US20100242957A1 - Combination Artificial Airway Device and Esophageal Obturator - Google Patents
Combination Artificial Airway Device and Esophageal Obturator Download PDFInfo
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- US20100242957A1 US20100242957A1 US12/816,443 US81644310A US2010242957A1 US 20100242957 A1 US20100242957 A1 US 20100242957A1 US 81644310 A US81644310 A US 81644310A US 2010242957 A1 US2010242957 A1 US 2010242957A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0402—Special features for tracheal tubes not otherwise provided for
- A61M16/0409—Special features for tracheal tubes not otherwise provided for with mean for closing the oesophagus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0402—Special features for tracheal tubes not otherwise provided for
- A61M16/0415—Special features for tracheal tubes not otherwise provided for with access means to the stomach
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0434—Cuffs
- A61M16/0445—Special cuff forms, e.g. undulated
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0434—Cuffs
- A61M16/0454—Redundant cuffs
- A61M16/0459—Redundant cuffs one cuff behind another
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0486—Multi-lumen tracheal tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0434—Cuffs
- A61M16/044—External cuff pressure control or supply, e.g. synchronisation with respiration
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- Emergency Medicine (AREA)
- Engineering & Computer Science (AREA)
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- Heart & Thoracic Surgery (AREA)
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- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
A combination artificial airway device and esophageal obturator (10) includes a pressure indicator (25) surrounding a pilot balloon (28) for continuous monitoring of the internal pressure within the cuffs (14 & 16).
Description
- This application is a divisional of application U.S. Ser. No. 11/368,881 filed on Mar. 6, 2006 which is a continuation-in-part of U.S. Ser. No. 10/289,655 filed on Nov. 7, 2002, now issued U.S. Pat. No. 7,040,322 B2 which is a continuation-in-part of U.S.
Provisional Application 60/339,092 filed on Nov. 8, 2001. - The field of this invention relates to medical airway device having a supraglottic inflatable cuff and a cuff pressure indicator.
- Endotracheal tubes have long been accepted to establish a direct path from the trachea to the ambient exterior or to a ventilation machine. However, endotracheal intubation requires a high degree of skill and the use of supporting medical devices such as a laryngoscope for visualization of the glottis. Furthermore, an endotracheal tube on its way to a trachea passes into the larynx and adjacent to delicate structures which poses a potential for serious damage to this important speech organ. Accidental insertion into the esophagus can also occur.
- Supraglottic masks which do not intrude into the trachea avoid the known problems of endotracheal tubes. Laryngeal masks, as a supraglottic device, have become accepted alternatives to avoid the need of sealing within the trachea or the accidental insertion of the endotracheal tube into the esophagus.
- Early versions of alternatives to endotracheal tubes used inflatable cuffs but needed an exterior face mask placed over the face of the patient to stop air leakage while the patient is being ventilated via the air ports.
- One widely accepted laryngeal mask device is disclosed in U.S. Pat. No. 4,509,514 to Archibald Brain. This artificial airway device is in the form of a laryngeal mask airway. This laryngeal mask airway comprises of a tube opening into the interior of a mask portion. The periphery of the mask may be inflatable and provides a seal around the inlet of the larynx.
- A disadvantage related with the use of this traditional laryngeal mask device is encountered in patients who are at risk from vomiting or regurgitating stomach contents while unconscious. Although the device is known to form a seal around the laryngeal inlet sufficient to permit artificial ventilation of the lungs, this seal may be sometimes insufficient to prevent lung contamination during retching, vomiting or regurgitation. Besides, the bulk size of these devices may impede, or create difficulties to the prompt access to the esophagus for the passage of an oral or nasal gastric tube to drain eventual esophageal/stomach contents. Due also to its design, it is possible that when a certain ventilation pressure is reached or when the device is not properly placed, a leak of gases from the repetitive ventilation attempts may reach and enter the esophagus, inflating the stomach increasing the risk of regurgitation and discharge of its contents.
- In order to minimize these serious problems, modifications were proposed and introduced on these laryngeal mask ventilation devices to provide a sort of gastric drainage as disclosed in U.S. Pat. Nos. 5,241,956 and 6,439,232 to Brain. These were all basically designed by adding a second esophageal tube, ending at the supraglottic mask distal cuff tip. This second tube is usually molded by a semi rigid open ring, inside the body of the pneumatic cuff of the mask. This construction, when all is working well, allows the hollow orifice of the esophageal tube to be properly aligned with the esophageal entrance, so it could drain its content or allow a passage of an oro-gastric tube through it.
- However for this device to work, proper insertion and positioning of the ventilation device (supraglottic mask) at the hypopharynx is critical. Its tip must be properly facing the esophageal entrance. If the mask is not in the right position, the proposed esophageal draining may not properly occur which may result in an increased risk of leakage of the esophageal/gastric contents. Any such contents may then be undesirably aspirated into the lungs with serious consequences. In order to accommodate an esophageal draining tube in addition to the tracheal tube, the thickness of this device is increased. The increased thickness may make proper insertion and installation of the device into the patient's throat more difficult.
- Another device directed to reducing the risk of regurgitation and at the same time to provide for lung ventilation is disclosed in U.S. Pat. No. 5,499,625 by Frass. This is a twin lumen coaxial device designed for use in emergency situations and difficult airways. It can be inserted blindly into the oropharynx and usually enters the esophagus in about 90% of times. It has a low volume inflatable distal cuff and a much larger proximal pharyngeal cuff designed to completely occlude the oropharynx and the nasopharynx. It provides effective lung ventilation regardless of whether esophageal or tracheal placement is accomplished. When it is placed in the trachea, it functions as an endotracheal tube, with the distal cuff sealing the tube against the tracheal wall. When its distal cuff is in the esophagus, ventilation is possible through a second lumen that ends at perforations at the pharyngeal side of the tube above the lower cuff that occludes the esophagus and below the upper pharyngeal cuff. Due to its design, this device is limited to unconscious patients over five feet (5) in height. Furthermore, an operator needs to be aware of symptoms to assure proper placement. If auscultation of breath sounds are negative and gastric insufflation is positive, the operator needs to immediately switch the lumen to provide air into the alternate airway. Its positioning is critical, as the airway could be occluded if not properly placed and the proper lumen is not used.
- U.S. Pat. No. 4,995,388 to Archibald I. Brain discloses a larynx mask with a drain tube intruding into the esophagus and with an esophageal sealing cuff. Proper insertion of this particular device is very difficult. Also, in this device, the inflation line leads to the pharynx cuff and then serially down to the esophageal cuff.
- U.S. Pat. Nos. 5,241,956; 5,355,879; 5,632,271; and 5,878,745 to Archibald Brain disclose a respective larynx mask with two inflatable seals for sealing about the pharynx. The seals may be inflated by a common inflation line or by separate inflation lines.
- U.S. Pat. No. 4,016,885 to Bruner issued on Apr. 12, 1997, has described a device to indicate the gas pressure in inflatable cuff-type catheters, by expansion of the cuff and scaling this expansion. The main goal of Bruner's device is to provide a pressure indicator for endotracheal and tracheostomy tubes, to avoid trauma due to overpressure. This is mainly achieved by employing an open ended spring wound at the mid-section of an elliptically shaped expansion chamber. However, this device is not designed to measure and alert the occurrence of under pressure events.
- What is needed is a supraglottic mask with an esophageal drain tube and esophageal cuff in combination with an improved seal on the pharynx cuff, an improved pressure indicator, and an improved method of installation that will quickly form an esophageal obturator to reduce risk of choking on gastrointestinal contents.
- In accordance with one aspect of the invention, an inflatable supraglottic mask for an artificial airway device has an inflatable supraglottic cuff with an inflatable peripheral seal with walls. Each wall has inner and outer surfaces in part defining the pressured interior of the peripheral seal. A plurality of tension supports extend between and are connected to both of the inner and outer surfaces and extend through the pressured interior of the peripheral seal to prevent the surfaces from lateral deformation outward when the cuff is inflated. For some applications, this supraglotical cuff could also be made plain with soft walls, without creases, in a tire like fashion.
- Preferably this supraglottic mask for an artificial airway device includes an inflatable supraglottic cuff having a peripheral seal with bellow shaped walls for inflating to a wedge shape. On the bellow shaped supraglotical cuff version, the bellow shaped walls have a plurality of bellow creases that fan out from an interior apex section when inflated to provide the inflated wedge shape from the interior apex section to a proximal wide section. The inflatable supraglottic cuff is connectable to air pressure lumen for control of inflation and deflation of the bellow shaped walls.
- In accordance with another aspect of the invention, an inflatable supraglottic mask for an artificial airway device has an inflatable supraglottic cuff with an inflatable peripheral seal. The seal has bellow shaped walls each having opposing pleated surfaces opposing each other. A plurality of tension supports extend between and are connected to both of the opposing pleated surfaces to prevent the pleated surfaces from deformation outward when the cuff is inflated.
- Preferably, the plurality tension supports each are in the form of a pocket with lateral walls extending from a lateral outer surface of the bellow shaped wall to a lateral inner surface of the bellow shaped wall. It is desired that the plurality of pockets are spaced about the peripheral seal of the cuff.
- In accordance with another aspect of the invention, an inflatable cuff for an artificial airway device has an inflatable peripheral seal with bellow shaped walls for inflating to a wedge shape. Each bellow shaped wall has a plurality of opposing pleated surfaces. A plurality of tension supports extend across the interior of the inflatable peripheral seal and are secured to both of the opposing pleated surfaces.
- Preferably the supraglottic mask has a conduit with two separate tracheal and esophageal lumens laterally positioned adjacent each other with the tracheal lumen having an inlet within the confines of the peripheral seal and the esophageal lumen extending through an esophageal limb posteriorily of the wedge in proximity to the apex section. It is desired that the posterior wall of the conduit is substantially flat to reduce rotation while positioned in the pharynx section of a patient.
- It is also desired that the double lumen conduit has a substantially rectangular cross-sectional configuration with rounded corners for reducing its thickness. The bulkiness in the oro-pharyngeal cavity and hypopharynx is thus reduced, which in turn reduces the chances of trauma, although preserving its cross-sectional area to assure the proper flow of air to the trachea and for any eventual esophageal drainage.
- It is further desired that an epiglottis band is attached near the wider or proximal border of the supraglottic cuff at an anterior section of the bellows for lateral extension and facing a laryngeal aperture to push forward and protect an epiglottis up to its natural flexed and opened position during the pneumatic expansion of the supraglottic cuff thereby reducing the risk of trauma to the epiglottis.
- In one embodiment, the conduit has a reinforced ring located at the proximal segment thereof just before the conduit separates into a ventilation limb and esophageal limb for reducing damage and kinking of the double lumen tube when it passes through the mouth and teeth.
- In accordance with another aspect of the invention, a combination artificial airway device and esophageal obturator includes a supraglottic inflatable cuff for installation above the esophageal opening at the oropharynx and the hypopharynx, and an esophageal inflatable cuff for installation in the esophagus. A tracheal lumen has an inlet within the peripheral seal formed by the supraglottic cuff. An esophageal drain lumen extends past the supraglottic inflatable cuff and through the esophageal cuff. An inflation line is serially connected to the esophageal cuff and then to the supraglottic cuff such that the inflating air supply passing through the inflation line passes to the esophageal cuff before passing to the supraglottic cuff.
- The inflatable supraglottic cuff has an inflatable peripheral seal with walls that have inner and outer surfaces in part defining the pressured interior of the peripheral seal. A plurality of tension supports extend between and are connected to both the inner and outer surfaces and extend through the pressured interior of the peripheral seal to prevent the surfaces from lateral deformation outward when the cuff is inflated.
- Preferably, the inner and outer walls have a bellow shaped with pleats for inflating to a wedge shape. The pleats fan out from a interior apex section when inflated to provide the inflated wedge shape from the interior apex section to a proximal wide section. The tension supports extend between and are connected to opposing pleats to prevent the pleats from blowing out to retain the bellow shape when the supraglottic inflatable cuff is inflated.
- It is preferred that a section of the inflation line passing from the esophageal cuff to the supraglottic cuff has more restriction than the inflation line leading to the esophageal cuff thereby promoting inflation of the esophageal cuff before inflation of the supraglottic cuff during normal inflation rates, such that the esophagus is isolated and previously sealed by the inflated esophageal cuff before the supraglottic cuff assumes its final inflated and sealing position.
- It is further desired that the supraglottic cuff has its peripheral seal formed from bellow shaped walls for inflating to a wedge shape. The bellow shaped walls have a plurality of pleats or folds that fan out from an interior apex section when inflated to provide the inflated wedge shape from the interior apex section to a proximal wide section.
- In another aspect of the invention it is desired that the supraglottic cuff could also have its peripheral seal formed from plain shaped walls for inflating to a wedge shape. The cuff walls expands out from an interior apex section when inflated to provide the inflated wedge shape from the interior apex section to a proximal wide section.
- In accordance with another aspect of the invention, a combination artificial airway device and esophageal obturator includes a supraglottic inflatable cuff for installation above the esophageal sphincter or opening at the oropharynx and hypopharynx, and an esophageal inflatable cuff for installation in the esophagus. A tracheal lumen has an inlet entrance within the confines of the supraglottic cuff and in communication with the tracheal passage of the patient.
- An esophageal lumen extends past the supraglottic inflatable cuff and through the esophageal cuff. An inflation line is for inflating both the esophageal cuff and supraglottic cuff. The supraglottic cuff has an asymmetrical inflatable section that has a wider proximal section situated above the epiglottis with its distal thinner termination end situated over the esophageal sphincter or entrance just behind the larynx to provide increased stability by its two points of sustain fixation. The stability is assured by a firmly positioned terminal esophageal cuff inside the esophagus, and the second, or the proximal point, at the exterior segment of the asymmetrical supraglottic cuff secured in the oropharynx area and fixed externally to the peri-oral aperture. This stable two point security makes it possible, during pneumatic expansion, to ergonomically embrace and seal the peri-laryngeal structures contour.
- Preferably, the tracheal lumen and esophageal lumen are in a low profile double lumen tube with the lumens asymmetrically positioned laterally side by side. Preferably the tracheal lumen is wider than the esophageal lumen. The tube has a substantially flat posterior wall. The posterior wall in one embodiment is directly abuttable with the posterior wall of the pharynx and hypopharynx thereby restraining the tubes rotation while providing a solid and also stable base for the supraglottic cuff expansion.
- Preferably, the supraglottic inflatable cuff is designed to be inflated in sequence after the esophageal cuff is pressurized by an independent backward fed internal inflation-deflation tube originating from the esophageal cuff and draining to the supraglottic cuff.
- It is also desired that the device has a slight “s” shape form with a downward inclination of its distal point to facilitate esophageal access and an upward inclination of approximately 70 degrees angle proximal to the supraglottic cuff to be compatible with the anatomy of the pharynx toward the mouth.
- It is preferred that a pilot balloon is mounted in the inflation line. The balloon is made from an elastic material and is circumferentially surrounded by a semi-spiral cylinder made from a resilient spring material. As a result of the pilot balloon inflation, the spring expands and is calibrated to indicate the pressure in the inflation line and cuffs. The expansion of the pilot balloon is a result of its inflation. The pressure build up will force an increase in the semi-spiral cylinder diameter that can be calibrated in a scale reflecting the internal pressure in the inflation line and cuffs.
- In accordance with another aspect of the invention, a cylindrical pilot balloon is inserted in an inflation line leading to the sealing cuff. A semi-spiral cylinder extends the entire length of and circumscribes, i.e., circumferentially surrounds the pilot balloon. The semi-spiral cylinder is made from a resilient spring like material. Its expansion is a result of expansion of the pilot balloon and is visually marked to indicate an acceptable pressure range in the inflation line. The semi-spiral cylinder has an increase in diameter and its free edge, acting as an indicator, sliding over another wall section of the semi-spiral cylinder which has a color scale thereon for continuously indicating the pressure status in the sealing cuff and to visually alert when a pressure outside the acceptable pressure range occurs. Other easily readable scales are also foreseen.
- Preferably, the color scale for continuously indicating the pressure in the sealing cuff has a green bar which when revealed by the sliding free edge, indicates that the internal cuff pressure is within the normal limits and at least one red bar for indicating an abnormal pressure condition. Desirably, the green bar is placed between two red bars.
- In accordance with another aspect of the invention, a method of intubation of a patient includes inserting an artificial airway device and esophageal obturator through the mouth and pharynx of a patient and inserting its distal end into the esophagus of the patient such that an esophageal drain tube and esophageal cuff are positioned in the esophagus and a supraglottic cuff with a tracheal lumen is positioned above the esophageal entrance with the tracheal lumen in communication with the trachea of the patient. The method further includes inflating the esophageal cuff to seal off the esophagus and subsequently inflating the supraglottic cuff to provide a seal about the peri-laryngeal structures of the patient.
- It is preferred that the method includes the supraglottic cuff being asymmetrically shaped such that when inflated, its proximal section is wider and positioned above the epiglottis and a narrow section is placed at the opening of the esophagus.
- It is preferred that the epiglottis of the patient is retained in its normal open up position toward the anterior wall of the pharynx by a strap laterally extending across the supraglottic cuff between two inflatable side walls of the cuff.
- Reference now is made to the accompanying drawings in which:
-
FIG. 1 is a perspective view of a larynx mask ventilation device; -
FIG. 2 is an enlarged fraymentary view illustrating the esophageal and supraglottic cuffs; -
FIG. 3 is a front elevational view of the cuffs shown inFIG. 2 ; -
FIG. 4 is a rear elevational view of the cuffs as shown inFIG. 2 ; -
FIG. 5 is a front perspective of the supraglottic cuff; -
FIG. 6 is a cross-sectional view taken along lines 6-6 shown inFIG. 2 ; -
FIG. 6A is a view similar toFIG. 6 showing a pleatless modified embodiment; -
FIG. 7 is a view similar toFIG. 6 illustrating a modified embodiment; -
FIG. 7A is a view similar toFIG. 7 showing a pleatless modified embodiment; -
FIG. 8 is a cross-sectional view of one wall of the supraglottic cuff taken along lines 8-8 shown inFIG. 5 ; -
FIG. 9 is a cross sectional view taken along lines 9-9 shown inFIG. 2 ; -
FIG. 10 is a schematic view illustrating the serial air path for sequentially inflating and deflating the esophageal and supraglottic cuffs; -
FIG. 11 is a diagrammatic and generally side elevational view shown in an initial position in a patient with both cuffs deflated; -
FIG. 12 is a view similar toFIG. 11 illustrating the esophageal cuff inflated in position; -
FIG. 13 is a view similar toFIG. 11 illustrating the device in a fully installed position with both the esophageal and supraglottic cuffs inflated; -
FIG. 14 is a enlarged fragmentary and exploded view of the pilot balloon shown inFIG. 1 ; and -
FIG. 15 is a cross-sectional view taken along lines 15-15 shown inFIG. 1 . - Referring now to
FIG. 1 , a combination artificial airway device andesophageal obturator 10 includes alaryngeal mask 12 that has an inflatablesupraglottic cuff 14. Thedevice 10 also includes an inflatableesophageal cuff 16 near a distal end of anesophageal drain tube 18. - The
device 10 is shown in a resting position with a “S” like shape with the distal end of thedrain tube 18 curved in a convex or upright direction as shown inFIGS. 11-13 and theconduit 20 curved approximately at an angle of 70 degrees in an opposite or concave direction, i.e. downward direction as shown in use inFIGS. 11-13 . Of course, the device is flexible to allow proper handling and installation. - The proximal end of conduit splits off into an
esophageal limb 22,tracheal limb 24 and inflation limb ortube 26 withpilot balloon 28. Thepilot balloon 28 can be made from an elastic material and is generally cylindrical in shape. As shown more clearly inFIGS. 14 and 15 , thepilot balloon 28 is circumscribed or circumferentially surrounded along its entire length by asemi-spiral cylinder 25 made from a resilient spring like material (thin metal or plastic) where its expansion, in consequence of the pilot balloon inflation, can be visualized and calibrated to indicate the internal pressure. It also will recoil, i.e., resiliently return to a normal rest position which corresponds to a deflated position of the pilot balloon. The expansion of this pilot balloon, as a result of its inflation and a pressure build up, will force an increase in the semi spiral cylinder diameter that can be calibrated through ascale 27. Thescale 27 may be an easily read text scale or a color scale, for example redcolored bars colored bar 31 interposed between the twored bars semi-spiral cylinder 25. Thedistal edge 23 of thespiral spring 25 lies over the under layer with the redcolored bars 33 and 37 and greencolored bar 31 thereon. By this way, monitoring and indicating of main cuff internal pressure is continuous during all times, reflecting its immediate inflation and deflation status. Thepilot balloon 28 with thebars main cuffs - A reinforcing
ring 30 is placed aboutconduit 20 just before the splitting off oflimbs limbs Limb 24 may have for example a 15 mm male connector.Limb 26 may have for example a unidirectional valve and a syringe adaptor. - Referring now to
FIGS. 2-4 , theconduit 20 is a double lumen tube with atracheal lumen 32,esophageal lumen 34 andinflation line 29 therein.Inflation line 29 is fluidly connected toinflation limb 26.Line 29 can be approximately 1 mm plastic tube for inflating and deflating thecuffs lumens common dividing wall 35 therebetween. Theconduit 20 has a flattened shape with relatively flatanterior wall 36 andposterior wall 38.Conduit 20 has a generally rectangular cross-section shape with rounded corners. - The
mask 12 includes thesupraglottic cuff 14 which provides aperipheral seal 15 that is substantially tear drop shaped or oval shaped about a concave front side with acenter recess 40 that has anentrance 42 to thetracheal lumen 32. Anepiglottic band 50 laterally extends acrossrecess 40 and is attached to the twoside walls 44 of the cuff in proximity to the proximalupper wall 48. The twoside walls 44 merge at adistal apex 46 section. - The
apex section 46 of the supraglottic cuff is spaced fromesophageal lumen 16 and connected thereby with anintermediate section 52 ofconduit 20. Thissection 52 haslumen 34 therein along withinflation line 29 extending directly toesophageal cuff 16 and arestrictive line 54 that extends from theesophageal cuff 16 to thesupraglottic cuff 14. Theline 54 is significantly more restrictive thanline 29 by having a substantially smaller diameter as clearly shown inFIG. 9 .Intermediate line 54 connects directly to and forms part of theesophageal drain tube 18. -
Esophageal cuff 16 is an annular inflatable bladder that inflates with air pressure introduced fromline 29. Theconduit line 54 of thedrain tube 18 passes therethrough and is sufficiently rigid to not collapse under normal operating cuff pressures exerted onesophageal cuff 16. Thedistal end 55 ofline 18 has a rounded duck bill shape, i.e. tapered shape, withdrain opening 56 therein. - Air pressure can pass into
line 54 to fill upsupraglottic cuff 14.Conduit 20 is similarly sufficiently rigid to withstand collapse from normal inflation pressures exerted byinflated cuff 14. - As shown more clearly in
FIG. 6 , theside walls 44 are formed by bellows orpleats 60 which give thewalls 44 an accordion like or pleated appearance. Proximalupper wall 48, not shown inFIG. 6 , is similarly constructed. The bellows orpleats 60 merge near the apex 46 to provide more expansion or inflation near the proximalupper wall 48 to provide a wedge shape for thecuff 14 when inflated. Aportion 61 ofside wall 44 is integral withside walls 62 ofconduit 20.Side walls 44 and proximalupper wall 48 are inflatable and thus expandable such that it forms a definedrecess 40 on its concave side in front of theanterior wall 36 ofconduit 20. The normal position of thebellows 60 may be in the deflated state as shown inFIGS. 1 and 11 . The pleats may provide some resilient bias to the deflated position which is shown inFIGS. 11 and 12 from the inflated state shown inFIG. 13 . - Alternatively as shown in
FIGS. 6A and 7A , the samesupraglottic cuff 14 may have thewalls 44 plain, i.e. have a pleatless columnar shape.FIG. 7A refers to the same design weresupraglottic cuff 14 extend to a posteriorinflatable section 64 that is situated posteriorly ofwall 38. - The
conduit 30 has a substantially rectangular cross-sectional configuration with rounded corners. Theposterior wall 38 is thus substantially flat in a lateral direction and forms a posterior wall that is abuttable against the posterior wall of the hypopharynx of the patient as shown inFIGS. 11-13 . - Alternatively as shown in
FIG. 7 , asupraglottic cuff 14 may have thewalls 44 extend to a posteriorinflatable section 64 that is situated posteriorly ofwall 38. In this embodiment, the posterior section has aposterior wall 66 that is spaced fromwall 38 and is shaped to abut against the posterior walls of the hypopharynx section of the patient. - The
walls outer surfaces FIGS. 5-8 . Thepleats 60 on eachsurface other supports 51 extend from opposingpleats 60 on therespective surfaces cuff 14 and become taut when the cuff is inflated to prevent thepleats 60 from flexing outward. Thus, thepleats 60 andcuff 14 are more stable against laterally directed stresses that may otherwise blow out thepleats 60 when the cuff is in the expanded inflated state. - These tensioning straps 51 may be spaced about
cuff 14 and on each set of opposingpleats 60. Due to manufacturing expediencies, thestraps 51 may be formed by molding about a punch so that apocket 57 is formed that extends all the way from theouter surface 47 to theinner surface 45. Thestraps 51 thus can haveside walls 58 and top andbottom walls 59. Thus, the spaced straps 51 with thepockets 57 have an asymmetrical look to them from theouter surface 47 to the connection withinner surface 45 as shown inFIGS. 5 , 6 and 8. - While the illustrated straps 51 and pockets appear to be flattened rectangular shapes, trapezoidal or tubular straps are also foreseen. Wedge shaped pockets 57 are also foreseen. Symmetrical straps formed by pockets extending from both
surfaces walls FIG. 7 shows analternate strap 51 which is a single layer of elastomeric material extending between thepleats 60 with no formedpocket 57. - In operation, the
device 10 is manually inserted through themouth 68 of a patient as shown inFIG. 9 in a deflated condition. The distal end is directed through theesophageal sphincter 72 and intoesophagus 70. The rounded duck bill end 55 of thedrain tube section 18 and the “S” shape of the device promote entry into theesophagus 70. The roundedduck bill end 55 reduces trauma when it breaches through the esophageal sphincter. - The positioning of the device is easy because resistance is felt when the
mask 14apex portion 46 is lowered behind the arytenoid cartilage on the posterior wall of the supraglottic larynx. More particularly apex 46 is nested at the esophageal sphincter. Further insertion is then resisted which can be easily felt by the nurse, doctor or the operator. This increased resistance signals when to stop insertion and begin inflation throughlimb 26. - In this intruded position, the reinforced
ring 30 is aligned with theteeth 69 withinmouth 68 such that any pressure to close theconduit 20 and any of thelumens inflation line 29 is successfully resisted by the structural support of thering 30. It is also foreseen that the conduit material itself may be reinforced in this area to be structurally resistance against collapse. - As inflation proceeds through
limb 26 theesophageal cuff 16 is the first cuff to inflate becauseline 29 proceeds directly tocuff 16. In other words line 29bypasses cuff 14 and proceeds directly tocuff 16. The inflation ofcuff 14 is also delayed because theline 54 that communicates fromcuff 16 back tocuff 14 is restrictive which delays the inflation ofcuff 14. Theline 54 is small enough to delay the inflation ofcuff 14 untilcuff 16 if fully inflated during normal inflation rates forsuch devices 10. A schematic of the inflation lines is shown inFIG. 10 which schematically showspilot 28,limb 26,line 29,esophageal cuff 14,restrictive line 54 andsupraglottic cuff 14 serially connected. - It is also foreseen that other mechanism can be used to sequence the inflation of the
cuffs cuff 16 may be more flexible and be slowed to inflate under less pressures than the materials used incuff 14. Another alternative is that thepleats 60 may provide enough resilient resistance toward the deflated position against the inflation until thecuff 16 is fully inflated. The main point is that the device provides for a sequenced inflation ofesophageal cuff 16 before the inflation of thecuff 14. - The advantage for the inflation of the
esophageal cuff 16 is that sequencing the inflation of the two cuffs provides for a faster inflation of theesophageal cuff 16 which provides faster protection against any potential regurgitation by the patient. -
FIG. 12 shows the intermediate step when theesophageal cuff 16 is fully inflated but thecuff 14 is still in the deflated position. As shown as thecuff 16 is fully inflated, air is still passed throughlimb 26 andline 29 and now it flows throughcuff 16 and back throughline 54 tosupraglottic cuff 16. - Referring now to
FIG. 13 , thecuff 16 inflates, the cuff or bellows expand to provide for theside walls 44 andproximal wall 48 to increase width and form a seal about thetracheal entrance 74. Thetracheal entrance 74 is sealed from the esophageal passage. The tracheal entrance is in communication withtracheal entrance 42 in the recess of themask 12. Thewalls posterior wall 78 of the pharynx such that the inflated walls push against theanterior tissues 80 about thelaryngeal entrance 74. - The
pleats 60 provide for an inflated cuff that is asymmetrical in shape. Namely, a wedge or cone type shape is accomplished with the apex 46 near a narrow or thinner end and thewall 48 at the wider or thicker end. This wedge shape corresponds more closely with the natural shape of the patient's oro-pharynx and hypopharynx cavity. The tension straps 51 provide for a more columnar format and deter the cuff sidewalls 44 and 48 from distorting or expanding laterally or to assume a rounded tire-like shape. - The laryngeal entrance is in communication with the concave side or
recess 40 and thetracheal lumen entrance 42 which lead out to thetracheal limb 24. - The
epiglottic band 50 is positioned and fixed on theside walls 44 to catch up with theepiglottis 82 and while thecuff 14 is inflating the band will push the epiglottis forward to its naturally open or flexed position as shown inFIG. 11 . This reduces trauma to theepiglottis 82 and reduces complications in lung ventilation. - As can now be recognized, any gastric or esophageal reflux can then be drained through the
tube 18 andlumen 34 out throughlimb 22. If necessary, an oro-gastric tube can be easily passed directly to the stomach through theesophageal limb 22,lumen 34 andentrance 56. - After the device is used and removal is desired, the
line 29 can be opened or a syringe can be used to deflate the twocuffs cuff 16 will deflate first and then thecuff 14 will deflate to allow quick removal from the esophagus. - In this fashion the
supraglottic cuff 14 will pneumatically inflate and expand to seal the peri-laryngeal structures only after the esophagus is isolated and has been previously sealed by the inflatedesophageal cuff 16. This assures the esophageal limb 22 a free pathway of any gastric-esophageal content to the exterior. Furthermore, a separate peripheral seal is formed about the peri-laryngeal mucosa adding an extra guarantee against any aspiration of gastro-esophageal contents. This seal also provides a clear way for the ventilation of the lungs. - The two cuffs, with a flat non-rotatable conduit provides for a stable intubation device less prone to undesirable displacement. The flat rectangular shaped conduit with the side by side double lumen structure positioned between the side
inflatable walls 44 provide for alow profile mask 12 which can be easily inserted and then inflated to render proper sealing. - Furthermore, the asymmetrical ergonomic wedge or cone like shape of the inflated supraglottic mask provides for less intrusion and trauma to the surrounding tissues with the apex situated over the esophageal entrance or sphincter just behind the larynx and its wide end situated above the epiglottis. The band also provides for reduced trauma to the epiglottis.
- The wedge like or cone like shape of the cuff allows the esophageal lumen to pass behind the
mask 12 while still maintaining a low profile for easier insertion through the oral cavity and its passage throughout the oro-pharynx, hypo-pharynx and finally into the esophagus with reduced trauma of these structures. - The device may be made from an elastomeric silicone rubber or from another bio-compatible plastics in either a non-disposable and reusable format or in a disposable format.
- The optional rear inflation section can provide even further pressure on the anterior wall of the hypo-pharynx to create increased forward pressure against the peri-laryngeal supraglottic structures and creating a tighter seal of the laryngeal entrance.
- It is also foreseen that the tension straps can be incorporated into columnar walls that do not have pleats where the walls are taller than the separation of the two
side surfaces - The reinforced ring provides for reduced damage and reduced risk of kinking of the
double lumen conduit 20 when it passes through the mouth and teeth. - The continuous pressure monitor reduces the chance of overpressure and an over expansion of the cuffs which in turn may cause deleterious effects on the circulation (an increase in compression blocks or delays the mucosal circulation). This increased intracuff pressure could lead to a higher incidence of sore throat pain or even necrosis, from the eventual ischemia and injury. Another reason to monitor the intracuff pressure besides to avoid its initial “overinflation” is, also when a ventilation device is used in anesthesia, and N2O (Nitrous Oxide) gas is added to oxygen (a common procedure to increase analgesia and reduce anesthetic consumption) this gas in time diffuses through the cuff walls to inside the cuff, it will also in time increase the intercuff pressure.
- Furthermore, an underpressure due to inappropriate cuff inflation could also be deleterious as the proper contact between the cuff walls and the mucosal surface may not occur. This could lead to leaks of air during the patient ventilation, resulting in not only inappropriate ventilation, but also an increased risk for lung aspiration of any eventual gastric content, in case of regurgitation, as the proper laryngeal seal is not achieved. The continuous monitoring by the pilot balloon provides an extra safeguard against these undesirable traumas.
- Variations and modifications are possible without departing from the scope and spirit of the present invention as defined by the appended claims.
Claims (9)
1. A cuff pressure indicator for an artificial airway device having a sealing cuff, said cuff pressure indicator comprising:
a cylindrical pilot balloon inserted in an inflation line leading to said sealing cuff;
a semi-spiral cylinder extending the entire length of and circumferentially surrounding said cylindrical pilot balloon;
said semi-spiral cylinder being made from a yieldably resilient spring like material where its expansion is caused by expansion of the pilot balloon, said semi-spiral cylinder being visually marked with visual indicia to indicate an acceptable pressure range in the inflation line; and
said semi-spiral cylinder having an increase in diameter and a distal edge sliding over another wall section of said semi-spiral cylinder which has said visual indicia thereon for continuously indicating the pressure in said sealing cuff and to visually alert when a pressure outside said acceptable pressure range occurs.
2. A cuff pressure indicator for an artificial airway as defined in claim 1 further comprising:
said visual indicia being a color scale thereon for continuously indicating the pressure in said sealing cuff, said color scale comprising a green bar for indicating that the internal cuff pressure is within the normal limits; and
at least one red bar for indicating an abnormal pressure condition.
3. A cuff pressure indicator for an artificial airway as defined in claim 2 further comprising:
said green bar placed between two red bars;
an indicator being the distal edge of a semi-spiral cylinder, sliding over another wall section of the same cylinder;
said semi-spiral cylinder increasing and decreasing in its diameter as a function of the expansion or contraction of said cylindrical pilot balloon; and
said cylinder shaped pilot balloon expanding and contracting as a function of its internal pressure corresponding to the relative cuff pressure.
4. A cuff pressure indicator for an artificial airway device having a sealing cuff, said cuff pressure indicator comprising:
a cylindrical pilot balloon inserted in an inflation line leading to said sealing cuff;
a semi-spiral cylinder extending along a length of and circumferentially surrounding said cylindrical pilot balloon;
said semi-spiral cylinder being made from a yieldably resilient spring like material where its expansion is caused by expansion of the pilot balloon;
said semi-spiral cylinder having a distal edge sliding over an inner coil wall section of said semi-spiral cylinder which has visual indicia thereon for continuously indicating the pressure in said sealing cuff and to indicate an acceptable pressure range in the inflation line.
5. A cuff pressure indicator for an artificial airway as defined in claim 4 further comprising:
said visual indicia being a color scale thereon for continuously indicating the pressure in said sealing cuff, said color scale comprising a green bar for indicating that the internal cuff pressure is within the normal limits; and
at least one red bar for indicating an abnormal pressure condition.
6. A cuff pressure indicator for an artificial airway as defined in claim 5 further comprising:
said green bar placed between two red bars;
an indicator being defined by the distal edge of a semi-spiral cylinder, sliding over said inner coil wall section of the same cylinder to lie over said green bar when a correct cuff pressure is present and to lie over one of said two red bars when said cuff pressure is either too low or too high;
said semi-spiral cylinder increasing and decreasing in its diameter as a function of the expansion or contraction of said cylindrical pilot balloon; and
said cylinder shaped pilot balloon expanding and contracting as a function of its internal pressure corresponding to the relative cuff pressure.
7. A cuff pressure indicator for an artificial airway device having a sealing cuff, said cuff pressure indicator comprising:
a cylindrical pilot balloon inserted in an inflation line leading to said sealing cuff;
a semi-spiral cylinder extending the entire length of and circumferentially surrounding said cylindrical pilot balloon;
said semi-spiral cylinder being made from a yieldably resilient spring like material where its expansion is caused by expansion of the pilot balloon; and
said semi-spiral cylinder having an increase in diameter and a distal edge sliding over another wall section of said semi-spiral cylinder which has a colored scale thereon for continuously indicating the pressure in said sealing cuff and to visually alert when a pressure outside said acceptable pressure range occurs.
8. A cuff pressure indicator for an artificial airway as defined in claim 7 further comprising:
said color scale thereon for continuously indicating the pressure in said sealing cuff comprising a green bar for indicating that the internal cuff pressure is within the normal limits; and
at least one red bar for indicating an abnormal pressure condition.
9. A cuff pressure indicator for an artificial airway as defined in claim 8 further comprising:
said green bar placed between two red bars;
an indicator defined by the distal edge of a semi-spiral cylinder sliding over another wall section of the same cylinder;
said semi-spiral cylinder increasing and decreasing in its diameter as a function of the expansion or contraction of said cylindrical pilot balloon; and
said cylinder shaped pilot balloon expanding and contracting as a function of its internal pressure corresponding to the relative cuff pressure.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/816,443 US20100242957A1 (en) | 2001-11-08 | 2010-06-16 | Combination Artificial Airway Device and Esophageal Obturator |
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US33909201P | 2001-11-08 | 2001-11-08 | |
US10/289,655 US7040322B2 (en) | 2001-11-08 | 2002-11-07 | Combination artificial airway device and esophageal obturator |
US11/368,881 US7762261B1 (en) | 2001-11-08 | 2006-03-06 | Combination artificial airway device and esophageal obturator |
US12/816,443 US20100242957A1 (en) | 2001-11-08 | 2010-06-16 | Combination Artificial Airway Device and Esophageal Obturator |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US11/368,881 Division US7762261B1 (en) | 2001-11-08 | 2006-03-06 | Combination artificial airway device and esophageal obturator |
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US12/816,443 Abandoned US20100242957A1 (en) | 2001-11-08 | 2010-06-16 | Combination Artificial Airway Device and Esophageal Obturator |
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US11/368,881 Expired - Fee Related US7762261B1 (en) | 2001-11-08 | 2006-03-06 | Combination artificial airway device and esophageal obturator |
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