Non-invasive ventilation via an air-entraining patient interface

Abstract

[0003] An embodiment provides a non-invasive ventilation patient interface. In one example, the patient interface includes a conduit having an entrainment opening and a nasal opening. The patient interface includes an orifice proximate the entrainment opening and configured to emit a jet of gas, and a surface having a first end and a second end, the first end proximate the orifice and extending substantially parallel to a direction of flow of the jet of gas emitted from the orifice, and the second end being closer to the nasal opening than the first end. In an operating state, the jet of gas adheres to the surface due to the Coanda effect, thereby entraining ambient air into the entrainment opening and delivering the jet of gas and ambient air through the nasal opening of the conduit.

Description

[Technical Field]

[0001] This patent application claims priority under 35 U.S.C. § 119 to U.S. Provisional Application No. 63 / 428,212, filed November 28, 2022, the contents of which are incorporated herein by reference. [Background technology]

[0002] The disclosed subject matter relates generally to patient ventilation interfaces. In particular, the disclosed subject matter relates to techniques for non-invasive ventilation via an intranasal patient entry interface.

[0003] Known solutions exist that can provide ambulatory noninvasive ventilation. For example, Inogen, Inc.'s TIDAL ASSIST ventilator (TAV) is a handheld controller that connects to a hyperbaric oxygen cylinder as the gas source. The TAV can deliver continuous-flow oxygen, pulsed-dose oxygen, or ventilation via tidal assist mode. In tidal assist mode, the controller delivers a 50-250 mL pulse of oxygen into a purpose-built air entrainment patient interface at a flow rate and pressure that creates noninvasive inspiratory positive airway pressure (IPAP) in the user's airway. The patient interface utilizes the Venturi principle to entrain air into the oxygen pulse, creating a larger flow rate and bolus delivered to the patient, which then slows the gas velocity as it enters the patient's airway, creating IPAP. TIDAL ASSIST and TAV are registered trademarks of Inogen, Inc. in the United States and / or other countries.

[0004] As another example, the LIFE2000 ventilator from Breathe Technologies, Inc. can also be used in conjunction with a high-pressure oxygen cylinder, but has two other configurations: either tethered to an air compressor base station or docked. The LIFE2000 ventilator can provide IPAP and expiratory positive airway pressure (EPAP) using air from an oxygen cylinder gas supply or from the air compressor base station. LIFE2000 is a registered trademark of Breathe Technologies, Inc. in the United States and other countries. Summary of the Invention [Problem to be solved by the invention]

[0005] Such known non-invasive nasal patient ventilation interfaces utilize a substantially sealed configuration whereby the gas jet entrains ambient air through the port due to Bernoulli's principle, which requires a sealed construction and results in the generation of significant noise. [Means for solving the problem]

[0006] One embodiment provides a non-invasive ventilation patient interface that utilizes the Coanda effect to control a jet of gas 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 proximate the entrainment opening and configured to emit a jet of gas, and a surface having a first end and a second end, the first end proximate the orifice and extending substantially parallel to the direction of flow of the jet of gas emitted from the orifice, and the second end being closer to the nasal opening than the first end. In an operating state, the jet of gas adheres to the surface due to the Coanda effect, thereby entraining ambient air into the entrainment opening and delivering the jet of gas and ambient air through the nasal opening of the conduit.

[0007] Another embodiment includes a device including a conduit means having an entrainment opening and a nose opening. The device includes an orifice means proximate the entrainment opening and configured to emit a jet of gas, and a surface means having a first end and a second end, the first end proximate the orifice and extending substantially parallel to the direction of the jet of gas emitted from the orifice means, and the second end being closer to the nose opening than the first end. In operation, the jet of gas attaches to the surface means by the Coanda effect, thereby entraining ambient air into the entrainment opening and delivering the jet of gas and ambient air through the nose opening of the conduit means.

[0008] A further embodiment provides a method including providing a conduit having an entrainment opening and a nose opening, the method including configuring an orifice proximate the entrainment opening for emitting a jet of gas, and providing a surface having a first end and a second end, the first end being proximate the orifice and extending substantially parallel to a direction of flow of the jet of gas emitted from the orifice, and the second end being closer to the nose opening than the first end. The method includes positioning the orifice and the surface to, in an activated state, attach the jet of gas to the surface by the Coanda effect, thereby entraining ambient air into the entrainment opening and delivering the jet of gas and ambient air through the nose opening of the conduit.

[0009] As will become apparent from a review of this specification, methods, apparatus, systems, and articles of manufacture are provided for practicing various embodiments.

[0010] The foregoing is a summary and, as such, may contain simplifications, generalizations, and omissions of detail; thus, those skilled in the art will appreciate that the summary is illustrative only and is not intended to be in any way limiting.

[0011] These and other characteristics and properties of the exemplary embodiments, and the method and function of operation of the associated structural elements, and combinations thereof, will become more apparent from a consideration of the following description and appended claims, taken in conjunction with the accompanying drawings, all of which form a part hereof. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 shows a cross-sectional view of a portion of an exemplary patient interface. [Figure 1A] FIG. 1A shows panel A of FIG. [Figure 2] FIG. 2 shows a cross-sectional view of an exemplary patient interface. [Figure 2A] FIG. 2A illustrates an exemplary patient interface in a partially exploded view. [Figure 3] FIG. 3 shows an exemplary diagram of airflow in an exemplary patient interface. [Figure 4] FIG. 4 shows a cross-sectional view of an exemplary patient interface. [Figure 4A] FIG. 4A shows panel A of FIG. [Figure 4B] FIG. 4B shows an end view of the mixing side of a portion of an exemplary patient interface. [Figure 4C] FIG. 4C illustrates a partial cross-sectional perspective view of the exemplary patient interface of FIGS. 4 and 4B. [Figure 4D] FIG. 4D illustrates an exemplary front view of the patient interface of FIG. [Figure 5] FIG. 5 shows an exemplary tube. [Figure 6] FIG. 6 shows an exemplary system. [Figure 7A] FIG. 7A shows an example of a skirt for a patient interface. [Figure 7B] FIG. 7B shows an example of a skirt for the patient interface. [Figure 8A] FIG. 8A shows an exemplary orifice arrangement. [Figure 8B] FIG. 8B shows an exemplary orifice arrangement. [Figure 8C] FIG. 8C shows an exemplary orifice arrangement. [Figure 8D] FIG. 8D shows an exemplary orifice arrangement. [Figure 8E] FIG. 8E shows an exemplary orifice arrangement. [Figure 8F] FIG. 8F shows an exemplary orifice arrangement. [Figure 8G] FIG. 8G shows an exemplary orifice arrangement. [Figure 8H] FIG. 8H shows an exemplary orifice arrangement. [Figure 9] FIG. 9 shows a diagram of an exemplary surface and orifice arrangement. [Figure 10A] FIG. 10A shows an exemplary sidewall and orifice arrangement. [Figure 10B] FIG. 10B shows an exemplary sidewall and orifice arrangement. [Figure 10C] FIG. 10C shows an exemplary sidewall and orifice arrangement. [Figure 10D] FIG. 10D shows an exemplary sidewall and orifice arrangement. [Figure 10E] FIG. 10E shows an exemplary orifice arrangement. [Figure 11] FIG. 11 shows a diagram of the components of an exemplary system. [Figure 12] FIG. 12 illustrates an exemplary method. DETAILED DESCRIPTION OF THE INVENTION

[0013] In the specification, unless the context clearly dictates otherwise, a reference to a plurality includes a reference to a plurality. In the specification, when two or more parts or components are "coupled," it means that the parts are joined or operate together, either directly or indirectly, i.e., through one or more intermediate parts or components, so long as they are interlocked. In the specification, "operably coupled" means that two or more elements are coupled to operate together or communicate with each other unidirectionally or bidirectionally. In the specification, "number" means one or an integer greater than one (i.e., plural). In the specification, "set" means one or more.

[0014] 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 provide a thorough understanding of the embodiments. However, those skilled in the art will recognize that various embodiments can be practiced without one or more of the specific details, or with other methods, components, materials, etc. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obfuscation.

[0015] One embodiment uses a surface to attach a jet of pressurized gas via the Coanda effect, allowing the jet of gas to be directed by using a desired surface shape. Thus, various embodiments utilize the Coanda effect to entrain ambient air with a jet of medical gas for delivery through a patient interface.

[0016] Bernoulli's principle describes the relationship between fluid velocity and fluid pressure: as fluid velocity increases, fluid pressure decreases. Thus, when a fluid (sometimes called a jet) flows into a region of low or zero velocity (sometimes called ambient air), the fluid inherently has a lower pressure than the ambient air, and therefore the ambient air is drawn toward the jet. In addition, the effect of shear-induced turbulent flux causes the ambient fluid to become entrained in the jet flow.

[0017] When a jet of fluid enters the surrounding fluid, an axisymmetric low pressure is created around the jet, and the resulting force, assuming balance around the entire jet and no other external forces, produces a steady flow that propagates in a straight line. If a boundary, such as a wall, is placed close enough to the jet, there is little surrounding fluid to balance the low pressure that forms around the jet near the boundary, and the resulting unbalanced force causes the jet's flow to become unstable, which tends to pull the jet toward the boundary. The jet remains attached to the boundary until the pressure differential is no longer strong enough to pull the jet toward the boundary. This is known as the Coanda effect and is explained by the tendency of fluid flows to be attracted to and remain attached to nearby boundaries, such as walls.

[0018] The description turns to the drawings. The illustrated exemplary embodiments will be best understood by referring to the drawings. The following description is intended by way of example only and merely illustrates specific exemplary embodiments.

[0019] FIG. 1 shows a portion (one side) of a patient interface 100 in cross section. In one embodiment, the patient interface 100 is a mechanism that interfaces directly with a patient's airway, e.g., the nasal passages. For example, the patient interface 100 has internal nasal pillows 101 that include elastomeric features that help the interface contour and seal with the patient's airway. The patient interface 100 includes geometries that assist in entraining and / or increasing positive pressure along the downstream direction of the patient interface 100, such as a conduit 102 and its entrainment opening 102a and nasal opening 102b. The patient interface 100 effectively extends the length of the conduit 102 and defines an entrainment opening further upstream from the nasal opening, as shown, for example, at 230a, 202a in FIG. 2A, while also including features, such as an optional and / or removable skirt (730b, 731b in FIG. 7), to control the sound or noise and flow rate or pressure of gas passing through the patient interface 100. The patient interface 100 includes rigid features, e.g., surface 103 and frame 213a, that serve to connect with other elements, such as skirts 730b, 731b, tubing 515, and internal nasal pillows 101, allowing parts of the patient interface 100 to be removed and replaced as needed to meet the requirements of a reimbursable mask.

[0020] 1 is formed with internal nasal pillows 101 (i.e., a seal inside the nose), it should be noted that the features of the embodiment may work with any other style of mask, including, but not limited to, a standard mask that seals on the outside of the patient's nose, any nasal pillow interface, nasal cushions, nasal masks, full face masks, etc. Additionally, while the internal nasal pillows 101 are formed from an elastomeric material to promote patient comfort and seal, other materials, e.g., rigid materials, may be used, and may utilize the internal shape of the patient's airway to create positive pressure, as opposed to generating positive pressure through the material of the patient interface 100.

[0021] As shown in Figure 1, patient interface 100 includes an inlet opening 102a and a nasal opening 102b defined by a conduit 102. The exemplary embodiment of Figure 1 includes a surface 103, shown as a curved shape, extending from a chamber 106a (see Figure 1A) containing a pressurized medical gas, such as oxygen, into conduit 102. Chamber 106a may be formed by a component such as a frame 113 having a port or interface 104 for attachment to tubing 515 (described further herein).

[0022] As shown, surface 103 begins within chamber 106a and terminates within conduit 102 via an approximately 90-degree bend. Pressurized medical gas (indicated by the dashed arrow in FIG. 1A ) is delivered as a high-velocity jet, e.g., at a velocity of approximately 310 m / s, through orifice 107a formed by the sidewall of chamber 106a and surface 103. As further shown in FIG. 1A , orifice 107a approaches surface 103 as it extends toward the interior of conduit 102. In one embodiment, an offset 108a is employed between orifice 107a and an extended portion (near the nose) of surface 103, as will be further described in connection with FIG. 3 . In one example, orifice 107a can be sized to have a cross-sectional area of ​​approximately 0.1 mm to approximately 0.4 mm. In one embodiment, offset 108a can be sized to be approximately 5 / 1000 inch to 20 / 1000 inch. In one embodiment, the sidewall 109a may be sized to be approximately 8 / 1000 inch to 0.1 inch high.

[0023] The jet of gas attaches to, or follows just above, surface 103 due to the Coanda effect. This allows the jet of gas to follow surface 103 into conduit 102 in a guided manner. As described further herein, surface 103 may include or be adjacent to one or more sidewalls, e.g., sidewall 109a in FIG. 1A, to further assist in directing the jet of gas in a desired manner.

[0024] In one example, the gas jet moves along or is attached to the surface 103 due to the Coanda effect. This entrains the ambient air near the entrainment opening 102a, which has a relative pressure of 0 Pa when there is no gas pulse. When the gas jet is supplied (at approximately 250 m / s), the pressure in the conduit 102 adjacent to the orifice (107a in FIG. 1A) drops to approximately -500 Pa, and the ambient air begins to move upward within the conduit 102 (at approximately 8 m / s). As the gas jet entrains the ambient air (see FIG. 3), the pressure in the middle and upper portions of the conduit 102 rises to approximately 1470 Pa, while the gas jet slows to approximately 150 m / s. At the nose opening 102b, the gas pressure is approximately 1960 Pa, and the gas jet and ambient air (entrained mixture) move at approximately 40 m / s.

[0025] As shown in FIG. 1, a sensor or pressure sensing element 105, such as an electrical pressure sensor or pressure sensing line, can be provided having an opening or pressure sensing port 105a proximate the nasal opening 102a of the conduit. Such a configuration can be provided, for example, to sense pressure proximate the patient's nasal passages. As shown in FIG. 1, the sensor 105 can take the form of a tube angled approximately 90 degrees to run along or approximately parallel to the medical gas delivery (initial) and the entrained mixture delivery (near the nasal tip). As will be appreciated, the sensor 105 can include other sensors in addition to or instead of a pressure sensing line as shown in FIG. 1, as will be described in connection with the example of FIG. 4.

[0026] The sensor 105 may be configured as a manometer-type tube that transfers the pressure generated in the nasal tip region 102b of the patient interface 100 into a second lumen (517 in FIG. 5) of a multi-lumen tube (515 in FIG. 5) for pressure measurement by an operably coupled controller. The blood pressure measurement is necessary for closed-loop feedback, allowing the controller to monitor and adjust the therapeutic pressure, for example, per breath or ventilation program, within ISO standards. This is necessary, for example, to account for ventilator therapy.

[0027] One suitable configuration for sensor 105 is a thin-walled tube of stainless steel that is bent or formed (e.g., bent at a 90-degree angle), capped, and side-drilled to form opening 105a to minimize the effect of flow on static pressure readings. Note that the opening may be at the end of sensor 105 rather than at a lateral location. Additionally, other materials may be used for the sensor tube, such as those described in connection with tube 515.

[0028] FIG. 2 shows an example of a patient interface with two sides, one for each nostril, where a first side 200a and a second side 200b are joined to form a nasal delivery interface for the patient. As shown in FIG. 1, side 200a corresponds to the patient interface 100 of FIG. 1. The drawing in FIG. 2 shows a conduit axis 212a that extends substantially parallel to the flow direction of the patient interface 100. For example, referring to FIG. 1, ambient air enters the conduit 102 through the entrainment end 102a, flows along the conduit axis 212a, and exits the nasal end 102b.

[0029] FIG. 2A shows an exemplary patient interface in a partially exploded view. In the view of FIG. 2A, the left side (as shown) is partially exploded to emphasize that a rigid frame 213a joins with a clip-on interface 219a (which may also be a rigid part that forms a conduit). This allows the frame 213a and surface 203a to be placed within the conduit, which in this view is covered by internal nasal pillows 201a and skirt 230a. Note that with the inclusion of skirt 230a in this example, the length of the conduit (entrainment opening 202a) is further upstream from the orifice that delivers the jet of gas into the conduit. FIG. 9 provides an unobstructed view of the frame 213a (913) as viewed from the orifice side, as described further herein.

[0030] FIG. 3 shows a side view of surface 303, offset 308, and orifice 307, as referenced in connection with FIG. 1A. Here, a jet of fluid (medical gas, indicated by the solid arrow) enters ambient air (dashed arrow), creating an axisymmetric low pressure around the jet. The resulting forces balance around the entire jet, creating a steady, linearly propagating flow. Here, surface 303 is positioned proximate to opening 307, so the jet is created proximate to surface 303, as determined by (optional) offset 308. There is little or no ambient air between surface 303 and the jet exiting opening 307 to balance the low pressure created around that portion of the jet exposed to ambient air, for example, in conduit 102 of FIG. 1, and the resulting unbalanced force (resultant force in FIG. 3) creates instabilities in the jet flow that attract the jet toward surface 303 and tend to cause the jet to attach to surface 303. The jet remains attached to surface 303 and entrains the surrounding air, forming an entrained mixture, until the pressure differential is no longer sufficient to draw the jet towards surface 303. This is known as the Coanda effect and is explained by the tendency of a fluid stream to be attracted towards and remain attached to a nearby boundary, such as surface 303.

[0031] Although the geometry of the patient interface 100 described in connection with FIG. 1 includes a medical gas delivery orifice oriented by the curved surface 103 perpendicular to the direction of the entrained flow, the patient interface 100 may be configured with various orifice angles relative to the entrained flow direction, for example, within a range of greater than 0 degrees and less than 180 degrees relative to the entrained flow direction.

[0032] By way of example, FIG. 4 illustrates, in cross section, one side of an embodiment in which surface 403 is provided by at least a partial circumferential element (circumferential in the sense that the surface extends relative to or around the conduit axis). As shown, surface 403 is enclosed within conduit 402 between entrainment opening 402a and nasal opening 402b. A port or interface 404 provides a supply of medical gas (solid arrow) that is pressurized into chamber 406. Chamber 406 cooperates with surface 403 to form openings, one of which is shown at 407a in FIG. 4A. As described herein, one or more supports 410 are attached to one or more of the port or interface 404 and the circumferential element that provides surface 403, as further described in connection with FIGS. 4A-C.

[0033] As shown in Figure 4, nasal pillows 401 surround conduit 402 at the nasal end while ambient air (dashed arrows) enters from the peripheral end. In the example shown in Figure 4, sensor 405 (pressure sensing line) extends linearly through conduit 402 such that the sensor opening is oriented parallel to the flow and sensor opening (or pressure sensing port) 405a is located proximate the nasal end of conduit 402. In one embodiment, as shown in Figures 4 and 4D, sensor opening 405a may alternatively or additionally be provided in one or more different regions, for example, in one or more supports 410d, as shown at 405b, or in the surface of surface 403d comprising elements. In an alternative embodiment, a pressure sensing element in the form of an electrical pressure sensor (e.g., a transducer, resistive sensor, capacitive sensor, piezoelectric sensor, optical sensor, or MEMS sensor) can be used as sensor 405 at one or more of the above-mentioned locations, with the electrical sensor electrically coupled (e.g., via a conductor through tube 515 or second lumen 517 shown in FIG. 5 , described below) to a remotely located unit, such as a microcontroller or communication element operably coupled thereto. This embodiment has the advantage of reducing the time delay associated with sensing air pressure, i.e., there is no time delay between a change in pressure at the sensor and the pressure being determined by sensor 405. In the case of a pressure sensing line as sensor 405 with sensor opening 405a, there is a delay of approximately 100 milliseconds. Similar to the configuration of FIG. 1, conduit axis 412a is shown in FIG. 4.

[0034] As can be seen in the detailed view of Figure 4A, in embodiments with a circumferential element providing surface 403, surface 403a and the wall of chamber 406a cooperate to form orifice 407a. This allows a jet of pressurized medical gas to be emitted from orifice 407a, where it is again attached to surface 403a by the Coanda effect. As shown in Figure 4, this allows the gas jet to mix with ambient air to form an entrained mixture of ambient air and medical gas, which is delivered to the patient via nose tip 402b.

[0035] 4, ambient air at approximately 0 Pa (no pulse of medical gas) is then entrained by the jet of gas adhering to surface 403 and exits the nose tip as an entrained mixture at approximately 1960 Pa, similar to that described in connection with FIG. 1. The pressure gradient within an embodiment configured as in FIG. 4 is approximately −10 Pa at the ambient or entraining end, approximately −1000 Pa near opening 407a (−1500 Pa on surface 403), and rises to approximately 320 Pa about halfway between opening 407a and the nose tip before exiting at approximately 1960 Pa. Similar to the flow velocities described in connection with FIG. 1, the ambient air is entrained by the pulse of gas at approximately 10 m / s at the entraining end, increases to approximately 100 m / s near opening 407a, and releases the gas at opening 407a at approximately 210 m / s. The entrained mixture slows to about 35 m / s about halfway between opening 407a and nose 402b before exiting at about 30 m / s.

[0036] A representation of the mixing end 402a of the embodiment shown in Figure 4 is provided in Figure 4B. Here, it is understood that the circumferential element can include an interface or port 404b supported by one or more supports or suspension elements 410b attached to or extending from an inner wall 411b of the conduit 402b to suspend said circumferential element, including surface 403b, in the middle or interior of the conduit 402b. As will be understood, fluid connectivity with a source of pressurized medical gas, for example, is provided via one or more supports 410b or via the interface or port 404b, which is then attached to a tube (not shown in Figure 4B, see 515 in Figure 5).

[0037] Figure 4C shows a partial cross-sectional perspective view of the exemplary patient interface of Figures 4 and 4B. Here, surface 403c formed by circumferential elements is shown with a portion of conduit 402c removed for illustrative purposes. Interface or port 404c provides an inflow of pressurized medical gas for delivery to the patient via orifices (one of which is shown at 407c) by the Coanda effect (attached to surface 403c). Supports, one of which is shown at 410c, are shown which may be attached to interface or port 404c and / or to the circumferential elements providing surface 403c.

[0038] FIG. 5 provides an exemplary representation of an embodiment of tubing 515 connected to or extending from a port or interface, e.g., port or interface 104 of FIG. 1 and port or interface 404 of FIG. 4, for delivering pressurized medical gas. The tubing 515 can include a first or main lumen 516, for example, to carry the pressurized medical gas to chambers 106a, 406, as shown in FIGS. 1 and 4, respectively. The tubing 515 can also include a second lumen 517 for carrying another element, e.g., the distal end of sensor 105 of FIG. 1, e.g., another type of gas, e.g., a second medical gas, or a combination of the foregoing. In some examples, the tubing 515 can include additional lumens for carrying multiple types of medical gases, e.g., air, oxygen, nitrous oxide, or for delivering a medication. The tubing 515 can be formed with a single first lumen 516. Although the tube 515 is shown without additional components, the tube 515 can have co-extruded components such as, for example, wiring for sensors, sensors, radioscopic elements (e.g., barium sulfate), tube reinforcement (spiral wire, braid, etc.), or combinations thereof.

[0039] 5, tube 515 includes anti-occlusion ribs 518a, 518b spaced approximately equidistant from one another and a second lumen 517. In one example, an embodiment includes a portion of a sensor, such as sensor 105, within second lumen 517, which extends rearwardly through patient interface 100 and transmits readings to an operably coupled, remotely located unit, such as a microcontroller or communications element.

[0040] The tube 515 may be formed as an elastomeric tube including at least two lumens 516, 517 separated by a septum. In one example, one lumen 516 is used to deliver pressurized medical gas to the Coanda surface, e.g., surface 103, and one lumen 517 is used to provide a pressure sensor, e.g., sensor 105, that senses pressure generated at the nose end 102b of the patient interface 100. The sensed pressure is fluidly connected to a controller for measurement and response. As described herein, the tube 515 optionally includes features, such as, for example, anti-occlusion ribs 518a, 518b, within the lumens 516, 517 to prevent the lumens from becoming completely occluded, for example, if the tube 515 becomes kinked.

[0041] Materials selected for this tubing may include Lubrizol's TECOFLEX EG-80A, which has an ultimate tensile strength approximately four times that of silicone, which allows for a thinner-walled tubing compared to silicone while still being able to withstand the internal pressure of medical gases within main lumen 516. The thin-walled tubing 515, combined with a relatively soft durometer (EG-80A is nominally 72A), provides tubing 515 with a softer, more flexible feel compared to silicone or PVC tubing of comparable performance. TECOFLEX EG-80A is a medical-grade thermoplastic polyurethane (TPU) that has passed the tests for ISO 10993-4 (hemolysis), ISO 10993-5 (cytotoxicity), ISO 10993-6 (intramuscular implantation, 2 and 13 weeks), ISO 10993-10 (intradermal injection), and ISO 10993-11 (systemic injection). TECOFLEX is a registered trademark of Lubrizol Advanced Materials, Inc. in the United States and / or other countries.

[0042] Arkema's PEBAX 2533 SA 01 MED is also used for the tubing 515. Like Tefcorex® EG-80A, PEBAX 2533 SA 01 MED has a maximum tensile strength approximately five times that of silicone, which allows for thinner-walled tubing compared to silicone while still being able to withstand the internal pressure of medical gases within the main lumen 515. The thin-walled tubing 515, combined with a relatively soft durometer (PEBAX 2533 SA 01 MED is nominally 77A), provides the tubing 515 with a softer, more flexible feel compared to silicone or PVC tubing of comparable performance. PEBAX 2533 SA 01 MED is a medical-grade TPU that has been tested and passed United States Pharmacopeia (USP) Class VI (systemic toxicity, skin irritation, and infection). PEBAX is a registered trademark of Arkema France Corporation in the United States and other countries.

[0043] It should be noted that although particular materials suitable for use with the tube 515 are described, several other medical grade elastomers may also be utilized, such as, but not limited to, silicone, polyvinyl chloride (PVC), thermoplastic elastomers (TPE), and the like.

[0044] 6 shows a system including a patient interface device 600 along with headgear elements (collectively designated 620) that may be detachable 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 in proximity to the patient's nasal passages. One or more clips 624, 625 may be provided to secure the tube 614 in a desired position.

[0045] 6, the main strap 621 includes a backing or padding for patient comfort. In one embodiment, the main strap 621 may branch to form two straps 622, 623 that further secure the patient interface 600 to the patient.

[0046] In one embodiment, the headgear 620 is a strap 621 that connects to the patient interface 600 and secures the patient interface 600 in place on the patient. The strap 621 may comprise a fabric strap with at least two separate loops or elements 623, 623 to meet the requirements of a refundable mask. The strap 621 includes an attachment mechanism, e.g., clips 624, 625, that securely clips onto the tubing 615 while allowing for patient adjustment of the fit. In one example, the headgear 620 includes a clip 624 toward the rear of the headgear that aligns the tubing 615 along the band or wider portion of the strap 621 of the headgear 620 and lifts the tubing 615 away from the patient's ears for improved comfort during use. The headgear 620 may be detachable and replaceable from the patient interface 600, for example, to meet the requirements of a refundable mask.

[0047] In one embodiment, the patient interface 100 includes a rigid or elastomeric feature wrapped around the surface 103 in the form of a skirt to improve mixing and / or pressure generation and / or reduce sound pressure levels at the patient interface 100. However, the patient interface 100 can function with no skirt, a partial skirt, a partially enclosed, or a fully enclosed configuration.

[0048] By way of example, examples of removable skirts for use in connection with patient interfaces 100, 200a, 200b, etc. are shown in Figures 7A and 7B. In one embodiment, no skirt is provided. However, in another embodiment, a skirt 730a is provided that partially surrounds the mixing opening of the conduit adjacent tubing 715a. In another embodiment, a skirt 731b is provided that completely surrounds the mixing side of the patient interface adjacent tubing 715b. As will be appreciated, either one of skirts 730a and 731b can be placed on the patient interface at the perimeter side opening and removed from the patient interface to modulate the noise associated with operation of the patient interface, which would be quite loud (e.g., approximately 80 dB) without any sound absorbing components.

[0049] 8A-8H show various examples of orifices 807a-h configured to provide a jet of gas proximate to a surface for use with the Coanda effect, as described herein. In the example of Figure 8A, two linear slots (one of which is shown as 807a) are provided to generate a jet of gas that adheres to surface 803a based on induction from a sidewall (one of which is shown as 809a).

[0050] In the example of FIG. 8B, multiple stacked slots, e.g., two slots (one of which is shown as 807b), are provided to generate a jet of gas that adheres to surface 803b based on induction from the sidewall (one of which is shown as 809b).

[0051] In the example of Figure 8C, multiple vertical slots (one of which is designated 807c) are provided as shown to generate a jet of gas that adheres to surface 803c based on induction from the sidewall (one of which is designated 809c).

[0052] In the example of FIG. 8D, linear orifices (one of which is shown at 807d) are provided to generate a jet of gas that is deposited on surface 803d upon induction from a sidewall (one of which is shown at 809d).

[0053] In the example of FIG. 8E, stacked orifices (one of which is shown at 807e) are provided to generate a jet of gas that adheres to surface 803e based on induction from a sidewall (one of which is shown at 809e).

[0054] In the example of FIG. 8F, a non-linear slot 807f is provided to generate a jet of gas that adheres to surface 803f based on induction from the sidewalls (one of which is shown as 809f).

[0055] In the example of FIG. 8G, a non-uniform section 807g is provided to generate a jet of gas that adheres to surface 803g based on induction from sidewalls (one of which is shown at 809g).

[0056] In the example of Figure 8H, multiple directional orifices (one of which is shown as 807h) are provided as shown to generate a jet of gas that adheres to surface 803h based on induction from the sidewall (one of which is shown as 809h).

[0057] As described herein, one or more sidewalls 109a may be included to help direct the jet of gas along surface 103, but they are not required. As shown in FIG. 9 , surface 903 extends from frame 913 and, in one example, curves approximately 90 degrees as the surface enters a conduit (not shown in FIG. 9 ). One or more sidewalls (one of which is shown as 909) help direct the jet of gas along surface 903 as the gas exits orifice 907 from the source via tube 915. Note also that in one embodiment, the curvature of the surface may include other angles, e.g., between 0 and 180 degrees (greater than 0 and less than 180 degrees). In one example, the curvature may be between 45 and 100 degrees.

[0058] Surface 903 may be a rigid component that interfaces with tube 915. A medical gas delivery orifice 907 delivers pressurized medical gas to the conduit through surface 903, which may be nonlinear and affect the direction of the pressurized medical gas via the Coanda effect. The example shown in FIG. 9 also includes two side walls, one of which is shown at 909, to help maintain and guide the Coanda effect. Elements may include an offset between orifice 907 and surface 903, as shown in FIG. 3, to improve the initial development of the Coanda effect via vortices. An offset may also be provided between orifice 907 and the outer edge of side wall 909 to help maintain and guide the Coanda effect.

[0059] As described in connection with Figures 8A-8H, varying the orifice can provide different levels of ambient air entrainment, different noise levels, etc., depending on the configuration selected and other patient interface elements present (e.g., skirts 730a, 731b). Additionally, different sidewall configurations can be utilized, as shown in Figures 10A-D. For example, Figure 10A shows a parallel configuration with two sidewalls separated by an intervening sidewall 1009a, two surfaces, one of which is designated 1003a, and two orifices, one of which is designated 1007a.

[0060] In the example of FIG. 10B, the converging configuration, with two side walls separated by an intervening converging side wall 1009b, comprises two converging surfaces, one of which is designated 1003b, and two orifices, one of which is designated 1007b.

[0061] In the example of FIG. 10C, the diverging configuration, with two side walls separated by an intervening diverging side wall 1009c, comprises two diverging surfaces, one of which is designated 1003c, and two orifices, one of which is designated 1007c.

[0062] In the example of FIG. 10D, two surfaces, one of which is designated 1003d, and two orifices, one of which is designated 1007d, are separated by two intervening side walls, one of which is designated 1009d.

[0063] 4 and 4C, in examples where a circumferential element is used to provide the surface 403c, a support 410c can suspend or attach the element including the surface 403c. In one example, one or more supports 410c are attached to the circumferential element having the surface 403c at or near the orifice 407c and extend toward the nasal opening of the conduit 402c. As shown in FIG. 10E, which is a representation of the nasal end of a patient interface having a circumferential profile, one or more orifices 1007e may be provided circumferentially around the surface 1003e. Here, the device is configured such that the surface 1003e and the port or interface 1004 cooperate to form the orifice 1007e in the circumferential direction. As discussed in connection with FIGS. 8A-8H, the one or more orifices 1007e can take a variety of forms, including those shown in FIGS. 8A-8H. Similarly, when used in a configuration such as that shown in FIG. 4, one or more orifices 1007e may be positioned adjacent to one or more side walls, as shown in FIGS. 10A-10D, for example.

[0064] With reference to Figure 11, it will be readily appreciated that certain embodiments include a controller or microcontroller for use in delivering pulses of medical gas from a medical gas source 1190 through the patient interface 1100, for example, in coordination with sensor data feedback provided by sensors 105 included in the patient interface 1100. Figure 11 illustrates an example of a computer and its components that may be used in a controller device to perform some of the functions or operations described herein, such as, for example, delivering timed pulses of medical gas. Additionally, circuitry other than that shown in Figure 11 may be utilized in one or more embodiments. The example of Figure 11, as shown, includes certain functional blocks integrated onto a single semiconductor chip to meet specific application requirements.

[0065] One or more processing units are provided, including a central processing unit (CPU) 1140, which includes an arithmetic logic unit (ALU) for performing arithmetic and logical operations, an instruction decoder for decoding instructions and providing information to the timing and control unit, and registers for temporarily storing data. The CPU 1140 may comprise a single integrated circuit made up of several units, the design and arrangement of which will vary according to the architecture chosen.

[0066] The computer also includes a memory controller 1170 having, for example, a direct memory access (DMA) controller for transferring data between memory 1180 and hardware peripherals. The memory controller 1170 includes a memory management unit (MMU) that functions to handle cache control, memory protection, and virtual memory. The computer supports a variety of communication protocols (e.g., I / O, 2 The controller may include a controller for communicating using a communication protocol such as C, USB, etc.

[0067] The memory 1180 can include various memory types, both volatile and non-volatile, such as read-only memory (ROM), random-access memory (RAM), electrically erasable programmable read-only memory (EEPROM), flash memory, and cache memory. The memory 1180 can include built-in programs, code, and downloaded software, such as a breathing or ventilation program 1180a for delivering medical gases via the patient interface 1100 as described herein. By way of example and not limitation, the memory 1180 can include an operating system, application programs, other program modules, code, and program data, which can be downloaded, updated, or modified via a remote device.

[0068] The system bus allows communication between the various components of the computer. Note that an I / O interface 1160 and a radio frequency (RF) device 1150, e.g., WiFi and telecommunications radio, are included to allow the computer to send and receive data to and from remote devices using wireless mechanisms; a data exchange interface is utilized for wired data exchange. The computer can operate in a networked or distributed environment using logical connections to one or more other remote computers or databases. Logical connections can also include other networks / buses, including networks such as a local area network (LAN) or a wide area network (WAN). For example, the computer can communicate data to and between sensor devices of the patient interface 1100 that collect sensor data.

[0069] Thus, the computer may execute program instructions or code configured to acquire, store, and analyze sensor data and perform other functions of the embodiments as described herein. A user may interact with the computer (e.g., input commands and information) via input devices connected to I / O interface 1160. A display or other type of device may be connected to computer 500 via an interface selected from I / O interface 1160.

[0070] It should be noted that various functions described herein are implemented using instructions or code stored in a memory, e.g., memory 1180, that are sent to and executed by a processor, e.g., CPU 1140. A computer includes one or more storage devices for persistently storing programs and other data. As used herein, this storage device is a non-transitory computer-readable storage medium. Some examples of non-transitory storage devices or computer-readable storage media include, but are not limited to, storage devices internal to the computer, such as memory 1180, a hard disk or solid-state drive, and removable storage devices, such as an optical disk or memory stick.

[0071] The program code stored in the memory or storage device may be transmitted using any suitable transmission medium, including, but not limited to, wireless, wired, fiber optic cable, RF, or any suitable combination of the above communication media.

[0072] 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 run entirely on a single device, as a stand-alone software package, partially on a single device, partially on a single device and partially on other devices, or entirely on other devices. In one embodiment, the program code can be stored on a non-transitory medium and executed by a processor to perform the functions or operations specified herein. In some cases, devices referenced herein may be connected via any type of connection or network, including a local area network (LAN) or a wide area network (WAN), or the connection may be via another device (e.g., via the Internet using an Internet Service Provider), via a wireless connection, or via a wired connection such as, for example, a USB connection.

[0073] Referring to FIG. 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. The method includes configuring (1202) an orifice proximate the entrainment opening for emitting a jet of gas. The method also includes providing (1203) a surface having a first end and a second end, the first end being proximate the orifice and extending substantially parallel to a direction of flow of the jet of gas emitted from the orifice, and the second end being closer to the nasal opening than the first end. The orifice and surface are positioned to, in an operative state, attach the jet of gas to the surface via the Coanda effect, thereby entraining ambient air into the entrainment opening and delivering the jet of gas and ambient air through the nasal opening of the conduit (1204).

[0074] Other embodiments may include, for example, a method of using a patient interface as shown and described in accordance with a breathing or ventilation program 1180a.

[0075] In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word "comprises" or "including" does not exclude the presence of elements or steps other than those listed in a claim. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The absence of a plurality of elements in a device claim does not exclude the presence of a plurality of elements. In any device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that several elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination. The use of "about" or similar relative terms applied to numbers includes the ordinary (conventional) rounding of numbers with fixed bases, for example, 5 or 10.

[0076] Although the present invention has been described in detail for purposes of illustration, based on what are presently considered to be the most practical and preferred embodiments, it should be understood that such details are for illustrative purposes only, and that the present invention is not limited to the disclosed embodiments, but is instead intended to include modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present invention contemplates combining, to the extent possible, one or more features of any embodiment with one or more features of any other embodiment.

Claims

1. a conduit having an inlet opening and a nose opening; an orifice adjacent the entrainment opening and configured to emit a jet of gas; a surface having a first end and a second end; 1. A non-invasive ventilation patient interface comprising: the first end is proximate to the orifice and extends substantially parallel to the direction of flow of the jet of gas emitted from the orifice; the second end is closer to the nasal opening than the first end; and wherein in operation, the jet of gas adheres to the surface by the Coanda effect, thereby entraining ambient air into the entrainment opening and delivering the jet of gas and the ambient air through the nose opening of the conduit. Non-invasive ventilation patient interface.

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

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

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

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

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

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

8. 3. The non-invasive ventilation patient interface of claim 2, wherein the surface is bounded by one or more side walls to control the jet of gas along the surface.

9. 10. The non-invasive ventilation patient interface of claim 1, wherein the orifice has a predetermined opening shape selected from one or more linear slots, multiple stacked slots, multiple vertical slots, one or more linear orifices, multiple stacked orifices, one or more non-linear slots, non-uniform sections, and multiple directional openings.

10. a conduit means having an inlet opening and a nose opening; orifice means adjacent said entrainment opening and configured to emit a jet of gas; a surface means having a first end and a second end; An apparatus having: the first end is adjacent to the orifice and extends substantially parallel to the direction of the jet of gas emitted from the orifice means; the second end is closer to the nasal opening than the first end; In operation, the jet of gas adheres to the surface means by the Coanda effect, thereby entraining ambient air into the entrainment opening and delivering the jet of gas and the ambient air through the nose opening of the conduit means. Device.

11. 11. The apparatus of claim 10, wherein said surface means has a convex surface that curves away from the direction of flow of said jet of gas.

12. 11. The device of claim 10, wherein said first end and said second end of said surface means are both inside said conduit means between said inlet opening and said nasal opening.

13. 11. The device of claim 10, wherein said first end of said surface means is exterior to said conduit means and said second end of said surface means is interior to said conduit means between said incorporation opening and said nasal opening.

14. 12. The apparatus of claim 11, wherein said first end of said surface means is substantially perpendicular to a flow direction of said conduit means and said second end of said surface means is substantially parallel to a flow direction of said conduit means.

15. providing a conduit having an inlet opening and a nasal opening; forming an orifice adjacent the entrainment opening for emitting a jet of gas; providing a surface having a first end and a second end; 1. A method comprising: the first end is proximate to the orifice and extends substantially parallel to the direction of flow of the jet of gas emitted from the orifice; the second end is closer to the nasal opening than the first end; the orifice and the surface are arranged to, in an operating state, cause the jet of gas to attach to the surface by the Coanda effect, thereby entraining ambient air into the entrainment opening and delivering the jet of gas and the ambient air through the nose opening of the conduit. method.

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