WO2015013378A1

WO2015013378A1 - Cuffed tracheal tube

Info

Publication number: WO2015013378A1
Application number: PCT/US2014/047765
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 fixed proximal cuff and a distal rolling cuff positionable on a tube having a distal end and a proximal end. The rolling cuff having a single attachment portion along the tube to allow the rolling cuff to roll from the distal end of the tube towards to the proximal end of the tube as it contacts the supraglottic structure and/or vocal cords of a patient. The proximal end of the tube being configured to include an adaptor to connect the tube to a ventilation device that provides an air/oxygen mixture or anesthetic to the patient through the tube.

Description

CUFFED TRACHEAL TUBE

CROSS-REFERENCE TO RELATED APPLICATIONS

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

Application Serial Number 61/858,246, 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 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, and an inner hollow body substantially adjacent to the tube, the rolling cuff being positioned towards the distal end of the tube. The rolling cuff may further include a single attachment portion to allow the rolling cuff to roll from the distal end of the tube towards the proximal end of the tube. 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 airway near the vocal cords and starts to transition towards the proximal end of the tube as the distal end of the tube and the rolling cuff both 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 entire rolling cuff is located below the vocal cords. 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 deflate and inflate.

[0011] In some embodiments, 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, a hollow body portion of the rolling cuff evaginates, i.e, 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.

[0012] 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 assembly for deflating and inflating the rolling cuff. The pilot balloon assembly may include a pilot balloon and at least one conduit having a distal end terminating within the rolling cuff and a proximal end coupled to the pilot balloon. 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 assembly may further include at least one pressure transducer and a sensor for indicating the pressure within the rolling cuff.

[0013] Other embodiments of an endotracheal tube assembly for intubating a patient may include a proximal balloon cuff in addition to the rolling cuff, the proximal balloon cuff being substantially fixed to the tube in a position proximal to the distal rolling cuff. The rolling cuff and proximal balloon cuff may be configured to deflate and inflate. The rolling cuff and proximal balloon cuff may be inflated and deflated by a first pilot balloon and a second pilot balloon. The first pilot balloon and second pilot balloon may be pre-calibrated depending on patient size to help prevent over or under inflation. The first pilot balloon and second pilot balloon may also be operatively associated with a pressure transducer, sensor, and graphical user interface to indicate proper inflation of the rolling cuff or proximal balloon cuff. First pilot balloon and second pilot balloon may be operatively associated with conduits for inflating and deflating the rolling cuff and the proximal balloon cuff. The pilot tube conduits may be positioned adjacent to the inner portion of the tube. In some embodiments, the conduits may comprise two adjacent conduits extending along the length of the tube.

[0014] The conduits may be operatively associated with a first pilot port for inflating and deflating the rolling cuff and with a second pilot port for inflating and deflating the proximal balloon cuff. The first pilot port may be positioned towards the proximal end of the rolling cuff near the attachment portion of the rolling cuff. Accordingly, the first 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. Similarly, the second pilot port is positioned within the proximal balloon cuff to provide a fluid that inflates and deflates the proximal balloon cuff. Both the rolling cuff and proximal balloon cuff may include a release valve to quickly deflate the cuffs to assist in extubation. In yet other embodiments, the rolling cuff and proximal balloon cuff may be configured to allow a single pilot balloon or syringe to deflate and inflate both cuffs.

[0015] The rolling cuff and proximal balloon 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 inflatable cuffs.

[0016] Another embodiment is a method for manufacturing the rolling cuff and proximal balloon cuff. The size and shape of the rolling cuff and proximal balloon 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 and proximal balloon 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 and the proximal balloon cuff 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.

[0017] In other embodiments, it may be desirable for the rolling cuff and/or the proximal balloon cuff to include an antimicrobial surface to prevent adhesion and propagation of biofilms. The rolling cuff may be formed from hydrophobic polymer with an outer antimicrobial layer including a hydrophilic polymer and an antimicrobial compound disposed on the outer surface of the rolling cuff. The antimicrobial layer may comprise an antimicrobial metal, such as gold, copper, or silver that exhibit antimicrobial properties. In some embodiments the antimicrobial metal may have sufficient reflective properties. Accordingly, in some embodiments, a medical professional may be able to detect the antimicrobial layer or other reflective layers by ultrasonography.

[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 and a proximal balloon 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; [0024] FIG. 3 is a perspective view of the distal rolling cuff after transitioning towards the proximal end of the endotracheal tube;

[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 having an inflated distal rolling cuff and an inflated proximal balloon cuff 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;

[0030] FIG. 9 is a coronal cross-sectional view of FIG. 6 illustrating the distal rolling cuff positioned below the vocal cords and the proximal balloon cuff above the vocal cords of a patient prior to inflation; and

[0031] FIG. 10 is a coronal cross-sectional view of FIG. 6 illustrating an inflated distal rolling cuff and proximal balloon cuff.

[0032] 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

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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. Tube 20 may form a slight curve along its length for ease of insertion into an airway 88 of 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.

[0038] 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, blood, vomit, saliva, foreign particles, or microbes from the mouth 74 or oropharynx of 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 for 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. 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.

[0039] In some embodiments, endotracheal tube assembly 10 may include a proximal balloon cuff 14. Proximal balloon cuff 14 may serve various purposes. For one, proximal balloon cuff 14 may serve to help seal the airway 88 of patient 78. After inflation, proximal balloon cuff 14 may act as a stopper to help prevent tube 20 from further advancing towards the carina 82 of patient 78. Accordingly, proximal balloon cuff 14 may help prevent the distal end 22 of tube 20 from contacting the carina 82 or from being pushed into a main stem bronchus 84, which can lead to complications, including atelectasis, hyperinflation of a lung 92, pneumothorax, tracheal damage, hypoventilation, and hypoxia.

[0040] 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. 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 the 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 inner portion 52, 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. [0041] As shown in FIG. 2, hollow body portion 36 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 hollow body portion 36 of rolling cuff 12 may alternatively be substantially ellipsoidal, rectangular, hexagonal, rectangular, square, or polygonal in shape.

[0042] Distal rolling cuff 12 and proximal balloon cuff 14 may be left deflated or semi-inflated prior to being positioned within the airway of the patient. Proximal balloon cuff 14 and rolling cuff 12 may be deflated or inflated by first pilot balloon 16 and second pilot balloon 18, respectively. First pilot balloon 16 and second pilot balloon 18 may be in the form of a syringe. As mentioned, once inflated, rolling cuff 12 and proximal balloon cuff 14 form a seal within the airway 88 to assist in the oxygenation and ventilation processes. To prevent over inflation, first pilot balloon 16 and second pilot balloon 18 may be pre- calibrated depending on the physical size of the patient 78 or according to the size of tube 20. First pilot balloon 16 and second pilot balloon 18 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 or proximal balloon cuff 14.

[0043] In yet other embodiments, distal rolling cuff 12 and proximal balloon cuff 14 may be configured to allow a single pilot balloon to deflate and inflate both cuffs. 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 allow a single pilot balloon to simultaneously inflate and deflate both rolling cuff 12 and proximal balloon cuff 14 to the proper pressure by offsetting size differences between rolling cuff 12 and proximal balloon cuff 14. For example, partially filling a larger sized rolling cuff 12 with a fluid may reduce the volume of rolling cuff 12 to substantially equal the volume of tracheal balloon cuff 14 thereby allowing a single pilot balloon to substantially create the same volume expansion in both cuffs by simultaneously providing air to both the rolling cuff 12 and proximal balloon cuff 14. In addition, 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.

[0044] Primarily referring now to FIGs. 1-3, first pilot balloon 16 and second pilot balloon 18 are operatively associated with pilot tube conduits 26. The pilot tube conduits 26 may be positioned adjacent to the inner portion 40 of tube 20. In some embodiments, pilot tube conduits 26 may comprise two adjacent conduits 26 extending along the length of tube 20. Pilot tube conduits 26 may be operatively associated with first pilot port 28 for inflating and deflating rolling cuff 12 and with second pilot port 30 for inflating and deflating proximal balloon cuff 14. First pilot port 28 may be positioned near or at attachment portion 34. Accordingly, first 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. First pilot 28 may also be configured to remove fluid from rolling cuff 12 to allow rolling cuff 12 to deflate. Similarly, second pilot port 28 is positioned within proximal balloon cuff 14 to provide a fluid that inflates proximal balloon cuff 14. Second pilot port 28 may also be configured to remove fluid from proximal balloon cuff 14 to allow proximal balloon cuff 14 to deflate. Both rolling cuff 12 and proximal balloon cuff 14 may include a release valve (not shown) to quickly deflate the cuffs to assist in extubation.

[0045] Rolling cuff 12 and proximal balloon cuff 14 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 suitable materials that would be readily apparent to a person having ordinary skill in the art after having read the present disclosure. 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).

[0046] Other materials may be suitable that exhibit properties enabling them to be processed into cuffs having thin walls on the order of about 5 to about 100 micrometers and more preferably, less than about 60 micrometers. Rolling cuff 12 and proximal balloon cuff 14 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 and proximal balloon cuff 14 may vary. In general, low pressure cuffs are inflated to about 20 to about 25 millibars within trachea 66. Cuffs configured for pressures significantly greater than about 50 millibars may be referred to as high-pressure cuffs.

[0047] Distal 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 1 1 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 and proximal balloon cuff 14 may also vary in size for children. [0048] Rolling cuff 12 and proximal balloon cuff 14 may be formed by various methods. For example, rolling cuff 12 and proximal balloon cuff 14 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 or proximal balloon cuff 14. 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. The cuffs may also be manufactured by a number of other techniques, including blow molding, stretch molding, extrusion, dip molding, casting, or any other suitable technique.

[0049] In some embodiments, rolling cuff 12 and proximal balloon cuff 14 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 and proximal balloon cuff 14 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.

[0050] In some embodiments, it may be desirable for rolling cuff 12 and proximal balloon cuff 14 to include an antimicrobial surface to prevent adhesion and propagation of biofilms. Accordingly, rolling cuff 12 and proximal balloon cuff 14 may be formed from hydrophobic polymer with an outer antimicrobial layer including a hydrophilic polymer and an antimicrobial compound disposed on the outer surface of rolling cuff 12 and proximal balloon cuff 14. The antimicrobial layer may comprise an antimicrobial metal, such as gold, copper, or silver. Accordingly, the outer layer of rolling cuff 12 and proximal balloon cuff 14 may exhibit antimicrobial properties. [0051] In some embodiments, endotracheal tube assembly 10 may comprise a suction-tube port (not shown) positioned in segment 58 (FIG. 3) between proximal balloon cuff 14 and attachment portion 34 of rolling cuff 12. 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.

[0052] 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 the 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.

[0053] 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). [0054] 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. 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.

[0055] Fixing attachment portion 34 of rolling cuff 12 to tube 20 helps allow 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. In some embodiments, rolling cuff 12 may comprise a textured portion (not shown) to 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. The textured portion may comprise an antimicrobial layer.

[0056] 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.

[0057] Turning now to FIG. 6 showing a partial plain view of the distal end 22 of tube 20 and distal rolling cuff 12 positioned in the trachea 66 of patient 78, as well as proximal balloon cuff 14 positioned proximal to vocal cords 62. 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, the proximal balloon cuff 14 and rolling cuff 12. Proximal balloon cuff 14 and rolling cuff 12 may be inflated simultaneously or separately. 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 also acts as an anchor below the vocal cords 62.

[0058] Similarly, as proximal balloon cuff 14 is inflated, a seal is created between the proximal balloon cuff 14 and the supraglottic area 60 to allow an air/oxygen mixture or anesthetic to be more efficiently provided to the patient 78 through tube 20. Proximal balloon cuff 14 may be inflated to a pressure that does not interfere with the circulation of blood to the surrounding structures in the supraglottic area 60. In some embodiments, proximal balloon cuff 14 may extend substantially close to the mouth 74 of patient 78. The inflated proximal balloon cuff 14 also helps protect the trachea 66 and lungs 92 from secretion contaminates that might otherwise pass along the outer portion 42 of tube 20. In addition, inflated proximal balloon cuff 14 may act as a stopper or anchor to prevent the distal end 22 of tube 20 from contacting the carina 82 or from being pushed into a main stem bronchus 84.

[0059] In some embodiments, proximal balloon cuff 14 may be deflated while maintaining the pressure of rolling cuff 12 to allow catheterization of esophagus 68. Under some circumstances it may be important to maintain a seal with the trachea 66 to allow air/oxygen mixture or anesthetic to be delivered to patient 78 while permitting a catheter to pass through the esophagus 68 and into the stomach (not shown) of patient 78.

[0060] After being positioned, rolling cuff 12 and proximal balloon cuff 14 may be inflated with first pilot balloon 16 and second pilot balloon 18 that are operatively associated with pilot tube conduits 26. In some embodiments, first pilot balloon 16 and second pilot balloon 18 are distinguishable by size. For example, first pilot balloon 16 may be substantially larger than second pilot balloon 18 to coordinate with rolling cuff 12 and proximal balloon cuff 14. Providing a distinguishable size difference may help allow a medical professional to readily identify which pilot balloon coordinates with rolling cuff 12 or proximal balloon cuff 14. First pilot balloon 16 and second pilot balloon 18 may also be distinguishable by the length of inflation conduits 26, color, or other markings that would allow a medical professional to easily distinguish between them.

[0061] Pilot tube conduits 26 may be positioned adjacent to the inner portion 40 or outer portion 42 of tube 20. Pilot tube conduits 26 may comprise two adjacent conduits 26 extending along the length of tube 20. Pilot tube conduits 26 may be operatively associated with first pilot port 28 for inflating and deflating rolling cuff 12 and with second pilot port 30 for inflating and deflating proximal balloon cuff 14. First pilot port 28 may be positioned near or at attachment portion 34. Accordingly, first 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. First pilot port 28 may also be configured to remove fluid from rolling cuff 12 to allow rolling cuff 12 to deflate.

[0062] If conduits 26 are positioned on the inner portion 40 of tube 20, first pilot port

28 and second pilot port 30 may be substantially flush with tube 20 to inflate and deflate the respective cuffs. First 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. Second pilot port 30 being disposed within proximal balloon cuff 14 to inflate or deflate proximal balloon cuff 14. First pilot port 28 and second pilot port 30 may also be disposed on the outer portion 42 of tube 20 to provide a fluid that inflates and deflates rolling cuff 12 and proximal balloon cuff 14.

[0063] Endotracheal tube assembly 10 shown in FIGs. 4-6 may further comprise a suction-tube port positioned near the rolling cuff 12 and/or in segment 58 between proximal balloon cuff 14 and attachment portion 34 of rolling cuff 12. 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.

[0064] Primarily referring now to FIGs. 7-10, 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 may be pushed towards the proximal end 24 of tube 20 by vocal cords 62 or by a portion of airway 88 (FIGs. 4-6) including supraglottic structures 60 (epiglottis 76) near the vocal cords 62.

[0065] As shown in FIG. 8, rolling cuff 12 continues to evaginate towards the proximal end 24 of tube 20 by a portion of the supraglottic structures 60 and/or vocal cords 62 as rolling cuff 12 enters the trachea 66. A medical professional may use position indicators 46 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, in adults, 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.

[0066] Turning now to FIG. 10, showing an inflated rolling cuff 12 positioned below the vocal cords 62 and an inflated proximal balloon cuff 14 positioned above the vocal cords 62 of patient 78. 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. Likewise, proximal balloon cuff 14 may be configured to substantially fill the airway 88 above the vocal cords 62, including supraglottic area 60, and epiglottis 76.

[0067] 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 tube having a proximal end and a distal end; and

an inflatable cuff associated with the tube, wherein the inflatable cuff is capable of transitioning from the distal end of the tube towards the proximal end of the tube.

2. The medical device of claim 1, further comprising a proximal balloon cuff positioned proximal to the inflatable cuff.

3. The medical device of claim 2, further comprising a first pilot balloon for inflating and deflating the inflatable cuff; and a second pilot balloon for inflating and deflating the proximal balloon cuff.

4. The medical device of claim 2, further comprising a pilot balloon for inflating and deflating the inflatable cuff and for inflating and deflating the proximal balloon cuff.

5. The medical device of claim 1, wherein the inflatable cuff comprises a single attachment portion for attaching the inflatable cuff to the tube and a hollow body adjacent to the tube, wherein at least a portion of the hollow body is not attached to the tube.

6. The medical device of claim 1, wherein the inflatable cuff comprises an adjustable attachment portion for attaching the inflatable cuff to the tube, wherein the location of the adjustable attachment portion, relative to the distal end of the tube, is adjustable.

7. The medical device of claim 1, wherein the inflatable cuff transitions from the distal end of the tube towards the proximal end of the tube by friction created between a textured portion of the inflatable cuff and an external surface of a patient.

8. The medical device of claim 1, further comprising indicator markers associated with the tube for indicating the position of the tube relative to a portion of a patient.

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

10. A medical device, comprising:

a tube having a proximal end and a distal end capable of being inserted into a passageway of a patient;

a cuff associated with the distal end of the tube, wherein the cuff is capable of transitioning from the distal end of the tube towards the proximal end of the tube; and

an attachment portion for attaching a portion of the cuff to the tube for helping to assist the cuff in transitioning from the distal end of the tube towards the proximal end of the tube.

11. The medical device of claim 10, further comprising a proximal balloon cuff associated with the proximal end of the tube.

12. The medical device of claim 1 1, further comprising at least one pilot balloon for inflating and deflating the cuff; and a second pilot balloon for inflating and deflating the proximal balloon cuff.

13. The medical device of claim 10, wherein the cuff comprises a material selected from the group consisting of polyvinyl chloride, silicone, neoprene, polyisoprene, polyurethane, polyethylene teraphthalate, and low-density polyethylene.

14. The medical device of claim 10, wherein the attachment portion for attaching the cuff to the tube has a first location that is adjustable relative to the distal end of the tube.

15. The medical device of claim 10, wherein the cuff transitions from the distal end of the tube towards the proximal end of the tube by rolling along the tube.

16. The medical device of claim 10, further comprising indicator markers associated with the tube for indicating the position of the tube relative to the patient.

17. The medical device of claim 10, wherein the cuff comprises a material selected from the group consisting of polyvinyl chloride, silicone, neoprene, polyisoprene, polyurethane, polyethylene teraphthalate, and low-density polyethylene.

18. A method for protecting a distal end of a tube during a medical procedure, comprising: substantially surrounding the distal end of the tube with a rolling cuff, wherein the rolling cuff is cable of rolling along the tube from the distal end of the tube to a proximal end of the tube; and

inserting the distal end of the tube into a passageway of a patient during a medical procedure.

19. The method for protecting a distal end of a tube during a medical procedure according to claim 18, wherein the rolling cuff is capable of being inflated to form a seal within an airway of the patient.

20. The method for protecting a distal end of a tube during a medical procedure according to claim 19, wherein the rolling cuff is capable of being deflated.

21. The method for protecting a distal end of a tube during a medical procedure according to claim 18, wherein the rolling cuff comprises a material selected from the group consisting of polyvinyl chloride, silicone, neoprene, polyisoprene, polyurethane, polyethylene teraphthalate, and low-density polyethylene.

22. The method for protecting a distal end of a tube during a medical procedure according to claim 21, wherein the rolling cuff comprises a wall having a portion less than 60 micrometers in thickness.

23. The method for protecting a distal end of a tube during a medical procedure according to claim 18, wherein an antimicrobial coating is disposed on at least a portion of the rolling cuff.