VENTURI NOZZLE WITH VARIABLE THROAT DIAMETER AND METHOD

Description

[0001] Non-invasive open ventilation (NIOV), in which the patient's airway remains open rather than being sealed by a mask, is of great advantage to patients with chronic obstructive pulmonary disease (COPD) and other respiratory conditions due to its minimal interference with activities of daily living. However, because the patient can freely exhale, there is no easy way to generate positive end-expiratory pressure (PEEP) for NIOV patients and doing so typically requires a high flow rate of gas to the patient, typically air and / or oxygen. The gas consumed generating PEEP is wasted, as is the energy to produce it. This results in larger, heavier devices and shorter battery run time. The required flow rate of gas can be reduced using pneumatic (e.g. poppet) valves or eliminated altogether using electrically operated valves. However, such valves are physically large, requiring the undesirable placement of a bulky element close to the patient's face, in addition to adding complexity and weight to the device and introducing dead space volume that increases carbon dioxide rebreathing.

[0002] WO9528193A1 discloses a ventilator comprising a venturi tube which can be connected to the patient and has a proximal end and a distal end, high-pressure gas connections for breathing gases, a control device for setting ventilation parameters, and a device for dosing the ventilation gases, characterized in that the ventilation channel of a Venturi tube has an area with a variable cross section below an injector nozzle.

[0003] US 2003 / 0159696 A1 discloses a device for respiratory assistance comprising a tube which forms a main channel, connected at a distal end to an airway of a patient so that the respiratory system is connected to the outside. At least one auxiliary channel is connected to a source of respirable gas to insufflate a jet of the gas into the respiratory system. Deflection means for the gas are also provided to create a pressure zone inside the main channel.

[0004] Throughout this specification the following non-SI units are used, which may be converted to the respective SI or metric unit according to the following conversion table: Name of unitSymbolConversion FactorSI / Metric unitPound per square inch gaugepsig6894.75728PaCentimeter H 2 OcmH 2 O98.0665PaStandard liters per minuteslpm1.6 •< x10 -05< m 3< / sinchesin0.0254m

[0005] The invention in its various aspects is defined in the appended independent claims, to which reference should be made. Preferred features are set out in the dependent claims.

[0006] According to an aspect of the invention, there is provided a variable throat jet venturi according to claim 1.

[0007] With the plenum in a first pressurization state, the variable throat jet venturi may achieve a pressure P shutoff , with the gas outlet occluded, of at least 55 cmH 2 O at a jet nozzle pressure P n of 10.5 psig and a jet nozzle flow V' n equal to or less than 30 slpm. With the plenum in a second pressurization state, the variable throat jet venturi may achieve a pressure P aw , with the gas outlet open, of 10 cmH 2 O at a jet nozzle flow V' n of less than 10 slpm, e.g. less than 5 slpm. With the plenum in the first pressurization state, a ratio A t / A n of a cross-sectional area of the deformable throat body to a cross-sectional area of the jet nozzle may be between 20 and 30. With the plenum in the second pressurization state, the ratio A t / A n may be between 2.0 and 5.0.

[0008] A distal tip of the jet nozzle may be outside the entrainment opening

[0009] According to another aspect of the invention, there is provided a patient ventilation interface according to claim 6. The nasal coupler may comprise a nasal pillow.

[0010] According to another aspect of the invention, there is provided a non-invasive ventilation system according to claim 8. The non-invasive ventilation system may comprise a controller programmed to energize the pilot pressure line to constrict the deformable throat body during an exhalation phase of positive end-expiratory pressure (PEEP) therapy. The non-invasive ventilation system may comprise a multi-lumen tube having a ventilation gas lumen terminating in the nozzle and a pilot pressure lumen in fluid communication with the pilot pressure line.

[0011] According to another aspect of the invention, there is provided a method according to claim 11.

[0012] The pressurizing of the plenum may include energizing a pilot pressure line fluidly coupled to a pilot pressure port defined by the housing.

[0013] The pressurizing of the plenum may comprise pressurizing the plenum from a first pressurization state, in which the variable throat jet venturi achieves a pressure P shutoff , with the gas outlet occluded, of at least 55 cmH 2 O at a jet nozzle pressure P n of 10.5 psig and a jet nozzle flow V' n equal to or less than 30 slpm, to a second pressurization state, in which the variable throat jet venturi achieves a pressure P aw , with the gas outlet open, of 10 cmH 2 O at a jet nozzle flow V' n of less than 10 slpm, e.g. less than 5 slpm. With the plenum in the first pressurization state, a ratio A t / A n of a cross-sectional area of the deformable throat body to a cross-sectional area of the jet nozzle may be between 20 and 30. With the plenum in the second pressurization state, the ratio A t / A n may be between 2.0 and 5.0.

[0014] The invention will now be further described by way of example with reference to the accompanying drawings, in which: Figure 1 shows an exemplary non-invasive ventilation system according to an embodiment of the present invention, with a variable throat jet venturi (according to an embodiment of the invention) of the system shown in cutaway; Figure 2A is a cross-sectional view of the variable throat jet venturi with a plenum thereof in a first pressurization state; Figure 2B is a cross-sectional view of the variable throat jet venturi with the plenum in a second pressurization state; Figure 3A is a perspective view of the variable throat jet venturi; Figure 3B is an exploded view of the variable throat jet venturi; Figure 3C is an exploded sectional view of the variable throat jet venturi; Figure 4 shows four exemplary candidate venturi geometries in relaxed and constricted states corresponding to first and second plenum pressurization states; and Figure 5 graphically depicts performance characteristics of an exemplary variable throat jet venturi.

[0015] The present disclosure encompasses various embodiments of a variable throat jet venturi for delivering ventilation gas to a patient, along with systems and methods for varying a ratio between a throat diameter and a jet nozzle diameter thereof. The detailed description set forth below in connection with the appended drawings is intended as a description of several currently contemplated embodiments and is not intended to represent the only form in which the disclosed invention may be developed or utilized. The description sets forth the functions and features in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions may be accomplished by different embodiments that are also intended to be encompassed within the scope of the present invention (provided they fall within the scope of the claims). It is further understood that the use of relational terms such as first and second and the like are used solely to distinguish one from another entity without necessarily requiring or implying any actual such relationship or order between such entities.

[0016] Figure 1 shows an exemplary non-invasive ventilation system 10 according to an embodiment of the present disclosure, including a patient ventilation interface 20 that incorporates a variable throat jet venturi 100 for delivering ventilation gas to a patient. Due to the increased velocity of the ventilation gas at a constriction of the variable throat jet venturi 100, there is a decrease in pressure that causes ambient air to be entrained via one or more entrainment ports 133. By amplifying the ventilation gas output by a jet nozzle 110 in this way, the variable throat jet venturi 100 may serve as an efficient flow generator when providing ventilation therapy to the patient. Meanwhile, so that it may also serve as an efficient PEEP generator, the variable throat jet venturi 100 may include a deformable throat body 120 to serve as the constriction, with a housing 130 of the variable throat jet venturi 100 defining a pilot pressure port 135 for pressurizing a plenum 140 surrounding the deformable throat body 120 (e.g. via a feed and bleed circuit). By selectively pressurizing the plenum 140, the plenum 140 can be transitioned between a first pressurization state for maximizing airflow to the patient (e.g. during inhalation) and a second pressurization state in which the deformable throat body 120 is more constricted. In the latter state, the reduced cross-sectional area of the deformable throat body 120 may significantly reduce the required nozzle flow for achieving a desired output pressure, making it possible to efficiently generate PEEP.

[0017] As shown by way of example in Figure 1, the patient ventilation interface 20 in which the variable throat jet venturi 100 is integrated may be a nasal interface having a pair of nasal couplers 24 (e.g. nasal pillows) for fluidly coupling a gas outlet of the deformable throat body 120 to the nostrils of the patient. Examples of such a nasal interface are described in U.S. Patent No. 9,132,250, entitled METHODS, SYSTEMS AND DEVICES FOR NON-INVASIVE VENTILATION INCLUDING A NON-SEALING VENTILATION INTERFACE WITH AN ENTRAINMENT PORT AND / OR PRESSURE FEATURE, U.S. Patent No. 9,675,774, entitled METHODS, SYSTEMS AND DEVICES FOR NON-INVASIVE OPEN VENTILATION WITH GAS DELIVERY NOZZLES IN FREE SPACE, U.S. Patent No. 9,962,512, entitled METHODS, SYSTEMS AND DEVICES FOR NON-INVASIVE VENTILATION INCLUDING A NON-SEALING VENTILATION INTERFACE WITH A FREE SPACE NOZZLE FEATURE, and U.S. Patent No. 10,792,449, entitled PATIENT INTERFACE WITH INTEGRATED JET PUMP. For example, the variable throat jet venturi 100 may be disposed within or constitute a manifold assembly 22 of the patient ventilation interface 20, with the jet nozzle 110 integrated therewith or attachable to an end thereof. The manifold assembly 22 may be configured to fit between the patient's nose and upper lip and may serve to direct exit flow from the variable throat jet venturi 100 to the patient's nostrils.

[0018] With reference to Figure 1, it is contemplated that the variable throat jet venturi 100 may be integrated in or otherwise provided at one side of the manifold assembly 22 only, with the exit flow thereof being directed simultaneously to both of the patient's nostrils as shown. Along these lines, as indicated above, the manifold assembly 22 of the patient ventilation interface 20 may be outfitted with the spaced, identically configured pair of the nasal couplers 24 (e.g. nasal pillows) engageable to and placeable into fluid communication with respective ones of the patient's nostrils, and the manifold assembly 22 may place the variable throat jet venturi 100 into fluid communication with both such nasal couplers 24 by a single flow passage. Alternatively, the manifold 22 may define separate flow passages for each of the patient's left and right nostrils, in which case the variable throat jet venturi 100 and some or all of its features described herein may be duplicated for each side of the manifold 22.

[0019] In order to provide for the pressurization of the plenum 140 as described above, the non-invasive ventilation system 10 includes a pilot pressure line 30 fluidly coupled to the pilot pressure port 135. A controller 40 may be programmed to energize the pilot pressure line 30 to constrict the deformable throat body 120 during an exhalation phase of PEEP therapy. In the illustrated example, the non-invasive ventilation system 10 includes a multi-lumen tube 50 having a ventilation gas lumen 52 terminating in the jet nozzle 110 and a pilot pressure lumen 54 in fluid communication with the pilot pressure line 30. The ventilation gas lumen 52 may receive ventilation gas from a ventilator or an oxygen concentrator, for example. The pilot pressure line 30 may extend from the multi-lumen tube 50 forward past the jet nozzle 110 to the pilot pressure port 135 of the variable throat jet venturi 100.

[0020] Additional lumens of the multi-lumen tube 50 may include, for example, a low-pressure gas lumen for oxygen (which may terminate in a low-pressure jet nozzle outlet port near the jet nozzle 110), a pressure sensing lumen (which may extend farther downstream to terminate nearer to the patient's nostril, such as at the base of the nasal coupler 24 closest the variable throat jet venturi 100 , for example), lumens for medicaments, etc. However, it is contemplated that in a preferred implementation, a second tube 50 may be provided which routes one or more of these lumens to the other side of the manifold assembly 22 (i.e., the side opposite that having the variable throat jet venturi 100 integrated therein). Such a pair of tubes 50 may branch upstream from a single multi-lumen tube using a wye connector such as that described in U.S. Patent No. 10,792,449. In Figure 1, for example, a second tube 50 is shown having, as its only lumen, a pressure sensing lumen 56 that extends to the base of one of the nasal couplers 24 in order to desirably measure pressure downstream of the variable throat jet venturi 100. In this example, the first tube 50 will have no pressure sensing lumen. Along these lines, it is contemplated that any of the above-described lumens may be provided individually or in some prescribed combination at one or both sides of the interface 20 using the first tube 50 with or without the second tube 50.

[0021] In a case where the non-invasive ventilation system 10 may include only a single multi-lumen tube 50 extending to the patient ventilation interface 20, it is also contemplated that the multi-lumen tube 50 may interface with the manifold 22 at a central position equidistant from the nasal couplers 24. For example, the multi-lumen tube 50 may connect to the manifold 22 between the nasal couplers 24 on the bottom or the front of the manifold 22 as viewed in Figure 1. In such case, this same central area, near the bases of the nasal couplers 24, may house a single variable throat jet venturi 100 that is fed by the multi-lumen tube 50 and whose output flow is directed simultaneously to both nasal couplers 24. As another possibility, the disclosed variable throat jet venturi 100 may be embodied in a detachable connector that interfaces the multi-lumen tube 50 with a mask or other patient interface at any appropriate position (and in some cases may be universally usable with multiple different patient interfaces). Examples of such connectors that can be equipped with the disclosed variable throat jet venturi 100 are the adaptors disclosed in U.S. Patent No. 10,307,552, entitled JET PUMP ADAPTOR FOR VENTILATION SYSTEM.

[0022] The controller 40 may be a standalone device dedicated to energizing the pilot pressure line 30 during PEEP therapy (e.g. based on sensor input indicative of an exhalation phase of a patient's breathing) or may be a controller of a ventilator or oxygen concentrator, for example. In this regard, exemplary ventilators and oxygen concentrators that may be used with the disclosed embodiments include, in addition to those mentioned above, those described in U.S. Patent No. 10,369,320, entitled MODULAR VENTILATION SYSTEM, U.S. Patent Application Pub. No. 2019 / 0307981, entitled MODULAR VENTILATION SYSTEM, and U.S. Patent Application No. 16 / 874,472, filed May 14, 2020 and entitled O2 CONCENTRATOR WITH SIEVE BED BYPASS AND CONTROL METHOD THEREOF". The controller 40 may energize the pilot pressure line 30 by controlling the pressure in the pilot pressure lumen 54 of the multi-lumen tube 50, for example, by controlling a valve of a pilot pressure output port of a ventilator, oxygen concentrator, or other gas source that houses or is connected to the controller 40.

[0023] Figures 2A and 2B are cross-sectional views of the variable throat jet venturi 100 with the plenum 140 in the first pressurization state and the second pressurization state, respectively. Figures 3A-3C are additional perspective, exploded and exploded sectional views of the variable throat jet venturi 100. As can be seen in Figures 2A and 2B, when pressure increases in the plenum 140 (e.g. by activation of a pilot pressure line 30, see Figure 1), the plenum 140 transitions from the first pressurization state (Fig. 2A) to the second pressurization state (Fig. 2B), with the buildup of pressure in the plenum 140 causing the deformable throat body 120 to become constricted. More specifically, a cross-sectional area A t of the deformable throat body 120 (e.g. a smallest cross-sectional area corresponding to a diameter D t in Figures 2A and 2B) decreases from the first pressurization state to the second pressurization state. Given a nozzle having a fixed cross-sectional area A n (corresponding to a diameter D n ), the ratio A t / A n thus decreases, reducing the required nozzle flow for achieving PEEP.

[0024] The deformable throat body 120 defines a gas inlet 122 and a gas outlet 124 and may have a generally tubular shape in its relaxed (e.g. as-molded) state as best shown in Figure 3B. Flanges 126 may be defined at either end. Referring back to Figures 2A and 2B, when the deformable throat body 120 is disposed within the housing 130, the flanges 126 may function to position the deformable throat body 120 in a cavity defined therein. The flanges 126 may also serve to delineate a longitudinal extent of the plenum 140 between an outer wall 126 of the deformable throat body 120 and an inner wall 137 of the housing 130. As the plenum 140 is pressurized as shown in Figure 2B, the pressure may cause the deformable throat body 120 to constrict about its center while the flanges 126 remain firmly against the inner wall 137 of the housing 130 (with or without the use of adhesive). Thereafter, as the plenum 140 is depressurized, the deformable throat body 120 may return to its relaxed state as shown in Figure 2A. The deformable throat body 120 may be a thermoplastic elastomer (TPE) or a thermoset produced by liquid injection molding (LIM) using liquid silicone rubber (LSR), for example.

[0025] The housing 130 may be assembled from one or more pieces 132, 134 as shown, which may be attached to each other by ultrasonic welding, for example. The pieces 132, 134 of the housing 130 may similarly be made of a thermoplastic or thermoset but may typically (but not necessarily) have greater rigidity than the deformable throat body 120. In the illustrated example, there is an entry piece 132 and an exit piece 134. In more detail, as shown in Figures 2A-3C, the entry piece 132 of the housing 130, according to the invention, includes a generally frustoconical portion which flares outwardly away from the plenum 140 and defines an entrainment opening 136 open to ambient air. The exit piece 134 includes the inner wall 137 that defines the plenum 140, and likewise includes a generally frustoconical portion which flares outwardly away from the plenum 140 and serves as a diffuser 138 that may provide the desired airflow and / or pressure to the patient, e.g. via the nasal couplers 24 (see Figure 1). According to the invention, the deformable throat body 120 receives the ventilation gas output by the jet nozzle 110 via the entrainment opening 136 of the housing 130, in addition to ambient air which is drawn through the entrainment port 133 of the manifold assembly 22 and likewise introduced into the entrainment opening 136. In this regard, as seen in Figure 1, the entrainment opening 136 (and hence the deformable throat body 120) fluidly communicates with both the jet nozzle 110 and entrainment port 133 of the manifold assembly 22. The distal tip of the jet nozzle 110 is outside the entrainment opening 136 as shown, with the entrainment of ambient air occurring around the periphery of the jet nozzle 110.

[0026] In the implementation shown in Figure 1 wherein the manifold assembly 22 includes the entrainment port 133 and the distal tip of the jet nozzle 110 is radially aligned with a portion of the entrainment port 133, it is contemplated that the entrainment opening 136 may likewise be radially aligned with a portion of the entrainment port 133, or located downstream therefrom.

[0027] The geometry of the variable throat jet venturi 100, including the cross-sectional area of the nozzle 110 and in particular the geometry of the deformable throat body 120 when the plenum 140 is in the first and second pressurization states, may be selected to achieve desired performance characteristics. For purposes of illustration, maximum ventilator output capabilities may dictate a nozzle flow V' n ≤ 30 slpm and a nozzle pressure P n = 10.5 psig, which, in turn, may limit the range of possible nozzle diameters. Using each of a plurality of possible nozzle diameters, candidate venturi geometries may be tested with the deformable throat body 120 in the relaxed state (plenum 140 in the first pressurization state as shown in Figure 2A) to determine a shutoff pressure P shutoff at the gas outlet 124 of the deformable throat body 120 and a maximum output flow V' aw-max at the maximum nozzle pressure P n = 10.5. In this way, it can be confirmed whether the candidate venturi geometry meets desired P shutoff -V' aw-max performance. The same candidate venturi geometries may then be tested with the deformable throat body 120 in the constricted state (plenum 140 in the second pressurization state as shown in Figure 2B) to determine the nozzle flow V' n needed to achieve PEEP, e.g. P' aw = 10 cmH 2 O, and the maximum output flow V' aw-max at that same nozzle flow V' n .

[0028] Exemplary data illustrating results of such a testing procedure is shown below in Tables 1 and 2, for a first nozzle 110 having a nozzle diameter D n = 0.043 inches (cross-sectional area A n = 0.0015 in 2< ) and a second nozzle 110 having a nozzle diameter D n = 0.048 inches (cross-sectional area A n = 0.0018 in 2< ), respectively. In Tables 1 and 2, the test numbers "#" are in the form "x.y" where x denotes different candidate venturi geometries 1, 2, 3, and 4 and y denotes relaxed ("1") and constricted ("2") states of the deformable throat body 120 thereof, as depicted in Figure 4. The venturi geometries themselves are defined by a minimum cross-sectional diameter D t (and minimum cross-sectional area A t ) of the deformable throat body 120, a length L t from the gas inlet 122 to the gas outlet 124 of the deformable throat body 120, and a length L d from the gas outlet 124 to the end of the diffuser 138. In the example data of Tables 1 and 2, the deformable throat body 120 is assumed to receive the ventilation gas output by the jet nozzle 110 through the entrainment opening 136 of the housing 130 as shown in Figures 2A and 2B, with the length between the nozzle 110 and the gas inlet 122 of the deformable throat body 120 being 0.4 inches. Table 1#D t (in) A t / A n L t (in) L d (in) L t +L a (in) P n (psig) V' n (slpm) P shutoff (cmH 2 O) P aw (cmH 2 O) V' aw (slpm) 1.10.25340.200.200.402.89.410.00.040.810.519.635.02.080.92.10.25340.400.200.602.69.610.00.045.210.519.539.03.089.03.10.25340.200.400.602.810.210.00.043.610.519.936.02.586.84.10.25340.400.400.802.69.510.00.048.010.519.439.03.595.81.20.08640.200.200.400.53.910.00.07.010.520.9150.00.030.82.20.08640.400.200.600.64.110.00.06.710.520.1145.00.027.73.20.08640.200.400.600.53.810.00.06.510.519.6150.00.028.64.20.08640.400.400.800.54.510.00.06.810.524.1150.00.031.6 Table 2 #D t (in) A t / A n L t (in) L d (in) L t +L d (in) P n (psig) V' n (slpm) P shutoff (cmH 2 O) P aw (cmH 2 O) V' aw (slpm) 1.10.25270.200.200.402.612.410.00.036.610.528.140.02.075.82.10.25270.400.200.602.210.910.00.036.010.528.947.52.583.03.10.25270.200.400.602.511.310.00.031.010.527.841.02.073.64.10.25270.400.400.802.210.310.00.035.410.528.247.03.085.01.20.08630.200.200.400.54.110.00.06.710.528.3150.00.032.72.20.08630.400.200.600.54.510.00.06.610.527.7150.00.032.03.20.08630.200.400.600.54.310.00.06.310.525.7150.00.032.04.20.08630.400.400.800.44.310.00.06.910.525.8150.00.033.9

[0029] An exemplary test procedure for generating data like that of Tables 1 and 2 may be as follows for each test number "#". First, the gas outlet 124 (or the end of the diffuser 138) is occluded and the nozzle flow V' n is increased until the outlet pressure P aw is equal to the target PEEP, e.g. P shutoff = 10 cmH2O. The nozzle flow V' n and nozzle pressure P n are recorded in the first row. The gas outlet 124 is then opened and the outlet pressure P aw and output flow V' aw are recorded in the same row. Next, the nozzle pressure P n is set to the target maximum 10.5 psig. The nozzle flow V' n, outlet pressure P' aw , and output flow V' aw are now recorded in the second row. Lastly, the gas outlet 124 is again occluded, and the shutoff pressure P shutoff corresponding to the maximum nozzle flow V' n is recorded in the second row. The procedure can be repeated for different nozzles and candidate venturi geometries with the deformable throat body 120 in both relaxed and constricted states (corresponding to the first and second states of the plenum 140 shown in Figures 2A and 2B).

[0030] To calculate the maximum output flow V' aw-max , the measured output flow V' aw taken at the target maximum nozzle pressure P n of 10.5 psig can be multiplied by the corresponding shutoff pressure P shutoff and divided by the difference between the shutoff pressure P shutoff and the corresponding measured outlet pressure P' aw , as follows: V' aw-max = V' aw * P shutoff / (P shutoff - P aw ). The ratio X max of the maximum output flow V' aw-max to the maximum nozzle flow V' n can be calculated as follows: X max = V' aw-max / V' n .

[0031] The performance characteristics of interest can then be tabulated from the combined data of the relaxed and constricted states of the deformable throat body 120 of each candidate venturi geometry, as summarized in Tables 3 and 4 below for nozzle diameters D n = 0.043 inches and D n = 0.048 inches, respectively: Table 3#RELAXED CONSTRICTED V' n at P n = 10.5 psig P shutoff at P n = 10.5 psig V' aw-max at P n = 10.5 psig X max V' n at PEEP = 10 mmH 2 O 119.635.085.84.43.9219.539.096.44.94.1319.936.093.34.73.8419.439.0105.25.44.5 Table 4 #RELAXED CONSTRICTED V' n at P n = 10.5 psig P shutoff at P n = 10.5 psig V' aw-max at P n = 10.5 psig X max V' n at PEEP = 10 mmH 2 O 128.140.079.82.84.1228.947.587.63.04.5327.841.077.42.84.3428.247.090.83.24.3

[0032] An exemplary venturi geometry that achieves desired performance characteristics is shown in Table 5, below, with unused data omitted, for a nozzle 110 having a nozzle diameter D n = 0.048 inches (cross-sectional area A n = 0.0018 in 2< ). Again, the deformable throat body 120 is assumed to receive the ventilation gas output by the jet nozzle 110 through the entrainment opening 136 of the housing 130 as shown in Figures 2A and 2B, with the length between the nozzle 110 and the gas inlet 122 of the deformable throat body 120 being 0.4 inches. Table 5#D t (in) A t / A n L t (in) L d (in) L t +L d (in) P n (psig) V' n (slpm) P shutoff (cmH 2 O) P aw (cmH 2 O) V' aw (slpm) 5.10.23230.400.400.80------10.0------10.524.357.03.091.05.20.08630.400.400.800.44.310.00.0---10.5------------

[0033] The tabulated performance characteristics of interest from the combined data of the relaxed and constricted states of the deformable throat body 120 of the above candidate venturi geometry #5 are summarized in Table 6 below: Table 6#RELAXED CONSTRICTED V' n at P n = 10.5 psig P shutoff at P n = 10.5 psig V' aw-max at P n = 10.5 psig X max V' n at PEEP = 10 mmH 2 O 524.357.096.14.04.3

[0034] As can be seen from Tables 5 and 6 (and as graphically depicted in Figure 5), a variable throat jet venturi 100 having candidate venturi geometry #5 achieves a shutoff pressure P shutoff at the gas outlet 124 of 57.0 cmH 2 O (meeting target performance characteristics of at least 55 cmH 2 0) at a jet nozzle pressure P n of 10.5 psig and a jet nozzle flow V' n of 24.3 lpm (which is less than or equal to 30 slpm) while the plenum 140 is in a first pressurization state (uninflated) corresponding to the relaxed state of the deformable throat body 120. A maximum output flow V' aw-max = 96.1 is achieved. Meanwhile, when the plenum 140 is in a second pressurization state (inflated) corresponding to the constricted state of the deformable throat body 120, the same variable throat jet venturi 100 achieves PEEP (gas outlet pressure P aw = 10 cmH 2 O) at a jet nozzle flow V' n of 4.3 slpm. Thus, using a variable throat jet venturi 100 having a deformable throat body 120 as described herein, PEEP (e.g. gas outlet pressure P aw = 10 cmH 2 O) can be achieved at a jet nozzle flow V' n of less than 10 slpm, which is less than half of the 20 slpm that is typically required with conventional NIOV devices and, in some cases, at a jet nozzle flow V' n of less than 5 slpm, which is less than a quarter of typical requirements. It is worth noting, however, that energizing a pilot pressure line 30 as used in some implementations of the disclosed deformable throat body 120 may use some airflow, e.g. 1 slpm.

[0035] Equivalent testing can be performed to select a venturi geometry that meets design constraints of any patient interface 20, for example, one in which one or more entrainment openings 136 have a side-by-side relationship with the jet nozzle 110 and / or for different lengths between the nozzle 110 and the gas inlet 122 of the deformable throat body 120. Along the same lines, the venturi geometry can be selected to meet different performance characteristics, including different maximum ventilator output capabilities other than nozzle flow V' n ≤ 30 slpm and nozzle pressure P n = 10.5 psig, different PEEP other than 10 mmH 2 O, different target shutoff pressure P shutoff and maximum output flow V' aw-max at the maximum nozzle pressure P n , etc.

[0036] The controller 40 of the non-invasive ventilation system 10 (which may be a controller of an oxygen concentrator or ventilator as noted above) may be implemented with a programmable integrated circuit device such as a microcontroller or control processor. Broadly, the device may receive certain inputs, and based upon those inputs, may generate certain outputs. The specific operations that are performed on the inputs may be programmed as instructions that are executed by the control processor. In this regard, the device may include an arithmetic / logic unit (ALU), various registers, and input / output ports. External memory such as EEPROM (electrically erasable / programmable read only memory) may be connected to the device for permanent storage and retrieval of program instructions, and there may also be an internal random access memory (RAM). Computer programs for implementing any of the disclosed functionality of the controller 40 may reside on such non-transitory program storage media, as well as on removable non-transitory program storage media such as a semiconductor memory (e.g. IC card), for example, in the case of providing an update to an existing device. Examples of program instructions stored on a program storage medium or computer-readable medium may include, in addition to code executable by a processor, state information for execution by programmable circuitry such as a field-programmable gate arrays (FPGA) or programmable logic device (PLD).

[0037] In the above examples, a variable throat jet venturi 100 is implemented with a deformable throat body 120 whose cross-sectional area A t is selectively changed relative to a fixed cross-sectional area A n of a jet nozzle 110. However, it is also contemplated that the cross-sectional area A n of the jet nozzle 110 may itself be selectively decreased or increase instead of or in addition to the cross-sectional area A t of a deformable throat body 120. For example, the cross-sectional area A n of the jet nozzle 110 may be selectively changed by translating a tapered pin axially along the nozzle 110 or pressurizing an inflatable bladder similar to the plenum 140 described above. As another possibility, two jet nozzles 110 may be used, one for achieving PEEP at low nozzle flow V' n and the other for achieving desired P shutoff -V' aw-max performance. Exemplary data of candidate jet nozzle diameters D t for use with the disclosed embodiments is shown in Table 7, below: Table 7V' n (slpm):0.94 mm1.1 mm1.2 mm1.4 mm1.5 mm1.6 mmP n (psig)0.037"0.043"0.048"0.055"0.059"0.063"1.05.05.88.010.912.02.08.38.912.314.916.84.011.412.917.822.024.86.013.915.821.326.730.38.015.818.124.931.210.017.820.128.012.019.822.030.314.021.324.016.023.025.918.024.928.120.026.430.022.028.224.029.826.031.628.032.930.034.4

[0038] For ease of explanation, the above disclosure assumes that the variable throat jet venturi 100 has a single jet nozzle 110. As such, the cross-sectional area A n is described as corresponding to the diameter D n of the jet nozzle 110. However, the disclosure is not limited in this regard. For example, the variable throat jet venturi 100 may include a plurality of jet nozzles 110 arranged in a ring or other pattern. In this case, the cross-sectional area A n may refer to the total cross-sectional area of the plurality of jet nozzles 110 for purposes of evaluating the ratio A t / A n .

[0039] The above description is given by way of example, and not limitation. Further, the various features of the embodiments disclosed herein can be used alone, or in varying combinations with each other and are not intended to be limited to the specific combination described herein, but the resulting subject-matter is according to the invention only if it falls within the scope of the claims.

Claims

1. A variable throat jet venturi (100) for delivering ventilation gas to a patient, the variable throat jet venturi (100) comprising: a jet nozzle (110); a deformable throat body (120) arranged to receive ventilation gas output by the jet nozzle (110) and defining a gas inlet (122) and a gas outlet (124); and a housing (130) containing the deformable throat body (120), the housing (130) defining a pilot pressure port (135) for pressurizing a plenum (140) between an outer wall (126) of the deformable throat body (120) and an inner wall (137) of the housing (130), characterised in that the housing (130) has a frustoconical portion that flares outwardly away from the plenum (140) and defines an entrainment opening (136) which is open to ambient air, and in that the deformable throat body (120) is arranged to receive the ventilation gas output by the jet nozzle (110) through the entrainment opening (136) of the housing (130).

2. The variable throat jet venturi (100) of claim 1, wherein, with the plenum (140) in a first pressurization state, the variable throat jet venturi (100) achieves a pressure Pshutoff, with the gas outlet (124) occluded, of at least 5394 Pa (55 cmH2O) at a jet nozzle (110) pressure Pn of 72395 Pa (10.5 psig) and a jet nozzle (110) flow V'n equal to or less than 0.005 m3 / s (30 slpm) and, with the plenum (140) in a second pressurization state, the variable throat jet venturi (100) achieves a pressure Paw with the gas outlet (124) open, of 981 Pa (10 cmH2O) at a jet nozzle (110) flow V'n of less than 0.000167 m3 / s (10 slpm).

3. The variable throat jet venturi (100) of claim 2, wherein, with the plenum (140) in the second pressurization state, the variable throat jet venturi (100) achieves a pressure Paw with the gas outlet (124) open of 981 Pa (10 cmH2O) at a jet nozzle (110) flow V'n of less than 0.0000833 m3 / s (5 slpm).

4. The variable throat jet venturi (100) of either claim 2 or claim 3, wherein, with the plenum (140) in the first pressurization state, a ratio At / An of a cross-sectional area of the deformable throat body (120) to a cross-sectional area of the jet nozzle (110) is between 20 and 30 and, with the plenum (140) in the second pressurization state, the ratio At / An is between 2.0 and 5.0.

5. The variable throat jet venturi (100) of any preceding claim, wherein a distal tip of the jet nozzle (110) is outside the entrainment opening (136).

6. A patient ventilation interface (20) comprising: the variable throat jet venturi (100)of any preceding claim; and a nasal coupler (24) for fluidly coupling the gas outlet (124) of the deformable throat body (120) to a nostril of the patient.

7. The patient ventilation interface (20) of claim 6, wherein the nasal coupler (24) comprises a nasal pillow.

8. A non-invasive ventilation system (10) comprising: the patient ventilation interface (20) of either claim 6 or claim 7; and a pilot pressure line (30) fluidly coupled to the pilot pressure port (135).

9. The non-invasive ventilation system (10) of claim 8, further comprising a controller (40) programmed to energize the pilot pressure line (30) to constrict the deformable throat body (120) during an exhalation phase of positive end-expiratory pressure (PEEP) therapy.

10. The non-invasive ventilation system (10) of either claim 8 or claim 9, further comprising a multi-lumen tube (50) having a ventilation gas lumen (52) terminating in the nozzle (110) and a pilot pressure lumen (54) in fluid communication with the pilot pressure line (30).

11. A method of varying a ratio between a throat diameter and a jet nozzle (110) diameter of a variable throat jet venturi (100), the variable throat jet venturi being suitable for delivering ventilation gas to a patient, the method comprising: providing a deformable throat body (120) arranged to receive ventilation gas output by a jet nozzle (110), the deformable throat body (120) defining a gas inlet (122) and a gas outlet (124); and pressurizing a plenum (140) between an outer wall (124) of the throat body (120) and an inner wall (137) of a housing (130) containing the deformable throat body (120) to constrict the deformable throat body (120), characterised in that the housing (130) has a frustoconical portion that flares outwardly away from the plenum (140) and defines an entrainment opening (136) which is open to ambient air, and in that the deformable throat body (120) is arranged to receive the ventilation gas output by the jet nozzle (110) through the entrainment opening (136) of the housing (130).

12. The method of claim 11, wherein said pressurizing the plenum (140) includes energizing a pilot pressure line (30) fluidly coupled to a pilot pressure port (135) defined by the housing (130).

13. The method of either claim 11 or claim 12, wherein said pressurizing comprises pressurizing the plenum (140) from a first pressurization state, in which the variable throat jet venturi (100) achieves a pressure Pshutoff with the gas outlet (124) occluded, of at least 5394 Pa (55 cmH2O) at a jet nozzle (110) pressure Pn of 72395 Pa (10.5 psig) and a jet nozzle (110) flow V'n equal to or less than 0.0005 m3 / s (30 slpm), to a second pressurization state, in which the variable throat jet venturi (100) achieves a pressure Paw ,with the gas outlet (124) open, of 981 Pa (10 cmH2O) at a jet nozzle (110) flow V'n of less than 0.000167 m3 / s (10 slpm).

14. The method of claim 13, wherein, with the plenum (140) in the second pressurization state, the variable throat jet venturi (100) achieves a pressure Paw with the gas outlet (124) open, of 981 Pa (10 cmH2O) at a jet nozzle (110) flow V'n of less than 0.0000833 m3 / s (5 slpm).