Noninvasive ventilation via air entrainment patient interface

Abstract

One embodiment provides a system having a non-invasive ventilation patient interface. In one example, the system includes a head-mounted element and a non-invasive ventilation patient interface removably coupled to the head-mounted element. A non-invasive ventilation patient interface includes a catheter having an entrainment opening and a nasal cavity opening disposed along a catheter axis. The pressure sensing element is disposed proximate the nasal cavity opening. One or more orifices proximate the entrainment opening are configured to discharge a gas jet. The one or more surfaces have a first end proximate the one or more orifices and directing a flow of a gas jet exiting the one or more orifices and a second end closer to the nasal opening than the first end. In the operational state, the gas jet adheres to the one or more surfaces via the Coanda effect to entrain ambient air into the entrainment opening to deliver the gas jet and ambient air through the nasal cavity opening of the catheter.

Description

[0001] Cross - Reference to Related Applications

[0002] This patent application claims the benefit of priority to U.S. Provisional Application No. 63 / 428,221, filed on November 28, 2022, under 35 U.S.C. 119(e), the contents of which are incorporated herein by reference. Technical Field

[0003] The disclosed subject matter generally relates to patient ventilation interfaces. Certain disclosed subject matter relates to techniques for non-invasive ventilation via an intranasal patient entrainment interface. Background Art

[0004] It is known that there are non-invasive ventilation solutions that can provide dynamics. For example, Inogen's TIDAL ASSIST (tidal assist) ventilator (TAV) is a handheld controller that is connected to a high-pressure oxygen cylinder as a gas source. TAV ​​can deliver continuous flow oxygen, pulse dose oxygen, or ventilate via tidal assist mode. In tidal assist mode, the controller delivers 50 to 250mL of oxygen pulses to a customized air entrainment patient interface with a flow and pressure that produces non-invasive inspiratory positive airway pressure (IPAP) in the user's airway. The patient interface utilizes the Venturi principle to entrain air into the oxygen pulse, thereby producing a larger flow and bolus delivered to the patient, and then as the speed of the gas entering the patient's airway slows down, an inspiratory positive airway pressure (IPAP) is produced. TIDAL ASSIST and TAV are registered trademarks of Inogen in the United States and / or other countries / regions.

[0005] As another example, the LIFE2000 ventilator from Breathe Technologies can also be used when connected to a high pressure oxygen cylinder, but it has two other configurations in which it can be used, namely, when tethered to or docked with an air compressor base station. The LIFE2000 ventilator can provide IPAP and expiratory positive airway pressure (EPAP) from either an oxygen cylinder gas source or air from a compressor base station. LIFE2000 is a registered trademark of Breathe Technologies in the United States and / or other countries.

[0006] This known non-invasive nasal patient ventilation interface utilizes a substantially closed configuration whereby a jet of gas entrains ambient air via the Bernoulli principle through a port. This requires a closed structure and generates a significant amount of noise. Summary of the invention

[0007] One embodiment provides a system having a non-invasive ventilation patient interface. In one example, the system includes a headgear element and a non-invasive ventilation patient interface detachably coupled to the headgear element. The non-invasive ventilation patient interface includes a conduit having an entrainment opening and a nasal opening disposed along a conduit axis. A pressure sensing element is disposed proximate the nasal opening. One or more orifices proximate the entrainment opening are configured to discharge a gas jet. One or more surfaces have a first end and a second end, wherein the first end is proximate the one or more orifices and directs the airflow discharged from the one or more orifices, and the second end is closer to the nasal opening than the first end. In an operating state, the airflow adheres to the one or more surfaces via the Coanda effect, thereby entraining ambient air into the entrainment opening and delivering the airflow and ambient air through the nasal opening of the conduit.

[0008] Another embodiment includes a system that includes a headgear device and a non-invasive ventilation patient interface device detachably coupled to the headgear device. The non-invasive ventilation patient interface device includes: a conduit device having an entrainment opening and a nasal opening disposed along a conduit axis; a pressure sensing device disposed proximate the nasal opening; one or more orifice devices proximate the entrainment opening and configured to discharge a gas jet; and one or more surface devices having a first end and a second end, the first end being proximate the one or more orifice devices and directing the flow of the gas jet discharged from the one or more orifice devices; the second end being closer to the nasal opening than the first end. In an operating state, the gas jet adheres to the one or more surface devices via the Coanda effect, thereby entraining ambient air into the entrainment opening and delivering the airflow and ambient air through the nasal opening of the conduit.

[0009] Another embodiment provides a method that includes: providing a conduit having an entrainment opening and a nasal opening disposed along a conduit axis; providing a pressure sensing element proximate the nasal opening; configuring one or more orifices proximate the entrainment opening to discharge a gas jet; and providing one or more surfaces having a first end and a second end, the first end being proximate the one or more orifices and configured to direct the flow of the gas jet discharged from the one or more orifices; the second end being closer to the nasal opening than the first end. In an operating state, the patient interface configured according to the method arranges the orifices and the surfaces to adhere the gas jet to the surface via the Coanda effect, thereby entraining ambient air into the entrainment opening and delivering the gas jet and ambient air through the nasal opening of the conduit.

[0010] It will be apparent from reading this specification that methods, devices, systems, and products are provided for implementing the various embodiments.

[0011] The foregoing is the invention content and may therefore contain simplifications, generalizations, and omissions of details; accordingly, those skilled in the art will understand that this invention content is merely illustrative and not intended to be limiting in any way.

[0012] These and other features and characteristics of the example embodiments, as well as the methods of operation and functions of the related structural elements and their combinations, will become more apparent upon reference to the accompanying drawings and in conjunction with the following description and the appended claims. The drawings form a part of this specification. However, it should be clearly understood that the drawings are for illustrative and descriptive purposes only and are not intended to limit the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 A cross-sectional view illustrating a portion of an example patient interface.

[0014] Figure 1A Illustrates Figure 1 Panel A of

[0015] Figure 2 A cross-sectional view illustrating an example patient interface.

[0016] Figure 2A An example patient interface is illustrated in a partially exploded view.

[0017] Figure 3 An example view of the airflow in an example patient interface is illustrated.

[0018] Figure 4 A cross-sectional view illustrating an example patient interface.

[0019] Figure 4A Illustrates Figure 4 Panel A of

[0020] Figure 4B An end view of the entrainment portion of a portion of an example patient interface is illustrated.

[0021] Figure 4C Illustrates Figure 4 and Figure 4B A perspective partial cross-sectional view of an example patient interface of

[0022] Figure 4D Illustrates Figure 4 An example front view of a patient interface of

[0023] Figure 5 An example tubular member is illustrated.

[0024] Figure 6 An example system is illustrated.

[0025] Figures 7A to 7B An example of a patient interface skirt is illustrated.

[0026] Figures 8A to 8H Illustrates an example orifice arrangement.

[0027] Figure 9 Views illustrating an example surface and opening arrangement.

[0028] Figures 10A to 10D Illustrates an example sidewall and orifice arrangement.

[0029] Figure 10E Illustrates an example orifice arrangement.

[0030] Figure 11 Schematic diagrams illustrating example system components.

[0031] Figure 12 Illustrates an example method. Detailed Description

[0032] As used herein, unless the context clearly dictates otherwise, the singular forms "a," "an," and "the" include plural referents. As used herein, two or more parts or components being "coupled" means these parts are directly or indirectly connected or operate together, e.g., through one or more intermediate parts or components, so long as a connection exists. As used herein, "operably coupled" means that two or more elements are coupled together to operate together or to communicate with each other unidirectionally or bidirectionally. As used herein, the term "number" shall mean one or an integer greater than one (i.e., a plural). As used herein, "a group" means one or more.

[0033] Furthermore, the described features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. In the following description, numerous specific details are provided to understand the embodiments. However, those skilled in the art should understand that the various embodiments may be implemented without one or more of the specific details, or using other methods, components, materials, etc. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obscuring the description.

[0034] One embodiment utilizes a surface to attach a pressurized gas jet via the Coanda effect, allowing the gas jet to be directed as needed by utilizing the surface geometry. Thus, various embodiments utilize the Coanda effect to entrain ambient air with a medical gas jet for delivery via a patient interface.

[0035] The Bernoulli principle describes the relationship between fluid velocity and fluid pressure, where an increase in fluid velocity results in a decrease in fluid pressure. Thus, when a fluid (sometimes referred to as a jet) flows into a region of lower or zero velocity (sometimes referred to as the ambient region), its inherent pressure is lower than the ambient pressure, and thus the ambient fluid is drawn towards the jet. Coupled with the shear-induced turbulent flux effect, this causes the ambient fluid to be entrained into the jet.

[0036] When a fluid jet enters an ambient fluid, an axisymmetric low pressure forms around the jet. The forces resulting therefrom remain balanced around the entire jet and create a stable flow that propagates in a straight line (assuming no other external forces act on it). If a boundary (such as a wall) is close enough to the jet, then little or no ambient fluid is available to balance the low pressure formed around that part of the jet, and thus the resulting unbalanced forces cause the jet to become unstable, which tends to pull the jet towards the boundary. The jet will remain attached to the boundary until the pressure difference is no longer sufficient to pull it towards the boundary. This is known as the Coanda effect, which is described as the tendency of a fluid flow to be pulled towards and remain attached to a nearby boundary (such as a wall).

[0037] Turning now to the drawings for illustration. With reference to the drawings, the exemplary embodiments shown can be better understood. The following description is only by way of example and is only for illustrating certain exemplary embodiments.

[0038] Figure 1 A cross-section of a portion (one side) of the patient interface 100 is shown. In one embodiment, the patient interface 100 is a mechanism that directly connects to a patient airway (e.g., the nasal cavity). For example, the patient interface 100 includes an internal nasal pillow 101 that contains (a plurality of) elastomeric features that assist in conforming the interface to and sealing against the patient airway. The patient interface 100 includes geometries such as a conduit 102 and its entrainment openings 102a and nasal opening 102b that assist in entraining and / or increasing positive pressure in the downstream direction of the patient interface 100. The patient interface 100 also includes features such as optional and / or removable skirts (730b, 731b in FIG. 7) for controlling the sound or noise and the flow or pressure of the gas passing through the patient interface 100, and effectively extending the length of the conduit 102 and defining an entrainment opening at a location more upstream of the nasal opening, such as Figure 2A shown as 230a, 202a in. The patient interface 100 also includes (a plurality of) rigid features such as a surface 103 and a frame 213a that assist in docking with other elements (such as skirts 730b, 731b, a tubular member 515, (a plurality of) internal nasal pillows 101, etc.) to allow for removal and replacement of portions of the patient interface 100 as needed to meet the requirements of a retrievable face mask.

[0039] It should be noted that while Figure 1The illustrated patient interface 100 employs an internal nasal pillow 101 (i.e., seals inside the nose), but the features of this embodiment can be used with any other type of face mask, such as (but not limited to) a standard face mask that seals over the outside of the patient's nasal cavity, any nasal pillow interface, nasal cushion, nasal mask, full face mask, etc. Additionally, while the internal nasal pillow 101 can be made of an elastic material for patient comfort and sealing, other materials (e.g., rigid materials) can also be used, and the internal geometry of the patient's airway can be utilized to generate positive pressure rather than through the material of the patient interface 100.

[0040] As Figure 1 shown, the patient interface 100 includes an entrainment opening 102a and a nasal opening 102b defined by a conduit 102. Figure 1 An example embodiment of which includes a surface 103, which is in a curved form here, that extends from a chamber 106a containing a pressurized medical gas (such as oxygen) (see Figure 1A ) and curves into the conduit 102. The chamber 106a can be formed by components (such as a frame 113 having a port or interface 140), such as for attachment to a tube 515 (as further described herein).

[0041] As shown, the surface 103 begins at the chamber 106a and terminates at the conduit 102 via a bend of approximately 90 degrees. The pressurized medical gas (indicated by the Figure 1A dashed arrow in ) is provided as a high-speed jet (e.g., at a speed of about 310 m / s) through an orifice 107a (e.g., formed by the (multiple) sidewalls of the chamber 106a and the surface 103). As Figure 1A further shown, the orifice 107a is close to the surface 103 and extends forward into the interior of the conduit 102. In one embodiment, an offset 108a is employed between the orifice 107a and an extension of the surface 103 (near the nasal end), which will be further described in conjunction with Figure 3 In one example, the orifice 107a can be sized to have a cross-sectional area of about 0.1 mm to 0.4 mm. In one example, the offset 108a can be sized to be about 5 / 1000 inches to 20 / 1000 inches. In one example, the (multiple) sidewalls 109a can be sized to be about 8 / 1000 inches to 0.1 inches high.

[0042] Due to the Coanda effect, the airflow adheres or clings above the surface 103. This allows the gas jet to enter the tube 102 in a guided manner along the surface 103. As will be further described herein, the surface 103 can be provided with or near one or more sidewalls (e.g., Figure 1A the sidewall 109a in ) to further guide the gas jet as needed.

[0043] In one example, a gas jet travels along or adheres to surface 103 via the Coanda effect. This entrains ambient air, which has a relatively zero pressure near the entrainment opening 102a in the absence of a gas pulse. When a gas jet is provided (at about 250 m / s), the pressure within conduit 102 near the orifice ( Figure 1A 107a therein) drops to about -500 Pa, and ambient air begins to move upward within conduit 102 (at about 8 m / s). As the gas jet entrains ambient air (see Figure 3 ), the pressure within the middle to upper portion of conduit 102 rises to about 1470 Pa, while the gas jet slows to about 150 m / s. At the nasal opening 102b, the gas pressure is about 1960 Pa, and the gas jet and ambient gas (entrained mixture) move at about 40 m / s.

[0044] As Figure 1 shown, a sensor or pressure sensing element 105 can be provided, for example, an electric pressure sensor or a pressure sensing line with an opening or pressure sensing port 105a near the nasal opening 102a of the conduit. Such an arrangement can sense the pressure, for example, near the patient's nasal cavity. As Figure 1 shown, the sensor 105 can be in the form of a tube that is angled approximately 90 degrees to be side-by-side or generally parallel with the medical gas delivery (initial) and the entrained mixture delivery (near the nasal end). It will be appreciated that the sensor 105 can include (multiple) other sensors in addition to Figure 1 the pressure sensing line shown, or instead of Figure 1 the pressure sensing line shown, as described in the example in conjunction with Figure 4 .

[0045] The sensor 105 can be formed as a manometer tube that transmits the pressure generated within the region of the nasal end 102b of the patient interface 100 to a sub-lumen tube ( Figure 5 517 in Figure 5 ) of a multi-lumen tube ( 515 in ) for pressure measurement at an operatively coupled controller. Pressure measurement is crucial for closed-loop feedback to allow the controller to monitor and adjust the treatment pressure within the ISO standard range according to, for example, a breathing or ventilation program. For example, this is considered necessary for ventilator treatment.

[0046] A suitable configuration of the sensor 105 is a stainless steel thin-walled tube that has been bent or shaped (such as bent to have a 90-degree angle), capped, and drilled on the side to form the opening 105a to minimize the flow-induced effects on the static pressure reading. It should be noted that the opening can be located at the end of the sensor 105 instead of the side location. Additionally, other materials can also be used for the sensor tubing, such as the materials described in relation to the tubing 515.

[0047] Figure 2 Shows an example of a dual-sided patient interface, i.e., one side for each nasal cavity. Here, the first side 200a and the second side 200b are connected together to form a nasal delivery interface for the patient. As Figure 1 shown, side 200a can correspond to Figure 1 the patient interface 100 in Figure 2 The view of Figure 1 shows the catheter axis 212a, which is substantially parallel to the flow direction of the patient interface 100. For example, referring to

[0048] Figure 2A An example patient interface is shown in a partially exploded view. In Figure 2A the view, the left side (as shown) is a partially exploded view to highlight the docking of the rigid part frame 213a with the clip interface 219a (which can also be the rigid part forming the catheter). This allows the frame 213a and the surface 203a to be positioned within the catheter, which in this view is covered by the inner nasal pillow 201a and the skirt 230a. It should be noted that since this example includes the skirt 230a, the length of the catheter (entrainment opening 202a) is upstream of the orifice of the gas jet within the delivery catheter. Figure 9 An unobstructed view of the frame 213a (913) as viewed from the orifice side is provided, as further described herein.

[0049] Figure 3 Shown in Figure 1A is a side view of the surface 303, the offset 308, and the orifice 307 in reference to Figure 1 Here, a fluid jet (illustrated as a medical gas - solid arrow) enters the ambient air (dashed arrow), and an axisymmetric low pressure is formed around the jet. The resulting forces are balanced around the entire jet, and a stable flow propagating in a straight line is produced. Here, the surface 303 is placed close to the opening 307, so the jet is generated close to the surface 303, which is determined by the (optional) offset 308. There is little or no ambient air between the surface 303 and the jet leaving the opening 307 to balance the low pressure formed around the part of the jet exposed to the ambient air (e.g., Figure 3The net force (in ) causes the jet flow to be unstable, and this instability tends to pull the jet towards and adhere it to surface 303. The jet will remain attached to surface 303 and entrain ambient air to form an entrained mixture until the pressure difference is no longer sufficient to pull the jet towards surface 303. This is known as the Coanda effect, which is described by the tendency of a fluid flow to be pulled towards and remain adhered to a nearby boundary (such as surface 303).

[0050] Combined Figure 1 The patient interface 100 geometry described includes a medical gas delivery orifice that is perpendicular to the direction of the entrained flow, which is guided by the curved surface 103; however, the patient interface 100 can be configured to have various orifice angles relative to the direction of the entrained flow, such as in the range greater than 0 degrees and less than 180 degrees relative to the direction of the entrained flow.

[0051] For example, Figure 4 One side of an embodiment is shown in a cross-sectional view, where surface 403 is provided by at least a partially circumferential element (by circumferential it is meant that the surface extends relative to or around the catheter axis). As shown, surface 403 is enclosed within catheter 402, which is located between the entrainment opening 402a and the nasal opening 402b. A port or interface 404 provides pressurized medical gas (solid arrows) within chamber 406. Chamber 406 cooperates with surface 403 to form an opening, one of which is shown as 407a in Figure 4A As described herein, one or more supports 410 can be attached to one or more of port or interface 404 and the circumferential element providing surface 403, which will be further described in conjunction with Figures 4A to 4C below.

[0052] As Figure 4 shown, the nasal pillow 401 closes catheter 402 at the nasal end, while ambient air (dashed arrows) is entrained from the ambient end. In Figure 4 the example shown, sensor 405 (pressure sensing line) linearly extends through catheter 402, positioning the sensor opening (or pressure sensing port) 405a near the nasal end of catheter 402 such that it is oriented to face in a direction parallel to the flow direction. In one embodiment, as shown in Figure 4 and Figure 4D shown, the sensor opening 405a can alternatively or additionally be provided in one or more different regions, such as on the surface of one or more supports 410d or on the surface of the element providing surface 403d, as shown at 405b. In alternative embodiments, a pressure sensing element (e.g., transducer, resistive, capacitive, piezoelectric, optical, or MEMS sensor) can be used as sensor 405 at one or more of the above positions, and the pressure sensing element is electrically coupled (e.g., through the wiring of tube 515 or sub-lumen 517, as described below in Figure 5shown) to a remote unit, such as a microcontroller or communication element operatively coupled thereto. An advantage of this embodiment is to reduce the time delay associated with pneumatic pressure sensing, i.e., there is no time delay between a pressure change at the sensor location and the determination of pressure by the sensor 405. In the case where the pressure sensing line is the sensor 405 with the sensor opening 405a, there may be a delay of approximately 100 milliseconds. Similar to the Figure 1 arrangement, Figure 4 the catheter axis 412a is shown.

[0053] From Figure 4A the detailed view, in an embodiment having a circumferential element (providing the surface 403), an orifice 407a is formed via the mating between the surface 403a and the wall of the chamber 406a. This enables a pressurized medical gas jet to discharge from the orifice 407a and again adhere to the surface 403a via the Coanda effect. As Figure 4 shown, this allows the gas jet to entrain ambient air to form an entrained mixture including ambient air and medical gas and supply it to the patient via the nasal end 402b.

[0054] For example, in the Figure 4 arrangement, ambient air at approximately 0 Pa (no medical gas pulse) is then entrained by the gas jet adhering to the surface 403 and discharged from the nasal end in the form of an entrained mixture at approximately 1960 Pa, similar to the Figure 1 situation described. In the embodiment of the Figure 4 shown configuration, the pressure gradient at the ambient or entrained end is approximately -10 Pa, approximately -1000 Pa near the orifice 407a (-1500 Pa on the surface 403), rising to approximately 320 Pa at approximately half way between the orifice 407a and the nasal end, and then leaving at a pressure of approximately 1960 Pa. Similar to the Figure 1 flow rate described, ambient air is entrained by a pulsed gas with a velocity of approximately 10 m / s at the entrained end, increasing to approximately 100 m / s near the orifice 407a, and then discharging the gas at a velocity of approximately 210 m / s. The entrained mixture slows down to approximately 35 m / s at approximately half way between the orifice 407a and the nasal end 402b and then discharges at a velocity of approximately 30 m / s.

[0055] Figure 4B provides Figure 4View of the entrainment end 402a of the illustrated embodiment. It will be understood here that the circumferential element may include an interface or port 404b which is supported by one or more support or suspension elements 410b which are attached to or extend from the inner wall 411b of the conduit 402 to suspend the circumferential element (including surface 403) in the middle or inside of the conduit 402. It will be understood that fluid connectivity may be provided through one or more supports 410b or interfaces or ports 404b, such as to a supply of pressurized medical gas, and the interface or port 404b may in turn be connected to a tubular member ( Figure 4B not shown in the figure, see Figure 5 515 in

[0056] Figure 4C illustrates Figure 4 and Figure 4B a partial cross-sectional perspective view of an exemplary patient interface in the figure. Here, for the sake of illustration, a surface 403c formed via the circumferential element is shown in the figure, with a part of the conduit 402c removed. The interface or port 404c provides an inflow of pressurized medical gas and delivers it to the patient via the Coanda effect (adhering to the surface 403c) via an orifice (one of which is designated 407c). A support is also shown in the figure, one of which is designated 410c, which may be attached to the interface or port 404c and / or provide the circumferential element of the surface 403c.

[0057] Figure 5 An example diagram of a tubular member 515 of an embodiment is provided, which may be connected to or extend from a port or interface (e.g., Figure 1 and Figure 4 the port or interface 104 or 404 in Figure 1 and Figure 4 ) to supply pressurized medical gas. The tubular member 515 may include a main lumen or primary lumen 516 for providing pressurized medical gas, e.g., to supply pressurized medical gas to the Figure 1 chambers 106a and chamber 406 shown in

[0058] In Figure 5 the example of, the tubular member 515 includes anti-clogging ribs 518a and anti-clogging ribs 518b, which are approximately equidistant from each other and from the secondary lumen 517. In one example, an embodiment includes a portion of a sensor (such as sensor 105) located within the secondary lumen 517 such that it can extend back through the patient interface 100 and transmit readings to a remote unit (such as a microcontroller or communication element) operatively coupled thereto.

[0059] The tubular member 515 can be formed as an elastomeric tubular member that includes at least two lumens 516, 517 separated by a septum. In one example, one lumen 516 is for delivering pressurized medical gas to a Coanda surface (e.g., surface 103), and another lumen 517 is for providing a pressure sensor (e.g., sensor 105) that senses the pressure generated at the nasal end 102b of the patient interface 100. The sensed pressure can be fluidly transmitted back to a controller for measurement and response. As described herein, the tubular member 515 optionally includes structures such as anti-clogging ribs 518a, 518b within the lumens 516, 517 to prevent it from becoming completely blocked (e.g., if the tubular member 515 kinks).

[0060] The material selected for the tubing can include Lubrizol TECOFLEX EG-80A. The ultimate tensile strength of TECOFLEX EG-80A is approximately four times that of silicone, which allows for a thinner wall compared to silicone and still be able to withstand the internal pressure of the medical gas within the primary lumen 516. The thinner wall tubing 515 combined with a relatively soft hardness (the nominal hardness of EG-80A is 72A) makes it softer and more flexible than equivalent performance silicone or PVC catheters. TECOFLEX EG-80A is a medical grade thermoplastic polyurethane (TPU) that has passed ISO10993-4 (hemolysis test), ISO10993-5 (cytotoxicity test), ISO10993-6 (muscle implantation, 2 weeks and 13 weeks), ISO10993-10 (intradermal injection), and ISO10993-11 (systemic injection) tests. TecoFlex is a registered trademark of Lubrizol Advanced Materials, Inc. in the United States and / or other countries.

[0061] Arkema PEBAX 2533SA 01MED can also be used for the tube 515. Like TECOFLEX EG-80A, the ultimate tensile strength of PEBAX 2533SA 01MED is approximately five times that of silicone, which allows for a thinner wall compared to silicone and still be able to withstand the internal pressure of the medical gas in the main lumen 515. Compared to silicone or PVC tubes of equivalent performance, the thinner wall tube 515 combined with a relatively soft durometer (the nominal durometer of PEBAX 2533SA 01MED is 77A) provides a softer and more flexible feel to the tubular member 515. PEBAX 2533SA 01MED is a medical grade TPU that has passed the United States Pharmacopeia (USP) Class VI (systemic toxicity, skin irritation, and infection) testing. PEBAX is a registered trademark of Arkema France in the United States and / or other countries.

[0062] Although certain materials have been described as suitable for use with the tubular member 515, it should be noted that several other medical grade elastomers can also be used, such as but not limited to silicone, polyvinyl chloride (PVC), thermoplastic elastomer (TPE), etc.

[0063] Figure 6 A system is shown that includes a patient interface device 600 and (a plurality of) headgear elements (collectively 620) that can be removed from or statically connected to the patient interface 600. In one example, the headgear 620 includes one or more straps 621, 622, 623 that secure the patient interface 600 close to the patient's nasal cavity. One or more clips 624, 625 can also be provided to secure the tube 614 to a desired location.

[0064] In Figure 6 the example, the main strap 621 includes a backing or padding to improve patient comfort. In one example, the main strap 621 can be divided into two straps 622 and 623 to further secure the patient interface 600 to the patient.

[0065] In one embodiment, the headgear 620 is a strap 621 that connects and secures the patient interface 600 to the patient. The strap 621 may include a fabric strap that has at least two separate loops or elements 623, 623 to meet the requirements of a retractable mask. The strap 621 includes connection features such as clips 624, 625 that can be firmly clipped onto the tube 615 and also allow for fitting adjustments to the patient. In one example, the headgear 620 includes (a plurality of) clips 624 towards the rear of the headgear that align the tube 615 along the strap-like or wider portion of the strap 621 of the headgear 620 and lift the tube 615 off the patient's ears to increase comfort during use. The headgear 620 may be removable and replaceable, for example, removable and replaceable from the patient interface 600 to meet the requirements of a retractable mask.

[0066] In one embodiment, the patient interface 100 includes rigid or flexible features that wrap around the surface 103 in the form of a skirt to improve entrainment and / or pressure generation, and / or reduce the sound pressure level of the patient interface 100. However, the patient interface 100 may operate in a configuration without a skirt, a partial skirt, a partial enclosure, or a full enclosure.

[0067] For example, Figure 7A and Figure 7B Examples of removable skirts that can be used in combination with patient interfaces 100, 200a, 200b, etc. are shown. In one embodiment, no skirt is provided. However, in another embodiment, a skirt 730a is provided that partially encloses the entrainment opening of the conduit near the tube 715a. In another embodiment, a skirt 731b is provided that fully encloses the entrainment side of the patient interface near the tube 715b. It will be understood that either of the skirts 730a and 731b can be placed on and removed from the patient interface at the ambient side opening, for example, to modulate the noise associated with the operation of the patient interface, which can be very loud (e.g., about 80 dB), without any sound buffering components.

[0068] Figures 8A to 8H Examples of various orifices 807a - h are shown that can be formed to provide a gas jet near the surface to utilize the Coanda effect described herein. In Figure 8A the example of, two linear slots (one designated as 807a) may be provided to produce a gas jet that adheres to the surface 803a and is guided using a sidewall (one designated as 809a).

[0069] In Figure 8BIn an example, multiple stacked slots can be provided, for example, two slots as shown (one represented by 807b), to generate an air flow that adheres to surface 803b, and is guided using side walls (one represented by 809b).

[0070] In Figure 8C an example, multiple vertical slots as shown (one represented by 807c) can be provided to generate an air flow that adheres to surface 803c, and is guided using side walls (one represented by 809c).

[0071] In Figure 8D an example, a linear orifice (one represented by 807d) can be provided to generate a gas jet that adheres to surface 803d, and is guided using side walls (one represented by 809d).

[0072] In Figure 8E an example, stacked orifices (one represented by 807e) can be provided to generate a gas jet that adheres to surface 803e, and is guided using side walls (one represented by 809e).

[0073] In Figure 8F an example, a non-linear slot 807f can be provided to generate a gas jet that adheres to surface 803f, and is guided using side walls (one represented by 809f).

[0074] In Figure 8G an example, a non-uniform section 807g can be provided to generate a gas jet that adheres to surface 803g, and is guided using side walls (one represented by 809g).

[0075] In Figure 8H an example, multiple directional orifices as shown (one represented by 807h) can be provided to generate an air flow that adheres to surface 803h, and is guided using side walls (one represented by 809h).

[0076] As described herein, one or more side walls 109a can be included to assist in guiding the gas jet along surface 103, but this is not required. As Figure 9 shown, surface 903 extends from frame 913, and in one example, when it enters the tubular member ( Figure 9When not shown) is bent by approximately 90 degrees. One or more side walls (one of which is denoted by 909) assist in guiding the gas jet along the surface 903 as the gas jet exits the orifice 907 through the tube 915. It should be noted that in one embodiment, the curvature of the surface can include other angles, such as between 0 and 180 degrees (greater than 0 degrees and less than 180 degrees). In one example, the curvature can be between 45 and 100 degrees.

[0077] The surface 903 can be a rigid portion that interfaces with the tube 915. The (multiple) medical gas delivery orifices 907 supply pressurized medical gas to the catheter through the surface 903, which can be non-linear, thereby affecting the inflow direction of the pressurized medical gas via the Coanda effect. Figure 9 The example shown also includes two side walls, one of which is denoted by 909, for assisting in maintaining and guiding the Coanda effect. This element can also provide an offset between the orifice 907 and the surface 903 to improve the initial generation of the Coanda effect through vortices, as Figure 3 shown. An offset can also be provided between the outer edge of the orifice 907 and the side wall 909 to assist in maintaining and guiding the Coanda effect.

[0078] As described in connection with Figures 8A to 8H changing the orifice size can achieve different degrees of entrainment of surrounding air, different degrees of noise, etc., depending on the selected configuration and other existing patient interface elements (such as skirts 730a, 731b). Additionally, as Figures 10A to 10D shown, different side wall configurations can be used. For example, Figure 10A the parallel configuration shown, where two side walls are separated by an intermediate side wall 1009a, thereby providing two surfaces (one of which is denoted by 1003a) and two orifices (one of which is denoted by 1007a).

[0079] In Figure 10B the example of, a converging configuration where two side walls are separated by a converging intermediate side wall 1009b provides two converging surfaces (one of which is denoted by 1003b) and two orifices (one of which is denoted by 1007b).

[0080] In Figure 10C the example of, a diverging configuration where two side walls are separated by a diverging intermediate side wall 1009c provides two diverging surfaces (one of which is denoted by 1003c) and two orifices (one of which is denoted by 1007c).

[0081] In Figure 10DIn the example, two surfaces (one surface is denoted as 1003d) and two orifices (one orifice is denoted as 1007d) in the separation configuration are separated by two intermediate sidewalls (one intermediate sidewall is denoted as 1009d).

[0082] Reference Figure 4 and Figure 4C , in the example of using a circumferential element to provide surface 403c, the support 410c can be suspended or attached to an element that includes surface 403c. In one example, one or more supports 410c are attached to a circumferential element having surface 403c, the circumferential element being located at or near orifice 407c and extending to the nasal opening of conduit 402c. As Figure 10E shown, this figure is a nasal end view of a patient interface having circumferential features, and one or more orifices 1007e can be disposed circumferentially around surface 1003e. Here, the device is configured such that surface 1003e and port or interface 1004e cooperate to form orifice 1007e in a circumferential manner. As described in connection with Figures 8A to 8H , one or more orifices 1007e can take various forms, including Figures 8A to 8H the form shown in Figure 4 . Similarly, when used in the configuration shown in Figures 10A to 10D , one or more orifices 1007e can be placed near one or more sidewalls, such as as shown in

[0083] Reference Figure 11 , it is readily understood that certain embodiments can include a controller or microcontroller for delivering a medical gas pulse from a medical gas source 1190 through patient interface 1100 and coordinating with sensor data feedback (such as feedback provided by sensor 105 included in patient interface 1100). Figure 11 illustrates an example of a computer and its components that can be used in a controller device to implement certain functions or actions described herein, such as providing timed medical gas pulses. Additionally, in one or more embodiments, other circuitry than that shown in Figure 11 can be used. As shown, Figure 11 the example of

[0084] One or more processing units are provided, which may include a central processing unit (CPU) 1140 that includes an arithmetic logic unit (ALU) for performing arithmetic and logical operations, an instruction decoder for decoding instructions and providing information to a timing and control unit, and registers for temporary data storage. The CPU 1140 may include a single integrated circuit that includes multiple units, the design and layout of which vary according to the selected architecture.

[0085] The computer also includes a memory controller 1170, for example, including a direct memory access (DMA) controller for transferring data between the memory 1180 and hardware peripherals. The memory controller 1170 includes a memory management unit (MMU) for handling cache control, memory protection, and virtual memory. The computer may also include a controller for communicating using various communication protocols (such as I2C, USB, etc.).

[0086] The memory 1180 may include various types of memory, including volatile and non-volatile memory, such as read-only memory (ROM), random access memory (RAM), electrically erasable programmable read-only memory (EEPROM), flash memory, and cache. The memory 1180 may include embedded programs, code, and downloaded software, for example, a respiration or ventilation program 1180a for delivering medical gas through the patient interface 1100 described herein. By way of example and not limitation, the memory 1180 may also include an operating system, application programs, other program modules, code, and program data, all of which may be downloaded, updated, or modified by a remote device.

[0087] The system bus allows communication between the various components of the computer. An I / O interface 1160 and radio frequency (RF) devices 1150 (such as WIFI and telecommunications radios) may be included to allow the computer to send and receive data to and from remote devices using wireless mechanisms. It should be noted that a data exchange interface for wired data exchange may be used. The computer may operate in a networked or distributed environment, using a logical connection to one or more other remote computers or databases. The logical connection may include a network, such as a local area network (LAN) or a wide area network (WAN), and may also include other networks / buses. For example, the computer may communicate data with the sensor devices of the patient interface 1100 that collect sensor data and communicate data between these sensor devices.

[0088] Thus, the computer can execute program instructions or code for acquiring, storing, and analyzing sensor data and performing other functions of the embodiments described herein. A user can interact with the computer (e.g., input commands and information) through an input device connected to the I / O interface 1160. A display or other type of device can be connected to the computer 500 through an interface selected from the I / O interface 1160.

[0089] It should be noted that the various functions described herein can be implemented using instructions or code stored in a memory (e.g., memory 1180), which are transmitted to and executed by a processor (e.g., CPU 1140). The computer includes one or more storage devices for persistently storing programs and other data. The storage devices used herein refer to non-transitory computer-readable storage media. Examples of non-transitory storage devices or computer-readable storage media include, but are not limited to: storage devices integrated into the computer (e.g., memory 1180), hard disks or solid-state drives, and removable storage devices (e.g., optical discs or memory sticks).

[0090] The program code stored in the memory or storage device can be transmitted using any suitable transmission medium, including but not limited to wireless, wired, fiber optic cable, RF, or any suitable combination of the foregoing.

[0091] The program code for performing operations according to various embodiments can be written in any combination of one or more programming languages. The program code can be executed entirely on a single device, partially on a single device, executed as a stand-alone software package, partially on a single device and partially on another device, or entirely on another device. In one embodiment, the program code can be stored in a non-transitory medium and executed by a processor to implement the functions or actions specified herein. In some cases, the devices mentioned herein can be connected through any type of connection or network connection, including a local area network (LAN) or a wide area network (WAN), or can be connected through other devices (e.g., through the Internet using an Internet service provider), a wireless connection, or a wired connection (e.g., through a USB connection).

[0092] Reference Figure 12, one embodiment includes a method of providing a patient interface as shown and described. In one example, the method includes providing (1201) a conduit having an entrainment opening and a nasal opening disposed along a conduit axis. The method includes providing (1202) a pressure sensing line having a pressure sensing port proximate the nasal opening and configuring (1203) one or more orifices proximate the entrainment opening to discharge a gas jet. The method further includes providing (1204) one or more surfaces having a first end and a second end, the first end proximate the one or more orifices and configured to direct the flow of the gas jet discharged from the one or more orifices, the second end being closer to the nasal opening than the first end. As shown, in an operating state, the orifices and the surface are arranged to adhere the gas jet to the surface (1205) via the Coanda effect, thereby entraining ambient air into the entrainment opening to deliver the gas jet and the ambient air through the nasal opening of the conduit.

[0093] Other embodiments may include methods of using a patient interface as shown and described, e.g., in accordance with a breathing or ventilation procedure 1180a.

[0094] In the claims, any reference numerals placed in parentheses shall not be construed as limiting the claim. The word "comprising" or "including" does not exclude the presence of elements or steps not listed in the claims. In a device claim enumerating several devices, several of these devices may be implemented by the same piece of hardware. The word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements. In any device claim enumerating several devices, several of these devices may be implemented by the same piece of hardware. The fact that certain elements are recited in mutually different dependent claims does not by itself preclude the combination of these elements. The relative terms "about" or similar used for a number include the ordinary (conventional) rounding of the number using a fixed base (e.g., 5 or 10).

[0095] Although the present invention has been described in detail based on the currently considered most practical and preferred embodiments, it should be understood that these descriptions are for illustrative purposes only, and the present invention is not limited to the disclosed embodiments. On the contrary, the present invention is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A system, comprising: A head-mounted element; A non-invasive ventilation patient interface removably coupled to the head-mounted element, and the non-invasive ventilation patient interface comprises: A conduit having an entrainment opening and a nasal opening disposed along a conduit axis; A pressure sensing element proximate the nasal opening; One or more orifices proximate the entrainment opening and configured to discharge a gas jet; and One or more surfaces having a first end and a second end, the first end proximate the one or more orifices and guiding the flow of the gas jet discharged from the one or more orifices, the second end being closer to the nasal opening than the first end; Wherein, in an operating state, the gas jet adheres to the one or more surfaces via the Coanda effect, thereby entraining ambient air into the entrainment opening to deliver the gas jet and the ambient air through the nasal opening of the conduit.

2. The system according to claim 1, comprising one or more suspension elements; Wherein the one or more suspension elements suspend the one or more surfaces within the conduit through-hole.

3. The system according to claim 1, wherein: The one or more surfaces extend circumferentially relative to the conduit axis, at least partially surrounding the conduit axis; and The one or more orifices comprise a plurality of orifices circumferentially disposed about the conduit axis proximate the first end of the one or more surfaces.

4. The system according to claim 1, wherein the non-invasive ventilation patient interface further comprises a dual lumen having a main lumen and a secondary lumen; Wherein the main lumen is configured to deliver gas to the one or more orifices; and Wherein the pressure sensing element comprises a pressure sensing line having an opening, and the secondary lumen comprises at least a portion of the pressure sensing line.

5. The system according to claim 4, wherein a pressure sensing port is disposed proximate an end of the secondary lumen, the pressure sensing port being substantially orthogonal to the conduit axis.

6. The method according to claim 4, wherein the secondary lumen is parallel to the main lumen.

7. The system according to claim 1, wherein the one or more orifices and the first end of the one or more surfaces are laterally offset.

8. The system according to claim 2, wherein one or more of the one or more surfaces are bounded on each side by the one or more suspension elements to control the gas jet along the one or more surfaces.

9. The system according to claim 1, wherein the one or more orifices comprise a predetermined opening shape selected from: one or more linear slots, a plurality of stacked slots, a plurality of vertical slots, one or more linear orifices, a plurality of stacked orifices, one or more non-linear slots, non-uniform sections, and multi-directional openings.

10. A system, comprising: A head-mounted device; Non-invasive ventilation patient interface device, the non-invasive ventilation patient interface device being detachably coupled to the headgear device, and the non-invasive ventilation patient interface device comprising: A conduit device having an entrainment opening and a nasal opening disposed along a conduit axis; A pressure sensing device proximate the nasal opening; One or more orifice devices proximate the entrainment opening and configured to discharge a gas jet; and One or more surface devices having a first end and a second end, the first end proximate the one or more orifice devices and guiding the flow of the gas jet discharged from the one or more orifice devices, the second end being closer to the nasal opening than the first end; Wherein, in an operating state, the gas jet adheres to the one or more surface devices via the Coanda effect, thereby entraining ambient air into the entrainment opening to deliver the gas jet and the ambient air through the nasal opening of the conduit device.

11. The system according to claim 10, comprising a suspension device; Wherein the one or more surface devices are suspended within the conduit device via the suspension device.

12. The system according to claim 10, wherein: The one or more surface devices extend circumferentially relative to the conduit axis, at least partially surrounding the conduit axis; and The one or more orifice devices include a plurality of orifices circumferentially disposed about the conduit axis proximate the first end of the one or more surface devices.

13. The system according to claim 10, comprising a lumen device having a main lumen and a secondary lumen; Wherein the main lumen is configured to deliver gas to the one or more orifice devices; and Wherein the secondary lumen includes the pressure sensing device.

14. The system according to claim 13, wherein the pressure sensing device includes a pressure sensing port disposed proximate an end of the secondary lumen, the pressure sensing port being substantially orthogonal to the conduit axis.

15. A method, comprising: Providing a conduit having an entrainment opening and a nasal opening disposed along a conduit axis; Providing a pressure sensing element proximate the nasal opening; Configuring one or more orifices proximate the entrainment opening to discharge a gas jet; And Providing one or more surfaces having a first end and a second end, the first end proximate the one or more orifices and configured to guide the flow of the gas jet discharged from the one or more orifices, the second end being closer to the nasal opening than the first end; Wherein, in an operating state, the orifices and the surfaces are arranged to adhere the gas jet to the surfaces via the Coanda effect, thereby entraining ambient air into the entrainment opening to deliver the gas jet and the ambient air through the nasal opening of the conduit.

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