter structure 208. Finally, housing 202 optionally forms or includes one or more openings outlet 216 and / or a nebulizer orifice 218. As with previous embodiments, nebulizer orifice 218, where provided, can be positioned adjacent to nozzle 204 and thus fluidly "downstream" of the flow diverter structure 208 to minimize aerosol obstruction.

With the therapy device 200 of Figures 6A and 6B, the flow diverter structure 208 includes a deflector 220 held slidably within housing 202. The deflector 220 includes or forms an obstruction body 222 fluidly associated with the orifice of CPP 212. More particularly, the deflector 220 operates to move the obstruction body 222 to and away from the CPP orifice 212, thereby altering the level of gas flow entering primary passage 206 of chamber 209 / CPP orifice 212, as well as the volume of ambient air entrained therein by the drag holes 214. In this regard, the obstruction body 222 can have a variety of different geometries selected to affect gas flow from the CPP port 212 as desired. Thus, the conical shape given to the obstruction body 222 in Figures 6A and 6B is just a non-limiting example.

The deflector device 220 can be configured in a variety of ways to provide the movement described above. For example, in one embodiment, the deflector device 220 includes an annular hub 224 having a front end 226 and a rear end 228. A radial support 230 extends from the front end 226 and maintains the obstruction body 222 relative to the hub 224. The support 230 forms channels 231 through which gas flow can occur. Additionally, hub 224 is slidably disposed within an annular opening 232 formed by housing 202, for example by a shoulder 234. Opening 232 is fluidly connected to the HF orifice 210 and is sized to establish a fluidly sealed relationship relative to the cube 224. In the final assembly, then, cube 224 is slidable into opening 232, moving the obstruction body 222 from the closed position (inactive pulse) of Figure 6A to the open position (active pulse) of Figure 6B, and vice versa, in response to gas flow / pressure acting at the rear end 228. In this regard, a request member 236 (for example, a spring) pushes the hub 224 to the closed position, with the shoulder 234 providing a stop surface for movement of the hub 224 in addition to the closed position of Figure 6A (i.e., the boss prevents the hub 224 from moving to the left in Figure 6A).

A pressure pulse given at opening 232 acts on hub 224, generating a force sufficient to overcome that of request member 236, causing hub 224 to move within opening 232 (on the right relative to the orientation of Figure 6A). This movement is transferred over the obstruction body 222 by the support 230. Thus, in response to a positive pressure pulse inside the opening 232 through the HF orifice 210, the deflector device 220 "moves" such that the obstruction body 222 is positioned away from the CPP orifice 212 as shown in the open state of Figure 6B. When the gas flow dispensed to opening 232 becomes “inactive”, the request member 236 forces the hub 224, and thus the obstruction body 222, to return to the normal closed position (Figure 6A). The effect of the obstruction body position 222 on gas flow through the CPP orifice 212 is described below. A wide variety of other constructions or mechanisms (energized or non-energized) can be used alternatively to effect movement of the obstruction body 222 relative to the CPP 212 orifice that may or may not operate in response to pulsed gas flow from an external source . Thus, in some embodiments, the HF 210 orifice can be eliminated.

In some embodiments, the CPP 212 port is adapted for connection to a constant positive pressure gas source, for example by piping (not shown), and is fluidly connected to and / or forms a CPP 238 nozzle. CPP 238 generates jet flow, exiting a nozzle end 240, which is otherwise fluidly associated or aligned with the obstruction body 222.

The drag holes 214 are open to the environment, and are fluidly associated with the nozzle end 240 of the CPP nozzle 238 a or "upstream" of the obstruction body 222. More particularly, the drag holes 214 are positioned such that flow of high-speed gas generated at the nozzle end 240 causes ambient air to be sucked in or drawn into the flow as described below.

The discharge openings 216 are similar to the discharge opening 66 (Figure 2) previously described, and may or may not be associated with a valve (not shown). Regardless, the discharge openings 216 facilitate patient breathing inside and outside the device 200 by providing an ambient opening to the primary passage 206.

The optional nebulizer orifice 218 is adapted for fluid connection to a nebulizer ((not shown), but similar to the nebulizer previously described). Where provided, the nebulizer orifice 218 is preferably positioned such that a stream of aerosol air in the primary passage 206 does not directly impact the flow diverter structure 208. In other words, the nebulizer orifice 218 is located along the primary passage 206, fluidly between the nozzle 204 and the obstruction body 222, thereby minimizing the prevalence of aerosol obstruction. Alternatively, the nebulizer orifice 218 can be located virtually anywhere else along housing 202, and in other embodiments it can be eliminated.

During use, the flow diverter structure 208 operates to selectively change the volume of gas flow from the CPP orifice 212 to the primary passage 206. As shown in Figure 6B, during cases where the obstruction body 222 is discretely spaced from the orifice of CPP 212 (and in particular of the nozzle end 240), a stream of gas jet is delivered to the chamber 209 and falls on the obstruction body 222. Gas flow contacts the obstruction body 222 and flows through channels 231, creating a vacuum effect, aspirating or dragging, a significant level of ambient air (through the drag holes 214).

Conversely, when the obstruction body 222 is positioned in close proximity to the nozzle end 240 (Figure 6A), gas flow from the nozzle end 240 is openly restricted, such that minimal gas flow from the CPP orifice 240 occurs. As a result, there is little, if any, induced drag of ambient air from the drag holes 214.

Due to the above, high pressure is achieved with the arrangement in Figure 6B, while significantly lower pressure is achieved with the arrangement in Figure 6A. When the obstruction body 222 cycles between the positions of Figures 6A and 6B, then high frequency oscillatory pressure is delivered to the patient via the primary passage 206 / nozzle 204. As a reference point, the deflector 220 can be configured to provide a known opening 242 in the state involved (Figure 6A) to achieve a desired minimum baseline pressure profile. Regardless, between pulses, the drag holes 214 and the discharge openings 216 effectively allow the patient to breathe in and out of the device 200 without significant resistance.

Finally, where provided, aerosol medication can be introduced into the gas stream being directed to the patient through the nebulizer orifice 218. In this regard, the drag holes 214 and the discharge openings 216 can be dimensionally balanced with valve arrangement (not shown) associated with nebulizer orifice 218 ensuring that nebulizer drag is "activated" during the patient's inspiratory breathing and between the oscillatory pulses that occur during a patient's inspiratory breathing.

Another embodiment of a respiratory therapy device 300 as per aspects of the present exhibit is shown in Figures 7A and 7B. Device 300 includes a housing 302 forming, maintaining, or connectable to a nozzle 304 (illustrated generally) through which a patient breathes. Gas flow to and from the nozzle 304 is provided by a primary passage 306 defined by the housing 302. A flow diverter structure 308 is fluidly connected to the primary passage 306 opposite the nozzle 304, and acts on the gas flow directed into a chamber 309 of housing 308 through a CPP orifice 310. In some embodiments, the flow diverter structure 308 is fluidly connected to an HF 312 orifice through which an oscillating pressure serves to actuate the flow diverter structure 308 as described below. In addition, housing 302 forms or includes one or more entrainment holes 314 through which ambient air is drawn in and entrained within the flow generated in the flow diverter structure 308. Finally, housing 302 optionally forms or includes one or more openings discharge outlet 316 and / or a nebulizer orifice 318. As with previous embodiments, the nebulizer orifice 318, where provided, can be positioned adjacent to the nozzle 304 and thus fluidly "downstream" of the flow diverter structure 308 to minimize aerosol obstruction.

With the therapy device 300 of Figures 7A and 7B, the flow diverter structure 308 includes a drive assembly 320 and obstruction bodies 322a, 322b. Generally speaking, the drive assembly 320 is held slidably within housing 302, and operates to maneuver the obstruction bodies 322a, 322b between an open position (Figure 7A) and a closed position (Figure 7B). The obstruction bodies 322a, 322b, in turn, are fluidly associated with the chamber 309 / CPP orifice 310, and operate to change the level of gas flow entering primary passage 306 of the chamber 309 / CPP orifice 310, as well as the volume of ambient air entrained in it from 314 drag holes.

The drive assembly 320 includes an annular hub 324 having a front end 326 and a rear end 328. An internal toothed surface 330 is formed adjacent the front end 326, and a recess 332 is formed between the toothed surface 330 and the rear end 328 With this construction, the hub 324 is dimensioned to be received slidingly inside an opening 334 formed by the housing 302, for example by an annular shoulder 336. In this regard, at least the rear end 328 and the opening 334 are thus dimensioned to establish a fluidly sealed relationship. Finally, the drive assembly 320 includes a request device 337 (for example, a spring) positioned to contact against the front end 326, urging the hub 324 to the closed position of Figure 7B.

The obstruction bodies 322a, 322b are configured to connect with hub 324. For example, each of the obstruction bodies 322a, 322b includes a valve plate 338 and a drive segment 340. The drive segment 340 is pivotally mounted or rotatably within housing 302 (for example, by a pin 342), and forms a gear end 344. The gear end 344 is configured according to the toothed surface 330 of the hub 324 such that when the hub 324 positions the toothed surface 330 adjacent to the gear ends 344, the corresponding teeth engage with each other and movement of the hub 324 is transferred to the segment of drive 340, thereby causing movement of the corresponding obstruction body 322a, 322b. Thus, for example, movement of cube 324 from the position of Figure 7A to the position of Figure 7B (i.e., left relative to the orientation of Figure 7A) causes the obstruction bodies 322a, 322b to pivot or rotate from the open position to the position closed as shown.

Finally, the flow diverter structure 308 includes one or more components that operate to selectively retain the obstruction bodies 322a, 322b at least in the open position of Figure 7A and / or that impel the obstruction bodies 322a, 322b to naturally assume the open position. For example, the flow diverter structure 308 may include one or more springs (not shown) that propel the obstruction bodies 322a, 322b to the open position, with a constant spring force of these springs being less than that of the request member 337 acting otherwise on hub 324 such that the request member 337 is able to promptly move hub 324 from the open position (Figure 7A) to the closed position ( Figure 7B) without being openly restricted by the interface with the obstruction bodies 322a, 322b. For example, a compression spring can be arranged between the valve plate 338 of the first obstruction body 322a and the corresponding immediately adjacent segment of the shoulder 336 that this requests the valve plate 338 for the shoulder segment 336; a torsion spring disposed between valve plates 338; etc. In other configurations, valve plates 338 can be magnetically attracted to the corresponding shoulder segment 316. Alternatively, the obstruction bodies 322a, 322b can be temporarily retained in a multiplicity of positions (for example, a ball and holder configuration), with the corresponding holding force being less than the constant spring force associated with the request member 337.

In the final assembly, the hub 324 is slidably disposed within the opening 334. Pulsed flow dispensed to the opening 334 through the HF orifice 312 causes the hub 324 to move. In particular, a pressure pulse given at opening 334 acts at the rear end 328 of hub 324, generating a force sufficient to overcome that of the request member 337, causing hub 324 to move within the opening, transitioning from the closed position of Figure 7B to the open position of Figure 7A. This movement is transferred over the obstruction bodies 322a, 322b through the gear interface between the toothed surface 330 and the gear end 344. In particular, movement of the hub 324 forces the obstruction bodies 322a, 322b to rotate over their corresponding pivot points (for example, pins 342), forcing the obstruction bodies 322a, 322b, and in particular the corresponding valve plates 338, to the open position of Figure 7A. Alternatively and / or in addition, the obstruction bodies 322a, 322b can articulate or rotate slightly with movement of the hub 324; however, at release d the engagement engaged between the toothed surface 330 and the gear end 344 (ie, the gear end 344 of each of the obstruction bodies 322a, 322b resides within the recess 332), the obstruction bodies 322a, 322b are no longer constrained by hub 324, and thus articulate freely to the position opened by the corresponding springs (not shown). Thus, in response to a positive pressure pulse within aperture 334, the obstruction bodies 322a, 322b are in an open position relative to chamber 309 / CPP orifice 310 (i.e., minimal gas flow obstruction present between the chamber 309 / CPP 310 orifice and primary passage 306).

Conversely, when the gas flow dispensed to opening 334 becomes “inactive”, the request member 337 forces the hub 324 to return to the normal closed position (Figure 7B). With this movement, the hub 324 contacts the obstruction bodies 322a, 322b as described above, thereby acting the obstruction bodies 322a, 322b to the closed position by engaging between the toothed surface 330 and the gear ends 344. The effect of the position of the obstruction bodies 322a, 322b on gas flow through the CPP orifice 310 is described below. However, a wide variety of other constructions or mechanisms (energized or not energized) can be used alternatively to effect movement of the obstruction bodies 322a, 322b relative to the 309 chamber / CPP orifice 310 which may or may not operate in response to flow of pulsed gas from an external source. Thus, in some embodiments, the HF 312 orifice can be eliminated.

In some embodiments, the CPP 310 port is adapted for connection to a gas source of constant positive pressure, for example by piping (not shown), and is fluidly connected to and / or forms a CPP 350 nozzle. The CPP nozzle 350 generates jet flow, leaving a nozzle end 352 which is otherwise fluidly associated or aligned with a center point 354 between the obstruction bodies 322a, 322b.

Trailing holes 314 are open to the environment, and are fluidly associated with the nozzle end 352 of the CPP nozzle

350 a or “upstream” of the obstruction bodies 322a, 322b. More particularly, the entrainment holes 314 are positioned such that the high-speed gas flow generated at the nozzle end 352 causes ambient air to be sucked in or drawn into the flow as described below.

The discharge openings are similar to the discharge opening 66 (Figure 2) previously described, and may or may not be associated with a valve (not shown). Regardless, the discharge openings 316 facilitate patient breathing inside and outside the device 300 by providing an ambient opening to the primary passage 306.

The optional nebulizer orifice 318 is adapted for fluid connection to a nebulizer (not shown), but similar to the nebulizer previously described. Where provided, the nebulizer orifice 318 is preferably positioned such that aerosol gas flowing in the primary passage 306 does not directly impact the flow diverter structure 308. In other words, the nebulizer orifice 318 is located along the primary passage 306 flows between the nozzle 304 and the obstruction bodies 322a, 322b, thereby minimizing the prevalence of aerosol obstruction. Alternatively, the nebulizer orifice 318 can be located virtually anywhere else along housing 302, and in other embodiments it can be eliminated.

During use, the flow diverter structure 308 operates to selectively change the gas flow volume from chamber 309 / CPP orifice 310 to primary passage 306. As shown in Figure 7A, during cases where the obstruction bodies 322a, 322b are in the open position, a stream of gas jet is dispensed from the nozzle end 352 and passes through, but at least partially affects, the obstruction bodies 322a, 322b and / or the reduced diameter defined by the front end 326 of the hub 324. This interface attracts, or drags, a significant level of ambient air through the drag holes 314.

Conversely, when the obstruction bodies 322a, 322b are in the closed position of Figure 7B, gas flow from the nozzle end 352 is openly restricted, such that minimum gas flow from chamber 309 / CPP orifice 310 to primary passage 306 occurs. . As a result, there is little, if any, induced drag of ambient air from the drag holes 314.

Due to the above, high pressure is achieved with the arrangement in Figure 7A, while significantly lower pressure is achieved with the arrangement in Figure 7B. When the obstruction bodies 322a, 322b cycle between the open and closed positions, then high frequency oscillatory pressure is delivered to the patient via primary passage 306 / nozzle 304. As a reference point, the obstruction bodies 322a, 322b can be configured to provide a small opening (not shown) at least in the closed position to achieve a desired minimum baseline pressure profile. Regardless, between pulses, the drag holes 314 and the discharge openings 316 effectively allow the patient to breathe in and out of the device 300 without significant resistance.

Finally, where provided, aerosol medication can be introduced into the gas stream being directed to the patient through the nebulizer orifice 318. In this regard, the drag holes 314 and the discharge openings 316 can be dimensionally balanced with valve arrangement (not shown) associated with nebulizer orifice 318, ensuring that nebulizer drag is "activated" during the patient's inspiratory breathing. and between the oscillatory pulses that occur during a patient's inspiratory breathing.

Although the present exhibition has been described with respect to preferred embodiments, skilled workers in the art will recognize that changes can be made in form and detail without departing from the spirit and extent of the present exhibition.