Non-invasive ventilation through air entrainment patient interface

Abstract

One embodiment provides a non-invasive ventilation patient interface. In one example, the patient interface includes a catheter having an entrainment opening and a nasal cavity opening. The patient interface includes an orifice proximate the entrainment opening and configured to expel a gas jet and a surface having a first end proximate the orifice and extending substantially parallel to a flow direction of the gas jet expelled from the orifice and a second end closer to the nasal cavity opening than the first end. In the operational state, the gas jet adheres to the surface by 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] Priority Claim / Cross-Reference to Related Applications

[0002] This patent application claims the benefit of priority to U.S. Provisional Application No. 63 / 428,212, 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 through an intranasal patient entrainment interface. Background Art

[0004] Solutions that can provide dynamic non-invasive ventilation are known to exist. For example, the Inogen Corporation TIDAL ASSIST (Tidal Assist) Ventilator (TAV) is a handheld controller that connects to a high-pressure oxygen cylinder as a gas source. The TAV can deliver continuous flow oxygen, pulse dose oxygen, or ventilation via a tidal assist mode. In tidal assist mode, the controller delivers pulses of 50 to 250 mL of oxygen to a custom air entrainment patient interface at 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 pulses, resulting in a larger flow and bolus volume delivered to the patient, followed by an inspiratory positive airway pressure (IPAP) as the rate at which the gas enters the patient's airway slows. TIDAL ASSIST and TAV are registered trademarks of Inogen Corporation in the United States and / or other countries.

[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 usable configurations, either connected 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 a port by the Bernoulli principle. This requires a closed structure and generates a significant amount of noise. Summary of the invention

[0007] One embodiment provides a non-invasive ventilation patient interface that utilizes the Coanda effect to control a gas jet and entrain ambient air. In one example, the patient interface includes a conduit having an entrainment opening and a nasal opening. The patient interface includes an orifice and a surface, the orifice being adjacent to the entrainment opening and configured to discharge a gas jet. The surface has a first end and a second end, the first end being adjacent to the orifice and extending substantially parallel to the direction of flow of the gas jet discharged from the orifice, and the second end being closer to the nasal opening than the first end. In operation, the gas jet adheres to the surface by 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.

[0008] Another embodiment includes an apparatus that includes a conduit device having an entrainment opening and a nasal opening. The apparatus includes an orifice device and a surface device, the orifice device being adjacent to the entrainment opening and configured to discharge a gas jet; the surface device has a first end and a second end, the first end being adjacent to the orifice and extending substantially parallel to the direction of the gas jet discharged from the orifice device; and the second end being closer to the nasal opening than the first end. In operation, the gas jet adheres to the surface device by 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.

[0009] Another embodiment provides a method that includes providing a conduit having an entrainment opening and a nasal opening. The method includes configuring an orifice adjacent to the entrainment opening to discharge a gas jet, and providing a surface having a first end and a second end, the first end being adjacent to the orifice and extending substantially parallel to the direction of flow of the gas jet discharged from the orifice, and the second end being closer to the nasal opening than the first end. The method includes arranging the orifice and the surface to adhere the gas jet to the surface by the Coanda effect in operation, 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, apparatuses, systems, and products for implementing the various embodiments are provided.

[0011] The foregoing is the summary of the invention and, as such, may contain simplifications, generalizations, and omissions of detail; accordingly, those skilled in the art will appreciate that the summary is illustrative only and is 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 invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 A cross-sectional view of a portion of an exemplary patient interface is shown.

[0014] Figure 1A Shown is Figure 1 panel A of

[0015] Figure 2 A cross-sectional view of an exemplary patient interface is shown.

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

[0017] Figure 3 An exemplary view of a gas jet in an exemplary patient interface is shown.

[0018] Figure 4 A cross-sectional view of an exemplary patient interface is shown.

[0019] Figure 4A Shown is Figure 4 panel A of

[0020] Figure 4B An entrainment end view of a portion of an exemplary patient interface is shown.

[0021] Figure 4C Shown is Figure 4 and Figure 4B a perspective partial cross-sectional view of an exemplary patient interface of

[0022] Figure 4D Shown is Figure 4 an exemplary front view of a patient interface of

[0023] Figure 5 An exemplary tube is shown.

[0024] Figure 6 An exemplary system is shown.

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

[0026] Figures 8A to 8H An exemplary orifice arrangement is shown.

[0027] Figure 9 A view of an exemplary surface and orifice arrangement is shown.

[0028] Figures 10A to 10D An exemplary sidewall and orifice arrangement is shown.

[0029] Figure 10E An exemplary orifice arrangement is shown.

[0030] Figure 11A schematic diagram showing example system components is presented.

[0031] Figure 12 An example method is described. Detailed implementation

[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 components or elements being "coupled" means that these components are directly or indirectly connected or work together, e.g., through one or more intermediate components or elements, as long as there is a connection. As used herein, "operatively coupled" means that two or more elements are coupled together to work together or communicate with each other unidirectionally or bidirectionally. As used herein, the term "number" shall refer to 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 fully 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 cases, 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 through the Coanda effect, allowing the gas jet to be guided 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. Together with the turbulent flux effect caused by shear, this results in the ambient fluid being entrained into the jet.

[0036] When a fluid jet enters the ambient fluid, an axisymmetric low pressure forms around the jet. The forces generated thereby remain balanced around the entire jet and produce 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. Referring to the drawings, the example embodiments shown can be better understood. The following description is only by way of example and is only for illustrating certain example 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 connects directly 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 the patient airway. The patient interface 100 contains geometries such as a conduit 102 and its entrainment openings 102a and nasal openings 102b that assist in entraining and / or increasing positive pressure in the downstream direction along the patient interface 100. The patient interface 100 also contains 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, while effectively lengthening the conduit 102 and defining the entrainment openings at a location more upstream of the nasal openings, such as Figure 2A shown as 230a, 202a in. The patient interface 100 also contains (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, tubing 515, (a plurality of) internal nasal pillows 101, etc.) to allow removal and replacement of components of the patient interface 100 as needed to meet the requirements of a reimbursable mask.

[0039] It is 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 outside 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 Example embodiments of Figure 1A include a surface 103, here in a curved shape, that extends from a chamber 106a containing a pressurized medical gas (such as oxygen) (see

[0041] As shown, the surface 103 begins at the chamber 106a and terminates at the conduit 102 with a bend of approximately 90 degrees. The pressurized medical gas (indicated by the Figure 1A dashed arrow in Figure 1A ) is provided as a high-speed jet (e.g., at a speed of approximately 310 m / s) through an orifice 107a (e.g., formed by the (multiple) sidewalls of the chamber 106a and the surface 103). As Figure 3 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 described further in connection with

[0042] In one example, the orifice 107a can be sized to have a cross-sectional area of approximately 0.1 mm to 0.4 mm. In one example, the offset 108a can be sized to be approximately 5 / 1000 inches to 20 / 1000 inches. In one example, the (multiple) sidewalls 109a can be sized to be approximately 8 / 1000 inches to 0.1 inches high.

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

[0043] In one example, a gas jet travels along or adheres to surface 103 by 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 approximately 250 m / s), the pressure within conduit 102 near the orifice ( Figure 1A 107a therein) drops to approximately -500 Pa, and ambient air begins to move upward within conduit 102 (at approximately 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 approximately 1470 Pa, while the gas jet slows to approximately 150 m / s. At the nasal opening 102b, the gas pressure is approximately 1960 Pa, and the gas jet and ambient gas (entrained mixture) move at approximately 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, for example, the pressure near the patient's nasal cavity. As Figure 1 shown, the sensor 105 can be in the form of a tubular body that is angled approximately 90 degrees to be side-by-side or generally parallel to the medical gas delivery path (initially) and the entrained mixture delivery path (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 secondary lumen ( Figure 5 517 in Figure 5 515) of a multi-lumen 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 for the sensor 105 is a stainless steel thin-walled tubular member that has been bent or shaped (such as bent to have a 90-degree angle), capped, and drilled on the side to form an opening 105a to minimize the flow-induced effects on the static pressure reading. Note that the opening can be located at the end of the sensor 105 instead of the side location. Additionally, other materials can be used for the sensor tubing, such as the materials described in connection with tubing 515.

[0047] Figure 2 An example of a dual-sided patient interface is shown, 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 a catheter axis 212a that 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 component frame 213a with the clip interface 219a (which can also be a rigid component forming the catheter). This allows the frame 213a and the surface 203a to be located within the catheter, which in this view is covered by the inner nasal pillow 201a and the skirt 230a. Note that since this example includes a 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) is provided as viewed from the orifice side, as further described herein.

[0049] Figure 3 Shown in Figure 1A is a side view of the surface 303, offset 308, and orifice 307 in reference to Figure 1a low pressure formed around the conduit 102 within), and the resulting unbalanced force ( Figure 3 the net force within) causes the jet flow to be unstable, and this instability tends to pull the jet towards and adhere it to the surface 303. The jet will remain attached to the surface 303 and entrain ambient air to form an entrained mixture until the pressure difference is no longer sufficient to pull the jet towards the 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 the surface 303).

[0050] Combined with Figure 1 The patient interface 100 geometry described includes a medical gas delivery orifice 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, for example, within a 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 the surface 403 is provided by at least a partially circumferential element (by circumferential is meant that the surface extends relative to or around the conduit axis). As shown, the surface 403 is enclosed within the conduit 402, which is located between the entrainment opening 402a and the nasal opening 402b. The port or interface 404 provides pressurized medical gas (solid arrow) within the chamber 406. The chamber 406 cooperates with the surface 403 to form an opening, one of which is denoted as 407a in Figure 4A As described herein, one or more supports 410 can be attached to one or more of the port or interface 404 and the circumferential element providing the surface 403, which will be further described in conjunction with Figures 4A - 4C Further described.

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

[0053] From the Figure 4A detailed view, in an embodiment having a circumferential element (providing the surface 403), an orifice 407a is formed by the mating between the surface 403a and the wall of the chamber 406a. This allows the pressurized medical gas jet to discharge from the orifice 407a and then adhere to the surface 403a again through the Coanda effect. As shown in 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 through the nasal end 402b.

[0054] For example, in the Figure 4 arrangement, ambient air at about 0 Pa (without a 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 about 1960 Pa, similar to the situation described in Figure 1 . In the embodiment of the configuration shown in Figure 4 , the pressure gradient at the ambient or entrained end is about -10 Pa, about -1000 Pa near the opening 407a (-1500 Pa on the surface 403), rising to about 320 Pa at about half-way between the opening 407a and the nasal end, and then leaving at a pressure of about 1960 Pa. Similar to the flow rate described in Figure 1 , ambient air is entrained by the pulsed gas with a velocity of about 10 m / s at the entrained end, increasing to about 100 m / s near the opening 407a, and then discharging the gas at a velocity of about 210 m / s. The entrained mixture slows down to about 35 m / s at about half-way between the opening 407a and the nasal end 402b and then discharges at a velocity of about 30 m / s.

[0055] Figure 4B provides Figure 4 a view of the entrainment end 402a of the illustrated embodiment. It will be appreciated here that the circumferential element may include an interface or port 404b that is supported by one or more support or suspension elements 410b that are attached to or extend from the inner wall 411b of the conduit 402b to suspend the circumferential element (including surface 403b) in the middle or interior of the conduit 402b. It will be understood that fluid connectivity may be provided through one or more supports 410b or the interface or port 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, see Figure 5 515 in).

[0056] Figure 4C shows Figure 4 and Figure 4B a partial cross-sectional perspective view of an exemplary patient interface as in. Here, for purposes of illustration, a surface 403c formed by the circumferential element is shown in the figure, with a portion of the conduit 402c removed. The interface or port 404c provides an inflow of pressurized medical gas and delivers it to the patient through an orifice (one of which is designated 407c) by the Coanda effect (adhering to the surface 403c). 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 provides an example view of a tubular member 515 of an embodiment that 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) to supply pressurized medical gas. The tubular member 515 may include a main lumen or main lumen 516 for providing pressurized medical gas, e.g., to supply pressurized medical gas to the chambers 106a and 406 shown in Figure 1 and Figure 4 respectively. The tubular member 515 may also include a secondary lumen 517 for carrying another element (such as Figure 1the distal end of sensor 105 therein), another gas type (such as a secondary medical gas), or a combination of both. In some examples, the tubular member 515 can include additional lumens, for example, for carrying multiple types of medical gases (such as air, oxygen, nitrous oxide, etc.) or delivering drugs. The tubular member 515 can also be formed by a single main lumen 516. The tubular member 515 does not include additional components as shown; however, the tubular member 515 can include co-extruded components such as wires for sensors, sensors, fluoroscopic elements (such as barium sulfate), tubular member reinforcements (helices, braids, etc.), or combinations of the foregoing components.

[0058] In Figure 5 an example, the tubular member 515 includes anti-clogging ribs 518a and 518b that are approximately equidistant from each other and from the secondary lumen 517. In one example, one 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) operably coupled thereto.

[0059] The tubular member 515 can be formed as an elastic tubular member that includes at least two lumens 516, 517 separated by a diaphragm. In one example, one lumen 516 is for delivering pressurized medical gas to a Coanda surface (such as surface 103), and another lumen 517 is for providing a pressure sensor (such as 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 (for example, if the tubular member 515 kinks).

[0060] The material selected for the tube may 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 tube wall compared to silicone while still being able to withstand the internal pressure of the medical gas in the main lumen 516. The thinner wall tube 515, combined with a relatively soft durometer (the nominal durometer of EG-80A is 72A), makes it softer and more flexible than silicone or PVC catheters of equivalent performance. 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 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 tube wall compared to silicone while still being able to withstand the internal pressure of the medical gas in the main lumen 515. 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 pliable feel to the tube 515 compared to silicone or PVC tubes of equivalent performance. PEBAX 2533SA 01MED is a medical grade TPU that has passed the United States Pharmacopeia (USP) Class VI (systemic toxicity, skin irritation, and infection) test. 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 tube 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 headband elements (collectively 620) that can be removed from or statically connected to the patient interface 600. In one example, the headband 620 includes one or more straps 621, 622, 623 that secure the patient interface 600 near the patient's nasal cavity. One or more clips 624, 625 may also be provided to secure the tube 614 to a desired location.

[0064] In Figure 6 the example of, 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 can include a fabric strap that has at least two separate loops or elements 623, 623 to meet the requirements for a reimbursable mask. The strap 621 includes connection features, such as clips 624, 625, that can be firmly clipped onto the tubing 615 while still allowing for adjustment for patient fit. In one example, the headgear 620 includes (a plurality of) clips 624 towards the rear of the headgear that align the tubing 615 along the strap-like or wider portion of the strap 621 of the headgear 620 and lift the tubing 615 away from the patient's ears to improve comfort during use. The headgear 620 can be removable and replaceable, for example, removable and replaceable from the patient interface 600 to meet the requirements for a reimbursable mask.

[0066] In one embodiment, the patient interface 100 includes rigid or elastic 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 can 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 illustrates examples of removable skirts that can be used in conjunction with patient interfaces 100, 200a, 200b, etc. 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 tubing 715a. In another embodiment, a skirt 731b is provided that fully encloses the entrainment side of the patient interface near the tubing 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 illustrates examples of various orifices 807a-h that can be formed to provide gas jets near the surface to utilize the Coanda effect described herein. In Figure 8AIn an example, two linear slits (one denoted as 807a) can be provided to generate a gas jet that adheres to the surface 803a, and sidewalls (one denoted as 809a) are utilized for guiding.

[0069] In Figure 8B an example, multiple stacked slits can be provided, for example, two slits (one denoted as 807b) as shown in the figure, to generate a gas jet that adheres to the surface 803b, and sidewalls (one denoted as 809b) are utilized for guiding.

[0070] In Figure 8C an example, multiple vertical slits (one denoted as 807c) as shown in the figure can be provided to generate a gas jet that adheres to the surface 803c, and sidewalls (one denoted as 809c) are utilized for guiding.

[0071] In Figure 8D an example, a linear orifice (one denoted as 807d) can be provided to generate a gas jet that adheres to the surface 803d, and sidewalls (one denoted as 809d) are utilized for guiding.

[0072] In Figure 8E an example, stacked orifices (one denoted as 807e) can be provided to generate a gas jet that adheres to the surface 803e, and sidewalls (one denoted as 809e) are utilized for guiding.

[0073] In Figure 8F an example, a non - linear slit 807f can be provided to generate a gas jet that adheres to the surface 803f, and sidewalls (one denoted as 809f) are utilized for guiding.

[0074] In Figure 8G an example, a non - uniform cross - section 807g can be provided to generate a gas jet that adheres to the surface 803g, and sidewalls (one denoted as 809g) are utilized for guiding.

[0075] In Figure 8H an example, multiple directional orifices (one denoted as 807h) as shown in the figure can be provided to generate a gas jet that adheres to the surface 803h, and sidewalls (one denoted as 809h) are utilized for guiding.

[0076] As described herein, one or more sidewalls 109a can be included to assist in guiding the gas jet along the surface 103, but this is not required. As Figure 9 shown, the surface 903 extends from the frame 913 and, in one example, when it enters the tubular member ( Figure 9When not shown) it bends approximately 90 degrees. One or more sidewalls (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 tubular member 915. It should be noted that in one embodiment, the amount of bending 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 amount of bending can be between 45 and 100 degrees.

[0077] The surface 903 can be a rigid member that mates with the tubular member 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 through the Coanda effect. Figure 9 The example shown also includes two sidewalls, 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 sidewall 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 ambient air entrainment, 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 sidewall configurations can be used. For example, Figure 10A the parallel configuration shown, where two sidewalls are separated by an intermediate sidewall 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, a convergent configuration where two sidewalls are separated by a convergent intermediate sidewall 1009b provides two convergent surfaces (one of which is denoted by 1003b) and two orifices (one of which is denoted by 1007b).

[0080] In Figure 10C the example, a divergent configuration where two sidewalls are separated by a divergent intermediate sidewall 1009c provides two divergent 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 side walls (one intermediate side wall is denoted as 1009d).

[0082] Reference Figure 4 and Figure 4C , in an 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 arranged 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 side walls, 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 shows an example of a computer and its components, which 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 includes certain functional blocks that can be integrated onto a single semiconductor chip to meet specific application requirements.

[0084] One or more processing units are provided, which may include a central processing unit (CPU) 1140 that includes an arithmetic logic unit (ALU) that performs arithmetic and logic operations, an instruction decoder that decodes instructions and provides information to a timing and control unit, and registers for temporarily storing data. The CPU 1140 may comprise 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 that, for example, includes 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 controllers that communicate using various communication protocols such as I2C, USB, etc.

[0086] The memory 1180 may include multiple 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 contain embedded programs, code, and downloaded software such as a respiration or ventilation program 1180a for delivering medical gases through the patient interface 1100 described herein. By way of example and not limitation, the memory 1180 may also contain 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 (e.g., WIFI and telecommunications radios) may be included to allow the computer to send and receive data to and from remote devices using wireless mechanisms, noting 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), or 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 obtaining, 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] Note that the various functions described herein can be implemented by 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: memories integrated into the computer (e.g., memory 1180), hard disks or solid-state drives, and removable memories (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 a 1201 catheter having an entrainment opening and a nasal opening. The method includes configuring 1202 an orifice near the entrainment opening to discharge a gas jet. A 1203 surface having a first end and a second end is provided, the first end being near the orifice and extending substantially parallel to the flow direction of the gas jet discharged from the orifice, and the second end being closer to the nasal opening than the first end. In an operating state, the orifice and the surface are arranged 1204 to adhere the gas jet to the surface by the Coanda effect, thereby entraining ambient air into the entrainment opening to deliver the gas jet and ambient air through the nasal opening of the catheter.

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

[0094] In the claims, any reference signs 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 claim. 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" before 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 in itself preclude the combination of these elements. The relative terms "about" or similar used for numbers include the ordinary (conventional) rounding of numbers 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 detailed 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 non-invasive ventilation patient interface, comprising: A conduit having a clamping opening and a nasal opening; An orifice near the clamping opening and configured to discharge a gas jet; And A surface having a first end and a second end, the first end being near the orifice and extending substantially parallel to the flow direction of the gas jet discharged from the orifice, the second end being closer to the nasal opening than the first end; Wherein, in the operating state, the gas jet adheres to the surface by the Coanda effect, thereby entraining ambient air into the clamping opening to convey the gas jet and the ambient air through the nasal opening of the conduit.

2. The non-invasive ventilation patient interface according to claim 1, wherein the surface is convex and curved away from the flow direction of the gas jet.

3. The non-invasive ventilation patient interface according to claim 2, wherein the amount of curvature along the surface is from 45 degrees to 100 degrees.

4. The non-invasive ventilation patient interface according to claim 1, wherein the orifice and the first end of the surface are laterally offset.

5. The non-invasive ventilation patient interface according to claim 1, wherein both the first end and the second end of the surface are located inside the conduit between the clamping opening and the nasal opening.

6. The non-invasive ventilation patient interface according to claim 1, wherein between the clamping opening and the nasal opening, the first end of the surface is located outside the conduit and the second end of the surface is located inside the conduit.

7. The non-invasive ventilation patient interface according to claim 2, wherein the first end of the surface is substantially perpendicular to the flow direction of the conduit and the second end of the surface is substantially parallel to the flow direction of the conduit.

8. The non-invasive ventilation patient interface according to claim 2, wherein the surface is defined by one or more sidewalls to control the gas jet along the surface.

9. The non-invasive ventilation patient interface according to claim 1, wherein the orifice comprises a predetermined opening shape selected from: one or more linear slits, multiple stacked slits, multiple vertical slits, one or more linear orifices, multiple stacked orifices, one or more non-linear slits, non-uniform cross-sections, and multi-directional openings.

10. An apparatus, comprising: A conduit device having a clamping opening and a nasal opening; An orifice device near the clamping opening and configured to discharge a gas jet; And A surface device having a first end and a second end, the first end being near the orifice and extending substantially parallel to the direction of the gas jet discharged from the orifice device, the second end being closer to the nasal opening than the first end; Wherein, in the operating state, the gas jet adheres to the surface device by the Coanda effect, thereby entraining ambient air into the clamping opening to convey the gas jet and the ambient air through the nasal opening of the conduit device.

11. The apparatus according to claim 10, wherein the surface device comprises a convex surface curved away from the flow direction of the gas jet.

12. The device according to claim 10, wherein both the first end and the second end of the surface device are located inside the conduit device between the entrainment opening and the nasal opening.

13. The device according to claim 10, wherein between the entrainment opening and the nasal opening, the first end of the surface device is located outside the conduit device and the second end of the surface device is located inside the conduit device.

14. The device according to claim 11, wherein the first end of the surface device is substantially perpendicular to the flow direction of the conduit device and the second end of the surface device is substantially parallel to the flow direction of the conduit device.

15. A method, comprising: providing a conduit having an entrainment opening and a nasal opening; configuring (1202) an orifice near the entrainment opening to discharge a gas jet; and providing (1203) a surface having a first end and a second end, the first end being near the orifice and extending substantially parallel to the flow direction of the gas jet discharged from the orifice, the second end being closer to the nasal opening than the first end; wherein the orifice and the surface are arranged (1204) in an operating state to adhere the gas jet to the surface by the Coanda effect, thereby entraining ambient air into the entrainment opening to convey the gas jet and the ambient air through the nasal opening of the conduit.

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