NASAL TRACHEAL DEVICES AND RELATED METHODS
20220143340 · 2022-05-12
Inventors
- Uday Reebye (Chapel Hill, NC, US)
- Alexander Guizzotti (Chapel Hill, NC, US)
- Andrew LEES (Wake Forest, NC, US)
Cpc classification
A61M16/208
HUMAN NECESSITIES
A61M16/0463
HUMAN NECESSITIES
A61M16/0488
HUMAN NECESSITIES
International classification
Abstract
Nasal tracheal devices include a tube with visual indicia of insertion depth corresponding to patient height and an inflatable cuff. The tube comprises or provides a plurality of lumens that are in fluid isolation including an airpath lumen and a pressurized fluid source for inflating the cuff. The devices may also be configured to suction patient fluid from a location adjacent and/or above the cuff.
Claims
1. A nasal tracheal device comprising: a tube comprising a distal end portion configured to reside inside a trachea of a patient, wherein the tube has axially spaced apart proximal and distal end portions, and wherein the tube comprises a segment that resides between the proximal and distal end portions that comprises visual indicia of insertion depth correlated to patient height; and an inflatable cuff integral to or coupled to the distal end portion of the tube, wherein the inflatable cuff is sized and configured to be positioned supraglottic.
2. The nasal tracheal device of claim 1, wherein the tube comprises a first lumen extending axially along the tube and a second lumen in fluid isolation with the first lumen and also extending axially along the tube, wherein the first lumen is in fluid communication with the inflatable cuff.
3. The nasal tracheal device of claim 1, wherein the visual indicia of insertion depth comprises a plurality of bands of different colors.
4. The nasal tracheal device of claim 1, wherein the plurality of bands comprises at least three bands of different colors, optionally 3-10 bands of different colors.
5. The nasal tracheal device of claim 1, wherein the inflatable cuff has a pear-shaped configuration or comprises a pear-shaped segment when in an inflated state.
6. The nasal tracheal device of claim 1, wherein the inflatable cuff is configured to define a fluid collection portion.
7. The nasal tracheal device of claim 2, wherein the tube comprises a third lumen extending axially along the tube in fluid isolation from the first and second lumens.
8. The nasal tracheal device of claim 2, wherein the proximal end portion of the device comprises at least one connector providing a first connection to the first lumen and a second connection to the second lumen.
9. The nasal tracheal device of claim 8, wherein the second lumen is configured to connect to a ventilator, the first lumen is configured to connect to an inflation fluid source and the third lumen is configured to connect to a vacuum source whereby the first lumen defines an inflation path, the second lumen defines an oxygen path and the third lumen defines an aspiration path.
10. The nasal tracheal device of claim 1, wherein the tube has a bend segment between the proximal and distal end portions, wherein the bend segment resides above the visual indicia of insertion depth and has an angle of between 90-120 degrees.
11. The nasal tracheal device of claim 7, wherein the third lumen is provided at least in part by a conduit that extends external to the tube with a free end that resides adjacent the cuff.
12. The nasal tracheal device of claim 11, wherein the conduit is configured to reside against a wall of the inflatable cuff when the cuff is in a non-inflated state, and wherein the conduit is configured to be pushed outward in response to inflation of the cuff.
13. The nasal tracheal device of claim 1, wherein the cuff comprises a neck at an upper end thereof that merge into a bottom portion that defines a maximal lateral extent of the inflatable cuff when inflated, and wherein the maximal lateral extent is 2-3 times greater than a lateral extent of the neck when the inflatable cuff is inflated.
14. The nasal tracheal device of claim 13, wherein the inflatable cuff has a radius of curvature that extends between the neck and the bottom portion that is in a range of 1-1.5 inches over 0.5-1 inch.
15. An intubation system comprising: a nasal tracheal device comprising a tube with an inflatable cuff, the tube comprising a distal end portion configured to reside inside a trachea of a patient above vocal cords of the patient, wherein the tube has axially spaced apart proximal and distal end portions, wherein the tube comprises a segment that resides between the proximal and distal end portions that comprises visual indicia of insertion depth correlated to patient height, and wherein the tube comprises a first lumen extending axially along the tube and a second lumen in fluid isolation with the first lumen and also extending axially along the tube, wherein the first lumen is in fluid communication with the inflatable cuff; a ventilator or anesthesia circuit in fluid communication with the second lumen of the tube; and an inflation fluid source in fluid communication with the first lumen of the tube to inflate the inflatable cuff.
16. The system of claim 15, further comprising a third lumen provided by the tube and/or a conduit coupled to the tube and a vacuum in fluid communication with the third lumen and defining an aspiration path.
17. The system of claim 15, wherein the inflatable cuff comprises a pear-shaped body when in an inflated state.
18. The system of claim 15, wherein the visual indicia of insertion depth comprises a plurality of bands of different colors.
19. A method of placing a nasal tracheal tube in a patient, comprising: determining or obtaining a height estimate of a patient; providing a nasal trachea device with a tube comprising an inflatable cuff and visual indicia of insertion depth correlated to different heights of patients; inserting the tube via an intranasal insertion path to an insertion depth in a trachea of the patient corresponding to the visual indicia associated with the estimated height of the patient thereby placing a distal end portion of the tube above the vocal cords (supraglottic) of the patient; and inflating the inflatable cuff so that the cuff seals against an inner wall of the trachea above the vocal cords.
20. The method of claim 19, wherein the inserting is carried out to place a color band associated with the estimated patient height at least partially external to a nostril of the patient.
21. The method of claim 19, wherein the inflatable cuff can comprise a pear-shaped body or pear-shaped body segment with a larger portion defining a maximal lateral extent of the inflatable cuff when inflated below a smaller upper portion, wherein the larger portion is 2-3 times larger than the smaller upper portion when inflated.
22. The method of claim 19, further comprising suctioning liquid from the patient using a conduit provided by or coupled to the tube adjacent the inflatable cuff.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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[0059] Further features, advantages and details of the present invention will be appreciated by those of ordinary skill in the art from a reading of the figures and the detailed description of the preferred embodiments that follow, such description being merely illustrative of the present invention.
DETAILED DESCRIPTION
[0060] The present invention now will be described more fully hereinafter with reference to the accompanying drawings, in which illustrative embodiments of the invention are shown. Like numbers refer to like elements and different embodiments of like elements can be designated using a different number of superscript indicator apostrophes (e.g., 10, 10′, 10″, 10″′).
[0061] In the drawings, the relative sizes of regions or features may be exaggerated for clarity. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.
[0062] It will be understood that, although the terms first, second, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer or section from another region, layer or section. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the present invention.
[0063] Spatially relative terms, such as “beneath”, “below”, “lower”, “above”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the exemplary term “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90° or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. The term “about” refers to numbers in a range of +/−20% of the noted value. Any numerical range stated to be between two numbers is inclusive of the end point numbers.
[0064] As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless expressly stated otherwise. It will be further understood that the terms “includes,” “comprises,” “including” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. It will be understood that when an element is referred to as being “connected” or “coupled” to another element, it can be directly connected or coupled to the other element or intervening elements may be present. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items.
[0065] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of this specification and the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
[0066] Turning now to
[0067] The tube 15 can comprise a third lumen 34 that extends between a suction source, such as a vacuum 120, to at least one suction intake port 34p. The at least one suction intake port 34p can reside adjacent the cuff 20, typically above the lower end portion 20l of the cuff 20, such as at or adjacent an upper end portion 20u or a medial 20m location of the cuff 20. The third lumen 34 can be fluidly isolated from the first and second lumens 30, 32. The first, second and third lumens 30, 32, 34 are shown in broken line in
[0068] In some embodiments, the first lumen 30 can be used to both inflate the cuff and to aspirate fluids during the procedure. For example, as shown in
[0069] Referring again to
[0070] The tube 15 is sized and configured to be insertable through the patient's nasal cavity, instead of through the oral cavity. Insertion through the nasal cavity allows intubation without obstructing the patient's oral cavity with a large foreign object, thereby allowing the surgeon to perform the required procedure without impediment. The patient is not required to be sedated or placed under general anesthesia for insertion of the tube through the nasal cavity. The nasal tracheal device 10 can be configured for human or veterinarian uses. The nasal tracheal device 10 can be used for ENT procedures, field, ambulance or EMT uses, hospital or field uses in military and civilian emergency medicine procedures, oral surgery, plastic surgery, and veterinarian procedures.
[0071] The nasal tracheal device 10 is configured so that the cuff 20 and the distal end 10d can be placed supraglottic, e.g., above the vocal cords. By positioning the device 10 above the vocal cords, risk of trauma to the vocal cords is eliminated or greatly reduced. Other potential side effects of endotracheal intubation are also eliminated or greatly reduced, including the risk of malignant hypothermia, since the patient is not required to be placed under general anesthesia.
[0072] Once in position, the cuff 20 can be inflated which inhibits and/or prevents fluids from entering the patient's lungs. The second lumen 32 of the tube 15 is attached to the ventilator 100 that continuously supplies oxygen to the lungs.
[0073] The cuff 20 can be sized and configured to seal the airway of the patient so that fluids do not enter the lungs outside the cuff 20. The cuff 20 can remain fully or partially deflated until it is in proper position, then the cuff 20 can be inflated using the inflation lumen 30. When inflated, the cuff 20 can abut and define a seal with a wall of the trachea Tw thereabout (
[0074] As shown in
[0075] Referring to
[0076] The third lumen 34 (e.g., “aspiration” or “suction” lumen) can be provided by the tube 15 as an internal lumen 34 or as an external conduit 40 with the lumen 34 or combinations of internal and external lumen segments that can extend over at least a major portion of a length of the tube 15.
[0077] Referring to
[0078] The visual indicia 18v can be provided to identify a plurality of different height ranges, typically in a range of three-six, shown as four different height ranges. The visual indicia closest to the proximal end portion 10p of the nasal tracheal tube 10 can correlate to a tallest patient height range and the visual indicia furthest away from the proximal end portion 10p can correlate to a shortest height range.
[0079] The visual indicia 18v can comprise a plurality of bands 18b of different color. The bands 18b can be extend circumferentially about an entire external circumference of the tube or only about a portion of the tube 15. The bands 18 can be provided in solid or patterned colors. The bands 18b of color are color coded to visually indicate approximately how far the tube 15 should be inserted, depending on the height of the patient. As shown, the bands 18b of different color are provided in red, blue, green and yellow. Other colors may be used and/or other color orders may be used. In some embodiments, other or additional visual indicia of suitable depth can be used, such as numerical or textual markings, or alphanumeric markings or graduated scaled markings and the like can be provided to indicate approximately how far the tube 15 should be inserted.
[0080] The nasal tracheal device 10 can be provided in pediatric and adult sizes with the visual indicia 18v modified to correlate height to position based on the target end use.
[0081] Thus, the tube 15 can be inserted via an intranasal insertion path to an insertion depth in a trachea of the patient corresponding to the visual indicia associated with the estimated height of the patient thereby placing a distal end portion of the nasal tracheal device 10 and the tube 15 above the vocal cords (supraglottic) of the patient and then the inflatable cuff 20 can be inflated so that the cuff 20 seals against an inner wall of the trachea above the vocal cords. As shown in
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[0095] In some embodiments, the overall length of the cuff 20, 20′ can be in a range of 1-1.5 inches.
[0096] Turning now to
[0097] The nasal trachea device can be connected to a ventilator so that a lumen of the tube provides an airpath between the ventilator and the trachea whereby oxygen is provided to the lungs of the patient (block 235).
[0098] Fluid can be suctioned from a location above the vocal cords and/or a bottom of the cuff the patient via a lumen provided by the nasal trachea device (block 237).
[0099] The cuff can be pear-shaped with a larger portion below a smaller upper portion.
[0100] The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention. Therefore, it is to be understood that the foregoing is illustrative of the present invention and is not to be construed as limited to the specific embodiments disclosed, and that modifications to the disclosed embodiments, as well as other embodiments, are intended to be included within the scope of the invention.