WO2012087814A2

WO2012087814A2 - Endotracheal tube having a recessed cuff and/or one or more suction apertures arranged in a cuff recess and method of making and/or using the same

Info

Publication number: WO2012087814A2
Application number: PCT/US2011/065460
Authority: WO
Inventors: Vasu Nishtala; Paul Ciccone; Richard Terry; Jack TUCKER
Original assignee: C.R. Bard, Inc.
Priority date: 2010-12-21
Filing date: 2011-12-16
Publication date: 2012-06-28
Also published as: WO2012087839A1; WO2012087814A3

Abstract

A endotracheal tube including a main tube with a proximal end and a distal end, and an inflatable cuff arranged thereon, the inflatable cuff including a main inflation area. The endotracheal tube includes at least one of: at least one recess or indentation is arranged in the main inflation area, at least one recess or indentation extends into the main inflation area, at least one recess or indentation extends between an adhered area of the cuff and a location in the main inflation area, at least one suction aperture is arranged in the main inflation area, at least one suction aperture is arranged in a recess or indentation located in the main inflation area, at least one suction lumen is arranged in a recess or indentation extending into the main inflation area, and at least one suction lumen extends into a recess or indentation located in the main inflation area.

Description

ENDOTRACHEAL TUBE HAVING A RECESSED CUFF AND/OR ONE OR MORE SUCTION APERTURES ARRANGED IN A CUFF RECESS AND METHOD OF MAKING AND/OR USING THE SAME

PRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Patent

Application No. 61/425,589, filed December 21, 2010, which is incorporated by reference in its entirety into this application.

BACKGROUND OF THE INVENTION

Field of Invention

[0002] The invention relates generally to the field of medical devices, e.g., a medical tube, e.g., an endotracheal tube (ET), including an inflatable cuff. According to various embodiments, the endotracheal tube utilizes the novel way of suctioning secretions from the trachea while minimizing the possibility of direct suctioning of the tracheal mucosa. This is accomplished using a cuff having one or more recesses or indentations arranged within and/or extending to a main inflation area or inflation plane area of the cuff. In embodiments, one or more suction apertures can be located in the recesses or indentations.

Discussion of Background Information

[0003] Conventional methods of endotracheal intubation involve the insertion of a tubular device, e.g., an endotracheal tube, into the trachea. The endotracheal tube typically passes through the trachea and terminates above the carina, allowing gases to be directed through the tube and into the lungs.

[0004] A primary objective of this type of treatment is the mechanical ventilation of a patient's lungs, which may be required or appropriate due to the subject's medical condition. In order to create the air pressure necessary to artificially ventilate the lungs, the passageways around the tube are typically sealed, which may be accomplished, e.g., using the inflatable cuff arranged on a distal end of a tube. The cuff is typically located within the trachea about 3-5 centimeters above the carina and is then inflated to expand and seal against the wall of the trachea. This prevents gases from being pumped into the lungs from backing up around the tube. [0005] Although cuffed endotracheal tubes perform an important service, they can allow secretions to collect proximate the cuff that provide a site for the possible accumulation of pathogens. Various methods have been devised for removing such secretions. For example, a small opening may be provided above the cuff with an associated suction lumen. Fluids and/or solids (e.g., secretions) can be periodically or continuously removed through the opening and lumen by suction.

[0006] It is also known that cuffed endotracheal tubes often do not self-center within the trachea upon inflation of the cuff. As a result, the suction openings of a particular tube may not be spaced apart from the tracheal wall. For example, due to the curvature of the tube and/or other factors, the suction opening may be located very near the tracheal wall, especially in the case where the suction aperture is aligned in the plane of curvature of the tube, as is typical. In some instances, the suction opening may actually contact the tracheal wall. In such situations, the tracheal wall membrane may be drawn into the suction opening upon application of a vacuum, thereby occluding the opening. This may prevent the proper removal of secretions from the subglottic space and/or may cause trauma to the tracheal wall.

[0007] Known endotracheal tubes also incorporate pigtail tubing to connect the cuff inflation lumen to an inflation syringe and a suction lumen to deliver suctioning into the trachea from a suction source. These pigtails typically separate from the main tube at a point below where the main tube is typically cut to fit a particular patient. While the pigtail for cuff inflation is small, the pigtail for suctioning is larger and can cause space issues within the limited space of the patient oral cavity. This is especially the case during, e.g., oral care and inspections.

[0008] With current endotracheal tubes, especially those for continuous aspiration of subglottic secretions, or "CASS" type tubes, the suction aperture is placed on the outer edge or side of the main tube curvature. One example is shown in FIG. 1 which illustrates an endotracheal tube 1 having a proximal end 2, a distal end 3, a main tube 4, a connector C for interfacing with a respiration source, an inflation lumen arranged in the main tube 4, a cuff 8, a suction aperture 9, and optionally a radiopaque stripe. An inflation device ID (or connector for connecting to the same) is used to cause inflation of the cuff 8 by passing a gas through a tube T and into the main tube 4. A suction device SD (or connector for connecting to the same) is used to create suction at the suction aperture 9 by allowing gas to pass through the tube T from the suction aperture 9. The cuff 8 includes a proximal end and a distal end. The suction aperture 9 is typically arranged about 8 mm away from the cuff 8 (measured along the axis of the main tube 4) in order to avoid the portion of the cuff 8 that is glued to the main tube 4. In this position, the suction aperture 9 is typically positioned where it will be at the lowest point within the trachea (when the patient is inclined). Because of this position of the suction aperture 9, it is possible that suction can be applied directly onto the tracheal mucosa wall. This can cause damage to the trachea and cause prolapse of the tissue into the suction aperture. This can, in turn, cause plugging of the suction aperture 9, and thereby prevent suctioning of the secretions or aspirates which pool around the cuff. In such endotracheal tubes, the suction aperture 9 is thus arranged at about the six o'clock position relative to the plane of curvature of the main tube 4, and when arranged in a patient lying generally horizontally.

[0009] Examples of devices which might overcome the problems associated with locating the suction aperture in the position shown in FIG. 1 include US 5,201,310 to TURNBULL, US 7,089,942 to GREY, US 7,293,561 to MADSEN et al., US 2008/0255951 to GREY, US 2008/0021386 to CLAYTON, US 2008/0047562 to COLBURN et al, and US 2008/0053454 to PASILLAS et al., each of which is expressly incorporated by reference in its entirety into this application.

[00010] It would be beneficial to have a CASS type endotracheal tube having a cuff which a recess or indentation that significantly extends into the cuff area, unlike those known from the above-noted prior art documents. It would also be beneficial to have an endotracheal tube having a cuff which has a recess or indentation within which a suction aperture is located. In embodiments, the suction aperture that is placed or located in the cuff recess or indentation reduces the likelihood of direct suctioning of the tracheal mucosa. In this new position, the suction aperture(s) would have the dual advantage of being less likely to directly suction the tracheal wall, and could suction the secretions which accumulate or pool immediately adjacent the cuff. In this new position, the suction aperture(s) would also have the advantage of being placed within a main inflation area or the inflation plane of the cuff and/or in an adhered area of the cuff which forms the recess or indentation instead of being spaced by some distance from an end of the cuff.

SUMMARY OF THE INVENTION

[00011] According to one non-limiting embodiment of the invention, there is provided a endotracheal tube utilizing a novel way of suctioning secretions from the trachea while minimizing the possibility of direct suctioning of the tracheal mucosa and which overcomes one or more of the deficiencies noted above.

[00012] In embodiments, the invention can utilize conventional cuffs of the type shown in FIG. 1 and/or of the type disclosed in US 5,201,310 to TURNBULL, US 7,089,942 to GREY, US 7,293,561 to MADSEN et al., US 2008/0255951 to GREY, US 2008/0021386 to CLAYTON, US 2008/0047562 to COLBURN et al, and US 2008/0053454 to PASILLAS et al., and which are modified to include the cuff recess and/or suction aperture configuration disclosed herein.

[00013] In embodiments, the invention can utilize ET tubes, as well as any features thereof, of the type disclosed in three concurrently filed PCT applications, claiming the benefit of priority, respectively, to the following: 1) U.S. Provisional Patent Application No. 61/425,584, filed December 21, 2010 with the title "ENDOTRACHEAL TUBE HAVING A RECESSED CUFF, ONE OR MORE SUCTION APERTURES ARRANGED THEREIN, AND/OR A CUFF HAVING STIFFENERS AND METHOD OF MAKING AND/OR USING THE SAME;" 2) U.S. Provisional Patent Application No. 61/425,593, filed December 21, 2010 with the title "ENDOTRACHEAL TUBE HAVING ONE OR MORE ANGULARLY OFFSET SUCTION APERTURES AND METHOD OF MAKING AND/OR USING THE SAME;" and 3) U.S. Provisional Patent Application No. 61/425,599, filed December 21, 2010 with the title "ENDOTRACHEAL TUBE HAVING A CUFF ELASTICALLY EXPANDABLE AND NON-ELASTICALLY EXPANDABLE PORTIONS AND METHOD OF MAKING AND/OR USING THE SAME." The disclosure of each of these documents is expressly incorporated by reference in its entirety into this application.

[00014] According to one non-limiting embodiment of the invention, there is provided an endotracheal tube including a main tube comprising a proximal end and a distal end. An inflatable cuff is arranged on the main tube. The inflatable cuff includes a main inflation area. At least one of; at least one recess or indentation is arranged in the main inflation area, at least one recess or indentation extends into the main inflation area, at least one recess or indentation extends between an adhered area of the cuff and a location in the main inflation area, at least one suction aperture is arranged in the main inflation area, at least one suction aperture is arranged in a recess or indentation located in the main inflation area, at least one suction lumen is arranged in a recess or indentation extending into the main inflation area, and at least one suction lumen extends into a recess or indentation located in the main inflation area.

[00015] The inflatable cuff may have a generally cylindrical cross-section shape. The main inflation area may be generally cylindrical in shape. The main inflation area may have an axial length that is between about 40% and about 90% of an overall axial length of the cuff. The main inflation area may have an axial length that is between about 50% and about 80% of an overall axial length of the cuff. The main inflation area may have an axial length that is between about 60% and about 75% of an overall axial length of the cuff.

[00016] The cuff may comprise one of at least one recess or indentation arranged in the main inflation area and at least one recess or indentation extending into the main inflation area, and the at least one recess or indentation may extend radially.

[00017] The cuff may comprise at least one recess or indentation extending into the main inflation area, and the at least one recess or indentation extends radially and has a width that is narrower than an axial length of the at least one recess or indentation.

[00018] The cuff may comprise at least one recess or indentation extending into the main inflation area, and the at least one recess or indentation may be open in an area of the proximal end of the cuff and opens out to an outer circumference of the cuff.

[00019] The cuff may comprise at least one recess or indentation extending into the main inflation area, and the at least one recess or indentation may be generally triangular or pie-wedge shaped.

[00020] The cuff may comprise at least one suction aperture arranged in a recess or indentation extending into the main inflation area, and the at least one suction aperture may have a center axis that intersects a circumference of the main inflation area.

[00021] The cuff may comprise at least one suction aperture arranged in a recess or indentation extending into the main inflation area, and the at least one suction aperture may have a center axis that intersects a center axis of the main tube.

[00022] The inflatable cuff may be arranged on the main tube and spaced from the distal end by an amount that is less than a spacing from the proximal end. The main tube may comprise at least one integrally formed suction lumen which extends to at least one suction aperture. The main tube may comprise at least one integrally formed inflation lumen which extends to at least one aperture for inflating the cuff. The main tube may comprise at least one radiopaque strip or stripe arranged in a wall of the main tube. The main tube may comprise at least one suction lumen that is arranged on a bending plane of the main tube. The main tube may comprise at least one suction lumen that is angularly offset from a bending plane of the main tube. The main tube may comprise at least one non-circular suction lumen that is arranged on a bending plane of the main tube. The main tube may comprise at least one non-circular suction lumen that is angularly offset from a bending plane of the main tube. The main tube may comprise a generally circular cross-section shape. The main tube may comprise a generally oval cross-section shape.

[00023] The cuff may comprise at least one suction aperture arranged in a recess or indentation extending into the main inflation area, and the at least one suction aperture may comprise two angularly offset suction apertures. The main tube may comprise at least one suction lumen coupled to at least one of the two angularly offset suction apertures. The main tube may comprise at least one integrally form suction lumen coupled to each of the two angularly offset suction apertures. The main tube may comprise two suction lumens each coupled to one of the two angularly offset suction apertures. Each of the two suction apertures may form an angle of between about 20 degrees and about 70 degrees relative to a bending plane of the main tube. The endotracheal tube may further comprise at least one inflation lumen generally oriented on a bending plane of the main tube.

[00024] The invention also provides for an endotracheal tube comprising a main tube comprising a proximal end and a distal end and an inflatable cuff arranged on the main tube. The inflatable cuff comprises a main inflation area, at least one recess or indentation extending into the main inflation area, and at least one suction aperture arranged in the recess or indentation.

[00025] The inflatable cuff may have a generally cylindrical cross-section shape. The main inflation area may be generally cylindrical in shape. The main inflation area may have an axial length that is between about 40% and about 90% of an overall axial length of the cuff. The main inflation area may have an axial length that is between about 50% and about 80% of an overall axial length of the cuff. The main inflation area may have an axial length that is between about 60% and about 75% of an overall axial length of the cuff. The at least one recess or indentation may extend radially. The at least one recess or indentation may extend radially and may have a width that is narrower than an axial length of the at least one recess or indentation. The at least one recess or indentation may be open in an area of the proximal end of the cuff and may open out to an outer circumference of the cuff. The at least one recess or indentation may be generally triangular or pie-wedge shaped. The at least one suction aperture may have a center axis that intersects a circumference of the main inflation area. The at least one suction aperture may have a center axis that intersects a center axis of the main tube. The inflatable cuff may be arranged on the main tube and spaced from the distal end by an amount that is less than a spacing from the proximal end.

[00026] The main tube may comprise at least one integrally formed suction lumen which extends to at least one suction aperture. The main tube may comprise at least one integrally formed inflation lumen which extends to at least one aperture for inflating the cuff. The main tube may comprise at least one radiopaque strip or stripe arranged in a wall of the main tube.

[00027] The invention also provides for a method for intubation using the endotracheal tube of the type described above, wherein the method comprises inserting at least a portion of an endotracheal tube into a trachea, inflating a cuff of the endotracheal tube, and supplying gas into a patient's lungs via the endotracheal tube.

[00028] The method may further comprise suctioning matter through the at least one suction aperture.

[00029] The invention also provides for a method of making the endotracheal tube of the type described above, wherein the method comprises arranging a cuff on a main tube and arranging a position of at least one suction aperture relative to the cuff such that at least one of the at least one suction aperture is in an inflation plane.

[00030] The invention also provides for an endotracheal tube comprising a main tube comprising a proximal end and a distal end and an inflatable cuff arranged on the main tube. The inflatable cuff comprises a main inflation area, at least one recess or indentation extending into the main inflation area, and at least one suction aperture arranged in the recess or indentation. The at least one recess or indentation is at least one of generally triangular, generally pie- shaped, and opens out in both an axial direction towards one end of the cuff and a radial direction towards a circumference of the main inflation area. [00031] The at least one suction aperture may have a center axis that intersects a circumference of the main inflation area. The at least one suction aperture may have a center axis that intersects a center axis of the main tube. The at least one suction aperture may be arranged on at least one suction lumen which extends axially into the recess or indentation.

BRIEF DESCRIPTION OF DRAWINGS OF THE EXEMPLARY EMBODIMENTS

[00032] The present invention is further described in the detailed description which follows, in reference to the noted plurality of drawings by way of non-limiting examples of exemplary embodiments of the present invention, in which like reference numerals represent similar parts throughout the several views of the drawings, and wherein:

[00033] FIG. 1 shows a side perspective view of an endotracheal tube of the type conventionally used in intubation in a bent or use configuration and with the cuff inflated;

[00034] FIG. 2 shows a side perspective view of the cuff end portion of an endotracheal tube of the invention and illustrates how the conventional main tube of FIG. 1 can be modified to utilize a cuff recess and a suction aperture arranged therein;

[00035] FIG. 3A shows an enlarged partial cross-section view of one optional way of configuring the cuff recess area shown in FIG. 2 in accordance with an exemplary embodiment of the invention;

[00036] FIG. 3B shows an enlarged partial cross-section view of another optional way of configuring the cuff recess area shown in FIG. 2 in accordance with an exemplary embodiment of the invention;

[00037] FIG. 4 shows an enlarged side cross-section view of a suction area of the endotracheal tube shown in FIG. 2 in accordance with an exemplary embodiment of the invention;

[00038] FIG. 5 shows an end cross-section view of the endotracheal tube shown in

FIG. 2 and illustrates how the suction aperture and recess or indentation is oriented on or parallel to the bending plane in accordance with an exemplary embodiment of the invention;

[00039] FIG. 6 shows a view similar to that shown in FIG. 2, but with the suction aperture and recess or indentation oriented 90 degrees to the bending plane and/or generally parallel to a center axis of the angled distal opening of the main tube in accordance with an exemplary embodiment of the invention. FIG. 6 also shows how the suction aperture can be enlarged/elongated so as to provide suctioning to a larger portion of the recess;

[00040] FIG. 7 shows a view similar to that shown in FIG. 5, but with the suction aperture and recess being angularly offset from the bending plane in accordance with an exemplary embodiment of the invention;

[00041] FIG. 8 shows a view similar to that shown in FIG. 7, but utilizing two suction apertures and recesses or indentations which are each angularly offset from a vertical oriented bending plane in accordance with an exemplary embodiment of the invention;

[00042] FIG. 9 shows a view similar to that shown in FIG. 2, but utilizing a suction lumen tube running outside the main tube and extending into the recess or indentation formed in the cuff in accordance with an exemplary embodiment of the invention;

[00043] FIG. 10 shows a partial enlarged cross-section view of FIG. 9 and illustrates how the suction lumen passes from inside the main tube to outside the main tube and extends into the recess or indentation formed in the cuff in accordance with an exemplary embodiment of the invention;

[00044] FIGS. 11 and 12 show a pre-inflated and inflated views of an ET tube similar to that shown in FIG. 6, but utilizing a generally spherical cuff in accordance with an exemplary embodiment of the invention;

[00045] FIG. 13 shows a view similar to that shown in FIG. 12, but utilizing a shorter and wider cuff recess and a round suction aperture in accordance with an exemplary embodiment of the invention;

[00046] FIG. 14 shows the ET tube of FIG. 13 in a bent configuration and in a trachea with the suction aperture oriented on the bending plane in accordance with an exemplary embodiment of the invention;

[00047] FIG. 15 shows a cross-section view of a conventional main tube and which can be used with any of the embodiments disclosed herein in accordance with exemplary embodiments of the invention; and [00048] FIGS. 16-18 show cross-section views of a main tube which can be used with any of the embodiments disclosed herein in accordance with exemplary embodiments of the invention.

DETAILED DESCRIPTION OF THE INVENTION

[00049] The following description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.

[00050] As used herein, the reference terms "proximal" and "distal" (proximal being closer than distal) refer to proximity with respect to a health care professional inserting the endotracheal tube into a patient. For example, the region or section of the endotracheal tube that is closest to the health care professional during insertion is referred to herein as "proximal," while a region or section of the endotracheal tube closest to the patient's lungs is referred to as "distal."

[00051] FIGS. 2-14 and 16-18 show non-limiting or exemplary embodiments of the invention wherein like numbers refer to same and like parts. Different embodiments generally utilize reference numbers increased by ten for similar/comparable features. For example, devices labeled with 4, 14, 24, 34, etc., all relate to comparable devices, i.e., a main tube. The present invention broadly relates to medical tubes (e.g., endotracheal, tracheostomy, or oropharyngeal tubes or other tubes or catheters) adapted to be intubated into one or more passageways (e.g., the trachea and/or pharynx) of a patient, subject or user in connection with a medical procedure. For example, certain embodiments are directed toward endotracheal tubes inserted into a subject's trachea to facilitate mechanical ventilation of the lungs. Certain embodiments include tubes having an improved configuration for periodic removal of fluids and/or solids that collect adjacent an inflatable cuff used to seal, secure, and/or position the tube against the tracheal wall. The endotracheal tube of the invention, in embodiments, includes at least one suction aperture arranged in at least one cuff recess or indentation of the cuff, and/or located as described herein, which advantageously suctions secretions from the trachea while minimizing the possibility of direct suctioning of the tracheal mucosa. As used throughout this document, the terms "subject", "patient" or "user" may include any human or animal. Furthermore, the term "main inflation area" is generally a center portion of the cuff whose axial length substantially corresponds to an area of contact between the cuff and a trachea when the ET tube is arranged in a patient and the cuff is sufficiently or fully inflated. Additionally, the term "overall inflatable length" is generally the length of the portion of the cuff which can be inflated and which generally excludes the portions of the cuff which are adhered to the main tube and which project out beyond the portion of the cuff which can be inflated.

[00052] With reference to FIG. 2, there is shown one non-limiting embodiment of an endotracheal tube in accordance with the invention. Like the embodiment shown in FIG. 1, the embodiment of FIG. 2 has a proximal end, a distal end, a main tube 14, a connector for interfacing with a respiration source, an inflation lumen, a cuff 18, a suction aperture 19, and optionally, a radiopaque stripe. An inflation device is used to cause inflation of the cuff 18 by passing a gas through a tube and into the main tube 14. The cuff 18 includes a proximal end and a distal end.

[00053] Unlike the ET tube of FIG. 1, however, in embodiments, the invention shown in FIG. 2 utilizes a cuff recess or indentation 20. This recess 20 provides the endotracheal tube with a novel way of suctioning secretions from the trachea while minimizing the possibility of direct suctioning of the tracheal mucosa. The recess 20 has a bottom side that is generally parallel and/or arranged adjacent an outside of the main tube 14. In embodiments, the bottom side of the recess 20 is formed by a wall portion of the cuff 18 which is adhered or otherwise secured to an outer surface of the main tube 14. Alternatively, a major portion the bottom surface of the recess 20 is formed by an outer surface of the main tube 14. The recess or indentation 20 has a closed end that is closer to the distal end of the cuff 18, but is open in a radial direction all the way to an outer circumferential or peripheral surface of the cuff and is also open in an axial direction all the way to the portion of the proximal end of the cuff which is secured to the main tube 14. In the recess configuration shown in FIG. 2, the space defined by the recess 20 (which if filled would resemble the opposite end of the cuff 18) and/or the recess 20 itself is generally triangular and/or generally pie- wedge shaped. As is apparent from FIG. 2, the recess or indentation 20 extends axially from the proximal end of the cuff 18 into a main inflation area MIA of the cuff 18. In embodiments, the recess or indentation 20 extends axially from the proximal end of the cuff 18 into the cuff 18 by an amount that is between about 15% and about 50% of the overall inflation length OIL. In embodiments, the recess or indentation 20 extends axially from the proximal end of the cuff 18 into the cuff 18 by an amount that is between about 25% and about 50% of the overall inflation length OIL. The recess 20 also has a width that is narrower than an axial length of the recess 20. The walls defining the width can be slightly tapered so as to open out towards the proximal end of the cuff 18 and/or towards outer peripheral surface (or circumference) of the cuff 18. In embodiments, the suction aperture 19 is arranged in the recess 20 so as to suction secretions which accumulate in the recess 20 and/or which accumulate very close to the cuff 18. The suction aperture 19 can also be arranged, at least partially, within the main inflation area MIA. Alternatively, the suction aperture 19 is arranged outside of the main inflation area MIA or fully within the main inflation area MIA.

[00054] Although FIG. 2 shows a single suction aperture 19 arranged in the cuff recess

20, the invention contemplates using plural suction apertures arranged in the recess 20. In this case, one of the suction apertures can be arranged within the main inflation area MIA while another is arranged outside the main inflation area MIA. Alternatively, both suction apertures can be arranged within the main inflation area MIA or outside the main inflation area MIA. In other embodiments, the suction apertures can be arranged circumferentially side-by- side and/or can have different shapes and/or sizes.

[00055] FIG. 3A shows one non-limiting way in which the recess 20 can be configured in the cuff 18. As can be seen in FIG. 3A, the recess or indentation 20 has a bottom side BS that is generally parallel to and arranged adjacent an outside of the main tube 14. The bottom side BS of the recess 20 is formed by a wall portion of the cuff 18 which is adhered to an outer surface of the main tube 14. The suction aperture 19 is formed through the adhered wall of the cuff 18 and penetrates an outer surface of the main tube 14 so as to be in fluid communication with the suction lumen arranged in the tube 14. A plug PG is arranged in the suction lumen (at a position forward of the aperture 19) so as to ensure that the suction occurs at the suction aperture 19. At a distal end of the recess 20, the wall of the cuff 18 extends upwards from the adhered area until it merges with the generally cylindrical portion of the cuff 18. This vertical portion of the wall forms the closed end CE of the recess 20. FIG. 3A also shows how the recess 20 is open radially all the way to an outer circumferential or peripheral surface of the cuff 18 as well as in an axial direction from the closed end all the way to the portion of the proximal end of the cuff 18 which is secured to the main tube 14. In the recess configuration shown in FIG. 3A, the recess 20 is generally triangular with the bottom side BS forming one side, the closed end CE forming another side, and an outer curved edge OCE of the cuff 18 forming the third side. As is also apparent from FIG. 3A, the recess 20 extends axially from the proximal end of the cuff 18 into a main inflation area of the cuff 18.

[00056] FIG. 3B shows another non-limiting way in which the recess 20' can be configured in the cuff 18'. As can be seen in FIG. 3B, the recess or indentation 20' has a bottom side that is generally parallel to and arranged adjacent an outside of the main tube 14'. The bottom side of the recess 20' is formed by a wall portion of the cuff 18' which is adhered to an outer surface of the main tube 14'. The suction aperture 19' is formed through the adhered wall of the cuff 18' and penetrates an outer surface of the main tube 14' so as to be in fluid communication with the suction lumen arranged in the tube 14'. A plug PC is arranged in the suction lumen (at a position forward of the aperture 19') so as to ensure that the suction occurs at the suction aperture 19'. At a distal end of the recess 20', the wall of the cuff 18' extends upwards from the adhered area until it merges with the generally cylindrical portion of the cuff 18. This merger area is different from that shown in FIG. 3A in that the closed end is generally straighter in the vertical direction and lacks the more curving wall shown in FIG. 3A. As a result, the recess 20' has a more triangular shape than the recess of FIG. 3A.

[00057] FIG. 4 shows an enlarged side cross-section view of a suction area of the endotracheal tube shown in FIG. 2, and illustrates how suction air flow (shown by arrows) can pass from the recess 20 into the suction aperture 19 and then into the suction lumen 16 arranged within the main tube 14. The arrows show how the recess 20 can provide the endotracheal tube with a novel way of suctioning secretions from the trachea while minimizing the possibility of direct suctioning of the tracheal mucosa. This is because the recess 20 is tucked inside the inflated cuff 18 and functions to provide a space between the suction aperture 19 and the trachea wall. The recess 20 also functions as a space which can accumulate/store secretions that can then be suctioned out via the suction aperture 19. In this embodiment, the main tube 14 includes an integrally formed ventilation lumen 15 as well as a smaller integrally formed suction lumen 16. [00058] As is apparent from FIG. 5, the main tube 14 can utilize a non-circular shaped suction lumen 16 and an inflation lumen 17 which are both oriented on the bending plane P in the same way as the suction aperture 9 shown in FIG. 1. In embodiments, the recess 20, the suction lumen 16, and the suction aperture 19 are all oriented on the plane P, i.e., at the six o'clock position.

[00059] In embodiments, the main tube 14 can be a one-piece member whereby the suction lumen 16 and the inflation lumen 17, also optionally the radiopaque stripe, are integrally formed therewith. By way of non-limiting example, the main tube 14 can be made of any medical grade plastic and can be generally circular in cross-section shape. Alternatively, the main tube 14 can have other shapes such as oval (see e.g., FIG. 18). In embodiments, the ventilation lumen 15 can be generally non-circular in cross-section shape. Alternatively, the ventilation lumen 15 can have other shapes. In embodiments, the suction lumen 16 can be generally oval in cross-section shape. Alternatively, the suction lumen 16 can have other shapes such as circular (see e.g., FIG. 18). In embodiments, the inflation lumen 17 can be generally circular in cross-section shape. Alternatively, the inflation lumen

17 can have other shapes.

[00060] In embodiments, the suction aperture 19 can be arranged about 8 mm in from an inflatable portion of the cuff 18 and, in embodiments, is arranged on the portion of the cuff

18 that is adhered to the main tube 14. In this and other embodiments discussed herein, other distances can also be utilized provided they function to remove secretions from with the recess 20 and do not otherwise interfere with the proper functioning or use of the cuff 18. In this position, the suction aperture 19 is positioned within the recess 20 from where it will be at the lowest point within the trachea (when the patient is inclined). Because of this position of the suction aperture 19, it is less likely that suction can be applied directly onto the tracheal mucosa wall. With this spaced arrangement of the suction aperture 19, there is a lower possibility of causing damage to the trachea and prolapse of the tissue into the suction aperture 19. Furthermore, because of the arrangement of the suction aperture 19 within the recess 20, there is a lower likelihood of plugging of the suction aperture 19, which, in turn, ensures that suctioning of the secretions or aspirates can continue even if the main tube 14 is in contact with the trachea. The arrangement of FIGS. 2-5 also advantageously allows suction of the secretions which accumulate or pool immediately adjacent the proximal end of the cuff 18 and/or in the recess 20. [00061] In the embodiment of FIGS. 2-5, the recess 20 and suction aperture 19 are each arranged at about the six o'clock position (relative to the bending plane). In embodiments, the suction aperture 19 can also be arranged angularly offset. In other embodiments, the suction aperture 19 can be arranged at about the seven o'clock position instead of the six o'clock position shown in FIG. 5. In other embodiments, the suction aperture 19 can also be arranged between about the seven and about the eight o'clock positions.

[00062] FIG. 6, for example, shows an embodiment similar to that shown in FIG. 2, but utilizing a suction aperture 29 and recess or indentation 30 oriented about 90 degrees to the bending plane and/or is generally parallel to a center axis of the angled distal opening of the main tube 24. FIG. 6 also shows how the suction aperture 29 can be enlarged/elongated so as to provide suctioning to a larger portion, e.g., a majority, of the recess 30. This elongated suction aperture 29 can also be utilized on other embodiments disclosed herein.

[00063] FIG. 7 shows an embodiment similar to that shown in FIG. 2, but utilizing a suction aperture 39 and recess or indentation 40 oriented at an angle A which can be between about 10 degrees and about 30 degrees to the bending plane. In embodiments, the main tube can be a one-piece member whereby the suction lumen 36 and the inflation lumen 37, also optionally the radiopaque stripe, are integrally formed therewith. By way of non-limiting example, the main tube can be made of any medical grade plastic and can be generally circular in cross-section shape. Alternatively, the main tube can have other shapes such as oval (see e.g., FIG. 18). In embodiments, the ventilation lumen 35 can be generally non- circular in cross-section shape. Alternatively, the ventilation lumen 35 can have other shapes. In embodiments, the suction lumen 36 can be generally oval in cross-section shape. Alternatively, the suction lumen 36 can have other shapes such as circular (see e.g., FIG. 18). In embodiments, the inflation lumen 37 can be generally circular in cross-section shape. Alternatively, the inflation lumen 37 can have other shapes. In the embodiment of FIG. 7, the recess 40 and suction aperture 39 are each also arranged angularly offset at about the seven o'clock position (relative to the bending plane P). In embodiments, the recess 40 and suction aperture 39 can also be arranged between about the seven and about the eight o'clock positions.

[00064] FIG. 8 shows an embodiment similar to that shown in FIG. 7, but utilizing two suction apertures 49a and 49b and recesses 50a and 50b which are each angularly offset to the bending plane. In embodiments, the main tube can be a one-piece member whereby the suction lumens 46a and 46b, the inflation lumen 47, also optionally the radiopaque stripe, are integrally formed therewith. By way of non-limiting example, the main tube can be made of any medical grade plastic and can be generally circular in cross-section shape. Alternatively, the main tube can have other shapes such as oval (see e.g., FIG. 18). In embodiments, the ventilation lumen 45 can be generally non-circular in cross-section shape. Alternatively, the ventilation lumen 45 can have other shapes. In embodiments, the suction lumens 46a and 46b can each be generally oval in cross-section shape. Alternatively, the suction lumens 46a and 46b can each have other shapes such as circular (see e.g., FIG. 18). In embodiments, the inflation lumen 47 can be generally circular in cross-section shape. Alternatively, the inflation lumen 47 can have other shapes. In the embodiment of FIG. 8, the recesses 50a and 50b and suction apertures 49a and 49b are each also arranged angularly offset at about the seven o'clock position (relative to the bending plane P). In embodiments, the recesses 50a and 50b and suction apertures 49a and 49b can also be arranged between about the seven and about the eight o'clock positions.

[00065] FIGS. 9 and 10 show another non-limiting embodiment of an ET tube in accordance with the invention. This embodiment is similar to that shown in FIG. 2, except that it utilizes a suction lumen tube 56 which, at a location near the cuff 58, passes through an aperture from inside the suction lumen of the main tube 54 to the outside thereof, and then runs outside (and generally parallel thereto) the main tube 54 into the recess or indentation 60 formed in the cuff 58. To provide sealing in the area AA where the tube 56 passes through an aperture in the tube 54, the area AA is coated or sealed with an adhering substance typically used in ET tubes. When area AA is properly sealed, gas will travel into the opening 59, pass through the tube 56, and then through the suction lumen of the tube 54 as shown by the arrows in FIG. 10. The distal end opening of the suction lumen tube 56 forms the suction aperture 59 that can suction secretions from the recess 60. One advantage or feature of this embodiment is that the suction opening 59 need not penetrate or be formed in any portion of the cuff 58. The suction opening 59 can also be moved to other locations/positions in the recess 60. In an alternative embodiment, no suction lumen is utilized in the tube 54, and instead an end opposite end (i.e., opposite aperture 59) of the tube 56 passes through the lumen 55 and extends all the way to the suction device SD. [00066] FIGS. 11 and 12 show another non-limiting embodiment of an ET tube in accordance with the invention. This embodiment is similar to that shown in FIG. 6, except that it utilizes a generally spherical cuff 68. FIG. 11 shows the cuff 68 in a pre-inflated state and having folds. FIG. 12 shows the cuff 68 in an inflated state. Although FIGS. 11 and 12 show a single suction aperture 69 arranged in the cuff recess 70, the invention also contemplates using plural suction apertures arranged in the recess 70. In this case, one of the suction apertures can be arranged within the main inflation area, like that shown in FIG. 12, while another is arranged outside the main inflation area. Alternatively, both suction apertures can be arranged within the main inflation area or outside the main inflation area. In other embodiments, the suction apertures can be arranged circumferentially side-by- side and/or can have different shapes and/or sizes.

[00067] FIGS. 13 and 14 show another embodiment of an ET tube that is similar to that shown in FIG. 12, and which utilizes a shorter and wider cuff recess 80 and a round suction aperture 79 arranged on a main tube 74. As is shown in FIG. 14, the bottom side of the recess 80 need not be formed by a wall portion of the cuff 78 adhered to an outer surface of the main tube 74, and can instead be formed by the outer surface of the main tube 74. Although FIGS. 13 and 14 show a single suction aperture 79 arranged in the cuff recess 80, the invention also contemplates using plural suction apertures arranged in the recess 80. In this case, one of the suction apertures can be arranged within the main inflation area, like that shown in FIGS. 13 and 14, while another is arranged outside the main inflation area. Alternatively, both suction apertures can be arranged within the main inflation area or outside the main inflation area. In other embodiments, the suction apertures can be arranged circumferentially side-by-side and/or can have different shapes and/or sizes.

[00068] FIG. 15 shows a cross-section view of a conventional main tube 4 having a ventilation lumen 5 and a suction lumen 6, and which can be used with any of the embodiments disclosed herein in accordance with exemplary embodiments of the invention. In embodiments, the dimension "a" can be about 0.441 inches. In embodiments, the area of the ventilation lumen 5 can be about 0.0664 square-inches and the area of the suction lumen 6 can be about 0.0086 square-inches.

[00069] FIG. 16 shows a cross-section view of a non-limiting embodiment of a main tube 14' having a ventilation lumen 15' and a suction lumen 16', and which can be used with any of the embodiments disclosed herein in accordance with exemplary embodiments of the invention. In embodiments, the dimension "a" can be about 0.404 inches. In embodiments, the area of the ventilation lumen 15' can be about 0.0676 square-inches and the area of the suction lumen 16' can be about 0.0032 square-inches.

[00070] FIG. 17 shows a cross-section view of a non-limiting embodiment of a main tube 14" having a ventilation lumen 15" and a suction lumen 16", and which can be used with any of the embodiments disclosed herein in accordance with exemplary embodiments of the invention. In embodiments, the dimension "a" can be about 0.412 inches. In embodiments, the dimension "b" can be about 0.475 inches. In embodiments, the area of the ventilation lumen 15" can be about 0.0685 square-inches and the area of the suction lumen 16" can be about 0.0204 square-inches.

[00071] FIG. 18 shows a cross-section view of a non-limiting embodiment of a main tube 14"' having a ventilation lumen 15"' and a suction lumen 16"', and which can be used with any of the embodiments disclosed herein in accordance with exemplary embodiments of the invention. In embodiments, the dimension "a" can be about 0.412 inches. In embodiments, the dimension "b" can be about 0.475 inches. In embodiments, the area of the ventilation lumen 15"' can be about 0.0639 square-inches and the area of the suction lumen 16"' can be about 0.0191 square-inches.

[00072] The main tube member may, in embodiments, be constructed from a suitable polymeric material, such as polyvinyl chloride, polyethylene or polypropylene, with PVC being advantageous. The components of the assembly disclosed herein can also be made from various well-known materials. The components the main tube can be molded or extruded according to well-known manufacturing techniques.

[00073] Materials commonly used to make the main tube member include, but are not limited to thermoplastic polymers and thermoplastic elastomers (TPE). In embodiments, materials which are environmentally green in nature and have no extractables can be utilized. Other materials include, but are not limited to natural rubber latexes (available, for example, from Guthrie, Inc., Tucson, Ariz.; Firestone, Inc., Akron, Ohio; and Centrotrade USA, Virginia Beach, Va.), silicones (available, for example, from GE Silicones, Waterford, N.Y., Wacker Silicones, Adrian, Mich.; and Dow Corning, Inc., Midland, Mich.), polyvinyl chlorides (available, for example, from Kaneka Corp., Inc., New York, N.Y.), polyurethanes (available, for example, from Bayer, Inc., Toronto, Ontario, Rohm & Haas Company, Philadelphia, Pa.; and Ortec, Inc., Greenville, S.C.), plastisols (available, for example, from G S Industries, Bassett, Va.), polyvinyl acetate, (available, for example from Acetex Corp., Vancouver, British Columbia) and methacrylate copolymers (available, for example, from Heveatex, Inc., Fall River, Mass.). Any combination of the foregoing materials may also be used in making ET tubes.

[00074] The invention also provides for a method for intubation using the assembly of

FIGS. 2-18, which includes inserting at least a distal portion of the endotracheal tube into a trachea, inflating the cuff, and supplying gas into a patient's lungs via the endotracheal tube. The method can further include suctioning matter through the one or more suction apertures located in a cuff recess and through a suction lumen.

[00075] The invention also provides for a method of making a device for intubation shown FIGS. 2-18, and specifically making the at least one suction aperture of the main tube be arranged in a cuff recess. The cuff recess can be formed in various non-limiting ways such as, e.g., by adhering (e.g., using heat and pressure) a portion of the circumference of the cuff to the outer surface of the main tube. The suction aperture can be formed in the recess by punching or cutting it through the adhered area of the cuff in the recess. Alternatively, a blow mold can be created and/or modified so that the blow mold prevents formation of any cuff wall over the suction aperture area while ensuring that edge areas of the cuff which define the recess are sealed and secured to the main tube.

[00076] The invention has been described and specific examples of the invention have been portrayed. While the invention has been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the invention is not limited to the variations of figures described. In addition, where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art will recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Therefore, to the extent there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is the intent that this patent will cover those variations as well. Finally, all publications and patent applications cited in this specification are herein incorporated by reference in their entirety as if each individual publication or patent application were specifically and individually put forth herein.

[00077] It is noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of the present invention. While the present invention has been described with reference to an exemplary embodiment, it is understood that the words which have been used herein are words of description and illustration, rather than words of limitation. Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present invention in its aspects. Although the present invention has been described herein with reference to particular means, materials and embodiments, the present invention is not intended to be limited to the particulars disclosed herein; rather, the present invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims.

Claims

CLAIMS What is claimed is:

1. An endotracheal tube, comprising:

a main tube including a proximal end and a distal end;

an inflatable cuff arranged on the main tube, the inflatable cuff including a main inflation area; and

at least one of:

at least one recess or indentation arranged in the main inflation area;

at least one recess or indentation extending into the main inflation area; at least one recess or indentation extending between an adhered area of the cuff and a location in the main inflation area;

at least one suction aperture arranged in the main inflation area;

at least one suction aperture arranged in a recess or indentation located in the main inflation area;

at least one suction lumen arranged in a recess or indentation extending into the main inflation area; and

at least one suction lumen extending into a recess or indentation located in the main inflation area.

2. The endotracheal tube of claim 1, wherein the inflatable cuff has a generally cylindrical cross-section shape.

3. The endotracheal tube of claim 1, wherein the main inflation area is generally cylindrical in shape.

4. The endotracheal tube of claim 1, wherein the main inflation area has an axial length that is between about 40% and about 90% of an overall axial length of the cuff.

5. The endotracheal tube of claim 1, wherein the main inflation area has an axial length that is between about 50% and about 80% of an overall axial length of the cuff.

6. The endotracheal tube of claim 1, wherein the main inflation area has an axial length that is between about 60% and about 75% of an overall axial length of the cuff.

7. The endotracheal tube of claim 1, wherein the cuff comprises one of at least one recess or indentation arranged in the main inflation area and at least one recess or indentation extending into the main inflation area, and wherein the at least one recess or indentation extends radially.

8. The endotracheal tube of claim 1, wherein the cuff comprises at least one recess or indentation extending into the main inflation area, and wherein the at least one recess or indentation extends radially and has a width that is narrower than an axial length of the at least one recess or indentation.

9. The endotracheal tube of claim 1, wherein the cuff comprises at least one recess or indentation extending into the main inflation area, and wherein the at least one recess or indentation is open in an area of the proximal end of the cuff and opens out to an outer circumference of the cuff.

10. The endotracheal tube of claim 1, wherein the cuff comprises at least one recess or indentation extending into the main inflation area, and wherein the at least one recess or indentation is generally triangular or pie- wedge shaped.

11. The endotracheal tube of claim 1, wherein the cuff comprises at least one suction aperture arranged in a recess or indentation extending into the main inflation area and wherein the at least one suction aperture has a center axis that intersects a circumference of the main inflation area.

12. The endotracheal tube of claim 1, wherein the cuff comprises at least one suction aperture arranged in a recess or indentation extending into the main inflation area and wherein the at least one suction aperture has a center axis that intersects a center axis of the main tube.

13. The endotracheal tube of claim 1, wherein the inflatable cuff is arranged on the main tube and spaced from the distal end by an amount that is less than a spacing from the proximal end.

14. The endotracheal tube of claim 1, wherein the main tube comprises at least one integrally formed suction lumen which extends to at least one suction aperture.

15. The endotracheal tube of claim 1, wherein the main tube comprises at least one integrally formed inflation lumen which extends to at least one aperture for inflating the cuff.

16. The endotracheal tube of claim 1, wherein the main tube comprises at least one radiopaque strip or stripe arranged in a wall of the main tube.

17. The endotracheal tube of claim 1, wherein the main tube comprises at least one suction lumen that is arranged on a bending plane of the main tube.

18. The endotracheal tube of claim 1, wherein the main tube comprises at least one suction lumen that is angularly offset from a bending plane of the main tube.

19. The endotracheal tube of claim 1, wherein the main tube comprises at least one non-circular suction lumen that is arranged on a bending plane of the main tube.

20. The endotracheal tube of claim 1, wherein the main tube comprises at least one non-circular suction lumen that is angularly offset from a bending plane of the main tube.

21. The endotracheal tube of claim 1, wherein the main tube comprises a generally circular cross-section shape.

22. The endotracheal tube of claim 1, wherein the main tube comprises a generally oval cross-section shape.

23. The endotracheal tube of claim 1, wherein the cuff comprises at least one suction aperture arranged in a recess or indentation extending into the main inflation area and wherein the at least one suction aperture comprises two angularly offset suction apertures.

24. The endotracheal tube of claim 23, wherein the main tube comprises at least one suction lumen coupled to at least one of the two angularly offset suction apertures.

25. The endotracheal tube of claim 23, wherein the main tube comprises at least one integrally formed suction lumen coupled to each of the two angularly offset suction apertures.

26. The endotracheal tube of claim 23, wherein the main tube comprises two suction lumens each coupled to one of the two angularly offset suction apertures.

27. The endotracheal tube of claim 23, wherein each of the two suction apertures forms an angle of between about 20 degrees and about 70 degrees relative to a bending plane of the main tube.

28. The endotracheal tube of claim 1, further comprising at least one inflation lumen generally oriented on a bending plane of the main tube.

29. An endotracheal tube, comprising:

a main tube including a proximal end and a distal end;

an inflatable cuff arranged on the main tube, the inflatable cuff including a main inflation area, at least one recess or indentation extending into the main inflation area, and at least one suction aperture arranged in the recess or indentation.

30. The endotracheal tube of claim 29, wherein the inflatable cuff has a generally cylindrical cross-section shape.

31. The endotracheal tube of claim 29, wherein the main inflation area is generally cylindrical in shape.

32. The endotracheal tube of claim 29, wherein the main inflation area has an axial length that is between about 40% and about 90% of an overall axial length of the cuff.

33. The endotracheal tube of claim 29, wherein the main inflation area has an axial length that is between about 50% and about 80% of an overall axial length of the cuff.

34. The endotracheal tube of claim 29, wherein the main inflation area has an axial length that is between about 60% and about 75% of an overall axial length of the cuff.

35. The endotracheal tube of claim 29, wherein the at least one recess or indentation extends radially.

36. The endotracheal tube of claim 29, wherein the at least one recess or indentation extends radially and has a width that is narrower than an axial length of the at least one recess or indentation.

37. The endotracheal tube of claim 29, wherein the at least one recess or indentation is open in an area of the proximal end of the cuff and opens out to an outer circumference of the cuff.

38. The endotracheal tube of claim 29, wherein the at least one recess or indentation is generally triangular or pie- wedge shaped.

39. The endotracheal tube of claim 29, wherein the at least one suction aperture has a center axis that intersects a circumference of the main inflation area.

40. The endotracheal tube of claim 29, wherein the at least one suction aperture has a center axis that intersects a center axis of the main tube.

41. The endotracheal tube of claim 29, wherein the inflatable cuff is arranged on the main tube and spaced from the distal end by an amount that is less than a spacing from the proximal end.

42. The endotracheal tube of claim 29, wherein the main tube comprises at least one integrally formed suction lumen which extends to at least one suction aperture.

43. The endotracheal tube of claim 29, wherein the main tube comprises at least one integrally formed inflation lumen which extends to at least one aperture for inflating the cuff.

44. The endotracheal tube of claim 29, wherein the main tube comprises at least one radiopaque strip or stripe arranged in a wall of the main tube.

45. A method for intubation using the endotracheal tube of any one of claims 1- 44, the method comprising:

inserting at least a portion of an endotracheal tube into a trachea; inflating a cuff of the endotracheal tube; and

supplying gas into a patient's lungs via the endotracheal tube.

46. The method of claim 45, further comprising suctioning matter through the at least one suction aperture.

47. A method of making the endotracheal tube of any one of claims 1-44, the method comprising:

forming at least one recess or indentation in the cuff such that at least one of: the at least one recess or indentation is arranged in the main inflation area; the at least one recess or indentation extends into the main inflation area; the at least one recess or indentation extends between an adhered area of the cuff and a location in the main inflation area;

at least one suction aperture is arranged in the at least one recess or indentation located;

at least one suction lumen is arranged in the at least one recess or indentation; and

at least one suction lumen extending into the at least one recess or indentation.

48. An endotracheal tube, comprising:

a main tube including a proximal end and a distal end;

an inflatable cuff arranged on the main tube, the inflatable cuff including a main inflation area, at least one recess or indentation extending into the main inflation area, and at least one suction aperture arranged in the recess or indentation, wherein the at least one recess or indentation is at least one of:

generally triangular;

generally pie- shaped; and

opens out in both an axial direction towards one end of the cuff and a radial direction towards a circumference of the main inflation area.

49. The endotracheal tube of claim 48, wherein the at least one suction aperture has a center axis that intersects a circumference of the main inflation area.

50. The endotracheal tube of claim 48, wherein the at least one suction aperture has a center axis that intersects a center axis of the main tube.

51. The endotracheal tube of claim 48, wherein the at least one suction aperture is arranged on at least one suction lumen which extends axially into the recess or indentation.