Embodiments of the present invention relate to oxygenation, ventilation, end tidal carbon dioxide (CO2) sampling during general anesthesia and deep sedation, and specifically to a nasal respiratory platform with various related features.
General anesthesia has historically utilized a full-face mask attached to an anesthesia machine to support providing anesthetic gases and oxygen, as well as ventilating the patient and monitoring exhaled end tidal CO2 levels. A major issue with using a full-face mask is that the mask must be removed for oral access to place an intubation tube, resulting in an apenic period. Respiratory compromise is a common result from the apenic period for high-risk patients.
Given the trend for more minimally invasive procedures, the use of intravenous deep sedation has grown significantly. Nasal cannula are used providing nasal oxygenation, but do not provide pressurization, sometimes resulting in respiratory compromise if the nasal pharynx becomes blocked.
Accordingly, there is a need for a nasal respiratory platform supporting pressurized nasal oxygenation, ventilation, and expired End Tidal CO2 sampling by interfacing with and sealing about the nasal base of the nose.
A representative inhalation and exhalation cycle (flow and pressure provided by the ventilator) for a patient-ventilator interface during noninvasive ventilation is shown in
To address the shortcomings of full-face masks and nasal cannula, nasal ventilation masks covering the nose and sealing against the face are becoming popular. nasal ventilation masks support pressurization required to overcome blockage of the nasal pharynx, but obstruct the region near the eyes, easily lose a seal if the mask is tilted or if there is facial hair such as a mustache is present.
A nasal respiratory apparatus according to principles described herein and its various embodiments and combinations of features addresses the major shortcomings of all three of these approaches, supporting pressurized oxygenation, ventilation and end-tidal CO2 sampling via nasal ventilation system that seals via the nares and nasal vestibule. This results in a more secure seal. The device is much more compact an unobtrusive than either mask approach, allowing for oral and eye access if required.
Accordingly, the present invention is directed to nasal respiratory apparatus that obviates one or more of the problems due to limitations and disadvantages of the related art.
According to principles described herein, a nasal respiratory assembly includes a nasal interface comprising at least one opening for fluid communication with the nares of a patient and an air chamber assembly comprising an air chamber, a gas supply port, an end tidal sample port and at least one opening in fluid communication with the nasal interface, wherein the nasal interface comprises a pliable material shaped to abut and seal a patient's nasal base such that respiratory gasses pass via the patient's nostrils, the at least one opening, the air chamber, the gas supply port, and the end tidal sample port.
In an aspect of the nasal respiratory assembly, the nasal interface includes a cavity of material having Shore A 5-20 durometers, and a membrane extends over the cavity. The at least one opening extends through the membrane into the cavity. The cavity further includes a second opening in a floor of the cavity and in fluid communication with the air chamber via the at least one opening in fluid communication with the nasal interface, whereby a patient's nasal base interface with the membrane for providing a seal.
The nasal interface may comprise a solid material having a roughly rectangular cross section and Shore A 5-20 durometers, whereby the at least one opening extends from a surface of the nasal interface through the solid material to an opposite surface of the material and aligns with the at least one opening in fluid communication with the nasal interface.
The accompanying figures, which are incorporated herein and form part of the specification, illustrate a new nasal respiratory apparatus. Together with the description, the figures further serve to explain the principles of the new nasal respiratory apparatus described herein and thereby enable a person skilled in the pertinent art to make and use the new nasal respiratory apparatus
Reference will now be made in detail to embodiments of the new nasal respiratory apparatus with reference to the accompanying figures. For convenience of explanation, various figures make use of a right-handed X, Y, Z-axis Cartesian Coordinate system reference space, with reference to X-Y, X-Z, and Y-Z planes.
It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.
An embodiment of a nasal dam 224 according to principles described herein is illustrated in
The nasal dam 224 as used herein abut a top part of the air chamber assembly 254 and has nares ports 248 that align with air chamber nares ports 242. The nasal dam 224 interfaces with the soft tissue of the nasal base, providing a pressure seal in order to contain airflow between the nasal pharynx and the nasal ventilator system via the nares ports 248/242 and the air chamber 206. The nasal dam may be of a soft Shore A 5-20 durometer material in order to conform to and seal the nasal base from a pressure differential between the air chamber 206 interior and the atmosphere.
The air chamber assembly 254 includes an air chamber 206, gas and end tidal sample ports (208, 218) in fluid communication with the air chamber 206 and nares ports 242 through an upper wall 260 that correspond to nares ports 248 in the nasal dam 224 that provide fluid communication between the air chamber 206 and the patient's nostrils. In the present example using the disclosed nasal dam 224, the nasal dam 224 is inserted to the rear of the air chamber assembly 254, thus enclosing the rear of the air chamber assembly 254 to provide at least one wall forming the air chamber 206. In addition, as shown in
A portion of lower surface 233 of the nasal dam 224 in an X-Y plane abuts an upper portion 235 of the air chamber assembly in the X-Y plane, with the nares ports 248/242 of both the nasal dam and the air chamber assembly aligning when the nasal dam 224 and the air chamber assembly 254 are aligned with one another to allow for fluid communication between the patient's nostrils and the air chamber 206, which in turn is in fluid communication with the gas port 208 and the end tidal sample port 218.
In addition, as shown in
The stiffness of the nasal interface for the solid nasal dam, Ks, as defined by the pressure between the nasal base 326 and nasal dam 224, δP, over an area approximated by a circle of radius r, and resulting in a displacement δZ, as illustrated in
K
s
=δP/δZ=E/L
s=7.5×107 N/m3 (1)
In another embodiment of a nasal respiratory apparatus, a hollow nasal dam may be used to provide comfort and possibly improved sealing against the patient's nasal base.
Referring to
Sectional views of the nasal respiratory assembly 500, as shown in
Details of the hollow nasal dam 524 are described with reference to
The air chamber assembly 254 mates with the hollow nasal dam as illustrated in
The stiffness of the nasal interface for the hollow nasal dam, Km, as defined by the pressure between the nasal dam 524 and the patient's nasal base, δP, over an area approximated by a circle of radius r, and resulting displacement in δZ has been modeled as a simply-supported circular plate of radius r and thickness Lm, as illustrated in
K
m
=δP/δZ=E L
m
3/(0.7r4)/Ls=3.4×105 N/m3 (2)
A circular plate for explaining the assumptions and calculations according to Equation (2) is shown in
Symbols used are as follows:
Stress at the center of the circular plate of
Deflection at the center, with v=0.3 is given by:
Where, D=flexural rigidity=Et3/(12*(1−v2)
A benefit of the hollow nasal dam design is that the stiffness in the Z direction can be two orders of magnitude smaller, 3.4×105 N/m3 versus 7.5×107 N/m3, for example. As a result, the same displacement in the Z direction required to achieve sealing between the nasal dam and nasal base requires 1/100th of the pressure. This may provide a significant reduction in pressure, which results in better sealing at lower applied pressure from the straps holding the nasal respiratory assembly in place on the patient, for example. Such reduced strap pressure may result in increased patient comfort, providing a reduced risk of pressure ulcers at any patient interface with the nasal respiratory apparatus.
PCT/US2019/068231 may be references for background information regarding a modular nasal dam/air chamber configuration, and relevant portions of that document may be incorporated herein by references as if fully set forth herein for all purposes to the extend allowed by relevant laws.
This application is claims priority to U.S. Provisional Patent Application Ser. No. 63/081,100, filed Sep. 21, 2020, which application is hereby incorporated by this reference in its entirety to the extent allowed by law.
Filing Document | Filing Date | Country | Kind |
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PCT/US2021/051214 | 9/21/2021 | WO |
Number | Date | Country | |
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63081100 | Sep 2020 | US |