Endotracheal tube

Abstract

To provide a resistant endotracheal tube.SOLUTION: A tube for delivering fluid comprises a tube extending between a first opening and a second opening, an expandable cuff formed on a distal end of the tube, a resistant member formed around a portion of the tube, and a sleeve formed around the resistant member. The sleeve presents a substantially smooth outer surface.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This disclosure claims the benefit of U.S. Provisional Application No. 62 / 850,784, filed May 21, 2019, the contents of which are incorporated herein in their entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to endotracheal tubes, and more particularly to endotracheal tubes having a resistant layer. [Background technology]

[0003] Often during medical procedures such as surgery, physicians desire to control the flow of fluids into and out of a patient. In one such example, an endotracheal tube is used to control the flow of fluids into the patient's lungs. During part of the insertion process, the endotracheal tube passes through the patient's mouth, past the vocal cords, and partially into the trachea. The endotracheal tube often includes an inflatable cuff at its distal end that is selectively inflatable to provide a fluid seal between the distal end of the endotracheal tube and the tracheal wall. The inflated cuff fluidly seals the endotracheal tube against the tracheal wall, such that the endotracheal tube provides a fluid channel that allows the physician to control the amount and type of fluid that flows into and out of the patient's lungs.

[0004] Fluids introduced through the endotracheal tube are often gaseous and contain oxygen to ensure adequate oxygenation to the patient's lungs during the procedure. Furthermore, many procedures involve manipulation on the soft tissues around the trachea or other parts of the patient's anatomy proximate to the endotracheal tube. In these procedures, the physician must take special care not to damage the endotracheal tube with the cutting device. Furthermore, many procedures involve the use of a surgical laser or other exothermic device as the cutting device.

[0005] Some endotracheal tubes are formed with a fire-resistant material surrounding the outside of the endotracheal tube. While this helps to prevent damage to the endotracheal tube from exothermic cutting devices, it also causes the exterior surface to be abrasive to the patient's soft tissue. More specifically, the endotracheal tube passes through, among other things, the vocal cords as it is placed in and removed from the patient's trachea. Thus, the abrasive exterior of conventional fire-resistant endotracheal tubes often excessively damages the patient's soft tissue during insertion and removal. Summary of the Invention

[0006] One embodiment is a tube for delivering a fluid comprising a tubing extending between a first opening and a second opening, an expandable cuff formed at a distal end of the tubing, a resistance member formed around a portion of the tubing, and a sleeve formed around the resistance member, where the sleeve presents a substantially smooth outer surface.

[0007] An example of this embodiment includes a second expandable cuff formed at a distal end of the tubular section. Additionally, this example includes a first inflation lumen formed partially within the wall of the tubular section and fluidly connectable to the expandable cuff. This example may include a second inflation lumen formed partially within the wall of the tubular section and fluidly connectable to the second expandable cuff. In one aspect of this example, the first and second inflation lumens are not fluidly connected to each other within the wall of the tubular section.

[0008] In yet another example, the resistance member is formed from a material that is resistant to penetration by a laser. In one aspect of this example, the resistance member is formed from an aluminum material. In yet another example, the resistance member is wrapped around at least a portion of the tubing. In one aspect of this example, a sleeve is disposed radially outward of the resistance member and extends at least the length of the resistance member.

[0009] In another example of this embodiment, an adhesive is applied to the proximal and distal ends of the resistant member and the sleeve to bond the resistant member and the sleeve to the tube. In one example, the sleeve is formed of silicone.

[0010] Another embodiment is an endotracheal tube assembly comprising an airway tube defining a tube wall forming a fluid channel from a first opening to a second opening, a resistance member formed around a portion of the airway tube, a sleeve formed around the resistance member, and a first cuff formed along the airway tube proximate the second opening, where the resistance member is formed around the airway tube and the sleeve is formed from a single material having a substantially smooth outer surface.

[0011] An example of this embodiment has a second cuff formed along the airway adjacent to the first cuff. One aspect of this example includes a first inflation lumen fluid channel defined within at least a portion of the vessel wall and fluidly coupled to the first cuff, and a second inflation lumen fluid channel defined within at least a portion of the vessel wall and fluidly coupled to the second cuff. In one aspect of this example, the first cuff and the second cuff are inflatable independently of one another. In yet another aspect, the resistance member is disposed radially inward of at least a portion of the first cuff.

[0012] In another example of this embodiment, the resistant material is wrapped around the airway tube and the sleeve radially compresses the resistant material towards the airway tube. In another aspect of this example, the resistant material and sleeve are adhesively bonded to the airway tube at the proximal and distal ends.

[0013] Another embodiment includes a method of manufacturing an endotracheal tube, the method including forming an airway tube having at least two inflation lumen passages defined within a wall of the airway tube, wrapping a resistance member around an outer portion of the airway tube, expanding and positioning a sleeve around the resistance member, contracting the sleeve to compress the resistance member against the airway tube, coupling proximal and distal cuffs to the airway tube, and fluidly coupling the other of the two inflation lumen passages to each of the proximal and distal cuffs.

[0014] One example of this embodiment involves applying an adhesive to the proximal and distal ends of both the sleeve and the resistant member and adhesively bonding the sleeve and resistant member to the airway tube.

[0015] The above aspects of the present disclosure and the manner of obtaining them will become more apparent, and the disclosure itself will be better understood, with reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings, in which:

[0016] Corresponding reference numerals are used throughout the several drawings to indicate corresponding parts. [Brief description of the drawings]

[0017] [Figure 1] FIG. 1 is an upright perspective view of an endotracheal tube assembly. [Diagram 2] FIG. 2 is a side view of the endotracheal tube assembly of FIG. 1 with the two cuffs inflated. [Diagram 3] 3 is a cross-sectional view of the endotracheal tube assembly of FIG. 2. [Figure 4a] FIG. 4a is a partial side view of the endotracheal tube assembly of FIG. 1 with the distal cuff inflated. [Figure 4b] FIG. 4b is a partial side view of the endotracheal tube assembly of FIG. 2 with the proximal cuff inflated. [Diagram 5] FIG. 5 is a method of manufacturing the endotracheal tube assembly of FIG. [Figure 6a] FIG. 6a is another embodiment of an endotracheal tube assembly. [Figure 6b] FIG. 6b is a partial side view of the endotracheal tube assembly of FIG. 6a with the distal cuff inflated. [Figure 6c] FIG. 6c is a partial side view of the endotracheal tube assembly of FIG. 6a with the proximal cuff inflated. [Figure 7] FIG. 7 is another side view of the endotracheal tube assembly of FIG. 6a in a straight orientation. [Figure 8] FIG. 8 is a partial cross-sectional view of one cuff of the endotracheal tube assembly of FIG. 6a. [Figure 9] FIG. 9 is a method of fluidly coupling a cuff to a lumen for the endotracheal tube assembly of FIG. 6a. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] For the purposes of promoting an understanding of the principles of the disclosure, reference will be made to the embodiments described herein and illustrated in the drawings, and specific language will be used to describe the same, it being understood, however, that no limitation on the scope of the disclosure is intended, and that such alterations and further modifications in the illustrated devices and methods, and further applications of the principles of the disclosure as set forth herein, as would normally occur to one skilled in the art to which the disclosure pertains, are contemplated.

[0019] 1-3, an endotracheal tube assembly 100 is shown detached from a ventilator or any other medical device. The endotracheal tube assembly 100 may be formed from an airway tube 106 having a first opening 102 at a proximal end and a second opening 108 at a distal end. The first opening 102 may have a coupler 104 coupled thereto. The coupler 104 may provide a location for fluidly coupling the first opening 102 to a ventilator or other medical device that selectively provides fluid for flow through the airway tube 106 and out the second opening 108. In one aspect of the present disclosure, the airway tube 106 provides a fluidically sealed channel 306 (see FIG. 3) between the first opening 102 and the second opening 108.

[0020] The airway tube 106 may be formed of silicone or any other material capable of providing a sterile, fluidly sealed interior channel 306. In one aspect of the disclosure, the airway tube 106 may be a substantially tubular structure having an airway wall 302 (see FIG. 3). The airway wall 302 may be of sufficient thickness to define first and second inflation lumen passages or lumens 304 (see FIG. 3) therein. The inflation lumen passages 304 may provide fluidly isolated passages from the corresponding first and second pilot balloons 114, 116 to the proximal cuff 118 and distal cuff 120. In one aspect of the disclosure, the first inflation pilot balloon 114 is fluidly coupled to one of the proximal cuff 118 or distal cuff 120 via one of the inflation lumen passages 304, thereby allowing that cuff to be selectively inflated (see FIGS. 4a and 4b). Similarly, the second pilot balloon 116 is fluidly coupled to the other of the proximal cuff 118 or the distal cuff 120 via the other inflation lumen passage 304, thereby allowing the other cuff to be selectively inflated.

[0021] The airway tube 106 may also have a resistance member 110 coupled to a radially outer surface of the airway tube 106. The resistance member 110 may be any material that is resistant to penetration by a surgical laser or other surgical instrument that may damage the airway tube 106. The resistance member 110 may extend a length of the airway tube 106 corresponding to the portion of the airway tube 106 that is intended to be placed within a patient during use. However, in one embodiment, the resistance member 110 may extend substantially the entire length of the airway tube 106 excluding its exposed portion 112. The exposed portion 112 may be a portion of the airway tube 106 located adjacent the coupler 104. In one example, the resistance member 110 extends from a radially inner portion of the distal cuff 120, through the proximal cuff 118, and along the airway tube 106 to the exposed portion 112. In other embodiments, the resistance member 110 extends between the proximal cuff 118 and the exposed portion 112.

[0022] In one aspect of the present disclosure, the resistant member 110 may be formed from a material that is resistant to penetration by a KTP laser. More specifically, a KTP laser with a 400 millimeter lens microbeam connected to a microscope may be positioned 35 centimeters away from the endotracheal tube assembly 100 and deliver a 380 micron focused spot. The KTP laser may have an angle of incidence of about 90 degrees to the resistant layer. In this scenario, the laser resistant material may be any material that can withstand a continuous beam from a laser continuously delivering a maximum power of about 15 watts for at least three minutes. More specifically, oxygen gas is pumped through the endotracheal tube assembly 100 around which the refractory member 110 is positioned, but the refractory member 110 may prevent combustion of the oxygen in the above conditions.

[0023] Alternatively or additionally, the fire-resistant member 100 may be any material capable of withstanding penetration by a CO2 laser. For example, the endotracheal tube assembly 100 may be positioned approximately 35.5 centimeters from a CO2 laser capable of delivering a fixed spot of approximately 0.38 millimeters. The CO2 laser may generate a continuous beam of CO2 laser for at least three minutes, delivering a maximum power of at least approximately 40-45 watts. In another example, the CO2 laser may deliver a maximum power of approximately 60 watts. The CO2 laser may perform multiple shots at different angles on the endotracheal tube assembly 100. In this scenario, the laser-resistant material may be any material capable of preventing combustion as oxygen gas is pumped through the endotracheal tube assembly 100 with the resistant layer exposed to the CO2 laser.

[0024] The above examples of laser-resistant materials are not exhaustive, and the resistant member 110 may be formed from any material capable of protecting the fluid flowing through the airway tube 106 from being affected by external ignition. Thus, any known resistant material may be used for the resistant member 110.

[0025] In one aspect of the present disclosure, the resistance member 110 is wrapped around the airway tube 106 in a helical pattern. In this configuration, adjacent portions of the resistance member 110 overlap one another along the airway tube 106, ensuring that the resistance member 110, when wrapped around the airway tube 106, completely covers the outer surface of the airway tube 106. In other words, the resistance member 110 is wrapped around the airway tube 106 to ensure that there are no uncovered portions of the airway tube 106 due to gaps in the wrapping pattern or gaps caused by folding the airway tube 106.

[0026] Although application of the resistance member 110 by wrapping has been described herein, other methods of application are contemplated. More specifically, instead of a helix, the resistance member 110 may be formed in a sheet that is wrapped around the airway tube 106 in one go. In this embodiment, the resistance member 110 may be formed from a substantially rectangular sheet having a desired length of the resistance member 110, which may then be wrapped slightly more than 360 degrees around the airway tube 106 to substantially cover the outer surface. Thus, any known method of application of the resistance member 110 is contemplated herein.

[0027] Regardless of the wrapping pattern or method, the resistance member 110 may have an outer surface that is abrasive to soft tissue. Thus, in one aspect of the present disclosure, a sleeve 122 may be placed around the radially outer portion of the resistance member 110. The sleeve 122 may be formed of a substantially continuous material having a smooth outer surface. In a non-exclusive example, the sleeve 122 is a tube having an inner diameter slightly smaller than the outer diameter of the resistance member 110 when placed around the airway tube 106. In this configuration, the sleeve 122 may be stretched or otherwise expanded to be placed around the outer surface of the resistance member 110. Once placed therearound, the sleeve 122 returns to its unstretched size, thereby providing radial compression to the resistance member 110 that compresses the underlying resistance member 110 towards the airway tube 106.

[0028] In other aspects of the disclosure, the sleeve 122 and resistant member 110 are adhesively bonded to the airway tube below them. In this aspect of the disclosure, the resistant member 110 and sleeve 122 may be disposed about the airway tube 106 as described herein. However, in addition to the sleeve 122 compressively loading the resistant member 110 to bond the resistant member 110 and sleeve 122 to the airway tube 106, an adhesive may be applied to the proximal and distal ends of the resistant member 110 and sleeve 122 to further bond them to the airway tube 106 with the adhesive. In a non-exclusive example, the adhesive may be a Room-Temperature-Vulcanizing ("RTV") silicone. However, any known adhesive is contemplated herein.

[0029] The sleeve 122 can have a wall thickness of any suitable magnitude. More specifically, the wall thickness can be thin enough to allow the sleeve to be stretched over the resistance member 110, while being thick enough to ensure that the sleeve does not tear during manufacture of the endotracheal tube assembly 100. In a non-exclusive example, the sleeve can be formed from silicone and have a wall thickness of about 8 / 1000ths of an inch to 10 / 1000ths of an inch. However, in other embodiments, the sleeve 122 can be formed from materials other than silicone. Additionally, the sleeve 122 can have a wall thickness less than 8 / 1000ths of an inch or more than 10 / 1000ths of an inch. Thus, the present disclosure contemplates many different sizes and materials for the sleeve 122.

[0030] 4a and 4b, two different configurations of cuffs 118, 120 are shown. In FIG. 4a, the proximal cuff 118 is shown in a non-inflated state and the distal cuff 120 is shown in an inflated state. Inflation of the proximal cuff 118 and the distal cuff 120 may be varied by selectively supplying fluid to the corresponding cuff via one of the first or second pilot balloons 114, 116. In the example shown in FIG. 4a, the first pilot balloon 114 may be supplied with compressed fluid that is delivered to the interior chamber of the distal cuff 120 via one of the inflation lumen passages 304 in the wall of the airway tube 106. Similarly, in FIG. 4b, the second pilot balloon 116 may be supplied with compressed fluid that is delivered to the interior chamber of the proximal cuff 118 via the other of the inflation lumen passages 304 in the wall of the airway tube 106. Further, both the proximal cuff 118 and the distal cuff 120 may be deflated, as shown in FIG. 1, or inflated, as shown in FIG. 2, depending on the amount, volume, and pressure of fluid supplied to the internal chambers of the corresponding cuffs 118, 120, as described herein.

[0031] 5, a non-exclusive example of a manufacturing method 500 is shown. First, at box 502, the airway tube 106 may be formed using known extrusion techniques. As part of the process of forming the airway tube 106, an expansion lumen passage 304 may also be formed in the wall of the airway tube 106. Next, at box 504, the airway tube 106 may be cut to a desired length depending on the desired application. At box 506, the airway tube 106 may be formed into an arc shape by applying heat treatment using an arc shaped mandrel. At box 508, a resistant member 110 may be formed around the airway tube 106 utilizing any of the techniques described herein, among others. Next, at box 510, a sleeve 122 may be stretched and pulled over the resistant member 110 and the airway tube 106. At box 512, adhesive may be applied to the sleeve 122, the resistant member 110, and both the proximal and distal ends of the airway tube 106.

[0032] At box 514, an inflation lumen passage 304 may be milled at the proximal end of the airway tube 106. Next, at box 516, the first and second pilot balloons 114, 116 may be bonded to the locations where the corresponding inflation lumen passages 304 have been milled. An adhesive or the like may be utilized to ensure fluid coupling of the first and second pilot balloons 114, 116 to the inflation lumen passages 304. At box 518, holes may be formed through a portion of the airway tube 106 to fluidly couple the inner portion of each cuff 118, 120 to the corresponding inflation lumen passage 304. The holes may be fluid ports within the cuffs 118, 120 that fluidly couple the corresponding inflation lumen passages 304 to the outer surface of the airway tube 106. Thus, at box 520, the proximal and distal cuffs 118, 120 may be positioned around the corresponding fluid ports and bonded to the airway tube 106. An adhesive may be used to fluidly couple the corresponding cuffs 118, 120 to the airway tube 106 and to further fluidly couple the corresponding cuffs 118, 120 to the corresponding first and second pilot balloons 114, 116.

[0033] At box 522, any inflation lumens may be backfilled, and at box 524, a Murphy eye may be formed at the distal end of the airway tube 106. Next, at box 526, inflation valves may be inserted into the pilot balloons 114, 116. Finally, at box 528, the endotracheal tube assembly 100 is leak tested.

[0034] 6a, another embodiment of an endotracheal tube assembly 600 is shown. In this embodiment, the resistant member 110 may extend from the beginning 604 of the endotracheal tube 106 to the end 602 of the endotracheal tube 106. In one aspect of the disclosure, the end 602 may be distal to the distal cuff 120. In other words, the resistant material 110 may extend under both cuffs 118, 120 toward the second opening 108. In this embodiment, the resistant material 110 may extend a resistance length 702 that is substantially the entire length of the airway tube 106 excluding the exposed portion 112. In this configuration, the portion of the airway tube 106 that is intended to be placed within the patient is surrounded by the resistant material 110 all the way up to the distal cuff 120.

[0035] In one aspect of the disclosure, the resistant material 110 is disposed radially between the cuffs 118, 120 and the inflation lumen 304. Thus, to fluidly couple the interior of the cuffs 118, 120 to the corresponding inflation lumen 304, a fluid passageway must be formed through the sleeve 122, the resistant material 110, and a portion of the airway wall 302. One aspect of the disclosure is a method for forming this fluid connection while ensuring a fluid-tight passage from the inflation lumen 304 through the airway wall 302, the resistant material 110, and the sleeve 122.

[0036] 8 and 9, a non-exclusive method of coupling the cuffs 118, 120 to the corresponding inflation lumens 304 is described. At box 902, the airway tube 106 may be wrapped with a resistant material 110 as described herein. At box 902, the resistant material 110 is placed and wrapped axially along the airway tube 106 such that it passes through the proximal cuff 118 and at least partially into the distal cuff 120. In one aspect of the present disclosure, the resistant material 110 is wrapped and extends axially along the airway tube 106 such that it passes axially through both the proximal cuff 118 and the distal cuff 120. Then, at box 904, a sleeve 122 is placed over the resistant material 110 and coupled to the airway tube 106 and the resistant material 110 as described herein.

[0037] At box 906, a cutter having a first diameter 802 is used to cut a first hole 806 through the sleeve 122 and the resistant material 110 at a location radially outside of the corresponding inflation lumen 304. The first hole 806 may be located radially outside of the inflation lumen 304 relative to an airway axis 804 defined as passing longitudinally through the center of the airway tube 106. In one aspect of the disclosure, the cutter is not advanced substantially radially into the airway wall 302 of the airway tube 106, but rather advanced sufficiently to cut a hole through the sleeve 122 and the resistant material 110. The cutter for the first hole 806 may slightly contact a portion of the airway tube 106 as it cuts the first hole 806, but does not advance into the inflation lumen 304. In other words, the cutter advances radially inward sufficiently to cut the first hole 806 into the sleeve 122 and the resistant material 110. All of the sleeve 122 and a portion of the resistant material 110 are removed from the first hole 806 exposing the radially outer surface of the airway tube 106 .

[0038] Next, at box 908, a second hole 808 may be cut partially through the airway tube 106 and into the inflation lumen 304 therebelow. The second hole 808 may be disposed substantially coaxially with the first hole 806. In a non-exclusive embodiment, the second hole 808 may have a second diameter 810 that is slightly smaller than the first diameter 802. The second hole 808 is simply defined through a portion of the airway wall 302 of the airway tube 106 to provide a vent (second hole 808) for the inflation lumen 304 therebelow radially outward from the airway tube 106. Eventually, one of the cuffs 118, 120 is positioned along the vent to fluidly couple the inflation lumen 304 to the interior chamber of that cuff 118, 120, as described herein.

[0039] In box 910, a stopper plug 822 can be positioned through the second hole 808 to substantially block the second hole 808. The stopper plug 822 can have a diameter the same as or slightly larger than the second diameter 810 to substantially block the second hole 808 when positioned therein. Additionally, the stopper plug 822 can extend radially away from the sleeve 122 that defines an annular channel 820 around the stopper plug 822. The annular channel 820 is defined by the stopper plug 822, the outer surface of the airway tube 106 between the first and second holes, the resistance member 110 along the periphery of the first hole 806, and the sleeve 122 along the periphery of the first hole 806. In box 910, with the stopper plug 822 positioned through the second hole 808, adhesive can be applied within the annular channel 820. By disposing adhesive within the annular channel 820, the adhesive can substantially fill any gaps between the sleeve 122, the resistant member 110, and the airway tube 106, ensuring that fluid cannot pass through the first hole 806 and into the space between the sleeve 122 and the outer surface of the airway tube 106. In other words, applying adhesive to the annular channel 820 prevents fluid from seeping into the layer of resistant material 110 when the corresponding cuff 118, 120 is inflated.

[0040] The adhesive may be any known adhesive, and in a non-exclusive embodiment is RTV silicone. Additionally, the plug may be formed from a material that is not easily adhered to by the adhesive. In a non-exclusive example, the plug is formed from a Teflon material. However, any known adhesive and plug material may be used, and all known adhesive and plug materials are contemplated in this disclosure.

[0041] Now, referring to box 912, after the adhesive has at least partially cured, the stopper plug 822 may be removed from the second hole 808. As described herein, the stopper plug 822 may be formed from a material that is not substantially susceptible to adhesion by the adhesive. Thus, the plug may be removed from the second hole 808 after the adhesive has at least partially cured. Additionally, because the adhesive has at least partially cured, the second hole 808 may remain compartmentalized to partially extend through the airway tube 106 to fluidly couple the inflation lumen 304 to the outer portion of the sleeve 122.

[0042] Next, at box 914, a corresponding cuff 118, 120 is positioned about the sleeve 122 in axial alignment with the second hole 808. More specifically, the cuff 118, 120 is aligned with the second hole 808 such that the second hole 808 fluidly couples the corresponding inflation lumen 304 to the void 818 of the cuff 118, 120. At box 916, each cuff 118, 120 may be adhesively bonded to the radially outer surface of the sleeve 122 at the proximal and distal ends 812, 814. The void 818 is formed between the inner surface of the cuff 118, 120 and the outer surface of the sleeve 122 between the proximal and distal ends 812, 814 of the cuff 118, 120. Additionally, a cap 816 may be formed with an adhesive on the distal end of the inflation lumen 304 to prevent fluid from exiting the distal end. This allows fluid delivered via inflation lumen 304 to flow through second hole 808 and into void 818 to inflate cuffs 118, 120 at predetermined pressure and volume conditions.

[0043] Finally, at box 918, a leak test may be performed to ensure fluid coupling of the inflation lumen 304 to the cuffs 118, 120. More specifically, fluid may be supplied to the inflation lumen 304 at a fluid pressure that has been proven to fill the void 818. Fluid may be supplied at the test pressure and monitored for a period of time to ensure that the test pressure does not drop. A drop in the test pressure may indicate a leak between the inflation lumen 304 and the cuffs 118, 120. As described herein, one aspect of the leak test may be to ensure that fluid does not pass around the first hole 806 and enter the space between the sleeve 122 and the airway tube 106. In other words, one aspect of the leak test is to ensure proper sealing of the sleeve 122, the resistant member 110, and the airway tube 106 around the perimeter of the first hole 806 by the adhesive applied to the annular channel 820.

[0044] While Figures 8 and 9 illustrate and describe a method for fluidly coupling one cuff to an inflation lumen, the present disclosure contemplates fluidly coupling two or more cuffs to an inflation lumen utilizing substantially the same methods described herein. More specifically, as shown in Figure 3, two inflation lumens 304 may be defined in the airway wall 302. In this embodiment, the methods described herein may be performed to couple the proximal cuff 118 to a first inflation lumen and then couple the distal cuff 120 to a second inflation lumen. In this configuration, first and second holes 806, 808 are positioned along a number of different locations on the airway tube 106 to fluidly couple the corresponding cuffs 118, 120 to one of the first and second inflation lumens. Thus, the teachings of the present disclosure are applicable to endotracheal tubes having any number of cuffs.

[0045] In use, the endotracheal tube assembly 100 described herein may be utilized in procedures that may expose the endotracheal tube assembly 100 to a surgical laser or the like. In these types of procedures, the endotracheal tube assembly 100 may be inserted partially into the patient's trachea beyond the vocal cords without abrasively contacting soft tissue. One or more cuffs may be inflated to fluidly seal the endotracheal tube assembly 100 against the tracheal wall. A physician may then perform the procedure utilizing a surgical laser or the like while fluid flows through the endotracheal tube assembly 100 and into the patient.

[0046] If a physician unintentionally contacts the endotracheal tube assembly 100 with a surgical laser, the resistance member 110 may substantially reflect or otherwise block the laser from entering the fluid passageway of the airway tube 106. Once the procedure is complete, the physician may deflate the cuff or cuffs to remove the endotracheal tube assembly 100 from the patient without contacting and rubbing against the trachea or vocal cords. More specifically, the sleeve 122 and cuffs 118, 120 cover substantially the entire outer surface of the resistance member 110 to ensure that the endotracheal tube assembly 100 can be smoothly inserted and removed from the patient.

[0047] As described herein, the resistance member 110 may extend axially along the airway 106, through the proximal cuff, and partially into or through the distal cuff. Extending the resistance member 110 along substantially the entire length of the airway 106 allows a physician to use a surgical laser or the like along portions of the patient adjacent the cuffs 118, 120. More specifically, even if a physician inadvertently redirects the surgical laser toward the cuffs 118, 120 and then toward the airway 106, the resistance member 110 may still substantially prevent the surgical laser from entering the airway 106.

[0048] While illustrative embodiments incorporating the principles of the present disclosure have been described herein, the present disclosure is not limited to such embodiments. Instead, this application is intended to cover various variations, uses, or adaptations of the present disclosure using its general principles. Moreover, this application is intended to cover departures from the present disclosure only within known or customary practice in the art to which the present disclosure pertains.

Claims

1. a tube portion extending between the first opening and the second opening; an expandable cuff formed on a distal end of the tube; a resistance member formed around a portion of the tubular portion; a sleeve formed around the resistance member; The sleeve presents a substantially smooth outer surface. A tube for delivering fluids.

2. The tube of claim 1 further comprising an expandable second cuff formed at the distal end of the tube section.

3. The tube of claim 2 , further comprising a first inflation lumen formed within a portion of a wall of the tube and fluidly connectable to the expandable cuff.

4. The tube of claim 3 , further comprising a second inflation lumen formed within a portion of the wall of the tubular portion and fluidly connectable to the second expandable cuff.

5. The tubing of claim 4 , further comprising: the first inflation lumen and the second inflation lumen not fluidly coupled to one another within a wall of the tube portion.

6. The tube of claim 1 , further comprising: the resistant member being formed from a material that is resistant to penetration by a laser.

7. The tube of claim 6 further comprising: said resistance member being formed from an aluminum material.

8. The tube of claim 6 , further comprising: the resistance member being wrapped around at least a portion of the tubular portion.

9. The tube of claim 8 , further comprising: the sleeve disposed radially outward of the resistance member and extending at least the length of the resistance member.

10. The tube of claim 1 , wherein an adhesive is applied to the proximal and distal ends of the resistance member and the sleeve to bond the resistance member and the sleeve to the tubing.

11. The tube of claim 1 further comprising: the sleeve being formed from silicone.

12. an airway tube defining a fluid channel from a first opening to a second opening and defining a tube wall; a resistance member formed around a portion of the airway tube; a sleeve formed around the resistance member; a first cuff formed along the airway tube proximate the second opening; The resistance member is formed around the airway tube, An endotracheal tube assembly wherein the sleeve is formed from a single piece of material having a substantially smooth outer surface.

13. 13. The endotracheal tube assembly of claim 12, further comprising a second cuff formed along the airway adjacent to the first cuff.

14. a first inflation lumen defined at least partially within the vessel wall and fluidly coupled to the first cuff; 14. The endotracheal tube assembly of claim 13, further comprising a second inflation lumen defined at least partially within said tube wall and fluidly coupled to said second cuff.

15. 15. The endotracheal tube assembly of claim 14, further comprising: said first cuff and said second cuff being inflatable independently of one another.

16. The endotracheal tube assembly of claim 12, further comprising: the resistance member disposed radially inward of at least a portion of the first cuff.

17. Further, the resistant material is wrapped around the airway tube; The endotracheal tube assembly of claim 12, wherein the sleeve radially compresses the resistant material towards the airway tube.

18. 18. The endotracheal tube assembly of claim 17, further comprising: said resistant material and said sleeve adhesively bonded to said airway tube at proximal and distal ends.

19. forming an airway tube having at least two inflation lumen passages defined within a wall of the airway tube; wrapping a resistant material around an exterior portion of the airway tube; Expanding and disposing a sleeve around the resistance member; contracting the sleeve to compress the resistance member against the airway; A method of manufacturing an endotracheal tube comprising coupling proximal and distal cuffs to said airway tube and fluidly coupling the other of said two inflation lumen passageways to each of said proximal and distal cuffs.

20. 20. The method of claim 19, further comprising applying an adhesive to the proximal and distal ends of both the sleeve and the resistant member and adhesively bonding the sleeve and the resistant member to the airway tube.

21. a tube portion extending between the first opening and the second opening; an expandable cuff formed on a distal end of the tube; a resistance member formed around a portion of the tubular portion; a sleeve formed around the resistance member; The resistance member is disposed at least partially between the expandable cuff and a tube for delivering a fluid.

22. an airway tube defining an inflation lumen within an airway wall; a resistance member disposed at least partially around a portion of the airway tube; a sleeve disposed at least partially around the resistance member; a cuff defining a space fluidly coupled to the inflation lumen; The inflation lumen is fluidly coupled to the gap through the resistance member.

23. providing an endotracheal tube having an inflation lumen therein, a resistant material disposed about at least a portion of said endotracheal tube, and a sleeve disposed about at least a portion of said resistant material; cutting a first hole through the sleeve and the resistance member adjacent to the inflation lumen; cutting a second hole inside the first hole so as to partially penetrate the endotracheal tube; inserting a stopper into the second hole and applying adhesive around the stopper along a periphery of the first hole; 23. A method of coupling a cuff to an inflation lumen for an endotracheal tube, comprising removing the stopper, coupling the cuff along the endotracheal tube, and fluidly coupling the cuff to the inflation lumen through the second hole.

Images