WO2015013381A1

WO2015013381A1 - Cuffed tracheal tube

Info

Publication number: WO2015013381A1
Application number: PCT/US2014/047772
Authority: WO
Inventors: Matthew LEDGES; Mike FALLON
Original assignee: Medical Instrument Ventures, Llc
Priority date: 2013-07-25
Filing date: 2014-07-23
Publication date: 2015-01-29

Abstract

An endotracheal tube assembly for intubating a patient including a rolling cuff positionable on a tube having a distal end and a proximal end. The rolling cuff having a distal end, a proximal end, an inner diameter forming a first elongated tubular section substantially adjacent to the tube, and an outer diameter forming a second elongated tubular section. The rolling cuff being positioned towards the distal end of the tube. The rolling cuff including a single attachment portion for attaching a portion of the first elongated tubular section to the tube, wherein the single attachment portion allows the rolling cuff to roll from the distal end of the tube towards the proximal end of the tube to expose an ultrasound imaging marker disposed on the first elongated tubular section.

Description

CUFFED TRACHEAL TUBE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to United States Provisional Patent

Application Serial Number 61/858,298, filed July 25, 2013, the disclosure of which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

[0002] The present disclosure relates to medical devices. More particularly, the disclosure relates to tracheal tube devices such as endotracheal tubes.

BACKGROUND OF THE INVENTION

[0003] This section is intended to introduce the reader to various aspects of art that may be related to aspects of the present invention which are described and/or claimed below. This section is believed to be helpful in providing the reader with background information to help understand the various aspects of the present invention. Accordingly, it should be understood that the statements in this section are to be read in this light, and not as admissions of prior art.

[0004] Tracheal intubation is an established procedure for controlling the airway of patients undergoing certain types of medical procedures. Conventional methods of tracheal intubation include the insertion of a tubular device, such as an endotracheal tube, through the patient's mouth and into the patient's trachea. The distal end of the endotracheal tube is then positioned above the patient's carina to allow air to pass through the tube and into the lungs. The tube is often coupled to an air source, such as a ventilator, to mechanically assist with oxygenation and ventilation of the lungs. To properly position the endotracheal tube, the medical professional may use various devices to improve their line of sight, such as, for example, laryngoscopes, flexible fiberoptic bronchoscopes, or video laryngoscopes. [0005] In order to create the necessary air pressure to mechanically oxygenate and ventilate the lungs, the gaps between the outer walls of the endotracheal tube and trachea should be sufficiently sealed. Sealing the passageway may be accomplished by using an inflatable cuff provided around the endotracheal tube near the distal end of the tube. Before sealing the passageway, the cuff is generally positioned within the trachea, below the vocal cords, and above the carina. Once inflated, the cuff may also act as an anchor below the vocal cords to help prevent displacement of the tube.

[0006] Although this method of treatment has been successful, problems remain. For example, a common problem with using tracheal tube devices is that during or prior to placement of the tube, the distal end of the tube may be contaminated with flora, mucus, saliva, blood, vomit, and other contaminates from the patient's mouth or oropharynx, and/or the surrounding environment. During intubation, the contaminated distal end of the tube may push the contaminants into the trachea or a main stem bronchus, potentially causing infections such as ventilator associated pneumonia leading to increased morbidity and mortality— markedly increasing the cost of care for these patients.

[0007] Other common problems result from improper placement of the tube. For example, the distal end of the tube may be improperly placed causing main stem bronchus intubation. Accidental intubation of a main stem bronchus may restrict air to the contralateral lung and lead to atelectasis, hypoventilation, and hypoxia. Moreover, intubating a main stem bronchus may hyperinflate the corresponding lung causing damage. A misplaced tube is difficult to diagnose and may only be apparent after careful examination of the patient and his vital signs and/or direct visualization of the endotracheal tube's position. While tubes placed too deeply can cause main stem bronchus intubation, a shallow tube can lead to vocal cord injuries or become dislodged. Other problems may result from not properly anchoring the tube with an inflated cuff below the vocal cords resulting in unplanned extubation. Accordingly, it is desirable to provide an improved tracheal intubation device.

BRIEF SUMMARY OF THE INVENTION

[0008] The disclosure is directed to several alternative designs, materials, and methods of manufacturing endotracheal tubes. It shall not limit the invention in any respect. A detailed and fully enabling disclosure is set forth in the detailed description section.

[0009] One embodiment of the present invention may include an endotracheal tube assembly for intubating a patient including a rolling cuff positionable on a tube having a distal end and a proximal end. The rolling cuff may be configured to transition along endotracheal tube from the distal end of the tube towards the proximal end of the tube. The rolling cuff comprising an elongated section having an ultrasound imaging marker substantially adjacent to the tube. The tube may be configured with a curve along its length, as well as a beveled portion at the distal end for ease of insertion into the airway of the patient. The proximal end of the tube may be configured to include an adaptor internally or externally coupled to the tube. The adapter may be configured to connect the tube to a ventilation device that provides an air/oxygen mixture or anesthetic to the patient through the tube.

[0010] The rolling cuff may be advantageously designed to protect the distal end of the tube during intubation to help reduce the amount of contaminants being pushed into the trachea. If left unprotected the distal end of the tube may be contaminated with flora, mucus, saliva, blood, vomit, or other contaminates from the mouth or oropharynx of the patient and/or the surrounding environment. The rolling cuff may include a distal end, a proximal end, an inner diameter forming a first elongated tubular section (inner hollow body) substantially adjacent to the tube, and an outer diameter forming a second elongated tubular section. The rolling cuff being positioned towards the distal end of the tube. The rolling cuff may further include a single attachment portion for attaching a portion of the first elongated tubular section to the tube. The single attachment portion allows the rolling cuff to roll from the distal end of the tube towards the proximal end of the tube. The cuff may further include an ultrasound imaging marker disposed on the first elongated tubular section. The ultrasound imaging marker helps a medical professional locate the rolling cuff during intubation with an ultrasound device having a transducer. Positioning the ultrasound imaging marker on the first elongated tubular section prior to intubation helps protect the ultrasound imaging marker from being damaged and from environmental contaminants. As the cuff rolls from the distal end of the tube towards the proximal end of the tube, the cuff evaginates and the ultrasound imaging marker is exposed. The ultrasound imaging marker may comprise any suitable material having resonant attributes. For example, the ultrasound imaging marker may comprise metallic materials such as alumina or gold, polymer mixtures, vinyl, silicon, glass, copolymers, bioabsorbable polymers, or other such equivalent materials.

[0011] In some embodiments, as the distal end of the tube passes through the vocal cords of the patient, the distal end of the rolling cuff contacts the vocal cords or a portion of the supraglottic structures near the vocal cords and starts to roll towards the proximal end of the tube as the distal end of the tube and the rolling cuff advance into the trachea of the patient. The distal end of the rolling cuff may transition past the proximal attachment portion of the rolling cuff. Once properly positioned, the rolling cuff is located below the vocal cords and the ultrasound imaging marker is exposed. In some embodiments, the rolling cuff may be pre-filled with a fluid, such as air, and allowed to remain at substantially the same pressure throughout intubation and extubation. In other embodiments, the rolling cuff may be configured to completely deflate and inflate. In some embodiments, the rolling cuff may be filled with gases that are detectable by ultrasound imaging or include an inner cuff filled with gases that are detectable by ultrasound imaging. [0012] The attachment portion of the rolling cuff may be adhesively or otherwise attached to the tube. The rolling cuff may also be fixed or coupled to the tube with solvent bonding, vibration welding for plastics, induction welding for plastics, mechanical fastening, or by any other biocompatible means that would provide for a sufficient attachment point to allow the distal end of the rolling cuff to transition from the distal end of the tube towards the proximal end of the tube. In some embodiments, the position of the attachment portion may be adjustable prior to positioning the rolling cuff within the airway of the patient. During placement of the tube, the distal end of the rolling cuff transitions towards the attachment portion/anchor point. The rolling cuff may start to roll towards the proximal end of the rolling cuff once the rolling cuff engages the vocal cords or surrounding structures of the supraglottis. As the cuff rolls, the inner hollow body portion of the rolling cuff is turned inside out. The hollow body portion of the rolling cuff may have a generally tubular or cylindrical expandable structure that is configured to conform to an outer portion of the tube. The cross-sectional shape of the hollow body portion of the rolling cuff may alternatively be substantially ellipsoidal, rectangular, hexagonal, rectangular, square, or polygonal in shape.

[0013] A number of feature refinements and additional features are applicable to the rolling cuff. For example, the rolling cuff may be operatively associated with at least one pilot balloon or syringe port assembly for deflating and inflating the rolling cuff. The pilot balloon assembly may include a pilot balloon pump and at least one conduit having a distal end terminating within the rolling cuff and a proximal end coupled to the pilot balloon pump. The conduit may be positioned along the inner portion of the tube for delivering or extracting a fluid, such as air, to or from the rolling cuff. The pilot balloon pump may be pre-calibrated depending on patient size to help prevent over or under inflation. The pilot balloon pump may also be operatively associated with a pressure transducer, sensor, and graphical user interface to indicate proper inflation of the rolling cuff. [0014] The conduit may be operatively associated with a pilot port for inflating and deflating the rolling cuff. The pilot port may be positioned towards the proximal end of the rolling cuff near the attachment portion of the rolling cuff. Accordingly, the pilot port may be configured and dimensioned to inflate or deflate the rolling cuff regardless of the position of the rolling cuff along the tube. The rolling cuff may include a release valve to quickly deflate the rolling cuff to assist in extubation.

[0015] The rolling cuff may be formed from materials having suitable mechanical properties resistant to punctures, tears, pin holes, and chemical properties to provide a suitable bond to the tube, as well as biocompatibility. The materials may include polyurethane or polyurethane-based compositions having suitable mechanical and chemical properties. Other materials may be suitable that exhibit properties enabling them to be processed into an inflatable cuff.

[0016] Another embodiment is a method for manufacturing the rolling cuff. The size and shape of the rolling cuff may be formed by various methods. For example, injection molding, blow molding, stretch molding, extrusion, dip molding, casting, or any other suitable technique. In some embodiments, the rolling cuff may be manufactured to include a slight taper, being wider at one end when inflated. The degree of taper, curvature and/or linearity at different parts of the rolling cuff may vary. For example, the rolling cuff may be tapered differently or opposite, or may be generally symmetrical, without substantial taper from one end to the other. Likewise, other cuff shapes having straight walls, curved walls, or combinations of straight and curved walls are possible and are within the scope of the present disclosure.

[0017] The ultrasound imaging marker may comprise a microbial control layer formed from hydrophobic polymers including a hydrophilic polymer. Accordingly, the ultrasound imaging marker may comprise an antimicrobial metal, such as gold, copper, or silver that exhibit antimicrobial properties and are detectable by an ultrasound device having a transducer. In addition, the ultrasound imaging marker may include an acrylamide polymerization solution (i.e., polyacrylamide solution) that may be polymerized and crosslinked by thermal initiation such as ultraviolet radiation. The pore size of the solution may be controlled by altering the amount of crosslinking and the percent of solids in the monomer solution. The ultrasound imaging marker may be applied to the rolling cuff by dipping the rolling cuff into a polyacrylamide solution. The thickness of the ultrasound imaging marker may be altered by varying the number of times or duration that the rolling cuff is dipped into the polyacrylamide solution. In some embodiments, the ultrasound imaging marker may be formed by sputtering or other deposition techniques. The ultrasound imaging marker may be applied to both the first elongated tubular section (inner hollow body) of the rolling cuff, and the outer diameter forming a second elongated tubular section of the rolling cuff. The ultrasound imaging marker may also be extruded, molded, co- extruded, blow-molded, electrostatically applied, or sprayed onto the rolling cuff.

[0018] In some embodiments, the endotracheal tube assembly may comprise a suction-tube port. An interior suction tube may connect to the suction-tube port for removal of fluids within the airway of the patient. The suction tube may be disposed adjacent to the tube extending therethrough towards the proximal end of the tube and connected to a vacuum source and fluid collection housing. The suction tube and suction-tube port may be operatively associated with a pressure transducer, sensor, and graphical user interface to determine information about the suction tube.

[0019] The above summary of some example embodiments is not intended to describe each disclosed embodiment or every implementation of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The invention may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:

[0021] FIG. 1 is a perspective view of an exemplary endotracheal tube assembly having a distal rolling cuff in accordance with one embodiment of the invention;

[0022] FIG. 2 is a perspective view of the distal rolling cuff positioned near the distal end of the endotracheal tube;

[0023] FIG. 2A is a perspective cross-sectional view of FIG. 2 illustrating an ultrasound imaging marker disposed on an inner portion of the distal rolling cuff;

[0024] FIG. 3 is a perspective view of the distal rolling cuff after transitioning towards the proximal end of the endotracheal tube with the ultrasound imaging marker exposed;

[0025] FIG. 4 is a partial plain view of an exemplary endotracheal tube assembly having a distal rolling cuff before having the distal end of the endotracheal tube pass through the vocal cords of a patient;

[0026] FIG. 5 is a partial plain view of an exemplary endotracheal tube as the distal rolling cuff passes through the vocal cords of a patient;

[0027] FIG. 6 is a partial plain view of an exemplary endotracheal tube assembly after the distal rolling cuff passes through the vocal cords of a patient;

[0028] FIG. 7 is a coronal cross-sectional view of FIG. 4 illustrating the distal end of endotracheal tube positioned in the supraglottic area of a patient;

[0029] FIG. 8 is a coronal cross-sectional view of FIG. 5 illustrating the distal rolling cuff passing through the vocal cords of a patient; and [0030] FIG. 9 is a coronal cross-sectional view of FIG. 6 illustrating the distal rolling cuff positioned below the vocal cords of a patient.

[0031] While the invention is susceptible to various modifications and alternative forms, specifics of the invention have been shown by way of example in the drawings and will be described in further detail below. It should be understood that the intention of the detailed description does not limit aspects of the invention to the particular embodiments described. On the contrary, the invention covers all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0032] The following defined terms disclosed in this detailed description of the invention shall apply to the invention, unless a different definition is given in the claims or elsewhere in this specification.

[0033] All numeric values are assumed to be modified by the term "about," whether or not explicitly indicated. The term "about" generally refers to a range of numbers that a person having ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In addition, in many instances, the term "about" may be indicative as including numbers rounded to the nearest significant figure. The recitation of numerical ranges by endpoints includes all numbers within that range. Although some suitable dimensions, ranges, and/or values pertaining to various components, features and/or specifications are disclosed, a person having ordinary skill in the art, incited by the present disclosure, would understand that the desired dimensions, ranges and/or values may deviate from those expressly disclosed. As used in this specification and the appended claims, the singular forms "a" "an" and "the" include the plural referents unless the content clearly dictates otherwise. As used in this specification and the claims, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. [0034] The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The detailed description and the drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention. The illustrative embodiments depicted are intended only as exemplary. Selected features of any illustrative embodiment may be incorporated into additional embodiments unless clearly stated to the contrary. While the embodiments herein may be described in terms of spatial orientation, the terminology used is not intended to be limiting, but instead to provide a straightforward description of the various embodiments.

[0035] Primarily referring now to FIGs. 1, 4, and 7, which show components of an exemplary endotracheal tube assembly 10 in accordance with one example embodiment. Endotracheal tube assembly 10 functions to intubate a patient 78. The endotracheal tube assembly 10 includes a distal rolling cuff 12 configured to transition along endotracheal tube 20 from the distal end 22 of tube 20 towards the proximal end 24 of tube 20. The distal rolling cuff 12 comprises an inner diameter forming a first elongated section or hollow body portion 36 having an ultrasound imaging marker 39, and an outer diameter forming a second elongated section 37. Tube 20 may form a slight curve along its length for ease of insertion into an airway 88 of the patient 78. The distal end 22 of tube 20 may also include a beveled portion 23 for ease of insertion into the airway 88. The proximal end 24 of tube 20 may comprise tube adapter 44 internally or externally coupled to tube 20. Adapter 44 may be configured to connect tube 20 to an assisted ventilation device (not shown) that provides an oxygen/air mixture or anesthetic gas to the patient 78 through tube 20.

[0036] Distal rolling cuff 12 may be configured to help protect the distal end 22 of endotracheal tube 20 prior to placement within the airway 88 of patient 78. If left unprotected the distal end 22 of tube 20 may be contaminated with mucus, flora, saliva, blood, vomit, foreign particles, or microbes from the mouth 74 or oropharynx of the patient 78 and/or the surrounding environment. If the distal end 22 of tube 20 is contaminated, tube 20 may push the contaminants into the trachea 66 and towards one of the bronchus 84 leading to infections causing increased morbidity and mortality— markedly increasing the cost of patient care. To help protect the distal end 22 of tube 20, rolling cuff 12 may be positioned at or near the distal end 22 of tube 20. The distal end 38 of rolling cuff 12 may be positioned over, near, or substantially close to opening 25. Opening 25 allows for an additional passageway for oxygenation and ventilation in the event the proximal end 22 of tube 20 becomes plugged. As the distal end 22 of tube 20 is positioned in the airway 88 of patient 78, rolling cuff 12 is permitted to roll towards the proximal end 24 of tube 20 and expose ultrasound imaging marker 39. Once positioned below the vocal cords 62, rolling cuff 12 may be inflated to form a seal in the trachea 66 and to help prevent unplanned extubation. As shown in the figures, rolling cuff 12 may have a generally tubular or cylindrical expandable structure that is configured to conform to the outer portion 42 of tube 20. However, the cross-sectional shape of rolling cuff 12 may alternatively be substantially ellipsoidal, rectangular, hexagonal, rectangular, square, or polygonal in shape.

[0037] Primarily referring now to FIGs. 2, 2A, and 3, distal rolling cuff 12 is disposed adjacent to tube 20 that is suitably sized and shaped to allow the passage of air or other gases therethrough. The attachment portion 34 of the rolling cuff 12 may be adhesively or otherwise attached to tube 20. The attachment portion 34 of rolling cuff 12 may be configured to allow the distal end 38 of rolling cuff 12 to transition from the distal end 22 of tube 20 towards the proximal end 24 of tube 20 and expose ultrasound imaging marker 39. As shown by arrows 48 and 54, during placement of the endotracheal tube assembly 10, the distal end 38 of rolling cuff 12 transitions towards the proximal end 32 of rolling cuff 12. Rolling cuff 12 may start to roll towards the fixed proximal end 32 of rolling cuff 12 once the rolling cuff 12 enters the airway 88 of patient 78. The proximal end 32 of rolling cuff 12 is fixed to tube 20. Fixing the proximal end 32 of rolling cuff 12 to tube 20 helps allow the first elongated section 36, i.e., hollow body portion 36 of rolling cuff 12 to roll towards the proximal end 24 of tube 20. Accordingly, rolling cuff 12 evaginates— as shown in FIGs. 2 and 3.

[0038] Primarily referring to FIG. 2A, ultrasound imaging marker 39 is disposed on the first elongated section 36. In some embodiments, ultrasound imaging marker 39 may be disposed on a portion of the second elongated section 37. Disposing ultrasound imaging marker 39 on the first elongated section 36 helps protect the ultrasound imaging marker from damage and environmental contaminants prior to entering the airway 88 of patient 78. As shown in FIG. 3, ultrasound imaging marker 39 is exposed as the distal end 38 of rolling cuff 12 transitions from the distal end 22 of tube 20 towards the proximal end 24 of tube 20.

[0039] Ultrasound imaging marker 39 may be any suitable material having resonant attributes. For example, the ultrasound imaging marker may comprise polymer mixtures, vinyl, silicon, glass, copolymers, bioabsorbable polymers, metallic materials such as alumina or gold, or other such equivalent materials. The resonant materials function to refract, deflect, or reflect ultrasound waves. Accordingly, the location of ultrasound imaging marker 39 and rolling cuff 12 become readily apparent. In some embodiments, ultrasound imaging marker 39 may comprise layered materials. For example, ultrasound imaging marker 39 may comprise layered materials of polymer mixtures. Other mixtures may include copolymers of polyethyleneimine, dimethylaminoethylmethacrylate and ammonio methacrylate, polyacrylamide, polymers of dimethylaminoethylmethacrylate, and polymers of ammonio methacrylate.

[0040] Various manufacturing techniques may be used to apply the ultrasound imaging marker 39 to rolling cuff 12. The rolling cuff 12 may be immersed into a solution comprising monomers that polymerize to rolling cuff 12. The ultrasound imaging marker 39 may also be extruded, molded, co-extruded, blow-molded, electrostatically applied, sputtered, or sprayed onto rolling cuff 12.

[0041] Distal rolling cuff 12 may be left deflated or semi-inflated prior to being positioned within the airway 88 of the patient 78. Rolling cuff 12 may be deflated or inflated by pilot balloon pump 16. Once inflated, rolling cuff 12 forms a seal between the trachea 66 and the outer portion 42 of tube 20 to assist in the ventilation process. To prevent over or under inflation, pilot balloon pump 16 may be pre-calibrated depending on the physical size of the patient 78 or according to the size of tube 20. Pilot balloon pump 16 may also be operatively associated with a pressure transducer (not shown) and sensor (not shown), and graphical user interface (not shown) to indicate proper inflation of rolling cuff 12.

[0042] Rolling cuff 12 may be partially filled with air, saline solution, or other suitable fluids having biocompatibility that would be readily apparent to a person having ordinary skill in the art after having read the present disclosure. Partially filling rolling cuff 12 with a fluid may help rolling cuff 12 transition from the distal end 22 of tube 20 towards the proximal end 24 of tube 20.

[0043] Primarily referring now to FIGs. 1-3, pilot balloon pump 16 is operatively associated with pilot tube conduit 26. The pilot tube conduit 26 may be positioned adjacent to the inner portion 40 of tube 20. Pilot tube conduit 26 may be operatively associated with pilot port 28 for inflating and deflating rolling cuff 12. Pilot port 28 may be positioned towards the proximal end 32 of rolling cuff 12 near attachment portion 34. Accordingly, pilot port 28 may be configured and dimensioned to provide a fluid, such as air, that inflates rolling cuff 12 regardless of the position of rolling cuff 12 along tube 20. Pilot 28 may also be configured to remove fluid from rolling cuff 12 to allow rolling cuff 12 to deflate. In addition, rolling cuff 12 may include a release valve (not shown) to quickly deflate the cuffs to assist in extubation.

[0044] Rolling cuff 12 may be formed from materials having suitable mechanical properties resistant to punctures, tears, pin holes, and chemical properties to provide a suitable bond to tube 20, as well as biocompatibility. The materials may include polyurethane or polyurethane-based compositions having suitable mechanical and chemical properties, such as, for example, polypropylene, low-density polyethylene, polyamide, polyvinyl chloride, polyethylene teraphthalate, silicone, neoprene, or polyisoprene. Copolymer admixtures for modifying the characteristics of the material may also be used, including low density polyethylene and ethylene-vinylacetate copolymer, or blends of the above mentioned materials, or other similar suitable materials. Examples of suitable polymeric compositions may include polymethylmethacrylate, polystyrene or vinyls (such as polyvinyl chloride and polyvinylacetate), polyacrylonitrile, polyamide (such as nylon), polycarbonate, polyesters (such as polyethylene terephthalate), polyolefins (such as polyethylenes and polypropylenes).

[0045] Other materials may be suitable that exhibit properties enabling them to be processed into a cuff having thin walls on the order of about 5 to about 100 micrometers and more preferably, less than about 60 micrometers. Rolling cuff 12 may also be configured to contain a pressure of about 20 to about 30 millibars upon inflation, for example. In some embodiments, the pressure of rolling cuff 12 may vary. In general, low pressure cuffs are inflated to less than 30 millibars within trachea 66. Cuffs configured for pressures significantly greater than about 50 millibars may be referred to as high-pressure cuffs.

[0046] Rolling cuff 12 may be configured closer in size to the diameter of the trachea

66. The average trachea diameter size may be based on the average size, weight, and height of an adult male/female or child. The diameter of an adult trachea may range in size from about 14 millimeters to about 27 millimeters, with the average being around 20 millimeters. The average length of an adult trachea is about 11 centimeters. Accordingly, rolling cuff 12 may be configured in accordance with the varying sizes of tracheas to allow for an acceptable pressure range upon inflation as described above. The size of rolling cuff 12 may also vary in size for children.

[0047] Rolling cuff 12 may be formed by various methods. For example, rolling cuff

12 may be formed by injection molding. In such a process, a polymer tubing may be placed in a hollow mold having internal dimensions of rolling cuff 12. One end of the tube is sealed and a working fluid is injected into the open end of the tube with sufficient pressure to cause the working fluid to expand the tubing. The pressure is decreased once the wall of the tubing is in contact with the inner surface of the mold. The polymer may then be annealed and cooled. Removing the mold leaves a portion of the tubing as an inflatable cuff. Cuff 12 may also be manufactured by a number of other techniques, including blow molding, stretch molding, extrusion, dip molding, casting, or any other suitable technique.

[0048] In some embodiments, rolling cuff 12 may have a slight taper, being wider at one end when inflated. The degree of taper, curvature and/or linearity at different parts of rolling cuff 12 may vary. For example, the cuffs may be tapered differently or opposite, or may be generally symmetrical, without substantial taper from one end to the other. Likewise, other cuff shapes having straight walls, curved walls, or combinations of straight and curved walls are possible and are within the scope of the present disclosure.

[0049] In some embodiments, endotracheal tube assembly 10 may comprise a suction-tube port (not shown). An interior suction tube may connect to the suction-tube port for removal of fluids including secretion contaminants within the airway 88 of patient 78. The suction tube may be disposed adjacent to tube 20 extending therethrough towards the proximal end 24 of tube 20. The suction tube may connect to a vacuum source and may be operatively associated with a pressure transducer, sensor, and graphical user interface to determine information about the suction tube. A suction tube may also be disposed along tube 20 such as, for example, above rolling cuff 12.

[0050] Turning now to FIGs. 4-6 illustrating partial plain views of an exemplary endotracheal tube assembly 10 having a rolling cuff 12 being positioned in airway 88 of patient 78. As shown in FIG. 4, initially, the distal end 22 of tube 20 is positioned through mouth 74, over tongue 70, and into airway 88 of patient 78. To help protect the distal end 22 of endotracheal tube 20 from microbes or other contaminants during intubation, rolling cuff 12 is positioned substantially close to distal end 22 of tube 20. Such microbial contaminants may include, for example, Streptococcus, Candida albicans (yeast), phomonas multiphilia, Staphlyoccus aureus, Pseudomonas aeruginosa, Staphylococcus aureus, Enterobacter spp, Haemophilus influenza, as well as mucus, saliva, blood, vomit, and other contaminates.

[0051] As the distal end 22 of tube 20 enters the supraglottic area 60 of patient 78, the medical professional may use various devices (not shown) to improve the line of sight and to help insure that the distal end 22 of tube 20 does not enter esophagus 68. Such devices may include, for example, laryngoscopes, flexible fiberoptic bronchoscopes, or video laryngoscopes. The endotracheal tube assembly 10 may also be sized and configured for use with a medical bougie (not shown).

[0052] Turning now to FIG. 5 showing a partial plain view of the distal end 22 of tube 20 passing through the vocal cords 62 of patient 78. As the distal end 22 passes through the vocal cords 62, rolling cuff 12 may begin to roll towards the attachment portion 34 of rolling cuff 12 thereby exposing ultrasound imaging marker 39. As shown, attachment portion 34 remains fixed to tube 20. Rolling cuff 12 may be sized and configured such that supraglottic structures 60 or the vocal cords 62 provide enough resistance (e.g. frictional engagement) to help rolling cuff 12 roll towards the proximal end 24 of tube 20. As rolling cuff 12 is positioned in trachea 66, a medical professional may view rolling cuff 12 having ultrasound imaging marker 39 on monitor 200 by using transducer 202 that emits and receives ultrasound waves. Transducer 202 may be connected to monitor 200 wirelessly, with a hard connection, or any other suitable means that would be apparent to a person having ordinary skill in the art.

[0053] While ultrasound detection may be used to detect tube 20 within trachea 66, the impedance mismatch between the tissue of trachea 66 and airspace within trachea 66 typically results in an inferior signal. Providing ultrasound imaging marker 39 on cuff 12 helps a medical professional distinguish cuff 12 from the surrounding airspace of trachea 66, as well as from surrounding tissue. In addition, providing ultrasound imaging marker 39 on the first elongated section 36 helps an operator or subsequent medical professional assess to what extent cuff 12 has evaginated and if cuff 12 has been properly positioned.

[0054] Fixing rolling cuff 12 to tube 20 helps allow the first elongated section 36 and second elongated section 37 of rolling cuff 12 to roll towards the proximal end 24 of tube 20. As rolling cuff 12 rolls towards the proximal end 24 of tube 20, rolling cuff 12 evaginates to expose ultrasound imaging marker 39 disposed on first elongated section 36. In some embodiments, rolling cuff 12 may comprise a textured portion (not shown) that may help control microbes and increase the friction between rolling cuff 12 and airway 88, including the vocal cords 62, trachea 66, or supraglottic area 60. The textured portion may be configured to transition to a position adjacent to tube 20 as rolling cuff 12 rolls along tube 20.

[0055] Attachment portion 34 of rolling cuff 12 may be fixed or coupled to tube 20 adhesively, with solvent bonding, vibration welding for plastics, induction welding for plastics, mechanical fastening, or by any other biocompatible means that would provide for a sufficient attachment point to allow rolling cuff 12 to transition along tube 20. In some embodiments, attachment portion 34 may be adjustable along the length of tube 20 relative to the distal end 22 of tube 20. An adjustable attachment portion 34 allows medical professionals to reposition rolling cuff 12 according to varying sizes of patient 78. Similarly, the size and length of rolling cuff 12 may vary depending on the size of patient 78. In some embodiments, rolling cuff 12 may be configured to fill a larger portion of trachea 66.

[0056] Turning now to FIG. 6 showing a partial plain view of the distal end 22 of tube 20 and rolling cuff 12 having ultrasound imaging marker 39 positioned in the trachea 66 of patient 78. As shown, segment 58 of tube 20 is positioned at the level of vocal cords 62. Segment 58 may include position markers or indicators 46, as will be explained in more detail below with reference to FIGs. 7-9. Once the distal end 22 of tube 20 and rolling cuff 12 are properly positioned in the trachea 66 of patient 78, the medical professional may begin to inflate, or finish inflating, rolling cuff 12. As rolling cuff 12 is inflated, a seal is created between the walls of trachea 66 and rolling cuff 12. Rolling cuff 12 is inflated to a pressure that does not interfere with the circulation of blood to the surrounding structures, such as trachea 66. The seal allows a ventilator to more efficiently provide an air/oxygen mixture or anesthetic to the patient without air leaks through tube 20. As mentioned, inflated rolling cuff 12 may also act as an anchor below the vocal cords 62.

[0057] After being positioned, rolling cuff 12 may be inflated with pilot balloon pump 16 that is operatively associated with pilot tube conduit 26. Pilot tube conduit 26 may be positioned adjacent to the inner portion 40 or outer portion 42 of tube 20. Pilot tube conduit 26 may extend along the length of tube 20. Pilot tube conduit 26 may be operatively associated with pilot port 28 for inflating and deflating rolling cuff 12. Pilot port 28 may be positioned near or at attachment portion 34. Accordingly, pilot port 28 may be configured and dimensioned to provide a fluid, such as air, that inflates rolling cuff 12 regardless of the position of rolling cuff 12 along tube 20. Pilot port 28 may also be configured to remove fluid from rolling cuff 12 to allow rolling cuff 12 to deflate. [0058] If conduit 26 is positioned on the inner portion 40 of tube 20, pilot port 28 may be substantially flush with tube 20. Pilot port 28 being disposed substantially near attachment portion 34 to inflate or deflate rolling cuff 12 while rolling cuff 12 is located at any point along tube 20. Pilot port 28 may also be disposed on the outer portion 42 of tube 20 to provide a fluid that inflates and deflates rolling cuff 12.

[0059] Endotracheal tube assembly 10 shown in FIGs. 4-6 may further comprise a suction-tube port (not shown) positioned near the rolling cuff 12 and/or in segment 58. An interior or exterior suction tube may connect to the suction-tube port for removal of fluids within the airway 88 of patient 78. The suction tube may be disposed adjacent to tube 20 extending therethrough towards the proximal end 24 of tube 20.

[0060] Primarily referring now to FIGs. 7-9, showing coronal cross-sectional views taken along portions of FIGs. 4-6 and illustrating the distal end 22 of tube 20 positioned in various sections of airway 88 to provide ventilation and oxygenation to lungs 92 through bronchi 84. Turning first to FIG. 7 showing a coronal cross-sectional view of FIG. 4 illustrating the distal end 22 of tube 20 positioned in the supraglottic area 60 of patient 78. As distal end 22 of tube 20 draws closer to vocal cords 62, the distal end 38 of rolling cuff 12 contacts vocal cords 62 and/or supraglottic structure 60 (epiglottis 76), thereby initiating the evagination of rolling cuff 12 towards the proximal end 24 of tube 20 and the ultrasound imaging marker 39.

[0061] As shown in FIG. 8, rolling cuff 12 continues to evaginate towards the proximal end 24 of tube 20 to expose ultrasound imaging marker 39. Position indicators 46 may also have resonant properties that may reflect and refract ultrasound waves. Accordingly, a medical professional may use position indicators 46 and ultrasound imaging marker 39 to properly position rolling cuff 12 within trachea 66. Position indicators 46 may include markings on tube 20 to allow the medical professional to gauge distance. Typically, the distal end 22 of tube 20 is positioned about 2 to 5 centimeters above the carina 82 of patient 78. Accordingly, position indicators 46 may allow the medical professional to determine the position of the distal end 22 of tube 20 relative to the carina 82 and vocal cords 62 depending on the size of patient 78. In some embodiments, the position indicators 46 may be color coded or include a pattern to indicate position.

[0062] Turning now to FIG. 9, showing an inflated rolling cuff 12 having ultrasound imaging marker 39 exposed. Once inflated, rolling cuff 12 may substantially fill the area of the trachea 66 below the vocal cords 62 to form a seal with trachea 66. Trachea 66 comprises walls having cartilage rings 94 separated by softer intervening tissue 90 such as, for example, fibrous tissue, muscular fibers, glands, and mucous membranes. Cartilage rings 94 may vary in number from about 15 to 20. Cartilage rings 94 may be spaced about 1 to 4 millimeters apart along the trachea 66. Rolling cuff 12 may be configured to conform to the walls of trachea 66 upon inflation.

[0063] While the invention may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail. However, it should be understood that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, alternatives, and equivalents falling within the spirit and scope of the invention as defined by the following claims.

Claims

What is claimed is:

1. A medical device, comprising:

a cuff having a proximal end and a distal end, an inner diameter forming a first elongated tubular section, and an outer diameter forming a second elongated tubular section; an ultrasound imaging marker disposed on the first elongated tubular section of the cuff; and

a tube having a proximal end and a distal end, the tube being positioned within the first elongated tubular section adjacent to the ultrasound imaging marker, wherein the cuff transitions along the tube and is configured to expose the ultrasound imaging marker after entering a passage way of a patient.

2. The medical device of claim 1, wherein the ultrasound imaging marker is layered on the cuff.

3. The medical device of claim 1, wherein the ultrasound imaging marker comprises alumina.

4. The medical device of claim 1, wherein the ultrasound imaging marker comprises gold.

5. The medical device of claim 1, further comprising a syringe port for inflating and deflating the cuff.

6. The medical device of claim 1, wherein the cuff comprises a single attachment portion for attaching a portion of the first elongated tubular section to the tube.

7. The medical device of claim 1, wherein the cuff comprises an adjustable attachment portion for attaching a portion of the first elongated tubular section to the tube, wherein the location of the adjustable attachment portion, relative to the distal end of the tube, is adjustable.

8. The medical device of claim 1, wherein the cuff transitions from the distal end of the tube towards the proximal end of the tube by rolling along the tube.

9. The medical device of claim 1, wherein the cuff comprises a material selected from the group consisting of polyvinyl chloride, silicone, neoprene, polyisoprene, polyurethane, polyethylene teraphthalate, and low-density polyethylene.

10. The medical device of claim 1, wherein the ultrasound imaging marker comprises a material selected from the group consisting of ammonio methacrylate, dimethylaminoethyl- methacrylate, and polyethyleneimine.

11. The medical device of claim 1 , wherein the ultrasound imaging marker comprises a material selected from the group consisting of alumina, gold, copper, and silver.

12. A method of manufacturing a medical device, comprising: providing a cuff having a proximal end and a distal end, an inner diameter forming a first elongated tubular section having an ultrasound imaging marker and an outer diameter forming a second elongated tubular section; and

providing a tube associated with the cuff, wherein the tube passes through first elongated tubular section of the cuff.

13. A medical device, comprising:

an inflatable balloon cuff having a proximal end and a distal end, an inner diameter forming a first elongated tubular section and an outer diameter forming a second elongated tubular section;

an ultrasound imaging marker disposed on the first elongated tubular section of the inflatable balloon cuff; and

an endotracheal tube having a proximal end and a distal end, the tube being positioned within the first elongated tubular section adjacent to the ultrasound imaging marker, wherein the inflatable balloon cuff rolls along the tube and is configured to expose the ultrasound imaging marker after entering a passage way of a patient, wherein the cuff comprises a single attachment portion for attaching a portion of the first elongated tubular section to the tube.

14. The medical device of claim 13, wherein the location of the single attachment portion is adjustable relative to the distal end of the endotracheal tube.

15. The medical device of claim 13, wherein the inflatable balloon cuff comprises a material selected from the group consisting of polyvinyl chloride, silicone, neoprene, polyisoprene, polyurethane, polyethylene teraphthalate, and low-density polyethylene.

16. The medical device of claim 13, wherein the ultrasound imaging marker comprises a material selected from the group consisting of ammonio methacrylate, dimethylaminoethyl- methacrylate, and polyethyleneimine.

17. A medical device, comprising:

a cuff having a proximal end and a distal end, an inner diameter forming a first elongated section and an outer diameter forming a second elongated section;

an ultrasound imaging marker disposed on the first and second elongated section of the cuff, wherein the ultrasound imaging marker has a pore size of less than 5 microns; and a tube having a proximal end and a distal end, the tube being positioned within the first elongated tubular section adjacent to the ultrasound imaging marker, wherein the cuff transitions along the tube and is configured to expose the ultrasound imaging marker after entering a passage way of a patient.

18. The medical device of claim 17, wherein the ultrasound imaging marker has a pore size of less than 0.2 microns.

19. The medical device of claim 17, wherein the cuff comprises a single attachment portion for attaching a portion of the first elongated section to the tube.

20. The medical device of claim 17, wherein the cuff comprises an adjustable attachment portion for attaching a portion of the first elongated section to the tube, wherein the location of the adjustable attachment portion, relative to the distal end of the tube, is adjustable.

21. The medical device of claim 17, further comprising indicator markers associated with the tube for indicating the position of the tube relative to a portion of the patient.

22. The medical device of claim 17, wherein the cuff comprises a material selected from the group consisting of polyvinyl chloride, silicone, neoprene, polyisoprene, polyurethane, polyethylene teraphthalate, and low-density polyethylene.

23. The medical device of claim 17, wherein the ultrasound imaging marker comprises a material selected from the group consisting of ammonio methacrylate, dimethylaminoethyl- methacrylate, and polyethyleneimine.