Patent Description:
The present disclosure relates to an endotracheal tube, and more specifically to an endotracheal tube that has a resistant layer.

Often during medical procedures such as surgeries and the like the physician desires to control the flow of fluids to and from the patient. In one such example, an endotracheal tube is utilized to control the flow of fluid to the patient's lungs. As part of the insertion process, the endotracheal tube is passed through the patient's mouth, past the vocal chords, and partially into the trachea. The endotracheal tube often has an inflatable cuff on a distal end that can be selectively inflated to provide a fluid seal between the distal end of the endotracheal tube and the surrounding walls of the trachea. The inflated cuff fluidly seals the endotracheal tube to the trachea walls to allow the endotracheal tube to provide a fluid channel with which the physician can control the volume and type of fluid entering and leaving the patient's lungs.

The fluid introduced through the endotracheal tube is often gaseous and includes oxygen to ensure the patients lungs are supplied sufficient oxygen during the procedure. Further, many procedures involve operating on soft tissue around the trachea or other portion of the patient's anatomy that is proximate to the endotracheal tube. In these procedures, the physician must take special care to ensure the endotracheal tube is not compromised with the cutting device. Further still, many procedures involve using a surgical laser or other heat-generating device as the cutting device.

Some endotracheal tubes are made of a fire-resistant material around the outside of the endotracheal tube. While this may aid in preventing the endotracheal tube from being compromised by the heat-generating cutting device, the exterior surface is abrasive to the patient's soft tissue. More specifically, as the endotracheal tube is positioned within, and removed from, the patient's trachea it will pass over the vocal chords among other things. Accordingly, the abrasive exterior of the conventional fire-resistance endotracheal tube often causes undue trauma to the soft tissue of the patient during insertion and extraction. <CIT> discloses a method for forming reinforced tubes. The method includes the steps of winding a reinforcing element onto the outer surface of a flexible tubular member, applying a first layer of flexible material to the tubular member substantially level with the outer surface of the reinforcing element, removing the reinforcement element from selected regions of the tubular member to form unreinforced regions intermediate reinforced regions along the tubular member, applying a second layer of a flexible material over the reinforced an unreinforced regions, and cutting the tubular member in the unreinforced regions to divide the tubular member into tubes having at least one unreinforced end. An inflatable cuff may be applied to each tube after cutting the tubular member into tubes. <CIT> describes a cuff assembly for catheter tubes of all types. The cuff includes an inner sleeve member or a plurality of seal rings or bands of high modulus and durometer silicone are provided on an outer, low modulus and durometer rubber bonded thereto. A polyvinylchloride tube may be bonded to the cuff assembly. <CIT> discloses tracheal tubes that include controlled-profile regions. The controlled-profile regions have a reduced profile, such as to reduce the profile of a balloon-cuff associated with the tracheal tube is minimized. The balloon-cuff may be affixed to or around the recessed region of the tracheal tube. <CIT> describes laser resistant endotracheal tubes with a concealed laser reflection material that can be exposed in response to a laser strike to the tube. A tube member is provided with a cuff for stabilizing the tube member in a trachea in a predetermined position. The tube member includes a flexible conduit portion wrapped in a sheath of laser reflective material. A smooth protective covering surrounds the laser reflective material to provide a smooth conformal exterior surface for the tube member. The protective covering is a non-metallic material that is capable of rupturing or breaking and shrinking when struck by a laser beam to expose the underlying reflective material. <CIT> describes a composite for protection of objects as well as patients and medical personnel during laser surgery. The composite may be applied to endotracheal tubes and comprises an adhesive backed foil, a layer of fire resistant fabric bonded to the foil on the side opposite the adhesive as well as a hydrogel acting as an insulative layer laminated to the fire retardant fabric. The composite may be made in a strip which is wound around a tube portion of an endotracheal tube for protecting the endotracheal tube from damage caused by an incident laser beam. The strip is thereby wound around the tube in spiral or barber pole fashion so as not to decrease the flexibility of the tube.

The present invention provides a method of coupling a cuff to an inflation lumen for an endotracheal tube as defined in claim <NUM>.

Reference will be made in the following description to various examples or embodiments of the present disclosure. Examples or embodiments disclosed herein which do not fall under the scope of the appended claims do not form part of the present invention, but are useful for understanding the principles of the invention.

One embodiment is a tube for delivering fluid that has 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. Wherein, the sleeve presents a substantially smooth outer surface.

One example of this embodiment has a second expandable cuff formed at the distal end of the tube. Further, this example has a first inflation lumen that is fluidly coupleable to the expandable cuff, the first inflation lumen being partially formed within a wall of the tube. This example may also have a second inflation lumen that is fluidly coupleable to the second expandable cuff, the second inflation lumen being partially formed within the wall of the tube. In one aspect of this example, the first inflation lumen and the second inflation lumen are not fluidly coupled to one another in the wall of the tube.

In yet another example, the resistant member is formed from a material that resists penetration by a laser. In one aspect of this example, the resistant member is formed of an aluminum material. In yet another example the resistant member is wrapped around at least a portion of the tube. In one aspect of this example, the sleeve is positioned radially outside of the resistant member and extends at least the length of the resistant member.

In another example of this embodiment, adhesive is applied to the proximal and distal end of the resistant member and the sleeve to couple the resistant member and the sleeve to the tube. In one example, the sleeve is formed of silicon.

Another embodiment is an endotracheal tube assembly that has an airway tube forming a fluid channel from a first opening to a second opening and defining a tube wall, a resistant member formed around a portion of the airway tube, a sleeve formed around the resistant member, and a first cuff formed along the airway tube proximate to the second opening. Wherein, the resistant member is formed around the airway tube and the sleeve is formed of a single material having a substantially smooth outer surface.

One 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 at least partially within the tube wall and fluidly coupled to the first cuff and a second inflation lumen fluid channel defined at least partially within the tube wall and fluidly coupled to the second cuff. In one aspect of this example, the first cuff and second cuff are inflatable independent of one another. In yet another aspect, the resistant member is positioned radially inside of at least a portion of the first cuff.

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 the sleeve are adhesively coupled to the airway tube at a proximal and a distal end.

Another embodiment includes a method for manufacturing an endotracheal tube that includes forming an airway tube with at least two inflation lumen passageways defined in a wall of the airway tube, winding a resistant member around an outer portion of the airway tube, expanding a sleeve and positioning the sleeve around the resistant member, allowing the sleeve to contract to thereby compress the resistant member against the airway tube, and coupling a proximal and distal cuff to the airway tube and fluidly coupling a different one of the two inflation lumen passageways to each of the proximal and distal cuffs.

One example of this embodiment includes applying adhesive to a proximal and distal end of both the sleeve and resistant member to thereby adhesively couple the sleeve and resistant member to the airway tube.

For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments described herein and illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the present disclosure is thereby intended, such alterations and further modifications in the illustrated devices and methods, and such further applications of the principles of the present disclosure as illustrated therein being contemplated as would normally occur to one skilled in the art to which the present disclosure relates.

Referring now to <FIG>, an endotracheal tube assembly <NUM> is illustrated isolated from a ventilator or any other medical device. The endotracheal tube assembly <NUM> may be formed from an airway tube <NUM> that has a first opening <NUM> on a proximal end and a second opening <NUM> on a distal end. The first opening <NUM> may have a coupler <NUM> coupled thereto. The coupler <NUM> may provide a location to fluidly couple the first opening <NUM> to a ventilator or other medical device to selectively provide fluid through the airway tube <NUM> and out the second opening <NUM>. In one aspect of this disclosure, the airway tube <NUM> provides a fluidly sealed channel <NUM> (see <FIG>) between the first opening <NUM> and the second opening <NUM>.

The airway tube <NUM> may be formed of silicon or any other material that can provide a sterile, fluidly sealed inner channel <NUM>. In one aspect of this disclosure, the airway tube <NUM> may be a substantially tubular structure that has an airway wall <NUM> (see <FIG>). The airway wall <NUM> may have a thickness that is sufficient to define a first and second inflation tube passageway or lumen <NUM> (see <FIG>) therein. The inflation lumen passageways <NUM> may provide a fluidly isolated passageway from a corresponding first and second pilot balloon <NUM>, <NUM> to a proximal and distal cuff <NUM>, <NUM>. In one aspect of this disclosure, the first inflation pilot balloon <NUM> can be fluidly coupled to one of the proximal or distal cuffs <NUM>, <NUM> through one of the inflation lumen passageways <NUM> to thereby allow the cuff to be selectively inflated (see <FIG>). Similarly, the second pilot balloon <NUM> can be fluidly coupled to the other of the proximal or distal cuffs <NUM>, <NUM> through the other of the inflation lumen passageway <NUM> to thereby allow the other cuff to be selectively inflated.

The airway tube <NUM> may also have a resistant member <NUM> coupled to a radially outer surface of the airway tube <NUM>. The resistant member <NUM> may be any material that resist penetration by a surgical laser or any other surgical instrument that may compromise the airway tube <NUM>. The resistant member <NUM> may extend a length of the airway tube <NUM> that corresponds with the portions of the airway tube <NUM> that are intended to be positioned within a patient during use. However, in one embodiment the resistant member <NUM> may extend substantially the entire length of the airway tube <NUM> less an exposed portion <NUM> thereof. The exposed portion <NUM> may be the portion of the airway tube <NUM> located adjacent to the coupler <NUM>. In one example, the resistant member <NUM> extends from a radially inner portion of the distal cuff <NUM>, past the proximal cuff <NUM>, and along the airway tube <NUM> to the exposed portion <NUM>. In yet another embodiment, the resistant member <NUM> extends between the proximal cuff <NUM> and the exposed portion <NUM>.

In one aspect of this disclosure, the resistant member <NUM> may be formed of a material that resists penetration from a KTP laser. More specifically, a KTP laser with <NUM> millimeter lens microbeam coupled to a microscope may be spaced <NUM> centimeters from the endotracheal tube assembly <NUM> and deliver a focused spot of <NUM> micron. The KTP laser may have an angle of incidence of about ninety degrees relative to the resistance layer. Under this scenario, a laser resistant material may be any material that can resist a continuous beam for at least three minutes with the laser delivering a maximum power of about fifteen watts, continuously. More specifically, oxygen gas can be pumped through the endotracheal tube assembly <NUM> with the fire resistant member <NUM> positioned there around and the fire resistant member <NUM> may prevent combustion of the oxygen in the above conditions.

Alternatively or additionally, the fire resistant member <NUM> may be any material capable of resisting penetration by a CO2 laser. For example, an endotracheal tube assembly <NUM> may positioned about <NUM> centimeters from the CO2 laser wherein the CO2 laser can deliver a constant spot of about. <NUM> millimeters. The CO2 laser may produce a continuous beam for at least three minutes with the CO2 laser delivering a maximum output of at least about forty to forty-five watts. In other examples, the CO2 laser may deliver a maximum output of about <NUM> watts. The CO2 laser may be applied multiple times at differing angles relative to the endotracheal tube assembly <NUM>. Under this scenario, a laser resistant material may be any material that can prevent combustion of oxygen gas as it is pumped through the endotracheal tube assembly <NUM> while the resistant later is being exposed to the CO2 laser.

The above examples of a laser resistant material are not exhaustive. The resistant member <NUM> may be formed of any material that can protect the fluid flowing within the airway tube <NUM> from being affected by an external ignition. Accordingly, any known resistant material may be used for the resistant member <NUM>.

In one aspect of this disclosure, the resistant member <NUM> is wrapped around the airway tube <NUM> in a helical pattern. In this configuration, adjacent portions of the resistant member <NUM> partially overlap one another along the airway tube <NUM> to ensure the resistant member <NUM> fully covers the outer surface of the airway tube <NUM> where wrapped there around. In other words, the resistant member <NUM> is wrapped around the airway tube <NUM> to ensure that there are no sections of airway tube <NUM> that are not covered due to gaps in the wrapping pattern or caused by bending the airway tube <NUM>.

While a wrapping application of the resistant member <NUM> is described herein, other applications are also considered. More specifically, the resistant member <NUM> may be formed in a sheet that is wrapped around the airway tube <NUM> a single time, instead of in a helical configuration. In this embodiment, the resistant member <NUM> may be formed from a substantially rectangular sheet that is the desired length of the resistant member <NUM>. The sheet may then be wrapped slightly greater than three-hundred and sixty degrees around the airway tube <NUM> to substantially cover the outer surface. Accordingly, any known method of applying a resistant member <NUM> is considered herein.

Regardless of the wrapping pattern or method, the resistant member <NUM> may have an outer surface that is abrasive to soft tissue. Accordingly, in one aspect of this disclosure a sleeve <NUM> may be positioned around the radially exterior portion of the resistant member <NUM>. The sleeve <NUM> may be formed from a substantially continuous material that has a smooth outer surface. In one non-exclusive example, the sleeve <NUM> is a tube having an inner diameter that is slightly less than the outer diameter of the resistant member <NUM> when positioned around the airway tube <NUM>. In this configuration, the sleeve <NUM> may be stretched or otherwise expanded to be positioned around the outer surface of the resistant member <NUM>. Once positioned there around, the sleeve <NUM> may return to the un-stretched size to thereby provide a radial compression to the underlying resistant member <NUM> compressing the resistant member <NUM> against the airway tube <NUM>.

In another aspect of this disclosure, the sleeve <NUM> and resistant member <NUM> may be coupled to the underlying airway tube with an adhesive. In this aspect of the disclosure, the resistant member <NUM> and sleeve <NUM> may be positioned around the airway tube <NUM> as discussed herein. However, in addition to the sleeve <NUM> applying a compressive load to the resistant member <NUM> to couple the resistant member <NUM> and the sleeve <NUM> to the airway tube <NUM>, an adhesive may be applied to the proximal and distal ends of the resistant member <NUM> and sleeve <NUM> to further couple them to the airway tube <NUM> with the adhesive. In one non-exclusive example, the adhesive may be a Room-Temperature-Vulcanizing ("RTV") silicone. However, any known adhesive is considered herein.

The sleeve <NUM> may have a wall thickness that is any suitable size. More specifically, the wall thickness may be thin enough to allow the sleeve to be stretched over the resistant member <NUM> but thick enough to ensure that the sleeve is not torn during manufacturing of the endotracheal tube assembly <NUM>. In one non-exclusive example, the sleeve may be formed of silicon and have a wall thickness of between about eight thousandths of an inch and ten thousandths of an inch. However, in other embodiments the sleeve <NUM> may be formed of a material other than silicon. Further still, the sleeve <NUM> may have a wall thickness less than eight thousandths of an inch or greater than ten thousandths of an inch. Accordingly, this disclosure considers many different sizes and materials for the sleeve <NUM>.

Referring now to <FIG>, two different configurations of the cuffs <NUM>, <NUM> are illustrated. In <FIG>, the proximal cuff <NUM> is illustrated deflated while the distal cuff <NUM> is illustrated inflated. The inflation of the proximal and distal cuffs <NUM>, <NUM> may be altered by selectively providing fluid to the corresponding cuffs <NUM>, <NUM> through one of the first or second pilot balloon <NUM>, <NUM>. In the example illustrated in <FIG>, the first pilot balloon <NUM> may be provided pressurized fluid that travels through one of the inflation lumen passageways <NUM> in the wall of the airway tube <NUM> and to an inner chamber of the distal cuff <NUM>. Similarly, in <FIG>, the second pilot balloon <NUM> may be provided pressurized fluid that travels through the other of the inflation lumen passageways <NUM> in the wall of the airway tube <NUM> and to an inner chamber of the proximal cuff <NUM>. Further, both the proximal and distal cuffs <NUM>, <NUM> may be deflated as in <FIG>, or inflated as in <FIG>, depending on the amount of fluid volume and pressure provided to the inner chambers of the corresponding cuffs <NUM>, <NUM> as discussed herein.

Referring now to <FIG>, one non-exclusive example of a manufacturing method <NUM> is illustrated. Initially in box <NUM>, the airway tube <NUM> may be formed utilizing known extrusion techniques. As part of forming the airway tube <NUM>, the inflation lumen passageways <NUM> may also be formed in the wall of the airway tube <NUM>. Next, in box <NUM>, the airway tube <NUM> may be cut to any desired length depending on the desired application. In box <NUM>, the airway tube <NUM> may be formed into an arc by utilizing an arc-shaped mandrel and applying a heat process thereto. In box <NUM>, the resistant member <NUM> may be formed around the airway tube <NUM> utilizing any of the techniques described herein among others. Next, the sleeve <NUM> may be expanded and pulled over the resistant member <NUM> and the airway tube <NUM> in box <NUM>. In box <NUM>, an adhesive may be applied to the sleeve <NUM>, the resistant member <NUM>, and the airway tube <NUM> at both a proximal and distal end thereof.

In box <NUM>, the inflation lumen passageways <NUM> may be skived at a proximal end of the airway tube <NUM>. Next, in box <NUM> the first and second pilot balloon <NUM>, <NUM> may be coupled to the corresponding skived locations of the inflation lumen passageways <NUM>. Adhesive or the like may be utilized to ensure the first and second pilot balloon <NUM>, <NUM> are fluidly coupled to the inflation lumen passageways <NUM>. In box <NUM>, holes may be formed through a portion of the airway tube <NUM> to fluidly couple the inner portion of each cuff <NUM>, <NUM> to the corresponding inflation lumen passageway <NUM>. The holes may be fluid ports that fluidly couple the corresponding inflation lumen passageway <NUM> to the external surface of the airway tube <NUM> within the cuff <NUM>, <NUM>. Accordingly, in box <NUM> the proximal and distal cuffs <NUM>, <NUM> may be positioned around the corresponding fluid port and coupled to the airway tube <NUM>. Adhesive may be used to fluidly couple the corresponding cuffs <NUM>, <NUM> to the airway tube <NUM> to further fluidly couple the corresponding cuffs <NUM>, <NUM> to the corresponding first and second pilot balloon <NUM>, <NUM>.

In box <NUM>, any inflation lumen may be back filled and in box <NUM> a murphy eye may be formed in the distal end of the airway tube <NUM>. Next, inflation valves may be inserted in the pilot balloon <NUM>, <NUM> in box <NUM>. Finally, in box <NUM> the endotracheal tube assembly <NUM> may be tested for leaks.

Referring now to <FIG>, another embodiment of an endotracheal tube assembly <NUM> is illustrated. In this embodiment, the resistant member <NUM> may extend from a starting portion <NUM> of the endotracheal tube <NUM> to an ending portion <NUM> of the endotracheal tube <NUM>. In one aspect of this disclosure, the ending portion <NUM> may be distal to the distal cuff <NUM>. In other words, the resistant material <NUM> may extend underneath both cuffs <NUM>, <NUM> towards the second opening <NUM>. In this embodiment, the resistant material <NUM> may extend a resistant length <NUM> that is substantially the entire length of the airway tube <NUM> less the exposed portion <NUM>. In this configuration, the portion of the airway tube <NUM> that is intended to be positioned within the patient is surrounded by the resistant material <NUM> up to the distal cuff <NUM>.

In one aspect of this disclosure, the resistant material <NUM> is positioned radially between the cuffs <NUM>, <NUM> and the inflation lumen <NUM>. Accordingly, to fluidly couple the inner portion of the cuff <NUM>, <NUM> with the corresponding inflation lumen <NUM> a fluid passageway must be formed through the sleeve <NUM>, resistant material <NUM>, and part of the airway wall <NUM>. One aspect of this disclosure is a method of forming this fluid connection while ensuring the passageway from the inflation lumen <NUM> through the airway wall <NUM>, resistant material <NUM>, and sleeve <NUM> is fluidly sealed.

Referring now to <FIG> and <FIG>, one non-exclusive method for fluidly coupling a cuff <NUM>, <NUM> to the corresponding inflation lumen <NUM> is described. In box <NUM>, the airway tube <NUM> may be wrapped with the resistant material <NUM> as discussed herein. In box <NUM>, the resistant material <NUM> is wrapped to be positioned axially along the airway tube <NUM> passed the proximal cuff <NUM> and at least partially into the distal cuff <NUM>. In one aspect of this disclosure, the resistant material <NUM> is wrapped to extend along the airway tube <NUM> axially past both the proximal and distal cuffs <NUM>, <NUM>. Next in box <NUM>, the sleeve <NUM> is positioned over the resistant material <NUM> and coupled to the airway tube <NUM> and resistant material <NUM> as discussed herein.

In box <NUM>, a cutter having a first diameter <NUM> is used to cut a first hole <NUM> through the sleeve <NUM> and the resistant material <NUM> at a location radially outward of a corresponding inflation lumen <NUM>. The first hole <NUM> may be radially outward of the inflation lumen <NUM> relative to an airway axis <NUM> defined longitudinally through a center portion of the airway tube <NUM>. In one aspect of this disclosure, the cutter is not advanced substantially radially into the airway wall <NUM> of the airway tube <NUM> but rather is only advanced far enough to cut holes through the sleeve <NUM> and the resistant material <NUM>. While a portion of the airway tube <NUM> may be slightly contacted when cutting the first hole <NUM>, the cutter for the first hole <NUM> does not advance into the inflation lumen <NUM>. In other words, the cutter only advances far enough radially inward to cut the first hole <NUM> in the sleeve <NUM> and the resistant member <NUM>. All portions of the sleeve <NUM> and resistant material <NUM> are removed from the first hole <NUM> to expose a radially outer surface of the airway tube <NUM>.

Next, in box <NUM>, a second hole <NUM> may be cut partially through the airway tube <NUM> into the underlying inflation lumen <NUM>. The second hole <NUM> may be aligned to be substantially coaxial with the first hole <NUM>. In one non-exclusive embodiment, the second hole <NUM> may have a second diameter <NUM> that is slightly less than the first diameter <NUM>. The second hole <NUM> is only defined partially through the airway wall <NUM> of the airway tube <NUM> in order to provide an outlet (the second hole <NUM>) for the underlying inflation lumen <NUM> to be routed radially outwardly from the airway tube <NUM>. As discussed herein, ultimately one of the cuffs <NUM>, <NUM> will be positioned along the outlet to fluidly couple the inflation lumen <NUM> to an inner chamber of the corresponding cuff <NUM>, <NUM>.

In box <NUM>, a stopper plug <NUM> may be positioned through the second hole <NUM> to substantially fill the second hole <NUM>. The stopper plug <NUM> may have a diameter that is the same or slightly greater than the second diameter <NUM> to substantially fill the second hole <NUM> when placed therein. Further, the stopper plug <NUM> may extend radially away from the sleeve <NUM> to define an annular channel <NUM> around the stopper plug <NUM>. The annular channel <NUM> may be defined by the stopper plug <NUM>, outer surface of the airway tube <NUM> between the first and second hole, the resistant member <NUM> along the perimeter of the first hole <NUM>, and the sleeve <NUM> along the perimeter of the first hole <NUM>. In box <NUM>, an adhesive can be applied into the annular channel <NUM> while the stopper plug <NUM> is positioned through the second hole <NUM>. By placing the adhesive in the annular channel <NUM>, any gaps between the sleeve <NUM>, resistant member <NUM>, and airway tube <NUM> may be substantially filled with adhesive to ensure no fluid can pass through the first hole <NUM> to occupy the space between the sleeve <NUM> and the outer surface of the airway tube <NUM>. In other words, applying adhesive to the annular channel <NUM> prevents fluid from bleeding into the resistant material <NUM> layer when the corresponding cuff <NUM>, <NUM> is inflated.

The adhesive may be any known adhesive and in one non-exclusive embodiment is RTV silicone. Further, the plug may be formed from a material that resists adhesion by the adhesive. In one non-exclusive example, the plug may be formed of a Teflon material. However, any known adhesive and plug material may be used, and this disclosure considers all known adhesives and plug materials.

Referring now to box <NUM>, the stopper plug <NUM> may be removed from the second hole <NUM> after the adhesive has at least partially cured. As discussed herein, the stopper plug <NUM> may be formed of a material that substantially resists adhesion to the adhesive. Accordingly, after the adhesive has at least partially cured, the plug may be removed from the second hole <NUM>. Further, since the adhesive is at least partially cured, the second hole <NUM> may remain defined partially through the airway tube <NUM> to fluidly couple the inflation lumen <NUM> to the outer portion of the sleeve <NUM>.

Next, in box <NUM> the corresponding cuff <NUM>, <NUM> may be positioned around the sleeve <NUM> at a location axially aligned with the second hole <NUM>. More specifically, the cuff <NUM>, <NUM> may be aligned with the second hole <NUM> so the second hole <NUM> fluidly couples a corresponding inflation lumen <NUM> with a cavity <NUM> of the cuff <NUM>, <NUM>. In box <NUM>, each cuff <NUM>, <NUM> may be coupled to the radially outer surface of the sleeve <NUM> at a proximal and distal end <NUM>, <NUM> with adhesive. The cavity <NUM> is formed between the inner surface of the cuff <NUM>, <NUM> and the outer surface of the sleeve <NUM> between the proximal and distal ends <NUM>, <NUM> of the cuff <NUM>, <NUM>. Further, a cap <NUM> may be formed at a distal end of the inflation lumen <NUM> with adhesive to prevent fluid flow out the distal end. Accordingly, fluid provided through the inflation lumen <NUM> passes through the second hole <NUM> and into the cavity <NUM> to thereby expand the cuff <NUM>, <NUM> under certain pressure and volume conditions.

Finally, in box <NUM> a leak test may be executed to ensure that the inflation lumen <NUM> is fluidly coupled to the cuff <NUM>, <NUM>. More specifically, fluid may be provided to the inflation lumen <NUM> at an established fluid pressure to fill the cavity <NUM>. The fluid may be provided at a test pressure and monitored for a period of time to ensure that the test pressure does not drop. A drop in test pressure may indicate a leak between the inflation lumen <NUM> and the cuff <NUM>, <NUM>. As discussed herein, one aspect of the leak test may be to ensure that fluid is not passing through the perimeter of the first hole <NUM> and into the space between the sleeve <NUM> and the airway tube <NUM>. In other words, one aspect of the leak test is to ensure that the adhesive applied to the annular channel <NUM> is properly sealing the sleeve <NUM>, resistant member <NUM>, and airway tube <NUM> about the perimeter of the first hole <NUM>.

While <FIG> and <FIG> illustrate and describe a method for fluidly coupling a single cuff to an inflation lumen, this disclosure contemplates utilizing substantially the same methodology discussed herein to fluidly couple two or more cuffs thereto as well. More specifically as illustrated in <FIG>, two inflation lumen <NUM> may be defined in the airway wall <NUM>. In this embodiment, the methods discussed herein can be implemented to couple the proximal cuff <NUM> to a first inflation lumen and then couple the distal cuff <NUM> to a second inflation lumen. In this configuration, the first and second holes <NUM>, <NUM> would be located along different portions of the airway tube <NUM> to thereby fluidly couple the corresponding cuff <NUM>, <NUM> to one of the first or second inflation lumen. Accordingly, the teachings of this disclosure may be applied to endotracheal tubes with any number of cuffs.

In use, the endotracheal tube assembly <NUM> described herein may be utilized for procedures that may expose the endotracheal tube assembly <NUM> to a surgical laser or the like. In these types of procedures, the endotracheal tube assembly <NUM> may be inserted partially past the vocal chords and into the trachea of a patient without abrasively contacting the soft tissue. The cuff or cuffs may be inflated to fluidly seal the endotracheal tube assembly <NUM> to the walls of the trachea. Then, the physician can perform the procedure utilizing a surgical laser or the like while fluid is passed through the endotracheal tube assembly <NUM> and into the patient.

If the physician unintentionally contacts the endotracheal tube assembly <NUM> with the surgical laser, the resistant member <NUM> may substantially reflect or otherwise block the laser from entering the fluid passageway of the airway tube <NUM>. Once the procedure is complete, the physician may deflate the cuff or cuffs and remove the endotracheal tube assembly <NUM> from the patient without abrasively contacting the trachea or vocal chords. More specifically, the sleeve <NUM> and cuffs <NUM>, <NUM> may cover substantially the entire outer surface of the resistant member <NUM> to ensure the endotracheal tube assembly <NUM> can be smoothly inserted and removed from the patient.

As discussed herein, the resistant member <NUM> may extend axially along the airway tube <NUM> past the proximal cuff and partially into, or past, the distal cuff. By extending the resistant member <NUM> substantially the entire length of the airway tube <NUM>, the physician can utilize a surgical laser or the like along portion of the patient that are adjacent to the cuffs <NUM>, <NUM>. More specifically, if the physician inadvertently redirects the surgical laser into the cuffs <NUM>, <NUM> and toward the airway tube <NUM>, the resistant member <NUM> may still substantially prevent the surgical laser from passing into the airway tube <NUM>.

Claim 1:
A method of coupling a cuff (<NUM>, <NUM>) to an inflation lumen (<NUM>) for an endotracheal tube (<NUM>), comprising:
a) providing an endotracheal tube (<NUM>) having an inflation lumen (<NUM>) defined therein, a resistant material (<NUM>) positioned around at least a portion of the endotracheal tube (<NUM>), and a sleeve (<NUM>) positioned around at least a portion of the resistant material (<NUM>);
b) cutting a first hole (<NUM>) through the sleeve (<NUM>) and the resistant material (<NUM>) at a location proximate to the inflation lumen (<NUM>);
c) cutting a second hole (<NUM>) partially through the endotracheal tube (<NUM>), the second hole (<NUM>) defined within the first hole (<NUM>), the second hole (<NUM>) being cut partially through the airway tube (<NUM>) into the underlying inflation lumen (<NUM>);
d) inserting a stopper plug (<NUM>) into the second hole (<NUM>) and applying an adhesive around the stopper plug (<NUM>) along a perimeter of the first hole (<NUM>);
e) removing the stopper plug (<NUM>) and coupling the cuff (<NUM>, <NUM>) along the endotracheal tube (<NUM>) to fluidly couple the cuff (<NUM>, <NUM>) to the inflation lumen (<NUM>) through the second hole (<NUM>).