Endotracheal tube and method of use

Abstract

An exemplary endotracheal tube is provided. The endotracheal tube includes a tube member extending from a proximal end to a distal end and defining an outer surface and an inner surface of the tube member. The endotracheal tube includes a first cuff positioned about a portion of the outer surface of the tube member, the first cuff defining an inner surface and an outer surface of the first cuff. The endotracheal tube includes a sensor disposed on or adjacent to the outer surface of the first cuff. The endotracheal tube includes a second cuff positioned over the sensor and at least partially over the first cuff. The sensor disposed between the first cuff and the second cuff thereby enables accurate measurement of vital signs and / or physiological parameters of the patient.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 235,256, filed August 20, 2021. The entire contents of the aforementioned provisional application are incorporated herein by reference.

[0002] The present disclosure relates to endotracheal tubes for use in medical facilities, and more particularly to endotracheal tubes that include one or more sensors for accurate measurement of a patient's vital signs and / or physiological parameters while avoiding foreign body complications. [Background technology]

[0003] Endotracheal tubes can be used in a variety of medical situations during patient care. For example, endotracheal tubes can be used during general anesthesia, intensive care, and / or emergency medical care for airway management and mechanical ventilation. A conventional endotracheal tube includes a tube and an inflatable cuff coupled to or near the distal end of the tube. The distal end of the tube is configured and sized for insertion into a patient's trachea to ensure that the airway is not blocked and allows air to reach the lungs. The inner diameter of the tube of an endotracheal tube can range in size from about 2 mm to about 10.5 mm, with the size being selected based on the patient's body size. For example, smaller sized tubes can be used for pediatric and neonatal patients, while larger sized tubes can be used for adults.

[0004] A cuff coupled or secured to or near the distal end of the endotracheal tube is initially maintained in a contracted configuration to allow insertion of the distal end of the tube into the patient's trachea. After insertion and positioning of the endotracheal tube at a desired location in the patient's trachea, the cuff can be inflated to form a seal between the outer surface of the endotracheal tube (i.e., the cuff of the endotracheal tube) and the trachea. The flexibility of the cuff allows it to conform to and abut the inner wall of the trachea as it is inflated. This seal between the cuff and the inner wall of the trachea helps to create a closed system that allows for an increase in the typical driving pressure used in mechanical ventilation. The seal between the cuff and the trachea also helps to secure the endotracheal tube against the trachea, thereby reducing or preventing migration of the endotracheal tube and maintaining it in a desired position, e.g., a highly vascularized area. Generally, when properly positioned, the distal end of the endotracheal tube can be located in the trachea in close proximity to the ascending aorta. A ventilator or similar machine can be connected to the endotracheal tube to allow for mechanical ventilation of the patient through the endotracheal tube. Summary of the Invention [Problem to be solved by the invention]

[0005] Generally, medical professionals may need to monitor one or more vital signs of a patient undergoing a medical procedure. Such monitoring may be necessary to ensure that the vital signs are at an appropriate level and / or to monitor how the patient responds to a particular drug and / or treatment used for the procedure. Various sensors may be used to monitor these vital signs. In some cases, one of the vital signs monitored may be the patient's oxygen level. Pulse oximeters are generally used to monitor a patient's oxygen levels and are commonly placed on the patient's fingers, toes, ears, nose, and / or forehead. However, obtaining accurate and consistent oxygen level data through traditional positioning of a pulse oximeter may be difficult due to various factors such as patient movement, patient temperature, etc. For example, for a patient undergoing dialysis, body temperature may drop significantly, resulting in difficulty in obtaining oxygen readings. [Means for solving the problem]

[0006] An exemplary endotracheal tube is provided that includes an elongated tube and an inflatable cuff disposed at or near the distal end of the elongated tube. The inflatable cuff includes one or more sensors disposed on an outer surface. In some embodiments, the one or more sensors may include a pulse oximeter for measuring the patient's oxygen level. The endotracheal tube includes a secondary cuff or cover positioned over the one or more sensors. In some embodiments, the secondary cuff can cover the entire outer surface of the inflatable cuff. In some embodiments, the secondary cuff only partially covers the outer surface of the inflatable cuff, specifically covering the one or more sensors and the outer surface of the inflatable cuff adjacent to the one or more sensors. After positioning the distal end of the endotracheal tube in the patient's trachea, the cuff can be inflated to create a seal with the inner wall(s) of the trachea.

[0007] When the cuff is inflated, the one or more sensors are positioned against the inner wall(s) of the trachea. The secondary cuff or cover protects the one or more sensors from damage during insertion into the trachea and / or inflation of the cuff while ensuring that the one or more sensors are properly positioned against the inner wall(s) of the trachea. Such positioning allows for accurate oxygenation measurements due to the highly vascularized area of ​​the tracheal wall(s). Additionally, due to the inflated cuff and the maintained position of the cuff (and sensor(s)) relative to the tracheal wall, patient movement does not affect or reposition the sensor, ensuring that consistent and accurate measurements of blood oxygen levels are detected as long as the cuff is maintained in the inflated configuration.

[0008] According to an embodiment of the present disclosure, an exemplary endotracheal tube is provided that includes an elongated tube member having a proximal end and a distal end, a first cuff positioned about an outer surface of the tube member, at least one sensor disposed on an outer surface of the first cuff, and a second cuff positioned over the at least one sensor such that the first cuff and the second cuff sandwich the at least one sensor.

[0009] According to an embodiment of the present disclosure, an exemplary endotracheal tube is provided. The endotracheal tube may include a tube member extending from a proximal end to a distal end and defining an outer surface and an inner surface of the tube member. The endotracheal tube may include a first cuff positioned about a portion of the outer surface of the tube member, the first cuff defining an inner surface and an outer surface of the first cuff. The endotracheal tube may include a sensor disposed on or adjacent the outer surface of the first cuff. The endotracheal tube may include a second cuff positioned over the sensor and at least partially over the first cuff, the sensor being disposed between the first cuff and the second cuff.

[0010] The inner surface of the first cuff faces the outer surface of the tubular member, and the outer surface of the first cuff faces outwardly from the tubular member. In some embodiments, the first cuff can be coupled to the outer surface of the tubular member at or near the distal end of the tubular member. In some embodiments, the first cuff can be inflatable. In some embodiments, the first cuff can include a first inflation tube extending through the tubular member and communicating with the interior of the first cuff to selectively inflate and deflate the first cuff.

[0011] In some embodiments, the second cuff may be non-inflatable. In some embodiments, the second cuff may be inflatable and the first inflation tube may be in communication with an interior of the second cuff and selectively inflate and deflate the second cuff. In some embodiments, the second cuff may be inflatable and the endotracheal tube may include a second inflation tube extending through the tube member, in communication with an interior of the second cuff and selectively inflating and deflating the second cuff independently of the first cuff.

[0012] The second cuff defines an inner surface and an outer surface of the second cuff, and the sensor is disposed between the first cuff and the second cuff such that the inner surface of the second cuff is positioned immediately adjacent to the sensor. In some embodiments, the sensor can be physically attached to the outer surface of the first cuff without being physically attached to the second cuff. In some embodiments, the sensor can be physically attached to the inner surface of the second cuff without being physically attached to the first cuff. In some embodiments, the sensor can be physically attached to the outer surface of the first cuff and the inner surface of the second cuff.

[0013] In some embodiments, the second cuff can be disposed over the entire surface area of ​​the exterior of the first cuff. In some embodiments, the second cuff is disposed over only a portion of the surface area of ​​the exterior of the first cuff, the portion of the surface area being less than 50%. In some embodiments, the portion of the surface area is less than 25%.

[0014] In some embodiments, the sensor may include a single pulse oximeter. In some embodiments, the sensor may include a plurality of different types of sensors. In some embodiments, the sensor may be configured to move radially outwardly away from the tubular member during inflation of the first cuff. A distal end of the tubular member may be configured to be positioned within the patient's trachea, and inflation of the first cuff moves the sensor radially outwardly away from the tubular member and against a wall of the trachea.

[0015] In some embodiments, the first cuff and the second cuff can be manufactured from the same material. In some embodiments, the first cuff and the second cuff can be manufactured from a biocompatible material. In some embodiments, the endotracheal tube can include an electrical conductor coupled to the sensor and extending through a portion of the tube member.

[0016] According to an embodiment of the present disclosure, an exemplary method of measuring one or more vital signs or physiological parameters of a patient is provided. The method includes inserting a distal end of an endotracheal tube into the trachea of ​​the patient. The endotracheal tube may include a tube member extending from a proximal end to a distal end and defining an outer surface and an inner surface of the tube member, a first cuff positioned about a portion of the outer surface of the tube member, the first cuff defining the inner surface and the outer surface of the first cuff, a sensor disposed on the outer surface of the first cuff or adjacent to the first cuff, and a second cuff positioned over the sensor and at least partially over the first cuff. The sensor is disposed between the first cuff and the second cuff. The method includes expanding the first cuff of the endotracheal tube to move the sensor radially outwardly away from the tube member and toward a wall of the trachea. The method includes measuring one or more vital signs or physiological parameters of the patient with the sensor.

[0017] In some embodiments, the method may include inflating a first cuff with a fluid to move the sensor radially outwardly away from the tube member and against the wall of the trachea, where the first cuff forms a seal with the wall of the trachea. In some embodiments, the method may include inflating a second cuff with a fluid to move the sensor radially outwardly away from the tube member and against the wall of the trachea. In some embodiments, the second cuff may define an inner surface and an outer surface of the second cuff, where the sensor is disposed between the first cuff and the second cuff such that the inner surface of the second cuff is positioned proximate to the sensor. In some embodiments, measuring one or more vital signs or physiological parameters of the patient with the sensor may include measuring an oxygen saturation of the patient when the first cuff is inflated and the sensor is positioned against the wall of the trachea.

[0018] According to an embodiment of the present disclosure, an exemplary tracheostomy tube is provided. The tracheostomy tube may include a tube member extending from a proximal end to a distal end and defining an outer surface and an inner surface of the tube member. The tracheostomy tube may include a first cuff positioned about a portion of the outer surface of the tube member, the first cuff defining an inner surface and an outer surface of the first cuff. The tracheostomy tube may include a sensor disposed on or adjacent the outer surface of the first cuff. The tracheostomy tube may include a second cuff positioned over the sensor and at least partially over the first cuff. The sensor is disposed between the first cuff and the second cuff.

[0019] In some embodiments, the tracheostomy tube may include a tracheal collar coupled to the proximal end of the tube member.

[0020] Any combination and / or permutation of the embodiments is contemplated. Other objects and features will become apparent from the following detailed description considered in conjunction with the accompanying drawings. It is to be understood, however, that the drawings are designed as illustrations only and not as a definition of the limits of the present disclosure.

[0021] To assist those skilled in the art in making and using the disclosed endotracheal tube, reference is made to the accompanying drawings, in which: [Brief description of the drawings]

[0022] [Figure 1] FIG. 1 is a schematic perspective view of an exemplary endotracheal tube according to the present disclosure including a cuff in a deflated / collapsed configuration and a sensor integrated into the cuff. [Diagram 2] FIG. 2 is a schematic perspective view of the exemplary endotracheal tube of FIG. 1, including the cuff in an inflated / expanded configuration. [Diagram 3] FIG. 1 is a schematic perspective view of an exemplary endotracheal tube according to the present disclosure including a cuff in an inflated / expanded configuration and a sensor integrated into the cuff. [Figure 4] FIG. 1 is a perspective view of an exemplary tracheostomy tube according to the present disclosure including a cuff in a deflated / collapsed configuration and a sensor integrated into the cuff. [Diagram 5] FIG. 1 is a perspective view of an exemplary tracheostomy tube according to the present disclosure including a cuff in an inflated / expanded configuration and a sensor integrated into the cuff. [Figure 6] FIG. 1 is a detailed perspective view of an exemplary tracheostomy tube according to the present disclosure including a cuff in an inflated / expanded configuration and a sensor integrated into the cuff. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] As used herein, the term "proximal," when used in reference to a component of an endotracheal tube, refers to the end of the component that is closest to the physician when the endotracheal tube is inserted into a patient. The term "proximal" can also refer to the portion of the endotracheal tube that is located outside the patient after placement.

[0024] As used herein, the term "distal," when used in reference to a component of an endotracheal tube, refers to the end of the component that is farthest from the physician when the endotracheal tube is inserted into a patient. The term "distal" may also refer to the portion of the endotracheal tube that is located inside the patient after placement.

[0025] As used herein, the terms "posterior" and "distal" should be interpreted relative to the operator of the endotracheal tube (e.g., a physician). "Posterior" should be understood as being relatively closer to the operator, and "distal" should be understood as being relatively further from the operator.

[0026] Endotracheal tubes (ETTs) are used as a means of providing ventilatory support in a variety of medical situations, such as during surgery or COVID-19 treatment.

[0027] The exemplary endotracheal tubes described herein can be equipped with a variety of one or more sensors. Although a pulse oximeter is described as the sensor incorporated into the endotracheal tube and used to measure oxygen saturation, it should be understood that other suitable sensors may be used in combination with or in place of the pulse oximeter. The one or more sensors that may be incorporated into the endotracheal tube assembly may include, for example, an ultrasound transducer, a temperature sensor, a blood gas sensor (e.g., a CO2 sensor and an infrared sensor for measuring tissue oxygen concentration), an airflow sensor, a capnography sensor (measuring CO2 gas), a sensor for esophageal electrocardiogram, one or more sensors for sampling exhaled gases (e.g., nitrous oxide or nitric oxide), a sensor for measuring humidity, combinations thereof, and the like. However, the list of sensor types provided herein is non-limiting, and any sensor known to one of skill in the art that provides information of interest to the attending physician and / or medical professional (e.g., information regarding the patient's vital signs and / or physiological parameters, etc.) may be incorporated into the endotracheal tube. In some embodiments, information from one or more sensors can be used to measure metabolic rate, for example, the rate of oxygen consumption and the rate of CO2 production, providing a measure of metabolic rate that can be used to monitor a patient's condition in critical care settings.

[0028] The endotracheal tubes described herein can be used in any medical situation where it is desirable to ensure that a patient's airway is maintained and where measurement of the patient's vital signs and / or physiological parameters (such as, but not limited to, oxygen saturation) would be beneficial. In some embodiments, the endotracheal tubes can be used in the performance of surgery where the patient is ventilated and / or treated with anesthesia. In some embodiments, the endotracheal tubes can be used in conjunction with cryosurgical procedures. In some embodiments, the endotracheal tubes can be used to monitor patients in critical care situations.

[0029] 1 is a schematic perspective view of an exemplary endotracheal tube 100 according to the present disclosure. Endotracheal tube 100 includes an elongated tube or tube member 115 extending generally between a proximal end 102 and a distal end 104. In some embodiments, tube member 115 can be manufactured from, for example, a medical grade plastic material, medical grade polyvinyl chloride (PVC), or the like. Tube member 115 defines an outer surface and an inner channel or passageway 120 that extends along the entire length of tube member 115 from the proximal end 102 to the distal end 104.

[0030] Endotracheal tube sizes are referred to by their inner diameter in millimeters (mm). ETTs are usually listed with both the inner and outer diameter of the tube (e.g., a 6.0 endotracheal tube is listed with both an inner diameter ID of 6.0 and an outer diameter OD of 8.8). The narrower the tube, the greater the resistance to gas flow. The largest tube appropriate for the patient is generally selected. This is critical for spontaneously breathing patients who must work harder to overcome the increased resistance of a smaller ETT (a size 4 ETT has 16 times more resistance to gas flow than a size 8 ETT).

[0031] The passageway 120 defines a uniform (or substantially uniform) diameter that may range, depending on the size of the patient, from 2-10.5 mm, 2-10 mm, 2-9 mm, 2-8 mm, 2-7 mm, 2-6 mm, 2-5 mm, 2-4 mm, 2-3 mm, 3-10.5 mm, 4-10.5 mm, 5-10.5 mm, 6-10.5 mm, 7-10.5 mm, 8-10.5 mm, 9-10.5 mm, 10-10.5 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 10.5 mm, etc., inclusive of the range boundaries. The passageway 120 allows for fluid communication between the surrounding atmosphere and the patient's lungs, as well as allowing for an artificial ventilator to supplement mechanical ventilation. The tubular member 115 can define a generally flexible and / or curved shape such that the distal end 104 of the endotracheal tube 100 can be inserted into the trachea via the mouth. In some embodiments, other shapes of the tubular member 114 can be used for insertion through the nose and / or tracheotomy.

[0032] The elongated tube member 115 may be in the form of a flexible, curved, hollow tube. However, the endotracheal tube 100 and / or the tube member 115 may take any shape and / or size known to one of skill in the art. The tube member 115 may be flexible or rigid. The tube member 115 (and / or any other components associated with the endotracheal tube 100) may be constructed from any suitable material used for endotracheal tubes known in the industry, for example, any biocompatible material. In some embodiments, materials that can be used to manufacture the tube member 115 may include, but are not limited to, polyvinyl chloride, latex, silicone, rubber, or other materials readily apparent to one of skill in the art. In some embodiments, the endotracheal tube 100 may be made from a transparent, biocompatible material. In some embodiments, other components of the endotracheal tube 100 (e.g., cuffs 125, 127) may be manufactured from the same material as the tube member 115.

[0033] The typical depth of an endotracheal tube is 23 cm for men and 21 cm for women, measured at the central incisors. The average tube size for adult males is 8.0 and the average tube size for adult females is 7.0. This is derived from practice, which is somewhat institution dependent. Pediatric tubes are sized using the formula: Size for uncuffed ETTs = ((age / 4)+4), with cuffed tubes being half a size smaller [Aker, J. AANA J. (2008) 76(4):293-300]. Pediatric ETTs are typically taped to a depth of 3 times the child's tube size (i.e., a 4.0 ETT is typically taped to a depth of approximately 12 cm). [Ahmed, RA and Boyer, TJ. Endotreacheeal Tube. StatPearls Publishing 2022, Jan. PMID:30969569].

[0034] The endotracheal tube 100 includes an inflatable flexible cuff 125 disposed at or near the distal end 104 of the tube member 115. The cuff is an inflatable balloon at the distal end of the ETT. A defective balloon can result in a loss of ability to protect the airway from aspirates and make mechanical ventilation difficult.

[0035] As shown in FIG. 1 , the cuff 125 can be spaced apart from the distal end 104 (e.g., between a midpoint of the tube member 115 and the distal end 104). In some embodiments, the cuff 125 can be integrally formed with the tube member 115. In some embodiments, the cuff 125 can be formed separately from the tube member 115 and attached to an outer surface of the tube member 115 in a sealed manner such that the cuff 125 can be selectively inflated and deflated by a user. The cuff 125 generally extends circumferentially around the tube member 115 such that, in an inflated configuration, the cuff 125 makes a circumferential seal with the inner wall of the patient's trachea. In some embodiments, the cuff 125 can be fabricated from a flexible medical grade material, such as plastic or PVC, to allow for inflation of the cuff 125.

[0036] In particular, the cuff 125 can be inflated to form a seal between the exterior surface of the endotracheal tube 100 and / or the exterior surface of the cuff 125 and the interior wall of the trachea. The endotracheal tube 100 includes an inflation tube 130 in fluid communication with the interior of the cuff 125, through which a substance (e.g., fluid, air, etc.) can be selectively introduced into and removed from the interior of the cuff 125. In some embodiments, the inflation tube 130 can be incorporated into the wall of the tubular member 115 such that the tube 130 is in fluid communication with the interior of the cuff 125 for inflation and deflation of the cuff 125. In some embodiments, the inflation tube 130 can extend along the interior wall of the passageway 120 of the tubular member 115 and be in fluid communication with the interior of the cuff 125. The substance passing through the inflation tube 130 can be acoustically transparent. The proximal end of the tube 130 may extend from the proximal end 102 of the tubular member 115 and may be equipped with a valve 131 that may be used to control the flow of substances into and out of the cuff 125 .

[0037] To facilitate placement through the vocal cords and provide improved visualization anterior to the tip, the ETT has an angle or bevel known as the bevel. The left bevel provides the best view as the endotracheal tube approaches the cord.

[0038] Murphy's eye is another opening of the tube positioned at the distal lateral wall. If the distal end of the ETT is obstructed by the wall of the trachea or by touching the carina of the trachea (where carina means the ridge at the base of the trachea that separates the openings of the right and left main bronchi (bronchi means the large airways that lead from the trachea to the lungs)), gas flow can still occur through Murphy's eye. This prevents complete obstruction of the tube. The carina is the most sensitive area of ​​the trachea and larynx that triggers the cough reflex.

[0039] The ETT connector attaches the ETT to a ventilator or a bag valve mask (BVM), sometimes called an Ambu bag, is a handheld tool used to deliver positive pressure ventilation to any subject who is having inadequate or ineffective breathing. It consists of a self-inflating bag, a one-way valve, a mask, and an oxygen reservoir.

[0040] The endotracheal tube 100 of the present disclosure includes one or more sensors 140 positioned on the exterior or outer surface of the cuff 125 (e.g., outside the interior volume defined by the cuff 125). The one or more sensors 140 can be used to detect and transmit one or more vital signs and / or physiological parameters associated with the patient. In some embodiments, one sensor 140 can be used to detect and transmit more than one type of vital signs and / or physiological parameters associated with the patient. In some embodiments, the one or more sensors 140 can be connected to a receiving station, computing device, etc. via wires (e.g., electrical conductor(s) 145) passing through the passageway 120 and / or the walls of the tube member 115. In some embodiments, the one or more sensors 140 can wirelessly transmit measured or detected data to an external receiving station and / or computing device. For example, the sensor 140 can be equipped with wireless transmission capabilities and can be used to transmit / receive signals from the sensor 140 to an appropriate external device. In some embodiments, one or more of the sensors 140 may be compatible with other medical devices, such as X-ray scanners and / or MRI scanners. For example, the sensor 140 may include an outer coating and / or shielding material 141 to prevent interference with external equipment.

[0041] In one embodiment, the sensor 140 may be a pulse oximeter for detecting the patient's oxygen level. In some embodiments, the pulse oximeter sensor may rely on red and infrared light emitting diodes to measure deoxygenated and oxygenated hemoglobin, for example, to determine the percentage of oxygen in red blood cells. The sensor 140 may be positioned on the cuff 125 at a central or substantially central location of the cuff 125. For example, the sensor 140 may be positioned at a midpoint between an upper area and a lower area of ​​the cuff 125 (e.g., an area connecting the cuff 125 to the tubular member 120). Such positioning of the sensor 140 relative to the cuff 125 may ensure that the sensor 140 (or a majority of the surface area of ​​the sensor 140) is positioned against the inner wall of the trachea when the cuff 125 is inflated.

[0042] In some embodiments, the sensor 140 can be directly coupled to the outer surface of the cuff 125 by adhesive, welding, or any other suitable technique. The coupling of the sensor 140 to the cuff 125 can be made in a flexible manner to allow at least partial movement of the sensor 140 as the cuff 125 expands during inflation and contracts during deflation. For example, a flexible adhesive can be used to bond the sensor 140 to the cuff 125, which adhesive allows at least partial movement of the sensor 140 as the cuff 125 is inflated and deflated while maintaining a desired position of the sensor 140 relative to the cuff 125. In some embodiments, the sensor 140 can be positioned on or immediately adjacent to the outer surface of the cuff 125 without being directly attached to the cuff 125. For example, the sensor 140 can be coupled to a second cuff 127 (described below) without being coupled to the cuff 125. In some embodiments, the sensor 140 can be attached to the endotracheal tube 100 by any method or material known to one of skill in the art. For example, in some embodiments, the sensor 140 can be permanently attached to the exterior surface of the first cuff 125 by heat sealing and / or adhesive. In some embodiments, the sensor 140 can be permanently attached to the interior surface of the second cuff 127 by heat sealing and / or adhesive, or can be free to move between the two cuffs 125, 127 (e.g., not directly bonded to either cuff).

[0043] As shown in FIG. 1, the endotracheal tube 100 may include a protective layer (e.g., second cuff 127) disposed over the sensor 140. The second cuff 127 is sized to be of a larger diameter than the first cuff 125 based on its positioning over the first cuff 125. The second cuff 127 may be secured to the tube member 115 to create a seal therebetween and to create a seal in the space between the first cuff 125 and the second cuff 127. In some embodiments, the second cuff 127 may be made from the same material as the first cuff 125. For example, the cuffs 125, 127 may be made from a flexible biocompatible material, e.g., a biocompatible plastic such as polyvinyl chloride (PVC). Any suitable material may be used to inflate the cuff 125 (and / or cuff 127 in embodiments in which the cuff 127 is also inflated). In some embodiments, the fluid(s) used to inflate the cuff 125 and / or cuff 127 may include, for example, water, saline, a buffer solution, sound absorbing gel, etc. When inflated, the cuff 125 and / or cuff 127 forms a seal against the inner wall of the trachea. Although FIG. 1 shows the cuff 125 symmetrically aligned around the tube member 115, it should be understood that in some embodiments, the cuff is asymmetrically aligned around the tube member 115. The cuff 125 is attached to the tube member 115 such that the cuff 125 retains the substance used to inflate it. Thus, the endotracheal tube 100 includes an inner cuff (i.e., the first cuff 125) positioned against the sensor 140 and an outer cuff (e.g., the second cuff 127). The second cuff 127 may be positioned over the sensor 140 and extends over the entire surface area of ​​the first cuff 125. The sensor 140 is thus sandwiched between the first cuff 125 and the second cuff 127 .

[0044] In some embodiments, the second cuff 127 can extend across the entire surface area of ​​the first cuff 125 (e.g., 100% of the first cuff 125). In some embodiments, the second cuff 127 can extend across a majority of the outer surface area of ​​the first cuff (e.g., over about 50%, over about 60%, over about 70%, over about 80%, over about 90%, over about 95%, etc.). In some embodiments, the outward facing surface of the sensor 140 can be bonded to the inner surface of the second cuff 127, for example, with an adhesive, welding, etc. In some embodiments, the inward facing surface of the sensor 140 can be bonded to the outer surface of the first cuff 125 and the outward facing surface of the sensor 140 can be bonded to the inner surface of the second cuff 127, which are bonded to prevent or reduce air between the sensor 140 and the second cuff 127. In some embodiments, an inward facing surface of the sensor 140 can be coupled to an outer surface of the first cuff 125 without being coupled to the second cuff 127, and the second cuff 127 can extend over the sensor 140 during inflation of the first cuff 125 to prevent or minimize an air layer between the sensor 140 and the second cuff 127. Although one sensor 140 is shown, if multiple sensors 140 are used, the sensors 140 can be positioned in a spaced relationship to each other between the cuffs 125, 127.

[0045] In some embodiments, the second cuff 127 may be non-inflatable and formed from a flexible material that allows the second cuff 127 to stretch and remain positioned over the sensor 140 as the first cuff 125 is inflated. In some embodiments, the second cuff 127 may be inflatable using the same or similar means as the first cuff 125 (or using a separate mechanism). In such embodiments, the second cuff 127 can be inflated at the same time or substantially the same time as the first cuff 125 is inflated. For example, as shown in FIG. 1, in a folded / deflated state or configuration, both the first cuff 125 and the second cuff 127 remain relatively close to the outer surface of the tubular member 115, and the sensor 140 remains between the cuffs 125, 127 in a compact manner. The deflated cuffs 125, 127 allow for insertion of the distal end 104 of the endotracheal tube 100 into the patient's trachea in a desired orientation to allow for measurement of the patient's ventilation and one or more vital signs and / or physiological parameters of the patient. For example, a GLIDESCOPE™ (available from Verathon Inc.) can be used to help orient and position the sensor 140 on the left side of the patient's trachea to ensure that the sensor 140 is positioned adjacent to a highly vascularized area of ​​the trachea following inflation of the cuff 125 (and / or cuff 127).

[0046] The endotracheal tube 100 may include one or more inflation tubes 130. In some embodiments, a single inflation tube 130 may be used to inflate the cuffs 125, 127. In some embodiments, a separate inflation tube 130 may be used to inflate each of the cuffs 125, 127, allowing for independent inflation and deflation control. In some embodiments, the inflation tube 130 may be formed as an integral part of the tubular member 115. In some embodiments, the inflation tube 130 may be formed as a separate tube that travels inside the passageway 120. A proximal end of the inflation tube 130 may remain outside the patient after placement of the endotracheal tube 100, while a distal end of the inflation tube 130 remains inside the cuff 125. Thus, the inflation tube 130 provides fluid communication from outside the patient to the interior of the cuff 125. The proximal end of inflation tube 130 may be equipped with a valve 131 for selectively controlling / regulating the flow of material into and out of cuff 125 (and / or cuff 127).

[0047] FIG. 2 illustrates the endotracheal tube 100 with the cuff 125 (and / or cuff 127) in an expanded / inflated configuration. In particular, as shown in FIG. 2, the cuff 125 or both cuffs 125, 127 can be expanded / inflated. Inflating the inner or first cuff 125 moves the sensor 140 radially outward in the direction of arrow 142 toward the tracheal wall, thereby pushing the sensor 140 outward from and against the tracheal wall. As the first cuff 125 is inflated, it expands, moving the sensor 140 radially outward toward the tracheal wall. The second cuff 127 simultaneously stretches outward to accommodate the expansion of the first cuff 125. In some embodiments, the second cuff 127 may be inflated (or at least partially inflated) such that an inner surface of the second cuff 127 is positioned spaced apart from an outer surface of the first cuff 125 (see, e.g., FIG. 2). Such expansion and / or inflation of the second cuff 127 creates a substantially uniform space between the first cuff 125 and the second cuff 127, resulting in a substantially uniform diameter of the second cuff 127. Such a uniform diameter may provide an improved seal with the surrounding tracheal wall.

[0048] In some embodiments, the second cuff 127 does not inflate, but instead merely stretches to accommodate the inflation of the first cuff 125. In such embodiments, the inner surface of the second cuff 127 is spaced from the outer surface of the first cuff 125 at the sensor 140, but can be positioned adjacent to one another in one or more areas spaced from the sensor 140. For example, the opposite side 143 of the cuff assembly (i.e., cuffs 125, 127) can include one or more sections of the second cuff 127 positioned adjacent to or against the first cuff 125. In some embodiments, the second cuff 127 can be large enough to accommodate the increased volume of the first cuff 125 during / after inflation.

[0049] In the inflated / expanded configuration, the inner surface of the second cuff 127 remains immediately adjacent or against the outward facing surface of the sensor 140, so that the sensor 140 and the tracheal wall are positioned immediately adjacent to one another, except for the second cuff 127 positioned therebetween. The sensor 140 is pushed toward the tracheal wall and maintained against the tracheal wall, thereby obtaining more consistent and accurate oxygen saturation readings. The presence of large blood vessels and vasculature near the tracheal wall provides greater accuracy in measuring oxygenation with the endotracheal tube 100. Due to the constant contact with the tracheal mucosa, pulse oximetry measurements are generally not lost, unlike when using a conventional peripheral pulse oximeter, where outside influences can distort the readings (e.g., use of vasoconstrictors, targeted temperature management protocols, etc.). Additionally, even when the patient has a low body temperature (e.g., during dialysis), the positioning of the sensor 140 against the tracheal wall can continue to provide accurate and consistent measurements.

[0050] The second cuff 127 can provide protection to the pharynx and / or trachea during insertion of the endotracheal tube from the sensor 140. With the sensor 140 sandwiched between the two cuffs 125, 127, the extra layer of protection of the second cuff 127 can provide protection from any deterioration of the tracheal wall. The sandwiched cuff 125, 127 configuration can also protect the sensor 140 from becoming dislodged from the tubing member 115 and being lost within the pulmonary circuit. For example, if the cuff 125 and / or cuff 127 ruptures, the connection between the sensor 140 and the cuffs 125, 127 can prevent the sensor 140 from escaping the endotracheal tube 100 assembly.

[0051] 2, the endotracheal tube 100 may generally include a proximal portion 116 and a distal portion 117, where the proximal portion 116 remains outside the patient after placement and the distal portion 117 is placed within the patient's trachea. The proximal portion 116, when placed in the patient's trachea, may exit either the patient's nasal cavity or mouth. In some embodiments, the proximal portion 116 may exit through a tracheotomy. When placed, the passageway 120 provides fluid communication from outside the patient to the lungs. The proximal portion 116 of the endotracheal tube 100 may be attached to any external device typically used to introduce gas into a patient's lungs, such as a bag ventilator, a mechanical ventilator, a combination thereof, and the like.

[0052] 3 is a schematic perspective view of an exemplary endotracheal tube 200 of the present disclosure. The endotracheal tube 200 may be substantially similar to the endotracheal tube 100, except for the differences described herein. Thus, like reference numbers refer to like structure. In particular, rather than including a second cuff 127 that surrounds or covers the entire surface area of ​​the first cuff 125, the endotracheal tube 200 includes a second cuff 202 that covers only a portion of the first cuff 125.

[0053] The second cuff 202 is sized to be smaller than the first cuff 125, and in particular, to cover at least the sensor 140. The second cuff 202 includes a perimeter 204 that is attached or coupled to an outer surface of the first cuff 125, such that a pocket 206 is formed between the first cuff 125 and the second cuff 202 that encases the sensor 140. In some embodiments, the perimeter 204 can be, for example, circular, rectangular, square, etc. Thus, the second cuff 202 covers only a small surface area (e.g., less than 50%, less than 40%, less than 30%, less than 25%, etc.) of the first cuff 125.

[0054] The inner surface of the second cuff 202 remains substantially adjacent to the outward facing surface of the sensor 140 to ensure proper positioning of the sensor 140 against the tracheal wall after inflation of the first cuff 125. In some embodiments, the second cuff 202 can be non-inflatable, inflatable, or both. Thus, the sensor 140 remains sandwiched between the two cuffs 125, 202. In some embodiments, one pocket 206 can be configured and dimensioned to accommodate two or more sensors 140. In some embodiments, separate cuffs 202 can be used to encase separate sensors 140 associated with the endotracheal tube 200.

[0055] In some embodiments, similar designs used with the endotracheal tube 100 can be incorporated into other supporting medical devices. For example, Figures 4-6 show an exemplary tracheostomy tube 300 that includes a dual-cuff design with sensors for monitoring one or more vital signs or physiological parameters of the patient.

[0056] The tube 300 generally includes an elongated tube member 302 extending between a proximal end 304 and a distal end 306. At or near the proximal end 304, the tube 300 may include a tracheal collar 308 (or an adapter configured to engage a tracheal collar). At or near the distal end 306, the tube 300 includes a cuff assembly 310 including a first cuff 312 (e.g., an inner cuff) and a second cuff 314 (e.g., an outer cuff). The cuff 312 is positioned about a portion of an outer surface of the tube member 302. The first cuff 312 may be inflatable such that the cuff 312 can be selectively inflated or deflated to position and maintain the position of the tube member 302 within the patient's trachea.

[0057] The sensor 316 is positioned on or adjacent to the outer surface of the cuff 312, and the second cuff 314 is positioned over at least the sensor 316 and at least a portion of the first cuff 312. In some embodiments, the second cuff 314 can cover the sensor 316 and an area immediately adjacent the first cuff 312 surrounding the sensor 316. In some embodiments, the second cuff 314 can cover the sensor 316 and about 50% of the surface area of ​​the first cuff 312. In some embodiments, the second cuff 314 can cover the sensor 316 and about 75% of the surface area of ​​the first cuff 312. In some embodiments, the second cuff 314 can cover the sensor 316 and about 100% of the surface area of ​​the first cuff 312. This positions the sensor 316 between the first cuff 312 and the second cuff 314. Although one sensor 316 is shown, it should be understood that multiple sensors may be incorporated into the tube 300 .

[0058] In some embodiments, one or more wires 318, 320 can pass inside and / or outside the tube member 302 for transmission of data / signals to and from the sensor 316 and to and from a computing or processing device (not shown). Each of the wires 318, 320 can include an electrical connector 322, 324 at a distal end to allow electrical connection to a computing or processing device so that data can be received from the sensor 316, which can then be analyzed and displayed to a medical professional.

[0059] While exemplary embodiments are described herein, it should be expressly noted that these embodiments should not be construed as limiting, but rather additions and modifications to those explicitly described herein are also included within the scope of the present disclosure.Furthermore, it should be understood that the features of the various embodiments described herein are not mutually exclusive and may exist in various combinations and permutations, which may be possible even if such combinations or permutations are not expressed herein, without departing from the spirit and scope of the present disclosure.

Claims

1. An endotracheal tube, comprising: a tube member extending from a proximal end to a distal end and defining an outer surface and an inner surface of the tube member; a first cuff positioned about a portion of the outer surface of the tube member and defining an inner surface and an outer surface of the first cuff; a sensor disposed on the outer surface of the first cuff or adjacent to the outer surface of the first cuff; a second cuff positioned over the sensor and at least partially over the first cuff, the sensor being disposed between the first cuff and the second cuff; the endotracheal tube.

2. The endotracheal tube according to claim 1, wherein the inner surface of the first cuff faces the outer surface of the tube member and the outer surface of the first cuff faces outward from the tube member.

3. The endotracheal tube according to claim 1, wherein the first cuff is coupled to the outer surface at or near the distal end of the tube member.

4. The endotracheal tube according to claim 1, wherein the first cuff is inflatable.

5. The endotracheal tube according to claim 2, further comprising a first inflation tube extending through the tube member and in communication with the interior of the first cuff for selectively inflating and deflating the first cuff.

6. The endotracheal tube according to claim 1, wherein the second cuff is non-inflatable.

7. The endotracheal tube according to claim 5, wherein the second cuff is inflatable and the first inflation tube is in communication with the interior of the second cuff for selectively inflating and deflating the second cuff.

8. The second cuff is inflatable, and the endotracheal tube further comprises a second inflation tube extending through the tube member and in communication with the interior of the second cuff for selectively inflating and deflating the second cuff independently of the first cuff.

9. The second cuff defines an inner surface and an outer surface of the second cuff, and the inner surface of the second cuff is positioned adjacent to and immediately beside the sensor by disposing the sensor between the first cuff and the second cuff.

10. The endotracheal tube according to claim 1, wherein the sensor is physically attached to the outer surface of the first cuff without being physically attached to the second cuff.

11. The endotracheal tube according to claim 1, wherein the sensor is physically attached to the inner surface of the second cuff without being physically attached to the first cuff.

12. The endotracheal tube according to claim 1, wherein the sensor is physically attached to the outer surface of the first cuff and the inner surface of the second cuff.

13. The endotracheal tube according to claim 1, wherein the second cuff is disposed over the entire surface area of the outer surface of the first cuff.

14. The second cuff is disposed only over a part of the surface area of the outer surface of the first cuff, and the part of the surface area is less than 50%, the endotracheal tube according to claim 1.

15. The part of the surface area is less than 25%, the endotracheal tube according to claim 14.

16. The endotracheal tube according to claim 1, wherein the sensor includes a single pulse oximeter.

17. The endotracheal tube according to claim 1, wherein the sensor includes a plurality of different types of sensors.

18. The endotracheal tube according to claim 1, wherein the sensor is configured to move radially outward away from the tube member during inflation of the first cuff.

19. The distal end of the tube member is configured to be positioned within a patient's trachea, and inflation of the first cuff moves the sensor radially outward away from the tube member and toward the wall of the trachea, the endotracheal tube according to claim 18.

20. The endotracheal tube according to claim 1, wherein the first cuff and the second cuff are made of the same material.

21. The endotracheal tube according to claim 1, wherein the first cuff and the second cuff are made of a biocompatible material.

22. The endotracheal tube according to claim 1, comprising a conductor coupled to the sensor and extending through a part of the tube member.

23. A tracheostomy tube, a tube member extending from a proximal end to a distal end and defining an outer surface and an inner surface of the tube member, the tube member, A first cuff positioned around a part of the outer surface of the tube member, the first cuff defining an inner surface and an outer surface thereof, and the first cuff; A sensor disposed on the outer surface of the first cuff or adjacent to the outer surface of the first cuff; A second cuff positioned over the sensor and at least partially over the first cuff, the sensor being disposed between the first cuff and the second cuff, and the second cuff; The tracheostomy tube comprising the same. **Claim 24** The tracheostomy tube according to claim 23, further comprising a tracheal collar coupled to the proximal end of the tube member.

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