Oxygen PEP cannula

Abstract

A cannula (4) configured to provide positive expiratory pressure (PEP) and oxygen to a patient, the cannula (4) comprising: a base (10) comprising an oxygen opening (11) and an inhalation opening (13); a valve (30) comprising an inhalation flap valve (31) to close the inhalation opening and a PEP flap valve (34); a valve holder (40) comprising a flow opening (41) and an exhalation opening (50), wherein the PEP flap valve closes the exhalation opening; and a nasal pillow (60) located on the valve holder.

Description

[0001] Cross Reference to Related Applications

[0002] This patent application claims priority under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 63 / 031,633, filed May 29, 2020, the contents of which are incorporated herein by reference. TECHNICAL FIELD

[0003] Various exemplary embodiments disclosed herein generally relate to a cannula device for providing oxygen and expiratory positive air pressure (PEP) to a patient using a cannula device. BACKGROUND

[0004] Chronic obstructive pulmonary disease (COPD) is associated with progressive, irreversible worsening of airflow limitation due to destruction of the alveolar walls, narrowing of the bronchioles, and inflammation of the airways. COPD patients typically exhibit limited exercise capacity. These individuals often experience dyspnea during exercise, causing the individual to stop exercising. At rest, COPD patients are typically able to maintain an inspiratory capacity (IC) and a stable end-expiratory lung volume (EELV). However, during exercise, the ventilation (or breathing) requirement increases, which can exacerbate expiratory flow limitation, increase dynamic hyperinflation, and lead to a rapid shallow breathing pattern.

[0005] The use of expiratory positive air pressure (PEP) has been clinically validated to improve functional exercise capacity in COPD patients. SUMMARY

[0006] Summaries of various exemplary embodiments are presented below. In the following summaries, some simplification and omission can be made in order to highlight and introduce certain aspects of the various exemplary embodiments, but are not limiting of the scope of the present invention. Exemplary embodiments will be described in sufficient detail below that one of ordinary skill in the art can manufacture and use it.

[0007] Various embodiments are described, including a cannula configured to provide expiratory positive air pressure (PEP) and oxygen to a patient, the cannula comprising: a base comprising an oxygen opening and an inhalation opening; a valve comprising an inhalation flap valve closing the inhalation opening and a PEP flap valve; a valve holder comprising a flow opening and an exhalation opening, wherein the PEP flap valve closes the exhalation opening; and a nasal pillow on the valve holder.

[0008] Various embodiments are described, further comprising a nozzle comprising a plurality of nozzle openings in the oxygen opening of the base.

[0009] Various embodiments are described, wherein the nozzle is configured to create a Venturi effect.

[0010] A number of embodiments are described, wherein the valve holder further comprises a flow opening wall, wherein an edge of the flow opening wall is an inhalation flap valve stop.

[0011] A number of embodiments are described, wherein the valve holder comprises a leg, there is a leg notch at a distal end of the leg, and the base comprises a tab configured to engage the leg notch.

[0012] A number of embodiments are described, wherein the PEP flap valve provides a static PEP value.

[0013] A number of embodiments are described, wherein the PEP flap valve comprises a biasing member configured to provide the static PEP value.

[0014] A number of embodiments are described, further comprising a plug configured to be placed in the oxygen opening.

[0015] A number of embodiments are described, wherein the valve holder comprises an outer wall, and wherein a portion of the outer wall adjacent to the exhalation opening is a PEP flap seal.

[0016] A number of embodiments are described, wherein the base further comprises an oxygen opening wall, wherein an edge of the oxygen opening wall is an inhalation flap seal.

[0017] A number of embodiments are described, wherein the inhalation flap valve is configured to open the inhalation opening when the patient inhales.

[0018] A number of embodiments are described, wherein the PEP flap valve is configured to open the exhalation opening when the patient exhales and provide a static PEP value.

[0019] Further, a number of embodiments relate to a cannula apparatus configured to provide positive expiratory pressure (PEP) and oxygen to a patient, the cannula apparatus comprising: two cannulas, wherein the two cannulas comprise: a base comprising an oxygen opening and an inhalation opening; a first valve comprising an inhalation flap valve to close the inhalation opening and a PEP flap valve; a valve holder comprising a flow opening and an exhalation opening, wherein the PEP flap valve closes the exhalation opening; and a nasal pillow on the valve holder; a connector to connect the two cannulas to each other; and an oxygen tube configured to be connected to the base.

[0020] A number of embodiments are described, further comprising a second valve, wherein the first valve and the second valve have different PEP values, and wherein the cannula is configured to swap the first valve and the second valve.

[0021] A number of embodiments are described, further comprising two plugs configured to be placed in the oxygen openings of the two cannulas.

[0022] A number of embodiments are described, wherein the inhalation flap valve is configured to open the exhalation opening when the patient inhales.

[0023] Various embodiments are described in which the PEP flap valve is configured to open the exhalation opening when the patient exhales and provide a static PEP value.

[0024] Various embodiments are described in which the two cannulas further comprise a nozzle comprising a plurality of nozzle openings in the oxygen opening of the base.

[0025] Various embodiments are described in which the nozzle is configured to create a Venturi effect.

[0026] Further, various embodiments relate to a cannula configured to provide positive expiratory pressure (PEP) and oxygen to a patient, the cannula comprising: a nares-sealing nasal interface having a body comprising an inhalation opening and an exhalation opening; an inhalation valve configured to open and close the inhalation opening, the inhalation valve being biased in a closed position; and a PEP valve configured to open and close the exhalation opening, the PEP valve being biased in a closed position, wherein nasal inhalation by the patient causes the inhalation valve to open and causes the exhalation valve to remain closed, and wherein nasal exhalation by the patient causes the inhalation valve to close and causes the PEP valve to open, providing positive expiratory pressure.

[0027] Various embodiments are described further comprising an oxygen tube configured to connect to the inhalation opening, the oxygen tube comprising a Venturi valve and an air entrainment opening.

[0028] Various embodiments are described further comprising an oxygen tube configured to connect to the inhalation opening and an ambient air valve configured to open when the patient inhales and close when the patient exhales. BRIEF DESCRIPTION OF DRAWINGS

[0029] For a better understanding of various exemplary embodiments, reference is made to the drawings, wherein:

[0030] Figure 1 An embodiment of a PEP cannula device is shown;

[0031] Figure 2 A perspective view of a cannula is shown;

[0032] Figure 3 An exploded perspective view of a cannula is shown;

[0033] Figure 4 And Figure 5 Top and bottom perspective views of a base are shown, respectively;

[0034] Figure 6 And Figure 7 Top and bottom perspective views of a valve are shown, respectively;

[0035] Figure 8 Another embodiment of a valve is shown;

[0036] Figure 9 A nozzle is shown;

[0037] Figure 10 and Figure 11 top and bottom perspective views of a valve retainer, respectively;

[0038] Figure 12 and Figure 13 top and bottom perspective views of a nasal pillow, respectively;

[0039] Figure 14 shows a cross-sectional view of a cannula;

[0040] Figure 15 shows the operation of the cannula when the patient is inhaling;

[0041] Figure 16 shows the operation of the cannula when the patient is exhaling;

[0042] Figure 17 and Figure 18 another embodiment of a PEP cannula device during inhalation and exhalation, respectively; and

[0043] Figure 19 shows another embodiment of a cannula.

[0044] For ease of understanding, the same reference numbers have been used to designate elements with substantially the same or similar structure and / or substantially the same or similar function. DETAILED DESCRIPTION

[0045] The principles of the application are described and illustrated in the description and drawings. It will thus be appreciated that those skilled in the art will be able to devise various arrangements that, although not explicitly described or shown herein, embody the principles of the application and are thus within its scope. Furthermore, all examples recited herein are principally intended to be only for pedagogical purposes to aid the reader in understanding the principles of the application and the concepts contributed by the inventor(s) to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, the use of the term "or" in referring to a list of items is intended to cover all possible combinations of these items under the heading "any of". Additionally, the various embodiments described herein are not necessarily mutually exclusive, as some embodiments can be combined with one or more other embodiments to form new embodiments.

[0046] Chronic obstructive pulmonary disease (COPD) is associated with progressive, irreversible worsening of airflow limitation due to destruction of the alveolar walls, narrowing of the bronchioles, and inflammation of the airways. COPD patients typically exhibit limited exercise capacity. These individuals often experience dyspnea during exercise, causing the individual to stop exercising. At rest, COPD patients typically maintain an inspiratory capacity (IC) and a stable end-expiratory lung volume (EELV). However, during exercise, the ventilatory (or breathing) demand increases, which can exacerbate expiratory flow limitation, increase dynamic hyperinflation, and result in a rapid shallow breathing pattern.

[0047] The use of positive expiratory pressure (PEP) has been clinically validated to improve functional exercise capacity in COPD patients. In addition, the use of PEP overcomes the sensation of breathlessness in patients. The referenced studies used a PEP valve with a corrugated tube and mouthpiece. The six-minute walk test (6MWT) was used to assess exercise capacity between the control and treatment groups.

[0048] A recent trend has been the introduction of E1FNC (high flow nasal cannula) therapy in the acute and home care settings. The various HFNC options available on the market require a 50 PSI gas source or compressor to operate, are capable of delivering very high flow rates to support ventilation (<70 1pm), are suitable for acute care and / or home care use, and typically include a venturi valve to increase entrained air and net gas flow.

[0049] Current systems that provide PEP therapy to patients are either bulky or hand-held. This makes it inconvenient or impossible for them to use during exercise, even when the patient is performing normal daily activities. An embodiment of a PEP cannula device will be described herein that is capable of delivering oxygen as well as PEP therapy.

[0050] The PEP cannula device described herein has significant advantages over previous PEP delivery models and can add PEP to newer, more sophisticated HFNC options for oxygen-dependent, non-ventilator-dependent COPD patients. Potential advantages include the following.

[0051] The PEP cannula device provides an adjustable static PEP value. The first study referenced above used a fixed flow-independent 5 cmH20 PEP valve applied through a mouthpiece that did indeed improve exercise tolerance. The second study used a flow resistor applied to a mouth-nose mask that produced a flow-dependent variable PEP value estimated to be between 10-20 cmH20. The first study's advantage was clearly the improvement in exercise tolerance, as well as significant improvements in Sp02 and heart rate. The second study's improvement was a significant improvement in dynamic hyperinflation, but at the cost of decreased exercise tolerance, decreased Sp02, and increased heart rate.

[0052] The PEP cuff device allows for adjustable or titratable static PEP values that can be individualized and adjusted using assessment metrics such as 6MWT, Borg scale of breathlessness, Sp02 and heart rate to maximize the therapeutic impact on the user. PEP adjustment can be achieved by the user exchanging different parts of our PEP cuff to achieve the desired effect.

[0053] The cuff incorporates PEP into the oxygen delivery system. The PEP cuff device will provide the benefits of PEP described previously as well as the ability to provide low flow, high flow or pulsed dose oxygen therapy. Long term oxygen therapy (TTOT) has been clinically proven to improve long term survival in COPD and is thought to improve exercise tolerance. The invention of oxygen therapy and PEP combined with the PEP cuff is thought to have the potential to further improve the impact on exercise tolerance and breathlessness for a single therapy.

[0054] The PEP cuff device provides PEP engagement as required. PEP engagement can be controlled by the user as oxygen can be delivered by simple nasal inhalation, while PEP engagement can be delivered by nasal exhalation, and finally oral (rather than nasal exhalation) can facilitate PEP delivery.

[0055] The PEP cuff device facilitates comfort and wearability by the user during ambulation, exercise and activities of daily living. The lightweight, minimal contact nature of the PEP cuff device improves patient comfort and facilitates the extension of the use of activities of daily living without significant coordination and technical requirements, while being very discreet in design. By comparison, if a current PEP device is used, an oxygen dependent individual with COPD would need to stop the exercise / current activity, retrieve the PEP device, hold the PEP device, while focusing on the appropriate technique (e.g. nasal inhalation, then oral exhalation), which can limit the use of both hands if the other arm is used to hold an oxygen delivery device such as a portable oxygen concentrator.

[0056] Figure 1An embodiment of the PEP cannula device 1 is shown. The PEP cannula device 1 includes two cannulas 4, a connector 6, and two oxygen supply tubes 2. The connector 6 connects the two cannulas 4 together so that each cannulas can be engaged with a patient's nostril. The oxygen supply tubes 2 are each connected to a cannulas 4 to provide an oxygen supply for oxygen therapy from an oxygen supply. The oxygen supply can be a portable supply, such as, for example, a portable oxygen cylinder or a portable oxygen concentrator. In other embodiments, the oxygen supply can be a more fixed supply, such as a larger oxygen cylinder, an oxygen concentrator, or a wall-mounted oxygen supply like those found in hospitals. In other embodiments, a single oxygen tube with two outlets connected to the two cannulas 4 can be used. Furthermore, the oxygen tubes 2 can provide the necessary structure for securing the PEP cannula device 1 to the patient when worn. Alternatively, an additional helmet can be used during use to keep the PEP cannula device in place.

[0057] Figure 2 A three-dimensional view of sleeve 4 is shown. Figure 3 An exploded perspective view of the sleeve 4 is shown. The sleeve includes a base 10, a valve 30, a nozzle 25, a valve retainer 40, and a nose pillow 60.

[0058] Figure 4 and Figure 5 Top and bottom perspective views of the base 10 are shown respectively. The base 10 is located at the bottom of the sleeve 4 and provides connection to the oxygen tube 2. The base 10 includes an oxygen opening 11 formed by an oxygen opening wall 12 that receives the end of the oxygen tube 2. The oxygen opening 11 includes an oxygen tube stop 20. The oxygen tube 2 is inserted into the oxygen opening 11 until it reaches the oxygen tube stop 20. The oxygen opening 11 is surrounded by the oxygen opening wall 12, which engages the oxygen tube 2 and secures the oxygen tube to the base 10 and thus to the sleeve 4. The body 10 also includes a generally circular annular lower inner surface 18 that supports the valve 30 and a generally frustoconical body side inner surface 19. The body 10 also includes three inhalation openings 13 between the oxygen opening wall 12 and the body lower inner surface 18. The inhalation openings 13 will provide a path for ambient air to be inhaled by the patient. The base 10 also includes three inhalation opening separators 14 that facilitate the formation and separation of the inhalation openings 13.

[0059] The oxygen opening 11 also includes a nozzle holder 16, which supports the nozzle 25 when placed on the body 10. As shown, the nozzle holder 16 and the oxygen tube stop 20 are part of the same structure, but in other embodiments, they may be separate structures within the oxygen opening 11. The oxygen opening wall 12 has a top surface, namely the intake flap seal 17. The intake flap seal 17 contacts the intake flap valve 31 on the valve 30 (see...). Figure 6 and Figure 7), to inhibit the flow of air through the inhalation opening 13. The body 10 includes three tabs 15 located on the lower inner surface 18 of the body and adjacent to the inhalation opening separator 14. These tabs 15 will interface with the leg notches 44 on the valve holder (see Figure 9 and Figure 10 ).

[0060] Figure 6 and Figure 7 show the top and bottom perspective views of the valve, respectively. The valve 30 has an outer wall 35 that has a generally frustoconical shape. The valve 30 includes three inhalation flap valves 31 that extend from the valve outer wall 35 toward the center of the valve 30. A portion 36 of the bottom surface of the inhalation flap valves 31 contacts the inhalation flap seal of the body 10. A portion 37 of the top surface of the inhalation flap valves 31 contacts the flap stops 47 on the valve holder 40 (see Figure 9 and Figure 10 ).

[0061] The valve 30 also includes three PEP flap valves 34. The PEP flap valves 34 extend in a perpendicular direction from the inhalation flap valves 31. The valve 30 includes biasing members 33 that provide a flexible connection between the valve inner surface 32 and the PEP flap valves 34. While two biasing members 33 are shown attached to each PEP flap valve 34, more or fewer biasing members can be used. Also, while the biasing members 33 are shown having a particular shape, other shapes that provide a flexible connection between the valve inner surface 32 and the PEP flap valves 34 are possible. Furthermore, the biasing members 33 can also be connected at different locations on the valve inner surface 32 and the PEP flap valves 34 than the locations specifically shown in Figure 6 and Figure 7 .

[0062] The tips of the inhalation flap valves 31 substantially form a circular opening that corresponds to the oxygen opening 11 of the body 10.

[0063] The valve 30 can be made of an elastomeric material (e.g., silicone or thermoplastic elastomer).

[0064] Figure 8 Another embodiment of the valve 30 is shown. In this embodiment, there are no biasing members 33. Instead, the rigidity of the PEP flap valves 34 and the various material dimensions and properties of the valve 30 produce the desired PEP value. This can allow for a static PEP value that is based on the specific properties of the PEP flap valves 34 and the valve 30 and is independent of the exhalation pressure or velocity.

[0065] Figure 9 A nozzle 25 is shown. The nozzle 25 has a plurality of nozzle openings 26. The nozzle 25 is installed within the upper end of the oxygen opening 11 and rests on the nozzle support 16.

[0066] Figure 10 and Figure 11 Top and bottom perspective views of the valve retainer are shown respectively. The valve retainer 40 is located on top of the valve 30 and the base 10 in the sleeve 4. The valve retainer 40 includes a flow opening 41 substantially aligned with the oxygen opening 11 of the base 10. The flow opening 41 is defined by an inner wall 42. The wall forming the flow opening 41 also has an outer wall 48. The valve retainer 40 includes an outer wall 45, and extending from the outer wall 46 is a nasal occipital ridge. The nasal occipital ridge 46 extends around the valve retainer 40 and is positioned near the top of the valve retainer 40. The nasal occipital ridge 46 engages the nasal occipital retainer 63 of the nasal occipital 60 (see...). Figure 13 ), to secure the nose pillow to the valve retainer 40.

[0067] The valve retainer 40 includes three downwardly extending legs 43, and each leg 43 includes a leg recess 44. When the sleeve 4 is in its assembled form, the legs 44 engage the tabs 15 of the body 10. The legs 43 have a bottom 49 extending toward the valve 30 and can exit the gap between the bottom 39 and the valve 30. In other embodiments, the bottom 49 may contact the valve 30.

[0068] Valve retainer 40 includes an expiratory opening 50 that facilitates airflow from the cannula 4 when the patient exhales using the PEP cannula device 2. The expiratory opening 50 is located between adjacent legs 43, and its operation will be explained further below. Valve retainer 40 includes a PEP valve seal 51, which is the portion of the outer wall 45 adjacent to the expiratory opening 50. The PEP valve seal 51 contacts the PEP valve 34 on valve 30 to inhibit airflow through the expiratory opening 50.

[0069] Figure 12 and Figure 13 The top and bottom perspective views of the nasal pillow are shown respectively. The nasal pillow 60 provides a sealed interface between the cannula 4 and the patient's nostril. The nasal pillow 60 includes a nasal opening 61 through which air flows between the patient's nostril and the cannula 4. The nasal pillow also includes a valve retainer opening 62, which interfaces with and rests on the valve retainer 40. A nasal pillow retainer 63 interfaces with a nasal pillow ridge 46 to secure the nasal pillow 60 to the valve retainer 40 and also provides an airtight connection between the nasal pillow 60 and the valve retainer 40. The nasal pillow 60 will be made of a material that is flexible and comfortable for the patient. It will also be made of a material that promotes an airtight or substantially airtight interface between the patient's nose and the nasal pillow 60. The nasal pillow may be made of an elastomeric material (e.g., silicone or thermoplastic elastomer).

[0070] Figure 14 A cross-sectional view of sleeve 4 is shown. Figures 14 to 16 This will be used to explain the operation of sleeve 4. Figure 14In the middle, the cannula is shown in a state where there is no inhalation or exhalation. Oxygen flows from the oxygen tube 2 (not shown) into the oxygen opening 11. Then, the oxygen flows through the nozzle opening 26 in the nozzle 25 into the valve holder 40 and then into the nasal pillow 60. The nozzle opening 26 can cause a Venturi effect when the patient inhales. In Figure 14 In the middle, the inhalation flap valve 31 is in contact with the inhalation flap seal 17 that prevents any air flow through the inhalation opening 13. Also, the PEP flap valve 34 is in contact with the PEP flap seal 51 that prevents any air flow through the exhalation opening 50.

[0071] Figure 15 The operation of the cannula 4 when the patient inhales is shown. When the patient inhales, this creates a negative pressure on the top side of the inhalation flap valve 31 that causes the inhalation flap valve 31 to rise until it contacts the flap stop 47. This then allows ambient air to be drawn in along the inhalation air path 70. This ambient air then mixes with the inflow of oxygen from the oxygen tube in the valve holder and nasal pillow. If the nozzle opening 26 creates a Venturi effect, this causes ambient air to assist the inhalation air flow, and the additional negative pressure to assist in opening the inhalation flap valve 31. Once the patient stops inhaling, the inhalation flap valve 31 will return to contact the inhalation flap seal 17 to stop the flow of ambient air. This can be achieved because the material of the inhalation flap valve 31 will seek to return to its original shape. Notably, the negative pressure created when the patient inhales causes the PEP flap valve 34 to remain firmly closed and in contact with the PEP flap seal 51 that prevents any air flow through the exhalation opening 50.

[0072] Figure 16 The operation of the cannula 4 when the patient exhales is shown. When the patient exhales, this creates a positive pressure on the inside of the PEP flap valve 34 that causes the PEP flap valve 31 to move away from the PEP flap seal 51 and this creates an opening. This then allows exhaled air to flow out through the exhalation opening 50 along the exhalation air path 71 and out of the cannula 4. Once the patient stops exhaling, the PEP flap valve 34 will spring back to contact the PEP flap seal 51 to stop the flow of air along the exhalation air path 71. Notably, the positive pressure created when the patient exhales causes the inhalation flap valve 31 to remain firmly closed and in contact with the inhalation flap seal 17 that prevents any air flow through the inhalation opening 13.

[0073] The biasing member 33 can be designed with different material dimensions and properties to allow for different stiffness values. The biasing member also allows for a static PEP value based on the specific properties of the biasing member 33 and independent of expiratory pressure or velocity. Therefore, a PEP cannula device 1 with multiple different valves 30 can be provided to the patient with different PEP values. The patient can easily exchange the different valves and determine which valve provides the best PEP treatment and benefit. This provides the patient with an adjustable and titratable PEP value.

[0074] During circulatory respiration by the patient through cannula 4, inspiratory valve 31 and PEP valve 34 work together to open and close inspiratory air path 70 and expiratory air path 71. During inspiration, inspiratory valve 31 opens to allow ambient air to enter the cannula to mix with oxygen from the oxygen source, and PEP valve 34 is safely pulled closed due to the negative pressure generated by the patient's inspiration. During expiration, PEP valve 34 opens to allow exhaled air to exit from cannula 4 through expiratory opening 50, and inspiratory valve 34 is safely pushed closed due to the positive pressure generated by the patient's inspiration.

[0075] The position of nozzle 25 within oxygen opening 11 will determine the Venturi effect provided by the input oxygen flow. For example... Figure 15 As shown, nozzle 25 can be positioned higher or lower within oxygen latch 11 to determine the specific Venturi effect provided by the nozzle. Furthermore, the position of the nozzle relative to the position of the intake opening 13 will also determine the overall Venturi effect. Therefore, nozzle 25 and intake opening 13 will be positioned to achieve the desired Venturi effect.

[0076] It is also worth noting that the cannula 4 may not have a nozzle 25, in which case the oxygen flow from the oxygen tube 2 will mix with the ambient air that flows in through the inhalation opening 13 when the patient inhales.

[0077] In another embodiment, the patient may only need to use the PEP cannula device 1 for PEP therapy without requiring oxygen therapy. This can be achieved by using a plug (not shown) that can be installed into the oxygen opening 11 to prevent the air exhaled by the patient from flowing out through the oxygen opening 11 and to allow it to flow along the expiratory path 71 through the PEP valve 34 that provides the required PEP therapy. In another embodiment, the inspiratory valve may extend to cover the oxygen opening 11 to prevent the air exhaled by the patient from flowing out through the oxygen opening 11 and to allow it to flow along the expiratory path 71 through the PEP valve 34 that provides the required PEP therapy.

[0078] In the description cannula, three inhalation flap valves 31 and three PEP flap valves 34 are described. This results in a corresponding number of inhalation openings 13, exhalation openings 50, legs 43, tabs 15, etc. It is noted that the number of inhalation flap valves 31 and PEP flap valves 34 can be fewer or more.

[0079] Another embodiment of the PEP cannula device 100 will now be described. Figure 17 and Figure 18 Another embodiment of the PEP cannula device 100 is shown during inhalation and exhalation, respectively. The PEP cannula device 100 includes a cannula 114, a connector 116, and an oxygen tube 112. The oxygen tube 112 can also include a Venturi valve 102 and an entrainment opening 104. The Venturi valve 102 creates a Venturi effect, entraining ambient air inhaled through the entrainment opening 104 with oxygen supplied through the oxygen tube 112.

[0080] The cannula 114 includes a main body 128 with an air opening 130. The oxygen tube 112 is connected to the air opening 130 to supply oxygen and ambient air to the cannula 114.

[0081] The cannula 114 also includes a nasal interface 132 with an exhalation opening 124, an inhalation flap 120, a PEP spring 122, and an exhalation plate 126. The inhalation flap 120 is over an opening in the exhalation plate 126. The PEP spring 122 biases the exhalation plate 126 upward.

[0082] As shown in Figure 17 During inhalation, the inhalation flap 120 opens due to the negative pressure caused by inhalation, which allows the patient to inhale oxygen mixed with ambient air. As shown in Figure 18 During exhalation, the inhalation flap 120 closes due to the positive pressure created by exhalation, and the exhalation plate 126 is pushed downward. When the exhalation plate 126 is pushed downward below the exhalation opening 124, the exhaled air exits the cannula 114 through the exhalation opening 124. Once exhalation is complete, the PEP spring 122 will bias the exhalation plate 126 upward again to cover the exhalation port 124.

[0083] As the patient goes through a breathing cycle with inhalation and exhalation, the inhalation flap 120 will rise to allow the patient to inhale oxygen and air during inhalation, then when the patient exhales, the inhalation flap 120 closes and the exhalation plate 126 lowers to expose the exhalation opening 124 to allow exhaled air to come out of the cannula. Next, when the patient takes the next breath, the exhalation plate 126 will rise back, thereby blocking the exhalation opening 124, and the inhalation flap 120 will rise, thereby allowing the oxygen and air mixture to pass through the patient.

[0084] A PEP spring is selected to provide the desired PEP value. The PEP spring 122 provides a static PEP value. The spring can be any of a variety of different types, including, for example, a coil spring, a disc spring, a resilient spring, etc. A coil spring can provide different PEP values by tightening the spring. Otherwise, the PEP value can be changed by raising or lowering the spring in the sleeve, requiring different force and thus pressure to move the spring through the exhalation opening. In addition, the patient can exchange the spring to provide different PEP values, or even multiple different sleeves can provide different PEP values, which can then be selected by the patient.

[0085] Figure 19 Another embodiment of the sleeve device 200 and sleeve 214 is shown. Instead of using a venturi valve to draw ambient air, this sleeve 214 includes an ambient air valve 134 that allows ambient air to be drawn into the sleeve body 128. In this case, the ambient air and oxygen from the oxygen tube 112 are mixed in the sleeve 214. Otherwise, the sleeve 124 has the same structure as the sleeve 114 and operates in the same manner.

[0086] As previously described, the sleeves 114 and 214 can operate in PEP mode only by blocking any flow of oxygen or ambient air into the sleeve using the plug.

[0087] In addition, while the exhalation opening 124, inhalation valve 120, exhalation flap, and PEP spring 122 are shown as part of the nasal interface, they can also be part of the body.

[0088] The PEP sleeve device provides the ability to provide oxygen therapy and PEP therapy to a patient in one compact, written, and easy to use single device. For example, the PEP sleeve device can be used for COPD patients who rely on oxygen to help and improve exercise tolerance and increase the ability to maintain normal activities of daily living. The PEP sleeve device can also be used in low, high, and pulsed oxygen flow situations. The PEP sleeve device also provides a static PEP value that the patient can select by exchanging components or sleeves. The PEP sleeve device can also be used in PEP mode only without oxygen therapy as described.

[0089] While each of the embodiments described above are described in terms of their structural arrangement, it should be recognized that the present invention also encompasses the related methods of using the embodiments described above.

[0090] While various example embodiments have been described in detail with particular references to certain exemplar}' aspects thereof, it should be understood that the application is capable of other embodiments and its details are capable of modifications in various obvious respects. As will be readily apparent to those skilled in the art, variations and modifications to the embodiments can be affected while still being encompassed by the application. Accordingly, the disclosure, description and drawings are to be considered illustrative only and not in a restrictive sense, and the scope of the application is only to be limited by the appended claims.

Claims

1. A cannula (4) configured to provide positive expiratory pressure (PEP) and oxygen to a patient, the cannula comprising: a base (10) comprising an oxygen opening (11) and an inhalation opening (13); a valve (30) comprising an inhalation flap valve (31) closing the inhalation opening and a PEP flap valve (34); a valve holder (40) comprising a flow opening (41) and an exhalation opening (50), wherein the PEP flap valve closes the exhalation opening; and a nasal pillow (60) on the valve holder, wherein a static PEP value is provided by a biasing element of the PEP flap valve or a rigidity of the PEP flap valve.

2. The cannula according to claim 1, further comprising a nozzle (25) comprising a plurality of nozzle openings in the oxygen opening (11) of the base (10).

3. The cannula according to claim 2, wherein the nozzle (25) is configured to create a Venturi effect.

4. The cannula according to claim 1, wherein the valve holder (40) further comprises a flow opening wall, wherein an edge of the flow opening wall is an inhalation flap stop.

5. The cannula according to claim 1, wherein the valve holder (40) comprises a leg having a leg notch at a distal end of the leg, and the base (10) comprises a tab configured to engage the leg notch.

6. The cannula according to claim 1, further comprising a plug configured to be placed in the oxygen opening (11).

7. The cannula according to claim 1, wherein the valve holder (40) comprises an outer wall, and wherein a portion of the outer wall adjacent to the exhalation opening is a PEP flap seal.

8. The cannula according to claim 1, wherein the base (10) further comprises an oxygen opening wall, wherein an edge of the oxygen opening wall is an inhalation flap seal.

9. The cannula according to claim 1, wherein the inhalation flap valve (31) is configured to open the inhalation opening (13) when the patient inhales.

10. The cannula according to claim 1, wherein the PEP flap valve (34) is configured to open the exhalation opening when the patient exhales.

11. A cannula device (1) configured to provide positive expiratory pressure (PEP) and oxygen to a patient, the cannula device comprising: two cannulas according to claim 1; a connector (6) connecting the two cannulas to each other; and an oxygen tube (2) configured to be connected to the base.

12. The cannula device according to claim 11, further comprising two plugs configured to be placed in the oxygen openings (11) of the two cannulas (4). ​ ​

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