ANATRAUMATICENDOTRACHEAL TUBE INTRODUCERANDATRAUMATIC INTUBATIONMETHODS
Background of the Invention
1. Technical Field The present invention pertains to the field of endotracheal intubation.
2. Related Art Endotracheal intubation is a procedure for creating an artificial airway in a patient by inserting an endotracheal tube ("ETT") into a patient's trachea through the patient's nose or mouth. Fiberoptic endotracheal intubation is an intubation technique that utilizes a fiberoptic endoscope ("fiberscope") to facilitate the proper placement or exchange of an ETT. A health care provider, using the direct visualization provided by the eyepiece of the fiberscope, directs the fiberscope, with an ETT pre-loaded ("piggy-backed") on the fiberscope's insertion cord, into a patient's trachea. Using the fiberscope as a guide wire, a distal tip of the ETT is then advanced over the fiberscope into the trachea between and beyond the vocal cords. In an endotracheal tube exchange, an in-place ETT in a patient is withdrawn over a tube exchanger that serves as a guide wire for its removal, and a fresh ETT is thereafter inserted into the patient's airway, by advancement over the tube exchanger, so that its distal tip passes between and beyond the vocal cords. When an ETT is advanced over the fiberscope or a tube exchanger, the distal tip of the ETT may impinge on the glottis, the epiglottis, the larynx, or other anatomy of the airway,
causing trauma and resisting further advancement into the trachea. The impingement of the ETT on the glottis, the epiglottis or the larynx has been attributed to a cleft that arises between the outer ETT that is concentric with either the inner guiding fiberscope or the inner guiding tube exchanger, over which the ETT rides. As the ETT is advanced along the fiberscope or tube exchanger, the cleft between them also advances, with a propensity for snaring tissues lying in its path. The present invention minimizes the risk of trauma to tissues in the course of fiberoptic intubation and ETT exchange by covering the offending cleft with an atraumatic, flexible shroud. The present invention also protects the vocal cords from trauma as the ETT is passed between them, particularly when vocal cord edema or mild stenosis is present, in both fiberoptic intubation and intubation performed with or without a laryngoscope to facilitate placement or exchange of an ETT. The present invention additionally offers advantages in both fiberoptic intubation and intubation performed with or without a laryngoscope to facilitate placement or exchange of an ETT, because of a streamlining effect created by the shroud that facilitates smooth insertion of the ETT. This advantage is especially important in difficult intubations when airway visibility is poor or when the opening between vocal cords through which the ETT must pass is very small.
Summary of the Invention The invention comprises a flexible endotracheal tube introducer ("introducer") for slidably removable disposition within an endotracheal tube ("ETT"), said introducer having a wall defining a lumen extending between a proximal end and a distal end of said introducer, said
wall having an outer diameter that is less than an inner diameter of said ETT, and said wall being circumscribed by an invertible shroud for distal-ward ("forward") flexion and proximal-ward ("rearward") flexion.
Brief Description of the Drawings
FIG. 1 is a schematic illustration of a flexible endotracheal tube introducer oriented for slidably removable disposition within an exemplary endotracheal tube.
FIG. 2 is a schematic illustration of a flexible endotracheal tube introducer.
FIG. 3 A is a schematic illustration of a shroud of a flexible endotracheal tube introducer in a first substantially frusto-conical shape.
FIG. 3B is a schematic illustration showing a longitudinal (sagittal) cross section of a first substantially frusto-conical shape of a shroud of a flexible endotracheal tube introducer.
FIG. 4A is a schematic illustration of a shroud of a flexible endotracheal tube introducer in a second substantially frusto-conical shape. FIG. 4B is a schematic illustration showing a longitudinal (sagittal) cross section of a second substantially frusto-conical shape of a shroud of a flexible endotracheal tube introducer.
FIG. 5 A shows a shroud of a flexible endotracheal tube introducer in an anteflexed, forward, or distal-ward conformation
FIG. 5B shows a shroud of a flexible endotracheal tube introducer in a retroflexed, rearward, or proximal-ward conformation
FIG. 6 is a schematic illustration of an exemplary endotracheal tube
FIG. 7A is a schematic illustration showing a flexible endotracheal tube introducer with its shroud in its anteflexed, forward or distal- ward conformation and having its proximal end placed within a lumen at a distal end of an endotracheal tube.
FIG. 7B is a schematic illustration showing a flexible endotracheal tube introducer advanced into an endotracheal tube so that a ring of the flexible endotracheal tube introducer apposes a beveled distal tip of the endotracheal tube.
FIG. 7C is a schematic illustration showing a shroud of a flexible endotracheal tube introducer flexed from its anteflexed, forward or distal- ward conformation to its retroflexed, rearward or proximal-ward conformation to cover a beveled tip and Murphy eye of an endotracheal tube. FIG. 7D is a schematic illustration showing a proximal end of a flexible endotracheal tube introducer fixed to a proximal end of an endotracheal tube using a fixation ring, thereby forming a combined endotracheal tube introducer-endotracheal tube unit. FIG. 7E is a schematic illustration showing a combined endotracheal tube introducer- endotracheal tube unit with a malleable stylet in place in a patient's airway. FIG. 7F is a schematic illustration showing a shroud of a flexible endotracheal tube introducer in its retro-flexed or proximal-ward position to cover a beveled tip and Murphy eye of an endotracheal tube, about to be withdrawn from an endotracheal tube.
FIG. 7G is a schematic illustration showing a shroud of a flexible endotracheal tube introducer in the process of being its anteflexed to its forward or distal- ard conformation as it is being withdrawn from an endotracheal tube.
FIG. 7H is a schematic illustration showing a shroud of a flexible endotracheal tube introducer in its anteflexed, forward or distal-ward conformation as it is being withdrawn f om an endotracheal tube.
FIG. 8 A is a schematic illustration of a combined introducer-ETT unit about to be advanced over a fiberscope.
FIG. 8B is a schematic illustration of a combined introducer-ETT unit piggy backed upon a fiberscope.
FIG. 8C is a schematic illustration of a combined introducer-ETT unit piggybacked upon a fiberscope and about to be advanced into a patient's airway. FIG. 9 A is a schematic illustration of an in-place ETT in a patient's airway.
FIG. 9B is a schematic illustration of an in-place ETT in a patient's airway, into which in-place
ETT a tube exchanger has been inserted.
FIG. 9C is a schematic illustration of in-place ETT having been withdrawn over a tube exchanger and removed from a patient's airway. FIG. 9D is a schematic illustration of a combined introducer-ETT unit about to be advanced over a tube exchanger into a patient's airway.
Detailed Description of the Invention As show in FIG. 1, the present invention comprises a flexible endotracheal tube introducer ("introducer") 100 for slidably removable disposition within an exemplary endotracheal tube ("ETT") 200, such as, for example, a No. 6.5, No. 7.0, No. 7.5 or No. 8.0 adult ETT.
As shown in FIG. 2, introducer 100 comprises a tubular member 109 having a longitudinal axis 111, and having a lumen 108, extending between a split proximal end 101 and a distal end 105 of tubular member 109 and defined by a cylindrical wall 107 that is circumscribed by a ring 112 to which there is invertibly attached a shroud 110. Cylindrical wall 107 of introducer 100 has an inner diameter of about 4.5 millimeters, a thickness of about 1 millimeter and an outer diameter of about 6.5 millimeters. Cylindrical wall 107 of introducer 100 has an outer diameter that is less than an inner diameter of exemplary ETT 200 (shown in FIG. 1). A first slit 103 in split proximal end 101 of tubular member 109 extends distal- ward for about 1.5 centimeters from a proximal opening 102 of tubular member 109. A second slit 104 in split proximal end 101 of tubular member 109 is generally parallel to first slit 103 and extends distal- ward for about 1.5 centimeters from proximal opening 102 of tubular member 109, beginning at a point on cylindrical wall 107 that is about 180 degrees away from first slit 103. Ring 112 is adherently fixed to tubular member 109 at a distance of about 4 centimeters from distal end 105 of tubular member 109. Ring 112 has a radial thickness of about 1 mm and a length of about 1 cm. FIG. 3A shows that shroud 110 may have a first substantially frusto-conical shape 117 that extends from a first circle 114 in a first plane that is perpendicular to longitudinal axis 111 of tubular member 109 (FIG. 1) and a second circle 115 in a second plane that is parallel to the first plane of first circle 114. Second circle of shroud 110 is generally coaxial with tubular member 109 (FIG. 1) and is unattached to tubular member 109 (FIG. 1).
FIG. 3b shows a longitudinal cross sectional view taken through first substantially f usto-conical shape 117 of shroud 110, appearing generally as a parallelepiped having proximal side 119, distal side 120, anterior side 121 and posterior side 122. In FIG. 3b, proximal side 119 measures about 6.5 millimeters, distal side 120 measures about 12 millimeters, anterior side 121 measures about 26 millimeters and posterior side 122 measures about 26 millimeters. FIG. 4A shows that shroud 110 may also have a second substantially frusto-conical shape 118 that extends from first circle 114 in a first plane that is perpendicular to longitudinal axis 111 of tubular member 109 (FIG. 1) to an ellipse 116 in a second plane that is either parallel or other than parallel to the first plane of first circle 114. Ellipse 116 is unattached to tubular member
109 (FIG. 1). FIG. 4B shows a longitudinal cross-sectional view taken through second substantially frusto-conical shape 118 of shroud 110, appearing generally as a parallelepiped having proximal side 123, distal side 124, anterior side 125 and posterior side 126. In FIG. 4B, proximal side 123 measures about 6.5 millimeters, distal side 124 measures about 13 millimeters, anterior sidel25 measures about 26 millimeters and posterior side 126 measures about 33 millimeters. Ring 112 (FIG. 2) may be manufactured, for example, from silicone, nylon or plastic, as a discrete structure to which shroud 110 is invertibly attached at first circle 114, or it maybe fashioned as an extruded cylinder that is a proximal-ward extension ("neck") of shroud 110 at first circle 114. Alternatively, ring 112 may be formed as a ring-like radial extrusion of tubular
member 109.
With ring 112 serving as a circumferential pivot about tubular member 109, shroud 110 may be inverted about ring 112 to assume two conformations: [i] an anteflexed, forward or distal- ward conformation; and, a [ii] a retroflexed, rearward or proximal-ward conformation. FIG. 5A shows shroud 110 in the anteflexed, forward or distal-ward conformation 110a. FIG. 5B shows shroud 110 in the retroflexed, rearward or proximal-ward conformation 110b. FIG. 6 shows an exemplary ETT 200 in greater detail, comprising an ETT tubular member 209 having an ETT lumen 208 for gas flow, defined by a cylindrical ETT wall 207, extending between a proximal opening 202 at a proximal ETT end 201 and a distal opening 204 at a distal ETT end 203 of ETT tubular member 209. Cylindrical wall 207 of ETT 200 has an inner diameter that is greater than the outer diameter of introducer 100 (FIG. 2). Inflatable cuff or balloon 213 circumscribes ETT tubular member 209 adjacent distal ETT end 203 and communicates with an inflation port 211 via inflation tubing 212. Proximal end 201 of tubular member 209 is adapted to receive a connector piece 210 into which tubing (not shown in FIG. 6) for gas flow to a patient may be attached. Distal ETT end 203 of ETT tubular member 209 terminates in a beveled tip whose shorter terminus 205 defines the anterior aspect of ETT 200. A Murphy eye 206 is fashioned into cylindrical wall 207 of ETT tubular member 209 adjacent distal end 203 to provide an alternative pathways for gas flow to a patient should distal opening 204 of ETT tubular member 209 become occluded. In an orotracheal intubation, introducer 100 is grasped with shroud 110 in its anteflexed, forward or distal- ward position 110a, as shown in FIG. 7A. Split proximal end 101 of introducer 100 is placed within ETT lumen 208 at distal end 203 of ETT 200 (FIG. 7A) and advanced into
ETT 200 until a proximal end of said invertibly attached shroud, such as ring 112 of introducer 100, apposes beveled distal tip 205 of ETT 200, as shown in FIG. 7B. Shroud 110 is then manually flexed from its anteflexed, forward or distal-ward position 110a to its retroflexed, rearward or proximal-ward position 110b to cover beveled tip 205 and Murphy eye 206 of ETT 200, as shown in FIG. 7C. Split proximal end 101 of introducer 100 is then fixed to proximal end 201 of ETT 200 by everting the split halves of proximal end 101 of introducer 100 over proximal end 201 of ETT 200, as shown in FIG. 7D, and using, for example, surgical tape (not shown in FIG. 7D) or a fixation ring 113, to stabilize the alignment of the respectively shrouded distal ends 105 and 203 of introducer 100 and ETT 200, now combined as introducer-ETT unit 400, the proximal aspect of which is shown in FIG. 7D. Lubrication must be generously applied between shroud 110 of introducer 100 and distal end 203 of ETT 200 to prevent sticking during subsequent withdrawal of introducer 100 from lumen 208 of ETT 200. A malleable stylet 300, shown in FIG. 7E, is inserted into lumen 108 of introducer 100, now forming combined introducer-ETT unit 400. Combined introducer-ETT unit 400 is advanced into a patient's airway 500, as shown in FIG. 7E , to place the shrouded end of combined introducer-ETT unit 400 between and beyond the patient's vocal cords (not shown in FIG. 7E). Surgical tape or fixation ring 113 is now removed and introducer 100 is withdrawn from
ETT 200. During the withdrawal of introducer 100 from ETT 200, shroud 110 is anteflexed to forward, distal-ward conformation 110a by the sliding motion of distal end 203 of ETT 200
relative to wall 107 of introducer 100, as shown in sequential FIGs. 7F through 7G, when viewed from left to right. In a nasal intubation, introducer 100 is grasped with shroud 110 in its anteflexed, forward or distal-ward position 110a, as shown in FIG. 7A. Split proximal end 101 of introducer 100 is placed within ETT lumen 208 at distal end 203 of ETT 200 (FIG. 7A) and advanced into ETT 200 until a proximal end of invertibly attached shroud 110, such as ring 112 of introducer 100, apposes beveled distal tip 205 of ETT 200, as shown in FIG. 7B. Shroud 110 is then manually flexed from its anteflexed, forward or distal-ward position 110a to its retroflexed, rearward or proximal-ward position 110b to cover beveled tip 205 and Murphy eye 206 of ETT 200, as shown in FIG. 7C. Split proximal end 101 of introducer 100 is then fixed to proximal end 201 of ETT 200 by everting the split halves of proximal end 101 of introducer 100 over proximal end 201 of ETT 200, as shown in FIG. 7D, and using, for example, surgical tape (not shown in FIG. 7D) or a fixation ring 113, to stabilize the alignment of the respectively shrouded distal ends 105 and 203 of introducer 100 and ETT 200, now combined as introducer-ETT unit 400, the proximal aspect of which is shown in FIG. 7D. Lubrication must be generously applied between shroud 110 of introducer 100 and distal end 203 of ETT 200 to prevent sticking during subsequent withdrawal of introducer 100 from lumen 208 of ETT 200. Combined introducer-ETT unit 400 is advanced into a patient's nostril and thence into the patient's nasopharynx until combined introducer-ETT unit 400 is visualized through the patient's mouth in the patient's oropharynx. Thereafter, the shrouded distal end of combined introducer- ETT unit 400 is grasped with a forceps introduced through the patient's mouth and thence
directed so as to place the shrouded distal end of combined introducer-ETT unit 400 between and beyond the patient's vocal cords (not shown in FIG. 7E). Surgical tape or fixation ring 113 is now removed and introducer 100 is withdrawn from ETT 200. During the withdrawal of introducer 100 from ETT 200, shroud 110 is anteflexed to forward, distal-ward conformation 110a by the sliding motion of distal end 203 of ETT 200 relative to wall 107 of introducer 100, as shown in sequential FIGs. 7F through 7G, when viewed from left to right. h an intubation using a fiberscope, introducer 100 is grasped with shroud 110 in its anteflexed, forward or distal-ward position 110a, as shown in FIG. 7A. Split proximal end 101 of introducer 100 is placed within ETT lumen 208 at distal end 203 of ETT 200 (FIG. 7A) and advanced into ETT 200 until a proximal end of invertibly attached shroud 110, such as ring 112 of introducer 100, apposes beveled distal tip 205 of ETT 200, as shown in FIG. 7B. Shroud 110 is then manually flexed from its anteflexed, forward or distal- ward position 110a to its retroflexed, rearward or proximal-ward position 110b to cover beveled tip 205 and Murphy eye 206 ofETT 200, as shown in FIG. 7C. Split proximal end 101 of introducer 100 is then fixed to proximal end 201 of ETT 200 by everting the split halves of proximal end 101 of introducer 100 over proximal end 201 of ETT 200, as shown in FIG. 7D, and using, for example, surgical tape (not shown in FIG. 7D) or a fixation ring 113, to stabilize the alignment of the respectively shrouded distal ends 105 and 203 of introducer 100 and ETT 200, now combined as introducer-ETT unit 400, the proximal aspect of which is shown in FIG. 7D. Lubrication must be generously applied between shroud 110 of introducer 100 and distal end 203 of ETT 200 to prevent sticking during subsequent withdrawal
of introducer 100 from lumen 208 of ETT 200As shown in FIG. 8 A, a fiberscope 600 is then inserted within lumen 108 of introducer 100, now forming combined introducer-ETT unit 400. With introducer-ETT unit 400 effectively "piggy-backed" upon fiberscope 600, as shown in FIG. 8B, fiberscope 600 is introduced into a patient's airway and is used to identify the patient's carina. Having identified the patient's carina, combined introducer-ETT unit 400 is advanced over fiberscope 600, using fiberscope 600 as a guide wire, (FIG. 8C) so as to place the shrouded distal end of combined introducer-ETT unit 400 between and beyond the patient's vocal cords (not shown in FIG. 8C). Surgical tape or fixation ring 113 is now removed and introducer 100 is withdrawn from ETT 200. During the withdrawal of introducer 100 from ETT 200, shroud 110 is anteflexed to forward, distal-ward conformation 110a by the sliding motion of distal end 203 of ETT 200 relative to wall 107 of introducer 100, as shown in sequential FIGs. 7F through 7G, when viewed from left to right. h an endotracheal tube exchange, introducer 100 is grasped with shroud 110 in its anteflexed, forward or distal-ward position 110a, as shown in FIG. 7A. Split proximal end 101 of introducer 100 is placed within ETT lumen 208 at distal end 203 of ETT 200 (FIG. 7A) and advanced into ETT 200 until a proximal end of invertibly attached shroud 110, such as ring 112 of introducer 100, apposes beveled distal tip 205 of ETT 200, as shown in FIG. 7B. Shroud 110 is then manually flexed from its anteflexed, forward or distal-ward position 110a to its retroflexed, rearward or proximal- ward position 110b to cover beveled tip 205 and Murphy eye 206 of ETT 200, as shown in FIG. 7C.
Split proximal end 101 of introducer 100 is then fixed to proximal end 201 of ETT 200 by everting the split halves of proximal end 101 of introducer 100 over proximal end 201 of ETT 200, as shown in FIG. 7D, and using, for example, surgical tape (not shown in FIG. 7D) or a fixation ring 113, to stabilize the alignment of the respectively shrouded distal ends 105 and 203 of introducer 100 and ETT 200, now combined as introducer-ETT unit 400, the proximal aspect of which is shown in FIG. 7D. Lubrication must be generously applied between shroud 110 of introducer 100 and distal end 203 of ETT 200 to prevent sticking during subsequent withdrawal of introducer 100 from lumen 208 of ETT 200. By analogy with the use of fiberscope 600, a tube exchanger 700 is now inserted into an in-place ETT 200x within a patient's airway 500 to serve as a guide wire for removal of in-place
ETT 200x (FIG. 9A and FIG. 9B). In-place ETT 200x is withdrawn over tube exchanger 700 (FIG. 9C) and thereafter combined introducer-ETT unit 400 is advanced over tube exchanger 700, using tube exchanger 700 as a guide wire (FIG. 9D), so as to place the shrouded distal end of combined introducer-ETT unit 400 between and beyond the patient's vocal cords (not shown in FIGs. 9A - 9D). Surgical tape or fixation ring 113 is now removed and introducer 100 is withdrawn from ETT 200. During the withdrawal of introducer 100 from ETT 200, shroud 110 is anteflexed to forward, distal-ward conformation 110a by the sliding motion of distal end 203 of ETT 200 relative to wall 107 of introducer 100, as shown in sequential FIGs. 7F through 7G, when viewed from left to right, leaving said ETT 200 properly positioned in the patient's trachea.