New matter introduced in this continuation-in-part is found at the BRIEF DESCRIPTION OF THE DRAWING section and includes new drawing
The invention relates generally to endotracheal tubes, and more particularly, to tubes including elements, singly and in combination, for improving ultrasound observability, for the warming of inhaled gases, and for the measurement of physiological parameters such as inflation cuff pressure and CO2/O2 concentration levels of respiratory gases.
Endotracheal intubation is the placement of a flexible plastic tube through the open mouth and into the trachea (windpipe) in order to maintain an open airway in patients who are unconscious or unable to breathe on their own. Oxygen, anesthetics, or other gaseous medications can be delivered through the tube using a self-filling bag and valve (bag valve) type hand operated pump/bellows or an automated mechanical ventilator.
Prior Art
The endotracheal tube 12 is typically placed into a patient with the aid of a laryngoscope (not illustrated), a hand-held device that permits the health care professional to view the larynx while aligning the endotracheal tube during insertion. The method is not without its difficulties, and there is a risk of serious injury to the throat, and in some cases of prolonged interruption of breathing, injury to the brain, and even death resulting from lack of oxygen. These risks are particularly pronounced in emergency situations.
U.S. Pat. No. 7,543,586 (the '586 patent) suggests the usefulness of ultrasound for observing the endotracheal tube within the patient. Unlike the laryngoscope which is inserted through the open mouth of a patient and allows a view only so far as the larynx, ultrasound permits views of the inner structures of the neck from outside the body, in theory providing the health care professional information useful to insure the tube is properly and safely inserted.
The '586 patent illustrates use of a wire stylete (‘stilette’ in the '586 patent) inserted through the tube's airway to both stiffen and guide the plastic tube during insertion. An intubating stylet is a malleable metal wire, among a class of devices that are inserted into the airway of an endotracheal tube to make the tube conform better to the anatomy of the specific individual, thus facilitating a safe insertion. The wire stylete of the '586 patent ends at a small metal ball located at the inserted end of the wire. The metal ball is primarily intended to prevent injury to the patient caused by the inserted end of the wire stylete, and in the '586 patent, serves also as an ultrasound target.
The intubating stylete has drawbacks, as do all the devices of this class, one of which is that its presence in the tube's airway prevents the attachment of a hand operated bag valve or of a mechanical ventilator during the intubation procedure. Only after the tube has been properly positioned in the patient and the wire stylete withdrawn can ventilation begin providing oxygen to the patient. As a result, use of a stylete risks a delayed airflow to the lungs during the critical intubation process, causing some health care professionals to avoid use of the intubating stylete and the other guidance devices of a similar nature. Another drawback is that the metal used to form a typical wire stylete is not sufficiently ultrasound reflective to make the wire easily observable within the patient; a point not made in the '586 patent.
The flexible plastic body of a typical endotracheal tube, of which
At times it is desirable to warm the gases being applied to an intubated patient. The typical endotracheal tube is basically a plastic tube incapable of warming the inhalation gases. It would be useful to have an endotracheal tube with a heating member for warming inhalation gases.
For endotracheal tubes equipped with an inflatable cuff near the distal end for sealing the trachea once intubation is achieved, there is always a danger that over inflation of the cuff may cause injury to the patient, while under inflation can result in regurgitated stomach content being forced into the lungs. Such accidents are especially prone to occur in emergency situations and during patient transport, such as in an ambulance or helicopter. It would be useful if the cuff-equipped endotracheal tube included a sensor for measuring the pressure between the inflated cuff and the tissues of the patient's trachea. This pressure measurement would help alleviate these problems.
Finally, no known endotracheal tube includes a sensor for measuring CO2 concentration of exhaled gases. At times it is critical to know such concentration while a patient is intubated. It would be desirable to have an endotracheal tube including a sensor for measuring CO2 concentration of exhaled breath of an intubated patient.
These needs, and others that will become apparent, are met by specific embodiments of an endotracheal tube that include at least one of the following elements: an ultrasound-observable flexible body, a heating member for warming inhalation gases, a sensor for measuring pressure between an inflation cuff and patient trachea tissues, and sensors for measuring CO2 and O2 concentration levels in respiratory gases; wherein all of these elements, alone and in various useful combinations, do not impede a normal flow of respiratory gases through the endotracheal tube.
a through 5g are partial pictorial diagrams that show various embodiments of ultrasound observable enhancements according to specific embodiments of the invention.
a through 6d are partial pictorial diagrams illustrating endotracheal tubes including internal heating members for warming inhalation gases.
a through 8c are partial pictorial diagrams illustrating an endotracheal tube including a sensor for measuring a physiological parameter such as cuff pressure or CO2/O2 concentration.
a, 9b are partial pictorial diagrams illustrating an endotracheal tube having a concentric construction of flexible plastic tubes, and at least one flexible tube being ultrasound reflecting.
With reference to
The hand held ultrasound wand 25 is located approximately above the patient's laryngeal prominence (Adam's apple). Experience teaches that this region is a likely place to view the ultrasound-reflecting elements 21 while the endotracheal tube is being inserted. Viewing by placing the hand-held wand 25 at the side of the patient's neck is also recommended because of the trachea is located in front of the esophagus within the neck, as more clearly seen in prior art
In general, the plastic tube itself is not visible using ultrasound. Rather, some ultrasound-reflecting element must be placed within or upon the tube to permit it to be seen in the ultrasound image 27 during intubation. What appears in the ultrasound image 27 to be a tube is actually an image of body tissues displaced by the tube and conforming along the tube's edges. The tube itself is difficult to see directly because a typical plastic material used to make an endotracheal tube of the type illustrated is not a good reflector of ultrasound. Experience has also taught that tissue conformance alone is not generally helpful while guiding the endotracheal tube to a proper and safe location within the trachea.
A solution to the problem presented by various embodiments of the present invention is to make the flexible plastic endotracheal tube ultrasound reflective. Note that in the description that follows, the phrases ‘ultrasound-reflecting’ and ‘ultrasound reflective’ are used interchangeably and are not intended to define different features or characteristics.
In a specific embodiment of the invention, the plastic material of the tube itself is made ultrasound reflective, as illustrated in
In an alternative embodiment, the material of the tube is not ultrasound reflective; instead, an ultrasound reflective tape is applied to an outer surface of the tube. This specific embodiment is illustrated in
a through 5g are partial pictorial diagrams that illustrate a typical portion of an endotracheal tube according to specific embodiments of the invention having an ultrasound reflective member located inside the body of the tube in various ways.
b illustrates a portion of an endotracheal tube according to another specific embodiment of the present invention. The tube is indicated generally by the reference numeral 50b, including a flexible plastic body 52b, having an airway passage indicated generally by the reference numeral 54b, and a secondary lumen 56b through which passes a metallic structure 58b.
c illustrates a portion of an endotracheal tube of concentric construction according to yet another specific embodiment of the present invention. The tube is indicated generally by the reference numeral 50c, including a first flexible plastic body 51c, having an outer surface 52c, an inner surface 53c, a first lumen 54c, a second flexible plastic body 55c fitted snugly within the first lumen, the second flexible body having a second lumen, indicated generally by the reference numeral 56c and forming a airway passage, an outer surface 57c, and ultrasound-reflecting elements 58c forming bands disposed upon the outer surface 57c. A person having an ordinary level of skill in the art will appreciate that a description of the endotracheal tube 50c stating that an inner tube fits snugly within an outer tube will result in the same structure as a description stating that an outer tube fits snugly over an inner tube. In another specific embodiment, the ultrasound-reflecting member(s) 58c are disposed between an inner surface of an outer tube and an outer surface of an inner tube. In yet another specific embodiment, the ultrasound-reflecting element(s) 58c comprise a reflective tape.
d illustrates a portion of an endotracheal tube including an ultrasound-reflecting element according to another embodiment of the invention. The endotracheal tube is indicated generally by the reference numeral 50d and includes a flexible body 51d having an airway-lumen indicated generally by the reference numeral 52d and a metallic construction 53d molded into the flexible body and providing an ultrasound-reflecting element. In another specific embodiment, the metallic construction 53d is a wire coiled about the airway-lumen and molded into the flexible body, as illustrated.
e illustrates a portion of an endotracheal tube having an ultrasound-reflecting element disposed upon an inner surface of an airway-lumen, and indicated generally by the reference numeral 50e. The tube 50e includes a flexible body 51e having an airway-lumen indicated generally by the reference numeral 52e, the airway-lumen has an inner surface 53e, and the tube has an ultrasound-reflecting element 54e disposed upon the inner surface.
f illustrates a portion of an endotracheal tube of concentric construction and indicated generally by the reference numeral 50f. The tube 50f includes a first flexible body 51f having a first lumen, indicated generally by the reference numeral 52f, the first lumen having an inner surface 53f. The endotracheal tube 50f also includes a second flexible body 54f having an outer surface 55f and an airway-lumen, indicated generally by the reference numeral 56f. The second flexible body fits snugly within the lumen of the first flexible body, and an ultrasound-reflecting element 57f is disposed between the two flexible bodies. The ultrasound-reflecting element is a metallic construction and in a specific embodiment comprises a braided wire shield.
g illustrates a portion of an endotracheal tube having a construction similar to that illustrated in
a through 6d are partial pictorial diagrams that illustrate a typical portion of an endotracheal tube according to specific embodiments of the invention in which a heating member located within the body of the tube heats inhaled respiratory gases moving through the tube.
a illustrates a portion of an endotracheal tube, indicated generally by the reference numeral 60a, having a flexible body 61a, an airway-lumen, indicated generally by the reference numeral 62a, and a heating member 63a disposed within the airway-lumen. The heating member warms a respiratory gas moving through the airway-lumen. In
In
c illustrates a typical portion of an endotracheal tube having a heating member molded into a flexible body. The tube is indicated generally by the reference numeral 60c and includes a flexible body 61c having an airway-lumen, indicated generally by the reference numeral 62c. A heating member 63c is coiled within the flexible body about the airway-lumen, as illustrated. Passing an electric current through the heating member warms respiratory gases moving through the airway-lumen. Though the coils appear evenly spaced in
d illustrates a typical portion of an endotracheal tube having a heating member disposed in coils within a concentric construction. The tube is indicated generally by the reference numeral 60d, and includes a first flexible body 61d having a first lumen, indicated generally by the reference numeral 62d, a second flexible body 63d having an airway-lumen, indicated generally by the reference numeral 64d. A heating member 65d is coiled between an inner surface 66d of the first lumen and an outer surface 67d of the second flexible body. In a specific embodiment, the first flexible body, the heating member, and the second flexible body fit snugly together to make possible a safe intubation.
a through 8c are partial pictorial diagrams illustrating a portion of an endotracheal tube having an inflatable cuff for sealing the trachea once insertion is achieved and a sensor for measuring a physiological parameter such as temperature, pressure, or gaseous concentration. Though the appearance of the inflatable cuff in
a illustrates such a tube having a protective sheath 80a surrounding a main breathing tube 81a and secondary tubes and/or wires/fiber optics 82a, and an inflatable cuff 83a. A purpose of the sheath is to protect the secondary tubes, wires, fiber optics and a patient from becoming entangled. The diameter of the protective sheath is exaggerated with respect to the diameter of the endotracheal main breathing tube, and in reality fits snugly about the breathing tube to facilitate successful intubation.
b illustrates a pressure sensor disposed upon an outer surface of the inflatable cuff for measuring pressure between an inflated cuff and patient's trachea. A problem that arises often, particularly in emergency situations, with use of an inflatable cuff is that it can easily become overinflated, causing injury to a patient. The endotracheal tube is indicated generally by the reference numeral 80b, and includes a main breathing tube 81b, an inflatable cuff 82b, a pressure sensor 83b, connecting wires 84b, and protective sheath 85b. As the inflatable cuff is inflated, pressure between the cuff and a patient's tracheal tissues (see
c illustrates a sensor located on an inner surface of the airway-lumen near the distal end of the tube. Such placement is useful for measuring temperature of a respiratory gas and gaseous concentration levels. The endotracheal tube is indicated generally by the reference numeral 80c and includes a flexible body 81c having an airway-lumen indicated generally by the reference numeral 82c, an inflatable cuff 83c, a sensor 84c and wires 85c for transmitting a sensor measured value outside the endotracheal tube and patient. A variety of sensors are useful for this embodiment including a thick film conductive type CO2 sensor, a nanotube molecular wires chemical sensor, and a fiber optic chemical sensor such as that disclosed in U.S. Pat. No. 4,842,783, the full disclosure of which is incorporated herein by reference. When a fiber optic is used to implement the CO2 sensor, it will be appreciated that the element 85c, previously referred to as a wire, is instead a fiber optic for carrying the sensor measurement back to a user. In an alternative embodiment of the invention, the sensor 84c is used for sensing O2 concentration levels in respiratory gases passing through the airway-lumen 82c.
In other embodiments (not illustrated), a sensor located near the distal end of the tube is used to measure patient body temperature. In one such embodiment, the temperature sensor is located on an outer surface of the inflatable cuff (e.g., sensor 83b of
a and 9b are partial pictorial diagrams that illustrate an endotracheal tube made of a concentric construction and in which at least one flexible tube of the construction is made of an ultrasound reflective material.
a illustrates a portion of an endotracheal tube of concentric construction according to yet another embodiment of the present invention. The tube is indicated generally by the reference numeral 90a, and includes a first flexible plastic body 91a, having an outer surface 92a, an inner surface 93a, a first lumen 94a, a second flexible plastic body 95a fitted snugly within the first lumen, the second flexible body having a second lumen, indicated generally by the reference numeral 96a and forming a airway passage, and an outer surface 97a. At least one of the first and second flexible bodies is made of an ultrasound reflective plastic. In another embodiment, at least one of the flexible bodies is made of an ultrasound opaque material. A person having an ordinary level of skill in the art will appreciate that a description of the endotracheal tube 90a stating that an inner tube fits snugly within an outer tube will result in the same structure as a description stating that an outer tube fits snugly over an inner tube.
b illustrates a portion of an endotracheal tube of concentric construction according to yet another embodiment of the present invention. The tube is indicated generally by the reference numeral 90b, and includes the two-layer structure illustrated in
While the invention has been described in relation to the embodiments shown in the accompanying Drawing figures, other embodiments, alternatives and modifications will be apparent to those skilled in the art. It is intended that the Specification be exemplary only, and that the true scope and spirit of the invention be indicated by the following Claims.
This non-provisional U.S. patent application is a continuation-in-part of co-pending U.S. patent application Ser. No. 12/901,491 filed 2010 Oct. 9 entitled ULTRASOUND-OBSERVABLE, RESPIRATORY GAS-WARMING, PARAMETER-SENSING ENDOTRACHEAL TUBE. This patent application claims priority from the filing date of said co-pending patent application pursuant to the provisions of 35 U.S.C. §120.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 12901491 | Oct 2010 | US |
| Child | 13158395 | US |