RU2447871C2 - Nasal and oral patient interface - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine. An interface comprises a body section intercommunicating with a first passage of a fluid medium. A first nostril interface extends from the body section and intercommunicates with the first passage of the fluid medium. A first fastening section extends from the body section close by the nostril interface and structurally geared with an external surface of a patient's nose to attach the patient interface to the patient's nose. A physiological function sensor for gearing with nose skin of said patient forms a signal on the ground of measuring the physiological function. The sensor comprises a signal emitter and a signal receiver. What is disclosed is a second structurally different version of the interface.

EFFECT: higher stability and comfort for the patient.

18 cl, 56 dwg

Description

PRIORITY STATEMENT

In accordance with Section 119 (e) of Section 35 of the Code of the Laws of the United States, this application claims priority for provisional applications for US Patent No. 60 / 835,735, filed August 4, 2006, and 60 / 947,523, filed July 2, 2007.

FIELD OF THE INVENTION

The present invention relates to improved patient interfaces for sampling carbon dioxide, additional oxygen supply and combined sampling of carbon dioxide and additional oxygen supply. In addition, the present invention relates to nasal and oral patient interfaces for monitoring gas and physiological functions and for other types of control. The present invention further relates to a combination of a nasal carbon dioxide sampler and a nasal / oral central photoplethysmographic sensor, which can be used as an apnea sensor.

BACKGROUND OF THE INVENTION

A sidestream gas sampling system transmits a gas stream from the patient’s airways through a sampling tube to a sample cell in which gas components are measured by a gas sensitive system. Gases are continuously sucked through the sampling tube into the sample cell, which is usually located inside the gas meter. Gases are typically sampled at rates ranging from about 50 ml / min to about 250 ml / min.

For purposes of description, the present explanation focuses on patient interfaces and / or cannulas for use in humans, but it should be understood that the present invention is not limited to the scope of use only in humans and may be useful for use in various other situations. For example, the present invention can also be applied in the field of veterinary medicine when the "patients" are animals.

Oral / nasal cannulas of different types are used to deliver oxygen to patients who need proper breathing support, to take a gas sample from patients to control breathing, or to perform both functions. These cannulas are used when they do not provide forced ventilation. The term “oral / nasal” refers to an adaptable configuration of said cannulas, which may be in close proximity to the oral cavity (mouth) or inserted into the patient's nasal cavity (nostril or nostrils). In each arrangement, the lateral flow of air exhaled by the patient flows through the cannula into the gas analyzer for analysis. The results of this non-invasive analysis provide an indication of the patient’s condition, for example, the state of perfusion of the patient’s lungs, respiratory system and / or metabolism.

Some nasal interfaces for sampling carbon dioxide are perceived as incapable of maintaining the correct position during control and are inconvenient. The differences between patients should also be taken into account, in particular the distance between the patient’s nostrils and the distance between the patient’s nose and mouth, as well as differences in air flow from the nostrils.

In addition, nasal resistance can vary significantly from person to person. By itself, the nasal airflow can often be distributed more or less asymmetrically between the two nostrils. This asymmetry can adversely affect the efficiency of oxygen delivery, since delivery will depend on the nature of the obstruction in one or both nostrils and on the method of oxygen delivery. Existing nasal cannulas for carbon dioxide sampling and oxygen delivery either deliver in one nostril, or deliver equally to both nostrils, or create a “cloud” of oxygen that is inhaled by humans. It is desirable to create a simple means for the preferred direction of oxygen into a less blocked nostril.

In addition to sidestream sampling methods, the present invention also relates to a variety of control methods. As you know, if the levels of oxygen in the blood in peripheral localizations become very low, then many different clinical problems can occur. In addition, diseases, acute injuries, and other conditions can adversely affect blood flow to and in the limbs, and inadequate blood flow reduces the amount of oxygen that is transported by the blood stream to the cells.

Blood oxygen levels are usually currently measured by pulse oximetry, which can be divided into transmitting and reflective types. Transmission or transmission oximetry involves a process in which a sensor measures the attenuation of light as light passes through a section of tissue supplied with blood. Light is transmitted from one side of the blood-supplied tissue site and is recorded by a receiver located on the opposite side of the same tissue site. On the other hand, with reflective oximetry, both a light source and a receiver located on one side of the tissue are used, and reflection from the tissue is measured.

With both types of oximetry, several signals from a photodetector or receiver can be used to estimate blood oxygen saturation and / or pulse rate from changes in light absorption received during blood pulsation cycles. The technology is based on the selective absorption of different wavelengths of light by different types of hemoglobin, known in the art.

Traditional pulse oximetry measurements for patients of certain classes, for example, patients with severe burns, may encounter serious difficulties, however, such control data are very important for operating rooms and intensive care units. Most modern pulse oximetric methods depend on available peripheral sites that allow transmission oximetry, which is sufficient for most surgical conditions and operations. However, in some cases, for example, in the case of patients with severe burns, only a few places may be suitable for the effective installation of a translucent pulse oximeter sensor. These patients often suffer from severe circulatory dysfunctions, which reduces the effectiveness of modern peripheral pulse oximeters. Therefore, oxygen saturation is preferably measured with a centralized meter.

In terms of control, the creation of, for example, a commercial error-resistant and inexpensive respiratory monitor, for adults, in particular, is still required. In the United States, the respiratory monitor is defined by the US Federal Regulations Act as “a complete system designed primarily to warn of breath holding, counted in time from the last recorded breath. The respiratory monitor also includes indirect methods for determining apnea, for example, monitoring the heart rate and other physiological parameters associated with the presence or absence of proper breathing. " See 21 C.F.R., § 868.2377 (paragraph 868.2377 of section 21 of the United States Federal Code). Accordingly, an easy-to-use device is required that implements error-tolerant and redundant methods for determining apnea.

The present invention further relates to providing a simple method for conducting outpatient diagnostic tests in a dream. Accordingly, an easy-to-use, localized in one place device is required that provides the ability to measure respiratory effort directly or indirectly, SpO ₂ or flow.

SUMMARY OF THE INVENTION

In accordance with one aspect of the present invention, there is provided a patient interface with enhanced stability and patient comfort. This goal is achieved by creating a patient interface, which contains a body section, configured to communicate with at least one fluid path. At least one nostril interface extends from the body portion and is configured to insert into the nostril of the patient and communicate with at least one fluid path. A pair of flexible stabilizers extends from the housing portion on opposite sides of the housing portion and is configured to substantially adhere to the patient when the interface is mounted on the patient.

In another embodiment, the aforementioned goal is achieved by creating a patient interface that includes a body portion configured to communicate with the first and second fluid paths. The first and second nostril interfaces protrude from the first side of the body section, the first nostril interface communicates with the first fluid path, the second nostril interface communicates with the second fluid path, with the first and second nostril interfaces being inserted into the left and right, respectively the patient’s nostrils, when the body section is in the first orientation, in order to ensure the communication of the first fluid path with the left nostril and the second tract a bunch of medium from the right nostril. The third and fourth nostril interfaces protrude from the second side of the body portion, and the third nostril interface communicates with the first fluid path. The fourth nostril interface communicates with the second fluid path. The third and fourth nostril interfaces are adapted to be inserted into the patient’s right and left nostrils, respectively, when the body section is in the second orientation, so that the first fluid path from the right nostril and the second fluid path from the left nostril communicate.

In another embodiment, the aforementioned goal is achieved by creating a patient interface that comprises a body portion configured to communicate with two fluid paths. A pair of nostril interfaces protrudes from the hull. The oral sampling section has a working connection with the body section and comprises an opening configured to communicate with at least one of the fluid paths. The oral sampling section has an adjustable design, which makes it possible to change and fix in different states the orientation of the opening of the oral sampling section.

In another embodiment, the aforementioned goal is achieved by creating a patient interface that comprises a body portion configured to communicate with at least one fluid path. The adjustable nostril interface has a working connection with the body section. The nostril interface is configured to fit the patient’s nose into the nostril and communicate with the fluid path. The nostril interface has an adjustable design that allows you to adjust the length and / or orientation of the nostril interface relative to the body section.

In another embodiment, the aforementioned goal is achieved by creating a patient interface that comprises a body portion configured to communicate with at least one fluid path. The nostril interface has a working connection with the body section to ensure communication of the fluid path with the nostril. The attachment device is structurally configured to attach the body portion to the nose of the patient. The attachment device comprises a nose engagement portion coupled to the device for engaging the outer surface of the patient's nose.

In another embodiment, said goal is achieved by creating a patient interface that includes a tube forming a fluid path, the tube having an opening at one end of the fluid path and through which fluid moves from and into the patient. The housing portion includes a tube holder portion that is structurally configured to secure a portion of the tube that is spaced so far from the hole to position the hole to provide fluid communication with the patient. To fix the body section on the patient’s head, an installation design is provided.

In another embodiment, the aforementioned goal is achieved by creating a patient interface that comprises a body portion configured to communicate with the fluid path. At least a section of the body portion may be an inflatable fluid. The nostril interface continues from the body portion and is structurally configured to provide communication between the patient’s nostrils and the fluid path.

In another embodiment, the aforementioned goal is achieved by creating a patient interface that comprises a body portion configured to communicate with the fluid path. The nostril interface and at least one attachment portion extend from the housing portion. An adhesive is provided at the attachment site for removably attaching the attachment portion to the patient's face.

In another embodiment, said goal is achieved by creating a patient interface that comprises a first nostril interface configured to be inserted into the first nostril of the patient and comprising a first channel for communication with the first nostril of the patient. The second nostril interface is configured to be inserted into the second nostril of the patient and comprises a second channel for communication with the second nostril of the patient. The first nostril interface allows its corresponding shift relative to the second nostril interface to create the ability to adjust the gap between these nostril interfaces.

In another embodiment, said goal is achieved by creating a patient interface that comprises a unitary structure comprising (1) a tube section forming the first and second fluid paths, and (2) a hardware section that contains a first nostril interface that communicates with a first fluid path, and a second nostril interface that communicates with a second fluid path.

In another embodiment, the aforementioned goal is achieved by creating a patient interface that comprises a body portion configured to communicate with the fluid path. The nostril interface communicating with the fluid path extends from the body portion. From the body section, the mounting section also extends. The fastening section is located near the nostril interface and engages the outer surface of the patient’s nose. The nostril interface and the mounting portion are able to interact to clamp the portion of the patient’s nose between them.

In another embodiment, the aforementioned goal is achieved by creating a patient interface that comprises a body portion configured to communicate with the fluid path. The nostril interface extends from the body portion and communicates with the fluid path. The mounting portion extends from the body portion. The fastening section is located near the nostril interface and contains two clamping sections for clamping between them the nose portion of the patient.

In another embodiment, said goal is achieved by creating a patient interface that comprises a head attachment unit configured to be fixed to the patient’s head. The head mount includes a docking section, structurally configured to be located near the nose of the patient. An apparatus is provided for attachment, with the ability to disconnect, to the docking station. The hardware section contains a nostril interface for providing communication of the first fluid path with the patient’s nostrils.

In another embodiment, said goal is achieved by providing a patient interface that comprises a body portion comprising a first passage configured to communicate with a first fluid path that diverts the first fluid from the patient. The second passage is configured to communicate with a second fluid path that introduces a second fluid into the patient. The nostril interface continues from the body portion and is configured to fit into the patient’s nose. The nostril interface contains a first opening that communicates with the first passage of the body portion to receive the first fluid from the patient. A second opening communicates with a second passage of the body portion to dispense a second fluid to the patient.

In another embodiment, said goal is achieved by creating a nostril interface configured to be inserted into a nostril of a patient. The nostril interface contains an internal channel extending through the nostril interface. The inner channel is configured to receive a first fluid from the nostrils of the patient. An external channel surrounds at least a portion of the internal channel. The external channel is configured to supply a second fluid to the nostril of the patient. The moisture exchanger is configured to receive moisture from the first fluid and supply moisture to the second fluid.

In another embodiment, the aforementioned goal is achieved by creating a patient interface that includes a fluid delivery channel configured to deliver a first fluid to at least one patient’s nostril. A nasal interface comprising a pair of nostril interfaces is adapted to be inserted into the nostrils of a patient to receive a second fluid from the patient. The fluid delivery channel is movable relative to the nostril interface, wherein the delivery of the first fluid to at least one patient’s nostril is controlled by the position of the fluid delivery channel relative to the nasal interface so that 1) when the fluid delivery channel is in the first position relative to the nasal interface, a fluid delivery channel is configured to deliver a first fluid to both nostrils of the patient; and 2) when the fluid delivery channel is in a second position relative to the nasal interface, the fluid delivery channel is configured to deliver the first fluid to one of the nostrils of the patient.

In another embodiment, the aforementioned goal is achieved by creating a patient interface that comprises a fluid delivery channel containing outlet openings configured to deliver a first fluid to the patient’s nose. A pair of nostril interfaces is configured to be inserted into the nostrils of the patient in order to receive a second fluid from the patient. The fluid delivery channel allows its corresponding movement relative to the nostril interfaces, which aligns the outlet openings for general adjustment of the relative amount of the first fluid sent to the first nostril of the patient compared to the amount of the first fluid sent to the second nostril of the patient.

In another embodiment, said goal is achieved by creating a patient interface that comprises a hardware portion comprising a nostril interface configured to fit into a patient’s nostril and allow fluid to move between the nostril and the fluid path. A physiological function sensor is attached to the hardware section to contact the patient’s nose skin and generate a signal based on the measurement of physiological function.

In accordance with another aspect of the present invention, there are provided patient interfaces, for example gas sampling cannulas, to selectively deliver oxygen to the nostrils so that oxygen can preferably be directed into either nostril or both nostrils.

In accordance with another aspect of the present invention, there is provided a patient interface that provides primary and secondary determination of a patient’s respiratory state.

In accordance with a further aspect of the present invention, there is provided an apnea monitor in which the primary and secondary determination signals are collected in one location on a patient.

In accordance with a further aspect of the present invention, there is provided an ambulatory sensor located in one place for sleep diagnostics that provides means for measuring force (eg, respiratory effort), SpO _2, or flow.

Mentioned and other aspects, signs and characteristics of the present invention, as well as methods of operation and functions of related structural elements and a combination of components and economic indicators of production will become more clear from a consideration of the following description and the attached claims, with reference to the accompanying drawings, which are an integral part the present description, where the same numeric positions denote the corresponding parts in various figures. However, it should be clearly understood that the drawings are intended only for illustration and description and do not imply any limitation of the invention. For the purposes of the present description and in the claims, the singular expressed by the indefinite and definite articles includes many reference objects, unless the context directly indicates otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of a patient interface for gas sampling, additional gas delivery, or combined gas sampling and additional gas delivery;

FIG. 2 is a more detailed view of an embodiment of the interface shown in FIG. one;

FIG. 3 is a more detailed view of another embodiment of the interface shown in FIG. one;

FIG. 4 is a perspective view of another embodiment of a patient interface for gas sampling, additional gas delivery, or combined gas sampling and additional gas delivery;

FIG. 5 is a more detailed view of an embodiment of the interface shown in FIG. four;

FIG. 6 is a perspective view of another embodiment of the interface shown in FIG. four

FIG. 7 is a perspective view of another embodiment of the interface shown in FIG. four;

FIG. 8 is a detailed view of another embodiment of the interface shown in FIG. 7;

FIG. 9 is a perspective view of another embodiment of a patient interface for gas sampling, additional gas delivery, or combined gas sampling and additional gas delivery;

FIG. 10 is a more detailed view on one side of the interface shown in FIG. 9;

FIG. 11 is a more detailed view of the interface shown in FIG. 9;

FIG. 12 is a perspective view of another embodiment of the interface shown in FIG. 9;

FIG. 13 is a perspective view of another embodiment of a patient interface for gas sampling, additional gas delivery, or combined gas sampling and additional gas delivery;

FIG. 14 is a side view of the interface shown in FIG. 13;

FIG. 15 is a perspective view of another embodiment of a patient interface for gas sampling, additional gas delivery, or combined gas sampling and additional gas delivery;

FIG. 16 is a more detailed view of the interface shown in FIG. fifteen;

FIG. 17 is a perspective view of another embodiment of a patient interface for gas sampling, additional gas delivery, or combined gas sampling and additional gas delivery;

FIG. 18 is a more detailed view of the interface shown in FIG. 17;

FIG. 19 is a detailed view of another embodiment of the interface shown in FIG. 17;

FIG. 20 is a perspective view of another embodiment of a patient interface for gas sampling, additional gas delivery, or combined gas sampling and additional gas delivery;

FIG. 21 is a more detailed view of the interface shown in FIG. twenty;

FIG. 22 is a cross-sectional view of another embodiment of a patient interface for sampling carbon dioxide, additional oxygen delivery, or combined sampling of carbon dioxide and additional oxygen delivery;

FIG. 23 is a perspective view of another embodiment of a patient interface for gas sampling, additional gas delivery, or combined gas sampling and additional gas delivery;

FIG. 24 is a sectional view of a portion of an interface tube shown in FIG. 23;

FIG. 25 is a schematic sectional view of a hardware portion of the interface shown in FIG. 23;

FIG. 26 is a more detailed view of the distal end of the nostril interface in the patient interface shown in FIG. 23;

FIG. 27 is a perspective view of another embodiment of a patient interface for gas sampling, additional gas delivery, or combined gas sampling and additional gas delivery from one nostril or into one nostril;

FIG. 28 is a perspective view of another embodiment of a patient interface for gas sampling, additional gas delivery, or combined gas sampling and additional gas delivery;

FIG. 29 is a perspective view of another embodiment of a patient interface for gas sampling, additional gas delivery, or combined gas sampling and additional gas delivery from one nostril or into one nostril;

FIG. 30 is a sectional view of a portion of an interface tube shown in FIG. 29;

FIG. 31 is a schematic sectional view of a hardware portion of an interface shown in FIG. 29;

FIG. 32 is a more detailed view of the nostril interface in the patient interface shown in FIG. 29;

FIG. 33 is a perspective view of an embodiment of the nostril interface for combined gas sampling and additional gas delivery;

FIG. 34 is a perspective view of another embodiment of a patient interface for gas sampling, additional gas delivery, or combined gas sampling and additional gas delivery;

FIG. 35 is a sectional view of an embodiment of a nasal interface portion in a patient interface for combined gas sampling and additional gas delivery;

FIG. 36 is a perspective view of an embodiment of a fluid delivery channel in a patient interface for combined gas sampling and additional gas delivery;

FIG. 37 is a perspective view of a patient interface for combined gas sampling and additional gas delivery, which contains a portion of the nasal interface shown in FIG. 35, and an embodiment of the fluid delivery channel shown in FIG. 36, with a fluid delivery channel in a first position relative to the nasal interface;

FIG. 38 is a more detailed view of one end of the patient interface shown in FIG. 37;

FIG. 39 is a perspective view of the patient interface shown in FIG. 37, with a fluid delivery channel in a second position relative to the nasal interface;

FIG. 40 is a perspective view of the patient interface shown in FIG. 37, with a fluid delivery channel in a third position relative to the nasal interface;

FIG. 41 is a perspective view of another embodiment of a patient interface shown in FIG. one;

FIG. 42 is a front view of another embodiment of a patient interface shown in FIG. 41;

FIG. 43 is a front view of another embodiment of a patient interface shown in FIG. 42;

FIG. 44 is a rear view of another embodiment of a patient interface shown in FIG. 10;

FIG. 45 is a rear view of another embodiment of a patient interface shown in FIG. 44;

FIG. 46 is a perspective view of another embodiment of a patient interface shown in FIG. 13;

FIG. 47 is a side view of another embodiment of a patient interface shown in FIG. 46;

FIG. 48 is a perspective view of another embodiment of a patient interface shown in FIG. 21;

FIG. 49 is a perspective view of another embodiment of a patient interface shown in FIG. 27;

FIG. 50 is a perspective view of another embodiment of a patient interface shown in FIG. 49;

FIG. 51 is a block diagram of an embodiment of a respiratory monitor;

FIG. 52 is a perspective view of an embodiment of the respiratory monitor shown in FIG. 51;

FIG. 53 is a flowchart of an apnea control method;

FIG. 54 is a perspective view of an embodiment of a patient interface for gas sampling from one nostril and additional gas delivery;

FIG. 55 is a cross-sectional view of a portion of the interface tube shown in FIG. 54; and

FIG. 56 is a perspective view of a ribbon that is configured to fit behind a patient’s ear.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

In FIG. 1 depicts a patient interface 10 in accordance with an embodiment of the present invention. The patient interface 10 can be used as a cannula or “apparatus” for combined oral and nasal gas sampling and / or can also be used as a cannula or “apparatus” for additional gas delivery. Typically, the sampled gas is carbon dioxide (CO ₂ ) and / or oxygen (O ₂ ), and the additional gas is oxygen (O ₂ ). However, the present invention contemplates that the sampled gas may be any gas or mixture of gases that can be measured using any existing methods. The present invention also contemplates that the additional gas may be any gas or mixture of gases, for example helium, nitrogen, helium-oxygen mixture (heliox), or nitrogen-oxygen mixture.

For the purposes of the present description, the term "patient interface" is intended to mean, in a broad sense, any device or structure that (s) mates or interacts with a patient, or contains a site that mates or interacts with a patient. The term “apparatus” refers, in a broad sense, to any device or structure that (i) introduces a fluid into a patient and / or draws a fluid from a patient. The term "cannula", for the purposes of the present description, refers to one type of "apparatus" and, in particular, refers to a structure that contains at least a portion that at least partially protrudes into at least one the nostril of the patient.

As shown, the patient interface 10 comprises a body portion 12 configured to communicate with at least one fluid path. In the shown embodiment, the first fluid path 14 and the second fluid path 15 are provided with tubes 11 and 16, respectively. For the purposes of the present description, the term “tube” is intended to mean a flexible, rigid or semi-rigid tube. Of course, for the formation of fluid paths, any suitable structure for fluid movement can be formed.

The present invention assumes that at least one fluid path transmits the sampled gas to a suitable measuring device, for example, a gas analyzer, a pressure sensor, a flow sensor, a temperature sensor, a humidity sensor, and the like. In the case of a gas analyzer, the sampled gas moves to the measurement site. In the case of measuring pressure or flow, the fluid path transmits gas to a suitable pressure or flow meter. Other sensors are also contemplated that measure other properties or components of the fluid, for example, temperature, humidity and gas composition, fluid motion, or optical communication with the fluid path.

In the shown embodiment, the housing portion 12 comprises a pair of tube connecting portions 17 and 19 for pairing and / or connecting to fluid paths 14 and 15, respectively. In one embodiment, the connecting sections 17 and 19 contain corresponding holes in the housing section 12, with each said hole having an inner diameter formed with the possibility of joining along the friction fit with the outer diameter of the corresponding tube 11, 16.

Other mechanisms are possible for forming connections between the body portion 12 and the tube or fluid paths. For example, the connecting sections on the housing section 12 may be in the form of protrusions, each containing a passage between them and having an outer surface with an outer diameter formed with the possibility of joining along the friction fit with the inner diameter of the corresponding one of the tubes, etc. In other embodiments, the implementation of the connection can be provided with an adhesive or other connecting structure. In another embodiment, the tubing and the housing portion may be integrally formed. The described embodiments do not imply any limitation of the invention.

As shown in the embodiment of FIG. 1, the tubes 11 and 16 of the patient interface 10 are adapted to extend from the body portion 12 and at least partially around each patient’s ear to fix the body portion 12 in a substantially stable position relative to the patient’s nose. The route of the tubes 11, 16 around each patient’s ear is just one example of how the body portion can be fixed in a substantially stable position relative to the patient’s nose. For example, in another embodiment, the tubes 11, 16 can be drawn from the body portion 12 through the patient’s head and secured in many different ways known in the art, including but not limited to clamps, adhesives, and the like. The embodiment shown does not imply any limitation of the invention.

The patient interface 10 also includes at least one generally tubular nostril interface 18 which protrudes from the body portion 12. In the present embodiment, two nostril interfaces 18 and 21 are shown. Although it is contemplated that, in some embodiments, only one nostril interface can be provided 18. The nostril interfaces 18 and 21 are adapted to be inserted into the corresponding nostril of the patient and contain corresponding internal holes communicating with the correspondingly connected tract 15 and 14, and fluid movement.

As shown in FIG. 2, communication between the nostril interface 18 and the opening of the connecting portion 17 is provided by the internal channel 23 in the housing portion 12. Similarly, the internal channel 25 provides the communication of the nostril interface 21 with the connecting section 19, as is known in the art. The above construction allows fluid paths 14 and 15 to communicate with fluid passages with nostrils so that fluids can be received from the patient and / or delivered to the patient. In one embodiment, the nostril interface 18, the connecting portion 17, and the fluid path 14 may be configured to supply a fluid that contains oxygen (O ₂ ) to a patient from a suitable fluid source, and the nostril interface 21, the connecting portion 19, and the fluid path 15 may be configured to produce a fluid that contains carbon dioxide (CO ₂ ) exhaled by the patient. In this embodiment, the fluid path 15 transfers carbon dioxide to a suitable device, such as a gas analyzer, so that the concentration of carbon dioxide in the exhaled fluid and / or the flow rate of the exhaled fluid can be controlled over time. In this embodiment, the inner wall structure 24 isolates the inner channel 23 communicating with the nostril interface 18 from the inner channel 25 communicating with the nostril interface 21. In one embodiment, said inner wall structure is formed in accordance with the principles of US Pat. No. 5,335,656, which is entirely Included in the present description by reference.

It should also be understood that although in the aforementioned embodiment, the fluid path 14, the connecting portion 17 and the nostril interface 18 are used for oxygen delivery, and although the aforementioned fluid path 15, the connecting portion 19 and the nostril interface 21 are used for sampling carbon dioxide, these elements can be inverted depending on which nostril (left or right) is preferable for sampling carbon dioxide instead of oxygen delivery.

In another embodiment, all nostril interfaces 18, 21 and corresponding fluid paths 14, 15 receive a fluid that contains carbon dioxide from the patient. In another embodiment, all nostril interfaces 18, 21 and associated fluid paths 14, 15 deliver oxygen to the patient.

The nostril interface 18 and / or 21 may take the form of a protrusion or a truncated tooth, which is structurally configured to extend into the nostril. The length of the tooth may vary and may depend on the size of the nostrils of the patient. For example, a tooth may be shorter for a child and longer for an adult patient. In addition, the nostril interface 18 and / or 21 may have a shape or an angle of inclination relative to the body portion 12 so as to substantially match the nostril, which may make the interface 10 more comfortable for the patient to wear.

As shown in FIG. 1, the patient interface 10 in one embodiment may also comprise an oral sampler 20 that is located on the side of the body portion 12 opposite to the nostril interfaces 18, 21 and protrudes from the body 12 in the direction opposite to the nostril interfaces 18, 21. The oral sampler 20 is configured with the possibility of obtaining fluid from the patient's mouth. The oral sampler 20 comprises an opening 27 or a sampling inlet that can be located near the patient’s mouth so that when the patient exhales, the oral sampler 20 can transfer a portion of the fluid containing carbon dioxide exhaled by the patient to the corresponding sampling fluid path leading into a suitable monitoring device, such as a gas analyzer. Oral sampler 20 may include a collector (not shown) that is configured to direct exhaled gases from the patient's mouth to opening 27. Said collector is shown in FIG. 10 and is described in more detail below.

In one embodiment shown in FIG. 3, the oral sampler 20 comprises an internal passage or channel 29 that connects an opening 27 in the oral sampler 20 with an internal channel 25 leading to the connecting portion 19 so that the fluid exhaled through one nostril and mouth can enter the fluid path 15 and move into the gas analyzer. As shown in the embodiment of FIG. 3, the internal channel 23 provides the fluid path 14 with only one of the nostril interfaces 18. The internal channels 23, 25 and 29 should have smooth surfaces and should be sized and shaped to minimize gas mixing and maintain the accuracy of the gas signal shape.

In an embodiment, the oral sampler 20 is adjustable with respect to the body portion 12 so that the hole 27 in the oral sampler 20 can be set to the optimal position relative to the patient’s mouth to account for differences in anatomy as well as the direction of flow from the oral cavity, i.e. the patient’s mouth. The oral sampler 20 may be adjustable by using suitable materials and / or structures. For example, in one embodiment, the oral sampler 20 may be made of a flexible material, for example, a polymeric or elastomeric material, which contains a deformable material, for example, a metal wire 31, so that the opening 27 can be moved and fixed in the desired position relative to the patient's mouth. The wire may be embedded in a flexible material, or the wire may be attached to the flexible material on its outer surface, as will be explained in more detail below for another embodiment, which is hereby incorporated into this embodiment by reference.

The possibility of adjustment can also be provided by means of a bellows or sliding accordion-like structure in the oral sampler 20, as will be explained in more detail below for another embodiment, which is hereby incorporated by reference. In one embodiment, the oral sampler 20 can be adjusted so that it does not work, i.e. could not transmit the fluid exhaled by the patient through the mouth. This condition can be achieved either by setting the hole 27 in a position that prevents the patient from receiving fluid exhaled, or, in another embodiment, this condition can be achieved by compressing the oral sampler 20 so that the passage 29 is squeezed. In yet another embodiment, a separate or attached plug or seal structure may be inserted into or inserted into the opening 27 to prevent exhaled fluid from entering the opening 27.

In the embodiment shown in FIG. 1-3, the patient interface 10 includes a pair of flexible stabilizers 22 or wings that extend laterally outward from the body portion 12 on opposite sides of the body portion 12, as shown in FIG. 1. In particular, each stabilizer 22 extends laterally outward from the corresponding one of the connecting sections 17, 19. As shown, each stabilizer 22 has a concave-convex cross section forming a section of the tubular configuration and goes into a fully tubular configuration that forms the connecting sections 17, 19. The stabilizers 22 are made of a material with a sufficiently low hardness to substantially adhere to the adjacent surface of the patient's face when the interface 10 is mounted on the patient. The stabilizers 22 extend from the body portion 12 and provide an ergonomic configuration for greater patient comfort. In addition, the stabilizers 22 are sized so that, in sequence with the fluid paths 14, 15, the nostril interfaces 18, 21 are locked in a substantially stable position. The fluid paths 14, 15 may be located along the stabilizers 22 and exert a supporting force on the stabilizers when the interface 10 is fixed to the user.

In an exemplary embodiment, the interface 10 is made of soft material (with low hardness) for a more comfortable fit to the patient. For example, the interface material may have a Shore A hardness of from about 10 to about 40, and the interface may be made, for example, of polyurethane or silicone. In one embodiment, the body portion 12, the stabilizers 22, the nostril interfaces 18, 21, and the oral sampler 20 are molded from the same material. In another embodiment, the body portion 12 and the stabilizers 22 are molded from the same material, and the nostril interfaces 18, 21 and the oral sampler 20 are molded from another material.

As mentioned above, the interface 10 shown in FIG. 1 can be used as a combined oral and nasal device for sampling carbon dioxide and / or can also be used as a device for oxygen delivery. Depending on the configuration in which the fluid paths 14, 15 and the internal channels 23, 25 are made, the interface 10 may be configured to provide carbon dioxide samples through one nostril interface and deliver oxygen through the other nostril interface, or both nostril interfaces can be used for sampling carbon dioxide. In one embodiment, the nostril interfaces can be configured to provide carbon dioxide sampling as well as to deliver oxygen through both nostrils.

It should be understood that the above-described structural elements of the interface 10 can also be used in embodiments of the following patient interfaces. Thus, the above described structural elements and features are incorporated by reference into each of the other embodiments described below.

In FIG. 4 depicts a patient interface 30 in accordance with a further embodiment of the invention. The patient interface 30 includes a body portion 32 that is configured to communicate with a first fluid path 33 and a second fluid path 34. The first nostril interface 35 and the second nostril interface 36 extend from the first side 37 of the body portion 32 and are adapted to be inserted into the patient's nostrils when the body portion is in the first orientation (shown in FIG. 4). The first nostril interface 35 communicates with the first 33 fluid path, and the second nostril interface communicates with the second 34 fluid path. The interface 30 also includes a third nostril interface 38 and a fourth nostril interface 39, which extend from the second side 40 of the body portion 32. The third nostril interface also communicates with the first 33 fluid path, and the fourth nostril interface 39 communicates with the second 34 fluid path . The third nostril interface 38 and the fourth nostril interface 39 are adapted to be inserted into the nostrils of the patient when the body portion 32 is in a second orientation, which is an orientation that is rotated 180 ° from the first orientation shown in FIG. 4 and shown in FIG. 5.

In particular, when the interface 30 is in the first orientation, the first nostril interface 35 is configured to be inserted into the patient’s left nostril, and the second nostril interface 36 is configured to be inserted into the patient’s right nostril to provide communication of the first fluid path 33 with the left nostril and a second fluid path 34 from the right nostril. Conversely, when the interface 30 is in the second orientation shown in FIG. 5, the third nostril interface 38 is configured to be inserted into the right nostril, and the fourth nostril interface 39 is configured to be inserted into the left nostril to provide communication of the first fluid path 33 with the right nostril and the second fluid path 34 with the left nostril.

As shown, the interface 30 is symmetrical in shape so that it can be used when the body portion 32 is in either the first or second orientation. When the body portion 32 is in a first orientation, the third nostril interface 38 and the fourth nostril interface 39 are arranged to be installed close to the patient’s mouth to provide communication between the first fluid path 33 and the second fluid path 34 with the patient’s oral cavity. Conversely, when the body portion 32 is in a second orientation, the first nostril interface 35 and the second nostril interface 36 are arranged to be installed close to the patient’s mouth to provide communication between the second fluid path 34 and the first fluid path 33 with the patient’s oral cavity.

In the exemplary embodiment shown in FIG. 5, all nostril interfaces 35, 36, 38, 39 can be at an angle relative to the body portion 32 to allow the nostril interfaces 35, 36, 38, 39 to fit to the nostrils for a more convenient fit on the patient, as well as the direction to the patient’s mouth, when being in the appropriate orientation. In addition, the body portion 32 may be provided with a slightly concave surface on its side when the body portion extends laterally to engage a portion of the skin surface under the patient’s nose. This concave surface engages in a portion of the skin surface under the nose of the patient, regardless of whether the body portion 32 is in the first or second orientation, and provides a comfortable grip with the patient.

As shown in FIG. 5, the first fluid path 33 and the second fluid path 34 are formed by tubes 41, 42, respectively, each of which fits into the body portion 32 from opposite ends of the body portion in the first connection portion 43 and the second connection portion 44, respectively. As shown, the first connecting portion 43 includes an opening 45 that is adapted to receive the tube 41. The diameter of the hole 45 may be equal to or slightly smaller than the external diameter of the tube 41 so that a seal can form between the body portion 32 and the tube 41. Similarly, the second connecting portion 44 includes an opening 46 that is configured to receive the tube 42 in a similar manner. Similarly to the embodiment shown in FIG. 1, the tubes 41, 42 may be flexible enough to extend from the body portion 32 and at least partially around each patient’s ear to hold the body portion 32 in a fixed position relative to the patient’s nose. The fixed position may be the first orientation in which the first nostril interface 35 and the second nostril interface 36 are located in the nostrils, or the fixed position may be the second orientation in which the third nostril interface 38 and the fourth nostril interface 39 are located in the nostrils.

As shown in FIG. 5 and as can be understood from the explanation regarding the embodiment shown in FIG. 1, the housing portion 32 may include a baffle or insulating gasket 47 that separates the first channel 48 or passage from the second channel 49 or passage inside the housing portion 32. The first channel 48 is configured to move fluid between the first nostril interface 35, the third nostril interface 38 and the first connecting section 43, and the second channel 49 is configured to move the fluid between the second nostril interface 36, the fourth nostril interface 39 and the second connecting section 44.

In one exemplary embodiment, both the first fluid path 33 and the second fluid path 34 are configured to move the fluid containing carbon dioxide that the patient exhales into a suitable monitoring device, such as a gas analyzer. That is, all four nostril interfaces 35, 36, 38, 39 can be configured to move carbon dioxide from the patient (through the mouth and nose) into the first and second fluid paths 33 and 34. In another embodiment, the first fluid path 33 and the nostril interfaces 35, 38 are configured to move the fluid exhaled by the patient to the gas analyzer, and the second fluid path 34 and the nostril interfaces 36, 39 are configured to supply oxygen to the patient for inhalation. Since the flow from the patient’s nostrils is usually not equivalent and often varies greatly (sometimes it differs by more than an order of magnitude), the symmetric design will allow “switching states” of interface 30, which makes it possible to take carbon dioxide samples from any of the patient’s nostrils and deliver oxygen to the other nostril.

In yet another embodiment, the first 33 fluid path and the second fluid path 34 and all four nostril interfaces 35, 36, 38, 39 are configured to move oxygen into the patient for inhalation.

In the embodiment shown in FIG. 6, which is a modified version of the patient interface 30 shown in FIG. 5, the patient interface 30 also includes a first flexible stabilizer 50 and a second flexible stabilizer 51, which are in the form of tubular sections extending from the housing 32 on opposite sides of the housing portion. Although the second stabilizer 51 is not shown in its entirety, it has the same construction as the first stabilizer 50. Like the stabilizers shown and described above with reference to the embodiment shown in FIG. 1, stabilizers 50, 51 may be configured to substantially adhere to the face of the patient when the interface 30 is fixed to the patient.

In the shown exemplary embodiment, the stabilizers 50, 51 have a substantially closed tubular configuration in cross section. In addition, the first connecting portion 43 is part of the first stabilizer 50 and is located at the distal end of the first stabilizer, and the second connecting portion 44 is part of the first stabilizer 51 and is located at the distal end of the stabilizer. Tubes 41, 42 are configured to attach to a respective attachment portion 43, 44 and extend from each of the stabilizers 50, 51 and at least partially around each patient’s ear to hold the body portion 32 in a fixed position relative to the nose.

In FIG. 7 shows another embodiment of the patient interface 30 of FIG. 6. As shown, the connecting stabilizers 50, 51 (the stabilizer 51 has the same construction as the stabilizer 50) have the same function and purpose as the stabilizers 22 in FIG. 1-3. As shown, each stabilizer 50, 51 has a flattened configuration that expands in the form of a rounded distal end portion to form a generally streamlined shape. The first connecting portion 43 is located in the intermediate section of the first stabilizer 50, as shown in FIG. 7, and the second connecting portion 44 is located in the intermediate section of the second stabilizer 51 (not shown).

The patient interface 30 also includes a modified design for attaching the patient interface to the patient’s head. In particular, in this embodiment, the patient interface 30 comprises a head mount or headset that includes a first ribbon 52 connected to a first stabilizer 50 at the distal end of the first stabilizer and a second ribbon (not shown, connected to the second stabilizer 51 at its distal end For the purpose of illustration, only the first ribbon 52 is described below, although it should be understood that similar reasoning should also apply to the second ribbon.

The ribbon 52 is configured to extend from the first stabilizer 50 and at least partially around the patient’s ear to hold the body portion 32 in a stable or fixed position relative to the patient’s nose. As seen in FIG. 7, in this embodiment, the ribbon 52 comprises a closed loop 52a at its distal end. The closed loop 52a is dimensioned so that its inner diameter is substantially equal to the outer diameter of the tube 41. The tube 41 extends from the first stabilizer 50, and the ribbon 52 is configured to receive the tube 41 to guide the tube from the stabilizer 50 and from the patient . Although in the shown embodiment, the tube 41 is placed in the ribbon 52 at its distal end, this configuration does not imply any restrictions. For example, tube 41 may fit with ribbon 52 in its intermediate portion.

In one embodiment, the housing portion 32 may also comprise an adjuster 53 located between the first nostril interface 35 and the second nostril interface 36, as well as between the third nostril interface 38 and the fourth nostril interface 39, as shown in FIG. 7. The adjustment device 53 is configured to adjust the position of the first nostril interface 35 relative to the second nostril interface 36 and the position of the third nostril interface 38 relative to the fourth nostril interface 39. In one embodiment, the adjustment device 53 is a flexible section of the body portion 32. In one embodiment, flexible the section may comprise a bellows portion 54 or any other sliding structure that allows elongation, shortening or folding Maintenance of the body portion 32 and an elongated fixation, the truncated or curved configuration. Said sliding or bellows constructions are known, for example, in the form of common plastic drinking tubes. The adjusting device 53 allows the patient interface 30 to be adjusted according to the anatomical changes observed in controlled patients of different ages and with different sizes, which provides a more convenient fit for a larger number of patients.

As shown in FIG. 8, the patient interface 30 may also comprise at least one sealing or plugging structure 55 configured to block the exchange of fluid (i.e., its passage into and out) with at least one of the nostril interfaces 35, 36 , 38, 39. The sealing structure 55 may be a plug that fits into the hole 56 of any of the nostril interfaces 35, 36, 38, 39, or the sealing structure 55 may be a cap that frictionally engages the outer surface of any of the nostril interfaces, or vice versa . It is also contemplated that the cap may have a screw structure that includes a thread on its inner surface that corresponds to a thread on the outer surface of the nostril interface. In the shown embodiment, one sealing structure 55 is connected to each nostril interface 35, 36, 38, 39 to block fluid exchange with all nostril interfaces 35, 36, 38, 39. In one embodiment, four sealing structures 55 blocking each nostril interface 35, 36, 38, 39, can be molded integrally with the corresponding nostril interface and can be selectively broken off, cut off or torn off by the doctor if necessary. Of course, the doctor may block the exchange of fluid with the nostril interfaces 35, 36, 38, 39 in their various combinations or not block any of them. It is contemplated that any other sealing structure may be used to clog the nostril interface. The presented embodiment does not imply any limitations of the invention.

In one embodiment, for example, in which the nostril interface 35 delivers oxygen to one nostril and the nostril interface 36 receives carbon dioxide from the other nostril, the nostril interface 39 may remain open to act as an oral sampling port, while the nostril interface 38 may be tightly closed sealing structure 55. This configuration can be created to increase the amount of oxygen delivered to the nostril through the nostril interface 35, compared with the configuration in which the nostril Interface 38 left unclosed.

In FIG. 9 depicts a patient interface 60 that includes an oral and nasal cannula or apparatus that is configured to take gas samples, such as carbon dioxide, and / or to supply gas, such as oxygen, to a patient. As shown, the patient interface 60 includes a body portion 62 that is configured to receive a first fluid path 61 and a second fluid path 63. The first nostril interface 64 and the second nostril interface 65 protrude from the upper surface 66 of the body portion 62. The nostril interfaces 64, 65 are adapted to align with the patient's nostrils when the patient interface 60 is attached to the patient. The nostril interfaces 64, 65 provide fluid movement between the nostrils and the respective fluid paths 61, 63.

The upper surface 66 of the body portion 62 is formed as a slightly concave surface to provide a gap between the upper surface 66 and the skin under and between the nostrils so that the patient’s nostrils are not blocked by the body portion 62, but, on the contrary, there remains the possibility of fluid exchange between the nostrils and the atmosphere outside the patient interface 60, with minimal interference with the flow into the nostrils and theirs. Although the nostril interfaces 64, 65 are shown as “short nipples”, it is also contemplated that in other embodiments, the nostril interfaces may be longer and have a shape that repeats the natural curvature of the inner space of the nostrils, as shown and explained for other embodiments in the present description. The embodiment shown does not imply any limitation of the invention.

As shown, the patient interface 60 also includes an oral sampling portion 67, which is operatively connected to the housing portion 62 and extends from the housing portion 62 away from the nostril interfaces 64, 65. The oral sampling portion 67 includes an opening 68 that is configured to communicate with at least one of the paths 61, 63 of the fluid. The opening 68 is configured to receive fluid exhaled from the oral cavity through the patient’s mouth or, in a different embodiment, to deliver a fluid, such as oxygen, for the patient to breathe.

As shown in FIG. 10, the oral sampling section 67 comprises a manifold 80 at its distal end, which is configured to direct exhaled gases from the patient's mouth to the opening 68. The collector 80 may be in the form of a spoon or any other shape that smoothly guides the flow with minimal disturbance and mixing of the flow . In the shown embodiment, the manifold 80 has a concave surface 81 that is shaped to generally direct the flow of exhaled gases that come in contact with the surface 81 to the opening 68. The embodiment shown does not imply any limitations of the invention.

The oral sampling portion 67 is formed as a deformable structure that allows you to change and fix the orientation of the hole 68 of the oral sampling portion 67 in different positions. In other words, the oral sampling section 67 can be made with the possibility of adjustment relative to the patient's mouth. In one embodiment, the oral sampling portion 67 comprises at least one deformable wire 70, which is configured to adjust the shape of the oral sampling portion. By bending the wire 70, the hole 68 in the oral sampling portion 67 can be shifted relative to the body portion 62, the adjusted position can be fixed, the oral sampling portion can be positioned, as required, relative to the patient’s mouth when the patient interface 60 is attached to the patient. In an exemplary embodiment, wire 70 typically fixes the shape of the bend wire and can be embedded in the oral sampling portion 67. In another embodiment, two deformable wires 70 and 71 may be on opposed outer surfaces 72a, 72b of the oral sampling portion 67, respectively. as shown in FIG. 10 and 11.

In a further exemplary embodiment, the housing portion 62, the nostril interfaces 64, 65, and the oral sampling portion 67 are molded from the same material as an integral part. The material may be any suitable material that fully complies with the applicable standards for these mating devices. For example, patient interface 60 may be molded from soft biocompatible materials, such as polyurethanes and silicones.

Fluid paths 61, 63 may be formed by suitable tubes 73, 74, respectively, which extend from the body portion 62 and at least partially around each patient’s ear to hold the body portion in a fixed position relative to the patient’s nose. The definition of “suitable” tube means a tube that complies with applicable standards for mating devices. The tubes 73, 74 should be sized such that kinks are prevented that would impede the flow of fluids in the fluid paths 61, 63. Tubes 73, 74 can be attached to the housing portion 62 in any of the ways described above.

In addition, in FIG. 9 also shows an adjusting device 75 for adjusting or controlling the tension provided in the tubes 73, 74 and the body portion 62 so that the body portion 62 remains in a fixed position relative to the patient’s nose. As shown, the adjusting device 75 has the shape of an adjustable slider and is configured to accommodate, with the possibility of shear, tubes 73, 74 coming from each ear to a position under the patient's chin. The adjusting device 75 comprises two passages 76, 77, which are adapted to provide frictional mating with the tubes 73, 74, respectively, to provide frictional resistance when the adjusting device is shifted relative to the tubes 73, 74. Of course, other configurations of adjusting devices are applicable. The embodiment shown does not imply any limitation of the invention.

As shown in FIG. 12, the housing portion 62 may also include a deformable structure 78 that interconnects the nostril interfaces 64, 65 to enable adjustment of the distance between the nostril interfaces. In one embodiment, the deformable structure 78 comprises a deformable wire 79. The wire 79 may be constructed in the form of a bellows structure in which the wire is bent as a serpentine, as shown in FIG. 12. In one embodiment, the wire 79 may be a continuation of the wire 70, which is part of the sampling section 68, as shown in FIG. 12. The wire 79 may be embedded in the housing portion 62 or may be connected to the housing portion 62 along the outer surface of the housing portion. Of course, to allow adjustment of the distance between the nostril interfaces 64, 65, any suitable deformable structure can be used. By providing a deformable structure 78 in the body portion 62, the patient interface 60 can be adjusted according to the anatomical changes observed in controlled patients of different ages and with different sizes, which provides a more convenient fit for a larger number of patients. The embodiment shown does not imply any limitation of the invention.

In FIG. 13 and 14 depict another embodiment of a patient interface 90 in accordance with the principles of the present invention. Interface 90 may be an oral and nasal cannula or apparatus for gas sampling and / or gas delivery. It is contemplated that this embodiment of a patient interface 90 may be, in particular, applicable to emergency care, as well as to tasks that include sedation procedures. The patient interface 90 includes a body portion 92 configured to communicate with at least one fluid path. In the shown embodiment, the body portion 92 is in communication with two fluid paths 91, 93, and the attachment device 94 is structurally adapted to attach the body portion 92 to the patient’s nose. The attachment device 94 comprises a nose engagement section 95 connected to a body portion 92 for engaging with the outer surface of the nose, as shown in FIG. 13.

The nose engagement portion 95 may comprise a spring clip 96 which is structurally adapted to engage on opposite sides of the patient's nose. In particular, the spring clip 96 may have a U-shape that is configured to engage the patient’s nose, as shown in FIG. 13. The paws of the U-shaped configuration can diverge to accommodate the nose and gently tighten against each other to clamp the nose between them. The attachment device 94 may additionally or alternatively comprise an adhesive 97 that is designed to detachably adhere to the patient’s nose to facilitate attaching the patient interface 90 to the patient. Adhesive 97 may be any suitable adhesive that will firmly fix the attachment device 94 in a predetermined location on the patient’s nose, but can be easily removed after applying suitable pressure. In one embodiment, the adhesive 97 is located on the spring clip 96, in portions of the spring clip that come into contact with the patient’s nose.

As shown in FIG. 13, two adjustable nostril interfaces 98, 99 are operatively connected to the body portion 92. Each nostril interface 98, 99 is configured to insert a patient’s nose into the nostril and communicate with the fluid paths 91, 93. Each nostril interface 98, 99 contains a deformable structure 100, 101, respectively, which makes it possible to adjust the length and / or orientation of the nostril interfaces 98, 99 relative to the body portion 92. In the shown embodiment, which cannot be considered as limiting the invention, deformable structures 100 101 contain a bellows construction similar to the aforementioned flexible drinking tube. In another embodiment, the nostril interfaces can be a deformable tube or tubes that can be fixed in a given place after the nostril interface is inserted into one of the patient's nostrils.

Cabinet 92 is configured to communicate with at least one of the paths 91, 93 of the fluid through the joint 103. The joint 103 may be a deformable section of the body section 92 or may be a deformable structure that is connected to the body section 92 on one the end. The fluid paths 91, 93 are formed by tubes 104, 105, respectively. One end of each tube 104, 105 fits into the joint 103, and the other end of each tube 104, 105 can be connected to a fluid source or fluid receiver. For example, one of the fluid paths 91, 93 can transfer oxygen to one of the nostrils through the corresponding tube 104, 105 and the nostril interface 98, 99, and the other of the fluid paths 91, 93 can transfer fluid from one of the nostrils through the corresponding tube 104, 105 and the nostril interface 98, 99. As can be understood from the description of other embodiments, the patient interface 90 can be performed only for sampling or only for delivery or as a combined patient interface for sampling and access avki.

The joint 103 is configured to adjust the position of the tubes 104, 105 relative to the body portion 92 for more convenient handling of the tubes. For example, an ambulance crew member (EMT) in an ambulance may need to route tubes up and over their heads, as shown. In other situations, the physician may need to route the tubes away from the patient’s head, as shown by dashed lines 106 in FIG. 13.

In one embodiment, the patient interface 90 may also comprise an oral sampler 108 that is operatively connected to the body portion 92 and is configured to communicate with at least one of the fluid paths 91, 93. The oral sampler 108 comprises an opening 109 configured to take samples of the fluid exhaled from the patient's mouth and / or deliver oxygen to the patient's mouth so that the patient can inhale oxygen. In one embodiment, the oral sampler 108 may comprise a deformable structure that allows for adjustment of the position of the opening 109 relative to the patient's mouth. The deformable structure may comprise any of the structures described herein, for example, deformable wires, bellows, and the like, and may be integrated into the oral sampler 108 to allow adjustment.

In FIG. 15 shows an embodiment of a patient interface 120 that can be used as an oral or nasal cannula or apparatus for gas sampling and / or gas delivery. As shown, the patient interface 120 includes a cabinet portion 122 that includes a tube holder portion 123. In one embodiment, the tube holder portion 123 comprises two lattice grids of grooves 121a, 121b, each of which comprises a plurality of branches, although in one embodiment only one groove may be provided that comprises a plurality of branches. The grooves 121a, 121b are adapted to receive tube sections 124, 125, respectively, as shown in more detail in FIG. 16. Each tube section 124, 125 forms a fluid path 126, 127, respectively, and each fluid path 126, 127 is configured to either move the fluid exhaled by the patient or inhaled by the patient, depending on the particular application, as possible understand from the above description.

Tube 124 includes an opening 128 at one end thereof, which coincides with one end of the fluid path 126. The tube holder portion 123 is structurally capable of securing the portion 129 of the tube 124, which is located at some distance from the hole 128, to position the hole to allow fluid path 126 to communicate with the patient, as shown in FIG. 15. The tube 124 can either be permanently attached to the tube holder portion 123, or it can detachably fit into the tube holder portion so that the tube can be removed from the tube holder portion without damaging the body portion 122. The groove 121a may be shaped and sized so in order to complement the dimensions of the tube 124. For example, the groove 121a may have a surface that is defined by a radius that is substantially equal to or slightly less than the outer radius of the tube 124 so that the tube 124 can be frictionally fitted into the groove 121a, without crimping the tube.

As shown in FIG. 16, the vertical branch 129 of the groove 121a extends from the upper surface 130 to the lower surface 133 of the tube holder portion 123. The upper surface 130 of the tube holder portion 123 is located near the patient’s nose, and the lower surface 133 is located near the patient’s mouth when the patient interface 120 is attached to the patient. The first horizontal branch 132 of the groove 121a intersects the vertical branch 129 at the branch 135a and extends laterally to the side surface 131 of the side portion of the tube holder portion 123. The second horizontal branch 134 of the groove 121a intersects the vertical branch 129 at the second branch location 135b and also extends to the side surface 131 of the portion 123 of the tube holder. In the shown embodiment, the fluid path 126 can be conducted from the upper surface 130 to the side surface 131 of the tube holder section 123 and from the patient by inserting the tube 124 into the upper section of the vertical branch 129, branch point 135a and the first horizontal branch 132. Of course, other possibilities are possible configurations. For example, in one embodiment, the tube 124 can be inserted into the upper and middle portions of the vertical branch 129, the branch 135b and the second horizontal branch 134, which allows you to adjust the distance between the upper surface 120 and the hole 128 of the pipe 124, i.e. the depth at which the tube 134 is inserted into the nostril of the patient.

The shown embodiment provides a symmetrical construction scheme with respect to the central, essentially horizontal axis, when the body portion 122 is mounted on the patient and the patient’s head is in a normal, vertical position relative to the horizontal. Of course, groove 121a may have other configurations. In the shown embodiment, the groove 121b has a symmetrical configuration with respect to the central, essentially vertical axis, when the body portion 122 is mounted on the patient and the patient's head is in a normal, vertical position relative to the horizontal. Therefore, the text does not give a detailed description of the branches and branch points of the groove 121b, and for the designation of the structural elements common with the groove 121a, common positions are used. The embodiment shown does not imply any limitation of the invention.

Tube 125 may include a T-branch 136, which is adapted to fit into one of the grooves 121a, 121b. As shown, the groove 121b is structurally adapted to secure the T-shaped branch 136, as well as sections of the tube 125 that extend from the T-shaped branch 136. The location 136 of the T-branching in the tube 125 allows you to place one hole 137 of the tube so as to provide communication path 127 of the fluid from the nostrils of the patient and to place another hole 138 of the tube 125 so as to provide communication path 127 of the fluid with the mouth of the patient, as shown in FIG. 15. Typically, the tube 125 can be used for sampling carbon dioxide, but can also be used for oxygen supply.

It should be understood that the embodiment shown in FIG. 15 and 16, allows the configuration of the patient interface 120 to be tailored to the specific requirements of the patient. For example, if the patient’s left nostril is partially blocked, which makes the right nostril more suitable for oxygen production, then the tube 124 can be inserted into the groove 121a, and oxygen can be supplied through the tube 124 and through the opening 128 to the right nostril using the fluid path 126. In addition, the tube 125 can be inserted into the groove 121a so that carbon dioxide can be removed from the partially blocked right nostril, as well as the patient’s mouth. In addition, one tube may be inserted into any groove 121a, 121b, and the other groove may be left loose. It is also contemplated that a multi-lumen tube can be inserted into any groove 121a, 121b so that oxygen can be delivered and carbon dioxide samples can be taken through the same nostril.

The patient interface 120 also includes an installation structure 139 for securing the body portion 122 to the patient’s head. As shown, the mounting structure 139 comprises a pair of ribbons 140 that extend from the body portion from its opposite sides and are configured to be bookmarked behind the patient's ears. Although only one of the ribbons is fully shown, the other ribbon may have a similar configuration. As shown, the ribbon 140 is connected to one side of the side surface 131 of the tube holder portion 123, extends around the patient’s ear and attached to the side surface 131 on the other side. The length of the ribbon 140 is selected so that the body portion 122 is properly installed between the nose and mouth of the patient and that the patient is comfortable. As such, it is contemplated that patient interfaces 120 should be of different sizes to provide a more accurate fit to the patient. In another embodiment, the straps 140 may be adjustable in length so that the patient interface 120 is “one size fits all”.

In FIG. 17 shows another different embodiment of a patient interface 150 that includes a body portion 152 configured to communicate with at least one fluid path, such as the fluid path 151 shown. The patient interface 150 may be an oral and nasal cannula or apparatus for gas sampling and / or gas delivery. The housing portion 152 includes a section 153 that is fluid inflated to provide a cushion design that can increase patient comfort when the patient interface is attached to the patient. Two nostril interfaces 154, 155 extend from the body portion 152 and are structurally configured to provide communication of at least one nostril of the patient with the fluid path 151.

The inflatable section 153 of the body portion 152 may be configured to communicate with the fluid path 151 such that the inflatable section can be inflated by the fluid from the fluid path. In an exemplary embodiment, the fluid in the fluid path 151 is oxygen. By supplying fluid to the inflatable section 153 with a back pressure sufficient to support the inflatable section in an inflated state, a “cushion” is created that can substantially correspond to the facial anatomy of the patient.

The inflatable section 153 may be made of an elastomeric material, for example polyurethane, which provides flexibility to the inflatable section, so that the inflatable section is relatively easily inflated and aligned with the patient's face, while also providing a substantially soft feeling to the patient. In one embodiment, the entire body portion 152 is made of elastomeric material. It is also contemplated that, in another embodiment, the inflatable section 153 may be made without communication with the fluid path 151, and instead may be structurally configured to be inflated manually with a pump or syringe, followed by tight closure, either before or after as a patient interface 150 is mounted on the patient.

As shown in FIG. 17 and in more detail in FIG. 18, in one embodiment, one nostril interface 154 communicates via a fluid channel 156 located within the housing portion 152 with a fluid path 151, and another nostril interface 155 communicates through a different fluid channel 158 with a second fluid path 157 Wednesday. The fluid paths 151 and 157 may be provided by suitable tubes 159 and 160, respectively, which are configured to connect to the body portion 152 by the methods described above. In the embodiment shown in FIG. 17 and 18, the patient interface is configured to supply oxygen to one of the nostrils of the patient and to sample the fluid exhaled by the patient from the other nostril.

As shown in FIG. 19, in one exemplary embodiment, both nostril interfaces 154 and 155 are configured to communicate via channel 161 with fluid path 157. In this embodiment, the accommodated fluid path 151 can also communicate with each of the nostril interfaces 154, 155 via another channel (not shown) located adjacent to but separate from channel 161. In addition, an opening 162 can be provided in the inflatable section 153 or communicating with it, so that the fluid path 151 communicates with the patient's mouth. It should be understood that different configurations are possible by providing suitable channels within the body portion that communicate with fluid paths 141, 157 and nostril interfaces 154, 155. The tube 160 forming the fluid path 157 may also fit inside the inflatable section 153 or can be attached to the inflatable section. The embodiments shown do not imply any limitation of the invention.

As shown in FIG. 17, the patient interface 150 also includes an installation structure 163 that includes a pair of ribbons 164 that are designed to extend from opposite sides of the body portion 152 to the patient's ears to hold the body portion in a fixed position relative to the patient's nostrils. Although only one ribbon 164 is fully shown, the other ribbon may have the same configuration. As shown, each ribbon 164 contains at one end a ring 165 that is configured to cover the ear around its circumference. The straps are preferably made of an elastic material, for example rubber, so that they can be pulled from the body portion 152 and secured to the patient's ears with sufficient tension to hold the body portion in a fixed position relative to the patient’s nose. Ribbons 164 must be sized to provide sufficient tension, but not too much tension, since too much tension can adversely affect the stability of pressure in the inflatable section 153.

In FIG. 20 shows an embodiment of a patient interface 170 that can be used as an oral and nasal cannula or apparatus for gas sampling and / or gas delivery. The patient interface 170 includes a cabinet portion 172 configured to communicate with the fluid path 171. The fluid path 171 may be formed by a tube 173, as shown in FIG. 20. The fluid path may be configured to receive fluid exhaled by the patient through the nasal cavity and / or oral cavity, or the fluid path 171 may be configured to supply oxygen containing fluid for the patient to inhale through the nasal cavity and / or oral cavity.

The patient interface 170 also includes two nostril interfaces 174, 175 that extend from the body portion 172, as shown in more detail in FIG. 21. Each nostril interface 174, 175 is configured to fit into the nostril of the patient, and either one or both communicate with the fluid path 171. As explained above, the housing portion 172 may include internal channels or passages that provide communication between the nostril interfaces 174, 175 and the fluid path 171. In addition, the tube 173 can be connected to the housing section 172 using a method and designs similar to those described above.

The patient interface 170 also includes an attachment portion 176, which comprises two protruding parts 177, 178 that extend from opposite sides of the body portion 172. Each protruding part 177, 178 may include a wing-shaped deformable structure that can be shaped to fit the face of the patient. The protruding portions at least partially lend stability to the patient interface 170 when the patient interface is attached to the patient. An adhesive 179 is provided at the distal ends 180, 181 of the protruding portions 177, 178. The adhesive 179 is designed to detachably attach the attachment portion 176 via the protruding portions 177, 178 on the patient’s face in order to hold the body portion 172 in a fixed position relative to the patient’s nose and so that thereby, the nostril interfaces 174, 175 were held in a fixed position. Adhesive 179 should be a material that is strong enough to temporarily adhere the attachment portion 176 to the face of the patient, but with the possibility of convenient tearing.

The body portion 172 may also be configured to accommodate a second fluid path 182 formed by the tube 183. If the fluid path 171 is configured to receive a fluid exhaled by a patient, then the second fluid path 182 may be adapted to feed patient breathing oxygen-containing fluid.

In the shown embodiment, both paths 171, 182 of the fluid can be accommodated by the body section 172 on one side of the body section. In another embodiment, the fluid paths 171, 182 may fit on opposite sides of the housing portion 172 so that the tubes 173, 183 extend from the housing portion 162 in substantially opposite directions. It is assumed that in the embodiments shown in FIG. 20 and 21, an oral sampler may additionally be introduced. The oral sampler may be a separate, adjustable structure that is secured to the body portion 172, or the body portion may be configured to collect gas exhaled through the mouth. The embodiment shown does not imply any limitation of the invention.

In FIG. 22 depicts a patient interface 190, which comprises a first nostril interface 191, which is configured to be inserted into the first nostril of the patient, and a second nostril interface 192, which is configured to be inserted into the second nostril of the patient. The first nostril interface 191 comprises a channel 193 for communicating with the first nostril of the patient. Similarly, the second nostril interface 192 includes a channel 194 for communication with the second nostril of the patient. As explained in more detail below, the first nostril interface 191 allows its corresponding shift relative to the second nostril interface 192 to enable adjustment of the gap between the first nostril interface 191 and the second nostril interface 192.

As shown, the patient interface 190 includes a connecting structure 195. Both the first nostril interface 191 and the second nostril interface 192 are frictionally engaged with the connecting structure 195 so that the sliding movement, with friction contact, of the first nostril interface and / or the second nostril interface 192 along the connecting structure allows you to adjust the distance between the first and second nostril interfaces. In an alternative embodiment, one of the nostril interfaces, for example, the first nostril interface 191, can be connected to the connecting structure 195 by suitable means, for example, by gluing, so that the first nostril interface does not move relative to the connecting structure 195 and only the second nostril interface allows adjustment by shift.

As shown in the embodiment of FIG. 22, the connecting structure 195 is in the form of a tube 196 that communicates with the fluid path 197 to the first nostril interface 191 through the channel 193. The first nostril interface 191 includes an engagement surface 198 that is shear tightly engaged with the tube 196 so that the lower expanded cavity 200, which forms the space inside the first nostril interface, is isolated from the environment. The described sealing coupling essentially prevents leakage of fluid moving between the fluid path 197 and the first nostril interface at the points of contact of the first nostril interface with the tube 196 forming the connecting structure 195. The tube 196 contains at least one opening 201 in a portion of the tube that is located inside the cavity 200 to allow fluid to move between the fluid path 197 and the first nostril interface 191. The cavity 200 may be part of a channel 193 or may communicate with conduit 193. Hole 201 can be a single large opening or may comprise a plurality of smaller holes as shown in FIG. 22.

The tube 196 can also be configured to provide communication between the second fluid path 202 and the second nostril interface 192. In particular, the second nostril interface 192 can be designed to frictionally engage, shiftably, with the tube 196 such that the tube provides a message the second path 202 with the second nostril interface 192 through the channel 194. The second nostril interface contains engagement surfaces 199 that are designed for tight engagement with the tube 196 so that the lower extension ennaya cavity 204 forming a lower space inside the second nostril interface 192 may be insulated from the environment. This configuration prevents leakage of fluid moving between the second fluid path 202 and the second nostril interface 192 at the points of contact of the second nostril interface with the tube 196 forming the connecting structure 195. The tube 196 has an opening 205 in the portion of the tube that is located inside the cavity 204 to allow fluid to move between the second fluid path 202 and the second nostril interface 192. The cavity 204 may be part of a channel 194 or may communicate with a channel 19 4. The hole 205 may be one wide hole, as shown in FIG. 22, or may contain multiple holes.

The patient interface 190 may also include a movement-limiting structure 206 that restricts the movement of the first nostril interface 191 with respect to the tube 196 in order to fix the position of the opening 201 within the cavity 200. The movement-limiting structure 206 can also be configured to limit the movement of the second nostril interface 192 with respect to the tube 196, in order to fix the position of the hole 205 inside the cavity 204. In one embodiment, the movement restricting structure 206 may comprise entu of material 207 that connects the first nostril to the second interface 191 Nozdryov interface 192. Feed material 207 may be, for example, cloth, or may be a flexible plastic.

In another embodiment, the travel-limiting structure 206 comprises a support structure that is formed on the tube 196. The support structure may include portions 208a and 208b that are capable of abutting against the outer surfaces 209a and 209b of the first nostril interface 191 so that the portions 208a and 208b cannot extend into cavity 200. Similarly, the abutment structure may also include portions 208c and 208d that are capable of abutting against the outer surfaces 210a and 210b of the second nostril interface 192 so that azom that portions 208c and 208d can not pass into the cavity 204.

As shown in FIG. 22, the patient interface 190 may also include an oral sampler 211 that can fit into one of the nostril interfaces 191, 192. The oral sampler 211 includes an opening 212 located near the patient’s mouth when the patient interface 190 is attached to the patient. The oral sampler 211 comprises a channel 213 for moving fluid between the patient’s mouth and a second fluid path 202. In the shown embodiment, the oral sampler 211 fits into the second nostril interface 192 and is associated with frictional engagement. It is also contemplated that the oral sampler 211 can be permanently connected to the nostril interface 192 with a suitable adhesive or plastic welding.

In another embodiment, the connecting structure 195 may be other than the tube. For example, the connecting structure may include a direct connecting link between the nostril interfaces 191, 192. In particular, the nostril interface 191 may include a protrusion that fits into a socket formed with tight tolerance on the outer surface of the nostril interface 192 to allow a sliding fit between them . In the connection design with this circuit, the nostril interfaces 191,192 can be directly welded or otherwise connected to the ends of the corresponding tubes of the respective fluid paths so that no movement of the nostril interfaces 191, 192 occurs relative to the corresponding tubes with which they are connected by the fluid passages.

The embodiment shown does not imply any limitation of the invention. In one embodiment, you can first assemble the nostril interface 191, 192 with a web of material 207 and, at the end of the manufacturing process, you can attach or not the oral sampler 211 at all. Instead, you can use a sealing structure (not shown) to seal the nostril interface 192 if the patient interface is not intended for oral sampling or oral delivery. Since the oral sampler 211 can be attached at the end of the manufacturing process, the oral sampler can be selected from a variety of samplers with standard sizes and shapes, taking into account the size of the patient and the gap between the nose and mouth, as well as the shape of the mouth and the nature of the expiratory flow (e.g., pulsating breathing and normal breath).

For embodiments in which the patient interface 190 is intended to be used as a cannula for sampling and delivery, the two fluid paths 197, 202 can be separated by a baffle 214 in the tube 196. For embodiments in which the patient interface 190 is intended to be used only as sampling cannulas, fluid paths 197, 202 may communicate within the tube 196, or, alternatively, the tube may form a single fluid path that receives exhaled fluid from both nostril interfaces 191, 192.

To fix the patient interface 190 to the patient, the tube 196 can be formed to extend from the first nostril interface 191 and the second nostril interface 192 and at least partially around each of the patient’s ears in the same way as shown, for example, in the embodiment shown on FIG. 1. Of course, any suitable design is applicable for attaching a patient interface 190 or any of the patient interfaces described herein to a patient.

In FIG. 23 depicts an embodiment of a patient interface 220 that includes an integrally molded structure 221. The integrally molded structure 221 comprises a tube portion 222 and a hardware portion 223. The integrally molded (eg, extruded) plastic tubing portion 222 forms a first fluid path 224 and a second fluid path 225 . The hardware section 223 comprises a first nostril interface 226 that communicates with a first fluid path 224, and a second nostril interface 227 that communicates with a second fluid path 225.

As shown in FIG. 24, the tube portion 222 includes a baffle 228 (eg, a wall) for separating the first fluid path 224 from the second fluid path 225. Thus, the portion 222 of the tube can be performed to obtain a fluid exhaled by the patient, as well as to supply a fluid, for example oxygen, for inhalation by the patient. The fluid paths 224, 225 may have equal cross sections, or the area of one of the cross sections may be larger than the other. For example, in one embodiment, the cross-sectional area of the fluid path 225 that delivers oxygen to the patient is larger than the cross-sectional area of the fluid path 224 that receives fluid from the patient to minimize pressure drop in the tube portion 222. The shown embodiment does not imply any limitations of the invention.

As shown in FIG. 25, the hardware section 223 also includes a baffle 229 that delimits a first channel 230 that extends between the first nostril interface 226 and a first fluid path 224, and a second channel 231 that extends between a second nostril interface 227 and a second fluid path 225 . Essentially, the septum 229 blocks fluid movement between the first nostril interface 226 and the second nostril interface 227.

The tube portion 222 and the hardware portion 223 are connected, for example, by ultrasonic welding or thermal bonding technology so that the partition 228 in the tube portion and the partition 229 in the hardware portion are connected and thereby block the movement of fluid between the first fluid path 224 and a second fluid path 225 throughout the entire molded structure 221. A first fluid path 224 can transfer fluid from a patient’s nasal cavity that exhales through one of the patient’s nostril, and the second fluid path 225 can transfer another fluid, such as oxygen, to the patient’s nasal cavity through another nostril. Hardware section 223 may also include a sampler. The embodiment shown does not imply any limitation of the invention.

As shown in FIG. 26, each of the nostril interfaces 226, 227 may comprise a plurality of ribs 230 that extend from the outer surface 231 of the nostril interface 226, 227 at its distal end 232. The ribs 230 are configured to position each nostril interface 226, 227 so that the hole 233 is on the distal end 232 of each nostril interface 226, 227 could be located at a distance from the inner surface of the corresponding nostril. In addition, ribs 230 can help reduce the amount of liquid and solids taken from the nasal cavity. In this case, less obstruction to the flow of fluid supplied to or obtained from the nasal plane can be created. Said ribbed construction can be used with any nasal cannula described in this application.

To support the fixation of the tube portion 222 in a predetermined position relative to the patient, the patient interface 220 may also include a spring clip 234, which is adapted to removably attach the tube portion 222 to the patient’s ear or garment. In one embodiment, the spring clip may be of a clothespin type design, with a through hole extending around the pivot axis, the opening being sized to accommodate, with the possibility of shear, the tube portion 222 into the through hole by friction fit.

As shown in FIG. 23, the hardware section 223 may also include a fixing section 235, which is located near one of the nostril interfaces 226 and is structurally adapted to engage the outer surface of the patient’s nose so that the fixing section and the nostril interface can interact so that the elasticity of their plastic material creates the possibility of clamping between them the portion of the lateral wing of the nose of the patient. In one embodiment, the second mounting portion may be located adjacent to the other nostril interface 227 and may be adapted to engage the outer surface of the patient’s nose so that the second mounting portion and the nostril interface may interact with the clip of another portion of the side wing of the patient’s nose. The embodiment shown does not imply any limitation of the invention.

In FIG. 27 depicts another embodiment of a patient interface 250 in accordance with the present invention, configured to function as a cannula for gas sampling and / or delivery of gas that takes fluid samples from one nostril and / or delivers fluid to it. It is contemplated that the patient interface 250 may be particularly useful if a nasogastric tube is used for artificial feeding, whereby one nostril is not actually available for sampling or oxygen delivery.

As shown, the patient interface 250 includes a body portion 252 that is configured to communicate with the fluid path 251. A single nostril interface 253 extends from the body portion 252 and is configured to fit the patient into the nostril and provide fluid movement between the nasal cavity and the fluid path 251 through the nostril.

In the shown embodiment, the fluid path 251 is formed by the tube 254. In one embodiment, the tube 254 is configured to transport the fluid exhaled by the patient through the nasal cavity through one nostril to a receiver, such as a gas analyzer, to determine the concentration of carbon dioxide in the fluid environment over time. In another embodiment, the tube 254 is configured to deliver a fluid containing oxygen to the nasal cavity when the patient inhales through the nostril.

It is also contemplated that tube 254 may also be configured to form a second fluid path or in a manner that is explained above and shown in FIG. 24, or by the method shown in FIG. 30, or by the method shown in FIG. 55, which is explained in more detail below. Similarly, in one embodiment, the body portion 252 and the nostril interface 253 may include baffles that separate fluids moving between the nostrils and the first and second fluid paths. An example of one nostril interface that allows the movement of two fluids in separate paths is explained in more detail below and presented in FIG. 31.

The interface 250 also includes a fastening section 255, which is located near the nostril interface 253 and is structurally adapted to engage the outer surface of the patient’s nose so that the fastening section and the nostril interface can interact to securely engage or easily clamp between them the side wing section of the patient’s nose . The resilience of the material forming the fastener portion 255 and / or the nostril interface 253 creates an inwardly directed spring force after said portions are separated to accommodate the side wing portion between them to engage or easily grip the side wing portion of the patient’s nose between the nostril interface and the fastener portion .

As shown in FIG. 27, the patient interface 250 may also optionally comprise a second mounting portion 256, which is located closer to the nostril interface 253 than the first mounting portion 255. The second mounting portion 256 may be structurally configured to engage with the first mounting portion 255 to clamp the portion the patient’s nose between them. Such an arrangement would not interfere with the nostril interface 253 and would not require the participation of the nostril interface in the clamping function.

As shown in FIG. 27, the patient interface 250 may include a headset that includes a ribbon 257 that is adapted to fit behind the patient’s ear and also connects to the tube 254 to support the tube 254. As shown, the ribbon 257 includes an ear receiving hole 258 and a holder 259 that configured to engage a portion of the tube 254 and allows the tube 254 to pass through it without creating a kink in the tube. It is also contemplated that in some embodiments, the patient interface 250 may include, instead of ribbon 257, a clip like the clip 234 shown in FIG. 23, which is configured to grip the patient’s ear so that the ear can serve as a direct support for the tube 254. The embodiment shown does not imply any limitation of the invention.

In FIG. 28 illustrates a patient interface 270 in accordance with yet another further embodiment of the invention. The patient interface 270 includes a head mount 272, which is adapted to be mounted on the patient’s head. The head attachment unit 272 includes a docking portion 273, which is structurally configured to be located near the patient’s nose, and an apparatus 274, which is removably attached to the docking portion. Apparatus 274 comprises at least one nostril interface, for example, nostril interface 275, for providing communication of fluid path 276 from the patient's nostrils.

Apparatus 274 also includes a housing portion 277 and a tube 278 that is attached to the housing portion. In one embodiment, the distal end 279 of the tube forms the nostril interface 275. The tube 278 also forms a fluid path 276. The housing portion 277 comprises a lattice grid of grooves 280 that are configured to receive the tube 278 and secure the tube to the housing portion. Grooves 280 may be structurally similar to grooves 121a, 121b described above and shown in FIG. 15 and 16, the description of which is included in this embodiment by reference.

As shown in FIG. 28, alternatively or additionally, it is possible to provide a second tube 281 containing a T-branch 282 and forming a second fluid path 283, and attach it to the body portion 277 similar to that described above for the tube 125 shown in FIG. 15 and 16.

The head mount 272 includes a pair of ribbons 283 that extend from the docking portion 273 from its opposite sides and are designed to fit behind the patient’s ears. Although only one of the ribbons is represented, the other ribbon can have an identical configuration. As shown, the ribbon 283 is connected to one side of the side surface 284 of the docking portion 273, extends around the patient’s ear and attached to the side surface 284 on the other side. The length of the ribbon 283 is selected so that the docking portion 273 is properly positioned between the nose and mouth of the patient and is comfortable for the patient, so that when the device is attached to the docking portion 273, the nostril interface is appropriately positioned relative to the nostril of the patient to provide communication paths 276 , 283 fluid movement with the patient's nostrils. Of course, the present invention assumes that to change the length of ribbon 283, an adjustment mechanism can be provided.

You can provide many head mounts containing ribbons of different lengths, but containing docking sections of the same size so that the head mounts of different sizes can be used with one device. This solution can provide the physician with the opportunity to select the head attachment unit of a suitable size for the patient and attach the device to the docking area of this particular head attachment unit. After using the device, the device can be removed from the docking area and discarded, and the head fastener can be cleaned and / or sterilized and reused on another patient, if desired, or the head fastener can also be discarded or disposed of.

In FIG. 29 depicts a patient interface 310 in accordance with an embodiment of the invention suitable for use as a cannula for sampling and gas delivery. The patient interface 310 includes a cabinet portion 312 and a nostril interface 313 that extends from the cabinet portion. The nostril interface 313 is configured to fit into the nostril of the patient’s nose. The patient interface 310 also includes a tube 314 that is connected to the body portion 313. The tube 314 forms a first fluid path 315 and a second fluid path 316.

As shown in the figure. 30, in an exemplary embodiment, the tube 314 includes a baffle 317 that separates the first fluid path 315 from the second fluid path 316 such that the second fluid path substantially surrounds or completely surrounds the first fluid path. Alternatively, two separate tubes may be connected to the opposite side of the body portion 312, one tube for oxygen delivery and the other for sampling exhaled gas.

As shown in the embodiment of FIG. 31, the housing portion 312 inside contains a first passage 318 that is configured to communicate with a first fluid path 315 for collecting fluid from a patient's nasal cavity. The housing portion 312 also includes a second passage 319 configured to communicate with a second fluid path 316 for supplying a fluid, such as oxygen, to the patient so that the patient can inhale the second fluid.

The nostril interface 313, shown in more detail in FIG. 32, comprises a first opening 320 at its distal end 321, which is configured to communicate with a first passage 318 of the body portion 312, and is also configured to receive fluid from a patient. The nostril interface 313 also contains a second opening 322 on its outer circumferential surface 323, which is configured to communicate with the second passage 319 of the body portion 312, and is also configured to dispense fluid (oxygen) to the patient. In the shown embodiment, the second orifice 322 comprises a plurality of orifices that can provide an improved distribution of fluid to the patient. The size, shape and number of holes 322 may vary.

As shown in FIG. 29, the patient interface 310 may also include a head attachment 324 that is configured to support the tube 314. The head attachment 324 may include a ribbon 325 that is attached to the body portion 312 and extends from the body portion to the patient’s ear. Although only one ribbon is shown, the head attachment assembly 324 may comprise a second ribbon, which is essentially the same as ribbon 325. Essentially, only ribbon 325 is described below.

Ribbon 325 comprises an annular portion 326 at one end thereof, which is configured to wrap around the patient’s ear, as shown in FIG. 29. The ribbon 325 also includes a holder portion 327 between the annular portion 326 and the body portion 312. The holder portion 327 is configured to hold the portion of the tube 314 in a manner that prevents the formation of kinks in the tube, and also allows the tube to extend through it. The head mount is configured to hold the body portion 312 in a fixed position between the nose and mouth of the patient. Other ribbon

 (not shown) may be configured to connect to the body portion 312 at one end, and may also include an annular portion at the other end to encompass around the other ear of the patient.

Furthermore, as shown in FIG. 29, another tube 328 may be connected to the housing portion 312 to act as an additional support for the housing portion so that the housing portion 312 and the nose interface 313 remain in a fixed position. In this embodiment, another ribbon may also support tube 328 using a holder portion similar to the holder portion 327 shown.

It is also contemplated that the body portion 312 may be configured such that only one path 315 of the fluid paths is formed by the tube 314 and the second fluid path 316 is formed by the tube 328. The body portion 312 may comprise internal channels or passages that transmit fluid received from the patient through the first opening 320 in the nostril interface 313 into the first fluid path 315, and the fluid supplied to the patient from the second fluid path 316 is also transmitted to the second tverstie 322. The illustrated embodiment is not intended to suggest any limitation of the invention.

It is also contemplated that in some embodiments, the head attachment assembly 324 may comprise, instead of ribbons, a clip that is adapted to attach to the patient’s ear in such a way as to support the tube 314, similar to the clip 234 shown in FIG. 23 and described above. The term “head mount” is intended to generically define a design that allows the tube 314 to use the patient’s head for support. The embodiment shown does not imply any limitation of the invention.

In yet another embodiment, it is possible to use a nose-clamping structure shown and described with reference to the embodiment of FIG. 27.

In FIG. 33 depicts an embodiment of the nostril interface 340, which is a slightly modified version of the nostril interface 313 described above and shown in FIG. 32. The nostril interface 340 is configured to be inserted into the nostril of the patient and comprises an internal channel 342 that extends through the nostril interface. The internal channel 342 is configured to receive a fluid that is exhaled by the patient from the nasal cavity through the nostril. The inner channel 342 includes an opening 343 at its distal end 344. The proximal end 345 of the inner channel 342 is configured to communicate with the fluid path of the patient interface, cannula or apparatus that transmits the fluid from the source or to the receiver, as described above.

The nostril interface 340 also includes an external channel 346 that surrounds at least a portion of the internal channel 342, as shown in FIG. 33. The external channel 346 is configured to transmit a second fluid to the patient’s nostril so that the patient can inhale the second fluid. The proximal end 347 of the external channel 346 is configured to communicate with the second fluid path of the patient interface, cannula or apparatus, which transmits the second fluid from the source or to the receiver.

One of the traditional problems in delivering oxygen to patients is that oxygen is often delivered as dry gas, which tends to dry the nasal passages. As shown in FIG. 33, the nostril interface 340 also includes a moisture exchanger 348, which forms the discharge gaps or openings 350 of the external channel 346 and surrounds the internal channel 342.

The moisture exchanger 348 is configured to receive moisture from the fluid exhaled by the patient through the nostrils (and not entering the opening 343 of the internal channel) and to supply at least a portion of the moisture contained therein to the fluid that is supplied to the patient through the opening 350 As shown in FIG. 33, the moisture exchanger 348 is made of a hydrophilic filter material 352. This moisture exchanger can also be a heat and moisture exchanger (HME), which also performs heat exchange. As the exhaled air passes through the moisture exchanger 348, some of the water vapor is absorbed from the saturated exhaled fluid. During a subsequent inhalation, a fluid, such as oxygen, which is delivered to the nostril interface 340, passes through a moisture exchanger 348, and an increase in the water content of the delivered fluid may be possible compared to the “dry” state. This solution can be especially useful for pulsed oxygen delivery systems. With the nostril interface you can apply other schemes of moisture exchangers. The embodiment shown does not imply any limitation of the invention.

In FIG. 34 depicts a patient interface 370 in accordance with another embodiment of the invention. The patient interface 370 includes a body portion 372 that is configured to communicate with the fluid path 374. The fluid path 374 may be formed by a tube 376 and may be configured to supply fluid to the body portion 372. The patient interface 370 also includes a first nostril interface 378 and a second nostril interface 379 that extend from the body portion 372. The first nostril interface 378 configured to fit into one nostril of a patient, and the second nostril interface 379 is configured to fit into another nostril. Housing section 372 contains at least one internal channel or passage that is configured to provide fluid path 374 with one of the nostril interfaces 378, 379, or both, so that gas can be supplied to one or both, or samples can be taken from one or both nostril interfaces 378, 379, respectively. In the shown embodiment, the housing portion 372 comprises a channel 380 that is configured to provide a fluid path 374 to the first nostril interface 378. The embodiment shown does not imply any limitation of the invention.

As shown in FIG. 34, the patient interface 370 also includes an oral sampling portion 382 that extends from the body portion 372. The oral sampling portion 382 is configured to receive fluid exhaled from the patient's mouth and transfer fluid to the second fluid path 386. The second fluid path 386 may be formed by a tube 388, which is connected to the sampling section 382 and extends from it to the receiver. As explained above, the receiver may comprise a gas analyzer so that the concentration of carbon dioxide in the fluid can be determined over time. The housing portion 372 may be configured to provide communication between one of the nostril interfaces 378, 379, or both with the second fluid path 386 through the internal channels so that the fluid exhaled by the patient through the nose can also be transmitted to the receiver. In the shown embodiment, the housing portion 372 comprises a second channel 390 that provides a second nostril interface 379 with a fluid path 386. The embodiment shown does not imply any limitation of the invention.

The oral sampling section 382 may include a deformable structure 392 that allows adjustment of the opening 393 at the distal end 394 of the oral sampling section 383 relative to the patient's mouth. The deformable structure 392 may comprise, as shown, a bellows 395 or a sliding structure that allows the oral sampling portion 382 to be extended, shortened or repositioned so that the opening 393 can be optimally positioned. In other embodiments, the deformable structure comprises a deformable wire or wires, as described above embodiments. The embodiment shown does not imply any limitation of the invention.

A pair of ribbons 396 (of which only one is shown in FIG. 34) may extend from the body portion 372 from its opposite sides. Each ribbon 396 may be configured to at least partially cover the patient’s ear to hold the body portion in a fixed position relative to the patient’s nostrils. In the shown embodiment, the tube 376 is configured to extend through the distal end 397 of the ribbon 396. The distal end of the ribbon 396 is movable along the tube 376 to adjust the tension of the ribbon 396, as well as the tube, when the patient interface 370 is attached to the patient. Similarly, the tube 388, which extends from the oral sampling section 382, may be configured to extend through the distal end of another ribbon. The distal end of the other ribbon may also be movable along the tube 388 to adjust the tension of the ribbon and tube 388 when the patient interface is attached to the patient. Of course, to secure the patient interface, you can use any type of head mount, including the head mounts described in this application. The embodiment shown does not imply any limitation of the invention.

It should be understood that in the above embodiments, the areas located in close proximity to the patient can function not only as components of the patient interface (for example, when the tube is wrapped around the patient’s ear), but can also be considered components of the apparatus. In addition, in some embodiments, the tube itself functions as a nostril interface, such as that shown in FIG. 15, 16 and 28, for example.

It is contemplated that any of the patient interface embodiments described herein may contain flavored regions or may deliver flavored fluid to the patient to relieve any stress that the patient may experience. They tried to add this odor through the nasal cannula, as reported in the article: Redd WH, Manne SL, Peters B., Jacobsen PB, and Schmidt H. “Fragrance administration to reduce anxiety during MR imaging”, 1994 J Magn Reson Imaging 4; 4 : 623-6, which is incorporated herein by reference in its entirety. Smells may include, but are not limited to, vanilla or strawberry.

It is also contemplated that the features presented and described in this application can be used in combinations that are not shown and are not described separately. Essentially, none of the shown and / or described embodiments does not imply any limitations of the present invention.

A recent study found that patients with significant obstruction in the nasal passage can reliably determine the side of the nose that is more blocked. See Clarke JD, Hopkins ML, Eccles R. "How good are patients at determining which side of the nose is more obstructed?", Am J Rhinol. 2006 Jan-Feb; 20 (1): 20-4, incorporated herein by reference in its entirety. Accordingly, it is possible, in some cases, it would be desirable to provide a patient interface that allows gas sampling from both nostrils and oxygen delivery is preferably either to the right or left nostril and which also allows for simple and multiple (if necessary) adjustment by a doctor, either by the patient, without removal from the face.

In FIG. 35 to 40 depict a patient interface 400 in accordance with embodiments of the present invention. As shown in FIG. 35, the patient interface 400 includes a nasal interface 402, which is configured to be inserted into the patient's nostrils to receive fluid exhaled by the patient from the nasal cavity through the nostrils. In particular, the nasal interface 402 comprises a first nostril interface 405 containing a first opening 403 for communication with the first nostril and a second nostril interface 406 containing a second opening 404 for communication with the second nostril. The nostril interfaces 405, 406, which should fit in the nostrils, can be curved to fit substantially with the internal curvature of the nostrils. Each nostril interface 405, 406 contains a corresponding sealing portion 407, 408, which is positioned to remain outside the nostrils, as will be explained in more detail below.

The patient interface 400 also includes a fluid delivery channel 410, as shown in FIG. 36, which is configured to deliver fluid to at least one of the nostrils of the patient. As explained in more detail below, the fluid delivery channel 410 is movable relative to the nostril interface 402. The fluid delivery channel 410 includes at least one outlet 412. In the embodiment shown in FIG. 37, 39 and 40, the fluid delivery channel 410 comprises two outlet ports 413, 414, each of which substantially surrounds a corresponding nostril interface 405, 406 of the nasal interface 402. As shown in FIG. 37, after inserting the nostril interface into the fluid delivery channel 410, the nostril interfaces 405, 406 extend through the outlet openings 413, 414, and the sealing portions 407, 408 remain inside the fluid delivery channel 410 and seal the outlet openings 413, 414, with this arrangement relatively the latter.

The fluid delivery channel 410 may have a pillow-like structure, which is made of a soft, flexible material, such as polyurethane, to act as an inflatable nasal pillow, more reminiscent of the structure described above and shown in FIG. 17, when a fluid is transferred to a fluid delivery path 410 from a tube 416, which forms a fluid path 417.

As shown in FIG. 37, the connecting portion 420 of the nasal interface 402 extends beyond the end 419 of the fluid delivery channel 410, which is opposite to the end 418, which houses the fluid path 417. The connecting portion 420 is configured to connect to a fluid path that transmits the fluid exhaled by the patient through the nostrils for delivery to the gas analyzer.

The end 419 may first be covered by a flexible membrane 421. The flexible membrane 421 can be punctured by the harder material of the connecting portion 420. After that, the elastic adhesion between the flexible membrane 421 and the connecting portion 420 provides a shear tight grip to block oxygen leakage during shear movement of the channel 410 delivery relative to the nasal interface 402. Alternatively, after piercing, the flexible membrane 421 can be glued to the connecting portion 420 so that the flexible element forcibly relocated (bent) from the nasal interface 402 when the fluid delivery channel and interface nostril moved relative to one another. The connecting portion 420 is configured to connect to a tube 422, which forms a fluid path 424, to produce exhaled gas.

In one embodiment, a patient interface 400 may be configured solely as a gas delivery cannula. As shown in FIG. 38, the end 420 of the nasal interface 402 can be connected to the tube 416 at the end 418 of the fluid delivery channel 410 in the same way as explained above for connecting the end 420 and the tube 422. In this embodiment, the end 419 can be hermetically sealed with a flexible membrane 421.

The delivery of oxygen to at least one nostril of the patient can be controlled by positioning the fluid delivery channel 410 relative to the nasal interface 402. For example, when the fluid delivery channel 410 is in a first position relative to the nasal interface 402, as shown in FIG. 37, a fluid delivery channel 410 is configured to deliver oxygen to both nostrils of a patient. In the first position, the nostril interfaces 405, 406 of the nasal interface 402 are located essentially in the middle of the outlet openings 413, 414, which allows oxygen to flow around the sealing portions 407, 408 and into the patient’s nostrils.

As shown in FIG. 39, when the fluid delivery channel 410 is in a second position relative to the nasal interface 402, the fluid delivery channel 410 is configured to deliver oxygen, substantially or even completely, to only one of the nostrils of the patient. This function is determined by the positions of the sealing portions 407, 408 with respect to the outlet openings 413, 414. In particular, the sealing portions 407, 408 do not extend laterally from the nostril interfaces 405, 406 at the same distance on both sides of the nostril interfaces 405, 406. As shown in FIG. 35, the inner sections 407i, 408i of the sealing sections 407, 408 are correspondingly shorter than the outer sections 407o, 408o of the sealing sections 407, 408. The inner sections 407i, 408i are defined as sections that are close to one another.

As shown in FIG. 39, since the inner section 408i is shorter than the outer section 407o, when the fluid delivery path 410 is biased slightly to the left relative to the nasal interface 402, the fluid may flow near the seal portion 408 and the fluid generally does not leak near the seal portion 407. In one embodiment, the sealing portion 407 cannot provide a complete seal to the fluid delivery path 410, but instead may provide a slightly leaking seal. Even with leaking compaction, most of the flow is provided to only one of the nostrils. Essentially, the fluid is delivered mainly in only one nostril.

Similarly, as shown in FIG. 40, when the fluid delivery path 410 is biased slightly to the right with respect to the nasal interface 402, fluid may leak near the seal portion 407, and the fluid does not flow near the seal portion 408. In one embodiment, the seal portion 408 cannot provide complete seal to the passage 410 fluid delivery, but instead may provide a leaking seal. Even with leaking compaction, most of the flow is provided to only one of the nostrils. Essentially, the fluid is delivered mainly in only one nostril.

By providing an adjustable patient interface in which fluid delivery, for example oxygen, to one or both nostrils can be controlled, more efficient delivery of fluid to the patient is possible. For example, if one of the patient’s nostrils is laid in such a way that the fluid cannot flow into the nasal cavity, then the patient interface 400 can be adjusted so that the fluid is delivered mainly to the unoccupied nostril.

In addition, when a fluid (oxygen) is supplied to both nostrils, the relative amount of fluid supplied to one nostril compared to the other can be set (controlled) by keeping one of the holes intentionally larger than the other by slightly offset from the center of the delivery channel 410 relative to the nasal interface 402.

The patient interface 400 may be secured to the patient in any suitable manner, for example, by holding tubes 416, 421 at least partially around the patient’s ears or attaching the tubes to ribbons that fit behind the ears. In one embodiment, any tube can be replaced by a “non-working” tube, which serves only to secure the interface to the patient. The above described embodiments are not intended to limit the invention.

The patient interfaces described in each of the above embodiments may be configured to provide measurements of physiological functions at vessels localization centers located in or near the nose, for example, in the external tissues of the nose, septum, upper lip, cheeks, and the like. Measurement data of physiological functions may include central photoplethysmography, which can be defined as the measurement and recording of photoplethysmogram (PPG) in vascular localization centers. Measurements at localization centers on the patient’s head provide access to areas with intense blood supply, which are branches of the internal or external carotid arteries.

Central photoplethysmographic measurements provide, in general, significantly more powerful, foolproof, and reliable signals than in peripheral localizations (localizations at the ends of the fingers or toes). For example, nasal localizations can reduce power requirements by about 10 or more times compared to peripheral localizations, for example, the patient’s fingertips, etc. Essentially, having the ability to combine measurements of physiological functions with measurements of a fluid in one common place can be beneficial in clinical practice. To perform the mentioned physiological measurements, a photoplethysmographic sensor can be used.

In particular, photoplethysmographic sensors can also be used to measure blood oxygen levels (SpO ₂ ) and respiratory effort. Photoplethysmographic sensors may be transmittance type sensors or reflective type sensors. A transmissive type sensor measures the attenuation of light when light passes through a section of tissue supplied with blood. For example, light from an emitter may be transmitted from one side of a portion of a tissue supplied with blood, and may be detected by a receiver that is located on the other side of that portion of a tissue. A reflective type sensor measures light that is reflected back from the fabric and contains a transmitter (for example, a radiation source) and a receiver that are located on one side of the fabric. With both types of sensors, several signals from the receiver can be used to assess blood oxygen saturation and the patient’s pulse rate from changes in light absorption received over the entire duration of the cardiac cycles. The technology is based on the selective absorption of different wavelengths of light by different types of hemoglobin, which is explained in more detail in US patent No. 7024235, which is fully incorporated into this description by reference.

Embodiments of the present invention, described in more detail below, relate to the improved patient interfaces described above that provide enhanced carbon dioxide sampling and carbon dioxide sampling and oxygen delivery by nasal and / or oral methods, and also provide a combined physiological function sensor, such as a central photoplethysmographic sensor.

In FIG. 41 depicts a patient interface 440 in accordance with an embodiment of the invention. As shown, the patient interface 440 contains the structural elements and features of the patient interface 10 shown in FIG. 1-3. Accordingly, general structural elements are indicated in FIG. 41 with the same positions as shown in FIG. 1-3, and are not explained below in detail. The interface 440 in accordance with the present embodiment may be a cannula or apparatus for oral and nasal sampling of carbon dioxide with an additional oxygen delivery, which also contains a physiological function sensor 442, which is connected to the body portion 12, as shown in FIG. 41. In one embodiment, the sensor 442 is a photoplethysmographic sensor.

In the embodiment shown in FIG. 42, the sensor 442 comprises an emitter 444 and a receiver 446. The emitter 444 of the sensor 442 is adapted to engage on the outer surface of the side wing of the nose, and the receiver 446 of the sensor 442 is configured to engage on the inner surface of the side wing of the nose, and therefore the side wing of the nose is located between the emitter 444 and the receiver 446. It is also contemplated that the emitter may engage on the inner surface of the lateral wing of the nose, and the receiver may engage on the outer surface of the lateral wing of the nose. In one embodiment, emitter 444 and receiver 446 are respectively formed on opposing tabs 443 and 445, respectively, of a U-shaped resilient structure forming part of the sensor body 442, so that when tabs 443, 445 of the U-shape are pulled apart to accommodate the side wing of the nose, the elasticity of the sensor 442 allowed him to capture or clamp the lateral wing of the nose between the legs 443, 445. Such a clamp can amplify the signal that is generated by the sensor, since external influences can be attenuated.

In one embodiment, emitter 444 comprises a light source 448, which may be a red or infrared LED or a light emitting diode. In another embodiment, emitter 444 also comprises a second light source 450, which may be a red or infrared LED. The output of the red LED can be centered around 660 nm, and the output of the infrared LED can be centered around 880 nm. However, it is also contemplated that other wavelengths of visible and infrared light may be used. Receiver 446 is configured to receive light with wavelength (s) (s) emitted by emitter 444 after light has passed through tissue between emitter 444 and receiver 446. A sensor of this type and processing signals generated by a sensor of this type are known in the art. and are described, for example, in patent No. 7024235, which is incorporated herein by reference in its entirety.

In an exemplary embodiment, the sensor 442 comprises an emitter 452 and a receiver 454, which can both engage on the outer surface of the patient’s nose, as shown in FIG. 41. The emitter 452 may include at least one light source 456, for example, LED. In this embodiment, the receiver 454 is configured to receive light that is reflected from the tissue into which the emitter emits light. This type of reflective type sensor is known in the art and is described, for example, in US Pat. No. 7,024,235, which is incorporated herein by reference in its entirety, and US Pat. No. 6,262,323, which is incorporated herein by reference in its entirety.

In another exemplary embodiment shown in FIG. 43, the sensor 442 comprises an emitter 458 that engages on one side of the septum of the patient’s nose, and a receiver 460 that engages on the other side of the septum so that the septum is essentially sandwiched between the emitter and the receiver. It should be noted that the pressure exerted on the septum is sufficient to ensure that the sensor remains in place, but does not create excessive pressure on the area of the septum. Similarly to the above-described emitters, the emitter 458 may include at least one light source 462 and the receiver 460 may be configured to determine the amount of light that passes through the partition.

A signal can be issued from each receiver 446, 454, 460 and transmitted to a central processor, which is configured to process the signal to output meaningful data for the doctor to the monitor. For example, the signal may serve to generate a PPG (photoplethysmographic signal) signal and / or to determine oxygen saturation (i.e. blood oxygenation) in the blood-supplied tissue from which the signal is received and / or to determine a patient's respiratory rate. As explained in more detail below, the patient interface 440 can also be used as part of a respiratory monitor.

Sensor 442 may include a wireless transmitter that transmits signals wirelessly to a central processing unit. In another embodiment, the sensor may have wire connections to wires laid or permanently molded together with tubes forming fluid paths.

Sensor 442 can be used in conjunction with any of the interfaces described above and shown in FIG. 1-34. The embodiment shown does not imply any limitation of the invention.

In FIG. 44 shows a patient interface 470 in accordance with an embodiment of the invention. The patient interface 470 contains the structural elements and features of the patient interface 60 shown in FIG. 9-11 and described above. Accordingly, general structural elements are indicated in FIG. 44 with the same positions as shown in FIG. 9-11 and are not explained below in detail. The interface 470 in accordance with the present embodiment may be a cannula or apparatus for oral and nasal sampling of carbon dioxide, with an oxygen delivery that also contains a physiological function sensor 472, which is connected to the body portion 62, as shown in FIG. 44. In one embodiment, the sensor 472 is a photoplethysmographic sensor.

In the embodiment shown in FIG. 44, the sensor 472 comprises an emitter 474 and a receiver 476. The emitter 474 of the sensor 472 is adapted to engage on the outer surface of the upper lip of the patient (or the skin area directly above the lip), and the receiver 476 of the sensor 472 is configured to engage on the inner surface of the upper lip (or area of soft tissue directly above the lip) so that the area of the upper lip (or soft tissue) is between the emitter and the receiver. It is also contemplated that the emitter may engage on the inner surface of the upper lip of the patient, and the receiver may engage on the outer surface of the upper lip of the patient. In one embodiment, emitter 474 and receiver 476 are provided on such a U-shaped gripping or clamping structure as described above to clamp the portion of the upper lip between them. Such clamping or locking engagement can amplify the signal, which is generated by the sensor, since weakening of external influences is possible.

In one embodiment, emitter 474 comprises a light source 478, which may be a red or infrared LED or a light emitting diode. In another embodiment, emitter 474 also comprises a second light source 480, which may be infrared or red LED. Receiver 476 is configured to receive light with wavelength (s) (s) emitted by emitter 474 after the light has passed through tissue between the emitter and receiver. As explained above, a sensor of this type and the processing of signals generated by a sensor of this type are known in the art.

In an exemplary embodiment, the sensor 472 comprises an emitter 482 and a receiver 484, which can both engage on the outer surface of the patient's upper lip, as shown in FIG. 45. The emitter 482 may contain at least one light source 486, for example, LED. In this embodiment, the receiver 484 is configured to receive light that is reflected from the tissue into which the light emits. As explained above, this type of reflective type sensor is known in the art.

Similarly to the above-described embodiments, a signal may be output from each receiver 476, 484 and transmitted to a central processor, which is configured to process the signal to output meaningful data for the doctor to the monitor. As explained above, the signal may be provided via a wireless interface or a wired interface with a processor. The signal can be used to generate a PPG signal (photoplethysmographic signal) and / or to determine the oxygen saturation (i.e. blood oxygenation) in the upper lip and / or to determine the patient's respiratory rate, as well as other measurement results from the PPG signal, which can be determined by known time-frequency methods. Mentioned measurement results may contain a constant level, and different frequency components can serve to determine intrathoracic pressure and blood pressure, as reported in PCT publication No. WO 04/080300 A1, which is incorporated herein by reference in its entirety. Patient interface 470 may also be used as part of the breathing monitor described below.

The sensor 472 may be configured to be used in conjunction with any of the interfaces described above that comprise an oral sampler. The embodiment shown does not imply any limitation of the invention.

In FIG. 46 shows a patient interface 490 in accordance with one embodiment of the invention. The patient interface 490 contains the structural elements and features of the patient interface 90 shown in FIG. 13 and 14 and described above. Accordingly, general structural elements are indicated in FIG. 46 with the same positions as shown in FIG. 13 and 14, and are not explained below in detail. Interface 490 may be a cannula or apparatus for oral and nasal sampling of carbon dioxide, with additional oxygen delivery and with a physiological function sensor 492. In one embodiment, the physiological function sensor 492 may be a photoplethysmographic sensor. Like the above-described sensors 442, 472, the sensor 492 may be a translucent type or a reflective type sensor.

As shown in FIG. 46, the sensor 492 comprises an emitter 494, which is connected to the attachment device 94, and a receiver 496, which is connected to one of the nostril interfaces 98, 99, which extends into the nostril of the patient. The emitter 494 engages in the outer surface of the nose, and the receiver 496 engages with the inner surface of the nostril so that a portion of the nose (lateral wing of the nose or above the wrinkle of the wing) is between the emitter and the receiver, as shown in FIG. 46. It is also assumed that the emitter can catch on the inside of the nostril and the detector can catch on the outside of the nose. In other words, emitter 494 and receiver 496 are on opposite sides of the same nasal tissue supplied with blood.

In the shown embodiment, the emitter 494 comprises a light source 498, which may be a red or infrared LED or a light emitting diode. In another embodiment, emitter 494 also comprises a second light source 500, which may be infrared or red LED. Receiver 496 is configured to receive light with wavelength (s) (s) emitted by the emitter after the light has passed through the fabric between the emitter and the receiver. As explained above, a sensor of this type and the processing of signals generated by a sensor of this type are known in the art.

In one embodiment, the sensor 492 comprises an emitter 502 and a receiver 504, which both can be connected to the attachment device 94 and can engage on the outer surface of the patient’s nose close to one another, as shown in FIG. 47. The emitter 502 may include at least one source 506 of light, for example, LED. In a similar embodiment, the receiver 504 is configured to receive light that is reflected from the tissue into which the emitter emits light.

Similarly to the above-described embodiments, a signal can be output from each receiver 496, 504 and transmitted to a central processor, which is configured to process the signal to output meaningful data for the doctor to the monitor. As explained above, the signal may be provided via a wireless interface or a wired interface with a processor. The signal may serve to generate a PPG signal and / or to determine oxygen saturation (i.e. blood oxygenation) in the lateral wing of the nose and / or to determine the patient's respiratory rate. The 490 patient interface can also be used as part of the breathing monitor described below.

In FIG. 48 illustrates a patient interface 510 in accordance with one embodiment of the invention. The patient interface 510 contains the structural elements and features of the patient interface 170 shown in FIG. 21 and described above. Accordingly, general structural elements are indicated in FIG. 48 with the same positions as shown in FIG. 21, and are not explained below in detail. The interface 510 may be a cannula or an apparatus for oral and nasal sampling of carbon dioxide, with additional oxygen delivery and a sensor for 512 physiological functions. In one embodiment, the physiological function sensor 512 may be a photoplethysmographic sensor. Like some of the other embodiments of the sensors 442, 472, 492 described above, the sensor 492 may be a reflective type sensor.

As shown in FIG. 48, the sensor 512 comprises an emitter 514 which is connected to the attachment device 176, in particular to one of the protruding parts 177, 178, and a receiver 516, which is also connected to the attachment device 176 on the same protruding part as the emitter. Both emitter 514 and receiver 516 engage in adjacent portions of the patient's cheek. The emitter 514 may include at least one light source 518, for example, LED. In this embodiment, the receiver 516 is configured to receive light that is reflected from the tissue into which the emitter emits light. As explained above, this type of reflective type sensor is known in the art.

Similar to the above-described embodiments, the signal can be provided by the receiver 516 and transmitted (wirelessly or by wire) to a central processor, which is configured to process the signal to output meaningful data for the doctor to the monitor. The signal may serve to generate a PPG signal (photoplethysmographic signal) and / or to determine oxygen saturation (i.e. blood oxygenation) in the cheek and / or to determine a patient's respiratory rate. The patient interface 510 may also be used as part of the breathing monitor described below.

In FIG. 49 illustrates a patient interface 530 in accordance with one embodiment of the invention. The patient interface 530 contains the structural elements and features of the patient interface 250 shown in FIG. 27 and described above. Accordingly, general structural elements are indicated in FIG. 49 with the same reference numbers as shown in FIG. 27, and are not explained below in detail. The patient interface 530 includes a cannula or apparatus for sampling carbon dioxide and / or oxygen delivery, which collects fluid samples and delivers fluid from one nostril / one nostril, respectively, and a physiological function sensor 532. In one embodiment, the physiological function sensor 532 may be a photoplethysmographic sensor.

Similarly to the embodiment shown in FIG. 41 and described above, in the embodiment shown in FIG. 49, the sensor 532 comprises an emitter 534 and a receiver 536. The emitter is adapted to engage on the outer surface of the nose (outer surface of the side wing), and the receiver is configured to engage on the inner surface of the nose (inner surface of the side wing) to the nose portion (side wing ) was between the emitter and the receiver. It is contemplated that the emitter may be adapted to engage on the inner surface of the nose and the receiver may be adapted to engage on the outer surface of the nose.

In one embodiment, emitter 534 and receiver 536 can be pushed against each other in the above-described ways to compress or securely engage a portion of the nose (side wing) between them by means of an attachment unit. For example, the emitter 534 may be located on the first mounting portion 255, and the receiver 536 may be located on the second mounting portion 256. Such reliable engagement can amplify the signal that is generated by the sensor, since external influences can be attenuated.

In one embodiment, emitter 534 comprises a light source 538, which may be a red or infrared LED or a light emitting diode. In another embodiment, the emitter also comprises a second light source 540, which may be infrared or red LED. The receiver is configured to receive light from the long wave (s) of wave (s) emitted by the emitter after the light passes through the tissue between the emitter 534 and the receiver 536. A sensor of this type and processing of signals generated by a sensor of this type are known in the art as mentioned above.

In one embodiment shown in FIG. 50, the sensor 532 comprises an emitter 542 and a receiver 544, which can both engage on the outer surface of the patient’s nose. The emitter may include at least one light source 546, such as an LED. As in the above embodiments, in this embodiment, the receiver is configured to receive light that is reflected from the tissue into which the emitter emits light. This type of reflective type sensor is known in the art, as mentioned above, and is not discussed in further detail.

The sensor 532 can also be used with options for implementing a patient interface that include the nostril interface 340 of FIG. 33. In these embodiments, the receiver 536 can be mounted on the nostril interface 340, or on the moisture exchanger 348, or on the outer surface of the external channel 346, and the emitter 534 can be provided on the outer surface of the side wing of the nose so that the side wing is located between the emitter and the receiver described above way. Alternatively, the sliding U-shaped gripping or clamping structure described above can be used, and the sensor does not interfere with the nostril interface.

Similarly to the above described embodiments, the signal can be output from the receivers 536, 544 and transmitted (wirelessly or by wire) to a central processor, which is configured to process the signal to output meaningful data for the doctor to the monitor. The signal may serve to generate a PPG signal and / or to determine oxygen saturation (i.e. blood oxygenation) in the upper lip and / or to determine the patient's respiratory rate. The patient interface 530 can also be used as part of the breathing monitor described below.

It should be understood that the above-described sensors of physiological functions can be configured to provide them with options for implementing the patient interface described in this application. The embodiments shown do not imply any limitation of the invention.

In addition, the above-described embodiments of the patient interface and physiological function sensors can be used as part of a respiratory monitor to control patient apnea. In the United States, a respiratory monitor is defined in paragraph 868.2377 (a) of section 21 of the Federal Regulations (21 CFR § 868.2377 (a)) as “a complete system designed primarily to warn of a delay in breathing, counted in time from the last recorded inspiration” . 21 C.F.R., § 868.2377 (a), also defines "The respiratory monitor also includes indirect methods for determining apnea, for example, monitoring heart rate and other physiological parameters associated with the presence or absence of proper breathing."

Guidance Document issued by the US Department of Health and Human Services on July 17, 2002, entitled “Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA ”and incorporated herein by reference in its entirety, recommends that the respiratory monitor contain at least one primary / direct acting apnea determination device; at least one auxiliary / indirect means for determining apnea, for example, through a heart rate; a timer for measuring the duration of apnea attacks; visual and audible alarms for signaling apnea attacks; visual and audible alarms for signaling a secondary / indirect condition caused by an apnea attack; and such a sensor failure signaling device for both the main / directly acting and auxiliary / indirectly acting means of determining apnea, which turns on no later than 5 seconds after the sensor failure. Ancillary / indirect methods measure physiological parameters that are measured as a result of apnea. For example, apnea can lead to hypoxia, which in turn can lead to bradycardia. Methods for measuring these parameters include pulse oximetry (POX) and electrocardiography (ECG). However, there is still a need for a foolproof, redundant way to control apnea.

In accordance with an exemplary embodiment of the present invention, a respiratory monitor 600 is provided. As shown in FIG. 51, the respiratory monitor 600 comprises a primary respiratory sensor 602, which is configured to directly measure the patient’s breathing by monitoring the expiration of the fluid from the patient’s nasal cavity and / or oral cavity. The primary respiratory sensor 602 may include any of the above described embodiments of patient interfaces, cannulas or apparatuses.

The respiratory monitor 600 also includes an auxiliary respiratory sensor 604, which is configured to indirectly measure the patient’s breathing by monitoring the physiological function of the patient near the patient’s nasal cavity and / or oral cavity. Auxiliary breathing sensor 604 may include any of the above-described embodiments of physiological function sensors.

As shown in FIG. 51, the respiratory monitor 600 also includes a processor 606 configured to process data from signals provided by the primary respiratory sensor 602 and the secondary respiratory sensor 604. The processor 606 is configured to use both signals to determine if apnea is present and to issue an alert or performing some other action if apnea occurs.

As shown in FIG. 52, the primary respiratory sensor 602 may include a patient interface 610 that is configured to be mounted on the patient’s head. The patient interface 610 includes an apparatus 612 that includes a nostril interface 613 that is configured to receive (and / or deliver) fluid from (and / or inside) the nasal cavity while the patient is breathing. The patient interface 610 also includes a fluid path 614 that communicates with the nostril interface 613. The fluid path 614 is configured to transmit fluid to a sensor 620 configured to measure the properties of the fluid. In one embodiment, the patient interface 610 may comprise an oral sampler 615 that is configured to receive fluid exhaled from the patient's mouth. The fluid path 616 communicates with the oral sampler 615 and is configured to transmit fluid to the sensor 620.

In one embodiment, the sensor 620 may form part of a gas analyzer 622 that is configured to analyze the concentration of a gas, such as carbon dioxide, in a fluid over time. The gas analyzer 622 is configured to provide an output signal to a processor 606.

In one embodiment, the sensor 620 is a pressure sensor 624, which is configured to measure the pressure in the fluid exhaled by the patient over time. In particular, the pressure sensor 624 may thus communicate with the fluid path 616 to measure pressure pulses that are generated in the fluid path during patient exhalation. If pressure changes are not detected in the fluid path 616 over a predetermined period of time, then this may indicate a respiratory arrest in the patient. Such pressure sensors are widely known and are not described in detail below. See, for example, Montserrat JM et al. Evaluation of Nasal Prongs for Estimating Nasal Flow, Am J Respir Crit Care Med. 1997 Jan; 155 (1): 211-5, which is incorporated herein by reference in its entirety. The pressure sensor 624 is configured to provide an output signal to a processor 606.

In another exemplary embodiment, the sensor 620 is an acoustic sensor 626, which is configured to determine if a patient exhales a fluid over time. In particular, the acoustic sensor 626 can be located on or near the patient interface 610 and set so that it is possible to measure the signals generated by the sensor when the patient exhales. If these signals are not detected within a predetermined period of time, this may indicate that the patient may have stopped breathing. These acoustic sensors are well known (and may also be ultrasonic sensors) and are not described in detail below. An acoustic sensor 626 is configured to provide an output signal to a processor 606.

In yet a further embodiment, the sensor 620 is a thermistor 628 that is configured to detect the temperature of the fluid exhaled by the patient over time. In particular, the thermistor 628 can detect sharp increases and decreases in temperature in the fluid path 616, which correspond to the patient’s normal breathing pattern. These thermistor sensors are known and not described in detail below. See, for example, US Pat. No. 5,190,048, which is incorporated herein by reference in its entirety. By monitoring these changes over time, the thermistor 628 can determine when the temperature in the fluid path 616 has not changed over an abnormal period of time, which may indicate a patient's respiratory arrest. Thermistor 628 is configured to provide an output to processor 606.

As indicated above, the auxiliary sensor 604 may include a physiological function sensor 630 of the type described above. In these embodiments, an auxiliary sensor may be mounted on apparatus 612 and may be a central photoplethysmographic sensor. At least a portion of the auxiliary sensor 604 may be adapted to engage the outer surface of the nose, or the septum of the nose, or the upper lip of the patient or the face (eg, cheek) of the patient in the manner described above and shown in the figures.

In one embodiment, the auxiliary respiratory sensor 604 is configured to transmit another output signal to the processor 606, from which the patient’s respiratory rate can be output independently of the main respiratory sensor 602. The method of receiving a signal from the physiological function sensor and obtaining the patient’s respiratory rate, with such a measurement, known in the art, for example, from PCT Publication No. WO 00/21438, which is incorporated herein by reference in its entirety, and US Published Patent Application No. 2005/0027205, which is incorporated in its entirety. om is incorporated herein by reference.

In one embodiment shown in FIG. 53, a method 700 for controlling apnea is provided. The method begins at step 702. At step 704, the patient’s breathing is controlled by a primary respiratory sensor. For example, at 704, a patient inspires oxygen or exhales a fluid from a nasal cavity or an oral cavity. At step 706, the physiological function of the patient in the immediate vicinity of the patient's nasal cavity or oral cavity is monitored by an auxiliary respiratory sensor 604. At step 708, data from the outputs of the primary respiratory sensor 602 and the auxiliary respiratory sensor 604 are processed. At step 710, a determination is made whether apnea occurs , according to the results of signal processing at step 706. If the determination shows that apnea is occurring, the method proceeds to step 712, at which a warning is issued ny signal. The method ends at step 714. If the determination indicates that there is no apnea, the method returns to step 704. Of course, the control of exhalations at step 704 and the control of physiological function at step 706 may be performed simultaneously or one may end immediately before (for example, a few milliseconds) or immediately after (for example, a few milliseconds) another.

By monitoring the main respiratory signal and the auxiliary respiratory signal in the same central location on or near the patient’s nose, a foolproof and highly sensitive measurement of respiratory rate and physiological function, for example, blood oxygenation, can be provided in one place. Furthermore, by using embodiments of a patient interface that includes a physiological function sensor, a single interface can be provided.

This so-called “localized in one place” sensor can find many applications, including, for example, cases of sedation with preservation of consciousness, pain control under the control of the patient (PCA), emergency medical care and ambulatory control. This sensor provides an opportunity for more foolproof and reliable control by ensuring the fusion of respiratory signal data, reducing sensitivity to problems of poor perfusion and artifacts associated with movement, which can interfere with peripheral oxygen saturation measurements, and to create a more foolproof and reliable alarm system. For example, it can be proved that monitoring oxygen saturation using a finger sensor (e.g., peripheral measurement) and ventilation through carbon dioxide sampling with a conventional nasal cannula results in a monitoring system that is less reliable than the system of the present invention due to known movement problems and poor perfusion in peripheral localization and the possibility of disconnection with two separate localizations.

According to calculations, when using a sensor located in one place, the sensitivity and specificity for determining clinical phenomena will be higher than with the traditional multi-seat approach. This result, in part, is due to a higher error tolerance of the central photoplethysmographic signal, as well as an increase in the rate of determination of clinical changes from this signal compared to a peripheral signal. The morphology of the central photoplethysmogram is less prone to filtering by the vasculature than the peripherally measured photoplethysmogram, and essentially provides a much more informative signal from which physiological parameters can be determined.

Patient-controlled analgesia (PCA) allows patients to take an analgesic drug, such as opioids (e.g., morphine, fentanyl), on demand. This approach is usually implemented by providing the patient with a button to turn on the pump delivery system.

Due to the growing concern about PCA safety, in particular with regard to respiratory depression, in addition to some conventional PCA pumps, capnography measurements using a traditional nasal cannula and pulse oximetry measurements, usually on a finger, were provided. Using capnography allows you to determine the respiratory depression that occurs as a result of the action of drugs before there is a decrease in the level of oxygenation of patients. A sensor located in one place can be used in conjunction with a PCA for security monitoring, as well as for inputting feedback data to a PCA system. This approach can provide a more fault tolerant system than that which can be achieved with a traditional sensor configuration.

Conscious sedation, i.e. moderate sedation / analgesia performed by the intravenous administration of certain drugs, for example, midazolam, propofol and fentanyl, allows the patient to respond to physical irritation and speech commands and maintain the airways without outside help. Conscious sedation facilitates diagnostic or therapeutic procedures, such as biopsy, x-ray imaging, endoscopic procedures, radiation therapy, or bone marrow sampling. Given the associated risks, such as respiratory depression, when using sedation with the preservation of consciousness, medical organizations have published rules authorizing or strongly recommending appropriate control. This control included pulse oximetry and capnography. A sensor located in one place in accordance with the present invention can be used during sedation while maintaining consciousness to monitor safety. This solution provides a system that is more fault tolerant than a system that can be provided with a traditional sensor configuration.

As explained for sedation with the preservation of consciousness, the features of the sensor, localized in one place, can also find application during emergency medical care and outpatient monitoring.

It is also contemplated that a localized sensor in accordance with the present invention may contain reusable and / or disposable components that can be shared. Embodiments of an exemplary gas sampling method using reusable components are described in provisional patent application US No. 60/833678, the entire contents of which are incorporated herein by reference. It is assumed that when using embodiments of a sensor localized in one place containing components such as a photoplethysmographic sensor, this area can be made removable from the rest of the sensor localized in one place so that it can be cleaned in between patients and before re-use.

It is also assumed that the cable to the physiological function sensor located in one place can transmit the measured signals using electric or pneumatic lines to the measuring components and that the lines can be physically separate or combined, as in a multi-lumen cable containing pneumatic and electric channels. This line can be connected to a wearable hub or module that can remotely transmit data and which can be installed behind the ear, secured to a belt or as part of clothing with sensors.

In addition, it is assumed that the patient interface includes a physiological function sensor connected to the hardware section, while the hardware section includes an airway sensor adapter for detecting carbon dioxide gas in a human expiratory gas, comprising an airway chamber configured to be located under the human nostrils; and an additional guide device for the mouth, made with the possibility of placing in front of the mouth of a person to limit the space in communication with the respiratory tract. Embodiments of airway adapters configured to be located under the nostrils of a person are described in US Patent Applications No. 10/779852 (US Patent Publication No. 2004/0206907) and 11/019792 (US Patent Publication No. 2005/0245836), wherein both fully incorporated into the present description by reference. It is contemplated that the sensor and airway adapter described in Application 10/779852 and Application 11/019792 can function as a primary respiratory sensor and that the physiological function sensor serves as an auxiliary respiratory sensor.

Embodiments of a localized in one place sensor described for apnea control can be extended to the sensor for outpatient diagnosis in a dream. In particular, exemplary embodiments of combined patient interfaces for gas sampling and photoplethysmographic measurements shown in FIG. 41-50, can be further developed for use as a sensor located in one place for outpatient diagnosis in a dream. Traditional systems for outpatient sleep diagnostics (e.g. Stardust II, Respironics, Inc. Murrysville, PA) require the person to be provided with a chest girdle as an indirect indicator of respiratory effort, a finger sensor for SpO ₂ measurements, and a nasal cannula to measure flow with using pressure measurement results.

According to the present invention, a central photoplethysmographic sensor is used in combination with a flow measurement system. The flow measurement system can operate based on known methods, for example, monitoring pressure and / or flow using a catheter or thermistor flow monitor. The present invention assumes that the signal from the central photoplethysmographic sensor, i.e. PPG signal, can be used as a non-invasively obtained indirect indicator of respiratory effort. Examples of this signal are described in applications for US patent No. 10/652992 (US patent publication No. 2004/0040560) and 11/758159, the contents of each of which are incorporated into this description by reference.

In addition, it is suggested that the combined nasal / oral cannula configuration should increase the sensitivity and specificity of the system for individuals who are prone to breathing through the mouth. EEG electrodes (for electroencephalograms) with leads passing through the interface can be integrated into the cannula tubes. To assess snoring and instability of the upper respiratory tract, you can optionally introduce acoustic microphones and vibration sensors anywhere (as already explained above) along the tubes or cannula. To determine the position of the patient relative to gravity and / or to ensure actigraphy, an accelerometer can additionally be introduced.

In FIG. 54 shows an additional embodiment of a patient interface 260 in accordance with the present invention, configured to function as a cannula for gas sampling / or gas delivery, which takes samples from one nostril and / or delivers fluid to one nostril or both nostrils. As noted for the patient interface 250, it is also contemplated that the patient interface 260 may be particularly useful if a nasogastric tube for artificial feeding is used, which is why one nostril is not actually available for sampling or oxygen delivery.

As shown, the patient interface 260 includes a body portion 262 that is configured to communicate with fluid paths 241 and 243. A single nostril interface 263 with an opening 266 extends from the body portion 262 and is configured to fit into the nostril of the patient and allow fluid to move through the nostril between the nasal cavity and the fluid path 243. The fluid delivery portion 267 extends from the body portion 262 and includes a plurality of openings 269 that are in fluid communication with the fluid path 241. The fluid path 241 and the openings 269 are sized to allow oxygen to be delivered to either nostril or both nostrils at a volume flow of at least 6 l / min. The present invention assumes that the length of the fluid delivery portion 267, as well as the number and size of the openings 269, can be changed in accordance with the different sizes of the patient interface 260.

In the shown embodiment, the fluid path 241 is formed by the tube 240. The tube 240 is configured to transport the fluid exhaled by the patient through the nasal cavity and one nostril to a receiver, such as a gas analyzer, to determine the concentration of carbon dioxide in the fluid over time. In another embodiment, the tube 254 is configured to deliver a fluid containing oxygen to the nasal cavity while the patient inhales through the nostril.

It is also contemplated that tube 254 may also be configured to form a second fluid path in the manner described above and shown in FIG. 24, or as shown in FIG. 30, or as shown in FIG. 55, which is explained in more detail below. Similarly, in one embodiment, the body portion 252 and the nostril interface 253 may include baffles that separate fluids moving between the nostrils and the first and second fluid paths.

The interface 260 also includes a mounting portion 265, which is located near the nostril interface 263 and is structurally adapted to engage the outer surface of the patient’s nose so that the fixing portion and the nostril interface interact to securely engage or slightly clamp between them the portion of the lateral wing of the patient’s nose. In the shown embodiment, the mounting portion 265 is bent and comprises a portion 268 with a protrusion that allows more convenient grip of the nostrils and placement on it. These design features allow a simple and convenient application to the nostrils of most patients. The elasticity of the material forming the attachment portion 265 and / or the nostril interface 263 creates an inwardly directed spring force after these portions are pulled apart to accommodate the side wing between them to engage or slightly compress the portion of the lateral wing of the patient’s nose between the nostril interface and the attachment portion.

The patient interface 260 may also optionally comprise a second fastening portion (not shown) that is closer to the nostril interface 263 than the first fastening portion 265. The second fastening portion can be structurally configured to engage with the first fastening portion 265 to clamp the nose portion patient between them. This design scheme will not interfere with the nostril interface 263 and will not require the nostril interface to participate in the clamping function.

Similarly to the embodiment shown in FIG. 49, the mounting portion 265 may include a transmitter portion 261 and a receiver portion 264. The emitter and receiver portions are adapted to engage on the outer surface of the nose (outer surface of the side wing). The receiver is configured to receive light with wavelength (s) (s) emitted by the emitter after the light is reflected by the tissue associated with the emitter section 261 534 and the receiver section 264. A sensor of this type and the processing of signals generated by a sensor of this type are known in the art.

The present invention also contemplates that the emitter section 261 and the receiver section 264 can be pushed against one another in the manner explained above to pinch or securely engage the nose section (side wing) between them. For example, the emitter portion 261 may be located on the mounting portion 265, and the receiver 264 may be located on the second mounting portion (not shown), which engages in the inner surface of the nose. The emitter section 261 contains at least one light source, which may be a red and infrared LED or a light emitting diode. The possibility of using multiple light sources is also contemplated. This embodiment will allow tissue measurements at different wavelengths in the range from ultraviolet to mid-infrared. Fields of application of such a constructive scheme include determining the concentration of hydroxy and deoxyhemoglobin, as well as dishemoglobins, for example, meth and carboxy hemoglobin. The possibility of determining hemoglobin and hematocrit and other substances in the blood / tissue is also assumed. Mentioned sources may be LEDs, semiconductor lasers (e.g., with end radiation, VCSEL (surface radiation with vertical resonators)), or other light sources known in the art.

As shown in FIG. 55, the tube 240 comprises two tube sections 241 and 243 separating the first 242 fluid path from the second fluid path 243. This solution allows the tube portion 243 to receive a fluid exhaled by the patient, and the tube portion 241 to supply a fluid, such as oxygen, for inhalation by the patient. The fluid paths 242, 243 may have the same cross section, or the area of one cross section may be larger than the other. For example, in an exemplary embodiment, the cross-sectional area of a fluid path 242 that supplies oxygen to a patient is greater than the cross-sectional area of a fluid path 243 that receives fluid from a patient. It is also contemplated that tube 240 may also be configured to form a second fluid path, either in the manner described above and shown in FIG. 24, or in the manner shown in FIG. 30. The embodiment shown does not imply any limitation of the invention.

As shown in FIG. 56, the patient interface 260 may include a headset that includes a ribbon 245 that is adapted to fit behind the patient’s ear and also connects to the tube 240 to support the tube 240 and provide outward tension. As shown, the ribbon 245 includes an opening 248 for receiving the ear and a portion 249 of the holder, which is configured to engage a portion of the tube 240 and allows the tube 240 to pass through it without creating a bend in the tube. In the shown embodiment, the holder portion 249 includes an opening 246 through which the tube 240 passes. In accordance with the present invention, it is contemplated to make the ribbon 245 from a material or combination of materials that are suitable for using technologies such as injection molding. As such, identification information, such as the name of the product or company, can be additionally easily applied to the outer surface of the loop portion 247. The embodiment shown does not imply any limitation of the invention.

Although each of the embodiments has been described above using their structural schemes as an example, it should be understood that the present invention also encompasses appropriate methods for applying the above embodiments.

The above, for the purpose of explanation, provides a detailed description of the invention by the example of embodiments that are currently considered the most useful and preferred, however, it should be understood that this detailed description is solely for the purpose mentioned and that the invention is not limited to the proposed options for implementation, but, on the contrary , provides for the coverage of modifications and equivalent structural schemes that do not go beyond the essence and scope of the attached claims. For example, it should be understood that the present invention assumes that, as far as possible, at least one characteristic feature of any embodiment can be combined with at least one characteristic feature of any other embodiment.

Claims (18)

1. A patient interface comprising:
a body portion configured to communicate with a first fluid path;
a first nostril interface extending from the body portion, wherein the nostril interface communicates with a first fluid path;
a first mounting portion extending from the body portion near the nostril interface, the mounting portion being structurally adapted to engage the outer surface of the patient’s nose to attach the patient interface to the patient’s nose; and
a physiological function sensor for adhering to the nasal skin of said patient and generating a signal based on a measurement of the physiological function, the sensor comprising an emitter for emitting a signal and a receiver for receiving a signal. 2. The patient interface according to claim 1, in which the fastening section is tightened to the first nostril interface, with the location of the fastening section on the patient’s nose. 3. The patient interface of claim 1, further comprising a first tube that forms a first fluid path. 4. The patient interface according to claim 3, further comprising a ribbon connected to the tube and configured to support the tube, wherein the ribbon is configured to be placed behind the patient’s ear. 5. The patient interface according to claim 1, in which the casing section communicates with the second fluid path and further comprises a second nostril interface extending from the casing section and having a working connection with the second fluid path. 6. The patient interface according to claim 5, further comprising:
a first tube that forms a first fluid path; and a second tube that forms a second fluid path. 7. The patient interface according to claim 6, further comprising a ribbon for supporting the second tube, the ribbon being configured to be placed behind the patient’s ear. 8. The patient interface according to claim 5, in which the second nostril interface is made and positioned to maintain a position under the patient’s nose when the patient interface is worn by said patient, and contains at least one opening formed therein for fluid delivery mentioned patient or receiving fluid from it. 9. The patient interface according to claim 1, in which the physiological function sensor is connected to the first mounting portion. 10. The patient interface according to claim 9, in which the emitter contains at least one light source, and the receiver contains a photodetector. 11. The patient interface according to claim 1, additionally containing a second mounting portion, structurally configured to engage on the inner surface of the patient’s nose so that the nose portion is located between the first mounting portion and the second mounting portion. 12. The patient interface of claim 12, wherein the physiological function sensor is connected to the first mounting portion, the second mounting portion, or both. 13. The patient interface according to item 12, in which the physiological function sensor is located on the first mounting portion, the second mounting portion, or both so that (a) the emitter is hooked to the outer surface of the nose portion, and the receiver is hooked to the inner surface of the nose portion, (b ) the receiver is hooked to the outer surface of the nose portion, and the emitter is hooked to the inner surface of the nose portion, (c) both the emitter and the receiver are hooked to the outer surface of the nose, or (d) both the emitter and the receiver are hooked beyond the inner surface of the nose. 14. A patient interface comprising:
a hardware section containing the nostril interface, while the nostril interface is configured to fit into the nostril of the patient and to ensure fluid movement between the nostril and the fluid path; and
a physiological function sensor connected to the hardware for adhering to the nasal skin of said patient and generating a signal based on a measurement of the physiological function, the sensor comprising an emitter for emitting a signal and a receiver for receiving a signal. 15. The patient interface according to 14, in which the hardware section also contains:
a body portion configured to communicate with the fluid path; and
a mounting portion extending from the body portion, wherein the mounting portion is located near the nostril interface and is structurally engaged to engage the outer surface of the patient’s nose, and the nostril interface and the mounting portion cooperate to secure the portion of the patient’s nose between them. 16. The patient interface according to clause 15, in which at least a portion of the sensor is located on the mounting portion so that the portion of the sensor is engaged on the outer surface of the portion of the nose of the patient. 17. The patient interface according to clause 16, in which (a) the emitter and the receiver are located on the fastening section and engage on the outer surface of the patient’s nose, (b) the radiator is located on the fastening section and engage on the outer surface of the patient’s nose, and the receiver is located inside the nostrils and hooks onto the inner surface of the patient’s nose, (c) the receiver is located on the mounting portion and hooks onto the outer surface of the patient’s nose, and the emitter is located inside the nostril and hooks onto the inner surface of the patient’s nose a, or (d) the transmitter and receiver are arranged inside the nostrils and engage the inner surface of the patient's nose. 18. The patient interface of claim 14, in which the emitter and receiver are pressed against each other.

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